Service Manual Humastar180

HumaStar 180
| User Manual
|
Cat.No. 16900/100
Revision List of the Manual
No. Rev. / DATE REVISION DESCRIPTION
1 01/2004-06 First edition
2 02/2005-06 Addition of Chapters 2.7.6 through 2.7.9
Update of all chapters for software version 1729
3 03/2006-07 Update of all chapters for software version 1801
Addendum for Report Editor
4 04/2007-06 Revision of small typing errors, new design, update of all chapters for
software version 1892
7 07/2009-02 Update of chapter 2 for software version 1975
8 08/2009-09 Software update
9 09/2011-09 Correction dimension
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1 INTRODUCTION
This manual is considered as a part of the instrument; it has to be at the operator’s hand as well as at the
maintenance operator’s availability. For accurate installation, use and maintenance, please read the following
instructions carefully. In order to avoid instrument or personal damages, carefully read the ”GENERAL SAFETY
WARNINGS”, describing the suitable operating procedures. In case of breakdowns or any troubles with the
instrument, apply to the local Technical Service.
2 USER WARRANTY
HUMAN warrants that instruments sold by one of its authorised representatives shall be free of any defect in
material or workmanship, provided that this warranty shall apply only to defects which become apparent within
one year from the date of delivery of the new instrument to the purchaser.
The HUMAN representative shall replace or repair any defective item at no charge, except for transportation
expenses to the point of repair.
This warranty excludes the HUMAN representative from liability to replace any item considered as expendable in
the course of normal usage, e.g.: lamps, valves, syringes, glassware, fuses, diskettes, tubing etc.
The HUMAN representative shall be relieved of any liability under this warranty if the product is not used in
accordance with the manufacturer's instructions, altered in any way not specified by HUMAN, not regularly
maintained, used with equipment not approved by HUMAN or used for purposes for which it was not designed.
HUMAN shall be relieved of any obligation under this warranty, unless a completed installation / warranty
registration form is received by HUMAN within 15 days of installation of this product.
This warranty does not apply to damages incurred in shipment of goods. Any damage so incurred shall be re-ported
to the freight carrier for settlement or claim.
3 INTENDED USE OF THE INSTRUMENT [IVD]

The instrument has to be used for the expected purposes and in perfect technical conditions, by qualified
personnel, in working conditions and maintenance operations as described in this manual, according to the
GENERAL SAFETY WARNINGS. This manual contains instructions for professional qualified operators.
4 GENERAL SAFETY WARNINGS

Use only chemical reagents and accessories specified and supplied by HUMAN and/or mentioned in this manual.
Place the product so that it has proper ventilation.
The instrument should be installed on a stationary flat working surface, free from vibrations.
Do not operate in area with excessive dust.
Work at room temperature and humidity, according to the specifications listed in this manual.
Do not operate this instrument with covers and panels removed.
Only use the power cord specified for this product, with the grounding conductor of the power cord connected to
earth ground.
Use only the fuse type and rating specified by the manufacturer for this instrument, use of fuses with improper
ratings may pose electrical and fire hazards.
To avoid fire or shock hazard, observe all ratings and markings on the instrument.
Do not power the instrument in potentially explosive environment or at risk of fire.
Prior to cleaning and/or maintaining the instrument, switch off the instrument and remove the power cord.
For cleaning use only materials specified in this manual, otherwise parts may become damaged.
It is recommended always to wear protective apparel and eye protection while using this instrument.
Respective warning symbols, if appearing in this manual, should be carefully considered.
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5 DISPOSAL MANAGEMENT CONCEPT
The currently valid local regulations governing disposal must be observed. It is in the responsibility of the user to
arrange proper disposal of the individual components.
All parts which may comprise potentially infectious materials have to be disinfected by suitable validated
procedures (autoclaving, chemical treatment) prior to disposal. Applicable local regulations for disposal have to be
carefully observed.
The Instruments and electronic accessories (without batteries, power packs etc.) must be disposed of according to
the regulations for the disposal of electronic components.
Batteries, power packs and similar power source have to be dismounted from electric/electronic parts and disposed
off in accordance with applicable local regulations.
6 INSTRUMENT DISINFECTION
Analytical instruments for in vitro diagnostic involve the handling of human samples and controls which should be
considered at least potentially infectious. Therefore every part and accessory of the respective instrument which
may have come into contact with such samples must equally be considered as potentially infectious.
Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated
parts. Before the instrument is removed from the laboratory for disposal or servicing, it must be
decontaminated/disinfected. Decontamination/disinfection should be performed by a authorised well-trained
personnel, observing all necessary safety precautions. Instruments to be returned have to be accompanied by a
disinfection certificate completed by the responsible laboratory manager. If a disinfection certificate is not
supplied, the returning laboratory will be responsible for charges resulting from non-acceptance of the instrument
by the servicing centre, or from authority’s interventions.
7 NOTICE
Every effort has been made to avoid errors in text and diagrams, however, HUMAN GmbH assumes no
responsibility for any errors which may appear in this publication. It is the policy of HUMAN GmbH to improve
products as new techniques and components become available. HUMAN GmbH therefore has to reserve the right
to change specifications if necessary in the course of such improvements.
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NOTICE
Analytical instruments for in vitro diagnostic application involve the handling of human samples and controls
which should be considered at least potentially infectious. Therefore every part and accessory of the respective
instrument which may have come into contact with such samples must equally be considered as potentially
infectious.
BIOHAZARD
The „BIOHAZARD“ warning label must be affixed to instrument prior to first use with biological material !
Servicing Note:
Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated
parts. Before the instrument is removed from the laboratory for disposal or servicing, it must be decontaminated.
Decontamination should be performed by authorised well-trained personnel only, observing all necessary safety
precautions. Instruments to be returned have to be accompanied by a decontamination certificate completed by
the responsible laboratory manager. If a decontamination certificate is not supplied, the returning laboratory will
be responsible for charges resulting from non-acceptance of the instrument by the servicing centre, or from
authority’s interventions.
HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
| Max-Planck-Ring 21 · 65205 Wiesbaden · Germany
| Tel.: +49 61 22/99 88-0 · Fax: +49 61 22/99 88-100
| e-Mail: tech-support@human.de · www.human.de
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User Manual HumaStar 1
PLEASE READ THIS MANUAL CAREFULLY BEFORE CONNECTING THE INSTRUMENT TO

POWER AND BEFORE PERFORMING ANY FURTHER STEPS.
BEFORE the HumaStar 180 can be used for testing samples, the complete System
must be configured, Methods must be defined and the defined Methods must be
calibrated and validated !
If you need further assistance, please contact your HUMAN Instruments

Distributor!
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Notice
Every effort has been made to avoid errors in text and diagrams, however, HUMAN GmbH assumes no
responsibility for any errors which may appear in this publication.
It is the policy of HUMAN GmbH to improve products as new techniques and components become available.
HUMAN GmbH therefore has to reserve the right to change specifications if necessary in the course of such
improvements.
About this Manual

This manual describes the installation, the use and necessary maintenance steps for HumaStar 180.
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Warnings, Cautions and Notes
There are three types of informational notices used in this manual. These notices highlight important
information or warn the user of a potentially dangerous situation. The following notices are:
Note
Gives helpful information
Caution
Indicates a possibility of instrument damage or data loss
if instructions are not followed.
Warning
Indicates the possibility of severe personal injury, loss of
life or equipment damage if the instructions are not
followed.
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Contents
0 Chapter 0 User Safety 2
0.1 Introduction 2
0.2 Hazards 2
0.2.1 Mechanical Hazards 2
0.2.2 Liquid Hazards 2
0.2.3 Electrical Hazards 2
0.3 Safety Precautions 2
0.3.1 Mains Power Connection 2
0.3.2 During Operation 3
0.4 Instrument Disinfection 4
0.4.1 Disinfection Solutions 4
0.4.2 Disinfection Procedure 5
1 Chapter 1 System Introduction 8
1.1 Introduction 8
1.2 Characteristics 8
1.3 Specifications 9
1.4 Functional Description 10
1.4.1 Process Management 10
1.4.2 Liquid Handling 10
1.4.3 Carousels, Temperature Control and Cooling 13
1.4.4 Measurement System 15
2 Chapter 2 System Setup 18
2.1 Introduction 18
2.2 Unpacking 18
2.2.1 Contents of Shipment 18
2.2.2 To be provided by User 18
2.2.3 Unpacking 18
2.3 Installation of HumaStar 180 20
2.3.1 Set YZ Arm to Home Position 20
2.3.2 Power Connection 21
2.3.3 Tubing and Bottle Connection 21
2.3.4 Connection of Reagent Cooling Option 22
2.3.5 Computer Connection 22
2.4 Installation of DETect Software Package 22
2.4.1 Computer Requirements 22
2.4.2 Software Installation Procedure 23
2.5 First Power Up 28
2.5.1 Switching on the Instrument 28
2.5.2 Start DETect Software Package 30
2.6 Carousels 33
2.6.1 Loading Inner Carousel 34
2.6.2 Loading Outer Carousel 36
2.7 Define Instrument Settings 38
2.7.1 Starting Instrument Settings Menu 39
2.7.2 Instrument Settings 39
2.7.3 Autocalibrate Bottles 39
3 Chapter 3 System Configuration 42
3.1 Introduction 42
3.2 Method Definition 42
3.2.1 Start Up DETect 42
3.2.2 Define New Protocols 43
4 Chapter 4 Calibration 62
4.1 Introduction 62
4.2 System Calibration 62
4.2.1 Preparation 62
4.2.2 Calibration 62
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5 Chapter 5 System Routine Use 74
5.1 Introduction 74
5.2 Start up HumaStar 180 and DETect 74
5.3 Set-up System for Daily Routine 74
5.3.1 Load Cuvettes 74
5.3.2 Preparation of Liquids 76
5.3.3 Set up Patient-Worklist in DETect 77
5.3.4 Loading barcoded samples 80
5.4 Analysis of Loaded Samples 84
5.4.1 Start the Run 84
5.4.2 Test Process 85
5.4.3 Display Intermediate Results 85
5.4.4 Print Patient Report 90
5.4.5 Patient Data Storage and - Recall 91
5.4.6 Empty Tray 91
5.4.7 Patient Data Store & Communication 91
5.4.8 Add Samples during run (Random Access) 92
5.4.9 Repeat Samples 94
5.4.10 Pausing / Stopping a Run 95
5.5 Additional Functions 96
5.5.1 Using the HT(date) .txt file 96
5.5.2 Display Kinetic-Curves of Measured Samples 97
5.6 Host Communication Settings (sending only) (RS 232 Protocol) Transport Layer 100
5.6.1 Protocol Layer 100
5.6.2 Standard Protocol 100
5.6.3 Reliable Protocol 100
5.7 Message Structure 100
5.7.1 Measured values 100
5.7.2 Version identification 100
5.7.3 System messages 100
5.8 Control Settings 101
5.8.1 Data 101
5.8.2 File 101
5.8.3 The result can also be transfered by FILE TRANSFER 101
6 Chapter 6 Quality Management 104
6.1 Introduction 104
6.2 QC Principal 104
6.2.1 Data Acquisition 104
6.2.2 Data Reduction 105
6.2.3 QC Data Storage and Recall 105
7 Chapter 7 Maintenance 110
7.2 Maintenance Routines 110
7.2.1 Daily Maintenance 110
7.2.2 Weekly Maintenance 111
7.2.3 Periodical Maintenance 111
7.3 Replacement of Worn Parts 114
7.3.1 Syringe Pumps 114
7.4 List of Replacement Parts 117
7.5 List of Disposables required 117
8 Features 120
9 Installation 120
10 Start the Software 121
11 Field Definition 124
11.1 Logo 124
11.2 Labels and Variable Fields 124
11.3 Results Field 125
Appendix 127
Trouble Shooting Guide
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Contents
0 Chapter User Safety 2

0.1 Introduction 2
0.2 Hazards 2
0.2.1 Mechanical Hazards 2
0.2.2 Liquid Hazards 2
0.2.3 Electrical Hazards 2
0.3 Safety Precautions 2
0.3.1 Mains Power Connection 2
0.3.2 During Operation 3
0.4 Instrument Disinfection 4
0.4.1 Disinfection Solutions 4
0.4.2 Disinfection Procedure 5
0 Chapter User Safety
- Hazards
- Safety Precautions
- Instrument Disinfection
0.1 Introduction
The instrument has been designed in a way to provide maximum safety to the user. This chapter gives information
and instructions on user safety when working with HumaStar 180.
This chapter also gives instructions on the disinfection procedure of the instrument.
0.2 Hazards
0.2.1 Mechanical Hazards
HumaStar 180 is a fully automated device with robotic functions. The unit operates under computer control. As
with most robotic devices there is a potential for injury and bodily harm from moving mechanical components
whenever the instrument is in operation.
The instrument is designed for automatic hands-off operation only. Never reach into the instrument workspace
when the unit is in an operating mode. The instrument is fitted with a safety door, that should only be opened by
keyboard intervention.
In case the door is opened during operation, the unit will automatically stop any running process in order to
prevent injury.
0.2.2 Liquid Hazards
Potential hazards to personnel may exist from the liquids being handled by the instrument. Infectious clinical
samples, toxic or corrosive chemicals may be present.
Although the hands-off operating feature of HumaStar 180 minimises exposure to these agents, the potential for
hazardous exposure still exists. Hand, eye and clothing protection should always be worn, where appropriate.
0.2.3 Electrical Hazards
The same precautions must be considered when using any electrical equipment.
Do not touch any switches or outlets with wet hands. Switch the instrument off before disconnecting the AC
power cord. Unplug the instrument prior to cleaning up any major liquid spills and prior to servicing any of the
electrical or internal components.
Only qualified personnel should perform electrical servicing. Replace all access covers before operating the
instrument.
0.3 Safety Precautions
When working with HumaStar 180 , the following instructions must be met:
0.3.1 Mains Power Connection
The instrument features autodetection of the supplied Voltage (85 – 264 VAC, 50 or 60 Hz). No further settings for
different Mains Voltage Systems are required.
Caution
Make sure, the instrument is switched off (main switch is set to “0”).
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Graph 0A.1: Instrument Rear View
Mains Power Serial USB Port Liquid RS 232 Port

Number Sensor
Information Connectors
Graph 0A.2: Mains Power Compartment
0
Mains Switch
in "OFF" position
Mains Power Connector
Mains Fuse Compartment
Plug the power cord, which comes with the accessories box, into the Mains Power Connector. The Mains Power
Connector is placed on the rear side of the Instrument. Leave the Mains Power Switch in “Power Off” position (“0“).
Connect the other end of the power cord with mains power.
Warning
In case of any problems or uncertainties, consult technical assistance through

an authorised service partner of Human GmbH .
0.3.2 During Operation

During operation, the front door of the instrument must be closed. This ensures, that no moving parts of the
complete system can be touched by the user.
3/3 Human HumaStar 180 User Manual

