EQ-27 - Manual-Ace-Elite-Pro PDF

INSTRUMENTATION LABORATORY
ACL ELITE* / ELITE PRO System
Training Modules
PN 722277 Rev. BB (November 2010)

Beckman Coulter, Inc.
Miami Education Center
Miami Lakes, FL 33014
* ACL Elite, HemosIL, and AccuTrak are registered Trademarks of Instrumentation Laboratories
ii of vi
WARNINGS AND PRECAUTIONS
READ ALL PRODUCT MANUALS AND CONSULT WITH BECKMAN COULTER-TRAINED PERSONNEL BEFORE
ATTEMPTING TO OPERATE THE INSTRUMENT. DO NOT ATTEMPT TO PERFORM ANY PROCEDURE
BEFORE CAREFULLY READING ALL INSTRUCTIONS. ALWAYS FOLLOW PRODUCT LABELING AND
MANUFACTURER’S RECOMMENDATIONS. IF IN DOUBT AS TO HOW TO PROCEED IN ANY SITUATION,
CONTACT YOUR BECKMAN COULTER REPRESENTATIVE.
HAZARDS AND OPERATIONAL PRECAUTIONS AND LIMITATIONS
WARNINGS, CAUTIONS and IMPORTANTS alert you as follows:

WARNING – Can cause injury.
CAUTION – Can cause damage to the instrument.
IMPORTANT – Can cause misleading results.
BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND
SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT
LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING
OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER.
WARNING Risk of operator injury if:

• All doors, covers and panels are not closed and secured in place prior to and during instrument operation.
• The integrity of safety interlocks and sensors is compromised.
• Instrument alarms and error messages are not acknowledged and acted upon.
• You contact moving parts.
• You mishandle broke parts.
• Doors, covers and panels are not opened, closed, removed and/or replaced with care.
• Improper tools are used for troubleshooting.
To avoid injury:
• Keep doors, covers and panels closed and secured in place while the instrument is in use.
• Take full advantage of the safety features of the instrument. Do not defeat safety interlocks and sensors.
• Acknowledge and act upon instrument alarms and error messages.
• Keep away from moving parts.
• Report any broken parts to your Beckman Coulter Representative.
• Open/remove and close/replace doors, covers and panels with care.
• Use the proper tools for troubleshooting.
CAUTION: System integrity might be compromised and operational failures might occur if:
• This equipment is used in a manner other than specified. Operate the instrument as instructed in the Product
Manuals.
• You introduce software that is not authorized by Beckman Coulter into your computer. Only operate your
system’s computer with software authorized by Beckman Coulter.
• You install software that is not an original copyrighted version. Only use software that is an original
copyrighted version to prevent virus contamination.
IMPORTANT
If you purchased this product from anyone other than Beckman Coulter or an authorized Beckman Coulter distributor,
and, if it is not presently under a Beckman Coulter service maintenance agreement, Beckman Coulter cannot
guarantee that the product is fitted with the most current mandatory engineering revisions or that you will receive the
most current information bulletins concerning the product. If you purchased this product from a third party and would
like further information concerning this topic, call your Beckman Coulter Representative.
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PN 626394A (December 2003)
iv of vi
REVISION STATUS
Revision A December 2005
Revision B August 2006
Revision BA August 2009
Software release 3.0.5, Library 1.15
Revision BB November 2010
Software release 3.01.04, Library 02.00.00
PN 722277BB (December 2010) v of vi

vi of vi PN 722277BB (December 2010)
IL ACL ELITE/ELITE PRO
COURSE GUIDE
TABLE OF CONTENTS
ACL ELITE / ELITE PRO Course Map…………………3
Group Discussions……...……………………………….5
Reminders……………………………...………………..…5
How Course Works…………………….…………………6-7
Course Modules
Additional Information
PN 722277BB (December 2010) Page 1of 8

Page 2 of 8 PN 722277BB (December 2010)
COURSE MAP
IL ACL ELITE/ELITE PRO – SYSTEM TRAINING
T
Training
ADVANCED TOPICS
ELECTIVE TOPICS
MS SSA
FA AT NL
Mixing Setup
Factor AccuTrak New Lot
Studies Security Access
Assay
CCI HEP
CT UT
Clot Curve Heparin
Copy Test Utility
Interpretation Assay
REQUIRED TOPICS
ES LD TS
Enable Liquid Definition Troubleshooting
INR
Setup
DD
SS MLT D-Dimer
Setup Multi-Test RT
Setup Reflex
Testing
SA3
SA2 Sample
Sample SQC Analysis
Setting up QC
RR
Analysis Replace
Rotors
SA1 RQC2
Sample Analysis M Running QC RWE
Maintenance Replace Wash R
Emulsion
RQC1 CAL
Running QC Calibration
R-PT Fib
RecombiPlasTin
IB RI &
Instrument Basics Reagent Clauss Fibrinogen
Insert
PREREQUISITE TOPICS
PR
Prerequisite
PN 722277BB (November 2010) Page 3 of 8
PERSONAL PROGRESS SUMMARY
Name__________________
Prerequisite Topics Date Achieved Sign-Off Apps
PR Prerequisite ___________ _______ _____
Required Topics
RI Reagent Insert ___________ _______ _____
IB Instrument Basics ___________ _______ _____
RQC1 Running Quality Control ___________ _______ _____
SA1 Sample Analysis 1 ___________ _______ _____
SS System Setup ___________ _______ _____
ES Enable/Disable ___________ _______ _____
LD Liquid Definition ___________ _______ _____
MLT Multi-Test Setup ___________ _______ _____
SQC Setup Quality Control ___________ _______ _____
M Maintenance ___________ _______ _____
CAL Calibrate: R-PT, R-FIB_ FIB-C ___________ _______ _____
RQC2 Running Quality Control ___________ _______ _____
DD D-Dimer ___________ _______ _____
TS Troubleshooting ___________ _______ _____
RWE Replace Wash R Emulsion ___________ _______ _____
RR Replace Rotor ___________ _______ _____
RT Reflex Testing ___________ _______ _____
INR INR Setup ___________ _______ _____
Elective Topics
CT Copy Test ___________ _______ _____
HEP ** Heparin Assay ___________ _______ _____
FA ** Factor Assay ___________ _______ _____
UT Utility ___________ _______ _____
MS Mixing Studies ___________ _______ _____
SSA Setup Security Access ___________ _______ _____
CCI Clot Curve Interpretation ___________ _______ _____
AT AccuTrak ___________ _______ _____
NL New Lot ___________ _______ _____
Advanced Topics
T Training ___________ _______ _____
Page 4 of 8 PN 722277BB (November 2010)

GROUP DISCUSSIONS
The following discussions take place in the discussion room (except for the time
in the Customer Cafe).
Monday
• Customer Cafe– General Education Center Information
• Learn about classmates
• Safety: Personal Protective Equipment and Fire Evacuation
• Introduction to the course and materials
• Location of additional reference materials
Tuesday
• Discussion: Software overview
Wednesday
• Discussion: Clot Curve Presentation
Thursday
• Last Day Course Evaluations
• Graduation
REMINDERS
Scheduled two fifteen minute breaks, one in the morning and one in the
afternoon.
Schedule dependent, lunch is between 45-60 minutes.
Cleanup at the end of the day (about 10 minutes before leaving for the day).
Daily answering any questions, make any announcements.
PN 722277BB (December 2010) Page 5 of 8

HOW COURSE WORKS

This course is probably unlike any previous training, unless you have taken a
criterion-referenced course before. What is criterion-referenced instruction?
Criterion-referenced instruction is a self-paced learning with pre-specified
performance criteria, Skill Checks verify achievement.
Learners select the module, based on the course map provided, modules provide
information and guidance. The learner may practice the skill until they feel
confident. A Skill Check measures achieved stated objectives.
The main features of training are:
• You do not relearn something already known
• You do not learn topics unnecessary to your job (However, make the best use
of your time while you are here so that what you do is most beneficial for you
and your lab.)
• You work at your own pace
• You practice a skill until confidence is achieved
Let’s look at the makeup of this course
Course Map
The course map shows how each module of the course relates to other modules
and to the course as a whole. It is a blueprint of the course, start at the bottom and
work your way up.
• Before beginning to study a module, complete all prerequisites for that
module (i.e., all modules shown by arrows that lead into your chosen module).
• Where no sequence is shown (i.e., there are no arrows leading into a module),
you are free to study the modules in any order you please.
• Completing Prerequisite Topics and Required Topics for your instrument
configuration, ensures mastering the basic course requirements.
• Choosing Elective Topics based on your particular training needs and time
remaining.
There is ample time to complete all the required topics as well as some or all
of the Elective Topics.

Modules
• Read the Objectives at the beginning of a new module.
• Complete the Skill Check for the module if you already know the task.
(Note: read the module for understanding the terminology used or procedural
surprises.)
• Read the module and complete the practice exercises for the new material
presented in the module. Refer to additional resources provided for the
module.
• Work through each module at your own pace. This is not a race.
• Some modules require you to work with a partner.
Resources
• Each module lists the resources available to complete the topic.
• Consult any resource that is appropriate to your needs. You may use some or
all of the resources.
• A Facilitator is always available to answer any questions you may have.
• Additional resources are available for your reference use. Your facilitator will
show you where these are located. Feel free to refer to them at any time during
the week.
• Some modules require you to work with a colleague or have a colleague
review your work against a checklist.
• Each module has a criterion test called a Skill Check. Complete the Skill
Check when you feel ready. To save yourself time, first make sure you can
answer “yes” to these questions:
Did I practice the skill(s) called for in the objective?
Did I get a colleague sign-off the module? (if applicable)
• If, after reading the module you feel ready to complete the Skill Check
without further study, do so.
• Skill Check performance is inadequate, you may be asked to complete a
duplicate or similar Skill Check.
• Completing a Skill Check, the facilitator checks your work and signs your
progress summary.
Personal Progress Summary

Ask your course facilitator to certify your module completion, by dating and
initialing your Personal Progress Summary.
Master Progress Chart

Facilitators use a Master Progress Chart for tracking class progress. Entries on
the Master Progress Chart mark module completion.
PN 722277BB (December 2010) Page 7 of 8


RI ACL ELITE/ELITE PRO
REAGENT / CALIBRATOR INSERT REVIEW
Objective
Given product inserts for any HemosIL Reagent and the Performance Guide
Skill Checks provided in this module, you will:
• Identify Reagent/Calibration preparation procedures
• Identify Reagent/Calibration storage, handling and stability claims on a
reagent insert
• Locate and identify the ISI for a PT reagent
• Locate and identify the calibration target values
• Identify limitations/interfering substances for specific reagents
• Identify test linearity ranges
NOTE: Your Facilitator will provide reagent inserts for this module.
Module Resources
• ACL ELITE / ELITE PRO System Training Module
• ACL ELITE / ELITE PRO Operator’s Manual, Chapter 4, Section 4.1.12
• HemosIL Reagent and Calibration Package Inserts
P/N 722277BB (December 2010) RI 1 of 6

ACL ELITE/ELITE PRO
Reagent Insert Review
Introduction
Every box of reagent comes with a reagent insert that explains the details of the
reagent. These details include, but may not be limited to, the following:
Insert Section Description
1. Intended Use Basic statement of what the reagent/calibrator test is used
for.
2. Summary and Detailed description of the reagent/calibration. Theory and
Principle methodology of the test and disease states in which
performing the test may be indicated.
3. Composition Detailed description of each reagent/calibration, how it is
supplied in the kit, and precautions and warnings
4. Preparation Instructions on how to prepare and handle each
reagent/calibration in the kit.
5. Reagent Storage and Instructions on storage throughout the reagent/calibration
Stability use. If a reagent requires a stir bar, it will be stated in this
section.
6. Instrument/Test Specific procedure relating to the assay. Usually referred
Procedures back to the individual instrument’s operator’s manual.
7. Specimen Collection Specific instructions relating to the assay, usually referred
and Preparation back to CLSI (formerly NCCLS).
8. Additional Reagents Contains a list of all reagents and/or controls that are not
and Control Plasmas included in the kit and must be purchased separately.
9. Quality Control Quality control statement and which controls are
recommended for the assay
10. Results Units in which the assay is reported.
11. Limitations/Interfering A list and concentrations of the most common interfering
Substances substance specific to the test.
12. Expected Values Normal range study information includes a description of
the method of data collection for each.
13. Performance Includes control precision, control range, and correlation
Characteristics data as well as a description of the method of data collection
for each. May contain additional information specific to the
test such as cut-off values.
14. Linearity When applicable, states assay/instrument linearity
information as well as how to treat a sample result which is
outside of the linear range.
15. Additional May include any additional test specific information such as
Information heparin therapeutic ranges.
RI 2 of 6 P/N 722277BB (December 2010)

ACL ELITE/ELITE PRO
Sample of a Reagent Insert
1 8
3
10
11
15
12
13
6
16
7
NOTE: Linearity (14) is not applicable to the Thrombin Time Test

ACL ELITE/ELITE PRO
RI

ACL ELITE/ELITE PRO
Performance Guide
Step Action
1 Obtain HemosIL reagent package inserts, from your facilitator.
2 Complete the Skill Check.

ACL ELITE/ELITE PRO
SKILL CHECK
1. Describe the preparation instructions for the PT reagent used in class
(RecombiPlastin-R2G)?
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
2. How long is this PT reagent (RecombiPlastin-R2G) stable on the ACL Elite/ElitePro?

_______________________________________________________________
3. What is the ISI for this PT reagent? __________ Where is the value found?
_____________________________________________________________________
4. What are the Limitations/Interfering Substances? What are the units of measure for
the Limitations/Interfering Substances?
________________________________ ________________
________________________________ ________________
________________________________ ________________
________________________________ ________________
5. What is the calibration target value for the D-Dimer reagent? _____________
Where is the value found?
______________________________________________________________
6. What is the linearity of the D-Dimer test?

______________________________________
7. Identify recommendation for a D-Dimer test exceeding linearity?

_________________________________________________
_____________________________________________________________________
8. What is the target value for the PT based Fibrinogen for this instrument and the
reagent used in class? (RecombiPlastin-R2G) ________
Where is the value found? _________________________
Sign Off
Instructor

IB IL ACL ELITE/ELITE PRO
INSTRUMENT BASICS
OBJECTIVES
Given an ACL ELITE/ELITE PRO workstation, the Operators Manual, Training

Manual and Quick Reference Guide you will:
• Locate the Working Area

• Navigate Menus and Sub-menus
• Identify the Status Area on the instrument
• Identify different Instrument Icons and their meanings
• Locate, Navigate and Review the functions of each of the Work Areas,
Toolbars and Message Box Icons
MODULE RESOURCES

• ACL ELITE / ELITE PRO Operator’s Manual, Chapter 3
• ACL ELITE / ELITE PRO Quick Reference Guide, Components/Icons/Colors
PN 722277BB (December 2010) IB 1 of 14

SOFTWARE TREE
ANALYSIS QC CALIBRATION DIAGNOSTIC SETUP UTILITY
Multi Test Session

Calibrate Tests ► Upgrade IL Library
Single Test Session
Review Calibration Multi-Test ► Backup / Restore
Loadlist
Analytical Reference Liquids Archive
Session History
Interfaces ► Software ►
System Configuration Save Rotor Map
Security Save Trace
Audible Alarms Test / Material ►
QC Priming Date / Time Debug (dimmed)
Setup / Review Cleaning Units Testing (dimmed)
Maintenance
Temperature Control
Needles Position
Session Error History View / Define SW Identification
File Error History Sort Test SW Upgrade ►
Logbook Interference Table
Service (dimmed) Default Tests
Reflex Tests
Software Upgrade
SW Master ►
SW Slave►
Profiles SW REM►
Test Groups
Test Group Profiles
Sort Multi-Tests Backup
Default Multi-Test Upload
Upload
Upgrade
Host
Printer
Internal Barcode
External Barcode
Keyboard
Network (dimmed)
Modem (dimmed)
IB 2 of 14 PN 722277BB (December 2010)

POWER ON AND LOG ON TO THE SYSTEM
Power On the ACL ELITE / ELITE System. The power switch is on the left
backside of the instrument. Move the switch to the “|” position. Wait for Login
and Password screen.
Classroom use only: The Login User Name is: Lab Manager, and The
Password is: level 3. (lower case)
Press Confirm to login.
User Name
Lab Manager
Password
level 3
Confirm
OPERATOR INTERACTIONS
The operator interacts with the ACL ELITE / ELITE PRO System through the
working area drop down menus and their sub-menu screens. Data input and
information retrieval uses windows and dialogue (message) boxes. Information
and instructions are entered into the system via a touch screen a standard PC
keyboard or a mouse.
How To Use the Touchscreen
• The touchscreen is used to select menu items and enter numeric data.
• Touch any area to be edited. Any dimmed object (menu, check box or button)
is currently disabled and not available at that time.
• If numeric entry is enabled, a numerical keypad may open on the screen.
Default or previously entered values will appear on the display.
• Editing functions are closed by selecting Confirm Cancel or
by touching another area of the screen.
• The eraser end of a pencil works well in place of your finger to make
selections on the touchscreen.

How To Use the Keyboard
• The standard USA PC keyboard may be used in place of the touch screen to
make menu selections and enter data. It is required for entry of alphanumeric
data.
• Move the cursor on screen by pressing TAB to move forward or SHIFT-TAB
to move backwards. To close editing functions and save changes, press
ENTER or select another field.
• The ESC key closes the editing function without accepting the changes. Pre-
existing values will remain.
• Main and secondary menus may be selected using the keyboard. The menus
are opened by pressing ALT + underlined letter. Select from the menu list
using the arrow keys and then press ENTER.
• The keyboard function keys (F1-F10) are used to activate the functions on the
bottom row of icons. Use Ctrl + F4 for keyboard Log off.
How To Use the Mouse
• A serial mouse is used as a selecting or pointing device, replacing the touch

screen. The USB port is the connectivity to a USB mouse to the analyzer.
• The mouse is used as a selecting device, replacing the use of the touch screen.
Note: If the USB mouse is ever disconnected the system must be

rebooted for mouse recognition and operational.

ACL ELITE/ELITE PRO SYSTEM DATABASE SCREEN
Key Screens Elements: Below are descriptions of the most significant items found within
the ACL ELITE / ELITE PRO screen.
Instrument
Status Numerical value
patients in Database
All 25 / 25
Working
Area
Toolbar
Area

Instrument Status
The Status area is at the top of the LCD screen. The current date and time are
displayed on the right and instrument status messages are displayed on the left.
Instrument Status includes:
¾ INIT (BOOT/START-UP): indicates that the instrument is performing
startup operations (Initializing).
¾ READY: indicates that there have been no errors detected, there are no
analytical operations in progress and the instrument is ready to start.
¾ OPERATING: indicates that either an analytical function is in progress
(i.e. calibration or sample analysis) or a diagnostic function is being
performed.
¾ HOLD: identifies a system "pause" reached during an analytical session
(i.e. STAT request, no rotors, etc.).
¾ FAILURE: indicates that the system has detected a malfunction of
internal mechanisms (devices, temperature control, etc.).
¾ STAND-BY: the status into which the instrument moves automatically
after 30 minutes of inactivity, the screen will darken.

Screen Icons
Window Icons Command / Action
Confirm
Cancel (dimmed if Edit action not

allowed)
Print
i ti
(Host) Transmit
Delete
d l t i
Add to the list
Remove an item from the list
Transfer an item from one list to

another
Details
Information in different languages
New Sample
Extract Sample Data
ti
Note
Patient Name
Patient Details
Save information to floppy disk

Toolbar Icons
Toolbar Icons Commands / Instrument Status

Actions (Icon active)
Short Turn Around Time Operating
(STAT)/(PAUSE) - Hold
Urgent sample Pressing
this button opens a window
that guides the operator.
Confirmation is required
Instrument Status Operating

Informs the operator about Hold
the status of the operation
in progress
Close/Open cover Ready

This operation is disabled Hold
if there is a possible
interference with the
instrument operation
Ready
STOP Operating
Confirmation is required Hold
Resume
Start or resume a run. Hold
Starts the operations
paused due to a STAT
request
Data Base View Ready
The system goes back to Operating
the database view or Hold
“Main” screen
Host Status Ready

This icon appears only Operating
during communication with Hold
h tdi
the Host to inform the Failure
operator about the status
of this action.
Warning Ready
This icon appears when Operating
there is at least one Hold
warning. Press to open Failure
“Warning List”.
Log Out Ready
Allows the operator to Failure
exit the screen.
Confirmation is required

Icon Meaning
QUALITY CONTROL: Indicates there are data (results) in
the database.
QUALITY CONTROL: Indicates a failure in a quality

control test result.
REAGENT VIAL ICON: Indicates the status of the reagent

map. (Warning No reagent).

map. (Warning reagent low).

map. (Sufficient reagent).
ERROR. To call attention to high priority failures and fault

messages.
WARNING. To deliver different kinds of messages, i.e. to

warn the user of a “not allowed/wrong” operation, or of
problems/errors detected by the instrument during or after an
operation.
QUESTION. To request confirmation by the user before
starting an operation or before canceling an action
INFORMATION. To offer general information. In some

boxes, but not always, the message is followed by a request
for confirmation.

Material Status Colors

Color Status Letter / Symbol Status
Empty or
STAT
Available
Not
Pending
Programmed
Programmed Complete
Not
Processing
Programmed
Sample
Complete
Processing
Quality
Pending
Control
Warning or Low
Errors Volume
Empty Cup in Sample not

Position Identified
Empty

Materials Map
Reagent Loading – The Materials map displays a graphical representation of liquid positions on
the instrument. The map displayed above represents an ACL Elite PRO only. An ACL Elite
does not have positions R9-R12. The External Barcode Reader (optional hardware) can be
used to load liquid reagents in the displayed materials map, or reagents are placed by selecting
the icons Reset Volume and Start Timer. This is an optional operation defined by the user.
The materials map screen displays the status of liquids currently onboard, with the following
colored circle positions:
Green – Volume of liquid position is greater than the warning limit, stability is OK
Orange – Volume of liquid position is less than the warning limit or the onboard or lot number
stability has expired.
Red – Instrument detects a shortage of liquid in the position.
NOTE: Select Start / Resume a run. The materials map is not checked by the instrument
sample arm liquid sensor for volume status. Always check the status of the reagents before
starting a run, physically and color indication and make appropriate adjustments. The colors
displayed are only visual alerts. The analysis proceeds regardless of color of the reagent position.
Performance Guide
In the Interface/External Barcode setup menu user defines the following options:
Reset Timer and / or Reset Reagent Volume when scanned. The pause timer
enabled will override the use of the reset options when reagents are scanned.
Ensure Pause Timer box is not enabled
Step Action
1 Load Reagents reconstituted and provided by facilitator
2 From the drop down menu select Analysis
3 Select Multi-Test Session
4 Select Materials Map icon
5 Using the External Barcode Scanner, scan barcode label on reagent

bottle, load reagent in flashing position on the materials map
The message “Unknown lot number and expiration date” indicates

6 that the liquid details are incorrect in the software. Select Liquid
Details icon to correct for current lot number and expiration date
7 Complete the Skill Check using the workstation, the quick reference
guide and/or the Instrument Basic Module reading

SKILL CHECK
Name the following Icons and their function(s):
Window Icons Command
i ti
d l t i

Sign Off
Instructor

RQC1 IL ACL ELITE/ELITE PRO
QUALITY CONTROL
OBJECTIVES

• Run HemosIL Normal Assayed, Low Fibrinogen Assayed and High

Abnormal Assayed Controls for the following tests on the ACL ELITE /
ELITE PRO:
− R-PT
− R-FIB_
− APTTSYS
MODULE RESOURCES

• ACL ELITE / ELITE PRO Operator’s Manual, Chapter 3, Section 3.2
• ACL ELITE / ELITE PRO Quick Reference Guide, Quality Control
PN 722277BB (December 2010) RQC1 1 of 4

Running Quality Controls on IL ACL ELITE / ELITE PRO
Performance Guide: Analyze Quality Control
Step Action
From the Working Area, Select Analysis, then select Multi-Test

Session and choose Routine
Main
Menu
1
Multi Test Session
Single Test Session
Loadlist
Session History
2 Select Loadlist No. icon.
3 Enter 20 into the loadlist number field.
4 Press Enter on Keyboard
Label 2.0 mL cups and place QC on the sample tray in the order
indicated.
To ensure controls are in the proper

5 order. Touch each position in the map
to identify the control (loadlist 20:
places QC levels in positions 1-3)
Select Materials Map icon and ensure that all materials, are in
the assigned position.
6 Use the external barcode reader to scan in your reagents displayed in
map. If an error message appears identifying the scanned liquid as an
“unknown lot number and expiration date” update the Liquid Details: lot
number, expiration date and onboard stability.
On ACL ELITE, rotors must be manually loaded from the rotor stack
storage area into the loading/analysis area. Press the rotor snap to properly
Note: seat and remove the rotor. A message will display “ROTOR EXCHANGE
NEEDED” load a new rotor and confirm.
7
Select Start or Run icon
RQC1 2 of 4 PN 722277BB (December 2010)
Review Daily QC Results
Step Action
Select the QC icon.

1 Note: If any QC results are out of range, the QC icon will include
a red alert (!) and an audible alarm will sound
2 Select the QC icon to review QC results. The results are all

listed on this list as soon as they become completed.
Print
Today QC
Cumulative
Print All
QC
Levey
Jennings
3 Within range results are displayed in black, out of range results ±2SD
are displayed in blue and outside of the ±3SD are displayed in red
To print your daily quality control runs, select the Print Today QC
4 icon. To print all QC in the QC list, select the Print All QC icon.
This list should be cleared daily, results are still visible in each QC file
5 To review a specific result and its accompanying QC file, place the

cursor on the result and press the Cumulative Results icon.
6 To view a Levey Jennings chart for a control, select the Plot and
Statistics icon.
7 Review and select Confirm

The Skill Check Consists of Showing Your Facilitator the

Printed QC results from the QC List Screen.
Sign Off
Instructor

SA1 ACL ELITE/ELITE PRO
SAMPLE ANALYSIS
OBJECTIVES

Manual, and Quick Reference Guide, you will:
• Analyze barcoded samples
MODULE RESOURCES

• ACL ELITE / ELITE PRO Quick Reference Guide, Process
Samples
PN 722277BB (December 2010) SA1 1 of 2

ACL ELITE/ELITE PRO
Sample Analysis: Barcoded Samples, Host Simulated

Performance Guide
Step Action
1 Place tubes onto the sample tray. Ensure caps are removed and barcodes
are facing outward
2
From the Database View Screen, select Start
On ACL ELITE, rotors must be manually loaded. The instrument will prompt the user to load a new rotor.
Message displays ROTOR EXCHANGE NEEDED. Depress the rotor snap located in the center of the rotor
loading/analysis area to properly seat the rotor upon removal/replacement.
The Skill Check consists of showing printouts of the

results to Your Facilitator. Be prepared to discuss any
errors printed on these samples. What type of report did
your instrument printout?
Sign Off
Instructor
SA1 2 of 2 PN 722277BB (December 2010)

SAMPLE ANALYSIS 2
OBJECTIVES

Manual and Quick Reference Guide, you will:
• Analyze Samples using the following modes of analysis:

− Sample ID - Barcode Samples or Cups with No Host Communication
− Manual Entry using Loadlist
− Manual Entry to create a Loadlist from samples in the Database
MODULE RESOURCES
• IL ACL ELITE / ELITE PRO Training Manual

• IL ACL ELITE / ELITE PRO Operators Manual, Chapter 3
• IL ACL ELITE / ELITE PRO Quick Reference Guide: Pre-run Checklist,
Process Samples, and Components/Icons/Colors

ACL ELITE/ELITE PRO
Sample Analysis – Barcoded Specimens - No Host Connection

Performance Guide:
Step Action
1 Load sample tubes with or without barcodes and sample cups on the sample
tray (Ensure that bar-coded tubes are oriented with the barcodes facing outward)
2 Select Analysis
Select Multi-Test Session
Note: The Multi-Test selected dictates what tests can be ordered and drives what
3 liquids are required on the instrument. Selecting a Multi-Test does not
automatically order any test. If a sample loaded has a test ordered that is not
within the Multi-Test selected, the sample status will remain “pending”
(designated with a “P” in the status column)
4 Use ‘▼’from the sub menu to select Routine
Select Read Bar Codes icon Sample tray will rotate, barcode reader
5 reads any barcoded specimens while the tube/cup sensor detects presence of
samples on tray
Samples without barcode labels will generate the following message:
Warning: Error in Sample Identification

6
OK
(Acknowledge the message by selecting OK)
7 Select the quadrant that contains the unidentified sample (s)

Select the first non-identified sample (yellow circle with a ?)
?
8 Use Program Sample icon to identify the selected unidentified sample.

Complete the Patient Demographics and order Test(s)

ACL ELITE/ELITE PRO
Step Action
9 Select Confirm
10 Follow steps 6-8 to update any additional unidentified sample(s) to be analyzed
To request identical Test(s) from the previous sample identified, select the
11 Previous Program icon. If test(s) requested for the sample differ,
select Test(s) from the enable test list
12 Select Confirm
13 Continue until all samples are programmed
Select the Materials Map icon and confirm the following:

• All reagents are on board and in the correct position
• All lot numbers are correct and volumes updated
14
• All reagents have ample time- onboard stability
• Rotors and Wash-R-Emulsion are available
Note: RED-warning for low volume, unable to proceed. ORANGE-warning for
reagents volume or onboard stabilty
15
Select Start icon
Note: A sample with an *(asterix or snowflake)on the database screen indicates the test for that
sample has been repeated by the user
On ACL ELITE, rotors must be manually loaded. The instrument will prompt the user to load
a new rotor. Message displays ROTOR EXCHANGE NEEDED. Depress the rotor snap
located in the center of the rotor loading/analysis area to properly seat the rotor upon
removal/replacement.

ACL ELITE/ELITE PRO
Sample Analysis – Manual Sample ID Entry- Using a Loadlist
Create a Loadlist
Step Action
1 Select Analysis
2 Select Multi-Test or Single Test
3 Select a Quadrant on the sample tray Quadrant
Click on any available position (gray color).

