Immi1kservice A1

IMMULITE & IMMULITE 1000 Service Manuals
and
Assembly/Schematic Drawings
Document Number: 600797

Revision A1
January 2007
Copyright 1991 by Siemens Medical Solutions Diagnostics. All rights reserved.

Copyright 1991 by Siemens Medical Solutions Diagnostics. All rights reserved.
This manual, and the software described in this manual, is copyrighted. No part of this manual or the described
software may be copied, reproduced, translated or reduced to any electronic medium or machine-readable form
without the prior written consent of Diagnostic Products Corporation except that you may make one copy of the
program CD solely for back-up purposes.
IMMULITE is registered trademark of Siemens Medical Solutions Diagnostics.

All other products mentioned are trademarks of their respective companies.
Siemens Medical Solutions Diagnostics

Certificate No: UQA0113493
Siemens Diagnostics quality products are manufactured under a quality

system that is registered to ISO 13485:2003.
IMMULITE Table of Contents
CHAPTER 1: GENERAL INFORMATION................................................................................................. 1-1
1.1 IMMULITE HISTORY ................................................................................................................................ 1-1
1.2 HOW TO USE THIS MANUAL ....................................................................................................................... 1-1
1.3 IMMULITE PRODUCT DESCRIPTION ......................................................................................................... 1-2
1.4 SYSTEM COMPONENTS ............................................................................................................................... 1-3
1.5 HOW IT WORKS .......................................................................................................................................... 1-5
1.6 SAFETY CONSIDERATIONS .......................................................................................................................... 1-6
1.7 SYMBOL DEFINITIONS ................................................................................................................................ 1-7
1.8 CONTACT INFORMATION .......................................................................................................................... 1-11
1.8.1 Technical Service......................................................................................................................... 1-11
CHAPTER 2: INSTALLATION..................................................................................................................... 2-1
2.1 REQUIREMENTS .......................................................................................................................................... 2-1
2.2 INSTRUMENT SET-UP .................................................................................................................................. 2-1
2.3 TESTING THE WATER .................................................................................................................................. 2-3
CHAPTER 3: THEORY OF OPERATION .................................................................................................. 3-1
3.1 INTRODUCTION ........................................................................................................................................... 3-1
3.2 OVERVIEW OF TEST PROCESS ..................................................................................................................... 3-1
3.3 INTERNAL CALCULATIONS ......................................................................................................................... 3-2
3.4 THE CHEMILUMINESCENT REACTION ......................................................................................................... 3-4
3.5 PRIMARY MODULES ................................................................................................................................... 3-6
3.5.1 Introduction ................................................................................................................................... 3-6
3.5.2 Incubator Carousel......................................................................................................................... 3-6
3.5.3 Load Chain .................................................................................................................................... 3-8
3.5.4 Luminometer................................................................................................................................ 3-10
3.5.5 Pipettor / Reagent Carousel ......................................................................................................... 3-13
3.6 SECONDARY MODULES ............................................................................................................................ 3-17
3.6.1 Introduction ................................................................................................................................. 3-17
3.6.2 Power Supply Chassis.................................................................................................................. 3-17
3.6.3 PMT (Photomultiplier Tube) and Pre-scaler/Power Supply ........................................................ 3-19
3.6.4 Substrate and Water Injector Pumps............................................................................................ 3-20
3.6.5 Substrate Heater........................................................................................................................... 3-22
3.6.6 Substrate Reservoir...................................................................................................................... 3-23
3.6.7 Syringe Pumps ............................................................................................................................. 3-24
3.6.8 Sample Collection Tray ............................................................................................................... 3-29
3.7 FLUIDICS .................................................................................................................................................. 3-30
3.7.1 Description................................................................................................................................... 3-30
3.7.2 Pipetting Sequence....................................................................................................................... 3-32
3.8 INSTRUMENT TEMPERATURES .................................................................................................................. 3-34
3.8.1 General Information..................................................................................................................... 3-34
3.8.2 Viewing Temperatures................................................................................................................. 3-36
3.8.3 Heater and Cooler Shutdown....................................................................................................... 3-38
3.8.4 Temperature Controller Status Indicators.................................................................................... 3-39
3.8.5 Effectively Troubleshooting Temperature Problems................................................................... 3-40
3.9 IMMULITE SOFTWARE PROGRAMS ........................................................................................................ 3-44
CHAPTER 4: PRINTED CIRCUIT BOARDS .................................................................................................... 4-1
4.1 INTRODUCTION ........................................................................................................................................... 4-1
4.2 CPU/SENSOR PCB ..................................................................................................................................... 4-1
4.3 STEPPER MOTOR DRIVER #1....................................................................................................................... 4-2
IMMULITE Service Manual 600797-A1 i

4.5 HEATER/DC MOTOR PCB .......................................................................................................................... 4-4
CHAPTER 5: SPECIFICATIONS ................................................................................................................. 5-1
CHAPTER 6: PREVENTIVE MAINTENANCE (PM)................................................................................ 6-1

6.1 DESCRIPTION .............................................................................................................................................. 6-1
6.2 GENERAL CHECKOUT ................................................................................................................................. 6-2
6.3 POWER SUPPLY........................................................................................................................................... 6-2
6.4 SYRINGE MODULE ...................................................................................................................................... 6-2
6.5 PIPETTOR/REAGENT CAROUSEL MODULE .................................................................................................. 6-4
6.6 LUMINOMETER MODULE ............................................................................................................................ 6-5
6.7 MAIN CAROUSEL MODULE ......................................................................................................................... 6-6
6.8 LOAD PLATFORM/SAMPLE TRAY MODULE ................................................................................................. 6-6
6.9 SOLENOID OR LINEAR ACTUATOR SUBSTRATE AND WATER WASH PUMPS ................................................ 6-7
6.10 SUBSTRATE MODULE ................................................................................................................................. 6-8
6.11 FLUIDICS .................................................................................................................................................... 6-8
6.12 COMPUTER SOFTWARE ............................................................................................................................... 6-8
6.13 TEMPERATURES .......................................................................................................................................... 6-9
6.14 FINAL CHECKOUT & CUSTOMER SATISFACTION......................................................................................... 6-9
CHAPTER 7: REPAIR INFORMATION ..................................................................................................... 7-1
7.1 TOOLS AND EQUIPMENT ............................................................................................................................. 7-1
7.2 THE CONFIGURATION TABLE...................................................................................................................... 7-2
7.3 REMOVAL AND REPLACEMENT OF ASSEMBLIES ......................................................................................... 7-9
7.3.1 General Information .................................................................................................................... 7-9
7.3.2 Reagent Carousel Assembly / TED Cooler............................................................................. 7-9
7.3.3 Sample Collection Tray Assembly.......................................................................................... 7-10
7.3.4 Syringe Pump Assembly.......................................................................................................... 7-11
7.3.5 Main Incubator Carousel Ring Gear Assembly .................................................................... 7-11
7.3.6 Load Platform Assembly .......................................................................................................... 7-12
7.3.7 Sample/Test Unit Barcode Reader Assembly ...................................................................... 7-13
7.3.8 Injector Pump Assembly .......................................................................................................... 7-15
7.3.9 Substrate Heater Assembly..................................................................................................... 7-15
7.3.10 Substrate Reservoir Assembly................................................................................................ 7-15
7.3.11 High Speed Spinner Motor and Drive Wheel Assembly ..................................................... 7-16
7.3.12 Tube Shuttle Upper Slide Bearing Assembly........................................................................ 7-17
7.3.13 Tube Shuttle Idler Wheel Assembly ....................................................................................... 7-17
7.3.14 Luminometer Casting Cover / Attenuator Motor and Belt ................................................... 7-18
7.3.15 Power Supply Module .............................................................................................................. 7-19
7.3.16 Replacement of the Chain Assemblies.................................................................................. 7-20
7.4 MISCELLANEOUS PROCEDURES ................................................................................................................ 7-25
7.4.1 Testing the Water Supply......................................................................................................... 7-25
7.4.2 System Decontamination ......................................................................................................... 7-30
7.4.3 Substrate Spike Replacement................................................................................................. 7-31
7.4.4 Fluidic Valve Testing ................................................................................................................ 7-32
7.4.5 Use of Pip-X Position Gauges (kit p/n 420078).................................................................... 7-36
7.4.6 Load Chain and Star Wheel Positioning................................................................................ 7-37
7.4.7 Spacing of the Sample Tube Guides ..................................................................................... 7-39
7.4.8 Sample/Assay Test Unit Barcode Motor Speed Adjustment .............................................. 7-40
7.4.9 Tuning the Sample/Test Unit Barcode Reader PCB P/N 450056 .................................. 7-40
7.4.10 HIGH SPEED SPINNER MOTOR ADJUSTMENT ............................................................................................. 7-41
7.4.11 BARCODE LASER SCANNER REPROGRAMMING .......................................................................................... 7-41
7.4.12 PROCEDURE TO REPLACE DATABASE COMPONENTS ............................................................................ 7-44
7.4.13 FIXING OR RESTORING A DATABASE .................................................................................................... 7-45
7.4.14 CHECKING THE ERROR LOG .................................................................................................................. 7-46
ii 600797-A1 IMMULITE Service Manual

7.4.15 TROUBLESHOOTING THE SYSTEM STEPPER MOTORS ............................................................................ 7-48
CHAPTER 8: DIAGNOSTICS ....................................................................................................................... 8-1
8.1 GENERAL INFORMATION ............................................................................................................................ 8-1
8.1.1 Investigate .................................................................................................................................... 8-1
8.1.2 Power............................................................................................................................................ 8-1
8.1.3 The Message Tables .................................................................................................................. 8-2
8.1.4 Loading the Correct Message Tables (versions 4.1 software and earlier)......................... 8-2
8.2 USING THE DIAGNOSTICS ........................................................................................................................... 8-3
8.3 RUNNING GETDATAT ............................................................................................................................. 8-6
8.4 RUNNING PC OR PCSTAT .................................................................................................................. 8-8
8.5 MAIN DIAGNOSTIC PROGRAMS................................................................................................................... 8-9
8.6 SYSTEM CONFIGURATIONS PROGRAMS .................................................................................................... 8-20
8.7 SYSTEM CONFIGURATION DIAGNOSTICS ERROR CODES ........................................................................... 8-27
CHAPTER 9: TROUBLESHOOTING .......................................................................................................... 9-1
9.1 DESCRIPTION .............................................................................................................................................. 9-1
9.2 TROUBLESHOOTING TECHNIQUES ............................................................................................................... 9-1
9.3 TYPICAL PROBLEMS ................................................................................................................................... 9-4
9.4 ERROR MESSAGE TABLE .......................................................................................................................... 9-14
CHAPTER 10: SPARE PARTS ...................................................................................................................... 10-1
GENERAL INFORMATION ...................................................................................................................................... 10-1
10.1 IMMULITE FIELD PARTS TO CARRY AT ALL TIMES ............................................................................... 10-1
10.2 IMMULITE SPARE PARTS INVENTORY FOR REGIONAL OFFICES ............................................................. 10-3
10.3 HAMILTON TUBING KIT (P/N 400305) ..................................................................................................... 10-5
10.4 EURO TUBING KIT (P/N 400306).............................................................................................................. 10-5
CHAPTER 11: FLUIDICS, CHASSIS AND ISOMETRIC DRAWINGS....................................................... 11-1
INDEX
IMMULITE Service Manual 600797-A1 iii

iv 600797-A1 IMMULITE Service Manual
Chapter 1: General Information
1.1 IMMULITE History

The company that conceived the IMMULITE was founded in 1987 by Dr. Arthur Babson and began
operations in 1988 in a rented classroom of the old Williamson School building in Chester, NJ. The
company started as Babson Technologies, was renamed Pegasus Technologies, and then was
renamed to Cirrus Diagnostics in 1990.
By the end of 1988, a breadboard immunoassay analyzer was completed. It was on this instrument that
many of the basic concepts of IMMULITE were developed and tested.
In 1990, three prototypes called the "A" series IMMULITE systems were built. One of these was shown
at the AACC meeting in July 1990. Although these systems incorporated many of the functions of the
breadboard, the layout was a radical departure. In the next year and a half, these instruments were used as
workhorses to further develop the hardware, software, and chemistry. At this time, the company had
approximately 20 people and had now expanded to four classrooms in the school building.
During the last half of 1991, 12 "B" series IMMULITE systems were produced. These were to be used
for beta site placements and in-house research and development. On July 17, 1991 instrument "B1" was
placed in Morristown Hospital as the company's first beta site instrument. During the next five months,
four more instruments were placed at beta sites in the New York City area.
On March 23, 1992, Instrument "B2" was placed at Diagnostic Products Corporation for evaluation. DPC
liked the IMMULITE so much that 60 days later, Cirrus Diagnostics became DPC Cirrus, a wholly
owned subsidiary of Diagnostic Products Corporation.
During the last half of 1992, 25 "C" series IMMULITE systems were produced by an instrumentation
manufacturing company located very close to DPC Cirrus. At this time, DPC Cirrus was still located in
the school building in Chester, NJ, had 33 employees, and occupied nine classrooms.
In December 1992, DPC Cirrus moved into a new building in Randolph, NJ and began to manufacture the
IMMULITE system in-house beginning with the "D" series.
Production volume continued to grow throughout the 1990s, and International Distribution of the
IMMULITE (and also the IMMULITE 2000, released in 1997) have been increasing ever since.
In late 2001, DPC Cirrus changed its name to DPC Instrument Systems Division, and established its
own newly built 80,000 Sq. Ft. Manufacturing Facility in Flanders, NJ, with plenty of room for future
expansion.
In July 2006, DPC was acquired by Siemens Medical Solutions. In January 2007, DPC was merged with
Bayer Diagnostics (also acquired by Siemens Medical Solutions) to form Siemens Medical Solutions
Diagnostics, a wholly owned subsidiary of Siemens Medical Solutions USA, Inc..
1.2 How to Use This Manual

This manual contains basic information necessary for after-sales service of the IMMULITE system. This
information is vital to the service person for maintaining high quality and reliable performance of the
system.
This manual is applicable to all IMMULITE Analyzer systems using version 4.3 software or later.
IMMULITE Service Manual 600797-A1 1-1

The IMMULITE Service Manual is designed solely for use by authorized IMMULITE service personnel.
Authorized IMMULITE service personnel are skilled in the areas of electronics, mechanical devices and
basic computer know how, and have attended the IMMULITE Service Training Seminar. Only personnel
so authorized should attempt the procedures in this manual.
Each area or module of the system will be covered including description, possible adjustments, diagnostic
programs, problems, and probable causes. Subjects such as troubleshooting down to the component level
on the circuit boards are not covered because the expertise required and the investment in special tools
and equipment make such tasks uneconomical.
A thorough understanding of the IMMULITE, based on information contained in this manual, the
operators manual, and the Service Information Bulletins is the only way to quickly locate the cause of
malfunctions and to repair them. A lesser understanding will slow servicing and could result in expensive
and even dangerous mistakes. Since knowledge of the IMMULITE is the best "tool" for diagnosing
problems, this manual will take more of an educational approach.
Information in this manual is subject to change as system elements are improved (and possibly re-
designed) and as procedures that are more effective are developed. All relevant information in such cases
will be supplied in Service Information Bulletins.
When diagnosing a problem on the IMMULITE, keep the following points in mind:
1. Aside from the software, the IMMULITE is not much different from any other electro-mechanical
device.
2. When diagnosing a problem, follow the Troubleshooting Techniques in the Troubleshooting section
of this manual. These techniques are tried and true and, if applied correctly, will significantly reduce
the time spent on diagnosing problems encountered with the system.
3. Repair the problem not the symptom, and replace only what is necessary.
1.3 IMMULITE Product Description
The IMMULITE Automated Immunoassay Analyzer is a random access instrument dedicated to

performing chemiluminescent immunoassays and immunometric assays. The system is built around a
proprietary Test Unit that provides for rapid and efficient washing of the captive antibody-coated bead by
spinning the Test Unit on its vertical axis. Sample, excess reagent, and wash solution are captured in a
coaxial waste chamber integral within the Test Unit.
The IMMULITE Systems utilize assay-specific, antibody-coated plastic beads as the solid phase, in a
specially designed Test Unit. This Test Unit serves as the reaction vessel for the immune reaction,
incubation, wash, and signal development. Light emission from the chemiluminescent substrate reacting
with enzyme conjugate bound to the bead is proportional to the amount of analyte originally present in the
patient sample.
The IMMULITE System is automated with respect to sample and conjugate handling, incubation,
washing, and substrate addition. A photomultiplier tube detects the light emission, and the systems on-
board computer generates printed reports for each sample.
Accordingly, basic operation is simple. Load a sample cup into a barcoded sample cup holder, place it on
the loading platform followed by up to five barcoded Test Units in any order; then load the barcoded
Reagent Wedges appropriate for each test. The IMMULITE System takes care of the rest.
1-2 600797-A1 IMMULITE Service Manual

1.4 System Components
A diagram of the IMMULITE Display Panel is shown below. Diagrams showing an overhead and side
view of the IMMULITE Analyzer appear on pages 1-4 and 1-5.
The Display Panel (located on the front of the instrument) displays IMMULITE instructions and error
messages. There are three buttons on the Display Panel (ALARM MUTE, PAUSE, and GO), which are
referred to throughout this manual.
The IMMULITE Display Panel buttons are explained in the table below:
Button Function
ALARM MUTE In the Run mode, it silences the audible alarm.
In Diagnostic modes, it is used to pause a motor movement. It
is also used in conjunction with the GO button to cancel a
diagnostic program.
PAUSE Temporarily stops pipetting and Load Chain movements only.
Shuts down the IMMULITE when pressed repeatedly.
Note: Using PAUSE to shut down the instrument ensures all parts
are in the home position.
GO In the Run mode, it activates the initialization (start-up)
procedure and the accompanying instructional messages
appearing on the Display Panel.
It also activates a reading of the Reagent Wedge barcodes if the
instrument is in pause mode when GO is pressed.
In Diagnostic modes, it activates the GO command for the
loaded diagnostic program. It is also used in conjunction with
the ALARM MUTE button to cancel a diagnostic program.

IMMULITE Analyzer Overhead View

IMMULITE Analyzer Side View
TEST UNIT
WASTE EXIT
1.5 How it Works

The IMMULITE System utilizes assay-specific, antibody, or antigen-coated plastic beads as the solid
phase, alkaline phosphatase-labeled reagent, and a chemiluminescent enzyme substrate. The bead is
housed in a proprietary Test Unit. This Test Unit serves as the reaction vessel for the immune reaction,
the incubation, and washing processes, and the signal development.
The IMMULITE System automates the entire assay process. After incubating the sample with the
alkaline phosphatase reagent, the liquid reaction mixture in the Test Unit is rapidly separated from the
bead when the bead is washed and the Test Unit is spun at a high speed on its vertical axis. The entire
fluid contents (the sample, excess reagent, and wash solution) are transferred to a coaxial waste chamber
in the Test Unit. The bead is left with no residual, unbound label. The bound label is then quantitated
with a dioxetane substrate, which produces light. The photomultiplier tube (PMT) detects the light
emission, and the system's computer generates printed reports for each sample.
The IMMULITE test process is outlined in Section 3.2.
The IMMULITE has two operating modes: Standard and Turbo. The Turbo mode essentially operates the
same as the Standard mode, except the time to first result is faster. This allows for true STAT
functionality for urgent situations such as cardiac markers or pregnancy detection. This manual covers
both modes of operation concurrently since they are identical, except for speed of tube transport.
Note: Different assay kits are required for each mode. Standard (Non-Turbo) kits cannot be run
while in Turbo mode and Turbo kits cannot be run while in Standard (Non-Turbo) mode.

1.6 Safety Considerations
** Service Personnel should be aware that if this equipment is used in a manner not
specified by the Manufacturer, then the protection provided by the equipment may be
impaired.
All service personnel must read and understand these safety procedures before working with this system.
WARNING and CAUTION instructions must be observed during servicing of the IMMULITE. These
are defined as follows:
WARNING: Given where failure to observe its instruction can result in injury or death to the operator or
service personnel.
CAUTION: Given where failure to observe its instruction can result in permanent damage to the
equipment.
The following WARNINGS are provided to avoid bodily injury:
1. Application of the incorrect AC power input voltage could cause an explosion, fire, or electrical
shock that may injure the operator or damage the equipment permanently.
2. Ensure that the AC power receptacle has the voltage and power rating specified for the
instrument. Use of an AC power receptacle with incorrect voltage and power rating could
overload a circuit and produce fire and electrical shock hazards.
3. Never use a three-conductor to two-conductor adapter to connect primary AC power to the any of
the IMMULITE components or test equipment. Use of an adapter disconnects the utility ground
and allows reversal of the live and neutral lines. A severe shock hazard could exist which could
cause severe injury or death. Use only a three-conductor connector and three-conductor grounded
receptacle to connect primary AC power to the IMMULITE and its components.
4. Do not assume AC power is removed from equipment when the power switch is off. Some
portions of the power supply chassis still contain power whenever the unit is connected to the AC
power receptacle.
5. Do not assume all AC power is removed from the equipment when any one of the IMMULITE
fuses is blown. Always switch the AC power off and disconnect the power cable from the
IMMULITE before attempting to replace fuses.
6. Since the instrument is used with patient specimen, all necessary precautions should be taken to
avoid transfer of infectious diseases.
The following CAUTIONS are provided to avoid instrument damage:
1. Use replacement fuses with the required current rating and specifications. Makeshift fuses, fuses
with higher current rating than specified, or short-circuiting of fuse holders may cause fire or
damage to the instrument.
2. Do not remove or replace cables or printed circuit boards when the instrument power is on.
Electrical transients created by connecting or disconnecting cables and printed circuit boards with
power applied can severely damage the instrument components. Always switch the AC power
off before disconnecting or connecting any components or cables.

1.7 Symbol Definitions
The following symbols may be seen on the IMMULITE Analyzer, or on related
documentation.
Symbol Definition
Consult instructions for use
Do not re-use
Fragile, handle with care.
Caution, refer to accompanying

documents
Batch code
Catalog number
Serial number

Symbol Definition
Use by (expiration date)
Sterile
Sterilized using aseptic

processing techniques
Sterilized using radiation
Sterilized using ethylene oxide
Sterilized using steam or dry

heat
Biological risk
Non-sterile
Do not re-sterilize
Keep away from heat
Keep dry

Symbol Definition
Protect from heat and
radioactive source
Lower limit of temperature
Temperature limitation
Upper limit of temperature
Control
Negative control
Positive control
Date of manufacture
Do not use if package is

damaged
In vitro diagnostic medical

device
Manufactured by

Symbol Definition
Authorized Representative
Contains sufficient for <X>

tests
For Performance Evaluation

only
European Community
Representative

1.8 Contact Information
Siemens Diagnostics is headquartered in Tarrytown, NY and Los Angeles, CA.
Siemens Medical Solutions Diagnostics Siemens Medical Solutions Diagnostics
511 Benedict Avenue 5210 Pacific Concourse Drive
Tarrytown, NY 10591-5097 Los Angeles, CA 90045-6900
U.S.A. U.S.A.
1.8.1 Technical Support

For questions regarding the IMMULITE System or its reagents, or for further information on this Service
Manual, contact Siemens Diagnostics Technical Support or your National Distributor.
Domestic
Tel: 1-800-372-1782
Fax: 1-866-466-8548
International
Tel: 1-973-927-2828
Fax: 1-973-927-4101

Chapter 2: Installation
Upon receipt of the IMMULITE Analyzer system, visually inspect the exterior of the shipping container
for damage. If there is any external damage to the container, notify your shipping department and contact
Siemens Diagnostics Technical Support.
2.1 Requirements
Electrical
Use of a dedicated, grounded service for the IMMULITE Analyzer, computer, monitor, and printer is
strongly recommended.
Use of an Uninterruptible Power Supply (UPS) or line conditioner is also strongly recommended.
Do not place the system near centrifuges, ultrasound or X-ray machinery, NMR scanners, or other
sources of magnetic fields.
Space
The IMMULITE must be placed on a flat, clean, horizontal surface.
The instrument requires a bench space of 75 inches (191 cm) across by 30 inches (76 cm) deep, with
any overhead cabinets at least 22 inches (56 cm) above the bench.
Environment
Ambient temperature should be between 65F - 86F (18C - 30C), Humidity 20-80% (no
condensation).
Do not place the IMMULITE system in direct sunlight.
Do not install the IMMULITE near heating or air conditioning vents or equipment.
2.2 Instrument Set-up

1. Set the IMMULITE on a bench containing at least the space specified above and the strength to
support the weight of the System and its components.
2. For ease of use, set the computer, monitor, and printer to the right side of the IMMULITE. Allow
enough room for the test unit waste container on the right of the analyzer, and Probe Wash and Water
containers on the left. NOTE: If the computer must be mounted on the left side of the instrument, the
standard RS232 cable may not be long enough. In this case, the optional 8-ft cable (P/N 400115-02)
will have to be ordered.
3. Set up the computer, monitor, laser scanner, and printer (make sure paper and ribbon are installed in
printer). For simplicity, attach all cables to the back of the computer first, specifically the gray
RS232 (plugs into serial port "A") communication cable for the IMMULITE, and the printer cable.
4. Plug the other side of the RS232 communication cable into the RS232 port located on the right side of
the IMMULITE toward the rear.

5. Check to insure that the IMMULITE power switch is in the OFF position.
6. Plug all the power cords from the IMMULITE system (IMMULITE, computer, monitor, and printer)
into the line conditioner or optional Uninterruptible Power Supply (UPS). Using cable ties, hank the
cables to eliminate electrical noise and provide a neat look.
Note: Do not turn on the IMMULITE power switch until instructed to do so.
7. Plug the optional Uninterruptible Power Supply (UPS) or line conditioner into the power outlet and
turn it on. NOTE: A dedicated electric power line is strongly recommended to reduce the effects of
electrical noise produced by other instruments.
8. Remove all the shipping tape from the IMMULITE, including the pipettor and its base, the sample
collection tray, the reagent tray, and the main carousel.
9. Install the gas struts by pressing the end of the strut onto the ball studs, then pressing in firmly to lock
them.
10. Install the syringes, with the large syringe on the left, and the small one on the right. Insert each
syringe into the luer lock fitting, and twist them to tighten. Thread in the thumbscrews into the
bottom of the plungers, and tighten.
11. Loosen the screws that hold down the cover for the printed circuit board compartment. Lift the cover,
and gently lift and reseat each of the four (4) printed circuit boards.
12. Turn the IMMULITE power switch to "on. The systems power is brought up safely in stages.
(Initially, the chirp of the +/- 5v & +/- 12v logic will first be heard.) After approximately 15
seconds, the syringes should "home" - that is, they should move to the top. If already there, they will
both move up a bit more to confirm home. This is desired, and confirms initiation of full 24v system
supply. If this does not happen, there are likely troubles of syringe module connections, or the 24v
supply itself.
13. Turn the power on to the computer, monitor, and printer.
14. Once the Start Menu appears on the monitor screen, go to the DOS prompt at CIRRUS/IMM: Type
dir*.cnf and return. Only one file should be listed. It should have a format of IMMXXX.cnf
(where XXX is the serial number of the instrument) and a file size of 488 bytes. Delete any other .cnf
files that may be present.
15. Obtain a formatted, high-density 3.5" floppy disk and perform a backup from the Start Menu.
16. Install the waste tubing and bottle using supplied straight or elbow fitting, while keeping the tubing
straight and to avoid kinks. Route this tubing as needed.
17. Spike a new bottle of substrate and fill the reservoir with substrate up to the fill line using the manual
prime button.
18. Enter diagnostics and load the program SOLE2S.
19. Run SOLE2S to prime the substrate pump and associated tubing.
20. Allow a minimum of 45-50 minutes to ensure full temperature stability of the system before
beginning to run any water and/or chemistry testing. Confirm proper and stable temperatures, using
of Section 3.8 Instrument Temperatures for guidance.
21. Before any initial chemistry testing begins, the proposed water supply source intended for the
IMMULITE must first be tested and properly qualified, as described on the next page.

2.3 Testing the Water
Before any water is primed into the IMMULITE, it should be tested for contamination of unacceptable
levels of Alkaline Phosphatase. Contamination can affect the IMMULITEs performance by altering the
matrix during the immunological reaction, or by increasing the post-wash counts per second (cps). It is
recommended that the customer test their water supply at least once a month. Test the intended source
water as follows:
Note: Room temperature distilled water is generally preferred to de-ionized water.
Use the Water Test Kit (catalog number: LKWT) in conjunction with the WATERTST diagnostic
program to perform the water test.
WATERTST
The WATERTST diagnostic program tests the water from any source, independent of the internal fluidics
of the IMMULITE. Water should be tested before priming water from a new source through the
IMMULITE System, or when contamination is suspected. The procedure for testing the water supply
using the WATERTST program appears below:
1. Before starting, ensure the IMMULITE has been powered on for at least 45 minutes and at a stable
operating temperature.
2. Make sure the printer is on-line.
3. Select two empty Water-Test Test Units.
4. Manually pipette 50 L of water directly from the source or from the water in the water bottle into the
first Test Unit only.
5. Load both Test Units onto the Load Chain. Place the Test Unit containing the water at the beginning
of the Load Chain (so it enters the Barcode Reader first).
6. From the Start-up menu, choose DIAGNOSTICS and then the sub-menu choice of DIAGNOSTICS.
Note: The IMMULITE must be Idle before performing step 6.
7. Select WATERTST and press [Enter].
8. When the loading is complete, press [Enter] again.
9. Press GO (on the IMMULITE) when instructed to do so.
10. Substrate is dispensed into the Test Units. The Test Units are then moved into the Luminometer and
incubated for 10 minutes.
11. Once the Test Units start moving, press [Esc] and choose EXIT TO DOS.
12. At the DOS prompt, type water and press [Enter].
The following screen appears:

13. Type a 1 to select the WATERTST and press [Enter].
The screen will post a Waiting for data message. In approximately 10 minutes, the first Test
Unit will be in front of the PMT. One set of 12 unattenuated readings is taken for each Test Unit.
14. Once the readings print, press [Esc] to exit to DOS.
15. Type start and press [Enter] to return to the IMMULITE Start-up menu.
16. Refer to Acceptance Criteria on the next page to determine the outcome of this test.

Acceptance Criteria
The criteria for acceptable water tests are listed below.
1. The cps (counts per second) for each Test Unit should be:
> 4,500 cps and < 9,000 cps
If the cps are . . . It is possible that . . .

the Luminometer is not warm
the substrate volume was
insufficient
< 4,500
the resident substrate is expired,
and losing its reactive properties
(Good for up to 30 days after
spiking onto the system)
unacceptable alkaline
> 9,000 phosphatase contamination is
present
If the cps is too high or too low, perform the test again to confirm the results.
If the cps is consistently outside the 4,500 cps to 9,000 cps range, find a new water source and test
this new source.
If the second test unit (substrate only) is > 9,000 cps, the substrate system may be contaminated or the
test units used for testing may not be clean. **The Water result is then not valid, as it is being falsely
biased (high) by the unacceptably high level of this baseline substrate only reading
2. Refer to last line printed with results:

External water source Substrate Only = XXX cps
If the value of XXX above is lower than 650 cps, insufficient substrate may have been dispensed into
one of the Test Units. This could be due to a clogged nozzle. Check both Test Units to determine if they
contain enough substrate. If the value of XXX above is above 2000 cps, DO NOT use this water source
on the IMMULITE Analyzer. Find a new water source, and test this new source.
CAUTION: If this water source is determined to be unacceptable, and has already been used on the
instrument, the fluidics system must be decontaminated. Refer to Section 7.4.2: System
Decontamination for information.

Sample of Acceptable Water Test Results
An example of acceptable test results for the WATERTST tests is shown below.
Sample of Acceptable Water Test (WATERTST)
External water source = 6000

Substrate Only = 5900
External water source Substrate Only = 100
Once an acceptable water source is obtained, it can be put into the rinsed water bottle, and the probe-wash
solution can be mixed. Once primed into the system using the PRIME common diagnostic program,
clear all air bubbles in the syringes. The instrument is now ready for chemistry testing.

Chapter 3: Theory of Operation
3.1 Introduction
The IMMULITE System is a random access immunoassay Analyzer, built around a proprietary means of
efficiently and rapidly washing the bead solid phase. The 0.25-inch polystyrene bead is captured in a Test
Unit that serves as the vessel for all incubations, washes, and signal development. After incubation of the
sample with alkaline phosphatase-labeled reagent, rapid separation and efficient washing of the Test Unit
and bead are achieved by high-speed spinning of the Test Unit on its vertical axis. The fluid contents are
completely transferred to the coaxial sump chamber of the Test Unit. Multiple washes are accomplished
within seconds, allowing uniform, sequential processing of the Test Units and leaving the bead with no
residual unbound label. The bound label is then quantified, using the dioxetane substrate to produce light.
Light emission from the chemiluminescent substrate, reacting with the bound label, is proportional to the
amount of analyte present in the sample.
3.2 Overview of Test Process

The steps below provide an overview of the testing process. The operator interface is very simple (steps
1-3). For step-by-step operational instructions, see Section 4: Routine Operation of the Operators
Manual part number 600032.
1. The operator loads the samples in barcoded sample cup holders and places them onto the Load
Platform.
Note: The materials needed to operate the IMMULITE are included in the IMMULITE Test Kits.
2. In normal testing, the operator then loads up to five barcoded Test Units after each sample, in any
order, for the tests desired on that sample. (See figure on page 1-4).
Additional samples and Test Units can be added at any time, and Stats can be placed at the
beginning of the Load Platform.
If on-board dilutions are also being used, with the correct diluent wedge resident on the reagent
carousel, the order of Load Platform tube placement becomes: sample cup, dilution cup, 1 empty
space, followed by up to four random test units.
3. The operator presses GO (on the IMMULITE Display Panel) and the Test Units are conveyed into
the Analyzer for barcode identification and then moved onto the Main Incubation Carousel.
4. The pipettor adds sample and alkaline phosphatase-labeled reagent. (The Reagent Carousel
accommodates up to twelve resident assays.)
Note: Reagent changes can be made during instrument operation by pressing the PAUSE button,
which stops the Load Chain and the Pipettor. Reagent Carousel will not go into pause if sequential
assays need to be pipetted. Normal operation resumes when the GO button is pressed.

5. Depending on the assay type, the Test Units are incubated on the Main Carousel at 37C for either 30
or 60 minutes (either 8 or 16 minutes in Turbo mode).
6. The Test Units are shuttled to the spin/wash station, where bound and free label are separated.
7. Substrate is added and the Test Units are transferred to the Luminometer Chain.
8. A 10-minute incubation (6-minute incubation in Turbo mode) at 37C begins, which causes the signal
to reach maximum limits.
9. The photon counts are measured with a photomultiplier tube (PMT). For photon counts, IMMULITE
employs the following principles:
Automatic filtration (attenuation) of the light signal increases the dynamic range of the measuring
system 100-fold, enabling accurate measurements at both extremely high and extremely low
concentrations.
Counts per second (cps) are converted to analyte concentrations (doses) using stored master
curves.
3.3 Internal Calculations

This section provides a step-by-step description of the internal calculations performed by the IMMULITE
System when determining test results. Refer to the table on the next page, which lists all the possible
calculations that can occur to get the final cps count.
1. Since the IMMULITE's ultra-sensitive assays can produce up to several hundred million counts per
second (cps), the IMMULITE uses an attenuator disk in front of the photomultiplier tube (PMT) to
provide accurate readings over a very broad range of light signals. This attenuator disk has three
positions:
Closed - completely blocks the PMT (also known as the home position)
Attenuated - positions a neutral density filter in front of the PMT
Open - an unfiltered position
The IMMULITE's attenuation filter restricts the number of photons entering the PMT. This is used to
prevent high light signals from saturating the PMT. Any readings above saturation are not accurate,
so the IMMULITE uses the attenuated light signal and compensates for the attenuation via software.
2. For each sample, the IMMULITE takes a one-second reading dark count in the closed position and a
one-second reading decision count in the attenuated position.
Note: To view the dark counts while in the run mode, select System Status and View Temps/Dark
Counts.
If the one-second attenuated reading is less than 10,240 cps, the attenuator disk moves to the open
position; otherwise, the attenuator disk remains in the attenuated position while the readings are
taken.
3. The IMMULITE takes twelve one-second readings and returns the attenuator disk to the closed
position.
4. Dark counts are calculated by averaging the last ten reads. This average is subtracted from each of
the twelve readings.

Note: A dark count measurement is taken every 30 seconds, whether or not there is a Test Unit in
the read position.
5. To ensure that the final reading is representative, the highest and lowest of the twelve individual
readings are dropped.
6. All PMTs are slightly different in sensitivity. Therefore each PMT has a unique PMT Multiplier
factor. This PMT Multiplier number is multiplied by the cps reading to get the final cps reading.
7. If the counts were measured attenuated, the trimmed mean of the ten individual readings is multiplied
by the instrument-specific attenuation factor to yield the total unattenuated counts per second (cps).
CPS (unattenuated)= CPS (attenuated) x attenuation factor
8. To determine analyte concentrations, the IMMULITE software refers to lot-specific master curve
parameters, which were entered into the system via the kit barcodes.
PMT CALCULATIONS EXAMPLE TABLE
1 2 3 4 5 6 7
PMT Pre-scaler Mean of last High and Mean X 10 (for Mean X Mean X
Output Output* 10 dark Low count Pre-Scaler*) PMT Attenuation
(CPS/10) count reads removed Multiplier Factor**
(20 CPS then mean Factor** (only if
used here) calculated (.90 used counts were
subtracted here) taken
from each attenuated)
count FINAL CPS
8000 800 780 780
8100 810 790 790
8200 820 800 800
8300 830 810 810
8400 840 820 820
8500 850 830 830
8600 860 840 840
8700 870 850 850
8800 880 860 860
8900 890 870 870
9000 900 880 880
9100 910 890 890
8350 7515 864225
8350/10 =
835
* Original IMMULITE instruments with serial numbers less than approximately 1900 have an external
pre-scaler. Later instruments above this serial number have the pre-scaler built into the PMT.
** The GETDATAT program does not compensate for the PMT Multiplier or the Attenuation factor. It
will factor in a pre-scaler if present.

3.4 The Chemiluminescent Reaction
This section provides a brief overview of the chemiluminescent reaction used in the IMMULITE system.
First, the alkaline phosphatase conjugate (reagent) is bound to the bead (within the Test Unit) during the
immunological reaction. The amount of alkaline phosphatase captured is proportional (for a sandwich
assay), or inversely proportional (for a competitive assay) to the concentration of the analyte in the patient
sample.
Once the Test Unit is washed, a luminogenic substrate is added to the Test Unit and it is moved onto the
Luminometer Chain.
Ten minutes later, the Test Unit arrives in front of the photomultiplier tube (PMT), where the light
generated by the luminogenic reaction is measured. Unlike chemiluminescent reactions involving
acridinium esters (which produce a flash of light) the enzyme-amplified reaction in the IMMULITE
System produces a prolonged glow, as indicated in the figure below.
IMMULITE Enzyme-Amplified Luminescence
In the luminogenic reaction (refer to figure below), the substrate (an adamantyl dioxetane phosphate 1 ) is
dephosphorylated into an unstable anion intermediate by the alkaline phosphatase conjugate captured on
the bead. The unstable intermediate emits a photon upon decomposition. The amount of light emitted is
directly proportional to the amount of bound alkaline phosphatase.
Compared to other means of detection, chemiluminescence provides the highest degree of sensitivity
available. In many cases, the sensitivity is orders of magnitude better than that attainable with
radioimmunoassays.
1
LUMIGEN PPD: 4-methoxy-4-(3-phosphatephenyl)-spiro-(1,2-dioxetane-3,2-adamantane). LUMIGEN is a
registered trademark of LUMIGEN, Inc., Southfield, MI.

The IMMULITE Chemiluminescent Substrate
O O
OCH3
DIOXETANE PHOSPHATE
(STABLE)
OPO3
ALKALINE PHOSPHATASE LABEL
O O
OCH3
UNSTABLE DIOXETANE
OCH3
O
O
LIGHT (hv)

3.5 Primary Modules
3.5.1 Introduction
Primary Modules are defined as those modules that include stepper motors and require configuration
parameters and adjustments. Primary Modules require alignment through the configuration table (see
Section 7.2: The Configuration Table). Secondary Modules (discussed in Section 3.6: Secondary
Modules) are modules that require mechanical or electrical adjustments.
The Primary Modules of the IMMULITE are as follows:
Incubator Carousel
Load Chain Platform
Luminometer
Pipettor / Reagent Carousel
3.5.2 Incubator Carousel

Description
This module transports the assay tubes from the pipettor dispensing area to the luminometer module. It
incubates the tubes at 37 degrees Centigrade and agitates
5
them with periodic shaking. It interfaces mechanically with
the Load Chain Pipettor, and Luminometer modules.
3
The main areas of interest are:
1. Main Carousel Ring Gear Assembly
2. Stepper motor and Gear Assembly
3. Interface PCB 2
4. Heater Pad
5. Position Sensor PCB & rotating tower

Incubator Carousel Adjustments
Carousel Ring Gear Positioning
The ring positioning is controlled by the McPos parameter #3 in the configuration table. The position is
adjusted by using the MCARADJ configuration diagnostic program. This position should be set so that
the shuttle is centered within the carousel baffles.
Main Carousel Position Indicators
Illustrated below is a single position indicator, p/n 500530. There are three position indicators located 20
positions apart from each other around the Main Carousel Ring Assembly. The position indicator is made
of black plastic. Its purpose is to partially block the position hole. This causes a shorter trigger pulse
sensed by the carousel positioning sensor (located near the Stepper Motor and Gear Assembly) whenever
a position indicator passes the sensor. The carousel positioning sensor signals are interpreted by an error
checking sub-routine within the IMMULITE software.
Main Carousel Ring Gear Assy.

Small hole, half-blocked
by position indicator
Large fully open position hole
During the RUN IMMULITE initialization process, the carousel will index before the run to find the first
position indicator. The carousel then stops just beyond the position indicator. The software then checks
for the passing of each of the three position indicators, 20 positions apart from each other. If the sensor
does not see another position indicator after 20 positions a Main Carousel Positioning Error will be
posted.
Note: When running the diagnostic CARPOS, the main carousel position error-checking sub-routines are
activated. A Main Carousel Positioning Error will post if triggered.
Incubator Carousel Test Programs

CARBACK
This program moves the carousel backward in single index steps when the user presses the prime button
located on the syringe module. This is very useful to remove sample cups that have mistakenly indexed
around the main carousel.
CARSHAKE
This program checks the carousel shaking function. It momentarily initializes, indexes the carousel one-
step, moves the shuttle in the space between the baffles and shakes the carousel for a few seconds.
CARPOS
This program indexes the carousel ring gear one position every 2 seconds. It is used to check the indexing
of the carousel.

CARCHECK
This program indexes the carousel ring gear one position, moves the shuttle into the space between the
carousel baffles, pauses for one second, moves the shuttle back to home, and repeats. This program is
used to check each carousel position and its positional relationship with the Tube Shuttle. If the shuttle
does not appear to pass centered through a space of the Main Carousel, this indicates the need for
Carousel position adjustment using the MCARADJ Configurations diagnostic.
MCARTST
Found on the Configurations diagnostic menu, this is a test for the positioning sensor of the Main
Carousel, to aid with troubleshooting related problems. On the display panel, the pulse size of each
position hole of the ring gear will display with each repeated index of the Main Carousel. Nominal pulse
sizes are a value range of 22 - 26 for large holes, and a value range of 8 - 12 for the 3 small holes where
the position indicators are placed.
SPINCHK
This program indexes the Carousel Ring Gear one position, moves the shuttle into the high speed spinner
area, activates the spinner motor for 2 seconds, moves the shuttle back to the carousel, and loops back to
the beginning. The program is very useful in testing the interaction of the Incubator Carousel module,
Luminometer module, and Load Chain module.
3.5.3 Load Chain

Description
This module transports sample cups and test units from the user loading area to the Barcode Reader, and
then to the used sample collection tray or the incubator carousel. It interfaces mechanically with the
sample collection tray, incubator carousel, and pipettor/reagent carousel module. The main areas of
interest are:
1
3
1. Load Chain stepper motor

6
2. Sample/Test Unit Bar code Reader
5
3. Interface PCB
4. Barcode Reader DC Motor
5. Star Wheel 4
6. Load Chain and chain path

2
7. Loading Platform Tube Guide
7
Load Chain Module Adjustments
1. Load Chain Position
The LcPos parameter #0 in the configuration table controls the position of the Load Chain. The position
is adjusted by using the LDCHNADJ configuration diagnostic program and should be adjusted to the
following parameters:
A sample or assay tube is reasonably centered in front of the optical portion of the barcode reader.
The load chain baffles do not inhibit assay tube travel in the transfer block (the crossover point
with path of Incubator Carousel).

2. Barcode Drive Wheel Travel
The stop screw on the drive motor bracket controls the drive wheel travel. The drive wheel should be
adjusted so that the outside of the drive O-ring is in the same vertical plane as the inside wall of the
transfer block channel. If the drive wheel is allowed to travel too far, the tubes can be forced against the
transfer block channel wall as they leave the barcode reader position possibly jamming the chain. If the
drive wheel does not move far enough toward the channel, the tubes may not be driven well enough
causing bad barcode reads.
3. Barcode Drive Wheel Motor Speed
The speed of the motor is controlled by R120 on the Heater/DC Motor PCB. Using an assay test unit, it
should be adjusted to read between 750 and 790 milliseconds per revolution in all four positions of the
assay tube roller assembly on the IMMULITE display by using the diagnostic program BCODESPD.
Refer to Section 7.4.8 for more information.
4. Star Wheel Adjustment
The Star Wheel is adjusted by loosening the hex nut located on top of the Star Wheel. The wheel should
be adjusted so that the leading edge of each arm will make light contact with the trailing edge of a
Sample Cup Holder when the holder is in pipetting position #5. This insures that the Star Wheel will also
be pushing the Sample Cup Holder into the Sample Tray along with the chain. If the wheel is positioned
ahead or behind this location the Load Chain baffles will push the Sample Cup Holder into the Sample
Tray unaided by the Star Wheel, possibly tipping the cups and causing a jam. Refer to Section 7.4.6 for
the complete adjustment procedure.
Load Chain Module Test Programs
LCHAIN
This program indexes the load chain one position every 2 seconds.
BCODE
This program will carry tubes into the barcode reader to be read and then into the Sample Tray for
retrieval. The rate at which the tubes are processed is approximately one tube every two seconds. BCODE
requires the use of the "PC" program to display the barcode information on the computer.
BCODEON
This program activates the sample Barcode Reader motor on/off by the Drive Wheel
and O-ring Tube-in-place
push of the GO button.
sensor flag
BCODESPD
This program is used to observe and/or adjust the Barcode Reader motor
speed, which is read out on the display panel.
Note: By pushing the "PAUSE" button during program operation, the

load chain will advance to read another barcode.
BCODETST
Gearbox
This program will advance a tube into the Barcode Reader, read it 25 Assembly
times, advance the chain looking for another tube to read, then repeat.
This is the most useful test for the barcode reader, and can show useful patterns Motor
for diagnosing intermittent problems.

3.5.4 Luminometer
Description
This module washes the bead in the test unit with a combination of water and high speed spinning, adds
substrate, then moves the test unit via the Luminometer Chain through the serpentine path of the
Luminometer to a position in front of the Photomultiplier (PMT) where the light output is read. This
module interfaces mechanically with the main carousel module via tubing to the substrate/wash pumps,
and electrically to the PMT pre-scaler/power supply module.
1. Stepper Motor for the shuttle 2. Luminometer Chain Motor

3. Attenuator Motor 4. Photomultiplier Tube (PMT)
5. Shuttle Assembly 6. Interface PCB
7. Luminometer Chain 8. Attenuator Assembly
9. High speed brushless DC motor 10. High-speed Spinner platform assembly
2
6 3
8
4 4
2
5
7
5
1
10
Luminometer Module Adjustments

1. Luminometer Chain position
The lumchain position is controlled by the "LumcPos" parameter #26 in the configuration table. The
position is adjusted by using the LUMCHADJ configuration diagnostic program. This position should be
set so that the shuttle is centered within a chain baffle.
2. PMT Attenuator home
The home position is controlled by the "Att Home-Extra" parameter #28 in the configuration table. The
value of this parameter is factory set and should not be changed.

3. PMT Attenuator position
The attenuator position is controlled by the "Att Pos Extra" parameter #29 in the configuration table. This
position should be set so that the attenuator disc windows are centered in front of the lumchain baffles at
the PMT position. The value of this parameter is factory set and should never need to be changed.
4. Shuttle at Carousel position
The shuttle at carousel position is controlled by the "Sh at Car" parameter #21 in the configuration table.
The position is adjusted by using the SHUTCADJ configuration diagnostic program. This position is
adjusted so that test units transfer from the carousel into the shuttle in a reasonably straight path.
5. Shuttle at Luminometer position
The shuttle at luminometer position is controlled by the "Sh at Lum" parameter #25 in the configuration
table. The position is adjusted by using the SHUTLADJ configuration diagnostic program. This position
is adjusted so that:
The assay tubes transfer from the shuttle into the Luminometer in a reasonably straight path.
The tube shelves of the shuttle do not interfere with Luminometer Chain movement.
6. Shuttle at Substrate Dispense position
The Shuttle at substrate position is controlled by the Sh at Sub parameter #22 in the configuration table.
The position is adjusted by using the SHUTSADJ configuration diagnostic. This position is adjusted so
that a test unit is centered under the substrate nozzle.
Any deviation of the factory setting will require the high-speed spinner tube pressure to be checked since
changes in this parameter will change the pressure (See below).
7. High-speed Spinner tube pressure
The pressure exerted on the assay tube while in the high-speed spin position is a function of two
parameters in the configuration table: the "Sh at Sub-Extra" parameter #22 and the "Sh Push-Extra"
parameter #24. Since varying the latter parameter only affects one area, it is to be adjusted last. The High-
speed Spinner tube pressure should only be changed by varying the "Sh Push Extra" parameter in the
configuration table. The pressure on the tube should be between 1.2 and 1.5 pounds.
8. High-speed Spinner motor speed
The speed of the High-speed Spinner is controlled by R107 located on the Heater/DC Motor PCB. It
should be adjusted to read between 5400 and 5600 on the IMMULITE display by using the WASHSPD
diagnostic program.
Luminometer Module Test Programs
LUMCHECK
This program is most useful to check the critical crossover alignments of shuttle and luminometer chain
(remove the spinner platform for best viewing). The program repeatedly indexes the luminometer chain,
alternating with the shuttle moving momentarily into each chain baffle, in order to check for centered
alignment.
LUMCHN
This program indexes the lumchain one position every second.

ATTURN
This program moves the attenuator disc to the home position, attenuated position, unattenuated position,
and then repeats. It is useful in verifying sensor operation.
SHUTLOAD
This program allows for the evaluation of the shuttle loading of the test unit into the spin position.
SPNCKTST
Found on the Configurations diagnostic menu, this tests the electronic logic operation of the spinner
motors error checking circuit. Following display prompts, a test unit will be loaded into the spinner, and
a 5-cycle check of spinner startup is evaluated. In 0.5 seconds after spin begins, the motor must be up to
at least 2500 rpm or the display indicates Test Failed. If the 5 cycles check properly, it indicates Test
Passed.
SPINCHK
This program allows for a quick visual check that the high-speed spinner motor is working. During this
test the test unit is loaded into the spin position and the spinner motor is turned on for one second.
SHUTSPIN
This program indexes the Main Carousel one position, moves the shuttle to the high-speed position and
then activates the high-speed spin motor for 30 seconds. It is used to check the rpm of the high-speed
spinner when using an optical tachometer.
SPINON
This program will turn the High-speed Spinner motor on and off in response to the "GO" button.
SHUTTLE
This program moves the shuttle to the Luminometer position, to the High-speed Spinner, to Shut Push,
out to substrate dispense position, a possible Shut @ Lum correction move, then back to the Carousel,
then repeats. It is used to check alignment of these various 5 positions of the shuttle.
DARKCNT
This program will move the attenuator to the home position, then take a set of 12 one-second dark counts
from the Photomultiplier Tube every 15 seconds. The data reduction program "GETDATAT" must be
used with this program to view the PMT data.
BKGNDCNT
This program will alternate moving the attenuator to the attenuated and then unattenuated position. While
at each position, a set of 12 one-second-background counts will be taken. The data reduction program
"GETDATAT" must be used with this program to view the PMT data.
PMTCOUNT
Using GETDATAT, the current PMT counts are displayed. Readings are taken from the existing
position of the attenuator and does NOT move the disk. Normal readings are dependant upon the position
of the disk for these readings.

3.5.5 Pipettor / Reagent Carousel
Description
This module transfers liquid from the Reagent Wedge and Sample Cup into the Test Unit and provides a
cooling chamber and Barcode Reader for the Reagent Wedges. It interfaces mechanically with the Main
Carousel and Load Chain modules, and to the Hamilton Syringe module and waste container via tubing.
1. Stepper motors for the Reagent Carousel, X-, and 5
Z-Pipettors (L-R respectively) 4

3
2
2. X- and Z- Pipettor mechanisms
3. Level Sensor PCB system (a level sense circuit
under the probe arm, and interface/conditioning
PCB mounted to the tower) 9
4. Reagent cooling chamber and tray assembly
5. Reagent Wedge Barcode Reader PCB 8
6. Module Interface PCB

7. Thermal Electric Device (TED Cooler Unit)
8. Pipettor Wash Station
6 1
9. Z-Pipette and Level Sense interfacing Spiral Cable 7
Pipettor/Reagent Carousel Module Adjustments
1. X-Pipettor Positioning
At the Home (Blind) Well
The position is controlled by the Px Home parameter #7 in the configuration table. It is adjusted by using
the PIPXWADJ configuration diagnostic program. The position should be adjusted so that the probe is
centered in the well when at this position.
At the Dump (Waste) Well
The position was formerly controlled by the Px Wash parameter #37 in the configuration table, however,
this is no longer used. This position is now a hard-coded standard of 20 motor steps from the home
position. It is adjusted by using the PIPXWADJ configuration diagnostic program, and when the home
well is centered, this position will also be correct by default of the physical assembly of the wash well
station.
At the Wash (Fresh Water) Well
The position was formerly controlled by the Px Dump parameter #38 in the configuration table, however,
well is centered, this position will also be correct by default of the physical assembly of the wash station.

At the Reagent Position
The position is controlled by the Reagent parameter #40 in the configuration table. It is adjusted by using
the PIPXRADJ configuration diagnostic program. The position should be adjusted so that the probe
passes through the center of the hole in the reagent-housing lid.
At the Sampling Positions
The positioning of the probe in the sampling cups is controlled by the S5 - S1 parameter numbers 43-47
in the configuration table. (The S1 position is in the extreme clockwise location.) This is because the first
tube behind a sample cup gets sample from the first sampling position, and the fifth tube behind a sample
cup gets sample from the fifth sampling position. The positions are adjusted by using the PIPXSADJ
configuration program along with special Pip-X Position Gauges. Refer to Section 7.4.5: Use of Pip-X
Position Gauges for more information. Each position must be adjusted so that the probe is centered in the
Sample Cup.
At the Test Unit Position
The positioning of the probe is controlled by the PX Disp parameter #48 in the configuration table. It is
adjusted by using the PIPXTADJ configuration diagnostic program along with special Pip-X Position
Gauges. Refer to section 7.4.5: Use of Pip-X Position Gauges for more information. The position should
be adjusted so that the probe is reasonably centered in the hole in the Test Unit when dispensing.
2. Reagent and Sample Dead Volumes
The minimum volumes for the reagent and sample are controlled by the LevSensS and LevSensR
parameters # 13 and #14 in the configuration table. They are set using the DEADVADJ (automatic) or
LEVSNADJ (manual method) configuration diagnostic programs. The minimum volume for the reagent
vial is 1000 ul, and 100 ul for the sample. After calibration, the setting should be immediately evaluated
using the check diagnostics of LENSENSS & LEVSENSR, described below.
3. Reagent Carousel Position
The position is controlled by the RcPos parameter #16 in the configuration table. It is set by using the
REAGPADJ configuration diagnostic program. The position should be set so that each position slot in
the carousel tray is centered over the sensor head below. If this position is not set correctly, mis-
positioning of the Reagent Carousel can occur.
4. Reagent Carousel Home
The position is controlled by the RcHome parameter #15 in the configuration table. Using the
REAGHADJ configuration diagnostic program sets this position. The position should be set so the red
light of the opto-sensor is shining at the spot on the label between the leading edge of the wedge and the
first bar of the barcode, when the reagent carousel is at home. If this position is not correct, misreading of
the Reagent Wedges can occur.
5. Probe Depth in the Dilution Cups
This newest probe depth parameter (previously an unused parameter in previous IMMULITE systems),
does not have a related adjustment diagnostic, and should not be changed by any user. The default factory
settings should always stay at 160 Error Steps, and the Extra Steps in this case are not used.
6. Probe Depth in the Home Well
This depth is controlled by the Z Home parameter #32 in the configuration table. It is adjusted by using
the PIPZHADJ configuration diagnostic program. When properly adjusted the probe should be between
1.25 and 1.50 mm from the bottom of the well.
7. Probe Depth in the Wash Well
This depth is controlled by the Z Wash parameter #33 in the configuration table. It is adjusted by using
the PIPZWADJ configuration diagnostic program. When properly adjusted, the probe should be
approximately 2 mm from the bottom of the well.
8. Probe Depth in the Test Unit
This depth is controlled by the Z Assay parameter #34 in the configuration table. It is adjusted using the
PIPZTCHK (automatic), or PIPZTADJ (manual) configuration diagnostic programs. When properly
adjusted the probe should "touch off" on the liquid dispensed and not come out of the test unit with a drop
on the end. Likewise, it should not go too far down so as to contact or push the bead to the side.
Pipettor/Reagent Carousel Module Test Programs
UPDOWNH
This program moves the X-pipettor to the home well position then moves the Z-pipettor up to the Home
sensor, down to the Mid sensor, down the amount of steps in the error column of parameter #32 (Z
Home) of the configuration table. It is very useful in testing the functions of the aforementioned sensors,
the centering of the probe in the home well and to roughly check the depth of the probe in the home well.
UPDOWNW
This program will move the X-pipettor to the wash station position, then moves the Z pipettor up to the
Home sensor, down to the Mid sensor, then down the amount of steps in the error column of parameter
#33 (Z Wash) of the configuration table. It is very useful in testing the functions of the aforementioned
sensors, the centering of the probe in the wash well, and to roughly check the depth of the probe in the
wash well.
UPDOWNA
This program will move the X-pipettor to the Test Unit dispensing position, then moves the Z-Pipettor up
to the Home sensor, down to the Mid sensor, then down the amount of steps in the "Error" column of
parameter #34 (Z Assay) of the configuration table. It is very useful in testing the functions of the
aforementioned sensors, the centering of the probe in the test unit, and to roughly check the depth of the
probe in the test unit.
PIPXPOS
This program moves the X-pipettor to each position, starting with home, lowering the Z pipettor into each
position for a moment to allow for visual inspection of the positioning.
RBCODE
This program moves the reagent carousel to the home position and then to each position while reading
Reagent Wedge barcodes. After reading the barcodes or not finding any, the program repeats.
LEVSENSR
This program will move the X-pipettor to the reagent position, and then move the Z-pipettor down to the
Mid sensor, then move the probe down looking for liquid. If liquid is found, the number of steps left
before the error steps were reached is displayed on the IMMULITE display as the "SL=" number. With
1000 ul of reagent in a reagent vial, the "SL" number displayed on the IMMULITE should be between 8
and 12 if the minimum volume is set correctly.

LEVSENSS
This program will move the pipettor down into the Sample Cup #1 position, looking for liquid. It will
display the amount of steps the Z-pipettor has remaining until the maximum number of allowable Z steps
is reached. With 100 ul of sample in a sample cup this SL= number on the display panel should
reasonably match the error steps of parameter #13 in the configuration table, which had been set when
running the previous DEADVADJ or LEVSNADJ calibration program.
REAGENTH
This program moves the reagent carousel to the home position, pauses, and repeats.
REAGENTP
This program moves the reagent carousel to each of the 12 positions, pausing between each.
PROBETST
This program will move the probe into the home well, dispense 3000 ul at maximum velocity (1000
ul/second), move the probe up and over to the dump position, and repeat. Since it simulates the washing
of the probe during the main program, it is very useful in testing the integrity of the washing. For
example, if the probe were partially occluded or damaged, the depth too far into the home well, or not
centered in the home well, the water coming out of the probe would be uncontrollable and "splash" out of
the well. Also an occlusion may be present if dripping from the probe occurs when it momentarily
positions over the dump well.
PROBANGL
This program is used to evaluate the dispense angle of the probe. The probe is positioned over the home
well and water is dispensed.
System Level Sensing Test Programs
LEVCRASH (found on the main diagnostic menu)
Running for up to 20 full pipettor rotation cycles, this program will look for a successful level-sensing
signal from liquid-filled cups pre-placed onto the system as per display panel instructions. If any errors
occur within the 20 cycles, the program will halt and the display panel will show Test Failed (it did not
see a level sense trigger when it was supposed to). If no errors occur within the 20 cycles, the display
panel will show a message of Test Passed, and the program will end.
LEVFALSE (found on the main diagnostic menu)
Running for up to 20 full pipettor rotation cycles, conversely to LEVCRASH, this program will look for
any false level sensing signals while rotating in open air. If any errors occur within the 20 cycles, the
program will halt and the display panel will show Test Failed (it did see a false level sense trigger when
it was not supposed to). If no errors occur within the 20 cycles, the display panel will show a message of
Test Passed, and the program will end.
LEVFSTST (found on the Configurations diagnostic menu)
This program tests for the tendency of the level sensor to false level sense at times when a signal is not
desired. It moves to and checks level sensing at empty positions of the reagent and the 5 sampling
positions, much the same as the existing LEVFALSE program. If the level sensor is working correctly, it
should not level sense anything, as the program repeats this sequence for up to 17 cycles, for a total of
102 potential level sensing signal checks, and then stop automatically. While running, the number of
errors (or false signals) is counted and show on the display panel each time the probe recycles to home.

LEVSNTST (found on the Configurations diagnostic menu)
Conversely to the above program of LEVFSTST, this program tests for a proper level sense signal when
one is desired. After initialization and a syringe priming process, the display panel prompts to load five
empty sample cups onto the load chain. Upon pressing Go, these sample cups will be brought into the
five sampling positions and the probe then automatically dispenses a mixture of water and probe wash
into each of the five sample cups. This program will repeatedly level sense into each cup and run for a
total of 20 cycles and then stop automatically and the display panel will then prompt for Repeat or
Exit. This gives up to 100 potential level sense signal checks. While running, the number of errors
detected are shown and counted on the display panel as they occur.
3.6 Secondary Modules
3.6.1 Introduction
Secondary Modules are defined as those support modules not directly responsible for tube transport,
and/or smaller modules that require mechanical or electrical adjustments.
3.6.2 Power Supply Chassis

Description
The power supply module contains three individual power supplies that convert the input AC voltage to
the necessary DC voltage required by the IMMULITE electronics. The module also contains line filters to
reduce the amount of noise the individual power supplies will see. The main areas of interest are:
1. The +24vdc switching supply (commonly known as the
8
heater/motor power supply - wired through F3)
2. The +/-5vdc +/-12vdc switching supply (commonly known
as the IC logic power supply - wired through F2)
3. The +/-5vdc +15vdc linear supply (commonly known as 2
the PMT power supply - wired through F1) 1
4. The input filter/fuse holder
5. Individual Supply Fuses
6. Instrument Main Power Switch
3
7. Power Supply Outer Fan
8. Variable Speed Fan Inner 24V Supply
Power Supply Module Adjustments
4
No adjustments of this module are necessary
Power Supply Module Testing

The best way to test the module is to measure the output
voltages at specific points in the instrument. A quick way of
testing the supply is to run a diagnostic that uses voltage from
that supply.
7 6 5
Heater/Motor Power Supply
Quick Test:
Run the CARPOS diagnostic program (uses +24v and +5v)
To measure output voltage:
Turn the power on and measure the appropriate voltage (consult the Syringe Interface PCB Schematic for
voltage location) on the J1 connector of the Syringe Interface PCB.
IC Logic Power Supply
Quick Test:
1. Run the PRIME diagnostic program (uses +24v, +5v, +12v, and -12v).
2. Run the BCODE diagnostic program (uses +24v, +5v and -5v).
PMT Power Supply

Quick Test:
Run the DARKCNT diagnostic program (uses +15v, +5v, and -5v)
1. Remove the front panel of the instrument.
2. Along the right side of the instrument the output of the PMT power supply is now
accessible (see below).
3. The wire color coding is as follows:
Black = Ground
Blue = -5vdc
Red = +5vdc
White = +15vdc
4. When done measuring, replace the front panel.
Inside the Front Panel View of the PMT Power Supply

3.6.3 PMT (Photomultiplier Tube) and Pre-scaler/Power Supply
PMT Description
This highly sensitive photometer tube gathers the photon signals from the glowing assay beads within the
Luminometer. Its signal is connected directly to the systems rear CPU PCB, for signal processing of the
CPS (Counts per Second). It has its own separated/filtered linear power supply as described in the
previous section.
Prescaler Description
Note: This module is only present on earlier manufactured instruments. At approximately serial number
1900, an integrated PMT was cut-in that contains the Pre-scaler components within the PMT itself.
This module provides the high voltage to the PMT and conditions the
resultant PMT counts. It interfaces with the PMT and CPU/Sensor
PCB. The main areas of interest are:
1. High voltage power supply
2. PMT prescaler
PMT Prescaler/Power Supply Module Adjustments
No adjustments of this module are necessary. The logic divider
switch at the bottom of the module must be set to 10 at all times
PMT Module Adjustments

No adjustments of this module are necessary or possible.
PMT Module Test Programs

DARKCNT
This program will move the attenuator disk to the home position, then take a set of 12 one-second dark
counts from the Photomultiplier Tube every 15 seconds. The data reduction program "GETDATAT" must
be used with this program to view the PMT data. Normal readings range between 0 60 CPS.
BKGNDCNT
This program will alternate rotating the attenuator disk to the attenuated and then unattenuated
position. While at each position, a set of 12 one-second-background counts will be taken. The data
reduction program "GETDATAT" must be used with this program to view the PMT data.

Normal readings are in a range of 0 40 CPS in attenuated (filtered) position, and comparable readings
in unattenuated (open aperture) position, which will have more values in the 30-40 range, along the 12
readings.
PMTCOUNT
Using the data reduction program GETDATAT, the current PMT counts are displayed. Readings are
taken in the current position of the attenuator, and it does NOT move the disk. Judgment of normal
readings is dependant on the current disk position, as above.
3.6.4 Substrate and Water Injector Pumps
MGM Injector Pumps Cirrus Injector Pumps DPC Injector Pumps

Description
Currently, there are three types of Substrate and Water Solenoid (Injector) pumps that can be found in
instruments:
1. MGM Injector Pumps Assembly P/N 400111 is the oldest style pump characterized by vertically
positioned prime buttons; white or tan valve manifolds and white dispension nozzles (P/N 500225).
This assembly was used in production on all instruments up to serial number F1558 and then all
even numbered instruments up to F1594. This assembly is no longer in production. Liquid
drawback cannot be adjusted on these pumps.
2. Cirrus Injector Pumps Assembly P/N 420060 was an improved design over the MGM style
assemblies. It is characterized by its shorter height, horizontally positioned prime buttons, and gray
dispension nozzles (P/N 500680). This assembly was phased into production with all odd serial
number instruments from F1559 to F1595 and then all instruments after serial number F1595 to
current production (as of this printing). Drawback is adjustable with this assembly via potentiometers
located on the pump PCBs (refer to section 7.4.4 for specifications). Since the Cirrus pump works
with a higher velocity than the MGM style pump, the dispension nozzles have a smaller inner
diameter (I.D.).
3. Linear Actuator Injector Pumps are a complete redesign of this module. (Single pump Assembly; p/n
400321. Full Wash Pump Kit; both pumps on base with cable: p/n 420120) These stepper-motor
actuated companion Substrate and Water Pump units have the advantage of two separate pumps,
where if one fails, only one needs replacing.

Note: All three types of pumps are interchangeable. The DPC Injector Pumps use different tubing that
also must be replaced if switching to these type pumps. The Cirrus and DPC Injector pumps also have an
available drip tray P/N 500702 that is mounted under the pumps. O-rings for this tray must also be
ordered using P/N 900836-08.
All Injector Pump modules automatically pump substrate and water into the assay tube during the
spin/wash cycle. The solenoid pumps interface via tubing to the water and substrate containers and the
Luminometer module. The solenoid pumps interface electrically with motherboard #1. The main areas of
interest are:
1. Solenoid pumps
2. Interface PCB
Substrate and Water Solenoid Pump Adjustments
1. Water or Substrate dispensing volume
The volumes of both solenoid pumps are factory set and should not need adjustment. Use the DISSUB or
DISWAT diagnostic programs (described below) to check the dispensing volumes. The volume should be
200ul 10ul for all pump types.
CAUTION: In regards to pump types #1 and 2, on the rare occasion where the volume of dispense is
incorrect, it can be adjusted within the inner assemblies of the pump module. However, as a general rule it
is better and safer to replace the entire pump assembly as the adjustment balance can easily be disturbed,
possibly leading to worse problems. If an adjustment in the field is absolutely necessary, contact
Technical Support for details.
NOTE: In regards to the newest design of the Linear Actuator Pumps, on the rare occasion when the
volume of dispense is incorrect, it can be adjusted within the inner assemblies of each pump module.
After removing the pump from its platform, the DIP switches inside control both volume and drawback
settings. Refer to Chapter 7: Miscellaneous Procedures for more details.
2. Water or Substrate drawback specifications

Drawback is checked using the SOLE1W or SOLE2S diagnostic programs (described below). Refer to
the end of section 7.4.4 Fluidics Valve Testing for information on drawback adjustment and
specifications for each of the three types of pumps.
Substrate and Water Solenoid Pump Test Programs
DISSUB
This program shows instructions on the display panel to load 5 empty test units onto the Load Platform,
and press Go. The tubes will be brought onto the incubator carousel, each receive a shot of substrate,
then the units will be transferred to the sample collection tray, for a visual inspection of proper and even
volumes in the 5 tubes.

DISWAT
and press Go. The tubes will be brought onto the incubator carousel, each receive a shot of wash water,
SOLE1W
This program dispenses one "shot" of water every second. It is very useful in checking drawback, or to
quickly prime the pump.
SOLE2S
This program dispenses one "shot" of substrate every second. It is very useful in checking the drawback,
or to quickly prime the pump.
Note: Refer to section 7.4.4 for more information on drawback. Drawback is not adjustable with the
MGM solenoid pumps. The MGM pump must be replaced, if the drawback is more than .
Input Tube support

PCB cover bracket (wiring behind)
3.6.5 Substrate Heater
Description
The Substrate Heater module is responsible for controlling the temperature of the
substrate before it is injected into the test unit. The heater will begin to heat the
substrate to 36.6, +/- .6C seven minutes before a test unit that requires substrate
reaches the dispensing area. This way the substrate is not always heated which
would cause a decrease in stability. The heater and controlling circuitry are
housed inside the module. The heater is activated by a signal coming from Q13
(which was originally intended to be used for valve #5) on the Heater/DC Motor
PCB via J10 on the Syringe Interface PCB (blue wire from J3). When the heater is
at temperature, a signal (digital 0 = not at temperature, digital 1 = at temperature)
comes from the Substrate Heater module to the CPU/Sensor PCB via the
Luminometer Interface PCB (yellow wire from J3).
Substrate Heater Adjustments Substrate Heater
Dispense Thumb Screw
No adjustments of this module are necessary. Nozzle for unit
removal
Substrate Heater Test Programs
SUBSHEAT
This program will activate the substrate heater. The temperature can be easily measured using a digital
voltage meter. Remove the PCB cover off the left side, and insert the leads of meter into the two white
test points (TP1 & TP2) on the PCB.
Note: The temperature of the heater should be at ambient when the program first starts. Multiply the
voltage measured by 100 and this will be the temperature in Centigrade. The stabilized temperature of the
heater should be 36.6 +/- .6C. When done measuring the temperature, be sure to terminate the program
so as not to heat the substrate for a long period of time.

SUBHTTST
This program (located in the system configuration diagnostics menu) will first check to see that the heater
is not at temperature (in the event the heater has shorted and is always on). If the heater is not on, the
program will activate the heater and check every 30 seconds to see if it has reached temperature. If the
heater was already at temperature when the program was started or does not reach the proper temperature
within 6 minutes, the program will indicate the test has failed.
If the proper temperature is reached within 6 minutes, the program will indicate the test has passed. The
heater will only come up to the on/off trigger point of approximately 35C - 35.5C and then shut off. It
will not heat to the full temperature of 36.6C +/- 0.6C.
Note: Since this program checks to see if the heater is always activated, it is very important that the heater
be deactivated for at least five minutes before the program is run or a false failure may occur. Remember
that the heater is only activated when a test unit requiring substrate is seven minutes away from the
substrate dispense position. For example, if this program is run successfully, and then run again
immediately afterward, it will fail since the heater is still at temperature.
3.6.6 Substrate Reservoir

Description
The substrate reservoir module holds the substrate bottle, contains a Prime button
7000ul (to fill line) reservoir and a level sensor that triggers when the -squeeze, do
reservoir level drops to 5000ul (posting a substrate low error). This not push
allows the operator 12 minutes to replace the bottle without interrupting
the operation of the instrument. Priming of the reservoir is accomplished
by repeatedly squeezing (not pressing) the gray rubber prime button Window and
located on the front of the reservoir until the level of substrate is at the level float
fill line. The level sensor signal is fed back to the CPU/Sensor PCB via
the substrate heater. The substrate flows from the bottle into the
reservoir through a replaceable I.V. spike.
Substrate Reservoir Module Adjustments Level Sensor
No adjustments of this module are necessary or possible. Refer to

Section 7.4.3: Substrate Spike Replacement for information on the spike
replacement.
Substrate Reservoir Module Test Programs
SUBLVTST
This program tests the proper operation of the Substrate Reservoirs level sensor. After instrument
initialization, the display panel prompts the user with step-by-step instructions to lower the substrate level
until it triggers the level sensor. After querying the sensor for a good level, the bottle is removed and the
level is pumped out hopefully, below the trigger of the sensor. The test can be recycled for a second
dispense cycle, until display panel indications of Test Passed or Test Failed are posted, as per expected
actions of the test, based on the visual level in the reservoir.

3.6.7 Syringe Pumps 8
3 4
3 4 8
6
V4
5
5 V2
V1 6 and 7
7
A B A B
1 and 2 1 and 2
Hamilton Syringe Pumps Euro Syringe Pumps

Description
Currently, there are three types of Syringe Pumps that can be found in instruments:
1. The Hamilton 900 Series Syringe Pumps Assembly is the oldest Syringe Pump Module used in
production up to serial number H2468. It is no longer available as a complete module, but can be
easily upgraded to the two newer designs described below. Individual diluters P/N 900999 and
individual repair of some components are still available for a limited time until stock is depleted. The
Hamilton 900 Series is characterized by the existence of individual Driver Circuit PCBs P/N
900998 located within the bodies of the A and B dilutor assemblies and the prime button located
to the right of the syringes. All cabling for sensors and stepper motors for the upper rotary valve drive
and leadscrew drive are connected to this Driver Circuit PCB. The two Driver Circuit PCBs are
connected to a Logic PCB P/N 900279 mounted on the right side of the Module Assembly. A Syringe
Interface PCB (A15) P/N 450013 interfaces the Module Assembly with the rest of the IMMULITE. A
Hamilton Tubing Kit P/N 400208 is available for tubing replacements. This module utilizes two
rotary valves; a Macrovalve for the A syringe (identified by a silver label) and a Microvalve for the
B syringe (identified by a gold label).
2. The Hamilton 500 Series Syringe Pumps Assembly has been in production starting with
instruments with serial number H2469 and above. It has been implemented into production alternately
(according to stock availability) with the Euro design described below. The complete module is
available under P/N 400273 and individual diluters are available under P/N 901664. It involved a
circuit redesign where the Driver Circuit PCB and Logic PCB were combined into a single
Logic/Driver PCB P/N 901666. The visual appearance is the almost the same as the Hamilton 900
Series Module Assembly. The prime button is also located to the right of the syringes, and the same
Hamilton Tubing Kit P/N 400208 and Syringe Interface PCB are used. The cabling for sensors and
motors of the rotary valve and leadscrew drives are all brought to the right side of the Module and
connected to the Logic/Driver PCB. A slight difference to note is that the older 900 Series uses four
wires (brown, red, orange, and yellow) to connect the small position Sensor PCBs on the top of each
dilutor, while the newer 500 Series only uses three wires (brown, red and orange). This module also
utilizes two rotary valves; a Macrovalve for the A syringe (identified by a silver label) and a
Microvalve for the B syringe (identified by a gold label).

3. The Euro Syringe Pumps Assembly, P/N 400263 is available as a complete assembly only. Individual
diluters cannot be replaced separately. The Euro design uses solenoid valves to direct the flow of
liquid in or out of the syringes. This assembly also utilizes a single large PCB which covers the entire
back wall of the module. It includes all the circuitry of the Driver Circuit, Logic and Syringe Interface
PCBs. The prime button is placed between the two syringes and the side fluidics valves have
connectors (labeled V1, V2 and V4) more easily accessible at the top rear of the module. The syringes
are secured into acrylic manifold blocks where the fluid is controlled by two more solenoid valves in
place of the rotary valve assemblies used with the Hamilton Modules above. Tubing is different for
the Euro Module and is available in a Euro Tubing Kit under P/N 400361.
Notes: The older Hamilton 900 series module taps all system voltages (+/- 5, +/- 12, +24v). In the newer
500 series, only the systems +24v is used, and then is reduced as needed by the circuits of the Hamilton
500 logic/driver PCB.
All types of pump modules are interchangeable, as the electrical connections to the modules are identical.
Tubing kits may need to be changed, if going from Hamilton to Euro or from Euro to Hamilton. Refer to
Chapter 10 for a listing of the tubing kits.
The Syringe Module performs precision liquid transfer using stepper motor driven syringes to pipette
water, wash, sample and reagent. It interfaces via tubing to the water and wash containers and to the
pipettor module. The main areas of interest are:
1. "A" and "B" Diluter assemblies
2. "A" syringe (5000ul) and "B" syringe (250ul)
3. Macrovalve
4. Microvalve
5. Solenoid Valves (V1, V2, and V4)
6. Controller PCB (The Euro Syringe Pump combines the Controller and Interface PCBs into one board)
7. Interface PCB (The Euro Syringe Pump combines the Controller and Interface PCBs into one board)
8. Prime Button
Syringe Module Adjustments
No adjustments of this module are necessary or possible. The inner armature lead-screws are lightly
lubricated at the yearly PM.
Changing a Syringe
1. Loosen the thumbscrew under the syringe to be changed to a point at which the syringe plunger is
free from the driver arm.
2. Use the diagnostic program SCHANGE to move the syringes down.
3. Unscrew the syringe from the valve above while taking care not to exert side pressure the valve stem.
4. Install the new syringe onto valve fitting above.
5. Press the "GO" button to move the syringes up and tighten the thumbscrews.

Changing the Microvalve or Macrovalve (Hamilton 900 and 500 units only)
Note: These rotary valves are changed at the yearly PM, ONLY if they are of the black-bodied style. The
newer white-bodied ceramic rotary valves are NOT replaced, and are intended as permanent.
1. Remove the syringe as described above, using the SCHANGE diagnostic.
2. Remove the tubing on either side of the valve.
3. Move the silver locking lever (below valve) to the right position to release the valve barrel.
4. Above the valve is a hex-cap capture setscrew, which must also be slightly backed off, in order to
release the valve barrel.
5. Remove the valve from diluter assembly.
6. When installing the new valve insure the slot in the valve stem is positioned so that it will mate
correctly with the stem inside the valve drive mechanism.
7. While making sure the valve body is flush to the dilutor manifold, retighten the top hex-cap setscrew
from above, until gently snug.
8. Move the locking lever to the downward position to lock the valve in place. Be sure the valve body is
flush with the valve manifold of the module.
9. Reinstall the tubing into each side of the valve and screw the fitting into the valve until the fitting
"bottoms" in the valve, then turn 1/4 of a turn more. Lock fitting in place with black locking nut.
Warning: Over-tightening the fittings into the valve above can deform the inner body of the valve and
cause air and/or water leaks.
Changing the Microvalve or Macrovalve (Euro units only)
Note: The clear acrylic manifold blocks are not regularly replaced. However, regular inspections should
be performed and the valves replaced if damage or cracks are found.
1. Making sure main power is off, disconnect short power wire of the solenoid valve from the rear
Controller PCB behind the acrylic manifold intended for replacement.
2. Remove three hex screws, which mount the acrylic manifold block to the front face of the module.
3. Remove the entire assembly (manifold and solenoid valve).
4. Install new manifold and solenoid valve in reverse order.
Syringe Module Test Programs
SCHANGE
This program moves both syringes down approximately halfway to permit their removal, waits until the
"GO" button is pressed, then moves both syringes up to home.
PRIME
This program primes the two syringes and the associated tubing. It exercises syringes "A and "B", valves
"A" and "B," and solenoid valves 1, 2, and 4. System error checking is active.

APRIME
This program is used to isolate priming of the "A" large syringe for diagnostic evaluation or to aid in
syringe tip replacement. System error checking is not active.
BPRIME
This is used to isolate priming of the "B" small syringe for diagnostic evaluation or to aid in syringe tip
replacement. System error checking is not active.
Note: Each of the three valve programs below assumes the valves not being tested are working properly.
This means if V1TEST is run and fails, insure V2 and V4 are working properly before replacing V1.
V1TEST
This program should alternately dispense water through the probe and the wash well. The change in
dispense point is altered by the activation or deactivation of V1. If the valve is not working, the water will
always dispense from the probe. If the valve is stuck in the activated position, the water will always come
from the wash well. If one of the two diaphragms in the valve is partially clogged, one port will slowly
drip while the other is dispensing.
V2TEST
This program should alternately dispense water through the probe and the detergent container tubing. The
change in dispense point is altered by the activation or deactivation of V2. If the valve is not working, the
water will always dispense from the probe. If the valve is stuck in the activated position, the water will
always come from the detergent container tubing. If one of the two diaphragms in the valve is partially
clogged, one port will slowly drip while the other is dispensing. Follow instructions on the IMMULITE
display panel.
Another way of testing V2 is to suspend the detergent container above the instrument and check to see if a
drop begins to form on the end of the probe. If a drop has not formed within 10 minutes, the valve is
sealing properly.
V4TEST
This program works exactly like V1TEST. This program should alternately dispense water through the
probe and the wash well. The change in dispense point is altered by the activation or deactivation of V4.
If the valve is not working, the water will always dispense from the probe. If the valve is stuck in the
activated position, the water will always come from the wash well. If one of the two diaphragms in the
valve is partially clogged, one port will slowly drip while the other is dispensing. This program uses V1
to direct the flow in a direction that can be differentiated from the other.
Note: All valve testing should be performed substituting a cut length of probe tubing acquired from a
previous PM service, installed in place of the existing system probe. This is needed in order to observe
and evaluate possible movement of the locked liquid level near the tip of this valve test tubing. The valves
should never be tested using the real system probe, as this liquid level near the tip cannot be seen. For
further details of proper valve testing, refer to the Section 7.4.4 in Miscellaneous Repair Procedures.

PROBETST
This program will move the probe into the home well, dispense 3000ul at maximum velocity
(1000ul/second), move the probe up and over to the dump position, and repeat. Because it simulates the
washing of the probe during the main program, it is very useful in testing the integrity of the washing. For
centered in the home well, the water coming out of the probe would be uncontrollable and would "splash"
out of the well. Also an occlusion may be present if dripping from the probe occurs when it momentarily
locates over the dump well.
PROBANGL
This program is used to evaluate the dispense angle of the probe.

3.6.8 Sample Collection Tray
1
3
Description 1
This module collects the sample cups and holders ejected from the load chain so the user can recover
them for reuse. It interfaces mechanically with the load chain module. The main areas of interest are:
1. Removable tray
2. Tray housing
3. Tray-In-Place and Tray-Full Buffer Sensors
Sample Collection Tray Module Adjustments
Sample Collection Tray Module Test Programs

SAMPFTST
This program located in the system configuration diagnostics menu is used to check the sample collection
tray full sensor (located under the Sample Collection Tray). Follow instructions on the IMMULITE
display panel.
SAMPTTST
tray-in-place sensor (located under the Sample Collection Tray). Follow instructions on the IMMULITE
display panel.

3.7 Fluidics
3.7.1 Description
Although most parts of the fluidic system are a part of one of the modules already discussed, a section in
this manual has been devoted to addressing the combination of all fluidic parts as a whole. The
components involved in the fluidic system are as follows:
Tubing
An older style of tubing (DIBA), used on Instruments up to L4917, is made where the shape of each piece
and the flare at each end are formed by the application of heat. When damaged, the entire tube assembly
must be replaced.
Each piece of tubing that comes in contact with liquid used for test unit processing is Teflon. The shape
of each piece is formed by the application of heat. The newer style tubes (Upchurch) may be repaired to
create a new clean end and a new ferrule of the appropriate size is mated to the end of the tube (wider
end of ferrule toward the tubes end). This repair work can be done using the Upchurch Tubing Repair
Kit, P/N 420109. Each tube is numbered and has color-coded fittings for easy tube identification. Color
coding also corresponds to the type of fluid that will pass through the tubing:
Blue - Fresh water from the water container
Red - Substrate
Yellow - Detergent or detergent and water mixture
White - Fresh water used to rinse the wash well
Green - Water to be used in the test unit
Each tube has a fitting that is designed to be gently tightened only with the tightening fitting, supplied
with the repair kit. (The probe has a hexagonal fitting and can be tightened with a wrench). The proper
technique for seating the tubing and tightening the fitting is:
1. Move the fitting away from the flared end approximately 15mm.
2. Insert the flared end into the port (of the valve, coupling, etc.) until it "bottoms."
3. Move the fitting into the port and tighten until it "bottoms."
4. For fittings in valves, tighten the fitting another 1/4 of a turn.
5. For fittings elsewhere, tighten until snug.
Note: Over-tightening the fittings can damage the flared end, or ferrule fitting, or the silicone O-ring of
the tubing (where used). It can strip the port of a solenoid valve, or deform the inner shape of a rotary
valve. If any of the mentioned parts are damaged, they must be replaced for proper fluidics operation. If
tubings are of the newer design using ferrules, these tubes can be repaired using the Upchurch Tubing
Repair Kit, p/n 420109.
Rotary Valves (Hamilton Syringe Pumps only)

Two styles of rotary valves may be used. A former style has black-colored valve bodies, and this type is
replaced at the yearly PM. These valves have a molded Kevlar inner piece surrounded by an aluminum
body. The piece that rotates inside is Teflon and is driven by a DC motor within the diluter assembly.
These parts are extremely sensitive to over-tightening of the tubing fittings. If this were to occur, the
valve will either allow air to enter the syringe, or allow water to leak out the valve stem.

Around November 2002, these valves were changed to a higher quality choice. These valves have a white
ceramic body and this type of rotary valve is meant to be permanent, and needs no replacement. The piece
that rotates inside is Teflon and is driven by a DC motor within the diluter assembly.
No replacement or adjustment of these ceramic valves should be necessary, except to check for full proper
seating against the dilutor manifold and that they are well secured by the Cam-lever underneath (locked at
the 6:00 position). If not fully seated, air can enter the fluidics through the rear barrel of the valve.
Solenoid Valves
Rocker-type Solenoid valves are the current standard for both the Hamilton and Euro syringe pumps and
are also used on the Substrate/Water Linear Actuator Injector Pumps.
It is a three-way valve composed of two main components: a 24vdc solenoid and a self contained
manifold. The manifold contains a common, normally open, and normally closed port. When no
power is applied to the valve, the common and normally open ports are connected. Conversely, when the
24vdc is applied to the solenoid, the common and normally closed ports are connected.
The quality of seal is greatly affected by dirt or any other particles that could come between the elastomer seal and
the seat. This is why filters are used on the input lines coming from the water and detergent containers.
Probe
The probe is constructed of a stainless steel outer jacket, inner Teflon tubing, and outer Tygon tubing.
The probe is durable and will last quite a long time under normal operating conditions. In the vertical
direction the probe is very strong and will withstand the occasional forgotten cap on the reagent vials. In
the horizontal direction however, the probe will bend (but will usually spring back) quite easily. If the
probe were to be permanently bent, it will not position correctly over any of the X-pipettor locations and
must be replaced immediately. Since the probe is washed after pipetting each test unit, there is no need to
periodically remove the probe for cleaning. However, the probe should be cleaned in accordance with the
probe cleaning procedure.
Substrate and Water Injector Pumps
The Solenoid-driven MGM and Cirrus Wash Pumps, as well as the newer design of the Linear Actuator
stepper-motor driven Injector Pumps pump substrate and water into the assay tube during the spin/wash
cycle. The pumps interface via tubing to the water and substrate containers and the Luminometer module.
Syringe Module
The Syringe Module contains two diluter pump and syringe assemblies, one for large volumes (5000 ul)
and one for small volumes (250ul). The Syringe Assembly performs precision liquid transfer using
stepper motor driven syringes to pipette water, wash, sample, and reagent. It interfaces via tubing to the
water and wash containers and to the pipettor module.
Water and Detergent Containers
The containers used for the water and detergent are of polyethylene material. The water container will
hold 2 liters; enough for approximately 450 tests. The detergent container holds 1 liter; enough for 1000
tests. Each container has disposable filters that will prevent particles as small as 20 microns from entering
the fluidics system. Each container also has a porous plug in the cap that allows for air to fill the void
created by the loss of liquid.