Graph 0A.3: Instrument view
Front Door
Front Door Handle Power On LED
The instrument is fitted with a safety switch that detects if the front door is closed.
In case the front door is being opened during operation, the instrument will immediately interrupt all active
movements and DETect software package will display an alert.
After closing the front door again, the system will continue processing the actual run, after the user has confirmed
the respective prompt in DETect.
0.4 Instrument Disinfection
All parts of the instrument that come into contact with potentially infectious material must be treated as
potentially infectious areas.
Caution
It is advisable to wear gloves when performing the measurement

procedure and also when making adjustments to the instrument.
It is very important that the instrument is thoroughly disinfected before it is removed from the laboratory or any
servicing is performed on it.
Before the instrument is returned to the distributor for servicing, it must be disinfected and a disinfection
certificate completed. If a disinfection certificate is not supplied, the instrument may not be accepted by the
servicing centre or it may be held by the customs authorities.
0.4.1 Disinfection Solutions
If the laboratory has no specific disinfection procedure, the following procedure should be used to disinfect the
instrument.
The instrument should be disinfected with 70% ethanol (Caution: flammable liquid) or specific instrument
disinfectants.
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Caution
The disinfection procedure should be performed by authorized trained
personnel in a well ventilated room, wearing disposable gloves and
projective glasses and clothing.
0.4.2 Disinfection Procedure
Please note that the disinfectant can influence the performance of your instrument if it is applied inside the
instrument. The following procedure should be used to disinfect the instrument.
1. Wear protective gloves, protective glasses and protective clothing.
2. Prepare an autoclavable bag for all disposables used during the disinfection procedure and label it with
autoclave tape.
3. Rinse the complete pump and tube system with the disinfectant. Fill the system with the disinfectant
solution and allow a contact time of five hours.
4. Disconnect the instrument from the mains power supply.
5. Disconnect the instrument from any accessories that are used for example: printer, computer and so on.
Accessories that should be shipped together with the instrument have to be included in the disinfection
procedure.
6. Carefully spray the disinfectant solution (or use a disposable soft tissue paper towel soaked in the
disinfectant) on all outer surfaces of the instrument.
7. After a minimum contact time of 10 minutes, repeat step 6 of this procedure.
8. After a contact time of five hours wipe the instrument using a soft paper towel and a mild detergent or
distilled water to remove all traces of the disinfectant.
9. Wipe dry the outer surfaces of the instrument.
10. Pack the instrument and its accessories.
11. Disinfect your hands and clean them with a mild detergent.
5/5 Human HumaStar 180 User Manual

Complete a disinfection certificate and attach it to the outside of the box so that it is clearly visible.
See below for an example of the disinfection certificate.
I declare that the instrument in this package has never been exposed to
any hazardous biological material or that it has been decontaminated or
disinfected to remove or inactivate any biological material which could
be dangerous to the service personnel.
Name: ................................................................................................................
Firm: ..................................................................................................................
Address: ............................................................................................................
...........................................................................................................................
...........................................................................................................................
...........................................................................................................................
Country: .............................................................................................................
Signature ...........................................................................................................
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Contents
1 System Introduction 8
1.1 Introduction 8
1.2 Characteristics 8
1.3 Specifications 9
1.4 Functional Description 10
1.4.1 Process Management 10
1.4.2 Liquid Handling 10
1.4.3 Carousels, Temperature Control and Cooling 13
1.4.4 Measurement System 15
1 System Introduction
- Characteristics, Specifications & Performance

- Functional Description
1.1 Introduction
HumaStar 180 is a fully automated, random access Clinical Chemistry Analyzer for wet chemistry applications. It
has an open structure, so that reagents from most manufacturers can be used on the system.
HumaStar 180 is computer controlled and uses the Software Package "DETect" for data reduction and result
evaluation.
HumaStar 180 has been developed in a way as to maximise throughput at maximum comfort, and at the same
time to minimise maintenance efforts to be taken by the user.
HumaStar 180 is fitted with a patented, maintenance free measuring street, featuring 20 photometer channels for
individual wavelength selection and maximum flexibility.
1.2 Characteristics
Access Modes: - Random Access

- Stat (immediate access and execution)
- Optimized batch
Processing Modes: - Patient by Patient

- Test by Test
Analysis Modes: - Endpoint (Substrates)

- Kinetic (Enzymes)
- Initial Rate (fixed time kinetics)
- Serum Blank (differential)
- Turbidimetric (immunoturbidimetry)
- Multi Standard (quantitative)
- Bichromatic
- Multi Chemistry
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1.3 Specifications
Throughput: - 180 Tests/hr under speed-optimised conditions
Carousel: - 25 reagent positions

- 50 sample positions (random access)
- 300 test positions (75x4 cuvettes)
Liquid Handling: - 2 independent Syringes: Sample: 3-250μl in 1μl steps

Reagent: 5-999μl in 1μl steps
- CV less 2% for Volumes > 10μl
- High pressure washing (1.4 bar)
- Autocleaning
- Backflush function
- Easy maintenance
Measurement System: - Maintenance Free!

- Light sources: LED
- Detectors: Photodiodes
- Standard filters: 340, 405, 505, 546 & 620nm (4 each)
- Resolution: 0,0001 OD
- Accuracy: <1% CV at 1 OD / 405nm
- Linearity: 0.00-3.00 OD better than +/- 1%
- Drift: less than 0.001 OD / hr
- Temperature controlled
- 5 built-in photometers, 4 channels each
- 20 independent channels
Temperature Control: - Cuvette heating (electrical) in carousel and reading path: 37°C
Power Requirements: - 85-264 VAC, 50/60 Hz (autodetecting)

- Power Consumption: max. 150 VA
- Mains Fuse: 2 x 2A T (slow blow)
Measures: - Dimensions ( W x D x H):

- Instrument without any components: 80 x 56 x 54 cm
- Space required for routine use: 140 x 100 x 64 cm
- Packaging: 99 x 73 x 67 cm
- Weight: Gross 51 kg, Net 39 kg
Environmental: - Operation: 18...35°C, 10-90% rel. Hum.

- Storage: - 40...70°C, 5-95% rel. Hum.
Options: - Reagent cooling (ambient minus 10°C) (water circulation w/ external cooler)
- Handheld Barcode Reader f. pos. Sample ID
Disposables: - Cuvette block for 4 tests each

- Reagent bottles
- Serum Cups
Overvoltage Cat.: II
Pollution Degree: 2
Method of Disposal: - Contaminated Waste
Usage: - Commercial
9 Human HumaStar 180 User Manual

1.4 Functional Description
The Clinical Chemistry Analyzer HumaStar 180 comprises the following main functional units:
- Process Management
- Liquid Handling
- Carousels
- Temperature control
- Cooling (optional)
- Measurement System
- DETect Software package
The following explains the functions of all these units, as well as their interference within each other.
1.4.1 Process Management
The working principal of HumaStar 180 is based on a modular system, which is controlled by a PC via the Process
Manager (built-in to HumaStar 180).
Each module is fitted with it’s own “intelligence” and functions as a slave to the Process Manager. The process
manager is connected to a PC via RS 232 and receives his orders from DETect Software package running on the PC.
When a process is started on DETect (e.g.: testing a sample for certain parameters), DETect cuts the complete
process into the required steps:
- Washing the probes

- Pipetting the reagent(s)
- Pipetting the sample
- Mixing
- Incubating
- Reading
These process steps are sent to the process manager in the instrument, one at a time, exactly when appropriate.
The process manager himself distributes the necessary commands to the modules.
The modules “fulfil the order” and report back to the process manager, which himself provides DETect with the
actual status accordingly.
1.4.2 Liquid Handling
The functional unit “Liquid Handling” consists of two independent liquid paths, one for sample pipetting and one
for reagent pipetting. All involved electrical components such as drive motors, valves and syringes are connected to
and controlled by the central process manager.
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Graph 1.1: Liquid Path
Z M ove m en t V a lve P o sitio n s:
VP a
X Mo ve me n t
3
VP b
6 4
VP c
13 11 5 2
10 7
9 8
12
Waste System
14 Liquid 1
Explanation:
1 System Liquid Bottle 6 Probe w. liquid detection 11 Wash Station

2 Membrane Pump 7 Cuvette 12 Splitting Valve
3 Syringe 3-way Valve 8 Reagent Container 13 Waste Membrane Pump
4 Syringe Pump & Syringe 9 Primary Sample Tube 14 Waste Bottle
5 Syringe Pump Drive 10 Serum Cups
Both liquid paths are built up identical, with the only difference of the size of the syringes and the probes:
Syringe: 1ml for reagent path Probe: 0.5mm inner diameter for reagent path
250μl for sample path 0.4mm inner diameter for sample path
X- and Z-movement are realised by the pipetting arm, which holds the probes and the probes drives, together with
all necessary motors, sensors and electronics.
1.4.2.1 Pipetting Cycle
The system is able to pipette reagents in either single or multi pipetting mode. Multi pipetting mode means that a
multiple of the required reagent volume per test of one reagent will be aspirated and then be distributed into the
different target containers (cuvettes) accordingly.
Depending on the overall routine definition for a specific run, DETect Software package will decide if or if not multi
pipetting should be used for reagents.
A complete pipetting cycle incorporates the following steps:

Single Pipetting (Sample or Reagent)
- Wash probe
- move probe in Z direction into wash station
- flush with system liquid for a pre-defined time span
- lift probe in Z direction to top position
- Pick up source liquid

- move probe in X direction to source container (reagent container, sample tube or serum cup)
- move probe in Z direction into source container until liquid is detected
- aspirate the required test volume (driven by syringe pumps)
REAGENT Pipetting:
- Pipette liquid into target container

- move probe in X direction to target container (Cuvette)
- move probe in Z direction into target container
- pipette required test volume into target container
SAMPLE Pipetting:

- move probe in X direction to target container (Cuvette)
- move probe in Z direction into target container until liquid is detected
- pipet required test volume into target container
- mix by aspirating and re-pipetting
- Move probe in X direction to home (Wash station)
Multi Pipetting (Reagent only)
- Wash probe
- move probe in Z direction into wash station
- flush with system liquid for a pre-defined time span
- Pick up source liquid

- move probe in X direction to source container (reagent container, sample tube or serum cup)
- move probe in Z direction into source container until liquid is detected
- aspirate a multiple of the required test volume (driven by syringe pumps)

- move probe in X direction to target container 1 (Cuvette)
- move probe in Z direction into target container 1
- pipette required test volume into target container 1
- move probe in X direction to target container 2 (Cuvette)
- move probe in Z direction into target container 2
- pipette required volume into target container 2
- repeat for target containers 3 - n
- Move probe to home (Wash station)
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1.4.3 Carousels, Temperature Control and Cooling
HumaStar 180 is using two carousels, the Inner and the Outer Carousel. Both carousels are directly connected to
and controlled by the central process manager.
- The Inner Carousel for carrying Samples, Reagents, Standards, Calibrators and Controls.
The inner carousel can optionally be cooled. This option comprises an external cooling unit and cooled
liquid is circulated underneath the inner carousel.
- The Outer Carousel for carrying the disposable Cuvettes.

The outer carousel is temperature controlled to 37°C (standard).
Graph 1.2: Carousels, loaded, inside Instrument
Inner
Outer
1.4.3.1 Inner Carousel
The Inner Carousel can easily be removed for loading.
Please refer to Chapter 2 for instructions on how to remove,

load and replace the Inner Carousel.

Graph 1.3: Inner Carousel
The Inner Carousel features:
25 Positions for Reagents, marked as 1, 2...25

25 Positions for Primary Sample Tubes, marked as 1,
2...25
25 Positions for Serum Cups for:
- 2 Controls, marked as C1 and C2
- 10 Standards/ Calibrators marked as S1, S2...S10
(if less or no Std / Cal are used, these positions
can be used for additional Samples)
- 13 free positions marked as 26, 27...48
Graph 1.4: Reagent Bottle Graph 1.5: Serum Cup
Empty Bottles can be ordered 1.5 ml Serum Cups can be

from your local Human ordered from your local Human
distributor: distributor:
max 10,5 mm
Cat.-no. 16900/2 (25 pcs) Cat.-no. 16904 (500 pcs)
1.4.3.2 Outer Carousel
The Outer Carousel can not be removed for loading. Graph 1.7 just gives a better impression of what the Outer
Carousel is like.
Graph 1.7: Outer Carousel Graph 1.8: Cuvette Block
Each Cuvette Block contains 4 Cuvettes, for one test

each.
Total loading volume: Cuvettes for 300 Tests
These Cuvette Blocks are unique and can only be

ordered from your local Human distributor:
The Outer Carousel features 75 Positions for Cuvette :
Blocks
Cat.-no. 16900/1 ( 1 pack with 200 blocks for 800 tests)
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1.4.3.3 Functions of the Carousels
Temperature control of Outer Carousel
The temperature control of the outer carousel is effected by thermo resistors, connected to an electronic regulating
circuit. Together with temperature sensitive sensors connected to the same regulating circuit, a stable temperature
is provided to the cuvettes throughout the whole test run.
Cooling Option of Inner Carousel
The cooling of the inner carousel is effected by cooled water circulating underneath the inner carousel, within a
closed spiral copper tube. This copper tube is connected to an external cooling generator, the system is closed and
independent from a tap water connection.
Insulation
In order to prevent temperature-interferences between the (optionally) cooled inner and the temperature
controlled outer carousel, an insulation ring is dividing the two carousels.
Rotation
Both carousels are controlled and rotated independently, within a co-axial mechanical system.
Besides keeping samples, reagents and test containers in stable temperature environment, actually the main
function of the carousels is to provide the Y-movement of the source and target containers within the pipetting
and measuring system of HumaStar 180.
The carousels are rotated while other processes within the complete system are being performed. By doing so, the
time required for rotating and positioning the carousels is not a critical factor in terms of process time and
throughput.
The Inner Carousel is only to be rotated during pipetting steps, as described under 1.4.2.
It is rotated in either clockwise or counter clockwise direction and provides the source containers required for a
specific pipetting step to be positioned precisely underneath the probes.
The Outer Carousel is to be rotated during pipetting steps as described under 1.4.2.
Additionally, the outer carousel is to be rotated during measurement steps as described under 1.4.4
For pipetting, it is rotated in either clockwise or counter clockwise direction and provides the target containers
required for a specific pipetting step to be positioned precisely underneath the probes.
For measurement steps, it is rotated in either clockwise or counter clockwise direction and provides the target
containers required for the measurement step to be positioned precisely at the entrance position of the linear
photometer street.
1.4.4 Measurement System
HumaStar 180 is fitted with a unique linear photometer, featuring 20 independent measurement channels for fast
and accurate reading of test results in the cuvettes.
These 20 channels are organised in 5 groups of 4 channels each, whereas each group of 4 channels is controlled by
two electronic boards: One light emitting board and one detection board. These are directly connected to the
central process manager
Each of the 5 light emitting boards is fitted with 4 light sources (LED, light emitting diodes) and the respective
control electronics.
Each of the 5 detection boards is fitted with 4 detectors (Silicon Diodes) and the respective signal converter
electronics, as well as with a RS 232 port which connects it with the process manager.