4
Select ADD QC icon to add QC
5 Select Program Sample icon to enter first sample ID
6 Enter QC level or patient’s demographic information as per your protocols and

select the Test(s) to be run
The tray positions display in dark blue with the letter P (pending) for sample,
QC for quality control liquids and N (not programmed) for samples with no
tests identified
8 To add additonal samples select the New Sample icon from the Database
View screen and repeat steps 5 and 6
Select the Store Loadlist icon. Enter a loadlist number (1-20)

9
Select Confirm icon
10 Load all samples in the sample tray, confirm the materials map, and select the
Start icon

ACL ELITE/ELITE PRO
Create a Loadlist-Samples pending within the Database
Step Action
1 Select Analysis
2 Select Loadlist
3 Select Make a Loadlist, Select the number you want to assign to the new
Loadlist
4 Select Mark Pending (located bottom center of screen)
5 Select Sample ID from List. A 9 appears left of selected Sample ID
6 Continue until all samples are identified for the loadlist
7 Select Confirm icon
8 A message will appear that 1 Loadlist was created regardless of the number
assigned to Loadlist from step 3
Using a Loadlist
Step Action
From the Working Area, select Analysis, select Multi-Test Session, then select
Routine
Working
area
1
Multi Test Session

Single Test Session
Loadlist
Session History
2 Select Loadlist No. icon
3 Created loadlist number is entered into number field. Load all samples in the
sample tray, confirm the materials map, and select Start icon

ACL ELITE/ELITE PRO
Skill Check
1. Barcode Reader detects the presence of a cup or a tube in the sample tray.
True False
(Do not forget the sensor)
2. What causes a materials map position to turn Red? Orange?

Red-________________________________________________________
Orange-______________________________________________________
3. How many loadlists can be stored? ________
4. What would be some advantages of using the loadlist configuration?

_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
5 When would manual entry be beneficial?

_______________________________________________________________
Sign Off
Instructor

SS ACL ELITE/ELITE PRO
SYSTEM SETUP
OBJECTIVES
Given an ACL ELITE/ELITE PRO workstation, the Operators Manual, Training Manual,
Quick Reference Guide, and an installed printer you will:
• Perform the Setup for the following:

− System Configuration
− Interfaces
− Keyboard
− Internal Barcode Reader
− External Barcode Reader
− Printer
− Host
− Audible Alarms
− Setup Date/Time
MODULE RESOURCES
• ACL ELITE / ELITE PRO Training Module

• ACL ELITE / ELITE PRO Quick Reference Guide, Components/Icons/Colors
PN 722277BB (December 2010) SS 1 of 10

ACL ELITE/ELITE PRO
Setup System Configuration and Interfaces
Performance Guide:
Step Action
From main menu drop down, Select Setup

Main
1 Menu
Tests
Multi-Tests
Liquids
Interfaces
2 Select System Configuration System Configuration
Security
Audible Alarms
Date/Time
Units
In System Configuration, define the Patient Database Listing

• Using the drop down arrow ▼ the choices are:
Last entered is at the top
3 Last entered is at the end
By Sample ID order Ascending
By Sample ID order Descending
Select Last entered is at the top:
Define the QC/AR Database Listing (Note: AR-Analytical Reference not used in
USA/Canada)
4 • Using the drop down arrow ▼ the choices are:
Last entered is at the top
Last entered is at the end
Select Last entered is at the top
Define your Reflex Status
• Using the drop down arrow ▼the choices are:
5 Program reflex Only –reflex test will show as pending
Execute reflex before closing session
Disable
Select Execute Reflex Before Closing Session
Ensure all Sensors are enabled by placing an (x) in each box for:
6 • Liquid
• Wash-R Emulsion
• REM Enable (HW Enable) (Only on the ACL ELITE PRO)
SS 2 of 10 PN 722277BB (December 2010)

ACL ELITE/ELITE PRO
Step Action
7 Current Language English Or Select the drop down ▼ box to change the language
of your choice
Default Screen
8 Database view
Multi-Tests Pre-Analysis
Select Multi-Tests Pre-Analysis
9 To modify or change any Setup Configurations, follow steps 1-8.

Review and select Confirm icon
Keyboard Type
Step Action
Select Setup/ Interfaces / Keyboard

Using the drop down arrow ▼
Set Keyboard type to USA
Main Menu
1 Host
Tests Printer
Multi-Tests Internal
Liquids External
Interfaces Keyboard
System Configuration
Security
Audible Alarms
Date/Time
Units
Set Numerical Keypad

2 Disabled
All Numerical Fields
All Numerical Fields and Sample ID
Select Disable
3 Review and select Confirm icon

ACL ELITE/ELITE PRO
Barcode Readers
Step Action
1 Select Setup/ Interfaces/ Internal Barcode
Place an (x) in box to Enable the Internal Barcode Reader (Internal BCR). Four
fields are visible with the corresponding four families of barcode types. These
four families of barcode types can be activated along with their corresponding
sub-categories based on the labels used in your facility or labeled tubes sent to
your facility.
2 Note: more than one family or barcode type can be enabled
Codabar – Select AIM Mod 16
Code 39 – Select Mod 43
I 2 of 5 (Interleaved 2 of 5) Select USS Mod 10
Code 128 – Select No Checksum
(Note: No Checksum indicates Enabled)
3 Review and Select Confirm icon.
4 Select Setup/ Interfaces/ External Barcode
Place an (x) in the box to Enable the External Barcode Reader (External BCR)
• Code 128 – Use The Drop Down Box: ▼ Select: No Checksum
• Toggle on (X) Reset Reagent Volume When Scanned (Optional Selection)
5 • Toggle on (X) Reset Start Timer When Scanned (Optional Selection)
Note: On Materials Map Pause Timer must be Deselected for these Resets to
occur when reagents are scanned using the external barcode reader.
6 Review and Select Confirm icon.

ACL ELITE/ELITE PRO
Printer
Step Action
1 Select Setup / Interfaces / Printer
Printed Samples
2 Any Analyzed
Just Completed
Select Just Completed
Printer Protocol
3 Using the drop down arrow ▼:
Select: HP-PCL
Report Type
• Using the drop down box ▼the choices are:
4 Sample Report
Cumulative Report
Select Cumulative Report
Paper Dimension
• Using the drop down box ▼choices are:
5 A4
Letter
Select Letter
6 Automatic Print Out

• Select the box (x) to Enable automatic print I (if desired)
Paper Format
• Using the drop down box▼the choices are:
7
Continuous Sheet
Single Sheet
Select Single Sheet
Select Customize Header icon

Highlight each line and insert your Institution Name, the Instrument Serial
8 Number (SN found underneath the keyboard-white sticker) and System ID (this is
assigned upon installation; create a System ID number for your instrument in
class).

ACL ELITE/ELITE PRO
Step Action
Sample Report Data

To modify what information printed on your reports select the Enable/Disable
icon for each:
• Instrument Name
• Normal Ranges
• Date & Time
Note: (9) in the S Column, indicates Enabled

ACL ELITE/ELITE PRO
Host
Step Action
Select Setup / Interfaces / Host

1
Note: Contact your LIS Programmer for these settings.
2 Select the Baud Rate to 2400 using the drop down box ▼
Configure Automatic Data Tx

• Use The Drop Down Box▼ from the choices:
Not Required
3 Patient Sample Only
QC, AR and Patient Samples
PLEASE, FOR THIS CLASS, DO NOT MAKE ANY SELECTION; instruments are
not connected to a Host
Unique Instrument ID
Select the box (x) to enable Unique Instrument ID. For each additional
instrument in your lab, input a single-digit ID in the box provided. (Digits
4
between 1-99 can be defined. Use option when multiple ACL ELITE instruments
are located in the same laboratory.)
PLEASE, FOR THIS CLASS, DO NOT MAKE ANY SELECTION
Enable Host Query

5 Select the box (x) to enable/disable
PLEASE, FOR THIS CLASS, DO NOT MAKE ANY SELECTION; instruments are
not connected to a Host
Delete Automatically after Transmission by selecting the check box, if

6 applicable
PLEASE, FOR THIS CLASS, DO NOT MAKE ANY SELECTION

ACL ELITE/ELITE PRO
Audible Alarms
The Audible Alarm setup screen allows laboratories to enable or disable an alarm
for sounding for various system conditions. Three non-configurable alarm sounds
are defined (A, B, or C). Alarm sounds at 60 second intervals for one hour.
Step Action
Select Setup / Audible Alarms

1
Enabled (√)
Sound:
A,B,or C
Cancel
Confirm
Enable/
Disable
PLEASE FOR THIS CLASS; DO NOT MAKE ANY SELECTION
2 Enabled is a (√) under the Enable column
Review and select Confirm icon

3
Note: You can enable/disable 10 audible alarms.

ACL ELITE/ELITE PRO
Setup Date/Time
Step Action
Select Setup / Date / Time
Drop Down
arrow
Cancel
Confirm
Date/Time
Using the drop down arrow ▼to select a Date Format the choices are:
• dd.mm.yyyy (European, and Canadian style)
2 • yyyy.mm.dd (Japanese style)
• mm.dd.yyyy (USA style)
Select applicable date based on your style
Two numeric fields are available to set date and time
Note: Changing date to a previous date may impact results (Patient, QC,
Calibration & AR) and the database FIFO (First In, First Out) operation.
Results processed on dates furthest from the current system date will be the first
3 ones to be automatically deleted-FIF.
Follow the same procedure when changing the time to Daylight Savings Time (if
applicable).The instrument will not automatically change during Daylight
Savings

ACL ELITE/ELITE PRO
Skill Check
1. What are the four internal family or barcode types on the instrument?
_____________, ______________, _____________, ______________
2. What are the options defined for Reflex Status in system setup?
__________________________________
__________________________________
__________________________________
3. Which Reflex Status setup selections eliminates operator from removing a

sample if a reflex test needs completed?
__________________________________
4. What Keyboard type should be interfaced?
__________________________________
5. Only one internal barcode type can be enabled.
True False
6. Why would multiple enabled internal barcode types be a benefit?

___________________________________________________________
7. How many audible alarms can you Enable/Disable on the instrument? How
many sounds are defined? Can you customize them?
No. of Alarms:_________________________________
No. of Sounds:_________________________________
Customize:____________________________________
Sign Off
Instructor

ACL 9000
ES IL ACL ELITE/ELITE PRO
ENABLE, DISABLE, MODIFY AND SORT TESTS
OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, the Operators Manual and Training
Manual you will:
• Enable, Modify and Sort Tests

• Define differences in units for Fibrinogen Test
• Understand the results of Disabling a test
• Identify the Mean Normal Range (MNR)
• Navigate to customize units displayed on Database View
MODULE RESOURCES

• ACL ELITE / ELITE PRO Operators Manual, Chapter 4
PN 722277BB (December 2010) ES 1 of 8

Performance Guide
Enable Tests:
The tests library contains up to 300 tests (200 are reserved by Instrumentation Laboratory,
these default as disabled). 100 tests can be customized by the user. Up to 100 can be active
or enabled at the same time, regardless of the mix. Each test in the setup submenu is
identified by an abbreviation and unique Test ID.
Step Action
1 From the working area, select Setup drop down
2 Select Tests
Select View/Define and cursor to the appropriate Test you wish to Enable or
3 Disable. Deselecting Show Enabled (no x in box) shows all the tests
available in the Software Library
4 Select the Enable/Disable icon
Enable the following Tests: APTTSYS

Note: The underscore ( _ ) in the R-FIB_ and R- APTTSYSe
FIBe_ indates USA units mg/dL. The test with no FIB-C_
underscore means SI units g/L.
FIB-C l_
5 FIB-C h_
R-FIB_
R-FIBe_
R-PT
R-PTe
6 Selecting Show Enabled narrows the list. Displays only the tests
enabled in step 5
7 Review that all tests are displayed in step 5 and select Confirm
ES 2 of 8 PN 722277BB (December 2010)

Modify Tests
Perform the following steps to show/hide the test result units displayed on the Database
Screen or to change the Normal Ranges of the test(s).
Step Action
1 Select Setup, Test, View/Define
To modify a test, move your cursor or use touch screen to that test. Modify all
2 tests in step 6 below to display the reporting units for the given test on the
Database View Screen
3 Select the Details icon
Highlight or cursor to the reportable unit of measure you do not want on the
4 Database View. Select the Ranges icon
Go to Show in Sample List box, uncheck / deselect the box if you do not want
5 the highlighted unit to appear; check / select (x) if you want this unit to appear;
Note: Default is all units are selected

Modify all Enabled Tests to Show in Sample List the following units displayed
in the right column:
Test Units
APTTSYS s
APTTSYSe s
FIB-C_ mg/dL
6
FIB-C l_ mg/dL
FIB-C h_ mg/dL
R-FIB_ mg/dL
R-FIBe_ mg/dL
R-PT s, INR
R-PTe s, INR
7 A message appears Database Update in Progress after each test modified,

Select OK each time
8 Using steps 2-7, continue modifying all Enabled tests in step 6 table
9 Review and Select Confirm

Entering The Mean of Your Normal Range (MNR)
Step Action
1 Select Setup/ Test / View/Define

Cursor to the test to be modified.
2 Hint: Any tests with Ratio as a unit must have a mean normal range (MNR)
Note: In this class you enabled R-PT (PT test) and APTTSYS
Select the Calculation Setup icon to enter the MNR for the selected
test in the Reference Value box.
Note: Reference value from the standard test is automatically imported into any
secondary related tests such as extended time tests (ie…R-PTe)
R-PT
1st derivative
MNR = Reference
Value
4
None
None
For classroom purposes only, enter a MNR of 11.8 for R-PT test and 30.0 for
APTTSYS test
Omission of the reference values will generate an error code W (Error in
Algorithms, Ratios or Ranges.)
5 Review and select Confirm on all screens

Sort Tests
Sorting Tests function allows a user to set the order tests appear on the Database Screen.
The tests order dictates the order tests run in Profiles and displayed on a printed report.
Step Action
1 Select Setup/Test/Sort Tests
2 Cut/remove all tests in the Sorted List using the scissors icon
Transfer the Enabled Tests to the Sorted Tests using the arrow icon
(9 in the Sorted column indicates the test(s) are in the Sorted Tests column).
Sorted Tests
Sorted Enabled tests
R-PT
9 APTTSYS
9 APTTSYSe R-PTe
9 FIB-C_ FIB-C_
3 FIB-Cl_
9 FIB-Cl_
9 FIB-Ch_ FIB-Ch_
9 R-FIB_ APTTSYS
9 R-FIBe_ APTTSYSe
9 R-PT R-FIB_
9 R-PTe R-FIBe_

Disabling a Test:
Step Action
1 Disable the R-PT test. A confirmatory message appears warning the

consequence of disabling a test, answer Yes
2 Refer to page ES 2 of 7; Re-Enable R-PT, modify units, verify MNR, and Sort
the test

Skill Check
1. How do you navigate between full test menu and the tests you enabled?
______________________________________________________________
2. What does an underscore beside a R-FIB_ test mean?

______________________________________________________________
3. Where do you enter the MNR (Mean of the Normal Range) of your lab?
_____________________________________________________________
4. Do you have to enter MNR into all associated PT tests?

_____________________________________________________________
5. Write the step sequence to customize units shown on the patient database
view screen and on printed reports.
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
6. What determines the order test results are displayed at the top of the database
view screen? _____________________
7. What message displays once a test is disabled?

_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
Instructor Tests Enabled ____

MNR____
Units____
Tests Sorted____
Sign Off


LD IL ACL ELITE/ELITE PRO
SETUP REAGENT AND LIQUID DEFINITIONS
OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, the Operators Manual, Quick
Reference Guide and Reagent Package inserts, you will:
• Setup and Define Reagents and Liquids

• Locate Calibrations Values
• Define Dead Volume and Assigned Volumes
MODULE RESOURCES

• ACL ELITE / ELITE PRO Quick Reference Guide, Reagent Loading, Lot
Change, and New Test Setup
• HemosIL Reagent/Calibration Package inserts
Note:
The ACL ELITE / ELITE PRO and the ACL 8, 9 and 10000 use similar
analytical systems. Reagents, Calibrators, Controls and their assigned values
are interchangeable between the two systems.
PN 722277BB (December 2010) LD 1 of 6

Setup Reagent and Liquid Definitions
Performance Guide
Step Action
Obtain a Reagent and Liquid Definition Table, located within the Package
1 Insert Folders from your facilitator. The table includes: reagent name, lot
number, expiration date and stability information
Select from the Main Menu Setup / Liquids
2 Note: To view the liquids corresponding to the enabled tests, select show
enabled icon to condense the list
3 Cursor or touch the appropriate liquid you want to define/modify
Select the Lot Number box and enter the lot number from the table, bottle or
4 package insert sheet
Select the Expiration Date box and enter the expiration date from
5 the table, bottle or insert sheet
Note: expiration date format based on format setup in Setup System module
6 Tab or touch the next box to be entered

Note: by Tabbing you will not miss any entries
Enter the reagent stability from the package insert.

7 Enter a number followed by h for hours or d for days
The Assigned Volume is the default volume in the Materials Map screen
8 (when reset volume is selected). The assigned volume is based upon the
liquid reagent vial size.
Note: PLEASE, FOR THIS CLASS, DO NOT MAKE ANY SELECTION
In the Warning Level box enter a value that is
slightly more than the dead volume. The Dead volume level is defined in
9 chapter 7, page 7.44 in the Operators Manual. A table displays the difference
between volume of the reagent vial, minus the usable volume.
Note: PLEASE, FOR THIS CLASS, DO NOT MAKE ANY SELECTION
10 Repeat steps 3-9 for all remaining Liquids on table provided.
PN 722277BB (December 2010)

LD 2 of 6 Miami Education Center
Entering the ISI Value:
Step Action
1 Select the Liquid ID associated with the enabled PT test (RecombiPT)
Cursor to Used By column(right side of screen) select the enabled PT test

2
(R-PT)
3 Select Assign Value icon
4 Enter the ISI value from the Reagent Package Insert sheet
6 A message will appear “Liquid Parameters have been changed. Do you

want to save them before proceeding?”
7 Select Yes
Note: It is not necessary to enter the ISI value for other subsequent PT tests.
i.e. Extended (e), Duplicate (d), Extended Duplicate (ed) tests. This value
is imported.
Note: To only view the liquids corresponding to the enabled test select the Show
Enabled icon

Entering Calibrator Values
Step Action
1 From the Liquid Setup Screen select Cal Plasma
2 In the Used by list (right side of screen) cursor to the appropriate test
Enter the value indicated in the Calibration Plasma package insert sheet by
selecting the Assign Value box
3
Note: This box will only be activated if a test has been enabled requiring cal
plasma for calibrating
Enter the Fibrinogen assayed value for R-FIB_, and the FIB-C_.
4
FIB_…US Units (underscore) mg/dL
Enter the value for the enabled R-PT test. (RPT = 100). The
5 calibrator value for any PT test run in the laboratory should be set
to 100
6 A message will appear “Liquid Parameters have been updated. Do you

want to save them before proceeding?”
7 Select Yes and continue to next test in the used by column
8 Select Confirm once all values have been entered

Skill Check
1. Under what liquid definition is the ISI value entered?___________________
2. Where is the Fibrinogen Calibration value entered?

_________________________________________________________
3. How is the Warning Volume determined?

_________________________________________________________
_________________________________________________________
4. Do you have to enter the ISI value into all associated PT tests (ie.extended or
duplicate tests)?_________
5. Where is the assigned volume entered for any reagent(s)? Where is this value
obtained?
________________________________________________________
________________________________________________________
Sign Off
Instructor


MLT ACL ELITE/ELITE PRO
MULTI-TESTS
OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, Operators Manual and Training Module
you will:
• State the difference between Test Profiles, Test Groups and Test Group Profiles
• Identify the symbols representing Profiles, Test Groups, and Test Group
Profiles in the Multi-Test Analysis dropdown menu
• Perform Setup of Test Profiles
• Use Sorting to visibly display test profiles defined in the system
• Identify Default Multi-Tests and Default Tests
• Locate and identify the number of Profiles and Test Groups available in the
software
• State what determines the order tests are run within a Profile
• State the number of Profiles that can be defined
• State the number of Test Groups
MODULE RESOURCES

• ACL ELITE / ELITE PRO Operator’s Manual, Chapter 4, Section 4.1.5, and
4.1.7-4.1.11
• ACL ELITE / ELITE PRO Quick Reference Guide, New Test Setup
PN 722277BB (December 2010) MLT-1 of 8

ACL ELITE/ELITE PRO
The software allows users to define and view their own choice of Multi-Tests (Profiles or Test
Group Profiles)
• Profiles contain one or more single tests
• Test Group Profiles are comprised of predefined Test Group combinations
Up to 30 Multi-Tests Profiles can be created (code numbers from 1 to 99). Each Multi-Test
Profile can contain a maximum of 20 test combinations. The actual number of tests added will
be dependent upon available reagent positions
Test Groups are defined in the software library. (Users can not change or delete these Test
Groups) Predefined Test Groups are a combination of tests using the same wavelength,
optical reference and acquisition cycle
Performance Guide
Define/Setup Profiles
Single tests are grouped or combined to form Profiles
Step Action
1 Select Setup from the main working area
2 Select Multi-Test
3 Select Profiles
4 Select New Profile icon
5 Enter Routine in the Profile ID box
Enter number 1 in the Profile Code box

6 Note: Starting at number 1 ensures that there is a continuous, consistent
identification system (1-99). Profiles and Test Group Profiles share the same
sequential numbering code
From the Enabled Tests box, transfer the following tests: R-PT, APTTSYS, R-
FIB_, R-PTe, APTTSYSe, and R-FIBe_ , to Tests in Profile box using the
7 arrow icon
To delete a test from the Test in Profile select icon
8 Review setup and Confirm
PN 722277BB (December 2010) MLT 2 of 8

ACL ELITE/ELITE PRO
Step Action
10 Enter DDimer in the Profile ID box
11 Enter number 2 in the Profile Code box
From Enabled Tests box, transfer the following tests: D-Dimer and DDh, to
12 Tests in Profile box using the arrow icon
15 Enter All in the Profile ID box
16 In the Profile Code box enter number 3
From the Enabled Tests box, transfer the following tests: R-PT, APTTSYS, R-
FIB_, R-PTe, APTTSYSe, R-FIBe_ , D-Dimer and DDh to Tests in Profile box
17 using the arrow icon

ACL ELITE/ELITE PRO
Sorting Multi-Tests
Profiles, Test Groups and Test Group Profiles that are not in the Sorted Multi Tests
list will not be visible as available Multi-Tests under Analysis drop down menu.
Step Action
1 Select Setup
2 Select Multi-Tests
Select Sort Multi-Tests. This opens a screen similar to:
Sorted Multi-Tests
Note: The 3 columns on the left side of the screen list Profiles, Test
Groups and Test Group Profiles. A check mark on the left side indicates
that item is a Sorted Multi-Test. The column on the right of the screen
displays all Sorted Multi-Tests; this order is determined by the user.

ACL ELITE/ELITE PRO
Step Action
Note: Profiles, Test Groups, and Test Groups Profiles that are not sorted
will not be visible on the Analysis menu drop down selection.
4
Transfer the following Multi-tests to the Sorted Multi Tests list using the
arrow icon, in the order displayed in the Sorted Multi-Test box.
●●●Test ● ● Test
●●●
Profiles Sorted
Group ●● Group Profile
Multi-Tests
Routine * * Routine
DDimer * *
DDimer
All * *
All
*Make No Selections
Test Groups sessions

Test Groups are IL created and locked (you can not delete and sort). The tests combined
in a Test Group use the same wavelength, optical reference and acquisition cycle.
Test Group Profile sessions

Test Group Profiles allows users to define and view their own choice of combined Test
Groups to run in a different named, Multi-Tests, analytical session. Each Test Group
Profile is assigned a Profile ID (maximum of eight alphanumeric characters).
Note: The symbols displayed prior to the test groups names in the analysis
drop down for the selected Multi-Test or Single Sessions have the following
meaning:
●●● Test Group Session- Predefined by IL

5 Profile Session, tests combined and ran as
●●●
batch testing, created by user

●● Test Group Profiles Session-combined Test
●● Groups created by user.
NOTE: No Test Groups and Test Group Profiles should appear in sorted
Multi-Tests list

ACL ELITE/ELITE PRO
Default Multi-Tests
The Default Multi-Tests selection determines the tests available and the material map
setup when using the Start icon on the Database View screen.
Enabling a Default Multi-Test also activates on the Database View screen the
following icons: Start and Materials Map creating navigational shortcuts
Step Action
1 Select Setup
2 Select Multi-Tests
3 Select Default Multi-Test
Transfer one desired Enabled Multi Tests to the Default Multi Tests list
using the arrow icon
(For example: ●●●Routine)

4 Note: The Default Multi Tests
selection activates the Start icon
and the Materials Map icon on
Database View Screen
Toggle on the Enable Default Multi-Test,

Check (X) will appear within the box.
5 Note: The desired tests for a run still needs to be
programmed on a sample even though the Default
Multi-tests are enabled when not connected to a LIS
(Chapter 4, pg 4.27-Operators Manual)

ACL ELITE/ELITE PRO
Default Test
If enabled, Default Tests are programmed on sample IDs that do not have
programmed test(s) in the internal database or after a host query.
Step Action
1 Select Setup/ Tests/ Default Test
Transfer the R-PT, Enabled Tests to the Default Tests list using the arrow
icon
2 Note: Default tests will be added to a sample after the instrument checks the
database and performs a host query. If host is down the Default Test selected
will run on each sample that receives no information from the database or
host query
3 To Enable Default Tests, place a Check (X) in the Enable Default Test box

ACL ELITE/ELITE PRO
Skill Check
1. What determines the order tests are run in a Profile?

_____________________
2. How many Profiles can be defined? ___________________
3. What is the total number of test groups? _______________
Hint: Operator’s Manual Chapter 7 Assay and Instrument Specifications:

page 7.47.
4. Sorted: Profiles, Test Groups, and Test Group Profiles will be visible under
Analysis menu drop down selection as:
a. Multi-Tests
b. Single Test
5. Match the following:
Test Individual tests grouped to run in ‘batch mode’

Group
Test Combination of tests using the same wavelength,
Group optical reference and acquisition cycle
Profiles
Profile Grouped tests, run in a single named Multi Test
6. After running samples, some tests ordered on a sample were not run. What
would you check?
__________________________________________________________
__________________________________________________________
__________________________________________________________
Sign Off

SQC etupACL ELITE/ELITE PRO
SETUP QUALITY CONTROLS FILES AND A QUALITY

CONTROL LOADLIST
OBJECTIVE
Given an ACL ELITE / ELITE PRO workstation, Operators Manual and Training
Module and Quick Reference Guide you will:
• Setup quality controls

• Create and print a Loadlist for Quality Controls
MODULE RESOURCES
• ACL ELITE / ELITE PRO System Training Manual

• ACL ELITE / ELITE PRO Quick Reference Guide
PN722277Rev BB (December 2010) SQC 1 of 6

ACL ELITE/ELITE PRO
Setup Quality Control
Performance Guide:
Step Action
1 Select QC from the Main Menu
2 Select Setup / Review

Deselect the check box for Show Enable
Cursor up or down to select the appropriate liquid, define and Setup the
following Quality Controls Files:
• Normal A
• High Abn A
4 • Fib Low
(Lot Number, Expiration Dates, Target means and Target SD ranges will
be provided by your facilitator) Answer Yes to any message that appears.
Using steps 5- 12 Set Up the QC files following the chart below.
(The A-annotates Assayed Controls and the U-annotates Unassayed Controls
to the left of the named control level)
Control Test Stored Unit SD Range

Material
Normal R-PT Sec 2
Normal A R-FIB_ mg/dL 2
APTT SYS Sec 2
5 Fib-C_ mg/dL 2
High Abnormal R-PT Sec 2
High Abn A APTT SYS Sec 2
Fibrinogen Low R-FIB_ mg/dL 2

Fib. low Fib-C_ mg/dL 2
SQC 2 of 6 PN722277Rev BB (December 2010)

ACL ELITE/ELITE PRO
Step Action
6 Select Setup icon
7 From the Enabled Test List, select a test by highlighting a test, use the arrow
icon to move the test to the Configured Test list
To edit the Configured Test list use the scissors icon to remove or
8
delete a test from the list
For each test that you configure, input: (see Classroom Inserts for values)
• Units, each test
9 • Target Mean
• Target SD
• SD Range
Note: Removing a test from this list deletes all the results from database
10 Select QC Range Check icon, the control will be checked and

flagged if out of range
Select Flag Patient Results icon to flag patient results when QC

out-of-range is detected
11
Note: QC outside defined ranges will flag on cummulative patient
printouts, therefore, always ensure QC flags are addressed prior to samples
being processed.
12 Print QC level Setup for your files (Do not have to do this in class, but could
after you setup each level in your laboratory)
14 Select Show Enabled (X) to view only your quality control list
created
PN722277Rev BB (December 2010) SCQ 3 of 6

ACL ELITE/ELITE PRO
Setting Up a QC Loadlist
Step Action
1 From the main menu select Analysis, select Multi-Test Session and choose
the Routine Profile
2 Select Add QC icon; QC liquid List is displayed select the appropriate

QC material
3 Repeat step 2 until all control materials are assigned
4 Select Store Loadlist icon and select the Loadlist Number of your
choice (1-20)
5 Select Confirm (Returns you to the Multi-Test Pre-Analysis screen)
6 Select Cancel to exit the screen

ACL ELITE/ELITE PRO
Skill Check
1. Show facilitator Quality Control Files and Loadlist.
2. What box is selected to narrow quality control liquid list (view only those
quality controls you use)?
_________________________________________________
3. In QC Setup, what is the difference between the Liquid details of

Normal A and Normal U?
____________________________________________________________
Instructor QC Files_______
Loadlist _______
Sign Off
PN722277Rev BB (December 2010) SCQ 5 of 6

ACL ELITE/ELITE PRO

M IL ACL ELITE/ELITE PRO
MAINTENANCE – NEEDLE ALIGNMENT

AND CLEANING PROCEDURE
OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, an Operator’s Manual, Training

• Perform Daily, Weekly, Biweekly, Monthly and As Needed Maintenance
• Perform needle block replacement and positioning procedure
MODULE RESOURCES

• ACL ELITE / ELITE PRO Quick Reference Guide, Daily Maintenance
PN 722277BB (December 2010) M 1 of 18

DIAGNOSTIC SOFTWARE OVERVIEW
8 Note: For further information regarding the instrument’s Diagnostic menu, please
refer to the IL ACL ELITE / ELITE PRO System Operator’s Manual.
Select Diagnostic; the following list displays:
• Priming
• Cleaning
• Maintenance
• Temperature Control
• Needles Position
• Session Error History
• File Error History
• Logbook
• Service (dimmed) - Only accessible to service
Priming
• Primes the ACL diluter pistons and associated tubing with Wash-R-
Emulsion. This should be done at the beginning and end of each shift and
as part of daily maintenance
• Prime required after replacing Wash R Emulsion. Operator requested
priming cycle lasts approximately 50 seconds, using 6mL of Wash R
Emulsion
• The ACL auto primes every 30 minutes of inactivity, using approximately

0.9mL of Wash R Emulsion, during a 20 second period
M 2 of 18 PN 722277BB (December 2010)

RINTED 02/14/2011 10:16:00 AM
Needles Cleaning Procedure

Materials needed: Four (4) 10mL bottles, Cleaning Solution and Factor Diluent
• Desired Cleaning solution must be placed in both positions R6 and R7

(Reagent positions: R6 for reagent line and R7 for sample line). Followed by
Factor Diluent in both positions R6 and R7
• Fill two (2) 10mL bottles with 8mL of Cleaning solution (Clean Solution per
IL’s recommendations) and two (2) 10mL bottles with 8mL of Factor
Diluent
• Cleaning Solution (also called Clean A)– 0.1Normal HCL (PN

9831700) is appropriate cleaning for weekly needle cleaning
procedure
• Cleaning Agent (also called Clean B) Sodium Hypochlorite solution
(PN 9832700) is the cleaning agent of choice for decontaminating the
needles. Prepare Solution of 1:8 Dilution: One (1) part cleaning
agent to seven (7) parts CLRW water
• Factor Diluent-(PN 9756600) used as a secondary step of daily

needle cleaning procedure
13 13
5 5
• The operator may define the configuration of the cleaning cycle by selecting:
Volume - volume of cleaning agent aspirated (in μL’s). Minimum volume

requirement 0 μL and maximum volume limit 130 μL. (Recommended
volume is 130 μL)
Cycles No. –number of cleaning cycles the ACL performs. The default is
three cycles. One cycle is the minimum that can be run and five the
maximum. (Recommended three (3) cycles)
Washing at Completion- number of rinse cycles that occurs after the
cleaning cycle has been completed. The default is five (5) rinse cycles with
a minimum of one (1) rinse cycle and a maximum of five rinse cycles.
(Range is 0-5, Recommended is 5)
PN722277BB (December 2010) M 3 of 18
MAINTENANCE
Maintenance log within the software, can be used for monitoring the frequency and
status of maintenance. A paper copy is also available including all maintenance
procedures (see page M 17)
Suggested
List of frequency for
suggested maintenance
maintenance Displayed in Days
operations
Print
Delete
Clear
Select this button
to automatically
enter the current
date in the “Last
Date” field
Confirm
Allows 30 alphanumeric
characters of free-text entry about
the procedure in the “Note” field
Note: If Maintenance log is used and the Date Field expires or becomes overdue a
procedure displays Red, the Yellow Alert Triangle will illuminate, provides a warning
and results will be flagged (M code). The Frequency is tracked by date not time
Temperature Control
Displays the real time, current temperatures and the acceptable limits of the rotor
holder, peltier, rotor stack, and rotor transporter.
• Acceptable temperatures:
Device Normal Range
Rotor Holder Temperature 38.0-39.0 °C (100.4-102.2 °F)
Peltier Temperature R1 - R4 10.0-16.0 °C (50.0-60.8 °F)
Peltier Temperature R9 - R12 10.0 -16.0 °C (50.0-60.8 °F) ELITE PRO only
Rotor Transport Temperature 34.0 - 40.0 °C (50.0-60.8 °F)
Rotor Stack Temperature 34.0 - 40.0 °C (50.0-60.8 °F)

RINTED 02/14/2011 10:16:00 AM
Needles Position (see pages M 13-14 for needle alignment procedure)

Needles Position used to verify or complete the alignment of the needle block to
the rotor on the rotor holder, as necessary. Selecting Needle Positioning
completes a quick self-initialization, which moves the arm over the rotor area.
The following screen is displayed:
Raises and lowers
the arm over the Moves the rotor
rotor holder area position on holder
by 90° or ¼ turn
8 Refer to the alignment procedure, under As Needed, Needle Block

Replacement on pages M 11-14 or refer to the Operators’ Manual, Chapter 5
Session Error History

Screen displays errors or alarms during the current analytical session.
• The most recent error of the session is on the top of the list. The instrument
will store 200 errors.
• The errors display until a new session begins. At that time, the previous
session errors are automatically removed and transferred to the File Error
History log.