Liquid Waste Container
The container used to hold the liquid waste is of a polyethylene material. It can hold approximately 3.75 liters,
enough for approximately 900 tests. It has a small vent hole in the cap for air to escape as the liquid level rises.
3.7.2 Pipetting Sequence

Syringe priming sequence at startup, during the in-cycle prime, and the PRIME diagnostic
program
1. Valve A to water jug 12. Valve 2 on (connect loop to detergent jug to
prevent pressurization)
2. Valve B to water jug
13. Valve 4 on (diverts flow from syringe A
3. Syringe A fill with 4000ul water
directly to tip rather than through loop)
4. Syringe B fill with 250ul water
14. Syringe A dispenses 2000ul into home well
5. Valve A to tip thru tip
6. Valve B to tip 15. Valve 2 off (disconnect loop from detergent
jug)
7. Valve 2 on (connects reservoir loop to
detergent jug) 16. Valve 4 off (restores normal flow from
syringe A)
8. Syringe A fills with 1000ul detergent (fills
reservoir loop halfway with detergent) 17. Valve 1 on (divert flow from syringe A to
wash well of wash station)
9. Valve 2 off (disconnects reservoir loop from
detergent jug) 18. Syringe A dispenses 1000ul into wash well
10. Syringe A dispenses 2000ul into home well 19. Valve 1 off (restore normal flow from
thru tip syringe A)
11. Syringe B dispenses 250ul into home well
thru tip
Loop flushing sequence (occurs at startup after priming is completed)

1. Valve A to water jug 7. Valve 4 on (divert flow from syringe A
2. Syringe A fills with 4000ul of water
8. Syringe A dispenses 1500ul of water into
3. Valve A to tip
home well to insure it is full
9. Valve 2 off (disconnect loop from detergent
dump well
jug)
5. Repeat steps 1-4
10. Valve 4 off (restore normal flow from
6. Valve 2 on (connect loop to detergent jug to syringe A)
prevent loop pressurization)

Main Pipetting Sequence
1. Valve A to water jug 16. Syringe B dispenses tip contents into test
unit
17. Syringe A dispenses a specific amount of
3. Syringe A fills with 3250ul water
water into test unit (volume of water is assay
4. Syringe B fills with water (amount is test dependent)
dependent)
18. Valve 2 on (connect loop to detergent)
5. Valve B to tip
19. Valve 4 off (restore normal flow from A
6. Syringe B fills with 5ul air slug syringe)
7. Syringe B fills with reagent (amount is test 20. A fills with 1000ul of detergent
dependent)
21. Valve 2 off (disconnect loop from detergent)
8. Syringe B fills with 5ul air slug
22. Syringe A dispenses 1500ul of detergent
9. Valve A to tip into dump well of wash station
10. Valve 1 on (divert flow from syringe A to 23. Valve 2 on (connect loop to detergent jug to
wash well of wash station) prevent loop pressurization)
11. A dispense of 1210ul of water to wash well 24. Valve 4 on (divert flow from A directly to
tip rather than through loop)
12. Syringe B fills with sample (amount is test
dependent) 25. Syringe A dispenses 1500ul of water
through tip into home well of wash station
26. Valve 2 off (disconnect loop from detergent jug)
syringe) 27. Valve 4 off (restore normal flow from A
syringe)
15. Valve 4 on (divert flow from A directly to

3.8 Instrument Temperatures
3.8.1 General Information

Within the IMMULITE system there are three areas of temperature control: the Luminometer and
Incubator Carousel are heated, and the Reagent Carousel is cooled. Aside from the areas that are
controlled, two other areas are also monitored: the ambient temperature of the electronics area and the test
unit processing area. For details on how the heating and cooling is measured and controlled see the
description of the Heater/DC Motor PCB in Chapter 4: Printed Circuit Boards.
Luminometer - (Blankets Cold Resistance should be less than 10 ohm.)
The Luminometer temperature is the most critical temperature in the IMMULITE system. It must be
controlled in the range of 36.9C - 37.1C to assure precise incubation of the Test Unit. The heater is a
75-watt etched foil type heater that is sandwiched between the base of the Luminometer module and the
lower part of the Luminometer housing. Since the Luminometer is a large mass of metal (aluminum) the
heater can take up to 45 minutes to be within normal range. On top of the Luminometer there is plastic
cover that will prevent any ambient air temperature change from affecting the Luminometer temperature.
The thermistor assembly that measures the temperature of the Luminometer is screwed into a hole located
directly behind the Luminometer chain motor assembly and connects to J7 on the Luminometer Interface
PCB. The DC resistance of this thermistor at 37.00C is 6013 ohms. The temperatures at which an alarm
will be activated are below 36.80C and above 37.20C.
Incubator Carousel Temperature (Blankets Cold Resistance should be less than 10 ohm.)
The incubator temperature is the second most critical temperature in the IMMULITE system. It must be
controlled in the range of 36.5C - 37.5C to assure precise incubation of the reagent, sample, water and
antibody coated bead. The heater is a 75-watt etched foil heater that adheres to the inside circumference
of the Incubator Carousel. The watt density of the heater is higher at the ends to prevent these areas from
being cooler. The warm up time of the Incubator Carousel is approximately 15 minutes. Around the two
sides and bottom of the incubator casting, foam insulation and a plastic cover keeps the temperature
uniform along the circumference. A clear plastic shroud on top of the casting and ring gear keeps the air
in the incubator casting at a constant temperature and protects the operator from coming in contact with
the moving ring gear. The thermistor assembly that measures the temperature of the incubator carousel is
screwed into a hole on the bottom side of the Incubator Carousel located at the 1:00 position of the
circumference, and then connects to J6 of the Incubator Carousel Interface PCB. The DC resistance of
this thermistor at 37.00C is 6013 ohms. The temperatures at which an alarm is activated are below
36.00C and above 38.00C.
Reagent Carousel Temperature
The amount of time the reagents are stable is directly proportional to the temperature at which they are
kept (the cooler they are kept, the longer the stability). The reagent carousel is cooled to an average
temperature of 16C by a thermal electric cooling device hereafter referred to as the TED. At instrument
power-up, the TED will begin to cool the reagent carousel only after the Incubator Carousel and
Luminometer have exceeded 35C. (This is to prevent a large current draw at power-up.) Under average
conditions (starting temperature of reagent carousel at 25C) the reagent carousel will take approximately
15 minutes to reach normal operating temperature. The thermistor that measures this temperature is
located on the upper right corner of the Reagent Bar Code Reader PCB and is identified as RT1 on the
PCB. The DC resistance of this thermistor at 16.00C is 15000 ohms. The temperature at which an alarm
will be activated is 22.00C.

System Ambient Temperature
This is the temperature of the cavity that is created when the main cover is closed. The temperature of this
area is monitored to alert the operator of rising ambient temperatures that could eventually cause a
problem with both of the incubation temperatures. The measuring thermistor is located on a small bracket
mounted on the incubator carousel motor assembly. The thermistor is connected to J7 on the Incubator
Carousel Interface PCB. The temperature at which an alarm will be activated is 34.00C.
Electrical Ambient Temperature
This is the temperature of the area where the main PCBs are located. The temperature of this area is
monitored to insure the main PCBs are operating in a relatively cool environment. The measuring
thermistor is located on the Heater/DC Motor PCB and is identified as RT1. The temperature at which an
alarm will be activated is 40.00C.
GENERAL TEMPERATURE INFORMATION

Incubator Reagent System Electrical
Luminometer
Carousel Carousel Ambient Ambient
Minimum
Control Range
Operating 36.90 36.50 16.0 N/A N/A

Temperature
Maximum
Operating 37.10 37.50 16.5 N/A N/A
Temperature
Lower Alarm
36.80 36.00 N/A N/A N/A
Temperature
Alarm
Range
Upper Alarm
37.20 38.00 22.00 34.00 40.00
Temperature
Minimum
displayable 34.XX 34.XX 11.60 11.60 11.60
Reportable
temperature
Range
Maximum
displayable 39.XX 39.XX 41.XX 41.XX 41.XX
temperature
6013 ohms @ 6013 ohms 15000 ohms 10000 ohms 10000 ohms
Thermistor Resistance
37.00C @ 37.00C @ 16.00C @ 25.00C @ 25.00C
Note: XX stands for the numbers that will vary depending on the circuit components of each specific
Heater-Motor PCB, and its controller circuitry.

3.8.2 Viewing Temperatures
The easiest way of viewing temperatures is to operate the IMMULITE as if tests were going to be
processed. Once the instrument is running for at least 1 minute, choose the "SYSTEM STATUS" option
(on the PC screen) and press <ENTER>. Then choose "TEMPS/DARK COUNTS" and press <ENTER>.
The latest temperature data sent to the PC from the IMMULITE will be displayed. New temperature data
will be sent to the computer every thirty seconds; to view the most recent information, press the space bar.
The average temperature data is the average of the last ten readings; therefore, it will only be displayed if
the instrument has been running for more than 5 minutes.
The quickest way of viewing the temperatures is to load a diagnostic program that will send temperature
data to the computer. The most commonly used diagnostic programs for this purpose is TEMPS
(PMTCOUNT, BKGNDCNT, or DARKCNT can also be used). Once the program is loaded and running,
exit to DOS and type PC; this will start the test-processing program. Answer the questions as usual (the
answers do not matter since the instrument will not be processing test units). The computer will try to
communicate with the IMMULITE, but will not be successful since the IMMULITE is "busy" running the
TEMPS diagnostic program. The monitor will display Cannot communicate with the IMMULITE -
Continue Running? (Y/N). Answer Y to continue.
The monitor will now display the Primary Screen. Choose "SYSTEM STATUS" and press <ENTER>.
Then choose "TEMPS/DARK COUNTS" and press <ENTER>. The latest temperature data sent to the
computer will be displayed. Using TEMPS, new temperature information will be sent to the computer
every ten seconds; to view the most recent information, press the space bar. The average temperature data
is the average of the last ten readings. Therefore, it will only be displayed if the instrument has been
running for more than 2.5 minutes.
The Operators Temperature Screen is depicted below.

Remember:
1. The temperature display does not automatically update; the space bar must be pressed for the most
recent information to be displayed. To verify if the displayed data is current, compare the time of the
read with the current time displayed in the upper left corner of the screen.
2. The instrument must be running a program that sends information to the computer in order for the
temperature data to be valid.
Note: When finished checking temperatures, be sure to log off properly.
Suggested procedure for viewing temperatures by Field Engineers

The raw data acquisition program GETDATAT can also be used to view temperatures. See section 8.3
Running GETDATAT for more information. This will post all five temperature parameters in real
time, every ten seconds, and this is usually a more useful viewing mode for the Repair Engineer.
When it is desired to print the real time temperature readings in this program, the FSE must let the screen
fill with three fresh blocks of data, then use the Print Screen key. Then let the screen update with three
more fresh readings, and press Print Screen again. In this way, up to six temperature updates can be
captured on one sheet of paper.
The real time temperatures are shown as the bottom line of each of these blocks of raw data.
A depiction of six temperature readings on one sheet of GETDATAT is shown below:

3.8.3 Heater and Cooler Shutdown
In the event the temperature control circuitry cannot establish or maintain one or all temperatures within a
certain range, the controlling circuitry assumes an irreversible condition exists and will shut down the
operation of the heaters and/or cooler in order to protect the instrument from possible damage. If one or
all of the temperatures are out of the normal operating range but not past the shutdown limits an error will
be posted on the computer, but nothing will enter into shutdown mode. For example: the reagent carousel
temperature rises to 23C due to the cover of the reagent carousel housing being left open for an extended
period of time. The error will be posted on the computer and the temperature control circuitry will attempt
to bring the temperature down for an indefinite period. Since the temperature is not above 30oC, the
cooler shutdown timer will not be activated.
If a condition exists that sends the Temperature Controller system into a full shutdown, a default code of
45.xx will be posted into the address location of the Luminometer temperature. Though the Luminometer
may not necessarily have been the cause of the shutdown, this value will always be posted into the
Luminometer parameter. It is just default display indication of a full shutdown condition.
If a Heaters/Coolers Shutdown or a Full Temperature Controller Failure condition exists an error

messages will be seen on the display (red alarm box) and on the printer.
Note: In the event a short circuit occurs in one of the transistors that controls the power applied to a
heater (resulting in full power applied to that heater), a thermostat will terminate the power to that heater
when the temperature of the heated device reaches 45C. The thermostat will allow current to flow to the
heater when the temperature of the device decreases to 43C. While it is not permissible to process test
units at this elevated temperature, no damage to the Luminometer or Incubator Carousel will occur if
these temperatures are reached.
A full Temperature Controller shutdown occurs under one or more of the following conditions:
Luminometer and/or Carousel temperature is less than 35C for more than 60 minutes
Luminometer and/or Carousel temperature is greater than 39C for more than 10 minutes
Reagent Carousel temperature is greater than 30C for more than 30 minutes
Reagent Carousel temperature is less than 15C for more than 10 minutes
Note: The only way to reset the Temperature Controller circuitry after a full shutdown is to turn the
instrument off, wait ten seconds and then power the instrument back on.

3.8.4 Temperature Controller Status Indicators
There are four LEDs on the Heater/ DC Motor PCB that indicate the status of the Luminometer heater,
Incubator Carousel heater, Reagent Carousel cooler and the controlling microprocessor. The controlling
microprocessor LED also called the time hack indicates that the microprocessor is active. The other three
LEDs indicate what the transistors that control the heaters and cooler are instructed to do, not necessarily
what they are actually doing. For example, if the source to drain junction is shorted on the transistor that
controls the Incubator Carousel that temperature will quickly rise. Once the temperature rises above 39C
(for 10 minutes) the microprocessor will instruct the transistor to turn off and the Incubator Carousel LED
will indicate the same. Since the transistor is shorted, power is still being applied to the heater. Therefore,
the activity of the heater and cooler LEDs is a reflection of the reported temperature of that particular
device, except if the microprocessor has chosen to shutdown the heaters and/or cooler.
TEMPERATURE CONTROLLER STATUS LEDS

LED # L4 L3 L2 L1
Luminometer
Identity TED (Cooler) Carousel Heater Time Hack
Heater
Microprocessor has had

LED Lum temp is below Car temp is below a fatal error. The status
Temp is above 16.5C
"ON" 35C 35C of all other LEDs is
invalid!
- Temp is below 16.5C

- Lum temp is above - Car temp is above
- Cooler has shut down 39C 39C Microprocessor has had
LED due to a heater or cooler a fatal error. The status
"OFF" temp error. - A Full Temperature - A Full Temperature of all other LEDs is
Controller Shutdown Controller Shutdown invalid!
- Lum and/or carousel has occurred. has occurred.
have not reached 35C
Heaters and cooler have Heaters and cooler have

Microprocessor is
LED Heaters and Cooler shut down due to Lum shut down due to car
functional and the CPU
Blinking have shut down due to temp high error. A Full temp high error. A Full
and Motor Driver PCBs
@ 1hz cooler temp error. Temperature Controller Temperature Controller
are in communication.
Shutdown has occurred Shutdown has occurred
LED
Lum temp is above Car temp is above 35C
Blinking N/A N/A
35C and below 39C and below 39C
@ 5hz

Rear LED Indicators:
The Temperature LED indicators are

easily visible through this slot in the
cover hinge, between the support
struts.
The order Left to Right of the LEDs

is # 4 1:
TED, Lum, Carousel, Time Hack
3.8.5 Effectively Troubleshooting Temperature Problems

Tips on properly changing the Thermal Electric Device (TED)
The newest Melcor model (as well as the previous model by TE Technologies), come as a
replacement kit, with a new heat transfer pad & a small foam gasket for placement into the
channel around the chamber plate above. Complete instructions are enclosed, and remember
important replacement notes:
Proper flat metal-to-metal contact
Presence of the Heat Transfer Pad
Placement of foam gasket around bottom

plate of the Chamber above
Tips for effective temperature problem-solving

Successful troubleshooting is very dependent on a full understanding of the theories of operation, so
piece together evidence from all sources:
Current temperature readings (use real time readings of the TEMPS diagnostic program).
Behavior of the four temperature LEDs in rear electronics.
Exact wording of Error Messages relating to the problem.
Are errors constant, or intermittent?
If circuits have shutdown, gather evidence, re-set Instrument logic, and re-evaluate readings and
LEDs after warm up time, in order to trace the true problem.

Use of the temperature diagnostic TEMPCAL in order to check the PCB Circuits
Found on the Configurations menu, this program helps determine if the true source of the trouble is
the temperature controller circuits, or else within the system itself. A value displayed out of specified
range would confirm the suspicion of the shutdown problem to be sourced at the Controller PCB, and
it is recommended to replace it, as there is no repair or re-calibration possible for the calibrator
resistor circuits.
The test indicates the calibration values of the 35-degree, and then the 39-degree calibrator
resistor circuits that control Reportable Range of the two heaters. Follow the instructions on the
IMMULITE display panel for any reading out of the following ranges:
Nominal value for the 35 Degree Calibrator is within a range of 3,800 - 4,401.
Key Points of operational theory for temperature display and control

The signal devices are NTC Thermistors
NTC = Negative Temperature Coefficient For rise in temperature, there is a drop in
devices resistance value reported to temperature control, and vice-versa.
This inverse relationship is essential to properly understanding any troubles.
Luminometer and Main Carousel only report real numbers in a reportable range of 35 -39C:
If the reading is frozen at 34.xx, check power to heater.
If the heater is getting power, then 34.xx may be an open circuit for anywhere along the
path of the thermistor signal to the Temperatures Mtr./Htr. PCB.
Reasons for 34.xx could also be an open or shorted heater blanket, but this is rare.
If the heater is reporting 39.xx, then the opposite is true: heater is overheated, or the
devices signal is shorted.
Reagent (and the 2 ambient monitors) can report a wider range of reportable numbers - 11.6C
42C.
If Reagent or two ambient temperatures report 11.6C, then there is always an open
thermistor signal path. (The Reagent cannot cool to such a low degree!!)
If Reagent is reporting 17C 19C, this usually indicates failure of one of the two inner
Peltier devices, which means imminent failure of the entire TED.
If Reagent is reporting a temp of 20C 27C, but the TED is running (fan breeze
underneath, and rear LED #4 on left is on) and the chamber feels warm, then this is
clear indication of a failed TED, which needs to be replaced.
Reagent will not come on at all, until both Heaters are first satisfied to above 35C, and
into displayable range.

Troubleshooting the cause of a full Temperature Controller Failure and Shutdown
Keep some key theories of shutdown operation in mind, in order to properly determine the true cause:
Upon the moment of controller circuit shutdown, all temperatures will freeze on the last
reported real temps at the moment of the shutdown. This would be very important to
investigation of the true cause.
Do not yet reset the Instruments power to restart the temperature control circuits. In doing so, you
will spoil an important piece of evidence.
View the readings in the real time environment of GETDATAT, after loading the TEMPS
diagnostic.
On the printout, take note of all temperature numbers, as these were the last true readings at the
time of shutdown:
Take note of the false reading of 45.xx at the Luminometer parameter. This is simply
the visual confirmation that the controller is currently shut down, and all temperatures
are turned off.
One of the five parameters is likely to report an abnormal reading and that is the likely
parameter that is the cause of the temperature shutdown. If all other numbers besides the
Luminometer looked like normal readings at the time of shutdown, then the likely cause
is the Luminometer. Though its final reading was overwritten by the false 45.xx, after
instrument reset, the Luminometer can be focused on to determine its problem.
The rear Temperature Indicator LEDs may or may not help reflect the parameter that is
truly at fault. In the case of the heaters, this is dependant upon the specific controller
circuits of that PCB. HOWEVER, if the TED is the cause of shutdown, the rear LEDs
will show numbers 1 (time hack) and 4 (TED) blinking slowly on/off together, or
alternating. This may also be true for the heaters causing shutdown, but in either case,
this unusual LED behavior confirms the circuits are currently in shutdown.
After gathering ALL the available evidence, then reset Instrument power, and observe the
temperatures after a warm-up, to then observe the improper operation of the troubled parameter.
This can confirm proper diagnosis.

3.9 IMMULITE Software Programs
When the "RUN IMMULITE" option is chosen from the Start Up Menu a number of files are
automatically loaded to the IMMULITE. The files and a description of each are as follows:
1. LO***.HEX - The Low Level Program
This program contains the assembly code and subroutines called upon by the high level program.
2. HI***.HEX - The High Level Program
This program contains the specific commands that call the subroutines in the low level code. For
example a typical command found in this program is "Pipettor X to home position." That command
calls a subroutine in the low level software that moves the X pipettor in a counterclockwise direction
and checks the X pipettor home sensor after every step the motor takes.
3. VOL***.HEX - The Volume Table
This table defines the amount of sample, reagent, water that are used to process every type of test
available in the current version of software. When a test unit is about to be pipetted, the low level
program checks the volume table to see how far to move the syringes for a specific volume.
4. MESS***.HEX - The Message Table
This table contains all the messages that are displayed on the IMMULITE vacuum fluorescent
display. This table currently holds approximately 75 different messages. When the high level program
must give the operator specific information or must ask the operator for information, it instructs the
low level program to display a specific message number. The low level program than retrieves the
text for that specific message number and sends it to the display.
5. ERR***.HEX - The Error Routine Program
This program contains specific routines that are called by the low level program in the event a motor
comes upon an error. (Refer to "CONFIGURATION TABLE- Parameter Error Number" for more
information). For example, if the load chain moves more than the number of error steps allowed, a
problem is assumed and corrective action must be taken. The low level program will then retrieve the
load chain error routine and run it. The success or failure of the routine will determine if the low level
program allows the load chain to continue to operate or terminates operation in the instrument
(resulting in front end shutdown). The corrective action is different for every motor in the instrument,
therefore every motor has a separate routine in the error routine program.
6. IMMXXX.CNF - The Configuration Table (Instrument specific)
This is the table that contains the settings for all the motors. Refer to section 7.2 The Configuration
Table for more information.
*** As the software is updated, these characters may also change to reflect the new software version
number. For example, with software version 4.3 the high level program is called HI43.HEX.
Note: For information on utility programs and procedures, refer to section 7.4 Miscellaneous
Procedures. For information on Diagnostic programs, refer to Chapter 8 Diagnostics.

Export Utility Program
Patient reports can be consolidated using the export program. This program allows the operator to access
data by test time and date and test type. The information can be viewed, printed, or saved in ASCII
format to a diskette The ASCII file is compatible with other software (i.e. spreadsheets).
Note: Export is not a menu option. You must exit the IMMULITE software to run this program.
To run the export program, follow the steps below:

1. From the Start-up menu, select EXIT TO DOS.
2. Type export and press [Enter]. The following screen appears:
3. Type 3 characters (at least one character must be entered to continue). The following screen appears:
4. At the Enter the starting date prompt, type the starting date (the year must be four digits) for
generating the data or press [Enter] to accept the default start-date.

Note: Information for the past 31 days can be generated. You can generate either a single day or
several days at once.
5. At the Enter the ending date prompt, type the ending date (the year must be four digits) or press
[Enter] to accept the default.
Note: The test time is the time the sample cup was read at the Barcode Reader or entered into the
worklist - not the time the Test Unit was measured by the PMT.
6. At the Enter the starting time prompt, type the starting time for generating the data or press [Enter]
to accept the default start-time.
7. At the Enter the ending time prompt, type the ending time or press [Enter] to accept the default.
8. At the Enter the test type prompt, type the Test Code or press [Enter] to accept the default (which is
ALL test types).
9. Results for controls, Adjustors, and patients can be printed together or separately. Select either:
1 - Control
2 - Adjustors
3 - Patients
4 - All
The following screen appears, giving the option to print, display, or put the data on disk.

10. Type the appropriate letter (P, D, A, B, or C), as desired. The following is an example of export data:
The export output file includes:

Sample cup holder number
Test Code
Accession number
Patient last name
Dose (concentration result)
Dilution factor
Response (in cps)
Kit lot
Analysis time
11. Press [Enter]. The following prompt appears:
12. Press [N] to exit or [Y] to continue retrieving data.

If [N] was selected, the c: prompt reappears. Type start and press [Enter] to access the Start-up
menu.

The On-line Tutorial
The On-Line Tutorial (or IMMULITE On-Line Reference Software) includes explanatory text,
drawings, photo-quality images of the IMMULITE System, and computer animation of various critical
system functions. Overall, it constitutes an interactive environment for:
reviewing the IMMULITE operating software, instrument operation, and assay chemistry
training secondary instrument operators
performing routine maintenance and diagnostic procedures
troubleshooting the system components
The tutorial is a mouse-driven program with a graphical user interface, which allows fast and easy access
to information without searching through long menus or using the keyboard. More information regarding
system components and concepts can be accessed by simply selecting the item using the mouse.
The tutorial can be accessed from either the Start-up menu or the DOS prompt.
From the DOS prompt, type tutorme and press [Enter].
From the Start-up menu, select Tutorial.
The tutorial allows the operator to access information using either the mouse or the keyboard. When the
operator moves the pointer and clicks on an area of interest, the system presents more information on that
subject.
MOUSE
To use the mouse, simply move the mouse to point to the item of interest and click on the item by
pressing one of the mouse buttons.
KEYBOARD
The cursor (or pointer) can also be moved using the arrow keys. After moving the cursor, select the item
by pressing either the Insert or the Delete key.
To exit the tutorial software:
1. Return to either the Main Menu or the Checklist screen
2. Either click the Exit button or press [F12].
To run the IMMULITE operating software after exiting the tutorial, type start and press [Enter] at the
DOS prompt.
CAUTION: Always leave the tutorial by selecting the Exit button or by pressing [F12]. If you exit the
program by any other means, or if a software error causes the program to stop, reboot the system by
turning the computer off, waiting ten seconds, and turning it back on.

The tutorial main menu options include:
Instrument
Software
Chemistry
Checklist
Index
Exit
The Instrument, Software, and Chemistry menu options include a general overview and access to more
detailed information. The Checklist menu option provides the steps taken during a normal IMMULITE
operators day. The Index menu option provides a listing, by category, of all topics contained in the
IMMULITE On-Line Reference Software.
To select a menu option, use the mouse to move the pointer to the desired item and click (by pressing one
of the mouse buttons).
INSTRUMENT
After selecting Instrument, a photo view of the IMMULITE appears, with the lid raised and all the
working components labeled. If the operator selects an individual part or module, an explanation of its
function can be seen. By pointing to and clicking on the boxes contained in the explanation, more
information can be accessed, including troubleshooting and maintenance assistance.
Each of the instrument module screens shows a photo view of the instrument with the selected module
circled, and a close-up view of that module. The primary module parts are identified. Some module
screens include animation to show how the module functions.
A general description of an instrument module contains hot buttons that connect with other module
descriptions. A larger photo view or drawing can also be selected. The operator can return to the
Instrument Menu or the Main Menu by simply clicking on that option.
SOFTWARE
Select Software to view examples of the IMMULITE operating software screens.
Software Overview accesses the IMMULITE Primary screen, which contains information regarding
samples, tests, and reagents on the instrument. From the Primary screen, selecting the Main Menu
options provides an explanation of each option.
CHEMISTRY
The Chemistry selection accesses information about the IMMULITE's enzyme-enhanced
chemiluminescence, master curve generation, two-point adjustment, and internal calculations used to
determine the final patient result. The operator may select the overview or more detailed information on
each topic.

CHECKLIST
The Checklist selection accesses the steps required to run the IMMULITE during an average day,
including start-up, running, and shutdown activities. The operator may select the overview or more
detailed information on each topic.
INDEX
The Index provides a listing, by category, of all topics contained in the IMMULITE On-Line Reference
Software. For information regarding a specific topic or question, select Index and click on the desired
topic.

Chapter 4: Printed Circuit Boards
4.1 Introduction
This section contains descriptions of the Printed Circuit Boards, or PC Boards. Refer to the Assembly and
Schematic Manual part number 600240 for actual drawings of the boards.
4.2 CPU/Sensor PCB

Description
Communicates with the computer, monitors all stepper motor
sensors, and valves, communicates with syringe pumps using
slave CPU, and communicates with heater control CPU (located
on DC motor/heater control PCB).
Theory of Operation
The heart of the IMMULITE's CPU board is the ZILOG Super 8
microcontroller. This versatile IC features 40 programmable I/O
lines, two 16 bit programmable counter/timers, an on chip
oscillator, DMA controller, a full duplex UART, 272 general
purpose registers, a sophisticated interrupt structure, and an
instruction set that supports multiply and divide instructions. A
single Super 8 microcontroller is used to perform the following
real time functions of the IMMULITE:
1. Control all the electro-mechanical motions except for those
of the syringe pumps.
2. Process all sensor and user control signals.
3. Message generation for the vacuum fluorescent display.
4. Reading and interpretation of the bar code label information.
5. PMT pulse counting.
6. Supervision of all data flow between the 3 processors on board the IMMULITE, and to the IBM
compatible PC.
Beginning at power on, the IMMULITE goes through its initialization routines. Program instructions stored in
EPROM #1 are accessed with 15 bit addressing. The lower byte is obtained from port 0 of the Super 8 and
latched from the address/data bus. Port 0 is wired to a multiplexed bidirectional address/data bus. The upper 7
bits of the address are gotten from port 1, which is dedicated to addressing. Program instructions from the
EPROM and data from the non-volatile static RAM are then placed on the data bus to be read by the
processor.
Note: The red DIP switches near the boards top edge do not affect system operation of this PCB, and are
only used for final vendor testing of PCB performance.

The memory mapped input output (I/O), only requires the lower byte of the full 15-bit address for data
transmission. The upper byte of the address is generally decoded for the I/O space. When an I/O function is to
be performed, the lower byte of the address is latched. The address is then decoded to select the proper data
path. For an output operation, data from the processor is placed on the data bus and this data is grabbed by the
proper output latch dependent upon the correct address decoding. For an input operation, the opposite takes
place, and information from a sensor is gated by one of 6 input buffers. When the proper input device is
selected via the address decoding, the sensor signal is placed on the data bus to be read by the processor or
stored in RAM to be processed at a later time.
Additional independent I/O ports of the Super 8 are used to process IMMULITE information. Separate input
port lines are used to read the conditioned signal from the sample/assay barcodes, the reagent carousel bar
code reader circuit. An additional port line is used to count the pulses produced by the signal conditioning
circuitry of the photo multiplier tube(PMT).
A second Super 8 resides on the CPU board. This processor, part of the IMMULITE's parallel processing
system, is used to control the operation of the syringe pumps. The controlling Super 8 sends pump commands
to the syringe pump CPU through the dual port RAM via the bi-directional data bus and the address bus
labeled BA. When the commands for the pump are received by this processor, the main CPU is free to process
information for other parts of the IMMULITE system. The Super 8 controlling the syringe pumps then
interprets this data to determine the type of operation required of the syringe pump. Numerical data must be
converted from hexadecimal to decimal base, binary information must be converted to ASCII format, and the
proper control characters for pump operation must be generated. When the commands have been processed,
the syringe pump Super 8 sends the serialized data to the syringe pump using the on board universal
asynchronous receiver transmitter or UART and an RS232 conversion IC. The syringe pump Super 8 also
receives information from the pump via the RS232 port describing status and error conditions.
Acknowledgement that the command has been received and the task properly carried out is controlled by the
Hamilton CPU. Upon completion of the pumping operation, the Hamilton Super 8 sends the appropriate
response to the main CPU through the dual port RAM.
As well as controlling data transmission within the IMMULITE, the main Super 8 microcontroller manages
the data flow between the IBM PC and the IMMULITE through its on board serial data path and an RS232
level shifting IC.
4.3 Stepper Motor Driver #1

Description
Contains the drive circuitry for the following stepper motors:
a. Main carousel
b. Load chain
c. Reagent carousel
d. Pipette X
e. Pipette Z

Theory of Operation:
Nearly all of the mechanical motion of the IMMULITE is performed with the use of four phase unipolar step
motors. All the motors are driven with a single common circuit designed to meet a wide variety of system
demands including mechanical power, positional resolution, power efficiency, and low cost. At the center of
this circuit is the L297 step motor controller. This single integrated circuit provides the step motors with pulse
width modulated current control, all the decoding logic necessary to sequence the motor phases properly, and
the ability to control both two phase or four phase motors. Because of the versatility of this IC the CPU
controlling the motor is relieved of much of the responsibility for motion control. The CPU only needs to
provide step and direction data to the control IC to achieve motor operation.
Beginning with power on initialization information from the main CPU is gated by the address and data
buffers on the step motor PWB. The initialization data sets up the motor controllers for full step, four phase
motor operation. After initialization, a motor will step when its address is decoded and a step pulse is sent to
the controller. Each time a step pulse is received by the controller, its internal translator causes the proper
motor phase winding to be energized which in turn causes the rotor to advance one position. The step motor
remains in this position until a subsequent step pulse is received.
When a motor phase is energized, a single MOSFET power transistor is turned on, allowing an electrical
current to be passed through the phase winding. To improve system efficiency and performance, the current
level circulating in the phase winding is controlled using pulse width modulation, PWM. A current sensing
resistor of low value is used to develop a voltage proportional to the winding current. This voltage is
conditioned to eliminate noise, and then sent to an input of the control IC. This input line is internally
connected to one port of a voltage comparitor. The other input to the comparitor is connected to a digitally
selectable voltage reference. The voltage reference is used to set the maximum allowable current supplied to
the motor winding. When the voltage developed by the sense resistor is equal to the reference voltage, an
internal flip flop is reset, causing the control IC to turn off the power transistor that allows current to pass
through the motor winding. An internal oscillator running at 24 kHz sets the flip flop and turns on the
transistor before the motor current has decayed below its set point value. In this way, the current passing
through the motor phase winding appears to remain constant, even though the power transistors driving the
motor windings are being turned on and off.
When the motor is not being used to actively drive a mechanical load, the reference voltage used to control
the magnitude of the phase current is digitally switched to a lower value. This will result in a lowering of the
current in the motor winding. Lowering the motor current will reduce the energy consumption of the system
while maintaining the fixed position of the mechanical load.
Motor protection in the form of a positive temperature coefficient (PTC) thermistor is provided. In the event
of a short circuit occurring in the system, the PTC devices, normally a low impedance device, would heat up
in 15 seconds of time. When the protection devices heat sufficiently, their impedance rises to a very high
value, thus shutting off the current to the load. The devices remain in this high impedance state until the short
is removed from the load.

Description
a. Luminometer chain
b. Shuttle
c. PMT attenuator
Note: Positions d and e, as per illustration on page 4-2, are not used on this Motor Driver #2 PCB.
The board is identical to the Stepper Motor Driver #1 except for switch settings.
4.5 Heater/DC Motor PCB

Description
Contains the drive circuitry for the following:
a. Solenoid pumps
b. Hamilton module valves
c. High speed spinner motor
d. Sample tube barcode reader motor
e. CPU, data acquisition, and control circuitry to drive
the heaters and cooler.
Circuit Description:
The heater/DC motor board performs the following control functions for the IMMULITE system: (1)
temperature measurement and control of the Luminometer, the Main Carousel Incubator, the Reagent
Carousel, the PC board housing, and the ambient temperature within the instrument package, (2) velocity
control of the reaction unit wash operation, (3) velocity control of the sample/assay bar code motor, (4)
power distribution to the solenoid valves and the wash fluid and substrate pumps.
To provide the temperature control critical to the performance of the IMMULITE system; a dedicated ZILOG
Super 8 microcontroller is used to process temperature measurement data in real time, and in response,
control the amount of heat applied to the assay incubator and luminometer and remove heat from the reagent
carousel. Temperature control begins with the precise temperature measurement at key system positions. A
semiconductor negative temperature coefficient (NTC) thermistor with a guaranteed measurement accuracy of
0.05 oC is embedded in the Luminometer and Main Carousel housings. This assures that the temperature of
measurement is as close as physically possible to that of the reaction temperature. The resistance vs.
temperature curve of the thermistor is linearized with a full bridge network. The bridge components consist of
high precision resistors, 0.1 % tolerance with a temperature coefficient of 25 ppm, and it is driven with a high

precision band gap voltage reference. The components were selected to provide signal linearization while
limiting the worst case power dissipated by the thermistor to 10 microwatts, thus eliminating any drift in
transducer accuracy due to self heating. This results in a bridge output signal of 424 microvolts / 0.1 oC over a
temperature range of 35 to 39 oC.
Four thermistor inputs are processed by the high precision section of the temperature measurement circuitry.
These are the signals from the Luminometer, the Main Carousel Incubator, and the 2 calibration resistors used
to set the system linearity each time the IMMULITE takes a series of measurements. The signals from these
sources are routed through a differential multiplexer was chosen for its low leakage currents and its ability to
reduce the magnitude of the common mode noise impressed on the low level signal. This signal is amplified
by an instrumentation amplifier with a gain of 233. The differential low level signal is converted to a single
ended output covering the full dynamic range of the amplifier optimizing the resolution of the signal when it
is converted to a 16 bit binary value.
This amplified signal, proportional to temperature is then passed through an analog switch, buffered, and
converted to a digital signal using a dual slope A/D converter. The digitized signal is then processed by the
Super 8 microcontroller and a special algorithm, stored in the EEPROM, designed to provide proportional and
integral type control of the system heaters. The measurement and control system is capable of maintaining the
temperature of the Luminometer at 37 +/- 0.1 oC. and that of the Main Carousel Incubator at 37 +/- 0.5 oC.
A second group of bridges and thermistors is used to measure the temperatures of the Reagent Carousel, the
main electronics housing, and the ambient temperature of the system itself. The temperature measurement
range of these areas is wider, 15 to 40 oC, and a less demanding degree of accuracy. Therefore, some
precision is sacrificed to keep the processing circuitry simple by using the high precision circuitry as a
calibration reference for this low precision circuitry. The signals are processed exactly as those of the high
precision circuitry, using good quality components. A second instrumentation amplifier with a gain of 43 is
used to convert the differential signal to a single ended output using the full linear range of the amplifiers
capability. This signal is also selected, buffered, and converted to a digital signal with the same dual slope
A/D converter as the high precision circuit.
Control Theory:
The operation of the heater/cooler control system is completely independent with respect to the main system
control. Data passed from the heat control CPU to the main control CPU consists only of the raw temperature
values. In return, the main CPU will only communicate with the heat control CPU when an error condition
within the system has been detected. All data is passed back and forth through a dual port RAM, capable of
storing data until the respective processors can service the interprocessor messages.
At power up, the heat control processor is activated. After a delay of approximately 20 seconds (so as to
prevent a power surge) the heater outputs are simultaneously turned on at over 99% of full power to bring the
system to temperature in the shortest possible time. After the luminometer and incubator carousel have
reached 35, the cooler is then activated. Two of the input signals to the high precision circuit are produced by
the calibration resistors resident on the printed wiring board (PWB). These high precision resistors produce a
bridge voltage representing the thermistor signals produced at exactly 35 and 39 oC. Under processor control,
the proper signal is selected, and routed through the addressable multiplexers and analog switches. The
control measures these voltages after a period of time, which allows the electronic circuits to rise to operating
temperature. This reduces the effect of temperature drift on measurement accuracy and precision. The control
algorithm performs a two point calibration based on the end point signals produced by the high precision
resistors. This sets the accuracy and precision of the entire temperature control system. This dynamic
calibration is performed at the beginning of every measurement cycle. It takes into account the small
inaccuracies caused by component offsets and eliminates the need for potentiometer trimming while
eliminating the long term effects caused by aging. The calibration of the lower precision measurement is
mathematically derived from the high precision values.

After calibration, the control algorithm makes periodic measurements of system temperatures and determines
the quantity of heat required by each system component. The processor then turns on the driver for the heater
or cooler for the appropriate amount of time. A proportional algorithm keeps the system temperature within
the correct range, while an integral algorithm eliminates the effect of varying ambient temperatures within the
systems operating specifications. The temperature controller stays on as long as the IMMULITE is powered
on to keep the system at the proper operating temperatures.
Motor Control:
This PCB also contains two DC motor velocity controllers. One (R120) is used to control the velocity of the
sample/assay bar code motor. The other (R107) is used to control the high speed wash station motor. Control
of the proper motor is performed by the main system CPU. The address sent out on the bus is decoded and the
data is latched by the circuitry on the board. The only control signals generated by the main CPU are to turn
on, off, and to brake the high speed motor.
The high speed wash motor is a special design of a 3 phase brushless DC motor produced for Siemens
Diagnostics. This motor was designed to meet the IMMULITE system requirements for small size, high
torque, and rapid acceleration. Control of the high speed motor is accomplished with the use of a chip set
from the Motorola corporation. This set consists of a controller IC, a full 3 phase power MOSFET bridge
driver, and a velocity detector. This chip set is used to produce the proper phasing sequence of the motor
windings, establish the pulse width modulation frequency, limit the motor winding current, and control the
velocity of the rotor.
When the enable signal from the main processor is received by the control IC, then a leg of the bridge driver
supplies electrical energy to a phase winding of the motor. Hall effect devices internal to the motor, monitor
the rotation of the rotor and return to the control IC a TTL level signal that determines the sequence in which
the motor windings are turned on and off. The amount of current flowing through the motor winding is
measured by the sense resistor at the base of the bridge driver. This current is limited to the rating of the
winding to avoid damage to the motor. A comparator internal to the control IC will turn off the winding when
this current level is reached. When the motor is first turned on, the winding will draw as much current as
possible to generate the large amount of torque required to accelerate the motor as quickly as possible to its
final velocity.
As the motor comes up to speed, the Hall effect device signals used to sequence the phasing of the motor
windings are sampled and integrated by the velocity detector. The output of this detector is a DC voltage that
is proportional to the speed of the motor. This is filtered to eliminate noise, and fed into the inverting input of
an op amp internal to the control IC. This op amp is configured as an inverting differential amplifier. The
other input to the amplifier is connected to an adjustable reference voltage which is used to set the motor
velocity. The output of this amplifier is used to the vary the duty cycle of the pulse width modulator in the
control IC. The motor will accelerate to the speed required to produce a detector voltage equal to the setting
of the reference voltage. If the detector voltage is less than the reference setting the motor speed will increase,
if the detector voltage is greater than the reference, the motor will slow down. This feedback control circuit
keeps the motor speed constant to tight tolerance without the use of an external shaft encoder keeping parts
count minimal and maintaining overall lower costs without sacrificing system performance.
When the enable signal is removed, the brake signal is applied to the control IC. This causes the motor
windings to be shorted together. This dynamic braking action brings the motor to a stop more quickly than
simply allowing the motor to coast.
The bar code motor circuit is also configured as a feedback control network. An oscillator internal to the
control IC sets the PWM frequency at approximately 4.8 kHz. When the enable signal is applied to the control
IC, the output of the controller turns on the PNP power transistor at the PWM frequency. This supplies
current from the power supply to the motor winding causing it to rotate. Because of physical constraints, the
motor and gearbox had to be positioned in a very small space.

There was no room for any type of encoder which could be used to control the motors velocity. It was decided
to control the motors velocity by measuring its back EMF, a voltage generated by the motor when it is
rotating and not being energized by the power transistor. When the controller turns off the power transistor, a
555 timer IC, used as a one shot is triggered. This produces a timed pulse used to enable the sample and hold
amplifier to measure the rotating motors back EMF. Since the motor is rotating, and the power transistor is
off, this back EMF is proportional to the speed of the motor. The magnitude of the back EMF is divided down
by R1 and R2 to limit its value and is then stored by the sample and hold, ( S/H ) amplifier. The output is then
low pass filtered to eliminate noise and sent to the inverting input to an op amp internal to the control IC. The
other input to the op amp is connected to an adjustable reference voltage which is used to set the motor speed.
The output of the amplifier is used to set the duty cycle of the pulse width modulator. In this way, the amount
of electrical energy sent to the motor windings is proportional to the difference between the set point voltage
and the back EMF generated by the motor. If the load on the motor increases, the speed of the motor will slow
unbalancing the amplifiers input and causing the output of the controller to apply more current to the motors
winding, thus causing its speed to increase toward the set point. If the motor load decreases, the opposite
takes place, the pulse width decreases, because the motor requires less energy to maintain its angular velocity.
Additional Circuits:
In addition to the motor and heat controls, the PWB supports the capability of turning on 8 general purpose
loads. For the IMMULITE, these loads consist of several solenoid valves, and the two injector solenoid
pumps supplying the system with water for bead washing, and the luminagenic substrate. The main control
CPU controls these devices and determines when and for how long to turn them on.

Chapter 5: Specifications
The following table describes the performance characteristics and specifications of the IMMULITE
Analyzer.
Specifications
General Standard Mode Throughput: Up to 120 tests per hour
Specifications:
Time to first result: 42 Minutes
(or 72 minutes for two cycle assays)
Tests per sample: Up to five per sample
General Turbo Mode Throughput: Up to 80 tests per hour
Specifications:
Time to first result: Less than 15 minutes for a one-cycle
assay
Less than 22 minutes for a two-cycle
assay
Luminometer Detection method: Photomultiplier Tube
Specifications:
Wavelength of Emitted 425 to 500 nm
Light:
Incubation temperature: 37C +/- 0.1C
Internal Computer Computer: IBM AT Compatible, 486DX
Specifications: 33Mhz or higher
Minimum Req. RAM: 4 MB or higher
Minimum Req. Hard drive: 120 MB or higher
Monitor: Super VGA
Auxiliary Drives: 3.5 Floppy Drive required

Specifications
Electrical Specifications Power requirements: 110/120 VAC, 60 Hz, 6 Amps
(120 Volts):
Power consumption At idle - 650 W (average)
(IMMULITE only): During Operation - 700 W
(220 Volts):
(IMMULITE only): During Operation - 800 W
Environmental Operating environment: Between 65F - 86F (18C -
Specifications: 30C), Humidity 20-80%
(no condensation)
Noise Specifications: Noise generated by the A weighting scale 60Db-SPL
IMMULITE System while B weighting scale 68Db-SPL
processing tests:
Fluidics Specifications: Water used per test: 4.20 mL (450 tests per full water
container)
Probe Wash used per test: 1.0 mL (1000 tests per full probe
wash container)
Physical Specifications: Dimensions: Height: 17 (44cm)
(Analyzer Only) Width: 40 (102cm)
Depth: 25 (63cm)
Weight: Approx. 185 lbs. (84 kg)
Heat Output Approx. 920 BTU/hr
Specifications:

EC Declaration of Conformity
according to directive 98/79/EC
We,
DPC Cirrus Inc.
62 Flanders-Bartley Road
Flanders, NJ 07836
a subsidiary of Diagnostic Products Corporation
5210 Pacific Concourse Drive
Los Angeles, CA 90045-6900
declare under sole responsibility that the following equipment to which this declaration relates,
meets the essential health and safety requirements and is in conformity with the relevant sections
of applicable EC standards and other normative documents. If changes are made to the product
which is covered by this declaration of conformity, the declaration of conformity is no longer
valid.
Equipment type: In Vitro Diagnostic Medical Device
Model: IMMULITE
Serial Number: __________
EC Directives: 93/68/EC, 89/392/EC (91/368/EC, 93/44/EC),

73/23/EC, 89/336/EC
Harmonized Standards
Used: EN55011, EN60555-2, EN60555-3, EN50082-1,
EN61000-3-2, EN61000-3-3
National and other IEC 1010-1, IEC 801-2,3,4, IEC 1000-4-2, IEC 1000-4-4,
standards and technical ENV50140, ISO 9001:1994 (BS EN ISO 9001:1994),
specifications: 21CFR, Part 820 FDA cGMP, EN46001: 1996;
ISO 13485: 1996; UL 1262, Laboratory Equipment
Notified body according
to Annex VII: Not Applicable employed to hold the documentation
and evaluate the safety issues of this equipment.
Date/Signature of manufacturer
or responsible party: ______________________________________________________
Title of signatory: Vice President, Regulatory Affairs and Quality Systems___2000
Date/Signature of EU representative
Title of signatory: ______________________________________________________

Instrument Warranty Statements
LIMITED WARRANTY
Siemens Diagnostics warrants that the items delivered hereunder are of good material and
workmanship, and are free from defects in design and manufacture. Siemens Diagnostics
responsibility is limited to repairing or replacing any item or part, for a period of one (1) year
after delivery to the original purchaser. Defects caused by improper operating conditions,
misuse, negligence, or alteration of the product void this warranty. Siemens Diagnostics shall
not be liable for any direct, indirect, incidental or consequential damages arising out of
possession or use of the items. Consumables, as defined in the appropriate Siemens Diagnostics
Price List for Instrument-Related Parts, Racks and Consumables are not covered by this
warranty.
LIMITED SOFTWARE WARRANTY

Siemens Diagnostics warrants that the Software will substantially conform to specifications and
to the documentation, provided that it is used on the computer hardware and with the operating
system for which it was designed. Siemens Diagnostics also warrants the disks on which the
Software is recorded to be free of defects in material and workmanship under normal used for a
period of ninety (90) days from the date of purchase.
CUSTOMER REMEDIES
Siemens Diagnostics entire liability and your exclusive remedy shall be replacement of the
Software that does not meet Siemens Diagnostics Limited Warranty and which is returned to
Siemens Diagnostics. The Limited Warranty is void if failure of the Software has resulted from
accident, abuse, or misapplication.
NO OTHER WARRANTIES
Because the software is inherently complex and may not be completely free of errors, you are
advised to verify your work. The software and related documentation are provided as is.
Siemens Diagnostics disclaims all other warranties, expressed or implied, including but not
limited to implied warranties of merchantability and fitness for a particular purpose, with respect
to the software and the accompanying written materials. Siemens Diagnostics shall not be liable
for any direct, incidental, or consequential damages arising out of possession or use of this
product.

Chapter 6: Preventive Maintenance (PM)
6.1 Description
Preventive maintenance is an important service function that must be performed at least once a year. This
prevents problems from occurring due to normal wear or adjustments changing over time. The following
Preventive Maintenance Kit part number 420054 is available which contains all the parts that may need to
be replaced:
Main Fan Filter 500342

Water and Probe Wash Filters 500499
Small Syringe Tip 901395
Large Syringe Tip 900271-01
Large Syringe O-ring 900271-02
Micro Valve (For Hamilton Syringe Pumps only) 901692
Macro Valve (For Hamilton Syringe Pumps only) 901693
Substrate Spike 900558
Assay Tube Roller O-rings 900613
Assay Barcode Drive O-ring 900771
Shuttle Idler Wheel Kit 420001
Probe Replacement Kit 420063
Bottle Cap Filters (Water and Probe Wash) 900966
Main Drain Tube 900691-27
Water Testing Units (Qty. 10) 500001
When performing Preventive Maintenance, be sure to use the IMMULITE Annual Preventive
Maintenance Report, available from Siemens Diagnostics Field Service as a guide to ensure all items are
covered. The rest of this chapter outlines each item in detail.

6.2 General Checkout
Discuss past performance with customer: This is one of the most important steps in a PM. Customer
communication ensures that any problems that the customer is experiencing are addressed. This helps to
guarantee that customer satisfaction is achieved after you leave. Ask for any specific situations that the
customer may have seen or heard on the IMMULITE. Make sure that items discussed are closely
investigated during your visit.
Check Error Log: Refer to Section 7.4.14: Checking the Error Log for more information. Review the
past two months. Check for consistent error messages. They could be warning signs of impending
problems. Two messages that are generally not of concern are Bad Parity and Message received out of
sequence, unless these messages are repeated frequently (this could be a sign of computer problems).
Also do not be concerned with individual isolated messages. They may just indicate an operator error.
Make any necessary upgrades: A list of current upgrades and standards are available from Siemens
Diagnostics Field Service. If necessary, Siemens Diagnostics Field Service can fax a copy to an FSE
onsite. Evaluate the instrument for the presence of all current upgrades and perform any necessary
revisions.
Change main fan filter and verify main fan operation: Check the fan filter and grill for any accumulated
dust, and clean if necessary. If the filter is lightly dusty, rinse and dry it like a sponge. Make sure that
nothing is obstructing the fan from spinning smoothly. Check to make sure the fan is operating whenever
the power is on.
6.3 Power Supply

Check voltages at the Syringe Interface PCB: Check voltages at the main power connector (A15-J1) on
the Hamilton/Euro Interface PCB. Pins can be accessed through the side of the connector with small pin-
type probes. A good chassis ground can be found at the grounding strap connected to the front latch of the
Instruments lid. Ensure voltages are in tolerance as shown on the PM report.
Check if voltages are in range at the PMT Power Supply: Check voltages for the PMT power supply by
locating the quick-connect connection for the cable of the PMT. Tap into these points to read the +/- 5V
supplies dedicated to the PMT. Ensure voltages are in tolerance as shown on the PM report.
Verify power supply fan operation: Ensure the Main Power supply fans located on the mid-right side of
the Instrument are running.
6.4 Syringe Module

Lubricate lead screws and guide shafts for each dilutor: It is recommended to use a medium-weight AFC
(Anti-Fretting Corrosion) grease. Use the recommended grease and a long plastic tool to lubricate the lead
screw and guide shafts for each dilutor. The lead screw can be accessed through the lower opening of
each dilutor and the guide shafts are located at the left sides of the same openings. Run the PRIME
diagnostics for at least a minute to work in the grease. Wipe off any excess grease.
Inspect or replace micro and macro valves on the syringe dilutors: The action to be taken here is specific
to what parts are in place on that Instrument:
The valves on the Euro units are clear acrylic manifolds only, but should be inspected for any
cracks or other damage, and replaced only as necessary. (Euro Macro valve p/n 901632, Euro
Micro valve p/n 901631).

For the Hamilton units, older systems may have the black-bodied Hamilton Rotary valves (Macro
valve p/n 901693, Micro valve p/n 901692). These are enclosed in the PM kit, and are replaced.
Remove the syringes using the SCHANGE diagnostics, and remove tubes from the valves.
Rotate each cam lever to the right to release the valves. If the valves cannot be removed, use a
strong blade screwdriver to check if the lock-down screw located on the top of the dilutor
assembly is tight. Do not strip the screw head. The screw may have lock-tite affixed to it. If
necessary, carefully break the seal. On newer instruments, this may be an easier hex type screw.
Before inserting the new valves, start the threads of the tubing first. Make sure the new valves are
fully seated against the manifold, before locking them into place. When tightening the screws, do
not apply too much pressure and do not use lock-tite.
The white-bodied ceramic rotary valves were cut into production in August 2001, and are
intended to be permanent. They should be checked for full proper seating against the manifold of
the dilutor. If a gap is seen, remove the syringes using the SCHANGE diagnostic. Rotate the cam
lever below each rotary valve to the right (3:00) to release. (If needed, loosen the top Allen set
screw that may be locking the valve stem in place). Reseat the valve fully against the dilutor
manifold, and re-secure the cam locking mechanism by pointing it again to the downward (6:00)
orientation.
Check straightness of syringe B plunger: Remove the plunger from the B syringe and roll it on a
straight surface, checking for wobble. If the plunger appears to be bent, replace the whole syringe. Do not
replace just the plunger, as the plunger and glass is a mated pair that is measured and calibrated together.
Do not re-insert the plunger into the syringe yet; proceed to the next PM item.
Replace 5000ul and 250ul syringe tips: Remove both plungers from both syringes. Replace the tips on
both plungers using a small pair of grip pliers (Be careful to prevent bending the plunger shaft of the
small syringe, and be sure the lower white plunger shaft guide is properly seated into the base of the
syringe barrel).
CAUTION: Make sure the tips are fully seated on the end of the plungers. Gently press the tips vertically
down onto a flat surface until a click is felt. The large syringe should also be gently rolled on its tip to be
sure it is straight. Take extreme care not to bend the shaft of the small syringe during this process.
It is recommended to pre-moisten the new large syringe tip with the IMMULITE water before re-inserting
it into the glass syringe. If resistance is felt, gently pull the plunger back out and re-insert until there is an
even smooth travel upon re-insertion. Do not rotate the plunger when re-inserting, this can cause the
syringe to dislodge again later.
Run the PRIME diagnostic and check for excessive bubbles particularly in the small syringe. If
necessary, disengage the thumbscrew from the plunger during the PRIME diagnostic and manually move
the small plunger abruptly up and down to clear persistent bubbles. Be careful to prevent any side pull as
this can bend or damage the plunger shaft.
Check operation of V1, V2, & V4: Tests the operation of V1, V2, and V4. Refer to Section 7.4.4:
Miscellaneous Procedures for information on checking the operation of the valves.
Check the operation of the micro and macro valves: Run the PRIME diagnostics. Proper operation can be
verified by checking that fluids are running in the proper direction.

6.5 Pipettor/Reagent Carousel Module
Check X-Pipettor belt for wear: Visually check for any fraying or cracks on the edges of the belt. The belt
should ride on a flat plane. General judgement of tension should be applied. It should deflect
approximately 1/8inch when the center of the belt is pushed. If a belt is too loose or too tight, intermittent
pipetting errors could occur.
Check X- and Z-Pipettor positions: For the X-Position, manually place the X-Pipettor Position Gauges
p/n 420078 and run the PIPXPOS diagnostic. Refer to Section 7.4.5: Miscellaneous Procedures for
more information.
For the Z-Position, run the UPDOWNA and UPDOWNH diagnostics. Evaluate if the probe bottoms out
in the home well when using UPDOWNH diagnostic, or hits the bead in the test unit position when using
the UPDOWNA diagnostic.
Check pipettor level sensor operation: Run the Configurations tests LEVFSTST and LEVSNTST, and
the regular menus LEVFALSE and LEVCRASH diagnostics. Refer to Section 3.5.5: Theory of
Operation, and Sections 8.5 and 8.6: Diagnostics of this manual for more information on the use of
these diagnostics.
Check Pipettor-Z lead screw and slide bearing: Visually check for excessive wear, dust or grime
accumulation. No lubrication is generally necessary as this can cause future dust accumulation. Check for
smooth travel.
Check tip-jam sensor operation: Run the TIPJMTST diagnostic found under the System Configurations
diagnostic menu. After the program checks five times, a pass/fail result is displayed on the control panel.
Check reagent tray positions (Home and Position): Check for the proper position of the home sensor by
placing a wedge in the home position (Position 1) of the Reagent Carousel and run the REAGENTH
diagnostic. The red LED should shine an oval shape centered between the edge of the wedge and the first
barcode line.
Check for the proper position of the individual position sensor using an empty reagent carousel and while
running the REAGENTP diagnostic. Look down directly through the individual notches found around
the edge of the carousel and check that one of the position sensor heads is centered in the notch. Verify all
wedge positions are centered over the sensor head underneath.
Change probe and check dispense: Replace the probe with the new one supplied in the PM kit.
CAUTION: Do not over-tighten the fitting.
The probe tubing must be placed in the notch of the vanity panel with the small rubber O-ring located
behind the panel. Manually turn the pipettor to ensure the tubing does not twist or kink. Adjust or flip the
tubing as needed to avoid coiling or wrapping around the pipettor tower.
Check the dispense quality of the new probe. Run the PROBETST diagnostic. Look for excess liquid
moving up the tip of the probe shaft, or any splashing out of the side of the home well. When the probe
momentarily lifts and moves to the dump well, look for any dripping out of the probe. Dripping indicates
backpressure or occlusion inside the probe or at its 4-way junction block at the syringes.

Run the PROBANGL diagnostic to evaluate the angle of dispensing. Verify that the dispense does not
exceed 7 - 10 degrees off center (check angle from various sides of the instrument). Also, check for
excess spiraling of the stream. No more than one spiral should occur per inch.
6.6 Luminometer Module

Lubricate and check upper shuttle bearing: Refer to Section 7.3.12: Removal and Replacement of
Assemblies, for instructions on the removal of the slide bearing assembly. Remove the upper section of
the shuttle assembly.
CAUTION: Be aware of the small rectangle shim located underneath this slide bearing. Be careful not to
drop or lose it. A dab of grease can be used upon re-assembly to help keep it in place.
Remove the slide bearing and rail. Clean off excess old grease. Use a clean small blade screwdriver to
work new grease into the rails where the ball bearings reside. After re-assembly into the instrument, slide
the bearing back and forth on the rail to work in the grease. Remove the excess grease.
CAUTION: Do not allow the slide railing to completely disengage from the bearing.
Change small idler wheel assembly: Refer to Section 7.3.13: Removal and Replacement of Assemblies
for instructions on the replacement of the small idler wheel assembly. The entire assembly including the
shaft on which the wheel rotates, should be cleaned.
Check the high- speed spinner O-rings: Take a flashlight to visually inspect the O-rings of both the rear
drive wheel and outer idler wheel for cracks or wear. Wipe clean with a damp paper towel or replace the
wheel assemblies if damage is found.
Set High- Speed Spinner speed (5400-5600) RPMs: Run both the configurations menus SPNCKTST,
and the regular menus WASHSPD diagnostics, to monitor and/or adjust the high speed spinner speed,
and its error-checking capabilities. Refer to Section 8.0: Diagnostics for more information on these tests.
Check shuttle positions and verify shuttle sensor flag is not bent: Run the SHUTTLE diagnostic to ensure
the proper positioning of the Shuttle in all positions. Refer to Section 8.0: Diagnostics for more
information. Use a flashlight and manually move the shuttle to check that the flag end moves correctly
and is not physically bent or broken.
Check for proper wash & spin of test unit: Load 15 test units with approximately 200 ul of water on the
carousel one position before the Shuttle position. Run the ATTENTM diagnostic to visually check for
proper wash and spin operation. The test unit should slightly lift on the first spin and the liquid should
quickly clear from the bottom of the tube. Watch that the bead moves off the bottom of the tube and floats
in air, while the tube is spinning. This item should also be checked during the final chemistry run of the
instrument.
Check Luminometer Chain positioning and tension: Run both the LUMCHECK and SHUTTLE
diagnostics to evaluate the Luminometer Chain position versus the shuttle. It is best to remove the
Spinner Platform for direct visual clearance for the checks. Refer to Section 8.0: Diagnostics for more
information on the chain position adjustment. The chain should align so the shuttle passes through the
center of a Luminometer Chain baffle.

Check the tension of the Luminometer Chain by gently pushing the front span of the Luminometer Chain
behind the load platform. It should gently touch the black drain trough assembly of the shuttle without too
much strain. The chain should not excessively tilt to one side as it enters the Luminometer. This indicates
a loose chain section at the Luminometer entrance, adjusted by the rear boot within the Luminometer.
Check for slippage between Lum Chain and motor shaft: Use the SCHANGE diagnostic (or any
diagnostic where motors do not move). This will energize all the motors in the system and put them in
standby. Look for excessive play at the front left tooth gear of the Luminometer chain. More than a very
slight play may indicate looseness of the inner drive coupler for the chain.
Check attenuator belt for wear: Look for any fraying or cracks on the edges of the belt. Check for
deflection of approximately inch at the center span of the belt.
Check attenuator sensor disk for slippage: Use the SCHANGE diagnostic (or any diagnostic where
motors do not move). This will energize all the motors in the system and put them in standby. Grip the
attenuator position sensor disk with one hand and shake it in and out and back and forth. It should only
have slight play and be tight to the shaft.
PMT: Background counts and Dark counts: Run the DARKCNT and BKGNDCNT diagnostics. Using
GetDataT, allow approximately five readouts to print for each test. Note the average readings on the
blank lines of this report, and enclose the printouts with the PM report.
Background counts should have no more than 20 - 40 cps difference between attenuated and unattenuated
counts. Dark counts should not have readings greater than 60 or 70 CPS, and cleaned CPS readings
should be in the range of 0 - 40 CPS.
6.7 Main Carousel Module

Check Main Carousel ring gear positions: Run MCARTST (on the configurations menu), CARPOS,
CARBACK, CARCHECK and CARSHAKE diagnostics to check the operation and positioning of the
carousel. When running CARCHECK, check for proper alignment of the ring gear with the shuttle.
Make sure the shuttle is centered between two baffles of the carousel ring gear.
6.8 Load Platform/Sample Tray Module

Disassemble and clean assay tube roller assembly: Entire roller assembly should be visually inspected
and cleaned. Look for spilled patient samples throughout the area and on the top of the load platform
casting where the sample cups travel. Evaluate the rollers and pins. Look for elongated holes on the inner
diameter of the rollers. This could cause the rollers to wobble as they turn. Look for worn ends of the
roller (they should be rounded). Check that the pins are not excessively scratched, scored, or show signs
of black dust. Replace rollers and/or pins as needed.
Replace assay tube roller O-rings: Refer to Section 7.3.7: Removal and Replacement of Assemblies for
instructions on the replacement of the assay tube roller O-rings.
Replace barcode reader drive O- ring: Refer to Section 7.3.7: Removal and Replacement of
Assemblies for instructions on the replacement of the bar code reader drive O-ring.
Set barcode reader speed to 750-790 ms/rev: Run BCODESPD diagnostic to adjust the barcode reader
speed. Use a minimum of four test units to check all four positions around the idler assembly. Each
position should not vary more than 40 msec of each other. If it does, check and/or replace rollers and pins
or check for even rotation of the drive O-ring.

Check operation of sample/test unit barcode reader: Run the BCODETST diagnostic. Evaluate if any of
the rollers are wobbling from their center axis. Look for any high or low spots on the orange barcode
reader main drive O-ring. Check readings on the PC screen to check that all barcode reads are complete
and there arent any white ghosts displayed. This item should also be checked during the final
chemistry run of the instrument.
Check Load Chain and star wheel positioning: Check Load Chain positioning using LCHAIN
diagnostics. Ensure that Load Chain baffles alignment across the Carousel casting is consistent. Refer to
Section 7.4.6: Miscellaneous Procedures for more information on these alignments.
Check spacing of Sample Tube Guides: Refer to Section 7.4.7: Miscellaneous Procedures for more
information on this alignment.
Check Sample Tray full and Tray removed sensor operation: Run the SAMPFTST and SAMPTTST
diagnostics found in the system configuration menu. Perform diagnostics as directed by the prompts on
the display.
Check Load Chain position sensor for dust accumulation: Access the position disk in the center lower
chassis. Use a flashlight to visually inspect for dust within the position sensor and check the top of the
sensor disk for dust accumulation. Run the LCHAIN diagnostics to turn the Load Chain position sensor
disk. Gently ride the wheel with a finger to remove dust accumulation. Move your finger outward
whenever a position slot is felt. This will avoid dust from depositing into the slots. Blow into the area to
remove any remaining dust accumulation.
6.9 Solenoid or Linear Actuator Substrate and Water Wash Pumps

Check volume of Substrate & Water Pumps: Make sure the shuttle is in the full left position so that
substrate doesnt accidentally leak onto the Luminometer Chain. Disconnect the tubing on top of the
substrate heater and hold a sample cup under the substrate tubing. Run the SOLE2S diagnostic to prime
up and then dispense two shots. Use the ALARM MUTE button to pause and control the shots into the
cup. The approximate level of substrate should be at the fourth line of the sample cup (two shots at 200 ul
= 400 ul).
Disconnect the water nozzle and hold a sample cup under the water nozzle. Run the SOLE1W diagnostic
to prime up and then dispense two shots. The approximate level of water should also be at the fourth line
of the sample cup.
Check that drawback of pumps is inch (+/- 1/8inch): Make sure the shuttle is in the full left position so
that substrate doesnt accidentally leak onto the Luminometer Chain. Disconnect the tubing on top of the
substrate heater. Observe the drawback at the end of the tubing. Refer to Section 7.4.4 for more details.
Hold a waste cup under the substrate tubing and run the SOLE2S diagnostic to dispense multiple shots of
substrate. Check that the drawback after each shot dispensed. For tubing #10 the proper drawback is 1/4
+/- 1/8. For tubing # 38 the proper drawback is 1/2inch +/- 1/4inch. If necessary, adjust the
potentiometer on the back of the Cirrus pump. Perform the same test for the water pump using the
SOLE1W diagnostic, disconnecting the water nozzle. The proper drawback is 1/4inch +/- 1/8inch.

6.10 Substrate Module
Replace substrate spike: Refer to Section 7.4.3: Miscellaneous Procedures for information on the
replacement of the substrate spike. Be sure to wear gloves while performing this procedure.
Check manual prime button: Verify proper operation by squeezing the button and checking for bubbles in
the substrate bottle and the reservoir level in the fill window moving up. Also run the configurations
diagnostic SUBLVTST to check proper operation of the reservoirs level sensor.
CAUTION: Do not push the button, as this can cause damage to the button.
6.11 Fluidics
Replace water & probe wash filters: Replace the probe wash and water end-of-line filters (inside the
bottles) while wearing gloves or using a lint-free tissue.
Replace air filter in caps of water and wash containers: Replace with filters from the PM kit.
Replace waste tubing and check waste path for blockage: Replace with waste tubing from the PM kit.
Check all other waste tubing and manifold block for blockage or clogs. Clean and/or rinse as needed.
Check all tubes for kinks and tighten all fittings: Visually check the tubing for any kinks. Check that all
tubes are finger tight. Specifically, check water tubes coming in from the water bottles for any kinks
and/or damage from the top cover edge (crushing the tubes when closed).
Decontaminate system and test for contamination: Refer to Section 7.4: Miscellaneous Procedures for
information on performing system decontamination. Enclose a copy of a printout of the final
WATERTPM test with the PM report. If decontamination of the substrate system is needed, consult
Siemens Diagnostics Technical Support for detailed options and procedures.
6.12 Computer Software

Verify Attenuation Factor is correct. CAF =: Access the KITS program to verify values. Ensure values
are written on configuration table sheet included in the electronics area of the instrument. Record the
value on the PM report as well.
Verify PMT Multiplier is correct. Multiplier =: Access the KITS program to verify values. Ensure
values are written on configuration table sheet included in the electronics area of the instrument. Record
the value on the PM report as well.
Check Software Version. Version =: Check the software version on Main Menu screen. Record it on the
PM report.
Insure configuration table matches instrument serial number: Go to the DOS prompt at CIRRUS/IMM.
Type dir*.cnf and return. Only one file should be listed. It should have a name format of IMMxxx.cnf
(where xxx is the serial number of the instrument) and it should always have a file size of 488 bytes.
Delete any other .cnf files that are present.

Print configuration table and place in electronic area: Run the TABLE diagnostic from the System
Configurations menu. Press print screen on the keyboard to print the first half. Press N to move to the
next half of the table and press print screen to print the second half.
Note: Be sure to manually write the instrument serial number, CAF value and PMT value on the printed
output of the configuration table.
6.13 Temperatures
First check the substrate heater temperature. Remove the cover on the substrate heater. Using a DVM set
to DC volts, place the leads on the test points of the Substrate Heater PCB. Run the SUBSHEAT
diagnostic. Record the starting (ambient) temperature and final (heated) temperature on the PM report.
The DVM reading is in direct correlation to the temperature. Multiply the measured voltage by 100 and
this will be the temperature in Centigrade. The stabilized temperature should be 36.6C +/- 6 o C. After
measuring the temperature, be sure to terminate the program so that the substrate is not heated for a long
period of time.
Check all other temperatures while running the final chemistry run (the next step in the PM) by going into
the System Status dropdown menu, and select the Temps and Dark Counts option. Press the space bar
to obtain updates of the temperatures until they stabilize. Record all temperatures on the PM report.
6.14 Final Checkout & Customer Satisfaction

Run Controls (adjust first if necessary): Verify proper system operation by running available chemistries
at the account. If adjustment of the assay is required, do this prior to running controls.
Note: Controls should be run in five replicates of each level control. Look for the majority of replicates to
be in range. Updated control ranges are issued regularly or can be found in the associated package insert
of the CON6 control module.
Check the error log after the adjustment and compare the last adjustment for that assay with the current
one run. Ensure there is reasonable consistency between the two.
Ensure the customer is happy with the final chemistry run results and that all issues and questions have
been addressed. Do not leave until final confirmation has been made with the customer.

Chapter 7: Repair Information
7.1 Tools and Equipment

To properly service the IMMULITE, certain tools and equipment are required. Some of these are not used
often, but are absolutely necessary for specific tasks. For example, the retaining O-ring pliers are seldom
used, but if the need arises to remove or install a retaining ring, no other tool will be a suitable substitute.
The list of tools and equipment a service person should have when servicing an IMMULITE is as follows:
Ballpoint hex key set (1/20", 1/16", 5/64", 3/32", 7/64", 1/8", 9/64", 5/32", 3/16")
Hex driver blade set with driver handle (same sizes as above)
4 inch and 8 inch blade extension
Metric ballpoint hex key set (1.5mm, 2mm, 2.5mm, 3mm, 4mm, and 5mm)
Large slotted screwdriver, 1/4" tip, 4" blade
Small slotted screwdriver, 1/8" tip, 4" blade
Large Phillips screwdriver, #2 tip, 4" blade
Small Phillips screwdriver, #1 tip, 4" blade
Flashlight
4" wire cutters
4" and 6" diagonal pliers
Wire strippers 26 - 16 awg (American wire gauge)
Retaining ring pliers (reversible)
Right angle retaining ring pliers
5-6" scribe
Potentiometer adjustment tool
Tweezers
Large (13") and small (5") pick-up tool
Inspection mirror
9/64" ballpoint hex driver blade, 4"
Soldering iron (with solder and a solder removal device)
Adjustable wrench
Miniature slotted and Phillips screwdrivers, 1mm blade width
Digital Multimeter
Miniature open-end wrench set (1/4", 5/16", 3/8")
Logic probe
Not all of the tools listed are readily available outside the United States however, any or all of the above
can be purchased from Siemens Diagnostics.

7.2 The Configuration Table
Description
The motor configuration table allows for mechanical adjustments to be made via software. This
eliminates the need for slotted sensors, long screwdrivers, and sore backs. Also, the design of the modules
was made easier since sensors did not have to be as accessible (don't worry, the two sensors that are a bit
"buried" rarely fail).
Since the configuration table holds all of the mechanical adjustment information, it can be considered the
heart of the instrument. As we all know a human heart cannot be transplanted in another body unless that
body is a perfect match. The configuration table to instrument match is very similar. If a configuration
table is put into an instrument that is not a perfect match, the instrument will not operate correctly. It is
possible for an instrument to have the wrong configuration table and still operate, but not correctly.
Depending on the severity of the mismatch an incorrect configuration table will cause problems of
varying magnitude, anywhere from slight to large. This is why it is very important the correct
configuration table be used with the instrument.
The configuration table is loaded into the instrument whenever a program (diagnostic or assay processing)
is run. The computer does not know which table to load, so it selects the first one it comes to as it scrolls
through the C:\CIRRUS\IMM directory list. Careful reading of the previous two sentences should allow
you to predict the possible result of having more than one configuration table in the \CIRRUS\IMM
directory of the IMMULITE's computer. If additional configuration tables were placed in this directory,
the computer might load this incorrectly, resulting in incorrect operation. However, warnings to this will
post to the user within the software.
During assembly, the IMMULITE is loaded with a generic configuration table. Thus we can say each
configuration table is created equally. The name of the generic configuration table is then changed to
reflect the serial number of the instrument is has been placed on. As each module in the instrument is
aligned, the values change in the configuration table to reflect the instrument that has become its new
"home." After the instrument is aligned, the configuration table and instrument are now "one" and must
never part.
Note: When facing the instrument, the IMMULITE serial number can be found on the left side of the
instrument in the upper right corner of the instrument label.
The configuration table is a file located in the C:\CIRRUS\IMM directory of the computer and is always
prefixed by the letters IMM followed by an alphanumeric or numeric number with a CNF extension.
For example, the configuration table for IMMULITE serial number D0100 is IMM100.CNF. The
alphanumeric or numeric number within the file name is part of the instrument serial number. (The serial
numbers prefix letter code is not in the file name.)
Parameters
The configuration table has many parameters, each of which represent an adjustment within the
instrument. Each parameter has a parameter number, parameter name, error number, and extra number.
These are defined as:
Parameter Number: The identification number of the parameter.
Parameter Name: The abbreviation of the specific adjustment the parameter represents.

Parameter Error Number (commonly known as "error steps"): All of the motors that move a device to a
specific position are stepper motors. Therefore, when a stepper moves a certain distance, that distance is
proportional to a number of steps. The number of steps that a motor should take to move to a position is
fairly constant from instrument to instrument. If the motor must take more steps than the nominal to reach
position, a problem exists and corrective action must be taken. This point or number of steps when the
corrective action is initiated is defined as the error steps.
Example: It is known that the number of steps the load chain motor must take to move from one position
to the next is approximately 550. After adding a tolerance factor, we set the error steps for this parameter
to 600. As long as the Load Chain motor reaches the next position within the 600-step limit, no errors are
reported. If for some reason one of the components that are necessary for a successful move has failed
(motor, sensor, cabling, etc.) or the chain has jammed, the number of steps sent by the microprocessor
will exceed 600 and corrective action will occur.
Notes: 1. For reasons too complicated to explain, the error steps in parameters 32, 33, and 34 do not set
the point of corrective action initiation, they set the depth of the probe in their respective
positions.
2. The error steps for parameters 36-40, and 42-48 are not used and set to zero. These parameters
use the error steps (200) from parameter 8.
Parameter Extra Number (commonly referred to as "extra steps"): This is the parameter that sets the
mechanical positioning of all sensors in the instrument. The mechanical components of the instrument
were designed such that when a device driven by a motor triggers a corresponding sensor, that device then
has a small number of steps more to move to be positioned properly. The small number of steps taken
after the sensor has been triggered; signaling a proper position of the device is defined as the extra steps.
Example: The Load Chain motor begins to move the Load Chain to the next position. After 550 steps the
open slot in the sensor disk reaches the optical sensor and allows light to flow through the sensor
triggering its output. The microprocessor then looks at the configuration table for the number of extra
steps needed to properly position the Load Chain and sends that additional number of steps to the motor.
To put the positioning in terms of coarse vs. fine, think of the mechanical placement of sensors as the
Error Step coarse adjustment and the Extra Steps as the fine adjustment.

Sample of Configuration Table Printout

Configuration Table Delineation
ERROR EXTRA
# NAME DESCRIPTION RANGE RANGE
0 LcPos Sets the positioning and error detection of the Load Chain. Fixed 35-180
Sets the positioning and error detection of the Main Carousel

3 McPos Fixed 5-25
Ring Gear.
Not currently used (McHome stands for Main Carousel Not Not
5 McHome
home). used used
Sets the error detection and horizontal positioning of the

7 PxHome Fixed 2-12
probe when moving to the home well.
Error steps are used for error detection of the pipettor when
8 PxPos moving to one of the X-Pipettor positions. Extra steps are Fixed 5-13
only used in a few diagnostics.
Not currently used Not Not

9 PxH2W
used used
Sets the positioning and error detection of the Z-Pipettor

10 PzHome Fixed Fixed
when moving up to home.

11 PzMid Fixed Fixed
position when moving down to the mid sensor.
Not currently used. Not Not

12 Tip Jam
used used
The error steps are used to set the minimum sample volume. Not
13 LevSensS 175-205
The extra steps are not used. used
The error steps are used to set the volume (1000 ul) at which
14 LevSensR 420-464 Fixed
the reagent vial is considered "empty" by the instrument.
Sets the positioning and error detection of the reagent

15 RcHome Fixed 50-60
carousel tray when moving to the home position.

16 RcPos Fixed 8-10
carousel tray when moving to each position.
Sets the positioning and error detection of the shuttle when

21 Sh at Car Fixed 20-40
moving to the incubator carousel position.

22 Sh at Sub Fixed 45-70
moving to the position under the substrate nozzle.
Sets the amount of pressure applied to the test unit when

spinning during the wash cycle. Not
24 Sh Push 50-60
Note: Typically, the extra steps from parameters 22 and 24 used
will have a sum of between 105 and 115.

ERROR EXTRA
Sets the position of the Shuttle when moving to the Not

25 Sh at Lum 2-15
Luminometer Chain position. used
Sets the positioning and error detection of the Luminometer

26 LumcPos Fixed 40-120
Chain when moving into position.
Sets the positioning and error detection of the Attenuator

28 Att Home Fixed 10-50
when moving to the home position.

29 Att Pos when moving to either the attenuated or unattenuated Fixed 10-80
position.
Defines the number of steps the Z-Pipettor moves down after

Not
32 Z Home passing the mid sensor when at the home well position of the 155-190
used
wash station.

Not
33 Z Wash passing the mid sensor when at the wash well position of the 80-110
used
wash station.

Not
34 Z Assay passing the mid sensor when at the test unit dispensing 455-492
used
position.
Sets the horizontal positioning of the probe in the home well Not
36 PX Blind 2-20
of the wash station. used
Used to set the horizontal positioning of the probe in the Not

37 PX Dump 2-20
dump well of the wash station. used

38 PX Wash 2-20
wash well of the wash station. used
This position is only used with a few diagnostic programs as

Not
39 (Blank) a "stop point." This setting has no effect while using the 1-15
used
main program.
Used to set the horizontal positioning of the probe at the Not

40 Reagent 2-20
reagent wedge position. used

Not
used
main program.

Not
used
main program.
Used to set the horizontal positioning of the probe at Not

43 S5 5-15
sampling position 5. used

ERROR EXTRA

44 S4 5-15

45 S3 5-15

46 S2 5-15

47 S1 5-15
Used to set the horizontal positioning of the probe when Not

48 PX Disp 2-20
dispensing into the test unit. used
General Configuration Table notes:

1. If a number in the table is zero, it indicates that number is unused and should stay set to zero.
2. If a number is not initially set to zero it must never be set to zero.
3. Non-zero settings for extra steps must be in the range of 1 - 255.
4. It is not unusual for a parameter in the table to change by a few steps as most of the settings are
subjective and a different pair of eyes may see a position differently. However, a relatively large
change is indicative of a problem. Even though the change may correct a symptom, a problem may
still exist.
Important: In the majority of cases where a certain motor position is to be changed, it involves many
common alignment positions. For these, it is highly recommended to use their corresponding ADJ
steps adjustment program on this same menu. These will give more accurate step tuning per-instrument.
Direct changes to the fields within the Motor Configuration Table itself are not recommended. If a table
parameter number does not have its own corresponding adjustment diagnostic program, then those table
settings generally never change from the original factory setting, and should not be changed without first
consulting Siemens Diagnostics Field Service.

Accessing the Configuration Table
1. At the Start-up Menu, use the cursor keys to choose DIAGNOSTICS, then [Enter]
2. Choose SYSTEM CONFIGS, then [Enter]
3. In software prior to version 4.3, you will be prompted to download the diagnostic message table;
answer "Y" for yes. In versions 4.3 software and above, this download of the proper text messages for
the display will load automatically before the menu appears.
4. When the System Configuration Program Menu appears choose TABLE, then [Enter].
5. After the TABLE program has loaded, the RUN command will be automatically highlighted. Press
the [Enter] key to run the TABLE program.
6. When the IMMULITE display indicates "Press GO to Start", press the "GO" button on the
IMMULITE.
7. The program will load the configuration table to the PC screen, then terminate.
Changing the Configuration Table Parameters

1. Enter the parameter number to be manipulated.
2. Enter the number of Error Steps to be placed in the table. If no change is being made, enter the
existing number; if a change is being made, enter the new number. Do not try to skip over this step by
pressing the [Enter] key! If the [Enter] key is pressed at this step, a 0 will be entered into this
position by default.
3. After the Error Steps are entered, the cursor will move over to the Extra Steps position. Enter the
number of Extra Steps to be placed in the table. As with the Error Steps, a number must be entered
here. If no change is being made, enter the existing number; if a change is being made, enter the new
number.
4. If another parameter is to be changed, move to Step 1, if not, continue.
5. To exit type "Q" then [Enter].
6. If the changes are to be saved, press "Y", if not, press "N".
7. To exit from the System Configuration Menu, press the [Esc] key.
8. When prompted to restore original configuration table values, answer accordingly; "N" to keep the
changes made, or "Y" to delete the changes made and retain the original values. This step will allow
for changes that may have been made accidentally, to be deleted.
9. In software below version 4.3, when prompted to load the main message table, press "Y". In versions
4.3 software and above, this download of the proper text messages will occur automatically, then the
Start-up Menu will appear.
Note: To keep a proper updated printout in the rear electronics, be sure to replace the existing printout
after any changes are made. Also, obtain the PMT and CAF numbers, and Instrument Serial number, and
write them on the final sheet. Replace into the rear electronics compartment. This printout is insurance of
easy retrieval of all of this information, in case of computer failure.

7.3 Removal and Replacement of Assemblies
It may be necessary from time to time to remove complete modules and/or assemblies for replacement or
to access other parts in the instrument. Some modules overlap each other in the system making it very
important to follow the order listed when removing modules.
After removing modules and/or assemblies, it is suggested to carefully set them aside onto an empty flat
surface with all interfacing parts and screws placed nearby to each other.
Note: All circuit boards in the instrument have an A number associated with it. All cables are labeled
with the interconnecting circuit board A number and a jack position J number. For instance, the Reagent
Carousel interface PCB is labeled A12 and there is a ribbon cable labeled A12-J8 that connects to jack
position J8.
CAUTION: The power cord must be removed from system before starting removal of any module.
7.3.2 Reagent Carousel Assembly / TED Cooler

Note: It is a good idea to drain the fluids from within the internal waste tubings by lifting the power
supply end of the instrument. Hold the instrument up until most of the fluids are drained out into the
waste bottle.
1. Loosen the thumbscrew on the substrate heater and move away from the carousel ring gear.
2. Loosen the ten slotted screws on the main section of the clear plastic carousel cover and remove the
cover.
3. Remove the probe tubing from the notch on black probe vanity panel.
4. Remove the probe by unscrewing it from the upper pipetting arm and unscrewing the fitting at the
syringe module.
5. Loosen two screws holding the probe vanity panel and remove the panel.
6. Loosen three screws holding the Reagent Carousel cover (two located on top and one located on the
left side of cover close to the chassis). Carefully move cover up and away from module.
7. Remove Reagent Carousel Tray.
8. After removing the front lower chassis panel, unplug the two-pin connector (A12-J5) on the Reagent
Carousel Interface PCB that is coming from the TED Cooler below.
9. Loosen the cardboard collar that surrounds the lower part of the TED fan [keeping it in place].
10. Remove two foam pads (do not discard) covering the top screws securing the TED Cooler from
above. Loosen the two screws allowing the TED Cooler to drop into the lower chassis cavity.
11. Manipulate the TED Cooler from out the front of the lower chassis area if replacement or inspection
of the TED Cooler is desired, otherwise the TED Cooler can remain in the lower chassis.
Note: Care must be taken in the TED removal, as space is limited. It may be necessary to shift and/or
remove some of the drain tubing in order to make room. Do not lose the thin black conductive pad
that is sandwiched between the head of the TED. It is required for proper heat transfer.

12. Carefully remove the following connectors from the Reagent Carousel Interface PCB (do not remove
any other cables):
Wide main connector (A12-J6)
6-pin connector (A12-J7)
Ribbon cable (A12-J8)
13. Locate and remove the wash well supply tubing (#6) fitting from below the wash well. Remove the
two drain tubes from below the module.
14. Loosen the two screws (keeping them in place) holding the inner sample tube guide located at the
base of the pipettor tower, and remove the inner tube guide with screws.
15. Using a long screwdriver or long nose pliers, free the pipettor tower spiral cable from under the main
carousel casting.
16. Loosen the five captive screws (two located on the left side, two located on either side of the
pipettors positioning sensor, and one located in front of the wash station) securing the module to the
chassis.
17. Grasp module carefully by the pipettor tower on the right and at the carousel casting on the left.
Carefully lift the module straight up from the chassis, being careful to avoid brushing the Reagent
Carousel Interface PCB against the chassis opening.
18. Re-assemble in reverse order. Do not damage to the Reagent Carousel Interface PCB upon re-
insertion into the chassis. Also be sure to re-tuck the pipettor spiral cable connector under the main
carousel casting and make sure the wash tubing #6 is re-connected on the bottom of the wash well.
Reconnect the drain tubing.
7.3.3 Sample Collection Tray Assembly

1. Remove the Reagent Carousel cover by following step 6 from Section 7.3.2.
2. Remove the Sample Collection Tray by pulling it straight up.
3. Loosen (but do not remove) the four screws securing the bottom tray to the chassis.
4. Carefully manipulate the bottom tray away from chassis. It is a tight squeeze under the syringe pump
module and Load Chain casting; however the tray will come out with some patience.
5. Carefully remove connector (A63-J1) releasing it from its retaining clip (located to the right of the
connector).
6. Remove the bottom tray.
7. Re-assemble in reverse order. Ensure sensor cable (A63-J1) and its retaining clip are properly routed
and assembled to avoid pinching of the wire.

7.3.4 Syringe Pump Assembly
1. Remove the Sample Collection Tray Assembly as described in previous section.
2. Remove the blue fitting of tubing (thin tubing at input of small syringe) from 3 point T junction
block mounted to chassis wall behind the module.
3. Remove the blue fitting of tubing at the input of the large syringe.
4. Remove the yellow fitting of tubing (input from probe wash) from Valve V2 (mounted on side of
module).
5. Remove the white fitting of tubing (wash feed tubing for pipettor wash well) from Valve V1
(mounted on side of module).
6. Remove the following connectors from the Syringe Interface PCB located on the right side of the
Syringe Pump Module:
Small blue wire (unlabeled, connects to A15-J10)
Wide 10-pin connector (A15-J1)
7. Using a long Phillips screwdriver with extension, carefully loosen the four captive screws at the base
of the Syringe Pump Module.
8. Carefully lift the module away from chassis.
9. Reassemble in reverse order. All tubing fittings are finger tight, do not cross thread or use a wrench or
pliers. A tightening tool by Upchurch may be used for newer style repairable tubings. Before re-
insertion onto the chassis, ensure there are no wires underneath which may be pinched.
CAUTION: Use extreme caution when re-inserting the power connector (A15-J1). If this connector
is not positioned correctly, irreversible damage can occur to several logic boards and/or the main
power supply.
7.3.5 Main Incubator Carousel Ring Gear Assembly

1. Remove all assemblies as described in sections 7.3.2 - 7.3.4.
2. Loosen two slotted screws on the rear section of the clear plastic carousel cover and remove cover.
3. Loosen (but do not remove) the four large outer hex screws (located in slotted holes) of the carousel
motor gearbox assembly. Slide the entire gearbox motor assembly away from the Main Carousel Ring
Gear.
4. Locate the three brown delrin blocks with bearings located at the 9:00, 1:00 and 5:00 positions of the
Main Carousel Ring Gear Assembly. Loosen (but do not remove) the 1/8 hex bearings from the top
and slide the delrin blocks away from the Main Carousel Ring Gear.
5. Locate the other three brown delrin blocks (without bearings) located at the 11:00, 2:00 and 7:00
positions of the Main Carousel Ring Gear Assembly. Loosen (but do not remove) the 5/32 hex bolts
from the top of the delrin blocks and slide the delrin blocks away from the Main Carousel Ring Gear.
6. Locate the Main Carousel positioning sensor located at approximately the 1:30 position. Loosen the
single 3/32 hex screw located at the base of the sensor assembly. Loosen (but do not remove) the hex
stud located at the base of the sensor assembly until it can swivel.
7. Holding the assembly by the silver rod at the top, rotate the entire sensor assembly clockwise
disengaging it from around the ring gear.