Graph 1.8: Measurement System
Cuvettes in 1 Cuvette block in

Reading Position Cuvette Transport Cuvette Transport
outer carousel
Notch Belt
Cuvette
Transport
Motor
Detection board
Detector
Interference Filter Cuvette Block
Optics (lens)
Light beam
Optics (lens)
Light source "LED"

Light emitting board
For reading, the Cuvette Block is transported from the Outer Carousel through the Linear Photometer by a
transport belt.
Depending on the wavelength required for the measurement, the Cuvette Block will be positioned into the 4 light
beams of the respective photometer block.
The light emitted by the LED’s is directed through a focusing lens. This lens ensures a light beam, which is as
parallel as required for having homogenous measurement conditions.
While passing the cuvettes, respectively the liquid in the cuvettes, a part of the light energy is being absorbed by
the liquid in the cuvette. The remaining light energy is now passing another lens and the respective interference
filter and is then being measured by the detectors.
16
Contents
2 System Setup 18
2.1 Introduction 18
2.2 Unpacking 18
2.2.1 Contents of Shipment 18
2.2.2 To be provided by User 18
2.2.3 Unpacking 18
2.3 Installation of HumaStar 180 20
2.3.1 Set YZ Arm to Home Position 20
2.3.2 Power Connection 21
2.3.3 Tubing and Bottle Connection 21
2.3.4 Connection of Reagent Cooling Option 22
2.3.5 Computer Connection 22
2.4 Installation of DETect Software Package 22
2.4.1 Computer Requirements 22
2.4.2 Software Installation Procedure 22
2.5 First Power Up 28
2.5.2 Start DETect Software Package 30
2.6 Carousels 33
2.6.1 Loading Inner Carousel 34
2.6.2 Loading Outer Carousel 36
2.7 Define Instrument Settings 38
2.7.1 Starting Instrument Settings Menu 38
2.7.2 Instrument Settings 39
2.7.3 Autocalibrate Bottles 39
2 System Setup
- Unpacking & Installation

- Instruments Settings
2.1 Introduction
This chapter gives the instructions on all steps which need to be performed in order to unpack, install and set up
the system properly.
Please read this chapter carefully and make sure that all the instructions herein are being followed. Failure in doing
so might cause injury to the user and / or damages to the instruments!
2.2 Unpacking
2.2.1 Contents of Shipment
The instrument is shipped in one box, which contains:
- HumaStar 180 Clinical Chemistry Analyzer with Sample & Reagent Carousel
- Accessory Box with:
- Power Cord
- Serial RS 232 Cable
- DETect Software Package
- 2 bottles, 2.5 ltrs each, one for System and one for Waste Liquid,
with caps fitted with tubing connectors
- 25 reagent bottles 50ml
- 25 reagent bottles 20ml
- 25 screw caps for reagent bottles
- 2 tubings, appr. 1 mtr each
- Cuvettes, 1 set
- User Manual (English), 1 pc
If any of the above is missing, or if the box is remarkably damaged

when you receive it, please report to the delivering forwarding agent
as well as to HUMAN GmbH immediately !
2.2.2 To be provided by User
- Windows (tm) based PC with one free RS 232 serial port

- Printer (any, that connects to Windows (tm))
- Mains Power Connection
- De-Ionised or distilled water
- Cleaning Agent (HUMAN GmbH, Wash Additive, Cat.-no. 18971)
- Container for completed cuvettes (the outlet is levelled at appr. 9cm / 3.5 inches)
2.2.3 Unpacking
2.2.3.1 Take the Instrument out of the Box
Take the instrument out of the box and place it on a flat, dust-free surface.
18
Graph 2.1: Instrument View
Dilutors
Outlet for
completed
Cuvettes
Front Door Handle

Liquid Connections
Power On LED
„Load Cuvette“ Button
Graph 2.2: Instrument Rear View
Mains Power Serial USB Port Liquid RS 232 Port

Number Sensor
Information Connectors
Immediately compare the serial number printed on the respective label on the rear side of the instrument with the
serial number printed on the delivery papers. If there is any difference, please report to your supplier immediately!
Only the correct Instrument Serial number allows the manufacturer

to rectify your claims in case of warranty!

2.2.3.2 Remove Packaging Foam
Open the Front Door of the instrument by holding the front door handle and moving the door in a semi-circular
movement to the left:
Graph 2.3: Door open
Support Foam Bottle Carrier Foam
Carefully remove the Support Foam

Carefully remove the Bottle Carrier Foam
Take the Bottles out of the Bottle Carrier Foam
Please store the complete packaging material ! When returning

the instrument to the supplier for any reason, the instrument
must be packed in original packaging material.
2.3 Installation of HumaStar 180

2.3.1 Set YZ Arm to Home Position
Graph 2.4: YZ Arm in “Transport Position” Graph 2.5: YZ Arm in “Home Position”
YZ Arm in
Transport
Position
YZ Arm in Home Position Front Stopper
20
Set the YZ Arm to Home Position by moving it to its front stopper, until you can feel it to engage firmly with the
front stopper.
Open the 3 plastic transport safety screws from below to enable the cuvette ring to move.
Caution
Do not remove the screws completely.
It is recommended, that the instrument is operated under stable

environmental conditions and that it is not exposed to direct sunlight.
2.3.2 Power Connection
Caution
Make sure, the instrument is switched off
(main switch is set to “ 0 ”).
Graph 2.6: Mains Power Compartment
0
Mains Switch
in "OFF" position
Mains Power Connector
Mains Fuse Compartment
Plug the power cord, which comes with the accessories box, into the Mains Power Connector. The Mains Power
Connector is placed on the rear side of the Instrument. Leave the Mains Power Switch in “Power Off” position (“0“).
Connect the other end of the power cord with mains power. The instrument features autodetection of the supplied
Voltage (85-264 VAC, 50 or 60 Hz). No further settings for different Mains Voltage Systems are required.
2.3.3 Tubing and Bottle Connection
The standard version of HumaStar 180 requires two external connections: System Liquid and Waste.
The bottles are packed in the foam of the instrument packaging, the tubings are already connected to the bottles.
Fill the Bottle labelled with “System Liquid” with a mixture of distilled or de-ionised water with 600μl Cleaning
Agent per litre (to be sourced from HUMAN GmbH , Cat.-no. 18971).
Connect the free end of the tubings to the according Liquid – connection on the right hand side of the instrument:

The tubing that is connected to the cap of the bottle labelled with “Waste” should be connected to the instrument
connector “Waste out”
The tubing that is connected to the cap of the bottle labelled with “System liquid” should be connected to the
instrument connector “System Liquid In”
Graph 2.7: Liquid Connectors (right side of Instrument):
W a s te o u t in out
S ys te m C o o lin g C irc u it
L iq u id in (o p tio n a l)
2.3.4 Connection of Reagent Cooling Option
If the Optional Reagent Cooling has been ordered, this must be connected to the Liquid Connectors as per
Graph 2.7.
2.3.5 Computer Connection

Plug the Serial Cable, which comes with the accessories box, into the “RS 232” connector. The “RS 232” is placed on
the rear side of the instrument. Connect the other end of the Serial Cable to a free RS 232 port on your computer.
2.4 Installation of DETect Software Package
2.4.1 Computer Requirements
Parameter Minimum Recommended
Operating system Windows 95, 98 or ME Windows XP or 2000
Memory 512 MB 1.0 GB
CPU Pentium 90 Pentium III
Resolution 800 x 600 1024 x 768
Port RS 232 RS 232, USB 2.0
All connected devices must comply with regulations EN 60950, UL 1950 or CSA C22.2 No. 950 for Data Processing
Devices
The PC shall be used only for the operation of the instrument.
Any other programs installed and used besides the instrument software may cause instrument malfunction and/or
breakdown. Such errors will not be covered under warranty.
2.4.2 Software Installation Procedure
DETect is installed using the following procedure:
1. Insert the installation CD ROM, which is supplied with the accessories box of the HumaStar 180
shipment, into the CD ROM drive of your PC
If your PC has “autorun” option activated, the installation wizard should start
automatically.
If it does not start automatically on your PC, you can manually start the installation process. Please
proceed as follows:
22
2. Start the installation program by entering the command: X:\setup1975.exe and click OK. (X here
stands for the name of your CD ROM drive.
If this is not known, please consult your PC or network administrator or get the related information from
the user Manual of your PC)
The installation program is now being started and the Set-up window is displayed.
Select the language (English) and click OK to continue.
3. Click Next to continue

4. Select whether you want a complete installation or just to update your current software and confirm
with Next
5. Specify whether you are using filter 340nm in the HS 180 or filter 365nm and continue with Next
Note: all instruments starting with serial number 7xxx are equipped with 340nm filter
6. Accept the license agreement and continue with Next
24
7. Select the installation directory (use the default one, recommended)
8. Choose the applications to be installed and continue with Next

9. Select the start menu folder and continue with Next
10. Choose to create a desktop icon and/or quicklaunch icon in taskbar, continue with Next
26
11. Confirm your selected option and start installation with the button Install
12. Now the installation will be started and install the files as selected

13. Click the button Finish to complete the installation process. HumaStar 180 is now ready for operation.
2.5 First Power Up

2.5.1 Switching on the Instrument
After both, set up of the instrument and installation of DETect have been completed as described above, DETect
and HumaStar 180 can be powered up.
28
Before switching on HumaStar 180
Graph 2.8: Position of “Power On” lamp
Front Door
Front Door Handle Power On LED
- Fill System Liquid Bottle (distilled or de-ionised water with 1.000μl Cleaning Agent)
- Check Tubing connections
- Start PC
- Close the front door of HumaStar 180
Caution
In case the bottle “System Liquid” is not
filled, the syringes might be damaged!
and then:
- Switch on HumaStar 180 using the Mains Switch, located on the rear side of the instrument
- When the instrument is connected to power and switched on, the “Power On” lamp in the front of the
instrument will be lit:
- Start DETect Software Package

2.5.2 Start DETect Software Package
Start “DETect” software package on your PC by clicking on the DETect - icon. During the start up procedure, DETect
will display the start up screen.
HumaStar 180 will automatically perform a full initialisation procedure. This initialisation procedure will be
performed every time DETect is being started.
During this initialisation procedure, the following steps will be performed:
- Initialise Z and X transport of pipettor probes

- Initialise both, reagent and cuvette carousel
- Initialise Photometer transport system
- Initialise syringes
- Power up temperature control of Cuvette Carousel and Measurement Street to 37°C
If any of the initialisation cycles fails, an error message will be prompted to the user.
In case of an error during initialisation, please refer to the “Trouble Shooting” section of this manual or contact the
Supplier of the Instrument.
After the Initialisation procedure has been completed, DETect is ready for all further steps.
Caution
If DETect is being started the first time, e.g. after the first installation
or after the installation of an update, the system must be configured,
Methods must be defined and the reagents must be calibrated!
2.5.2.1 DETect Start Up Screen

When DETect has been started, the Start up Screen will be displayed:
Graph 2.9: Start up Screen
30
Each time the software is started below window will be displayed. If the instrument was already powered on for at
least 30 minutes you can close this warmup message.
In case the serial port of the PC is not connected or configured incorrect below message will be shown. In this case
end the HumaStar 180 software and verify your serial connection.
In case WINDOWS™ reports any error message like “Application error” you should delete the registry entries for
the HumaStar 180 software completely as described below:
Click on the WINDOWS™ START button.

From the opened window select RUN.
Enter into the command line of the small RUN window REGEDIT and press ENTER.
Locate in the registry file displayed the directory:
\HKEY\CURRENT_USER\Software\BCG App Wizard-Generated Applications\Rhino\Settings
and delete it.
Now the software should start without any error. The deleted registry entries are automatically generated by the
software during next start.

2.5.2.2 Action Menu Bar
The Action Bar of DETect provides the user with the following options:
Graph 2.10: Action Menu Bar
TRAY Button: shows the programmed layout of the inner tray
Results Button: Display Results and print report
Calib Results Button: Display CALIBRATION Results and print report
New Sample Button: Define new Sample Requests
Barcode Sample: Read or type the barcode of the sample
Calibration Button: Start Calibration of the Reagents
Change Methods Button: Define new or update existing Protocols
QC Button: displays the saved QC results
Daily Cleaning Button: starts the automatic daily cleaning procedure
2.5.2.3 Main Menu Bar

The Main Menu Bar of DETect provides the user with the following options:
Graph 2.11: Main Menu “Action”
This menu gives exactly the same options as

described under 2.5.2.2 “Action Menu Bar”
32
Graph 2.12: Main Menu “Instrument”
“Prime Liquid” allows to manually initialise the

liquid channels of the system
“Instrument Settings” for authorised Service
personnel only !
“Autocalibrate Bottles” to adjust the needle depth
onside bottles 1, 2 and 3 and in the sample cups
used
“Belt Adjust” allows the user to perform the
adjustment of the cuvette transport in case of
error
“Daily Cleaning” starts the automatic cleaning
cycle
“Special Cleaning” starts the weekly recommended
cleaning procedure
“Unload All Cuvettes” can be used to remove
cuvettes from the cuvette ring
“Move Arm To Remove Tray” moves the pipetting
needles up and to the left. This allows save
unlocking of the pipettor arm
2.6 Carousels
HumaStar 180 is using two Carousels:
- The Inner Carousel for carrying Samples, Reagents, Standards, Calibrators and Controls.
The Inner Carousel can optionally be cooled. This option comprises an external cooling unit and cooled liquid is
circulated underneath the inner carousel.
- The Outer Carousel for carrying the disposable Cuvettes.
The Outer Carousel is temperature controlled (standard).
Inside the Instrument, these two Carousels are controlled and moved independently, within a co-axial mechanical
system. In order to prevent temperature – interferences between the (optionally) cooled inner and the temp.
controlled outer carousel, an insulation ring is between the carousels.

Graph 2.13: Carousels, loaded, inside Instrument
Inner
Outer
2.6.1 Loading Inner Carousel
25 Positions for Reagents, marked as 1, 2...25

25 Positions for Primary Sample Tubes, marked as 1,
2...25
25 Positions for Serum Cups for:
- 10 Standards/ Calibrators marked as S1, S2...S10
(if less or no Std / Cal are used, these positions
can be used for additional Samples)
34
2.6.1.1 Remove the Inner Carousel from the Instrument:
The Inner Carousel can easily be removed for loading:
Graph 2.15: Inner Carousel removal
To remove the Inner Carousel,

hold the handle in the center of
the carousel and lift the carousel
carefully until it can easily be
unloaded from the instrument.
2.6.1.2 Load the Reagent Bottles
Graph 2.16: Reagent Bottle
Empty Bottles can be ordered

from your local Human
Distrbutor:
Cat.-no. 16900/2 (25 pcs)
- Start with the position being marked with number 1 and continue in increasing order.
- Make a list of the respective reagents with their position in the carousel.
- Mark the reagent bottles with the respective position number by using a permanent (water resistant)
marker
It is required to dedicate each of the reagent positions of the carousel to

one certain reagent and permanently keep this position for further runs!
When programming Methods in DETect Software, the position(s) of the

reagent(s) for the respective method must be entered!

2.6.1.3 Load Controls / Calibrators
These must be pipetted into Cups (e.g.: Serum Cups from HUMAN GmbH ) before.
Graph 2.17: Serum Cup
1.5 ml Serum Cups can be

ordered from your local
Human Distrbutor:
max 10,5 mm
Cat.-no. 16904 (500 pcs)
2.6.1.4 Insert the Inner Carousel into the Instrument
Graph 2.18: Inserting Inner Carousel
To insert the Inner Carousel after loading, the carousel

must be placed so that the
two red arrow markings
(one on the Carousel, one on the Carousel

compartment) fit perfectly together.
2.6.2 Loading Outer Carousel

The outer carousel can not be removed for loading. Graph 2.19 just gives a better impression of what the outer
carousel is like.
Graph 2.19: Outer Carousel
The Outer Carousel features 75 Positions for Cuvette Blocks
36
Caution
For safer handling of samples and patient data, HUMAN has

decided to use disposable Cuvettes!
HumaStar 180 does not feature a cuvette washing station.
Do NOT wash and re–use Cuvettes! Manually washing and

reusing cuvettes may effect the system to give wrong results
and can cause mechanical damages to the system!
Graph 2.20: Cuvette Block
Each Cuvette Block contains 4 Cuvettes, for one test

each.
Total loading volume: Cuvettes for 300 Tests
These Cuvette Blocks are unique and can only be
ordered from your local Human Distrbutor:
Cat.-no. 16900/1 ( 1 pack with 200 blocks for 800 tests)
Before the outer Carousel can be loaded

with Cuvettes, the instrument should be
switched on.
2.6.2.1 Switch the Instrument on

For powering up the system, please refer to paragraph 2.4.1 of this manual.
For loading Cuvettes, DETect Software package does not need to be started.
2.6.2.2 Insert the Cuvette Blocks

The cuvette blocks are to be loaded manually. The cuvettes should be taken from the transport box directly into the
carousel.
Caution
DO NOT touch the reading windows of the Cuvettes!
Finger prints and/or scratches within the reading widows

may effect the precision of the system.
See Graph 5.2 for description of Reading Windows
Cuvette Loading Button

Press the “Cuvette Loading Button” to move the outer carousel clockwise for easier loading of all segments. The
Cuvette Loading Button is situated in the front right part of the instrument:

Graph 2.21: Cuvette Loading Button
2.7 Define Instrument Settings
Caution
If DETect is being started the first time, e.g. after the first
installation or after the installation of an update, the
system must be configured, Methods must be defined and
the reagents must be calibrated !
The following screens give instructions on how to define the standard settings for HumaStar 180 within DETect.
The settings as per the following screens are correct for most instruments already from delivery. Defining different
Settings is only required in case of malfunctions.
Caution
Using Settings different to the settings below, might effect in
malfunction of the complete system.
Changes should only be performed by authorised Service Personnel!
Unauthorised change of settings will effect in immediate loss of
warranty by manufacturer!
2.7.1 Starting Instrument Settings Menu
Graph 2.22: Main Menu “Instrument"
38
In the DETect start-up screen, from the Main Menu, select “Instrument” and then “Instrument Settings”. This will
start the “Instrument Settings” Menu.
Caution
Access to this menu is possible by
password for authorised persons only.
2.7.2 Instrument Settings
Select “Instrument Settings” from the menu and enter the requested password (051101) to open this function.
This will open the CONFIGURATOR in which all

required settings can be changed as required.
Each setting has ist own little help text for
more information displayed on the screen.
You will also see the suggested values to be
set as well as the possible range to be entered
if required.
2.7.3 Autocalibrate Bottles
This function will AUTOMATICALLY adjust the way the needles will travel inside the reagent bottles and sample
cups used.