File Error History
• Stores up to 100 errors and warnings that have occurred on the ACL ELITE /
ELITE PRO System. FIFO-First In First Out.
• Lists the error/warning along with the date and time.
Service Only
Logbook
• Records and stores operator actions or for example, change in QC range,
modification in setup configuration, etc.
Allows 30 alphanumeric
characters for free-text
entry about each action in
the “Note” field

RINTED 02/14/2011 10:16:00 AM
PERFORMANCE GUIDE
Daily:
Step Action
Check Wash-R Emulsion- Replace the bottle when the level of liquid is 1.5
1 to 2.0 cm from the bottom approximately, a 100 mL volume will trigger
alarm for low volume
Check Liquid Waste Container- Check the level of the liquid in the waste
2
container and empty if necessary as per your laboratory protocol
Empty Rotor Waste Container-Check the amount of used rotors in the
container and empty if necessary. (A sensor is located in the rear and is
activated when the waste container is in place on ACL Elite PRO only)
• Open the small door on the front right-hand side of the analyzer body
to access the rotor waste container
• Grab the handle of the container and pull outwards to remove it
• Dispose of the used rotors found in the waste container
• Replace the waste container, handle facing out to activate the waste
3 sensor, close door
Needle Cleaning Procedure-Performed to reduce protein buildup on the

needles block assembly
• From the working area select: Diagnostic / Cleaning
• Fill two (2) glass 10 mL vials with 0.1 normal HCl solution Clean A
4 and place vials in reagent positions R6 and R7
• Select the number of cycles, then Start
• Replace 0.1 normal HCL solution Clean A with two (2) 10mL vials
of fresh Factor Diluent and Repeat entire procedure
• After entire cleaning cycles are completed return Clean A to R6 and
perform Priming cycle

Step Action
Clean Waste Line/Verify Needle Position- Clean the waste line as needed,
dependent upon daily workload of your laboratory (may be required daily)
• Open the reagent cover area
• From the working area select: Diagnostic /Needles Position
• Select Yes to open the rotor holder area. Once Needles are over Rotor
Holder area, verify Needle Position, adjust only if needed (Refer to
As Needed: Needle positioning procedure on page 12-13)
• Remove the Rinse Reservoir, clean weekly (See Rinse Reservoir
cleaning procedure on page 9)
5
• Attach a suitable piece of tubing to a syringe (20mL recommended),
fill with approximately 20mL reagent grade, deionized water. Insert
the tubing into the waste line opening. Push the deionized water into
the waste line opening and ensure the water flows freely through the
waste line
• Repeat the procedure as necessary, to ensure removal of any potential
buildup
• Replace the rinse reservoir
• Select and confirm with OK. This repositions the arm and
returns the instrument to READY status
Perform Priming Procedure- Prime the instrument at the beginning and

end of each working day or once per shift
• From the working area select: Diagnostic / Priming
• Visually inspect for the following:
1. If bubbles are present, pinch the chamber outlet tubing as the
6 pistons are descending and release before the piston reaches the
bottom. Repeat until the bubbles are gone
2. There are no blockages or leaks in the liquid flow path and that
liquid is flowing freely from the reservoir to the dilutors and from the
dilutors to the needles
3. The liquid is flowing freely down the waste line to the liquid
waste container

RINTED 02/14/2011 10:16:00 AM
Weekly:
Step Action
General Instrument Cleaning Procedure

• Clean all exposed surfaces of the instrument, the inside of the
Autosampler, and the Rotor Compartment (excluding the rotor holder)
1
using 0.1 N HCl (HemosIL Cleaning Solution PN 9831700), Clean A
• Rinse with Deionized Water and dry
Clean Rinse Waste Reservoir

• From the working area select:
Diagnostic Rinse/Waste
Reservoir
Needles Position
This causes the needle arm to move over the rotor holder.
• Remove the rinse reservoir and wash it with 0.1 normal HCl, Clean A,
followed by rinsing with Deionized Water
2
• Place the reservoir back into its position
• Select and confirm with OK. The needle arm returns to its home
position

Biweekly Maintenance:
Step Action
Clean Rotor Holder and Optic Path
Select to open the rotor holder cover.

Using cotton tip applicators, lightly moistened with deionized water and clean the
following areas:
Rotor
Chromogenic Cover
Channel
Sensor Filter
LED
Fiber LED
Optic Sensor
1 Surface Surface
Optical window
Surface of the on rotor holder
Channel Total (20)
Sensor
− all 20 optical windows in the rotor holder area

− the surface of the Channel Sensor
− the LED Sensor surface
− the LED Fiber Optic surface
− the Chromogenic Channel Sensor filter
2 Use a clean, dry cotton tip applicator to dry these areas after cleaning
3 Clean around rotor holder with 2x2 gauze moistened with distilled water
4 Close the rotor holder cover
5 Reboot Analyzer- Select the log off icon then power off instrument,
wait a few seconds and power back on

RINTED 02/14/2011 10:16:00 AM
Monthly:
Step Action
Clean Air Filter- Remove the air filter from the right hand side of the
1
instrument by pulling the air filter holder upwards
Clean the filter using compressed air or by washing it in water and blowing dry.
Put back in the holder and reinsert back into position. Do not put a wet filter on
the ACL ELITE / ELITE PRO System
As Needed Maintenance:
Step Action
Replace Needle Block:
Select open the rotor cover icon to expose the rotor holder for alignment
completed after replacement of needle block
From the working area select: Diagnostic / Needles Position
Moves the sample arm over the rotor holder
1 • Loosen the white knob on the back of the sample arm, label sample tubing,
the disconnect both tubings, disconnect the sensor cable and remove the
needle block
• Insert the new needle block, connect the sensor cable, re-connect both tubes,
and position the block higher than the arm’s top surface
• Follow the Needle Positioning Procedure to align the needle block
correctly
Step Action
Needles Positioning:
• From the working area select: Diagnostic / Needles Position; when the
dialogue box asks if you want to open cover select Yes (disregard if open)
This moves the needle arm over the rotor holder
Using the rotor snap, remove the rotor and insert the Needle Adjustment
2 Tool onto the rotor holder with the white reference dots facing up
3 Select the Raise / Lower icon. This lowers the sample arm down to the
Needles Adjustment Tool
The needles should touch the upper surface of the tool. To adjust the height,
4 loosen the white knob on the back of the needle arm and move the needle block
up or down so that the needles are just touching the surface of the tool
When the height is correct, tighten the white knob finger tight to ensure the
5 needle height does not change, the probes should be within the white dots.
NOTE: Alignment is to the rotor (see step7) not to this tool. This tool is only
for height adjustment
6 Select the icon to raise the needle arm
7 Use the rotor snap to properly remove the needles adjustment tool and replace
with a new clean ACL rotor
Select the icon. This lowers the needle block into the rotor. See
picture for proper alignment within rotor (note: or biased slightly left)

RINTED 02/14/2011 10:16:00 AM
Step Action
9 Verify the needle block position is in the center of the rotor or slightly biased to
the left of center as shown in previous step
10 Select icon to raise the needle arm.
11 Select icon, this moves the rotor a quarter turn to cuvette position 6.
Select icon to lower the arm and repeat the same procedure.
12
Raise, Rotate, Lower, Look (90° or ¼ turn/rotation)
Sequence is repeated in rotor positions 1, 6, 11 and 16 (all four quadrants)

13 If adjustments are required, loosen the white knob on the back of the needles
arm and move it by turning the knob until needles are positioned in the center or
slightly left within the cuvette wells. Recheck each quadrant
14 Select icon to close the rotor holder cover and reinitialize sample arm
Step Action
Maintenance Diskette:
1 Performance of scandisk and defragmentation operation uses the Hard Drive
Maintenance disk received in your Software packet to improve the overall
performance of the system
Log off, power down instrument, insert Maintenance Disk and power on.
2 Allow software embedded on diskette to complete a scan and defragmentation,
DO NOTHING until message appears: “Hard Drive Maintenance Procedure
Completed, please remove disk and reboot instrument.”
Remove diskette, power off, wait a few seconds, power on and log in to
3
software

Step Action
Decontamination-Refer to Operators Manual Chapter 5, Section 5.2.7, page

5.28-5.29
This procedure should be used if instrument contamination is suspected or for
QC recovery issues. This procedure is workload dependent and may be done as
often as monthly (DO NOT perform this procedure in CLASS)
The disinfecting agent used to perform this procedure is a 1:8 dilution of
HemosIL Cleaning Agent PN 9832700, one part Cleaning Agent-Clean B to
seven parts CLRW water
1
Caution: The use of undiluted IL Cleaning Agent, Clean B, may cause
corrosion of metal parts.
Chapter 5, Section 5.2 :
Step Action
Clean LCD Screen

As needed, to remove smudges or dirt build-up. Any standard glass cleaner,
1 without ammonia, can be used to clean the touchscreen. Always spray the glass
cleaner on a clean, soft cloth or towel and then clean the touchscreen. Avoid glass
cleaner sprayed directly on the monitor; this could result in a leak within the non-
sealed unit and cause damage (Elo-TouchSystems recommendations)
Log Maintenance
Diagnostics/Maintenance/Date/Note
2
Note: Log is NOT done automatically, operator must document completion
(Paper Maintenance Log Sheet available for all maintenance procedures on M 17)

RINTED 02/14/2011 10:16:00 AM
Skill Check
1. What is the default cycle for the needles cleaning cycle? ____________
How often is this procedure performed? __________
2. State the recommendations for the following maintenance procedures.
Maintenance Procedure Interval

1. Check Wash R-Emulsion
2. Clean Waste Line
3. Clean Needle Procedure
4. Clean Air Filter
5. Align Needles
6. Verify the Needles Alignment
3. What is the frequency for using the maintenance disk? What is the purpose for
this procedure?
___________________________________________________________
___________________________________________________________
Instructor Maintenance log _______

Needles Alignment ________
Sign Off


RINTED 02/14/2011 10:16:00 AM
ACL ELITE / ELITE PRO System Maintenance Log

Month______________ 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Year ___________
Daily
Check Wash R-Emulsion Level
Empty Liquid Waste If Necessary
Empty Rotor Waste Container
Perform Needle Cleaning Procedure
Clean Waste Line, daily workload
dependent
Priming - Start of shift/day
Priming- End of shift/day
Weekly
Clean Instrument
Clean Rinse Reservoir
Biweekly
Reboot the Analyzer
Clean Rotor Holder and Optic Path
Monthly
Check and Clean Air Filter
As Needed Maintenance
Replace Needle
Needles Position
Perform Waste Line Bleaching
Decontamination Procedure
Clean LCD Screen
Hard Drive Maintenance Disk
Tech Initials
PN722277BB (November 2010) M 17 of 18

M 18 of 18 PN 722277BA (August 2009)

CAL IL ACL ELITE/ELITE PRO
CALIBRATION
OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, an Operators Manual, Training

• Perform the Calibrations for: FIB-C_, R-PT and R-FIB_ using procedures
in training modules
• Obtain an r2 value > 0.980 for R-PT
• Obtain an r2 value > 0.980 for FIB-C_, and R-FIB_
MODULE RESOURCES

• ACL ELITE / ELITE PRO Operator’s Manual Chapter 3, Section 3.4
• ACL ELITE / ELITE PRO Quick Reference Guide, Calibration

Miami Education Center CAL 1 of 6
The variables involved in a calibration, are the test-specific reagents and specific
materials used for the test calibrated. The calibration procedure is common to all
calibrated tests.
Some calibrations are within run (In Session) and some are performed prior to
sample analysis (Dedicated), with samples processed off a stored Calibration
curve.
Refer to the package insert for specifications on reagent preparation, storage and
stability.
Dedicated: A separate session is done to perform a calibration. The session is

initiated by going to the calibration menu.
In Session: The calibration is executed the first time with the sample run, and can
then be re-used for later sample runs. (If Cal Plasma is present, a new calibration
will be performed automatically. If no Cal Plasma is present, the stored calibration
is used.)
Each Rotor: Every time a rotor is loaded with samples the calibration must be
done for that assay.
Note:
Refer to the Operator’s Manual in the Calibration section for further
explanation of which tests are Dedicated, In Session, or Each Rotor.
Note:
The ACL ELITE / ELITE PRO® and the ACL8, 9 and 10000 use identical
analytical systems. Reagents, Calibrators, Controls and their assigned
values are interchangeable between the two systems.

CAL 2 of 6 Miami Education Center
CALIBRATION OF THE PT-FIBRINOGEN_ (RecombiPlastin)

Performance Guide
Step Action
Note: Always ensure Daily Maintenance has been completed prior to

Calibration-refer to M (Maintenance) Module.
1 Note: Ensure there is ample volume of Wash-R-Emulsion-refer to RWE
module (Replace Wash-R-Emulsion).
Select Diagnostic
2 Select Priming (To ensure there are no bubbles in the lines)
3 From the working area select Calibration
4 Select Calibrate
5 From the Tests to Calibrate drop down menu select R-PT
Select Materials Map icon, ensure all reagents and liquids are placed
on the system as indicated; update volumes and expiration date of the reagents.
6
• Using a cup adapter, place reconstituted Cal Plasma in a labeled 2.0 ml cup
• Place a 10 mL vial of Fresh Factor Diluent according to materials map
Select Start
7
Once calibration is complete, review data and ensure that the r2 value is > 0.980
8
Note: If the r2 value is in red the calibration value is outside the limit, repeat
calibration
Recognize any errors that exist by selecting the Error View

9 Individual replicates may be omitted from the calibration by selecting Omit
Replicate icon. Refer to the Operator’s Manual, chapter 3, page 3.68 for further
explanation of omitting replicates points
10 Successful calibration select Confirm

CALIBRATION OF THE FIB-C_ (Clauss Fibrinogen)

Performance Guide
Step Action
Note: Always ensure Daily Maintenance has been completed prior to

Calibration-refer to M (Maintenance) Module.
1 Ensure there is enough Wash-R-Emulsion-refer to RWE (Replace Wash-R-
Emulsion) module.
Select Diagnostic
2 Select Priming (To ensure no bubbles in the lines)
3 From the working area select Calibration
4 Select Calibrate
5 From the Tests to Calibrate menu select FIB-C_
Select Materials Map icon and ensure all reagents and liquids are placed
on the system as indicated; update volumes and expiration date of the reagents.
6
• Using a adapter place reconstituted Cal Plasma in a labeled 2.0 ml cup
• Place a 10 mL vial of Fresh Factor Diluent according to materials map
7 Select Start
Upon completion review data and ensure that the r2 value is > 0.980
8
Note: If the r2 value is in red the calibration value is outside the limit, repeat
calibration
Recognize any errors that exist by selecting the Error View

9 Individual replicates may be omitted from the calibration by selecting Omit
Replicate icon. Refer to the Operator’s Manual, Chapter 3, page 3.68 for further
explanation of omitting replicates points
10 Successful calibration, select Confirm

Skill Check
1. Your R-PT calibrated and the PT based Fibrinogen (R-FIB_) did not
calibrate, what would you check or verify?
_______________________________________________________________
_______________________________________________________________
2. What could cause both R-PT and R-FIB_ calibrations to fail?

_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
3. Where in the software do you enter the Clauss Fibrinogen (FIB-C_)

calibration value? What is that value?
_______________________________________________________________
_______________________________________________________________
4. Where would you obtain the Fibrinogen (R-FIB_) calibration value?

_______________________________________________________________
_______________________________________________________________
5. What is an acceptable r2 value for R-PT and R-FIB_ calibration?

_______________________________________________________________
6. Where can you find the acceptable r2 value?

_______________________________________________________________
7. Can you omit an individual replicate from the calibration? Can you restore
omitted replicates?
_______________________________________________________________
8. Show your printouts from the Calibration to your facilitator.
Sign Off
Instructor


RQC2 ACL ELITE/ELITE PRO
QUALITY CONTROL
OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, an Operators Manual, Training

• Run HemosIL Normal Control, High Abnormal Control, and Low

Fibrinogen Control for the following tests on the ACL ELITE/ELITE PRO:
− R-PT
− APTTSYS
− R-FIB_
− FIB-C_
• Review the QC results, make any corrections and repeat as necessary
MODULE RESOURCES

• ACL ELITE / ELITE PRO Quick Reference Guide, Quality Control

ACL ELITE/ELITE PRO
REVIEWING QUALITY CONTROL DATA
QC Review of Results
Select the QC Setup/Review or the QC icon to review the QC results
Quality
Control List
Clear
Clear Single
All
Print
Print Today
All QC QC Levey
Jennings Cumulative
Charts Results
The QC List retains the last 100 QC results. To view any Levey Jennings charts
and Cumulative Results, use the icons at the bottom of this database screen (Plot
and Statistics and Cumulative Results)
Use the Clear All icon daily to clear the QC list. All QC data will remain in the
QC database file after it is cleared from the list
Select the Print Today QC icon to print today’s quality control runs

ACL ELITE/ELITE PRO
Plot and Statistics
Select the QC material, select the Plot and Statistics icon on the QC List to
display the Levy Jennings chart.
Defines the
Returns data
start and Cumulative
displayed to
end dates Print Results
the last 30
days
8 The QC Plot and Statistics screen displays the 30 day intervals of QC results
(use arrows at base of chart). QC results within range are displayed as a black
“”, within ± 2SD are displayed as a violet blue “o”, and outside of ± 3 SD are
displayed in red “△ or ▽”

ACL ELITE/ELITE PRO
Cumulative Results
To review all QC data for the selected enabled QC material, select from the QC
List screen Cumulative Results icon or the QC Plot and Statistics screen.
View single
result
details
Add text
note (up
to 30
characters
)
Omit selected
Cumulative result from
Results statistics
Columns:
F – Flags; Calibration error codes (see pg. 6.23 Operators Manual)
S – Status; Transmitted to host or Local
O – Results Omitted cannot be restored
8 The QC Cummulative screen displays a running list of QC results. QC

results outside set ranges will display a Q in the F column to indicate QC has
failed. A “9” (checkmark) in the O column will indicate when a data point has
been omitted from the statistical data.

ACL ELITE/ELITE PRO
QC – Host Communication
On the QC Setup/Review screen or the QC list screen, select QC Host
Communication icon.
Host
Communication
screen
• Once the transmission criteria are defined by the user, the transmission can
be activated by selecting the icon
QC – Extract Data
From the QC Setup/Review or QC List screen, select either the QC Cumulative
Results or Plot and Statistics.
Quality
Control
Extract
To open the QC Extract Data screen, select the Extract Results icon (screen similar
to Host Communication screen).
The data configuration allows the user to select the date range for the QC results to be
viewed. The Liquid ID/Test ID is also visible on the upper part of the screen.

ACL ELITE/ELITE PRO
Running Quality Controls

Performance Guide
Analyze Quality Control
Step Action
1 Select Analysis from the working area, select Multi-Test Session, Routine
Profile
2 Check Loadlist Box icon.
Enter the Loadlist number you Setup in SQC Module, press Enter on keyboard
Label 0.5 or 2.0 mL cups and place QC on the sample tray in the order indicated.
To ensure controls are in the proper order. Touch each position in the map to see
3 which level of the control liquid is assigned to that position, or select Loadlist
icon. QC within loadlist 1, will be displayed.
Note: Tests run on the QC materials are automatically determined by the
configured tests for that particular liquid and the tests allowed in the mode of
analysis you are using
Select Materials Map icon and ensure that all materials are in their
assigned position
If an error message appears identifying the scanned liquid as an “unknown lot
number and expiration date” you should verify the current lot number used by
4
selecting Liquid Details icon to update the liquid reagent information
On ACL ELITE rotors must be manually loaded. The instrument will prompt the user to
load a new rotor. Message displays ROTOR EXCHANGE NEEDED. Depress the rotor
snap located in the center of the rotor loading/analysis area to properly seat the rotor upon
removal/replacement
5 Select Start icon

ACL ELITE/ELITE PRO
Review QC Results
Step Action
Select the QC icon
1 Note: If any QC results are out of range, the QC icon will include a red alert
(!), and an audible alarm will sound
The QC list displays QC results completed.
Within range results are displayed in black, out of range results are displayed in
violet blue ±2SD, and results outside of the ±3SD are displayed in red
Quality
Control List
2 Clear
All Clear
Single
Print Print
All Today
QC Levey Cumulative
QC Results
Jennings
Charts
Select Print Today QC icon to print your daily quality control runs
3
Select the Print All QC icon to print all QC on the QC list

ACL ELITE/ELITE PRO
Step Action
4 Select the Cumulative Results icon to review a specific result and its
accompanying QC file.
5 Select the Plot and Statistics icon to view a Levy Jennings chart for a control.

ACL ELITE/ELITE PRO
Skill Check
1. What is the total number of QC results in each statistic file?

___________________________________________________
Hint: Operator’s Manual Chapter 7 Assay and Instrument Specification: page 7.47
2. How many days of results are viewable on the Levy Jennings chart?
___________________________________________________
3. What indicates a result is omitted in the Cumulative Results view?

____________________________________________________
4. What symbol is displayed on the Plot and Statistic when data points are
omitted from the Levy Jennings?
____________________________________
5. Can you restore a result once it is omitted? Yes No
6. Can you Print your Daily Quality Control runs from the QC List
Screen?______________
If yes, how?
________________________________
7. What does QC invalid mean when printed on a cumulative report or in the

cumulative data in a QC file?_______________________________
Sign Off
Instructor

ACL ELITE/ELITE PRO

SAMPLE ANALYSIS 3
OBJECTIVES

Manual, Quick Reference Guide, Reagents/Liquids, System Configuration, Interfaces
Setup, and Tests: R-PT, R-Fib_ and APTTSYS enabled, you will:
• Analyze Samples using the following modes of analysis:

− Sample ID or Barcoded specimen using the STAT/Pause function
− Manual Entry – Default Tests
MODULE RESOURCES
• IL ACL ELITE / ELITE PRO Training Manual

• IL ACL ELITE / ELITE PRO Operators Manual, Chapter 3
• IL ACL ELITE / ELITE PRO Quick Reference Guide: Pre-run Checklist,
Process Samples, and Components/Icons/Colors

ACL ELITE/ELITE PRO
Sample Analysis – Pause Session

Performance Guide
Add a STAT sample
Step Action
To Pause the system during the analytical session,

1
Select STAT/Pause icon (“Ambulance”)
2 A message will appear “Do you really want to hold the session?” Answer Yes
to this message
3 A prompt will appear: “STAT samples can be inserted now” Select OK
4 Add primary tubes or cups to the sample tray in the next available position
5 Select Read Bar Code Select Start icon, allow the instrument to place
and/or identify the cup/tube or barcoded specimen
Select the Quadrant that contains the sample(s) added, touch the position and
6 enter the Patient information and demographics per your facilites protocol, then
order tests
7 Select Confirm
Select Start to resume

8 Note: the Running Man icon replaces the ambulance icon in the lower left corner,
until the start icon is selected. The instument status will indicate HOLD in the
upper right hand corner of the screen
9 “STAT was sucessfully resumed” will be displayed, Select OK
All priority samples (STAT) are indicated in the database with a √ under the ✙ column

ACL ELITE/ELITE PRO
Sample Analysis – Manual Entry with Default Test Enabled
Performance Guide
Program and Enable Default Test
Step Action
1 Select Setup/Tests/Default Tests
2 Use the Arrow to select enabled tests to the Default List
3 Enable the Default Test by placing an X in the Enable Default Test box
Perform Analysis using Default Test
Step Action
Select Multi-Test Session using ‘▼’

Note: The Multi-test selected dictates what tests can be ordered and drives what
1 liquids are required to run the tests within the selected Multi-test. Selecting a
Multi-test does not automatically order any test. If a sample loaded has a test
ordered that is not within the Multi-test selected, the sample status will remain
“pending” (designated with a “P” in the status column).
2 Select Read Bar Codes icon
Samples without barcode labels will generate the following message:
Warning: Error in Sample Identification

3 OK
Acknowledge the message by selecting OK

Quadrant
Select the Quadrant that contains the samples
4 Select the first non-identified sample (yellow with a ?)

ACL ELITE/ELITE PRO
Step Action
5 Enter patient’s demographic information as per your protocols; do not select tests,
remember- Default Tests are enabled
6 Samples with barcode labels are identified when the icon is selected;
do not select tests, remember- Default Tests are enabled
7 Select Confirm Continue until all samples are programmed
Select the Materials Map icon and confirm:

8 • All reagents are on board and in the correct position
• All lot numbers are correct and volumes updated
• Rotors and Wash-R Emulsion are available
9
Review and select the Start icon
On ACL ELITE, rotors must be manually loaded. The instrument will prompt the user to load
a new rotor. Message displays ROTOR EXCHANGE NEEDED. Depress the rotor snap
located in the center of the rotor loading/analysis area to properly seat the rotor upon

ACL ELITE/ELITE PRO
Sample Analysis – Manual Sample ID Entry- Using a Loadlist
Performance Guide
Create a Loadlist
Step Action
1 Select Analysis
2 Select Multi-Test or Single Test
3 Select a Quadrant on the sample tray Quadrant
4 Click on an available position (gray color)

(Note: Use ADD QC icon to add QC material)
5 Select Program Sample icon to enter first sample ID
6 Select the Test(s) to be run and enter patient’s demographic information as per
your protocols
The tray positions will be displayed in dark blue with the letter P (Pending) for
7 samples and a QC for a quality control liquid
8 To add additional samples, select the New Sample icon from the database
view screen, repeat step 6
Select the Store Loadlist icon, enter a loadlist number (1-20)

9
Select Confirm icon
Load all samples in the sample tray, confirm the materials map, and select the
10 Start icon

ACL ELITE/ELITE PRO
Skill Check
1. When you are in a Multi-Test / Profile Mode, not connected to an LIS, and
with no Default tests enabled; are tests automatically ordered? Yes No
2. Does the Barcode Reader alone, detect the presence of a cup or a tube in the
sample tray? (Hint: Don’t forget the sensor) Yes No
3. What causes a materials map position to turn red?

________________________________________________________
__________________________________________________________
4. Can you re-start a session after adding a reagent liquid to the instrument?
Yes No
1. What action(s) can be taken for a sample/reagent using the Pause Session
icon?
a) ___________________________
b) ___________________________
c) ___________________________
2. Can you add a control using the Stat/ Pause icon? Yes No
Sign Off
Instructor

DD ACL ELITE/ELITE PRO
D-DIMER
OBJECTIVES
Module you will:
• Enable DDimer and DDh tests, create a Test Profile

• Create Reflex Rules
• Perform Calibration, with an acceptable r2 value for the Calibration Curve
>0.980
• Perform QC with two levels of D-Dimer controls
MODULE RESOURCES
• ACL ELITE / ELITE PRO Quick Reference Guide New Test Setup
PN 722277BB (December 2010) DD 1 of 8

ACL ELITE/ELITE PRO
D-Dimer Helpful Hints

Reagent Handling
Calibrator D-Dimer calibrator is provided in the kit

Calibrator is Lot specific
Only use with appropriate lot and value from appropriate insert sheet
IL Products All IL products should be used for this assay

Do not use washed rotors
Water CLSI CLRWater or equivalent should be used for reconstitution
Reconstitution After the addition of the water, the material should sit at 15-25°C for 30 min
then gently inverted. Do not shake! Avoid foam and bubbles formation.
(Follow reagent Reconstitution instructions in package insert)
Stability For optimal stability, remove reagents from the ACL ELITE / ELITE PRO
and store at 2-8°C in the original vial
Sample Cups Calibrator should be placed in a 0.5 mL sample cup
Reagent Vials Reagent may be left in the original vials

Stir bars not used
Old vs. New Pooling of new reagent into older reagent should be minimized since this
shortens the life of the new reagent stability
DD 2 of 8 PN 722277BB (December 2010)

ACL ELITE/ELITE PRO
D-Dimer Helpful Hints-continued
Reportable Units
DD Test Mode DD test reportable range is 200-1050ng/mL

Any result below 200 should be reported as <200
Any result greater than 1050 should be repeated in the D-Dh test mode
D-Dh Test DDh test reportable range is 1000-5250ng/mL.