8. Carefully remove the ring gear straight up.
CAUTION: It is very important that the main carousel casting below the ring gear assembly is not
removed unless absolutely necessary. This is the very first element that is secured into the
instrument. It acts as the point of reference for all other interfacing modules. If it is shifted or
removed, all modular motor movements will have to be re-aligned and the motor configuration
table changed. Consult Siemens Diagnostics Field Service whenever it is deemed absolutely
necessary to remove the main carousel lower base casting.
9. Reassemble in reverse order. Before re-inserting the Main Carousel Ring Gear Assembly, check that
the Main Carousel positioning sensor is still rotated out of the way. Do not over-mesh the gears of the
motor assembly to the Main Carousel Ring Gear. Use moderate pressure only.
7.3.6 Load Platform Assembly

1. Remove all assemblies as described in previous sections 7.3.2 - 7.3.5.
2. Remove three screws securing the Barcode Reader PCB from the top.
3. Remove Barcode Reader PCB. Carefully disconnect connector (A44-J1).
4. Carefully, manipulate cable (A44-J1) through hole and into the lower chassis.
5. Loosen the nine captive screws located around the edges of the load platform base and around the star
gear portion at the left end.
6. Locate the grounding strap located between the Barcode Reader motor bracket and one of the screws
securing the black top cover latch. Remove the grounding strap from the latch end.
7. Slowly and carefully lift the module a small distance from the chassis, being careful not to damage
the cables attached from below. Remove the following cables:
8. The module can now be carefully lifted out of the chassis. Note that the left end is very tight. Be
careful to guide the Barcode Reader PCB cable (A44-J1) out, which is soldered to the interface board.
9. Re-assemble in reverse order. Do not attempt to re-connect cables until assembly is nearly inserted all
the way back into the chassis. Ensure the cable (A44-J1) is properly routed through the lower chassis
before full re-insertion of the assembly.
CAUTION: Be careful not to damage the wires or Interface PCB upon re-insertion through the
chassis cutout.

7.3.7 Sample/Test Unit Barcode Reader Assembly
Sample/Test Unit Barcode Reader PCB Removal/Replacement
CAUTION: Ensure power is turned off before starting the removal procedure. Damage to the
Barcode Reader PCB can occur easily.
1. Remove two 9/64 hex screws that are securing the bracket on the top of the Barcode Idler assembly.
Remove bracket.
2. Remove three Phillips head screws securing the Barcode PCB, do not drop any washers into the
instrument.
3. Manipulate the PCB out from its mounts and remove the J1 connector.
4. Re-assemble in reverse order
Sample/Test Unit Barcode Reader Drive Motor Removal/Replacement

Note: Barcode Motor Replacement Kit 420056 must be on-hand to perform the following.
1. Remove the Sample/Test Unit Barcode Reader PCB as described in steps 1 through 4 in Section
7.3.7.
2. Lift the entire motor and bracket assembly from the lower pivot point bushing, while holding the
motor return spring, which is inserted towards the rear of the bracket.
3. Loosen the 5/64 locking hex screw of the barcode motor drive wheel and remove the drive wheel
from the motor shaft.
4. Remove the two small 1.5 mm hex screws securing the motor to the top of the bracket.
5. Cut the wire tie securing the motor wires to the motor body. Trim the heat shrink tubing of the wires
to expose the connection point with the power cable, which is routed through the small hole in the
bracket.
6. Cut the motor wires from the power cable. Strip new ends to the power cable. Slip a new piece of
shrink tubing (supplied with kit) onto the power cable and through the bracket hole.
7. Solder the connections of the new motor wires, insulating one from the other with electrical tape.
Slide the new shrink tubing over the solder joints. Ensure connections are protected.
8. Use a heat gun to carefully shrink the tubing around the solder joint and through the bracket.
9. Remove the DC Motor/Heater PCB (A2).
10. Replace the Q17 driver FET with one supplied in the kit with a solder iron.
11. Re-assemble the motor to bracket and secure wires to motor body with new wire tie.
12. Re-assemble the Sample/Test Unit Barcode Reader Motor in reverse order. Carefully re-insert the
drive motor return spring.
CAUTION: When re-securing the drive wheel to the motor shaft, be sure to align the screw with the
flat of the motor shaft. Also ensure the drive wheel is at the proper height so as not to rub the motor
mounting screws below or to contact the Barcode Reader PCB opto-sensor above.

Rollers, Pins and O-ring Removal/Replacement
Remove the bracket.
Note: Entire roller assembly should be visually inspected and cleaned. Look for spilled patient samples
throughout the area and on the top of the load platform casting where the sample cups travel.
2. Remove star-shaped retaining bracket by pulling it straight up.

3. While holding the first roller, grasp the pin in the center with needle nose pliers and pull the pin
straight up. Repeat this step to remove all rollers, pins and O-rings.
4. Evaluate the rollers, pins and O-rings. Look for elongated holes on the inner diameter of the rollers.
This could cause the rollers to wobble as they turn. Look for worn ends of the roller (they should be
rounded). Check that the pins are not excessively scratched, scored, or show signs of black dust.
Replace rollers, pins and O-rings as needed.
5. Re-assemble in reverse order.
Drive O-ring Removal/Replacement
Remove bracket.
2. Remove the Sample/Test Unit Barcode Reader PCB as per instructions in Section 7.3.7.
3. Grasp end of O-ring with needle nose pliers and pinch it to break it off.
CAUTION: Be careful not to scratch or damage the drive wheel itself.
4. Prepare the new O-ring and drive wheel by gently moistening them with water.
5. Use two fingers to partially stretch the O-ring around the drive wheel to insert the new O-ring.
6. Just before the O-ring is completely around the drive wheel, carefully insert a small blade screwdriver
between the O-ring and the far side of the drive wheel. Use the screwdriver to pry the remaining part
of the O-ring onto the drive wheel. Do not remove the screwdriver yet.
Note: Once the screwdriver is removed, it is not possible to re-align the seam of the O-ring. If the
seam is not straight, it must be replaced and the procedure started over again.
7. Gently rotate the screwdriver around the drive wheel 5 to 6 times. Visually check that the O-rings
molding seam is straight around the drive wheel without spiraling. Carefully, remove the
screwdriver.
8. Manually press the O-ring into place around the circumference of the drive wheel. Inspect for a
straight seam with no high or low areas on the O-ring circumference.

7.3.8 Injector Pump Assembly
CAUTION: Ensure power is turned off before starting any Pump Module removal or replacement
procedure. Damage to the Injector Pumps PCBs can occur easily.
1. In the case of Linear Actuator Pumps, carefully remove single connector behind the pump, leading
from the Y cable from rear of each pump. In the older Cirrus Solenoid Pumps, the single cable
connection to the rear PCB is carefully removed, after removal of a snap-on plastic cover.
2. Move the shuttle assembly manually to the far left, to the home position at the Main Carousel.
3. Remove front output fitting of the red substrate side and the two rear input fittings from the Wash
Pump Assembly (keep the Water Pump output fitting at front connected).
Note: After removing tubing from the substrate side rear input, raise the tubing and tape it to the
Substrate Reservoir Assembly or bottle, to prevent leakage of substrate.
4. Using a Phillips screwdriver, loosen the two captive screws at the rear edge of the base of the Wash
Pump Assembly.
CAUTION: Do not let the screwdriver shaft damage the pumps or the PMT behind.
5. Lift the Injector Pump Assembly straight up and out of the instrument.
7.3.9 Substrate Heater Assembly
2. Loosen the screw at the rear of the heater to free the wire clip and the L-bracket securing the tube
fitting.
3. Disconnect all wiring from the rear of the Substrate Heater (A162-J1, J2, and J3).
4. Disconnect red substrate output fitting from the top of the Substrate Heater. Allow a few seconds for
the substrate to drain from the heater into shuttle drain below.
5. Loosen the thumbscrew securing the heater to the platform. Remove the entire assembly.
7.3.10 Substrate Reservoir Assembly
1. Disconnect the reservoir level sensor wire from the rear of the substrate heater at J2.
2. Disconnect the tubing from the Wash Pump Substrate input.
Note: After removing the tubing from the substrate pump input side, raise the tubing and tape it to
the Substrate Reservoir Assembly or bottle, to prevent leakage of substrate.
3. If present, disengage the bottom drain tubing of the Substrate Reservoir Assembly.
4. Loosen the single captive screw at the base of the Substrate Reservoir Assembly.
5. Remove the entire assembly from the platform being aware of the slot that is cut into the base at the
rear of assembly.

7.3.11 High Speed Spinner Motor and Drive Wheel Assembly
Note: The following instructions cover removal steps for the entire assembly and then the High Speed
Spinner Motor and Drive Wheel Assemblies. Proceed as far as needed to the last step as appropriate.
1. Remove the Substrate Heater Assembly and the Substrate Reservoir Assembly.
2. Remove the single screw and the tube guide at the top of the black plastic cover of the Luminometer
Module and carefully manipulate the cover off and out of instrument.
3. Manually move the shuttle from the left side, about two inches in toward the Luminometer.
4. Disconnect the 8-pin connector (A10-J4) from the Luminometer Interface PCB.
5. Loosen four captive screws located at the four corners of the High-Speed Spinner Assembly.
6. Remove the entire spinner platform assembly including the Spinner motor and idler wheel.
Motor Assembly removal from platform
7. Remove the three 9/64 hex screws (in a triangle format) holding the High-Speed Spinner Motor and
Drive Wheel.
8. Gently separate the upper cylinder bracket from the motor assembly below. The Spinner platform is
sandwiched in-between.
9. Remove the cable clip holding the cable going to the High Speed Spinner Motor.
Motor removal
10. Orient the assembly so that the drive wheel is facing toward the top.
11. Locate the motors spring coupler in the center of the assembly. Loosen the two .050 hex screws of
the coupler closer to the drive wheel.
CAUTION: Do not loosen the two hex screws closer to the High Speed Spinner Motor.
12. Loosen (but do not remove) the four 5/64 hex screws securing the High-Speed Spinner Motor
Assembly. Access these screws through two holes found in the Drive Wheel Assembly. Drop the
motor out from the bottom.
CAUTION: Keep the assembly upright and do not remove the screws from the bracket since re-
insertion of these screws is very difficult.
Drive Wheel removal

13. After removal of the two outer 5/64 screws at either side of the circumference of the Drive Wheel,
loosen (but do not remove) the two inner 5/64 hex screws, until they are loose from the (2) 180 flats
of the drive shaft.
14. Pull the upper shaft and bearing assembly from the top. The Drive Wheel can now be removed. Upon
re-assembly, be sure the inner screws are properly located to the flats of the shaft before tightening.
15. Re-assemble in reverse order. If the Motor has been removed, be careful to orient it so that the motor
cable protrudes toward the rear corner of the assembly, in order to avoid wire damage snagging on the
moving tube shuttle. Ensure that the wire clip mounted underneath the platform secures the wire from
the motor. The wire clip itself must not encroach into the rear of the platform. Also, ensure the Shuttle
Assembly is positioned approximately two inches from the left before re-assembly.

7.3.12 Tube Shuttle Upper Slide Bearing Assembly
1. Remove the probe vanity panel, and move the shuttle to the far-left home position.
2. Remove the main section of the clear carousel cover.
3. Loosen (but do not remove) the (4) 1.5 mm hex screws located on either side of the top of the shuttle
assembly.
4. Grasp the top shuttle assembly with both hands at both ends. Gently, manipulate the upper part of the
assembly out while keeping the upper spring from disengaging. The upper assembly will separate
from the lower spring, which is captured on a post. The lower spring and guidepost will stay in place
above the shuttle slide bearing.
5. Loosen the two 2 mm hex screws at each end of the slide bearing assembly.
Note: Use a ball end hex key to remove the two 2 mm hex screws.
6. With the screws loose, carefully remove the slide bearing and rail off of the shuttle assembly.
CAUTION: Do not allow the bearing assembly to completely slide off the rail.
7. Clean and/or lubricate the slide bearing and re-assemble in reverse order.
CAUTION: Do not lose a small thin rectangular shim located towards the rear of the bearing
assembly. The shim is necessary for proper alignment and performance of the upper shuttle
assembly. A dab of grease may be applied to the shim to hold it in place during re-assembly.
7.3.13 Tube Shuttle Idler Wheel Assembly

Note: The Tube Shuttle Idler Wheel Assembly is a standard replacement part whenever performing
Preventive Maintenance. Refer to Chapter 6 for information on PM procedures. Between Preventive
Maintenance sessions, the assembly can simply be inspected for dirt or damage. The O-rings and
surrounding areas can be cleaned with a damp cloth.
1. Remove the Tube Shuttle Upper Slide Bearing Assembly referring to steps 1 through 5 in Section
7.3.12.
2. Using a small-blade screwdriver partially spread the small retaining-clip at the top of the Idler Wheel
shaft, until the clip is removed from the catch groove.
3. Once the tiny clip is removed, the silver cap above the Idler Wheel can be removed and should be
cleaned.
4. Below the silver cap is a small wave-washer. This is replaced (P/N 900261) as part of the Shuttle
Idler Wheel replacement kit (P/N 420001).
Important: The wave washer must be re-installed with the bowl of the washer facing up.
5. After removal of the cap and wave washer, the Idler Wheel can be pulled off the shaft and cleaned or
replaced. Once removed, the opportunity should be taken to carefully clean the entire area of the
upper shuttle body assembly around the idler wheel.
6. Re-assemble in reverse order with the wheel on the shaft and re-capture, using a new retaining-clip
(P/N 900262) of the Shuttle Idler Wheel replacement kit (P/N 420001).

7.3.14 Luminometer Casting Cover / Attenuator Motor and Belt
Note: These instructions are for the removal of the upper Luminometer Casting Cover to access to
the Luminometer Chain and the Attenuator Disk Assembly. In rare cases where removal of the lower
section of the Luminometer is necessary, please contact IMMULITE Technical Support.
1. Remove all assemblies as described in sections 7.3.8 through 7.3.11.

2. Remove the two screws at each end of the test unit exit ramp on the right side of the unit.
3. Remove the test unit exit ramp from instrument.
CAUTION: Power must be turned off before attempting to remove the PMT.
4. Locate the black metal bracket ring located at the end of the PMT. Remove the three 7/64 hex
screws that hold this ring in place. Carefully, slide the ring away from the PMT.
5. Gently shake the PMT back and forth and outward to facilitate removal.
CAUTION: After the PMT is removed, even with the power off, caution must be taken to not
expose the PMT to ambient light, as damage can occur. Carefully, tuck the PMT face into the back
corner of the instrument and cover if necessary. DO NOT TOUCH THE PMT LENS!
6. Remove all the connections from the Luminometer Interface PCB (A10). Release the five plastic
standoffs that secure the A10 PCB to the top of the Luminometer.
7. Lean the PCB back and off the rear of the Luminometer cover. The PCB cannot be totally removed
because the other wires are soldered to the right edge of the PCB.
8. Remove the two sensor wires from the attenuator home and positioning sensors found on the right
side of the Luminometer cover. Properly mark the connectors to facilitate re-assembly.
9. Loosen the five 9/64 hex screws located around the lip of the upper Luminometer cover. There are
three screws along the left edge of the cover, one at the front center and one in the rear right corner.
Tool extensions may be necessary. The rear right corner hex screw has a wire clip under it that
secures a number of sensor wires. Keep the hex screw inserted in the clip for easier re-assembly later.
10. Read all four cautions listed below before proceeding to the next step.
CAUTIONS: 1.When attempting to lift the Luminometer cover off, some resistance may be felt
due to tightness within the locator pins. It may be necessary to gently pry the
cover free of its locator pins with a screwdriver.
2. The Luminometer cover may be trapped along the left edge under the plastic
casing of the lower Main Carousel casting. Gently flex or pry the Main Carousel
casing to free the Luminometer cover.
3. Do not damage the Luminometer Temperature Thermistor, which remains
screwed into the top cover, located behind the Chain Drive Motor Assembly.
4. Do not touch the attenuator lens located on the disk assembly within the
Luminometer cover. Maintenance on this assembly is rarely needed. For further
details on this assembly, please contact IMMULITE Technical Support.
11. Grasp the motor assembly from the top and carefully lift the cover off the module, while pivoting the
Luminometer Interface PCB out of the way. The Luminometer chain is now exposed.

12. The attenuator motor and belt are mounted to a plate, which is slot mounted to the upper
Luminometer cover. Loosen or remove the 1/4 screws securing the mounting plate. Sliding the
motor/plate assembly inward can loosen the belt. To remove the belt, the two disk positioning sensors
and their standoffs must be removed first and then the belt can be looped off the positioning sensor
disk assembly.
13. Reassemble in reverse order. Be aware of cautions listed in step 10, and follow additional cautions
listed below:
CAUTIONS: 1.The attenuator belt tightness is subjectively a 1/8 to 1/4 deflection when the
central portion of the belt expanse is pressed with moderate pressure. A belt that
is too tight (little or no deflection) can result in premature wear of the bearings in
the attenuator disk shaft within the Luminometer cover. It may also result in a
seizure of the attenuator disk assembly.
2. Before reassembling the Luminometer cover onto the base, check the
alignment of the Luminometer motor coupling with respect to the Luminometer
chain coupling. If these are not aligned, the cover will not fully seat. If upon re-
assembly the Luminometer cover still does not sit down firmly (instead it rocks
back and forth), move the Luminometer chain manually. This will re-engage the
Luminometer drive cog with the drive motor coupling from above. Once re-
engaged, the Luminometer cover should then set into place flatly. Ensure that
there are no loose wires pinched under the cover.
7.3.15 Power Supply Module

1. Disconnect the Instrument from AC Power, and remove the plastic solid waste container from the
right side of the IMMULITE.
2. Locate the lower right end of the chassis where the Power Supply Module is housed. Loosen the two
captive screws, which then allow a side plate door to flip down.
3. Opening this outer panel door exposes two more captive screws. Loosen the front plate of the Power
Supply Module gradually, until both captive screws have released.
4. Carefully slide the Power Supply Module out the right side of the instrument until the three main
connectors are exposed.
5. Carefully remove the J1, J2, and J3 system cable harnesses, and pull off the yellow grounding strap
connection near the supply AC input.
6. Slide the entire Power Supply Module out of the right side of the instrument.
CAUTION: Ensure J1, J2, and J3 wire harnesses are re-routed as they were. When re-inserting the
power supply do not damage any harness wires on sharp chassis edges above. The Power Supply
Module should slide in easily. If there are any problems with re-insertion, pull the Power Supply
Module out and check the wire harness routing.

7.3.16 Replacement of the Chain Assemblies
The general principle for replacement of either the entire Load Platform Chain Assembly (P/N 400190-
01), or of the Luminometer Chain Assembly (P/N 400190-02), is that neither of these chains should ever
be completely removed from the drive cogs and driving source areas of these two modules. Instead,
quicker and easier replacement of both chains is better accomplished by:
Choosing a point to gently separate the old Chain Assembly, at an accessible location
Securely attach a matching end of the new Chain Assembly (and afterward, clearly marking
the division-point of old to new chain).
Using the old chain to manually and carefully pull the new chain entirely through the route
of the chain through its Module, until the point that they are joined, comes around again to the
starting point.
Re-separation of the two chains accurately at the proper point and joining the matching ends of
the finished new chain, appropriately disposing of the old used chain assembly.
Upon completion, to double check for complete and proper assembly, operation, smooth
movement, and proper alignments.
Note: Before replacement of either one of these chains as detailed below, please be sure to read the
cautions noted at the end of this section.
Load Platform Chain Replacement

1. Remove the Probe Vanity Panel supporting the probe tubing, to expose the left end of the Load
Chain assembly, sampling, and star-wheel areas.
2. From the upper tube guide, which comprises the top surface of the loading area, loosen all of the 11
captured screws that secure it to the top of the loading area. After they are loose, the tube guide is
carefully lifted off, exposing the serpentine loading portion of the chain assembly. (All screws stay
captured within this tube guide, by small rubber O-rings from below.)
3. The front length of this chain closest to the FSE is now openly and easily accessible. To choose a
link point just right of the barcode reader area (where the tubes enter the system), first gently hold
the upper baffle, and give gentle pressure, pushing the baffle off to the side of its link, in order to
allow the baffle to gently pop off of the top of a chain link. Then separate the exposed chain link
and swing plate below, as described in the initial bullet points above. (See Caution 2 at the end of
this section.)
4. Next, choose another point of this old chain at the rear-most span of the loading area, where it
passes in front of the Luminometer. Again, separate the chain link at this chosen point.
5. Now, all of the old chain between these two points, can be initially removed from around the
numerous bearings which guide the chain through this loading serpentine, and thus, half of the old
chain is now gone, the load area is now clear. The remainder of the chain to the left is still within
the more complex drive portion of its Module.
Caution: The Old chain is a Bio-Hazard Handle and dispose of properly!!

6. Prepare the new chain, by choosing which end of it matches how the old chain was just
separated. Orient the new chain so that it will enter the system in the same direction as normal
chain travel. Snap together the two chains end-to-end by the swing plate below and then carefully
replace the snap-on baffle above, to secure the joining of the two chains. Mark this joining point, in
some clearly visible way, in order to correctly re-separate the two chains at the proper point upon
completion. (See Caution 1 at the end of this section.)
7. With the Instrument in the Idle state (or turned off), grasp the Star Wheel at the left end of the
module, left of the sampling positions. This is the top of the actual drive shaft point for the chain.
Manually and slowly rotate the Star Wheel clockwise in order to use the old chain to pull the new
chain carefully through the entire Module Assembly. At the same time, with the right hand, keep a
gentle tension in the other loose end of the chain at the rear of the loading area. Preventing the slack
while feeding the new chain through, ensures the chain does not buckle and snag anywhere within
its assembly path during this pull-through procedure.
8. Carefully pull the new chain through, until it is fed throughout the left-end drive portion of the
module, until the mark put on the joining point earlier, is seen to come out to the rear of the open
loading area. The remainder of the new chain is still left to feed into the system.
9. Note the marked point at which the chains are joined and the links are again carefully separated at
the exact same point and relationship as the way in which they were joined. (See Caution 1 at the
end of this section.) The remainder of the old chain is now free from the system.
Caution: The old chain is a Bio-Hazard Handle and dispose of properly!!
10. Release the Star Wheel, and now simply manually weave the remainder of the new chain, around
each of the serpentine pattern of roller bearings, and string the chain rearward toward the waiting
free end at the rear of the loading area.
11. Securely snap the bottom swing plate to join the completed chain assembly, and then gently replace
the snap-on baffle on top.
12. Replace the Load Platform Tube Guide, being sure to fully secure all screws, so the top of the
loading area is smooth and un-obstructed.
13. This Load Platform Chain Assembly is automatically tensioned throughout its module by the two
spring-loaded tensioning arms, located on either side of the Main Incubator Carousel ring gear at
the crossover point of the two modules. There should never be a need to have any concern about
manual tension adjustment by the FSE so long as the new chain is properly fed through the module.
(See Caution 1 at the end of this section.)
14. Run the LCHAIN main diagnostic program, and visually inspect for proper operation and alignment
of the new chain assembly. As long as the new chain is fed correctly, the FSE should find no need
to make any alignment adjustment, but this should always be double checked upon completion. If a
serious alignment change has occurred after chain replacement, then the FSE should inspect again
for proper procedure. (See Caution 1 at the end of this section.) Additionally, see Section 7.4.6:
Miscellaneous Procedures, for details on proper Load Chain alignment.

Luminometer Chain Replacement
1. Remove the following portions of the upper Luminometer, as described in the previous section for
removal of assemblies:
Substrate Heater Assembly as per previous Section 7.3.9.
Substrate Reservoir Assembly as per previous Section 7.3.10
2. Remove the single screw and tube guide at the top of the Luminometer Module, and carefully
manipulate this top plastic cover off and out of the Instrument.
3. Remove the High-Speed Spinner Platform Assembly, as per previous Section 7.3.11, following only
steps 1 through 6 of that procedure.
4. The front portion of the Luminometer Chain Assembly is now exposed openly for the FSE to
choose a point along this front span, in which to separate the old chain, in the same manner as the
Load Chain instruction above. BUT, before separating the old chain read the next step.
5. Locate the right-front corner turn of this chain, where it rounds a roller bearing guide just past the
tube exit ramp. This is front tension adjustment for the chain. Take note or mark the original position
of the base of this moveable bearing before loosening it. This mark helps guide proper tensioning
and reset of this bearing upon completion of chain replacement. Loosen (slightly!) the 9/64 sized
hex screw at the top of this bearing.
6. After a slight loosening of the chain tension at this right-front corner bearing, the chain will now
relax to ease the FSEs physical separation of a link of the old chain. (See Caution 2 at the end of
this section.)
7. Prepare the new chain, much in the same manner as described in step #5 of the Load Chain
procedure above. Carefully and clearly mark the baffle that is above the joining point of old the
two chains, after snapping them together end-to-end. (See Caution 1 at the end of this section.)
8. In a similar manner to the Load Chain replacement procedure above, the FSE will now use the old
chain to pull the new chain into and completely through the inner Luminometer Module.
Note: Feed this new chain into the Luminometer, in the same direction as normal operation of the chain
(entering at the left, behind the spinner station.) This better ensures the new chain seats and settles around
the inner drive assemblies in the same way as the old chain did.
9. While gently pulling the chain slowly through from the right end at the Luminometer exit ramp,
carefully try to avoid snagging the chain on the inner end of the tube exit ramp, as it is coming out of
the Luminometer exit.
10. Pull the new chain throughout the Module until the FSEs baffle mark of the joining point of the
two chains, is seen out of the right side exit of the Luminometer. Continue pulling, around the right
front corner tension adjustment bearing, to bring this leading end of the new chain at the marked
point to this accessible front open area.
11. Carefully separate the chain link at the mark joining point of the two chains (See Cautions 1 & 2 at
the end of this section.) The old chain is now free from the system, and can be discarded
Caution: The old chain is a Bio-Hazard handle and dispose of properly!!
12. Bring the two free matching ends of the new chain together in this front open area, and carefully
snap the bottom swing plate together, finishing the chain assembly. Replace the snap-on baffle on
top.

13. Being sure that the chain is properly seated around it re-apply a gentle pull on this right-front
tension roller bearing. Pull the new chain to a position that the tensioning bearing is positioned in the
same spot as was the tensioning of the old chain. (This is subjective, but attempt to get as close as
possible.) This roller bearing is then tightened to secure chain tension.
14. Finally, reassemble the finished Luminometer Module in reverse order, and test all applicable
functions.
Tips on judging proper tension of the Luminometer Chain
Proper tension of this chain has no exact specification. It is somewhat subjective and may vary slightly
between assemblies. The general rule is that after tightening down the roller bearing, check the resulting
tension by applying a gentle two-finger pressure to the center spot of this front chain span, and push the
chain rearward, toward the black metal drain trough base of the shuttle.
The chain should just touch this black shuttle drain base behind it, with little effort. If a strong effort has
to be used to reach and touch that black metal behind, loosen the chain tension a bit by re-positioning the
right-front tensioning roller bearing.
Conversely, if the chain easily touches behind at this point, and actually stays there when finger pressure
is released, then a bit more tension should be added, by slightly re-positioning the right-front tension
roller bearing.
Note: Overall, if deciding on Luminometer Chain tension being too tight, or too loose, it is always
better to have the final tension on the loose side. Historically, it has been seen that the chain is far more
likely to have movement troubles if chain tension is set too tight. A chain tension that is too tight will
cause torque and drive strength problems for the chain drive motor. This is also evident if there is a
ratcheting noise, or jittering or back-stepping behaviors are seen during chain motion. These
behaviors of a tight or stiff/sticky chain will likely cause intermittent and random positioning problems,
and problems with proper guidance of tubes through the area, as well as a higher risk of conflicts at the
cross-over point where the tube shuttle passes through the Luminometer Chain at the wash/spin position.
This area is one of the most crucial mechanical alignment points in the System.
As with the Load Platform Chain, generally after a replacement of this chain, there should be no need for
any change to the chains positional alignment, as set in the motor configuration table, and adjusted using
the LUMCHADJ configuration diagnostic. If the new chain was carefully fed through the module in the
exact manner as instructed, there should be no need to do any major adjustment from the setting of the old
chain. This is also providing that final tension of the new chain is very closely set to what the old chain
was, via the right-front corner adjustable tension roller bearing.
Be aware that this Luminometer Chain lends itself to a much more subjective judgment of chain tension
(unlike the Load Chain, which is self-tensioning). Therefore, the tension, positioning, and proper
alignment of this new Luminometer chain should always be double-checked, and carefully scrutinized, to
be absolutely sure.

Important Cautions:
In a replacement of either of these chain assemblies, please take note:
-- When choosing a point to join the old chain to the new one before pulling it through, carefully
snap the top chain baffle onto that joining point, then clearly mark that baffle somehow, such as
with a small piece of colored tape. Also take careful mental note of the link relationship at the
joining point of the two chains. If a chain link or its lower swing plate below is not properly
separated again in the exact same relationship after the pull-through, then upon completion,
incorrect assembly within the module will result. Consequently, the new chain assembly may have
one too many, or one too few links and/or swing plates in it. The result will guarantee that the
chain will not operate correctly, will not tension correctly, and will not align correctly.
-- The blade of a small screwdriver may be needed at times, in order to be able to initially separate
a chain link. If this is done, take extreme caution to not nick or damage any piece that may
perhaps be intended to remain as part of the finished instrument assembly (as a piece of the final
new chain). A deep nick or other such damage may hinder the proper flexibility of that chain
link, causing random and intermittent positioning or alignment problems for the chain assembly.
-- When separating or re-joining ends of a chain, always take note of proper top and bottom
placement of the lower swing plates. The small bushing molded on one side, should always be
oriented up toward its chain link above. The top baffles likewise have this small molded bushing,
above its link. These molded bushings on these pieces ensure easy and proper rotation of a link
joint.

7.4 Miscellaneous Procedures
7.4.1 Testing the Water Supply
Upon installation of the IMMULITE Analyzer, the laboratory-distilled water supply must be tested for
alkaline phosphatase contamination. Contamination can affect the IMMULITEs performance by altering
the matrix during the immunological reaction, or by increasing the post-wash counts per second (cps). It
is recommended that the customer test their water supply at least once a month.
Room temperature distilled water must be used in the IMMULITE water reservoir. The water test
procedure involves using two IMMULITE diagnostics programs:
WATERTST
WATERTPM
Use the Water Test Kit (catalog number: LKWT) in conjunction with these diagnostic programs to
perform the water tests. Instructions for using the WATERTST and WATERTPM diagnostic programs
and for evaluating their results appear below.
WATERTST
of the IMMULITE. Water should be tested before priming water from a new source through the
IMMULITE System, or when contamination is suspected. The procedure for testing the water supply
using the WATERTST program appears below:
1. Before starting, ensure the IMMULITE has been powered on for at least 45 minutes and at a stable
operating temperature.
3. From the Start-up menu, select DIAGNOSTICS. Then choose the submenu DIAGNOSTICS.
4. If not already done in the previous instrument setup process, be sure the substrate is well primed. If
needed, load and run the SOLE2S program to fully prime the substrate nozzle.
Note: The IMMULITE must be Idle before performing this step, or before step 9.
8. From the Diagnostic Menu, load and run the WATERTST program.

12. At the DOS prompt, type WATER and press [Enter]. The following screen appears:
13. Type a 1 to select the WATERTST and press [Enter].

The screen will post a Waiting for data message. In approximately 10 minutes, the first Test
16. Refer to Acceptance Criteria on page 7-28 to determine the outcome of this test.
instrument, the fluidics system must be decontaminated. Refer to section 7.4.2 System
WATERTPM
The WATERTPM diagnostic program tests the water dispensed from the probe and the water pump.
Use this procedure when contamination within the system is suspected.
1. Check to make sure the daily maintenance has been performed and that the substrate and the Wash
Pump water lines have both been sufficiently primed.
3. Select four empty water Test Units.
Note: Do not pipette water into any of the Test Units.
4. Load all four water Test Units onto the Load Chain.
5. From the Start-up screen, choose DIAGNOSTICS and then the submenu DIAGNOSTICS.
6. Select WATERTPM and press [Enter].
7. When the loading is complete, press [Enter] again.

The following process occurs:
Water from the probe is pipetted into the first Test Unit.
Water from the wash line is dispensed into the second Test Unit.
Water from the second Test Unit is pipetted into the third Test Unit.
Substrate is added to the first, third, and fourth Test Units.
The first, third and fourth Test Units are incubated in the Luminometer for 10 minutes and
readings are taken. The second Test Unit is indexed off the Main Carousel and onto the Load
Chain for easy removal.
10. At the DOS prompt, type water and press [Enter]. The following screen appears:
11. Type a 2 to select the WATERTPM and press [Enter].

The screen will then post a Waiting for data message. In approximately 10 minutes, the first Test
Note: The first result is for the water from the probe, the second is for the water from the water
pump, and the third is for the Test Unit containing substrate.
14. Refer to Acceptance Criteria on the next page to determine the outcome of this test.

ACCEPTANCE CRITERIA
> 4,500 cps and < 9,000 cps

The Luminometer is not warm
The substrate volume was
insufficient
< 4,500 The resident substrate is expired,
and loosing its reactive properties
(good for up to 30 days after
Unacceptable alkaline
present
If the CPS is too high or too low, perform the test again to confirm these results.
If the CPS is consistently outside the 4,500 CPS to 9,000 CPS range, find a new water source and
test this new source.
If the second test unit (substrate only) is > 9,000 CPS, the substrate system may be contaminated
or the test units used for testing may not be clean.
Note: The Water result is then not valid, as the unacceptably high level of this baseline substrate only
reading is falsely biasing it.
1. For WATERTST, refer to last line printed with results:

External water source Substrate Only = XXX CPS
If the value of XXX in the subtraction above is lower than 650 CPS, insufficient substrate may have
been dispensed into one of the Test Units. This could be due to a clogged nozzle. Check both Test
Units to determine if they contain enough substrate. If the value of XXX in the subtraction above is
above 2000 CPS, do not use this water source on the IMMULITE Analyzer. Find a new water
source, and test this new source.
CAUTION: If this water source was used, the system must also be decontaminated.
2. For WATERTPM, refer to the last two lines printed with results:
Probe Water Substrate Only = XXX CPS
Pump Water Substrate Only = XXX CPS
If the value of XXX for either equation above is lower than 650 CPS, insufficient substrate may have
been dispensed into one of the Test Units. This could be due to a clogged nozzle. Visually check all
Test Units to determine if the liquid level is equally distributed between the Test Units. If the value of
XXX above is above 2000 CPS, perform the test again to confirm these results. If the CPS is
consistently above 2000 CPS, decontaminate the system. Refer to section 7.4.2 System
Decontamination on the next page.

Acceptable test results for WATERTPM and WATERTST tests are shown below.

Sample of Acceptable Water Test (WATERTPM)
Probe Water = 6000

Water dispensed from the pump = 5800 cps
Substrate Only = 5900 cps
Probe Water Substrate Only = 100 cps

Pump Water Substrate Only = -100 cps
If the system is contaminated, refer to Section 7.4.2: System Decontamination.

7.4.2 System Decontamination
If the system is contaminated, follow the steps below to decontaminate the system.
1. Put the IMMULITE in idle by pressing ALARM MUTE and GO.
2. Obtain the following supplies:
Probe Wash (Part No. LPWS2)
Water filters (Part No. 10-500499)
Gloves
Sterile cotton swabs (Q-Tips)
3. Empty the waste from the waste container.
4. Remove and discard the water filter canisters from the rear left corner wall.
5. Remove, empty and set aside the water container.
6. Remove, empty and clean the Probe Wash Bottle with a flushing of 70% Isopropyl Alcohol, followed
by at least 5 times repeated rinsing with acceptable IMMULITE water, then a fresh (prepared 10X
dilution) solution of probe wash.
7. Place the blue water lines into the new container containing the probe wash.
8. From the Start-up menu, choose DIAGNOSTICS and submenu DIAGNOSTICS.
9. Select DECON and press [Enter].
11. Run the program for ten minutes to ensure the probe wash has thoroughly penetrated the system.
12. Press ALARM MUTE and GO to stop the DECON program. (Best to stop when Syringes are in a
down position, in order to maximize decontamination within the syringe barrels.)
13. Let the system sit for a minimum of thirty minutes. During this time, continue with steps 14 -16.
14. Place 100mL of 70% isopropyl alcohol into the original water container. Place the blue cap and inner
water lines into the original water container and tighten the cap. Shake well to ensure the alcohol
contacts all surfaces in the container, including the cap.
15. Discard the alcohol and rinse the water container and cap with distilled water at least five times (with
the cap on) to ensure all surfaces have been thoroughly rinsed.
16. Install new end-of-line water & probe wash filters.
Note: Un-powdered gloves must be used when handling the new filters and their related tubing,
since direct contact with the skin can contaminate the immediate tube areas near the filters.
17. Refill the water container with fresh IMMULITE acceptable distilled water.
18. Using a sterile cotton swab, wipe the accessible surface of the wash station to help remove any
growth.
19. Run the DECON1 diagnostic program with fresh distilled water:
Note: Prior to filling the container, the water must be tested using the WATERTST diagnostic program.
From the same Diagnostics Menu, choose DECON1, and press [Enter].
When program has finished loading, press [Enter] again.
Press GO on the IMMULITE when instructed to do so.
The program is finished automatically, in approximately fifteen minutes.
20. Re-test the system for contamination using the WATERTPM diagnostic program to verify the
system now meets the proper criteria.

7.4.3 Substrate Spike Replacement
To replace the substrate spike, follow the instructions below:
1. Remove the substrate bottle by pulling it straight up.
2. Loosen (do not remove) the two screws on either side of the spike using a Phillips-head screwdriver
(see figure below.)
3. Remove the substrate vial support assembly.
4. Grasp the spike and lift up out of the manifold block.
CAUTION: The O-ring may stick to the bottom of the vial support. If this occurs, be sure to
remove it. (Normally, it rests on the spike tip.)
5. Remove the new spike from its sterile packaging.

6. Remove and discard the colored fitting over the base of the spike.
Note: Keep the tip guard on and do not to touch the tip of the spike, since this could cause
contamination.
7. Re-seat the spike in the manifold block.

8. Hold the wings of the spike,
remove the tip guard and place
the O-ring over the spike tip.
9. Clean the substrate spike support assembly
and the upper bottle support using 70% Isopropyl
alcohol.
10. Carefully re-position the
support over the spike and O-ring,
aligning the screw holes.
11. Re-tighten the screws until snug.
Do not over-tighten.
12. Replace the substrate bottle.

7.4.4 Fluidic Valve Testing
Testing the Solenoid Valves and Associated Tubing
Remove the probe line fitting from the 4-way block. Attach a discarded probe, having the metal jacket cut
off and the outer tubing removed, to the 4-way block. Run the tests below and look for the appropriate
water movement at the end of the tubing. Water movement that occurs as the valve actuates or de-actuates
is normal, but should be no more than 1/4 inch.
1. Valve #1 Testing
Run the V1TEST diagnostic. The water should alternately dispense from the "probe" and from the
wash well. Except for valve throw, the water should never move in the tubing when the water is
dispensing up from the bottom of the wash well. If water is moving down the probe when it should
not be, this can cause under-aspirating of reagent and/or sample. It can also cause fluid to be drawn
into the probe from the home well resulting in carryover.
2. Valve #4 Testing
Run V4TEST diagnostic. The water should alternately dispense from the probe and from the wash
well. Except for valve throw, the water should never move in the tubing when the water is dispensing
up from the bottom of the wash well. If water is moving down the probe when it should not be, this
can cause under-aspirating of reagent and/or sample. It can also cause fluid to be drawn into the probe
from the home well resulting in carryover.
3. Valve #2 Testing
Run the V2TEST diagnostic. The water should alternately dispense from the probe and the tubing
that goes into the probe wash container (that has been removed from the wash container and placed
into a container or the wash station for this test). Follow the instructions given on the IMMULITE
Display. Except for the valve throw, the water should never move in the probe tubing when the water
is dispensing from the disconnected Probe Wash tubing.
4. Fluid Flow Testing
Run the PRIME diagnostic. During dispense, the 5000 ul syringe stops momentarily to switch a
valve. During this moment the water should come out in drips only since only the 250 ul syringe is
moving. If not, there is backpressure building in the fluidics that is being released during this
moment. This backpressure could be the result of a partially occluded piece of tubing, air in the lines,
or a piece of tubing that is expanding excessively from the pressure during dispensing. When the
water is finished dispensing, make sure no water backs up in the tubing. Water flow back-up in the
tubing is indicative of a solenoid valve failure.
5. Valve Leakage Testing
Secure the tubing to the Main Carousel shroud with tape. Then place the wash bottle on top of the
instrument and check for fluid movement. If none occurs, place the wash bottle at tabletop level and
once again check for fluid movement.
Water movement in the tubing (when the tubing is secured) is indicative of a Valve # 2 failure. This
type of failure usually results in the first test that is run after the pipettor has been idle for a while to
have a very different result than the test units after it (assuming the other test units are replicates of
the first, like that of an adjustment.)

Testing the Microvalve and Macrovalve
Place the water bottle on top of the instrument and check for fluid movement down the tubing. If any
occurs, the defective valve can be isolated by removing one of the lines from the water bottle and
placing it at table top level; if the water movement stops, the defective valve is the one attached to the
tubing now at table top level. This type of failure usually results in imprecision, especially if the
failure is the microvalve.
2. Valve Stem Tightening (Hamilton Syringe Modules Only)
Remove each valve from their diluter and insure the silver valve barrel is tightly secured into the
valve body. If not, air can leak into the valve or water can leak out, both resulting in imprecision.
Testing the Probe
1. Probe Dispense Angle Testing
With the probe in place, run the PROBANGL diagnostic. The angle of dispense should be no greater
than 7 - 10 degrees. If the probe is dispensing at an angle, it is indicative that the tip of the probe has
been damaged or is partially occluded. Check the stream angle from various sides of the instrument.
2. Probe Dispense Integrity Testing
Run the PRIME diagnostic. Lift the probe out of the home well and move it over the dump well. The
stream should be straight and clear without excessive cavitation (air mixing with the stream).
Excessive cavitation may be indicative of probe tip damage or partial tip occlusion.
3. Testing for Probe Occlusion
Run the PRIME diagnostic and again lift the pipettor up and over the dump well. During dispense,
the 5000ul syringe stops momentarily (approximately 1 second) to switch a valve. During this
moment, the water should only come out in drips since only the 250 ul syringe is moving. If not,
there is backpressure building in the fluidics that is being released during this moment. This
backpressure may be the result of a partially occluded probe or connecting tubing, air in the lines, or a
piece of tubing that is expanding excessively.
4. Run the PROBETST diagnostic. The probe will locate into the home well and repeatedly dispense
using the Large Syringe only. Any splashing of the water out of the home well indicates a serious
dispense problem. Also any drops or streams coming from the probe while it is moving over the
dump well is evidence of an occlusion or back pressure within or leading to the probe.
Testing the Water Linear Actuator (or Cirrus Solenoid) Wash Pump
Remove the nozzle from the end of the water dispense tube. With the water bottle at tabletop level,
check to see if the water is moving back towards the bottle. Any movement is indicative of a valve
failure. This type of failure could cause the first and possibly second (depending in the severity of the
failure) injection of water into the test unit to have insufficient volume resulting in a less than
optimum bead wash.
2. Water Drawback Testing
Run the SOLE1W diagnostic. Observe how far into the dispense tubing (with the nozzle removed)
the liquid moves. Refer to the drawback specification table below. Drawback in excess of the
specification is indicative of a kink in the pumps input tubing or a slow valve. Either of which could
result in a less than an optimum wash.
3. Test the volume of the pump by using DISWAT. The volume should be 200 ul +/- 5%.

Testing the Substrate Linear Actuator (or Cirrus Solenoid) Pump
Make sure the shuttle is in the far-left home position to prevent substrate leakage on the shuttle
assembly. Remove the tubing from the top of the substrate heater and place into a container at
tabletop level (making sure the drain is below the heater). Check for any movement of substrate down
the tubing. Any movement is indicative of a valve failure. This type of failure may cause the substrate
to slowly drain out of the vial and depending on the severity of the leak, cause substrate to leak onto
and bind the Luminometer chain.
2. Substrate Drawback Testing
Run the SOLE2S diagnostic. Observe how far into the dispense tubing (which is removed from the
substrate heater) the liquid moves. Refer to the drawback specification table below. Drawback in
excess of specification is indicative of a kink in the pumps input tubing or a slow valve. This type of
failure mode can cause the substrate to "spit" out of the nozzle instead of flow out smoothly which
can result in imprecision, especially with assays having very low counts.
3. Test the volume of the pump by using SOLE2S or DISSUB. The volume should be 200ul 10%.
CAUTION: In regards to the MGM and Cirrus Solenoid type pumps only: On the rare occasion
where the volume of dispense is incorrect, it can be adjusted (if the dispense is off by less than 50 ul)
within the inner assemblies of the pump module. However if the dispense is off by more than 50ul, as
a general rule it is better and safer to replace the entire pump assembly as the adjustment balance can
easily be disturbed, possibly leading to worse problems. If an adjustment in the field is absolutely
necessary, contact Technical Support for details.
Drawback Specifications of the MGM and Cirrus Solenoid type Pumps

There currently are three different types of Injector Pumps that can be found in the field. Refer to Section
3.6.4 in Chapter 3 Theory of Operation for more information, on the differences between the Injector
Pumps.
Drawback adjustments are different between the different Injector Pumps and/or different tubing
configurations. The drawback adjustment (not possible with MGM pumps) adjusts the timing between the
throw of the valve and the pump of the bellows. Refer to the table below for specific drawback
adjustments that relate to the specific Solenoid Injector Pump and tubing installed in that system.
Drawback Specification Table
Pump Style and Water Drawback Substrate Drawback

Adjustable?
Assembly Part Number Specification Specification
< 3/4 < 3/4 No, Assembly must be
MGM P/N 400111
w/ tubing #8 w/ tubing #10 replaced
1/4 1/8 w/ tubing
1/4 1/8 Yes, use potentiometers on
CIRRUS P/N 420060 #10 or #78
w/ tubing #8 PCB under rear cover
1/2 1/4 w/ tubing #38
1/4 1/8 w/ tubing Yes, change #6 & 7 DIP
LINEAR ACTUATOR 1/4 1/8
#10 or #78 switch settings within
P/N 420120 w/ tubing #8
1/2 1/4 w/ tubing #38 pump base

Volume and Drawback Specifications of the Linear Actuator type Pumps
The drawback adjustment adjusts the timing between the throw of the valve and the actuation of the
stepper motor-driven bellows. Refer to the instructions below for specific drawback adjustments that
relate specifically to the Linear Actuator Pump Assembly (p/n 420120).
For both the Water and Substrate pumps, the standard Drawback specification is for +/- .
Easy Access under the pumps to adjust drawback

and fine-tune the volume via DIP switches:
Internal Stepper Motor & Opto-Sensor
DIP Switch with outer-end-down

(rocker down) position, is ON
DIP Switch with inner-end-down

(OFF) position is OFF
Jumpers to the left are not used in

IMMULITE, and should remain
at factory settings.
Switch #8 is master volume rough setting:

- off = 200ul for IMMULITE, both sides
- on = 400ul (for IMMULITE 2000 Water side)
Switches #1 - 5 add tiny fine-tuning increments to

the rough volume setting of #8, in small increasing
uL increments, as shown on the inner label. Preset at
factory, but can be adjusted as needed.
Switches 6 & 7 control drawback setting in four

stages:
- #6 ON + #7 ON = Maximum setting
- #6 ON + #7 OFF = Nominal Setting
(standard factory setting)
- #6 OFF + #7 ON = > Nominal
- #6 OFF + #7 OFF = < Nominal
(minimum setting)

Important Cautions:
Precautions involving this Linear Actuator Pump Design:
-- When priming before chemistry, be sure to press and hold the prime button down for each full cycle.
This creates a more proper full extension of the bellows, for a better, quicker prime.
-- When running decontamination programs DECON & DECON1, it is suggested to tape down the
water prime button, for the same purpose as above.
-- Be sure to always have the Instruments Power off whenever removing or connecting the power cable
to the pump. -- Doing so with the power on will cause instant and permanent damage to the pumps
electronics!!
7.4.5 Use of Pip-X Position Gauges (kit p/n 420078)

General Information
The Pip-X position gauge kit contains two gauges of different sizes.
One has a groove cut in it around the circumference of the gauge near the top. This gauge represents a
sample cup holder. It has a slightly wider lower body in diameter than a sample cup to prevent side-to-
side play when seated between two baffles of the load chain.
The other gauge is larger and wider than the first and it does not have a groove cut in it. This gauge
represents a test unit. It has a wider upper body to prevent side-to-side play when seated between two
baffles of the carousel ring gear.
Using the Pip-X Position Gauges
CAUTION: The customers probe must be removed and a straight spare dummy probe must be used
during this procedure. Failure to use a dummy probe may cause irreversible damage to the customers
probe.
1. Insert the larger gauge (representing the test unit) into the carousel ring gear position where the load
chain crosses the carousel ring gear.
2. Manually rotate the carousel ring gear three spaces back towards the shuttle.
3. Initiate and load the CARCHECK diagnostic from the main diagnostic menu. Refer to Chapter 8:
Diagnostics for more information on the initiation and loading of diagnostics.
4. After pressing GO, watch the test unit gauge increment one space at a time alternating with the
shuttle.
5. Press and hold the ALARM MUTE button and then press the GO button when the test unit gauge
arrives at the dispensing position one step beyond the load chain.
6. Initiate and load the LCHAIN diagnostic. Press GO and allow the load chain to increment two steps
to be sure it is properly indexed. Press the ALARM MUTE button and the GO button to stop the
diagnostic.
7. Place the smaller gauge (representing the sample cup) at the left most (number 5) sampling position at
the Star Wheel (See next section for Star Wheel details.)

8. Initiate and load the PIPXPOS diagnostic. After pressing GO the pipettor will automatically begin at
the home position and then move to each position with a brief pause at the bottom (used to judge
alignment). It automatically increments through the three wash positions and the reagent position. In
each position, use the ALARM MUTE button(holding it down) to pause the diagnostic when the
probe is located in the fully down position. Note any positions that are not within one probe width of
center.
9. After the reagent pipettor position, the probe will continue clockwise to the S5 position, lower onto
the gauge and pause. Observe the probe position onto the gauge. The pause down onto the gauge is
brief, use the ALARM MUTE button (holding it down) to pause the diagnostic when the probe is
located in the down position. After judging the position, releasing the ALARM MUTE button will
continue the movement clockwise to the S4 position, and so on. Move the gauge between positions as
needed and observe each of the five sampling positions (which are the most crucial of the whole set).
Note any positions that are not within one probe width of the center target of the test gauge.
10. After the S1 position, the pipettor will complete the cycle at the carousel dispense position. Observe
the probes position on the Test Unit gauge. The ideal position is one probe width to the left
(counterclockwise) of the target of the test gauge. Once completed, the probe will return to home and
repeat the cycle. Press ALARM MUTE and GO to end the diagnostic.
11. Adjust any probe positions that are not within one probe width from the center by using the
PIPXADJ diagnostic under the System Configurations menu. Repeat the above procedure to re-check
alignments.
7.4.6 Load Chain and Star Wheel Positioning

Load Chain Positioning
As in the illustration below, the Load Chain position is properly aligned when the trailing edge of a baffle
is flush with the outer wall of the carousel casting pathway and the leading edge is slightly encroached
into the carousel casting.
If adjustment is necessary, use the LDCHNADJ diagnostic from the System Configurations Menu and
follow the prompts.
Incubator Carousel Pathway and direction of
tube travel should be as unobstructed as
possible for both entry and return paths of the
chain
Leading edge
Will encroach slightly into
Carousel casting
Trailing edge
Should be flush with outer
wall of Carousel casting
Sampling
Position #1
Space of
tube on
chain

Star Wheel Positioning
Note: Before checking the Star Wheel position, ensure the Load Chain position is correct as shown on
previous page.
The correct position of the Star Wheel is determined by the following two points of reference:
The position of a sample cup at the number 5 sampling position
The position of a sample cup as it loses contact with the Star Wheel and enters the sample
collection tray
towards sample collection tray
sampling position number 5
1. Place five sample cups on the load chain.

2. Run the LCHAIN diagnostic from the Diagnostic Screen. Watch the sample cups as they enter the
Star Wheel area. If the sample cups tilt or flick as they ride past the Star Wheel, an adjustment is
needed.
3. Use an adjustable wrench to loosen the large nut at the top of the Star Wheel.
CAUTION: Only loosen the nut far enough that the Star Wheel rotates freely. Do not remove the
nut. Re-assembly after the nut is removed can be very time consuming.
4. Manually, place one sample cup in sampling position number 5 and another in the Load Chain
position just past the Star Wheel. Rotate the Star Wheel to the position where contact with the sample
cup in sample position number 5 is with the right Star Wheel tooth, and the other sample cup is
perpendicular with the opposite Star Wheel arm. Refer to the illustration above.
5. Once proper alignment is performed, carefully hold the Star Wheel in position and tighten the nut on
top, being careful not to change the Star Wheel position.
6. Repeat steps 1 and 2 to verify alignment. If necessary, repeat the adjustment.
7. Finally, check the adjustment under a high load condition. Fill the Sample Collection Tray with
sample cup holders to nearly full. Repeat step 2 watching for proper travel with the high load
condition.

7.4.7 Spacing of the Sample Tube Guides
Proper alignment of inner and outer sample tube guides is as shown. An upside-down sample cup should
travel freely through this area with slight play back and forth. If the inner and outer sample tube guides
seem out of alignment, follow the procedure listed below.
upside-down sample cup has slight play

outer sample
tube guide
inner sample
tube guide
pipettor base
1. Using a Phillips-head screwdriver, loosen the two screws securing the inner sample tube guide.
2. Use a standard piece of paper folded in fours as a gap tool. Gently slide the folded piece of paper in-
between the inner sample guide and the pipettor base.
3. Using a gentle even pressure onto the center point of the inner guide, tighten the two screws down
and remove the piece of paper.
4. Inspect for an even gap at each end of the inner sample tube guide against the pipettor base.
5. Using a Phillips-head screwdriver, loosen the two screws securing the outer sample tube guide.
6. Insert sample cup holders upside-down in between the inner and outer sample tube guides at each
end.
7. Apply gentle pressure on the center of the outer sample tube guide against the upside-down sample
cups and tighten the two screws down.
8. Inspect the adjustment by riding an upside-down sample cup through the space of the two sample
tube guides. There should some slight play without any resistance or obstruction throughout the entire
pathway.
9. Perform a final test by placing 5 to 10 sample cup holders on the Load Chain and run the LCHAIN
diagnostic from the Diagnostic Screen. View the sample cups as they move through the sample tube
guide area. There should be no tilting of the sample cups or any resistance or obstruction seen.

7.4.8 Sample/Assay Test Unit Barcode Motor Speed Adjustment
1. Place four assay test units on the load chain. Load and run the BCODESPD diagnostic from the Main
Diagnostic Menu. Follow the prompts on the display until the first test unit is indexed in front of the
barcode reader.
2. Note the millisecond per revolution (ms/rev) measurement on the display.
3. If necessary, adjust potentiometer R120 on the Heater DC Motor Fluidics PCB (#A2) to a range of
750 msec. to 790 msec. Fluctuation of up to 30 msec., is possible and still okay.
Note: If using sample cup holders the range is 800 msec. - 840 msec., since the circumference is
larger.
4. Press and hold the PAUSE button to index the next test unit. Release the PAUSE button once
indexing starts.
5. Repeat the above adjustment for each of the remaining three positions around the Barcode Idler
Assembly.
Note: The four positions around the Idler Assembly may differ from each other as much as 40
ms/rev. This is acceptable. If the differences are greater than 40 ms/rev, inspect the condition of the
rollers, O-rings, pins, and main drive O-ring. Refer to Section 7.3.7 for more details on the
inspection of these parts.
Cautions: Be aware of false readings. These are tube-specific, based on the different mode in
which this test uses the reader circuit. False readings are ranged 200 440 ms/rev, and are known to
be false, as the reader motor cannot rotate more than 500 ms/rev. When these false readings are seen,
it is suggested to try using a test unit of a different assay, until 4 tubes are found which remain
stable, when rotating in the reader. The barcodes of some assays may randomly hinder accurate
readings of these speed tests.
Also note that if numbers are jumping between real and false, note the audible tone of the barcode
motor. The jumping numbers are known to be false, as usually there is no corresponding variation in
the tone of the motor.
7.4.9 Tuning the Sample/Test Unit Barcode Reader PCB P/N 450056
1. Turn IMMULITE power on.
2. Connect a DVM to TP1 (positive) and TP2 (negative) using alligator clips.
3. Place a test unit on the Load Chain and run the BCODESPD diagnostic from the Diagnostic Screen.
4. Press GO to index the test unit. Once the test unit reaches the barcode reader, press ALARM MUTE
and GO to stop the test unit from indexing.
5. Manually rotate the test unit so that the barcode readers red beam is reading the all-white section of
the test unit.
6. Adjust potentiometer R1 to 3.0 VDC.

7.4.10 High Speed Spinner Motor Adjustment
1. Place a test unit on the Load Platform and initialize the WASHSPD diagnostic from the Main
Diagnostic Menu.
2. Follow the prompts on the display to index the test unit around the Main Carousel and into the high-
speed spinner.
3. Note the RPM speed on the display.
5400 RPM to 5600 RPM (as close as possible to 5500 RPM).
7.4.11 Barcode Laser Scanner Reprogramming

The universal barcode language used for all cup and kit barcodes of the IMMULITE is the Code 39
configuration.
There have been three types of hand-held scanners in use throughout the production of IMMULITE:
Intermec (Pencil) Barcode Scanner
To program the Intermec (Pencil) Barcode Scanner to be used with the IMMULITE, exit to DOS and
perform the following steps:
Note: When scanning the barcodes below, a single high beep indicates a successful scan, while three low
beeps indicates an invalid scan.
1. Scan the below barcodes to set the factory settings.

Null Config.
$ + T A 3
Default Config.
. +
2. Scan the below barcode to configure for an IBM AT U.S. Keyboard.

Config. IBM AT Key
$ + T A 1
3. The enter key on a personal computer is typically a carriage return <CR>. To set the postamble to
<CR>, scan the barcode below.
Carriage Return
$ + A C " < C R > "

4. To test that the programming was successful, scan the barcode below and verify the text string below
the barcode appears after the DOS prompt.
Test 123
T e s t 1 2 3
PSC Laser Scanner

To program the PSC Laser Scanner to be used with the IMMULITE, exit to DOS and perform the
following steps:
Note: When scanning the barcodes below, the yellow light on the back of the scanner will indicate when
the laser is on and the green light will indicate a successful scan. The scans in steps 1 through 3 will also
provide a low beep followed by a high chirp when successful. Steps 4 through 6 will provide a single low
beep. Step 7 will provide a low beep for the first five scans and a high chirp on the last scan.
1. Scan the Wedge Mode Enable barcode (Hex Equivalent is CE):
2. Scan the Reset to Default barcode (Hex Equivalent is ZA):
3. Scan the PC-AT, PS/2 and 50/60/80 barcode (Hex Equivalent is CF):
4. Scan the Enter Postamble barcode (Hex Equivalent is LB):

5. Scan the Postamble 1 barcode (Hex Equivalent is 0):
6. Scan the Postamble 2 barcode (Hex Equivalent is D):
7. Scan the Postamble 3 barcode six times (Hex Equivalent is 0):
8. Scan the Confirmation barcode and verify 01234567 appears after the DOS prompt with an error
Bad command or file name. This is normal since DOS doesnt know what to do with this
information:
Welch-Allyn Laser Scanner

The newest hand-held Barcode Scanner of the IMMULITE is made by Welch-Allyn Inc. , and is set
from the factory to be ready for the default Code 39 language used on all IMMULITE accessories.
If for any reason the factory setting is disturbed (by power interruption, surge, or PC fault), the following
Factory Default barcode from Welch-Allyn Operators Manual (page 12-1) can be scanned in order to
re-set for all IMMULITE Assay Kit and Sample Cup barcodes:

7.4.12 Procedure to Replace Database Components
The following database components may be replaced if problems in these databases are suspected.
DBASE317.ISM CNF317.ISM
Patient Results Laboratory Name (PC Screen)
Control Results LIS Configuration
Adjustment Slope and Intercept Parameters Dark Count Limit
Kit Entry Information PMT Multiplication Factor
Patient Normal Ranges Attenuation Factor
Control Ranges
Test Parameters
QCLIS317.ISM PAT30.INI
Control Data Long Report Format
Patient Data
Current Worklist
Current LIS Worklist
CAUTION: Before replacing any file, make a copy of the file to avoid loss of data. In the event of a
problem, or if replacing the file was not the solution, it can be returned to its previous status.
To replace the DBASE317.ISM file from the installation disk, do the following:
1. Insert the version 4.0 software diskette into drive a.
2. At the c:\CIRRUS\PC prompt, type the following:
arj x a:pcver40.exe dbase317.ism then press [Enter].
3. Following the extraction procedure, the system will prompt the following message:
DBASE317.ISM is same or newer, Overwrite?
4. Type y for Yes, then press [Enter].
You may now execute the RUN IMMULITE or START TURBO program from the start-up menu.
To replace other components of the database, simply use any other .ISM filename in the above procedure.

7.4.13 Fixing or Restoring a Database
In the event of a serious system error, the restore function is used to copy the database stored on diskette
(during back-up) to the computer's hard disk. Before restoring the database, attempt to fix the database
using the FIXIT program. If FIXIT does not correct the problem, use the Restore function to restore the
database, using the latest copy of the back-up disk.
Running Fixit
Instructions for running the FIXIT program appears below:
2. At the c: prompt, type fixit and press [Enter].
3. The FIXIT program checks the software for damage and attempts to correct the problem.
4. When the c: prompt reappears, type start and press [Enter] to return to the Start-up menu.
Restoring a Lost or Damaged Database
If FIXIT does not correct the problem, follow the steps below to restore the database when it is damaged
or lost:
1. From the Start-up menu, select BACKUP/RESTORE and press [Enter].
2. Select RESTORE DATA BASE and press [Enter].
The following message appears:
3. Press [Y] to continue.


4. Place the disk (containing the database latest archive) into the disk drive and press any key to
continue.
5. Press [Y] to continue.

A message appears, stating that the database isunpacking. This process will take 1-3 minutes.
When the restoration is complete, the Start-up menu appears.
7.4.14 Checking the Error Log

General Information
While the IMMULITE is in a Run sequence there are two error logs present on the system. These error
logs contain information regarding events occurring during the operation of the IMMULITE that can aid
in troubleshooting problems.
While in Run mode a real time error log can be accessed through the System Status drop down menu
of the primary screen. This error log contains all the events since the last log on. Once the operator logs
off, this error log is lost. All events are also registered into the Historical Error Log which is located in the
\CIRRUS\PC directory and is accessed as described in Viewing the Historical Error Logsection.
The events that are written, or logged to this file are as follows:
1. Log on with operator initials
2. Log off with operator initials
3. Any mechanical or temperature related errors encountered in the instrument
4. Assay adjustment information (slope, intercept, and assay type)
5. All Reagent Carousel Barcode Read sequences in hexadecimal code
6. All successful software update events
7. Any changes to the settings of PMT Multiplier or CAF (Chemistry Attenuation Factor).
The Historical Error Log is of the perpetual type and will forever hold the above information even when
new software is installed. As the file size does not increase very rapidly there is no need to worry about
the file taking up too much space on the computer.
Note: The Historical Error Log file is copied onto the backup disk whenever a backup is done.

Viewing the Historical Error Log
To view the Historical Error Log, simply go to the c:\CIRRUS\IMM directory in DOS and type status.
The error log appears starting at the first event in history of the IMMULITE. Press CTRL and PGDN to
move up to the latest history, and then use the arrow keys or the PGUP/PGDN keys to move through
prior history. Along the bottom of the screen is a guide to the "F" key functions. The data can be edited,
printed, or even deleted if so desired. To quit viewing the error log, just press the F1 key.
Siemens Diagnostics has licensed the use of the E16 program as a text editor to use with the IMMULITE
system. It resides in the \CIRRUS\PC directory and is installed along with the other software.
Refer to Chapter 9: Troubleshooting for more details on specific error messages, their definitions
(Section 9.4: Error Message Table), and their possible solutions according to area of the instrument
(Section 9.3: Typical Problems).

7.4.15 Troubleshooting the System Stepper Motors
In the vast majority of cases for any drive or motor issue, historically the problem has rarely been the
motor. They are much heartier than the application that are used for. Any strange activity of the motor is
more likely to be a fault for its support diodes on the module interface PCBs.
Testing the resistance of the motor windings is as seen in the small chart above. If readings are in spec, it
is assured the motor has no issue.
The purpose for the diodes is to protect the driver circuits on the Motor Driver PCBs #s 1 and 2 from
spikes that occur from collapsing EMF from the motors.
The purpose of the PTC devices is to protect the drive circuitry in case a short occurs in the motor. The
PTC device will heat up due to higher current, and the resistance will increase, therefore keeping the
current down, limiting damage that can occur.
Note: As of IMMULITE 1000 serial number D0640 produced in January 2005, all these devices have
been removed and hard-jumpered. In older systems where these devices are present, if they break or
become damaged, simply remove the device and solder in a jumper.

Chapter 8: Diagnostics
8.1 General Information
8.1.1 Investigate
Discuss past performance with customer: Customer communication ensures that all problems experienced
by the customer are covered. Proper communication helps guarantee customer satisfaction is achieved after
you leave. Ask for any specific situations that the customer may have seen or heard on the IMMULITE.
Check Error Log: Review at least two months of the log. Check for consistent error messages. They could
be warning signs of impending problems. Also, do not be concerned with individual isolated messages.
They may simply indicate an operator error.
Check for IMMULITE upgrades: A list of current upgrades and standards are available from Siemens
revisions.
Can the problem be duplicated?: Does the same problem occur every time a certain situation is duplicated?
Does the problem occur randomly?
Follow typical troubleshooting techniques to narrow down the location of the problem: Refer to Section
9.2 for more information.
8.1.2 Power
Check that AC power is within range: 110-volt systems should have incoming VAC voltage of 100 120
volts. 220-volt systems should have incoming VAC voltage of 210 230 volts. Check the intended wall
socket using a line voltage tester (available through Technical Support).
Check voltages at the Syringe Interface PCB: Check DC voltages at the main power connector (A15-J1) on
the Hamilton/Euro Interface PCB. Pins can be accessed through the side of the connector with small pin
instruments lid. Ensure voltages are in tolerance as indicated below:
5 VDC: (4.9 to 5.2) -5 VDC: (-5.2 to 4.8)
12 VDC: (11.8 to 12.2) -12 VDC: (-12.2 to 11.8)
24 VDC: (23.8 to 24.2)
locating the quick-connect connection for the cable of the PMT, and tap into these points to read the +/-
5V supplies dedicated to the PMT. Ensure voltages are in tolerance as shown below.
5 VDC: (4.8 to 5.2) -5 VDC: (-5.2 to 4.8)
15 VDC: (14.8 to 15.2)

8.1.3 The Message Tables
Most diagnostics contain a specific set of messages or instructions that need to be presented on the
IMMULITE display panel to aid the user in the diagnostic procedure. These messages are found in special
message table files. Contained within the Main Diagnostic menu are two message table files as
follows:
MESS43 - Main Message Table for Main Diagnostic Menu (DIAGNOSTICS) and RUN
IMMULITE (43 indicates the software revision that the last change was made)
MESG Diagnostic Message Table for the (SYSTEM CONFIGS) Menu
Important information to remember on message tables is as follows:
The MESS43 (Main Message Table) is loaded automatically with the RUN
IMMULITE/START TURBO command from the start-up menu.
The Main Diagnostic Menu (DIAGNOSTICS) uses whatever message table was last loaded.
The SYSTEM CONFIGS. Menu allows the loading of different message tables upon entry
and exit of the menu.
Note: The rest of this page below applies only to older software versions up to 4.1. For version 4.3 and
later, loading these message files is automatic when navigating between the two menus.
When selecting DIAGNOSTICS from the start-up menu and then SYSTEM CONFIGS., the user must be
careful when answering of questions relating to the message tables. Normal operation is listed below.
1. When entering SYSTEM CONFIGS., the following question should always be answered with
a Y for Yes:
Download Diagnostic Message Table? Y/N

2. When exiting SYSTEM CONFIGS., the following question should also always be answered
with a Y for Yes:
Download Main Message Table? Y/N
CAUTION: Answering the above questions incorrectly can cause wrong messages or a blank display
while running diagnostics. If this occurs, follow the procedure below.
8.1.4 Loading the Correct Message Tables (versions 4.1 software and earlier)
RUN IMMULITE/START TURBO The Main Message table is automatically loaded when RUN
IMMULITE/START TURBO is activated. For this reason, there is no need to reload message tables in
this mode.
Main Diagnostics (DIAGNOSTICS) If wrong messages or a blank display are seen while running these
diagnostics, simply download the MESS43 message table file (found on this menu) and then another
Go command will also be sent, where the chosen program will now run with correct text on the panel.

SYSTEM CONFIGS. - If wrong messages or a blank display are seen while running these diagnostics,
the user must exit the SYSTEM CONFIGS. menu and re-enter it. Upon re-entry follow step 1 above.
Also, be sure to follow step 2 above upon exit.
8.2 Using the Diagnostics

Diagnostics is an important troubleshooting tool. Use your eyes and ears along with the diagnostics to help
narrow down where problems may be.
Note: Refer to Section 9: Troubleshooting for more troubleshooting information, including a list of error
messages.
Diagnostic programs are used to test particular components of the IMMULITE System. When the cursor is
positioned on the diagnostic program name, a description of the program appears at the bottom of the
screen.
To load and run the diagnostic programs, follow the steps below:
1 Ensure IMMULITE is in Idle. From the Start-up menu, select DIAGNOSTICS.
2 To access the Main Diagnostic Menu, select DIAGNOSTICS and press [Enter].

3 A list of the various Main Diagnostic programs appears (listed alphabetically).
4 There are also special Configurations diagnostics, which can be accessed by selecting SYSTEM
CONFIGS from the menu choice screen.

Note: The SYSTEM CONFIGS menu is mostly used by Field Repair Engineers for individual instrument
position adjustments. The motor configuration table (TABLE) used for all motor movement step
assignments is also accessed and adjusted through this menu.
5 A list of the SYSTEM CONFIGS diagnostic programs appears (listed alphabetically).
Note: Additional diagnostic programs may become available with future software updates.
6 Once you have entered the needed menu, select the desired diagnostic program by pressing the arrow
keys to highlight the program name and press [Enter].
7 When the loading is complete, press [Enter] again (sending the * RUN * command).
8 Press GO (on the IMMULITE) when instructed to do so.
9 Whenever terminating diagnostics that are in motion progress, first press and hold the ALARM
MUTE button until all motion stops, and while still holding the ALARM MUTE button, then press
GO to stop the program, which will set the instrument into Idle mode, ready for the next download.
Note: Some routines stop automatically at the end of the program cycle, while others repeat until the
ALARM MUTE and GO buttons are pressed in sequence described above.

If the prior program is not cleared before loading another, the following message appears:
IMMULITE cannot communicate...
Programs can be downloaded when a blank screen or the following message appears:
DPC IMMULITE IDLE
Select RUN IMMULITE to begin.
Some diagnostic programs require additional programs to run in conjunction, to properly monitor
certain diagnostic procedures (GetDataT, PC or WATER). Determine if one of these programs is
required, by referring to the table in Section 8.5: Main Diagnostic Programs. After loading the desired
diagnostic program where applicable, press [Esc], then EXIT TO DOS, then enter the desired data
program at the DOS prompt.
Refer to Section 7.4.1: Testing the Water Supply for instructions on using the WATER data program,
which is also initiated by pressing [Esc] and EXIT TO DOS and then typing water after loading
WATERTST or WATERTPM.
Notes:
Error checking routines are not activated during the use of most main diagnostics except in specially
needed cases.
Error messages are posted during CARPOS, CARSHAKE, MCARTST, TEMPS, PRIME, and
PMTCOUNT main diagnostics, and when using certain System Configs adjustment and logic test
programs.
8.3 Running GetDataT

Some diagnostic programs require obtaining raw cps data from the Luminometer via a data collection
program called GetDataT. This program must be started after the diagnostic program has been loaded and
before the tube is counted by the PMT. To run the GetDataT program, follow the steps below:
1. After the diagnostic program begins running (after pressing GO on the IMMULITE), press [Esc].
3. Type getdatat and press [Enter]. A menu appears.
4. Press [P] to turn on the printer (if a printout is desired).
Notes: Make sure the printer is on-line and properly loaded with paper.
If a printout of PMT signals only is desired, then activate printing by the step 4 above. It will not include
the bottom line of data depicting real time temperature readings.
If a printout of the temperatures is needed, leave the printer off in this screen, allow the screen
to fill with readings, then use the Print Screen key to print all data including the temperatures.
5. Press [S] to input data and store the readings.

6. Respond to the next three questions by pressing [Enter] after each. If desired, you may name the file
for future reference.
A typical printout of data from this program is seen below. A key below explains the labeled items in the
data that are of use to the Field Engineer.
Key to the labeled items above (all data is in real time as it posts to the screen):
1 This is one single block of the Getdatat raw data readings (three readings are shown here).
2 The exact date and time of the reading.
3 Twelve one-second CPS signals from the PMT (the highest and lowest are dropped, to create #4).
4 A general average of the twelve PMT readings in the line above (termed as Cleaned CPS).
5 The bottom line of each block gives real time readings of all five temperature parameters.
The remaining contents of this data beyond the labeled items above, are erroneous numbers that should be
ignored, and are of no practical use to field repair work.

7. Once all the data desired has been printed, stop the IMMULITE by pressing ALARM MUTE and GO
(on the IMMULITE).
8. Press [Esc] and then [Q] to quit the data collection program.
8.4 Running PC or PCSTAT

Some diagnostic programs require that certain information be displayed (i.e. results from the Barcode
Reader) using the PC program. The PC program allows access to a simulated primary screen for
diagnostic purposes. This screen is not for running actual chemistry tests. The PCSTAT program should
not be used except for the rare circumstance listed in the following note.
Note: In some rare circumstances, communication may be lost (PC Communication Failure) during a
chemistry run. If the IMMULITE is still running normally, the PC program may be used to track the
chemistry run progress. If a TURBO chemistry run is in progress, the user must use the PCSTAT
program. Care must be taken to use the correct program PC or PCSTAT depending on the assay run in
progress, otherwise the display and indexing of the instrument motions may be incorrect and mis-
matched.
To run the PC or PCSTAT program, follow the steps below:
1. After the diagnostic program begins running (after pressing GO on the IMMULITE), press [Esc].
3. Type PC or PCSTAT and press [Enter].
4. Respond to the questions displayed by pressing [Enter] three times.
5. When the following message appears, choose [Y] for yes:
Cannot communicate with the IMMULITE.
Continue running? Y/N
6. To exit, select Log Off and Log Off System.

8.5 Main Diagnostic Programs
The table below describes the diagnostic programs in detail, including whether or not they stop
automatically, if another data program is required (GetDataT or PC), and which module(s) and/or
component(s) to which the diagnostic applies.
Note: There are some on this menu that are of no use to the FSE, and therefore, are not listed below. They
include ERR36X, HI43, HISTAT43, IMMxxx, LO43, LOSTAT43, MESG, MESS43, and VOLxx.
The programs are listed alphabetically as they appear on the Diagnostics screen.
Auto- Applies to which module(s)

Main Diagnostic Function and Procedure
Stop? and/or component(s)
APRIME
Used to isolate priming of "A" large syringe for diagnostic No Syringe A Pump Assembly
evaluation. Also, useful when performing a large syringe tip
replacement.
ATTENT4
This test is very useful for checking the volume consistency No Water and Substrate Pumps,
of the water and substrate pumps and the PMT consistency Luminometer, Attenuator,
of readings/results. Place four test units onto the load Shuttle
platform and the system will bring them around to the shuttle
and into the wash position. An initial spin cycle is performed,
followed by four washes with water. A shot of substrate is
added and the test unit is moved to the Luminometer Program used to View:
entrance. Each tube is read by the photomultiplier tube GetDataT
(PMT) for twelve one-second counts in both attenuated and
unattenuated modes. The test units are eventually indexed to
the waste collection rail.
ATTENTM
Same function and procedure as ATTENT4 diagnostic except Yes Wash Pumps, Luminometer,
with this test load 15-test units one position before entering Attenuator, Shuttle
the shuttle. The test will automatically stop after the 15th test
unit is read by the PMT in both attenuated and unattenuated Program used to View:
modes. GetDataT
ATTURN
Use this program to visually check the PMT attenuator disk No PMT Attenuator Disk
motion and to verify sensor operation. The test cycles the
attenuator disk to the home position, attenuated position and
the unattenuated position. This can be monitored by watching
the position of the single sensor notch found on the right side
of the Luminometer cover above the PMT. The single sensor
notch points to a 9:00 position at home, 5:00 in the
attenuated position and 1:00 in the unattenuated position.
BCODE
Verifies proper functionality of the sample/assay barcode No Sample/Test Unit Barcode
reader. Place as many test units as desired onto the load Reader
platform. A test unit is read once every two seconds, then the
next test unit is indexed in front of the barcode reader. Verify Program used to View:
proper barcodes using the PC program. PC

BCODEON
This test turns on the sample/test unit barcode reader motor. No Sample/Test Unit Barcode
It can be toggled on and off by pressing the GO button on the Reader Motor
display panel. It verifies operation and is used for cleaning
the barcode reader drive wheel O-ring.
BCODESPD
This program is used to observe and/or adjust the motor No Sample/Test Unit Barcode
speed of the sample/assay barcode reader. Load at least four Reader
test units onto the load platform. Run the program and
observe the motor speed. It should be between 750 to 790
ms/rev. Press the pause button to advance to the next test
unit. Each position should not be more than 40 ms/rev of
each other.
BCODETST
platform. Each test unit is read 25 times, and then the next
test unit is indexed in front of the barcode reader. Verify Program used to View:
proper barcodes using the PC program. PC
BKGNDCNT
This program provides the current background counts for the No PMT
instruments PMT. It will alternate moving the attenuator
between the attenuated and unattenuated position. While at Program used to View:
each position, a set of 12 one-second background counts is GetDataT
taken. The GetDataT program provides the actual raw
background counts.
BPRIME
Used to isolate priming of "B" small syringe for diagnostic No Syringe B Pump Assembly
evaluation. Also, useful when performing a small syringe tip
replacement.
CARBACK
Useful for removing sample cups that have been mistakenly No Incubator Carousel
indexed around the incubator carousel. This program moves
the carousel backward in single index steps by pressing the
syringe prime button momentarily, or indexes continuously by
holding the prime button.
CARCHECK
This program is used to judge the position of the Main No Incubator Carousel
Incubator Carousel in relation to the tube Shuttle. It indexes
the carousel ring gear one position, moves the shuttle into
the space between the carousel baffles, pauses for one
second, moves the shuttle back to home and repeats.
CARPOS
This test checks the indexing of the main incubator carousel. No Incubator Carousel
It indexes the carousel ring gear one position every second.
Also activates system error checking to aid diagnosis.

CARSHAKE
Checks the carousel shaking function. Momentarily initializes, Yes Incubator Carousel
indexes the carousel one-step, moves the shuttle in the
space between the baffles and shakes the carousel for a few
seconds.
DARKCNT
This program provides the current dark counts for the No PMT
instrument. It moves the attenuator to the home position, then
takes a set of twelve one second dark counts with the PMT Program used to View:
every fifteen seconds. The GetdataT program provides the GetDataT
actual raw dark counts.
DECON
This program is used to introduce decontamination material No Fluidics (Decontamination)
into the fluidics of the Instrument. Refer to Maintenance
Procedure listed in Section 7.4.2 for further details. This
procedure draws the decontamination fluid into both syringes,
one at a time and then into the water pump five times. This
procedure should be run for at least 15 minutes, followed by
the DECON1 procedure.
DECON1
This program must be used after the DECON procedure. The Yes Fluidics (Decontamination)
purpose of this program is to flush out the decontamination
fluid and replace it with fresh fluids. Refer to Maintenance
Procedure listed in Section 7.4.2 for further details. This test
will automatically stop after approximately twenty minutes.
The test will cycle through filling each syringe twice then the
water pump ten times.
DISSUB
This program tests substrate pump dispensing volume. Place Yes Substrate Pump
five test units on the load platform as per display. If the wrong
number of vessels is used, the program will halt with Test
Failed. The program indexes each test unit around the
Incubation Carousel then shuttles them to the substrate fill
position. A shot of substrate is added, and the test units
moved to the sample collection tray for evaluation.
DISWAT
This program tests water pump dispensing volume. Place five Yes Water Pump
test units on the load platform. If the wrong number of
vessels is used, the program will halt with Test Failed. The
program indexes each test unit around the Incubation
Carousel then shuttles them to the water fill position. A shot
of water is added and the test units moved to the sample
collection tray for evaluation.

EMPTYTUB
This program is very useful to check the main driving motor No Entire Tube Transport Path
movements of the instrument. This is mainly used to evaluate
proper coordination between interfacing driving motors of the
system. Tubes can be placed on the load platform and
indexed through the entire system.
LCHAIN
This program is used to visually check the functionality and No Load Chain
positioning of the load chain. It indexes the chain one position
every 2 seconds.
LEVCRASH
This program tests for the proper level sensing of the probe No Pipettor (Level Sensing)
in each of the five pipetting positions. Manually, pipette a
minimum of 100 uL of liquid into five sample cups. Place the
five sample cups into the five pipetting positions. During the
test, the Pipettor will level sense each sample cup starting in
position five and then progress cup by cup to position one.
The program will time-out after 20 rotational cycles (~ 100
potential signals) Any failures to level sense the liquid will trip
the tip jam sensor, which in turn will indicate test failed.
LEVFALSE
in the reagent, five sampling, and assay dispense pipetting
positions. This test requires no sample cups to run. Remove
the Reagent Tray. The Pipettor will start at the home position
and then checks level sensing at the reagent position, each
of the five sample pipetting positions, and then return to the
home position to start again. The program will time-out
automatically after 20 full cycles to home (~ 120 potential
signals). Any false level sense triggers will trip the tip jam
sensor, which in turn will indicate test failed. During the
sequence the technician can also jiggle the wires or cables to
attempt to purposely initiate intermittent problems.
LEVSENSR
This program is used in conjunction with LEVSENSS to No Pipettor
check the auto calibration of the DEADVADJ (automatic), or (Level Sense Reagent Dead
LEVSNADJ (manual set-up) dead volume Configurations Volume Check)
programs. This program should display an SL (steps left)
number between 8 and 12. If the program does not confirm
good SL numbers, repeat the Configurations DEADVADJ
Auto-calibration. Or if the LEVSNADJ test is used, re-check
for proper manual pipetting of the minimum dead volume in
the test reagent vial.

LEVSENSS
This program is used in conjunction with LEVSENSR to No Pipettor
check the auto calibration of the DEADVADJ (automatic), or (Level Sense Sample Dead
programs. This program should display an SL number that is
reasonably close to the value for parameter 13 of the
CONFIG table. If the program does not confirm good SL
numbers, repeat the Configurations DEADVADJ Auto-
calibration. Or if the LEVSNADJ test is used, re-check for
proper manual pipetting of the minimum dead volume in the
test sample cup.
LUMCHECK
This is one of the most useful tools for close inspection of the No Luminometer Chain
crucial crossover alignment of the Shuttle and Luminometer (at the crucial cross-over point
Chain. The program repeatedly inserts the shuttle partially with the shuttle)
into the indexing lum.chain baffles.
Note: It is recommended to remove the entire Spinner
platform assembly to more properly judge this crucial
alignment, sighted from straight up above the area.
Alignment should be inspected so the shuttle is centered in

each baffle of the indexing lum.chain.
LUMCHN
This program checks the movement of the Luminometer No Luminometer Chain
chain by indexing it one position every second.
LUMTEST 4, LUMTEST 5,
LUMTEST 6, LUMTEST 9
Used in manufacturing only. N/A N/A
PIPXPOS
This program allows for visual inspection of the Pipettor No Pipettor
positioning. It moves the X-Pipettor to each of 10 rotational
positions, starting with home. At each position, it lowers the
Z-Pipettor momentarily. This test is used in conjunction with
the Pip-X Positioning Gauges. Refer to Section 7.4.5 for
more information.
PMTCOUNT
Activates measurement readings by the PMT, but does not No PMT
move the attenuator disk. Use the GetDataT program to see Program used to View:
the current readings. GetDataT

PRIME
This program primes the two syringes and the associated No Syringe Pump Assembly and
tubing. Priming removes excessive air bubbles and allows for Fluidics
accurate dispensing of water and probe wash. It exercises
syringes A and B and solenoid valves 1,2 & 4. The systems
error checking is active, to aid in diagnosis. Also refer to
Section 7.4.4 for more fluidics information.
PROBANGL
This program is used to evaluate the dispensing angle of the No Probe
probe. The program positions the probe over the dump well
and then dispenses water. Check that the dispensing does
not exceed 7 to 10 degrees off center. Also, check for excess
spiraling of the stream. Subjectively, no more than 1 spiral
should occur per inch. Also, refer to Section 7.4.4 for more
fluidics details.
PROBETST
This program is used to evaluate the dispense of the probe No Probe
for any occlusion. It dispenses 3000 ul at a maximum velocity
of 1000 ul/second into the home well. Look for excessive
movement of the liquid up the probe shaft and/or any
splashing out of the side of the home well. During the cycle,
the probe lifts up and momentarily moves to the dump well.
Look for any dripping out of the probe at this moment.
Dripping indicates backpressure or occlusion inside the
probe or its associated tubing. Also, refer to Section 7.4.4 for
more fluidics details.
PRBCLEAN
This program runs a special enzyme cutting probe wash Yes Probe
routine, which is part of daily maintenance. A special probe
wash kit must be used in conjunction with this diagnostic.
Refer to the package insert instructions included with the kit
for more details.
RBCODE
This program tests the Reagent Carousel barcode reader. No Reagent Carousel Barcode
Load a number of reagent wedges in the reagent carousel. Reader
The program moves the reagent carousel to the home
position and then to each position while reading reagent Program used to View:
wedge barcodes. Use the PC program to visually confirm the PC
actual reagent wedge barcode reads.

REAGENTH
This program is used to check the Reagent Carousel home No Reagent Carousel Home Sensor
position sensor. Check for proper position of the home
sensor by placing a wedge in the home position (position 1)
of the reagent carousel and running this program. The red
LED should shine an oval centered between the edge of the
wedge and the first barcode line when the carousel pauses at
home. Use the ALARM MUTE button to extend the pause at
home for a closer evaluation.
REAGENTP
This program is used to check the Reagent Carousel position No Reagent Carousel Position
sensor in all twelve positions. Check for the proper position of Sensor
the individual position sensor using an empty reagent
carousel and running this diagnostic. Look directly through
the individual notches found around the edge of the carousel
and check that one of the position sensor heads is centered
below each position notch. Verify all wedge positions are
centered over the sensor head below. Use the ALARM
MUTE button to extend the pause in each position for a
closer evaluation.
SCHANGE
This program is used when changing the syringe tips. It Yes Syringe Module
moves both syringes down approximately halfway to permit
the removal of the syringes. After replacing the syringe tips,
press GO to move the syringes back to their home position.
SHUTLOAD
This program allows for the evaluation of the shuttle as it No Shuttle
loads test units into the spin position. Manually load a test
unit onto the carousel one position before entering the
shuttle. The test unit will be loaded into the spin position.
Inspect for proper actuation of the springs of the shuttle, so
that the test unit fits snugly pushed into the spinner wheels.
The test unit should sit on a straight angle (without tilting).
Press GO to have the program eject the test unit for removal.
SHUTSPIN
This program is used to evaluate the high-speed spinner Yes Shuttle, High Speed Spinner
cycle. Manually load a test unit with 200 uL of liquid pipetted Motor
into it, onto the carousel one position before entering the
shuttle. The test unit will be loaded into the spin position and
the high-speed spin motor will activate for 30 seconds. The
test unit should slightly lift up and the liquid should quickly
clear from the bottom of the tube. Watch that the bead moves
off the bottom of the tube and floats in air, while the tube is
spinning. To check the actual spinner speed, use the
WASHSPD diagnostic.

SHUTTLE
This program is used to check the positioning of the shuttle. No Shuttle
First, the shuttle is moved from the home position to a neutral
Luminometer position. Next the shuttle is moved to the
spinner wheels (which also is the water dispense position), a
brief Sh Push adjustment is applied, then the shuttle is
moved to the substrate dispense position. In some
instruments, if necessary, a slight movement to the
Sh at Lum position is made to align the shuttle with the
Luminometer entrance. The cycle is then repeated.
SOLE1W
This program is used to check the drawback adjustment of No Water Pump
the water pump. Disconnect the water nozzle and hold a
sample cup under the water nozzle. Run the SOLE1W
diagnostic to dispense two shots. Use the ALARM MUTE
button to pause and control the shots into the cup. The
approximate level of water should be at the fourth line of the
sample cup (2 shots at 200 ul = 400 ul). Confirm that the
drawback is within specification of , +/- . Also refer to
the end of Section 7.4.4 for further adjustment details.
SOLE2S
This program is used to check the drawback adjustment of No Substrate Pump
the substrate pump. Disconnect the tubing on top of the
substrate heater and hold a sample cup under the substrate
tubing. Run the SOLE2S diagnostic to dispense two shots.
Use the ALARM MUTE button to pause and control the shots
into the cup. The approximate level of substrate should be at
the fourth line of the sample cup (2 shots at 200 ul = 400 ul).
Confirm that the drawback is within specification at , +/-
. Also refer to the end of Section 7.4.4 for further
adjustment details.
SPINCHK
This program allows for a quick visual check that the high- No High Speed Spinner Motor
speed spinner motor is working. Manually load as many test
units as desired onto the carousel and manually rotate to one
position before entering the shuttle. The test unit will be
loaded into the spin position and the spinner motor will turn
on for about 3 seconds.
SPINON
This program turns the high-speed spinner motor on or off, No High Speed Spinner Motor
when pressing the GO button.

SUBSHEAT
This program is used to monitor the substrate heater. No Substrate Heater
Remove the cover on the substrate heater. Using a DVM set
to DC volts, place the leads on the test points of the Heater
PCB. Run the program and monitor the starting (ambient)
temperature and final (heated) temperature. The DVM
reading is in direct correlation to the temperature. Multiply the
voltage measured by 100 and this will be the temperature in
Centigrade.
The stabilized temperature should be 36.6 .6oC. After
measuring the temperature, be sure to exit the program so
that the substrate is not heated for a long period of time.
TEMPS
This program is used to monitor instrument temperatures. No Temperature Sensors of:
The temperatures are updated every thirty seconds and can Reagent Carousel,
be seen using the GetDataT or PC programs (GetDataT Luminometer, Main Carousel,
gives readings in real time). The screens can also be Ambient System, Ambient
printed. Electrical
Also, refer to Section 3.8 for complete temperature
Program used to View:
information.
GetDataT or PC
Note: The PMT is not addressed in this diagnostic and
therefore will read zero.
UNATTN10
UPDOWNA
This program is very useful for checking the centering and No Probe
rough depth of the probe in the test unit and the functions of
the Z-Pipettor home sensor and mid sensor. Load a test unit
on the load platform. Use the EMPTYTUB diagnostic to index
the test unit to the Main Carousel dispense position. The
program will move the X-Pipettor to the test unit dispensing
position, then move the Z-Pipettor to the home sensor, down
to the mid sensor, then down the amount of error steps for
parameter 34 (Z Assay) of the configuration table.
UPDOWNH
rough depth of the probe in the home well and the functions
of the Z-Pipettor home sensor and mid sensor. The program
will move the X-Pipettor to the home well position, then move
the Z-Pipettor to the home sensor, down to the mid sensor,
then down the amount of error steps for parameter 32 (Z
Home) of the configuration table.