Select what need to be adjusted and press OK.
Follow the instructions displayed.
Confirm the new calibration if correct.
40
Contents
3 System Configuration 42
3.1 Introduction 42
3.2 Method Definition 42
3.2.1 Start Up DETect 42
3.2.2 Define New Protocols 43
3 System Configuration
- Method Definition
3.1 Introduction
Before HumaStar 180 can be used for daily routine work, there are several steps to be performed in order to ensure
correct operation and safe results:
This part of the HumaStar 180 User Manual gives instructions on how to set up methods in DETect Software
package, on how to perform the required calibration procedures for the defined methods.
After all these steps have been performed satisfactory, HumaStar 180 is ready for daily routine. On how to define
patient samples and how to set-up and start a run in daily routine is explained in chapter 4.
Important basic information for method settings
Reagent Volume:
for MONO reagent application the maximum reagent volume should be 200 – 250 μl
for 2-SHOT reagent application the maximum reagent volume should be 250 - 300 μl
Mixing:
the mixing volume should NOT exceed 200 μl, the maximum possible volume is controlled by software
the mixing cycles are depending on the method, recommended are 2 cycles
OD Limit for used up substrate:
for decreasing reactions (e.g. GOT/ASAT) the limit should be set to 250
for increasing reactions (e.g. GGT) the limit should be set to 2.500
Any change to a method must be saved by clicking on the

disk icon!
3.2 Method Definition

3.2.1 Start Up DETect
After installation of the system and after the installation of DETect as per Chapter 2 of this User Manual, paragraph
2.4. has been completed, DETect can be started.
Before Starting DETect, switch on HumaStar 180!
42
3.2.1.1 Start Up Screen
When DETect has been started, the Start up Screen will be displayed:
Graph 3.1: Start up Screen
3.2.2 Define New Protocols
When being started the first time, DETect will have all Human protocols defined. Before starting to use HumaStar
180 for daily routine, these protocols may need to be adapted to local requirements (units, normal ranges,etc.),
additional protocols maybe defined as well.
DETect has been designed in a way, that manual routines can easily be implemented. A Wizard will guide the user
throughout the complete programming procedure. The user just needs to enter the parameters as described in the
package inserts of the reagents step by step.
To define protocols, please proceed as follows:
In the boxes of the reagents you are going to use on HumaStar 180, there should be a package insert describing the
manual procedure for the respective test.
If this manual is not packed with your reagent kit, or if the

procedure described therein is unclear, please contact the
supplier of the reagents for further assistance!
3.2.2.1 Start the Method Definition Wizard:

In the Start Up Screen of DETect, select “Program Method” from the Main Menu “Action”, or just click on the
“Change Method” Button in the Action Menu Bar.
On the screen, that will now be displayed, click on the menu button “New Method”:
Graph 3.5: “Change Method” Screen
Click here to DELETE a method
Click here to MODIFY a method
Click here to CREATE a method
When the Button “New Method” has been selected, the Method definition Wizard will automatically be started
and the following screen will be displayed:
Graph 3.6: Method Definition Wizard Start Screen
Into the free spaces, enter the parameters as per the package insert of the kit manufacturer as described on the
following pages.
Caution
The following screen-prints contain invalid example data!
Do NOT enter these data into your methods!
44
3.2.2.2 Definition of an Endpoint (Substrate) Method:
Example:
Parameter: Glucose
Manufacturer: HUMAN
Reagents: Monoliquid
Calibration: Multicalibrator
Wavelength: 546nm
Required volumes: Reagent: 250μl
Sample: 3μl
Incubation: 300 sec at 37°C
Controls: yes
Substrate Blank: yes, validation Range: 100 – 300 mOD
Upper linearity Limit: 2000 mOD (retest with diluted sample if exceeded)
Units: mg/dl
Caution
Graph 3.7: Method Definition Wizard Endpoint Start Screen
Enter Test Identification, e.g. GLU (for Glucose)
Enter the full Test name (e.g. Glucose)
Enter the name of the reagent manufacturer
According to the test procedure, select either:

- “Kinetic” for Enzymatic tests with multiple
measurements required
- “Endpoint” for Substrate tests
- “Initial Rate” for Two – Point Enzymatic tests
After the fields have been entered correctly, select “Continue”.

As “Endpoint” has been selected in this example, the Wizard will automatically select the further procedure for
“Endpoint” and the next Wizard screen will be displayed.

Graph 3.8: Method Definition Wizard Endpoint Screen 1
Select the unit which the results should be

represented in: - mg / dl
- mmol / l
-U/l
Select the required incubation temperature for

the test procedure: 25, 30 or 37°C
Define the validation limits for:

- Reagent Blank in mOD
- Man, Woman or Child in the selected Units
Define the Linearity Limit of the Reagent.

In case, during a test run, with any sample this
limit is exceeded, this respective sample will
automatically be diluted by a factor of 1:2 and
then be re-tested
Select if the optical density of the reagent blank

has to be subtracted from the optical density of
every sample before calculating the results.
Select the required measurement Wavelength
You can only select those wavelengths, which are actually

installed in your instrument.
Graph 3.9: Method Definition Wizard Endpoint Liquids Screen
Define the Sample Volume in μl

Range: 2 to 100μl in 1μl increments
Select, if one, two or three reagents are required for

the test
Select the required volume in μl for each reagent.

Range: 50 – 900 μl in 5 μl increments
Define the Tray position for the specific Reagent
Select between three different Bottle Types.

The bottle Types are predefined in the Instruments
Setting Menu of DETect.
See: “Instrument Setting Menu”, Chapter 2 of this
manual
After all the required Parameters have been defined, select “Continue”.
46
Graph 3.10: Method Definition Wizard Endpoint Reaction Screen
Select a dilution volume for reagents if required.

This dilution volume is defined in μl and will be
added for every “PW” step (see next Screen).
PW stands for “Pipet Water”
Enter the calibration factor, if “Fix Factor” has

been defined as Calibrator in the prior screen.
A Correction Factor can be used to egalise

common differences in results between two
different systems.
(e.g.: if HumaStar is used as a backup unit)
After all the required Parameters have been defined, select “Continue”.
Graph 3.11: Method Definition Wizard Endpoint Workcycle Screen
Screen for flexible chaining of process steps. The

pipetting steps will use the values as defined before.
PR1 Pipet Reagent one
PR2 Pipet Reagent two
PR3 Pipet Reagent three
PW Pipet Water
PS Pipet Sample
M Mix
InkRxx Incubate in Cuvette
MeasOD Read
Mixing Parameters for the method
Volume: amount used for mixing inside
the cuvette
Repetition: number of mixing cycles
Use Multipipetting can be selected by method
Select the required commands and move them to the “Actual test” window by clicking the “Add” button.
Incubation commands will automatically activate a pop-up-window to enter the required incubation time in
seconds.
The buttons “Move Up”, “Remove” and “Move Down” allow to edit the defined routine, respectively to move
commands within the Window “Actual Test”.
To do so, select one of the steps in the “Actual Test” window by clicking on it.
Now, clicking one of the buttons “Move Up”, “Remove” or “Move Down” will affect the selected command.

In our example, the routine for Glucose requires:
Requirement of the test: Command: This will be done:
Pipette the pre-defined amount of Reagent PR1 Pipette Reagent one
Add the pre-defined amount of Sample PS Pipette Sample
Mix reagent and sample is automatically done (M) (Mix reagent and sample)
Incubate for 300 seconds InkR300 Incubate in Carousel
Read the Optical Density and calculate the result MesOD Read the cuvette, send Data to PC for
evaluation
After all steps have been performed, click the “finish” button. At this point, either further methods can be defined,
or the calibration for already defined methods can be performed.
3.2.2.3 Definition of a Multipoint Kinetic (Enzymatic) Method:
Example:
Parameter: Gamma GT
Manufacturer: HUMAN
Reagents: Reagent 1 and 2
Required volumes: Reagent 1: 200μl

Reagent 2: 50μl
Sample: 3μl
Wavelength: 405nm
Reading: mOD / min (Delta OD over a period of time)
Controls: yes
Substrate Blank: yes, validation range: 100 – 300 mOD
Units: mg/dl
Caution
and the first screen of the Method definition wizard will be displayed:
48
Graph 3.13: Method Definition Wizard Kinetic Start Screen
Enter Test Identification, e.g. GGT (Gamma GT)
Enter the full Test name (e.g. Gamma GT)

- “Kinetic” for Enzymatic tests with multiple
measurements required
- “Endpoint” for Substrate tests

As “Kinetic” has been selected in this example, the Wizard will automatically select the further procedure for
“Kinetic” and the next Wizard screen will be displayed.
Graph 3.14: Method Definition Wizard Kinetic Screen 1

- mmol / l
-U/l



then be re-tested
You can only select those wavelengths, which are

actually installed in your instrument.
In case additional wavelengths are required, please
contact your nearest HUMAN GmbH Distributor!

Graph 3.15: Method Definition Wizard Kinetic Liquids Screen

Range: 2 to 100 μl in 1 μl increments

the test.

Define the Tray positions for the specific Reagents
Select whether or not Controls are required for the

calibration of the reagents
Select which calibration is used for the reagents of

this method:
Multicalibrator, if the manufacturer of your reagents
provides one calibrator for the complete panel
Single Calibrator, if every reagent requires its own
calibrator
The botte types are predefined in the Instruments Setting
Fix Factor, if a calculated value is used instead of a
Menu of DETect.
calibrator. If Fix Factor is selected, the input of the
See: "Instrument Setting Menu", Chapter 2 of this manual. factor will be requested in the following screen.
After all the required parameters have been defined, select “Continue”.
Graph 3.16: Method Definition Wizard Kinetic Reaction Screen
Select a dilution volume for reagents if required. This

dilution volume is defined in μl and will be added for
every "PW" step (see next Screen). PW stands for
"Pipet Water"
Enter the calibration factor, if "Fix Factor" has been

defined as Calibrator in the prior screen.
A Correction Factor can be used to egalise common

differences in results between two different systems.
(e.g.: if HumaStar 180 is used as a backup unit)
50
Graph 3.17: Method Definition Wizard Kinetic Workcycle Screen:

PR1 Pipet Reagent one
PR2 Pipet Reagent two
PR3 Pipet Reagent three
PW Pipet Water
PS Pipet Sample
M Mix
Meas mOD/min Read Reaction Curve
Volume amount used for mixing inside
the cuvette
Repetition number of mixing cycles
Incubation commands will automatically activate a pop- up- window to enter the required incubation time in
seconds.
In our example, the routine for Gamma GT requires:
Pipette the pre-defined amount of Reagent 1 PR1 Pipette Reagent one
Add the pre-defined amount of Reagent 2 PR2 Incubate in Carousel
Read the Optical Density and calculate the MesOD30 Read the cuvette multiple time for a
Delta OD per minute period of one minute, send Data to PC
for evaluation

3.2.2.4 Definition of a Two - Point Initial Rate (Enzymatic) Method:
Example:
Parameter: Creatinine
Manufacturer: HUMAN
Reagents: Reagent 1 and Reagent 2
Required volumes: Reagent 1: 240μl

Reagent 2: 60μl
Sample: 30μl
Wavelength: 505nm
Reading: two readings within 60 seconds
Controls: yes
Substrate Blank: yes, validation Range: 100-300 mOD
Units: mg/dl
Caution
Graph 3.19: Method Definition Wizard Kinetic Start Screen
Enter Test Identification, e.g. CRE (for Creatinine)
Enter full Test name (e.g. Creatinine)

- "Kinetic" for Enzymatic tests with multiple
measurements
- "Endpoint" for Substrate tests
- "Initial Rate" for Two-Point Enzymatic tests
As “Initial Rate” has been selected in this example, the Wizard will automatically select the further procedure for
“Initial Rate” and the next Wizard screen will be displayed:
52
Graph 3.20: Method Definition Wizard Initial Rate Screen 1

- mmol / l
-U/l



then be re-tested
You can only select those wavelengths, which are actually installed in
your instrument.
In case additional wavelengths are required, please contact your nearest
HUMAN GmbH Distributor !
Graph 3.21: Method Definition Wizard Kinetic Liquids Screen


the test.

Select whether or not Controls are required for the

calibration of the reagents
Select which calibration is used for the reagents of

this method:
Multicalibrator, if the manufacturer of your reagents
provides one calibrator for the complete panel
Single Calibrator, if every reagent requires its own
calibrator
The bottle types are predefined in the Instruments Setting
Fix Factor, if a calculated value is used instead of a
Menu of DETect.
calibrator. If Fix Factor is selected, the input of the
See: "Instrument Setting Menu", Chapter 2 of this manual. factor will be requested in the following screen.

Graph 3.22: Method Definition Wizard Kinetic Reaction Screen

every "PW" step (see next Screen). PW stands for
"Pipet Water"
Enter the calibration factor, if "Fix Factor" has been

defined as Calibrator in the prior screen.


PR1 Pipette Reagent one
PR2 Pipette Reagent two
PR3 Pipette Reagent three
PW Pipette Water
PS Pipette Sample
M Mix
MeIRxxx Measures Initial Rate
the cuvette
seconds.
54
In our example, the routine for Creatinine requires:
Mix reagent and sample is done automatically (M) (Mix reagent and sample)
Incubate in the ring for 30 seconds InkR30 Pipette Reagent two
Add reagent 2 PR2 Cuvette remains in the ring for 30 sec
Incubate in the ring for 10 seconds InkR10 Cuvette remains in ring for 10 sec
Make first and second reading and calculate the MelR60 Read the cuvette, move it back to the ring,
Delta OD within the two readings read the second point again with the defined
wavelength, send Data to PC for evaluation
3.2.2.5 Definition of an Immuno Turbidimetric Method:
Example:
Parameter: HbA1c
Manufacturer: HUMAN
Reagents: Reagent 1 and Reagent 2
Calibration:
VERSION 1: Standard Curve with Standard curve from pre-diluted vials
VERSION 2: Standard Curve with Standard curve by autodilution of standards
Required volumes: Reagent 1: 200 μl

Reagent 2: 67 μl
Sample: 5 μl
Wavelength: 620 nm
Reading: one reading 5 minutes after reaction start
Controls: yes
Substrate Blank: yes, validation Range: 100 – 300 mOD
Units: mg/dl
Caution
Do NOT enter these data into your methods !