Mode Any result less than 1000 should NOT be reported from a D-Dh test
Precision Issues
Typical CV’s
Mean %CV
310 6.01%
732 2.42%
1055 1.31%
Bubbles Check for bubbles in the dilutor block. Debubble if necessary

Check for bubbles in reagent vials and sample cups, remove if necessary
Needles Perform needles cleaning.

Cleaning
Step Action
1 Place Clean A(0.1N HCl) in positions R6
and R7
2 From Main Menu, select Diagnostic,
Cleaning
3 Cycles No. 3
4 Select Start
5 Replace Clean A with 2 vials of Factor
Diluent and repeat
6 Wipe both needles with alcohol wipe
Optics Clean optics for the Chromogenic Channel.

Don’t forget the 405 filter in the rotor holder cover

ACL ELITE/ELITE PRO
D-Dimer Helpful Hints continued

Precision Issues, continued
Rinse Reservoir Clean Rinse Reservoir.
Step Action
1 From Main Menu, select Diagnostics,
Needles Position
2 At the Open Cover prompt, select Yes
3 Once the needles move to the rotor holder
area, remove the Rinse Reservoir
4 Clean thoroughly with Clean A (0.1N HCl)
5 Rinse with DI water and replace Reservoir
6 Press the Stop icon to move the needles back
to the Rinse Reservoir
Precision Run Perform a precision run of 10 cups of the same sample (not done in this class)
Verify the proper protocol for sample collection and handling, reference
CLSI Guidelines
Calculate CV and compare to Typical CVs *
If problem persists, try new Latex and Buffer reagents (remove any bubbles)
* Refer to Verification Manual PN 722276 for Precision Run acceptable CV’s

ACL ELITE/ELITE PRO
Control Recovery
Reconstitution Reconstitute controls with CLSI CLRWater or equivalent as specified on the
control vial and package inserts
Assayed Range Cumulative mean of laboratory control should be within assayed range listed
in package insert
Establish a 2SD range around this mean
Needles Perform Needles Cleaning procedure

Cleaning
Step Action
1 Place Clean A(0.1N HCl) in positions R6
and R7
Cleaning
3 Select Cycles No. 3
4 Select Start
Diluent and repeat
6 Wipe both needles with an alcohol wipe
Probe Verify probe alignment using Maintenance Module of the ACL ELITE /
Alignment ELITE PRO Training Guide
Optics Clean optics for the Chromogenic channel.

Don’t forget the 405 nm in the rotor holder cover
Rinse Reservoir Clean Rinse Reservoir

Step Action
Needles Position
2 At the Open Cover? prompt, select No.
area, remove the Rinse Reservoir
5 Rinse with DI water and replace Reservoir
to the Rinse Reservoir
Recalibrate Recalibrate the D-Dimer assay with fresh Latex and Buffer,
Rerun controls.

ACL ELITE/ELITE PRO
D-Dimer
Performance Guide
Step Action
1 Enable D-Dimer and D-Dh (Refer to ES module to enable/select units for tests)
2 Select ng/mL and Offset for units
3 Setup Test Profile containing D-Dimer and D-Dh (Refer to the MLT module to
create new profile)
4 Transfer the new Test Profile column to the Sorted Multi-Test Profiles list.
(Refer to the MLT module performance guide to sort the profile).
5 Select Setup / Liquids from the working area
6 Enter the reagent information for all liquids used in the test (Refer to LD module
for liquid set up)
7 Assign the calibration value found within the DDimer package insert sheet for
the DDimer Calibrator
8 Review and select Confirm for all liquids
Configure D-Dimer Controls (Refer to SQC module for QC setup) (Use values
provided by facilitator for classroom)
9
• Low D-Dimer Control (DDimer test only)
• High D-Dimer Control (DDimer test only)
10 Select Calibration, Calibrate and select DDimer from Tests to Calibrate drop
down list. (Refer to CAL module for calibrations)

Review liquid positions, update volumes, check lot numbers, rotors etc.
12 Select Start icon
On ACL ELITE, rotors must be manually loaded. The instrument will prompt the user to

ACL ELITE/ELITE PRO
Step Action
13 Once calibration is complete, review data and ensure that the r2 value is > 0.980
14 To analyze D-Dimer test, follow same procedure for analyzing any sample (Refer
to SA1 or SA2 modules)
Warning:
Do not reflex or run a D-Dimer high test for a D-Dimer result under 1000 ng/mL.
By enabling DDh test and a Reflex Rule the ACL ELITE / ELITE PRO System will
automatically make a 1:5 dilution of the sample. Any result below 1000 ng/mL will
dilute below the linear range of the D-Dimer test (200 ng/mL). Reflex Rule should
read: D-Dimer is > 1050, then perform a D-Dh.
Linearity:
D-Dimer: 200 ng/mL-1050 ng/mL DDh: 1000 ng/mL-5250 ng/mL

ACL ELITE/ELITE PRO
Skill Check
1. Show your facilitator the D-Dimer Calibration Report and a run of controls.
2. What is the reportable range for the D-Dimer High test (DDH)?
_____________________________ ng/ml
3. If the D-Dimer controls recovery is not acceptable, what can you check?
Control Recovery
A.
B.
C.
D.
E.
F.
G.
4. Do not reflex to a D-Dimer High test (DDH) if results of the D-Dimer test is
under 1035ng/ml. Please explain Why?
__________________________________________________________
__________________________________________________________
__________________________________________________________
Sign Off
Instructor

TS ACL ELITE/ELITE PRO
TROUBLESHOOTING
OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, Operators Manual, Training Module
and Quick Reference Guide you will:
• Read, understand Chapter 6, Troubleshooting in the Operators Manual and
answer the questions within the module
MODULE RESOURCES

• ACL ELITE / ELITE PRO System Training Guide
• ACL ELITE / ELITE PRO Quick Reference Guide, Troubleshooting,

Errors, TS Calibrations
PN 722277BB (December 2010) TS 1 of 4

ACL ELITE/ELITE PRO
Types of messages generated with system problems
Warnings: displays as a yellow icon in the lower right toolbar region. Selecting the
warning icon allow viewing of description of error. Instrument may continue to run, with
some limitations depending on problem.
Alarm: warns user of problem requiring immediate attention. Some sub-functions and
operations will still be available. Log off instrument, power off and on again; if error
persists contact Call Center.
Failure: message indicates a problem serious enough to prevent further use of

instrument. Attempt to log off instrument (if serious enough may not be able to navigate
in software), power off and on again; if error persists contact Call Center.
Troubleshooting steps:
1. Gather information (what, how, when….)
2. Identify the symptoms (only when we do ____ )
3. Broadly Categorize (QC, sample tray, rotor area, temperature…)
4. Isolate the issue and develop a plan (what can I do before calling Call
Center?)
5. Correct the issue
6. Verify the corrective action (run QC, re-calibrate, run samples….)
7. Document (use for regulatory or future training for peers)
Coagulation Errors
Error Description Abbreviated Flag Priority
Data Reduction Errors R 1 (highest)
Temperature Errors T 2
Instrument Errors E 3
Calibration Errors C 4
Analytical Reference Errors A 5
QC Errors Q 6
Parallelism Errors P 7
Errors on Algorithms, Ratio, Ranges W 8
Materials Errors M 9 (lowest)
TS 2 of 4 PN 722277BB (December 2010)
ACL ELITE®/ELITE PRO
PN 722277BA (December 2010) TS 3 of 4

ACL ELITE/ELITE PRO
Skill Checks:
1. Does a failure prevent you from using the instrument?

__________________________
2. What can cause the Peltier Temperature to be out of range?
______________________________________________________
______________________________________________________
3. What happens if you leave the cover to the rotor stack or holder area open?
______________________________________________________
______________________________________________________
4. Define an error code 7, and what action do you take, if encountered?

______________________________________________________
5. a. What type of error is error code 14 and 30 when received for the D-Dimer test?
b. Will a result be reported?
c. What action can be taken, if encountered?
a. ____________________________________________________
b. ____________________________________________________
c. ____________________________________________________
6. Define the following messages: warning, alarm or failure and whether you can
continue operating your instrument.
Warning__________________________________________________
Alarm____________________________________________________
Failure____________________________________________________
Sign Off
Instructor
TS 4 of 4 PN 722277BB (December 2010)

RWE ACL ELITE/ELITE PRO
REPLACE WASH-R-EMULSION
OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, Operators Manual, Training Module
and Wash-R-Emulsion you will:
• Perform the replacement procedure and prime Wash-R-Emulsion Fluid

• Identify the alarm volume of Wash-R-Emulsion Fluid
• Discover what screen indicates the Wash-R-Emulsion volume
• Identify how results are transmitted when the Wash R Emulsion liquid sensor
is disabled
MODULE RESOURCES
• ACL ELITE / ELITE PRO Operator’s Manual Chapters 1, 2, 6 and 7

PN 722277BB (December 2010) RWE 1 of 4

ACL ELITE/ELITE PRO
Wash - R - Emulsion
• Avoid spillage of the Wash-R-Emulsion when replacing on the

system.
• Wash-R-Emulsion is a silicon-based suspension, used as an internal and
external wash solution for the needles. It washes the probes between
aspiration of samples and/or reagents. This minimizes carryover and prevents
contamination.
• It is also used as an optical reference to set 100% light scatter for the
nephelometric channels. The ACL ELITE / ELITE PRO System compares all
readings to this reference point.
• Wash - R- Emulsion is packaged in a plastic container containing 1000 mL.
• A sensor is located within the cap assembly, which monitors liquid level and
alerts the user when liquid volume falls below 100 mL.
• If the Wash-R level is detected to be low, the Start icon will not be displayed
in the Multi-test Analysis Screen or the Database View screen.
• Open and closed bottles are stable until the expiration date stated on the label.
• When replacing with the same lot number, prime once. When replacing with a
different lot number, prime 3-4 times and recalibrate the PT-FIB curve.
• The new lot number and expiration date must be entered.
• Calibration schedule for PT-Fib based fibrinogens:
At the installation of a new instrument or major service repair.
With a change of the thromboplastin lot number.
With a change of the Wash-R Emulsion lot number (only if reporting PT-
based Fibrinogen).
With a change of rotor lot number Alpha characters (only if reporting PT-
based Fibrinogen).
At the request of a Beckman Coulter representative.
To follow the requirements of the appropriate regulatory agency.
Note: When the instrument is in standby, an automatic priming cycle is

performed approximately every 30 minutes. The consumption of Wash-R-
Emulsion is approximately 0.9 mL (3 strokes per single piston dilutor- total of 6
strokes; each single stroke of 0.15 mL).
RWE 2 of 4 PN 722277BB (December 2010)

ACL ELITE/ELITE PRO
Replace and Prime Wash-R-Emulsion

Performance Guide
Step Action
1 Open cover by depressing the push latch in the Diluter Block/Wash-R-Emulsion

area
2 Remove the liquid level sensor cap assembly and place in front of the bottle area
3 Remove empty bottle
Place a new bottle of Wash-R-Emulsion with the cap ON and the opening to
the left. (Note: Opening to the left, allows the cable from the board to Liquid
4 Level Sensor Cap to maintain a parallel line with the back cover of the
instrument. This orientation of the cable helps to avoid crimping or breakage of
the sensor cable)
Remove cap of new bottle, use the Wash-R-Emulsion reservoir region as leverage
5 to unscrew new bottle cap, then replace the Liquid Level Sensor Cap on new
bottle (Removing the cap on the new bottle after placing on the instrument
prevents any spills to occur)
6 Press cap down firmly, or until the cap ‘snaps’ into position
7 Prime the system, select Diagnostics, Priming. Ensure all bubbles dissipate in
the diluter lines to the waste reservoir
8 Verify the volume adjusts on the Materials Map screen, the upper right box
displays Wash R level in mL
Note:
If the liquid and/or Wash-R Sensors are disabled, the system will not automatically
transmit the results to the host.
At the end of each run, a warning message will appear, instructing the operator to
check the material and sample levels to ensure there is sufficient residual volume in
all reagent and Wash R bottles. Once the check is performed then the results can be
manually transmitted to the host. When the sensors are re-enabled, the auto
transmission will resume. (Chapter 3, page 3.47 of Operators Manual)
PN 722277BB(December 2010) RWE 3 of 4

Skill Check
1. Approximately how many mLs of Wash-R-Emulsion triggers a low volume
alarm? _______mL.
2. Where is the volume for Wash-R-Emulsion displayed?________________
3. What does a “Flush warning” error message indicate and what corrective
action should be taken?
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
4. If the Wash R-Emulsion sensor is disabled, does the instrument automatically
transmit results to the LIS (Host computer)?
Yes No
If not what can you do to transmit the results? If yes, does the user require any
action?
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
Sign Off
Instructor
RWE 4 of 4 PN 722277BB (December 2010)

RR ACL ELITE/ELITE PRO
REPLACE ROTORS
OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, Operators Manual, Training Module,
Rotors and Rotor Insertion Tool you will:
• Replace or Add Rotors to the Rotor Stack using the Rotor Tool
• Locate the status / icons within Software indicating Rotors OK on the ACL
ELITE PRO
• Identify the number of rotors the Rotor Stack can accommodate on the ACL
ELITE
MODULE RESOURCES
• ACL ELITE / ELITE PRO Operators Manual, chapter 1, section 1.4.7

PN 722277BB (December 2010) RR 1 of 6

ACL ELITE/ELITE PRO
Rotors
• The twenty (20) cuvette units is called a rotor. Optical readings occur in the
outer portion of the rotor
• There are two (2) compartments: a small inside area toward the center to hold
sample and/or reagent and a larger outside one, which holds reagent only.
There is a bridge that separates the reagent and sample until testing, acting as
a partial dam or bridge between the two (2) compartments.
• When centrifugal action starts, the liquids within the inner well flow over the
dam/bridge to mix with the reaction reagent in the outer well. The optical
readings are then taken based on the acquisition time of the designated test.
Bridge
Inner Well
Caution: Avoid
touching the area of
the rotor where Outer Well
Optical Readings
occur
Each rotor has twenty measuring cuvette positions. Each individual cuvette is
used for: control plasmas, patient samples or a reference blank. After incubation
and mixing, the optical channels take readings while the rotor is spinning. This is
known as Centrifugal Analysis
At the start of each run the instrument checks each rotor position for light scatter
to determine prior usage of the rotor
When all cuvettes are used, the rotor is automatically discarded into a waste
container by the system on the ACL ELITE PRO only
On the ACL ELITE a message will display that “rotor exchange is needed”.
Select open/close icon to raise or lower the analysis compartment. Replace the
rotor by depressing the rotor snap and lifting the used rotor out of the analysis
compartment. Replace with new rotor by depressing the rotor snap again to allow
the rotor placement onto the analysis area
RR 2 of 6 PN 722277BB (December 2010)

ACL ELITE/ELITE PRO
Rotor Stack
• Is located on the top of the analyzer on the right side
• Holds up to 12 rotors for a total of 240 usable test capacity
• On the Materials Map the upper right corner offers a display which indicates the status
of rotors
• Is thermostatically controlled and insulated to maintain temperature range of 36-39ºC
Rotor Exchange Module (REM) (ACL ELITE PRO only, not applicable
on the ACL ELITE)
• Is located below the rotor stack cover
• Moves the bottom rotor in the stack to the rotor arm mechanism
• Robotic arm moves a new rotor to the rotor holder in the analysis compartment
• The rotor arm also removes used rotor from rotor holder to rotor waste container once
fully utilized or when a user requests a new rotor
• REM enabled/disable is located on the System Configuration screen

• Software for the REM is viewed from the Utility drop down menu, software and
software identification. REM software should be 6.0 version
ACL ELITE/ELITE PRO
• On the ACL ELITE, rotors must be manually loaded from the rotor stack/storage area
into the analysis compartment area. Depress the rotor snap on the center of the hub in
the analysis compartment to properly seat and remove the rotor
Always Use
Rotor Snap to
add or remove
rotors
Rotor Waste Area
• Used rotors are dropped inside a waste container by the rotor arm (on the
ACL ELITE PRO only). On the ACL ELITE system, rotors are manually
moved into the waste bin or discarded immediately into a designated
biohazard waste container
The rotor waste container is accessed by opening the door in the front right of
analyzer. Waste container is removed then replaced after used rotors are
disposed. Disposal of rotors is in accordance with the waste management
procedure of the laboratory and in compliance with local waste regulations
• On the ACL ELITE PRO, the waste area has a micro-switch located in the
rear of the compartment. When the waste container is removed the sensor will
verify the presence/absence of the waste container. The waste container can
accommodate eleven used rotors. Once the waste container is full, a message
will be displayed “Waste container is full or open. Please check and press
RESUME or STOP” The micro switch is unavailable on the ACL Elite, waste
container should be checked as needed
• Warning: Cuvettes within the rotor are intended for one time use only. IL
does not recommend or support the re-use of previously used or washed
rotors.

ACL ELITE/ELITE PRO
Replace Rotors
Performance Guide
Step Action
1 Using the Rotor Insertion Tool, depress the button on top, slide into keyed area of
the rotor stacked in a new package of rotors and release button
Remove the rotors from the package, using the tool displayed. Tearing the
perforated orange strip on the packaged rotor stack as needed, to remove only
rotors located on the Rotor Insertion Tool
3 Open the Rotor Stack cover
Feed the Rotors into the Rotor Stack lining up the keyed slots on the rotors as a
guide (ACL ELITE has no keyed slots within the rotor stack)
Slide down into position, hold down the rotors, depress the Rotor Insertion Tool
5 button on the top, and remove from the rotor
Note: Rotors must be flat and not on an angle
6 Close cover to rotor stack

ACL ELITE/ELITE PRO
Skill Check
1. How many rotors will the rotor stack accommodate? ______________

2. On the ACL ELITE PRO, where can find “rotors OK” message
displayed?________________________________________________
3. What message is displayed when cuvette waste is full on an ACL ELIE PRO?
__________________________________________________________
Sign Off
Instructor

RT ACL ELITE/ELITE PRO
SETUP REFLEX TESTING
OBJECTIVES
Module you will:
• Setup Reflex Rules

• Perform execution of Reflex Rules created
• Define the number of reflex rules stored in database
• Identify the number of tests each reflex rule can run
• Innumerate the number of criteria identified per reflex rule created
MODULE RESOURCES
• ACL ELITE / ELITE PRO Operators Manual, Chapter 4 and 7
PN 722277BB (December 2010) RT 1 of 6

ACL ELITE/ELITE PRO
Setup Reflex Testing
Performance Guide
Step Action
Using the steps 2-11 below, create the following Reflex Rules:
A. If a R-PT sec is greater than or equal to 50 or gives a Coag Error 6,7,12
or 31. Then perform an R-PTe.
B. If an APTTSYS sec is greater than or equal to 100 or gives a Coag

1 Error 6, 7, 13 or 31. Then perform an APTTSYSe.
C. If a R-PT INR greater than or equal to 4.0. Then perform an R-PT.
D. If a D-Dimer ng/mL is greater than or equal to 1050. Then perform a

D-Dh
2 Select Setup / Test / Reflex Test from the Main Menu
3 To add a new rule select Add to List icon
4 To add a condition to the rule select Add to List icon
5 Cursor to the test and use drop down to select Test ID
6 Select Units and choose unit required if applicable
7 Select Comparison Choose: =, > or <
8 Select either the Value or Error
9 To select Value input the value in the box
10 To select the Error code icon Cursor to error code desired and choose
the Select icon (Multiple errors may be selected)
RT 2 of 6 PN 722277BB (December 2010)

ACL ELITE/ELITE PRO
Step Action
12 Repeat steps 4-11 to add other conditions to these Reflex Rule (if needed)
From the Actions Tests list, transfer, using arrow icon, the test(s) you want to
13 reflex to the Programmed Tests list Note: Up to ten actions (tests) can be
defined
Repeat steps 1-12 to create additional rules.

15 Note: When creating a rule with more than one condition, use the And/Or
The choice(s) determine if both conditions need to be met (And), or just one
(Or)
Modify an Existing Rule (Optional)
Step Action
1 Cursor to the rule that you want to modify and select the Details icon
2 Cursor to the condition to be modified and select the Details icon
3 Repeat steps 3-14 above for any changes or modification
4 Print out your reflex rules and review them
Disable a Rule (Optional)
Step Action
1 Select the rule to be disabled
2 Select the Enable/Disable icon
3 A message window will appear “Do you really want to Disable the selected
Reflex Rule?”
4 Make the appropriate selection

ACL ELITE/ELITE PRO
Perform Reflex Test
Step Action
1 Analyze patients, provided by your facilitator, for both PT and APTT tests
2 Analyze a D-Dimer patient, provided by your facilitator
3 Select the appropriate Multi-test that has all tests within, verify this the proper
Multi-test by reviewing your materials map prior to start of the run
4 Review results of the Reflex or Extended Assays
Reflex Rules Examples
1. R-PT > 50 seconds then RPT-e

2. R-PT (sec) = error 6 then RPT-e
3. R-PT (sec) = error 7 then RPT-e
4. R-PT (INR) >= 4.0 then RPT
5. APTTSYS > 110 seconds then APTTSYS-e
6. APTTSYS (sec) = error 6,7 then APTTSYS-e
7. Fib-C < 70 mg/dL (or 7 g/L) Fib-C l
8. Fib-C > 700 mg/dL (or 7 g/L) Fib-C H
9. D-Dimer > 1050 ng/mL D-D h
10. VWF > 150 % VWF h
(Reference Operators Manual, Ch.4,pg 4.12)

ACL ELITE/ELITE PRO
Skill Check
1. How many Reflex rules can be defined?
Hint: Operator’s Manual Chapter 7 Assay and Instrument Specifications or
Chapter 4 section 4.1.6
________________________________________________
2. How many conditions can be defined in each single rule?

Hint: Operator’s Manual Chapter 7 Assay and Instrument Specifications
________________________________________________
3. How many tests/actions can be generated by each single Reflex Rule?

Hint: Operator’s Manual Chapter 7 Assay and Instrument Specifications
________________________________________________
4. Show facilitator your reflex rules and patient printouts executing these reflex
rules.
Sign Off
Instructor

ACL ELITE/ELITE PRO

INR ACL ELITE/ELITE PRO
INR SETUP
OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, Operators Manual, Training

Module, New Lot Information for PT reagent (or package insert), you will:
• Enter a New Lot number of RecombiPlastin
• Enter the New Mean Normal Range
• Enter the New ISI value
• Identify correct INR setup values
• Describe Mean Normal Range (MNR)
MODULE RESOURCES

• ACL ELITE / ELITE PRO Easy Reference Guide, Lot Changes
Warning:
If the INR calculation is not properly setup, erroneous patient results may be
reported. If the product lot number changes, the new ISI value from the
package insert must be entered. On the ACL ELITE / ELITE PRO, both the
Database Screen and Patient Printouts will display the Ratio and INR units
separately, if enabled. MNR number needs to be verified on each lot change
of PT reagent as per your laboratory regulating agency.
PN 722277BB (December 2010) INR 1 of 4

ACL ELITE/ELITE PRO
INR Setup
Performance Guide
Your laboratory has just received a new lot number of RecombiPlastin reagent. The new
normal range study has been completed and this lot number is ready to be used for reporting
patient results.
Setup the new information on your instrument; refer to ES and LD modules.

The new lot information is:
Lot Number: N123456

Expiration date: 12/31/(current year)
Mean Normal Range: 11.9
ISI: 0.89
Enter Mean Normal Range
Step Action
1 Select Setup / Test / View/Define
2 Cursor or select the test PT to be modified. (i.e. PT, PTHS, PTHS plus, PT-R,
R-PT) Select R-PT for this class
4 Select the Calculation Setup icon and enter the Mean of your Normal Range
(MNR) in the Reference Value box
Note: It is not necessary to enter the MNR value for other subsequent PT
tests…. i.e. Extended (e), Duplicate (d), Extended Duplicate (ed) tests.
This value is imported from the primary test.
INR 2 of 4 PN 722277BB (December 2010)

ACL ELITE/ELITE PRO
Entering the ISI Value
Step Action
1 Select Setup / Liquids
2 Select the Liquid ID (RecombPT) and cursor or touch the appropriate PT test in
the Used By / Value ISI column i.e. R-PT
3 Select the Assign Value icon
4 Enter the ISI value from the reagent insert sheet
6 A message will appear “Liquid Parameters have been changed. Do you want to
save them before proceeding?”
7 Select: Yes
8 Run QC materials and samples to demonstrate new lot performance and accuracy
of lot number changes made (no need to recalibrate for classroom purpose)
Note: It is not necessary to enter the ISI value for other subsequent PT tests.
i.e. Extended (e), Duplicate (d), Extended Duplicate (ed) tests. The value is
imported.
PN 722277BB (December 2010) INR 3 of 4

ACL ELITE/ELITE PRO
Skill Check
1. What two values need verified for correct INR reporting?
__________________________________________________________
2. For any applicable test, where do you enter the MNR (Mean of the Normal
Range)?
__________________________________________________________
3. For the PT reagent used in this class, where do you enter the ISI (International
Sensitivity Index)?
__________________________________________________________
4. Is the MNR and ISI re-entered in all associated PT tests?

__________________________________________________________
Why or why not?

___________________________________________________________
___________________________________________________________
5. How do you obtain a MNR (Mean of the Normal Range) based on your
regulating agency?
___________________________________________________________
Sign Off
Instructor
INR 4 of 4 PN 722277BB (December 2010)

CT ACL ELITE/ELITE PRO
COPY TEST-NEW LOT CORRELATION SETUP
OBJECTIVE
Given an ACL ELITE / ELITE PRO workstation, the Operators Manual, Training
Manual, Quick Reference Guide and an installed Printer you will:
• Create/Copy and Edit a Test to Perform New Lot Testing

• Create a new liquid called NLR- PT
• Create a new liquid called NLPTTSys
• Create a new liquid called NL CaCl2
• Create a new test called R- PTNL
• Create a new test called R- FIB_NL
• Create a new test called APTTSYSN
• Create a new liquid called DDLatexNL
• Create a new liquid called DDBufferNL
• Create a new liquid called DDCalNL
• Create a new test called DDimerNL
• Create new QC files
• Setup new QC materials
• Create a QC loadlist
MODULE RESOURCES
• ACL ELITE /ELITE PRO Training Manual

• ACL ELITE /ELITE PRO Operators Manual, Chapter 4, Section 4.1.12
• ACL ELITE /ELITE PRO Quick Reference Guide, Reagent Loading, Lot
Change and New Test Setup
• HemosIL Reagent/Calibration Package Inserts
Note:
All responsibility for parameter development and validation of a new or
copied test belongs to the user alone.
PN 722277BB (December 2010) CT 1 of 24

ACL ELITE/ELITE PRO
Performance Guide
Create a New Lot R-PT Reagent

This procedure is for new lots of R-PT (HemosIL R2G) and enable user to enable two
different lots for the same reagents/tests (R-PT), for sole reason to complete
correlations prior placing the new lot into use for daily analysis and result reporting.
Step Action
1 From the main menu select Setup / Liquids
2 Select the New Liquid icon
3 Enter NLR-PT in the Liquid ID field
4 Enter New Lot R-PT in the Extended Name field
5 Start the new Liquid Code above 501. Enter Liquid Code 615 (IL uses many of
the codes below this number for their own test liquids – see Operators Manual)
6 Enter the new Lot No.: ________ Expiration Date: ________On board
Stability:________
7 Assigned Volume and Warning Volume will be “vial” dependent. Use a 10 mL

vial. (See LD Module, page LD 3)
8 Accessing Needle: Reagent
9 Default Position: R4
10 Liquid Type: Reagent
11 Check the Refrigerated box (and Stirred box, if applicable)
12 Select Confirm x 2
*Note: ISI assignment is not completed until a new test is created and this new
liquid is then assigned to the new test.
Note: If a message appears “A valid and unique liquid code is required……”

This indicates that the number is used by another liquid, the system will not
allow you to save this liquid. You must use a code that has not been previously
defined; use a number greater than 501.
CT 2 of 24 PN 722277BB (December 2010)

ACL ELITE/ELITE PRO
Create/copying a New R-PT (R2G) Test
Note: All responsibility for parameter development and validation of a new or copied test
belongs to the user alone.
Step Action
1 Select Setup, Test, View / Define
2 Cursor or touch to select the R-PT test
3 Select the Copy Test icon
4 Enter R-PTNL in the New Test ID and New Lot R-PT in the Extended Name
5 Enter Test Code for Host: 616 (501-999 used for host communication)
6 Enter Test Code: Same as Host Test Code (501-999 used for host
communication)
7 Select Confirm
8 Disable Show Enabled box and Enable the test you created: R-PTNL
9 Cursor to new test R-PTNL, select Test Details screen, use the ▲▼ to select the
units that will be shown in the database view screen and on reports
10 Verify the units from your current R-PT test have a checkmark in the show
column
11 Changes to units displayed are in Range Setup, also modify your laboratory
established ranges as necessary
12 Select Confirm
13 Select the Details icon for the R-PTNL test for next step-Analysis Setup

ACL ELITE/ELITE PRO
All of the changes to the new Copied Test parameters will be performed within Analysis
Loading Setup parameters. This is the area of the test parameters where we define the
loading sequence for the test. In addition, we will re-create the Reagent Aspiration, and
Calibration Loading Setup parameters areas.
Analysis Loading Setup
Step Action
1 Select Analysis Loading Setup in the Test Details screen
2 Cursor or touch to select Index Step 1 Sample
4 Select the Parameters icon (right of the Reagent Line)
5 In the No Dilution Liquid ID box use the drop down arrow and change RPT to
the new liquid ID NLR-PT
6 Select Confirm
7 A box will come up stating: “A New Liquid has been selected. If you save the
new test setup, the Test will be removed from all profiles” Select YES
Note: A message will appear concerning modified tests..wish to continue, select Yes.