UPDOWNW
rough depth of the probe in the wash well and the functions
will move the X-Pipettor to the wash well position, then move
Wash) of the configuration table.
V1 TEST
This program tests the functionality of Valve 1 (V1) of the No Syringe Valve 1
syringe assembly. This program alternately dispenses water
through the probe and the wash well. The change in
dispense point is altered by the activation or deactivation of
V1. If the valve is not working at all the water will always
dispense from the probe. If the valve is stuck in the activated
position, the water will always come from the wash well. If
one of the two diaphragms in the valve is partially clogged,
one port will slowly drip while the other is dispensing.
V2TEST
through the probe and the detergent container tubing. The
change in dispense point is altered by the activation or
deactivation of V2. If the valve is not working at all the water
will always dispense from the probe. If the valve is stuck in
the activated position, the water will always come from the
detergent container tubing. If one of the two diaphragms in
the valve is partially clogged, one port will slowly drip while
the other is dispensing. Another way of testing V2 is to
suspend the detergent container above the instrument and
check to see if a drop begins to form on the end of the probe.
If a drop has not formed within 10 minutes, the valve is
sealing properly.
V4TEST
syringe assembly. This program works exactly like V1TEST.
This program should alternately dispense water through the
probe and the wash well. The change in dispense point is
altered by the activation or deactivation of V4. If the valve is
not working at all the water will always dispense from the
probe. If the valve is stuck in the activated position, the water
will always come from the wash well. If one of the two
diaphragms in the valve is partially clogged, one port will
slowly drip while the other is dispensing. This program uses
V1 to direct the flow in a direction that can be differentiated
from the other.

WASHSPD
This program tests and/or allows adjustment of the speed of Yes High-Speed Spinner Speed
the high-speed spinner motor. Follow the prompts given on
the IMMULITE display panel. Adjust potentiometer R107 on
the DC Motor/Heater PCB to achieve 5500 RPM. Press GO
to stop the program.
WATERTPM
This program is used whenever system fluidics contamination Yes Fluidics
is suspected in the instrument. Refer to Section 7.4.1: (suspected water contamination
Miscellaneous Procedures for further information. in the instrument)
Note: This program needs 4 Water Test Vessels. If the wrong Program used to View:
number of vessels is placed onto system, the test will stop WATER
and indicate Test Failed on the display panel.
WATERTST
This program is used whenever water contamination is Yes Fluidics
suspected from the source water supply. The program tests a (suspected water contamination
water source independent of the systems fluidics. Refer to from the water supply)
Section 7.4.1: Miscellaneous Procedures for further
information.
Program used to View:
Note: This test needs 2 Water Test Vessels. If the wrong WATER
number of vessels is placed onto system, the test will stop

8.6 System Configurations Programs
automatically, and which module(s) and/or component(s) to which the diagnostic applies.
The programs are listed alphabetically as they appear on the System Configurations Menu.
Auto- Applies to which module(s) /

Configuration Function and Procedure
Stop? component(s)
BSYRN10, BSYRN25, BSYRN75
DEADVADJ
This program automatically sets the proper Dead Yes Pipettor
Volume Z-step calibration for Reagent and Sample, (Auto-Calibration of Minimum Dead
using the systems own fluidics. This is potentially more Volumes)
accurate than a similar test LEVSNADJ, where the fluids
are set up manually. Follow instructions on the display
panel. When the program ends, leave test vials in place
and run the check diagnostics of LEVSENSR and
LEVSENSS to confirm proper setting.
DISP1000
This program is used for dispensing reconstitution Yes Pipettor
volumes into adjustor or control vials, using the systems
fluidics automatically. The diagnostic will dispense
exactly 1000ul of clean water from the large syringe and
probe, for each time that the GO button is pressed. Up to
10 shots at 1ml each will be supplied in each cycle to
Idle. Repeated loading of the cycle may be necessary to
get all needed shots.
LDCHNADJ
This is the adjustment program for the position of the Yes Load Chain
Load Chain. Proper adjustment entails evaluating where
the Load Chain crosses the pathway of the Main
Carousel. The correct adjustment is where the baffle of
the Load Chain is flush with the outer wall of the
Carousel casting. The inner baffle will slightly encroach
into the inner wall of the Carousel casting. Refer to
Section 7.4.6 for more information.
LEVFSTST
This program tests the tendency of the level sensor to Yes Pipettor (Level Sensing)
false trigger when a signal is not desired. The program
checks for level sensing at empty positions of reagent
and five samples. If all is well, it will not level sense
anything, and Errors Encountered on the display panel
should ideally stay at 0. The FSE can also attempt to
trigger false signals while jiggling related wiring during
motion. This diagnostic will stop automatically after 17
rotational cycles (up to 102 potential level sense
triggers.) Note: Always use this as a companion to the
converse test LEVSNTST.

Stop? component(s)
LEVSNADJ
This program calibrates the minimum dead volume for Yes Probe
sample and reagent. It is pre-set using manually pipetted (manual calibration for Dead
fluids into empty test vials. Follow prompts on the Volume settings)
IMMULITE display. Place a reagent wedge with 1 ml of
probe wash solution in Position 1 of the Reagent
Carousel. Also, place a sample cup with 100 uL of probe
wash on the load platform. The program will index the
sample cup to the first sample position. Then the probe
will use level sense to search for the level in the reagent
wedge, then the sample cup. Once the probe finds the
levels, the IMMULITE will display Calibration
Successful. While leaving the reagent wedge and
sample cup in position, verify the adjustment by running
the LEVSENSR and LEVSENSS diagnostics from the
main diagnostic menu. LEVSENSR should display an SL
(steps left) number between 8 and 12. The LEVSENSS
should display an SL number that is reasonably close to
the value for parameter 13 of the Configuration Table
during the calibration. If main diagnostics do not confirm
good SL numbers, repeat this test from the beginning,
checking for proper pipetting. Also see the automatic
version of DEADVADJ.
LEVSNTST
This program is the companion to the LEVFSTST, and Yes Pipettor (Level Sensing)
conversely to that, the level sensing will touch down into
pre-set sample cups filled with probe wash. It will cycle
up to 20 rotational cycles (100 potential signal checks). It
is looking for level sensing signals when one is desired.
Follow instructions for set up on the display panel. After
filling the cups, it will begin the repeated level sense
checks, and if it does not see the liquid in a cup, it will
begin to count the errors on the display. Ideally, as with
the LEVFSTST, the Errors Encountered should remain
at 0.
Note: Always use this as a companion test with
LEVFSTST.
LUMCHADJ
This program performs an adjustment for Luminometer Yes Luminometer Chain
Chain position. Following the prompts on the display
panel, adjust the chain to a position where the shuttle
passes directly through the center of the luminometer
chain. This is best viewed from above with the spinner
assembly removed.

Stop? component(s)
MCARADJ
This program performs an adjustment for The Main Yes Main Carousel Ring Gear
Carousel Ring Gear. Following the prompts on the
display panel, adjust the ring gear so that the shuttle
body passes directly centered between two baffles of
the ring gear. Confirm proper adjustment by running the
main diagnostic CARCHECK.
MCARTST
This program is a test for the positioning sensor of the No Main Incubator Carousel
Main Incubator Carousel, for the use of troubleshooting (Position Sensor)
related problems. On the display panel, the hole width of
each position hole of the ring gear (in steps) will display
with each repeated index of the Main Carousel.
-- Nominal values are a range of 22 26 for large holes.
-- Nominal values are a range of 8 12 for small holes.
PIPXRADJ
This program performs an isolated adjustment of rotation Yes Probe
alignment of probe over reagent wedge. After pre-setting (X-rotational position at Reagent)
an open reagent wedge at the probe position with
REAGENTP, and with the reagent chamber lid open, use
the small opening of the reagent vial as sight judgement
for a centering target of the probes X-Position over this
hole.
PIPXSADJ
This program ensures the probe is centered in sample Yes Probe
cups in the five pipetting positions. To prevent damage to (X-rotational position
the customer probe, install a dummy probe. The smaller at all 5 Sample Cups)
notched Pip-X positioning gauge (from Kit p/n 420078)
is used to precisely target and/or adjust each of the five
sample pipetting positions. The program actions will work
clockwise around from position S5 to S1. Start the target
gauge at S5, and set the probe one at a time, using the
Go button for raising the test probe and shift the target
gauge to next S-position. Ensure the probe comes down
within one probe width of the center target of the gauge.
PIPXTADJ
This program allows the adjustment of the rotational Yes Probe
alignment of the probe at the dispensing position into the (X-rotational position at Assay Test
test unit. Place the larger (without a notch) Pip-X Unit Dispense Position)
positioning gauge (from Kit p/n 420078) in the test unit
dispensing position using CARCHECK. Run the
diagnostic and check for proper positioning either
centered or within one probe width to the rear (counter-
clockwise). Refer to Section 7.4.5 for more information.

Stop? component(s)
PIPXWADJ
This program allows the adjustment of the rotational X- Yes Probe
alignment of the probe over the three positions at the (X-rotational position at Home Well
front wash station. The Dump and Wash wells are of the front wash station)
hard-coded from the rightmost Home X-position. 20
steps to Dump, 40 steps to Wash Well. Once the
program has centered the Home Well, the other two
should also be centered properly.
PIPZHADJ
This program performs an automatic self-calibrating Yes Probe
adjustment for Z probe depth in the Home Well. The (Z-up/down self-calibration for
program places the probe in the home well and fills it with optimal Home depth)
water until no bubbles are present. The probe is then
level sensed to the water level. The IMMULITE display
will post a Calibration Successful message.
PIPZTADJ
This is an auto-calibrating program that optimizes Z- Yes Probe
probe depth in a beaded test unit at the dispense (Z-up/down calibration for optimal
position. Assay depth manual setup
Note: This requires accurate manual setup. Place a method)
beaded test unit with 210 uL of probe wash on the load
platform before starting the program. Run program and
follow display prompts. Proper calibration is determined
by the proper pipetting of 210 uL into the test unit.
PIPZTCHK
This is an automatic self-calibration for optimal Z-probe Yes Probe
depth in a 210 ul beaded test unit. This is a newer, more (Z-up/down automatic calibration
accurate version of the PIPZTADJ program above, in for optimal Assay depth)
that the empty test unit is given a more accurate 210 ul
test volume, through the higher accuracy of the small
syringe.
PIPZWADJ
Automatic self-calibrating program that adjusts probe Yes Probe
depth in the wash well. The syringes fill to an optimal (Z-up/down self-calibration for
water level in the wash well then the probe is level optimal Wash Well depth)
sensed to the water level. The IMMULITE display will
post a Calibration Successful message.
REAGHADJ
This program is used to adjust the reagent carousel Yes Reagent Carousel
home position. Follow the prompts on the display panel.
Confirm proper positioning using main diagnostic
REAGENTH.
REAGPADJ
This program is used to adjust the twelve reagent Yes Reagent Carousel
carousel positions. Follow the prompts on the display
panel. Confirm the proper positioning using main
diagnostic REAGENTP.

Stop? component(s)
SAMPFTST
This program tests the sample collection tray full sensor. Yes Sample Collection Tray
Place a sample cup in position to block the sample (Tray Full upper sensors)
collection tray full sensor and run the diagnostic. Follow
the prompts on the display panel. A Pass/Fail condition
will post.
SAMPTTST
This program tests the sensor that detects the presence Yes Sample Collection Tray
of the sample collection tray in its lower casing. Follow (Tray Absent lower sensors)
prompts on the display panel. A Pass/Fail condition will
post.
SHUTCADJ
This program is used to adjust the shuttle home position Yes Shuttle
at the Main Carousel (Sh at Car parameter #21). Follow
the prompts on the display panel to adjust the degree for
which the shuttle idler wheel encroaches into the
carousel. The proper adjustment is when the lower
shoulder of the shuttle at its idler wheel aligns flush with
the inner wall of the carousel casting. Confirm proper
alignment by running main diagnostic SHUTTLE with a
test unit placed in the shuttle.
SHUTLADJ
This program is used to adjust the shuttle position at Yes Shuttle
entry into the luminometer (Sh at Lum parameter #25).
Remove the spinner assembly for a clear view and place
a test unit on the shuttle. Follow the prompts on the
display panel to adjust. Proper alignment allows a
smooth transition of the test unit off the shuttle and into
the luminometer. The test unit should be centered and
should not contact either side of the Luminometer
entrance. Confirm proper alignment by running main
diagnostic SHUTTLE with the test unit still placed in
shuttle.
SHUTSADJ
This program is used to adjust the shuttle position at the Yes Shuttle
substrate dispensing position (Sh at Sub parameter
#22). Remove the substrate heater for a clear view from
above and place a test unit on the shuttle. Follow the
prompts on the display panel to adjust. Adjust for a
centered test unit under the substrate dispensing
position. It is possible for the Luminometer entrance
position and the substrate dispensing position to be the
same.

Stop? component(s)
SPNCKTST
This is a test of the High Speed Spinner Motors Yes High Speed Spinner Motor
Spincheck Logic circuit and the proper error and error checking circuit
interpretation from the motors Hall Effect return current
to the system CPU. Follow the display panel prompts, as
the system will feed a test unit into the spinner and
perform a 5-cycle test of the spinner, posting a Test
Passed at end or Test Failed if within the 5 cycles, it
failed to reach at least 2,500 rpm in 0.5 seconds. The
user may also Repeat the cycles as often as desired, or
Exit to end the test and eject the test unit.
SUBHTTST
This program tests the on/off logic trigger point of the Yes Substrate Heater
substrate heater. Remove the substrate heater cover and
attach a DVM set to DC volts to the white test points. The
DVM reading is in direct correlation to the temperature.
The actual temperature is the DVM reading with the
decimal point moved two places to the right. Run the
program and look for the on/off trigger point of
approximately 35 degrees. A Pass/Fail condition will be
posted on the display panel.
SUBLVTST
This program tests the proper operation of the Substrate Yes Substrate Low
Reservoirs level sensor. After initialization, be sure to Reservoir Level Sensor
carefully follow the prompts on the display panel. The
user will be instructed to properly cycle the substrate
pump until the level is visibly below the window Fill Line,
where it will trigger the level sensor to indicate Test
Passed. Be sure to correctly judge a Test Failed
message, if the actual level is still above the fill line. In
this case, press the Pause button to Repeat the
pumping cycles through all the prompts again, cycling out
more until the level is actually low enough to trip the
sensor.
TABLE
This program is initiated to access, display, change, or N/A All motors
print the systems Instrument-specific motor configuration
table. Refer to Section 7.2 for full details.
CAUTION: Do not make changes to this table without
consulting the full details of Section 7.2.

Stop? component(s)
TEMPCAL
This program, though mainly created for the benefit of Yes Precision Calibrator Resistor Circuits
final production testing, is used for troubleshooting the of the Heater Temperature Control
35 and 39 Calibrator Resistors of the Temperature
Control Circuits. They test the accuracy of critical Main
Incubator Carousel and Luminometer heater control
upper and lower parameters. Follow the prompts on the
display panel to post first the 35 Degree Calibrator
Value=, and then the 39 Degree Calibrator Value =.
These readings are the current electrical values of these
precision components, translated into a decimal
equivalent. If the values are out of spec, then
temperature problems can be confidently sourced to the
likely need for a change of the 450002 Motor/Heater
PCB.
Nominal range for the 35 = 3,800 - 4,401
Nominal range for the 39 = 28,191 - 28, 791
Note: Be sure to consult Section 3.8 for full details of

temperature control and proper troubleshooting.
TIPJMTST
This is the preferred diagnostic to test the tip jam circuit. Yes Probe
The program bottoms out the probe five times to trip the (Tip Jam Sensor Function)
tip jam sensor. A Pass/Fail condition will be posted on
the display panel. Can be repeated several times to
ensure proper operation.

8.7 System Configuration Diagnostics Error Codes
In the functions of a select few of the Configurations Diagnostic programs, there is logic tie-in to post
related Error Codes, onto the IMMULITE display panel, while the program runs. These error codes
reflect certain good or bad conditions of the Configuration being performed. The table below explains
these error codes and their definitions.
System Configuration Diagnostics Error Codes
Code No. Error Definition

01 Tip Jam Sensor acts as if always blocked.
02 Tip Jam Sensor is unblocked prematurely.
03 Sample Tray Full Sensor is always unblocked.
04 Sample Tray Full Sensor is always blocked.
05 Sample Collection Tray In Place Sensor is always unblocked.
06 Sample Collection Tray In Place Sensor is always blocked.
07 Substrate Heater is up to temp prematurely or still hot from previous test.
08 Substrate Heater did not reach temperature within 5 minutes.
09 Substrate Level Sensor did not trigger within the expected time frame.
10 Program detected Level Sensor was triggered before any substrate was dispensed.
11 Spin Check Circuit output is prematurely indicating that motor is spinning.
12 Spin Check Circuit is indicating that the motor is not spinning.

Chapter 9: Troubleshooting
9.1 Description
This section is designed to aid in the quick, accurate diagnosis of IMMULITE problems. While many
people can make IMMULITE repairs, accurate troubleshooting is a rare skill for the experienced as well
as the inexperienced.
In its simplest state, troubleshooting is an exercise in logic. It is essential to realize that the IMMULITE is
really composed of a series of modules. Some of these modules are interrelated, others are not. The
instrument operates within a framework of logical rules and physical laws, and the key to troubleshooting
is a good understanding of all the IMMULITE modules.
9.2 Troubleshooting Techniques

One of the key ingredients in diagnosing a problem is information. The following are questions to ask the
operator (or even yourself if you are experiencing a problem) in an attempt to draw the proper
information needed for troubleshooting.
1. What is the instrument serial number? - This will allow positive identification of the instrument.
Once the serial number is known, its age and history can be found.
2. What is the software version? - This is a very important question especially during periods when the
software is in the process of being updated. Certain assumptions are made about the operation of an
instrument with a particular version of software. Do not make these assumptions until the software
version is verified. Also, certain problems may be caused by an old version of software and updating
to the new software may be the solution.
3. What is the exact nature of the problem? - Try to determine exactly what is wrong rather than
accepting Its broken from the operator. Determining exactly what is wrong will allow you to either
solve the problem over the phone or know what part is needed for the repair when visiting the site.
4. When did the problem first occur? - Determining when the problem first occurred will allow it to be
then tied to an event. Or, if the customer says the problem has always occurred (which is unusual but
not impossible) the problem could be with a procedure the operator incorrectly follows every time the
instrument is used. If the first occurrence can be determined, we then try to tie an event to this with
the next question.
5. Was anything unusual done to the instrument prior to the problem? - In many cases the reason for the
problem is found with the answer to this question. For example, the customer is having many air
bubbles in the small syringe and it has been determined that this started the day before. When the
question of "Was anything unusual being done..." is asked, the customer remembers that the small
syringe tip was changed yesterday. So, the reason for the problem is the new syringe tip or the
process by which it was changed.

6. Is the problem reproducible? - If the problem is reproducible, it can be considered a "phone
confirmed problem" and then steps can be taken to rectify it. A phone confirmed problem does not
necessarily mean it is one that involves an instrument problem; it could very well be a procedural
problem. For example, if the operator complains of " Reagent Carousel Temperature High" errors for
five minutes every morning, the problem is most likely that the lid of the Reagent Carousel housing
was open for a long time. If the problem is not reproducible, it may be a one-time event. Although
these are rare, they do happen. It is wise to be very persistent in reproducing or confirming a problem
before determining it to be a one-time event. Remember, this one time event could be a generous
warning of an impending failure.
7. Is the instrument making any unusual sounds? - If the problem is mechanical in nature, chances are
good it is accompanied by a noise that is different than normal. When an operator works with the
instrument for a while they learn the "normal" sounds of the instrument. A seemingly insignificant
change in the "normal" sound of the instrument could be a vital clue in diagnosing the problem.
8. At what point in the run does the problem occur? - The answer to this question will indicate if the
problem is related to something entering into a section of the instrument (Test Units, Sample Cups,
Reagent Wedges, water, etc.). The answer can further indicate (if the problem is mechanical) where
the problem is located, since the location of the components can be mapped based on when the
problem occurred. For example, if the instrument has a Shuttle-Carousel error immediately after the
instrument starts to run after shut down, the problem is not due to any components entering the
system. In this particular case, the problem is most likely due to the instrument not being shut down
properly by the Operator, leaving the shuttle improperly positioned for initialization.
9. If the instrument is down, have the operator leave the instrument as is. - Many clues, valuable for
diagnosing, are left behind when an instrument has had a problem. If the operator cleans up the
instrument in preparation for the arrival of a field service person, they may be removing these clues.
(Of course, some things such as samples and reagent vials must be removed and refrigerated to
prevent degrading.) For example, the instrument has had a problem with test units jamming the
Incubator Carousel. The customer has left the instrument in the jammed condition for the arrival of
the field service person. Since the field service person can see where on the Incubator Carousel the
jam occurred and the condition of the jammed tube, a determination of what caused the jam can
quickly follow.
If a field service person must now visit the site (or is already in front of the instrument and has completed
the above steps) the following steps will make for an efficient troubleshooting and/or repair session.
1. Before visiting the customer try to duplicate the problem at the office. - If the problem can be
duplicated on an instrument at the field service office, in most cases, so can the solution. This can
make for a smoother and quicker repair, since the repair procedure is rehearsed and the necessary
parts brought.
2. If the solution to the problem is not clear, create a diagnostic plan before arriving at the site. -
Generally, when the customer greets the field service person, they ask what could be causing the
problem and how long will it take to repair. A clear definitive answer will put the customer at ease
and give them confidence in the repair process. This clear definitive answer can only be the result of a
well, thought-out plan of diagnosing the problem. This plan should contain all possible causes of the
problem and how to check for each one. It should also contain a brief history of the instrument
including: age, past problems, dates of any modifications, and current revision status.

3. Upon arrival, observe the condition of the instrument and its environment. - The condition of the
instrument could be the cause of the problem or a contributor. For example, if the Reagent Carousel
Tray has evidence of spilled reagent, this could explain why the Reagent Carousel Tray sensor PCB
has failed. The environment of the instrument could also be the cause of the problem or a contributor.
For example, if the system is having intermittent "Electrical Ambient High" errors, the cause of the
problem could be high laboratory temperature or an instrument located behind the IMMULITE
exhausting warm air onto the rear of the IMMULITE. If the environment is the cause of a problem
but never considered as possibility, the problem may never be solved.
4. If possible, duplicate or verify the problem before diagnosing or repairing! - A very common mistake
made in repairing anything is to begin to diagnose, or even worse, repair a problem without first
trying to duplicate or verify it. In many cases the information the customer supplies about the
problem is not very precise, therefore allowing the diagnosis process to proceed down the wrong
"path". Worse yet is to repair (replace a part, make an adjustment, etc.) a problem without knowing if
the repair is really necessary. Occasionally, there may not be a reasonable way of duplicating a
particular problem; these are the most difficult problems to diagnose.
5. Check the error.log file. - The error.log file can contain information unnoticed by the customer.
Check this file to get more information about a problem at the beginning of the diagnosis. Refer to
Section 7.4.13 for information on the error log file.
6. Do not ignore the obvious! - Never assume the solution to a problem is complex. Most problems are
easily diagnosed and repaired.
7. When the problem is found and fixed, check the area around the problem to insure the repair created
no other problems. - Most of the components in the IMMULITE are close together and interact with
other assemblies. Therefore, during the repair process, it is possible to cause another problem while
repairing the one diagnosed. Always check, visually and via diagnostics that all components around
the problem area are functioning properly after the repair work is complete.
8. Unless unusual circumstances exist, run controls to check the instrument. - This step is very
necessary in determining if the repair was truly successful and no other problems exist.

9.3 Typical Problems
Location and Useful Diagnostics Problem Cause/Solution

Main Incubator Carousel Main Carousel Ring not Motor or motor drive circuitry
moving. failure.
The "McPos" parameters in the
CARPOS configuration table are incorrect.
A sample cup is on the Carousel and
CARCHECK is jammed under the Carousel ring
drive area.
CARBACK The shuttle has mis-positioned and
is blocking movement of the
MCARTST Carousel.
The Load Chain has not advanced
SHUTTLE correctly and thus an assay tube or
sample cup holder is blocking
Carousel movement.
Main Carousel Ring not The position sensor has failed.
EMPTYTUB positioning correctly. The position sensor assembly is not
located correctly.
configuration table are incorrect.
Main Carousel momentarily The shuttle is not positioning at the
jamming during an index. Carousel (home) correctly
resulting in the Carousel baffles
hitting the shuttle.
TEMPS The Carousel is not heating to The heater is not getting power or
temperature. not plugged into the interface PCB.
TEMPCAL The heater drive circuitry has failed.
The thermistor is shorted (39.xx).
The thermostat has opened (34.xx).
The Carousel is overheating. The thermistor has opened or is not
plugged in.
The heater drive circuitry has
shorted "on."
Load Chain Load Chain is not moving. The sample tray is full.
A baffle has been dislodged and is
jamming the chain.
The motor or motor driver circuitry
LCHAIN has failed.
The "LcPos" parameter in the
EMPTYTUB configuration table is incorrect.
A Sample Cup Holder or Test Unit
has tipped and is jamming the chain.
Load Chain is not moving to The "LcPos" parameter in the
the correct position. configuration table is incorrect.
The position sensor or related
cabling has failed or the position
sensor disk has dust interference.

Load Chain (Cont.) Bad Sample Cup Holder or One or more of the idler assembly
Test Unit barcode read. rollers are fouled causing
inconsistent movement.
Driver O-ring is worn preventing
good grip on driven surface.
Incorrect Barcode Reader motor
BCODETST
speed.
Drive Wheel does not spin tubes
BCODESPD
smoothly due to dirt/grease build-up
on the Drive Wheel and/or tubes.
BCODE (quick test)
Drive Wheel motor or motor drive
circuitry has failed.
The Drive Wheel set screw has
loosened allowing slippage between
the motor shaft and the Drive
Wheel.
Chain misalignment in front of
optical reader.
LCHAIN Intermittent Load Chain errors. The chain has become stiff from
spilled liquids.
EMPTYTUB The position sensor disk has dust
interference.
Luminometer Luminometer Chain is not The "LumcPos" parameters in the
moving. config table are incorrect.
The motor and/or motor drive
The shuttle is mispositioned and
interfering with the chain.
A lumchain baffle has become
dislodged and is interfering with the
LUMCHN chain.
An assay tube or partially dislodged
LUMCHECK Luminometer Chain baffle has
become jammed inside the
MCARTST luminometer, thus jamming the
chain.
SHUTTLE The chain tension has increased
surpassing the torque capabilities of
the motor.
Luminometer Chain is not The "LumcPos" parameters in the
moving to the correct position. config table are incorrect.
The position sensor has become
dislodged.
The slotted sensor disk has become
loose.
The chain tension has increased
causing the motor to miss steps and
"time out" during a move.
Drive Motor coupling inside cover
may be shifting loose.

Luminometer (Cont.) Shuttle is not moving. The shuttle parameters in the
dislodged and is interfering with
shuttle movement.
The main Carousel has
mispositioned and is blocking
shuttle movement.
SHUTTLE Shuttle is not moving to the The shuttle parameters in the
correct position. configuration table are incorrect.
LUMCHECK A sensor has failed or become
dislodged.
LUMCHN A lumchain baffle has become
shuttle movement.
A tube has fallen into the path of the
shuttle and/or has broken the shuttle
sensor flag.
PMT Attenuator Disc is not The attenuator parameters in the
moving. configuration table are incorrect.
ATTURN circuitry has failed.
The belt or associated components
have come loose.
Associated bearings for the disk
inside the cover have seized.
The PMT Attenuator Disc is The attenuator parameters in the
not moving to the correct configuration table are incorrect.
position. The sensor for that specific position
has failed.
The sensor cable for the specific
position has failed or is not
connected.
The Luminometer is not The heater is not plugged into the
heating to temperature. interface PCB.
The heater drive circuitry has failed.
TEMPS The thermistor has shorted (39.xx).
TEMPCAL Overheating heater connections at
PCB causing intermittent contact.
The Luminometer is The thermistor has opened or is not
overheating. plugged in.
shorted "on."
SPINCHK The High-Speed Spinner is not The motor or motor drive circuitry
moving. has failed.
WASHSPD The motor cable is not plugged in.
The stainless steel motor coupling
SPNCKTST has loosened or broken.
The tube pressure is too high.
(Shut Push.)

Luminometer (Cont.) The High-Speed Spinner is not The tube pressure is incorrect.
spinning at the correct speed. The motor drive circuitry is faulty.
SPINCHK The stainless steel motor coupling
has loosened.
WASHSPD The O-rings are worn or missing,
allowing slippage.
SPNCKTST
Pipettor / Reagent Carousel Pipettor X, Z, or Reagent The Pipettor X, Z, or Reagent

Carousel not moving. Carousel parameters in the
REAGENTH configuration table are incorrect.
A mechanical jam has occurred,
REAGENTP preventing the motor from moving.
The X-Pipettor belt has broken
RBCODE preventing any X movement.
Motor or motor drive circuitry has
failed.
PIPXPOS Pipettor X, Z, or Reagent Sensor of desired position has
Carousel not stopping at home failed.
UPDOWNH or position. The X-Pipettor belt has become
loose or worn preventing precise X
UPDOWNW movement.
The configuration table parameter
UPDOWNA setting for the sensor in question is
incorrect.
Open circuit in the cable connecting
the sensors to the microprocessor.
The Probe is stopping above Intermittent short or open in level
the Reagent Wedge or Sample sensor flex cable (Euro system).
LEVFSTST Cup. Liquid level is too high.
"LevSensR Error" configuration
LEVSNTST table parameter set too low.
"LevsensS Error" configuration
LEVFALSE (quick test) table parameter set too low.
The ground wire on the probe block
LEVCRASH (quick test) is not connected.
The level sensor is not Short or open circuit in level sensor
detecting reagent or sample. flex cable (Euro system).
An open circuit in the cable
connecting the level sensor output
to the microprocessor.
An open circuit between the level
sensor flex cable (Euro system) and
the probe.
Level-sense errors due to Probe is dispensing on an angle.
splashing. Probe dispense velocity is too great.
PROBANGL X-Pipettor is misaligned in the
home well.
PROBETST Z-Pipettor is misaligned in the home
well.
PRIME Air is in the system.

Pipettor / Reagent Carousel Bad or missing Reagent Wedge "RcHome" configuration table
(Cont.) barcode reads. parameter setting is incorrect.
Faulty Reagent home or position
RBCODE sensor.
Faulty barcode reader PCB.
Dirty barcode reader lens.
Wedge is incorrectly placed in the
tray.
The barcode label is poor quality or
obstructed by a substance.
DEADVADJ Grossly incorrect or missing "LevSensR" parameters in the
"Tests Remaining" number. configuration table incorrect.
Reagent Carousel has
mispositioned.
The probe has stopped over the
Reagent Wedge.
TIPJMTST Tip jam errors are encountered. The probe is not sliding through the
lower guide arm smoothly, thus
activating the tip jam sensor.
The probe block is sticking in the
raised position.
The probe block hold-down spring
has become loose.
TEMPS The Reagent Carousel is not The TED has become defective.
cooling. The Reagent Carousel temperature
thermistor has an open circuit.
The Luminometer and/or Incubator
Carousel have not yet reached 35C.
The TED has been shut down by the
temperature controller due to a
temperature error.
The cold plate of the TED is not
making good contact with the
casting of Reagent Carousel.
The TED drive section of the
Heater/DC Motor Board is
defective.
Power Supply Chassis The PC is indicating a problem The fuse for the IC logic power
communicating with the supply (F2) has blown.
IMMULITE (also no red LEDs The IC logic power supply has
of the system are seen). become defective.
EMPTYTUB No motors are moving nor is The fuse for the heater/motor power
the main cooling fan moving. supply (F3) has blown.
The heater/motor power supply has
become defective.
DARKCNT The CPS of the test units is The fuse for the PMT power supply
zero. (F1) has blown.
BKGNDCNT The PMT power supply has become
defective.

Power Supply Chassis (Cont.) No power from all of the The main input fuse has blown.
individual supplies The input filter/fuse holder has
become defective.
The power cord has become
defective.
The power switch has become
defective.
PMT Data points showing as zero. Blown fuse in Power Supply (F1)
(Photo-Multiplier Tube) for the PMT power supply.
PMT output coax has been
DARKCNT disconnected from CPU.
PMT is not plugged into the power
BKGNDCNT supply.
The PMT has become defective.
PMTCOUNT
Linear Actuator Substrate / Air bubbles have appeared in An up-line fitting has loosened.
Water Injector Pumps the tubing. The water or substrate supply is low
enough to allow air to start entering
the system.
DISSUB (substrate) No substrate being dispensed. The substrate nozzle is clogged.
The substrate spike is clogged,
DISWAT (water) causing a vacuum.
The Substrate bottle is empty.
The Substrate actuator pump or
driver circuitry has failed.
Substrate volume dispensed is The substrate nozzle is partially
incorrect. clogged causing the substrate to
SOLE2S (substrate) dispense at an angle partially
missing the assay tube.
SOLE1W (water) Clogged air filter in the substrate
spike.
Reservoir was never primed.
Defective substrate actuator pump.
No water being dispensed. Water container is empty.
A line fitting up-line has become
very loose.
Water actuator pump or driver
Water volume being dispensed The water supply bottle has become
is incorrect. empty.
Defective water actuator pump.
Air leak in the input line to the
pump.
Clogged in-line water filter.

Substrate Heater The substrate heater is not The blue wire (from J3 to A15-J10)
coming to temperature. connecting the heater to the Syringe
SUBSHEAT Interface PCB has become
disconnected.
SUBHTTST The heater circuitry has failed.
The yellow wire (from J3 to A10
solder point #9) has become
disconnected causing a break in the
"Heater at Temperature" signal.
Substrate Reservoir No substrate being drawn from The reservoir was overfilled causing
bottle. the substrate to back up into the air
SUBLVTST filter, clogging it.
A fitting is loose on the input to the
substrate solenoid pump.
The substrate is being used The operator is priming excessively
much faster than normal. when starting a run.
A loose and leaking tube fitting at
lower right of reservoir.
The air filter on the spike is missing
or punctured.
Internal failure or leakage within the
pump.
The solenoid pump dispensing
volume is too great.
Syringe Pumps Syringe overload error. A solenoid valve has a blockage.
The diluter has become defective.
A blockage had occurred in the
tubing.
Syringe controller PCB failure.
The probe has descended onto a
PRIME solid surface and is not able to
dispense or aspirate.
The rotary valve has leaked water
onto the metal guide shaft of the
diluter causing it to rust and seize
the guide arm bearing.
Incorrect amount of liquid One or more of the fittings has an
being dispensed and/or air or water leak.
aspirated. The syringe thumbscrews have
become loose or have fallen out.
One or both of the Teflon syringe
tips are worn.
One or more of the solenoid valves
has a leak in the diaphragm(s).
The water and/or wash container are
empty or near empty.
The water and/or wash in-line filter
is clogged.

Syringe Pumps (Cont.) Syringe communication failure. The communication cabling has
become disconnected or damaged.
The termination jumper (P8) on the
PRIME controller PCB is missing.
The +12 or -12 volts source is
missing.
The controller PCB has failed.
The syringe control part of the
CPU/Sensor PCB has failed.
V1TEST The probe drips as it is moving V1 is not activating or is partially
from the wash well to the activating.
V2TEST sample cup. V4 is not activating or is partially
activating.
V4TEST There is an air leak in the system
allowing liquid to leak from the
probe.
The level in the detergent V4 is failing to activate.
bottle is increasing instead of V2 is stuck in the activated position.
decreasing.
bottle is not decreasing.
Air in the plumbing system. Clogged water or wash in-line filter.
Loose fittings or kinked tubing(s).
The syringe(s) are loose from valve
above.
Worn syringe tips.
Bad micro or macro-valves.
Empty water or wash container.
SCHANGE Air is entering the small The water container is empty.
syringe One or more of the fittings
involving the small syringe are
loose.
The small syringe barrel is loose
from the microvalve.
The small syringe tip is extremely
worn.
The water filter is clogged, causing
air to be drawn into one of the
fittings.
The microvalve is worn and not
sealing properly.
Air is entering the large The water container is empty.
syringe. One or more of the fittings
involving the large syringe are
loose.
The large syringe barrel is loose
from macrovalve.
The large syringe tip is extremely
worn.
fittings.
The macrovalve is worn and not
sealing properly.

Sample Collection Tray Sample Cups not smoothly The sliding surfaces of the sample
entering collection tray area or tray are dirty, restricting tube
jamming the Load Chain. movement.
The sample tray is not in the full
SAMPTTST down position.
The sample collection tray has
SAMPFTST become full.
The Star Wheel is incorrectly
adjusted.
The Tray-Place sensor is being The tray is not in the correct
falsely activated. position.
The sensor has failed.
Some liquid has spilled onto the
sensor.
The Tray-Full sensor is being The sensor has failed.
falsely activated. Some liquid has spilled onto the
sensor.
Sample Barcode Reader Bad Test Unit and Sample Cup An idler roller is not moving very
barcode reads. smoothly.
BCODETST Worn idler O-rings.
Worn or dirty drive O-ring.
BCODESPD Barcode reader motor speed is
incorrect
BCODE Bad motor.
The return spring has mispositioned.
Chemistry Results Low counts - CPS = 0. PMT power supply fuse (F1) is
blown.
PMT is defective.
Low counts - CPS = 10 to 100. No tube in front of PMT.
Low counts - CPS = 100 to No substrate dispensed.
1000.
Low counts - CPS = 2000 to No reagent pipetted. Could be a
10000. result of the wedge placed into the
tray incorrectly, level sensor falsing,
or the Reagent Carousel Tray
mispositioning.
Low counts - CPS > 15000, but No sample pipetted.
much less than normal. Probe wash is in the Test Unit.
Valve #2 may be failing.
"Dead" test unit.
Intermittent High counts. Test unit did not spin well or not at
all.
Test unit was "flicked."
If high result occurs on the first tube
of a run, valve #2 is most likely at
fault.
Consistent High Counts. Water is contaminated.
Substrate is contaminated.

9.4 Error Message Table
Error Message Cause Solution
Adjustor lots Test Unit lot numbers are not the Re-run the Adjustor (or Adjustors)
between replicates same for all the Adjustor using matching Test Unit lots.
don't match replicates.
Adjustor replicates The Test Codes behind an Re-run the Adjustors with matching
not identical Adjustor sample cup are not all the replicate Test Codes.
same (i.e. not all TSH replicates).
Adjustor result The result file could not be found. Call Technical Support.
file not found
Ambient Elec. Temp The ambient electronics Clean the intake fan filter on the
High [nn] temperature reading is higher than right side of the IMMULITE.
the acceptable range. Lift the top panel to allow the
Note: This is not a fatal error electronics to cool.
condition. Note: The temperature falls back
into an acceptable range within a
short amount of time.
Ambient Temp. High The internal ambient air This problem should correct itself.
temperature reading is higher than Call Technical Support if the error
the acceptable range. message persists.
Note: The lab temperature should
be less than 30C.
Atten. Factor not The attenuation factor was not set. Call Technical Support.
set
Note: This message should not be
encountered if the computer has
been configured correctly.
Atten. Home Error Appears on the IMMULITE Troubleshoot with related
Display Panel if the error corrects diagnostics (ATTURN), and check
itself. sensor connections. Evaluate for
possible seized bearings for the
Note: If the IMMULITE cannot
attenuator disk.
correct the error, the instrument
automatically shuts down and an
error message appears.
Atten. -Pos. Refer to the explanation above for Refer to the solution above for the
Error. the error message: Attenuator error message: Attenuator
Home Error. Home Error.

Bad barcode last Either: Wipe the label with a lint-free
Sample #nn towel or wash the label with water.
Torn, wrinkled or dirty
barcode labels, which cause If the barcode is torn or
Test Units not to spin wrinkled, discard the Test Unit
smoothly. or the sample cup holder.
Dirty Barcode Reader O-rings. Perform maintenance on the
barcode Drive Wheel O-ring
Barcode Reader speed is off in
and/or tube shuttle idler wheel
one or all positions.
assembly, as per section 7.3.7.
Run the BCODESPD diagnostic
program.
Bad File Name or The computer was turned off or Press any key to return to the
Number in Line xx reset without following the proper DOS command line.
of Module PC yy at Log Off procedure. At the C:\CIRRUS\IMM
address zz. Hit prompt, type fixit and press
any Key to Return [Enter].
to System.
A message indicating that the
software is attempting to repair
the database will be displayed
until the damage is corrected.
Note: Some data may be lost in
this process.
Type start and press
[Enter] to return to the Start-up
menu.
Repeat all tests in progress.
Note: Ensure the IMMULITE
is in an idle state before
choosing RUN IMMULITE or
START TURBO. Call
Technical Support if the
problem persists.
Bad LIS Checksum Checksum did not match Re-send results to the LIS.
(transmission error).
Bad or Missing Usually indicates a bug in the LIS Re-send the results to the LIS.
Frame Number software; however, could be If the error continues to occur,
caused by a bad message (due to Customer should contact their
line noise, etc.). LIS provider.
Bad Parity Error Due to electrical noise on the The problem will correct itself.
power line, information was sent If the error continues, problems
to the software and incorrectly for the PC Hard drive are
read as a message. suspected.

Calc error Occurs when the system cannot If all results give Calc
properly calculate a dose. error, check to see if there is
enough water and if the syringe
thumbscrews are tight.
If an individual result shows
this error and it is a competitive
assay, the dose may be too high.
Dilute and rerun specimen.
If the results show < 25,000
cps, refer to the Chemistry
Results category in section 9.3
for more information.
Cannot calculate An invalid value was received for Go to the Temperatures screen
average temperature a temperature reading because of a to verify temperatures are
due to error temperature controller error or within specifications.
failure. Turn the IMMULITE power off
for a couple seconds and then on to
reset the controller.
Check the temperature after 10
minutes.
If the Luminometer or Main
Carousel feels hot, troubleshoot
further using Section 3.8.
Cannot calculate An invalid value was received for Refer to solution above for:
last temperature. a temperature reading because of a Cannot calculate average
Delta error temperature controller error or temperature due to error
encountered. failure.
Cannot communicate RUN IMMULITE or START Ensure the IMMULITE Display
with IMMULITE TURBO was selected while the Panel reads IDLE.
Display Panel showed something Press ALARM MUTE and GO
other than the message: DPC and re-load the software.
IMMULITE IDLE, Run
START Program to begin. Note: Make sure the power is on
and the RS232 ports are connected.
Cannot find Order A record required for LIS Re-send the test order to
Record communications is not found. IMMULITE.
Cannot find record The IMMULITE sent a reading to Re-run the test using a different
for result Sample the computer; however, it did not sample cup holder number.
#nn TestCode know where the result belonged in
the database and the result for this
Test Unit was lost.

Cannot find record The sample cup was identified as Repeat the tests, identifying the
to place Adjustor an Adjustor, control, or verifier Adjustor, control, or verifier to the
[Control] after passing the Barcode Reader. software before the sample cup
[Verifier] Entry. passes the Barcode Reader.
Note: The error
message will read
Adjustor, Control,
or Verifier,
depending upon the
situation.
Carousel Shut Down This message appears when the Repeat all tests in progress after
Main Carousel is disabled (i.e. the cause of the shutdown is
when a shuttle/Carousel jam is determined and corrected.
detected). Troubleshoot with all related
Note: Any tests in the movement and alignment tests,
Luminometer will continue if as well as an evaluation of the
possible. An accompanying position sensor hole sizes
message will be posted using MCARTST.
Attempting to complete active
tubes.
Carousel Temp. High The Incubation Carousel The IMMULITE should correct
[Low] temperature is above or below the itself. If it does not, within 20
Note: The error acceptable range. minutes, troubleshoot using
Section 3.8.
message will read Note: All results generated during
either High or Low. the high or low temperature period If the component feels hot, turn
will be flagged on the printout. the instrument off, allow it to
cool, and reset and evaluate
using Section 3.8.
Collection Tray The sample collection tray is full If the sample collection tray is
Full or missing. full, remove the sample cups
from the collection tray and
Note: An alarm sounds and the replace the sample collection
IMMULITE goes into tray.
AutoPAUSE mode.
If the sample collection tray is
missing, replace it.
Follow the instructions on the
instrument Display Panel to
continue.

<CR> or <LF> Usually indicates a programming Customer should contact their LIS
Missing in LIS bug in the LIS software, but may Provider.
Transmission. be a bad message (e.g. line noise).
Dark Count High The dark count measured exceeds Call Technical Support.
[nn]. the maximum acceptable limit
(300 cps).
Note: The preceding sample may
have had very high cps.
Database needs The computers power was turned Press any key to exit to DOS.
repair in line 0 of off or reset without following the Type fixit and press [Enter].
module Pcxxx at proper log off procedure. The message: Attempting
address xxxx:yyyy.
Hit any key to to repair database is
return to the displayed, followed by a
system. message indicating the damaged
files have been repaired.
Note: This process can take as
long as 15 minutes, depending
on the amount of data stored.
Type start and press [Enter]
to return to the Start-up menu.
Data lost. The computer and the IMMULITE Check the RS232 cable.
Simulation screen were not communicating for more For further assistance, call
may not be correct. than 32 cycles. Some of the data Technical Support.
OLD=[xx], NEW=[yy] was not received; therefore, reports
will be missing.
Date Time conflict The computer's date or time was Do the following:
set earlier than the date or time Enter the current date and/or
recorded with results already time.
generated by the IMMULITE.
Re-run the tests.
Diluted Samples Diluted sample is below the Re-run sample undiluted.
below curve detection limit.
Division by 0 An invalid or 0 cps caused by Call Technical Support.
during Adjust either:
TestCode
Invalid parameters or kit
barcodes
Mechanical problems
Error during Refer to the explanation below for Refer to the solution below for the
Control QC the error message: Error error message: Error during
during Patient QC. Patient QC.
Error during Unforeseen error Call Technical Support.
Patient QC

Error in last The LIS encountered an error Re-send the results to the LIS.
request when processing the IMMULITE's
If the error continues to occur,
request for information.
Customer should contact their LIS
provider.
Fatal Curve Adjust An unknown error was Call Technical Support.
error #nn TestCode encountered.
Five Replicates More than the required four Test No action is necessary. The
used for Curve Units were run behind the Adjustor software looks for quadruplicates
Adjust. 5th sample cup. only; therefore, the fifth Test Unit is
replicate dropped. ignored.
Front End Shut Down The Load Chain and pipettor are Wait for the IMMULITE to
disabled because an error was complete the tests in progress.
detected in the Load Chain, Investigate the cause of the
pipettor, or syringes, which the problem by checking the
IMMULITE could not correct. associated error messages or
Note: If possible, the IMMULITE looking for an obstruction.
will continue processing the tests For further assistance, call
currently in progress. Technical Support.
Full Instrument This is a fatal error. The Check for anything that would
Shutdown A Main instrument cannot function and interfere with the operation of
Carousel Error May automatically shuts down. the Shuttle, Carousel, and/or
Have Occurred Luminometer Chain.
Note: All tests currently in
progress are lost. Use related diagnostics to check
all movements and critical
alignments of this area.
Repeat all tests that were in
progress.
Heaters Shut Down The 35 or 39-degree calibration Use Section 3.8 to troubleshoot.
35 [39] Degree resistor cannot be read properly
Error due to a heater controller error.
Note: The error
message will read
either 35 or 39.
Heaters Shut Down The Incubator Carousel heat is not Use Section 3.8 to troubleshoot.
Car. Heater Error working correctly because of a
heater controller error or a
thermistor failure.
Heaters shut down Reagent cooling is not working Use Section 3.8 to troubleshoot.
cooler error properly because of a heater
controller error or a thermistor
failure.

Heaters shut down - The Luminometer heating is not Use Section 3.8 to troubleshoot.
Lum heater error working properly because of a
heater controller error or
thermistor failure.
Heater startup Either: Do the following:
error. Heaters
shut down. The IMMULITE components Turn the IMMULITE off to
have not reached operating reset the heater timers.
temperature, even though it Turn the IMMULITE on.
has been 60 minutes since
Check the temperature after 45
start-up.
minutes (by choosing System
The power to the instrument Status and Temperature and
was interrupted. Dark Counts from the Primary
screen).
Notes:
The IMMULITE software does not
need to be loaded before the system
warms-up.
Once the IMMULITE has reached
operating temperature, it should be
left on.
If the error message persists,
use Section 3.8 to troubleshoot.
High and Low Different high and low Adjustor Re-run the Adjustors using the
Adjustor Test Codes Test Codes. (i.e. An Adjustor is correct Adjustor definition.
don't match defined as TSH and the high =
TSH, but the low = T4.)
High [Low] After dropping the high or low Evaluate the cps of the replicates:
Adjustor's CVs Adjustor replicate, which If the CVs are very high (50%
between replicates contributes to imprecision the or more), call Technical
are > than nn%. most, the CVs are still too high.
Adjust aborted. Support.
Note: This error can only be If the CVs are not high, re-run
encountered only during the the Adjustor that caused the
adjustment process. adjustment to fail, ensuring
there are no bubbles on the
surface of either the sample or
the reagent.
Note: Another sample cup
must be identified as an
Adjustor and followed by four
Test Units.
Illegal function Occurs while calculating an illegal Call Technical Support, and/or fax
call during Calc. math operation. them the data.
test TestCode

Illegal function An invalid or 0 cps, caused by Call Technical Support.
call during Curve either:
Adjust test
TestCode Kit Lot nn Invalid parameters or kit
barcodes
Mechanical problems
in Progress or The auto-number feature was Operator should not try to auto-
resulted, selected, in the LIS Data number records that are closed or
skipping. Management screen, for records are in progress.
already in progress or resulted.
Insufficient sample Refer to the explanation for the Refer to the solution for the error
error message: No Sample message: No Sample
Pipetted Sample #nn Pipetted Sample #nn
TestCode TestCode
Insuf. Reagent Pip. Either: Do the following:
Not enough reagent is Ensure there is sufficient
available to complete the test reagent available to complete all
A level-sense error was tests.
encountered Ensure there are no bubbles on
A Test Unit and Reagent the surface of the sample and
Wedge were mismatched reagent.
Replace the incorrect kit
component.
Invalid LIS ID LIS error message that occurs Do the following:
when the Sender ID or Receiver ID From the Start-up menu, choose
is incorrect. LIS PARAMS.
Check that the Receiver ID
matches the LIS Sender ID and
that the Sender ID matches the
LIS Receiver ID.
Invalid LIS LIS error message that occurs Do the following:
Password when the Header Message From the Start-up menu, choose
Password is incorrect. LIS PARAMS.
Check that the Header
Message Password field shows
the same Header Message
Password used by the LIS.
Kit not Found The kit parameters were Enter the kit barcodes (using the
TestCode Kit Lot overwritten with those of another laser scanner), and re-run the
nn. Curve Adjust kit after pipetting. adjustment.
aborted.
Note: Do not delete a kit that is
currently running.

Less than 4 Refer to the explanation below for: Refer to the solution below for the
replicates. Adjust Less than 4 replicates, error message: Less than 4
aborted. or Adjustor results for replicates, or Adjustor
all levels are not yet results for all levels
available. are not yet available.
Less than 4 Either: Depending on the cause, either:
replicates, or
Adjustor results A record for one of the Re-run the Adjustor.
for all levels are Adjustor replicates was deleted Re-run the Adjustor that was
not yet available because of a pipetting error. short the required number of
An insufficient number of replicates.
replicates were loaded. Note: This sample cup must be re-
identified and followed by four Test
Units.
Level Sense Error The IMMULITE has not level- Call Technical Support.
sensed either the reagent or the
sample.
Note: If five Level Sense
errors occur, the IMMULITE goes
into AutoPAUSE. The error
messages associated with the
sample cup number are recorded in
the Error Log.
LIS Sent an INVALID Sender ID incorrect. Enter correct Sender ID in LIS
ID of NULL, record PARAMS. Check with LIS
not saved provider for correct ID.
LIS Timeout The LIS is not responding to the Re-send the results to the LIS.
IMMULITE. This can be caused
If the error continues to occur, call
by:
Technical Support.
Cable problem
Hardware problem
Bug in the LIS software
Load Chain Error. Appears on the IMMULITE Look for source of the error
Display Panel if an error is condition (i.e. a sample cup
detected and the IMMULITE is incorrectly seated in the sample
able to correct itself. cup holder or a crushed Test
Unit).
correct the error, the instrument Check for accumulation of dust
automatically shuts down the on the position sensor disk
pipetting (front end) operation and below.
a message indicates this has
occurred. (The instrument will
continue to process the tests in
progress.)

Low and High A Test Unit lot matches two Remove the Reagent Wedge
Adjustor reagent different Reagent Wedge lots. (i.e. that should not be used for the
lots dont match Two Reagent Wedge lots are adjustment and re-run both
loaded. The first Reagent Wedge Adjustors with only one reagent
is used for the low Adjustor lot loaded on the instrument.
replicates, but there is not enough
reagent for the high Adjustor
replicates, so the second Reagent
Wedge lot is used.)
Low and High Two kit lots share the same Re-run the Adjustors using the
Adjustor Test lots Reagent Wedge lot number but correct Test Units (from the kit
don't match have different Test Unit lots; which is being adjusted).
therefore, the low and high
Adjustor replicates are run with
different Test Unit lots.
Low cps sample xx The counts for a result are less Ensure that:
[test code] than 15,000. There is sufficient reagent
(sample) available to complete
all tests
There are no bubbles on the
surface of the liquid
The syringe thumbscrew is tight
Re-run the test for the record
that has the low cps.
Lum. Chain and There is a Luminometer chain jam. Look for the source of the jam.
Atten. Shut Down. Since this is a fatal error, the
IMMULITE will stop.
Investigate all related positions
and alignments.
Lum. Chain Error. Appears on the IMMULITE Check for Test Units (or other
Display Panel if an error is obstructions, such as
detected and the IMMULITE is Luminometer chain baffles) that
able to correct itself. may interfere with the chain
movement.
correct the error, the instrument Investigate all related positions
automatically shuts down and a and alignments.
message indicates this has Note: Repeat any tests that
occurred. were in progress.

Lum. Temp. High The temperature reading for the The IMMULITE should correct
[Low] Luminometer is above or below itself. If it does not,
Note: The error the acceptable range. troubleshoot using Section 3.8.
message will read Note: All results generated during If the component feels hot,
either High or Low. a high or low temperature period troubleshoot using Section 3.8.
will be flagged on the printout.
Main Car. Error This message will appear on the Run related diagnostics,
IMMULITE Display Panel if the including the test of the sensor
error corrects itself. hole sizes MCARTST.
Note: If the problem cannot be
corrected, the instrument
error message indicates this has
occurred. This is often caused by
a sample cup holder jammed on
the Carousel under the drive gear.
Mechanical error Either: Based on the cause, either:
encountered
(pipetting) This message appears in Determine the cause of all bad
conjunction with numerous barcode reads and correct if
bad barcode reads. possible. If persistent,
A problem was encountered troubleshoot related tests for the
with the pipettor. BC Reader area.
Determine the source of the
pipettor interference and correct
if possible.
Message received The computer missed a message The software automatically
out of sequence, from the IMMULITE. requests that the message be re-
Seq = xx sent.
OldSeq = yy If the message persists,
problems are evident for the
computers hard drive.
Message Too Short Usually indicates a bug in the LIS Re-send the results to the LIS.
LIS mesg. Too software; however, could be If the error continues to occur,
short\bad frame caused by a bad message (due to Customer should contact their
line noise, etc.). LIS provider.
Negative Slope Sample cups were identified as low Re-run both levels of Adjustors,
calculated! Are the and high, but either the levels pipetting each level into the correct
Adjustor levels dispensed into the cups were in the sample cup holder.
reversed? reverse order or only one level was
run for both samples.

nn days since your The database has not been backed- Either:
last backup up in the last 7 or more days. Ignore this message
Note: Execution speed is greatly Back-up the system
reduced.
No info on this # The LIS has no information Check the LIS to verify that the
regarding the accession number accession number has been
sent in the query. assigned.
Non-Turbo kits Non-Turbo reagent wedges have Either:
cannot be run while been loaded onto the Reagent Remove all Non-Turbo Reagent
in Turbo Mode. Carousel while in Turbo Mode. Wedges and press GO to
Please take all
non-turbo kits off continue running in Turbo
the Reagent mode.
Carousel. Log off and Choose RUN
IMMULITE to run the Non-
Turbo kits.
No Patient Record A record required for LIS Re-send the test order to
for Order communications is not found. IMMULITE.
No place in Either: Based on the cause, either:
database for Test
Code xx result. The sample cup was identified Repeat the tests, identifying the
as a control or Adjustor after control or Adjustor to the
passing the Barcode Reader. software before the sample cup
The date on the computer is passes the Barcode Reader.
incorrect. Note: If the problem persists,
call Technical Support.
Check the computer's date and
time.
No Place in Either: Based on the cause, either:
Database to Put
Tube, Displayed as The Barcode Reader read a Ensure that all sample cups are
Bad. Test Unit that was not loaded ahead of the Test Units
preceded by a sample cup. on the Load Platform.
The operator logged off and on Press ALARM MUTE and GO
the computer while the simultaneously, log off (via the
Analyzer was still operating. Primary Screen) and re-run the
tests.

No Reagent for Either: Depending on the cause either:
approaching
TestCode Tube Part A Reagent Wedge is missing Replace the missing Reagent
[Reagent Part] from the Reagent Carousel Wedge.
Lot#[lot#] tray. CAUTION: The Reagent
The Reagent Wedge and Test Wedge must be replaced within
Unit lot numbers are 5 minutes or this test result is
mismatched. lost.
Refer to the solution for the
error message: Reagent
part A missing.
No Reagent for Indicates either: Depending on the cause either:
TestCode tube at
the Barcode Reader There is no Reagent Wedge on Add the correct Reagent Wedge
board matching the Test Unit and press GO to re-read the
just read at the Barcode Reader Reagent Carousel.
The current Reagent Wedge Press PAUSE to ignore the
has Zero Tests message and this test will not be
Remaining. (The pipetted.
instrument will go into Remove all incorrect sample
AutoPAUSE mode.) cups and test units that need to
Turbo and Non-Turbo kits are be run in a different mode
on board at the same time. (Turbo or Non-Turbo) and press
GO.
No Reagent for Indicates either: Depending on the cause either:
TestCode tube(s) on
the load chain After the Test Unit(s) passed Add the correct Reagent Wedge
the Barcode Reader, the and press GO to re-read the
Reagent Wedge for these tests Reagent Carousel, or, press
went to Zero Tests PAUSE to ignore the message
Remaining. (this test will not be pipetted).
The Reagent Wedge and Test Refer to the solution for the
Unit lot numbers are error message: Reagent
mismatched. part A missing.
Turbo and Non-Turbo kits are Remove all incorrect sample
on board at the same time. cups and test units that need to
be run in a different mode
(Turbo or Non-Turbo) and press
GO.

No Reagent Pipetted Either: Re-run the test for the record which
Sample #nn TestCode
Not enough reagent is left to was deleted, making sure there is
continue testing. enough:
Note: The error will be recorded Sample (above the required
in the Error Log and on the 100ul dead volume)
printed report. For this Test Unit, Reagent (above the 1 mL dead
the report will say: Record volume)
Deleted Pipetting If the problem is hardware
Error. related, troubleshoot using all
Its a hardware-related error related level sensing tests.
(as indicated on the instrument
Display Panel).
No sample cup for Either: If there was a bad barcode read:
Test Unit Wipe the label with a lint-free
A bad barcode read occurred
for the tube just before the towel or wash the label with
Test Unit (which may or may light detergent.
not be a sample cup) If the barcode is torn or
There are more than five Test wrinkled, discard the Test Unit
Units behind a sample cup or sample cup holder.
There is no sample cup in front Perform maintenance on the
of the Test Unit barcode Drive Wheel as per
section 7.3.7.
Repeat the tests.
If there are more than five Test
Units, place the correct number
of Test Units behind the sample
cup and re-run the test.
If there is no sample cup in
front of the Test Unit, place a
sample cup in front of the Test
Unit and re-run the test.

No Sample Pipetted No sample was pipetted because If the error was due to
Sample #nn TestCode an error was detected. The error insufficient sample, ensure there
can be: is adequate sample in the
sample cup and re-run the test.
Hardware-related
If it is a hardware error, remove
Due to insufficient sample
any obstructions, troubleshoot
If any other messages related level sensing tests, and
accompanies the No Sample re-run the lost assay tests.
Pipetted Sample #nn
TestCode message, it is a
hardware problem.
Note: The error will be recorded
in the Error Log and on the printed
report. For this Test Unit, the
printed report will say: Record
Deleted Pipetting Error.
Overflow Error A variable was set equal to a very Note the exact overflow error
during Adjust test large number. message and call Technical Support.
TestCode Kit Lot nn
Note: This error is infrequent
when the master curve parameters
are correct and the IMMULITE is
running properly.
Overflow error Either: Call Technical Support.
during calculation
test TestCode A variable was set to a very
large number.
A hardware error occurred.
The RS232 cable is loose or
disconnected.
Note: This is an infrequent error
when the master curve parameters
are correct and the IMMULITE is
running properly.
Pause mode; 5 Level The instrument will go into Call Technical Support if each error
Sense Errors AutoPAUSE mode if the following was not due to insufficient volume
Encountered errors occur 5 times within a run: for reagent or sample.
Insuf. Reagent Pip.
Not enough sample
error

PC IMMULITE COMM Communication between the PC Check cable connections
FAILURE and the IMMULITE has been between the IMMULITE and
Check you cable interrupted. the PC.
connection now! Reset power on both the PC and
Resuming normal the IMMULITE and select
operation in 15 RUN IMMULITE or START
seconds. TURBO from the start-up
menu.
Note: Call Technical Support if
this message persists.
Reagent Home Error This message appears on the Ensure the Reagent Carousel is
IMMULITE Display Panel if the seated properly and that nothing
error corrects itself. is blocking the sensor beneath
Note: If the problem cannot be the Carousel Tray.
corrected, the front end of the Examine Sensor PCB below for
instrument automatically shuts damage or failure.
down and an error message
indicates this has occurred. Any
tests in progress will continue to
be processed.
Reagent Level Sense Probe level senses above the Check for cap on Reagent
Error. maximum height of liquid. Wedge or large bubble on top
Are there Caps on of reagent.
the Reagent Vials?
Troubleshoot with all related
tests for level sensing.
Reagent lot# xmit The correct lot information could Re-read the reagent barcodes.
error not be transmitted to the If the problem persists,
IMMULITE. troubleshoot related movements
and the BC Reader.
Reagent pipetted Either: Re-run the Adjustors and enter
does not match kit. the correct kit.
Adjust aborted. Different Reagent Wedge lots
were pipetted throughout the Note: Be sure to use the correct kit
two Adjustor levels. components.
The kit needing adjustment
does not correspond to the
Test Units and Reagent Wedge
used.

Reagent part A Either: If the Test Unit and Reagent Wedge
missing
The Test Unit and Reagent lots are mismatched:
Wedge lots are mismatched. Check the Reagent Status or Kit
A mismatched lot occurs when Entry screen for kit component
the Test Units and Reagent lot numbers.
Wedge currently on-board are Confirm that the actual lot
not from the same kit lot. numbers of Test Units agree
Note: Pause is automatically with the Reagent Wedge on-
initiated. board.
Change either the Reagent
The Reagent Wedge has not
Wedge or the Test Units, as
been placed in the Reagent
needed.
Carousel Tray.
The Reagent barcodes have Note: Mismatched Test Units
not been read after the kit appear as white circles on the
barcodes were scanned into the Primary screen. Depending on
Kit Entry screen. the error condition, these Test
Units may be carried around the
Turbo and Non-Turbo kits are Incubation Carousel and sent to
on board at the same time. the sample collection tray; or,
they may be shuttled directly to
the sample collection tray.
Otherwise, do the following (based
on the cause):
Place the Reagent Wedge in the
Reagent Carousel Tray.
Re-read the reagent barcodes.
Remove all incorrect sample
cups and test units that need to
be run in a different mode
(Turbo or Non-Turbo) and press
GO.
Reagent Pos. Error Refer to the explanation for the Refer to the solution for the
error message: Reagent error message: Reagent
Carousel Home Error. Carousel Home Error.
Examine Sensor PCB below for
damage or failure.
Reagent Temp High The Reagent Carousel temperature Troubleshoot using Section 3.8.
is above 22 C.

Record Deleted [No Either: If there was insufficient sample, do
Sample] or [No
The records were deleted the following:
Reagent] Pipetted
because of insufficient sample Check the printout or the Error
Note: This message prints or reagent. Log for error messages.
on the report.
The Reagent Wedge went to Note: The Test Unit will be in
Zero Tests Remaining the sample collection tray.
after the Barcode Reader read
the Test Units and the Reagent Re-run the test (Re-loading the
Wedge was not replaced reagent and sample if
before the Test Units reached necessary.)
the Carousel. For the other two causes listed, re-
The second Reagent Wedge run the assays.
for a sequential assay was
missing or went to Zero
Tests Remaining and the
Reagent Wedge was not
replaced in time to complete
the second step of the assay.
Sample cup # A communication error occurred Call Technical Support.
mismatch between the IMMULITE and the
Call Tech Services software.
Shut-Car Error This message appears on the Look for the cause of the jam
IMMULITE Display Panel if an (Test Units, a bent shuttle flag,
error is detected and the or a baffle that popped off the
IMMULITE is able to correct Luminometer chain).
itself. Check all related movements,
Note: If the problem cannot be and critical alignments of the
corrected, the instrument area.
error message indicates this has
occurred.
Shut-Pos. Error Refer to the explanation above for Refer to the solution above for the
the error message: Shut-Car. error message: Shut Car.
Error. Error.
Steps Left Overflow The IMMULITE sent an invalid If the problem persists, call
value for calculating the amount of Technical Support.
reagent remaining.
Substrate Heater Substrate Heater did not reach Call Technical Support.
failure operating temp (37 C) in allowed
time.

Substrate Low Level of substrate in reservoir has Replace substrate bottle and
dropped below fill-line. squeeze the gray button on
substrate reservoir to fill the
reservoir to the fill-line.
Substrate spike is clogged,
creating a vacuum.
Check for proper sensor
connections to the PCB of the
Substrate Heater.
Syringe A [B] Error A movement error in the large Note: This message remains on the
Corrected syringe (A) or the small syringe Display Panel until it is replaced by
Note: The error message (B) was detected. The message another message.
reads A or B. will appear on the IMMULITE Check to see if a test result was
Display Panel if the IMMULITE affected: the Test Unit will
was able to correct itself. appear as a white circle on the
Note: If the error was not Primary screen and a Record
correctable, the instrument Deleted, Pipetting
automatically shuts down the front Error appears on the results
end. An error message indicates printout.
this has occurred.
Syringe ACK error Either: If GO was pressed less than one
GO was pressed less than one minute after Start-up, do the
minute after Start-up. The following:
small pipettor syringes then Turn the IMMULITE power off
fail to acknowledge for a minute, then on again.
commands. Wait for the syringes to move to
Note: The Test Unit appears the top of the plunger and select
on the screen as a white circle. RUN IMMULITE or START
TURBO from the Start-up menu.
A hardware failure occurred.
Note: If the error message
persists, call Technical Support.
If a hardware failure occurred,
the system should correct itself.
If it does not, call Technical
Support.
Temperature The temperature controller failed. Troubleshoot using Section 3.8.
controller failure
Temperature The temperature controller has Troubleshoot using Section 3.8.
controller not failed.
operating properly
Test Unit lots do The Test Units being used do not Re-run the Adjustors using the
not match kit. match the kit to be adjusted. correct Test Units.
Adjust aborted

Tip Jam Error. Are Indicates either that: Depending on the cause either:
there caps on the
reagent vials? There is no sample Check the sample volume. If
Caps were left on the reagent necessary, add more sample and
re-run the tests.
The probe is not positioning
correctly Remove cap(s) from the
reagent.
Watch the pipettor to try and
determine the cause of jam.
If the message persists or if the
source of problem is unclear,
troubleshoot level sensing.
Turbo kits cannot Turbo reagent wedges have been Either:
be run while in loaded onto the Reagent Carousel Remove all Turbo Reagent
Normal Mode. Please while in Normal Mode.
take all turbo kits Wedges and press GO to
off the Reagent continue running in Normal
Carousel. mode.
Log off and Choose START
TURBO to run the Turbo kits.
Valve A [B] Error A problem with the valve on the See Front End Shut Down
Note: A or B appears, large (or small) syringe was error message.
depending on the situation. detected. If the IMMULITE
cannot correct the error, the front
end will shut down.
Note: The tests in progress will be
completed.
Warning: Part B A sequential assay Reagent Wedge Replace the missing part B reagent
reagent missing. is missing. and press GO to read the reagents.
Hit PAUSE to ignore
or GO to read
reags.

X Home Error. Something has interfered with the Do the following:
Note: This message appears probe movement or a hardware Determine if anything (e.g.
on the IMMULITE Display error occurred. If the system probe tubing) is interfering with
Panel and in the daily Error cannot correct itself, the the pipettor movements.
Log. instrument automatically shuts
down the front end (pipetting and Once the Test Units in process
Load Chain indexing). An error are finished, correct the
message indicates this occurred. problem and restart the
IMMULITE.
Note: The instrument will
continue to process tests currently
in progress.
X Pos. Error Refer to the explanation for the Refer to the solution for the error
Note: Appears on the error message: X Home Error message: X Home Error
IMMULITE Display Panel
and in the daily Error Log.
Z Home Error Refer to the explanation for the Refer to the solution for the error
Note: Appears on the error message: X Home Error message: X Home Error
IMMULITE Display Panel
and in the daily Error Log.

Chapter 10: Spare Parts
General Information
Generally, when traveling to an IMMULITE site to replace a part, it should be known before leaving what
part or parts will be needed. However, there have been situations when for a number of possible reasons,
the part that will fix the problem is either incorrect or not on hand. (A few situations have occurred where
a service person has been in the vicinity of a "down" instrument but did not have the correct part to make
a speedy repair). If this is the case when the service person is far away from the office, it could mean
many more hours, possibly another day, before the instrument is able to operate. A list of parts to have on
hand when responding to a trouble call has been developed based on the experience of IMMULITE
service people around the world. Even though some parts on the list have never failed, they should be
carried since they are small, but critical to instrument operation.
10.1 IMMULITE Field Parts to Carry at All Times

PART # DESCRIPTION REQD QTY
400008 S/A Barcode Reader Assay Tube Roller Assembly 1
400083-01 Thermistor Assembly 1
400190-01 Load Chain Assembly 1
400190-02 Luminometer Chain Assembly 1
400115-01 RS232 Cable 1
420001 Small Shuttle Idler Wheel replacement kit 2
420038 High-Speed Motor replacement kit 1
420040 High-Speed Spinner Idler Wheel replacement kit 1
420041 High-Speed Spinner Drive Wheel replacement kit 1
420056 Sample/Assay Barcode Reader Motor replacement kit 1
420059 Burkert Valve replacement kit 3
420063 Probe kit 1
420072 Euro Level Sense replacement kit 1
420094 Sample/Test Unit Barcode Reader PCB 1
450006 General Purpose Opto-sensor PCB 2
450007 Reagent Barcode Reader PCB 2
450014 Reagent Home and Position Sensor PCB 1
450017 Pipettor-X Position sensor PCB 1
450021 Sample Buffer Emitter PCB 1
450022 Sample Buffer Detector PCB 1
450029 Main Incubator Carousel Position Sensor PCB 1
500048-1 1.235 inch chain baffle for Load Chain 5
500048-2 1.00 inch chain baffle for Luminometer Chain 5
500059 Rollers for 400008 Idler assembly 12
500061 Attenuator Shaft 1
500110 X-Pipettor Belt Pulley (Motor Shaft) 1

500174 Shuttle-at-Lum Sensor Flag 5
500499 Water and Probe Wash End-of-Line Filters 12
500527 Substrate Heater S Tubing 2
500536 Pins for 400008 Idler Assembly 12
500680 Gray Nozzle for Injector Wash Pump 4
500342 Main Fan Filter 2
Fuses Used in 110v
900236-09 2 amp Fuse, time delay, 250v ceramic body (F2) 5
901535-02 amp Fuse, time delay, 250v (F1) 5
Fuses Used in 220v
900236-11 3 amp Fuse, time delay, 250V ceramic body (F3) 5
900897-22 4 amp Fuse, time delay, 250v (F4 and F5) 5
900016 Inner Bearing 1
900017 Shoulder Bearing for Attenuator, inner 1
900026 Attenuator Belt 1
900028 Bearing 1
900039 Bearing 1
900118 Bearing 1
900124 Gear Clamp 1
900159 Upper Shuttle Slide Bearing 1
900182 MOSFET RFP4N06C 5
900210 2N3904 NPN Transistors 6
900246 Bearing for Attenuator, outer 1
900247 Bearing 1
900248 Bearing 1
900271 5000ul Syringe 1
900271-01 5000ul Syringe Tips 12
900271-02 5000ul Syringe Tip O-rings 6
900335 Diode MBR360 (stepper motor Interface Ckts.) 10
900336 Diode IN5363 (stepper motor Interface Ckts.) 10
900367 TIP30C Transistor (for Q17 on the HTR/MTR PCB) 5
900422 TED Thermal Sheet 5
900551-02 Cable Ties, nylon 10
900558 Mini Spike 3
900613 Sample/Assay Barcode Reader Drive O-ring 10
900647-03 3 pin .100 center Connector 3

900730-03 .156 Connector Terminals 10
900771 Sample/Assay Barcode Reader Idler O-rings 32
900874 .100 Connector Terminals 10
901132 High-Speed Motor Flexible Coupling 1
901395 250ul Syringe Tips, 3-land 12
901396 250ul Syringe, 3-land 1
901631 Micro Valve Block w/Valve For Euro Dilutor 1
901632 Macro Valve Block w/Valve For Euro Dilutor 1
902138 Ceramic Micro Valve 2
902139 Ceramic Macro Valve 2
10.2 IMMULITE Spare Parts Inventory for Regional Offices

These are suggested parts and larger elements of the system, which are suggested to remain on hand in a
main office inventory, available for field dispatch as needed. They are generally not carried in the field at
all times, due to their size, delicacy, or comparatively rare need. The suggested quantities are
approximate, in order to support 10 instruments. Quantity should be maintained according to instrument
population.

400064-02 Motor Assembly Pipettor-X 1
400194 Substrate Reservoir Assembly 1
400196-02 Substrate Heater Assembly 1
400360 Hamilton Dilutor Tubing Kit 1
400361 Euro Dilutor Tubing Kit 1
400115-01 RS232 Cable 1
420001 Shuttle Idler Wheel replacement kit 2
420038 High-Speed Spinner Motor replacement kit 1
420054 12 Month Preventative Maintenance kit 2
420059 Burkert Valve Assembly 6
420063 Probe Assembly 3
420072 Euro Level Sense and Z-Pipettor PCB kit 2
420094 Sample/Assay Barcode Reader PCB kit 2
420096 T.E.D. Cooler Assembly replacement kit 2

420120 Linear Wash Pump Kit (Full Module) 2
420126 Linear Actuator Pump (Single Pump) 2
450000-01 CPU/Sensor PCB 1
450001-01 Motor Driver PCB 1
450002-02 DC Motor/Heater/Fluidics PCB 1
450007 Reagent Carousel Barcode Reader PCB 3
450014 Reagent Carousel Home and Position Sensor PCB 2
450017 X-Pipettor Home and Position Sensor PCB 1
450021 Sample Buffer Emitter Sensor PCB 1
450022 Sample Buffer Detector Sensor PCB 1
500499 Water and Probe Wash End-of-Line Filters 50
900114 X-Pipettor Belt 1
900182 Transistor (HUF76633P3) RFP4N06C 5
Fuses Used in 110v and 100v Systems:
Fuses Used in 220v Systems:
900271 5000ul Syringe 2
900271-02 5000ul Syringe Tip O-ring 24
900367 TIP 30 Transistor 3
900558 Mini-Spike 30
901132 High-Speed Spinner Flexible Coupling 1
901395 250ul Syringe Plunger Tip, 3-land 30
901396 250ul Syringe 2
901664 Dilutor Assembly for Hamilton 500 Series Dilutor 2
901666 Logic/Driver PCB for Hamilton 500 Series Dilutor 1
902138 Ceramic Micro Rotary Valve 2
902139 Ceramic Macro Rotary Valve 2

10.3 Hamilton Tubing Kit (P/N 400305)
PART # DESCRIPTION QTY
500756 Tube Assembly, #1 1
902096 Fitting, Bottle Adapter, -28 to 10-32 flat bottom 1
10.4 Euro Tubing Kit (P/N 400306)

902096 Fitting, Bottle Adapter, -28 to 10-32 flat bottom 1

Chapter 11: Fluidics, Chassis and Isometric Drawings
The following pages contain the Fluidics, Chassis Wiring Diagrams and Isometric Drawings. For
board drawings refer to the Schematic and Assembly Drawings section.
Fluidics Drawing Hamilton Syringe configuration..300001-08
Fluidics Drawing Euro Syringe configuration.300001-09
Chassis Wiring Diagram (8 sheets).350016
Isometric Drawing: Main Incubator Carousel Assembly400003
Isometric Drawing: Luminometer Module.400020-02
Isometric Drawing: Pipettor / Reagent Carousel Module400023
Isometric Drawing: Load Platform Module.400199

400083-02
CABLE ASSY,AMBIENT
SYSTEM THERMISTOR
450029
MAIN CAROUSEL
POSITION PCB
450020
MAIN CAROUSEL
INTERFACE PCB
(A14)
500387-11
MAIN CAROUSEL FOAM KIT
400120
MAIN CAROUSEL HEATER PAD
(LOCATED UNDER MAIN CAROUSEL
FOAM KIT)
400083-01 400064-04
CABLE ASSY,MAIN MAIN CAROUSEL
NOTE:BEARING ASSEMBLY AT CAROUSEL THERMISTOR MOTOR ASSEMBLY
9:00 POSITION IS ADJUSTABLE BY (LOCATED UNDER
USING TWO 1/8" HEX SCREWS CASTING)
LOCATED BELOW.
400142-01
GROUND STRAP
ISOMETRIC DRAWING,
IN C U B A T O R C A R O U S E L
ASSEMBLY P/N 400003
SHEET 1 of 1
500339
LUMINOMETER COVER
400064-06
LUMINOMETER CHAIN
MOTOR ASSEMBLY
450011
LUMINOMETER/WASH
INTERFACE PCB
(A10)
400095
HIGH SPEED SPINNER ASSEMBLY
400084-01
LUMINOMETER
THERMISTOR ASSEMBLY
420040
HIGH SPEED SPINNER IDLER KIT
400064-08
LUMINOMETER
ATTENUATOR MOTOR
ASSEMBLY
420038
HIGH SPEED SPINNER MOTOR
ASSEMBLY
(901132
WITH COUPLING)
450006
SHUTTLE AT HOME
420001 GENERAL PURPOSE
OPTOSENSOR
SHUTTLE IDLER
500110
REPLACEMENT KIT ATTENUATOR MOTOR
SHAFT PULLEY
900262
RETAINING CLIP
500183
SHUTTLE IDLER WHEEL
COVER PLATE 400126
NON-INTERGRATED
900261
900026 PHOTOMULTIPLIER
WAVE WASHER TUBE ASSEMBLY
LUMINOMETER
500577 ATTENUATOR BELT
UPPER SHUTTLE SHIM OR
400164
(LOCATED UNDER TWO 450006
SHUTTLE IDLER WHEEL
REAR SCREWS) ATTENUATOR POSITIONING 400248
900731-16 GENERAL PURPOSE INTERGRATED
UPPER SHUTTLE SPRING OPTOSENSOR PHOTOMULTIPLIER
TUBE ASSEMBLY
450006
900731-32 ATTENUATOR HOME
LOWER SHUTTLE SPRING GENERAL PURPOSE
OPTOSENSOR
900159 450006
SHUTTLE UPPER SHUTTLE AT SPIN &
BEARING ASSEMBLY SUBSTRATE POSITIONS
400190-02 GENERAL PURPOSE
LUMINOMETER CHAIN ASSEMBLY 500048-02 OPTOSENSOR
BAFFLE,MOLDED
900160 LUMINOMETER CHAIN 400064-07
LOWER SLIDE BEARINGS SHUTTLE MOTOR
500506 500507
SIDE PLATE,CHAIN ROLLER,CHAIN
900160
LOWER SLIDE BEARINGS
ISOMETRIC DRAWING,
COMPLETE LUMINOMETER MODULE
SHUTTLE ASSEMBLY P/N 400020-02
SHEET 1 of 1
400185
REAGENT COOLING
CHAMBER ASSY
450014
REAGENT CAROUSEL
HOME & POSITION PCB
450007
REAGENT CAROUSEL
BAR CODE READER PCB
(A49)
400145
REAGENT TRAY
450051
LEVEL SENSING &
PROBE JAM
SENSOR PCB
(REFER TO KIT 420072
INSTRUCTIONS FOR
INSTALLATION)
420072
COMPLETE EURO
LEVEL SENSING KIT
(INCLUDES 450050 PCB,
450051 PCB AND MOUNTING
HARDWARE)
450050
PIPETTE Z AND
LEVEL SENSE
INTERFACE PCB
LED
450017
PIPETTOR X
HOME / POSITION PCB
450010
REAGENT CAROUSEL
INTERFACE PCB
(A12)
400064-01
REAGENT
CAROUSEL 400184
MOTOR SPIRAL CABLE ASSEMBLY
900422
TE D
THERMAL SHEET
400064-03
PIPETTOR "Z" MOTOR
400178
T E D ASSEMBLY 900114
PIPETTOR "X" MOTION DRIVE BELT
(FROM PIP-X MOTOR AROUND
Z-MOTION LEAD SCREW - NOT SHOWN)
ISOMETRIC DRAWING,
420096
T E D KIT P IP E T T O R / R E A G E N T
(INCLUDES THERMAL SHEET
AND FAN COWLING)
CAROUSEL
400064-02 MODULE P/N 400023
PIPETTOR "X" MOTOR
SHEET 1 of 1
CABLE ASSEMBLY TO LOAD CHAIN
POSITION GENERAL PURPOSE
COVER,BARCODE READER PCB OPTO SENSOR
500479 450006
PRINTED CIRCUIT BOARD

BARCODE READER SAMPLE/ASSAY
450056 (KIT WITH TUNING INSTR.420094) CABLE ASSEMBLY TO
ORIGINALLY PCB WAS 450003 READER PCB (A44-J1)
(A44) 400087
CHAIN BAFFLE,
1.235 INCH
500048-01

LOAD PLATFORM INTERFACE
(A11)
450012
BARCODE ARM ASSY

RETURN SPRING DRIVE O-RING
900612 SAMPLE ASSAY
BARCODE READER
900613
LOAD CHAIN
DRIVE MOTOR LOAD CHAIN ASSEMBLY
DRIVE WHEEL ASSEMBLY 400190-01
400021 400064-05
PIN
}
500536
GROUND STRAP C O M P L E TE B A R C O D E
400142-03 O-RING IDLER ASSEMBLY
900771 400008
ROLLER
500059
(A TTA C H ED W ITH SC R EW
TO IN STR U M EN T LID LA TC H )
O-RING
900771
CABLE ASSEMBLY TUBE GUIDE

LOAD PLATFORM INTERFACE PCB (A11-J2) 500044
TO BARCODE READER
400086 BARCODE READER MOTOR
AND GEARBOX ASSEMBLY
WITH WIRES ATTACHED
400242
(BARCODE READER
MOTOR ASSEMBLY
REPLACEMENT KIT
WITH ACCESSORIES
420056)
L O W E R S E C T IO N O F C H A IN
POSITION SENSOR ASSEMBLY
(REFERENCE)
ISOMETRIC DRAWING,
PRINTED CIRCUIT BOARD LOAD PLATFORM
GENERAL PURPOSE
OPTO SENSOR
MODULE P/N 400199
450006
SHEET 1 of 1
IMMULITE Index
Decontamination, 7-30
Diagnostic Error Codes, 8-27
A Diagnostics, 2-3, 2-6
Ambient Temperature GetDataT, 8-6
Electrical, 3-35 Investigation, 8-1
System, 3-35 Level Sensing Tests, 3-16
Assemblies Main Programs, 8-9
Removal, 7-9 Message Tables, 8-2
Attenuator Motor and Belt PC, 8-8
Removal, 7-18 PCSTAT, 8-8
Power, 8-1
Syringe Module Test Programs, 2-6
B Testing Drawback, 2-2
Using, 8-3
Barcode Drive Wheel
DPC History, 1-1
Motor Speed, 3-9
Drive Wheel
Travel, 3-9
Removal, 7-16
Barcode Laser Scanner
PSC Laser, 7-42
Reprogramming, 7-41 E
Welch-Allyn, 7-43
EC Declaration of Conformity, 5-3
Error Log, 7-46
C Historical, 7-47
Error Message Table, 9-14
Chemiluminescence, 3-4
Euro Syringe Pumps, 3-25
Cirrus Injector Pumps, 3-20
Euro Tubing Kit, 3-25
Common Diagnostics, 2-3, 2-6
EuroTubing Kit, 10-5
Configuration Table, 3-6
Export Utlility Program, 3-45
Accessing, 7-8
Changing Parameters, 7-8
Delineation, 7-5 F
Description, 7-2
Parameters, 7-2 Final Checkout, 6-9
Sample Printout, 7-4 Fixit, 7-45
Configurations, 8-20 FIXIT, 7-45
Diagnostic Error Codes, 8-27 Fludics
CPU/Sensor PCB Description, 3-30
Description, 4-1 Fluidic Valve
Theory of Operation, 4-1 Testing, 7-32
Fluidics, 3-30
D
G
Dark Counts
Viewing, 3-2 General Checkout, 6-2
Database GetDataT, 8-6
Fixing, 7-45
Fixit, 7-45 H
Restoring, 7-45
Database Components HamiltonTubing Kit, 10-5
Replacing, 7-44 Heater and Cooler
DECON1, 7-30 Shutdown, 3-38
IMMULITE Service Manual 600797-A1 Index-1

Heater/DC Motor PCB, 4-4 Luminogenic reaction, 3-4
Description, 4-4 Luminometer, 3-10
High Speed Motor Description, 3-10
Adjustment, 3-11 Module Adjustments, 3-10
High Speed Spinner Module Test Programs, 3-11
Adjustment, 7-41 Temperature, 3-34
High Speed Spinner Assembly Removal, 7-16 Luminometer Casting Cover
High Speed Spinner Assembly Removal, 7-18
Removal, 7-16 Luminometer Chain
Replacement, 7-22
I
M
IMMULITE Analyzer
Overhead View, 1-4 Main Carousel
Side View, 1-5 Position Indicators, 3-7
IMMULITE History, 1-1 Ring Gear Assembly, 3-6
IMMULITE Software Programs, 3-44 Main Carousel Ring Gear Assembly, 7-11
In Vitro Diagnostic Symbols, 1-7 Maintenance
Incubator Carousel, 3-6 Power Log, 2-1
Adjustments, 3-7 Message Tables, 8-2
Temperature, 3-34 Loading, 8-2
Test Programs, 3-7 MGM Injector Pumps, 3-20
Injector Pump Assembly, 7-15 Microvalve
Installation, 2-1, 2-3, 2-6 Testing, 7-33
Testing the Water, 2-3 Miscellaneous Procedures, 2-3, 2-6
Installation Requirements, 2-1
Electrical, 2-1
Environment, 2-1
P
Space, 2-1 PC, 8-8
Instrument Operation PCSTAT, 8-8
Theory, 3-1 Photomultiplier Tube, 3-2, 3-3, 3-19
Instrument Set-Up, 2-1 Pipetting Sequence, 3-32, 3-33
Instrument Temperatures, 3-34, 3-39 Pipettor/Reagent, 3-15
General Information, 3-34 Pipettor/Reagent Carousel, 3-13
Internal Calculations, 3-2 Description, 3-13
IVD Symbol Definitions, 1-7 Pipettor/Reagent Carousel Module Adjustments, 3-13
PMT
L Description, 3-19
Module Adjustments, 3-19
Level Sensing Module Test Programs, 3-19
Test Programs, 3-16 PMT Prescaler/Power Supply
Linear Actuator Injector Pumps, 3-20 Module Adjustments, 3-19
Linear Actuator Pumps Power Supply Chassis, 3-17
Testing Substrate, 7-34 Power Supply Module
Testing Water, 7-33 Removal, 7-19
Liquid Waste Container, 3-32 Prescaler
Load Chain, 3-8 Description, 3-19
Description, 3-8 Preventive Maintenance, 6-1
Module Adjustments, 3-8 Computer Software, 6-8
Module Test Programs, 3-9 Customer Satisfaction, 6-9
Positioning, 7-37 Description, 6-1
Load Platform Assembly, 7-12 Final Checkout, 6-9
Load Platform Chain Fluidics, 6-8
Replacement, 7-20 General Checkout, 6-2
Index - 2 600797-A1 IMMULITE Service Manual

Linear Actuator Pumps, 6-7 Environmental, 5-2
Load Platform, 6-6 Fluidics, 5-2
Luminometer Module, 6-5 Luminometer, 5-1
Main Carousel Module, 6-6 Physical, 5-2
Pipettor/Reagent Carousel Module, 6-4 Standard Mode, 5-1
Power Supply, 6-2 Turbo Mode, 5-1
Solenoid Pumps, 6-7 Star Wheel
Substrate Module, 6-8 Adjustment, 3-9
Syringe Module, 6-2 Positioning, 7-37
Temperatures, 6-9 Stepper Motor Driver, 4-2
Primary Modules Description, 4-2
Definition, 3-6 Stepper Motor Driver 2, 4-4
Printed Circuit Boards, 4-1 Description, 4-4
Introduction, 4-1 Theory of Operation, 4-4
Probe Substrate
Testing, 7-33 Heater, 3-22
Product Description, 1-2 Reservoir, 3-23
Substrate Heater
Adjustments, 3-22
R Description, 3-22
Reagent Carousel Test Programs, 3-22
Temperature, 3-34 Substrate Heater Assembly
Reagent Carousel Assembly Removal, 7-15
Removal, 7-9 Substrate Reservoir
Repair Information, 7-1 Description, 3-23
Tools and Equipment, 7-1 Module Adjustments, 3-23
Restore function, 7-45 Substrate Reservoir Assembly
Restoring Database, 7-45 Removal, 7-15
Rotary Valves Substrate Reservoir Module
Hamilton Syringe Pumps, 3-30 Test Programs, 3-23
Substrate Spike
Replacement, 7-31
S Substrate/Water Injector Pumps, 3-20
Description, 3-20
Safety Considerations, 1-6
Substrate/Water Solenoid Pump
Sample Collection Tray, 3-29
Adjustments, 3-21
Description, 3-29
Test Programs, 3-21
Module Adjustments, 3-29
Syringe Module, 3-25, 3-31
Module Test Programs, 3-29
Adjustments, 3-25
Sample Collection Tray Assembly, 7-10
Syringe Module Test Programs, 3-26
Sample Tube Guides
Syringe Pump Assembly, 7-11
Spacing, 7-39
Syringe Pumps, 3-24
Sample/Assay Test Unit Barcode Motor
System Components, 1-3, 2-5, 3-1, 3-2, 3-13, 3-35,
Speed Adjustment, 7-40
3-39
Sample/Test Unit Barcode Assembly, 7-13
Luminometer, 3-4
Sample/Test Unit Barcode Reader
Primary Modules, 3-6
Drive Motor Removal, 7-13
System Configurations
PCB Removal, 7-13
Programs, 8-20
Tuning, 7-40
Solenoid Valves, 3-31
Spare Parts, 10-1 T
Regional Office Inventory, 10-3
Specifications, 5-1 TED Cooler, 3-13
Computer, 5-1 Temperature Controller
Electrical, 5-2 Status Indicators, 3-39
Temperatures
IMMULITE Service Manual 600797-A1 Index-3