Graph 3.25: Method Definition Wizard Immuno Start Screen
Enter Test Identification, e.g. HbA1c
Enter the full Test name (e.g. HbA1c)
According to the test procedure, select:

The required calibration type
As “Immuno” has been selected in this example, the Wizard will automatically select the further procedure for
“Immuno” and the next Wizard screen will be displayed:
Graph 3.26: Method Definition Wizard Immuno Screen 1

reported in: - mg / dl
- mmol / l
-U/l
Select the required reference temperature for



then be re-tested
You can only select those wavelengths, which are actually installed in
your instrument.
In case additional wavelengths are required, please contact your nearest
HUMAN GmbH Distributor !
56
Graph 3.27: Method Definition Wizard Immuno Standard Curve Definition Screen
Select which is the required method for

obtaining the standard concentrations of the
Calibration curve for this method:
Automatic Instrument Dilution, if the
manufacturer of your reagents provides one
calibrator which has to be diluted by the
instrument automatically
Single Standard Vials, if every standard
required for the Calibration curve is provided
prediluted, in a separate vial
VERSION 1: Standard Curve with standards from pre-diluted vials:
Graph 3.28: Method Definition Wizard Immuno Standard definition Screen
Enter the number of standard vials provided

with the test kit.
Select the mathemical formula required for

interpolation of the standard values onto a
standard curve
Available functions:
Akima
Four Parameter
Lin Regression
Logit Log
Point to Point
Polynomial
Spline

VERSION 2: Standard Curve by autodilution performed by HumaStar 180:
Graph 3.29: Method Definition Wizard Immuno Standard definition Screen
Enter the Target vessel for the required diluent.
Select the mathematical formula required for

interpolation of the standard values onto a
standard curve
Available functions:
Akima
Four Parameter
Lin Regression
Logit Log
Point to Point
Polynomial
Spline
Enter the Dilution factors for each standard.

Every completely entered dilution factor will
automatically open the next selection window.
After the standards and their dilutions have been defined correctly, select “Continue”.
Graph 3.30: Method Definition Wizard Immuno Liquids Screen


the test.

Select whether or not Controls are required for QC of

the reagents

The bottle types are predefined in the Instruments Setting
Menu of DETect.
See: "Instrument Setting Menu", Chapter 2 of this manual.
58
Graph 3.31: Method Definition Wizard Immuno Reaction Screen

every "PW" step (see next Screen). PW stands for "Pipet
Water"


PR1 Pipette Reagent one
PR2 Pipette Reagent two
PR3 Pipette Reagent three
PW Pipette Water
PS Pipette Sample
M Mix
MeIRxxx Measures Initial Rate
the cuvette
seconds.

In our example, the routine for HbA1c % requires:
Incubate for 5 Min (300 Sec) InkR300 Cuvette remains in rotor for 300 sec
Pipette the pre-defined amount of Reagent 2 PR2 Pipette Reagent two
Incubate for 5 Min (300 Sec) InkR300 Cuvette remains in rotor for 300 sec
Read Absorbance of sample MesODF1 Read the cuvette with the defined wavelength,
send Data to PC for evaluation
60
Contents
4 Calibration 62
4.1 Introduction 62
4.2 System Calibration 62
4.2.1 Preparation 62
4.2.2 Calibration 62
4 Calibration
- Calibration
- Verification of Calibration
4.1 Introduction
This Chapter gives exact description on how to calibrate new and re-calibrate existing methods with DETect and
HumaStar 180.
Caution
For information on re-calibration requirements, especially with
regards to repeated calibration and calibration periods, please
refer to the instructions of the manufacturer!
4.2 System Calibration
Every time a new Method is being implemented, the complete System “Instrument plus Chemistry” must be
calibrated before real samples can be tested.
Calibrations must be repeated regularly, according to the guidelines of the reagent manufacturer.
Before a Method can be calibrated, the Method must have been implemented in DETect, as per Chapter 3.2.
4.2.1 Preparation
4.2.1.1 Liquids:
Before starting calibrating a method, please prepare the following:
- one bottle of each of the reagent(s) of the Method to be calibrated

- the required calibrator(s), pipetted into serum cups
- the required control(s), pipetted into serum cups
- the nominal values of the calibrator(s) (as per the data sheet coming with the Calibrator)
- the nominal values and limits of the control(s) (as per the data sheet coming with the control)
4.2.1.2 HumaStar 180 & DETect:
- Switch on HumaStar 180 as described in Chapter 2 of this manual

- Fill the Bottle labelled with “System Liquid” with a mixture of distilled or de-ionised water with 1.000μl
Cleaning Agent per litre water (to be sourced from your local Human Distributor:, Cat.-no. 18971).
- Load the reagent bottles into the inner Carousel of HumaStar 180, as described in chapter 2.6.1.2
- Load empty cuvettes into the outer Carousel of HumaStar 180, as described in chapter 2.6.2 of this
manual
- Switch on the PC which is connected to HumaStar 180 as described in Chapter 2.5.1 of this manual
- Start up DETect Software package as described in Chapter 2.5.2 of this manual
4.2.2 Calibration
4.2.2.1 Start Calibrate Menu:
In DETect, select the Calibration Menu from the Action Menu Bar:
62
After the Calibration button has been selected, the following menu will be displayed on the screen:
Graph 4.2: Calibration Menu, empty
This Window automatically gives a full selection of all methods which are defined in DETect. In this example, these
are the methods which had been defined in Chapter 3.2.2
4.2.2.2 Enter values for Calibrators and Controls:
Caution
Do NOT enter these data into your methods !
Select those methods which need to be calibrated in the row “Calibrate” by simply clicking into the little square
boxes aside the name of the method:
Graph 4.3: Select Method to be calibrated
Now enter the standard concentration of the calibrator(s) for the specific parameter (method) and the upper and
lower limits of the control(s) to be used.
You can find the correct values for the calibrators and
controls you are using in the data sheets of your control(s)
and calibrator(s).

If defined in the method “Single Standard Vials” also Multipoint calibration curves can be calibrated using the
same (single) standard by selecting “SSV Multicalibrator”.
Note: The highest concentrated standard must be standard number 1 and the last standard must be “0”.
Do not mix the standards (e.g. correct: 1000, 600, 300, 150, 0 / incorrect: 1000, 300, 600, 150, 0)
64
Graph 4.4: Enter values
When all values have been entered correctly, click the “OK” button.
It is possible to select only Blank reading and Control measurement or just Control measurement as well.
4.2.2.3 Load Calibrators and Controls:
After the values of the calibrators and controls have been entered and the “OK” button has been selected, the
following screen will be displayed:
Caution
The following screen-print contain invalid example data!
Do only use those positions as displayed on the screen of
YOUR PC Screen!

Graph 4.5: Positioning calibrators and controls
Since in those protocols, which have been defined as examples in this manual are all using a multicalibrator, only
one such multicalibrator is required to be placed onto HumaStar 180.
DETect automatically dedicates the positions accordingly.
Load the serum cups with the pre-pipetted calibrators and controls into the inner carousel of HumaStar 180, as
described in chapter 2.6.1.3 of this manual.
Place these Calibrators and Controls into exactly those positions as displayed on the PC screen.
Select the “Calibrate” button in the centre of the screen.
4.2.2.4 Calibration Process:
Once the “Calibrate” button has been selected, HumaStar 180 will automatically start the Calibration procedure by
processing all defined steps for the respective Method for the Calibrator.
The Calibrator will be handled according to the definitions for “Sample” for the respective method.
During the same run, the defined controls are being processed, according to the definitions for “Sample” for the
respective methods.
4.2.2.5 Calibration Result:
After the process for Calibrators and Controls has been completed, DETect will calculate the required Calibration
factor or the required Standard Curve respectively, for the defined methods by using the following formulas.
Endpoint and Kinetic methods will require a factor for processing samples, whereas immunoturbidimetric methods
require a standard curve of concentrations.
66
Finding the factor for Endpoint and Kinetic Methods:
Endpoint Method: Kinetic, Initial Rate Method:
StdConcCALIBRATOR StdConcCALIBRATOR
Factor = Factor =
MeasODCALIBRATOR DeltaODCALIBRATOR
StdConcCalibrator pre-defined concentration, according to description of reagents manufacturer.
MeasODCalibrator measured OD value of the processed endpoint-calibrator.
DeltaODCalibrator measured change in optical density over the required reaction time of the processed kinetic-
calibrator.
All calculated factors for the Calibrators, will be stored in the memory of DETect software package under the
respective Method. These factors will be used for all further samples which are being tested for the parameter of
the respective Method.
Calibration factors will be stored and used until a new calibration of the respective Method has been performed.
Caution
For information on recalibration requirements, please
refer to the instructions of the reagent manufacturer!
Plotting the Standard Curve for Immunoturbidimetric Tests:
A Standard Curve will be calculated from all the OD values measured for the respective Standard concentrations:
Graph 4.6: Example for a Standard Curve
The calculated Standard Curve for the Calibrators, will be stored in the memory of DETect software package under
the respective Method. All further samples which are being tested for the parameter of the respective Method will
be calculated by using this curve.
Curve-Data will be stored and used until a new calibration of the respective Method has been performed.

Caution
For information on re-calibration requirements, please refer
to the instructions of the respective manufacturer!
4.2.2.6 Calibration Verification:
In order to verify the calibration, the results for the Controls which have been processed during the calibration run
will now be calculated.
The measured OD values of the Controls for the respective methods will now be converted into concentration
values, according to the following formulas:
Endpoint Method:
ConcControl = (MeasODControl) * (Factor)
Kinetic, Initial Rate Method:
ConcControl = (DeltaODControl) * (Factor)
Immunoturbidimetric Tests:
The measured OD Values of the processed Controls will be transformed into concentration values, by laying the OD
value of the respective Control onto the calculated Standard curve of the calibrators:
Graph 4.7: Example for a Standard Curve
These results will then automatically be verified by DETect to be within the limits, which had been defined for
these Controls (see “ 4.2.2.2 Enter values for Calibrators and Controls” ).
68
4.2.2.7 Calibration Report:
Once the calibration process as defined has been completed, the calibration results will be displayed on the PC
screen:
Graph 4.8: Example for Calibration Result Screen
Column: Description:
TestID This is the ID which has been selected when defining the respective Method
Art This is the kind of method: whether Endpoint, Kinetic, Initial Rate or Immuno
Conc.Std This number represents the nominal Std Concentrations, as defined under
“4.2.2.2 Enter values for Calibrators and Controls”
OD blank Optical Density of reagent blank
Factor Calculated factor for the respective method (see 4.2.2.5)
OD C1-C3 measured Optical density of the control sera, tested along with calibrators
Res C1-C3 result of the control sera, tested along with calibrators
In case a Control Sera is out of the defined validity range, the respective method will be highlighted.
If any of the Control Sera is out of validation range, this might have several reasons.
- Perform the Weekly Maintenance Routine, as described in Chapter 7.2.2

- Repeat the calibration procedure
- In case the problem persists, please call the supplier of the instrument.
4.2.2.8 Print Calibration Report:
Within the Calibration Report Screen, click the “printer” button to get a report printed via the printer which is
connected to the PC, where DETect is installed.

Graph 4.9: Print Report
click for
printed
report
click for printed report
Graph 4.10: Example Printout
70
4.2.2.9 Calibration Data Storage and - Recall
All calibration data will be stored automatically on the hard drive of your PC.
The data sets can be distinguished by the date of the respective Calibration having been processed.
Calibration data can be recalled by opening the respective file using the menu FILE.
The software creates automatically a file every day called “default (DATE).rhi.
The datasets default 2005-xx-xx.rhi contains those data which the analyzer stores every time when the software is
shut down.
If you open for example default 2005-11-18.rhi the software will use the setup (calibration data/methods etc)
which have been used on 2005-11-18.

The actual file is indicated on the left top corner of the screen.
If you want to use that setup as your “default setup” just store this setup as follows:
File/Save as
Rename the file to: default.rhi and click SAVE
Please note that the software is starting up always with the default.rhi file!
72
Contents
5 System Routine Use 74

5.1 Introduction 74
5.2 Start up HumaStar 180 and DETect 74
5.3 Set-up System for Daily Routine 74
5.3.1 Load Cuvettes 74
5.3.2 Preparation of Liquids 76
5.3.3 Set up Patient-Worklist in DETect 77
5.3.4 Loading barcoded samples 80
5.4 Analysis of Loaded Samples 84
5.4.1 Start the Run 84
5.4.2 Test Process 85
5.4.3 Display Intermediate Results 85
5.4.4 Print Patient Report 90
5.4.5 Patient Data Storage and - Recall 91
5.4.6 Empty Tray 91
5.4.7 Patient Data Storage & Communication 91
5.4.8 Add Samples during run (Random Access) 92
5.4.9 Repeat Samples 94
5.4.10 Pausing / Stopping a Run 95
5.5 Additional Functions 96
5.5.1 Using the HT(date) .txt file 96
5.5.2 Display Kinetic-Curves of Measured Samples 97
5.6 Host Communication Settings (sending only) (RS 232 Protocol)Transport Layer 100
5.6.1 Protocol Layer 100
5.6.2 Standard Protocol 100
5.6.3 Reliable Protocol 100
5.7 Message Structure 100
5.7.1 Measured values 100
5.7.2 Version identification 100
5.7.3 System messages 100
5.8 Control Settings 101
5.8.1 Data 101
5.8.2 File 101
5.8.3 The results can also be transfered by FILE TRANSFER 101
5 System Routine Use
- Define Patient Samples
- Perform Daily Routine
5.1 Introduction
This Chapter gives exact description on how to set up and run HumaStar 180 and DETect for daily routine work.
5.2 Start up HumaStar 180 and DETect
5.2.1 Switching on the Instrument

Start “DETect” software package on your PC by clicking on the HumaStar 180-icon. During the start up procedure,
DETect will display the start up screen.
HumaStar 180 will automatically perform a full initialisation procedure. This initialisation procedure will be
performed every time DETect is being started.
During this initialisation procedure, the following steps will be performed:
- Initialise Z and X transport of pipettor probes

- Initialise both, reagent and cuvette carousel
- Initialise Photometer transport system
- Initialise syringes
- Power up temperature control of Cuvette Carousel and Measurement Street to 37°C
Caution
HumaStar 180 requires a warm up time of at least 15 minutes after power
up to allow the temperature control to warm up to the required
temperature!
Do NOT start any sample testing before these 15 minutes are completed!
If any of the initialisation cycles fails, an error message will be prompted to the user.
In case of an error during initialisation, please refer to the “Trouble Shooting” section of this manual or contact the
Supplier of the Instrument.
After the initialisation procedure has been completed, DETect is ready for all further steps.
Before a sample can be tested for any parameter, the respective methods must have been implemented in DETect,
as per Chapter 3.2.
5.3 Set-up System for Daily Routine
5.3.1 Load Cuvettes
Caution
Due to safer handling of samples and patient data, HUMAN
GmbH has decided to use disposable Cuvettes!
HumaStar 180 does not feature a cuvette washing station.
Do NOT wash and reuse Cuvettes!
Manually washing and reusing cuvettes may effect the
system to give wrong results and can cause mechanical
damage to the system!
74
Graph 5.1: Cuvette Block
Each Cuvette Block contains 4 Cuvettes,

for one test each.
Total loading volume: Cuvettes for 300
Tests
These Cuvette Blocks are unique and can
only be ordered from your local Human
Distrbutor:
Cat.-no. 16900/1 (200 blocks for 800
Reading Window tests)
Caution
NEVER touch the reading windows of the cuvettes!
Fingerprints and scratches might have bad influence
to the instrument performance!
Cuvettes are to be loaded into the outer carousel. The cuvette blocks are to be loaded manually. The cuvettes
should be taken from the transport box directly into the carousel.
The outer carousel can not be removed for loading.
Graph 5.2: Outer Carousel
The Outer Carousel features 75

Positions for Cuvette Blocks
Fill all positions in the outer carousel with new, unused cuvettes.
The instrument can be loaded with cuvette blocks for up to 300 tests for un-interrupted work.
Cuvette Loading Button
Press the “Cuvette Loading Button” to move the outer carousel clockwise for easier loading of all segments. The
Cuvette Loading Button is situated in the front right part of the instrument:
75 HumaStar 180 User Manual