ACL ELITE/ELITE PRO
Calibration Loading Setup
Step Action
1 Select Calibration Loading Setup icon
2 Cursor or touch to select Index step 1 for the Std 1 (Standard 1)
4 Select the Parameters icon to the right of the Reagent Line
5 In the No Dilution Liquid ID box using the drop down menu and change RPT to
the new liquid NLR-PT
6 Select Confirm
8 Select Confirm
Cursor or touch to select Index step 2, for the Std 2 (standard 2), Repeat steps
9 2-8. Note: You may not get the same warning message from step 7, continue by
selecting confirm
Cursor or touch to select Index step 3, for the Std 3 (standard 3), Repeat steps
10 2-8. Note: You may not get the same warning message from step 7, continue by
selecting confirm
11 Select Confirm multiple times to exit, and select YES to any questions
Note:
Verify the INR for the new PT test, by input of the MNR (Mean of the
Number Range) under the Setup, Calculation Setup area, and the new ISI
from the package insert under the Setup / Liquids area.
Note:
The ACL ELITE / ELITE PRO and the ACL 8, 9 and 10000 use identical

ACL ELITE/ELITE PRO
Create/Copying a New R-FIB_ Test
Step Action
2 Cursor to R-FIB_
3 Select the Print icon, to print the R-FIB_ test parameters
4 Select Yes to prompt “Do you want to print the test report”?
5 Select the Copy Test icon to make an exact copy of R-FIB_
6 Name the New Test ID R-FIB_ NL and the Extended name New Lot R-FIB
7 Give the new test a Test Code for Host and Test Code 654 (501-999 used for
host communication)
8 Select Confirm
9 Enable the test you defined R-FIB_NL
10 Cursor to new test R-FIB_NL, select Test Details screen, use the ▲▼ to select
the units that will be show in the database view screen and on reports
12 Use the drop down and Change Import Raw Data From to R-PTNL and
Imports Calibration from None
A message will appear “That the use of imported raw data has been modified.
Current parameters for the loading…will be lost… proceed?” Select Yes to save
13 changes. (Do not confirm, go to Editing the Parameters, page CT 7)
NOTE: ALL parameters will be erased for this test and requires re-entry!

ACL ELITE/ELITE PRO
Editing the Parameters when Raw Data is imported:
Step Action
1 Select Calculation Setup icon
2 Verify Scope = Sample
3 Change Algorithm Type to Delta Algorithm
4 Ratio: use the drop down menu and select R=S/Std1
5 A message will appear that “selecting a change will erase results…confirm?”

Press Yes to save the changes
6 Select Define Parameters icon, right of Scope, to open Delta Algorithm screen
7 Enable the 1st Smooth and enter value of 15 for Degree, and Enter
8 Enable the 2nd Smooth and enter value of 9 for Degree, and Enter
9 For the First Part of the Reaction Curve, enable Offset and enter 10 for Points
10 For the Final Part of the Reaction Curve, enable Final and enter 10 for Points
11 Select Curve Check Parameters icon
12 Enable 1st Threshold
13 Select the Threshold Parameters icon
14 Check that Threshold Search Direction is selected to Forward
15 Check Threshold Mode is selected to Absolute
16 Enter the Value of 3 under the 1st Threshold
17 Select Confirm

ACL ELITE/ELITE PRO
Step Action
18 A message will appear: “Selecting a new Parameter for the current list….. Do
you confirm this new selection?” Press “Yes” to save the changes
19 Enable Saturation (x)
20 Enable 2nd Threshold and enter the number 6
Enable Final Slope and enter the following:

21 a. Points = 101
b. Value = 5
21 Select Confirm
22 A message will appear that “selecting a change will erase results…confirm?”

Press Yes to save the changes
23 Check the box Delta Correction (x) on the Delta Algorithm screen
24 Select Correction Parameters box
Enter the following Parameters: (Tab between each field) A message will appear
stating that a new correction can cause inconsistency of results stored in Patient,
AR, QC and Calibration databases….Do you confirm new selection? Select OK
25 Min Max M(coeff) q(coeff)

st
1 Interval 100.00 200.00 0.0023 0.7701
2nd Interval 200.00 400.00 0.0014 0.9479
3rd Interval 400.00
New Corrective action message appears, answer OK
27 Select Calibration Setup icon

ACL ELITE/ELITE PRO
Step Action
Select ALL Std on the left side of the screen and input the data in the table below
for Std 1, Std 2 and Std 3
NOTE: A message will appear after every Dilution Ratio% for which
parameters have been changed… “As a consequence the stored calibration will
be erased …confirm?” Press Yes to save these changes
28
Standards Dilution CV
Ratio %
Std 1 100.00 8.0
Std 2 50.00 12.0
Std 3 25.00 12.0
29 Response Type: use the drop down arrow menu and select Delta ∆
30 Check the box Check CV (x) to enable
31 Check the box Outlier (x) to enable
32 Final Unit use the drop down arrow and selects mg/dL
A message will appear “Selecting a result unit for the current test all results
33 already stored in patient QC, AR and calibration databases will be erased. Do
you confirm the new selection?” Press Yes to save these changes
Select Calibration Curve Setup button, and enter the following information:
34 X= r = x/Std1
Y= y
Under Calibration Curve section enter the following information using the drop
down arrow:
35
Start End F(x) G(y) q’ Translation
Point Point Point
1st Std 1 Std 3 x y (x) to enable Std 1

ACL ELITE/ELITE PRO
Step Action
Under Calibration Curve Checks section enter the following information.

36 Slope Range r² > =
st
1 Curve 0.0000 to 1000.0 0.980
37 Select the Define as Mandatory icon
38 Select Std 2 and then select Define as Mandatory icon
39 Select Std 3 and then select Define as Mandatory icon
40 You should have a check mark (√) in each of the standards (Std1, Std2 and Std3)
41 Press Confirm x 2
42 Scope Select Std 1 and press Define Parameters icon
43 Enable the 1st Smooth and enter value of 15, select Enter
44 Enable the 2nd Smooth and enter value of 9, select Enter
45 For the First Part of the Reaction Curve, select Offset and enter 10 for Points
46 For the Final Part of the Reaction Curve, select Final and enter 10 for Points
47 Press the Curve Check Parameters icon
49 Select the Threshold Parameter icon
50 Check that Threshold Search Direction is selected to Forward
51 Check Threshold Mode is selected to Absolute

ACL ELITE/ELITE PRO
Step Action
Select Confirm
53
A message will appear “Selecting a new Parameter……” Select Yes to save the
changes
Enable Final Slope and enter the following:

55 a. Points = 101
b. Value = 5
57 Press Confirm
A message will appear Selecting a change of curve check for the current test all
58 results already stored in patient, QC, AR and calibration databases will be
erased. Do you confirm? Select Yes to save these changes
59 Select Confirm
60 Select Std 2 and press Define Parameters icon
61 Repeat steps 43-61
63 Repeat steps 43-61
Select Confirm until you are back at the initial Test Details screen for
64 RFIB_NL
Use the ▲▼ to select the unit that will be showing in the database
65 Select the Ranges icon and modify ranges as necessary
Check the Show in Sample List box (x) if you want this unit to appear in the
66 Database Screen. Uncheck the box if you do not want the unit to
appear on database view and reports

ACL ELITE/ELITE PRO
Step Action
67 RFIB_NL only show unit mg/dL
68 Input the Test Range and Scale Range for Delta/Ratio/mg/dL
Select the unit and press the Ranges box to input the ranges:
Test Range Scale Range
69 Delta Δ 0.000-400.000 0.000-999.000
R 0.000-10.000
mg/dL 80.000-700.000 0.000-3000.00
70 Press Confirm
71 A message will appear “Because of the modified setup….will be erased.” Do you

confirm the new selection? Press Yes to save these changes.
72 A message appears Database Update in Progress
73 Print the new RFIB_NL test definition and compare it to the original test
definition R-FIB_ (printed previously)
Do not forget to enter the calibrator value for the new Fibrinogen Assay
74 RFIB_NL from the Cal Plasma package insert. Select Setup/ Liquids/ Cal
Plasma
75 Calibrate the new tests: NLR- PT and RFIB_NL
NOTE:
All responsibility for parameter development and validation of a
new or copied test belongs to the user alone.

ACL ELITE/ELITE PRO
Create a New Lot APTTSYS and CACL Reagents
This procedure is to be used for new lots of APTT reagents (HemosIL APTTSYS and
CACL),are created to enable two different lots for the same reagents/tests (APTTSYS),
so correlations can be completed prior to use for daily analysis and result reporting.
Step Action
1 Select Setup / Liquids from the main menu
3 Enter NLAPTTSY in the Liquid ID field
4 Enter New APTT SynthASil in the Extended Name field
Start the new Liquid Code above 501. You may enter Liquid Code 624 (IL
5 uses many of the codes below this number for their own test liquids – see
Operator’s Manual)
6 Lot No.: ________ Expiration Date: ________On board Stability:________

vial (See LD-3 Module for the table displaying volume assignments)
11 Check the Refrigerated box
12 Select Confirm
13 Select New Liquid
14 Enter NLCACL2 in the Liquid ID field
15 Enter New Lot CACL2 in the Extended Name field

ACL ELITE/ELITE PRO
Step Action
Operator’s Manual).
17 Lot No.: ________ Expiration Date: ________On board Stability:________
18 Assigned Volume and Warning volume will be “vial” dependent. Use a 10 mL

vial. (See LD-3 Module (table displaying volume assignments)
19 Accessing Needle: Sample
22 Select Confirm
Create/copying a New APTTSYS Test

Step Action
2 Cursor or touch to select the APTTSYS test
4 Enter APTTSYSN in the New Test ID and New APTTSythASil in the

Extended Name
communication)

ACL ELITE/ELITE PRO
Step Action
7 Select Confirm
8 Disable Show Enabled box and Enable the test you created: APTTSYSN
9 Cursor to new test APTTSYSN, select Test Details screen, use the ▲▼ to select
11 Select Calculation Setup, input the Reference Value for your lab (mean normal
range)
12 Select Confirm
Loading Setup parameters. This is the area of the test parameters where we define the loading
sequence for the test. In addition, we will re-create the Reagent Aspiration, and Calibration
Loading Setup parameters areas.
Step Action
1 Select Analysis Loading Setup in the Test Details screen of APTTSYSN test
2 Select Reagent Priming box
3 Select Diluted Liquid ID (located in right column under the Reagent Line),
change diluted liquid ID to CleanA
4 Select Confirm
5 A message will come up stating: “A New material has been detected. Test will be
removed from all profiles..” Select OK to save.
6 Select Confirm

ACL ELITE/ELITE PRO
Step Action
7 Cursor or touch to select Index step 1 for the Sample and select Details icon
8 Press the Parameters icon to the right of the Reagent Line
9 In the No Dilution Liquid ID box use the drop down menu and change
APTTSYS to the new liquid NLAPTTSY
10 Select Confirm
12 Select Confirm
13 Cursor or touch to select Index step 3 and select Details icon
14 Select Parameters icon for the Sample Line
15 In the No Dilution Liquid ID use the drop down menu to select NLCACL2
16 Select Confirm multiple times to exit and select YES to any questions
Interference Table
This test must be added to the Interference Table for reagent priming to occur, this
improves the system performance and minimizes carryover between tests.
Step Action
1 Select Setup / Tests / Interference Table
2 For APTTSYSN, move the new lots identified as: R- PTNL and RFIB_NL
assays from the Enabled Test List to the Interfering Test List.
3 Select Confirm A message appears: “Do you want to save….modified

test?” Select Yes

ACL ELITE/ELITE PRO
Create a New Lot DDimer Reagents

This procedure is to be used for new lots of DDimer. Create to enable two different lots
for the same reagents/tests for DDimer. Use for correlations, prior to use in daily
analysis and result reporting.
Step Action
3 Enter DDBufferNL in the Liquid ID field
4 Enter New DD Buffer in the Extended Name field
Operator’s Manual).
6 Lot No.: ________ Expiration Date: ________On board Stability:_xxd

(d=days)
7 Assigned Volume and Warning volume will be “vial” dependent. Use a 10mL
vial (See LD-3 Module for the table displaying volume assignments)
9 Default Position: A6
10 Liquid Type: Solution, Fill in the Assigned Volume: _________and Warning

Volume: _________
11 Select Confirm
13 Enter DDLatexNL in the Liquid ID field
14 Enter New DDLatex in the Extended Name field

ACL ELITE/ELITE PRO
Step Action
Start the new Liquid Code above 501. You may enter Liquid Code 853 (IL uses
15 many of the codes below this number for their own test liquids – see Operator’s
Manual).
16 Lot No.: ________ Expiration Date: ________On board Stability: xx d
(d=days)
17 Assigned Volume and Warning volume will be “vial” dependent. Use a 4 mL vial
(See LD-3 Module for the table displaying volume assignments)
20 Liquid Type: Reagent, Fill in the Assigned Volume:________ and Warning

Volume:________
21 Check the Refrigerated box (and Stirred box, if applicable)
23 From the Drop Down Menu Select Setup / Liquids
25 Enter DDCalNL in the Liquid ID field
26 Enter New Lot DDimer Cal in the Extended Name field

Start the new Liquid Code above 501. You may enter Liquid Code 753 (IL uses
27 many of the codes below this number for their own test liquids – see Operator’s
Manual).
28 Lot No.: ________ Expiration Date: ________On board Stability: xxd
(d=days)
29 Assigned Volume and Warning volume will be “vial” dependent. Use a 1mL vial.
(See LD-3 Module for the table displaying volume assignments)
32 Liquid Type: Calibrator, Fill in the Assigned Volume:________ and Warning

Volume:________

ACL ELITE/ELITE PRO
Create/copying a New DDimer Test
Step Action
1 Select Setup, Test , View/Define
2 Cursor or touch to select the DDIMER test
4 Enter DDimerNL in the New Test ID and New Lot DDimer in the Extended
Name
communication)
7 Select Confirm
8 Disable Show Enabled box and Enable the test you created: DDimerNL
9 Cursor to new test, DDimerNL, select Test Details screen, use the ▲▼ to select
Select the Details icon for the DDimerNL test, select Calculation Setup define
11 the reference value for your lab (mean normal range). Make no changes, but
MUST go into this screen
12 MUST Select Confirm (Note: Failure to select Confirm, an error

occurs when attempt to calibrate the new lot)
loading sequence for the test. In addition, we will re-create the Reagent Aspiration and
Calibration Loading Setup parameters areas.

ACL ELITE/ELITE PRO
Step Action
1 Select Analysis Loading Setup in the Test Details screen of DDimerNL test
2 Select Index Step 3, then details
3 Select Parameters to the right of the Sample Line, do not change the in line
dilution
4 Select from the drop down selections within the Diluent Liquid ID, displayed
under the In Line Dilution to the DDBufferNL
5 Select Confirm
6 A message will come up stating: “A New material has been detected. Test will be
removed from all profiles..” Select OK to save
7 Select Confirm
8 Select Parameters to the right of the Reagent Line, do not change the no
dilution drop down
9 Select from the drop down selections within the Liquid ID, displayed under the
No Dilution to the DDLatexNL
10 Select Confirm
12 Select Confirm
14 From the Test Details select Calibration Loading Setup
15 Cursor to Index step #3, Scope Std 2,3, Select Details icon
16 Select Parameters to the right of the Sample Line, do not change the no
dilution drop down
No Dilution to the DDBufferNL

ACL ELITE/ELITE PRO
Step Action
18 Select Confirm and YES until return to Calibration Loading Setup

screen
19 Cursor to Index step #4, Scope Std 1, Select Details icon
dilution drop down
21 Within the Liquid ID, Select from the drop down selections and displayed as
Diluent Liquid ID the DDBufferNL
22 Within the Liquid ID, Select from the drop down selections and displayed as the
Diluted Liquid ID the DDCalNL
23 Select Confirm Confirm all messages with Yes
dilution drop down
25 Within the Liquid ID, select from the drop down selections and displayed as the
Liquid ID the DDLatexNL
26 Select Confirm and YES until Calibration Loading Setup screen
dilution drop down
Diluted Liquid ID the DDCalNL
30 Select Confirm
dilution drop down
32 Within the Liquid ID, select from the drop down selections and displayed under
the Liquid ID the DDLatexNL
32 Select Confirm and YES until Calibration Loading Setup screen

ACL ELITE/ELITE PRO
Step Action
34 Repeat steps 28-32 above. Select Confirm multiple times to exit, and select YES to
any questions until returned to Test Details Screen
Select Calculation Setup, make no changes, however must select confirm

or a message displays “an inconsistency……”
35
NOTE: This step is important, if missed user will not be able to calibrate new
test
Utilize Copy Tests
Complete any Calibrations, set up new QC, Loadlists and Intereference Table for tests
with reagent priming (PTT).
Step Action
1 Setup Multi-test Profile to include New and Old Tests, to collect correlation
data
2 Setup or create new QC files to include new tests
3 Create Loadlist(s) with new test(s) to collect correlation data
4 Create an Interference Table for all new APTT tests (see page 16)
Note:
Verify the INR for the new PT test by input of the MNR (Mean of the Number
Range) under the Setup, Calculation Setup area, and the new ISI from the
package insert under the Setup / Liquids area.
Note:
The ACL ELITE / ELITE PRO and the ACL 8, 9 and 10000 use identical
Proceed to the Skill Check for this Module

ACL ELITE/ELITE PRO
Skill Check
1. Show your facilitator or your application specialist the setup files that include:
Tests created, Liquids created, Multi-tests created, QC levels, Interference
Tables, Loadlists, the results obtained from Calibrating new lots as required
and the Correlation Data accumulated.
Sign Off
Instructor

ACL ELITE/ELITE PRO

HEP ACL ELITE/ELITE PRO
LIQUID HEPARIN-XA
OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, Operators Manual, Quick

Reference Guide and Training Module you will:
• Enable Liq HEP test, create a Test Profile

• Perform Calibration, with an acceptable r2 value for the Calibration Curve
>0.980
• Perform QC with (2) two levels of Heparin controls per kit, total of (2) two
kits
MODULE RESOURCES
• ACL ELITE / ELITE PRO Operators Manual
• ACL ELITE / ELITE PRO Quick Reference Guide, New Test Setup
PN 722277BB (December 2010) HEP 1 of 6

ACL ELITE/ELITE PRO
Principles of Procedure
Heparin is analyzed as a complex with antithrombin present in the sample. The
concentration of this complex is dependent on the availability of the patient’s endogenous
antithrombin. When the heparin – antithrombin complex is formed, two competing reactions
take place
1. Factor Xa is neutralized by the heparin-antithrombin complex

2. Residual Factor Xa is quantified with a synthetic chromogenic substrate. The
paranitroaniline released is monitored kinetically at 405nm and is inversely proportional
to the heparin level in the sample
In order to reduce the influence from heparin antagonists, such as platelet factor 4 (PF4), dextran
sulfate is included in the reaction mixture. (HemosIL Liquid Heparin package insert issued
06/2009, Instrumentation Laboratory)
Control Recovery
Reconstitution Reconstitute controls with CLSI CLRWater or equivalent as specified on the
control vial and package inserts
Assayed Cumulative mean of laboratory control should be within assayed range listed
Range in package insert
Establish a 2SD range around this mean
Needles Perform Needles Cleaning procedure

Cleaning
Step Action
1 Place Clean A(0.1N HCl) in positions R6 and
R7
Cleaning
3 Change Cycles No. from 3 to 5
4 Select Start
Diluent and repeat.
6 Wipe both needles with an alcohol wipe.
HEP 2 of 6 PN 722277BB (December 2010)

ACL ELITE/ELITE PRO
Probe Verify probe alignment using Maintenance Module of the ACL ELITE /
Alignment ELITE PRO Training Guide
Optics Clean optics for the Chromogenic channel

Don’t forget the 405 nm in the rotor holder cover
Rinse Reservoir Clean Rinse Reservoir
Step Action
Needles Position.
2 At the Open Cover? prompt, select No.
area, remove the rinse reservoir.
5 Rinse with DI water and replace.
to the rinse reservoir.

ACL ELITE/ELITE PRO
Xa Kit
Performance Guide
Step Action
1 Enable Liq HEP (Refer to ES module to enable/select units for tests)
2 Select IU/mL units
3 Select Setup / Liquids from the working area

Enter the reagent information for all liquids used in the test (Refer to LD module
6 for liquid set up) Five reagents in kit: HEP Cal 1, HEP Cal 2, HEP Cal 3, LHep
FXa and LHep Sub.
7 Assign the calibration values found within the Heparin Calibrator package
insert sheet
8 Review and select Confirm for all liquids
Configure Heparin Controls (Refer to SQC module for QC setup) (Use values
provided by facilitator for classroom)
• LMW Low Control
9 • LMW High Control
• UFH Low Control
• UFH High Control
10 Select Calibration, Calibrate and select Liq Hep from Tests to Calibrate drop
down list. (Refer to CAL module for calibrations)

Review liquid positions, update volumes, check lot numbers, rotors etc.
12 Select Start icon
On ACL ELITE, rotors must be manually loaded. The instrument will prompt the user to

ACL ELITE/ELITE PRO
Step Action
13 When calibration is complete, review data and ensure that the r2 value is > 0.980
14 To analyze Liq Hep test, follow same procedure for analyzing any sample (Refer
to SA1 or SA2 modules)

ACL ELITE/ELITE PRO
Skill Check
Show your facilitator the Liq HEP Calibration Report and a run of controls.
Sign Off
Instructor

FA ACL ELITE/ELITE PRO
FACTOR CALIBRATION AND ANALYSIS
OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, Operators Manual, and Training
Module you will:
• Perform Factor Assay Calibration and Analysis

− The acceptable r2 value for all segments of the curve > 0.980
MODULE RESOURCES

• ACL ELITE / ELITE PRO Operators Manual, Chapter 3 and 7
• ACL ELITE / ELITE PRO Easy Reference Guide, New Test Setup
PN 722277BB (December 2010) FA 1 of 8

ACL ELITE/ELITE PRO
FACTOR ASSAYS CALIBRATION for Non Parallelism Tests

This information is valid for all eight factor assays (VII, X, V, II, XII, XI, IX and VIII*)
when using the IL tests library. The calibration curve for factors is divided into three
segments:
High Curve: Prepared using Cal Plasma with levels at 100%, 50% and 25%.
Low Curve: Prepared using Low Cal F with levels ranging from 6.25%, 3.125% and
1.56%.
Middle segment: connects the 25% from segment one and the 6.25% from segment
three.
*excludes Chromogenic Factor VIII
Below is a summary of the six dilutions used by the ACL ELITE / ELITE PRO to
perform a Factor Assay calibration when all three segments are performed.
Dilution Preparation
Ratio in %
100 Undiluted Calibration Plasma
50 Cal Plasma - Dilution done
automatically by the ACL ELITE /
ELITE PRO ™.
25 Cal Plasma - Dilution done
automatically by ACL ELITE / ELITE
PRO ™.
6.25 Cal Low F - Manually prepared
diluting the Calibration Plasma 1+15
with Factor Diluent. (1:16 Dilution)
Note: Cal LowF is automatically
prepared with the following selected
test(s): FVIII SP/SS and FIX SP/SS
3.12 Cal Low F - Dilution done
ELITE PRO ™ Factors VIII SP, IX
SP,
VIII SS and IX SS (only).
1.56 Cal Low F - Dilution done
ELITE PRO ™ Factors VIII SP, IX
SP, VIII SS and IX SS (only).
FA 2 of 8 PN 722277BB (December 2010)

ACL ELITE/ELITE PRO
FACTOR ASSAYS FOR PARALLELISM TESTS

Introduction
Factor Parallelism is a technique used to determine the influence or effect inhibitors have
on a sample’s Factor Assay activity result. The possible presence of an inhibitor and its
effect may be determined by assaying the Factor using a series of dilutions. The impact of
the dilutions on the factor activity can then be observed.
The purpose of the Parallelism function on the ACL ELITE / ELITE PRO is to assist with
the identification of an inhibitor in an easy, automated fashion. The Parallelism test mode
is a means to create operator definable dilutions. The instrument will execute all
dilutions, perform testing on the dilutions, and will provide evaluation data on the results
to assist in determining the presence of an inhibitor.
The software provides multiple checks of the data generated and provides the operator
with valuable information to assist in identifying the presence of an inhibitory pattern.
Some of the checks include comparison to the original undiluted result and precision data
of the additional dilutions.
Performing Factor Parallelism is an optional feature and if executed will provide an

operator a definable Flag to alert the operator if a limit has been exceeded. If an inhibitor
is suspected, confirmatory testing is suggested.

ACL ELITE/ELITE PRO

Factor Calibration (Dedicated) and Parallelism
Performance Guide
Factor Parallelism FVIII SP, FIX SP, FVIII SS or FIX SS (Dedicated

Calibration)
FVIII SP and FIX SP uses the SP reagent (Synthetic Phospholipids)

FVIII SS and FIX SS uses the SS reagent (SynthASil)
Dedicated Calibration means: A separate session is done to perform a calibration.

When calibrating Factor Parallelism FVIII SP, FIX SP, FVIII SS or
FIX SS place 3 empty cups in the required position and the instrument will make the
CAL Low F automatically. Only one calibration can be performed at a time.
Step Action
Select Setup/Test /View Define enable a Factor test: FVIII SP, FIX SP, FVIII
1 SS, or FIX SS. (The test is dependent on the reagent in use, remember to also
enable the factor Parallelism test F8SP-P, F9SP-P, F8SS-P or F9SS-P both tests
have to match the reagents)
2 Select Setup / Liquids and enter information for Factor deficient plasma(s)
enabled. (FVIII Def or FIX Def)
Select Cal Plasma liquid and assign the calibration value from the Cal Plasma
3 insert sheet in the Used By list with the appropriate factor test(s) (FVIII SP or
FIX SP or FVIII SS or FIX SS).
4 Select Setup/Multi-Tests/Profiles, Test Groups or Test Group Profiles. Create

a multi-test with enabled factor(s), Sort this multi-test.
5 Select Calibration/Calibrate, identify Factor to calibrate. Check materials map

to ensure all reagents are available, select run.
6 When calibration is complete, review data and ensure that the r2 value is > 0.980.
Note: if the error icon is activated, review error.
7 Select Confirm
8 Setup QC material based on Factor Assay Package insert(s), run QC, then run
your patient samples as a Single test or within a crated Multi-Test

ACL ELITE/ELITE PRO
Factor Calibration (In Session) and Sample Analysis
Factor Assay (In Session Calibration)
May be utilized for the following factor assays: (VII, X, V, II, XII, XI, IX and VIII*)
*excludes Chromogenic Factor VIII.
In Session Calibration means: The calibration is executed the first time with the
sample run, and can then be re-used for later sample runs. (If Cal Plasma is
present, a new calibration will be performed automatically. If no Cal Plasma is
present, the stored calibration is used.)
*Multiple calibrations can be performed using In Session calibrations
Performance Guide
Step Action
1 Select Setup/Tests/View Define, enable Factor(s)
2 Select Setup/Liquids enter information for Factor Deficient plasma enabled.
3 Select Cal Plasma liquid and assign the calibration value from the Cal Plasma
insert sheet in the Used By list for the enabled factor test(s).
4 Setup the appropriate QC for the Factor assay(s) enabled
5 Select
6 Select Setup/Multi-Tests/Profiles, Test Groups or Test Group Profiles. Create

a multi-test with enabled factor(s), Sort this multi-test.
7 Select Analysis from the Main Menu dropdown and select the Multi-test with the
Factor assay(s) enabled
Verify your materials map and ensure you have prepared the Cal Low F for
8 calibration. Make a 1:16 dilution of Calibration Plasma into a labeled 0.5 mL cup
(i.e. 20μL Cal Plasma and 300μL Factor Diluent).
Load controls and/or samples into positions of the sample tray.

Load Cal Plasma and Cal Low F in the sample tray if you are calibrating for
9 the first time. If you do not, the system will use the last stored curve-if available
(up to five calibration curves can be stored and the last stored calibration will
be used if cal plasma is not loaded prior to analysis)
10 Use SA2 module to load QC and sample along with calibrators, select Run

Skill Check
1. Show your facilitator the Calibration Report and two patient and applicable
parallelism reports.
Sign Off
Instructor

ACL ELITE/ELITE PRO

UT ACL ELITE/ELITE PRO
UTILITY
OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, Operators Manual, System Training
Module you will:
• Save/Restore all instrument setup

• Archive Quality Control
• Archive Patient Data
• Define Save Last Rotor Data use
• Identify the use for Save Trace File
MODULE RESOURCES

• Floppy Disks, IBM Formatted
• Quick Reference Guide
PN 722277BB (December 2010) UT 1 of 8

ACL ELITE/ELITE PRO
SOFTWARE OVERVIEW
8 Note: For further information regarding the instrument’s Utility menu,

please refer to the IL ACL ELITE / ELITE PRO System Operator’s Manual,
Section 4.3.
Utility dropdown menu displays the following selections:
Upgrade IL Library
Upgrades IL test parameter library. Data base files from a diskette are loaded,
then displayed on a similar screen below.
After upgrade,
modifications and
date are listed.
UT 2 of 8 PN 722277BB (December 2010)

ACL ELITE/ELITE PRO
Backup/Restore
• Backs up or restores the ACL ELITE / ELITE PRO System Configuration
• Back-up should be created:
1. Before and After any software upgrades
2. Any Setup changes ( ie ..tests, profiles, liquids)
3. Any changes in alignments by your Service Engineer
Note: Patient results, Calibration curves, and QC results can not be backed up and
restored, see Archive
Restore System
View the Configuration
backup from a diskette
date
Media storage on
your instrument
(Floppy or USB)
Archive
• Used to copy/transfer various data to a diskette in either excel or txt format.
• Recommended for QC and patient data on regular basis.
Select this to
archive patient
data. Type in the
date range desired.
Select this to archive

Analytical Reference data.
Type in date range and select
Test desired. (AR not used in
USA or Canada)

QC data. Type in date
range and select
Liquid and Test
Select this to delete
selected data once
Calibration data and
archive is complete
Select Test desired

ACL ELITE/ELITE PRO
Software
Software Identification:
• Displays the level of software the ACL ELITE / ELITE PRO System is
currently using.
Software Upgrade-Upload
• Allows ACL ELITE / ELITE PRO System operator to upgrade and upload
system software when a new software release is available.
• Follow instructions which are included in the upgrade packet.
Save Rotor Map
• Saves the raw data for all testing performed for one of the last 31 days of the
last run to a floppy disk (includes QC and Patient results).
Select to save
as a DAT file
for Windows
Research
Select to save as a
text file compatible
with most text
editors

ACL ELITE/ELITE PRO
Save Trace
• Saves all operations performed by the ACL ELITE / ELITE PRO System to a
diskette.
• Used for troubleshooting- software issues
Always save
data using the
.txt extension

ACL ELITE/ELITE PRO
UTILITY
Performance Guide
Backup/Restore
Step Action
1 Select Utility
Select Backup or Restore
View the
backup date
Restore System
Configuration
from a diskette
Media storage on
your instrument
(Floppy or USB)
3 A message displays “Backup in progress please, wait”
4 Another message will appear, “Storage media (instrument configured specific”
5 After inserting, Select OK (The Backup or Restore will take a few minutes to
complete)

ACL ELITE/ELITE PRO
Archive
Step Action
1 Select Utility / Archive
2
patient data. Type in the
date range desired.