Troubleshooting, 3-39
Test Process, 3-1
U
Testing the Water Supply Upchurch Tubing, 3-30
Acceptance criteria, 2-5
From any source, 2-3
Testing Water Supply, 7-25 V
Acceptance Criteria, 7-28
Viewing Temperatures, 3-36
WATERTPM, 7-26
WATERTST, 7-25
Transport Chain Assemblies W
Replacement, 7-20
Troubleshooting Warranty Statements, 5-4
Techniques, 9-1 Water Acceptance Criteria, 2-5
Typical Problems, 9-4 Water Supply
Tube Shuttle IdlerWheel Testing, 2-3, 2-5, 2-6
Assembly Removal, 7-17 Water tests
Tube Shuttle Upper Slide Bearing Acceptance criteria, 2-5
Assembly Removal, 7-17 From any source, 2-3
Water/Detergent Containers, 3-31
WATERTPM, 7-26
WATERTST, 2-3, 7-25
Index - 4 600797-A1 IMMULITE Service Manual

IMMULITE 1000 Table of Contents
CHAPTER 1: GENERAL INFORMATION................................................................................................. 1-1
1.1 IMMULITE HISTORY ................................................................................................................................ 1-1
1.2 HOW TO USE THIS MANUAL ....................................................................................................................... 1-1
1.3 IMMULITE 1000 PRODUCT DESCRIPTION ................................................................................................ 1-2
1.4 SYSTEM COMPONENTS ............................................................................................................................... 1-3
1.5 HOW IT WORKS .......................................................................................................................................... 1-5
1.6 SAFETY CONSIDERATIONS .......................................................................................................................... 1-6
1.7 SYMBOLS DEFINITIONS............................................................................................................................... 1-7
1.8 TECHNICAL ASSISTANCE .......................................................................................................................... 1-11
1.8.1 Technical Support........................................................................................................................ 1-11
CHAPTER 2: INSTALLATION..................................................................................................................... 2-1
2.1 REQUIREMENTS .......................................................................................................................................... 2-1
2.2 INSTRUMENT SET-UP .................................................................................................................................. 2-1
2.3 TESTING THE WATER .................................................................................................................................. 2-4
CHAPTER 3: THEORY OF OPERATION .................................................................................................. 3-1
3.1 INTRODUCTION ........................................................................................................................................... 3-1
3.2 OVERVIEW OF TEST PROCESS ..................................................................................................................... 3-1
3.3 INTERNAL CALCULATIONS ......................................................................................................................... 3-2
3.4 THE CHEMILUMINESCENT REACTION ......................................................................................................... 3-4
3.5 PRIMARY MODULES ................................................................................................................................... 3-6
3.5.1 Introduction ................................................................................................................................... 3-6
3.5.2 Incubator Carousel......................................................................................................................... 3-6
3.5.3 Load Chain .................................................................................................................................... 3-8
3.5.4 Luminometer................................................................................................................................ 3-10
3.5.5 Pipettor / Reagent Carousel ......................................................................................................... 3-13
3.6 SECONDARY MODULES ............................................................................................................................ 3-17
3.6.1 Introduction ................................................................................................................................. 3-17
3.6.2 Power Supply Chassis.................................................................................................................. 3-17
3.6.3 PMT (Photomultiplier Tube) ....................................................................................................... 3-19
3.6.4 Substrate and Water Linear Actuator (Injector) Pump ................................................................ 3-20
3.6.5 Substrate Heater........................................................................................................................... 3-21
3.6.6 Substrate Reservoir...................................................................................................................... 3-23
3.6.7 Syringe Pumps ............................................................................................................................. 3-24
3.6.8 Sample Collection Tray ............................................................................................................... 3-28
3.6.9 Water Supply Bottle and Probe Wash Bottle Level Indicators.................................................... 3-28
3.7 FLUIDICS .................................................................................................................................................. 3-29
3.7.1 Description................................................................................................................................... 3-29
3.7.2 Pipetting Sequence....................................................................................................................... 3-31
3.8 INSTRUMENT TEMPERATURES .................................................................................................................. 3-33
3.8.1 General Information..................................................................................................................... 3-33
3.8.2 Viewing Temperatures................................................................................................................. 3-35
3.8.3 Heater and Cooler Shutdown....................................................................................................... 3-36
3.8.4 Temperature Controller Status Indicators.................................................................................... 3-37
3.8.5 Effectively Troubleshooting Temperature Problems................................................................... 3-38
3.9 IMMULITE 1000 COMPUTER & WINDOWS SOFTWARE PROGRAMS ........................................................ 3-41
3.9.1 The IMMULITE 1000 On-Board Computer ............................................................................... 3-41
3.9.2 IMMULITE 1000 Software Programs......................................................................................... 3-42
CHAPTER 4: PRINTED CIRCUIT BOARDS ............................................................................................. 4-1
4.1 INTRODUCTION ........................................................................................................................................... 4-1
IMMULITE 1000 Service Manual 600797-A1 i

4.2 CPU/SENSOR PCB ..................................................................................................................................... 4-1
4.5 HEATER/DC MOTOR PCB .......................................................................................................................... 4-4
CHAPTER 5: SPECIFICATIONS ................................................................................................................. 5-1
CHAPTER 6: PREVENTIVE MAINTENANCE (PM)................................................................................ 6-1

6.1 DESCRIPTION .............................................................................................................................................. 6-1
6.2 GENERAL CHECKOUT ................................................................................................................................. 6-2
6.3 POWER SUPPLY........................................................................................................................................... 6-2
6.4 SYRINGE MODULE ...................................................................................................................................... 6-2
6.5 PIPETTOR/REAGENT CAROUSEL MODULE .................................................................................................. 6-3
6.6 LUMINOMETER MODULE ............................................................................................................................ 6-4
6.7 MAIN CAROUSEL MODULE ......................................................................................................................... 6-6
6.8 LOAD PLATFORM/SAMPLE TRAY MODULE ................................................................................................. 6-6
6.9 LINEAR ACTUATOR SUBSTRATE AND WATER WASH PUMPS ...................................................................... 6-7
6.10 SUBSTRATE MODULE ................................................................................................................................. 6-7
6.11 FLUIDICS .................................................................................................................................................... 6-7
6.12 COMPUTER SOFTWARE ............................................................................................................................... 6-8
6.13 TEMPERATURES .......................................................................................................................................... 6-8
6.14 FINAL CHECKOUT & CUSTOMER SATISFACTION......................................................................................... 6-9
CHAPTER 7: REPAIR INFORMATION ..................................................................................................... 7-1
7.1 TOOLS AND EQUIPMENT ............................................................................................................................. 7-1
7.2 THE CONFIGURATION TABLE...................................................................................................................... 7-3
7.3 REMOVAL AND REPLACEMENT OF ASSEMBLIES ....................................................................................... 7-10
7.3.1 General Information .................................................................................................................. 7-10
7.3.2 Reagent Carousel Assembly / TED Cooler........................................................................... 7-10
7.3.3 Sample Collection Tray Assembly.......................................................................................... 7-11
7.3.4 Syringe Pump Assembly.......................................................................................................... 7-11
7.3.5 Main Incubation Carousel Ring Gear Assembly .................................................................. 7-12
7.3.6 Load Platform Assembly .......................................................................................................... 7-13
7.3.7 Sample/Test Unit Barcode Reader Assembly ...................................................................... 7-14
7.3.8 Injector Pump Assembly .......................................................................................................... 7-16
7.3.9 Substrate Heater Assembly..................................................................................................... 7-16
7.3.10 Substrate Reservoir Assembly................................................................................................ 7-16
7.3.11 High Speed Spinner Motor and Drive Wheel Assembly ..................................................... 7-17
7.3.12 Tube Shuttle Upper Slide Bearing Assembly........................................................................ 7-18
7.3.13 Tube Shuttle Idler Wheel Assembly ....................................................................................... 7-18
7.3.14 Luminometer Casting Cover / Attenuator Motor and Belt ................................................... 7-19
7.3.15 Power Supply Module .............................................................................................................. 7-20
7.3.16 Replacement of the Chain Assemblies.................................................................................. 7-21
7.4 MISCELLANEOUS PROCEDURES ................................................................................................................ 7-26
7.4.1 Testing the Water Supply......................................................................................................... 7-26
7.4.2 System Decontamination ......................................................................................................... 7-33
7.4.3 Substrate Spike Replacement................................................................................................. 7-35
7.4.4 Fluidic Valve Testing ................................................................................................................ 7-36
7.4.5 Use of Pip-X Position Gauges (kit p/n 420078).................................................................... 7-39
7.4.6 Load Chain and Star Wheel Positioning................................................................................ 7-41
7.4.7 Spacing of the Sample Tube Guides ..................................................................................... 7-43
7.4.8 Sample/Assay Test Unit Barcode Motor Speed Adjustment .............................................. 7-44
7.4.9 Tuning the Sample/Test Unit Barcode Reader PCB ........................................................... 7-44
7.4.10 High Speed Spinner Motor Adjustment ................................................................................. 7-45
7.4.11 Barcode Laser Scanner Reprogramming.............................................................................. 7-45
ii 600797-A1 IMMULITE 1000 Service Manual

7.4.12 The IMMULITE 1000 Database .............................................................................................. 7-46
7.4.13 Checking the Error Log ............................................................................................................ 7-50
7.4.14 Troubleshooting the System Stepper Motors ....................................................................... 7-55
7.4.15 Calibration of the Liquid Level Sense Display PCB ............................................................. 7-56
CHAPTER 8: DIAGNOSTICS ....................................................................................................................... 8-1
8.1 GENERAL INFORMATION ............................................................................................................................ 8-1
8.1.1 Investigate...................................................................................................................................... 8-1
8.1.2 Power ............................................................................................................................................. 8-1
8.2 USING THE DIAGNOSTICS ........................................................................................................................... 8-2
8.3 MAIN DIAGNOSTIC PROGRAMS................................................................................................................... 8-6
8.4 SYSTEM CONFIGURATIONS PROGRAMS .................................................................................................... 8-17
8.5 SYSTEM CONFIGURATION DIAGNOSTICS ERROR CODES ........................................................................... 8-24
CHAPTER 9: TROUBLESHOOTING .......................................................................................................... 9-1
9.1 DESCRIPTION .............................................................................................................................................. 9-1
9.2 TROUBLESHOOTING TECHNIQUES ............................................................................................................... 9-1
9.3 TYPICAL PROBLEMS ................................................................................................................................... 9-4
9.4 ERROR MESSAGE TABLE .......................................................................................................................... 9-14
CHAPTER 10: SPARE PARTS ...................................................................................................................... 10-1
10.1 GENERAL INFORMATION .......................................................................................................................... 10-1
10.2 IMMULITE 1000 FIELD PARTS TO BE CARRIED AT ALL TIMES ................................................................ 10-1
10.3 IMMULITE 1000 SPARE PARTS INVENTORY FOR REGIONAL OFFICES .................................................... 10-3
10.4 HAMILTON TUBING KIT (P/N 400360) ..................................................................................................... 10-5
10.5 EURO TUBING KIT (P/N 400361).............................................................................................................. 10-5
CHAPTER 11: FLUIDICS, CHASSIS AND ISOMETRIC DRAWINGS....................................................... 11-1
INDEX
IMMULITE 1000 Service Manual 600797-A1 iii

iv 600797-A1 IMMULITE 1000 Service Manual
Chapter 1: General Information
1.1 IMMULITE History

The company that conceived the IMMULITE was founded in 1987 by Dr. Arthur Babson and began
operations in 1988 in a rented classroom of the old Williamson School building in Chester, NJ. The
company started as Babson Technologies, was renamed Pegasus Technologies, and then was
renamed to Cirrus Diagnostics in 1990.
By the end of 1988, a breadboard immunoassay analyzer was completed. It was on this instrument that
many of the basic concepts of IMMULITE were developed and tested.
In 1990, three prototypes called the "A" series IMMULITE systems were built. One of these was shown
at the AACC meeting in July 1990. Although these systems incorporated many of the functions of the
breadboard, the layout was a radical departure. In the next year and a half, these instruments were used as
workhorses to further develop the hardware, software, and chemistry. At this time the company had
approximately 20 people and had now expanded to four classrooms in the school building.
During the last half of 1991, 12 "B" series IMMULITE systems were produced. These were to be used for
beta site placements and in-house research and development. On July 17, 1991 instrument "B1" was
placed in Morristown Hospital as the company's first beta site instrument. During the next five months
four more instruments were placed at beta sites in the New York City area.
On March 23, 1992, Instrument "B2" was placed at Diagnostic Products Corporation for evaluation. DPC
liked the IMMULITE so much that 60 days later, Cirrus Diagnostics became DPC Cirrus, a wholly owned
subsidiary of Diagnostic Products Corporation.
During the last half of 1992, 25 "C" series IMMULITE systems were produced by an instrumentation
manufacturing company located very close to DPC Cirrus. At this time DPC Cirrus was still located in the
school building in Chester, NJ, had 33 employees, and occupied 9 classrooms.
In December 1992, DPC Cirrus moved into a new building in Randolph, NJ and began to manufacture the
IMMULITE system in-house beginning with the "D" series.
Production volume continued to grow throughout the 1990s, and International Distribution of the
IMMULITE (and also the IMMULITE 2000, released in 1997) have been increasing ever since.
In late 2001, DPC Cirrus changed its name to DPC Instrument Systems Division, and established its
own newly built 80,000 Sq. Ft. Manufacturing Facility in Flanders, NJ, with plenty of room for future
expansion. In October 2002, DPC released the new and improved IMMULITE 1000.
In July 2006, DPC was acquired by Siemens Medical Solutions. In January 2007, DPC was merged with
Bayer Diagnostics (also acquired by Siemens Medical Solutions) to form Siemens Medical Solutions
Diagnostics, a wholly owned subsidiary of Siemens Medical Solutions USA, Inc..
1.2 How to Use This Manual

This manual contains basic information necessary for after-sales service of the IMMULITE 1000 system.
This information is vital to the service person for maintaining high quality and reliable performance of the
system.
This manual is applicable to all IMMULITE 1000 Analyzer systems version 5.0 software or later having
the Windows 2000 Operating System.
IMMULITE 1000 Service Manual 600797-A1 1-1

The IMMULITE 1000 Service Manual is designed solely for use by authorized IMMULITE service
personnel. Authorized IMMULITE service personnel are skilled in the areas of electronics, mechanical
devices and basic computer know how, and have attended the IMMULITE Service Training Seminar.
Only personnel so authorized should attempt the procedures in this manual.
Each area or module of the system will be covered including description, possible adjustments, diagnostic
programs, problems and probable causes. Subjects such as troubleshooting down to the component level
on the circuit boards are not covered because the expertise required and the investment in special tools
and equipment make such tasks uneconomical.
A thorough understanding of the IMMULITE 1000, based on information contained in this manual, the
operators manual, and the Service Information Bulletins is the only way to quickly locate the cause of
malfunctions and to repair them. A lesser understanding will slow servicing and could result in expensive
and even dangerous mistakes. Since knowledge of the IMMULITE 1000 is the best "tool" for diagnosing
problems, this manual will take more of an educational approach.
Information in this manual is subject to change as system elements are improved (and possibly re-
designed) and as better, more effective procedures are developed. All relevant information in such cases
will be supplied in Service Information Bulletins.
When diagnosing a problem on the IMMULITE 1000, keep the following points in mind:
1. Aside from the software, the IMMULITE 1000 is not much different from any other electro-
mechanical device.
2. When diagnosing a problem, follow the Troubleshooting Techniques in the Troubleshooting section
of this manual. These techniques are tried and true and, if applied correctly, will significantly reduce
the time spent on diagnosing problems encountered with the system.
3. Repair the problem not the symptom, and replace only what is necessary.
1.3 IMMULITE 1000 Product Description
The IMMULITE 1000 Automated Immunoassay Analyzer is a random access instrument dedicated to
performing chemiluminescent immunoassays and immunometric assays. The system is built around a
proprietary Test Unit that provides for rapid and efficient washing of the captive antibody-coated bead by
spinning the Test Unit on its vertical axis. Sample, excess reagent and wash solution are captured in a
coaxial waste chamber integral within the Test Unit.
The IMMULITE Systems utilize assay-specific, antibody-coated plastic beads as the solid phase, in a
specially designed Test Unit. This Test Unit serves as the reaction vessel for the immune reaction,
incubation, wash and signal development. Light emission from the chemiluminescent substrate reacting
with enzyme conjugate bound to the bead is proportional to the amount of analyte originally present in
the patient sample.
The IMMULITE 1000 System is automated with respect to sample and conjugate handling, automatic on-
board dilutions, incubation, washing, and substrate addition. A photomultiplier tube detects the light
emission, and the systems on-board computer generates printed reports for each sample.
Accordingly, basic operation is simple. Load a sample cup into a barcoded sample cup holder, place it on
the loading platform followed by up to five barcoded Test Units in any order (up to four test units, if a
dilution cup is used), then load the barcoded Reagent Wedges appropriate for each test. The IMMULITE
1000 System takes care of the rest.
1-2 600797-A1 IMMULITE 1000 Service Manual

1.4 System Components
A diagram of the IMMULITE 1000 Display Panel is shown below. Diagrams showing an overhead and
side view of the IMMULITE 1000 Analyzer appear on pages 1-4 and 1-5.
The Display Panel (located on the front of the instrument) displays IMMULITE 1000 instructions and
error messages. There are three buttons on the Display Panel (ALARM MUTE, PAUSE, and GO),
which are referred to throughout this manual.
The IMMULITE 1000 Display Panel buttons are explained in the table below:
Button Function
ALARM MUTE In the Run mode, it silences the audible alarm.
In Diagnostic modes, it is used to pause a motor movement. It
is also used in conjunction with the GO button to cancel a
diagnostic program.
PAUSE Temporarily stops pipetting and Load Chain movements only.
Shuts down the IMMULITE 1000 when pressed repeatedly.
Note: Using PAUSE to shut down the instrument ensures all parts
are in the home position.
GO In the Run mode, it activates the initialization (start-up)
procedure and the accompanying instructional messages
appearing on the Display Panel.
It also activates a reading of the Reagent Wedge barcodes if the
instrument is in pause mode when GO is pressed.
In Diagnostic modes, it activates the GO command for the
loaded diagnostic program. It is also used in conjunction with
the ALARM MUTE button to cancel a diagnostic program.

IMMULITE 1000 Analyzer Overhead View

IMMULITE 1000 Analyzer Side View
Fan Filter
Monitor Arm
System Power Supply On-Off Switch & Main Fuse

Power Fuses F1, 2 & 3
1.5 How it Works

The IMMULITE 1000 System utilizes assay-specific, antibody or antigen-coated plastic beads as the
solid phase, alkaline phosphatase-labeled reagent, and a chemiluminescent enzyme substrate. The bead is
housed in a proprietary Test Unit. This Test Unit serves as the reaction vessel for the immune reaction,
the incubation and washing processes, and the signal development.
The IMMULITE 1000 System automates the entire assay process. After incubating the sample with the
alkaline phosphatase reagent, the liquid reaction mixture in the Test Unit is rapidly separated from the
bead when the bead is washed and the Test Unit is spun at a high speed on its vertical axis. The entire
fluid contents (the sample, excess reagent, and wash solution) are transferred to a coaxial waste chamber
in the Test Unit. The bead is left with no residual, unbound label. The bound label is then quantitated
with a dioxetane substrate, which produces light. The photomultiplier tube (PMT) detects the light
emission, and the system's computer generates printed reports for each sample.
The IMMULITE 1000 test process is outlined in Section 3.2.
The IMMULITE 1000 has two operating modes: Standard and Turbo. The Turbo mode essentially
operates the same as the Standard mode, except the time to first result is faster. This allows for true
STAT functionality for urgent situations such as cardiac markers or pregnancy detection. This manual
covers both modes of operation concurrently since they are identical, except for speed of tube transport.
Note: Different assay kits are required for each mode. Standard (Non-Turbo) kits cannot be run
while in Turbo mode and Turbo kits cannot be run while in Standard (Non-Turbo) mode.

1.6 Safety Considerations
** Service Personnel should be aware that if this equipment is used in a manner not
specified by the Manufacturer, then the protection provided by the equipment may be
impaired.
All service personnel must read and understand these safety procedures before working with this system.
WARNING and CAUTION instructions must be observed during servicing of the IMMULITE 1000.
These are defined as follows:
WARNING: Given where failure to observe its instruction can result in injury or death to the operator or
service personnel.
CAUTION: Given where failure to observe its instruction can result in permanent damage to the
equipment.
The following WARNINGS are provided to avoid bodily injury:
1. Application of the incorrect AC power input voltage could cause an explosion, fire, or electrical
shock that may injure the operator or damage the equipment permanently.
2. Ensure that the AC power receptacle has the voltage and power rating specified for the
instrument. Use of an AC power receptacle with incorrect voltage and power rating could
overload a circuit and produce fire and electrical shock hazards.
3. Never use a three-conductor to two-conductor adapter to connect primary AC power to the any of
the IMMULITE 1000 components or test equipment. Use of an adapter disconnects the utility
ground and allows reversal of the live and neutral lines. A severe shock hazard could exist which
could cause severe injury or death. Use only a three-conductor connector and three-conductor
grounded receptacle to connect primary AC power to the IMMULITE 1000 and its components.
4. Do not assume AC power is removed from equipment when the power switch is off. Some
portions of the power supply chassis still contain power whenever the unit is connected to the AC
power receptacle.
5. Do not assume all AC power is removed from the equipment when any one of the IMMULITE
1000 fuses is blown. Always switch the AC power off and disconnect the power cable from the
IMMULITE 1000 before attempting to replace fuses.
6. Since the instrument is used with patient specimen, all necessary precautions should be taken to
avoid transfer of infectious diseases.
The following CAUTIONS are provided to avoid instrument damage:
1. Use replacement fuses with the required current rating and specifications. Makeshift fuses, fuses
with higher current rating than specified, or short-circuiting of fuse holders may cause fire or
damage to the instrument.
2. Do not remove or replace cables or printed circuit boards when the instrument power is on.
Electrical transients created by connecting or disconnecting cables and printed circuit boards with
power applied can severely damage the instrument components. Always switch the AC power off
before disconnecting or connecting any components or cables.

1.7 Symbols Definitions
The following symbols may be seen on the IMMULITE 1000 Analyzer, or on related
documentation.
Symbol Definition
Consult instructions for use
Do not re-use
Fragile, handle with care.
Caution, refer to accompanying

documents
Batch code
Catalog number
Serial number

Symbol Definition
Use by (expiration date)
Sterile
Sterilized using aseptic

processing techniques
Sterilized using radiation
Sterilized using ethylene oxide
Sterilized using steam or dry

heat
Biological risk
Non-sterile
Do not re-sterilize
Keep away from heat
Keep dry

Symbol Definition
Protect from heat and
radioactive source
Lower limit of temperature
Temperature limitation
Upper limit of temperature
Control
Negative control
Positive control
Date of manufacture
Do not use if package is

damaged
In vitro diagnostic medical

device
Manufactured by

Symbol Definition
Authorized Representative
Contains sufficient for <X>

tests
For Performance Evaluation

only
European Community
Representative

1.8 Technical Assistance
Siemens Diagnostics is headquartered in Tarrytown, NY and Los Angeles, CA.
Siemens Medical Solutions Diagnostics Siemens Medical Solutions Diagnostics
511 Benedict Avenue 5210 Pacific Concourse Drive
Tarrytown, NY 10591-5097 Los Angeles, CA 90045-6900
U.S.A. U.S.A.
1.8.1 Technical Support

For questions regarding the IMMULITE 1000 or its reagents, or for further information on this Service
Manual, contact Siemens Diagnostics Technical Support or your National Distributor.
Domestic
Tel: 1-800-372-1782
Fax: 1-866-466-8548
International
Tel: 1-973-927-2828
Fax: 1-973-927-4101

Chapter 2: Installation
Upon receipt of the IMMULITE 1000 Analyzer system, visually inspect the exterior of the shipping
container for damage. If there is any external damage to the container, notify your shipping department
and contact Siemens Diagnostics Technical Support.
2.1 Requirements
Electrical
Use of a dedicated, grounded service for the IMMULITE 1000 Analyzer, computer, monitor, and printer
is strongly recommended.
Use of an Uninterruptible Power Supply (UPS) or line conditioner is also strongly recommended.
Do not place the system near centrifuges, ultrasound or X-ray machinery, NMR scanners, or other
sources of magnetic fields.
Space
The IMMULITE 1000 must be placed on a flat, clean, horizontal surface.
The instrument requires a bench space of 75 inches (191 cm) across by 26 inches (66 cm) deep, with
any overhead cabinets at least 28 inches (71 cm) above the bench.
Environment
Ambient temperature should be between 65F - 86F (18C - 30C), Humidity 20-80% (no
condensation).
Do not place the IMMULITE 1000 system in direct sunlight.
Do not install the IMMULITE 1000 near heating or air conditioning vents or equipment.
2.2 Instrument Set-up

1. Set the IMMULITE 1000 on a bench containing at least the space specified above and the strength to
support the weight of the System and its components.
2. Install the Ergo-arm to the rear right corner of the chassis, as per enclosed hardware.
Arm Bracket
Hardware
Monitor Arm Upper Monitor Pole

Installation of Monitor Arm Assembly (also refer to assembly drawings manual for details)
Mount the arm bracket to the IMMULITE 1000 using two 5/16-18 X 5/8 socket-head cap
screws, washers, and lock washers.
Place the brass washer on top of monitor arm bracket and place the monitor arm into bracket.
Tighten the set-screw in the bracket just enough so the arm does not lift out from the bracket.
Remove the screw at the top end of the arm and install the keyboard table onto the arm. Reinstall
the screw just removed, to secure the keyboard table.
Install the upper monitor pole into the arm, and secure the set-screw to prevent this upper pole
from pulling out of the arm.
Install the flat screen monitor to the flat plate, using the four small screws supplied.
3. Set up the laser scanner and its holding bracket, keyboard, and trackball onto the arm.
Route the monitor power cord and communication connections of the monitor, scanner, keyboard
and trackball neatly, down the arms underside plastic cable guide, routing them all through the
small 1X 2 chassis skin cutout at the corner beneath the arm. Neatly distribute the peripheral
end connections with slightly slacked loops, to each of their rear computer ports of the
instrument.
The laser-jet printer can be positioned adjacent to, or beneath the system, as case-appropriate.
See on-board computer photos and identification labels within Chapter 3: Theory of Operation,
Section 3.6.2.
Attach all communication cables of the monitor, printer, keyboard (lower circular PS/2 port), and
trackball (upper circular PS/2 port) to the corresponding ports on the rear of the on-board
computer.
Setup and wire in the USB RS232 router to the lower of two USB ports on the rear of the
computer, and neatly secure the unit behind the Instrument in whatever way is case-appropriate.
The upper USB port, and modem phone cable connection above are unused.
4. Check to insure that the IMMULITE 1000 main power switch is in the OFF position.
Note: See on-board computer photos and identification labels within Section 3.6.2.
The power switch for the on-board Computer is a spring-loaded rocker switch, always defaulting
to the right. Be sure to press and hold the rocker switch to the left for a second or two, in order
to be sure to initiate power on of the on-board PC. The proper way to power off the PC is by
using the Windows 2000 standard shutdown command boxes. Upon Windows 2000 shutdown,
the PC will shut its own internal power off. This is separate from Analyzer power.
Positioned to the right of the power switch (see photo in Section 3.6.2), are three vertically placed
LEDs, which reflect computer status:
Green LED: PCs power on/off indicator
Red LED: Hard Drive Activity and Status indicator
5. Plug the power cord from the IMMULITE 1000s rear power supply AC jack, into the supplied UPS
or Line Conditioner unit. The Printers power cord should be plugged directly to the wall outlet, to
avoid its own surges from affecting the systems power stability.
Note: Do not turn the IMMULITE 1000 power switches on until instructed to do so.

6. Plug the optional Uninterruptible Power Supply (UPS) or line conditioner into the power outlet and
turn it on. A dedicated electric power line is strongly recommended to reduce the effects of electrical
noise produced by other instruments.
7. Remove all the shipping tape from the IMMULITE 1000, including the pipettor and its base, the
sample collection tray, the reagent tray, and the main carousel.
8. Install the gas struts by pressing the end of each strut onto the ball studs, then pressing in firmly to
lock them.
9. Install the syringes with the large syringe on the left, and the small one on the right. Insert each
syringe into the luer-lock fitting, and twist them to tighten. Thread in the thumbscrews into the
bottom of the plungers, and tighten.
10. Loosen the screws that hold down the cover for the printed circuit board compartment. Lift the cover,
and gently lift and reseat each of the four (4) printed circuit boards.
11. Turn the IMMULITE 1000 power switch to "on." The systems power is brought up safely in
stages. (Initially, the chirp of the +/- 5v & +/- 12v logic will first be heard.) After approximately
15 seconds, the syringes should "home" - that is, they should move to the top. If already there, they
will both move up a bit more to confirm home. This is desired, and confirms initiation of full 24v
system supply. If this does not happen, there are likely troubles of syringe module connections, or the
24v supply itself.
12. Turn the power on to the computer, monitor, and printer.
13. Install the waste tubing and bottle using supplied straight or elbow fitting, while keeping the tubing
straight and to avoid kinks. Route this tubing as needed.
14. Spike a new bottle of substrate and fill the reservoir with substrate up to the fill line using the manual
prime button.
15. Enter diagnostics and load the program SOLE2S.
16. Run SOLE2S to prime the substrate solenoid pump and associated tubing.
17. Allow a minimum of 45-50 minutes to ensure full temperature stability of the system before
beginning to run any water and/or chemistry testing. Confirm proper and stable temperatures, using of
Section 3.8 Instrument Temperatures for guidance.
18. Before any initial chemistry testing begins, the proposed water supply source intended for the
IMMULITE 1000 must first be tested and properly qualified, as described on the next page.
19. After the proposed water source has passed acceptable test criteria, the Water and Probe Wash bottle
sensors should now be tested and re-calibrated if necessary. The bottle sensors are tuned at the factory
using a standard set of bottles for all factory initial calibrations. In history it has been seen that
different sets of bottles can potentially have slightly different reflective properties for the individual
bottles enclosed with the new system. Therefore, at installation of each new system, the tuning of
these sensors should be checked following the procedure found in Section 7.4.15 .

2.3 Testing the Water
Before any water is primed into the IMMULITE 1000, it should be tested for contamination of
unacceptable levels of Alkaline Phosphatase. Contamination can affect the IMMULITE 1000s
performance by altering the matrix during the immunological reaction, or by increasing the post-wash
counts per second (cps). It is recommended that the customer test their water supply at least once a
month. Test the intended source water as follows:
Note: Room temperature distilled water is generally preferred to de-ionized water.
Use the Water Test Kit (catalog number: LKWT) in conjunction with the WATERTST diagnostic
program to perform the water test.
WATERTST
of the IMMULITE 1000. Water should be tested before priming water from a new source through the
IMMULITE 1000 System, or when contamination is suspected. The procedure for testing the water
supply using the WATERTST program appears below:
1. Before starting, ensure the IMMULITE 1000 has been powered on for at least 45 minutes and at a
stable operating temperature.
3. From the Start-up screen, select the DIAGNOSTICS button. The Common Diagnostics screen
appears:

4. Select Common Diagnostics. The following screen appears:
needed, load and run the SOLE2S program to fully prime the substrate nozzle. The IMMULITE 1000
must be Idle before performing this step, or before step 9.
7. Manually pipette 50 L of water directly from the source or from the water bottle into the first Test
Unit only.
10. Press GO (on the IMMULITE 1000) when instructed to do so. Substrate is dispensed into the Test
Units. The Test Units are then moved into the Luminometer and incubated for 10 minutes.
11. Once the Test Units start moving, select the VIEW button. The following screen appears:

After approximately 10 minutes, the two tubes come in front of the PMT for final readings, as seen in the
example above.
12. When the test result appears, the following are further choices for this data:
Select the Print Screen button to print this screen once the data appears.
Select the Save Data button to save the data to a disk.
Select the Retrieve Data button to retrieve data from a disk.
Select GetDataT to obtain more detailed raw WATERTST data, stored from previous tests.
Upon selection of GetDataT, the following screen appears:

13. While in this screen, the following choices are available:
Select the Print button to print this screen.
Select the Save Data button to save the WATERTST data to a disk, or folder of the Hard Drive Disk
(HDD).
Select the Retrieve Data button to retrieve WATERTST data from a disk or folder of the HDD.
Select the EXIT button in order to return to the Diagnostics screen to select another diagnostic
program if desired OR select CLOSE to return to the Start-Up menu if other diagnostic programs are
not desired at this time.
Refer to Acceptance Criteria on the next page to determine the outcome of this test.

Acceptance Criteria
> 4,500 cps and < 9,000 cps

the Luminometer is not warm
the substrate volume was
insufficient
< 4,500
the resident substrate is expired,
and losing its reactive properties
(Good for up to 30 days after
unacceptable alkaline
present
If the cps is too high or too low, perform the test again to confirm the results.
If the cps is consistently outside the 4,500 cps to 9,000 cps range, find a new water source and test
this new source.
If the second test unit (substrate only) is > 9,000 cps, the substrate system may be contaminated or the
test units used for testing may not be clean. **The Water result is then not valid, as it is being falsely
biased (high) by the unacceptably high level of this baseline substrate only reading
2. Refer to last line printed with results:

External water source Substrate Only = XXX cps
If the value of XXX above is lower than 650 cps, insufficient substrate may have been dispensed into
one of the Test Units. This could be due to a clogged nozzle. Check both Test Units to determine if they
contain enough substrate. If the value of XXX above is above 2000 cps, DO NOT use this water source
on the IMMULITE 1000 Analyzer. Find a new water source, and test this new source.
instrument, the fluidics system must be decontaminated. Refer to Section 7.4.2: System

An example of acceptable test results for the WATERTST tests is shown below.

Once an acceptable water source is obtained, it can be put into the rinsed water bottle, and the probe-wash
solution can be mixed. Once primed into the system using the PRIME common diagnostic program, clear
all air bubbles in the syringes. The instrument is now ready for chemistry testing.

Chapter 3: Theory of Operation
3.1 Introduction
The IMMULITE 1000 System is a random access immunoassay Analyzer, built around a proprietary
means of efficiently and rapidly washing the bead solid phase. The 0.25-inch polystyrene bead is captured
in a Test Unit that serves as the vessel for all incubations, washes, and signal development. After
incubation of the sample with alkaline phosphatase-labeled reagent, rapid separation and efficient
washing of the Test Unit and bead are achieved by high-speed spinning of the Test Unit on its vertical
axis. The fluid contents are completely transferred to the coaxial sump chamber of the Test Unit. Multiple
washes are accomplished within seconds, allowing uniform, sequential processing of the Test Units and
leaving the bead with no residual unbound label. The bound label is then quantified, using the dioxetane
substrate to produce light. Light emission from the chemiluminescent substrate, reacting with the bound
label, is proportional to the amount of analyte present in the sample.
3.2 Overview of Test Process

The steps below provide an overview of the testing process. The operator interface is very simple (steps
1-3). For step-by-step operational instructions, see Section 4: Routine Operation of the Operators
Manual part number 600467.
1. The operator loads the samples in barcoded sample cup holders and places them onto the Load
Platform.
Note: The materials needed to operate the IMMULITE 1000 are included in the IMMULITE 1000
Test Kits.
2. In normal testing, the operator then loads up to five barcoded Test Units after each sample, in any
order, for the tests desired on that sample. (See figure on page 1-4).
Additional samples and Test Units can be added at any time, and Stats can be placed at the
beginning of the Load Platform.
If on-board dilutions are also being used, with the correct diluent wedge resident on the reagent
carousel, the order of Load Platform tube placement becomes: sample cup, dilution cup, 1 empty
space, followed by up to four random test units.
3. The operator presses GO (on the IMMULITE 1000 Display Panel) and the Test Units are conveyed
into the Analyzer for barcode identification and then moved onto the Main Incubation Carousel.
4. The pipettor adds sample and alkaline phosphatase-labeled reagent. (The Reagent Carousel
accommodates up to twelve resident assays.)
Note: Reagent changes can be made during instrument operation by pressing the PAUSE button,
which stops the Load Chain and the Pipettor. Reagent Carousel will not go into pause if sequential
assays need to be pipetted. Normal operation resumes when the GO button is pressed.

5. Depending on the assay type, the Test Units are incubated on the Main Carousel at 37C for either 30
or 60 minutes (either 8 or 16 minutes in Turbo mode).
6. The Test Units are shuttled to the spin/wash station, where bound and free label are separated.
7. Substrate is added and the Test Units are transferred to the Luminometer Chain.
8. A 10-minute incubation (6-minute incubation in Turbo mode) at 37C begins, which causes the signal
to reach maximum limits.
9. The photon counts are measured with a photomultiplier tube (PMT). For photon counts, IMMULITE
1000 employs the following principles:
Automatic filtration (attenuation) of the light signal increases the dynamic range of the measuring
system 100-fold, enabling accurate measurements at both extremely high and extremely low
concentrations.
Counts per second (cps) are converted to analyte concentrations (doses) using stored master
curves.
3.3 Internal Calculations

This section provides a step-by-step description of the internal calculations performed by the IMMULITE
1000 System when determining test results. Refer to the table on the next page, which lists all the possible
calculations that can occur to get the final cps count.
1. Since the IMMULITE 1000's ultra-sensitive assays can produce up to several hundred million counts
per second (cps), the IMMULITE uses an attenuator disk in front of the photomultiplier tube (PMT)
to provide accurate readings over a very broad range of light signals. This attenuator disk has three
positions:
Closed - completely blocks the PMT (also known as the home position)
Attenuated - positions a neutral density filter in front of the PMT
Open - an unfiltered position
The IMMULITE 1000's attenuation filter restricts the number of photons entering the PMT. This is
used to prevent high light signals from saturating the PMT. Any readings above saturation are not
accurate, so the IMMULITE 1000 uses the attenuated light signal and compensates for the attenuation
via software.
2. For each sample, the IMMULITE 1000 takes a one-second reading dark count in the closed position
and a one-second reading decision count in the attenuated position.
Note: To view the dark counts while in the run mode, select System Status and View Temps/PMT
Counts.
If the one-second attenuated reading is less than 10,240 cps, the attenuator disk moves to the open
position; otherwise, the attenuator disk remains in the attenuated position while the readings are
taken.
3. The IMMULITE 1000 takes twelve one-second readings and returns the attenuator disk to the closed
position.
4. Dark counts are calculated by averaging the last ten reads. This average is subtracted from each of
the twelve readings.

Note: A dark count measurement is taken every 30 seconds, whether or not there is a Test Unit in
the read position.
5. To ensure that the final reading is representative, the highest and lowest of the twelve individual
readings are dropped.
6. All PMTs are slightly different in sensitivity. Therefore each PMT has a unique PMT Multiplier
factor. This PMT Multiplier number is multiplied by the cps reading to get the final cps reading.
7. If the counts were measured attenuated, the trimmed mean of the ten individual readings is multiplied
by the instrument-specific attenuation factor to yield the total unattenuated counts per second (cps).
CPS(unattenuated)= CPS(attenuated) x attenuation factor
8. To determine analyte concentrations, the IMMULITE 1000 software refers to lot-specific master
curve parameters, which were entered into the system via the kit barcodes.
PMT CALCULATIONS EXAMPLE TABLE
1 2 3 4 5 6 7
PMT Pre-scaler Mean of last High and Mean X 10 (for Mean X Mean X
Output Output* 10 dark Low count Pre-Scaler*) PMT Attenuation
(CPS/10) count reads removed Multiplier Factor**
(20 CPS then mean Factor** (only if
used here) calculated (.90 used counts were
subtracted here) taken
from each attenuated)
count FINAL CPS
8000 800 780 780
8100 810 790 790
8200 820 800 800
8300 830 810 810
8400 840 820 820
8500 850 830 830
8600 860 840 840
8700 870 850 850
8800 880 860 860
8900 890 870 870
9000 900 880 880
9100 910 890 890
8350 7515 864225
8350/10 =
835
* Original IMMULITE ONE instruments with serial numbers less than approximately 1900 have an
external pre-scaler. Later instruments including all IMMULITE 1000 Instruments have the pre-scaler
built into the PMT.
** The GetdataT program does not compensate for the PMT Multiplier or the Attenuation factor. It will
factor in a pre-scaler if present.

3.4 The Chemiluminescent Reaction
This section provides a brief overview of the chemiluminescent reaction used in the IMMULITE 1000
system.
First, the alkaline phosphatase conjugate (reagent) is bound to the bead (within the Test Unit) during the
immunological reaction. The amount of alkaline phosphatase captured is proportional (for a sandwich
assay), or inversely proportional (for a competitive assay) to the concentration of the analyte in the patient
sample.
Once the Test Unit is washed, a luminogenic substrate is added to the Test Unit and it is moved onto the
Luminometer Chain.
Ten minutes later, the Test Unit arrives in front of the photomultiplier tube (PMT), where the light
generated by the luminogenic reaction is measured. Unlike chemiluminescent reactions involving
acridinium esters (which produce a flash of light) the enzyme-amplified reaction in the IMMULITE 1000
System produces a prolonged glow, as indicated in the figure below.
IMMULITE 1000 Enzyme-Amplified Luminescence
In the luminogenic reaction (refer to figure below), the substrate (an adamantyl dioxetane phosphate 1 ) is
dephosphorylated into an unstable anion intermediate by the alkaline phosphatase conjugate captured on
the bead. The unstable intermediate emits a photon upon decomposition. The amount of light emitted is
directly proportional to the amount of bound alkaline phosphatase.
Compared to other means of detection, chemiluminescence provides the highest degree of sensitivity
available. In many cases, the sensitivity is orders of magnitude better than that attainable with
radioimmunoassays.
1
*LUMIGEN PPD: 4-methoxy-4-(3-phosphatephenyl)-spiro-(1,2-dioxetane-3,2-adamantane). LUMIGEN is a
registered trademark of LUMIGEN, Inc., Southfield, MI.

The IMMULITE 1000 Chemiluminescent Substrate
O O
OCH3
DIOXETANE PHOSPHATE
(STABLE)
OPO3
ALKALINE PHOSPHATASE LABEL
O O
OCH3
UNSTABLE DIOXETANE
OCH3
O
O
LIGHT (hv)

3.5 Primary Modules
3.5.1 Introduction
Primary Modules are defined as those modules that include stepper motors and require configuration
parameters and adjustments. Primary Modules require alignment through the configuration table (see
Section 7.2: The Configuration Table). Secondary Modules (discussed in Section 3.6: Secondary
Modules) are modules that require mechanical or electrical adjustments.
The Primary Modules of the IMMULITE 1000 are as follows:
Incubator Carousel
Load Chain Platform
Luminometer
Pipettor / Reagent Carousel
3.5.2 Incubator Carousel

Description
This module transports the assay tubes from the pipettor
dispensing area to the luminometer module. It incubates
5
the tubes at 37 degrees Centigrade and agitates them
with periodic shaking. It interfaces mechanically with
the Load Chain, Pipettor, and Luminometer modules. 3
1. Main Carousel Ring Gear Assembly

2. Stepper motor and Gear Assembly 2
3. Interface PCB
4. Heater Pad
5. Position Sensor PCB & rotating tower

Incubator Carousel Adjustments
Carousel Ring Gear Positioning
The ring positioning is controlled by the McPos parameter #3 in the configuration table. The position is
adjusted by using the MCARADJ configuration diagnostic program. This position should be set so that
the shuttle is centered within the carousel baffles.
Main Carousel Position Indicators
Illustrated below is a single position indicator, p/n 500530. There are three position indicators located 20
positions apart from each other around the Main Carousel Ring Assembly. The position indicator is made
of black plastic. Its purpose is to partially block the position hole. This causes a shorter trigger pulse to be
sensed by the carousel positioning sensor (located near the Stepper Motor and Gear Assembly) whenever
a position indicator passes the sensor. The carousel positioning sensor signals are interpreted by an error
checking sub-routine within the IMMULITE 1000 software.
Main Carousel Ring Gear Assy.

Small hole, half-blocked
by position indicator
Large fully open position hole
During the RUN IMMULITE initialization process, the carousel will index before the run to find the first
position indicator. The carousel then stops just beyond the position indicator. The software then checks
for the passing of each of the three position indicators, 20 positions apart from each other. If the sensor
does not see another position indicator after 20 positions a Main Carousel Positioning Error will be
posted.
Note: When running the diagnostic CARPOS, the main carousel position error-checking sub-routines are
activated. A Main Carousel Positioning Error will post if triggered.
Incubator Carousel Test Programs

CARBACK
This program moves the carousel backward in single index steps when the user presses the prime button
located on the syringe module. This is very useful to remove sample cups that have mistakenly indexed
around the main carousel.
CARSHAKE
This program checks the carousel shaking function. It momentarily initializes, indexes the carousel one-
step, moves the shuttle in the space between the baffles and shakes the carousel for a few seconds.
CARPOS
This program indexes the carousel ring gear one position every 2 seconds. It is used to check the indexing
of the carousel.
CARCHECK
This program indexes the carousel ring gear one position, moves the shuttle into the space between the
carousel baffles, pauses for one second, moves the shuttle back to home, and repeats. This program is
used to check each carousel position and its positional relationship with the Tube Shuttle. If the shuttle
does not appear to pass centered through a space of the Main Carousel, this indicates the need for
Carousel position adjustment using the MCARADJ Configurations diagnostic.

MCARTST
Found on the Configurations diagnostic menu, this is a test for the positioning sensor of the Main
Carousel, to aid with troubleshooting related problems. On the display panel, the pulse size of each
position hole of the ring gear will display with each repeated index of the Main Carousel. Nominal pulse
sizes are a value range of 22 - 26 for large holes, and a value range of 8 -12 for the 3 small holes where
the position indicators are placed.
SPINCHK
This program indexes the Carousel Ring Gear one position, moves the shuttle into the high speed spinner
area, activates the spinner motor for 2 seconds, moves the shuttle back to the carousel, and loops back to
the beginning. The program is very useful in testing the interaction of the Incubator Carousel module,
Luminometer module, and Load Chain module.
3.5.3 Load Chain

Description
This module transports sample cups and test units from the user loading area to the Barcode Reader, and
then to the used sample collection tray or the incubator carousel. It interfaces mechanically with the
sample collection tray, incubator carousel, and pipettor/reagent carousel module. The main areas of
interest are:
1
3
1. Load Chain stepper motor

6
2. Sample/Test Unit Bar code Reader
5
3. Interface PCB
4. Barcode Reader DC Motor
5. Star Wheel 4
6. Load Chain and chain path

2
7. Loading Platform Tube Guide
7
Load Chain Module Adjustments
1. Load Chain Position
The position of the Load Chain is controlled by the LcPos parameter #0 in the configuration table. The
position is adjusted by using the LDCHNADJ configuration diagnostic program and should be adjusted to
the following parameters:
A sample or assay tube is reasonably centered in front of the optical portion of the barcode reader.
The load chain baffles do not inhibit assay tube travel in the transfer block. (The cross-over point
with path of the Incubator Carousel)

2. Barcode Drive Wheel Travel
The stop screw on the drive motor bracket controls the drive wheel travel. The drive wheel should be
adjusted so that the outside of the drive O-ring is in the same vertical plane as the inside wall of the
transfer block channel. If the drive wheel is allowed to travel too far, the tubes can be forced against the
transfer block channel wall as they leave the barcode reader position possibly jamming the chain. If the
drive wheel does not move far enough toward the channel, the tubes may not be driven well enough
causing bad barcode reads.
3. Barcode Drive Wheel Motor Speed
The speed of the motor is controlled by R120 on the Heater/DC Motor PCB. Using an assay test unit, it
should be adjusted to read between 750 and 790 milliseconds per revolution in all four positions of the
assay tube roller assembly on the IMMULITE 1000 display by using the diagnostic program
BCODESPD. Refer to Section 7.4.8 for more information.
4. Star Wheel Adjustment
The Star Wheel is adjusted by loosening the hex nut located on top of the Star Wheel. The wheel should
be adjusted so that the leading edge of each arm will make light contact with the trailing edge of a
Sample Cup Holder when the holder is in pipetting position #5. This insures that the Star Wheel will also
be pushing the Sample Cup Holder into the Sample Tray along with the chain. If the wheel is positioned
ahead or behind this location the Load Chain baffles will push the Sample Cup Holder into the Sample
Tray unaided by the Star Wheel, possibly tipping the cups and causing a jam. Refer to Section 7.4.6 for
the complete adjustment procedure.
Load Chain Module Test Programs
LCHAIN
This program indexes the load chain one position every 2 seconds.
BCODE
This program will carry tubes into the barcode reader to be read and then into the Sample Tray for
retrieval. The rate at which the tubes are processed is approximately one tube every two seconds. BCODE
requires the use of the "PC" program to display the barcode information on the computer.
BCODEON
Drive Wheel
This program activates the sample Barcode Reader motor on/off by the and O-ring
push of the GO button.
BCODESPD
This program is used to observe and/or adjust the Barcode Reader motor
speed, which is read out on the display panel.
Tube-in-place
sensor flag
Note: By pushing the "PAUSE" button during program operation, the
load chain will advance to read another barcode.
Gearbox
BCODETST
Assembly
This program will advance a tube into the Barcode Reader, read it 25
times, advance the chain looking for another tube to read, then repeat.
This is the most useful test for the barcode reader, and can show useful patterns
for diagnosing intermittent problems. Motor

3.5.4 Luminometer
Description
This module washes the bead in the test unit with a combination of water and high speed spinning, adds
substrate, then moves the test unit via the Luminometer Chain through the serpentine path of the
Luminometer to a position in front of the Photomultiplier (PMT) where the light output is read. This
module interfaces mechanically with the main carousel module via tubing to the substrate/wash pumps,
and electrically to the PMT pre-scaler/power supply module.
1. Stepper Motor for the shuttle 2. Luminometer Chain Motor

3. Attenuator Motor 4. Photomultiplier Tube (PMT)
5. Shuttle Assembly 6. Interface PCB
7. Luminometer Chain 8. Attenuator Assembly
9. High speed brushless DC motor 10. High-speed Spinner platform assembly
2
6 3
8
4 4
2
5
7
5
1
10
Luminometer Module Adjustments

1. Luminometer Chain position
The lumchain position is controlled by the "LumcPos" parameter #26 in the configuration table. The
position is adjusted by using the LUMCHADJ configuration diagnostic program. This position should be
set so that the shuttle is centered within a chain baffle.
2. PMT Attenuator home
The home position is controlled by the "Att Home-Extra" parameter #28 in the configuration table. The
value of this parameter is factory set and should not be changed.

3. PMT Attenuator position
The attenuator position is controlled by the "Att Pos Extra" parameter #29 in the configuration table. This
position should be set so that the attenuator disc windows are centered in front of the lumchain baffles at
the PMT position. The value of this parameter is factory set and should never need to be changed.
4. Shuttle at Carousel position
The shuttle at carousel position is controlled by the "Sh at Car" parameter #21 in the configuration table.
The position is adjusted by using the SHUTCADJ configuration diagnostic program. This position is
adjusted so that test units transfer from the carousel into the shuttle in a reasonably straight path.
5. Shuttle at Luminometer position
The shuttle at luminometer position is controlled by the "Sh at Lum" parameter #25 in the configuration
table. The position is adjusted by using the SHUTLADJ configuration diagnostic program. This position
is adjusted so that:
The assay tubes transfer from the shuttle into the Luminometer in a reasonably straight path.
The tube shelves of the shuttle do not interfere with Luminometer Chain movement.
6. Shuttle at Substrate Dispense position
The Shuttle at substrate position is controlled by the Sh at Sub parameter #22 in the configuration table.
The position is adjusted by using the SHUTSADJ configuration diagnostic. This position is adjusted so
that a test unit is centered under the substrate nozzle.
Any deviation of the factory setting will require the high-speed spinner tube pressure to be checked since
changes in this parameter will change the pressure (See below).
7. High-speed Spinner tube pressure
The pressure exerted on the assay tube while in the high-speed spin position is a function of two
parameters in the configuration table: the "Sh at Sub-Extra" parameter #22 and the "Sh Push-Extra"
parameter #24. Since varying the latter parameter only affects one area, it is to be adjusted last. The High-
speed Spinner tube pressure should only be changed by varying the "Sh Push Extra" parameter in the
configuration table. The pressure on the tube should be between 1.2 and 1.5 pounds.
8. High-speed Spinner motor speed
The speed of the High-speed Spinner is controlled by R107 located on the Heater/DC Motor PCB. It
should be adjusted to read between 5400 and 5600 on the IMMULITE 1000 display by using the
WASHSPD diagnostic program.
Luminometer Module Test Programs
LUMCHECK
This program is most useful to check the critical crossover alignments of shuttle and luminometer chain
(remove the spinner platform for best viewing). The program repeatedly indexes the luminometer chain,
alternating with the shuttle moving momentarily into each chain baffle, in order to check for centered
alignment.
LUMCHN
This program indexes the lumchain one position every second.

ATTURN
This program moves the attenuator disc to the home position, attenuated position, unattenuated position,
and then repeats. It is useful in verifying sensor operation.
SHUTLOAD
This program allows for the evaluation of the shuttle loading of the test unit into the spin position.
SPNCKTST
Found on the Configurations diagnostic menu, this tests the electronic logic operation of the spinner
motors error checking circuit. Following display prompts, a test unit will be loaded into the spinner, and
a 5-cycle check of spinner startup is evaluated. In 0.5 seconds after spin begins, the motor must be up to
at least 2500 rpm or the display indicates Test Failed. If the 5 cycles check properly, it indicates Test
Passed.
SPINCHK
This program allows for a quick visual check that the high-speed spinner motor is working. During this
test the test unit is loaded into the spin position and the spinner motor is turned on for one second.
SHUTSPIN
This program indexes the Main Carousel one position, moves the shuttle to the high-speed position and
then activates the high-speed spin motor for 30 seconds. It is used to check the rpm of the high-speed
spinner when using an optical tachometer.
SPINON
This program will turn the High-speed Spinner motor on and off in response to the "GO" button.
SHUTTLE
This program moves the shuttle to the Luminometer position, to the High-speed Spinner, to Shut Push,
out to substrate dispense position, a possible Shut @ Lum correction move, then back to the Carousel,
then repeats. It is used to check alignment of these various 5 positions of the shuttle.
DARKCNT
This program will move the attenuator to the home position, then take a set of 12 one-second dark counts
from the Photomultiplier Tube every 15 seconds.
BKGNDCNT
This program will alternate moving the attenuator to the attenuated and then unattenuated position. While
at each position, a set of 12 one-second background counts will be taken.
PMTCOUNT
The current PMT counts are displayed. Readings are taken from the existing position of the attenuator and
does NOT move the disk. Normal readings are dependant upon the position of the disk for these readings.

3.5.5 Pipettor / Reagent Carousel
Description
This module transfers liquid from the Reagent Wedge and Sample Cup into the Test Unit and provides a
cooling chamber and Barcode Reader for the Reagent Wedges. It interfaces mechanically with the Main
Carousel and Load Chain modules, and to the Hamilton Syringe module and waste container via tubing.
5
1. Stepper motors for the Reagent Carousel, X-, and
3
Z-Pipettors (L-R respectively) 4
2
2. X- and Z- Pipettor mechanisms
3. Level Sensor PCB system (a level sense circuit
under the probe arm, and interface/conditioning
PCB mounted to the tower)
9
4. Reagent cooling chamber and tray assembly
5. Reagent Wedge Barcode Reader PCB 8
6. Module Interface PCB

7. Thermal Electric Device (TED Cooler Unit)
1
8. Pipettor Wash Station
6
9. Z-Pipette and Level Sense interfacing Spiral Cable 7
Pipettor/Reagent Carousel Module Adjustments
1. X-Pipettor Positioning
At the Home (Blind) Well
The position is controlled by the Px Home parameter #7 in the configuration table. It is adjusted by using
the PIPXWADJ configuration diagnostic program. The position should be adjusted so that the probe is
centered in the well when at this position.
At the Dump (Waste) Well
The position was formerly controlled by the Px Wash parameter #37 in the configuration table, however,
well is centered, this position will also be correct by default of the physical assembly of the wash well
station.
At the Wash (Fresh Water) Well
The position was formerly controlled by the Px Dump parameter #38 in the configuration table, however,
well is centered, this position will also be correct by default of the physical assembly of the wash station.
At the Reagent Position
The position is controlled by the Reagent parameter #40 in the configuration table. It is adjusted by using
the PIPXRADJ configuration diagnostic program. The position should be adjusted so that the probe
passes through the center of the hole in the reagent-housing lid.

At the Sampling Positions
The positioning of the probe in the sampling cups is controlled by the S5 - S1 parameter numbers 43-47
in the configuration table. (The S1 position is in the extreme clockwise location.) This is because the first
tube behind a sample cup gets sample from the first sampling position, and the fifth tube behind a sample
cup gets sample from the fifth sampling position. The positions are adjusted by using the PIPXSADJ
configuration program along with special Pip-X Position Gauges. Refer to Section 7.4.5: Use of Pip-X
Position Gauges for more information. Each position must be adjusted so that the probe is centered in the
Sample Cup.
At the Test Unit Position
The positioning of the probe is controlled by the PX Disp parameter #48 in the configuration table. It is
adjusted by using the PIPXTADJ configuration diagnostic program along with special Pip-X Position
Gauges. Refer to section 7.4.5: Use of Pip-X Position Gauges for more information. The position should
be adjusted so that the probe is reasonably centered in the hole in the Test Unit when dispensing.
2. Reagent and Sample Dead Volumes
The minimum volumes for the reagent and sample are controlled by the LevSensS and LevSensR
parameters # 13 and #14 in the configuration table. They are set using the DEADVADJ (automatic) or
LEVSNADJ (manual method) configuration diagnostic programs. The minimum volume for the reagent
vial is 1000 ul, and 100 ul for the sample. After calibration, the setting should be immediately evaluated
using the check diagnostics of LENSENSS & LEVSENSR, described below.
3. Reagent Carousel Position
The position is controlled by the RcPos parameter #16 in the configuration table. It is set by using the
REAGPADJ configuration diagnostic program. The position should be set so that each position slot in the
carousel tray is centered over the sensor head below. If this position is not set correctly, mis-positioning
of the Reagent Carousel can occur.
4. Reagent Carousel Home
The position is controlled by the RcHome parameter #15 in the configuration table. Using the
REAGHADJ configuration diagnostic program sets this position. The position should be set so the red
light of the opto-sensor is shining at the spot on the label between the leading edge of the wedge and the
first bar of the barcode, when the reagent carousel is at home. If this position is not correct, misreading of
the Reagent Wedges can occur.
5. Probe Depth in the Dilution Cups
This newest probe depth parameter (previously an unused parameter in previous IMMULITE systems),
does not have a related adjustment diagnostic, and should not be changed by any user. The default factory
settings should always stay at 160 Error Steps, and the Extra Steps in this case are not used.
6. Probe Depth in the Home Well
This depth is controlled by the Z Home parameter #32 in the configuration table. It is adjusted by using
the PIPZHADJ configuration diagnostic program. When properly adjusted the probe should be between
1.25 and 1.50 mm from the bottom of the well.
7. Probe Depth in the Wash Well
This depth is controlled by the Z Wash parameter #33 in the configuration table. It is adjusted by using
the PIPZWADJ configuration diagnostic program. When properly adjusted, the probe should be
approximately 2 mm from the bottom of the well.

8. Probe Depth in the Test Unit
This depth is controlled by the Z Assay parameter #34 in the configuration table. It is adjusted using the
PIPZTCHK (automatic), or PIPZTADJ (manual) configuration diagnostic programs. When properly
adjusted the probe should "touch off" on the liquid dispensed and not come out of the test unit with a drop
on the end. Likewise, it should not go too far down so as to contact or push the bead to the side.
Pipettor/Reagent Carousel Module Test Programs
UPDOWNH
This program moves the X-pipettor to the home well position then moves the Z-pipettor up to the Home
sensor, down to the Mid sensor, down the amount of steps in the error column of parameter #32 (Z
Home) of the configuration table. It is very useful in testing the functions of the aforementioned sensors,
the centering of the probe in the home well and to roughly check the depth of the probe in the home well.
UPDOWNW
This program will move the X-pipettor to the wash station position, then moves the Z pipettor up to the
Home sensor, down to the Mid sensor, then down the amount of steps in the error column of parameter
#33 (Z Wash) of the configuration table. It is very useful in testing the functions of the aforementioned
sensors, the centering of the probe in the wash well, and to roughly check the depth of the probe in the
wash well.
UPDOWNA
This program will move the X-pipettor to the Test Unit dispensing position, then moves the Z-Pipettor up
to the Home sensor, down to the Mid sensor, then down the amount of steps in the "Error" column of
parameter #34 (Z Assay) of the configuration table. It is very useful in testing the functions of the
aforementioned sensors, the centering of the probe in the test unit, and to roughly check the depth of the
probe in the test unit.
PIPXPOS
This program moves the X-pipettor to each position, starting with home, lowering the Z pipettor into each
position for a moment to allow for visual inspection of the positioning.
RBCODE
This program moves the reagent carousel to the home position and then to each position while reading
Reagent Wedge barcodes. After reading the barcodes or not finding any, the program repeats.
LEVSENSR
This program will move the X-pipettor to the reagent position, and then move the Z-pipettor down to the
Mid sensor, then move the probe down looking for liquid. If liquid is found, the number of steps left
before the error steps were reached is displayed on the IMMULITE 1000 display as the "SL=" number.
With 1000 ul of reagent in a reagent vial, the "SL" number displayed on the IMMULITE 1000 should be
between 8 and 12 if the minimum volume is set correctly.
LEVSENSS
This program will move the pipettor down into the Sample Cup #1 position, looking for liquid. It will
display the amount of steps the Z-pipettor has remaining until the maximum number of allowable Z steps
is reached. With 100 ul of sample in a sample cup this SL= number on the display panel should
reasonably match the error steps of parameter #13 in the configuration table, which had been set when
running the previous DEADVADJ or LEVSNADJ calibration program.

REAGENTH
This program moves the reagent carousel to the home position, pauses, and repeats.
REAGENTP
This program moves the reagent carousel to each of the 12 positions, pausing between each.
PROBETST
This program will move the probe into the home well, dispense 3000 ul at maximum velocity (1000
ul/second), move the probe up and over to the dump position, and repeat. Since it simulates the washing
of the probe during the main program, it is very useful in testing the integrity of the washing. For
centered in the home well, the water coming out of the probe would be uncontrollable and "splash" out of
the well. Also an occlusion may be present if dripping from the probe occurs when it momentarily
positions over the dump well.
PROBANGL
System Level Sensing Test Programs
LEVCRASH (found on the main diagnostic menu)
Running for up to 20 full pipettor rotation cycles, this program will look for a successful level-sensing
signal from liquid-filled cups pre-placed onto the system as per display panel instructions. If any errors
occur within the 20 cycles, the program will halt and the display panel will show Test Failed (it did not
see a level sense trigger when it was supposed to). If no errors occur within the 20 cycles, the display
panel will show a message of Test Passed, and the program will end.
LEVFALSE (found on the main diagnostic menu)
Running for up to 20 full pipettor rotation cycles, conversely to LEVCRASH, this program will look for
any false level sensing signals while rotating in open air. If any errors occur within the 20 cycles, the
program will halt and the display panel will show Test Failed (it did see a false level sense trigger when
it was not supposed to). If no errors occur within the 20 cycles, the display panel will show a message of
Test Passed, and the program will end.
LEVFSTST (found on the Configurations diagnostic menu)
This program tests for the tendency of the level sensor to false level sense at times when a signal is not
desired. It moves to and checks level sensing at empty positions of the reagent and the 5 sampling
positions, much the same as the existing LEVFALSE program. If the level sensor is working correctly, it
should not level sense anything, as the program repeats this sequence for up to 17 cycles, for a total of
102 potential level sensing signal checks, and then stop automatically. While running, the number of
errors (or false signals) are counted and show on the display panel each time the probe recycles to home.

LEVSNTST (found on the Configurations diagnostic menu)
Conversely to the above program of LEVFSTST, this program tests for a proper level sense signal when
one is desired. After initialization and a syringe priming process, the display panel prompts to load five
empty sample cups onto the load chain. Upon pressing Go, these sample cups will be brought into the
five sampling positions and the probe then automatically dispenses a mixture of water and probe wash
into each of the five sample cups. This program will repeatedly level sense into each cup and run for a
total of 20 cycles and then stop automatically and the display panel will then prompt for Repeat or
Exit. This gives up to 100 potential level sense signal checks. While running, the number of errors
detected are shown and counted on the display panel as they occur.
3.6 Secondary Modules
3.6.1 Introduction
Secondary Modules are defined as those support modules not directly responsible for tube transport,
and/or smaller modules that require mechanical or electrical adjustments.
3.6.2 Power Supply Chassis

Description
The power supply module contains three individual power supplies that convert the input AC voltage to
the necessary DC voltage required by the IMMULITE 1000 electronics. The module also contains line
filters to reduce the amount of noise the individual power supplies will see. See Chapter 5: Specifications
for required fuse ratings. The main areas of interest are:
1. The +24vdc switching supply (commonly known as the heater/motor power supply - wired through
F3)
2. The +/-5vdc, +/-12vdc switching supply (commonly known
as the IC logic power supply, wired through F2)
3. The +/-5vdc, linear supply (commonly known as the PMT power supply, wired through F1)
4. The VAC in Power Cable jack, input filter/fuse holder (F4, F5) 3
8
5. Individual Supply Fuses F1, F2, F3
6. Instrument Main Power Switch 2 1
7. Power Supply Outer Fans
8. Cabling connections to system
6
7 5 4
7
5 4
6

Power Supply Module Adjustments
The 24v module in the center of the drawer can be adjusted using the potentiometer module p/n 422268.
All instruments s/n C0230 and up have this in place. In IMMULITE 1000, this voltage should be adjusted
no lower than 24v. In most cases, when true failure is found, the entire Power Supply assembly drawer is
swapped out of the instrument chassis.
Power Supply Module Testing
The best way to test the module is to measure the output voltages at specific points in the instrument. A
quick way of testing the supply is to run a diagnostic that uses voltage from that supply.
Heater/Motor Power Supply
Quick Test:
Power Supply Module faceplate
Run the CARPOS diagnostic program (uses +24v and +5v)
IC Logic Power Supply
Quick Test:
1. Run the PRIME diagnostic program (uses +24v, +5v, +12v, and -12v).
2. Run the BCODE diagnostic program (uses +24v, +5v and -5v).

PMT Power Supply

Quick Test:
1. Run the DARKCNT or BKGNDCNT diagnostic program (uses +5v, and -5v)
1. Locate the quick-connect power cable connector, just outside of the end of the PMT tube.
2. With black DVM lead attached to system ground, check for +5 and -5 voltages with red DVM lead, at
this 3-pin quick connector.

3.6.3 PMT (Photomultiplier Tube)
Description
This highly sensitive photometer tube gathers the photon signals from the glowing assay beads within the
Luminometer. Its signal is connected directly to the systems rear CPU PCB, for signal processing of the
CPS (Counts per Second). It has its own separated/filtered linear power supply as described in the
previous section.
PMT Module Adjustments

PMT Module Test Programs

DARKCNT
This program will move the attenuator disk to the home position, then take a set of 12 one-second dark
counts from the Photomultiplier Tube every 15 seconds. The button VIEW must be used with this
program to view the PMT data. Normal readings range between 0 60 CPS.
BKGNDCNT
This program will alternate rotating the attenuator disk to the attenuated and then unattenuated
position. While at each position, a set of 12 one-second background counts will be taken. The button
VIEW must be used with this program to view the PMT data. Normal readings are in a range of 0 40
CPS in attenuated (filtered) position, and comparable readings in unattenuated (open aperture)
position, which will have more values in the 30-40 range, along the 12 readings.
PMTCOUNT
Using the VIEW button, the current PMT counts are displayed. Readings are taken in the current position
of the attenuator, and it does NOT move the disk. Judgment of normal readings is dependant on the
current disk position, as above.

3.6.4 Substrate and Water Linear Actuator (Injector) Pump
Single pump Assembly; p/n 400321. Full Wash Pump Kit; both pumps on base with cable: p/n 420120
Description
These stepper-motor actuated companion Substrate and water side Pump modules automatically pump
substrate and water into the assay tube during the spin/wash cycle. The pumps interface via tubing to the
water and substrate containers and the Luminometer module. The pumps interface electrically with
motherboard #1.
NOTE: In order to prime this pump most effectively, the upper prime buttons should be held manually
during pre-chemistry priming, or when using the priming diagnostic programs. This creates a fuller
compression of the bellows assembly. When using the DECON and DECON1 decontamination
procedures, it is also advised to secure the prime button of the water side pump using tape, to create the
fullest compression of the bellows.
Substrate and Water Pump adjustments

1. Water or Substrate dispensing volume
The volumes of both solenoid pumps are factory set and should not need adjustment. Use the DISSUB or
DISWAT diagnostic programs (described below) to check the dispensing volumes.
The dispensing volumes of both Pumps should be 190 - 210ul.
NOTE: On the rare occasion when the volume of

dispense is incorrect, it can be adjusted within the
inner assemblies of each pump module. After
removing the pump from its platform, the DIP
switches inside control both volume and drawback
settings. Refer to Chapter 7: Miscellaneous
Procedures for more details.
2. Water or Substrate drawback specifications

Drawback is checked using the SOLE1W or SOLE2S diagnostic programs (described below). Refer to
the end of Section 7.4.4: Fluidics Valve Testing for information on drawback adjustment and
specifications, which are adjusted via the jumpers within each pump, as illustrated above.

Substrate and Water Pump Test Programs
DISSUB
and press Go. The tubes will be brought onto the incubator carousel, each receive a shot of substrate,
DISWAT
and press Go. The tubes will be brought onto the incubator carousel, each receive a shot of wash water,
SOLE1W
This program dispenses one "shot" of water every 2 seconds. It is very useful in checking the drawback,
or to quickly prime the pump.
SOLE2S
This program dispenses one "shot" of substrate every 2 seconds. It is very useful in checking the
drawback, or to quickly prime the pump.
Note: Refer to Section 7.4.4 for more information on drawback.

Input tube support
PCB cover bracket (wiring
3.6.5 Substrate Heater
behind)
Description
The Substrate Heater module is responsible for controlling the temperature of the
substrate before it is injected into the test unit. The heater will begin to heat the
substrate to 36.6, +/- .6C seven minutes before a test unit that requires substrate
reaches the dispensing area. This way the substrate is not always heated which
would cause a decrease in stability. The heater and controlling circuitry are housed
inside the module. The heater is activated by a signal coming from Q13 (which
was originally intended to be used for valve #5) on the Heater/DC Motor PCB via
J10 on the Syringe Interface PCB (blue wire from J3). When the heater is at
temperature, a signal (digital 0 = not at temperature, digital 1 = at temperature)
comes from the Substrate Heater module to the CPU/Sensor PCB via the
Luminometer Interface PCB (yellow wire from J3).
Substrate Heater Adjustments Substrate Heater
Dispense Thumb Screw
No adjustments of this module are necessary. Nozzle for unit
removal

Substrate Heater Test Programs
SUBSHEAT
This program will activate the substrate heater. The temperature can be easily measured using a digital
voltage meter. Remove the PCB cover off the left side, and insert the leads of meter into the two white
test points (TP1 & TP2) on the PCB.
Note: The temperature of the heater should be at ambient when the program first starts. Multiply the
voltage measured by 100 and this will be the temperature in Centigrade. The stabilized temperature of the
heater should be 36.6 +/- .6C. When done measuring the temperature, be sure to terminate the program
so as not to heat the substrate for a long period of time.
SUBHTTST
This program (located in the system configuration diagnostics menu) will first check to see that the heater
is not at temperature (in the event the heater has shorted and is always on). If the heater is not on, the
program will activate the heater and check every 30 seconds to see if it has reached temperature. If the
heater was already at temperature when the program was started or does not reach the proper temperature
within 6 minutes, the program will indicate the test has failed.
If the proper temperature is reached within 6 minutes, the program will indicate the test has passed. The
heater will only come up to the on/off trigger point of approximately 35C - 35.5C and then shut off. It
will not heat to the full temperature of 36.6C +/- 0.6C.
Note: Since this program checks to see if the heater is always activated, it is very important that the heater
be deactivated for at least five minutes before the program is run or a false failure may occur. Remember
that the heater is only activated when a test unit requiring substrate is seven minutes away from the
substrate dispense position. For example, if this program is run successfully, and then run again
immediately afterward, it will fail since the heater is still at temperature.

3.6.6 Substrate Reservoir
Description
The substrate reservoir module holds the substrate bottle, contains a
7000ul (to fill line) reservoir and a level sensor that triggers when the Prime button
reservoir level drops to 5000ul (posting a substrate low error). This -squeeze, do
allows the operator 12 minutes to replace the bottle without interrupting not push
the operation of the instrument. Priming of the reservoir is accomplished
by repeatedly squeezing (not pressing) the gray rubber prime button
located on the front of the reservoir until the level of substrate is at the Window and
fill line. The level sensor signal is fed back to the CPU/Sensor PCB via level float
the substrate heater. The substrate flows from the bottle into the
reservoir through a replaceable I.V. spike.
Level Sensor
Substrate Reservoir Module Adjustments
No adjustments of this module are necessary or possible. Refer to
Section 7.4.3: Substrate Spike Replacement for information on the spike
replacement.
Substrate Reservoir Module Test Programs
SUBLVTST
This program tests the proper operation of the Substrate Reservoirs level sensor. After instrument
initialization, the display panel prompts the user with step-by-step instructions to lower the substrate level
until it triggers the level sensor. After querying the sensor for a good level, the bottle is removed and the
level is pumped out hopefully, below the trigger of the sensor. The test can be recycled for a second
dispense cycle, until display panel indications of Test Passed or Test Failed are posted, as per expected
actions of the test, based on the visual level in the reservoir.

3.6.7 Syringe Pumps 8
3 4
3 4 8
6
V4
5
5 V2
V1 6 and 7
7
A B A B
1 and 2 1 and 2
Hamilton Syringe Pumps Euro Syringe Pumps

Description
Currently, there are two types of Syringe Pumps that can be found in the IMMULITE 1000 instrument:
1. The Hamilton 500 Series Syringe Pumps Assembly has been in production since instruments
starting with serial number H2469 and above. It has been implemented into production alternately
(according to stock availability) with the Euro design described below. The complete module is
available under P/N 400273 and individual diluters are available under P/N 901664. It involves a
circuit redesign where the Driver Circuit PCB and Logic PCB were combined into a single
Logic/Driver PCB, P/N 901666. The prime button is also located to the right of the syringes and the
same IMMULITE 1000 Hamilton Tubing Kit, P/N 400360 and Syringe Interface PCB are used. The
cabling for sensors and motors of the rotary valve and lead-screw drives are all brought to the right
side of the Module and connected to the Logic/Driver PCB. This module also utilizes two rotary
valves; a Macrovalve for the A syringe (identified by a symbol M) and a Microvalve for the B
syringe (identified by a symbol ).
2. The Euro Syringe Pumps Assembly, P/N 400263 is available as a complete assembly only. Individual
diluters cannot be replaced separately. The Euro design uses solenoid valves to direct the flow of
liquid in or out of the syringes. This assembly also utilizes a single large PCB which covers the entire
back wall of the module. It includes all the circuitry of the Driver Circuit, Logic and Syringe Interface
PCBs. The prime button is placed between the two syringes and the side fluidics valves have
connectors (labeled V1, V2 and V4) more easily accessible at the top rear of the module. The syringes
are secured into acrylic manifold blocks where the fluid is controlled by two more solenoid valves in
place of the rotary valve assemblies used with the Hamilton Modules above. Tubing is different for
the Euro Module and is available in a Euro Tubing Kit under P/N 400361.
Note: All types of pump modules are interchangeable, as the electrical connections to the modules are
identical. Tubing kits may need to be changed, if going from Hamilton to Euro or from Euro to Hamilton.
Refer to Chapter 10 for a listing of the tubing kits.

The Syringe Module performs precision liquid transfer using stepper motor driven syringes to pipette
water, wash, sample and reagent. It interfaces via tubing to the water and wash containers and to the
pipettor module. The main areas of interest are:
1. "A" and "B" Diluter assemblies
2. "A" syringe (5000ul) and "B" syringe (250ul)
3. Macrovalve
4. Microvalve
5. Solenoid Valves (V1, V2, and V4)
6. Controller PCB (The Euro Syringe Pump combines the Controller and Interface PCBs into one board)
7. Interface PCB (The Euro Syringe Pump combines the Controller and Interface PCBs into one board)
8. Prime Button
Syringe Module Adjustments
No adjustments of this module are necessary or possible. The inner armature lead-screws are lightly
lubricated at the yearly PM.
Changing a Syringe
1. Loosen the thumbscrew under the syringe to be changed to a point at which the syringe plunger is
free from the driver arm.
2. Use the diagnostic program SCHANGE to move the syringes down.
Note: Removing a syringe without first moving the syringe arm down can crack the fitting on the valve
above.
3. Unscrew the syringe from the valve above while taking care not to exert side pressure on the valve
stem.
4. Install the new syringe onto valve fitting above.
5. Press the "GO" button to move the syringes up and tighten the thumbscrews.
Changing the Microvalve or Macrovalve (Hamilton 500 units only)
Note: These rotary valves are changed at the yearly PM, ONLY if they are of the black-bodied style. The
newer white-bodied ceramic rotary valves are NOT replaced, and are intended as permanent.
1. Remove the syringe as described above, using the SCHANGE diagnostic.
2. Remove the tubing on either side of the valve.
3. Move the silver locking lever (below valve) to the right position to release the valve barrel.
4. Above the valve is a hex-cap capture setscrew, which must also be slightly backed off, in order to
release the valve barrel.
5. Remove the valve from diluter assembly.
6. When installing the new valve insure the slot in the valve stem is positioned so that it will mate
correctly with the stem inside the valve drive mechanism.
7. While making sure the valve body is flush to the dilutor manifold, retighten the top hex-cap setscrew
from above, until gently snug.

8. Move the locking lever to the downward position to lock the valve in place. Be sure the valve body is
flush with the valve manifold of the module.
9. Reinstall the tubing into each side of the valve and screw the fitting into the valve until the fitting
"bottoms" in the valve, then turn 1/4 of a turn more. Lock fitting in place with black locking nut.
Warning: Over-tightening the fittings into the valve above can deform the inner body of the valve and
cause air and/or water leaks.
Changing the Microvalve or Macrovalve (Euro units only)
Note: The clear acrylic manifold blocks are not regularly replaced. However, regular inspections should
be performed and the valves replaced if damage or cracks are found.
1. Making sure main power is off, disconnect short power wire of the solenoid valve from the rear
Controller PCB behind the acrylic manifold intended for replacement.
2. Remove three hex screws, which mount the acrylic manifold block to the front face of the module.
3. Remove the entire assembly (manifold and solenoid valve).
4. Install new manifold and solenoid valve in reverse order.
Syringe Module Test Programs
SCHANGE
This program moves both syringes down approximately halfway to permit their removal, waits until the
"GO" button is pressed, then moves both syringes up to home.
PRIME
This program primes the two syringes and the associated tubing. It exercises syringes "A and "B", valves
"A" and "B," and solenoid valves 1, 2, and 4. System error checking is active.
APRIME
This program is used to isolate priming of the "A" large syringe for diagnostic evaluation or to aid in
syringe tip replacement. System error checking is not active.
BPRIME
This is used to isolate priming of the "B" small syringe for diagnostic evaluation or to aid in syringe tip
replacement. System error checking is not active.
Note: Each of the three valve programs below assumes the valves not being tested are working properly.
This means if V1TEST is run and fails, insure V2 and V4 are working properly before replacing V1.
V1TEST
This program should alternately dispense water through the probe and the wash well. The change in
dispense point is altered by the activation or deactivation of V1. If the valve is not working, the water will
always dispense from the probe. If the valve is stuck in the activated position, the water will always come
from the wash well. If one of the two diaphragms in the valve is partially clogged, one port will slowly
drip while the other is dispensing.

V2TEST
This program should alternately dispense water through the probe and the detergent container tubing. The
change in dispense point is altered by the activation or deactivation of V2. If the valve is not working, the
water will always dispense from the probe. If the valve is stuck in the activated position, the water will
always come from the detergent container tubing. If one of the two diaphragms in the valve is partially
clogged, one port will slowly drip while the other is dispensing. Follow instructions on the IMMULITE
1000 display panel.
Another way of testing V2 is to suspend the detergent container above the instrument and check to see if a
drop begins to form on the end of the probe. If a drop has not formed within 10 minutes, the valve is
sealing properly.
V4TEST
This program works exactly like V1TEST. This program should alternately dispense water through the
probe and the wash well. The change in dispense point is altered by the activation or deactivation of V4.
If the valve is not working, the water will always dispense from the probe. If the valve is stuck in the
activated position, the water will always come from the wash well. If one of the two diaphragms in the
valve is partially clogged, one port will slowly drip while the other is dispensing. This program uses V1
to direct the flow in a direction that can be differentiated from the other.
PROBETST
This program will move the probe into the home well, dispense 3000ul at maximum velocity
(1000ul/second), move the probe up and over to the dump position, and repeat. Because it simulates the
washing of the probe during the main program, it is very useful in testing the integrity of the washing. For
centered in the home well, the water coming out of the probe would be uncontrollable and would "splash"
out of the well. Also an occlusion may be present if dripping from the probe occurs when it momentarily
locates over the dump well.
PROBANGL

3.6.8 Sample Collection Tray
3 1
Description
1
This module collects the sample cups and holders ejected from the load chain so the user can recover
them for reuse. It interfaces mechanically with the load chain module. The main areas of interest are:
1. Removable tray
2. Tray housing
3. Tray-In-Place and Tray-Full Buffer Sensors
Sample Collection Tray Module Adjustments
Sample Collection Tray Module Test Programs
SAMPFTST
tray full sensor (located under the Sample Collection Tray). Follow instructions on the IMMULITE 1000
display panel.
SAMPTTST
tray-in-place sensor (located under the Sample Collection Tray). Follow instructions on the IMMULITE
1000 display panel.
3.6.9 Water Supply Bottle and Probe Wash Bottle Level Indicators
Description
LED sensors detect the level in the bottles for three main levels of operation. The four conditions of the
LEDs are as follows:
No LEDs lit = Bottle removed
Red LEDs lit = Bottle present but empty
Yellow LEDs lit = Bottle approx. full
Green LEDs lit = Bottle above full
Refer to section 7.4.15 for detailed calibration procedure.

3.7 Fluidics
3.7.1 Description
Although most parts of the fluidic system are a part of one of the modules already discussed, a section in
this manual has been devoted to addressing the combination of all fluidic parts as a whole. The
components involved in the fluidic system are as follows:
Tubing
Each piece of tubing that comes in contact with liquid used for test unit processing is Teflon. The shape
of each piece is formed by the application of heat. The tubes may be repaired to create a new clean end
and a new ferrule of the appropriate size is mated to the end of the tube (wider end of ferrule toward the
tubes end). This repair work can be done using the Upchurch Tubing Repair Kit, P/N 420109. Each
tube is numbered and has color-coded fittings for easy tube identification. Color coding also corresponds
to the type of fluid that will pass through the tubing:
Blue - Fresh water from the water container
Red - Substrate
Yellow - Detergent or detergent and water mixture
White - Fresh water used to rinse the wash well
Green - Water to be used in the test unit
Each tube has a fitting that is designed to be gently tightened only with the tightening fitting, supplied
with the repair kit. (The probe has a hexagonal fitting and can be tightened with a wrench). The proper
technique for seating the tubing and tightening the fitting is:
1. Move the fitting away from the flared end approximately 15mm.
2. Insert the flared end into the port (of the valve, coupling, etc.) until it "bottoms."
3. Move the fitting into the port and tighten until it "bottoms."
4. For fittings in valves, tighten the fitting another 1/4 of a turn.
5. For fittings elsewhere, tighten until snug.
Note: Over-tightening the fittings can damage the flared end or ferrule, fitting, or the silicone O-ring of
the tubing (where used). It can strip the port of a solenoid valve, or deform the inner shape of a rotary
valve. If any of the mentioned parts are damaged, they must be replaced for proper fluidics operation, but
tubings of the type known as Upchurch can be repaired using the Upchurch Tube Repair Kit, p/n 420109.
Rotary Valves (Hamilton Syringe Pumps only)

These valves have a white ceramic body and this type of rotary valve is meant to be permanent, and needs
no replacement. The piece that rotates inside is Teflon and is driven by a DC motor within the diluter
assembly.
No replacement or adjustment of these valves should be necessary, except to check for full proper seating
against the dilutor manifold and that they are well secured by the Cam-lever underneath (locked at the
6:00 position). If not fully seated, air can enter the fluidics through the rear barrel of the valve.

Solenoid Valves
Rocker-type Solenoid valves are the current standard for both the Hamilton and Euro syringe pumps and
are also used on the Substrate/Water Linear Actuator Injector Pumps.
It is a three-way valve composed of two main components: a 24vdc solenoid and a self contained
manifold. The manifold contains a common, normally open, and normally closed port. When no
power is applied to the valve, the common and normally open ports are connected. Conversely, when the
24vdc is applied to the solenoid, the common and normally closed ports are connected.
The quality of seal is greatly affected by dirt or any other particles that could come between the elastomer seal and
the seat. This is why filters are used on the input lines coming from the water and detergent containers.
Probe
The probe is constructed of a stainless steel outer jacket, inner Teflon tubing, and outer Tygon tubing.
The probe is durable and will last quite a long time under normal operating conditions. In the vertical
direction the probe is very strong and will withstand the occasional forgotten cap on the reagent vials. In
the horizontal direction however, the probe will bend (but will usually spring back) quite easily. If the
probe were to be permanently bent, it will not position correctly over any of the X-pipettor locations and
must be replaced immediately. Since the probe is washed after pipetting each test unit, there is no need to
periodically remove the probe for cleaning. However, the probe should be cleaned in accordance with the
probe cleaning procedure.
Linear Actuator (Injector) Pumps
Two Stepper-motor driven Injector Pumps pump substrate and water into the assay tube during the
spin/wash cycle. The pumps interface via tubing to the water and substrate containers and the
Luminometer module.
Syringe Module
The Syringe Module contains two diluter pump and syringe assemblies, one for large volumes (5000 ul)
and one for small volumes (250ul). The Syringe Assembly performs precision liquid transfer using
stepper motor driven syringes to pipette water, wash, sample, and reagent. It interfaces via tubing to the
water and wash containers and to the pipettor module.
Water and Detergent Containers
The containers used for the water and detergent are of polyethylene material. The water container will
hold 2 liters, enough for approximately 450 tests. The detergent container holds 1 liter, enough for 1000
tests. Each container has a quick-connect clip fitting in the cap for fast interchange from the tubing
system, and also a porous plug in the cap that allows for air to fill the void created by the loss of liquid.
Liquid Waste Container
The container used to hold the liquid waste is of a polyethylene material. It can hold approximately 3.75 liters,
enough for approximately 900 tests. It has a small vent hole in the cap for air to escape as the liquid level rises.