Graph 5.3: Cuvette Loading Button
After all positions are loaded with cuvettes, proceed to the next step.
5.3.2 Preparation of Liquids
5.3.2.1 Remove the Inner Carousel from the Instrument:
The Inner Carousel can easily be removed for loading. Open the front door of HumaStar 180 and then remove the
Inner Carousel:
Graph 5.4: Inner Carousel removal
To remove the Inner Carousel,

hold the handle in the center of
the carousel and lift the carousel
carefully until it can easily be
unloaded from the instrument.
The different containers for reagents, controls, patient samples etc, are all to be loaded onto the Inner Carousel:

- 25 Positions for Reagents, marked as 1, 2...25
- 25 Positions for Primary Sample Tubes, marked as 1, 2...25
- 25 Positions for Serum Cups for:
- 10 Standards/ Calibrators marked as S1, S2...S10 (if less
or no Std/ Cal are used, these positions can be used for
additional Samples)
76
5.3.2.2 Analysis of Loaded Reagents
HumaStar 180 is able to handle a very common type of reagent bottles:
Graph 5.6: 50 ml reagent bottle
Empty bottles can be ordered

from your local Human
Distrbutor:
Cat.-no. 16900/2 (25 pcs)
In case your reagent kit manufacturer supplies the reagents filled in this bottle type already, load the Reagents for
the required parameters onto the Carousel.
If the original vessels are different to those 50ml bottles, please contact your local HUMAN distributor for a
possible adapter to fit the original vessels onto HumaStar 180.
If, for any reason, no adapter is available or can be provided, the reagents must be re-filled from the original vessel
into the 50ml bottles.
The correct position of the respective reagent are

defined in the Methods in DETect Software Package!
It is required to dedicate each of the reagent
positions of the carousel to one certain reagent and
permanently keep this position for further runs!
5.3.3 Set up Patient-Worklist in DETect
HumaStar 180 is able to process samples from either primary sample tubes, or from Serum Cups. Patient Samples,
however, must be pre-centrifuged, so that clean serum can be aspirated from the top.
The sample preparation should be completed before performing the following steps.
5.3.3.1 Start “New Sample” Menu
In DETect, select the New Sample Menu from the Action Menu Bar:
Graph 5.7: Menu Action Bar
After the “New Sample” button has been selected, the following menu will be displayed on the screen:

Graph 5.8: Add New Samples
This window and the respective dialog box will pop up automatically, for every single patient sample which is to be
added. Enter Patient data as required. The graph in the background gives a layout of the Sample & Control section
of the inner carousel.
5.3.3.2 Define Test Profiles (Panels)
In order to reduce the required steps and to prevent mistakes, Test Profiles can be defined.
These Profiles should contain those methods, which e.g. are mandatory for every patient sample which is being
tested in the respective laboratory.
The New Patient Dialog box automatically gives a full selection of all methods which are defined in DETect. In this
example, these are the methods which had been defined in Chapter 3.2.2 of this manual.
Graph 5.9: New Sample Dialog Box
To define a profile, select those methods, which

are to be within a profile.
Every method can be used multiple, in different

profiles.
After all methods for this profile have been

selected, click
“Save as Profile”
You will now be prompted to enter a name for this profile. Enter a name, e.g.: “Mandatory” and confirm with “OK”.
This new profile is now available from the “Profiles” List and can be selected for entering test data for new patient
samples.
78
5.3.3.3 Define Patient Data
After the Button “New Sample” from the Action Bar has been selected, the “Add new sample” Dialog Box will be
displayed:
Graph 5.10: Add New Samples Dialog Box
- This dialog will be displayed for every patient.

-
- Enter the Patient ID, the patient name as appropriate.
-
- Select whether the respective patient is female, male or a child.
-
- Select for which parameters the patient is to be tested by either ticking the single procedures, or by double
clicking the required profile
-
- Once all data for this patient have been entered, either click “>>Next” for further patients, or “Finished” if no
further patients are to be defined.
-
- This procedure will be repeated until the test panels for all patients have been defined, respectively as long as the
“>>Next” button is being selected.
-
- To program a number of samples having the same test/method selection the button “>>>Mult.” is be used
(Batch programming). This window will be displayed:
- Enter the number of samples requested and press OK.
- After the last patient has been entered and the “Finished” (“Cancel” if “>>>Mult.” was used) button has been
selected, the following screen will be displayed:

5.3.4 Loading barcoded samples
To enable the instrument to read the barcode a file must be created named “smpldata.bc” and need to be
transferred to the HumaStar 180 directory. The content of the file is as described at the end of this chapter “DATA
EXCHANGE”
Graph 5.11: Read barcode
After reading or typing the barcode of the sample this window will be shown.
The sample is assigned to the next empty position in the tray.
80
Graph 5.12: Sample Layout on Instrument
Reagent positions of the required chemistries are

displayed.
Yellow = Bottle type 1
Orange = Bottle type 2
Dark Orange = Bottle type 3
All sample positions are automatically defined by

DETect, as patients are being entered.
List of defined Patient names,
The positions correlate to the list at the left.
with respective position on carousel
DO NOT CLICK THE START BUTTON AT THIS TIME !!
5.3.4.1 Re-organise predefined Positions
If patient samples are not in primary tubes, but have been pipetted into serum cups, the layout must be changed.
This can easily be done by double clicking the respective position on the layout. This position will then be
highlighted:
Graph 5.13: Highlighted Position
Highlighted Position
Now select the new position, where this respective sample will be placed and double click on this position. The
sample will automatically be “transferred” to this new position.

Also, the sample list will be updated accordingly:
Graph 5.14: Sample Position Changed
New Position for Patient „Kent“
After all Positions have finally been defined for all patient samples to be tested, the sample tubes must now
physically be loaded onto the carousel.
5.3.4.2 Loading Patients Samples
Caution
Loading the Patient Samples into the Carousel
must be exact according to the layout defined.
82
During loading patient sample tubes, the layout screen must be displayed on the PC screen:
Graph 5.15: Patient Sample Layout screen
Place the Sample tubes and reagents

into exactly the positions as displayed
in the list and the layout screen !
Forgot Patient Data ?

- When double clicking a patient name in the Patient list, the information for this specific patient will be displayed
as an information:
Graph 5.16: Patient Data info
After all reagent bottles and sample tubes or serum cups have been loaded into the carousel, the carousel needs to
be replaced into the instrument.

5.3.4.3 Insert the Inner Carousel into the Instrument
Graph 5.17: Inserting Inner Carousel
To insert the Inner Carousel after

loading, the carousel must be placed so
that the
two red arrow markings
(one on the Carousel, one on the

Carousel compartment) fit perfectly
together.
After the Carousel has been inserted into the instrument, the analyzer can be started to test all the loaded patient
samples with the respective Methods.
5.4 Analysis of Loaded Samples
5.4.1 Start the Run
Caution
In order to prevent injury of the user during a run, the front door of the
instrument is fitted with a safety switch.
Before a run can be started, the front door of the Analyzer must be closed!
If the door is being opened during the analyzer is processing samples, the
instrument will immediately stop any operation.
The system will only continue after the door has been closed again.
To start the analysis of the loaded samples, the “Start” button has to be selected.
Graph 5.18: Start Button
Click Start Button to start analyzer
84
5.4.2 Test Process
Once the “Start” button has been selected, HumaStar 180 will automatically start the analysis procedure by
processing all defined steps for all loaded samples with the respective Methods.
DETect has a built-in, highly sophisticated dynamic scheduler.
This scheduler will automatically calculate the shortest procedure in order to finish the complete analysis of all
samples within the shortest possible time.
This means, that specific samples are not necessarily completed for all methods, before the next sample is being
processed.
Within DETect, all data for each sample will be stored. After one method for one patient sample has been finished,
the result can be displayed on the result screen.
5.4.3 Display Intermediate Results
In order to see results of patient analysis permanently online, as soon as a specific method for a sample has been
finished, click the “Results” button from the Action Menu Bar.
The following screen will be displayed:
Graph 5.19: Online display of Sample results

Column: Description:
Name Gives the Patient name, as entered under 5.3.3.3
PatID Gives the Patient ID, as entered under 5.3.3.3
Testname Name of the Method, that has been completed for this specific patient
Result (Range) Gives the result for this patient, for the respective parameter. The values displayed in brackets
stand for range of normal for this parameter, as defined within the method.
Units Units as defined for this method
RefTemp Temperature under which the test is valid
ODVal Measured OD Value of the Sample
FitVal Linearity compared to the optimum (1.00), for Kinetics only
It is possible to select the columns to be displayed by means of the menu “View-Result Column Chooser”
Graph 5.19 a
By means of the below window one can drag and drop each column header to the box or from the box to the
screen. Each column header can be moved to any position on the screen as required.
Graph 5.19 b
86
5.4.3.1 Erasing columns
Columns can also be erased directly from the screen.

Just make a mouse click with the left button on the column to erase and move the column to the top of the screen.
Graph 5.19 c
column to be erased.
The displayed results can be sorted (ascending, decending) by clicking on the different headers.
To reload a column to the screen:
- Open the menu view/result column chooser

- Klick on result column chooser.
Graph 5.19 d
i.e.: reload FIT Val:

Click on Fit Val and move the cursor to the position were you want to place the column.
Graph 5.19 e

Using the drag and drop function one can also sort the display by the header selected and placed into the field
“Drag a column header here to group that column” as shown in below examples.
Graph 5.19 f
Graph 5.19 g
88
Graph 5.19 h
Graph 5.19 i

5.4.4 Print Patient Report
Within the Sample Report Screen, click the “printer” button to get a report printed via the parallel or USB printer
which is connected to the PC where DETect is installed.
In case you want to print all results immediately as they show up you need to enable HST communication and
connect a serial printer to the second available serial port of the PC.
Graph 5.20: Print Report
click to print report
Graph 5.21: Example Printout
90
5.4.5 Patient Data Storage and - Recall
All Patient Data will be stored automatically on the Hard drive of your PC on the file “default(date).rhi”. If the
communication is set in instrument settings to “Enable Communication Host File” a file containing patient
information, results and measurement date is created. This file is named HT(date).TXT.
5.4.6 Empty Tray

After a run has been completed, all sample tubes need to be removed from the Sample Tray as well as from Detect.
To empty the “Software Tray” after a completed run, click the “Empty Tray” – Button in Detect:
Graph 5.22: Empty Tray
Button „Empty Tray“
5.4.7 Patient Data Storage & Communication
PLEASE NOTE: Detect is not intended to act as a patient database.
Patient data will be stored in Detect under the Screen “View Results”, until being deleted. To delete Patient data,
click the “Delete Patient Data” – button:
Graph 5.23: Delete Patient Data
Button „Delete Patient Data“
Detect is prepared to communicate with external Lab-PC packages in two ways. Both Functions must be enabled or
disabled in the instrument settings submenu, please contact your HUMAN partner for further details.

Active Communication: In case this setting is enabled, all patient results will automatically be sent via RS232 /
com Port 2 to another PC.
Passive Communication: In case this setting is enabled, all patient results will automatically be stored in a text file,
which can be located in the same directory as Detect is. These text files can be sent /
copied to any other PC and their contents be imported into any other application
(e.g. EXCEL).
5.4.8 Add Samples during run (Random Access)

5.4.8.1 Add Emergency patients during run (STAT Access)
HumaStar 180 is a Random Access Analyzer. New Samples or Emergency Samples can be added at any time. The
routine is the same for both, emergency samples or standard samples.
Emergency samples will be processed immediately after the run has been re-started.
The instrument does not need to be interrupted, all will be done automatically!
Please exactly follow these steps ! samples are to be added in the software first, only then the system will interrupt
the run and give access to insert the new samples into the tray physically.
If, during a run, one or more new samples need to be added, simply click the “New Sample” button from the Action
menu:
Button “ New Sample”
92
This window and the respective dialog box will pop up automatically, for every single patient sample which is to be
added.
Graph 5.25: Add New Samples
For every Sample the following must be defined:
Patient ID: Sample ID – number, can be scanned from the primary tube by an optional Barcode scanner
Patient Name: Enter the full Patient name
Predilution: Select whether or not the sample should be pre-diluted before processing. If selected, the
pipetted sample specimen will be reduced by 50% to the defined nominal volume for the
respective methods.
Emergency patient: Select whether or not this Patient is an Emergency patient (STAT).
After all new Samples have been entered, select “finished”
Now, the tray with all the new Samples will be displayed. For changing positions, please proceed as described
under 5.3.4.1
In case of Emergency patients, these will automatically be placed in positions C2 and 25.
If more than 2 Emergency patients are to be processed, you must finish the sample enter – process, re-position the
emergency patients away from C2 and 25 and then re-enter the “New Sample” procedure.
The samples on the tray are displayed in three different colours:
- Samples that are under process are in red colour

- Samples that are already completed are in blue colour
- New added samples, that have not yet been scheduled are in green colour.
Graph 5.26
In order to take over the new samples into the actual run, press the “Start” Button.
Now the system will finish the actual step and then automatically pause the actual run, so that the new samples
can be physically added:

Graph 5.27
This message will be displayed until the actual step is finished. During that time, the system will complete any
running process (like pipetting a reagent or a sample etc).
As soon as the system is ready to interrupt the actual run for taking new samples, the following message will be
displayed:
Graph 5.28
The door lock will now be released. Load the new samples onto the defined positions on the tray. After all samples
are loaded, press “OK” and “Continue”
As soon as this is completed, all newly added samples are being taken into the scheduled run, and the run will be
re-scheduled.
If new samples need to be added, this can be done at any time again.
5.4.9 Repeat Samples
Automatic repeat:
If a sample for any tested method has exceeded the linearity limit or the limit for used up substrate (see Method
definition), the specific sample will be repeated automatically with the specific method.
The sample will be repeated up to two times, with two different dilutions:
1st repeat: Same Reagent volume as defined, 50% of the defined sample volume
2nd repeat: Double Reagent volume as defined, 50% of the defined sample volume
If during Add Sample procedure already “Predilution” had been defined for the respective sample, then only 2nd
repeat will apply!
After the run is finished, all results of each sample will be displayed in the results screen.
94
The little square at the very left of each result shows, what the status of this specific result is:
Graph 5.29
Result status
M Manually Repeated
S Result exceeded limit of used up substrate and was repeated
L Result exceeded linearity limit and was repeated
Rpt 1 This is the first repetition of this sample for this test
Rpt 2 This is the second repetition of this sample for this test
INVALID is reported in case a result can not be calculated (air bubble inside cuvette) or below the value of
the lowest standard (multipoint measurement only).
Manual repeat:
If one or more samples need to be repeated for a specific method, this is to be done as follows.
A manual repeat can be defined at any time, either during or after a run. It must be assured that the respective
sample vial is still in the tray and in exactly the same position as it was during the original process. After “Empty
Tray” has been selected, samples can only be repeated by defining them completely new.
In the results screen, select the result that needs to be repeated so that it is highlighted, then click the RIGHT
mouse key:
Graph 5.30
When selecting “Repeat test” this sample will automatically be repeated with the respective method.
5.4.10 Pausing / Stopping a Run
If, for whatever reason, a run must be paused or completely stopped, press the “Pause”-Button:
Graph 5.31
Button “ Pause”
Now the system will finish the actual step and then automatically pause the actual run, so that the new samples
can be physically added:
This message will be displayed until the actual step is finished. During that time, the system will complete any
running process (like pipetting a reagent or a sample etc).