Analytical Reference
data. Type in date range
and select Test desired.
Select this to archive QC

data. Type in date range
and select Liquid and Test Select this to
desired. delete data from Select this to archive
the data base Calibration data.
Select Test desired.
Select from these two options:

3 A. Archive Patient Data
B. Archive QC Data
(For the class exercise, select both: Archive Patient Data and QC)
4 Select Start, the Archiving will take a few minutes to complete

ACL ELITE/ELITE PRO
Skill Check
1. Show your facilitator the Backup file.
2. Show your facilitator the Archived file.
3. When would a Save Trace File be beneficial? ________________________
4. When should a back-up of all setup information be created?
______________________________________________________________
______________________________________________________________
______________________________________________________________
Sign Off
Instructor

MS ACL ELITE/ELITE PRO
MIXING STUDIES
OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, Operators Manual, and System
Training Module, you will:
• Explain why we perform Mixing Studies

• Define a new liquid called NPlasma
• Create a new test called PTT 1:1
• Demonstrate that the reflex rule has worked
• Complete a Case Study
MODULE RESOURCES
• ACL ELITE / ELITE PRO Operators Manual, Chapter 4, Section 4.56

PN 722277BB (December 2010) MS 1 of 6

ACL ELITE/ELITE PRO
Mixing Studies
Note:
All responsibility for parameter development and validation of a new or copied test
belongs to the user alone. Please refer to pages 3-5 of the ELITE / ELITE Pro Training
Manual and Operators manual Chapter 4, 4.56.
A mixing study is used in the laboratory to discern whether an abnormal APTT or

PT is caused by a Factor Deficiency or by an Inhibitor within the sample. When the
patient’s sample is mixed with normal pool plasma and the time is corrected, it is usually
a Factor deficiency. If it is not corrected the sample usually contains an Inhibitor.
Performance Guide
Create a New Liquid
Step Action
1 Select Setup / Liquids
3 Enter NPlasma in both the Liquid ID and Extended Name fields
Enter Liquid Code 606 (IL designates available numbers 501-999 for open
4 assays, liquids, test codes.– see Operator’s Manual Appendix A 7.0 ACL
Elite/Elite Pro Test Codes).
5 Lot No.: NA
6 Assigned Volume and Warning volume will be vial dependent. Use a 2.0mL cup
9 Liquid Type: Reagent Fill in Assigned Volume:_______ and Warning

Volume:_____________
10 Select Confirm
MS 2 of 6 PN 722277BB (December 2010)

ACL ELITE/ELITE PRO
Create a Test
Step Action
1 Select Setup/ Test/ View Define
2 Cursor to APTTSYS
3 Select Copy Test icon
4 Enter PTT1:1 in both the New Test ID and Extended Name Fields
6 Enter Test Code: Same as Host Test Code
7 Select Confirm
8 Enable the PTT1:1 test and select the Details icon
Select Analysis Loading Setup in the Test Details screen.

All of the changes to the new created test will be performed on the Analysis
9 Loading Setup screen. This is the area of the software where we define the
loading sequence for the new test; also we will change the current sample
aspiration parameters
10 Scroll down to the index step for the Sample and select Details icon
11 Change Sample Line Loading Type from the drop down menu to In Line
Dilution
12 Select Parameters icon for the Sample Line
11 Find the In Line Dilution box, Diluent Liquid ID, Select NPlasma from the
drop down menu
12 Enter 26.5 in the Volume box
13 Select the drop down box for the Diluted Liquid ID and select Plasma
14 Enter 26.5 in the Volume box
15 Select Confirm multiple times to exit and answer YES to any message

ACL ELITE/ELITE PRO
Interference Table
This test must be added to the Interference Table for reagent priming to occur, this
improves the system performance and minimizes carryover between tests.
Step Action
2 For PTT1:1, move the R-PT and R-PTe assays from the Enabled Test List to the
Interfering Test List
3 Select Confirm
Mixing Studies Analysis

Step Action
1 Define a Reflex rule: If the APTTSYS > 80s perform PTT1:1. (Refer to the
“RT” module performance guide to set up reflex rules)
2 Define a Profile that contains both APTTSYS and PTT 1:1 (Refer to the MLT
module performance guide to sort the profile)
3 Sort the Multi-Test profile (Refer to the MLT module performance guide to set
up the profile)
4 Analyze a sample from your facilitator to complete an APTTSYS test and initiate
the reflex rule created for a PTT1:1 assay

ACL ELITE/ELITE PRO
Skill Check
1. Show your facilitator the setup, and the results obtained from a patient sample.
2. Why do we perform mixing studies in the laboratory?
_______________________________________________________________
_______________________________________________________________
3. Case Study:
A 3 year old boy presents with a painful left elbow after mild trauma.
Evaluation reveals a hemarthrosis. The child is adopted so no family history is
available. The patient’s mother reports no other problems with the child. The
PT is normal, an APTT is prolonged.
Patient Laboratory Results

PT Test APTT Test Mixing Studies Normal Pooled
(APTT) used in the study
12.3(secs) 95.0 (secs) 33.4 (secs) 30.1
Conclusion:
What Coagulation Pathway is in question here? Please Check one.
a. Extrinsic Pathway?__________
b. Intrinsic Pathway?___________
What additional testing might a physician request for this patient?

______________________________________________________
______________________________________________________
Sign Off
Instructor

ACL ELITE/ELITE PRO

SSA ACL ELITE/ELITE PRO
SETUP SECURITY ACCESS
OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, Operators Manual, and System
Training Module you will:
• Create new user at Operator access level

• Create security access for the new user, per laboratory needs
MODULE RESOURCES
• ACL ELITE / ELITE PRO Operators Manual, Chapter 4, Section 4.46
PN 722277BB (December 2010) SSA 1 of 10

ACL ELITE/ELITE PRO

This area of the software allows the Laboratory Manager to configure the levels of
entry for the other users (as Supervisor and Operator) and define all passwords for all
the personnel using the ACL ELITE / ELITE PRO System.
Up to 99 users can be defined in the Security area.

The first operation to be done by the Laboratory Manager is the definition of the level
of entry for the other two user groups.
Delete
Details
New
Lab User
Manager
View
Confirm
The Laboratory Manager, using his password, will have access to the Lab
Manager View button.
It is advisable for the Laboratory Manager to define, upon installation of the
system, his new password to avoid misuse of the system.
Select the Lab Manager View icon, a screen will appear where both Supervisor
and Operator access may be defined.
SSA 2 of 10 PN 722277BB (December 2010)

ACL ELITE/ELITE PRO
LAB MANAGER VIEW SCREEN
Lab Manager
View
Details
In this screen, for each menu/submenu, the Laboratory Manager, according to the
specific laboratory needs, can define the level of entry.
For each menu/submenu the Laboratory Manager has three basic options:
− No Access
− Access, View only
− Access, Edit
No Access means that it will not be possible to enter the menu or submenu; the
option will be dimmed.
Access-View Only means that the access is possible. The screens can be viewed
but no modification can be done.
Access-Edit means that the access is possible and Edit capability is available
(depending on the type of screen).

ACL ELITE/ELITE PRO
ACCESS DETAILS SCREEN
Access
Details
Confirm
By selecting the Details icon after choosing the menu/submenu, the above screen
will appear.
In the Access Mode box the Laboratory Manager can define the Access/No
Access for the specific menu/submenu.
If the Access option is chosen the Laboratory Manager can then define either
View Only or Editing capability for the selected menu/submenu if available.
Select the New User icon from the main Security entry screen to create a new
user.
New
User
Lab
Manager
View

ACL ELITE/ELITE PRO
The next screen will appear.
User
Details
In this screen the following information needs to be entered:

USER NAME: type the user name (it must be unique). It is advisable to keep the
name short (minimum of 3 characters) as it will be used to log in to the system.
EXTENDED USER NAME: type the extended user name to differentiate
between users.
LEVEL: the Laboratory Manager defines the entry level for each user:
− Lab Manager
− Supervisor
− Operator
PASSWORD: the new user enters his/her password.

ACL ELITE/ELITE PRO
CONFIRM PASSWORD: re-enter the same password for confirmation.

Password has to be minimum of 3 characters.
When logging into the system User Name and Password will be required.
LOGIN SCREEN:
User
Name
Password
Confirm
It is recommended that the user log out when the system is not in use (using the
key icon) requiring the next user to log-in.
When using the Security / Password system, log all important operations into the
Logbook.

SSA ACL ELITE/ELITE PRO
Performance Guide
Step Action
1 Select Setup / Security
Select Lab Manager View

2
• Note: Upon installation of the system, it is advisable for the Laboratory Manager to
define a new log in using his/her new password to avoid misuse of the system.
Define the level of access. For this class select operator

3
Operator
4 Scroll down to each menu and submenu by using the ▼
Define, for each menu/submenu, the level of entry according to the specific
laboratory needs. For each menu/submenu, the Laboratory Manager has three
basic options:
• No Access
• Access, View only
• Access, Edit
6
No Access: means that it will not be possible to enter the menu or
submenu; the option will be dimmed
Access-View Only: means that the access is possible. The screens can
be viewed but no modification can be done
Access-Edit: means that the access is possible and Edit capability is
available (depending on the type of screen)
7 Select Confirm several times, until you reach the database view

ACL ELITE/ELITE PRO
Create New User
Step Action
1 Select the New User Icon from the main security screen.
Complete the user details:
USER NAME: type the user name (it must be unique). It is advisable to keep the
name short (minimum 3 characters)
EXTENDED USER NAME: full user name to differentiate between users
2 LEVEL: the Laboratory Manager defines the entry level for each user. Can
designate new user as: Lab Manager, Supervisor, or Operator (Use Operator for
this exercise)
PASSWORD: the new user enters his/her password
CONFIRM PASSWORD: re-enter the same password for confirmation.
Password has to be minimum of 3 characters
When logging into the system User Name and Password will be required
3 Select Confirm x2
4 Log Off the system using the log-out key icon
Log On to the system using your new created User and Password
User
Confirm
Password

ACL ELITE/ELITE PRO
Skill Check
1. In the Access Details screen give the meaning of the following terms:
a. No Access:
____________________________________
____________________________________
____________________________________
b. Access, View only:

____________________________________
____________________________________
____________________________________
c. Access, Edit:
____________________________________
____________________________________
____________________________________
2. How many users can you define in the ACL ELITE / ELITE PRO?
____________________________________
3. Name the Icon used to Log-Off from the ACL ELITE / ELITE PRO?
____________________________________
Sign Off
Instructor

ACL ELITE/ELITE PRO

CCI ACL ELITE/ELITE PRO
CLOT CURVE INTERPRETATION
OBJECTIVES
Module you will:
• Print a Clot Curve from your instrument
• Identify and label the four components of the Clot Curve
• Define representation of the X and Y axis on a clot curve
• Innumerate the number of optical readings taken per acquisition

cycle
• Define the actions taken when error codes occur
MODULE RESOURCES

• ACL ELITE / ELITE PRO Training Module, Additional Information
PN 722277BB (December 2010) CCI 1 of 10

ACL ELITE/ELITE PRO
This is a normal clot curve
In the above diagram we observe a normal Clot Curve.

There are other ways in which we observe a Clot Curve, for example: when
performing a Tilt Tube Method we visually see the end point of a clot. That is
when Fibrinogen has been converted into Fibrin.
CCI 2 of 10 PN 722277BB (December 2010)

ACL ELITE/ELITE PRO
The table below compares the Tilt Tube Method and Instrumentation.
Tilt Tube Instrumentation
• Operator adds reagents and • Test is automated

incubates
• Visually determines end point or clot • Instrument takes optical readings

• Notes time from addition of last • Uses formula or algorithm to convert
optical readings to endpoint
reagent to clot
Tilt Tube Instrument

Method Reading
Result A = Result B
The Clot Curves can tell us what the instrument sees at any point in time during
the acquisition period. The acquisition time is the period when the instrument
acquires approximately 1100 data points on each sample being analyzed.
The analyzer “looks” at the clot formation, as we would have done using the Tilt
Tube Method. The analyzer draws a picture to show us what the clot formation
looks like.
A Clot Curve can show us a picture of the clot
Clot Curves help verify a result or investigate a problem with a sample, reagent
or instrument.
Let’s examine how the ACL ELITE / ELITE PRO detects a clot.

ACL ELITE/ELITE PRO
Optics Detection
When a light ray passes through a substance containing a finely

dispersed phase in suspension (ffibrin clot),
– Light is diffused
Light Scattered
Hi hli h
The scattered light is measured at a 90° angle to the light source

(nephelometry). As the clot forms, light scatter increases until the clot
formation is complete.
The Clot/Reaction Curve displays the normalized data points recorded during
the acquisition phase. The “Y” axis displays the total reaction change divided into
5 points. The reaction change is rounded to 2 decimal places; therefore samples
with a small amount of change may display duplicate points within the 5 that are
displayed. Curves for clotting assays typically will be presented in a “S” pattern.
The curve is generally composed of 4 sections: Baseline, Acceleration,
Deceleration and Endpoint.

ACL ELITE/ELITE PRO
A Clot Curve Is:
A series of data points that

represent individual optical
readings
A Normal Clot Curve

Endpoint
Deceleration
Optical
Reading Delta
Acceleration
Baseline
Time

ACL ELITE/ELITE PRO
Basics
Let’s learn the basics of what a Clot Curve is, and its components.
• Si
Single point: a data reading is taken every 100-300 ms
• Line: all data readings in series
• X-Axis : Data Acquisition Time in seconds
• Y-Axis : optical readings
• Baseline: Readings taken after the reagent and sample are

mixed but before the clot starts forming
• Acceleration area: Readings taken while the clot is forming
• Deceleration: Time when the clot formation begins to slow
down
• Endpoint: Readings taken after the clot is complete
Various algorithms are used by the system to select the actual clotting time.
Some examples of these include:
¾ First Derivative: Time at which the maximum speed of clot formation is
noted.
¾ Second Derivative: Time at which the maximum change in speed
(maximum acceleration) of clot formation is noted.
¾ Threshold: Time when a pre-set optical density value is reached.
¾ Threshold- 2nd Derivative: If the threshold reading is not met, then the
system will use the 2nd Derivative value.
When viewing clot curves some items you should make note of include:
¾ Shape of the curve (Flat curves may indicate no clotting).
¾ Long baselines indicate a prolonged clotting time.
¾ Range of the “Y” axis. A tight range may indicate no clotting or a low
fibrinogen value. Compare the questionable sample’s “Y” axis with one
from a normal sample. A wide range on the “Y” axis may indicate a high
fibrinogen value.
¾ Continual rise in the Acceleration phase with no endpoint indicates the
sample did not clot within the acquisition time.
¾ A drop in the endpoint may indicate an unstable clot formation.

ACL ELITE/ELITE PRO
Abnormal Situations
This sample gave an Error 13. The manual states: “Maximum peak of the second
derivative is below the selected limit value. Second derivative peak is not
significant enough to indicate a real clotting reaction point. Review the clot curve.
Repeat the test in extended acquisition time.”
Look at the scale of the S/R*100. The units are from about 10 to 19. Compared to
a normal curve, that is much too small of a change to indicate clot formation has
occurred.
The change that we are seeing on this curve is probably just noise.
This sample should be repeated in Extended Acquisition Time.

ACL ELITE/ELITE PRO
Clot Curve Interpretation

Performance Guide
Step Action
1 Perform a R-PT and APTTSYS on the samples provided to you by the facilitator,
or retrieve a sample result from the Database
2 Select Details icon
3 Use the cursor to select a test result, Select Details icon
4 Select Print to print the Clot Curve
5 Label the four components of a Clot Curve and save for skill check

ACL ELITE/ELITE PRO
Skill Check
1. When looking at a Clot Curve what does the following represent?
a. X-Axis: ___________________________________________
b. Y-Axis: ___________________________________________
2. Approximately how many data points does the instrument acquire during
acquisition time?
____________________________________________________
3. What action is required when you receive an error code and no results?
____________________________________________________
4. What action is required if an error code 14 for a DDimer test occurs?
____________________________________________________
5. How can Clot Curves benefit the laboratory? ___________________
Sign Off
Instructor

ACL ELITE/ELITE PRO

AT ACL ELITE/ELITE PRO
AccuTrak
Objective
Given an ACL ELITE / ELITE PRO using Quality Control Data (QC) within the
Database Files, the RQC2 Modules in the ACL ELITE / ELITE PRO Training
• Understand basic quality control principles
• Understand the different AccuTrak reporting options
• Collect data from your instrument for a specific time period
• Interpret AccuTrak data
• Maintain QC files in your instrument database
Module Resources
• ACL ELITE / ELITE PRO Operators Manual, Chapter 3, Section 3.3.7

• ACL ELITE / ELITE PRO Quick Reference Guide
PN722277BB (December 2010) AT 1 of 24

ACL ELITE/ELITE PRO
AccuTrak
Introduction
All ACL Coagulation Systems with an on-board quality control program use the
Levey-Jennings Chart to plot individual data points. In interpreting the plot made
on the chart, it is important to keep in mind the statistical significance of the
±2SD lines. Once a method has been evaluated and found to be acceptable, values
assayed for a single lot number of control should show normal distribution about
the mean with points falling above and below the mean value with relatively even
frequency. The ±2SD lines delineate the area of the normal distribution in which
95.5% of the points should fall.
Approximately once in every 20 tests, the value will fall outside these limits
(mainly between 2 and 3 SD). This will occur by chance and thus cannot be said
to indicate a definite “out of control” situation. Points falling outside 2SD must be
interpreted in light of the preceding values. Repeating the determination will often
result in a value falling within the statistical bounds. Frequently, a single outlier
reflects a random error.
If the frequency of the points falling outside ±2SD limits is greater than 1 in 20,
or there are successive points outside the same limiting line, an investigation
should be made to determine the cause of the bias.
When six successive points fall on the same side of the mean line (even though
they are within ±2SD), the situation is considered to be “out of control”. The
procedure should be evaluated and the problem corrected.
QC Terminology
• Accuracy The degree of closeness of a measurement to its “true”

(accepted) value. AccuTrak reports evaluate accuracy in terms of
your individual mean as compared to the peer group mean.
• Precision The reproducibility of multiple measurements of the same
sample. Precision does not necessarily correlate with accuracy. It
is possible for a group of measured values to show excellent
precision without being accurate.
• Shift A shift is said to have occurred when 6 successive values have
consistently fallen on one side of the mean.
• Trend These results are not consistent, but rather, successively increase
or decrease on either side of the mean.
• Mean The average of the control values submitted by a laboratory for a
particular test (excluding the outlier values). It is used to show
central tendency of a group of data. It can be used to evaluate
accuracy if a reference to which it can be compared is available.
AT 2 of 24 PN722277BB (December 2010)

ACL ELITE/ELITE PRO
• Group = The peer group mean. It is used to evaluate inter-laboratory

Mean ( X ) accuracy by serving as the reference to which individual means
can be compared.
• Standard Spread or scatter around the mean. It checks for precision.
Deviation 68% of all results should fall within 1SD
95.5% of all results should fall within 2SD
99.7% of all results should fall within 3SD
• Pooled The average standard deviation of the method (group)
Standard irrespective of variations in means between laboratories. It is
Deviation weighted by the number of results each lab has reported.
(PSD) Or
When pertaining to the individual laboratory, the average SD
from month to month irrespective of variation in the monthly
means
• Standard An indicator of accuracy by showing how well your lab mean
Deviation compares to the peer group mean qualitatively (+ or -) and
Index (SDI) quantitatively. The term SDI, as used by CAP-QAS, is also
known as “Z-Score” SDI is used to demonstrate bias. If it is
always negative, your method could be recovering low.
An SDI of ± 2 indicates the lab mean is more than 2SD from the
group mean and will generate an alert on the report. When the
SDI is ±2, check the following:
• Is the lab running within the group 2SD?
• Are there few labs reporting on this lot?
• Is the group running very tight?
An SDI of ±3 indicates a large bias and should be investigated
thoroughly.
• Coefficient Measures variability around the mean. It is an indication of
of Variation precision expressing the standard deviation as a percentage
(CV%) around the mean. The CV allows you to compare and measure
precision at different levels. However, raw numbers should be
examined to establish the CV’s significance.
• Coefficient Allows you to compare your precision to that of your peers. It is
of Variation a ratio of your CV to the Group CV and is an estimate of
Index precision.
(CVI)
PN 722277BB (December 2010) AT 3 of 24

ACL ELITE/ELITE PRO
AccuTrak
AccuTrak is Instrumentation Laboratory’s inter-laboratory quality control
program. This program will assist your QC program by:
• Statistically comparing your results with other labs using like reagents
and instrumentation.
• Providing users with ongoing peer comparisons for managing laboratory
quality.
• Monitoring laboratory accuracy and precision.
• Providing users with a selection of reports excellent for reviewing
instrument performance and satisfying regulatory requirements.
Enrolling in AccuTrak
There are two choices for enrollment.
1. Call the AccuTrak center at 1-800-678-0710, option 7 and request a new

user’s account. You will be mailed a start-up packet that will include all
supplies needed for the first two months including:
• AccuTrak Laboratory Code Number.

• AccuTrak Quality Control Program Procedures Manual.
• 2 sets of data input forms.
• Pre-addressed mailing envelopes.
• Calendar with mailing dates indicating when your data should be
put in the mail.
• AccuTrak On-Line Account Access registration information for
on-line QC services.
After that, additional supplies can be ordered online at the website below or
by calling at the number above.
2. Enroll on-line at www.ilus.com by selecting:
Service and Support ► AccuTrak ►complete enrollment information

then Send Request.
An Accutrak Representative will contact you shortly.
AT 4 of 24 PN722277BB (December 2010)

ACL ELITE/ELITE PRO
Reviewing AccuTrak Reports
Individual Laboratory Report
This report is a compilation of statistics for each of your laboratory tests, systems
and methods for the last reporting period. It is the basic evaluation of your
performance. It also includes your lab history – a summary of your laboratory
cumulative statistics (past performance).
The Individual Laboratory Report is generated immediately after receipt of your

monthly data. It is sent to you promptly as documentation of data received in
addition to the preprinted forms of your choice. The statistical data is divided into
two sections:
• Statistical Bounds – Values for the current data submitted
• Lab History – Year to date historical data for each specific method
Each Individual Laboratory Report contains the following information:

See Page AT-6 for a Sample of a Report
1. Reporting period covered for this report, your Lab Code Number, Control
Code and description of Control submitted
2. Test/System/System #/Method, Level and Lot numbers
3. The temperature of your lab method (T). This applies to methods in which a
temperature code is given
STATISTICAL BOUNDS
4. N – Number of values submitted and acceptable for the specific method
5. Asterisk (*) – Indicates exclusion of outlier values from that method’s data
calculations. A footnote indicating this appears at the bottom of the report.
Excluded values are also summarized in the Data Description Report for the
corresponding month
6. Mean – Average of all values reported for a particular method. Outlier
values are not included
7. 1 SD – Your lab’s 1 Standard Deviation. This is a measure of the variance
of your method values from their mean. It is a measure of precision
8. -2 SD/+2 SD – Statistical Bounds or Confidence Limits. These values are
the limits of the range from 2SD below to 2 SD above your lab’s mean
9. CV – Coefficient of Variation refers the reproducibility of your results. It
describes the variation around the mean and is expressed as a percent of the
mean
LAB HISTORY
10. N- Cumulative number of values submitted for the lot/system/method
11. Mean – Weighted average of means for the preceding reporting periods
12. PSD – Pooled Standard Deviation is the weighted average of Standard
Deviations for preceding reporting periods
13. CV – Average of Coefficient of Variation for preceding reporting periods

ACL ELITE/ELITE PRO
AT 6 of 24 PN 722277BB (December 2010)

ACL ELITE/ELITE PRO
AccuLert Message/Exception Summary Report

This report notifies you systematically of exceptional program considerations in
two categories:
1. (This report is standard and received by all participants) General

information related to your lab’s monthly submission report such as:
a. Lot expiration - The expiration date for your current lot of control
material will appear in the report 3 months prior to expiration.
b. Submission by your lab of less than 2 valid data points per test
required for processing your data for that test.
c. Historical data deleted per your request (generally due to new lot
number).
2. (Optional at participant’s request) “ALERT” messages calling your
attention to possible problems relating to your data, such as:
a. Incidence of outlier data values.
b. Unusual data variations reflected in your lab’s mean values in
comparison to the group mean values (Standard Deviation Interval
or Z-score), or messages about your SD range in relationship to the
group’s SD range.
You will receive the AccuLert Message/Exception Report along with any other
optional peer group comparison reports you have requested either online or
mailed. If no exceptional considerations of the types described above apply to
your program for a given month, you will receive a message stating such.
Note: If you have chosen NOT to receive the Alert messages for the Optional
report based on statistical data comparisons, you will receive this report based on
the Standard messages only.
The following information appears on the report: (Messages are grouped by

Control, Test/System/Method, Level/Lot)
1. Reporting Period to which this report pertains
2. Technical Support telephone numbers for assistance in interpreting
AccuLert messages
3. Control – Code and description
4. Test/System/Method for which messages are noted
5. Messages pertaining to the specific Test, System, Method, Level and Lot of
control
Alert – Indicates a data exception message related to the statistics derived from
your laboratory’s data submission. We suggest you review such messages with
reference to the statistics for the pertinent Test/System/Method in your various
output reports. For help interpreting alert messages, call Technical Support at
1-800-526-7694.

ACL ELITE/ELITE PRO

ACLELITE/ELITE PRO
Laboratory Summary Report

The Laboratory Summary Report provides a month-to-month tabulation (up to 12 months) of summarized results from your lab
and the group using your method, together with cumulative individual and group statistics. The report also includes your SDI
comparing your lab mean with the group mean.
TIP: This report is useful for detecting shifts and trends and is excellent for satisfying inspectors by verifying instrument
performance.
The Laboratory Summary Report contains the following information:
1. Reporting Period, Lab Code Number, Control Code Number, Description of Control Submitted.
LAB AND GROUP YEAR TO DATE (YTD) VALUES
2. Mean (Lab YTD) – Your lab’s cumulative mean.
3. Mean (Group YTD) – Cumulative mean of all laboratories using the same method for the given test.
4. PSD (Lab YTD) – Your lab’s pooled 1SD. The PSD (Lab YTD) is a weighted average of the monthly SD values.
5. PSD (Group YTD) – Cumulative pooled 1SD for all laboratories using the same Lot/System/Method for a given test. The PSD is a weighted
average of the monthly PSD.
MONTHLY DATA
6. Month – Lists each (YTD) monthly reporting period with last month first.
7 N – The total number of data (excluding outliers) submitted for the specific System/Method combination. An asterisk (N*) indicates outlier data
were excluded from your lab’s calculated statistics. A footnote stating this appears at the bottom of the report on which it appears.
8. Lab Mean – The average of all values (excluding outliers) reported by your lab for the specific method during the month indicated. An asterisk
next to your lab mean indicates your data was excluded from the group. A footnote stating this will appear on the report on which this occurs.
9. Group Mean – The weighted average of the means for all labs using your Lot/System/Method for a given test.
10. SDI (Standard Deviation Interval) – Indicates the position of your lab’s mean in the distribution of all means calculated for that method. An SDI
of >±2.0 indicates your lab’s mean is more that 2SD from the group mean. Factors to consider when your SDI is >±2SD: Are there a small
number of labs reporting to the group? Is the range of values within the group relatively small?
11. Number of Labs – The number of labs reporting results determined by you Lot/System/Method for a given test.
12. Lab 1SD – One Standard Deviation as determined by the results you lab submitted for the month indicated.
13. Group PSD – Weighted average 1SD for all labs using your method for the given test, for the month indicated
14. Lab CV – Your lab’s CV as computed for your data for the month indicated.
15. Group CV – Average CV of all labs using your method for the given test. Computed for the month indicated.
16. Test/System/Method for which the data is tabulated on the following lines.
17. Level and Lot of control for which data are shown

ACL ELITE/ELITE PRO
All-Methods Summary Report

ACLELITE/ELITE PRO
The All-Methods Summary Report provides each participating laboratory’s statistics for the last month reporting to your
Test/System/Method combination. Also included are year-to-date statistics for each lab.
TIP: This report allows you to view each laboratory’s data submitted to the group and compare for accuracy and precision.
The All-Methods Summary Report contains the following information:
1. Reporting Period, Lab Code Number, Control Code Number, Description of Control submitted.
2. Lab – Lab code numbers for each participating laboratory. A “T” after the lab code indicates the lab’s own computed statistics submitted on the
in-house Computer Data Summary Form or Impact. The identity of each lab remains confidential
3. System – The instrument and its designation (instrument #1, 2 etc.) reported.
4. Method – for which data is shown
5. Temperature of method – Applies only to methods for which a temperature code is given
DATA FOR LAST REPORTING PERIOD FOR ALL LABS INCLUDED WITH THE PEER GROUP
6. N – The total number of data (excluding outliers) submitted during the last reporting period by that lab for that specific System/Method
combination. An asterisk next to a number in the N column indicates outlier data were excluded from the lab’s calculated statistics. A footnote
stating this will appear at the bottom of the page.
7. Mean – The average of all reported values for that respective lab. A mean value marked with an asterisk indicates the mean has been excluded
from the group as an outlier. A footnote stating this will appear at the bottom of the page.
8. SDI (Standard Deviation Interval or Z Score) – Indicator of the position of each individual lab’s mean in the distribution of all means calculated
for that method. An SDI of >±2.0 indicates your lab’s mean is more that 2SD from the group mean. Factors to consider when your SDI is >±2SD:
Are there a small number of labs reporting to the group? Is the range of values within the group relatively small?
9. 1SD – One Standard Deviation is derived from that lab’s data for the reporting period.
10. -2SD/+2SD Confidence Limits (Stat Bounds) – The values in these two adjacent columns are the limits of the range from 2SD below the mean to
2SD above the mean.
11. CV – Coefficient of Variation describes the variation around the mean and is expresses as a percentage of the mean.
CUMULATIVE DATA – PRIOR TO LAST MONTH IS SUMMARIZED IN THE LAST THREE COLUMNS UNDER LAB HISTORY
12. Mean (in each individual lab’s data line) – The cumulative mean for that lab
13. PSD – The Pooled Standard Deviation is the cumulative weighted average YTD of cumulative 1SD values for that lab.
14. CV – The Coefficient of Variation is derived from the YTD means and PSD values for that lab.
INFORMATION FOR SPECIFIC TESTS, LEVEL AND LOT OF CONTROL
15. Test – The test for which the data below are shown.
16. Level and lot number of control – for which data are shown
17. Peer Group Data – Provides the weighted average group mean 1SD, ±2SD range and CV.
18. Standard Deviation of Means – 1SD performed on the means submitted to the group for reporting.