3.7.2 Pipetting Sequence
Syringe priming sequence at startup, during the in-cycle prime, and the PRIME diagnostic
program
1. Valve A to water jug 12. Valve 2 on (connect loop to detergent jug to
prevent pressurization)
13. Valve 4 on (diverts flow from syringe A
3. Syringe A fill with 4000ul water
4. Syringe B fill with 250ul water
14. Syringe A dispenses 2000ul into home well
5. Valve A to tip thru tip
6. Valve B to tip 15. Valve 2 off (disconnect loop from detergent
jug)
7. Valve 2 on (connects reservoir loop to
detergent jug) 16. Valve 4 off (restores normal flow from
syringe A)
8. Syringe A fills with 1000ul detergent (fills
reservoir loop halfway with detergent) 17. Valve 1 on (divert flow from syringe A to
wash well of wash station)
9. Valve 2 off (disconnects reservoir loop from
detergent jug) 18. Syringe A dispenses 1000ul into wash well
10. Syringe A dispenses 2000ul into home well 19. Valve 1 off (restore normal flow from
thru tip syringe A)
11. Syringe B dispenses 250ul into home well
thru tip
Loop flushing sequence (occurs at startup after priming is completed)

1. Valve A to water jug 7. Valve 4 on (divert flow from syringe A
2. Syringe A fills with 4000ul of water
3. Valve A to tip
home well to insure it is full
9. Valve 2 off (disconnect loop from detergent
dump well
jug)
5. Repeat steps 1-4
10. Valve 4 off (restore normal flow from
6. Valve 2 on (connect loop to detergent jug to syringe A)
prevent loop pressurization)

Main Pipetting Sequence
1. Valve A to water jug 16. Syringe B dispenses tip contents into test
unit
17. Syringe A dispenses a specific amount of
3. Syringe A fills with 3250ul water
water into test unit (volume of water is assay
4. Syringe B fills with water (amount is test dependent)
dependent)
18. Valve 2 on (connect loop to detergent)
5. Valve B to tip
6. Syringe B fills with 5ul air slug syringe)
7. Syringe B fills with reagent (amount is test 20. A fills with 1000ul of detergent
dependent)
21. Valve 2 off (disconnect loop from detergent)
22. Syringe A dispenses 1500ul of detergent
9. Valve A to tip into dump well of wash station
10. Valve 1 on (divert flow from syringe A to 23. Valve 2 on (connect loop to detergent jug to
wash well of wash station) prevent loop pressurization)
11. A dispense of 1210ul of water to wash well 24. Valve 4 on (divert flow from A directly to
dependent) 25. Syringe A dispenses 1500ul of water
through tip into home well of wash station
26. Valve 2 off (disconnect loop from detergent jug)
syringe) 27. Valve 4 off (restore normal flow from A
syringe)
15. Valve 4 on (divert flow from A directly to
Dilution Pipetting Sequence

Note: This sequence is the same as Main Pipetting Sequence, with an interim dilution sequence to
obtain and mix the diluent with sample.
After step 6 in the main Pipetting sequence, the following interim dilution sequence occurs:
1. Syringe B fill with diluent (amount is test 9. Valve 1 on (divert flow from syringe A to
dependent) wash well of wash station)
2. Pipettor rinses at wash station 10. A dispense of 1210ul of water to wash well
3. Valve 1 on (divert flow from syringe A to 11. Sequence then resumes from step # 7 in the
wash well of wash station) Main Pipetting sequence
4. A dispense of 1,210ul of water to wash well
dependent)
6. Pipettor to dilution cup
7. Syringe B mixes sample with diluent in
dilution cup
8. Pipettor to wash station

3.8 Instrument Temperatures

Within the IMMULITE 1000 system there are three areas of temperature control: the Luminometer and
Incubator Carousel are heated, and the Reagent Carousel is cooled. Aside from the areas that are
controlled, two other areas are also monitored: the ambient temperature of the electronics area and the test
unit processing area. For details on how the heating and cooling is measured and controlled see the
description of the Heater/DC Motor PCB in Chapter 4: Printed Circuit Boards.
Luminometer Temperature - (Blankets Cold Resistance should be less than 10 ohms.)
The Luminometer temperature is the most critical temperature in the IMMULITE 1000 system. It must be
controlled in the range of 36.9C - 37.1C to assure precise incubation of the Test Unit. The heater is a
75-watt etched foil type heater that is sandwiched between the base of the Luminometer module and the
lower part of the Luminometer housing. Since the Luminometer is a large mass of metal (aluminum) the
heater can take up to 45 minutes to be within normal range. On top of the Luminometer there is plastic
cover that will prevent any ambient air temperature change from affecting the Luminometer temperature.
The thermistor assembly that measures the temperature of the Luminometer is screwed into a hole located
directly behind the Luminometer chain motor assembly and connects to J7 on the Luminometer Interface
PCB. The DC resistance of this thermistor at 37.00C is 6013 ohms. The temperatures at which an alarm
will be activated are below 36.80C and above 37.20C.
Incubator Carousel Temperature (Blankets Cold Resistance should be less than 10 ohms.)
The incubator temperature is the second most critical temperature in the IMMULITE 1000 system. It
must be controlled in the range of 36.5C - 37.5C to assure precise incubation of the reagent, sample,
water and antibody coated bead. The heater is a 75-watt etched foil heater that adheres to the inside
circumference of the Incubator Carousel. The watt density of the heater is higher at the ends to prevent
these areas from being cooler. The warm up time of the Incubator Carousel is approximately 15 minutes.
Around the two sides and bottom of the incubator casting, foam insulation and a plastic cover keeps the
temperature uniform along the circumference. A clear plastic shroud on top of the casting and ring gear
keeps the air in the incubator casting at a constant temperature and protects the operator from coming in
contact with the moving ring gear. The thermistor assembly that measures the temperature of the
incubator carousel is screwed into a hole on the bottom side of the Incubator Carousel located at the 1:00
position of the circumference, and then connects to J6 of the Incubator Carousel Interface PCB. The DC
resistance of this thermistor at 37.00C is 6013 ohms. The temperatures at which an alarm is activated are
below 36.00C and above 38.00C.
Reagent Carousel Temperature
The amount of time the reagents are stable is directly proportional to the temperature at which they are
kept (the cooler they are kept, the longer the stability). The reagent carousel is cooled to an average
temperature of 16C by a thermal electric cooling device hereafter referred to as the TED. At instrument
power-up, the TED will begin to cool the reagent carousel only after the Incubator Carousel and
Luminometer have exceeded 35C. (This is to prevent a large current draw at power-up.) Under average
conditions (starting temperature of reagent carousel at 25C) the reagent carousel will take approximately
15 minutes to reach normal operating temperature. The thermistor that measures this temperature is
located on the upper right corner of the Reagent Bar Code Reader PCB and is identified as RT1 on the
PCB. The DC resistance of this thermistor at 16.00C is 15000 ohms. The temperature at which an alarm
will be activated is 22.00C.

System Ambient Temperature
This is the temperature of the cavity that is created when the main cover is closed. The temperature of this
area is monitored to alert the operator of rising ambient temperatures that could eventually cause a
problem with both of the incubation temperatures. The measuring thermistor is located on a small bracket
mounted on the incubator carousel motor assembly. The thermistor is connected to J7 on the Incubator
Carousel Interface PCB. The temperature at which an alarm will be activated is 34.00C.
Electrical Ambient Temperature
This is the temperature of the area where the main PCBs are located. The temperature of this area is
monitored to insure the main PCBs are operating in a relatively cool environment. The measuring
thermistor is located on the Heater/DC Motor PCB and is identified as RT1. The temperature at which an
alarm will be activated is 40.00C.
GENERAL TEMPERATURE INFORMATION

Incubator Reagent System Electrical
Luminometer
Carousel Carousel Ambient Ambient
Minimum
Control Range
Operating 36.90 36.50 16.0 N/A N/A

Temperature
Maximum
Operating 37.10 37.50 16.5 N/A N/A
Temperature
Lower Alarm
36.80 36.00 N/A N/A N/A
Temperature
Alarm
Range
Upper Alarm
37.20 38.00 22.00 34.00 40.00
Temperature
Minimum
displayable 34.XX 34.XX 11.60 11.60 11.60
Reportable
temperature
Range
Maximum
displayable 39.XX 39.XX 41.XX 41.XX 41.XX
temperature
6013 ohms @ 6013 ohms 15000 ohms 10000 ohms 10000 ohms
Thermistor Resistance
37.00C @ 37.00C @ 16.00C @ 25.00C @ 25.00C
Note: XX stands for the numbers that will vary depending on the circuit components of each specific
Heater-Motor PCB, and its controller circuitry.

3.8.2 Viewing Temperatures
The easiest way to view temperatures is to operate the IMMULITE 1000 as if tests are processing. Once
the instrument is running for at least 1 minute, choose the "System Status" option (on the task bar at the
top of PC screen). Then choose "View Temps and PMT Counts." The latest temperature data sent to the
PC from the IMMULITE 1000 will be displayed. New temperature data will be updated to the computer
every 10 seconds during the chemistry run cycle, in real time.
The quickest way to view the temperatures when not running chemistry is to load the diagnostic program
that will send temperature data to the computer. The diagnostic program for this purpose is TEMPS. After
selecting the diagnostic from the menu and choosing RUN, select VIEW to display the current
temperatures. Updates will appear approximately every 10 seconds in real time.
For both viewing options described, the Temperature Screen will appear, as in the example below:

3.8.3 Heater and Cooler Shutdown
In the event the temperature control circuitry cannot establish or maintain one or all temperatures within a
certain range, the controlling circuitry assumes an irreversible condition exists and will shut down the
operation of the heaters and/or cooler in order to protect the instrument from possible damage. If one or
all of the temperatures are out of the normal operating range but not beyond the shutdown limits, an error
will be posted on the computer, but nothing will enter into shutdown mode. For example, the Reagent
Carousel temperature rises to 23C because the cover of the Reagent Carousel housing is open for an
extended period of time. The error will post on the computer and the temperature control circuitry will
attempt to bring the temperature down for an indefinite period. Since the temperature is not above 30oC,
the cooler shutdown timer will not be activated.
Note: If a condition exists that sends the Temperature Controller system into a full shutdown, the error
display box will overlay the existing screen, which will specify the area of trouble which actually caused
the controller circuit shutdown. This is a main part of evidence for proper diagnosis.
If a Heaters/Coolers Shutdown or a Full Temperature Controller Failure condition exists, error messages
will be seen on the display and in the error log.
Note: In the event a short circuit occurs in one of the transistors that controls the power applied to a
heater (resulting in full power applied to that heater); a thermostat will terminate the power to that heater
when the temperature of the heated device reaches 45C. This Runaway Thermostat will again allow
current to flow to the heater when the temperature of the device decreases to 43C. While it is not
permissible to process test units at this elevated temperature, no damage to the Luminometer or Incubator
Carousel heater blankets occurs if these temperatures are reached.
A full Temperature Controller shutdown occurs under one or more of the following conditions:
Luminometer and/or Carousel temperature is less than 35C for more than 60 minutes
Luminometer and/or Carousel temperature is greater than 39C for more than 10 minutes
Reagent Carousel temperature is greater than 30C for more than 30 minutes
Reagent Carousel temperature is less than 15C for more than 10 minutes
Note: The only way to reset the Temperature Controller circuitry after a full shutdown is to turn the
instrument off, wait ten seconds and then power the instrument back on.

3.8.4 Temperature Controller Status Indicators
There are four LEDs on the Heater/ DC Motor PCB that indicate the status of the Luminometer heater,
Incubator Carousel heater, Reagent Carousel cooler and the controlling microprocessor. The controlling
microprocessor LED also called the time hack indicates that the microprocessor is active. The other three
LEDs indicate what the transistors that control the heaters and cooler are instructed to do, not necessarily
what they are actually doing. For example, if the source to drain junction is shorted on the transistor that
controls the Incubator Carousel that temperature will quickly rise. Once the temperature rises above 39C
(for 10 minutes) the microprocessor will instruct the transistor to turn off and the Incubator Carousel LED
will indicate the same. Since the transistor is shorted, power is still being applied to the heater. Therefore,
the activity of the heater and cooler LEDs is a reflection of the reported temperature of that particular
device, except if the microprocessor has chosen to shutdown the heaters and/or cooler.
TEMPERATURE CONTROLLER STATUS LEDS

LED # L4 L3 L2 L1
Luminometer
Identity TED (Cooler) Carousel Heater Time Hack
Heater
Microprocessor has had

LED Lum temp is below Car temp is below a fatal error. The status
Temp is above 16.5C
"ON" 35C 35C of all other LEDs is
invalid!
- Temp is below 16.5C

- Lum temp is above - Car temp is above
- Cooler has shut down 39C 39C Microprocessor has had
LED due to a heater or cooler a fatal error. The status
"OFF" temp error. - A Full Temperature - A Full Temperature of all other LEDs is
Controller Shutdown Controller Shutdown invalid!
- Lum and/or carousel has occurred. has occurred.
have not reached 35C
Heaters and cooler have Heaters and cooler have

LED Microprocessor is
Heaters and Cooler shut down due to Lum shut down due to car
functional and the CPU
Blinking have shut down due to temp high error. A Full temp high error. A Full
and Motor Driver PCBs
@ 1hz cooler temp error. Temperature Controller Temperature Controller
are in communication.
Shutdown has occurred Shutdown has occurred
LED
Lum temp is above Car temp is above 35C
Blinking N/A N/A
35C and below 39C and below 39C
@ 5hz

Rear LED Indicators:
The Temperature LED indicators are

easily visible through this slot next to
the cover support struts.
The order Left to Right of the LEDs

is # 4 1:
TED, Lum, Carousel, Time Hack
3.8.5 Effectively Troubleshooting Temperature Problems

Tips on properly changing the Thermal Electric Device (TED)
The newest Melcor model (as well as the previous model by TE Technologies), come as a
replacement kit, with a new heat transfer pad & a small foam gasket for placement into the
channel around the chamber plate above. Complete instructions are enclosed, and remember
important replacement notes:
Proper flat metal-to-metal contact
Presence of the Heat Transfer Pad
Placement of foam gasket around bottom

plate of the Chamber above
Tips for effective temperature problem-solving

Successful troubleshooting is very dependent on a full understanding of the theories of operation, so
piece together evidence from all sources:
Current temperature readings (use real time readings of the TEMPS diagnostic program).
Behavior of the four temperature LEDs in rear electronics.
Exact wording of Error Messages relating to the problem.
Are errors constant, or intermittent?
If circuits have shutdown, gather evidence, re-set Instrument logic, and re-evaluate readings and
LEDs after warm up time, in order to trace true problem.

Use of the temperature diagnostic TEMPCAL in order to check the PCB Circuits
Found on the Configurations menu, this program helps determine if the true source of the trouble is
the temperature controller circuits, or else within the system itself. A value displayed out of specified
range would confirm the suspicion of the shutdown problem to be sourced at the Controller PCB, and
it is recommended to replace it, as there is no repair or re-calibration possible for the calibrator
resistor circuits.
The test indicates the calibration values of the 35-degree, and then the 39-degree calibrator
resistor circuits which control Reportable Range of the two heaters. Follow the instructions on
the IMMULITE 1000 display panel for any reading out of the following ranges:
Key Points of operational theory for temperature display and control

The signal devices are NTC Thermistors
NTC = Negative Temperature Coefficient For rise in temperature, there is a drop in
devices resistance value reported to temperature control, and vice-versa.
This inverse relationship is essential to properly understanding any troubles.
Luminometer and Main Carousel only report real numbers in a reportable range of 35 -39C:
If the reading is frozen at 34.xx, check power to heater.
If the heater is getting power, then 34.xx may be an open circuit for anywhere along the
path of the thermistor signal to the Temperatures Mtr./Htr. PCB.
Reasons for 34.xx could also be an open or shorted heater blanket, but this is rare.
If the heater is reporting 39.xx, then the opposite is true: heater is overheated, or the
devices signal is shorted.
Reagent (and the 2 ambient monitors) can report a wider range of reportable numbers - 11.6C
42C.
If Reagent or two ambient temperatures report 11.6C, then there is always an open
thermistor signal path. (The Reagent cannot cool to such a low degree!!)
If Reagent is reporting 17C 19C, this usually indicates failure of one of the two inner
Peltier devices, which means imminent failure of the entire TED.
If Reagent is reporting a temp of 20C 27C, but the TED is running (fan breeze
underneath, and rear LED #4 on left is on) and the chamber feels warm, then this is
clear indication of a failed TED, which needs to be replaced.
Reagent will not come on at all, until both Heaters are first satisfied to above 35C, and
into displayable range.

Troubleshooting the cause of a full Temperature Controller Failure and Shutdown
Keep some key theories of shutdown operation in mind, in order to properly determine the true cause:
Upon the moment of controller circuit shutdown, all temperatures will freeze on the last
reported real temps at the moment of the shutdown. This would be very important to
investigation of the true cause.
Do not yet reset the Instruments power to restart the temperature control circuits. In doing so, you
will spoil an important piece of evidence.
View the readings in the real time environment of VIEW button, after loading the TEMPS
diagnostic.
Wait until fatal errors post which indicate the controller has shut down. Close the error boxes to
reveal a sampling of the temperature readings, and click the PRINT button to capture this screen
on paper.
Note: After five cycles of the software acknowledging temperature shutdown, it will recognize this as
a fatal condition, and will automatically shutdown the IMMULITE 1000 software to the Windows
desktop. If the user wishes to avoid this, stop the TEMPS diagnostic on the IMMULITE 1000 before
it has the chance to post five fatal shutdown errors.
On the printout, take note of all temperature numbers, as these were the last true readings at the
time of shutdown:
One of the five parameters is likely to report an abnormal reading and that is the likely
parameter which is the cause of the temperature shutdown.
The rear Temperature Indicator LEDs may or may not help reflect the parameter which is
truly at fault. In the case of the heaters, this is dependant upon the specific controller
circuits of that PCB. HOWEVER, if the TED is the cause of shutdown, the rear LEDs
will show numbers 1 (time hack) and 4 (TED) blinking slowly on/off together, or
alternating. This may also be true for the heaters causing shutdown, but in either case,
this unusual LED behavior confirms the circuits are currently in shutdown.
After gathering ALL the available evidence, then reset Instrument power, and observe the
temperatures after a warm-up, to then observe the improper operation of the troubled parameter.
This can confirm proper diagnosis.

3.9 IMMULITE 1000 Computer & Windows Software Programs
3.9.1 The IMMULITE 1000 On-Board Computer

Specifications:
Integrated PC with Intel Motherboard ProX 1650 or 1750; consisting of onboard audio,
video, and networking
Processor: Intel Pentium IV or Celeron; 700 MHz or higher, Flip-Chip
Single Hard Drive: 20 GB or higher
RAM: 256 MB
Operating System: Microsoft Windows 2000
24X CD ROM Drive and 3 Floppy Disk Drive
15 Inch Flat Screen Monitor with Touch Screen capability 1024 X 768 resolution
Trackball and Micro Keyboard
Peripheral Devices: DeskJet or Laser Printer, USB/RS232 Router
Power Supply: PC-Standard Compatible switching 110/200/220 VAC
Power & C Drive activity Indicators:

Right Green = Computer Power On/Off
Vent Filter On-Board PC Power Switch Left Red = Hard Drive activity
FRONT
3 Floppy A Drive and CD ROM Drive
REAR
Part Identifications:
1. Power Cord 5. IMMULITE Port (COM1) 9. Touch screen Port (COM 2)

2. Power Switch 6. Printer 10. Modem Port (COM 3) 3.
3. Mouse 7. Video Output 11. LIS port (COM 4)
4. Keyboard 8. Sound output

Maintenance Notes Regarding the On-Board Computer
Generally, the computer is conceived and designed to be an easy slide-in/slide-out
replacement as an entire module, in the case of a major hardware problem or failure.
However, in specific cases, the Floppy or CD-ROM Drives can be replaced from a standard
commercial computer parts supply retailer.
Refer to Sections 7.4.12 and 7.4.13 for specific information regarding software database
contents and maintenance procedures.
Consult Siemens Diagnostics Technical Support for apparently uncorrectable file or drive
problems.
3.9.2 IMMULITE 1000 Software Programs

When the "RUN IMMULITE" option is chosen from the Start Up Menu Task Bar, a number of
files are automatically loaded to the IMMULITE 1000. The files and a description of each are as
follows:
1. LO***.HEX - The Low-Level Program
This program contains the assembly code and subroutines called upon by the high-level program.
2. HI***.HEX - The High-Level Program

This program contains the specific commands that call the sub-routines in the low-level code. For
example a typical command found in this program is "Pipettor X to home position." That command
calls a sub-routine in the low-level software that moves the X-pipettor in a counter-clockwise
direction and checks the X-pipettor home sensor after every step made by the motor.
3. VOL***.HEX - The Volume Table
This table defines the amount of sample, reagent, water that are used to process every type of test
available in the current version of software. When a test unit is about to be pipetted the low-level
program checks the volume table to see how far to move the syringes for a specific volume.
4. MESS***.HEX - The Message Table
This table contains all the messages that are displayed on the IMMULITE 1000 vacuum fluorescent
display. This table currently holds approximately 75 different messages. When the high-level
program must give the operator specific information or must ask the operator for information, it
instructs the low level program to display a specific message number. The low-level program then
retrieves the text for that specific message number and sends it to the display.
5. ERR***.HEX - The Error Routine Program
This program contains specific routines that are called by the low level program in the event a motor
comes upon an error. (Refer to "Configuration Table- Parameter Error Number" for more
information). For example, if the Load Chain moves more than the number of error steps allowed, a
problem is assumed and corrective action must be taken. The low-level program will then retrieve the
Load Chain error routine and run it. The success or failure of the routine will determine if the low-
level program allows the load chain to continue to operate or terminates operation in the instrument
(resulting in front end shutdown). The corrective action is different for every motor in the instrument,
therefore, every motor has a separate routine in the error routine program.

6. IMMXXX.CNF - The Configuration Table (Instrument specific)
This is the table that contains the settings for all the motors. Refer to Section 7.2: The Configuration
Table for more information.
As the software is updated, these characters may also change to reflect the new software version
number.
Note: For information on utility programs and procedures, refer to Section 7.4: Miscellaneous
Procedures. For information on Diagnostic programs, refer to Chapter 8: Diagnostics.
Export Utility Program

Patient reports can be consolidated using the export program. This program allows the user to access data
by test time and date and test type. The information can be viewed, printed, or saved in ASCII format to
a diskette. The ASCII file is compatible with other software (i.e. spreadsheets).
It can be used to:
Retrieve data resulted during a specific time period
Retrieve a particular type of data (Patient, Adjustor, Control, etc.)
Retrieve data pertaining to a particular test
Procedure
Select System Status from the Drop-down Menu.
Select Export Results. The following screen appears:

Select DATE AND TIME. The following screen appears:
Note: The test time is the time the sample cup was read at the Barcode Reader - not the time the Test Unit
was measured by the PMT.
Select ALL to export all data. Select TODAY ONLY to export data generated today. Select
SPECIFIC RANGE to export from a specific date and time range.
If SPECIFIC RANGE is chosen:
Click in the From Date field and select a date from the calendar window, followed by OK.
Click in the From Time field and select a time from the clock window, followed by OK.
Click in the To Date field and select a time from the calendar window, followed by OK.
Click in the To Time field and select a time from the clock window, followed by OK.
Select OK.
Choose the Data Type to be exported by selecting ALL, PATIENT, ADJUSTOR,

CONTROL, and/or VERIFIER.
Use the UP and DOWN arrow buttons to highlight the Test Type to be exported.
Select export method:

SCREEN to view the selected data on the screen
FILE to export the selected data to a file
PRINTER to print the selected data
If FILE is chosen as the export method, use the down arrow to choose a file from the list.
Select the sorting method:
PATIENT NAME
ACCESSION #
Select the Field Delimiter:

Click Tab to separate the data with tabs
Click Comma to separate the data with commas
The export output file includes:

Sample Cup Holder number
Test Code
Accession number
Patient last name
Dose (concentration result)
Dilution factor
Response (in CPS)
Kit lot
Analysis time (time of final result)
The On-line Help Option

The On-Line Help tab on the upper tool bar provides several avenues of familiarity with the system:
Reviewing the IMMULITE 1000 operating software, instrument operation, and assay chemistry
Training secondary instrument operators
Performing routine maintenance and diagnostic procedures
Troubleshooting the system components

Chapter 4: Printed Circuit Boards
4.1 Introduction
This section contains descriptions of the Printed Circuit Boards, or PC Boards. Refer to the Assembly and
Schematic Manual for actual drawings of the boards.
4.2 CPU/Sensor PCB

Description
The CPU/Sensor PCB communicates with the computer, monitors
all stepper motor sensors, and valves, communicates with syringe
pumps using slave CPU, and communicates with heater control
CPU (located on the DC Motor/Heater Control PCB).
Theory of Operation
The heart of the IMMULITE 1000's CPU board is the ZILOG
Super 8 microcontroller. This versatile IC features 40
programmable I/O lines, two 16-bit programmable counter/timers,
an on-chip oscillator, DMA controller, a full duplex UART, 272
general purpose registers, a sophisticated interrupt structure, and
an instruction set that supports multiplication and division
instructions. A single Super 8 microcontroller is used to perform
the following real-time functions of the IMMULITE 1000:
1. Control all electro-mechanical motions except for those of
the syringe pumps.
2. Process all sensor and user control signals.
3. Generate appropriate messages for the vacuum fluorescent display.
4. Read and interpret the barcode label information.
5. PMT pulse counting.
6. Supervise all data flow between the three processors on board the IMMULITE 1000, and the On-
Board PC.
When the power is turned on, the IMMULITE 1000 performs initialization routines. Program instructions
stored in EPROM #1 are accessed with 15-bit addressing. The lower byte is obtained from Port 0 of the
Super 8 and latched from the address/data bus. Port 0 is wired to a multiplexed bi-directional address/data
bus. The upper seven bits of the address are obtained from Port 1, which is dedicated to addressing.
Program instructions from the EPROM and data from the non-volatile static RAM are then placed on the
data bus to be read by the processor.

The memory mapped input-output (I/O), only requires the lower byte of the full 15-bit address for data
transmission. The upper byte of the address is generally decoded for the I/O space. When an I/O function
is performed, the lower byte of the address is latched. The address is then decoded to select the proper
data path. For an output operation, data from the processor is placed on the data bus and this data is
grabbed by the proper output latch dependent upon the correct address decoding. For an input operation,
the opposite takes place and information from a sensor is gated by one of six input buffers. When the
proper input device is selected via the address decoding, the sensor signal is placed on the data bus to be
read by the processor or stored in RAM to be processed at a later time.
Additional independent I/O ports of the Super 8 are used to process IMMULITE 1000 information.
Separate input port lines are used to read the conditioned signal from the sample and assay barcodes, and
the Reagent Carousel barcode reader circuit. An additional port line is used to count the pulses produced
by the signal conditioning circuitry of the Photo Multiplier Tube (PMT).
A second Super 8 resides on the CPU board. This processor, part of the IMMULITE 1000's parallel
processing system, is used to control the operation of the syringe pumps. The controlling Super 8 sends
pump commands to the syringe pump CPU through the dual port RAM via the bi-directional data bus and
the address bus labeled BA (refer to the Schematic of the CPU PCB, drawing number 350004). When the
commands for the pump are received by this processor, the main CPU is free to process information for
other parts of the IMMULITE 1000 system. The Super 8 controlling the syringe pumps then interprets
this data to determine the type of operation required of the syringe pump. Numerical data must be
converted from hexadecimal to decimal base, binary information must be converted to ASCII format, and
the proper control characters for pump operation must be generated. When the commands have been
processed, the syringe pump Super 8 sends the serialized data to the syringe pump using the on board
universal asynchronous receiver transmitter or UART and an RS232 conversion IC. The syringe pump
Super 8 also receives information from the pump via the RS232 port describing status and error
conditions.
Acknowledgement that the command has been received and the task properly carried out is controlled by
the Hamilton CPU. Upon completion of the pumping operation, the Hamilton Super 8 sends the
appropriate response to the main CPU through the dual port RAM.
In addition to controlling data transmission within the IMMULITE 1000, the main Super 8
microcontroller manages the data flow between the on-board PC and the IMMULITE 1000 through the
on-board serial data path and an RS232 level shifting IC.

Description
Contains five drive circuitry positions for the following Front End
stepper motors (driver positions labeled L-R):
a. Pipette Z
b. Pipette X Driver Positions L-R; a, b, c, d, e
c. Reagent Carousel
d. Load Platform Chain
e. Main Incubator Carousel

Nearly all of the mechanical motion of the IMMULITE 1000 is performed with the use of four phase
unipolar step motors. All the motors are driven with a single common circuit designed to meet a wide
variety of system demands including mechanical power, positional resolution, power efficiency, and low
cost. At the center of this circuit is the L297 step motor controller. This single integrated circuit provides
the step motors with pulse width, modulated current control, all the decoding logic necessary to sequence
the motor phases properly, and the ability to control two-phase and four-phase motors. Because of the
versatility of this IC, the CPU controlling the motor is relieved of much of the responsibility for motion
control. The CPU only needs to provide step and direction data to the control IC to achieve motor
operation.
Power on initialization information from the main CPU is gated by the address and data buffers on the
Stepper Motor PCBs. The initialization data sets up the motor controllers for full step four-phase motor
operation. After initialization, a motor will step when its address is decoded and a step pulse is sent to the
controller. Each time a step pulse is received by the controller, its internal translator causes the proper
motor phase winding to energize, which causes the rotor to advance one position. The step motor remains
in this position until a subsequent step pulse is received.
When a motor phase is energized, a single MOSFET (Metal Oxide Semiconductor Field Effect
Transistor) power transistor is turned on, allowing an electrical current to be passed through the phase
winding. To improve system efficiency and performance, the current level circulating in the phase
winding is controlled using Pulse Width Modulation, (PWM). A current sensing resistor of low value is
used to develop a voltage proportional to the winding current. This voltage is conditioned to eliminate
noise and is then transmitted to an input of the control IC. This input line is internally connected to one
port of a voltage comparitor. The other input to the comparitor is connected to a digitally selectable
voltage reference. The voltage reference is used to set the maximum allowable current supplied to the
motor winding. When the voltage developed by the sense resistor is equal to the reference voltage, an
internal flip flop is reset, causing the control IC to turn off the power transistor that allows current to pass
through the motor winding. An internal oscillator running at 24 kHz sets the flip flop and turns the
transistor on before the motor current has decayed below its set point value. This way, the current passing
through the motor phase winding appears to remain constant, even though the power transistors driving
the motor windings are turned on and off.
When the motor is not used to actively drive a mechanical load, the reference voltage used to control the
magnitude of the phase current is digitally switched to a lower value. This will result in a lower current in
the motor winding. Lowering the motor current will reduce the energy consumption of the system while
maintaining the fixed position of the mechanical load.
Motor protection in the form of a Positive Temperature Coefficient (PTC) thermistor is provided. In the
event of a short circuit in the system, the PTC device, normally a low impedance device, heats up in 15
seconds. When the protection device heats sufficiently, the impedance rises to a very high value, thus
shutting off the current to the load. The device remains in this high impedance state until the circuit short
is removed from the load.

Description
a. PMT Attenuator Disk Motor
b. Tube Transport Shuttle Motor
c. Luminometer Chain Motor
Note: Positions d and e, as per illustration on page 4-2, are not used on this Motor Driver #2 PCB.
This board is identical to the Stepper Motor Driver #1 except for the switch settings of the jumpers at the
top edge.
4.5 Heater/DC Motor PCB

Description
Contains the drive circuitry for the following:
1. Linear Actuator Wash Pumps
2. Syringe module valves
3. High-Speed Spinner motor
4. Sample/Assay Barcode Reader motor
5. CPU, data acquisition, and control circuitry to drive the
heaters and cooler.
Circuit Description:
The Heater/DC Motor board performs the following control functions for the IMMULITE 1000 system:
(1) temperature measurement and control of the Luminometer, the Main Carousel Incubator, the Reagent
Carousel, the PC board housing, and the ambient temperature within the instrument package, (2) velocity
control of the reaction unit wash operation, (3) velocity control of the sample/assay bar code motor and
(4) power distribution to the solenoid valves and the wash fluid and substrate pumps.
To provide the temperature control critical to the performance of the IMMULITE 1000 system, a
dedicated ZILOG Super 8 microcontroller is used to process temperature measurement data in real time
and in response, control the amount of heat applied to the assay incubator and Luminometer and remove
heat from the Reagent Carousel. Temperature control begins with the precise temperature measurement at
key system positions. A semiconductor Negative Temperature Coefficient (NTC) thermistor with a
guaranteed measurement accuracy of 0.05 oC is embedded in the Luminometer and Main Carousel

housings.
This assures that the temperature measured is as close as possible to that of the reaction temperature. The
resistance vs. temperature curve of the thermistor is linearized with a full bridge network. The bridge
components consist of high precision resistors, 0.1 % tolerance with a temperature coefficient of 25 ppm,
and it is driven with a high precision band gap voltage reference. The components were selected to
provide signal linearization while limiting power dissipation by the thermistor to 10 microwatts, thus
eliminating any drift in transducer accuracy due to self-heating. This results in a bridge output signal of
424 microvolts / 0.1 oC over a temperature range of 35C - 39 oC.
Four thermistor inputs are processed by the high precision section of the temperature measurement
circuitry. These are the signals from the Luminometer, the Main Carousel Incubator, and the two
calibration resistors used to set the system linearity each time the IMMULITE 1000 takes a series of
measurements. The signals from these sources are routed through a differential multiplexer that was
chosen for its low- leakage currents and its ability to reduce the magnitude of the common mode noise
impressed on the low- level signal. This signal is amplified by an instrumentation amplifier with a gain of
233. The differential low-level signal is converted to a single ended output covering the full dynamic
range of the amplifier; optimizing the resolution of the signal when it is converted to a 16-bit binary
value.
This amplified signal, proportional to temperature is then passed through an analog switch, buffered, and
converted to a digital signal using a dual slope A/D converter. The digitized signal is then processed by
the Super 8 microcontroller and a special algorithm, stored in the EEPROM, designed to provide
proportional and integral type control of the system heaters. The measurement and control system is
capable of maintaining the temperature of the Luminometer at 37C+/- 0.1C and that of the Main
Carousel Incubator at 37C+/- 0.5oC.
A second group of bridges and thermistors is used to measure the temperatures of the Reagent Carousel,
the main electronics housing, and the ambient temperature of the system itself. The temperature
measurement range of these areas is wider, 15 C to 40 C and has a less demanding degree of accuracy.
Therefore, some precision is sacrificed to keep the processing circuitry simple by using the high precision
circuitry as a calibration reference for this low precision circuitry. The signals are processed exactly as
those of the high precision circuitry, using quality components. A second instrumentation amplifier with a
gain of 43db is used to convert the differential signal to a single-ended output using the full linear range
of the amplifiers capability. This signal is also selected, buffered, and converted to a digital signal with
the same dual slope A/D converter as the high precision circuit.
Control Theory:
The operation of the heater/cooler control system is completely independent with respect to the main
system control. Data passed from the heat control CPU to the main control CPU consists only of the raw
temperature values. In return, the main CPU will only communicate with the heat control CPU when an
error condition within the system has been detected. All data is passed back and forth through a dual port
RAM, capable of storing data until the respective processors can service the inter-processor messages.
At power up, the heat control processor is activated. After a delay of approximately 20 seconds (to
prevent a power surge) the heater outputs are simultaneously turned on at over 99% of full power to bring
the system to temperature in the shortest possible time. After the Luminometer and Incubator Carousel
have reached 35, the cooler is then activated. Two of the input signals to the high precision circuit are
produced by the calibration resistors resident on the printed wiring board (PWB). These high precision
resistors produce a bridge voltage representing the thermistor signals produced at exactly 35C and 39oC.
Under processor control, the proper signal is selected, and routed through the addressable multiplexers

and analog switches. The control measures these voltages after a period of time, which allows the
electronic circuits to rise to operating temperature. This reduces the effect of temperature drift on
measurement accuracy and precision. The control algorithm performs a two-point calibration based on the
end point signals produced by the high precision resistors. This sets the accuracy and precision of the
entire temperature control system. This dynamic calibration is performed at the beginning of every
measurement cycle. It takes into account the small inaccuracies caused by component offsets and
eliminates the need for potentiometer trimming while eliminating the long-term effects caused by aging.
The calibration of the lower precision measurement is mathematically derived from the high precision
values.
After calibration, the control algorithm makes periodic measurements of system temperatures and
determines the quantity of heat required by each system component. The processor then turns on the
driver for the heater or cooler for the appropriate length of time. A proportional algorithm keeps the
system temperature within the correct range, while an integral algorithm eliminates the effect of varying
ambient temperatures within the systems operating specifications. The temperature controller stays on to
keep the system at the proper operating temperatures as long as the IMMULITE 1000 is powered on.
Motor Control:
This PCB also contains two DC motor velocity controllers. One (R120) is used to control the velocity of
the Sample/Assay Barcode Motor. The other (R107) is used to control the high speed wash station motor.
Control of the proper motor is performed by the main system CPU. The address sent out on the bus is
decoded and the data is latched by the circuitry on the board. The only control signals generated by the
main CPU are to turn on, off and to stop the high-speed motor.
The high-speed wash motor is a special design of a 3-phase brushless DC motor produced for Siemens
Diagnostics. This motor was designed to meet the IMMULITE 1000 system requirements for small size,
high torque, and rapid acceleration. Control of the high-speed motor is accomplished with the use of a
chip set from the Motorola Corporation. This set consists of a controller IC, a full 3-phase power
MOSFET bridge driver, and a velocity detector. This chip set is used to produce the proper phasing
sequence of the motor windings, establish the pulse width modulation frequency, limit the motor winding
current, and control the velocity of the rotor.
When the enable signal from the main processor is received by the control, IC a leg of the bridge driver
supplies electrical energy to a phase winding of the motor. Hall Effect devices internal to the motor
monitor the rotation of the rotor and return to the control IC a Transistor-Transistor Logic (TTL) level
signal that determines the sequence in which the motor windings are turned on and off. The amount of
current flowing through the motor winding is measured by the sense resistor at the base of the bridge
driver. This current is limited to the rating of the winding to avoid damage to the motor. A comparator
internal to the control IC will turn off the winding when this current level is reached. When the motor is
first turned on, the winding will draw as much current as possible to generate the large amount of torque
required to accelerate the motor as quickly as possible to its final velocity.
As the motor comes up to speed, the Hall Effect device signals used to sequence the phasing of the motor
windings are sampled and integrated by the velocity detector. The output of this detector is a DC voltage
that is proportional to the speed of the motor. This is filtered to eliminate noise, and fed into the inverting
input of an op amp internal to the control IC. This op amp is configured as an inverting differential
amplifier. The other input to the amplifier is connected to an adjustable reference voltage, which is used
to set the motor velocity. The output of this amplifier is used to vary the duty cycle of the pulse width
modulator in the control IC.

The motor will accelerate to the speed required to produce a detector voltage equal to the setting of the
reference voltage. If the detector voltage is less than the reference setting, the motor speed will increase.
If the detector voltage is greater than the reference, the motor will slow down. This feedback control
circuit keeps the motor speed constant to tight tolerance without the use of an external shaft encoder,
keeping parts count minimal and maintaining overall lower costs without sacrificing system performance.
When the enable signal is removed, the brake signal is applied to the control IC. This causes the motor
windings to be shorted together. This dynamic braking action brings the motor to a stop more quickly
than simply allowing the motor to coast to a stop.
The Sample/Assay Bar Code Motor circuit is also configured as a feedback control network. An oscillator
internal to the control IC sets the PWM (Pulse-Width Modulation) frequency at approximately 4.8 kHz.
When the enable signal is applied to the control IC, the output of the controller turns on the PNP power
transistor, at the same PWM frequency. This supplies current from the power supply to the motor
winding, causing it to rotate. Because of physical constraints, the motor and gearbox are positioned in a
very small space. There is no room for any type of encoder, which could be used to control the motors
velocity. Thus, the motors velocity is controlled by measuring its back EMF (Electro-Magnetic Field), a
voltage generated by the motor when it is rotating and not energized by the power transistor. When the
controller turns the power transistor off, a 555 timer IC used as a one shot is triggered. This produces a
timed pulse used to enable the sample and hold the amplifier to measure the rotating motors back EMF.
Since the motor is rotating and the power transistor is off, this back EMF is proportional to the speed of
the motor. The magnitude of the back EMF is divided by R1 and R2 to limit its value and is then stored
by the sample and hold (S/H) amplifier. The output is then low pass filtered to eliminate noise and sent to
the inverting input to an op amp internal to the control IC. The other input to the op amp is connected to
an adjustable reference voltage which is used to set the motor speed. The output of the amplifier is used to
set the duty cycle of the pulse width modulator. This way, the amount of electrical energy sent to the
motor windings is proportional to the difference between the set point voltage and the back EMF
generated by the motor. If the load on the motor increases, the speed of the motor will slow down,
unbalancing the amplifiers input and will cause the output of the controller to apply more current to the
motors winding, thus causing its speed to increase toward the set point. If the motor load decreases, the
opposite occurs, the pulse width decreases because the motor requires less energy to maintain its angular
velocity.
Additional Circuits:
In addition to the motor and heat controls, the PCB supports the capability of turning on eight general
purpose loads. For the IMMULITE 1000, these loads consist of several solenoid valves, and the two
injector pumps supplying the system with water for bead washing, and the luminagenic substrate. The
main control CPU controls these devices and determines when and for how long to turn them on.

Chapter 5: Specifications
The following is a table describing the performance characteristics and specifications of the IMMULITE
1000 Analyzer.
Specifications
General Standard Mode Throughput: Up to 120 tests per hour
Specifications:
Time to first result: 42 Minutes
(or 72 minutes for two cycle assays)
(four if dilution cup included)
General Turbo Mode Throughput: Up to 80 tests per hour
Specifications:
Time to first result: Less than 15 minutes for a one-cycle
assay
Less than 22 minutes for a two-cycle
assay
(four if dilution cup included)
Luminometer Detection method: Photomultiplier Tube
Specifications:
Wavelength of Emitted 425 to 500 nm
Light:
Incubation temperature: 37C +/- 0.1C
Internal Computer Computer: Intel Motherboard ProX 1750 with
Specifications: on-board audio, video and
networking
Minimum Req. RAM: 256 MB
Minimum Req. Hard drive: 10 GB
Monitor: 15inch Flat with Touch Screen
1024 X 768 resolution
Auxiliary Drives: 3.5 Floppy / 24X CD ROM Drives

Specifications
(120 Volts):
(IMMULITE 1000 only): During Operation - 700 W
(220 Volts):
(IMMULITE 1000 only): During Operation - 800 W
Environmental Operating environment: Between 65F - 86F (18C -
Specifications: 30C), Humidity 20-80%
(no condensation)
Noise Specifications: Noise generated by the A weighting scale 60Db-SPL
IMMULITE 1000 System B weighting scale 68Db-SPL
while processing tests:
Fluidics Specifications: Water used per test: 4.20mL (450 tests per full water
container)
Probe Wash used per test: 1.0mL (1000 tests per full probe
wash container)
Physical Specifications: Dimensions: Height: 19 (48cm)
(Analyzer Only) Width: 46 (117cm)
Depth: 26 (66cm)
Weight: Approx. 240 lbs. (109 kg)
Heat Output Approx. 1000 BTU/hr
Specifications:

EC Declaration of Conformity
according to directive 98/79/EC
We,
DPC Cirrus Inc.
62 Flanders-Bartley Road
Flanders, NJ 07836
a subsidiary of Diagnostic Products Corporation
5210 Pacific Concourse Drive
Los Angeles, CA 90045-6900
declare under sole responsibility that the following equipment to which this declaration relates, meets the essential
health and safety requirements and is in conformity with the relevant sections of applicable EC standards and other
normative documents. If changes are made to the product which is covered by this declaration of conformity, the
declaration of conformity is no longer valid.
Equipment type: In Vitro Diagnostic Medical Device
Model: IMMULITE1000
Serial Number: __________
EC Directives: 93/68/EC, 89/392/EC (91/368/EC, 93/44/EC),

73/23/EC, 89/336/EC
Harmonized Standards
Used: EN55011, EN60555-2, EN60555-3, EN50082-1,
EN61000-3-2, EN61000-3-3
National and other IEC 1010-1, IEC 801-2,3,4, IEC 1000-4-2, IEC 1000-4-4,
standards and technical ENV50140, ISO 9001:1994 (BS EN ISO 9001:1994),
specifications: 21CFR, Part 820 FDA cGMP, EN46001: 1996;
ISO 13485: 1996; UL 3101-1, Laboratory Equipment
Notified body according

to Annex VII: Not Applicable
employed to hold the documentation and evaluate the safety issues of this equipment.
Date/Signature of manufacturer
Title of signatory: Vice President, Regulatory Affairs and Quality Systems___2000
Date/Signature of EU representative
Title of signatory: ______________________________________________________

Instrument Warranty Statements
LIMITED WARRANTY
Siemens Diagnostics warrants that the items delivered hereunder are of good material and
workmanship, and are free from defects in design and manufacture. Siemens Diagnostics
responsibility is limited to repairing or replacing any item or part, for a period of one (1) year
after delivery to the original purchaser. Defects caused by improper operating conditions,
misuse, negligence or alteration of the product void this warranty. Siemens Diagnostics shall not
be liable for any direct, indirect, incidental or consequential damages arising out of possession or
use of the items. Consumables, as defined in the appropriate Siemens Diagnostics Price List for
Instrument-Related Parts, Racks and Consumables are not covered by this warranty.
LIMITED SOFTWARE WARRANTY

Siemens Diagnostics warrants that the Software will substantially conform to specifications and
to the documentation, provided that it is used on the computer hardware and with the operating
system for which it was designed. Siemens Diagnostics also warrants the disks on which the
Software is recorded to be free of defects in material and workmanship under normal used for a
period of ninety (90) days from the date of purchase.
CUSTOMER REMEDIES
Siemens Diagnostics entire liability and your exclusive remedy shall be replacement of the
Software that does not meet Siemens Diagnostics Limited Warranty and which is returned to
Siemens Diagnostics. The Limited Warranty is void if failure of the Software has resulted from
accident, abuse, or misapplication.
NO OTHER WARRANTIES
Because the software is inherently complex and may not be completely free of errors, you are
advised to verify your work. The software and related documentation are provided as is.
Siemens Diagnostics disclaims all other warranties, either expressed or implied, including but
not limited to implied warranties of merchantability and fitness for a particular purpose, with
respect to the software and the accompanying written materials. Siemens Diagnostics shall not
be liable for any direct, incidental, or consequential damages arising out of possession or use of
this product.

Chapter 6: Preventive Maintenance (PM)
6.1 Description
Preventive maintenance is an important service function that must be performed at least once a year. This
prevents problems from occurring due to normal wear or adjustments changing over time. The following
Preventive Maintenance Kit (p/n 420140) is available which contains all the parts that may need to be
replaced:
Main Fan Filter 500818

Water Filter (Replacement Kit for tube #82) 400364
Probe Wash Filter (Replacement Kit for tube #83) 400365
Small Syringe Tip 901395
Large Syringe Tip 900271-01
Large Syringe O-ring 900271-02
Substrate Spike 900558
Assay Tube Roller O-rings 900613
Assay Barcode Drive O-ring 900771
Shuttle Idler Wheel Kit 420001
Probe Replacement Kit 420063
Bottle Cap Filters (Water and Probe Wash) 900966
Main Drain Tube (5 ft) 900691-27
Water Testing Units (Qty. 10) 500001
Computer Filter (Qty.1) 902584
When performing Preventive Maintenance, be sure to use the IMMULITE 1000 Annual Preventive
Maintenance Report, available from Siemens Diagnostics Field Service as a guide to ensure all items are
covered. The rest of this chapter outlines each item in detail.

6.2 General Checkout
Discuss past performance with customer: This is one of the most important steps in a PM. Customer
communication ensures that any problems that the customer is experiencing are addressed. This helps to
guarantee that customer satisfaction is achieved after you leave. Ask for any specific situations that the
customer may have seen or heard on the IMMULITE 1000. Make sure that items discussed are closely
investigated during your visit.
Check Error Log: Refer to Section 7.4.13: Checking the Error Log for more information. Review the
past two months. Check for consistent error messages. They could be warning signs of impending
problems. Also do not be concerned with individual isolated messages. They may just indicate an
operator error.
Make any necessary upgrades: A list of current upgrades and standards are available from Siemens
revisions.
Change main fan filter and verify main fan operation: Check the fan filter and grill for any accumulated
dust, clean if necessary. If the filter is only lightly dusted, it can be rinsed out and dried like a sponge.
Make sure that nothing is obstructing the fan from spinning smoothly. Check to make sure the fan is
operating whenever power is on.
6.3 Power Supply

Check voltages at the Syringe Interface PCB: Check voltages at the main power connector (A15-J1) on
the Hamilton/Euro Interface PCB. Pins can be accessed through the side of the connector with small pin-
Instruments lid. Ensure voltages are in tolerance as shown on the PM report.
locating the quick-connect connection for the cable of the PMT. Tap into these points to read the +/- 5V
supplies dedicated to the PMT. Ensure voltages are in tolerance as shown on the PM report.
Verify power supply fan operation: Also ensure Main Power supply fans on the mid-right side of the
Instrument are running.
6.4 Syringe Module

Lubricate lead screws and guide shafts for each dilutor: It is recommended to use a medium-weight AFC
(Anti-Fretting Corrosion) grease. Use the recommended grease and a long plastic tool to lubricate the lead
screw and guide shafts for each dilutor. The lead screw can be accessed through the lower opening of
each dilutor and the guide shafts are located at the left of the same openings. Run the PRIME diagnostics
for at least a minute to work in the grease. Wipe off any excess grease.
Inspect micro and macro valves on the Hamilton dilutors: The valves on the Euro units are clear acrylic
manifolds only, but should be inspected for any cracks or other damage. For the Hamilton units, these
white-bodied ceramic rotary valves should be checked for full proper seating against the manifold of the
dilutor. If a gap is seen, remove the syringes using the SCHANGE diagnostic. Rotate the cam lever below
each rotary valve to the right (3:00) to release. (If needed, loosen the top Allen set screw that may be
locking the valve stem in place). Reseat the valve fully against the dilutor manifold, and re-secure the cam
locking mechanism by pointing it again to the downward (6:00) orientation.

Check straightness of syringe B plunger: Remove the plunger from the B syringe and roll it on a
straight surface, checking for wobble. If the plunger appears to be bent, replace the whole syringe. Do not
replace just the plunger, as the plunger and glass is a mated pair that is measured and calibrated together.
Do not re-insert the plunger into the syringe yet; proceed to the next PM item.
Replace 5000ul and 250ul syringe tips: Remove both plungers from both syringes. Replace the tips on
both plungers using a small pair of grip pliers (Be careful to prevent bending the plunger shaft of the
small syringe, and be sure the lower white plunger shaft guide is properly seated into the base of the
syringe barrel).
CAUTION: Make sure the tips are fully seated on the end of the plungers. Gently press the tips straight
down onto a flat surface until a click is felt. The large syringe should also be gently rolled on its tip to be
sure it is straight. Take extreme care not to bend the shaft of the small syringe during this process.
It is recommended to pre-moisten the new large syringe tip with the IMMULITE 1000 water before re-
inserting it into the glass syringe. If resistance is felt, gently pull the plunger back out and re-insert until
there is an even smooth travel upon re-insertion. Do not rotate the plunger when re-inserting, this can
cause the syringe to dislodge again later.
Run the PRIME diagnostic and check for excessive bubbles particularly in the small syringe. If necessary,
disengage the thumbscrew from the plunger during the PRIME and manually move the small plunger
abruptly up and down to clear persistent bubbles. Be careful to prevent any side pull as this can bend or
damage the plunger shaft.
Check operation of V1, V2, & V4: Tests V1, V2, and V4 operation. Refer to Section 7.4.4: Miscellaneous
Procedures for information on checking the operation of the valves.
Check the operation of the micro and macro valves: Run the PRIME diagnostics. Proper operation can be
verified by checking that fluids are running in the proper direction.
6.5 Pipettor/Reagent Carousel Module

Check X-Pipettor belt for wear: Visually check for any fraying or cracks on the edges of the belt. The belt
should ride on a flat plane. General judgment of tension should be applied. It should deflect
approximately 1/8inch when the center of the belt is pushed. If a belt is too loose or too tight, intermittent
pipetting errors could occur.
Check X- and Z-Pipettor positions: For the X-Position, manually place the X-Pipettor Position Gauges
p/n 420078 and run the PIPXPOS diagnostic. Refer to Section 7.4.5: Miscellaneous Procedures for
more information.
For the Z-Position, run the UPDOWNA and UPDOWNH diagnostics. Evaluate if the probe bottoms out
in the home well when using UPDOWNH diagnostic, or hits the bead in the test unit position when using
the UPDOWNA diagnostic.
Check pipettor level sensor operation: Run the Configurations tests LEVFSTST and LEVSNTST, and the
regular menus LEVFALSE and LEVCRASH diagnostics. Refer to Section 3.5.5: Theory of Operation,
and Sections 8.3 and 8.4: Diagnostics of this manual for more information on the use of these
diagnostics.
Check Pipettor-Z lead screw and slide bearing: Visually check for excessive wear, dust or grime
accumulation. No lubrication is generally necessary as this can cause future dust accumulation. Check for
smooth travel.

Check tip-jam sensor operation: Run the TIPJMTST diagnostic found under the System Configurations
diagnostic menu. After the program checks five times, a pass/fail result is displayed on the control panel.
Check reagent tray positions (Home and Position): Check for the proper position of the home sensor by
placing a wedge in the home position (Position 1) of the Reagent Carousel and run the REAGENTH
diagnostic. The red LED should shine an oval shape centered between the edge of the wedge and the first
barcode line.
Check for the proper position of the individual position sensor using an empty reagent carousel and while
running the REAGENTP diagnostic. Look down directly through the individual notches found around the
edge of the carousel and check that one of the position sensor heads is centered in the notch. Verify all
wedge positions are centered over the sensor head underneath.
Change probe and check dispense: Replace the probe with the new one supplied in the PM kit.
CAUTION: Do not over-tighten the fitting.
The probe tubing must be placed in the notch of the vanity panel with the small rubber O-ring located
behind the panel. Manually turn the pipettor to ensure the tubing doesnt twist or kink. Adjust or flip the
tubing as needed to avoid coiling or wrapping around the pipettor tower.
Check the dispense quality of the new probe. Run the PROBETST diagnostic. Look for any excess liquid
moving up the tip of the probe shaft, or any splashing out of the side of the home well. When the probe
momentarily lifts and moves to the dump well, look for any dripping out of the probe. Dripping indicates
back pressure or occlusion inside the probe or at its 4-way junction block at the syringes
Run the PROBANGL diagnostic to evaluate the angle of dispensing. Verify that the dispense does not
exceed 7 - 10 degrees off center (check angle from various sides of the instrument). Also, check for
excess spiraling of the stream. No more than one spiral should occur per inch.
6.6 Luminometer Module

Lubricate and check upper shuttle bearing: Refer to Section 7.3.12: Removal and Replacement of
Assemblies, for instructions on the removal of the slide bearing assembly. Remove the upper section of
the shuttle assembly.
CAUTION: Be aware of the small rectangle shim located underneath this slide bearing. Be careful not to
drop or lose it. A dab of grease can be used upon re-assembly to help keep it in place.
Remove the slide bearing and rail. Clean off any excess old grease. Use a clean small blade screwdriver to
work new grease into the rails where the ball bearings reside. After re-assembly into the instrument, slide
the bearing back and forth on the rail to work in the grease. Wipe off any excess.
CAUTION: Do not allow the slide railing to completely disengage from the bearing.
Change small idler wheel assembly: Refer to Section 7.3.13: Removal and Replacement of Assemblies
for instructions on the replacement of the small idler wheel assembly. The entire assembly including the
shaft on which the wheel rotates, should be cleaned.

Check the high- speed spinner O-rings: Take a flashlight to visually inspect the O-rings of both the rear
drive wheel and outer idler wheel for cracks or wear. Wipe clean with a damp paper towel or replace the
wheel assemblies if damage is found.
Set High- Speed Spinner speed (5400-5600) RPMs: Run both the configurations menus SPNCKTST, and
the regular menus WASHSPD diagnostics, to monitor and/or adjust the high speed spinner speed, and its
error-checking capabilities. Refer to Section 8.0: Diagnostics for more information on these tests.
Check shuttle positions and verify shuttle sensor flag is not bent: Run the SHUTTLE diagnostic to ensure
the proper positioning of the Shuttle in all positions. Refer to Section 8.0: Diagnostics for more
information. Use a flashlight and manually move the shuttle to check that the flag end moves correctly
and is not physically bent or broken.
Check for proper wash & spin of test unit: Load 15 test units with approximately 200 ul of water on the
carousel one position before the Shuttle position. Run the ATTENTM diagnostic to visually check for
proper wash and spin operation. The test unit should slightly lift on the first spin and the liquid should
quickly clear from the bottom of the tube. Watch that the bead moves off the bottom of the tube and floats
in air, while the tube is spinning. This item should also be checked during the final chemistry run of the
instrument.
Check Luminometer Chain positioning and tension: Run both the LUMCHECK and SHUTTLE
diagnostics to evaluate the Luminometer Chain position versus the shuttle. It is best to remove the
Spinner Platform for direct visual clearance for the checks. Refer to Section 8.0: Diagnostics for more
information on the chain position adjustment. The chain should align so the shuttle passes through the
center of a Luminometer Chain baffle.
Check the tension of the Luminometer chain by gently pushing the front span of the Luminometer Chain
behind the load platform. It should gently touch the black drain trough assembly of the shuttle without too
much strain. The chain should not excessively tilt to one side as it enters the Luminometer. This indicates
a loose chain section at the Luminometer entrance, adjusted by the rear boot within the Luminometer.
Check for slippage between Lum Chain and motor shaft: Use the SCHANGE diagnostic (or any
diagnostic where motors do not move). This will energize all the motors in the system and put them in
standby. Look for excessive play at the front left tooth gear of the Luminometer chain. More than a very
slight play may indicate looseness of the inner drive coupler for the chain.
Check attenuator belt for wear: Look for any fraying or cracks on the edges of the belt. Check for
deflection of approximately inch at the center span of the belt.
Check attenuator sensor disk for slippage: Use the SCHANGE diagnostic (or any diagnostic where
motors do not move). This will energize all the motors in the system and put them in standby. Grip the
attenuator position sensor disk with one hand and shake it in and out and back and forth. It should only
have slight play and be tight to the shaft.
PMT: Background counts and Dark counts: Run the DARKCNT and BKGNDCNT diagnostics. Using
GetDataT (selecting the VIEW button), allow approximately five readouts to print for each test. Note
the average readings on the blank lines of this report, and enclose the printouts with the PM report.
Background counts should have no more than 20 - 40 cps difference between attenuated and unattenuated
counts. Dark counts should not have readings greater than 60 or 70 CPS, and cleaned CPS readings
should be in the range of 0 - 40 CPS.

6.7 Main Carousel Module
Check Main Carousel ring gear positions: Run MCARTST (on the configurations menu), CARPOS,
CARBACK, CARCHECK and CARSHAKE diagnostics to check the operation and positioning of the
carousel. When running CARCHECK, check for proper alignment of the ring gear with the shuttle. Make
sure the shuttle is centered between two baffles of the carousel ring gear.
6.8 Load Platform/Sample Tray Module

Disassemble and clean assay tube roller assembly: Entire roller assembly should be visually inspected
and cleaned. Look for spilled patient samples throughout the area and on the top of the load platform
casting where the sample cups travel. Evaluate the rollers and pins. Look for elongated holes on the inner
diameter of the rollers. This could cause the rollers to wobble as they turn. Look for worn ends of the
roller (they should be rounded). Check that the pins are not excessively scratched, scored, or show signs
of black dust. Replace rollers and/or pins as needed.
Replace assay tube roller O-rings: Refer to Section 7.3.7: Removal and Replacement of Assemblies for
instructions on the replacement of the assay tube roller O-rings.
Replace barcode reader drive O- ring: Refer to Section 7.3.7: Removal and Replacement of
Assemblies for instructions on the replacement of the bar code reader drive O-ring.
Set barcode reader speed to 750-790 ms/rev: Run BCODESPD diagnostic to adjust the barcode reader
speed. Use a minimum of four test units to check all four positions around the idler assembly. Each
position should not vary more than 40 msec of each other. If it does, check and/or replace rollers and pins
or check for even rotation of the drive O-ring.
Check operation of sample/test unit barcode reader: Run the BCODETST diagnostic. Evaluate if any of
the rollers are wobbling from their center axis. Look for any high or low spots on the orange barcode
reader main drive O-ring. This item should also be checked during the final chemistry run of the
instrument.
Check Load Chain and star wheel positioning: Check Load Chain positioning using LCHAIN
diagnostics. Ensure that Load Chain baffles alignment across the Carousel casting is consistent. Refer to
Section 7.4.6: Miscellaneous Procedures for more information on these alignments.
Check spacing of Sample Tube Guides: Refer to Section 7.4.7: Miscellaneous Procedures for more
information on this alignment.
Check Sample Tray full and Tray removed sensor operation: Run the SAMPFTST and SAMPTTST
diagnostics found in the system configuration menu. Perform diagnostics as directed by the prompts on
the display.
Check Load Chain position sensor for dust accumulation: Access the position disk in the center lower
chassis. Use a flashlight to visually inspect for dust within the position sensor and check the top of the
sensor disk for dust accumulation. Run the LCHAIN diagnostics to turn the Load Chain position sensor
disk. Gently ride the wheel with a finger to remove dust accumulation. Move your finger outward
whenever a position slot is felt. This will avoid dust from depositing into the slots. Blow into the area to
remove any remaining dust accumulation.

6.9 Linear Actuator Substrate and Water Wash Pumps
Check volume of Substrate & Water Pumps: Make sure the shuttle is in the full left position so that
substrate doesnt accidentally leak onto the Luminometer Chain. Disconnect the tubing on top of the
substrate heater and hold a sample cup under the substrate tubing. Run the SOLE2S diagnostic to prime
up and then dispense two shots. Use the Alarm Mute button to pause and control the shots into the cup.
The approximate level of substrate should be at the fourth line of the sample cup (two shots at 200 ul =
400 ul).
Disconnect the water nozzle and hold a sample cup under the water nozzle. Run the SOLE1W diagnostic
to prime up and then dispense two shots. The approximate level of water should also be at the fourth line
of the sample cup.
Check that drawback of pumps is inch (+/- 1/8inch): Make sure the shuttle is in the full left position so
that substrate doesnt accidentally leak onto the Luminometer Chain. Disconnect the tubing on top of the
substrate heater. Observe the drawback at the end of the tubing. Refer to Section 7.4.4 for more details.
Hold a waste cup under the substrate tubing and run the SOLE2S diagnostic to dispense multiple shots of
substrate. Check that the drawback after each shot dispensed. The proper drawback is inch +/- 1/8 inch.
Perform the same test for the water pump using the SOLE1W diagnostic, disconnecting the water nozzle.
The proper drawback is inch +/- 1/8inch.
6.10 Substrate Module

Replace substrate spike: Refer to Section 7.4.3: Miscellaneous Procedures for information on the
replacement of the substrate spike. Be sure to wear gloves while performing this procedure.
Check manual prime button: Verify proper operation by squeezing the button and checking for bubbles in
the substrate bottle and the reservoir level in the fill window moving up. Also run the configurations
diagnostic SUBLVTST to check proper operation of the reservoirs level sensor.
CAUTION: Do not push the button, as this can cause damage to the button.
6.11 Fluidics
Replace water & probe wash filters: Replace the probe wash and water in-line filters (clipped to left rear
instrument wall), using the filter assemblies supplied in the PM kit. The blue marked assembly is for
water, and the yellow marked assembly is for probe wash.
Take careful note of the proper orientation of the replacement filter canisters and related tubing, being
sure the filters mount correctly as per instructions. Refer to Section 7.4.2: Miscellaneous Procedures for
more details.
Replace air filter in caps of water and wash containers: Replace with filters from the PM kit.
Replace waste tubing and check waste path for blockage: Replace with waste tubing from the PM kit.
Check all other waste tubing and manifold block for blockage or clogs. Clean and/or rinse as needed.
Check all tubes for kinks and tighten all fittings: Visually check the tubing for any kinks. Check that all
tubes are finger tight.

Decontaminate system and test for contamination: Refer to Section 7.4: Miscellaneous Procedures for
information on performing system decontamination. Enclose a copy of a printout of the final
WATERTPM test with the PM report. If decontamination of the substrate system is needed, consult
Siemens Diagnostics Technical Support for detailed options and procedures.
6.12 Computer Software

Verify Attenuation Factor is correct. CAF =: Access the KITS.EXE program to verify values. Ensure
Verify PMT Multiplier is correct. Multiplier =: Access the KITS.EXE program to verify values. Ensure
Check Software Version. Version =: Check the software version on Main Menu screen. Record it on the
PM report.
Insure configuration table matches instrument serial number: From the Desktop, go to Windows
Explorer. Select the IMMULITE 1000 folder, then double-click the subfolder DOWNLOAD. Within
this folder you will see the Instrument-specific file. Only one file should be listed. It should have a name
format of IMMxxx.cnf (where xxx is the serial number of the instrument) and it should always have a file
size of 488 bytes. Delete any other .cnf files that are present.
Print configuration table and place in electronic area: Run the TABLE diagnostic from the System
Configurations menu. After pressing Go on the IMMULITE 1000, the table is posted. Select the PRINT
button to print the full table, including motor parameter numbers.
Note: Be sure to manually write the instrument serial number, CAF value and PMT value on the printed
output of the configuration table.
6.13 Temperatures
First check the substrate heater temperature. Remove the cover on the substrate heater. Using a DVM set
to DC volts place the leads on the test points of the Substrate Heater PCB. Run the SUBSHEAT
diagnostic. Record the starting (ambient) temperature and final (heated) temperature on the PM report.
The DVM reading is in direct correlation to the temperature. Multiply the measured voltage by 100 and
this will be the temperature in Centigrade. The stabilized temperature should be 36.6C +/- 6 o C. After
measuring the temperature, be sure to terminate the program so that the substrate is not heated for a long
period of time.
Check all other temperatures while running the final chemistry run (the next step in the PM) by going into
the System Status menu, and select the View Temp/Dark Counts option. Record all temperatures on the
PM report.

6.14 Final Checkout & Customer Satisfaction
Run Controls (adjust first if necessary): Verify proper system operation by running available chemistries
at the account. If adjustment of the assay is required, do this prior to running controls.
Note: Controls should be run in five replicates of each level control. Look for the majority of replicates to
be in range. Updated control ranges are issued regularly or can be found in the associated package insert
of the CON6 control module.
Check the database logs after the adjustment and compare the last adjustment for that assay with the
current one run. Ensure there is reasonable consistency between the two.
Ensure the customer is happy with the final chemistry run results and that all issues and questions have
been addressed. Do not leave until final confirmation has been made with the customer.

Chapter 7: Repair Information
7.1 Tools and Equipment

To properly service the IMMULITE 1000, certain tools and equipment are required. Some of these are
not used often, but are absolutely necessary for specific tasks. For example, the retaining O-ring pliers are
seldom used, but if the need arises to remove or install a retaining ring, no other tool will be a suitable
substitute. The list of tools and equipment a service person should have when servicing an IMMULITE
1000 is as follows:
Ballpoint hex key set (1/20", 1/16", 5/64", 3/32", 7/64", 1/8", 9/64", 5/32", 3/16")
Hex driver blade set with driver handle (same sizes as above)
4 inch and 8 inch blade extension
Metric ballpoint hex key set (1.5mm, 2mm, 2.5mm, 3mm, 4mm, and 5mm)
Large slotted screwdriver, 1/4" tip, 4" blade
Small slotted screwdriver, 1/8" tip, 4" blade
Large Phillips screwdriver, #2 tip, 4" blade
Small Phillips screwdriver, #1 tip, 4" blade
Flashlight
4" wire cutters
4" and 6" diagonal pliers
Wire strippers 26 - 16 awg (American wire guage)
Retaining ring pliers (reversible)
Right angle retaining ring pliers
5-6" scribe
Potentiometer adjustment tool
Tweezers
Large (13") and small (5") pick-up tool
Inspection mirror
9/64" ballpoint hex driver blade, 4"
Soldering iron (with solder and a solder removal device)
Adjustable wrench
Miniature slotted and Phillips screwdrivers, 1mm blade width

Digital Multimeter
Miniature open end wrench set (1/4", 5/16", 3/8")
Logic probe
Not all of the tools listed are readily available outside the United States however, any or all of the above
can be purchased from Siemens Diagnostics.

7.2 The Configuration Table
Description
The motor configuration table allows for mechanical adjustments to be made via software. This eliminates
the need for slotted sensors, long screwdrivers, and sore backs. Also, the design of the modules was made
easier since sensors did not have to be as accessible (don't worry, the two sensors that are a bit "buried"
rarely fail).
Since the configuration table holds all of the mechanical adjustment information, it can be considered the
heart of the instrument. As we all know a human heart cannot be transplanted in another body unless that
body is a perfect match. The configuration table to instrument match is very similar. If a configuration
table is put into an instrument that is not a perfect match, the instrument will not operate correctly. It is
possible for an instrument to have the wrong configuration table and still operate, but not correctly.
Depending on the severity of the mismatch an incorrect configuration table will cause problems of
varying magnitude, anywhere from slight to large. This is why it is very important the correct
configuration table be used with the instrument.
The configuration table is loaded into the instrument whenever a program (diagnostic or assay
processing) is run. The computer does not know which table to load, so it selects the first one it comes to
as it scrolls through the C:\IMMULITE 1000\DOWNLOAD folder list. Careful reading of the previous
two sentences should allow you to predict the possible result of having more than one configuration table
in the DOWNLOAD folder of the IMMULITE 1000's computer. If additional configuration tables were
placed in this directory, the computer might load this incorrectly, resulting in incorrect operation.
However, warnings to this will post to the user within the software.
During assembly, the IMMULITE 1000 is loaded with a generic configuration table. Thus we can say
each configuration table is created equally. The name of the generic configuration table is then changed
to reflect the serial number of the instrument is has been placed on. As each module in the instrument is
aligned, the values change in the configuration table to reflect the instrument that has become its new
"home." After the instrument is aligned, the configuration table and instrument are now "one" and must
never part.
Note: When facing the instrument, the IMMULITE 1000 serial number can be found on the left side of
the instrument in the upper right corner of the instrument label.
The configuration table is a file located in the C:\IMMULITE 1000\DOWNLOAD folder of the computer
and is always prefixed by the letters IMM followed by an alphanumeric or numeric number. The type
of file is known as speedial. This is the Windows recognition of the DOS .cnf file type. For example,
the configuration table for IMMULITE 1000 serial number D0100 is IMM0100.CNF. The alphanumeric
or numeric number within the file name is part of the instrument serial number. (The serial numbers
prefix letter code is not in the file name.)
Parameters
The configuration table has many parameters, each of which represent an adjustment within the
instrument. Each parameter has a parameter number, parameter name, error number, and extra number.
These are defined as:
Parameter Number: The identification number of the parameter.
Parameter Name: The abbreviation of the specific adjustment the parameter represents.

Parameter Error Number (commonly known as "error steps"): All of the motors that move a device to a
specific position are stepper motors. Therefore, when a stepper moves a certain distance, that distance is
proportional to a number of steps. The number of steps that a motor should take to move to a position is
fairly constant from instrument to instrument. If the motor must take more steps than the nominal to reach
position, a problem exists and corrective action must be taken. This point or number of steps when the
corrective action is initiated is defined as the error steps.
Example: It is known that the number of steps the load chain motor must take to move from one position
to the next is approximately 550. After adding a tolerance factor, we set the error steps for this parameter
to 600. As long as the Load Chain motor reaches the next position within the 600 step limit, no errors are
reported. If for some reason one of the components that are necessary for a successful move has failed
(motor, sensor, cabling, etc.) or the chain has jammed, the number of steps sent by the microprocessor
will exceed 600 and corrective action will occur.
Notes: 1. For reasons too complicated to explain, the error steps in parameters 32, 33, and 34 do not set
the point of corrective action initiation, they set the depth of the probe in their respective
positions.
2. The error steps for parameters 36-40, and 42-48 are not used and set to zero. These parameters
use the error steps (200) from parameter 8. 3.
The error steps for parameter 35 (Diluent) should stay set at 160, and should not change. Extra
steps are not used.
Parameter Extra Number (commonly referred to as "extra steps"): This is the parameter that sets the
mechanical positioning of all sensors in the instrument. The mechanical components of the instrument
were designed such that when a sensor is triggered by a device driven by a motor, that device then has a
small number of steps more to move to be positioned properly. The small number of steps taken after the
sensor has been triggered, signaling a proper position of the device is defined as the extra steps.
Example: The Load Chain motor begins to move the Load Chain to the next position. After 550 steps the
open slot in the sensor disk reaches the optical sensor and allows light to flow through the sensor
triggering its output. The microprocessor then looks at the configuration table for the number of extra
steps needed to properly position the Load Chain and sends that additional number of steps to the motor.
To put the positioning in terms of coarse vs. fine, think of the mechanical placement of sensors as the
Error Step coarse adjustment and the Extra Steps as the fine adjustment.

Sample of Configuration Table Printout

Configuration Table Delineation
ERROR EXTRA
# NAME DESCRIPTION
RANGE RANGE
0 LcPos Sets the positioning and error detection of the Load Chain. Fixed 35-180
Sets the positioning and error detection of the Main Carousel

3 McPos Fixed 5-25
Ring Gear.
Not currently used (McHome stands for Main Carousel Not Not
5 McHome
home). used used
Sets the error detection and horizontal positioning of the

7 PxHome Fixed 2-12
probe when moving to the home well.
Error steps are used for error detection of the pipettor when
8 PxPos moving to one of the X-Pipettor positions. Extra steps are Fixed 5-13
only used in a few diagnostics.
Not currently used Not Not

9 PxH2W
used used

10 PzHome Fixed Fixed
when moving up to home.

11 PzMid Fixed Fixed
position when moving down to the mid sensor.
Not currently used. Not Not

12 Tip Jam
used used
The error steps are used to set the minimum sample volume. Not
13 LevSensS 175-205
The extra steps are not used. used
The error steps are used to set the volume (1000 ul) at which
14 LevSensR 420-464 Fixed
the reagent vial is considered "empty" by the instrument.

15 RcHome Fixed 50-60
carousel tray when moving to the home position.

16 RcPos Fixed 8-10
carousel tray when moving to each position.

21 Sh at Car Fixed 20-40
moving to the incubator carousel position.

22 Sh at Sub Fixed 45-70
moving to the position under the substrate nozzle.
Sets the amount of pressure applied to the test unit when

spinning during the wash cycle. Not
24 Sh Push 50-60
Note: Typically, the extra steps from parameters 22 and 24 used
will have a sum of between 105 and 115.

ERROR EXTRA
# NAME DESCRIPTION
RANGE RANGE
Sets the position of the Shuttle when moving to the Not

25 Sh at Lum 2-15
Luminometer Chain position. used
Sets the positioning and error detection of the Luminometer

26 LumcPos Fixed 40-120
Chain when moving into position.

28 Att Home Fixed 10-50
when moving to the home position.

29 Att Pos when moving to either the attenuated or unattenuated Fixed 10-80
position.

Not
32 Z Home passing the mid sensor when at the home well position of the 155-190
used
wash station.

Not
33 Z Wash passing the mid sensor when at the wash well position of the 80-110
used
wash station.

Not
34 Z Assay passing the mid sensor when at the test unit dispensing 455-492
used
position.
Sets the horizontal positioning of the probe in the home well Not
36 PX Blind 2-20
of the wash station. used

37 PX Dump 2-20
dump well of the wash station. used

38 PX Wash 2-20
wash well of the wash station. used

Not
used
main program.
Used to set the horizontal positioning of the probe at the Not

40 Reagent 2-20
reagent wedge position. used
This position is only used with the new configurations

41 Diluent during the diluent pipetting cycle. This setting should not 160 1-15
change.

Not
used
main program.

43 S5 5-15
44 S4 Used to set the horizontal positioning of the probe at Not 5-15

ERROR EXTRA
# NAME DESCRIPTION
RANGE RANGE

45 S3 5-15

46 S2 5-15

47 S1 5-15
Used to set the horizontal positioning of the probe when Not

48 PX Disp 2-20
dispensing into the test unit. used
General Configuration Table notes:

1. If a number in the table is zero, it indicates that number is unused and should stay set to zero.
2. If a number is not initially set to zero it must never be set to zero.
3. Non-zero settings for extra steps must be in the range of 1 - 255.
4. It is not unusual for a parameter in the table to change by a few steps as most of the settings are
subjective and a different pair of eyes may see a position differently. However, a relatively large
change is indicative of a problem. Even though the change may correct a symptom, a problem may
still exist.
Important: In the majority of cases where a certain motor position is to be changed, it involves many
common alignment positions. For these, it is highly recommended to use their corresponding ADJ
steps adjustment program on this same menu. These will give more accurate step tuning per-instrument.
Direct changes to the fields within the Motor Configuration Table itself are not recommended. If a table
parameter number does not have its own corresponding adjustment diagnostic program, then those table
settings generally never change from the original factory setting, and should not be changed without first
consulting Siemens Diagnostics Field Service.

Accessing the Configuration Table
1. At the Start-up screen, choose DIAGNOSTICS.
2. Choose SYSTEM CONFIGURATIONS.
3. When the System Configuration Program Menu appears choose TABLE, then [RUN].
4. Upon pressing GO on the IMMULITE 1000, the motor configuration table will now be displayed as a
grid of changeable fields:
Note: The actual parameter numbers are not displayed on the screen. Print the table to see a listing which
includes the numbers.
Changing the Configuration Table Parameters

1. Use the trackball to select the parameter number to alter.
Note: Error Steps should NEVER be changed by the user.
2. Enter the number of steps to place, in the Extra Steps column of the table. Click cursor to a
different field than the one just changed, such as a 0 box. Select Save Data to save changes.
3. If another parameter is to change, repeat Step 1.
4. When all changes are complete, choose the Print button to obtain a paper printout as illustrated on
page 7-5.
Note: To keep a proper updated printout in the rear electronics, be sure to replace the existing printout
after any changes are made. Also, obtain the PMT and CAF numbers, and Instrument Serial number, and
write them on the final sheet. Replace into the rear electronics compartment. This printout is insurance of
easy retrieval of all of this information, in case of computer failure.

7.3 Removal and Replacement of Assemblies

It may be necessary from time to time to remove complete modules and/or assemblies for replacement or
to access other parts in the instrument. Some modules overlap each other in the system making it very
important to follow the order listed when removing modules.
After removing modules and/or assemblies, it is suggested to carefully set them aside onto an empty flat
surface with all interfacing parts and screws placed nearby to each other.
Note: All circuit boards in the instrument have an A number associated with it. All cables are labeled
with the interconnecting circuit board A number and a jack position J number. For instance, the Reagent
Carousel interface PCB is labeled A12 and there is a ribbon cable labeled A12-J8 that connects to jack
position J8.
CAUTION: The power cord must be removed from system before starting removal of any module.
7.3.2 Reagent Carousel Assembly / TED Cooler

Note: It is a good idea to drain the fluids from within the internal waste tubings by lifting the power
supply end of the instrument. Hold the instrument up until most of the fluids are drained out into the
waste bottle.
1. Loosen the thumbscrew on the substrate heater and move away from the carousel ring gear.
2. Loosen the ten slotted screws on the main section of the clear plastic carousel cover and remove the
cover.
3. Remove the probe tubing from the notch on black probe vanity panel.
4. Remove the probe by unscrewing it from the upper pipetting arm and unscrewing the fitting at the
syringe module.
5. Loosen two screws holding the probe vanity panel and remove the panel.
6. Loosen three screws holding the Reagent Carousel cover (two located on top and one located on the
left side of cover close to the chassis). Carefully move cover up and away from module.
7. Remove Reagent Carousel Tray.
8. After removing the front lower chassis panel, unplug the two-pin connector (A12-J5) on the Reagent
Carousel Interface PCB that is coming from the TED Cooler below.
9. Loosen the cardboard collar that surrounds the lower part of the TED fan [keeping it in place].
10. Remove two foam pads (do not discard) covering the top screws securing the TED Cooler from
above. Loosen the two screws allowing the TED Cooler to drop into the lower chassis cavity.
11. Manipulate the TED Cooler from out the front of the lower chassis area if replacement or inspection
of the TED Cooler is desired, otherwise the TED Cooler can remain in the lower chassis.

Note: Care must be taken in the TED removal, as space is limited. It may be necessary to shift and/or
remove some of the drain tubing in order to make room. Be careful not to lose the thin black
conductive pad that is sandwiched between the head of the TED. It is required for proper heat
transfer.
12. Carefully remove the following connectors from the Reagent Carousel Interface PCB (do not remove
any other cables):
Wide main connector (A12-J6)
13. Locate and remove the wash well supply tubing (#6) fitting from below the wash well. Remove the
two drain tubes from below the module.
14. Loosen the two screws (keeping them in place) holding the inner sample tube guide located at the
base of the pipettor tower, and remove the inner tube guide with screws.
15. Using a long screwdriver or long nose pliers, free the pipettor tower spiral cable from under the main
carousel casting.
16. Loosen the five captive screws (two located on the left side, two located on either side of the
pipettors positioning sensor, and one located in front of the wash station) securing the module to the
chassis.
17. Grasp module carefully by the pipettor tower on the right and at the carousel casting on the left.
Carefully lift the module straight up from the chassis, being careful to avoid brushing the Reagent
Carousel Interface PCB against the chassis opening.
18. Re-assemble in reverse order. Be careful not to damage to the Reagent Carousel Interface PCB upon
re-insertion into the chassis. Also be sure to re-tuck the pipettor spiral cable connector under the main
carousel casting and make sure the wash tubing #6 is re-connected on the bottom of the wash well.
Reconnect the drain tubing.
7.3.3 Sample Collection Tray Assembly

1. Remove the Reagent Carousel cover by following step 6 from Section 7.3.2.
2. Remove the Sample Collection Tray by pulling it straight up.
3. Loosen (but do not remove) the four screws securing the bottom tray to the chassis.
4. Carefully manipulate the bottom tray away from chassis. It is a tight squeeze under the syringe pump
module and Load Chain casting; however the tray will come out with some patience.
5. Carefully remove connector (A63-J1) releasing it from its retaining clip (located to the right of the
connector).
6. Remove the bottom tray.
7. Re-assemble in reverse order. Ensure sensor cable (A63-J1) and its retaining clip are properly routed
and assembled to avoid pinching of the wire.

7.3.4 Syringe Pump Assembly
1. Remove the Sample Collection Tray Assembly as described in previous section.
2. Remove the blue fitting of tubing (thin tubing at input of small syringe) from 3 point T junction
block mounted to chassis wall behind the module.
3. Remove the blue fitting of tubing at the input of the large syringe.
4. Remove the yellow fitting of tubing (input from probe wash) from Valve V2 (mounted on side of
module).
5. Remove the white fitting of tubing (wash feed tubing for pipettor wash well) from Valve V1
(mounted on side of module).
6. Remove the following connectors from the Syringe Interface PCB located on the right side of the
Syringe Pump Module:
Small blue wire (unlabeled, connects to A15-J10)
Wide 10-pin connector (A15-J1)
7. Using a long Phillips screwdriver with extension, carefully loosen the four captive screws at the base
of the Syringe Pump Module.
8. Carefully lift the module away from chassis.
9. Reassemble in reverse order. All tubing fittings are finger tight, do not cross thread or use a wrench or
pliers. A tightening tool by Upchurch may be used for newer style repairable tubings. Before re-
insertion onto the chassis, ensure there are no wires underneath which may be pinched.
CAUTION: Use extreme caution when re-inserting power connector (A15-J1). If this connector is
not positioned correctly, irreversible damage can occur to several logic boards and/or the main power
supply.
7.3.5 Main Incubation Carousel Ring Gear Assembly

2. Loosen two slotted screws on the rear section of the clear plastic carousel cover and remove cover.
3. Loosen (but do not remove) the four large outer hex screws (located in slotted holes) of the carousel
motor gearbox assembly. Slide the entire gearbox motor assembly away from the Main Carousel Ring
Gear.
4. Locate the three brown delrin blocks with bearings located at the 9:00, 1:00 and 5:00 positions of the
Main Carousel Ring Gear Assembly. Loosen (but do not remove) the 1/8 hex bearings from the top
and slide the delrin blocks away from the Main Carousel Ring Gear.
5. Locate the other three brown delrin blocks (without bearings) located at the 11:00, 2:00 and 7:00
positions of the Main Carousel Ring Gear Assembly. Loosen (but do not remove) the 5/32 hex bolts
from the top of the delrin blocks and slide the delrin blocks away from the Main Carousel Ring Gear.
6. Locate the Main Carousel positioning sensor located at approximately the 1:30 position. Loosen the
single 3/32 hex screw located at the base of the sensor assembly. Loosen (but do not remove) the hex
stud located at the base of the sensor assembly until it can swivel.

7. Holding the assembly by the silver rod at the top, rotate the entire sensor assembly clockwise
disengaging it from around the ring gear.
8. Carefully remove the ring gear straight up.
CAUTION: It is very important that the main carousel casting below the ring gear assembly is not
removed unless absolutely necessary. This is the very first element that is secured into the
instrument. It acts as the point of reference for all other interfacing modules. If it is shifted or
removed, all modular motor movements will have to be re-aligned and the motor configuration
table changed. Consult Siemens Diagnostics Field Service whenever it is deemed absolutely
necessary to remove the main carousel lower base casting.
9. Reassemble in reverse order. Before re-inserting the Main Carousel Ring Gear Assembly, check that
the Main Carousel positioning sensor is still rotated out of the way. Do not over-mesh the gears of the
motor assembly to the Main Carousel Ring Gear. Use moderate pressure only.
7.3.6 Load Platform Assembly

1. Remove all assemblies as described in previous sections 7.3.2 - 7.3.5.
2. Remove three screws securing the Barcode Reader PCB from the top.
3. Remove Barcode Reader PCB. Carefully disconnect connector (A44-J1).
4. Carefully, manipulate cable (A44-J1) through hole and into the lower chassis.
5. Loosen the nine captive screws located around the edges of the load platform base and around the star
gear portion at the left end.
6. Locate the grounding strap located between the Barcode Reader motor bracket and one of the screws
securing the black top cover latch. Remove the grounding strap from the latch end.
7. Slowly and carefully lift the module a small distance from the chassis, being careful not to damage
the cables attached from below. Remove the following cables:
8. The module can now be carefully lifted out of the chassis. Note that the left end is very tight. Be
careful to guide the Barcode Reader PCB cable (A44-J1) out, which is soldered to the interface board.
9. Re-assemble in reverse order. Do not attempt to re-connect cables until assembly is nearly inserted all
the way back into the chassis. Ensure the cable (A44-J1) is properly routed through the lower chassis
before full re-insertion of the assembly.
CAUTION: Be careful not to damage the wires or Interface PCB upon re-insertion through the
chassis cutout.

7.3.7 Sample/Test Unit Barcode Reader Assembly
Sample/Test Unit Barcode Reader PCB Removal/Replacement
CAUTION: Ensure power is turned off before starting the removal procedure. Damage to the
Barcode Reader PCB can occur easily.
Remove bracket.
2. Remove three Phillips head screws securing the Barcode PCB, do not drop any washers into the
instrument.
3. Manipulate the PCB out from its mounts and remove the J1 connector.
4. Re-assemble in reverse order
Sample/Test Unit Barcode Reader Drive Motor Removal/Replacement
Note: Barcode Motor Replacement Kit 420056 must be on-hand to perform the following.
1. Remove the Sample/Test Unit Barcode Reader PCB as described in steps 1 - 4 in Section 7.3.7.
2. Lift the entire motor and bracket assembly from the lower pivot point bushing, while holding the
motor return spring, which is inserted towards the rear of the bracket.
3. Loosen the 5/64 locking hex screw of the barcode motor drive wheel and remove the drive wheel
from the motor shaft.
4. Remove the two small 1.5 mm hex screws securing the motor to the top of the bracket.
5. Cut the wire tie securing the motor wires to the motor body. Trim back the heat shrink tubing of the
wires to expose the connection point with the power cable, which is routed through the small hole in
the bracket.
6. Cut the motor wires from the power cable. Strip new ends to the power cable. Slip a new piece of
shrink tubing (supplied with kit) onto the power cable and through the bracket hole.
7. Solder the connections of the new motor wires, insulating one from the other with electrical tape.
Slide the new shrink tubing over the solder joints. Ensure connections are protected.
8. Use a heat gun to carefully shrink the tubing around the solder joint and through the bracket.
9. Remove the DC Motor/Heater PCB (A2).
10. Replace the Q17 driver FET with one supplied in the kit with a solder iron.
11. Re-assemble the motor to bracket and secure wires to motor body with new wire tie.
12. Re-assemble the Sample/Test Unit Barcode Reader Motor in reverse order. Carefully re-insert the
drive motor return spring.
CAUTION: When re-securing the drive wheel to the motor shaft, be sure to align the screw with the
flat of the motor shaft. Also ensure the drive wheel is at the proper height so as not to rub the motor
mounting screws below or to contact the Barcode Reader PCB opto-sensor above.

Rollers, Pins and O-ring Removal/Replacement
Remove the bracket.
Note: Entire roller assembly should be visually inspected and cleaned. Look for spilled patient samples
throughout the area and on the top of the load platform casting where the sample cups travel.
2. Remove star-shaped retaining bracket by pulling it straight up.

3. While holding the first roller, grasp the pin in the center with needle nose pliers and pull the pin
straight up. Repeat this step to remove all rollers, pins and O-rings.
4. Evaluate the rollers, pins and O-rings. Look for elongated holes on the inner diameter of the rollers.
This could cause the rollers to wobble as they turn. Look for worn ends of the roller (they should be
rounded). Check that the pins are not excessively scratched, scored, or show signs of black dust.
Replace rollers, pins and O-rings as needed.
Drive O-ring Removal/Replacement
Remove bracket.
2. Remove the Sample/Test Unit Barcode Reader PCB as per instructions in Section 7.3.7.
3. Grasp end of O-ring with needle nose pliers and pinch it to break it off.
CAUTION: Be careful not to scratch or damage the drive wheel itself.
4. Prepare the new O-ring and drive wheel by gently moistening them with water.
5. Use two fingers to partially stretch the O-ring around the drive wheel to insert the new O-ring.
6. Just before the O-ring is completely around the drive wheel, carefully insert a small blade screwdriver
between the O-ring and the far side of the drive wheel. Use the screwdriver to pry the remaining part
of the O-ring onto the drive wheel. Do not remove the screwdriver yet.
Note: Once the screwdriver is removed, it is not possible to re-align the seam of the O-ring. If the
seam is not straight, it must be replaced and the procedure started over again.
7. Gently rotate the screwdriver around the drive wheel 5 to 6 times. Visually check that the O-rings
molding seam is straight around the drive wheel without spiraling. Carefully, remove the
screwdriver.
8. Manually press the O-ring into place around the circumference of the drive wheel. Inspect for a
straight seam with no high or low areas on the O-ring circumference.

7.3.8 Injector Pump Assembly
CAUTION: Ensure power is turned off before starting any Pump Module removal or replacement
procedure. Damage to the Injector Pumps PCBs can occur easily.
1. Carefully remove single connector behind the pump, leading from the Y cable from rear of each
pump.
3. Remove front output fitting of the red substrate side and the two rear input fittings from the Wash
Pump Assembly (keep the Water Pump output fitting at front connected).
Note: After removing tubing from the substrate side rear input, raise the tubing and tape it to the
Substrate Reservoir Assembly or bottle, to prevent leakage of substrate.
4. Using a Phillips screwdriver, loosen the two captive screws at the rear edge of the base of the Wash
Pump Assembly.
CAUTION: Do not let the screwdriver shaft damage the pumps or the PMT behind.
5. Lift the Injector Pump Assembly straight up and out of the instrument.
7.3.9 Substrate Heater Assembly

2. Loosen the screw at the rear of the heater to free the wire clip and the L-bracket securing the tube
fitting.
3. Disconnect all wiring from the rear of the Substrate Heater (A162-J1, J2, and J3).
4. Disconnect red substrate output fitting from the top of the Substrate Heater. Allow a few seconds for
the substrate to drain from the heater into shuttle drain below.
5. Loosen the thumbscrew securing the heater to the platform. Remove the entire assembly.
7.3.10 Substrate Reservoir Assembly

1. Disconnect the reservoir level sensor wire from the rear of the substrate heater at J2.
2. Disconnect the tubing from the Wash Pump Substrate input.
Note: After removing the tubing from the substrate pump input side, raise the tubing and tape it to
the Substrate Reservoir Assembly or bottle, to prevent leakage of substrate.
3. If present, disengage the bottom drain tubing of the Substrate Reservoir Assembly.
4. Loosen the single captive screw at the base of the Substrate Reservoir Assembly.
5. Remove the entire assembly from the platform being aware of the slot that is cut into the base at the
rear of assembly.