Graph 5. 323
As soon as the system is ready to interrupt the actual run, the following message will be displayed:
Graph 5.33
Now the system is safe, the door-lock will be released.
Please note: During the system is paused, nothing will be lost, provided that at the end of the required pause
period, the operator presses the “Continue” button.
There might be cuvettes in the photometer for kinetic reading. The reading will be finished in the background
during the pause period.
As soon as the operator selects “Continue” the actual run will be continued.
As soon as the operator selects “Stop”, the actual run will be completely interrupted and all pipetted cuvettes will
be disposed.
5.5 Additional Functions
5.5.1 Using the HT(date) .txt file
- This function requires Microsoft Excel to be installed on your PC !
On the installation CD you can find a file called HTFile.xls.
If the communication is set in instrument settings to “Enable Communication Host File” a file containing patient
information, results and measurement date is created. This file is named HT(date).TXT and can be opened by
means of the little program HTFile.xls in EXCEL. You can sort the results using EXCEL and generate any kind of
report.
96
Graph 5.34
5.5.2 Display Kinetic-Curves of Measured Samples
Capture Kinetic Curve Data:
Detect in its standard set-up would not safe kinetic curve data of Samples and Controls, but only those of
measured Standards (during calibration).
Kinetic Curves for Standards can be viewed as described in Chapter 4.2.2.7
In order to display kinetic curves of measured samples and controls, please follow these instructions.
- This function requires Microsoft Excel to be installed on your PC!

- This function requires changes in the windows registry of the PC, that is connected to HumaStar 180. Please
contact your local HUMAN-partner, who will be able to provide you with the required registry-files
“KinCurvON.reg” and “KinCurvOFF.reg”
As soon as “Record Kinetic Curves” has been activated, Detect will store a Microsoft Excel™ file for each measured
sample and control in the directory of Detect:

Graph of Windows Explorer, directory of “HumaStar 180”:
Graph 5.35
The filenames are automatically generated by Detect and determine where the data are originated. e.g.:
Curve_ALT(Control1)_04.07.2003-19.51.csv
This stands for

- Curve of Control 1
- Method ALT
- Measured on July 4th, 2003 at 19:51 (= 7:51 p.m.)
By means of the little program “CSVFile.xls” supplied on the CD one can open an EXCEL worksheet and import the
curve file required.
Graph 5.36
In order to view a reaction curve, do the following:
1. In EXCEL, double click on IMPORT and select the *.csv - file you would like to see the curve of.
2. Microsoft Excel™ will automatically open and display the below information including the curve:
98
Graph 5.37
time of measured value in calculated correlation of measured points

“seconds after starting measurement” to Linear Regression of all measured points
Raw OD value of specimen at respective time calculated DeltaOD/min

5.6 Host Communication Settings (sending only) (RS 232 Protocol)Transport Layer
Transport Media: RS232
Baudrate: 9600
Parity: N (one)
Databits: 8
Stopbits: 1
PC Hosttype interface (null modem cable required)
5.6.1 Protocol Layer
Protocol selection can be defined in the instruments settings menu. Rev.1 will support Standard Protocol
only unless otherwise noted.
5.6.2 Standard Protocol
Each data block will be sent with a trailing CR (carriage return, 0x0D, 13d) code. This ensures the most
simple readout even by means of a terminal program. No handshake and no start character is used.
Example:
0001;Jean Luc Picard;GGT;1.2mg/dl [CR]
5.6.3 Reliable Protocol
Each data block is prefixed with an STX (start of text, 0x02, 2d) character, trailing checksum (2bytes hex
code) and finished with a ETX (end of text, 0x03, 3d) character.
To create the checksum start with the first character after the STX to the last character in front of the
checksum and sum up all byte values in a byte. Then build the ascii representation of this byte and append
it to the data block.
Example:
[0x02]0002;Janeway;GGT;0.9mg/dl3A[0x03]
where 3A would be the checksum (sample figure only, not real calculated)
5.7 Message Structure

5.7.1 Measured values
Each measured method per sample leads to following message:
[ID-Sample];[Name of sample];[Testshortname];[result or error string]
ID-Sample, Name of sample: as defined in “new sample” dialog
Testshortname: shortname of method as defined in methodsettings
Result or error string: textual representation of the result/error
5.7.2 Version identification
After powerup and software startup the device will send following message:
Humastar 180;Version;V01.00.00;final release build
Humastar 180: indicates that a system message is received
Version: indicates that the system message is a version information
V01.00.00 is the actual software version
“final release build” is an comment which indicates useful service information
5.7.3 System messages
Depending of the version of the software additional system codes can be sent. Every system message is
prefixed with above declared “Humastar 180” and a second parameter specifying the type of message.
These messages are subject to change and not needed for the normal operation of the instrument.
100
5.8 Control Settings
Invocation of host communication exclusively from the Humastar 180. In the settings menu is an option to
turn communication on/off and to select protocol.
After the Humastar 180 is powered on and the software is started a string with the current version number
of the software is sent (following current protocol settings, see above).
5.8.1 Data
For each Patient and Parameter one set of datas is required. Each line must contain the following:
• Patient ID
• Patient Name
• Test Name
• Typ (0..male, 1..female, 2..child)
• Predilution (0..no Predilution, 1..Predilution)
• Trayposition (-1..automatic positioning, 0-49..Traypositionen 1-50)
Each field is seperated by a Tabulator.
5.8.2 File
• The name of the file has to be smpldata.rem.
• For use of barcode reader the file must be named smpldata.bc
• Each line is seperated by „Carriage Return“ and „Line Feed“.
• The way it works is File transfer to the hard disk.
Example:
3 Hofer Sabine gamma GT 1 0 1
3 Hofer Sabine Uric Acid 1 0 1
5 Maier Franz Cholesterin 0 0 1
5 Maier Franz Glucose 0 0 1
5 Maier Franz Triglycerides 0 0 -1
9 Schmid Maria Cholesterin 1 0 1
10 Muller Hans Cholesterin 0 0 -1
10 Muller Hans Glucose 0 0 -1
10 Muller Hans gamma GT 0 0 -1
11 Huber Max Cholesterin 0 0 -1
15 Muster Wolfgang Cholesterin 0 0 -1
5.8.3 The results can also be transfered by FILE TRANSFER

The name of the file has to be HT (date).TXT
Example:
5 Maier Franz Cholesterin 230.000000mg/dl 14.05.03,09:51:02
5 Maier Franz Glucose 11.000000 mg/dl 14.05.03,09:51:03
3 Hofer Sabine Uric Acid 6.600000 mg/dl 14.05.03,09:51:05
3 Hofer Sabine gamma GT 66.000000 U/l 14.05.03,09:51:06
10 Müller Hans Cholesterin 250.000000mg/dl 14.05.03,09:51:07
10 Müller Hans Glucose 90.000000 mg/dl 14.05.03,09:51:08
10 Müller Hans gamma GT 65.000000 U/l 14.05.03,09:51:10
15 Muster Wolfgang Cholesterin 210.000000mg/dl 14.05.03,09:52:07
5 Maier Franz Triglycerides 170.000000mg/dl 14.05.03,09:53:04
11 Huber Max Cholesterin 150.000000mg/dl 14.05.03,09:53:07
9 Schmid Maria Cholesterin 120.000000mg/dl 14.05.03,09:54:07

102
Contents
6 Quality Management 104

6.2 QC Principal 104
6.2.1 Data Acquisition 104
6.2.2 Data Reduction 105
6.2.3 QC Data Storage and Recall 105
6 Quality Management
- Recording QC Data
6.1 Introduction
This Chapter gives information on the Quality Management System of HumaStar 180.
6.2 QC Principal
6.2.1 Data Acquisition
Data, which are required for QC approval of the complete system are being acquired every time a method is being
calibrated.
Note:
Acquisition, calculation and storage of QC Data is done fully
automatically, each time a Calibration of a method is being performed.
No manual steps are to be performed by the user!
When a calibration is performed on a method defined in DETect, there will always Controls be processed along
with the calibrators. Please check Chapter 4 to get more information on calibration runs.
As Controls are being processed, the results of these controls are being compared with the nominal values, resp. to
be within the upper and lower limits, as per the package insert of the reagent kit.
These nominal values and the limits have been defined in DETect when calibrating a method:
Graph 6.1: Nominal Value definition in DETect
Note: field “blocked” are not defined in the method to use controls
104
6.2.2 Data Reduction
The data for the controls for a method, acquired during a calibration, are being plotted in a graph, compared
against nominal value of the respective control in standard deviation.
Every time a calibration is being made, new values for the controls for this parameter are being added to the graph.
Control status will be plotted into a Levey Jennings Chart by the 12s and 13s rule. These rules are defined as follows:
12s refers to the control rule that is commonly used with a Levey-Jennings chart when the control limits are
set as the mean plus/minus 2s. In many laboratories, this rule is used to reject a run when a single control
measurement exceeds a 2s control limit.
13s corresponds to a Levey-Jennings chart having control limits set as the mean plus/minus 3s. An analytical
run is rejected when a single control measurement exceeds a 3s control limit.
The 12s rule is very commonly used today, and while it provides high error detection, the use of 2s control limits
gives an expected high level of false rejections. The 13s rule provides an alternative QC procedure that has lower
false rejections, but also lower error detection.
6.2.3 QC Data Storage and Recall
The data for the controls for each method will automatically be stored on the PC Hard drive.
To recall QC Data, click the “Quality Management” button in the Action Menu Bar of DETect:
Quality Management: View track of control readings

After the “Quality Management” button has been selected, you will be requested to select the method and the
time period of the results of interest:
Graph 6.4: Data selection screen
Select the method of interest. As soon as the selected method is highlighted, the Control section will display the
available controls. Select which control of the selected method should be displayed.
A separate track is recorded for every single control of every single method.
There can always be only one control of one method displayed.
After the respective control has been selected, press either “Show last 30 days” or “show All Data” and the Levey
Jennings Graph for the respective Control will be displayed:
106
Any of the control results can be disabled by simply clicking on it and the selecting “Toggle Calc State”.
As soon as “Toggle Calc State” has been selected, the graph will be re-calculated:
e.g.: Result 3 has been disabled
On your PC hard disc you will find the QC data in a sub-folder called “qcdata”.
This sub-folder is within the Main folder from which you started detect.exe from.
The subfolder qcdata contents all the data from the calibration as well as the limits for the control serum used
(parameter specific).
By using an editor software you now can re-arrange the data within your file.
Just open the .dat files with the editor.
(For example to make corrections after known interferences during calibration.)
The .dat file indicates: date/limit low/limit high/control value measured.
With the editor you can change or delete values. After doing so just save the file.
If you now open the quality management menu in DETect, you get a new Levey Jenning graph.

108
Contents
7 Maintenance 110
7.2 Maintenance Routines 110
7.2.1 Daily Maintenance 110
7.2.2 Weekly Maintenance 111
7.2.3 Periodical Maintenance 111
7.3 Replacement of Worn Parts 114
7.3.1 Syringe pumps 114
7.4 List of Replacement Parts 117
7.5 List of Disposables required 117
7 Maintenance
- Daily Maintenance
- Weekly Maintenance
- Periodical Maintenance
- Replacement of Disposables
7.1 Introduction
This Chapter gives information and instructions on how to maintain the complete system regularly, in order to
achieve maximum life time.
Also, this chapter gives instructions on how to replace disposables such as tubings and syringes, which might or do
come into contact with contaminated sample material.
7.2 Maintenance Routines
Note:
The following Maintenance instructions are essential in order to maximise

operational functionality and to minimise downtimes and cost for service.
7.2.1 Daily Maintenance
Even though, the system is being flushed every time a sample or a reagent is being pipetted during operation, an
additional rinsing step should be performed after each working day.
For this daily rinsing procedure, no special fluids are required.
Make sure, that the system liquid bottle is properly filled with xx ml de-ionised or distilled water containingwith
1000μl Cleaning AgentWash Additive (available your local Human Distrbutor:HUMAN GmbH, Cat.-no. 18971)
In DETect, from the software menu select “Daily Cleaning”
Graph 7.1: Daily Cleaning
Once this menu has been selected, both the reagent and the sample probes will be moved into the respective
washing stations automatically and the instrument will perform a thorough flush of the complete liquid path for
both channels, with system liquid.
After the process is finished, both probes will be moved into their home position (top).
The instrument can now be switched off.
110
7.2.2 Weekly Maintenance
Once a week the system should be flushed with a detergent or in extreme cases with an active solution of cleaning
agent.
For this maintenance routine, use a standard reagent bottle and fill it with 2-5% hHypochlorite solution.
Warning: Corrosive!
C Protect hands and eyes, avoid contact with skin, eyes and mucuous membranes.
May develop toxic gases in contact with acidic solutions!
(R-Phrases: 31-34;
S-Phrases: 26-36/37/39-45).
Refer to material safety data sheet from supplier
Graph 7.2: Reagent bottle
Empty Bottles can be ordered from your local

Human Distributor:HUMAN GmbH
Cat.-no. 16900/2 (25 pcs)
In DETect, from the software main menu select “Instrument” and then “Special Cleaning”:
Graph 7.3: Instrument Menu
Once this menu has been selected, DETect will prompt the user to insert the bottle with special cleaning agent into
a certain position in the reagent carousel.
After this bottle has been placed correctly, confirm by selecting the “OK” button.
HumaStar 180 will now automatically perform a thorough cleaning program for both pipetting probes. After the
process is finished, a daily maintenance routine according to 7.2.1 should be performed.
7.2.3 Periodical Maintenance
7.2.3.1 Cleaning of Probe Washing Station
In addition to daily and weekly maintenance, the probe - washing station should be cleaned at least every
3 months.

Graph 7.4: Probe Washing Station
For this maintenance routine, use a standard reagent bottle and fill it with 2 – 5% Hypochlorite or Sodium
hydroxide solution.
The washing station should be cleaned properly inside as well as outside.
7.2.3.2 Maintenance of Syringe pumps
Graph 7.5: Syringe Pumps
Dispense Tubing
Aspiration Tubing
Valve
Plunger
Syringe
Plunger drive
During normal operation, the syringe pumps only come into contact with system liquid, which is a mixture of xx ml
de-ionised or distilled water containing with 1000 μl Wash AdditiveCleaning Agent (HUMAN GmbH, Cat.-no.
18971) and this way are working under optimum conditions.
The syringe pumps normally will not require additional maintenance attention, however, you should iInspect the
pumps for visual leaks.
In case the instrument has been left to stand without operation for a longer period of time, the system should be
flushed according to “Daily Maintenance” as per 7.2.1 for at least 3 times.
7.2.3.3 Maintenance of Photometer Street
Even though the photometer street is covered by a semi-transparent, acrylic plate, the path might get dusty after
some time. For this reason, the reading path should be cleaned every three months by using a dust free cloth and
some weak detergent (window cleaner).
Before cleaning, the acrylic cover must be removed from the photometer street:
112
Graph 7.6: Remove acrylic cover from photometer street
Grab the acrylic cover

and slide it towards
the right end of the
instrument, until it
can be completely
removed
With a dust free cloth, which should be moistened with a weak detergent (window cleaner) gently wipe through
the complete photometer street.
Afterwards, use a clean, dry dust free cloth and wipe dry the complete photometer street.
Finally, replace the acrylic cover onto the photometer street by sliding it into the respective space. The cover must
go underneath the side window of the housing.
The cover should be slid into place gently, do not use force to replace the cover!
Graph 7.7: Acrylic cover in place:

7.3 Replacement of Worn Parts
7.3.1 Syringe pumps
There will be parts which require regular replacement as they become worn due to heavy use. These are tubings,
syringe seals, and valve. If they become worn, you will most likely face one or more the following symptoms:
- Poor precision and accuracy

- Variable or moving air gap
- Leakage
These problems may be caused by either
- Input and Output Tubing fitting loose

- Plunger Seal worn
- Valve worn
As per the manufacturer of these syringe pumps, the frequency of replacement will depend on the duty cycle, fluids
used, and instrument maintenance.
The following parts can be replaced by the user:
- Plunger Seals
- Valves
- Syringes
The following parts can not be replaced by the user and require an authorised technician:
- Input tubing
- Output tubing
7.3.1.1 Replacement of Syringes
Syringes:
16910 Sample Syringe 250 μl