ACL ELITE/ELITE PRO

ACLELITE/ELITE PRO
All-Methods Summary Condensed Report
The All-Methods Summary Report is the condensed version of peer group comparisons for All Systems and Methods reporting to
you Test/System/Method combination, level and lot number of control(s) reported
TIP: This report is useful in comparing data for other methodologies.
The All-Methods Summary Report contains the following information:

1. Reporting Period, Lab Code Number, Control Code Number, and Description of Control submitted.
2. Test/System/Method for which peer comparison data is provided on the following lines.
3. T – indicates temperature and applies only to methods for which temperature is required.
4. #Labs – The number of labs reporting results to your Test/System/Method, control level and lot number indicated for the reporting
period.
5. Group Mean – The weighted average of the means for labs of all Systems and Methods reporting to your control levels and lots.
6. PSD – Pooled Standard Deviation is the weighted average 1SD from the group.
7. -2SD/+2SD Confidence Limits (Stat Bounds) – The values in these two adjacent columns are the limits of the range from 2SD
below the mean to 2SD above the mean.
8 CV – Coefficient of Variation describes the variation around the mean and is expresses as a percentage of the mean.
9. Level and lot number of control – for which data are shown

ACL ELITE/ELITE PRO
Condensed Laboratory Summary Report

The Condensed Laboratory Summary Report allows you to view your Current Month, Cumulative and Peer Group Statistics for a
specific analyzer in a simple and concise monthly report.
TIP: An excellent report for quick review of an instrument’s performance and satisfies the requirements of inspectors and other key
individuals in your organization.
The Condensed Laboratory Summary Report contains the following information:
1. Your Lab Code Number, Facility Name and Contact.
2. Control Code and Description
3. Reporting Period, Business Unit, System Type and Machine (instrument designation 1, 2, 3 etc).
4. Method (reagent), Test, Level and Lot Number of Control.
5. Current Month Statistics:
• N – Total number of data (excluding outliers) submitted for the specific System/Method combination. An asterisk indicates outlier data were excluded from your
lab’s calculated statistics. A footnote stating this will appear at the bottom of reports on which this occurs.
• Lab Mean – The average of all values (excluding outliers) reported by you lab for the specific method during the month indicated. An asterisk indicates the mean has
been excluded from the group. A footnote stating this will appear at the bottom of the page.
• Lab 1SD – One Standard Deviation as determined by the results your lab submitted for the month indicated.
• -2SD/+2SD Confidence Limits (Stat Bounds) – The value in these two adjacent columns are the limits of the range from 2SD below to 2SD above the mean.
• CV – Coefficient of Variation describes the variation around the mean and is expresses as a percentage of the mean.
• SDI (Standard Deviation Interval or Z Score) – Indicator of the position of your lab’s mean in the distribution of all means calculated for that method. It is an
estimation of accuracy. An SDI of >±2.0 indicates your lab’s mean is more that 2SD from the group mean. Factors to consider when your SDI is >±2SD: Are there a
small number of labs reporting to the group? Is the range of values within the group relatively small.
• CVI (Coefficient of Variation Index – An indicator of precision that allows you to compare your precision to that of your peers.
6. Cumulative Statistics:
• N – Total number of data submitted to date for the Lot/System/Method combination.
• Mean – The cumulative mean for your lab.
• PSD (Pooled Standard Deviation) – The cumulative weighted average YTD of cumulative 1SD values for your lab.
• CV – Coefficient of Variation is derived from the YTD means and pooled SD values for your lab.

ACLELITE/ELITE PRO
Condensed Laboratory Summary Report

The Condensed Laboratory Summary Report allows you to view your Current Month, Cumulative and Peer Group Statistics for a
specific analyzer in a simple and concise monthly report.
TIP: An excellent report for quick review of an instrument’s performance and satisfies the requirements of inspectors and other key
individuals in your organization.
The Condensed Laboratory Summary Report contains the following information:
5. Current Month Statistics:
• N – Total number of data (excluding outliers) submitted for the specific System/Method combination. An asterisk indicates outlier data were excluded from your
lab’s calculated statistics. A footnote stating this will appear at the bottom of reports on which this occurs.
• Lab Mean – The average of all values (excluding outliers) reported by you lab for the specific method during the month indicated. An asterisk indicates the mean has
been excluded from the group. A footnote stating this will appear at the bottom of the page.
• Lab 1SD – One Standard Deviation as determined by the results your lab submitted for the month indicated.
• -2SD/+2SD Confidence Limits (Stat Bounds) – The value in these two adjacent columns are the limits of the range from 2SD below to 2SD above the mean.
• CV – Coefficient of Variation describes the variation around the mean and is expresses as a percentage of the mean.
• SDI (Standard Deviation Interval or Z Score) – Indicator of the position of your lab’s mean in the distribution of all means calculated for that method. It is an
estimation of accuracy. An SDI of >±2.0 indicates your lab’s mean is more that 2SD from the group mean. Factors to consider when your SDI is >±2SD: Are there a
small number of labs reporting to the group? Is the range of values within the group relatively small.
• CVI (Coefficient of Variation Index – An indicator of precision that allows you to compare your precision to that of your peers.
6. Cumulative Statistics:
• N – Total number of data submitted to date for the Lot/System/Method combination.
• Mean – The cumulative mean for your lab.
• PSD (Pooled Standard Deviation) – The cumulative weighted average YTD of cumulative 1SD values for your lab.
• CV – Coefficient of Variation is derived from the YTD means and pooled SD values for your lab.
7. Peer Group Statistics:
• Labs – The number of laboratories reporting results determined by you Lot/System/Method for a given test.
• Mean – The weighted average of the means of all labs using your Lot/System/Method for the given test.
• PSD – Weighted average 1SD for all labs using your Lot/System/Method for a given test.
• CV – The average CV of all labs using your Lot/System/Method for the given test.
• SD of Means – 1SD performed on the means submitted to the group for the reporting period.

ACL ELITE/ELITE PRO
Instrument Performance Plot

The Instrument Performance Plot Report provides you with an overview of your laboratory’s precision and accuracy as compared
to the peer group
TIP: The statistical terms used in the explanations that follow are defined in the QC Terminology section starting on page AT-2 of
this module.
The Instrument Performance Plot Report contains the following information:
PLOT
5. Level and Lot # of control
6. • Lab SDI (Standard Deviation Index) – An estimate of accuracy as it compares your mean to the peer group mean
• CVI (Coefficient of Index) – An estimate of precision as it compares your CV to the peer group CV.
BASED ON 3SD AND 3CVI
7. X-axis – Represents the CVI indicating precision.
8. Y-axis – Represents the SDI indicating accuracy.
■ – Represents your lab co-ordinates for SDI and CVI
INTERPRETATION*
9. 0.0 - ±2.0 is Typical Peer Group Performance (95% of peer population)
±2.0-±3.0 is Borderline Peer Group Performance (5% of peer population)
NOTE: These interpretations are strictly statistical in nature and should be used as guidelines only. It is the responsibility of
each laboratory to determine clinical significance and whether corrective action is necessary.

ACLELITE/ELITE PRO

ACL ELITE/ELITE PRO

ACL ELITE/ELITE PRO
AccuTrak
Performance Guide
Extracting Data
Step Action
1 Select QC / Setup/ Review
2 Select Normal Control and the RPT test, then Select Plot and Statistics icon to
access the QC Levey-Jennings Charts
3 Select the Interval icon
Define date range, input the Start Date, and the End Date, also narrow results
from the following choices: Valid Results, Invalid Results, Not Numeric
Results, Out of Scale Results, Omitted Results, Transmitted or Not
Transmitted and Flagged or Not Flagged.
NOTE: In your lab, the start date would be the date you wish to start collecting
4 data from for AccuTrak. For example, if you are preparing data from the 1st of
the previous month to the 1st of the current month, enter the 1st of the previous
month here. Any data points from QC run after midnight on this date will be
found in this report. The end date is when you want to stop collecting data for
AccuTrak. Any QC run after midnight on this date will not get placed in this
report
5 Select the Confirm icon.
6 Compare your data format to the Self Evaluation on page AT-22
Review the data and make any modifications such as omitting data using OMIT
RESULT icon and/or adding comments to a data point using ADD TEXT icon
TIP: Typically, any data point outside of 3SD is omitted with supporting
7 documentation. Data points between 2 and 3SD are not omitted as they
represent the 5% of results that statistically will fall within this range and
represent normal random error. Omitting these data points may eventually
create a mean and SD that are too tight.
From the QC Plot and Statistics screen as accessed above in steps 1-5, select the
8
Print to print all QC files
Repeat the steps above 1-8 to extract and print all Quality Control Folders. One
9
QC test at a time
10 Once data has been reviewed is ready to be sent to AccuTrak

ACL ELITE/ELITE PRO
Printing the Laboratory Cumulative Reports
Step Action
1 Select QC / Setup
2 Select Normal Control and Review, select RPT test, then select Cumulative
Report icon
3 Select the Extract icon
4 Input the Start Date, and the End Date to select the interval of time to extract
the statistical data
5 Press the Extract icon
6 Compare your data format to the Self Evaluation on page AT-23

Review the data and make any modifications such as omitting data using OMIT
RESULT icon and/or adding comments to a data point using ADD TEXT icon
TIP: Typically, any data point outside of 3SD is omitted with supporting
7 documentation. Data points between 2 and 3SD are not omitted as they
represent the 5% of results that statistically will fall within this range and
represent normal random error. Omitting these data points may eventually
create a mean and SD that are too tight
8 Select Cumulative Report as accessed above in steps 1-5, select the Print to
print all QC files. (One QC test at a time)
Selecting the Data from Printouts to Be Sent to AccuTrak
Identify by highlighting the following information to be sent to AccuTrak for peer
review:
• Actual Mean found in the middle left of the Levey-Jennings Report.
• Target Mean found on the middle left of the Levey-Jennings Report.
• Actual SD found in the middle left of the Levey-Jennings Report.
• Target SD found in the middle left of the Levey-Jennings Report.
• Actual CV found in the middle left of the Levey-Jennings Report.
• No. of Results in Statistics found on the middle left of the Levey-Jennings
Report.
ACL ELITE/ELITE PRO
Sending in Your Data Decide which method you wish for submission of your data then
follow the guidelines for either as outlined by AccuTrak for proper submission
SKILL CHECK
1. Show facilitator printouts of the Levey-Jennings chart and Cumulative Report with
the highlighted data to be sent to AccuTrak
2. Define the following:
Accuracy _________________________________________
Mean ____________________________________________
Precision _________________________________________
Shift _____________________________________________
Standard Deviation _________________________________
Trend ____________________________________________
3. Define four things the AccuTrak program provides for QC assistance.
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
4. How many different types of reports does AccuTrak have available? ______
Name them.
______________________________________________________________
______________________________________________________________
______________________________________________________________
______________________________________________________________
______________________________________________________________
______________________________________________________________
Sign Off
Instructor

ACL ELITE/ELITE PRO
SKILL CHECK
QC ran after 12:00 on this

date will automatically go
into this Report
QC ran before 12:00 on this

date will automatically go into
this Report
Mean & 1SD and No of

results in Statistics to be
submitted to AccuTrak®
Levey Report

ACL ELITE/ELITE PRO
SELF-EVALUATION SKILL CHECK
Only QC data points range

between these dates will be
in this Report
Data point has been

omitted and a note
attached

ACL ELITE/ELITE PRO

T ACL ELITE/ELITE PRO
TRAINING
OBJECTIVES
Module you will:
• Produce an outline as a Training Plan for your lab

• Document at least one module completion
MODULE RESOURCES
• ACL ELITE / ELITE PRO System Training Modules
PN 722277BB (December 2010) T 1 of 12

ACL ELITE/ELITE PRO
MENTOR/TRAINER
Introduction
You’ve just completed training on the ACL ELITE / ELITE PRO Coagulation
System and you are about to return to work. Once the mail has been gone through
and you have put out all of the fires that were started while you were gone, how
will you apply the skills you’ve learned in class? How will you move yourself and
your department in the direction of reporting patient results from your new
instrument?
Your new skills won’t do you or anyone else any good if you don’t get a chance
to apply them and they won’t last unless you use them before they wither away.
Use it or lose it! Unless you do some planning, you may find yourself
overwhelmed by the pressure of work. Here is your opportunity to get a game
plan together to help make the training a little more streamline. Remember the
saying “see one, do one, teach one” and remember that by training, you are
practicing your skills.
Attitude
While it is nearly impossible to control all of the factors that influence attitude
toward learning or change, we as instructors can set the tone. In other words, if we
are positive and excited about what we are teaching and embrace change, we can
be quite contagious and in most cases, a positive attitude will rub off. Your
approach will make or break the transition of your new instrument into your lab.
Training Plan
Before you start……HAVE A PLAN! Refer to the example on page T-6. The
plan should be specific as to what you want to accomplish, what resources and
which people, will be involved to complete this plan. Your plan should also
contain a timeline and how success will be measured.
An example of a Training Plan might be as follows:
• List all personnel to be trained including the following:

o What shift do they work and when you expect them to train (does a
3rd shift person stay late to meet your schedule or do you come in
early to meet theirs)
o What Security Level will they have (how in depth is their training)
T- 2 of 12 PN 722277BB (December 2010)

ACL ELITE/ELITE PRO
• Devise a Training Outline (see example on pages T-8 thru T-12):

o Include specific objectives, let them know what you expect
o Include procedural guides and other aids (flowcharts, etc)
TIP: Job Aids are a quick, handy tool to act as a reminder on how to perform a
specific task(s) after the official training has been completed.
o Include skill checks or other methods of measuring proficiency

o Include a place for the trainee and trainer to document that the
trainee has demonstrated proficiency for each objective
• Propose a detailed timeline:
o When training will start
o Who will train when
o When all training will be completed, including practice time
o The “Go Live” date and time
• How proficiency will be documented and continuously monitored
• What festivities there will be to celebrate the completion of training!
(good to include with the “Go Live” date)
Training Tips
• KISS – Keep It Super Simple, Teach only what they need to know
• Have supplies ready: copies of Training Outlines, Modules, Skill Checks,
Job Aids, etc
• Provide practice, practice, and more practice for trainees!
• Watch trainees, but let them do the “hands-on” stuff!
• It’s OK for trainees to make a mistake! Don’t jump in too quickly, unless
there is a real danger involved.
• Offer encouragement and positive reinforcement!
• Have trainees tell you what they learned about the topics.
• Training is an ongoing process, not a one-time event!
• Encourage pride in a job well done.

ACL ELITE/ELITE PRO
Performance Guide
Choose one of the following to be completed in class:
1. Using the Training Plan outline provided on page T-6, T-7, devise a
basic training plan for your lab.
Or
2. Select one topic from the Training Outline on page T-8 and teach it to
your lab partner and have them give you feedback to include the
following:
• Presentation:___________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
• Content (were all objectives covered?):_______________________________

________________________________________________________________
________________________________________________________________
________________________________________________________________
• Additional Notes:________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________

ACL ELITE/ELITE PRO
ACL ELITE/ELITE PRO Training Plan
1. Trainees (list all to be trained on this instrument):
Training
Security Training Training
Name Shift Start
Level End Date Complete
Date
2. Training Materials to be used:
3. How will proficiency be documented?
4. How will proficiency be continuously monitored?

ACL ELITE/ELITE PRO
5. Training timeline:
Start End Start End

Task Task
Date Date Date Date
6. “Go Live” date and festivities:

__________________________________________________________________
__________________________________________________________________
__________________________________________________________________

ACL ELITE/ELITE PRO
ACL ELITE/ELITE PRO Training Outline
Department of Laboratory and Pathology Services
Training Documentation
SUBJECT: ACL ELITE / ELITE PRO
Trainee Name: ______________________________________ Training Date:_____________
Trainer Name: ______________________________________
Topic Trainee Date Trainer

Initials Initials
1. Instrument overview (Module IB)
2. Instrument Maintenance (Module M)
3. Reagent Reconstitution/Stability (Product Inserts)
4. Specimen Handling
5. Running QC (Modules RQC2)
6. Running Patients/Barcode (Module SA2b)
7. Running Patients/No Barcode (Module SA2c)
8. Viewing Results/Errors (Module SA2)
9. Clot Curve Interpretation (Module CCI)
10.Verifying Results
I have received all of the information relating to the above topics. I understand that I am
responsible for making sure all competencies are acceptable and current.
Trainee Signature:______________________________________________
Trainer Signature: ______________________________________________

ACL ELITE/ELITE PRO
ACL ELITE/ELITE PRO Training Outline
1. Instrument Overview
• Discuss all major components of the instrument and consumables:
o Objective:
D Identify major components of the analyzer
D Consumables – when used and when you can replace including Rotors,
sample cups, reagents, Cleaning Solution 0.1N HCL (PN 9831700),
Cleaning Agent Sodium Hypochlorite solution (PN 9832700), Wash R
Emulsion
• Software Overview: Complete Module IB
o Objectives:
D Navigate different sections of the Main Screen
D Identify functions of the F keys
D Access the Main Menu
o Skill Check:
D Navigate correctly as directed in the Performance Guide.
D Correctly answer the questions in the Skill Check
2. Instrument Maintenance:
• Daily Maintenance: Complete Module M
o Objectives:
D Perform Cleaning Cycle (Routine)
D Perform additional daily maintenance task per module
o Skill Check:
D Correctly perform and document maintenance per the ACL Elite/Elite Pro
Maintenance Log.
D Correctly answer the questions in the skill Check
• Scheduled Maintenance: Complete Module M
o Objectives:
D View Maintenance Demonstration
D Perform Weekly maintenance
D Understand how to perform As Needed maintenance
o Skill Check:
D View Maintenance Demonstration
D Correctly perform and document maintenance per the ACL Elite/Elite Pro
Maintenance Log

ACL ELITE/ELITE PRO
D Correctly answer the questions in the skill Check
3. Reagent Reconstitution:
• Review:
Pipettes
Water
Procedure
When to Make New
o Objective:
D Demonstrate proper reconstitution procedures
o Skill Check:
D Controls pass using reagents prepared by trainee
4. Specimen Handling
• Review:
“To Ice or Not to Ice”
Spin Time
Platelet Poor Specimens
Freezing Specimens
CLSI Recommendations
o Objective:
D Demonstrate proper processing of a specimen
o Skill Check:
D Specimen has been properly processed
5. Running QC:
• Review:
When to Run QC
Using INSERT to Select the QC Material
What QC to Run
Handling QC
Troubleshooting Out of Range QC
• Complete Module RQC1
o Objectives:
D Run QC
D Identify failed QC from the QC Determination screen

ACL ELITE/ELITE PRO
o Skill Check:
D Produce correct screen comparisons and printouts as directed in the
Performance Guide
• Complete Module RQC2
o Objectives:
D Run QC
D Review QC from the Levey-Jennings Chart
D Omit and Restore results using the OMIT/RESTORE key
D Add a Note using the ADD NOTE button
o Skill Check:
Performance Guide
6. Running Patients/Barcode and no Barcode:
• Complete Module SA1
o Objectives:
D Run samples with and without barcode labels
o Skill Check:
Performance Guide
7. Running Patients/Barcodes/No Barcode/No Host:
• Complete Module SA2 up to Reviewing Results
o Objectives:
D Run samples without barcodes or Host Computer
D Run Samples with barcodes and a Standard Profile
D Review Status Symbols on the Main Screen
o Skill Check:
D The Skill Check for this section will be completed at the end of section 8,
Viewing Results/Errors

ACL ELITE/ELITE PRO
8. Viewing Results:
• Complete Module SA2 starting at Reviewing Results
o Objectives:
D Identify results with Flags
D View More Detail for sample results
o Skill Check:
Performance Guide
9. Clot Curve Interpretation:
• Complete Module CCI
o Objectives:
D Understand Nephelometry
D Describe how a Clot Curve is formed
D Identify the components of a Clot Curve
D Understand the significance of the Error/Warning Flags
D Use the Error/Warning Flag and Clot Curve to troubleshoot abnormal
results
o Skill Check:
D Correctly answer the questions in the Performance Guide
10. Verifying Results:
• Review the rules for verifying results in the LIS
Does the result satisfy delta rules?
Is the result physiologically possible?
Does the result make sense?
Is the specimen of good quality?
Garbage In………Garbage Out
o Objectives:
D Understand the rules for verifying the results in the LIS
o Skill Check:
D Correct results were verified in the LIS as demonstrated by Quality
Assurance review

ACL ELITE/ELITE PRO
Skill Check
When you have completed the module, Show your Facilitator or

Application Specialist the completion of pages T 5, T 6, and T 7 of the
ACL ELITE / ELITE PRO Training Plan.
Facilitator(s)
or
Applications Specialist onsite
Facilitator
Applications sign off
____________________

NL ACL ELITE/ELITE PRO
NEW LOT SETUP

OBJECTIVE
Given an ACL ELITE / ELITE PRO workstation, the Operators Manual, Training
Manual, Quick Reference Guide and an installed printer you will:
• Create/Copy and Edit a Test to Perform New Lot Testing

• Create a new liquid called NLPT Fib
• Create a new test called PTNL
• Create a new test called NLFIB_
• Create a new liquid called NLPTTSP
• Create a new test called NLAPTTSP
• Create a new liquid called NLCaCl2SP
• Create a new test called NLAPTTSP
• Create a new liquid called NLPTHS+
• Create a new test called NLPTHS+
• Transfer the profile to the Sorted List
• Interference Table
• Create/Setup a new QC files
• Test/Material Backup and Upload
MODULE RESOURCES
• ACL ELITE /ELITE PRO Training Manual

• ACL ELITE /ELITE PRO Operators Manual, Chapter 4, Section 4.1.12
• ACL ELITE /ELITE PRO Quick Reference Guide, Reagent Loading, Lot
Change and New Test Setup
• HemosIL Reagent/Calibration Package Inserts
Note:
copied test belongs to the user alone. Please refer to Chapter 4, page 4.55 of
the ELITE / ELITE PRO Operators Manual.
PN 722277BB (December 2010) NL 1 of 22

ACL ELITE/ELITE PRO
New Lot PT (PT FIB) Reagent
Performance Guide
Copy Tests/New Lots are used to run two different lot numbers of the same
reagents (PT Fibrinogen) prior to use for analysis and result reporting.
Create a New PT Liquid
Step Action
3 Enter NLPT Fib in the Liquid ID field
4 Enter New Lot PT FIB in the Extended Name field
Start the new Liquid Code above 501. Enter 602 for Liquid Code (IL uses
5 many of the codes below this number for their own test liquids – see Operators
Manual).
6 Enter the new Lot No.: ________ Expiration Date ________On board
Stability________
7 Assigned Volume and Warning volume will be “vial” dependent. Use a 10 mL

vial. (See LD Module, page LD 3)
11 Check the Refrigerated box and Stirred box
Note: If a message appears “A valid and unique liquid code is required……” This
indicates that the liquid code number is used by another liquid; the system will not allow
you to save this liquid. You must use a code that has not been previously defined; use a
number greater than 501.
NL 2 of 22 PN 722277BB (December 2010)

ACL ELITE/ELITE PRO
Create/Copy a New PT Test (using PT Fib reagent)
Step Action
1 Select Setup / Tests / View Define from the main menu
2 Select the PT Test / Copy Test
3 Enter PTNL in the New Test ID field
4 Enter New Lot PTFIB in the Extended Name field
6 Enter Test Code: Same as Host Test Code (601)
7 Select Confirm
8 Enable the test you defined PTNL
9 Select Test Details. Use the ▲▼ to highlight the unit to be removed in the
database view
10 Select Ranges. Deselect the show in sample list icon. Do this for % and ratio
11 Modify any ranges established by your laboratory in the Normal Ranges:

min/max values for s and INR
12 Select Confirm Proceed to Analysis Loading Setup

ACL ELITE/ELITE PRO
All changes to the new Copied Test parameters will be performed in the Analysis
Loading Setup parameters.
Step Action
1 Select Analysis Loading Setup
2 Select Index Step 1, AR
4 Select Parameters icon for the Reagent Line
5 In the No Dilution Liquid ID box use the drop down arrow and change PT FIB
to the new liquid ID NLPT Fib
Select Confirm At message appears: “A New Liquid has been selected.

6 If you save the new test setup, the Test will be removed from all profiles”, Select
Yes
7 Select Index Step 2, Sample
9 Select Parameters icon for the Reagent Line
10 In the No Dilution Liquid ID box use the drop down arrow and change PT FIB
to the new liquid ID NLPT Fib
11 Select Confirm X 2

ACL ELITE/ELITE PRO
Calibration Loading Setup

Change the Reagent Aspiration and Calibration Loading Setup to define the
loading sequence of reagents and samples.
Step Action
1 Select Calibration Loading Setup icon
2 Highlight and select Index Step 1 for the Std 1
4 Select the Parameters icon for the Reagent Line
5 In the No Dilution Liquid ID box using the drop down menu and change PT FIB
to the new liquid NLPT Fib
Select Confirm A message appears: “A New Liquid has been selected. If

6 you save the new test setup, the Test will be removed from all profiles” Select
YES
7 Select Confirm
8 Highlight and select Index Step 2 for the Std 2 and repeat steps 3-7 above
9 Highlight and select Index Step 3 for the Std 3 and repeat steps 3-7 above
11 If only performing PT Test, no PT calibration is necessary
12 If performing Fibrinogen test in your laboratory, continue with the procedure to

create the new PT based fibrinogen FIB_ NL test procedure (pages NL 6-12)
Note: Verify the INR for the new PT test, you must input the MNR (Mean of the
Number Range) under the Setup/Test area, and the new ISI from the package insert
under the Setup / Liquids area.
The ACL ELITE / ELITE PRO and the ACL 8, 9 and 10000 use identical analytical
systems. Reagents, Calibrators, Controls and their assigned values are interchangeable
between the two systems.
All responsibility for parameter development and validation of a new or copied test

ACL ELITE/ELITE PRO
Create/Copy a New PT FIB Fibrinogen Assay
Step Action
1 Select Setup / Test / View/Define
2 Select Fib_
3 Select Print icon to print the test parameters, Select YES to prompt: “Do
you want to print the test report?” Set printed report aside for later use
4 Select Copy Test icon to make an exact copy of FIB_
5 Name the New Test ID FIB_NL and the Extended name New lot PT FIB
6 Enter Test Code 630 for Host and Test Code 630
7 Select Confirm
8 Enable FIB_NL test
9 Select Details
10 Use the drop down and Change Import Raw Data From to PTNL, and Imports
Calibration from None
11 A message appears: “The use of imported raw data has been modified. Current
parameters for the loading…will be lost… proceed?” Select YES
Note: ALL parameters will be erased for this test and requires re-entry by
editing parameters.

ACL ELITE/ELITE PRO
Editing the Parameters when Raw Data is imported
Step Action
1 Select Calculation Setup
2 Change Algorithm Type to Delta Algorithm
3 Change Scope to Sample
4 Ratio: use the drop down menu and select R=S/Std1
5 A message appears: “Selecting a change will be erased results…confirm?”

Select Yes
6 Select Define Parameters icon
7 Enable the 1st Smooth and enter value of 15 for Degree, and press (Enter)
8 Enable the 2nd Smooth and enter value of 9 for Degree, and press (Enter)
9 For the First Part of the Reaction Curve, enable Offset and enter 10 for Points
10 For the Final Part of the Reaction Curve, enable Final and enter 10 for Points

Enable Final Slope and enter the following numbers:
13 a. Points = 101
b. Value = 5
15 Select Threshold Parameters icon
17 Verify Threshold Search Direction is selected to Forward
18 Verify Threshold Mode is selected to Absolute

ACL ELITE/ELITE PRO
Step Action
19 Confirm A message appears: “Selecting a new Parameter for the current

list….. Do you confirm this new selection?” Select YES
21 Confirm A message appears: “Selecting a new Parameter for the

current list….. Do you confirm this new selection?” Select YES
22 Enable the box Delta Correction (x)
Select Correction Parameters icon

A message appears: A new Correction can cause inconsistency of results
already stored in Patient QC, AR….. Do you confirm this new selection?
Select Yes
23
Enter the following parameters:
Min Max M(coeff) q(coeff)
st
1 Interval 100.00 200.00 0.0023 0.7701
2nd Interval 200.00 400.00 0.0014 0.9479
rd
3 Interval 400.00 leave these blank
24 Confirm x 2
25 Change Scope to AR
26 Repeat Step 6 through 24 for AR Scope
27 Select Calibration Setup icon
Select All Std on the left side of the screen and enter the values displayed in
green, in the table below:
Note: A message appears for every Dilution Ratio% : “As a consequence store
calibration will be erased …confirm”? Select Yes
28
Standards Dilution CV
Ratio %
Std 1 100.00 8.0
Std 2 50.00 12.0
Std 3 25.00 12.0

ACL ELITE/ELITE PRO
Step Action
29 Response Type: use the drop down arrow menu and select Delta Δ
30 Select Check CV (X) to enable
31 Select Outlier (X) to enable
Final Unit use the drop down arrow and selects mg/dL. A message appears
32 “Selecting a result unit for the current test all results already stored in patient QC,
AR and calibration databases will be erased. Do you confirm the new selection?”
Select YES
Select Calibration Curve Setup icon, and enter the following information.
33 X= r = x/Std1
Y= y
In Calibration Curve Setup table, enter the following information using the
drop down arrow:
34
Start End F(x) G(y) q’ Translation
Point Point Point
1st Std 1 Std 3 x y (x) to enable Std 1
In Calibration Curve Checks table, enter the following information:
35
Slope Range r² > =
st
1 Curve 0.0000 to 1000.0 0.980
36 Select the Define as Mandatory icon
37 Select Std 2 and the Define as Mandatory icon
38 Select Std 3 and the Define as Mandatory icon
39 A check mark (√) in each of the standards (Std 1, Std 2 and Std 3)
40 Confirm x 2
42 Enable the 1st Smooth and enter value of 15 and press Enter

ACL ELITE/ELITE PRO
Step Action
43 Enable 2nd Smooth and enter value of 9 and press Enter
44 First Part of the Reaction Curve, Select Offset and enter 10 for Points
45 Final Part of the Reaction Curve, press on Final and enter 10 for Points
47 Enable Saturation (X)
Enable Final Slope and enter the following numbers:

48 a. Points = 101
b. Value = 5
50 Select the Threshold Parameter icon
52 Verify the Threshold Search Direction is selected to Forward
53 Verify the Threshold Mode is selected to Absolute
54 Select Confirm A message appears: “Selecting a new Parameter for the

current list…. Do you confirm this new selection?” Select YES
Select Confirm A message appears: “Selecting a result unit for the current
56 test all results already stored in patient QC, AR and calibration databases will be
erased. Do you confirm the new selection? Select Yes
57 Select Confirm
58 Select Std 2 and Define Parameters icon, Repeat steps 42-57
59 Select Std 3 and Define Parameters icon, Repeat steps 42-57

ACL ELITE/ELITE PRO
Step Action
Select Confirm until back at the Test Details screen for FIB_NL
Units Showing
▲▼
60
Ranges
61 Use the ▲▼ to select the units that will be showing in the database
62 Highlight the unit and select the Ranges icon
Check the Show in Sample List box (X) if you want this unit to
63 appear in the Database Screen. Uncheck the box if you do not want the unit to
appear (FIB_NL only show unit mg/dL)
Input the Test Range and Scale Range for Delta / Ratio / mg/dL
Select the unit and press the Ranges icon to input the following ranges:
Min. Value Max. Value

64
Test Range Scale Range
Delta Δ 0.000-400.000 0.000-999.000
R 0.000-10.000
mg/dL 70.000-900.000 0.000-3000.00

ACL ELITE/ELITE PRO
Step Action
65 Select Confirm
A message appears: “Selecting a result unit for the current test all results already
66 stored in patient QC, AR and calibration databases will be erased. Do you
confirm the new selection?” Select YES
A message appears: “Database Update in Progress”
Print the new FIB_NL test definition and compare it to the original test definition
67 FIB_, previously printed. (Note: You will have more printed pages than original
test since you set up each Std level, Sample and AR Scope separately.)
Do not forget to enter the calibrator value for the new Fibrinogen Assay FIB_NL
68 under Setup/ Liquids/ Cal Plasma. The value is found within the Calibration
Plasma package insert.
69 Calibrate the new tests: the PTNL and FIB_NL
Note:
copied test belongs to the user alone.