7.3.11 High Speed Spinner Motor and Drive Wheel Assembly
Note: The following instructions cover removal steps for the entire assembly and then the High Speed
Spinner Motor and Drive Wheel Assemblies. Proceed as far as needed to the last step as appropriate.
1. Remove the Substrate Heater Assembly and the Substrate Reservoir Assembly.
2. Remove the single screw and the tube guide at the top of the black plastic cover of the Luminometer
Module and carefully manipulate the cover off and out of instrument.
3. Manually move the shuttle from the left side, about two inches in toward the Luminometer.
4. Disconnect the 8-pin connector (A10-J4) from the Luminometer Interface PCB.
5. Loosen four captive screws located at the four corners of the High-Speed Spinner Assembly.
6. Remove the entire spinner platform assembly including the High-Speed Spinner motor and idler
wheel.
Motor Assembly removal from platform
7. Remove the three 9/64 hex screws (in a triangle format) holding the High-Speed Spinner Motor and
Drive Wheel.
8. Gently separate the upper cylinder bracket from the motor assembly below. The Spinner platform is
sandwiched in-between.
9. Remove the cable clip holding the cable going to the High Speed Spinner Motor.
Motor removal
10. Orient the assembly so that the drive wheel is facing toward the top.
11. Locate the motors spring coupler in the center of the assembly. Loosen the two .050 hex screws of
the coupler closer to the drive wheel.
CAUTION: Do not loosen the two hex screws closer to the High Speed Spinner Motor.
12. Loosen (but do not remove) the four 5/64 hex screws securing the High-Speed Spinner Motor
Assembly. Access these screws through two holes found in the Drive Wheel Assembly. Drop the
motor out from the bottom.
CAUTION: Keep the assembly upright and do not remove the screws from the bracket since re-
insertion of these screws is very difficult.
Drive Wheel removal

13. After removal of the two outer 5/64 screws at either side of the circumference of the Drive Wheel,
loosen (but do not remove) the two inner 5/64 hex screws, until they are loose from the (2) 180 flats
of the drive shaft.
14. Pull the upper shaft and bearing assembly from the top. The Drive Wheel can now be removed. Upon
re-assembly, be sure the inner screws are properly located to the flats of the shaft before tightening.
15. Re-assemble in reverse order. If the Motor has been removed, be careful to orient it so that the motor
cable protrudes toward the rear corner of the assembly, in order to avoid wire damage snagging on the
moving tube shuttle. Ensure that the wire clip mounted underneath the platform secures the wire from
the motor. The wire clip itself must not encroach into the rear of the platform. Also, ensure the Shuttle
Assembly is positioned approximately two inches from the left before re-assembly.

7.3.12 Tube Shuttle Upper Slide Bearing Assembly
1. Remove the probe vanity panel, and move the shuttle to the far-left home position.
2. Remove the main section of the clear carousel cover.
3. Loosen (but do not remove) the (4) 1.5 mm hex screws located on either side of the top of the shuttle
assembly.
4. Grasp the top shuttle assembly with both hands at both ends. Gently, manipulate the upper part of the
assembly out while keeping the upper spring from disengaging. The upper assembly will separate
from the lower spring, which is captured on a post. The lower spring and guide post will stay in place
above the shuttle slide bearing.
5. Loosen the two 2 mm hex screws at each end of the slide bearing assembly.
Note: Use a ball end hex key to remove the two 2 mm hex screws.
6. With the screws loose, carefully remove the slide bearing and rail off of the shuttle assembly.
CAUTION: Do not allow the bearing assembly to completely slide off the rail.
7. Clean and/or lubricate the slide bearing and re-assemble in reverse order.
CAUTION: Do not lose a small thin rectangular shim located towards the rear of the bearing
assembly. The shim is necessary for proper alignment and performance of the upper shuttle
assembly. A dab of grease may be applied to the shim to hold it in place during re-assembly.
7.3.13 Tube Shuttle Idler Wheel Assembly

Note: The Tube Shuttle Idler Wheel Assembly is a standard replacement part whenever performing
Preventive Maintenance. Refer to Chapter 6 for information on PM procedures. Between Preventive
Maintenance sessions, the assembly can simply be inspected for dirt or damage. The O-rings and
surrounding areas can be cleaned with a damp cloth.
1. Remove the Tube Shuttle Upper Slide Bearing Assembly referring to steps 1 - 5 in Section 7.3.12.
2. Using a small-blade screwdriver partially spread the small retaining-clip at the top of the Idler Wheel
shaft, until the clip is removed from the catch groove.
3. Once the tiny clip is removed, the silver cap above the Idler Wheel can be removed and should be
cleaned.
4. Below the silver cap is a small wave-washer. This is replaced (P/N 900261) as part of the Shuttle
Idler Wheel replacement kit (P/N 420001).
Important: The wave washer must be re-installed with the bowl of the washer facing up.
5. After removal of the cap and wave washer, the Idler Wheel can be pulled off the shaft and cleaned or
replaced. Once removed, the opportunity should be taken to carefully clean the entire area of the
upper shuttle body assembly around the idler wheel.
6. Re-assemble in reverse order with the wheel on the shaft and re-capture, using a new retaining-clip
(P/N 900262) of the Shuttle Idler Wheel replacement kit (P/N 420001).

7.3.14 Luminometer Casting Cover / Attenuator Motor and Belt
Note: These instructions are for the removal of the upper Luminometer Casting Cover to access to
the Luminometer Chain and the Attenuator Disk Assembly. In rare cases where removal of the lower
section of the Luminometer is necessary, please contact IMMULITE 1000 Technical Support.

2. Remove the two screws at each end of the test unit exit ramp on the right side of the unit.
3. Remove the test unit exit ramp from instrument.
CAUTION: Power must be turned off before attempting to remove the PMT.
4. Locate the black metal bracket ring located at the end of the PMT. Remove the three 7/64 hex
screws that hold this ring in place. Carefully, slide the ring away from the PMT.
5. Gently shake the PMT back and forth and outward to facilitate removal.
CAUTION: After the PMT is removed, even with the power off, caution must be taken to not
expose the PMT to ambient light, as damage can occur. Carefully, tuck the PMT face into the back
corner of the instrument and cover if necessary. DO NOT TOUCH THE PMT LENS!
6. Remove all the connections from the Luminometer Interface PCB (A10). Release the five plastic
standoffs that secure the A10 PCB to the top of the Luminometer.
7. Lean the PCB back and off the rear of the Luminometer cover. The PCB cannot be totally removed
because the other wires are soldered to the right edge of the PCB.
8. Remove the two sensor wires from the attenuator home and positioning sensors found on the right
side of the Luminometer cover. Properly mark the connectors to facilitate re-assembly.
9. Loosen the five 9/64 hex screws located around the lip of the upper Luminometer cover. There are
three screws along the left edge of the cover, one at the front center and one in the rear right corner.
Tool extensions may be necessary. The rear right corner hex screw has a wire clip under it that
secures a number of sensor wires. Keep the hex screw inserted in the clip for easier re-assembly later.
10. Read all four cautions listed below before proceeding to the next step.
CAUTIONS: 1.When attempting to lift the Luminometer cover off, some resistance may be felt
due to tightness within the locator pins. It may be necessary to gently pry the
cover free of its locator pins with a screwdriver.
2. The Luminometer cover may be trapped along the left edge under the plastic
casing of the lower Main Carousel casting. Gently flex or pry the Main Carousel
casing to free the Luminometer cover.
3. Do not damage the Luminometer Temperature Thermistor, which remains
screwed into the top cover, located behind the Chain Drive Motor Assembly.
4. Do not touch the attenuator lens located on the disk assembly within the
Luminometer cover. Maintenance on this assembly is rarely needed. For further
details on this assembly, please contact IMMULITE 1000 Technical Support.
11. Grasp the motor assembly from the top and carefully lift the cover off the module, while pivoting the
Luminometer Interface PCB out of the way. The Luminometer chain is now exposed.

12. The attenuator motor and belt are mounted to a plate, which is slot mounted to the upper
Luminometer cover. Loosen or remove the 1/4 screws securing the mounting plate. Sliding the
motor/plate assembly inward can loosen the belt. To remove the belt, the two disk positioning sensors
and their standoffs must be removed first and then the belt can be looped off the positioning sensor
disk assembly.
13. Reassemble in reverse order. Be aware of cautions listed in step 10, and follow additional cautions
listed below:
CAUTIONS: 1. The attenuator belt tightness is subjectively a 1/8 to 1/4 deflection when the
central portion of the belt expanse is pressed with moderate pressure. A belt that
is too tight (little or no deflection) can result in premature wear of the bearings in
the attenuator disk shaft within the Luminometer cover. It may also result in a
seizure of the attenuator disk assembly.
2. Before reassembling the Luminometer cover onto the base, check the
alignment of the Luminometer motor coupling with respect to the Luminometer
chain coupling. If these are not aligned, the cover will not fully seat. If upon re-
assembly the Luminometer cover still does not sit down firmly (instead it rocks
back and forth), move the Luminometer chain manually. This will re-engage the
Luminometer drive cog with the drive motor coupling from above. Once re-
engaged, the Luminometer cover should then set into place flatly. Ensure that
there are no loose wires pinched under the cover.
7.3.15 Power Supply Module

1. Disconnect the Instrument from AC Power, and remove the plastic solid waste container from the
right side of the IMMULITE 1000.
2. Locate the lower right end of the chassis where the Power Supply Module is housed. Loosen the two
captive screws to loosen the front plate of the Power Supply Module.
3. Carefully slide the Power Supply Module out the right side of the instrument until the three main
connectors are exposed at the far inner-end.
4. Carefully remove the J1, J2, and J3 system cable harnesses.
CAUTION: Ensure J1, J2, and J3 wire harnesses are re-routed as they were. When re-inserting the
power supply do not damage any harness wires on sharp chassis edges above. The Power Supply
Module should slide in easily. If there are any problems with re-insertion, pull the Power Supply
Module out and check the wire harness routing.
Note: The 24v module in the center of the drawer can be adjusted using the potentiometer module
p/n 422268. All instruments s/n C0230 and up have this in place. In IMMULITE 1000, this voltage
should be adjusted no lower than 24v.

7.3.16 Replacement of the Chain Assemblies
The general principle for replacement of either the entire Load Platform Chain Assembly (P/N 400190-
01), or of the Luminometer Chain Assembly (P/N 400190-02), is that neither of these chains should ever
be completely removed from the drive cogs and driving source areas of these two modules. Instead,
quicker and easier replacement of both chains is better accomplished by:
Choosing a point to gently separate the old Chain Assembly, at an accessible location
Securely attach a matching end of the new Chain Assembly (and afterward, clearly marking the
division-point of old to new chain).
Using the old chain to manually and carefully pull the new chain entirely through the route of
the chain through its Module, until the point that they are joined, comes around again to the starting
point.
Re-separation of the two chains accurately at the proper point and joining the matching ends of the
finished new chain, appropriately disposing of the old used chain assembly.
Upon completion, to double check for complete and proper assembly, operation, smooth movement,
and proper alignments.
Note: Before replacement of either one of these chains as detailed below, please be sure to read the
cautions noted at the end of this section.
Load Platform Chain Replacement

1. Remove the Probe Vanity Panel supporting the probe tubing, to expose the left end of the Load
Chain assembly, sampling, and star-wheel areas.
2. From the upper tube guide, which comprises the top surface of the loading area, loosen all of the 11
captured screws which secure it to the top of the loading area. After they are loose, the tube guide is
carefully lifted off, exposing the serpentine loading portion of the chain assembly. (All screws stay
captured within this tube guide, by small rubber O-rings from below.)
3. The front length of this chain closest to the FSE is now openly and easily accessible. To choose a
link point just right of the barcode reader area (where the tubes enter the system), first gently hold
the upper baffle, and give gentle pressure, pushing the baffle off to the side of its link, in order to
allow the baffle to gently pop off of the top of a chain link. Then separate the exposed chain link
and swing plate below, as described in the initial bullet points above. (See Caution 2 at the end of
this section.)
4. Next, choose another point of this old chain at the rear-most span of the loading area, where it
passes in front of the Luminometer. Again, separate the chain link at this chosen point.
5. Now, all of the old chain between these two points, can be initially removed from around the
numerous bearings which guide the chain through this loading serpentine, and thus, half of the old
chain is now gone, the load area is now clear. The remainder of the chain to the left is still within
the more complex drive portion of its Module.
Caution: The Old chain is a Bio-Hazard Handle and dispose of properly!!

6. Prepare the new chain, by choosing which end of it matches how the old chain was just
separated. Orient the new chain so that it will enter the system in the same direction as normal chain
travel. Snap together the two chains end-to-end by the swing plate below and then carefully replace
the snap-on baffle above, to secure the joining of the two chains. Mark this joining point, in some
clearly visible way, in order to correctly re-separate the two chains at the proper point upon
completion. (See Caution 1 at the end of this section.)
7. With the Instrument in the Idle state (or turned off), grasp the Star Wheel at the left end of the
module, left of the sampling positions. This is the top of the actual drive shaft point for the chain.
Manually and slowly rotate the Star Wheel clockwise in order to use the old chain to pull the new
chain carefully through the entire Module Assembly. At the same time, with the right hand, keep a
gentle tension in the other loose end of the chain at the rear of the loading area. Preventing the slack
while feeding the new chain through, ensures the chain does not buckle and snag anywhere within
its assembly path during this pull-through procedure.
8. Carefully pull the new chain through, until it is fed throughout the left-end drive portion of the
module, until the mark put on the joining point earlier, is seen to come out to the rear of the open
loading area. The remainder of the new chain is still left to feed into the system.
9. Note the marked point at which the chains are joined and the links are again carefully separated at
the exact same point and relationship as the way in which they were joined. (See Caution 1 at the
end of this section.) The remainder of the old chain is now free from the system.
Caution: The old chain is a Bio-Hazard Handle and dispose of properly!!
10. Release the Star Wheel, and now simply manually weave the remainder of the new chain, around
each of the serpentine pattern of roller bearings, and string the chain rearward toward the waiting
free end at the rear of the loading area.
11. Securely snap the bottom swing plate to join the completed chain assembly, and then gently replace
the snap-on baffle on top.
12. Replace the Load Platform Tube Guide, being sure to fully secure all screws, so the top of the
loading area is smooth and un-obstructed.
13. This Load Platform Chain Assembly is automatically tensioned throughout its module by the two
spring-loaded tensioning arms, located on either side of the Main Incubator Carousel ring gear at
the cross-over point of the two modules. There should never be a need to have any concern about
manual tension adjustment by the FSE so long as the new chain is properly fed through the module.
(See Caution 1 at the end of this section.)
14. Run the LCHAIN main diagnostic program, and visually inspect for proper operation and alignment
of the new chain assembly. As long as the new chain is fed correctly, the FSE should find no need
to make any alignment adjustment, but this should always be double checked upon completion. If a
serious alignment change has occurred after chain replacement, then the FSE should inspect again
for proper procedure. (See Caution 1 at the end of this section.) Additionally, see Section 7.4.6:
Miscellaneous Procedures, for details on proper Load Chain alignment.

Luminometer Chain Replacement
1. Remove the following portions of the upper Luminometer, as described in the previous section for
removal of assemblies:
Substrate Heater Assembly as per previous Section 7.3.9.
Substrate Reservoir Assembly as per previous Section 7.3.10
2. Remove the single screw and tube guide at the top of the Luminometer Module, and carefully
manipulate this top plastic cover off and out of the Instrument.
3. Remove the High-Speed Spinner Platform Assembly, as per previous Section 7.3.11, following only
steps 1-6 of that procedure.
4. The front portion of the Luminometer Chain Assembly is now exposed openly for the FSE to
choose a point along this front span, in which to separate the old chain, in the same manner as the
Load Chain instruction above. BUT, before separating the old chain read the next step.
5. Locate the right-front corner turn of this chain, where it rounds a roller bearing guide just past the
tube exit ramp. This is front tension adjustment for the chain. Take note or mark the original position
of the base of this moveable bearing before loosening it. This mark helps guide proper tensioning
and reset of this bearing upon completion of chain replacement. Loosen (slightly!) the 9/64 sized
hex screw at the top of this bearing.
6. After a slight loosening of the chain tension at this right-front corner bearing, the chain will now
relax to ease the FSEs physical separation of a link of the old chain. (See Caution 2 at the end of
this section.)
7. Prepare the new chain, much in the same manner as described in step #5 of the Load Chain
procedure above. Carefully and clearly mark the baffle that is above the joining point of old the
two chains, after snapping them together end-to-end. (See Caution 1 at the end of this section.)
8. In a similar manner to the Load Chain replacement procedure above, the FSE will now use the old
chain to pull the new chain into and completely through the inner Luminometer Module.
Note: Feed this new chain into the Luminometer, in the same direction as normal operation of the chain
(entering at the left, behind the spinner station.) This better ensures the new chain seats and settles around
the inner drive assemblies in the same way as the old chain did.
9. While gently pulling the chain slowly through from the right end at the Luminometer exit ramp,
carefully try to avoid snagging the chain on the inner end of the tube exit ramp, as it is coming out of
the Luminometer exit.
10. Pull the new chain throughout the Module until the FSEs baffle mark of the joining point of the
two chains, is seen out of the right side exit of the Luminometer. Continue pulling, around the right
front corner tension adjustment bearing, to bring this leading end of the new chain at the marked
point to this accessible front open area.
11. Carefully separate the chain link at the mark joining point of the two chains (See Cautions 1 & 2 at
the end of this section.) The old chain is now free from the system, and can be discarded
Caution: The old chain is a Bio-Hazard handle and dispose of properly!!
12. Bring the two free matching ends of the new chain together in this front open area, and carefully
snap the bottom swing plate together, finishing the chain assembly. Replace the snap-on baffle on
top.

13. Being sure that the chain is properly seated around it re-apply a gentle pull on this right-front tension
roller bearing. Pull the new chain to a position that the tensioning bearing is positioned in the same
spot as was the tensioning of the old chain. (This is subjective, but attempt to get as close as
possible.) This roller bearing is then tightened to secure chain tension.
14. Finally, reassemble the finished Luminometer Module in reverse order, and test all applicable
functions.
Tips on judging proper tension of the Luminometer Chain
Proper tension of this chain has no exact specification. It is somewhat subjective and may vary slightly
between assemblies. The general rule is that after tightening down the roller bearing, check the resulting
tension by applying a gentle two-finger pressure to the center spot of this front chain span, and push the
chain rearward, toward the black metal drain trough base of the shuttle.
The chain should just touch this black shuttle drain base behind it, with little effort. If a strong effort has
to be used to reach and touch that black metal behind, loosen the chain tension a bit by re-positioning the
right-front tensioning roller bearing.
Conversely, if the chain easily touches behind at this point, and actually stays there when finger
pressure is released, then a bit more tension should be added, by slightly re-positioning the right-front
tension roller bearing.
Note: Overall, if deciding on Luminometer Chain tension being too tight, or too loose, it is always
better to have the final tension on the loose side. Historically, it has been seen that the chain is far more
likely to have movement troubles if chain tension is set too tight. A chain tension which is too tight will
cause torque and drive strength problems for the chain drive motor. This is also evident if there is a
ratcheting noise, or jittering or back-stepping behaviors are seen during chain motion. These
behaviors of a tight or stiff/sticky chain will likely cause intermittent and random positioning problems,
and problems with proper guidance of tubes through the area, as well as a higher risk of conflicts at the
cross-over point where the tube shuttle passes through the Luminometer Chain at the wash/spin position.
This area is one of the most crucial mechanical alignment points in the System.
As with the Load Platform Chain, generally after a replacement of this chain, there should be no need for
any change to the chains positional alignment, as set in the motor configuration table, and adjusted using
the LUMCHADJ configuration diagnostic. If the new chain was carefully fed through the module in the
exact manner as instructed, there should be no need to do any major adjustment from the setting of the old
chain. This is also providing that final tension of the new chain is very closely set to what the old chain
was, via the right-front corner adjustable tension roller bearing.
Be aware that this Luminometer Chain lends itself to a much more subjective judgment of chain tension
(unlike the Load Chain, which is self-tensioning). Therefore, the tension, positioning, and proper
alignment of this new Luminometer chain should always be double-checked , and carefully scrutinized, to
be absolutely sure.

Important Cautions:
In a replacement of either of these chain assemblies, please take note:
-- When choosing a point to join the old chain to the new one before pulling it through, carefully
snap the top chain baffle onto that joining point, then clearly mark that baffle somehow, such as
with a small piece of colored tape. Also take careful mental note of the link relationship at the
joining point of the two chains. If a chain link or its lower swing plate below is not properly
separated again in the exact same relationship after the pull-through, then upon completion,
incorrect assembly within the module will result. Consequently, the new chain assembly may have
one too many, or one too few links and/or swing plates in it. The result will guarantee that the
chain will not operate correctly, will not tension correctly, and will not align correctly.
-- The blade of a small screwdriver may be needed at times, in order to be able to initially separate
a chain link. If this is done, take extreme caution to not nick or damage any piece that may
perhaps be intended to remain as part of the finished instrument assembly (as a piece of the final
new chain). A deep nick or other such damage may hinder the proper flexibility of that chain
link, causing random and intermittent positioning or alignment problems for the chain assembly.
-- When separating or re-joining ends of a chain, always take note of proper top and bottom
placement of the lower swing plates. The small bushing molded on one side, should always be
oriented up toward its chain link above. The top baffles likewise have this small molded bushing,
above its link. These molded bushings on these pieces ensure easy and proper rotation of a link
joint.

7.4 Miscellaneous Procedures
7.4.1 Testing the Water Supply

Upon installation of the IMMULITE 1000 Analyzer, the laboratory distilled water supply must be tested
for alkaline phosphatase contamination. Contamination can affect the IMMULITE 1000s performance
by altering the matrix during the immunological reaction, or by increasing the post-wash counts per
second (cps). It is recommended that the customer test their water supply at least once a month.
Room-temperature distilled water must be used in the IMMULITE 1000 water reservoir. The water test
procedure involves using two IMMULITE 1000 diagnostics programs:
WATERTST
WATERTPM
Use the Water Test Kit (catalog number: LKWT) in conjunction with these diagnostic programs to
perform the water tests. Instructions for using the WATERTST and WATERTPM diagnostic programs
and for evaluating their results appear below.
WATERTST
of the IMMULITE 1000. Water should be tested before priming water from a new source through the
IMMULITE 1000 System, or when contamination is suspected. The procedure for testing the water
supply using the WATERTST program appears below:
1. Before starting, ensure the IMMULITE 1000 has been powered on for at least 45 minutes and at a
stable operating temperature.
3. From the Start-up menu, select the DIAGNOSTICS button. The Common Diagnostics screen
appears:

4. Select Diagnostics. The following screen appears:
needed, load and run the SOLE2S program to fully prime the substrate nozzle.
Note: The IMMULITE 1000 must be Idle before performing this step, or before step 9.
10. Press GO (on the IMMULITE 1000) when instructed to do so.
12. Once the Test Units start moving, select the VIEW button. The following screen appears:

13. After approximately 10 minutes, the two tubes come in front of the PMT for final readings, as seen in
the example above.
Select the Print Screen button to print this screen once the data appears.
Select GetDataT to obtain more detailed raw WATERTST data.
The following screen appears:

Select the Save Data button to save the WATERTST data to a disk, or folder of the HDD.
Select the Retrieve Data button to retrieve WATERTST data from a disk or folder of the HDD.
16. Select EXIT in order to return to the Diagnostics screen to select another diagnostic program if
desired or select CLOSE to return to the Start-Up screen if other diagnostic programs are not desired
at this time.
17. Refer to Acceptance Criteria on page 7-31 to determine the outcome of this test.
instrument, the fluidics system must be decontaminated. Refer to section 7.4.2 System
WATERTPM
The WATERTPM diagnostic program tests the water dispensed from the probe and the water pump.
Use this procedure when contamination within the system is suspected.
1. Check to make sure the daily maintenance has been performed and that the substrate and the Wash
Pump water lines have both been sufficiently primed.
3. Select four empty water Test Units.
Note: Do not pipette water into any of the Test Units.
4. Load all four water Test Units onto the Load Chain.
appears.
6. Select Diagnostics, then select WATERTPM and select Run.
The following process occurs:
Water from the probe is pipetted into the first Test Unit.
Water from the wash line is dispensed into the second Test Unit.
Water from the second Test Unit is pipetted into the third Test Unit.
Substrate is added to the first, third, and fourth Test Units.
The first, third and fourth Test Units are incubated in the Luminometer for 10 minutes and
readings are taken. The second Test Unit is indexed off the Main Carousel and onto the Load
Chain for easy removal.

8. Once the Test Units start moving, select VIEW. The screen will wait for all three tubes to result.
9. When all three test cups have resulted, the following screen appears:
Note: The first result is for the water from the probe, the second is for the water from the water
pump, and the third is for the Test Unit containing substrate.
Select the Print button to print this screen once the data appears.
Select GetDataT to obtain more detailed raw WATERTPM data, stored from past tests. As
with the previous test, the following screen appears:

Select the Save Data button to save the WATERTPM data to a disk, or folder of the HDD.
Select the Retrieve Data button to retrieve WATERTPM data from a disk or folder of the HDD.
12. Select EXIT in order to return to the Diagnostics screen to select another diagnostic program if
desired or select CLOSE to return to the Start-Up screen if other diagnostic programs are not desired
at this time.
13. Refer to Acceptance Criteria below to determine the outcome of this test.
ACCEPTANCE CRITERIA
> 4,500 cps and < 9,000 cps

The Luminometer is not warm
The substrate volume was
insufficient
< 4,500
The resident substrate is expired,
and loosing its reactive properties
(good for up to 30 days after
Unacceptable alkaline
present
If the CPS are too high or too low, perform the test again to confirm these results.
If the CPS are consistently outside the 4,500 CPS to 9,000 CPS range, find a new water source
and test this new source.
If the second test unit (substrate only) is > 9,000 CPS, the substrate system needs to be
decontaminated or the test units used for testing may not be clean.
Note: The Water result is then not valid, because the unacceptably high level of this baseline substrate-
only reading is falsely biasing it.
1. For WATERTST, refer to last line printed with results:

External water source Substrate Only = XXX CPS
If the value of XXX in the subtraction above is lower than 650 CPS, insufficient substrate may have
been dispensed into one of the Test Units. This could be due to a clogged nozzle. Check both Test
Units to determine if they contain enough substrate. If the value of XXX in the subtraction above is
above 2000 CPS, do not use this water source on the IMMULITE 1000 Analyzer. Find a new water
source, and test this new source.
CAUTION: If this water source was used, the system must also be decontaminated.
2. For WATERTPM, refer to the last two lines printed with results:
Probe Water Substrate Only = XXX CPS
Pump Water Substrate Only = XXX CPS
If the value of XXX for either equation above is lower than 650 CPS, insufficient substrate may have
been dispensed into one of the Test Units. This could be due to a clogged nozzle. Visually check all
Test Units to determine if the liquid level is equally distributed between the Test Units. If the value of
XXX above is above 2000 CPS, perform the test again to confirm these results. If the CPS is
consistently above 2000 CPS, decontaminate the system. Refer to section 7.4.2 System
Decontamination on the next page.
Acceptable example results for WATERTPM and WATERTST tests are shown below.

Sample of Acceptable Water Test (WATERTPM)
Probe Water = 6000

Water dispensed from the pump = 5800 cps
Substrate Only = 5900 cps
Probe Water Substrate Only = 100 cps

Pump Water Substrate Only = -100 cps
If the system is contaminated, refer to Section 7.4.2: System Decontamination.

7.4.2 System Decontamination
If the system is contaminated, follow the steps below to decontaminate the system.
1. Put the IMMULITE 1000 in idle by pressing ALARM MUTE and GO.
2. Obtain the following supplies:
Probe Wash (Part No. LPWS2)
2 In-Line Water and Probe Wash Filter Assemblies (Part Numbers 400364 & 400365 )
Gloves
Sterile cotton swabs (Q-Tips)
3. Empty the waste from the waste container.
4. Remove and discard the water filter canisters from the rear left corner wall.
5. Remove, empty and set aside the water container.
6. Remove, empty and clean the Probe Wash Bottle with a flushing of 70% Isopropyl Alcohol, followed
by at least 5 times repeated rinsing with acceptable IMMULITE 1000 water, then a fresh (prepared
10X dilution) solution of probe wash.
7. Swap the blue water lines into the new container containing the probe wash.
appears.
9. Select Diagnostics, then select DECON and select RUN.
11. Run the program for ten minutes to ensure the probe wash has thoroughly penetrated the system.
12. Press ALARM MUTE and GO to stop the DECON program. (Best to stop when Syringes are in a
down position, in order to maximize decontamination within the syringe barrels.)
13. Let the system sit for a minimum of thirty minutes. During this time, continue with steps 14 -16.
14. Place 100mL of 70% isopropyl alcohol into the original water container. Place the blue cap and inner
water lines into the original water container and tighten the cap. Shake well to ensure the alcohol
contacts all surfaces in the container, including the cap.
15. Discard the alcohol and rinse the water container and cap with distilled water at least five times (with
the cap on) to ensure all surfaces have been thoroughly rinsed.
16. Install new water filters, as per instructions in the in-line filter replacement kit. Be sure to take note of
the proper orientation of the filters, which both show fluid travel to go upward.
17. Refill the water container with fresh IMMULITE 1000 acceptable distilled water, and replace into
bottle chamber.
18. Using a sterile cotton swab, wipe the accessible surface of the wash station to help remove any
growth.

19. Run the DECON1 diagnostic program with fresh distilled water:
Note: Prior to filling the container, the water must be tested using the WATERTST diagnostic program.
From the same Diagnostics Menu, select DECON1, and then select RUN.
Press GO on the IMMULITE 1000 when instructed to do so.
The program is finished automatically, in approximately fifteen minutes.
20. Re-test the system for contamination using the WATERTPM diagnostic program to verify the
system now meets the proper criteria.
Replacement of the In-Line Water Filters

Remove old filter canisters by releasing the quick-connect clips above, and also at the bottle
caps, also carefully removing the tubes that run along the surface of the component deck, and lead
to the bottle caps.
Treat all related tubes and tube clips in the areas of filters and bottles with care. Be sure tubes
route evenly along the chassis deck with no kinks.
Be sure to take note of the proper orientation of the new filter canisters, always having the arrows
pointing up. Fluid flow is towards the Syringes.
Each filter is dedicated to its bottle, so be sure to note tube markings and the different lengths to
the bottles. Tubings are assigned as #82 tube for Water (blue band) and #83 Tube for Probe Wash
(yellow band).
Be careful that both filters have proper clearance from the chassis deck, placed centered in the
rear left corner wall clips, and no kinks or obstructions to any related tubes running along the
deck to the bottles.

7.4.3 Substrate Spike Replacement
To replace the substrate spike, follow the instructions below:
1. Remove the substrate bottle by pulling it straight up.
2. Loosen (do not remove) the two screws on either side of the spike using a Phillips-head screwdriver
(see figure below.)
3. Remove the substrate vial support assembly.
4. Grasp the spike and lift up out of the manifold block.
CAUTION: The O-ring may stick to the bottom of the vial support. If this occurs, be sure to
remove it. (Normally, it rests on the spike tip.)
5. Remove the new spike from its sterile packaging.

6. Remove and discard the colored fitting over the base of the spike.
Note: Keep the tip guard on and do not to touch the tip of the spike, since this could cause
contamination.
7. Re-seat the spike in the manifold block.

8. Hold the wings of the spike,
remove the tip guard and place
the O-ring over the spike tip.
9. Clean the substrate spike support assembly
and the upper bottle support using 70% Isopropyl
alcohol.
10. Carefully re-position the
support over the spike and O-ring,
aligning the screw holes.
11. Re-tighten the screws until snug.
Do not over-tighten.
12. Replace the substrate bottle.

7.4.4 Fluidic Valve Testing
Testing the Solenoid Valves and Associated Tubing
Remove the probe line fitting from the 4-way block. Attach a discarded probe, having the metal jacket cut
off and the outer tubing removed, to the 4-way block. Run the tests below and look for the appropriate
water movement at the end of the tubing. Water movement that occurs as the valve actuates or de-actuates
is normal, but should be no more than 1/4 inch.
1. Valve #1 Testing
Run the V1TEST diagnostic. The water should alternately dispense from the "probe" and from the
wash well. Except for valve throw, the water should never move in the tubing when the water is
dispensing up from the bottom of the wash well. If water is moving down the probe when it should
not be, this can cause under-aspirating of reagent and/or sample. It can also cause fluid to be drawn
into the probe from the home well resulting in carryover.
2. Valve #4 Testing
Run V4TEST diagnostic. The water should alternately dispense from the probe and from the wash
well. Except for valve throw, the water should never move in the tubing when the water is dispensing
up from the bottom of the wash well. If water is moving down the probe when it should not be, this
can cause under-aspirating of reagent and/or sample. It can also cause fluid to be drawn into the probe
from the home well resulting in carryover.
3. Valve #2 Testing
Run the V2TEST diagnostic. The water should alternately dispense from the probe and the tubing
that goes into the probe wash container (that has been removed from the wash container and placed
into a container or the wash station for this test). Follow the instructions given on the IMMULITE
1000 Display. Except for the valve throw, the water should never move in the probe tubing when the
water is dispensing from the disconnected Probe Wash tubing.
4. Fluid Flow Testing
Run the PRIME diagnostic. During dispense, the 5000 ul syringe stops momentarily to switch a
valve. During this moment the water should come out in drips only since only the 250 ul syringe is
moving. If not, there is back pressure building in the fluidics which is being released during this
moment. This back pressure could be the result of a partially occluded piece of tubing, air in the lines,
or a piece of tubing that is expanding excessively from the pressure during dispensing. When the
water is finished dispensing, make sure no water backs up in the tubing. Water flow back-up in the
tubing is indicative of a solenoid valve failure.
Secure the tubing to the Main Carousel shroud with tape. Then place the wash bottle on top of the
instrument and check for fluid movement. If none occurs, place the wash bottle at tabletop level and
once again check for fluid movement.
Water movement in the tubing (when the tubing is secured) is indicative of a Valve # 2 failure. This
type of failure usually results in the first test that is run after the pipettor has been idle for a while to

have a very different result than the test units after it (assuming the other test units are replicates of
the first, like that of an adjustment.)
Testing the Microvalve and Macrovalve
Place the water bottle on top of the instrument and check for fluid movement down the tubing. If any
occurs, the defective valve can be isolated by removing one of the lines from the water bottle and
placing it at table top level; if the water movement stops, the defective valve is the one attached to the
tubing now at table top level. This type of failure usually results in imprecision, especially if the
failure is the microvalve.
2. Valve Stem Tightening (Hamilton Syringe Modules Only)
Remove each valve from their diluter and insure the silver valve barrel is tightly secured into the
valve body. If not, air can leak into the valve or water can leak out, both resulting in imprecision.
Testing the Probe
1. Probe Dispense Angle Testing
With the probe in place, run the PROBANGL diagnostic. The angle of dispense should be no greater
than 7 - 10 degrees. If the probe is dispensing at an angle, it is indicative that the tip of the probe has
been damaged or is partially occluded. Check the stream angle from various sides of the instrument.
2. Probe Dispense Integrity Testing
Run the PRIME diagnostic. Lift the probe out of the home well and move it over the dump well. The
stream should be straight and clear without excessive cavitation (air mixing with the stream).
Excessive cavitation may be indicative of probe tip damage or partial tip occlusion.
3. Testing for Probe Occlusion
Run the PRIME diagnostic and again lift the pipettor up and over the dump well. During dispense,
the 5000ul syringe stops momentarily (approximately 1 second) to switch a valve. During this
moment the water should only come out in drips since only the 250 ul syringe is moving. If not,
there is back pressure building in the fluidics which is being released during this moment. This back
pressure may be the result of a partially occluded probe or connecting tubing, air in the lines, or a
piece of tubing that is expanding excessively.
4. Run the PROBETST diagnostic. The probe will locate into the home well and repeatedly dispense
using the Large Syringe only. Any splashing of the water out of the home well indicates a serious
dispense problem. Also any drops or streams coming from the probe while it is moving over the
dump well is evidence of an occlusion or back pressure within or leading to the probe.
Testing the Water Linear Actuator Wash Pump
Remove the nozzle from the end of the water dispense tube. With the water bottle at tabletop level,
check to see if the water is moving back towards the bottle. Any movement is indicative of a valve
failure. This type of failure could cause the first and possibly second (depending in the severity of the
failure) injection of water into the test unit to have insufficient volume resulting in a less than
optimum bead wash.

2. Water Drawback Testing
Run the SOLE1W diagnostic. Observe how far into the dispense tubing (with the nozzle removed)
the liquid moves. Refer to the drawback specification table below. Drawback in excess of the
specification is indicative of a kink in the pumps input tubing or a slow valve. Either of which could
result in a less than an optimum wash.
3. Test the volume of the pump by using DISWAT. The volume should be 200 ul +/- 5% for both pumps.
Testing the Substrate Linear Actuator Pump
Make sure the shuttle is in the far-left home position to prevent substrate leakage on the shuttle
assembly. Remove the tubing from the top of the substrate heater and place into a container at
tabletop level (making sure the drain is below the heater). Check for any movement of substrate down
the tubing. Any movement is indicative of a valve failure. This type of failure may cause the substrate
to slowly drain out of the vial and depending on the severity of the leak, cause substrate to leak onto
and bind the Luminometer chain.
2. Substrate Drawback Testing
Run the SOLE2S diagnostic. Observe how far into the dispense tubing (which is removed from the
substrate heater) the liquid moves. Refer to the drawback specification table below. Drawback in
excess of specification is indicative of a kink in the pumps input tubing or a slow valve. This type of
failure mode can cause the substrate to "spit" out of the nozzle instead of flow out smoothly which
can result in imprecision, especially with assays having very low counts.
3. Test the volume of the pump by using DISUB. The volume should be 200ul 10% for both pumps.
Volume and Drawback Specifications
The drawback adjustment adjusts the timing between the throw of the valve and the actuation of the
stepper motor-driven bellows. Refer to the instructions below for specific drawback adjustments that
relate specifically to the Linear Actuator Pump Assembly (p/n 420120).
For both the Water and Substrate pumps, the standard Drawback specification is for , +/- .
Easy Access under the pumps to adjust drawback

and fine-tune the volume via DIP switches:
Internal Stepper Motor & Opto-Sensor
DIP Switch with outer-end-down

(rocker down) position, is ON
DIP Switch with inner-end-down

(OFF) position is OFF
Jumpers to the left are not used in

IMMULITE 1000, and should remain
at factory settings.

Switch #8 is master volume rough setting:
- off = 200ul for IMMULITE 1000, both sides
- on = 400ul (for IMMULITE 2000 Water side)
Switches #1 - 5 add tiny fine-tuning increments to

the rough volume setting of #8, in small increasing
ul increments, as shown on the inner label. Preset
at factory, but can be adjusted as needed.
Switches 6 & 7 control drawback setting in four

stages:
- #6 ON + #7 ON = Maximum setting
- #6 ON + #7 OFF = Nominal Setting
(standard factory setting)
- #6 OFF + #7 ON = > Nominal
- #6 OFF + #7 OFF = < Nominal
(minimum setting)
Important Cautions:
Precautions involving this Pump Design:
-- When priming before chemistry, be sure to press and hold the prime button down for each full cycle.
This creates a more proper full extension of the bellows, for a better, quicker prime.
-- When running decontamination programs DECON & DECON1, it is suggested to tape down the
water prime button, for the same purpose as above.
-- Be sure to always have the Instruments Power off whenever removing or connecting power cable to
pump. -- Doing so with power on will cause instant and permanent damage to pumps electronics!!

7.4.5 Use of Pip-X Position Gauges (kit p/n 420078)
General Information
The Pip-X position gauge kit contains two gauges of different sizes.
One has a groove cut in it around the circumference of the gauge near the top. This gauge represents a
sample cup holder. It has a slightly wider lower body in diameter than a sample cup to prevent side-to-
side play when seated between two baffles of the load chain.
The other gauge is larger and wider than the first and it does not have a groove cut in it. This gauge
represents a test unit. It has a wider upper body to prevent side-to-side play when seated between two
baffles of the carousel ring gear.
Using the Pip-X Position Gauges
CAUTION: The customers probe must be removed and a straight spare dummy probe must be used
during this procedure. Failure to use a dummy probe may cause irreversible damage to the customers
probe.
1. Insert the larger gauge (representing the test unit) into the carousel ring gear position where the load
chain crosses the carousel ring gear.
2. Manually rotate the carousel ring gear three spaces back towards the shuttle.
3. Initiate and load the CARCHECK diagnostic from the main diagnostic menu. Refer to Chapter 8:
Diagnostics for more information on the initiation and loading of diagnostics.
4. After pressing GO, watch the test unit gauge increment one space at a time alternating with the
shuttle.
5. Press and hold the ALARM MUTE key and then press the GO key when the test unit gauge arrives
at the dispensing position one step beyond the load chain.
6. Initiate and load the LCHAIN diagnostic. Press GO and allow the load chain to increment two steps
to be sure it is properly indexed. Press the ALARM MUTE button and the GO button to stop the
diagnostic.
7. Place the smaller gauge (representing the sample cup) at the left most (number 5) sampling position at
the Star Wheel (See next section for Star Wheel details.)
8. Initiate and load the PIPXPOS diagnostic. After pressing GO the pipettor will automatically begin at
the home position and then move to each position with a brief pause at the bottom (used to judge
alignment). It automatically increments through the three wash positions and the reagent position. In
each position, use the ALARM MUTE key (holding it down) to pause the diagnostic when the probe
is located in the fully down position. Note any positions that are not within one probe width of center.
9. After the reagent pipettor position, the probe will continue clockwise to the S5 position, lower onto
the gauge and pause. Observe the probe position onto the gauge. The pause down onto the gauge is
brief, use the ALARM MUTE button (holding it down) to pause the diagnostic when the probe is
located in the down position. After judging the position, releasing the ALARM MUTE button will
continue the movement clockwise to the S4 position, and so on. Move the gauge between positions as
needed and observe each of the five sampling positions (which are the most crucial of the whole set).
Note any positions that are not within one probe width of the center target of the test gauge.

10. After the S1 position, the pipettor will complete the cycle at the carousel dispense position. Observe
the probes position on the Test Unit gauge. The ideal position is one probe width to the left
(counterclockwise) of the target of the test gauge. Once completed, the probe will return to home and
repeat the cycle. Press ALARM MUTE and GO to end the diagnostic.
11. Adjust any probe positions that are not within one probe width from the center by using the
PIPXADJ diagnostic under the System Configurations menu. Repeat the above procedure to re-check
alignments.
7.4.6 Load Chain and Star Wheel Positioning

Load Chain Positioning
As in the illustration below, the Load Chain position is properly aligned when the trailing edge of a baffle
is flush with the outer wall of the carousel casting pathway and the leading edge is slightly encroached
into the carousel casting.
If adjustment is necessary, use the LDCHNADJ diagnostic from the System Configurations Menu and
follow the prompts.
Incubator Carousel Pathway and direction of
tube travel should be as unobstructed as
possible for both entry and return paths of the
chain
Leading edge
Will encroach slightly into
Carousel casting
Trailing edge
Should be flush with outer
wall of Carousel casting
Sampling
Position #1
Space of
tube on
chain

Star Wheel Positioning
Note: Before checking the star wheel position, ensure the Load Chain position is correct as shown on
previous page.
The correct position of the star wheel is determined by the following two points of reference:
The position of a sample cup at the number 5 sampling position

The position of a sample cup as it loses contact with the star wheel and enters the sample
collection tray
towards sample collection tray
sampling position number 5
1. Place five sample cups on the load chain.

2. Run the LCHAIN diagnostic from the Diagnostic Screen. Watch the sample cups as they enter the
star wheel area. If the sample cups tilt or flick as they ride past the star wheel, an adjustment is
needed.
3. Use an adjustable wrench to loosen the large nut at the top of the star wheel.
CAUTION: Only loosen the nut far enough that the star wheel rotates freely. Do not remove the nut.
Re-assembly after the nut is removed can be very time consuming.
Note: Instrument s/n C0493 and above have a newer design to a hex-screw clamp collar.
4. Manually, place one sample cup in sampling position number 5 and another in the Load Chain
position just past the star wheel. Rotate the star wheel to the position where contact with the sample
cup in sample position number 5 is with the right star wheel tooth, and the other sample cup is
perpendicular with the opposite star wheel arm. Refer to the illustration above.
5. Once proper alignment is performed, carefully hold the star wheel in position and tighten the nut on
top, being careful not to change the star wheel position.
6. Repeat steps 1 and 2 to verify alignment. If necessary, repeat the adjustment.
7. Finally, check the adjustment under a high load condition. Fill the Sample Collection Tray with
sample cup holders to nearly full. Repeat step 2 watching for proper travel with the high load
condition.

7.4.7 Spacing of the Sample Tube Guides
Proper alignment of inner and outer sample tube guides are as shown. An upside-down sample cup should
travel freely through this area with slight play back and forth. If the inner and outer sample tube guides
seem out of alignment, follow the procedure listed below.
upside-down sample cup has slight play

outer sample
tube guide
inner sample
tube guide
pipettor base
1. Using a Phillips-head screwdriver, loosen the two screws securing the inner sample tube guide.
2. Use a standard piece of paper folded in fours as a gap tool. Gently slide the folded piece of paper in-
between the inner sample guide and the pipettor base.
3. Using a gentle even pressure onto the center point of the inner guide, tighten the two screws down
and remove the piece of paper.
4. Inspect for an even gap at each end of the inner sample tube guide against the pipettor base.
5. Using a Phillips-head screwdriver, loosen the two screws securing the outer sample tube guide.
6. Insert sample cup holders upside-down in between the inner and outer sample tube guides at each
end.
7. Apply gentle pressure on the center of the outer sample tube guide against the upside-down sample
cups and tighten the two screws down.
8. Inspect the adjustment by riding an upside-down sample cup through the space of the two sample
tube guides. There should some slight play without any resistance or obstruction throughout the entire
pathway.
9. Perform a final test by placing 5 to 10 sample cup holders on the Load Chain and run the LCHAIN
diagnostic from the Diagnostic Screen. View the sample cups as they move through the sample tube
guide area. There should be no tilting of the sample cups or any resistance or obstruction seen.

7.4.8 Sample/Assay Test Unit Barcode Motor Speed Adjustment
1. Place four assay test units on the load chain. Load and run the BCODESPD diagnostic from the Main
Diagnostic Menu. Follow the prompts on the display until the first test unit is indexed in front of the
barcode reader.
2. Note the millisecond per revolution (ms/rev) measurement on the display.
750 msec. to 790 msec. Fluctuation of up to 30 msec., is possible and still okay.
Note: If using sample cup holders the range is 800 msec. - 840 msec., since the circumference is
larger.
4. Press and hold the PAUSE button to index the next test unit. Release the PAUSE button once
indexing starts.
5. Repeat the above adjustment for each of the remaining three positions around the Barcode Idler
Assembly.
Note: The four positions around the Idler Assembly may differ from each other as much as 40
ms/rev. This is acceptable. If the differences are greater than 40 ms/rev, inspect the condition of the
rollers, O-rings, pins, and main drive O-ring. Refer to Section 7.3.7 for more details on the
inspection of these parts.
Cautions: Be aware of false readings. These are tube-specific, based on the different mode in
which this test uses the reader circuit. False readings are ranged 200 440 ms/rev, and are known to
be false, as the reader motor cannot rotate more than 500 ms/rev. When these false readings are seen,
it is suggested to try using a test unit of a different assay, until 4 tubes are found which remain
stable, when rotating in the reader. The barcodes of some assays may randomly hinder accurate
readings of these speed tests.
Also note that if numbers are jumping between real and false, note the audible tone of the barcode
motor. The jumping numbers are known to be false, as usually there is no corresponding variation in
the tone of the motor.
7.4.9 Tuning the Sample/Test Unit Barcode Reader PCB

1. Turn IMMULITE 1000 power on.
2. Connect a DVM to TP1 (positive) and TP2 (negative) using alligator clips.
3. Place a test unit on the Load Chain and run the BCODESPD diagnostic from the Diagnostic Screen.
4. Press GO to index the test unit. Once the test unit reaches the barcode reader, press ALARM MUTE
and GO to stop the test unit from indexing.
5. Manually rotate the test unit so that the barcode readers red beam is reading the all-white section of
the test unit.
6. Adjust potentiometer R1 to 3.0 VDC.

7.4.10 High Speed Spinner Motor Adjustment
1. Place a test unit on the Load Platform and initialize the WASHSPD diagnostic from the Main
Diagnostic Menu.
2. Follow the prompts on the display to index the test unit around the Main Carousel and into the high-
speed spinner.
3. Note the RPM speed on the display.
5400 rpm to 5600 rpm (as close as possible to 5500 rpm).
7.4.11 Barcode Laser Scanner Reprogramming

The universal barcode language used for all cup and kit barcodes of the IMMULITE 1000 is the Code
39 configuration.
The Hand-held Barcode Scanner of the IMMULITE 1000 is made by Welch-Allyn Inc. , and is set from
the factory to be ready for the default Code 39 language used on all IMMULITE 1000 accessories.
If for any reason the factory setting is disturbed (by power interruption, surge, or PC fault), the following
Factory Default barcode from Welch-Allyn Operators Manual (page 12-1) can be scanned in order to
re-set for all IMMULITE 1000 Assay Kit and Sample Cup barcodes:

7.4.12 The IMMULITE 1000 Database
The database of the IMMULITE 1000 Windows-based software, stores the database folders and contents
within a series of sub-folders, and is structured with the standard Windows .mdb file format.
The latest database of all results since previous Log-Off is automatically backed up onto the PCs Hard
Drive each time the user logs off the IMMULITE 1000 software.
Maintenance Tips
Maintenance procedures include standard drag and drop of backup files, to overwrite damaged or
corrupted database files, using the standard database backup features of the Windows-based Software.
If there is a computer failure, but the drive can still be accessed, the database files can be copied
onto any USB memory stick and then reinstalled into the rebuilt computer. The files that need to
be retrieved from the old computer are as follows:
o IMMULITE1K.mdb located in the IMMULITE 1000\Databases folder.
o ErrorLog.mdb located in the IMMULITE 1000\Databases folder.
o IMMxxxx (where xxxx is the Instrument serial number) speedial file located in the
IMMULITE 1000\Download folder.
A Ghosting kit (p/n 420181-0001) is also available to use for corruptions of the Operating
System. The same files listed above should first be copied to a USB memory stick, for
reinstallation into the Ghosted system.
Note: Regarding IMMULITE 1000 s/n D0693 and above, computers are going out of
Manufacturing with 1750 Motherboards. The Ghosting CD Kit needs to be for a 1750
Motherboard. Do not Ghost a 1650 Computer with a 1750 Ghost CD. Likewise, do not ghost
1750 Computer with a 1650 Ghost CD. This kit now has both 1750 and 1650 Ghost CDs
There is a folder called Retains found in IMMULITE 1000\Backup. This is configurable

through the Backup Agent function to retain 5-10 of the most recent backups (default setting is
5). If a current database becomes corrupt, it can be replaced by one of these previous backup files
(named and listed by date and time of file creation). The retrieved file is then renamed
IMMULITE1K.
By left-clicking on Start (or using Alt+Tab to bring up the Start button), the following
configuration areas are accessible under IMMULITE 1000:
o Kits program for assay configurations and also PMT and CAF settings
o The Backup Agent
o The Event Viewer to access historical error log.
The following pages depict basic screen captures involved in accessing the database levels of the C: Drive
Folders. Consult Siemens Diagnostics Technical Support for detailed information.

From the desktop, right-click the Start button and choose Explorer. Double-click on Local Disc (C:). A
screen similar to the one below appears. The IMMULITE 1000 Folder is highlighted:
Below this level, within the IMMULITE 1000 folder, a sub-folder structure similar to the following is
seen, (the Databases sub-folder is highlighted:)

Below this folder level of Databases, a folder structure similar to the following exists:
Also under the previous IMMULITE 1000 level, the Backup folder is seen, where the Retains can be
accessed:

The Retains folder holds the previous 5-10 backups, set through the Backup Agent:
The systems motor configuration table file (a Speedial file) can be found in the IMMULITE
1000\Download folder.

7.4.13 Checking the Error Log
General Information
While the IMMULITE 1000 is in a Run sequence there are two error logs stored on the system. These
Session and Historical error logs contain three levels of information priority regarding events
occurring during the operation of the IMMULITE 1000 that can aid in troubleshooting problems:
White Box Errors not crucial to instrument operation or chemistry results
Yellow Box Errors may affect chemistry or run sequence if repeated
Red Box Errors problems crucial to chemistry results full instrument shutdown
While in Run mode both error logs can be accessed through the System Status drop down menu of the
upper toolbar. The events that are logged to this file are as follows:
1. All Log on with operator initials and all Log off (with NO operator initials)
2. Any mechanical or temperature related errors encountered in the instrument
3. Assay adjustment information (posts only that a kit has been adjusted.) See the adjustment log for the
detailed slope and intercept of the posted kit adjustment.
The full historical event error log is continual and will indefinitely hold the above information even
when the software has been updated.
Note: The historical error log file is copied into the backup folder whenever the auto-backup performs
any time after Log-Off is chosen.
When a Yellow Box or Red Box fatal error occurs, an audible alarm sounds from the IMMULITE
1000 Display Panel, and the message is simultaneously printed, and written to both the Session and
Historical Error Logs.

Viewing the On-Line Session Error Log
The session error log shows the error messages for a single test-processing session only. A session
consists of the time period from Log On to Log Off. Follow the instructions below to view the Session
Error Log:
From the drop-down menu on the Home Screen, click System Status and View Session
Error Log. The following screen appears:
Select the PREVIOUS and NEXT buttons to page through the errors.
Select the FIRST PAGE and LAST PAGE buttons to move to the beginning and end of the
error list, respectively.
Select the PRINT button to print the Session Error Log.
Select CLOSE to exit the Session Error Log.
The Session Error Log is accessible at any time during a chemistry run. It may be used to determine the
status of a ghost Test Unit or many other error conditions.
This log is active from Log-On to Log-Off. All errors are deleted from this log at the time of Log-Off,
but they are not deleted from permanent record. They are also stored permanently in the Historical Event
Viewer.

The Event Viewer Screen
The Event Viewer screen provides access to the systems permanent Historical Event Log. Follow the
instructions below to access the Event Viewer screen.
Log-Off the system by selecting the LOG OFF button on the horizontal toolbar. The Start-up
screen appears.
Select the EVENT VIEWER button on the Start-up screen. The Event Viewer screen
appears which is used to specify the date and time range in which the events occurred, the
severity level of the events, and the event number range.
If detailed system messages (not visible to the operator) are also desired, click on the Detail
Level box. Enter the password C1RRUS to access full detailed events.
The procedure on the following pages provides instruction on how to use the Event Viewer screen to
access information regarding specific events.

Viewing the Event Error Log (Historical):
From the event viewer screen, select DATE AND TIME. The following screen appears:
Select ALL to view the entire event history. Select TODAY ONLY to view the current event
log. Select SPECIFIC RANGE to view the events from a specific date and time range.
If SPECIFIC RANGE is chosen:

o Click the From Date field and select a date from the calendar window, followed by OK.
o Click the From Time field and select a time from the clock window, followed by OK.
o Click the To Date field and select a date from the calendar window, followed by OK.
o Click the To Time field and select a time from the clock window, followed by OK.
Select OK.
When choosing the Event Number Range, click ALL to view all events or SELECTED
RANGE to view specific events (for example, Pipettor Tip Jam errors).
If SELECTED RANGE is chosen on the event viewer screen, enter the event numbers
which appear on the event messages for the desired events in the From and To fields.
When choosing the Severity Level, select ALL to view all events.

Select the WARNINGS, ERRORS, or SEVERE button on the event viewer screen, to view
only a certain type of event.
Sort the events by either DATE/TIME or EVENT NUMBER. Select the desired option
under Sort By.
Select the VIEW button. The Event Log screen appears, listing the events which meet the
criteria chosen.
Additional Event Log Options

Select the PREVIOUS and NEXT buttons to page through the events.
Select the FIRST PAGE and LAST PAGE buttons to move to the beginning and end of the
event list, respectively.
Select the PRINT button to print the events displayed on the screen.
Select CLOSE to exit the Event Log screen.

7.4.14 Troubleshooting the System Stepper Motors
In the vast majority of cases for any drive or motor issue, historically the problem has rarely been the
motor. They are much heartier than the application they are used for. Any strange activity of the motor is
more likely to be a fault for its support diodes on the module interface PCBs.
Testing the resistance of the motor windings is as seen in the small chart above. If readings are in spec, it
is assured the motor has no issue.
The purpose for the diodes is to protect the driver circuits on the Motor Driver PCBs #s 1 and 2 from
spikes that occur from collapsing EMF from the motors.
The purpose of the PTC devices is to protect the drive circuitry in case a short occurs in the motor. The
PTC device will heat up due to higher current, and the resistance will increase, therefore keeping the
current down, limiting damage that can occur.
Note: As of IMMULITE 1000 serial number D0640 produced in January 2005, all these devices have
been removed and hard-jumpered. In older systems where these devices are present, if they break or
become damaged, simply remove the device and solder in a jumper.

7.4.15 Calibration of the Liquid Level Sense Display PCB
After power up, please allow at least 5 minutes for the sensors to be at temperature before calibration.
Also make sure no sunlight is over the bottles. Connect the common lead of a voltmeter to TP5 (ground)
on the display PCB.
Water Bottle Sensors. Place one of the empty water bottles with the empty probe wash bottle into the
housing. Calibrate the lower and upper water sensors (TP1 with R10 and TP2 with R6) at 3.20 volts and
then check that the Empty voltages of the bottom and upper sensors of the second water bottle* read 3.2
+/- 0.4 volts (2.80V to 3.60V). Adjust if necessary. Use table 1.
Fill the water bottles with distilled water and check that the bottom and upper sensors read between 1.1V
to 1.9V. Then remove the water bottle to verify that the no-bottle voltages are less than 0.8V. Place the
water bottle back into the housing. Verify the operation of the water display LEDs.
Probe wash Bottle Sensors. With the empty probe wash bottle, calibrate the lower and upper sensors
using TP4 with R25 and TP3 with R20 to 3.3V. Refer to table 2. Fill the bottle with probe wash and
verify the voltages are between 1.1 to 1.9 volts. Remove the bottle from the housing and verify that the
voltages are less than 0.8 volts. Verify that the operation of the probe wash display LEDs is correct.
Table 1
Water Bottle/Test point/Pot Empty Liquid No-bottle
1 TP1 (bottom sensor) R10 Set at 3.20V ________ (1.1 to 1.9) ______ (< 0.8)
1 TP2 (upper sensor) R6 Set at 3.20V ________ (1.1 to 1.9) ______ (< 0.8)
2* TP1 (bottom sensor) R10 _______ (3.2+/- 0.2) ________ (1.1 to 1.9) ______ (< 0.8)
2* TP2 (upper sensor) R6 _______ (3.2+/- 0.2) ________ (1.1 to 1.9) ______ (< 0.8)
* Second Water Bottle
Table 2
Probe wash Bottle/Pot Empty Liquid No-bottle
TP3 (upper sensor) R20 Set at 3.3V ________ (1.1 to 1.9) _______ (< 0.8)
TP4 (bottom sensor) R25 Set at 3.3V ________ (1.1 to 1.9) _______ (< 0.8)
A photo of the LED Display PCB with labeled

tuning points is shown.
Note: To enable the sensing function for the

software, jumpers JP1 and JP2 should be set on the
pins closest to the adjacent white cable connector.

Chapter 8: Diagnostics
8.1.1 Investigate
Discuss past performance with customer: Customer communication ensures that all problems experienced
by the customer are covered. Proper communication helps guarantee customer satisfaction is achieved after
you leave. Ask for any specific situations that the customer may have seen or heard on the IMMULITE
1000.
Check Error Log: Review at least two months of the log. Check for consistent error messages. They could
be warning signs of impending problems. Also, do not be concerned with individual isolated messages.
They may simply indicate an operator error.
Check for IMMULITE 1000 upgrades: A list of current upgrades and standards are available from Siemens
revisions.
Can the problem be duplicated?: Does the same problem occur every time a certain situation is duplicated?
Does the problem occur randomly?
Follow typical troubleshooting techniques to narrow down the location of the problem: Refer to Section
9.2 for more information.
8.1.2 Power
Check that AC power is within range: 110-volt systems should have incoming AC voltage of 100 120
volts. 220-volt systems should have incoming VAC voltage of 210 230 volts. Check the intended wall
socket using a line voltage tester (available through Technical Support).
Check voltages at the Syringe Interface PCB: Check DC voltages at the main power connector (A15-J1) on
the Hamilton/Euro Interface PCB. Pins can be accessed through the side of the connector with small pin
instruments lid. Ensure voltages are in tolerance as indicated below:
5 VDC: (4.9 to 5.2) -5 VDC: (-5.2 to 4.8)
12 VDC: (11.8 to 12.2) -12 VDC: (-12.2 to 11.8)
24 VDC: (23.8 to 24.2)
Note: The 24 volt level can be adjusted using the potentiometer wired to the supply. This voltage reading
should never be less than 24 volts.
locating the quick-connect connection for the cable of the PMT, and tap into these points to read the +/-
5V supplies dedicated to the PMT. Ensure voltages are in tolerance as shown below.
5 VDC: (4.8 to 5.2) -5 VDC: (-5.2 to 4.8)

8.2 Using the Diagnostics
Diagnostics is an important troubleshooting tool. Use your eyes and ears along with the diagnostics to help
narrow down where problems may be.
Note: Refer to Section 9: Troubleshooting for more troubleshooting information, including a list of error
messages.
Diagnostic programs are used to test particular components of the IMMULITE 1000 System. Click on the
desired diagnostic of the menu, to see a description of the program in the lower text box.
To load and run the diagnostic programs, follow the steps below:
Ensure IMMULITE 1000 is in Idle. From the Home Screen, select DIAGNOSTICS. The Common
Diagnostics screen appears:

Select the DIAGNOSTICS button located beneath Program Type at the bottom of the screen.
A list of the various Main Diagnostic programs appears (listed alphabetically):
Select a desired diagnostic program with the trackball and a brief description of the diagnostics
function can be seen in the Program Description box.
To run any diagnostic, select the desired program, and click the Run button.

There are also special Configurations diagnostics, which can be accessed by selecting System
Configurations.
A password field is then seen. The Password is C1RRUS (note the second character is a 1)
A list of the System Configurations diagnostic programs appears (listed alphabetically):
Note: The System Configurations menu is mostly used by Field Repair Engineers for individual
instrument position adjustments. The motor configuration table (TABLE) used for all motor movement
step assignments is also accessed and adjusted through this menu.
A desired diagnostic program is selected with the trackball, and a brief description of the diagnostics
function can be seen in the Program Description box.
To run any diagnostic, select the desired program, and click the Run button.

Whenever terminating diagnostics that are in motion progress, first press and hold the ALARM
MUTE button until all motion stops, and, while still holding the ALARM MUTE button, then press
GO to stop the program, which will set the instrument into Idle mode, ready for the next download.
Note: Some routines stop automatically at the end of the program cycle, while others repeat until the
ALARM MUTE and GO buttons are pressed in sequence described above.
If the prior program is not cleared before loading another, the following message appears in a red box
on the PC monitor:
300770 Computer cannot communicate with the Instrument
Programs can be downloaded when a blank display panel or the following message appears:
DPC IMMULITE IDLE
Select RUN IMMULITE to begin.
Notes:
Error checking routines are not activated during the use of most main diagnostics except in specially
needed cases.
Error messages are posted during CARPOS, MCARTST, CARSHAKE, TEMPS, PRIME, and
PMTCOUNT main diagnostics, and when using certain system Configurations adjustment and logic test
programs.

8.3 Main Diagnostic Programs
automatically, and which module(s) and/or component(s) the diagnostic applies to.
The programs are listed alphabetically as they appear on the Diagnostics screen.

APRIME
Used to isolate priming of "A" large syringe for diagnostic No Syringe A Pump Assembly
evaluation. Also, useful when performing a large syringe tip
replacement.
ATTENT4
This test is very useful for checking the volume consistency No Water and Substrate Pumps,
of the water and substrate pumps and the PMT consistency Luminometer, Attenuator,
of readings/results. Place four test units onto the load Shuttle
platform and the system will bring them around to the shuttle
and into the wash position. An initial spin cycle is performed,
followed by four washes with water. A shot of substrate is
added and the test unit is moved to the Luminometer
entrance. Each tube is read by the photomultiplier tube
(PMT) for twelve one-second counts in both attenuated and
unattenuated modes. The test units are eventually indexed to
the waste collection rail.
ATTENTM
Same function and procedure as ATTENT4 diagnostic except Yes Water and Substrate Pumps,
with this test load 15 test units one position before entering Luminometer, Attenuator,
the shuttle. The test will automatically stop after the 15th test Shuttle
unit is read by the PMT in both attenuated and unattenuated
modes.
ATTURN
Use this program to visually check the PMT attenuator disk No PMT Attenuator Disk
motion and to verify sensor operation. The test cycles the
attenuator disk to the home position, attenuated position and
the unattenuated position. This can be monitored by watching
the position of the single sensor notch found on the right side
of the Luminometer cover above the PMT. The single sensor
notch points to a 9:00 position at home, 5:00 in the
attenuated position and 1:00 in the unattenuated position.
BCODE
platform. A test unit is read once every two seconds, then the
next test unit is indexed in front of the barcode reader. Verify
proper barcodes choosing the VIEW button.

BCODEON
This test turns on the sample/test unit barcode reader motor. No Sample/Test Unit Barcode
It can be toggled on and off by pressing the GO button on the Reader Motor
display panel. It verifies operation and is used for cleaning
the barcode reader drive wheel O-ring.
BCODESPD
This program is used to observe and/or adjust the motor No Sample/Test Unit Barcode
speed of the sample/assay barcode reader. Load at least four Reader
test units onto the load platform. Run the program and
observe the motor speed. It should be between 750 to 790
ms/rev. Press the pause button to advance to the next test
unit. Each position should not be more than 40 ms/rev of
each other.
BCODETST
platform. Each test unit is read 25 times, then the next test
unit is indexed in front of the barcode reader. Verify proper
barcodes choosing the VIEW button.
BKGNDCNT
This program provides the current background counts for the No PMT
instruments PMT. It will alternate moving the attenuator
between the attenuated and unattenuated position. While at
each position, a set of 12 one-second background counts is
taken. The GetdataT button provides the actual raw
background counts.
BPRIME
Used to isolate priming of "B" small syringe for diagnostic No Syringe B Pump Assembly
evaluation. Also, useful when performing a small syringe tip
replacement.
CARBACK
Useful for removing sample cups that have been mistakenly No Incubator Carousel
indexed around the incubator carousel. This program moves
the carousel backward in single index steps by pressing the
syringe prime button momentarily, or indexes continuously by
holding the prime button.
CARCHECK
This program is used to judge the position of the Main No Incubator Carousel
Incubator Carousel in relation to the tube Shuttle. It indexes
the carousel ring gear one position, moves the shuttle into
the space between the carousel baffles, pauses for one
second, moves the shuttle back to home and repeats.
CARPOS
This test checks the indexing of the main incubator carousel. No Incubator Carousel
It indexes the carousel ring gear one position every second.
Also activates system error checking to aid diagnosis.

CARSHAKE
Checks the carousel shaking function. Momentarily initializes, Yes Incubator Carousel
indexes the carousel one-step, moves the shuttle in the
space between the baffles and shakes the carousel for a few
seconds.
DARKCNT
This program provides the current dark counts for the No PMT
instrument. It moves the attenuator to the home position, then
takes a set of twelve one second dark counts with the PMT
every fifteen seconds. The GetdataT button provides the
actual raw dark counts.
DECON
This program is used to introduce decontamination material No Fluidics (Decontamination)
into the fluidics of the Instrument. Refer to Maintenance
Procedure listed in Section 7.4.2 for further details. This
procedure draws the decontamination fluid into both syringes,
one at a time and then into the water pump five times. This
procedure should be run for at least 15 minutes, followed by
the DECON1 procedure.
DECON1
This program must be used after the DECON procedure. The Yes Fluidics (Decontamination)
purpose of this program is to flush out the decontamination
fluid and replace it with fresh fluids. Refer to Maintenance
Procedure listed in Section 7.4.2 for further details. This test
will automatically stop after approximately twenty minutes.
The test will cycle through filling each syringe twice then the
water pump ten times.
DISSUB
This program tests substrate pump dispensing volume. Place Yes Substrate Pump
five test units on the load platform as per display. If the wrong
number of vessels is used, the program will halt with Test
Failed. The program indexes each test unit around the
Incubation Carousel then shuttles them to the substrate fill
position. A shot of substrate is added, and the test units
moved to the sample collection tray for evaluation.
DISWAT
This program tests water pump dispensing volume. Place five Yes Water Pump
test units on the load platform. If the wrong number of
vessels is used, the program will halt with Test Failed. The
program indexes each test unit around the Incubation
Carousel then shuttles them to the water fill position. A shot
of water is added and the test units moved to the sample
collection tray for evaluation.

EMPTYTUB
This program is very useful to check the main driving motor No Entire Tube Transport Path
movements of the instrument. This is mainly used to evaluate
proper coordination between interfacing driving motors of the
system. Tubes can be placed on the load platform and
indexed through the entire system.
LCHAIN
This program is used to visually check the functionality and No Load Chain
positioning of the load chain. It indexes the chain one position
every 2 seconds.
LEVCRASH
in each of the five pipetting positions. Manually, pipette a
minimum of 100 uL of liquid into five sample cups. Place the
five sample cups into the five pipetting positions. During the
test, the Pipettor will level sense each sample cup starting in
position five and then progress cup by cup to position one.
The program will time-out after 20 rotational cycles (~ 100
potential signals) Any failures to level sense the liquid will trip
the tip jam sensor, which in turn will indicate test failed.
LEVFALSE
in the reagent, five sampling, and assay dispense pipetting
positions. This test requires no sample cups to run. Remove
the Reagent Tray. The Pipettor will start at the home position
and then checks level sensing at the reagent position, each
of the five sample pipetting positions, and then return to the
home position to start again. The program will time-out
automatically after 20 full cycles to home (~ 120 potential
signals). Any false level sense triggers will trip the tip jam
sensor, which in turn will indicate test failed. During the
sequence the technician can also jiggle the wires or cables to
attempt to purposely initiate intermittent problems.
LEVSENSR
This program is used in conjunction with LEVSENSS to No Pipettor
check the auto calibration of the DEADVADJ (automatic), or (Level Sense Reagent Dead
programs. This program should display an SL (steps left)
number between 8 and 12. If the program does not confirm
good SL numbers, repeat the Configurations DEADVADJ
Auto-calibration. Or if the LEVSNADJ test is used, re-check
for proper manual pipetting of the minimum dead volume in
the test reagent vial.

LEVSENSS
This program is used in conjunction with LEVSENSR to No Pipettor
check the auto calibration of the DEADVADJ (automatic), or (Level Sense Sample Dead
programs. This program should display an SL number that is
reasonably close to the value for parameter 13 of the
CONFIG table. If the program does not confirm good SL
numbers, repeat the Configurations DEADVADJ Auto-
calibration. Or if the LEVSNADJ test is used, re-check for
proper manual pipetting of the minimum dead volume in the
test sample cup.
LUMCHECK
This is one of the most useful tools for close inspection of the No Luminometer Chain
crucial crossover alignment of the Shuttle and Luminometer (at the crucial cross-over point
Chain. The program repeatedly inserts the shuttle partially with the shuttle)
into the indexing lum.chain baffles. *It is recommended to
remove the entire Spinner platform assembly to more
properly judge this crucial alignment, sighted from straight up
above the area. Alignment should be inspected so the shuttle
is centered in each baffle of the indexing lum.chain.
LUMCHN
This program checks the movement of the Luminometer No Luminometer Chain
chain by indexing it one position every second.
LUMTEST 4, LUMTEST 5,
LUMTEST 6, LUMTEST 9
PIPXPOS
This program allows for visual inspection of the Pipettor No Pipettor
positioning. It moves the X-Pipettor to each of 10 rotational
positions, starting with home. At each position, it lowers the
Z-Pipettor momentarily. This test is used in conjunction with
the Pip-X Positioning Gauges. Refer to Section 7.4.5 for
more information.
PMTCOUNT
Activates measurement readings by the PMT, but does not No PMT
move the attenuator disk. Use the VIEW button to see the
current readings, or the GetdataT button for historical files.
PRIME
This program primes the two syringes and the associated No Syringe Pump Assembly and
tubing. Priming removes excessive air bubbles and allows for Fluidics
accurate dispensing of water and probe wash. It exercises
syringes A and B and solenoid valves 1,2 & 4. The systems
error checking is active, to aid in diagnosis. Also refer to
Section 7.4.4 for more fluidics information.

PROBANGL
This program is used to evaluate the dispensing angle of the No Probe
probe. The program positions the probe over the dump well
and then dispenses water. Check that the dispensing does
not exceed 7 to 10 degrees off center. Also, check for excess
spiraling of the stream. Subjectively, no more than 1 spiral
should occur per inch. Also, refer to Section 7.4.4 for more
fluidics details.
PROBETST
This program is used to evaluate the dispense of the probe No Probe
for any occlusion. It dispenses 3000 ul at a maximum velocity
of 1000 ul/second into the home well. Look for excessive
movement of the liquid up the probe shaft and/or any
splashing out of the side of the home well. During the cycle,
the probe lifts up and momentarily moves to the dump well.
Look for any dripping out of the probe at this moment.
Dripping indicates backpressure or occlusion inside the
probe or its associated tubing. Also, refer to Section 7.4.4 for
more fluidics details.
PRBCLEAN
This program runs a special enzyme cutting probe wash Yes Probe
routine, which is part of daily maintenance. A special probe
wash kit must be used in conjunction with this diagnostic.
Refer to the package insert instructions included with the kit
for more details.
RBCODE
This program tests the Reagent Carousel barcode reader. No Reagent Carousel Barcode
Load a number of reagent wedges in the reagent carousel. Reader
The program moves the reagent carousel to the home
position and then to each position while reading reagent
wedge barcodes. Use the VIEW button to visually confirm the
actual reagent wedge barcode reads.
REAGENTH
This program is used to check the Reagent Carousel home No Reagent Carousel Home Sensor
position sensor. Check for proper position of the home
sensor by placing a wedge in the home position (position 1)
of the reagent carousel and running this program. The red
LED should shine an oval centered between the edge of the
wedge and the first barcode line when the carousel pauses at
home. Use the ALARM MUTE button to extend the pause at
home for a closer evaluation.

REAGENTP
This program is used to check the Reagent Carousel position No Reagent Carousel Position
sensor in all twelve positions. Check for the proper position of Sensor
the individual position sensor using an empty reagent
carousel and running this diagnostic. Look directly through
the individual notches found around the edge of the carousel
and check that one of the position sensor heads is centered
below each position notch. Verify all wedge positions are
centered over the sensor head below. Use the ALARM
MUTE button to extend the pause in each position for a
closer evaluation.
SCHANGE
This program is used when changing the syringe tips. It Yes Syringe Module
moves both syringes down approximately halfway to permit
the removal of the syringes. After replacing the syringe tips,
press GO to move the syringes back to their home position.
SHUTLOAD
This program allows for the evaluation of the shuttle as it No Shuttle
loads test units into the spin position. Manually load a test
unit onto the carousel one position before entering the
shuttle. The test unit will be loaded into the spin position.
Inspect for proper actuation of the springs of the shuttle, so
that the test unit fits snugly pushed into the spinner wheels.
The test unit should sit on a straight angle (without tilting).
Press GO to have the program eject the test unit for removal.
SHUTSPIN
This program is used to evaluate the high-speed spinner Yes Shuttle, High Speed Spinner
cycle. Manually load a test unit with 200 uL of liquid pipetted Motor
into it, onto the carousel one position before entering the
shuttle. The test unit will be loaded into the spin position and
the high-speed spin motor will activate for 30 seconds. The
test unit should slightly lift up and the liquid should quickly
clear from the bottom of the tube. Watch that the bead moves
off the bottom of the tube and floats in air, while the tube is
spinning. To check the actual spinner speed, use the
WASHSPD diagnostic.
SHUTTLE
This program is used to check the positioning of the shuttle. No Shuttle
First, the shuttle is moved from the home position to a neutral
Luminometer position. Next the shuttle is moved to the
spinner wheels (which also is the water dispense position), a
brief Sh Push adjustment is applied, then the shuttle is
moved to the substrate dispense position. In some
instruments, if necessary, a slight movement to the
Sh at Lum position is made to align the shuttle with the
Luminometer entrance. The cycle is then repeated.

SOLE1W
This program is used to check the dispense volume and/or No Water Pump
drawback adjustment of the water pump. Disconnect the
water nozzle and hold a sample cup under the water nozzle.
Run the SOLE1W diagnostic to dispense two shots. Use the
ALARM MUTE button to pause and control the shots into the
cup. The approximate level of water should be at the fourth
line of the sample cup (2 shots at 200 ul = 400 ul). Confirm
that the drawback is within specification of , +/- . Also
refer to the end of Section 7.4.4 for further adjustment details.
SOLE2S
This program is used to check the dispensing volume and/or No Substrate Pump
drawback adjustment of the substrate pump. Disconnect the
tubing on top of the substrate heater and hold a sample cup
under the substrate tubing. Run the SOLE2S diagnostic to
dispense two shots. Use the ALARM MUTE button to pause
and control the shots into the cup. The approximate level of
substrate should be at the fourth line of the sample cup (2
shots at 200 ul = 400 ul). Confirm that the drawback is within
specification at , +/- . Also refer to the end of Section
7.4.4 for further adjustment details.
SPINCHK
This program allows for a quick visual check that the high- No High Speed Spinner Motor
speed spinner motor is working. Manually load as many test
units as desired onto the carousel and manually rotate to one
position before entering the shuttle. The test unit will be
loaded into the spin position and the spinner motor will turn
on for about 3 seconds.
SPINON
This program turns the high-speed spinner motor on or off, No High Speed Spinner Motor
when pressing the GO button.
SUBSHEAT
This program is used to monitor the substrate heater. No Substrate Heater
Remove the cover on the substrate heater. Using a DVM set
to DC volts, place the leads on the test points of the Heater
PCB. Run the program and monitor the starting (ambient)
temperature and final (heated) temperature. The DVM
reading is in direct correlation to the temperature. Multiply the
voltage measured by 100 and this will be the temperature in
Centigrade.
The stabilized temperature should be 36.6 .6oC. After
measuring the temperature, be sure to exit the program so
that the substrate is not heated for a long period of time.

TEMPS
This program is used to monitor instrument temperatures. No Temperature Sensors of:
The temperatures are updated every thirty seconds and can Reagent Carousel,
be seen using the VIEW button. The screens can also be Luminometer, Main Carousel,
printed. Ambient System, Ambient
Electrical
Also, refer to Section 3.8 for complete temperature
information.
NOTE: The PMT is not addressed in this diagnostic and
therefore will read zero.
UNATTN10
UPDOWNA
rough depth of the probe in the test unit and the functions of
the Z-Pipettor home sensor and mid sensor. Load a test unit
on the load platform. Use the EMPTYTUB diagnostic to index
the test unit to the Main Carousel dispense position. The
program will move the X-Pipettor to the test unit dispensing
position, then move the Z-Pipettor to the home sensor, down
to the mid sensor, then down the amount of error steps for
parameter 34 (Z Assay) of the configuration table.
UPDOWNH
rough depth of the probe in the home well and the functions
will move the X-Pipettor to the home well position, then move
Home) of the configuration table.
UPDOWNW
rough depth of the probe in the wash well and the functions
will move the X-Pipettor to the wash well position, then move
Wash) of the configuration table.

V1 TEST
through the probe and the wash well. The change in
dispense point is altered by the activation or deactivation of
V1. If the valve is not working at all the water will always
dispense from the probe. If the valve is stuck in the activated
position, the water will always come from the wash well. If
one of the two diaphragms in the valve is partially clogged,
one port will slowly drip while the other is dispensing.
V2TEST
through the probe and the detergent container tubing. The
change in dispense point is altered by the activation or
deactivation of V2. If the valve is not working at all the water
will always dispense from the probe. If the valve is stuck in
the activated position, the water will always come from the
detergent container tubing. If one of the two diaphragms in
the valve is partially clogged, one port will slowly drip while
the other is dispensing. Another way of testing V2 is to
suspend the detergent container above the instrument and
check to see if a drop begins to form on the end of the probe.
If a drop has not formed within 10 minutes, the valve is
sealing properly.
V4TEST
syringe assembly. This program works exactly like V1TEST.
This program should alternately dispense water through the
probe and the wash well. The change in dispense point is
altered by the activation or deactivation of V4. If the valve is
not working at all the water will always dispense from the
probe. If the valve is stuck in the activated position, the water
will always come from the wash well. If one of the two
diaphragms in the valve is partially clogged, one port will
slowly drip while the other is dispensing. This program uses
V1 to direct the flow in a direction that can be differentiated
from the other.
WASHSPD
This program tests and/or allows adjustment of the speed of Yes High-Speed Spinner Speed
the high-speed spinner motor. Follow the prompts given on
the IMMULITE 1000 display screen. Adjust potentiometer
R107 on the DC Motor/Heater PCB to achieve 5500 RPM.
Press GO to stop the program.

WATERTPM
This program is used whenever system fluidics contamination Yes Fluidics
is suspected in the instrument. Refer to Section 7.4.1: (suspected water contamination
Miscellaneous Procedures for further information. in the instrument)
NOTE: This program needs 4 Water Test Vessels. If the

wrong number of vessels is placed onto system, the test will
stop and indicate Test Failed on the display panel.
WATERTST
This program is used whenever water contamination is Yes Fluidics
suspected from the source water supply. The program tests a (suspected water contamination
water source independent of the systems fluidics. Refer to from the water supply)
Section 7.4.1: Miscellaneous Procedures for further
information.
NOTE: This test needs 2 Water Test Vessels. If the wrong

number of vessels is placed onto system, the test will stop

8.4 System Configurations Programs
automatically, and which module(s) and/or component(s) the diagnostic applies to.
The programs are listed alphabetically as they appear on the System Configurations Menu.

Stop? component(s)
BSYRN10, BSYRN25, BSYRN75
DEADVADJ
This program automatically sets the proper Dead Yes Pipettor
Volume Z-step calibration for Reagent and Sample, (Auto-Calibration of Minimum Dead
using the systems own fluidics. This is potentially more Volumes)
accurate than a similar test LEVSNADJ, where the fluids
are set up manually. Follow instructions on the display
panel. When the program ends, leave test vials in place
and run the check diagnostics of LEVSENSR and
LEVSENSS to confirm proper setting.
DISP1000
This program is used for dispensing reconstitution Yes Pipettor
volumes into adjustor or control vials, using the systems
fluidics automatically. The diagnostic will dispense
exactly 1000ul of clean water from the large syringe and
probe, for each time that the GO button is pressed. Up to
10 shots at 1ml each will be supplied in each cycle to
Idle. Repeated loading of the cycle may be necessary to
get all needed shots.
LDCHNADJ
This is the adjustment program for the position of the Yes Load Chain
Load Chain. Proper adjustment entails evaluating where
the Load Chain crosses the pathway of the Main
Carousel. The correct adjustment is where the baffle of
the Load Chain is flush with the outer wall of the
Carousel casting. The inner baffle will slightly encroach
into the inner wall of the Carousel casting. Refer to
Section 7.4.6 for more information.
LEVFSTST
This program tests the tendency of the level sensor to Yes Pipettor (Level Sensing)
false trigger when a signal is not desired. The program
checks for level sensing at empty positions of reagent
and five samples. If all is well, it will not level sense
anything, and Errors Encountered on the display panel
should ideally stay at 0. The FSE can also attempt to
trigger false signals while jiggling related wiring during
motion. This diagnostic will stop automatically after 17
rotational cycles (up to 102 potential level sense
triggers.) Note: Always use this as a companion to the
converse test LEVSNTST.

Stop? component(s)
LEVSNADJ
This program calibrates the minimum dead volume for Yes Probe
sample and reagent. It is pre-set using manually pipetted (manual calibration for Dead
fluids into empty test vials. Follow prompts on the Volume settings)
IMMULITE 1000 display. Place a reagent wedge with 1
ml of probe wash solution in Position 1 of the Reagent
Carousel. Also, place a sample cup with 100 uL of probe
wash on the load platform. The program will index the
sample cup to the first sample position. Then the probe
will use level sense to search for the level in the reagent
wedge, then the sample cup. Once the probe finds the
levels, the IMMULITE 1000 will display Calibration
Successful. While leaving the reagent wedge and
sample cup in position, verify the adjustment by running
the LEVSENSR and LEVSENSS diagnostics from the
main diagnostic menu. LEVSENSR should display an SL
(steps left) number between 8 and 12. The LEVSENSS
should display an SL number that is reasonably close to
the value for parameter 13 of the Configuration Table
during the calibration. If main diagnostics do not confirm
good SL numbers, repeat this test from the beginning,
checking for proper pipetting. Also see the automatic
version of DEADVADJ.
LEVSNTST
This program is the companion to the LEVFSTST, and Yes Pipettor (Level Sensing)
conversely to that, the level sensing will touch down into
pre-set sample cups filled with probe wash. It will cycle
up to 20 rotational cycles (100 potential signal checks). It
is looking for level sensing signals when one is desired.
Follow instructions for set up on the display panel. After
filling the cups, it will begin the repeated level sense
checks, and if it does not see the liquid in a cup, it will
begin to count the errors on the display. Ideally, as with
the LEVFSTST, the Errors Encountered should remain
at 0. Note: Always use this as a companion test with
LEVFSTST.
LUMCHADJ
This program performs an adjustment for Luminometer Yes Luminometer Chain
Chain position. Following the prompts on the display
panel, adjust the chain to a position where the shuttle
passes directly through the center of the luminometer
chain. This is best viewed from above with the spinner
assembly removed.

Stop? component(s)
MCARADJ
This program performs an adjustment for The Main Yes Main Carousel Ring Gear
Carousel Ring Gear. Following the prompts on the
display panel, adjust the ring gear so that the shuttle
body passes directly centered between two baffles of
the ring gear. Confirm proper adjustment by running the
main diagnostic CARCHECK.
MCARTST
This program is a test for the positioning sensor of the No Main Incubator Carousel
Main Incubator Carousel, for the use of troubleshooting (Position Sensor)
related problems. On the display panel, the hole width of
each position hole of the ring gear (in steps) will display
with each repeated index of the Main Carousel.
-- Nominal values are a range of 22 26 for large holes.
-- Nominal values are a range of 8 12 for small holes.
PIPXRADJ
This program performs an isolated adjustment of rotation Yes Probe
alignment of probe over reagent wedge. After pre-setting (X-rotational position at Reagent)
an open reagent wedge at the probe position with
REAGENTP, and with the reagent chamber lid open, use
the small opening of the reagent vial as sight judgement
for a centering target of the probes X-Position over this
hole.
PIPXSADJ
This program ensures the probe is centered in sample Yes Probe
cups in the five pipetting positions. To prevent damage to (X-rotational position
the customer probe, install a dummy probe. The smaller at all 5 Sample Cups)
notched Pip-X positioning gauge (from Kit p/n 420078)
is used to precisely target and/or adjust each of the five
sample pipetting positions. The program actions will work
clockwise around from position S5 to S1. Start the target
gauge at S5, and set the probe one at a time, using the
Go button for raising the test probe and shift the target
gauge to next S-position. Ensure the probe comes down
within one probe width of the center target of the gauge.
PIPXTADJ
This program allows the adjustment of the rotational Yes Probe
alignment of the probe at the dispensing position into the (X-rotational position at Assay Test
test unit. Place the larger (without a notch) Pip-X Unit Dispense Position)
positioning gauge (from Kit p/n 420078) in the test unit
dispensing position using CARCHECK. Run the
diagnostic and check for proper positioning either
centered or within one probe width to the rear (counter-
clockwise). Refer to Section 7.4.5 for more information.

Stop? component(s)
PIPXWADJ
This program allows the adjustment of the rotational X- Yes Probe
alignment of the probe over the three positions at the (X-rotational position at Home Well
front wash station. The Dump and Wash wells are of the front wash station)
hard-coded from the rightmost Home X-position. 20
steps to Dump, 40 steps to Wash Well. Once the
program has centered the Home Well, the other two
should also be centered properly.
PIPZHADJ
This program performs an automatic self-calibrating Yes Probe
adjustment for Z probe depth in the Home Well. The (Z-up/down self-calibration for
program places the probe in the home well and fills it with optimal Home depth)
water until no bubbles are present. The probe is then
level sensed to the water level. The IMMULITE 1000
display will post a Calibration Successful message.
PIPZTADJ
This is an auto-calibrating program that optimizes Z- Yes Probe
probe depth in a beaded test unit at the dispense (Z-up/down calibration for optimal
position. NOTE: This requires accurate manual setup. Assay depth manual setup
Place a beaded test unit with 210 uL of probe wash on method)
the load platform before starting the program. Run
program and follow display prompts. Proper calibration is
determined by the proper pipetting of 210 uL into the test
unit.
PIPZTCHK
This is an automatic self-calibration for optimal Z-probe Yes Probe
depth in a 210 ul beaded test unit. This is a newer, more (Z-up/down automatic calibration
accurate version of the PIPZTADJ program above, in that for optimal Assay depth)
the empty test unit is given a more accurate 210 ul test
volume, through the higher accuracy of the small syringe.
PIPZWADJ
Automatic self-calibrating program that adjusts probe Yes Probe
depth in the wash well. The syringes fill to an optimal (Z-up/down self-calibration for
water level in the wash well then the probe is level optimal Wash Well depth)
sensed to the water level. The IMMULITE 1000 display
will post a Calibration Successful message.
REAGHADJ
This program is used to adjust the reagent carousel Yes Reagent Carousel
home position. Follow the prompts on the display panel.
Confirm proper positioning using main diagnostic
REAGENTH.
REAGPADJ
This program is used to adjust the twelve reagent Yes Reagent Carousel
carousel positions. Follow the prompts on the display
panel. Confirm the proper positioning using main
diagnostic REAGENTP.