16910/1 Reagent Syringe 1000 μl
Caution
Even though under normal operation this should not be the case,
Syringes might still be contaminated!
Before replacing one of the syringes, make sure to wear lab gloves!
Graph 7.8: Syringe Pump
Dispense Tubing
Aspiration Tubing
Valve
Plunger
Syringe
Plunger drive
Self aligning ball
114
To replace one of the syringes, proceed as follows:
Tools required: Plier
Removal:
- Always remove only one syringe at a time

- Remove all liquid from the syringe by pulling the tubing out of the system liquid bottle, and then
running one or max. two priming cycles (as described under 7.2.1)
- Lower the Plunger drive manually, by firmly pushing down on the carriage assembly
- Unscrew the syringe from the valve:
- use the pliers on the syringe fitting (upper end, metal ring) and turn it anti-clockwise, until it can
be turned manually
- turn the ring anti-clockwise manually, until the syringe is free from the valve
- remove syringe and plunger together, carefully
- Dispose the old and defective syringe to hazardous waste.
Replacement:
Caution
The instrument uses two syringes, of different size which must be
replaced by exactly the same type:
- 250 μl for Sample (left syringe) 16910
- 1.0 ml for Reagent (right syringe) 16910/1
Failure in doing so will cause the instrument to pipet wrong volumes
and furthermore will give wrong analysis results.
- Take the new syringe out of it’s original box

- The plunger drive should still be in lowest position
- Place the self-aligning ball into the respective space in the plunger drive
- Pull up the syringe barrel and screw the fitting into the valve unit, until it is finger tight
- Using pliers on the fitting, turn the syringe fitting clockwise for an additional quarter turn
- Make sure, the syringe is securely screwed into the valve
7.3.1.2 Replacement of Syringe Seals
Syringe Seals:
16910/2 Syringe Seal, 250 μl (set of 4)

16910/3 Syringe Seal, 1.0 ml (set of 4)
To replace one of the syringe seals, proceed as follows:
Tools required: single edged razor or precision knife
Removal:
- Always only remove only one syringe at a time

- Remove the respective syringe from the pump, as described in 7.3.1.1
- Remove the Syringe Plunger from the syringe
- Using a single edge razor or a precision knife, carefully slice the old seal lengthwise and remove it from
the plunger

Care must be taken not to damage the plunger or O-Ring beneath the seal !
Graph 7.9: Plunger
Sharp Raised Edge
Teflon Syringe Seal
O-Ring
Table Edge
Replacement:
- Wet the O-ring and the plunger tip with distilled or deionised water
- Place the new Syringe seal onto a flat surface, with the open end facing up
- Press the plunger tip firmly into the hole until it snaps into position
- Lay the plunger on a flat table top and position it, so that the seal (from the O-ring up) hangs over the
table edge (see graph 7.7 above)
- Slowly roll the plunger along the table edge, pressing firmly on the portion of the seal below the O-ring.
- Rotate the plunger for 3 complete turns. This is necessary to make the sharp raised edge of the plunger
bite into the seal for a secure fit
- Wet the seal with distilled or deionised water and replace the plunger into the syringe carefully
- Replace the syringe into the pump, as described under 7.3.1.1
7.3.1.3 Replacement of Syringe Valve
16910/4 Syringe Valve
To replace one of the syringe seals, proceed as follows:
Tools required: Philips screw driver, size 1
Removal:
- Always only remove only one syringe and valve at a time

- Remove the respective syringe from the pump, as described in 7.3.1.1
- Remove the tubings from the syringe valve
- Remove the two mounting screws from the syringe valve
- Remove the valve from the pump
Graph 7.10: Syringe Valve
Mounting Screws
Valve Coupler Fitting
Front View Rear View
116
Replacement:
- Install the valve by placing it in the front panel of the pump

- The valve coupler fitting must be in the correct position
- The valve will slide in to position gently and requires no pressure to be put on
- NOT USE FORCE TO REPLACE THE VALVE
- place the mounting screws, tighten ¼ to ½ turn after the screws contact the valve body.
- NOT TIGHTEN THE SCREWS MORE THAN THIS
7.4 List of Replacement Parts
Part Number Part Name
16910 Sample Syringe 250 μl
16910/1 Reagent Syringe 1000μl
16910/2 Syringe Seal, 250 μl (set of 4)
16910/3 Syringe Seal, 1.0 ml (set of 4)
16910/4 Syringe Valve
16910/5 Inlet Tubing Kit, Sample/Reagent Syringe
16910/8 Outlet Tubing Kit Sample/Reagent Syringe
7.5 List of Disposables required
Part Number Part Name
16900/1 Cuvette Block (pack of 200 blocks for 800 tests)
16900/2 Reagent bottles 50ml (pack of 25)
16900/3 Reagent bottles 10 ml (pack of 25)
16900/4 Adapter for 10 ml bottles (1 pcs.)
16900/5 Adapter primary tubes / 12,5 mm
16900/6 Adapter Reagent bottle 20 ml
16900/7 Adapter for 4ml Reagent Tubes / 12 mm
16900/8 Reagent bottles 20ml (Pack of 25)
16904 Serum Cups 1.5 ml with cap (500 pcs.)
18971 4 x 25 ml Cleaning AgentWash Additive,, concentrated (for

system liquid)

118
Contents
8 Features 120
9 Installation 120
10 Start the software 121
11 Field definition 124
11.1 Logo 124
11.2 Labels and Variable Fields 124
11.3 Results field 125
HumaStar 180 REPORTEDITOR
8 Features
This new additional software for the HumaStar 180 is adding the capability to provide customized reports for the
user.
One can display and print results, method settings, calibration curves, QC reports. The distributor can create this
report individual for each customer.
If no report is designed the software will use the standard settings for the reports provided that the file
PRINTLOGE.BMP is installed with the HumaStar 180 software.
9 Installation
Note: this new feature requires the HumaStar 180 software version 1791 or higher.
Copy the files provided to the same directory as the HumaStar 180 software is already installed in.
The files required are:
- ReportEditorxxxx.exe
- Printlogo.bmp
- calibration.rpt
- calibration_immuno.rpt
- calibration_kinetic.rpt
- dmethod_endpoint.rpt
- dmethod_immuno.rpt
- dmethod_initialrate.rpt
- dmethod_intermethod.rpt
- dmethod_kinetic.rpt
- dmethod_mpir.rpt
- method_endpoint.rpt
- method_immuno.rpt
- method_initialrate.rpt
- method_intermethod.rpt
- method_kinetic.rpt
- method_mpir.rpt
- qc_lj.rpt
Note: the customized reports are only used if installed into the same directory as the HumaStar 180 software.
Note: do not change the file names
Note: if you have to install the HumaStar 180 software first delete the registry entry “SETTING” as described
below.
Click on the WINDOWS™ START button.

From the opened window select RUN.
Enter into the command line of the small RUN window REGEDIT and press ENTER.
Locate in the registry file displayed the directory:
\HKEY\CURRENT_USER\Software\BCG App Wizard-Generated Applications\Rhino
Select the subdirectory SETTING and delete it.
120
10 Start the software
Create a shortcut on the Windows desktop for the “ReportEditorxxxx.exe”, see Windows User Handbook for
details.
Double click on the icon to start the software. The following window will be displayed.
Main window
Graph 10.1
On the left a list of available functions is show, on the right side the pre-defined files are listed. To make any
change select the desired file from the list at the right.
There are two kind of reports
- Reports to be printed
- Reports to be displayed
Each report can be defined different in layout and format.

Example:
Patient report
Graph 10.2
Laboratory name,
defined in the registry - personalization
Logo
Patient information Result area
Each report has defined fields you can use to print data from the software. To get a list of information available
create a field in the respective report as described below.
a) Add a “Variable Field” to an empty space (e.g. Result area).

b) Open the new field by double click.
c) Enter the field text “debugshowall” and confirm with OK
122
Graph 10.3
d) Save the change to the report using SAVE.

e) From the HumaStar 180 result screen print a single report.
f) In this report you see now the list of available information for the patient report.
Graph 10.4

g) Add the required field to the title, e.g. Patient ID.: “patid”.
h) The title must be defined in a “Label” field.
i) Each information field must be defined in a “Variable Field”.
j) The logo is placed in a “Image” field.
11 Field definition
For each single field one can define the font, size, justification, box, lines as shown in below example.
11.1 Logo
Graph 11.1
11.2 Labels and Variable Fields
Graph 11.2
124
11.3 Results field
Graph 11.3
One can add/delete fields from the list, edit field size, select a border and/or dividers around the fields. Also the
used measurement size can be selected.
In addition to the above one can add boxes, ellipses and lines to “pep-up” the report graphically, also one can use
several logo’s in one report.
After any change is done save the new design and check it in the HumaStar 180 software.
A little tip: to make the positioning of fields more easy one can activate the “GRID” and “SNAP ON GRID”. The
page layout can be also selected using “Page Properties”.

126
APPENDIX
Trouble Shooting Guide
SYMPTOM CAUSES AND REMEDIES
Analyzer does not turn On - check power supply cord if inserted

- check fuse
- check voltage input
- Make sure that the PC is ON
- Make sure to Turn ON first the analyzer and only after that the PC.
- Check for the correct serial connection port.
Program does not load - Turn OFF the PC

- Wait 10 sec and turn ON again
Printer does not turn ON - Make sure that the power cord is plugged in
- Make sure it is connected to the PC
- Check ON/OFF switch
Printer does not print Patient Reports or - Make sure the printer is On Line
other print-outs
Tubing leading to the two Needles are - Check system liquid container, it may be empty
empty - Leak or torn tubing – check – change tubing if necessary
- Leaking syringe – check and change piston if necessary
- Make sure that all tubing is full of wash solution and
- there are no air bubbles in the system.
Air bubbles in the tubing leading to the - Torn tubing – replace

Needles - Check connections of the tubing
- Leaking Syringe – replace
- Check syringe
- Check valve
Photometer does not read - try to read on another wavelength
Diluter Module stops - clean syringe with a good laboratory detergent

- change the whole syringe
Diluter does not aspirate or dispense - squeezed or torn syringe tubing

- loose or badly connected needle
- blocked needle – clean
- Wash solution container empty – check
Syringe has difficulty in filling or - Make sure there is Wash Solution in the container.
emptying - Check for leaking piston or blocked tubing
- Remove syringe and clean them
- Check valve
Results are not reproducible - Dirty reaction cuvettes.

- Reagent volume in cuvette too small. Make sure there is at least a
minimum of 200 μl.
- Checking Reagent Blank
- Check sample and reagent volumes
- Badly connected needles or torn tubing – check
- Dirty Sample needle – clean
- Dirty or old system liquid – prepare fresh
- Make sure that the Liquid Level Sensor works properly
- Verify for correct washing
- Check the lower end of the needle, it may be broken
127 HumaStar 180 Trouble Shooting Guide

Serum controls not within expected - All the above
range - Check units used
- Check controls for expiration date and correct lot number
- Check method, it may have been inadvertently reprogrammed
- Make sure that method conforms with reagent suppliers
specifications
- Make sure the controls are not deteriorated
- Re-assay by an alternative system, method or different reagent
- If substrates – recommend to re-standardise analyzer using fresh
primary standards or calibrators
- Make sure the factors used are correct
- Make sure that the values of expected range are for the method
used on this analyzer.
Syringe leaks - Check piston

- Check piston tip
- Check the OUT- tubing for blockage
- Make sure the needle is not blocked
- Change Syringe and piston
Air bubbles inside the syringe - Make sure the piston is tight and there are no leaks
- Make sure that the system liquid is correctly prepared and has
WAD 18971 in it. ( 300μl per litre of dist. Water)
- Make sure that the INLET connection into the syringe is tight
Samples are being contaminated - Reagent and/ or Sample needle is badly connected or leaking
- Missing system liquid or old, dirty or contaminated wash solution
– prepare fresh.
- Make sure that the needles are washed properly
The sample Level Sensor sometimes does - Check the needle adjustment
not work properly – flags “no sample” – - Check the Level Sensor connection
but there is sample in the cup
Reagent Level Sensor sometimes does not - The same as above for the Sample
work properly – flags “ no Reagent” – but
there is reagent in the container
Needles sometimes miss the entrance to - Make sure that the needles are perfectly straight. Bent probes will
their proper places produce errors of that type
Analyzer stops and software requires re- - Check the connection to the PC
start - Reagent needle was touching the bottom of the reagent bottle
- A cuvette block was jammed between incubator and photometer
DURING OPERATION DO NOT - Change or cancel methods

- Do not change values of standards or calibrators
- Do not change control values – the Analyzer may go into Error and
STOP
- Add cuvette blocks – only if the software ask for
- Modify the DATE and TIME of the PC – the Analyzer may STOP
- Add reagent or sample – always PAUSE the analyzer first
128
HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
| Max-Planck-Ring 21 · 65205 Wiesbaden · Germany
| Tel.: +49 61 22/99 88-0 · Fax: +49 61 22/99 88-100
| e-Mail: human@human.de · www.human.de

Service Manual Humastar180

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HumaStar 180

3 INTENDED USE OF THE INSTRUMENT [IVD]

4 GENERAL SAFETY WARNINGS

PLEASE READ THIS MANUAL CAREFULLY BEFORE CONNECTING THE INSTRUMENT TO

If you need further assistance, please contact your HUMAN Instruments

About this Manual

Gives helpful information

Indicates a possibility of instrument damage or data loss

if instructions are not followed.

Indicates the possibility of severe personal injury, loss of

life or equipment damage if the instructions are not

0 Chapter User Safety 2

0.2.2 Liquid Hazards

0.2.3 Electrical Hazards

0.3 Safety Precautions

0.3.1 Mains Power Connection

Mains Power Serial USB Port Liquid RS 232 Port

Graph 0A.2: Mains Power Compartment

Mains Power Connector

Mains Fuse Compartment

In case of any problems or uncertainties, consult technical assistance through

0.3.2 During Operation

3/3 Human HumaStar 180 User Manual

Front Door Handle Power On LED

0.4 Instrument Disinfection

It is advisable to wear gloves when performing the measurement

0.4.1 Disinfection Solutions

0.4.2 Disinfection Procedure

1. Wear protective gloves, protective glasses and protective clothing.

4. Disconnect the instrument from the mains power supply.

7. After a minimum contact time of 10 minutes, repeat step 6 of this procedure.

9. Wipe dry the outer surfaces of the instrument.

10. Pack the instrument and its accessories.

5/5 Human HumaStar 180 User Manual

- Characteristics, Specifications & Performance

Access Modes: - Random Access

Processing Modes: - Patient by Patient

Analysis Modes: - Endpoint (Substrates)

Throughput: - 180 Tests/hr under speed-optimised conditions

Carousel: - 25 reagent positions

Liquid Handling: - 2 independent Syringes: Sample: 3-250μl in 1μl steps

Measurement System: - Maintenance Free!

Power Requirements: - 85-264 VAC, 50/60 Hz (autodetecting)

Measures: - Dimensions ( W x D x H):

Environmental: - Operation: 18...35°C, 10-90% rel. Hum.

Disposables: - Cuvette block for 4 tests each

Method of Disposal: - Contaminated Waste

9 Human HumaStar 180 User Manual

1.4.1 Process Management

- Washing the probes

1.4.2 Liquid Handling

Z M ove m en t V a lve P o sitio n s:

1 System Liquid Bottle 6 Probe w. liquid detection 11 Wash Station

1.4.2.1 Pipetting Cycle

11 Human HumaStar 180 User Manual

- Pick up source liquid

- Pipette liquid into target container

- Pipette liquid into target container

- Move probe in X direction to home (Wash station)

Multi Pipetting (Reagent only)

- Pick up source liquid

- Pipette liquid into target container

- Move probe to home (Wash station)