Stop? component(s)
SAMPFTST
This program tests the sample collection tray full sensor. Yes Sample Collection Tray
Place a sample cup in position to block the sample (Tray Full upper sensors)
collection tray full sensor and run the diagnostic. Follow
the prompts on the display panel. A Pass/Fail condition
will be posted.
SAMPTTST
This program tests the sensor that detects the presence Yes Sample Collection Tray
of the sample collection tray in its lower casing. Follow (Tray Absent lower sensors)
prompts on the display panel. A Pass/Fail condition will
be posted.
SHUTCADJ
This program is used to adjust the shuttle home position Yes Shuttle
at the Main Carousel (Sh at Car parameter #21). Follow
the prompts on the display panel to adjust the degree for
which the shuttle idler wheel encroaches into the
carousel. The proper adjustment is when the lower
shoulder of the shuttle at its idler wheel aligns flush with
the inner wall of the carousel casting. Confirm proper
alignment by running main diagnostic SHUTTLE with a
test unit placed in the shuttle.
SHUTLADJ
This program is used to adjust the shuttle position at Yes Shuttle
entry into the luminometer (Sh at Lum parameter #25).
Remove the spinner assembly for a clear view and place
a test unit on the shuttle. Follow the prompts on the
display panel to adjust. Proper alignment allows a
smooth transition of the test unit off the shuttle and into
the luminometer. The test unit should be centered and
should not contact either side of the Luminometer
entrance. Confirm proper alignment by running main
diagnostic SHUTTLE with the test unit still placed in
shuttle.
SHUTSADJ
This program is used to adjust the shuttle position at the Yes Shuttle
substrate dispensing position (Sh at Sub parameter
#22). Remove the substrate heater for a clear view from
above and place a test unit on the shuttle. Follow the
prompts on the display panel to adjust. Adjust for a
centered test unit under the substrate dispensing
position. It is possible for the Luminometer entrance
position and the substrate dispensing position to be the
same.

Stop? component(s)
SPNCKTST
This is a test of the High Speed Spinner Motors Yes High Speed Spinner Motor
Spincheck Logic circuit and the proper error and error checking circuit
interpretation from the motors Hall Effect return current
to the system CPU. Follow the display panel prompts, as
the system will feed a test unit into the spinner and
perform a 5-cycle test of the spinner, posting a Test
Passed at end or Test Failed if within the 5 cycles, it
failed to reach at least 2,500 rpm in 0.5 seconds. The
user may also Repeat the cycles as often as desired, or
Exit to end the test and eject the test unit.
SUBHTTST
This program tests the on/off logic trigger point of the Yes Substrate Heater
substrate heater. Remove the substrate heater cover and
attach a DVM set to DC volts to the white test points. The
DVM reading is in direct correlation to the temperature.
The actual temperature is the DVM reading with the
decimal point moved two places to the right. Run the
program and look for the on/off trigger point of
approximately 35 degrees. A Pass/Fail condition will be
posted on the display panel.
SUBLVTST
This program tests the proper operation of the Substrate Yes Substrate Low
Reservoirs level sensor. After initialization, be sure to Reservoir Level Sensor
carefully follow the prompts on the display panel. The
user will be instructed to properly cycle the substrate
pump until the level is visibly below the window Fill Line,
where it will trigger the level sensor to indicate Test
Passed. Be sure to correctly judge a Test Failed
message, if the actual level is still above the fill line. In
this case, press the Pause button to Repeat the
pumping cycles through all the prompts again, cycling out
more until the level is actually low enough to trip the
sensor.
TABLE
This program is initiated to access, display, change, or N/A All motors
print the systems Instrument-specific motor configuration
table. Refer to Section 7.2 for full details. CAUTION: do
not make changes to this table without consulting the full
details of Section 7.2.

Stop? component(s)
TEMPCAL
This program, though mainly created for the benefit of Yes Precision Calibrator Resistor Circuits
final production testing, is used for troubleshooting the of the Heater Temperature Control
35 and 39 Calibrator Resistors of the Temperature
Control Circuits. They test the accuracy of critical Main
Incubator Carousel and Luminometer heater control
upper and lower parameters. Follow the prompts on the
display panel to post first the 35 Degree Calibrator
Value=, and then the 39 Degree Calibrator Value =.
These readings are the current electrical values of these
precision components, translated into a decimal
equivalent. If the values are out of spec, then
temperature problems can be confidently sourced to the
likely need for a change of the 450002 Motor/Heater
PCB.
Nominal range for the 35 = 3,800 - 4,401
Nominal range for the 39 = 28,191 - 28, 791
NOTE: Be sure to consult Section 3.8 for full details of

temperature control and proper troubleshooting.
TIPJMTST
This is the preferred diagnostic to test the tip jam circuit. Yes Probe
The program bottoms out the probe five times to trip the (Tip Jam Sensor Function)
tip jam sensor. A Pass/Fail condition will be posted on
the display panel. Can be repeated several times to
ensure proper operation.

8.5 System Configuration Diagnostics Error Codes
In the functions of a select few of the Configurations Diagnostic programs, there is logic tie-in to post
related Error Codes, onto the IMMULITE 1000 display panel, while the program runs. These error codes
reflect certain good or bad conditions of the Configuration being performed. The table below explains
these error codes and their definitions.
System Configuration Diagnostics Error Codes
Code No. Error Definition

01 Tip Jam Sensor acts as if always blocked.
02 Tip Jam Sensor is unblocked prematurely.
03 Sample Tray Full Sensor is always unblocked.
04 Sample Tray Full Sensor is always blocked.
05 Sample Collection Tray In Place Sensor is always unblocked.
06 Sample Collection Tray In Place Sensor is always blocked.
07 Substrate Heater is up to temp prematurely or still hot from previous test.
08 Substrate Heater did not reach temperature within 5 minutes.
09 Substrate Level Sensor did not trigger within the expected time frame.
10 Program detected Level Sensor was triggered before any substrate was dispensed.
11 Spin Check Circuit output is prematurely indicating that motor is spinning.
12 Spin Check Circuit is indicating that the motor is not spinning.

Chapter 9: Troubleshooting
9.1 Description
This section is designed to aid in the quick, accurate diagnosis of IMMULITE 1000 problems. While
many people can make IMMULITE 1000 repairs, accurate troubleshooting is a rare skill for the
experienced as well as the inexperienced.
In its simplest state, troubleshooting is an exercise in logic. It is essential to realize that the IMMULITE
1000 is really composed of a series of modules. Some of these modules are interrelated, others are not.
The instrument operates within a framework of logical rules and physical laws, and the key to
troubleshooting is a good understanding of all the IMMULITE 1000 modules.
9.2 Troubleshooting Techniques

One of the key ingredients in diagnosing a problem is information. The following are questions to ask the
operator (or even yourself if you are experiencing a problem) in an attempt to draw the proper
information needed for troubleshooting.
1. What is the instrument serial number? - This will allow positive identification of the instrument.
Once the serial number is known, its age and history can be found.
2. What is the software version? - This is a very important question especially during periods when the
software is in the process of being updated. Certain assumptions are made about the operation of an
instrument with a particular version of software. Do not make these assumptions until the software
version is verified. Also, certain problems may be caused by an old version of software and updating
to the new software may be the solution.
3. What is the exact nature of the problem? - Try to determine exactly what is wrong rather than
accepting Its broken from the operator. Determining exactly what is wrong will allow you to either
solve the problem over the phone or know what part is needed for the repair when visiting the site.
4. When did the problem first occur? - Determining when the problem first occurred will allow it to be
then tied to an event. Or, if the customer says it has always done this (which is unusual but not
impossible) the problem could be with a procedure the operator incorrectly follows every time the
instrument is used. If the first occurrence can be determined, we then try to tie an event to this with
the next question.
5. Was anything unusual done to the instrument prior to the problem? - In many cases the reason for the
problem is found with the answer to this question. For example, the customer is having many air
bubbles in the small syringe and it has been determined that this started the day before. When the
question of "Was anything unusual being done..." is asked, the customer remembers that the small
syringe tip was changed yesterday. So, the reason for the problem is the new syringe tip or the
process by which it was changed.

6. Is the problem reproducible? - If the problem is reproducible, it can be considered a "phone
confirmed problem" and then steps can be taken to rectify it. A phone confirmed problem does not
necessarily mean it is one that involves an instrument problem; it could very well be a procedural
problem. For example, if the operator complains of "Reagent Carousel Temperature High" errors for
five minutes every morning, the problem is most likely that the lid of the reagent carousel housing has
been left open for a long time. If the problem is not reproducible, it may be a one-time event.
Although these are rare, they do happen. It is wise to be very persistent in reproducing or confirming
a problem before determining it to be a one-time event. Remember, this one time event could be a
generous warning of an impending failure.
7. Is the instrument making any unusual sounds? - If the problem is mechanical in nature, chances are
good it is accompanied by a noise that is different than normal. When an operator works with the
instrument for a while they learn the "normal" sounds of the instrument. A seemingly insignificant
change in the "normal" sound of the instrument could be a vital clue in diagnosing the problem.
8. At what point in the run does the problem occur? - The answer to this question will indicate if the
problem is related to something (Test Units, Sample Cups, Reagent Wedges, water, etc.) entering into
a section of the instrument. The answer can further indicate (if the problem is mechanical) where the
problem is since the location of the components can be mapped based on when the problem occurred.
For example, if the instrument has a shuttle carousel error immediately after the instrument starts to
run after being shut down, the problem is not due to any components entering the system. In this
particular case, the problem is most likely due to the instrument not being shut down properly,
leaving the shuttle improperly positioned for initialization.
9. If the instrument is down, have the operator leave the instrument as is. - Many clues, valuable for
diagnosing, are left behind when an instrument has had a problem. If the operator cleans up the
instrument in preparation for the arrival of a field service person, they may be removing these clues.
(Of course, some things such as samples and reagent vials must be removed and refrigerated to
prevent degrading.) For example, the instrument has had a problem with test units jamming the
incubator carousel. The customer has left the instrument in the jammed condition for the arrival of the
field service person. Since the field service person can see where on the incubator carousel the jam
occurred and the condition of the jammed tube, a determination of what caused the jam can quickly
follow.

If a field service person must now visit the site (or is already in front of the instrument and has completed
the above steps) the following steps will make for an efficient troubleshooting and/or repair session.
1. Before visiting the customer try to duplicate the problem at the office. - If the problem can be
duplicated on an instrument at the field service office, in most cases, so can the solution. This can
make for a smoother and quicker repair, since the repair procedure is rehearsed and the necessary
parts brought.
2. If the solution to the problem is not clear, create a diagnostic plan before arriving at the site. -
Generally, when the customer greets the field service person, they ask what could be causing the
problem and how long will it take to repair. A clear definitive answer will put the customer at ease
and give them confidence in the repair process. This clear definitive answer can only be the result of a
well, thought-out plan of diagnosing the problem. This plan should contain all possible causes of the
problem and how to check for each one. It should also contain a brief history of the instrument
including: age, past problems, dates of any modifications, and current revision status.
3. Upon arrival, observe the condition of the instrument and its environment. - The condition of the
instrument could be the cause of the problem or a contributor. For example, if the reagent carousel
tray has evidence of spilled reagent, this could explain why the reagent carousel tray sensor PCB has
failed. The environment of the instrument could also be the cause of the problem or a contributor. For
example, if the system is having intermittent "Electrical Ambient High" errors, the cause of the
problem could be high laboratory temperature or an instrument located behind the IMMULITE 1000
exhausting warm air onto the rear of the IMMULITE 1000. If the environment is the cause of a
problem but never considered as possibility, the problem may never be solved.
4. If possible, duplicate or verify the problem before diagnosing or repairing! - A very common mistake
made in repairing anything is to begin to diagnose, or even worse, repair a problem without first
trying to duplicate or verify it. In many cases the information the customer supplies about the
problem is not very precise, therefore allowing the diagnosis process to proceed down the wrong
"path". Worse yet is to repair (replace a part, make an adjustment, etc.) a problem without knowing if
the repair is really necessary. Occasionally, there may not be a reasonable way of duplicating a
particular problem; these are the most difficult problems to diagnose.
5. Check the error.log file. - The error.log file can contain information unnoticed by the customer.
Check this file to get more information about a problem at the beginning of the diagnosis. Refer to
Section 7.4.13 for information on the error log file.
6. Do not ignore the obvious! - Never assume the solution to a problem is complex. Most problems are
easily diagnosed and repaired.
7. When the problem is found and fixed, check the area around the problem to insure no other problems
were created by the repair. - Most of the components in the IMMULITE 1000 are close together and
interact with other assemblies. Therefore, during the repair process, it is possible to cause another
problem while repairing the one diagnosed. Always check, visually and via diagnostics that all
components around the problem area are functioning properly after the repair work is complete.
8. Unless unusual circumstances exist, run controls to check the instrument. - This step is very
necessary in determining if the repair was truly successful and no other problems exist.

9.3 Typical Problems

Main Incubator Carousel Main Carousel ring not Motor or motor drive circuitry
moving. failure.
CARPOS configuration table are incorrect.
A sample cup is on the carousel and
CARCHECK is jammed under the carousel ring
drive area.
CARBACK The shuttle has mis-positioned and
is blocking movement of the
MCARTST carousel.
The Load Chain has not advanced
SHUTTLE correctly and thus an assay tube or
sample cup holder is blocking
carousel movement.
Main Carousel ring not The position sensor has failed.
EMPTYTUB positioning correctly. The position sensor assembly is not
located correctly.
Main Carousel momentarily The shuttle is not positioning at the
jamming during an index. carousel (home) correctly
resulting in the carousel baffles
hitting the shuttle.
TEMPS The Carousel is not heating to The heater is not getting power or
temperature. not plugged into the interface PCB.
TEMPCAL The heater drive circuitry has failed.
The thermistor is shorted (39.xx).
The Carousel is overheating. The thermistor has opened or is not
plugged in.
shorted "on."
Load Chain Load Chain is not moving. The sample tray is full.
A baffle has been dislodged and is
jamming the chain.
The motor or motor driver circuitry
LCHAIN has failed.
The "LcPos" parameter in the
EMPTYTUB configuration table is incorrect.
A Sample Cup Holder or Test Unit
has tipped and is jamming the chain.
Load Chain is not moving to The "LcPos" parameter in the
the correct position. configuration table is incorrect.
The position sensor or related
cabling has failed or the position
sensor disk has dust interference.

Load Chain (Cont.) Bad Sample Cup Holder or One or more of the idler assembly
Test Unit barcode read. rollers are fouled causing
inconsistent movement.
Driver O-ring is worn preventing
good grip on driven surface.
Incorrect Barcode Reader motor
BCODETST
speed.
Tubes are not spun smoothly by
BCODESPD
drive wheel due to dirt/grease build-
up on the drive wheel and/or tubes.
BCODE (quick test)
Drive wheel motor or motor drive
The drive wheel set screw has
loosened allowing slippage between
the motor shaft and the drive wheel.
Chain misalignment in front of
optical reader.
LCHAIN Intermittent Load Chain errors. The chain has become stiff from
spilled liquids.
EMPTYTUB The position sensor disk has dust
interference.
Luminometer Luminometer Chain is not The "LumcPos" parameters in the
moving. config table are incorrect.
The shuttle is mispositioned and
interfering with the chain.
dislodged and is interfering with the
LUMCHN chain.
An assay tube or partially dislodged
LUMCHECK Luminometer Chain baffle has
become jammed inside the
MCARTST luminometer, thus jamming the
chain.
SHUTTLE The chain tension has increased
surpassing the torque capabilities of
the motor.
Luminometer Chain is not The "LumcPos" parameters in the
moving to the correct position. config table are incorrect.
The position sensor has become
dislodged.
The slotted sensor disk has become
loose.
The chain tension has increased
causing the motor to miss steps and
"time out" during a move.
Drive Motor coupling inside cover
may be shifting loose.

Luminometer (Cont.) Shuttle is not moving. The shuttle parameters in the
shuttle movement.
The main carousel has
mispositioned and is blocking
shuttle movement.
SHUTTLE Shuttle is not moving to the The shuttle parameters in the
correct position. configuration table are incorrect.
LUMCHECK A sensor has failed or become
dislodged.
LUMCHN A lumchain baffle has become
shuttle movement.
A tube has fallen into the path of the
shuttle and/or has broken the shuttle
sensor flag.
PMT Attenuator Disc is not The attenuator parameters in the
moving. configuration table are incorrect.
ATTURN circuitry has failed.
The belt or associated components
have come loose.
Associated bearings for the disk
inside the cover have seized.
The PMT Attenuator Disc is The attenuator parameters in the
not moving to the correct configuration table are incorrect.
position. The sensor for that specific position
has failed.
The sensor cable for the specific
position has failed or is not
connected.
The Luminometer is not The heater is not plugged into the
heating to temperature. interface PCB.
The heater drive circuitry has failed.
TEMPS The thermistor has shorted (39.xx).
TEMPCAL Overheating heater connections at
pcb causing intermittent contact.
The Luminometer is The thermistor has opened or is not
overheating. plugged in.
shorted "on."
SPINCHK The High-Speed Spinner is not The motor or motor drive circuitry
moving. has failed.
WASHSPD The motor cable is not plugged in.
The stainless steel motor coupling
SPNCKTST has loosened or broken.
The tube pressure is too high.
(Shut Push.)

Luminometer (Cont.) The High-Speed Spinner is not The tube pressure is incorrect.
spinning at the correct speed. The motor drive circuitry is faulty.
SPINCHK The stainless steel motor coupling
has loosened.
WASHSPD The O-rings are worn or missing,
allowing slippage.
SPNCKTST
Pipettor / Reagent Carousel Pipettor X, Z, or Reagent The Pipettor X, Z, or Reagent

Carousel not moving. Carousel parameters in the
REAGENTH configuration table are incorrect.
A mechanical jam has occurred,
REAGENTP preventing the motor from moving.
The X-Pipettor belt has broken
RBCODE preventing any X movement.
Motor or motor drive circuitry has
failed.
PIPXPOS Pipettor X, Z, or Reagent Sensor of desired position has
Carousel not stopping at home failed.
UPDOWNH or position. The X-Pipettor belt has become
loose or worn preventing precise X
UPDOWNW movement.
The configuration table parameter
UPDOWNA setting for the sensor in question is
incorrect.
Open circuit in the cable connecting
the sensors to the microprocessor.
The Probe is stopping above Intermittent short or open in level
the Reagent Wedge or Sample sensor flex cable (Euro system).
LEVFSTST Cup. Liquid level is too high.
"LevSensR Error" configuration
LEVSNTST table parameter set too low.
"LevsensS Error" configuration
LEVFALSE (quick test) table parameter set too low.
The ground wire on the probe block
LEVCRASH (quick test) is not connected.
The level sensor is not Short or open circuit in level sensor
detecting reagent or sample. flex cable (Euro system).
An open circuit in the cable
connecting the level sensor output
to the microprocessor.
An open circuit between the level
sensor flex cable (Euro system) and
the probe.
Level-sense errors due to Probe is dispensing on an angle.
splashing. Probe dispense velocity is too great.
PROBANGL X-Pipettor is misaligned in the
home well.
PROBETST Z-Pipettor is misaligned in the home
well.
PRIME Air is in the system.

Pipettor / Reagent Carousel Bad or missing Reagent Wedge "RcHome" configuration table
(Cont.) barcode reads. parameter setting is incorrect.
Faulty Reagent home or position
RBCODE sensor.
Faulty barcode reader PCB.
Dirty barcode reader lens.
Wedge is incorrectly placed in the
tray.
The barcode label is poor quality or
obstructed by a substance.
DEADVADJ Grossly incorrect or missing "LevSensR" parameters in the
"Tests Remaining" number. configuration table incorrect.
Reagent Carousel has
mispositioned.
The probe has stopped over the
Reagent Wedge.
TIPJMTST Tip jam errors are encountered. The probe is not sliding through the
lower guide arm smoothly, thus
activating the tip jam sensor.
The probe block is sticking in the
raised position.
The probe block hold-down spring
has become loose.
TEMPS The Reagent Carousel is not The TED has become defective.
cooling. The Reagent Carousel temperature
thermistor has an open circuit.
The Luminometer and/or Incubator
Carousel have not yet reached 35C.
The TED has been shut down by the
temperature controller due to a
temperature error.
The cold plate of the TED is not
making good contact with the
casting of Reagent Carousel.
The TED drive section of the
Heater/DC Motor Board is
defective.
Power Supply Chassis The PC is indicating a problem The fuse for the IC logic power
communicating with the supply (F2) has blown.
IMMULITE 1000 (also no red The IC logic power supply has
LEDs of the system are seen). become defective.
EMPTYTUB No motors are moving nor is The fuse for the heater/motor power
the main cooling fan moving. supply (F3) has blown.
The heater/motor power supply has
become defective.
DARKCNT The CPS of the test units is The fuse for the PMT power supply
zero. (F1) has blown.
BKGNDCNT The PMT power supply has become
defective.

Power Supply Chassis (Cont.) No power from all of the The main input fuse has blown.
individual supplies The input filter/fuse holder has
become defective.
The power cord has become
defective.
The power switch has become
defective.
PMT Data points showing as zero. Blown fuse in Power Supply (F1)
(Photo-Multiplier Tube) for the PMT power supply.
PMT output coax has been
DARKCNT disconnected from CPU.
PMT is not plugged into the power
BKGNDCNT supply.
The PMT has become defective.
PMTCOUNT
Linear Actuator Substrate / Air bubbles have appeared in An up-line fitting has loosened.
Water Injector Pumps the tubing. The water or substrate supply is low
enough to allow air to start entering
the system.
DISSUB (substrate) No substrate being dispensed. The substrate nozzle is clogged.
The substrate spike is clogged,
DISWAT (water) causing a vacuum.
The Substrate bottle is empty.
The Substrate actuator pump or
driver circuitry has failed.
Substrate volume dispensed is The substrate nozzle is partially
incorrect. clogged causing the substrate to
SOLE2S (substrate) dispense at an angle partially
missing the assay tube.
SOLE1W (water) Clogged air filter in the substrate
spike.
Reservoir was never primed.
Defective substrate actuator pump.
No water being dispensed. Water container is empty.
A line fitting up-line has become
very loose.
Water actuator pump or driver
Water volume being dispensed The water supply bottle has become
is incorrect. empty.
Defective water actuator pump.
Air leak in the input line to the
pump.
Clogged in-line water filter.

Substrate Heater The substrate heater is not The blue wire (from J3 to A15-J10)
coming to temperature. connecting the heater to the Syringe
SUBSHEAT Interface PCB has become
disconnected.
SUBHTTST The heater circuitry has failed.
The yellow wire (from J3 to A10
solder point #9) has become
disconnected causing a break in the
"Heater at Temperature" signal.
Substrate Reservoir No substrate being drawn from The reservoir was overfilled causing
bottle. the substrate to back up into the air
SUBLVTST filter, clogging it.
A fitting is loose on the input to the
substrate solenoid pump.
The substrate is being used The operator is priming excessively
much faster than normal. when starting a run.
A loose and leaking tube fitting at
lower right of reservoir.
The air filter on the spike is missing
or punctured.
Internal failure or leakage within the
pump.
The solenoid pump dispensing
volume is too great.
Syringe Pumps Syringe overload error. A solenoid valve has a blockage.
The diluter has become defective.
A blockage had occurred in the
tubing.
Syringe controller PCB failure.
The probe has descended onto a
PRIME solid surface and is not able to
dispense or aspirate.
The rotary valve has leaked water
onto the metal guide shaft of the
diluter causing it to rust and seize
the guide arm bearing.
Incorrect amount of liquid One or more of the fittings has an
being dispensed and/or air or water leak.
aspirated. The syringe thumbscrews have
become loose or have fallen out.
One or both of the Teflon syringe
tips are worn.
One or more of the solenoid valves
has a leak in the diaphragm(s).
The water and/or wash container is
empty or near empty.
The water and/or wash in-line filter
is clogged.

Syringe Pumps (Cont.) Syringe communication failure. The communication cabling has
become disconnected or damaged.
The termination jumper (P8) on the
PRIME controller PCB is missing.
The +12 or -12 volts source is
missing.
The controller PCB has failed.
The syringe control part of the
CPU/Sensor PCB has failed.
V1TEST The probe drips as it is moving V1 is not activating or is partially
from the wash well to the activating.
V2TEST sample cup. V4 is not activating or is partially
activating.
V4TEST There is an air leak in the system
allowing liquid to leak from the
probe.
bottle is increasing instead of V2 is stuck in the activated position.
decreasing.
bottle is not decreasing.
Air in the plumbing system. Clogged water or wash in-line filter.
Loose fittings or kinked tubing(s).
The syringe(s) are loose from valve
above.
Worn syringe tips.
Bad micro or macro-valves.
Empty water or wash container.
SCHANGE Air is entering the small The water container is empty.
syringe One or more of the fittings
involving the small syringe are
loose.
The small syringe barrel is loose
from the microvalve.
The small syringe tip is extremely
worn.
fittings.
The microvalve is worn and not
sealing properly.
Air is entering the large The water container is empty.
syringe. One or more of the fittings
involving the large syringe are
loose.
The large syringe barrel is loose
from macrovalve.
The large syringe tip is extremely
worn.
fittings.
The macrovalve is worn and not
sealing properly.

Sample Collection Tray Sample Cups not smoothly The sliding surfaces of the sample
entering collection tray area or tray are dirty, restricting tube
jamming the Load Chain. movement.
The sample tray is not in the full
SAMPTTST down position.
The sample collection tray has
SAMPFTST become full.
The Star Wheel is incorrectly
adjusted.
The Tray-Place sensor is being The tray is not in the correct
falsely activated. position.
The sensor has failed.
Some liquid has spilled onto the
sensor.
The Tray-Full sensor is being The sensor has failed.
falsely activated. Some liquid has spilled onto the
sensor.
Sample Barcode Reader Bad Test Unit and Sample Cup An idler roller is not moving very
barcode reads. smoothly.
BCODETST Worn idler O-rings.
Worn or dirty drive O-ring.
BCODESPD Barcode reader motor speed is
incorrect
BCODE Bad motor.
The return spring has mispositioned.
Chemistry Results Low counts - CPS = 0. PMT power supply fuse (F1) is
blown.
PMT is defective.
Low counts - CPS = 10 to 100. No tube in front of PMT.
Low counts - CPS = 100 to No substrate dispensed.
1000.
Low counts - CPS = 2000 to No reagent pipetted. Could be a
10000. result of the wedge placed into the
tray incorrectly, level sensor falsing,
or the Reagent Carousel Tray
mispositioning.
Low counts - CPS > 15000, but No sample pipetted.
much less than normal. Probe wash is in the Test Unit.
Valve #2 may be failing.
"Dead" test unit.
Intermittent High counts. Test unit did not spin well or not at
all.
Test unit was "flicked."
If high result occurs on the first tube
of a run, valve #2 is most likely at
fault.
Consistent High Counts. Water is contaminated.
Substrate is contaminated.

9.4 Error Message Table
The table below lists numeric error numbers and the corresponding messages, causes and the
solutions. Error messages are logged in the Session Error and Event Log.
Error Number Problem Cause Solution

201 CV Calculation The software encountered Call Technical
Error an unexpected value in the Services.
database.
202 Standard The software encountered Call Technical
Deviation an unexpected value in the Services.
Calculation database.
Error
300 LIS Error: The LIS is not responding Check the cable
Timeout During to the IMMULITE 1000. connection.
Receive This can be caused by:
Re-download the orders
A cable problem to the IMMULITE
1000.
A hardware problem
If the error continues to
A bug in the LIS
occur, the Customer
software
should contact their LIS
provider.
301 LIS Error: Usually indicates a bug in Re-download the orders
Invalid Frame the LIS software; to the IMMULITE
Number however, it could be 1000.
caused by a bad message
(e.g. due to line noise,
occur, Customer should
etc.).
contact their LIS
provider.
302 LIS Error: Checksum did not match Re-download the orders
Invalid (transmission error). to the IMMULITE
Checksum 1000.
303 LIS Error: Usually indicates a Customer should
Missing Control programming bug in the contact their LIS
Character LIS software, but may be provider.
a bad message (e.g., line
noise).
304 LIS Error: There are fewer than five Customer should
Invalid Message characters in an incoming contact their LIS
Length ASTM formatted data provider.
message.

305 LIS Error: The frame number is not Customer should
Invalid Frame sequential for an incoming contact their LIS
Sequence ASTM formatted data provider.
message.
306 LIS Error: No No communication Check LIS cable for
Acknowledgement between the IMMULITE secure connection.
from LIS 1000 and the LIS.
If problem persists,
Customer should
contact their LIS
provider.
307 LIS Error: The LIS is not responding Re-send the results to
Timeout During to the IMMULITE 1000. the LIS.
Send This can be caused by:
A cable problem occur, Customer should
contact their LIS
A hardware problem
provider.
A bug in the LIS
software
308 LIS Error: There are numerous LIS Customer should
Excessive LIS errors during a session. contact their LIS
errors are provider.
occurring
309 LIS Error: Log There was an error while Call Technical
File Error writing to the Log File. Services.
314 LIS Error: The Header Message Call Technical
Header Message Password is incorrect. Services.
Not Received
There is no header
message.
315 LIS Error: A record required for LIS Re-send the test order
Patient Message communications is not to the IMMULITE
Not Received found. 1000.
If the problem persists,
Customer should
contact their LIS
provider.
316 LIS Error: EOT An LIS message was Customer should
received prior received out of sequence contact their LIS
to ENQ when establishing a provider.
communication session.
317 LIS Error: An invalid message type Customer should
Invalid LIS code was transmitted. contact their LIS
Message provider.

318 LIS Error: Communication Error Call Technical
Unexpected Services.
Communication
from LIS
319 LIS Error: Serial port is not Call Technical
Cannot open configured properly or not Services.
communication at all.
port.
452 Programmer Occurs when an Call Technical
Error 452 No underlying hardware error Services.
test input causes a software
file. Call communication issue.
Technical
Services.
453 Serial port There has been a Call Technical
already open. communication error with Services.
the serial port.
454 Cannot open There has been a Call Technical
serial port. communication error with Services.
the serial port.
455 Error in data There has been a Call Technical
send communication error. Services.
456 Error in data There has been a Call Technical
receive communication error. Services.
457 Error in Comm There has been a Call Technical
Event communication error. Services.
Error 458 underlying hardware error Services.
Error in debug causes a software
form. Call communication issue.
Technical
Services.
30000 Substrate Low Level of substrate in Replace the substrate
reservoir has dropped bottle and squeeze the
below fill-line. gray button on the
substrate reservoir to
fill the reservoir to the
fill-line.
Check wire connection
to rear of Substrate
Heater.
Test sensor using
SUBLVTST.

30001 Water and/or Water and/or probe wash Re-fill container(s) and
Probe Wash is bottle is empty. press GO on the
Empty. Re-fill display panel.
container(s)
and press GO.
30003 Reagent Either: Ensure there is
Pipetting Error sufficient reagent
Not enough reagent is
Marking Test available to complete
Unit as Bad available to complete
tests.
the test.
Ensure there are no
A level-sense error was
bubbles on the surface
encountered.
of the sample and
OR reagent.
A Test Unit and Place matching Test
Reagent Wedge were Unit and Reagent
mismatched. Wedge on board.
If intermittent and
continues, troubleshoot
using all related Level
Sensor checks.
30004 No Reagent Part Either: Replace the missing
xxx for Reagent Wedge.
approaching xxx A Reagent Wedge is
(assay) test missing from the Caution: The Reagent
unit, lot xxx Reagent Carousel Tray. Wedge must be
replaced within five
OR
minutes or this test
The Reagent Wedge result is lost.
and Test Unit lot
Place matching Test
numbers are
Unit and Reagent
mismatched.
Wedge on board

30008 Shuttle-Main The shuttle has not found Look for the cause of
Carousel Error the sensor at the Home the jam (Test Units, a
position ( at main bent shuttle flag or a
carousel) baffle that popped off
the Luminometer
Chain).
Note: This message will
Notes:
also appear on the
Instrument display panel If the problem cannot
when the error is detected. be corrected, the
A notice will appear on instrument
the display panel if the automatically shuts
IMMULITE 1000 is able down and Error #
to correct itself. 30042 will occur.
Troubleshoot using all
related movement and
alignment tests.
30009 Shuttle The shuttle has not found Look for the cause of
Position Error the sensor at the the jam (Test Units, a
Luminometer position. bent shuttle flag or a
baffle that popped off
the Luminometer
also appear on the
Chain).
Instrument display panel
when the error is detected. Troubleshoot with all
A notice will appear on related movement and
the display panel if the alignment tests.
IMMULITE 1000 is able
Notes:
to correct itself.
If the problem cannot be
corrected, the instrument
automatically shuts down
and Error Number 30042
will occur.
30011 Main Carousel The Main Carousel has Run related diagnostics,
Error not found a position including the test of the
sensor. sensor holesizes
MCARTST.
also appear on the Note: If the problem
Instrument display panel. cannot be corrected,
A notice will appear on Error Numbers 30040
the display panel if the and 30041 will occur.
to correct itself.

30012 Load Chain The Load Chain has not Look for the source of
Error found a position sensor. the error on the Load
Platform.
Check for accumulation
of dust on position
also appear on the
sensor disk below.
when the error is detected. Notes:
A notice will appear on
If the IMMULITE 1000
the display panel if the
cannot correct the error,
the instrument
to correct itself.
automatically shuts
down the pipetting
(front-end) operation
and Error Number
30040 will occur.
The instrument will
continue to process the
tests in progress.
30013 Pipettor Z- Something has interfered Determine if anything
direction has with the probe movement is interfering with the
jammed looking or a hardware error has pipettor movements
for Home occurred. (i.e., probe tubing).
Once the Test Units in
process are finished,
correct the problem and
also appear on the
restart the IMMULITE
1000.
when the error is detected.
A notice will appear on Notes:
If the problem cannot
be corrected, Error
to correct itself.
Number 30040 will
occur. The instrument
will continue to process
tests currently in
progress.
30014 Pipettor X- Refer to the explanation Refer to the solution for
direction has for Error Number 30013. Error Number 30013.
jammed
30015 Pipettor X- Refer to the explanation Refer to the solution for
jammed looking
for Home.

30016 Pipettor Z- Refer to the explanation Refer to the solution for
jammed looking
for Mid-Z. Note: If the probe was on
the Main Carousel when
the error occurred, Error
30041 will occur.
30017 Level Sense The IMMULITE 1000 has Troubleshoot with
Error not level-sensed either the related level sensing
reagent or the sample. diagnostics.
Note: If five Level Sense
errors occur, the
IMMULITE 1000 goes
into Auto PAUSE. See
also, Error Number
30044.
30018 Tip Jam Error Indicates that: Check the sample
volume. If necessary,
There is no sample.
add more sample and
Caps were left on the re-run the tests.
reagent.
Remove cap(s) from the
OR reagent.
The probe is not Watch the pipettor and
positioning correctly. try to determine the
cause of jam.
Perform the Probe
Angle Diagnostic to
assure probe integrity.
or the source of the
problem is unclear,
troubleshoot with all
related diagnostics for
TIPJMTST and level
sensing checks.

30019 Large Syringe A movement error in the Check to see if a test
Error large syringe was result was affected. An
detected. affected Test Unit will
appear as a white circle
on the Home screen.
also appear on the
Instrument display panel If there are affected
when the error is detected. Test Units and/or the
A notice will appear on error was not
the display panel if the correctable, call
IMMULITE 1000 is able Technical Services.
to correct itself.
Note: If the error is not
correctable, the Instrument
the front-end and Error
Number 30040 will occur.
30020 Small Syringe A movement error in the Check to see if a test
Error small syringe was result was affected. An
detected. affected Test Unit will
appear as a white circle
on the Home screen.
also appear on the
Instrument display panel If there are affected
when the error is detected. Test Units and/or the
A notice will appear on error was not
the display panel if the correctable, call
IMMULITE 1000 is able Technical Services
to correct itself.
Note: If the error is not
correctable, the Instrument
the front-end and Error

30021 Reagent Reagent Carousel has not Ensure that the Reagent
Carousel has found the Home Sensor. Carousel is seated
jammed looking properly and nothing is
for Home. blocking the sensor
Note: This message will beneath the Carousel
also appear on the Tray.
Check the bottom of the
Carousel Tray for a
bent tab. If bent, call
Technical Services.
to correct itself. Note: If the problem is not
correctable, Error Number
30040 will occur.
30022 Reagent Reagent Carousel has not Refer to the solution for
Carousel has found a position sensor. Error Number 30021.
jammed.
Note: If the problem is not
correctable, Error Number
30040 will occur.
also appear on the
to correct itself.
30023 Luminometer If this error occurs, the Call Technical Services
Chain Error Luminometer Chain has to determine the
Tests currently jammed and may be mis- validity of tests in the
running may be positioned. Tests on the Luminometer.
invalid. Call
Main Carousel are valid.
Technical Investigate all related
Services. positions and
alignments.
30024 High Speed Spinner has Run associated tests
Spinner Error malfunctioned. WASHSPD and
SPNCKTST to
Note: As a result of this
determine the solution.
error, tubes may not have
been washed properly.

30025 Attenuator Disk Attenuator Disk has not Investigate disk
has jammed found the Home Sensor. movement using
looking for ATTURN.
Home.
If intermittent, the
cause is likely that the
also appear on the
inner shaft bearings for
the attenuator disk are
beginning to fail, seize,
and need replacement.
Consult Siemens
Diagnostics Field
to correct itself.
Service for detailed
repair information.
If the problem is not
correctable, Error
Number 30043 will
occur.
30026 Attenuator Disk Attenuator Disk has not Refer to the solution for
has jammed found a position sensor. Error Number 30025.
looking for
position. Note: Same note as in
above error 30025.
30027 No Sample Cup A bad barcode read Depending on the cause:
available for occurred for the tube
Wipe the barcode label
Test Unit just before the Test
with a lint-free towel.
Unit (which may or
If the barcode is torn or
may not be a sample
wrinkled, discard the
cup).
Test Unit or sample cup
There are more than holder. Re-run the test.
five Test Units behind a
Clean orange O-ring.
sample cup.
Place the correct
There is no sample cup
number of Test Units
in front of the Test
behind the sample cup
Unit.
and re-run the test.
If there is no sample
cup in front of the Test
Unit, place a sample

30028 Sample The sample collection tray Remove the sample
Collection Tray is full. cups from the
Full collection tray and
replace the collection
tray.
Follow the instructions
on the Instrument
Display Panel to
continue.
evaluate using
diagnostics
SAMPTTST or
SAMPFTST.
30029 Display Panel Display Panel failure Check cable
Communication connections to rear of
Error Display Panel
Assembly
30032 No Reagent There is no Reagent Add the correct
found for (test Wedge on board Reagent Wedge and
name) xxx test matching the Test Unit press GO on the
unit after the just read at the Barcode Display Panel to re-
Barcode Reader.
Reader. read the Reagent
Carousel.
The current Reagent
Wedge has Zero Tests Press PAUSE to ignore
Remaining (the the message and this
Instrument will go into test will not be pipetted.
Auto PAUSE mode).
30034 Main Carousel Main Carousel has mis- Troubleshoot with all
Indexing Error. positioned and missed one related movement and
Instrument has of its home sensors. alignment tests, as well
shut down. as an evaluation of the
Call Technical Note: All previously
position sensor
Services. resulted tests are valid.
holesizes, using
All tests on board are
MCARTST.
invalid.

30035 Large Syringe A problem with the valve If problem persists, it is
Valve Error on the Large Syringe was a likely need to replace
detected. the dilutor of that side,
and the Logic/Driver
PCB. Consult Siemens
also appear on the
Diagnostics Field
Service for further
repair information.
the display panel if the Note: If the problem is not
IMMULITE 1000 is able correctable, the front-end
to correct itself. will shutdown and Error
The tests in progress will
be completed.
30036 Small Syringe A problem with the valve If problem persists,
Valve Error on the Small Syringe was review same note for
detected. previous error 30035.
Note: This message will Note: If the problem is not
also appear on the correctable, the front-end
Instrument display panel will shutdown and Error
when the error is detected. Number 30040 will occur.
A notice will appear on The tests in progress will
the display panel if the be completed.
to correct itself.

30037 Syringe Either: If GO was pressed less
Communication than one minute after
GO was pressed on the
Error Start-up, perform the
Instrument less than
following:
one minute after Start-
up. The small pipettor Check for solid
syringe then fails to connection of the flat
acknowledge ribbon communication
commands. cable, at the Syringe
Module.
OR
Turn the IMMULITE
A hardware failure
1000 power off for one
occurred.
minute, and then turn
on again.
Confirm that syringes
come to home.
Note: If the problem is
not correctable, the front-
end will shutdown and
Error Number 30040 will
occur. The tests in
progress will be
completed.
30038 Substrate The Substrate Heater did Test the substrate
Heater Failure not reach operating heater circuits with
temperature of 37 C in related tests.
allowed time.
30040 Front End Load Chain, Pipettor, Wait for the Instrument
Shutdown has Syringes and Reagent to complete tests in
occurred. Carousel have shut down progress.
Instrument will due to a jam in one of the
attempt to Investigate the problem
following areas: Load
complete tests by checking any
Chain, Z-pipettor, X-
in progress on associated error
pipettor, Main Carousel,
Main Carousel messages or looking for
Reagent Carousel or
and in the an obstruction.
Luminometer. Syringe Pumps.
Assays For further assistance,
Note: If possible, the
requiring call Technical Services.
additional Instrument will attempt to
reagent will be complete tests currently in
lost. progress on the Main
Carousel and
Luminometer. Assays
requiring additional
reagent will be lost.

30041 Main Carousel Main Carousel has The Instrument will
Shut Down. jammed or the pipettor is attempt to complete tests
Call Technical stuck in the pipetting in progress in the
Services. position on the Main Luminometer.
Carousel. This error often
Perform the following:
occurs because a sample
cup is on the Main Stop the IMMULITE
Carousel. 1000 (press ALARM
MUTE and GO).
Notes:
Log off the system.
This error will always
occur in conjunction with Run the CARBACK
Error Number 30040. diagnostic to check for
a sample cup on the
Main Carousel.
Press the Prime button
on the syringe module
to index the Incubation
Carousel
counterclockwise.
Remove the Test Units
from the carousel, as
they become accessible
in the Load
Chain/Carousel
intersection area.
Remove the sample cup
holder from the
carousel.
Select RUN
IMMULITE 1000 or
RUN TURBO from the
Start-up screen to
repeat the aborted tests.
Note: Remove the Test
Units from the Load
Chain (between the
Barcode Reader and the
carousel) before restarting
the tests. For further
assistance, call Technical
Services.
30042 Fatal Shuttle The Shuttle is not Troubleshoot with
Error. reaching one of its related movement and
Instrument has positions. The Instrument alignment tests.
shut down. cannot complete tests.

30043 Luminometer Luminometer Chain or Troubleshoot with
Chain Error or Attenuator Disk jam. related movement and
Attenuator Disk alignment tests.
Error.
Instrument has
shut down.
30044 Five Level The instrument will go If the errors were not
Sense Errors into Auto PAUSE mode if caused by insufficient
encountered Error Number 30017 sample or reagent
Entering Pause occurs five times within a volume, troubleshoot
Mode
run. with related level
sensing tests.
30045 Communication The correct lot Re-read the reagent

Error Reagent information could not be barcodes. If the
Transmit transmitted to the problem persists, call
IMMULITE 1000. Technical Services.
30046 Temperature The temperature Use Section 3.8 to
Controller controller failed due to troubleshoot.
Failure either:
Invalid Caution: Do not run the
Results. A brief power outage IMMULITE 1000 until
Software the Instrument is serviced.
A hardware or
Program will
now shut down. controller circuitry
Call Technical failure.
services
30057 Communication The computer and the Check cable
Error. IMMULITE 1000 were connections between
Simulation not communicating for the computer and the
screen may not more than 32 cycles. IMMULITE 1000.
be correct.
Some of the data was not
Call Technical Call Technical
received; therefore,
Services. Services.
reports will be missing.
Old = xxx New =
xxx.
30059 Heaters have The Luminometer or Main Use Section 3.8 to
shut down prior Carousel heating is not troubleshoot.
to start-up. working properly because
of a heater controller error
or thermistor failure.
30060 Heaters have The 35-degree calibration Use Section 3.8 to
shut down due resistor cannot be read troubleshoot.
to 35-degree properly due to a heater
calibrator controller error.
error.

30061 Heaters have The 39-degree calibration Use Section 3.8 to
shutdown due to resistor cannot be read troubleshoot.
39-degree properly due to a heater
calibrator controller error.
error.
30064 Heaters have Reagent cooling is not Refrigerate reagents
shut down due working properly because between 2 C and 8 C
to a Reagent of a heater controller error when not in use.
Carousel or a TED Cooler Unit
temperature Use Section 3.8 to
failure.
error. troubleshoot.
30065 Heaters have The Incubator Carousel Use Section 3.8 to
shut down due heater is not working troubleshoot.
to a Main correctly because of a
Carousel heater controller error or a
temperature
thermistor failure.
error.
30066 Heaters have The Luminometer heating Use Section 3.8 to
shut down due is not working properly troubleshoot.
to a because of a heater
Luminometer controller error or a
temperature
thermistor failure.
error.
30072 Software will The PC attempted 3 times Make sure the
not load after to communicate and the Instrument is in IDLE
three attempts. IMMULITE 1000 did not mode and try to re-
respond. establish
communication.
30073 IMMULITE 1000 Communication Error. Call Technical
Buffer Empty Services.
Timeout. Call
Technical
Services.
30076 File.lst or Corrupted files. Call Technical
Stat.lst file Services.
is missing.
Call Technical
Services.

30078 The file to be Files required for Call Technical
downloaded is instrument operation are Services.
missing. Call missing.
Technical
Services.
30079 The The configuration file to Call Technical
configuration be downloaded is missing. Services.
file is
missing. Call
Technical
Services.
30080 Multiple More than one Enter the
configuration configuration file is DOWNLOADS
files exist. present. folder, and delete the
Call Technical xxx.cnf file that does
Services. Note: This message
NOT belong to that
should not be encountered
Instrument serial
if the computer has been
number.
configured correctly.
30081 Attenuation The attenuation factor was Call Technical
Factor is out not set. Services.
of range. Call
Technical Note: This message
Services. should not be encountered
30082 PMT Multiplier The PMT is out of range. Call Technical
is out of Services.
range. Call
Technical Note: This message
Services. should not be encountered
30083 There were no No files are listed in either Call Technical
files listed in the .lst directory or the Services.
xxx (file name) stat.lst directory.
Error 30100. underlying hardware error Services.
Call Technical causes a software
Services. communication issue.

30102 Adjustment The kit parameters were Enter the kit barcodes
Aborted. Kit overwritten with those of (using the scanner), and
not found. XXX another kit after pipetting. re-run the entire
(test name) xxx adjustment.
(lot number).
Note: Do not delete a kit
that is currently running.
30110 Adjustor Database error occurred. Call Technical
algorithm for Services.
test not found
xxx (assay
name).
30111 Kit Information Kit information was Re-scan and re-adjust
Deleted. deleted. the kit.
Master Curve
not available.
30115 Test Unit Lots The Test Units being used Re-run both High and
do not match do not match the kit to be Low Adjustor using the
kit. adjusted. correct Test Units.
Adjustment
Aborted.
30116 Either High or The second adjustor is not Re-run both the High
Low Adjustor on board the Instrument. and Low adjustor.
missing.
Adjustment
Aborted.

30117 Adjustor Record The result file could not Call Technical
not found in be found. Services.
Database
30120 Low CPS, Sample Refer to Section 9.3 Refer to Section 9.3
#xxx (test
name) xxx
30121 High Adjustor After dropping the high Evaluate the CPS of the
does not meet Adjustor replicate, the replicates:
acceptance CVs are still too high.
criteria. If the CVs are very
Adjustment Note: This error can only high (30% or more),
Aborted. be encountered during the call Technical Services.
adjustment process.
If the CVs are not high,
re-run the entire
adjustment ensuring
there are no bubbles on
the surface of the
sample or reagent.
Note: Re-run both the
High and the Low
adjustor.
30124 Manual Dilution Manual dilution is not Re-run the assay
not allowed. allowed on this assay. without a manual
dilution.

30125 Low Adjustor After dropping the low Evaluate the cps of the
does not meet Adjustor replicate, the replicates:
acceptance CVs are still too high.
criteria. If the CVs are very
Adjustment Note: This error can only high (30% or more),
Aborted. be encountered during the call Technical Services.
adjustment process.
If the CVs are not high,
re-run the entire
adjustment ensuring
there are no bubbles on
the surface of the
sample or reagent.
Note: Re-run both the
High and the Low
adjustor.
30130 High and Low Sample cups were This message is for
Adjustors identified as low and high, information purposes
Reversed. but either the levels only. Verify adjustor
Slope and dispensed into the cups results based on the lab-
Intercept
were in the reverse order specific adjustment
Recalculated
xxx (assay or only one level was run criteria.
name). for both samples.
30140 Dark Count High The dark count measured Troubleshoot using
xxx exceeds the maximum related PMT tests to
acceptable limit (300 evaluate signals.
CPS).
Note: The preceding
sample may have had very
high CPS.

30141 No place to put Database error Call Technical Services
answer
30142 Calculation The IMMULITE 1000 Call Technical
Error: Unable encountered an error Services.
to calculate while calculating test
result for test results. This error may be
xxx.
caused by the following:
A hardware error
occurred.
The RS232 cable is
loose or disconnected.
Invalid parameters or
kit barcodes.
Note: This is an
infrequent error when the
master curve parameters
are correct and the
IMMULITE 1000 is
running properly.
30143 Calculation A calculation error Call Technical
Error during occurred during Services.
Adjustment xxx adjustment.
(assay name)
xxx (kit lot)
30145 Dark Count High Dark counts exceed Troubleshoot using
results acceptable high number. related PMT tests to
invalid. Call Results are invalid. evaluate signals.
Technical
Services.
30146 FATAL CURVE Kit information is Re-scan and re-adjust
ADJUST ERROR incorrect in the database. the kit.
Assay
information
incorrect in
Kit Database
xxx (assay
name) xxx (kit
lot)
30150 Dilution not On-board dilution of this If dilution is needed,
allowed for assay or sample is not perform a manual
this assay or allowed. dilution.
sample type
30151 Dilution Dilution is required for Re-run tests using on-
Required this assay. board dilution.

31201 Turbo kits Turbo Reagent Wedges Lift out the Reagent
cannot be run have been loaded onto the Tray and remove all
while in RUN Reagent Carousel while in Turbo Reagent
IMMULITE 1000 Normal mode. Wedges, then replace
mode. Please
the Tray to continue
remove all
Turbo kits from running in Normal
the Reagent mode after re-
Carousel. interrogation of the
Wedges.
OR
Press PAUSE on the
display panel 3 times.
Once the Instrument is
in Idle mode, select
Mode from the drop
down menu to switch to
Turbo Mode, in order
to run the Turbo kits.
31202 IMMULITE 1000 Non-Turbo Reagent Lift out the Reagent

kits cannot be Wedges have been loaded Tray, remove all Non-
run while in onto the Reagent Carousel Turbo Reagent Wedges
Turbo mode. while in Turbo Mode. and replace the Tray to
Please remove
continue running in
all IMMULITE
1000 kits from Turbo Mode after re-
the Reagent interrogation of the
Carousel. Wedges.
OR
Press PAUSE on the
display panel three
times. Once the
Instrument is in Idle
mode, select the RUN
IMMULITE 1000
button from the toolbar
to run the non-Turbo
kits.

31203 No Sample Cup Either: For a bad barcode read,
for Test Unit
A bad barcode read Wipe the label with a
occurred for the tube lint-free towel or wash
just before the Test the label with light
Unit (which may or detergent.
may not be a sample
If the barcode is torn or
cup).
wrinkled, discard the
OR Test Unit or sample cup
holder.
There is no sample cup
in front of the Test Perform maintenance
Unit. on the barcode drive
wheel, and run all
related barcode reader
diagnostics to evaluate.
If there is no sample
Unit, place a sample
31204 Mechanical Mechanical Pipettor Check seating of probe
Pipetting Error Jam. tube at Vanity Panel.
of Multiple Bad
Barcode Reads A problem for the Troubleshoot barcode
barcode reader, which reader, using related
produced multiple bad tests.
reads in a row.
The washer belongs
behind the Vanity
Panel.
If the problem is not
correctable, Error
Number 30040 will
occur.
31205 No Sample No sample was pipetted If the error was due to
Pipetted. because an error was insufficient sample,
Sample # xxx detected. The error may ensure there is adequate
(test name) be: sample in the sample
xxx.
cup (above the required
Hardware related
dead volume) and re-
Due to insufficient run the test.
sample
If it is a hardware error,
Note: If any other error troubleshoot pipettor
message accompanies this movements and level
one, it is a hardware sensing.
problem.

31206 No Reagent Either: Re-run the test ensuring
Pipetted Sample there is enough reagent
Not enough reagent is
- # xxx (test (above dead volume).
name) xxx left to continue testing.
If the problem is
OR
hardware related,
It is a hardware-related Troubleshoot using all
error (as indicated on related level sensing
the Instrument Display tests.
Panel).
31208 Assay not found An assay is not in the Call Technical
volume table. Services.
31211 Test Unit limit The allowable number of Re-run test(s) with the
has been test units has been acceptable limit of test
exceeded exceeded. units.
Note: A maximum of five
Test Units can follow a
sample cup for a normal
run. A maximum of four
Test Units can follow a
dilution cup.

31212 Tip Jam in Indicates that: Depending on the cause:
dilution cup
There was an error Verify the system is
creating the dilution in fully primed.
the previous cycle.
Remove cap(s) from the
There is no sample cup diluent wedge(s).
in the dilution cup
Watch the pipettor and
holder.
try to determine the
OR cause of jam.
The probe is not Run the PROBANGL
positioning correctly. Diagnostic to assure
probe integrity.
Troubleshoot using
related tests for level
sensing, tip-jam, and
pipettor movements.
31213 Dilution is not An on-board dilution was Re-run assay
allowed for requested for an assay that performing a manual
xxx. does not allow dilution on dilution.
board.
31214 Dilution not An on-board dilution was Place the missing
made for xxx. requested and a diluent diluent wedge on
wedge was not on-board. board.
31215 Improper Cups are out of sequence. Re-run in proper
placement of sequence.
dilution cup on
Load Chain Note: Dilutions must be
(Sequence: run as follows: Sample
Sample Cup, Cup Dilution Cup
Dilution Cup, Empty Space Up to
Space, Assay, four Test Units.
Assay, Assay,
Assay).

31216 Bad barcode The error is may be Depending on the cause,
last Sample #xx caused by one or more of perform the following:
the following:
If the barcode is torn,
Torn, wrinkled or dirty wrinkled or dirty,
barcode labels, which discard the Test Unit or
cause Test Units not to the sample cup holder.
spin smoothly.
Perform maintenance
Dirty Barcode Reader on the barcode drive
O-rings. wheel.
Barcode Reader speed Run the BCODESPD
is off in one or all and BCODETST
positions. diagnostics, to
investigate.
31217 No Diluent for Either: Replace the missing
approaching xxx Diluent Wedge.
(assay name) A Diluent Wedge is
missing from the Caution: The Diluent
Reagent Carousel Tray. Wedge must be replaced
within five minutes or this
OR
test result is lost.
The Diluent Wedge and
Test Unit lot numbers
are mismatched.
Services. communication error.
31220 Reagent Level Probe level senses above Check for cap on
Sense Error the maximum height of Reagent Wedge or
liquid. bubbles on top of
reagent.
troubleshoot using all
related tests for level
sensing, evaluating for
false triggers.
31222 Reagent Volume The volume in a Reagent Replace Reagent
Low or Empty Wedge is low or empty. Wedge.
31225 Expired Kit An expired kit was Scan a current kit into
scanned. the software.

31226 Adjustment Kit adjustment is overdue. Re-run adjustors for the
Overdue kit.
31227 Kit Never Adjustors for kit were Adjust the kit.
Adjusted never run.
31230 Five Replicates More than the required No action is necessary.
used for Curve four Test Units were run The software only
Adjust. 5th behind the adjustor looks for
Replicate sample cup. quadruplicates;
dropped.
therefore, the fifth Test
Unit is ignored.
31231 Less than 4 This Error can be caused Re-run the high and
replicates. by: low adjustor.
Adjustment
Aborted xxx A record or one of the
(sample cup). adjustor replicates was
deleted because of a
pipetting error.
An insufficient number
of replicates were
loaded.
31232 Kit Components This Error can be caused Re-run the adjustment
not matched. by: using the correct kit and
Adjustment kit components.
Aborted. Test Unit lot numbers
are not the same for all
the adjustor replicates.
The Test Codes behind
an adjustor sample cup
are not all the same (i.e.
not all TSH replicates).
Different Reagent
Wedge lots were
pipetted throughout the
two adjustor levels (this
occurs if two kits share
common test unit lots).
The kit was adjusted
using the incorrect kit
components.
31233 Communication Control side is not in sync Call Technical
Error: with User side. Services.
Simulation
Screen may not
be correct.
Call Technical
Services.

31250 Reagent The Reagent Carousel If just powering up the
Temperature temperature is above 22 system, you must wait
High xxx C. C. 45 minutes for the
analyzer to reach
Note: If temp keeps
optimal temperatures.
rising, but TED fan and its
LED #4 stay on, this is If the problem persists,
clear evidence of TED troubleshoot using
failure. Section 3.8.
31251 Ambient The internal ambient air The problem should
Temperature temperature reading is correct itself.
High xxx C. higher than the acceptable
range.
call Technical Services.
Note: The lab temperature
Note: This is not a fatal should be less than 30 C.
error condition.
31252 Ambient The ambient electronics Clean the intake fan
Electrical temperature reading is filter on the right side
Temperature higher than the acceptable of the IMMULITE
High xxx C. range. 1000.
Note: The lab
temperature should be less
Note: This is not a fatal
error condition. than 30 C. The
temperature should fall
back into an acceptable
range within a short
amount of time.
31253 Luminometer The temperature reading All results generated
Temperature for the Luminometer is during the high
HIGH! above the acceptable temperature period will
range. be flagged on the
printout.
The IMMULITE 1000
may correct itself. If it
does not within 20
minutes, troubleshoot
using Section 3.8.
However, if the
component feels hot,
turn the instrument off,
allow it to cool, then
reset and re-evaluate
using Section 3.8.

31254 Luminometer The temperature reading All results generated
Temperature for the Luminometer is during the low
LOW! below the acceptable temperature period will
range. be flagged on the
printout.
The IMMULITE 1000
may correct itself. If it
does not within 20
using Section 3.8.
31255 Main Carousel The Incubation Carousel The IMMULITE 1000
Temperature temperature is above the may correct itself. If it
HIGH! acceptable range. does not within 20
using Section 3.8.
Note: All results
However, if the
generated during the high
component feels hot,
temperature period will be
turn the instrument off,
flagged on the printout.
allow it to cool, then
reset and re-evaluate
using Section 3.8.
31256 Main Carousel The Incubation Carousel The IMMULITE 1000
Temperature temperature is below the may correct itself. If it
LOW! acceptable range. does not within 20
Note: All results
using Section 3.8.
generated during the low
temperature period will be
flagged on the printout.

31260 Cannot An invalid value was Go to the Temperatures
Calculate Last received for a temperature screen to verify
Temperature. reading because of a temperatures are within
Delta Error temperature controller specifications.
Encountered.
error or failure.
If the temperatures are
not within
specifications, turn the
IMMULITE 1000
power off to reset
controller, then turn on.
Check the temperatures
after 10 minutes.
If the Luminometer or
Main Carousel feels
hot, troubleshoot
further using Section
3.8.
31261 Cannot An invalid value was Go to the Temperatures
Calculate received for a temperature screen to verify
Average reading because of a temperatures are within
Temperature due temperature controller specifications.
to Error.
error or failure.
If the temperatures are
not within
specifications, turn the
IMMULITE 1000
power off to reset
controller, then turn on.
Check the temperatures
after 10 minutes.
If the Luminometer or
Main Carousel feels
hot, troubleshoot
further using Section
3.8.
31262 Cannot An invalid value was See same suggestions
calculate received for a temperature as for above messages
Luminometer reading because of a 31260 and 31261.
temperature due hardware failure.
to error.

31263 Cannot An invalid value was See same suggestions
Calculate Main received for a temperature as for above messages
Carousel reading because of a 31260 and 31261.
Temperature due temperature controller
to error.
error or failure.
31264 Communication There has been a If problem persists, call
Error: Invalid communication error Technical Services.
Sample Number between the Instrument
and the PC. Results for
this sample will not post.
31410 Error occurred There is an issue with an Attempt to re-import
while importing imported worklist. the worklist.
worklist
Duplicate key If the problem persists,
31420 LIS Error: LIS Occurs when the Send or Wait for the current
In Session Re-send button is pressed session to complete and
in the LIS Data initiate Send or Re-send
Management screen while again.
the PC is communicating
with the LIS.
31421 LIS Error: No Tagged records are not Re-send the results to
Results found in the database. the LIS.
Selected
31422 LIS Error: LIS The LIS is not responding Re-download the orders
Unavailable to the IMMULITE 1000. from the LIS.
This can be caused by:
Check the cable
A cable problem connection.
A hardware problem If the problem persists,
Customer should
A bug in the LIS
contact their LIS
software
provider.
31423 LIS Error: There is a terminator code Customer should
Terminator Code error. contact their LIS
Error provider.
31424 LIS Error: LIS The terminator code is Customer should
Terminator Code invalid. contact their LIS
Invalid provider.

31425 LIS Error: Occurs when the Header Review password with
Password Error Message Password is LIS provider and verify
incorrect. that password in LIS
configurations matches
that of the LIS
provider.
31426 LIS Error: Occurs when the Receiver Perform the following:
Sender ID Error ID is incorrect.
From the
Configurations screen,
select the LIS
PARAMETERS button.
Check that the Receiver
ID matches the LIS
Sender ID. If incorrect,
check with the LIS
provider for the correct
ID.
31428 LIS Error: The LIS is missing a Call Technical
Patient ID patient ID. Services.
Missing
31429 LIS Error: The Patient ID has Call Technical
Patient ID exceeded the allowable Services.
exceeded 20 number of characters.
characters.
31430 LIS Error: The accession number is Call Technical
Accession missing. Services.
Number Missing.
31431 LIS Error: The accession number has Call Technical
Accession exceeded the allowable Services.
Number exceeded number of characters.
20 characters.
31433 LIS Error: No Control information is not Enter control
Control Record in the database. information via Control
Found Entry on the Worklist
screen.
Re-download the
control sample from the
LIS.
31435 LIS Error: Control data is in an Check the format for
Invalid Control invalid format. control data and re-
Data download from the LIS.

31437 LIS Error: LIS Occurs when an Call Technical
Unavailable in underlying hardware or Services.
Test Mode. configuration error causes
a software communication
issue.
31438 LIS Error: Communication Error Attempt to re-send
Unsuccessful results.
Send
If problem persists, call
Technical Services.
Error 31439. underlying hardware or Services.
Call Technical configuration error causes
Services. a software communication
issue.
31440 LIS Error: The LIS encountered an Initiate another query to
Query Failure error when processing the the LIS.
IMMULITE 1000s
request for information.
Customer should
contact their LIS
provider.
31500 Data Export An error occurred during Attempt to export
Error data export. Data will not again. If problem
export as expected. persists, call Technical
Services.
31520 LIS Error: IMMULITE 1000 LIS If LIS parameters have
Query software is not changed, re-boot
Communication responding. LIS software. If problem
Error Configuration parameters persists, call Technical
may have changed. Services.

Chapter 10: Spare Parts

Generally, when traveling to an IMMULITE 1000 site to replace a part, it should be known before
leaving what part or parts will be needed. However, there have been situations when, because of a number
of different reasons, the part that will fix the problem is either incorrect or not on hand. (A few situations
have occurred where a service person has been in the vicinity of a "down" instrument but did not have the
correct part to make a speedy repair). If this is the case when the service person is far away from the
office, it could mean many more hours, possibly another day, before the instrument is able to operate. A
list of parts to have on hand when responding to a trouble call has been developed based on the
experience of IMMULITE 1000 service people around the world. Even though some parts on the list have
never failed, they should be carried since they are small, but critical to instrument operation.
10.2 IMMULITE 1000 Field Parts to be carried at all times

400349 RS232 Cable 1
400364 In-line Water Filter Assembly 2
400365 In-line Probe Wash Filter Assembly 2
420001 Small Shuttle Idler Wheel replacement kit 2
420038 High-Speed Motor replacement kit 1
420059 Burkert Valve replacement kit 3
420063 Probe kit 1
420072 Euro Level Sense replacement kit 1
420094 Sample/Test Unit Barcode Reader PCB 1
450007 Reagent Barcode Reader PCB 2
450014 Reagent Home and Position Sensor PCB 1
450017 Pipettor-X Position sensor PCB 1
450021 Sample Buffer Emitter PCB 1
450022 Sample Buffer Detector PCB 1
500048-1 1.235 inch chain baffle for Load Chain 5
500048-2 1.00 inch chain baffle for Luminometer Chain 5
500059 Rollers for 400008 Idler assembly 12

500061 Attenuator Shaft 1
500110 X-Pipettor Belt Pulley (Motor Shaft) 1
500174 Shuttle-at-Lum Sensor Flag 5
500536 Pins for 400008 Idler Assembly 12
500680 Gray Nozzle for Injector Wash Pump 4
500818 Main Fan Filter 2
900016 Inner Bearing 1
900017 Shoulder Bearing for Attenuator, inner 1
900028 Bearing 1
900039 Bearing 1
900118 Bearing 1
900124 Gear Clamp 1
900182 MOSFET RFP4N06C 5
900210 2N3904 NPN Transistors 6
900246 Bearing for Attenuator, outer 1
900247 Bearing 1
900248 Bearing 1
900271 5000ul Syringe 1
900271-02 5000ul Syringe Tip O-rings 6
900335 Diode MBR360 (stepper motor Interface Ckts.) 10
900336 Diode IN5363 (stepper motor Interface Ckts.) 10
900367 TIP30C Transistor (for Q17 on the HTR/MTR PCB) 5
900422 TED Thermal Sheet 5
900551-02 Cable Ties, nylon 10
900558 Mini Spike 3
900613 Sample/Assay Barcode Reader Drive O-ring 10

900730-03 .156 Connector Terminals 10
900771 Sample/Assay Barcode Reader Idler O-rings 32
900874 .100 Connector Terminals 10
901132 High-Speed Motor Flexible Coupling 1
901395 250ul Syringe Tips, 3-land 12
901396 250ul Syringe, 3-land 1
902138 Ceramic Micro Valve 2
902139 Ceramic Macro Valve 2
902584 Computer Fan Filter 2
10.3 IMMULITE 1000 Spare Parts Inventory for Regional Offices

These are suggested parts and larger elements of the system, which are suggested to remain on hand in a
main office inventory, available for field dispatch as needed. They are generally not carried in the field at
all times, due to their size, delicacy, or comparatively rare need. The suggested quantities are
approximate, in order to support 10 instruments. Quantity should be maintained according to instrument
population.

400064-02 Motor Assembly Pipettor-X 1
400194 Substrate Reservoir Assembly 1
400196-02 Substrate Heater Assembly 1
400360 Hamilton Dilutor Tubing Kit 1
400361 Euro Dilutor Tubing Kit 1
400349 RS232 Cable 1
400364 In-line Water Canister Filters 5
400365 In-line Probe Wash Canister Filters 5
420001 Shuttle Idler Wheel replacement kit 2
420038 High-Speed Spinner Motor replacement kit 1
420054 12 Month Preventative Maintenance Kit 2
420059 Burkert Valve Assembly 6
420063 Probe Assembly 3
420072 Euro Level Sense and Z-Pipettor PCB kit 2
420094 Sample/Assay Barcode Reader PCB kit 2
420096 T.E.D. Cooler Assembly replacement kit 2
420120 Linear Wash Pump Kit (Full Module) 2

420126 Linear Actuator Pump (Single Pump) 2
450000-01 CPU/Sensor PCB 1
450001-01 Motor Driver PCB 1
450002-02 DC Motor/Heater/Fluidics PCB 1
450007 Reagent Carousel Barcode Reader PCB 3
450017 X-Pipettor Home and Position Sensor PCB 1
450021 Sample Buffer Emitter Sensor PCB 1
450022 Sample Buffer Detector Sensor PCB 1
900114 X-Pipettor Belt 1
900182 Transistor (HUF76633P3) RFP4N06C 5
900271 5000ul Syringe 2
900271-02 5000ul Syringe Tip O-ring 24
900367 TIP 30 Transistor 3
900558 Mini-Spike 30
901132 High-Speed Spinner Flexible Coupling 1
901395 250ul Syringe Plunger Tip, 3-land 30
901396 250ul Syringe 2
901664 Dilutor Assembly for Hamilton 500 Series Dilutor 2
901666 Logic/Driver PCB for Hamilton 500 Series Dilutor 1
902138 Ceramic Micro Rotary Valve 2
902139 Ceramic Macro Rotary Valve 2

10.4 Hamilton Tubing Kit (P/N 400360)
10.5 Euro Tubing Kit (P/N 400361)


Chapter 11: Fluidics, Chassis and Isometric Drawings
The following pages contain the Fluidics, Chassis Wiring Diagrams and Isometric Drawings. For
board drawings refer to the Schematic and Assembly Drawings section.
Fluidics Drawing Hamilton Syringe configuration..300001-10
Fluidics Drawing Euro Syringe configuration.300001-11
Chassis Wiring Diagram (8 sheets)350061
Isometric Drawing: Main Incubator Carousel Assembly400003
Isometric Drawing: Luminometer Module.400020-02
Isometric Drawing: Pipettor / Reagent Carousel Module400023
Isometric Drawing: Load Platform Module.400199

400083-02
CABLE ASSY,AMBIENT
SYSTEM THERMISTOR
450029
MAIN CAROUSEL
POSITION PCB
450020
MAIN CAROUSEL
INTERFACE PCB
(A14)
500387-11
MAIN CAROUSEL FOAM KIT
400120
MAIN CAROUSEL HEATER PAD
(LOCATED UNDER MAIN CAROUSEL
FOAM KIT)
400083-01 400064-04
CABLE ASSY,MAIN MAIN CAROUSEL
NOTE:BEARING ASSEMBLY AT CAROUSEL THERMISTOR MOTOR ASSEMBLY
9:00 POSITION IS ADJUSTABLE BY (LOCATED UNDER
USING TWO 1/8" HEX SCREWS CASTING)
LOCATED BELOW.
400142-01
GROUND STRAP
ISOMETRIC DRAWING,
IN C U B A T O R C A R O U S E L
ASSEMBLY P/N 400003
SHEET 1 of 1
500339
LUMINOMETER COVER
400064-06
LUMINOMETER CHAIN
MOTOR ASSEMBLY
450011
LUMINOMETER/WASH
INTERFACE PCB
(A10)
400095
HIGH SPEED SPINNER ASSEMBLY
400084-01
LUMINOMETER
THERMISTOR ASSEMBLY
420040
HIGH SPEED SPINNER IDLER KIT
400064-08
LUMINOMETER
ATTENUATOR MOTOR
ASSEMBLY
420038
HIGH SPEED SPINNER MOTOR
ASSEMBLY
(901132
WITH COUPLING)
450006
SHUTTLE AT HOME
420001 GENERAL PURPOSE
OPTOSENSOR
SHUTTLE IDLER
500110
REPLACEMENT KIT ATTENUATOR MOTOR
SHAFT PULLEY
900262
RETAINING CLIP
500183
SHUTTLE IDLER WHEEL
COVER PLATE 400126
NON-INTERGRATED
900261
900026 PHOTOMULTIPLIER
WAVE WASHER TUBE ASSEMBLY
LUMINOMETER
500577 ATTENUATOR BELT
UPPER SHUTTLE SHIM OR
400164
(LOCATED UNDER TWO 450006
SHUTTLE IDLER WHEEL
REAR SCREWS) ATTENUATOR POSITIONING 400248
900731-16 GENERAL PURPOSE INTERGRATED
UPPER SHUTTLE SPRING OPTOSENSOR PHOTOMULTIPLIER
TUBE ASSEMBLY
450006
900731-32 ATTENUATOR HOME
LOWER SHUTTLE SPRING GENERAL PURPOSE
OPTOSENSOR
900159 450006
SHUTTLE UPPER SHUTTLE AT SPIN &
BEARING ASSEMBLY SUBSTRATE POSITIONS
400190-02 GENERAL PURPOSE
LUMINOMETER CHAIN ASSEMBLY 500048-02 OPTOSENSOR
BAFFLE,MOLDED
900160 LUMINOMETER CHAIN 400064-07
LOWER SLIDE BEARINGS SHUTTLE MOTOR
500506 500507
SIDE PLATE,CHAIN ROLLER,CHAIN
900160
LOWER SLIDE BEARINGS
ISOMETRIC DRAWING,
COMPLETE LUMINOMETER MODULE
SHUTTLE ASSEMBLY P/N 400020-02
SHEET 1 of 1
400185
REAGENT COOLING
CHAMBER ASSY
450014
REAGENT CAROUSEL
HOME & POSITION PCB
450007
REAGENT CAROUSEL
BAR CODE READER PCB
(A49)
400145
REAGENT TRAY
450051
LEVEL SENSING &
PROBE JAM
SENSOR PCB
(REFER TO KIT 420072
INSTRUCTIONS FOR
INSTALLATION)
420072
COMPLETE EURO
LEVEL SENSING KIT
(INCLUDES 450050 PCB,
450051 PCB AND MOUNTING
HARDWARE)
450050
PIPETTE Z AND
LEVEL SENSE
INTERFACE PCB
LED
450017
PIPETTOR X
HOME / POSITION PCB
450010
REAGENT CAROUSEL
INTERFACE PCB
(A12)
400064-01
REAGENT
CAROUSEL 400184
MOTOR SPIRAL CABLE ASSEMBLY
900422
TE D
THERMAL SHEET
400064-03
PIPETTOR "Z" MOTOR
400178
T E D ASSEMBLY 900114
PIPETTOR "X" MOTION DRIVE BELT
(FROM PIP-X MOTOR AROUND
Z-MOTION LEAD SCREW - NOT SHOWN)
ISOMETRIC DRAWING,
420096
T E D KIT P IP E T T O R / R E A G E N T
(INCLUDES THERMAL SHEET
AND FAN COWLING)
CAROUSEL
400064-02 MODULE P/N 400023
PIPETTOR "X" MOTOR
SHEET 1 of 1
CABLE ASSEMBLY TO LOAD CHAIN
POSITION GENERAL PURPOSE
COVER,BARCODE READER PCB OPTO SENSOR
500479 450006

BARCODE READER SAMPLE/ASSAY
450056 (KIT WITH TUNING INSTR.420094) CABLE ASSEMBLY TO
ORIGINALLY PCB WAS 450003 READER PCB (A44-J1)
(A44) 400087
CHAIN BAFFLE,
1.235 INCH
500048-01

LOAD PLATFORM INTERFACE
(A11)
450012
BARCODE ARM ASSY

RETURN SPRING DRIVE O-RING
900612 SAMPLE ASSAY
BARCODE READER
900613
LOAD CHAIN
DRIVE MOTOR LOAD CHAIN ASSEMBLY
DRIVE WHEEL ASSEMBLY 400190-01
400021 400064-05
PIN
}
500536
GROUND STRAP C O M P L E TE B A R C O D E
400142-03 O-RING IDLER ASSEMBLY
900771 400008
ROLLER
500059
(A TTA C H ED W ITH SC R EW
TO IN STR U M EN T LID LA TC H )
O-RING
900771
CABLE ASSEMBLY TUBE GUIDE

LOAD PLATFORM INTERFACE PCB (A11-J2) 500044
TO BARCODE READER
400086 BARCODE READER MOTOR
AND GEARBOX ASSEMBLY
WITH WIRES ATTACHED
400242
(BARCODE READER
MOTOR ASSEMBLY
REPLACEMENT KIT
WITH ACCESSORIES
420056)
L O W E R S E C T IO N O F C H A IN
POSITION SENSOR ASSEMBLY
(REFERENCE)
ISOMETRIC DRAWING,
PRINTED CIRCUIT BOARD LOAD PLATFORM
GENERAL PURPOSE
OPTO SENSOR
MODULE P/N 400199
450006
SHEET 1 of 1
IMMULITE 1000 Index
Testing Drawback, 2-3, 2-5, 3-20, 3-21, 6-7,

A 7-27, 7-38, 8-13, 9-9
Tuning Barcode Reader PCB, 3-9, 6-6, 7-44,
Adjustors, 9-33, 9-40 8-7, 9-5, 9-12, 9-39
Assemblies Display Panel Buttons, 9-17, 9-20, 9-24, 9-26, 9-
Replacement, 3-6, 3-7, 3-13, 7-10, 7-11, 7-12, 27, 9-28, 9-35
7-13, 7-14, 7-16, 7-17, 7-18, 7-19, 7-21, 7-
23, 7-45, 8-10, 8-12, 8-13, 8-22, 9-29, 10-3 E
C Event Log
Historical, 7-52
Common Diagnostics, 2-4, 2-5, 2-6, 2-7, 2-9, 7- EXPORT output file, 3-45
26, 7-27, 7-28, 7-29, 7-30, 7-31, 7-32, 7-34,
8-16, 9-38 F
CPU Board, 4-1, 4-4
Fluidics, 3-14, 3-15, 3-24, 3-25, 3-26, 3-28, 3-
D 29, 3-30, 5-2, 6-1, 6-2, 7-21, 7-32, 7-33, 7-34,
7-36, 7-37, 8-11, 8-12, 8-14, 8-18, 8-19, 8-20,
Data 8-23, 9-7, 9-12, 9-17, 9-20, 9-26, 9-39, 10-1,
Accessing by test time/date and test type, 3- 10-2, 10-3, 10-4
43 Valve Testing, 3-24, 3-25, 3-26, 3-30, 7-36,
Saving in ASCII format, 3-43 7-37, 7-38
Data Reduction and Chemiluminescent
Reaction, 9-30 G
DECON1, 7-34
Decontamination, 7-33, 7-34, 7-39, 8-8 General Information
Diagnostics, 2-4, 2-5, 2-6, 2-7, 2-9, 3-14, 3-15, DPC, 1-1
3-16, 3-17, 3-27, 6-3, 6-4, 7-26, 7-27, 7-28, 7- In Vitro Diagnostic Symbols, 1-7
29, 7-31, 7-32, 7-34, 7-37, 8-9, 8-10, 8-11, 8- Product Description, 1-2
12, 8-14, 8-16, 8-17, 8-18, 8-19, 8-20, 9-7, 9- Safety Considerations, 1-6
8, 9-38 System Components, 1-3
Barcode Motor Speed Adjustment, 3-9, 6-6, System Operation, 1-5
7-44, 8-7, 9-5, 9-12, 9-39 Technical Assistance, 1-11
Load Chain Test Programs, 3-9, 3-18, 6-6, 7- Using the Manual, 1-1
22, 7-40, 7-42, 7-43, 7-44, 8-6, 8-7, 8-9, 9-
4, 9-5, 9-12, 9-39 H
Luminometer Test Programs, 3-8, 3-11, 3-12,
3-18, 3-19, 6-5, 8-5, 8-6, 8-7, 8-8, 8-10, 8- High Speed Motor
12, 8-13, 8-21, 8-22, 9-4, 9-5, 9-6, 9-7, 9-8, Adjustment, 3-11, 6-5, 7-45, 8-12, 8-15, 9-6,
9-9, 9-22, 9-23 9-7, 9-22
Programs, 2-4, 2-5, 6-4, 6-8, 7-26, 7-27, 7-29, High Speed Spinner, 7-17
7-33, 7-41, 8-2, 8-4, 8-17
Syringe Module Test Programs, 2-9, 3-18, 3- I
25, 3-26, 3-27, 3-31, 6-2, 6-3, 6-5, 7-36, 7-
37, 8-5, 8-6, 8-7, 8-10, 8-12, 8-15, 9-7, 9- IMMULITE 1000
10, 9-11
Introduction, 9-15, 9-16, 9-18, 9-20, 9-21, 9- Fuses, 1-6
22, 9-24, 9-26, 9-27, 9-28, 9-29, 9-30, 9- PMT, 3-18, 6-2, 8-1
31, 9-32, 9-33, 9-34, 9-35, 9-36, 9-37, 9- Primary Modules
38, 9-39, 9-41, 9-42, 9-43, 9-44, 9-45, 9-46 Definition, 3-6
IMMULITE 1000 Computer, 3-41, 3-42 Priming
IMMULITE 1000 Software, 3-41, 3-45 Syringes, 9-26
Installation, 2-4, 2-5, 2-6, 2-7, 2-9, 7-26, 7-27,
7-28, 7-29, 7-31, 7-32, 7-34, 7-37, 8-16 R
Installation Requirements, 2-1
Instrument Overview, 9-24, 9-37 Reagent Supplies, 9-17
Instrument Temperatures, 3-33, 3-34, 3-35, 3- Repair Table, 3-6, 3-42, 3-43, 7-3, 7-5, 7-6, 7-8,
36, 3-37, 3-40, 7-19, 9-2, 9-28, 9-42 7-9, 8-18
L S
Large Syringe Tip Sample Collection, 3-7, 3-8, 3-17, 3-28, 6-6, 7-
Changing, 9-23, 9-39 15, 7-42, 7-43, 8-7, 8-9, 8-18, 8-19, 9-24
Linear Actuator Pump Assembly, 3-20, 3-30, 4- Slope, 9-33
4, 6-7, 7-16, 7-29, 7-30, 8-6, 8-8, 8-13, 8-22 Software Overview, 9-27, 9-29, 9-35
Load Platform Assembly, 7-13 Spare Parts, 3-24, 10-1, 10-5
Luminogenic reaction, 3-4 Inventory, 10-3
Specifications
M Computer, 5-1
Computer, 5-1
Maintenance, 9-16, 9-26 Electrical, 5-2
Daily, 9-16, 9-26 Electrical, 5-2
Error Log, 6-2, 7-50, 7-51, 7-53, 8-1 Electrical, 5-2
Power Log, 2-1, 2-3, 3-17, 3-18, 3-41, 6-2, 7- Environmental, 5-2
20, 9-8, 9-9 Environmental, 5-2
Preventive, 6-1 Fluidics, 5-2
Menu Bar Fluidics, 5-2
Options, 9-28, 9-35, 9-46 General, 5-1
Miscellaneous Procedures, 2-4, 2-5, 2-6, 2-7, 2- Luminometer, 5-1
9, 3-14, 3-23, 6-1, 6-6, 7-26, 7-27, 7-28, 7-29, Luminometer, 5-1
7-30, 7-31, 7-32, 7-34, 7-35, 7-36, 7-39, 7-40, Noise, 5-2
7-43, 8-10, 8-16, 8-19 Physical, 5-2
Physical, 5-2
O Start Up, 3-7, 3-42, 8-5, 9-27, 9-35
Substrate
Operating Modes, 9-35 Reservoir Module, 3-23, 7-16, 7-17, 7-23, 8-
22, 9-10, 10-3
P Temperature, 3-21, 3-22, 6-8, 7-16, 7-17, 7-
23, 8-13, 8-22, 8-24, 9-10, 9-16, 9-26, 10-
Photomultiplier Tube, 1-5, 2-6, 3-2, 3-3, 3-4, 3- 2, 10-3, 10-4
10, 3-11, 3-12, 3-17, 3-18, 3-19, 3-35, 3-44, Syringe Pumps, 3-24, 3-29
4-1, 4-2, 4-4, 6-2, 6-5, 6-8, 7-9, 7-16, 7-19, 7- System Components, 1-3, 2-5, 2-8, 3-1, 3-2, 3-4,
28, 8-1, 8-6, 8-7, 8-8, 8-10, 8-14, 9-6, 9-8, 9- 3-6, 3-8, 3-9, 3-10, 3-11, 3-12, 3-13, 3-14, 3-
9, 9-12, 9-30, 9-33, 9-34 15, 3-19, 3-20, 3-21, 3-30, 3-33, 3-34, 3-36,
Pipetting Sequence, 3-31, 3-32 3-37, 3-39, 3-42, 4-2, 4-4, 4-5, 5-1, 6-1, 6-3,
Power Supply, 3-10, 3-17 6-4, 6-5, 6-6, 6-7, 7-4, 7-6, 7-7, 7-10, 7-11, 7-
17, 7-19, 7-20, 7-21, 7-22, 7-23, 7-24, 7-27,
7-29, 7-31, 7-38, 7-40, 7-41, 7-42, 7-43, 7-44, Error Messages, 9-14
8-6, 8-8, 8-9, 8-10, 8-11, 8-12, 8-14, 8-17, 8- Event Viewer Screen, 7-52
18, 8-20, 8-21, 8-23, 9-2, 9-4, 9-5, 9-6, 9-7, 9- Techniques, 1-2, 9-1
8, 9-12, 9-17, 9-18, 9-19, 9-20, 9-22, 9-23, 9- Typical Problems, 9-4
24, 9-26, 9-27, 9-28, 9-29, 9-30, 9-35, 9-36,
9-38, 9-39, 9-41, 9-42, 9-43, 10-1, 10-2, 10-3, W
10-4
Warranty Statements, 5-4
T Water Acceptance Criteria, 2-8, 7-31
Water Supply
Temperatures Testing, 2-4, 2-5, 2-6, 2-7, 2-8, 2-9, 7-26, 7-
Troubleshooting, 3-13, 3-33, 3-37, 3-38, 3-39, 27, 7-28, 7-29, 7-30, 7-31, 7-32, 7-33, 7-
3-40, 7-10, 7-11, 9-8, 9-29, 9-41, 10-2 34, 7-39, 8-8, 8-16
Testing the Water Supply Water tests
Acceptance criteria, 2-8, 7-31 Acceptance criteria, 2-8, 7-31
From any source, 2-4, 7-26 From any source, 2-4, 7-26
Probe and wash station, 7-29 Probe and wash station, 7-29
Theory of Operation, 3-1, 3-2, 3-4 WATERTPM, 7-29
Troubleshooting, 9-14, 9-43, 9-46 WATERTST, 2-4, 7-26
Error Log, 6-2, 7-50, 7-51, 7-53, 8-1
IMMULITE & IMMULITE 1000
Assembly & Schematic Drawings
Schematic and Assembly drawings are collated in numerical order of Drawing Number.
Note: The revisions listed are the drawing revisions. They do not necessarily reflect the actual PCB
revision. The drawing revisions shown below were the latest available when this manual was released.
Consult Field Services for up to date information on any possible new PCB revisions.
ASSEMBLY DRAWINGS
Drawing Number Drawing Description PCB Part Number

450000 CPU / Sensor PCB (A4) 450000
450001 Motor Driver #1 PCB (A1) 450001
450002 Heater / DC Motor / Fluidics PCB (A2) 450002-02
450005 Motor Driver #2 PCB (A3) 450005
SCHEMATIC DRAWINGS
Drawing Number Drawing Description PCB Part Number

350001 Motor Driver #1 and #2 PCBs (A1 / A3) 450001 / 450005
350002 Heater / DC Motor / Fluidics PCB (A2) (2 sheets) 450002-01 / 450002-02
350004 CPU / Sensor PCB (A4) (2 sheets) 450000
350005 Motherboard #1 PCB (A5) 450009
350006 Motherboard #2 PCB (A6) 450008 / 450008-02
350007 User Interface PCB (A7) 450023
350010 Luminometer Interface PCB (A10) 450011-02
350011 Loading Platform Interface PCB (A11) 450012
350012 Reagent Carousel Interface PCB (A12) 450010
350014 Incubator Carousel Interface PCB (A14) 450020
350015 Hamilton Syringe Interface PCB (A15) 450013
350020 Reagent Carousel Barcode Reader PCB (A49) 450007
350021 PMT Power Supply N/A
350025 Pipette-X Home and Position Sensor PCB 450017
350028 Sample Buffer Detector PCB (A63) 450022
350035 Sample Tray Emitter PCB (A62) 450021
350037 Incubator Carousel Position Sensor PCB (A69) 450029
350039 Substrate Heater PCB (A162) 450038
350040 Cirrus Injector Pump (A13) 450040
350050 Euro Level Sense Conditioning PCB (A52) 450050
350051 Euro Level Sensing PCB 450051
350052 Euro Syringe Controller PCB 450052
350056 Sample / Assay Barcode Reader PCB 450056
350058 Linear Actuator Pump PCB N/A
350063 Bulk Liquid Level Display PCB N/A
IMMULITE & IMMULITE 1000 600797-A1 i

ii 600797-A IMMULITE & IMMULITE 1000

Immi1kservice A1

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IMMULITE & IMMULITE 1000 Service Manuals

Document Number: 600797

Copyright 1991 by Siemens Medical Solutions Diagnostics. All rights reserved.

IMMULITE is registered trademark of Siemens Medical Solutions Diagnostics.

Siemens Medical Solutions Diagnostics

Siemens Diagnostics quality products are manufactured under a quality

IMMULITE Service Manual 600797-A1 i

CHAPTER 6: PREVENTIVE MAINTENANCE (PM)................................................................................ 6-1

ii 600797-A1 IMMULITE Service Manual

IMMULITE Service Manual 600797-A1 iii

1.1 IMMULITE History

1.2 How to Use This Manual

IMMULITE Service Manual 600797-A1 1-1

The IMMULITE Automated Immunoassay Analyzer is a random access instrument dedicated to

1-2 600797-A1 IMMULITE Service Manual

IMMULITE Service Manual 600797-A1 1-3

1-4 600797-A1 IMMULITE Service Manual

1.5 How it Works

IMMULITE Service Manual 600797-A1 1-5

1-6 600797-A1 IMMULITE Service Manual

Fragile, handle with care.

Caution, refer to accompanying

IMMULITE Service Manual 600797-A1 1-7

Sterilized using aseptic

Sterilized using radiation

Sterilized using ethylene oxide

Sterilized using steam or dry

Keep away from heat

1-8 600797-A1 IMMULITE Service Manual

Lower limit of temperature

Upper limit of temperature

Do not use if package is

In vitro diagnostic medical

IMMULITE Service Manual 600797-A1 1-9

Contains sufficient for <X>

For Performance Evaluation

1-10 600797-A1 IMMULITE Service Manual

1.8.1 Technical Support

IMMULITE Service Manual 600797-A1 1-11

2.2 Instrument Set-up

IMMULITE Service Manual 600797-A1 2-1

2-2 600797-A1 IMMULITE Service Manual

IMMULITE Service Manual 600797-A1 2-3

2-4 600797-A1 IMMULITE Service Manual

If the cps are . . . It is possible that . . .

2. Refer to last line printed with results:

IMMULITE Service Manual 600797-A1 2-5

External water source = 6000

External water source Substrate Only = 100

2-6 600797-A1 IMMULITE Service Manual

3.2 Overview of Test Process

IMMULITE Service Manual 600797-A1 3-1

3.3 Internal Calculations

3-2 600797-A1 IMMULITE Service Manual

PMT CALCULATIONS EXAMPLE TABLE

IMMULITE Service Manual 600797-A1 3-3

IMMULITE Enzyme-Amplified Luminescence

3-4 600797-A1 IMMULITE Service Manual

ALKALINE PHOSPHATASE LABEL

IMMULITE Service Manual 600797-A1 3-5

3.5.2 Incubator Carousel

3-6 600797-A1 IMMULITE Service Manual

Main Carousel Ring Gear Assy.