ACL ELITE/ELITE PRO
New Lot (APTT-SP) Reagent

Copy Tests/New Lots are used to run two different lot numbers of the same
reagents (APTT SP) prior to use for analysis and result reporting.
Create a New Liquid
Step Action
3 Press space bar and enter NLAPTTSP in the Liquid ID
4 Enter NEW LOT APTT-SP in the Extended Name field
6 Lot No: _______________ and Expiration Date: _________________
7 Assigned Volume and Warning Volume, “vial” dependent. Use a 10 mL vial
11 Check the Refrigerated box
12 Select Confirm
15 Press space bar and enter NL CACL2 in the Liquid ID

ACL ELITE/ELITE PRO
Step Action
16 Enter NEW LOT CACL2 in the Extended Name field
18 Lot No: _______________ and Expiration Date: __________________
Create a Test
Step Action
1 Select Setup/ Test/ View/Define
2 Select APTT SP
3 Select Copy Test icon
4 New Test ID: APTTSPNL for the Extended name: NEW LOT APTT SP
6 Enter Test Code: Same as Host Test Code
7 Select Confirm

ACL ELITE/ELITE PRO
Editing Test Definition

All of the changes to the new Test parameters will be performed to the Analysis
loading sequence for the test. We will change the current Reagent Aspiration,
Reagent Priming parameters.
Step Action
1 Enable APTTSPNL test, and select Details icon
2 Select Analysis Loading Setup icon within the Test Details screen
3 Select Index 1 for the AR and select Details icon
4 Select the Parameters icon to the right of the Reagent Line
5 In the No Dilution Liquid ID box, using the drop down menu, change APTTSP
to the liquid you have defined as your new liquid i.e. NLAPTTSP
Select Confirm
6 A message appears: “A New liquid was selected. Saving the new setup the test
will be removed from profiles.” Select YES
7 Select Index 2 for the Sample and select Details icon
8 Select Parameters icon to the right of the Reagent Line
In the No Dilution Liquid ID box, using the drop down menu, change APTTSP
9
to the liquid you have defined as your new liquid i.e. NLAPTTSP
11 Select Index 4 for the Sample AR and press the Details icon
12 Select Parameters icon to the right of the Sample Line
13 In the No Dilution Liquid ID box, using the drop down menu, change APTT CaCL2 to
the liquid you have defined as your new liquid: NL CACL2
14 A message appears: “A New liquid was selected. Saving the new setup the test
will be removed from profiles.” Select YES
15 Select Confirm multiple times to exit, answering YES to any message

ACL ELITE/ELITE PRO
Interference Table
To minimize reagent carryover between the PT and APTT tests, it was found
experimentally that performing an operation called “needle conditioning” or
“reagent priming” may improve the system performance. The Interference Table
option is used to activate this feature between test pairs.
Step Action
2 This screen contains three windows: Test with reagent priming, Interfering Tests
and Enabled Tests. Select the new APTT test: APTTSPNL
From the Enabled Tests column, select the PTNL. Use the arrow Í icon to add
3 and the scissor icon to remove test (s) that interfere (s) with APTTSPNL test in
the Interfering test column
4 Select Confirm
5 Repeat steps 2-3 choosing APTT SP, and APTT SPe individually
6 A message appears: “Do you want to save the Interference Table…” Select YES
Define a Profile
Step Action
1 Select Setup / Multi-Tests / Profiles
3 Select Confirm
4 Define a profile called NEW LOT with the following tests: PTNL, FIB_NL,
APTTSPNL
5 Select Setup / Multi Test / Sort Multi Test, Sort New Lot using Î icon
6 Proceed to analyzing samples using this Profile
belongs to the user alone. Please refer to ELITE / ELITE PRO Operators Manual.

ACL ELITE/ELITE PRO
Create New QC Liquids
Step Action
1 Select Setup/Liquids
Select the New Liquid icon. Enter the name of your control liquids. Begin each
2 Liquid ID with a single space as this will bring the liquid name to the top of the
liquid list.
Set up the following control liquids:
Liquid ID Extended Name Liquid Code
3 Normal 2 Normal Control 2 620
High 2 High Abn Control 2 622
Low Fib 2 Low Fib Control 2 623
4 Assign: Lot no., Expiration Date and On Board Stability for each new liquid
5 Select Liquid Type, use dropdown ▼to select Control
7 Repeat steps 3-6 with all liquids displayed in step 3 table

ACL ELITE/ELITE PRO
Create New QC Files
Step Action
1 Select QC / Setup / Review
2 Deselect the check box for Show Enable
Cursor (▲▼) to the new QC liquids (defined on previous page), and Setup the
following Quality Controls Files (refer to SQC Module):
Control Material Test Stored Unit Target Mean Target SD SD Range

RPT-2 Sec Use Your Use Your SD 2
Normal 2 NEWFIB_ mg/dL Target Range 2
SYS2 Sec Range 2
3
Low 2 RPT-2 Sec Use Your Use Your SD 2
SYS2 Sec Target Range 2
Range
High 2 RPT-2 Sec Use Your Use Your SD 2
SYS2 Sec Target Range 2
Range
Low Fib 2 NEWFIB_ mg/dL Use Your Target Use Your SD 2
Range Range
For each test that you configure, input:
• Units used for each test
• Target Mean
4
• Target SD
• SD Range
Note: Removing a test from this list will also delete all the results saved for this
test.
Select QC Range Check icon (the control will be checked and flagged if out of
5 range) Select Flag Patient Results icon (flags any patient results after an out-of-
range control is detected)
6 Select Confirm
7 Select Show Enabled (X) to narrow the quality control liquid list on the QC
Review screen to those setup with configured tests and values assigned

ACL ELITE/ELITE PRO
Create Test Profile

Step Action
1 Select Setup / Multi-test / Profiles / New Profile
2 Select Profile ID(provide a name) Profile Code (0-99)
3 Select the New Lot Tests in the Enable Test column and Î to the Test in Profile
column
4 Select Confirm
5 Select Setup / Multi-test / Sort Multi-Tests
6 Use Î to Sort new Profile from steps 1-4
7 Select Confirm
QC LoadList
Step Action
1 Select Analysis /Multi-Test Session / New Profile from above
2 Select Add QC
3 Add QC levels from list
4 Select Store Loadlist icon, select a loadlist number
5 Select Confirm
6 Proceed to run QC

ACL ELITE/ELITE PRO
Test/Material Backup and Upload
This allows single material and test definitions created by user, to be copied onto disks
and uploaded from disk to the ACL ELITE or ELITE PRO (copied from same instrument
type is recommended; for example copy can go from an ACL Elite to an ACL Elite Pro
but not the reverse. If attempt to copy from ACL ELITE PRO to ACL ELITE the Error
message appears: “cannot save data into database” if attempt to go from an ACL ELITE
PRO to an ACL ELITE.
Step Action
1 Select Utilities/ Test/Materials/ Backup
2 Select Test or Materials
3 Locate Materials or Test in the list
4 Provide a file name (type in exactly as original) and select Confirm to backup to
disk
To upload to another “like” instrument, select Utilities/ Test/Materials/ Upload

5 (Upload Materials first, then repeat process for Test) Note: If you are uploading
a PT and PT based Fib test, upload PT test first to avoid an error
6 Select Confirm, Upload will commence
7 Tests and Materials can be located in Setup Tests/Liquids, and enabled
8 Copied tests may need to be calibrated
Remember: All responsibility for parameter development and validation of a

new or copied test (s) belongs to the user alone.

ACL ELITE/ELITE PRO
Skill Check
1. Show your facilitator or your application specialist the setup files and the
results obtained from a New Lot Setup.
Sign Off
Instructor

ACL ELITE/ELITE PRO

Jan.2008 - Rev. 0 ACL ELITE/ELITE™ PRO - Application Chart Page 1 of 8
PT and PT-Based Fibrinogen

PT-Fib P/N 0009756710, PT-Fib HS P/N 0008468210, PT-Fib HS Plus P/N 0008469810, PT- Fib Recombinant P/N 0020005000,
PT-Fib RecombiPlasTin P/N 0020002900, PT-Fib RecombiPlasTin 2G P/N 0020002950
Material Location● Analysis Calibration Preparation Notes (**) Dedicated Calibration
PT Reagent R1+ Stirbar X X Dilute with 8 mL water (RecombiPlasTin/(2G) and HS+ dilute with enclosed diluent)
Factor Diluent (*) A2 X Ready to use
Cal Plasma (*) A1 X X Dilute with 1 mL water (Optional for AR - Analysis)
APTT
APTT Synthasil P/N 0020006800, APTT-SP P/N 0020006300, APTT SynthAFax P/N 0020007400
Material Location● Analysis Calibration Preparation Notes (**)
APTT Reagent R2 X Ready to use; Invert to mix (For SP Reagent shake for 15 seconds)
CaCl2 R8 X Ready to use
Cal Plasma (*) A1 X Dilute with 1 mL water (Optional for AR with APTT SP, others not required)
Clean A(*) R6 X Ready to use
APTT-Lyo
Lyophilized Silica P/N 0008468710
APTT Lyo Reagent R2 X Dilute with 9 mL water
CaCl2 R8 X Ready to use
Cal Plasma (*) A1 X Dilute with 1 mL water
Fibrinogen Clauss
Fibrinogen-C P/N 0008469110
Fib - C Thrombin R5 X X Dilute with 2 mL water; Invert to mix
Factor Diluent (*) A2 X X Ready to use
Clean A(*) R6 X X Ready to use
(*) Material not included in kit. (**) Refer to insert sheet for complete instructions.
(●) Refer to Material Map on analyzer for reagent postions during analysis
Antithrombin
Liquid Antithrombin P/N 0020002500
AT FXa- Liquid R3 X X Ready to use; Invert to mix
AT Substrate R7 X X Ready to use; Invert to mix
APCR+V
APCR+V P/N 0020008700
APC V APTT R2 X Ready to use, Mix thoroughly
Factor V Reagent Plasma A8 X Dilute with 4 mL water
APCR V CaCl2 w/APC R7 X Dilute with 2 mL water
APC V CaCl2 R8 X Ready to use
Cal Plasma (*) A1 X Dilute with 1 mL water (Optional for AR - Analysis)
D-Dimer
D-Dimer P/N 0020008500
DD Buffer A4 X X Ready to use; Invert to mix
DD Latex R4 X X Dilute with 3 mL water; Avoid foaming
DD Calibrator A3 X Dilute with 1 mL water; Avoid foaming
Factor II
Factor II Deficient Plasma P/N 0008466050
Material Location● Analysis Calibration Preparation Notes (**) In-Session Calibration
FII Deficient Plasma A8 X X Dilute with 1 mL water
PT-Reagent(*) R1 X X Dilute with 8 mL water (RecombiPlasTin/(2G) and HS+ dilute with enclosed diluent)
Cal Plasma (*) A1 X X Dilute with 1 mL water
Cal Low F (*) A3 X X 300ul Factor Dil + 20ul Cal Plasma - Optional for low calibration curve
Clean A (*) R6 X X Clean A -Ready to use: RecombiPlasTin Factors only
Factor V
Factor V Deficient Plasma P/N 0008466150
FV Deficient Plasma A8 X X Dilute with 1 mL water
Factor VII
Factor VII Deficient Plasma P/N 0008466250
FVII Deficient Plasma A8 X X Dilute with 1 mL water
Factor X
Factor X Deficient Plasma P/N 0008466350
FX Deficient Plasma A8 X X Dilute with 1 mL water
Factor VIII
VIII Deficient Plasma P/N 0008466450
Material Location● Analysis Calibration Preparation Notes (**) Dedicated Cal except Lyo & SynthAFax
FVIII Deficient Plasma A8 X X Dilute with 1 mL water
APTT(*) R2 X X Ready to use, mix per insert requirement (APTT-Lyo Dilute with 9mL water)
APTT CaCl2(*) R8 X X Ready to use
Factor IX
Factor IX Deficient Plasma P/N 0008466550
Material Location● Analysis Calibration Preparation Notes (**) Dedicated Cal except Lyo & SynthAFax
FIX Deficient Plasma A8 X X Dilute with 1 mL water
Factor XI
Factor XI Deficient Plasma P/N 0008466650
FXI Deficient Plasma A8 X X Dilute with 1 mL water
Factor XII
Factor XII Deficient Plasma P/N 0020201200
FXII Deficient Plasma A8 X X Dilute with 1 mL water
Free Protein S
Free Protein S P/N 0020002700
FPS C4BP Latex R5 X X Reconstitute with C4BP Buffer, sit for 30 min at 15-250C
FPS MAb Latex R7 X X Invert to mix
Heparin
Heparin P/N 20009400
Factor Xa reagent R5 X X Dilute with 5 mL water
Chromogenic Substrate R8 X X Dilute with 4 mL water
Antithrombin N/A X X Dilute with 3 mL water
Buffer N/A X X Dilute concentrated buffer 1:10 (1ml buffer + 9ml water
Working Diluent A7 X X To 24 mL of dilute buffer; add 1ml of reconstituted antithrombin reagent
Clean A(*) R6 X X Dilute Clean A 1:8 (1mL of Clean A solution + 7mL of water)
Cal 0.0(*) A6 X NPP without heparin
Cal 0.8(*) A5 X NPP spiked with 0.8 heparin
Hepatocomplex (HCX) not available in all countries

Hepatocomplex P/N 0009758710
Bovine Plasma A5 X X Dilute with 3 mL water
Thrombin R3 X X Dilute with 7 mL PCX/HPX diluent(*)
Factor Diluent(*) A2 X Ready to use
Homocysteine
Homocysteine P/N 0020007800
HCY Buffer A1 X X Invert to mix prior to use
HCY Calibrator A2 X Invert to mix prior to use
HCY Conjugate A3 X X Invert to mix prior to use
HCY Enzyme R2 X X Invert to mix prior to use
HCY Latex A4 X X Dilute with 2 mL water
HCY Reductant R1 X X Invert to mix prior to use
LAC Screen / LAC Confirm

LAC Screen P/N 0020008000
LAC Screen R5 X Dilute with 2 mL water
LAC Confirm P/N 0020008200
LAC Confirm R6 X Dilute with 2 mL water
Plasmin Inhibitor
Plasmin Inhibitor P/N 0020009200
Plasmin R6 X X Dilute with 2.5 mL Diluted Buffer
Substrate R7 X X Dilute with 4 mL water
Buffer A7 X X Dilute as needed 1:10 (1 part Buffer + 9 parts water)
Plasminogen
Plasminogen P/N 0020009000
Streptokinase R6 X X Dilute with 2.5 mL water
Substrate A6 X X Dilute with 2 mL water
Pro-IL Complex (PCX) not available in all countries

Pro-IL Complex P/N 0009758810
Bovine Plasma A5 X X Dilute with 3 mL water
Thrombin R3 X X Dilute with 7 mL PCX/HPX Diluent(*)
Factor Diluent (*) A2 X Ready to use
Protein C (Chromogenic)
Protein C P/N 0020009100
PC Activator R6 X X Dilute with 2.5 mL water
PC Substrate A6 X X Dilute with 2 mL water
PChrom Diluent (*) A7 X X Dilute PC Diluent (*) 1:10 with water (1 mL of PC Diluent to 9mL of water)
ProClot: APTT-SP or APTT Lyo

Protein C P/N 0008468310
P-Clot Def A8 X X Dilute with 1 mL water
P-Clot Working Dil A3 X X Dilute PC Diluent (*) 1:10 with water (1 mL of PC Diluent to 9mL of water)
APTT SP(*) R2 X X Refer to instructions for APTT
CaCl2(*) R8 X X Refer to instructions for APTT
Pro-S
Pro-S P/N 0020002800
Prot S Reagent R3 X X Dilute with 3 mL water
PS Deficient Plasma A8 X X Dilute with 1 mL water
ProS 50% Cal A3 X X Cal Plasma diluted 1:1 with Protein S Deficient Plasma
Silica Clotting Time Screen/Confirm

Silica Clotting Time P/N 0020004800
SCT Screen R2 X Add 50ul Confirm, gently mix
SCT Confirm R3 X Ready to use
SCT CaCl2 R7 X Ready to use
Thrombin Time 2/5/8

Thrombin Time P/N 0009758515
Buffer N/A Dilute buffer at a 1:5 (1ml + 4ml) ratio with water
Bovine Thrombin R5 X Dissolve the contents of each vial with:
Diluted buffer 2.0 mL to 7.5 UNIH/mL Thrombin concentration
VW Factor Activity
VW Factor Activity P/N 002004700
VWF:Act Latex R1 X X Pour vial of buffer into latex bottle; avoid foaming
VW Factor Antigen
VW Factor Antigen P/N 0020002300
VWF:Ag Buffer A6 X X Invert to mix
VWF:Ag Latex R1 X X Invert to mix
R. Gagnon August 2009
Contents
1. Introduction- What is a clot signature curve………………….. 3
2. Parts of the clot signature curve……………………………….. 3
3. What to examine in the curve segments……………………… 4
4. What can affect the curve appearance?................................. 5
5. Curve shape characteristics and possible causes………….... 6
6. Comparison of good and bad curves……………….………….. 7
7. How to display a curve on the ACL ELITE / ELITE PRO……..9
8. Examples of clot curves …..…………………………………… 11
9. Data Reduction flow chart for PT/APTT/TT ….……………….19
9. Analytical Error and Warning Codes………………….…….…. 20
2
The Clot Signature Curve; many of you have heard of it but what do you really know about it?
This document is intended to provide answers to the following questions about clot signature
curves:
- What is a Clot Signature Curve?

- How is a Clot Signature Curve created?
- What things will impact the formation of the Clot Signature Curve?
- How can I use the Clot Signature Curve in my laboratory?
What is a Clot Signature Curve?

A clot signature curve is a visual representation of the coagulometric or absorbance reaction
taking place in a cuvette on the analyzer. A clot signature curve can easily be displayed for all
results on the ACL ELITE / ELITE PRO analyzers.
The clot signature curve can be a valuable tool for investigating abnormal or questionable results.
In addition, it can also be used to investigate warnings or errors during sample analysis.
Y- Axis
X- Axis
Parts of the Clot Signature Curve

- Y – Axis: Representation of nephelometric (light scatter) reading. As fibrin forms it
increases the amount of light scattered. On the ELITE this is represented as a ratio
between the sample and reference (Wash-R) times 100.
- X – Axis: Increase in Time going from left to right
- Delay: Sample monitoring begins at time zero. During the Delay time the sample
and reagent are initially mixed. Data acquired during this period is not used in the
data reduction calculations.
3
- Baseline: Commences the start of the data acquisition. This segment begins after
the delay time; after the sample and reagent are mixed. During this segment little
change in the optical reading will occur until the fibrin clot begins to form. The
baseline is generally short for normal clotting reactions, and will be longer for
abnormal samples.
- Acceleration: This segment represents the fibrin formation period. During this
segment the optical change will be rapid resulting in the steep slope rise. Slow clot
formation will be displayed as a curve with a shallow slope.
- Deceleration: Immediately follows the Acceleration segment and represents the
decrease in the rate of clot formation. During this segment the available fibrinogen
will have been converted to fibrin and thus the optical change and reaction slope
plateaus off. Weak clots from samples with low fibrinogen may exhibit a slight
decrease during this segment as the clot formed is fragile.
- Endpoint: The point at which the data acquisition stops.
- Delta: Change in absorbance between the baseline and endpoint phase
What to examine in the curve segments

The clot curve above has the characteristic Sigmoidal, or “slanted S” shape. The “S” shape
results from the baseline, acceleration and deceleration segments.
The areas to investigate within each of these segments include the following:
1. Baseline
- Starting point reading on the “Y” axis
- End point reading on the “Y” and “X” axis
- Stability: Is the baseline segment smooth or bumpy?
- Slope: Is the baseline rising rapidly?
2. Acceleration segment
- Starting point reading on the “Y” and “X” axis
- End point reading on the “Y” and “X” axis
- Slope: Is it a steep rise or low, gradual rise?
- Is the Acceleration segment line smooth or bumpy?
3. Deceleration and Plateau segment
- Starting point reading on the “Y” and “X” axis
- End point reading on the “Y” axis
- Stability: Is this segment smooth or bumpy?
- Slope: Is the plateau flat, rising or falling?
4
What can affect the Curve appearance?
The clot/reaction curve results from the interaction of the sample and reagent in conjunction with
the analyzer (temperature, mixing, incubation time, etc). Anything that can affect these items
could impact the clot curve.
- Sample quality
o Improper collection
o Clotted sample
o Improper sample storage
o Inadequate centrifugation
o Over anti-coagulated (elevated hematocrit)
o Under anti-coagulated (low hematocrit)
o Frozen sample thawed incorrectly
o Sample Age
- Reagents
o Improper reconstitution
o Expired reagents (onboard stability and / or lot expiration)
o Incorrect placement on analyzer
o Lack of stir bar usage when required
o Reagent contamination
- Instrument Issues
o Sample and Reagent Probe condition
o Sample and Reagent Aspiration component condition
o Spills / Dust in the reading area
o Environmental surroundings – electrical interference
o Contamination
o Dirty cuvettes
o Damaged optical components
- Clinical Condition of the Patient

o Factor level deficiency
o Disseminated Intravascular Coagulation (DIC)
o Sepsis
o Excessive lipemia
o Liver Disease
o Anticoagulant therapy
o Drug interference
5
Curve Characteristics (shape) and possible causes
Curve Characteristics Possible Cause

- Flat Curve (Indicative of no clot formation) - Lipemia or other interfering substance
masking clotting activity
- Low Fibrinogen
- Excessive Anticoagulant
- Reagent Quality
- Sample Quality
- Instrument fluidic handling issue
- Shallow Acceleration Segment - Slow clot formation due to slow conversion of

fibrinogen to fibrin (similar to a flat curve)
- Small changes in Raw Counts from - If extremely small Optical change and very short
Baseline to Endpoint clot time, noisy baseline causing false result
- Low Fibrinogen concentration
- Large Change in Raw Counts from - High Fibrinogen concentration

Baseline to endpoint.
- Endpoint drops towards Baseline - Unstable clot
- Endpoint rises - Clot formation is still progressing
- Acceleration segment seen but no Endpoint - Clot formation did not occur within the
Acquisition time
- Long Baseline - Prolonged/impaired clotting mechanism
6
Comparison of good and bad curves
800
700
600
500
400
Note the Bumpy Baseline Starting around 300
300 on the “Y” Axis
200
100 Note Smooth Baseline Starting around 220 on the “Y” Axis
10 15 20 25 30 35 40 45 50
800
700 This curve has an acceleration

segment with a good slope
600
500
400
300
200 This curve has an acceleration segment with a

shallow slope and increasing plateau segment.
100
10 15 20 25 30 35 40 45 50
7
This curve has a nice stable plateau
800
700
600
500
400
300
This curve has a decreasing baseline and a
200 plateau segment that decreases over time
and ends up lower than the starting point.
100
10 15 20 25 30 35 40 45 50
8
How to Display a Curve on the ACL ELITE / ELITE PRO:
- Select the desired sample from the main results (database) screen and press the “Detail”
icon
- Select the desired result for which you wish to view the clot curve and press the “Detail”
icon
- The clot curve will then be displayed
9
Example of a printed Clot Curve from the ELITE / ELITE PRO Analyzers
Important Summary Notes:

When you look at a clot curve always remember to observe the following:
1. The scale of the “Y” axis on the graph, see if it is a narrow or wide optical reading
band.
The system always maximizes the curve to fit the entire window. Observation of the
“Y” axis readings is the only way to determine the delta between the baseline and
endpoint.
2. The shape of the curve, it should generally have the 3 segments: baseline,
acceleration, and plateau.
3. What are the initial and endpoint readings?
4. Note the vertical line which denotes the clot point.
10
Example Clot Curves for PT and APTT
This section of the document will present PT and APTT clot curves from the ELITE / ELITE PRO
systems. The examples will include discussion information on the shape of the curve along with
any flagging that occurred
1. Normal PT Curve
This PT curve illustrates what a normal sample for PT should look like. This curve has a classic
baseline, acceleration and plateau phase. Also note the “Y” axis scale illustrates a good delta
between the baseline and endpoint. The Clot time was 12 seconds for this sample.
11
2. Extended PT Curve
This sample illustrates a typical clot curve for a sample with an extended PT clotting time. On this
sample you will note:
- Long baseline phase
- Standard acceleration phase
- Standard deceleration/plateau phase
- Acceptable delta between baseline and endpoint based upon the “Y” axis readings
The reading for this sample is taken at 75.2 seconds.
12
3. PT – Delta Error
This sample illustrates a PT clot curve with an unstable decreasing plateau phase
- The reaction starts out as a normal “S” shaped curve, however after the maximum
reading is achieved the reaction begins to decrease.
- Note the “Y” axis delta ranges from 43 to 89 which is good
- This is indicative of a clot that is not stable.
This sample resulted in a “Failed” reading with an error 11 (curve dropping after reaching its
maximum) This sample should be repeated.
13
4. PT – Error due to Reagent Issue
This sample illustrates what appears to be a standard clot curve. When viewing the curve note:
- “Y” axis scale ranges from 14 to 26.6 resulting in a low delta for the curve
- “Y” axis reading is starting off very low compared to a normal PT
- Low reactivity resulting from reagent issue (contamination, degradation)
This sample resulted in a “Failed” reading, error 12 (coag error), for the PT. Sample should be
repeated. If failure occurs a second time then controls should be run. If the controls are not
within the specifications, new reagent should be prepared. If the controls are acceptable, then the
sample should be investigated for possible low fibrinogen concentration.
14
5. Normal APTT Sample
This sample illustrates a typical clot curve for a sample with a normal APTT clotting time. On this
- Standard baseline phase for APTT
- Standard deceleration/plateau phase
- Acceptable delta between baseline and endpoint based upon the “Y” axis readings
The reading for this sample was 29.8 seconds.
15
6. Extended APTT Sample
This sample illustrates a clot curve for a sample with an extended APPT clotting time. On this
- Extended baseline phase for APTT
- Commencement of the deceleration/plateau phase
- Acceptable delta between baseline and endpoint.
This sample resulted in a reading of 118.2 seconds for the APTT.
16
7. APTT Error
This sample illustrates a clot curve for an APTT sample run in the standard mode. On this
- Lack of the standard “S” shape to the reaction curve
- Readings on the “Y” axis range from 45 to 50 reflecting a lack or reactivity and therefore
a low delta
- A rising baseline appears to be present followed by what appears to be the start of the
acceleration phase.
- This sample should be rerun using the extended mode
The reading for this sample resulted in a “Failed” result from error 31 (minimum delta not met).
This clot curve was obtained from a patient on heparin
17
8. Lipemic Sample APTT
This sample illustrates a APTT clot curve for an extremely lipemic sample
- Note the Y Axis reading. The reading starts around 340. For a normal sample this is
generally in the range around 40.
- The curve does not present the classic “S” form.
This sample resulted in a “Failed” reading with an error 31 (minimum delta not met)
18
Data Reduction for PT and APTT
Note:
The first derivative is defined as the “maximum velocity of the curve”.
The second derivative is defined as the “maximum change in velocity (acceleration) of the curve
or the fastest rate of fibrin formation.
19
Analytical Error and Warning Codes
The tables below include codes and flags that may be associated with curves/ results
Error code - 5
Meaning Optical failure
Cause ADC saturation (signal above 9.5 V at the end of the clotting
curve).
Flags R
Results Error 5 instead of the result.
Remedial Possible high Fibrinogen concentration. Dilute the sample
Action 1:1 with factor Diluent and repeat the test.
Error code – 6
Meaning Not coag
Cause First threshold not passed.
Flags R
Remedial Sample does not clot within the acquisition time.
Action Repeat the test in extended acquisition time.
Error code – 7
Meaning Coag error
Cause Second threshold not passed.
Flags R
Remedial Sample clot curve is noisy and does not give a normal clot
Action signal within the acquisition time. Repeat the test in extended
acquisition time.
Error code - 8
Meaning Coag error
Cause Delta time between the two thresholds is higher than the
selected value.
Flags R
Remedial Possible non-phasic clotting curve. Review the clot curve.
Action Possible sample interference with the clotting reaction.
20
Error code - 9
Meaning Coag error
Cause Initial slope of the reaction curve is higher than the
selected value.
Flags R
Remedial Possible bi-phasic clotting curve. Review the clot
Action curve. Possible sample interference with the clotting
reaction.
Error code - 10
Meaning Coag error
Cause Final slope of the reaction curve is higher than the
selected value.
Flags R
Remedial Unstable endpoint of the clotting curve. Review the clot
Action curve. Possible sample interference with the clotting
reaction. Repeat the test in extended acquisition time.
Error code - 11
Meaning Final delta error is a check that the curve is not
dropping too much after reaching its maximum reading
Cause Final delta of the reaction curve (maximum abs reading
– final abs. reading) is higher than the selected value.
Flags R
Remedial If this is a nephelometric reaction, it may be an
Action indication of an unstable endpoint in the clotting curve.
Review the clot curve. Possible sample interference
with the clotting reaction. Repeat the test in extended
acquisition time.
If this is an absorbance test, it may be an indication of
an absorbance value outside the specified limit.
21
Error code - 12
Meaning Coag error
Cause Maximum peak of the first derivative is below the
selected limit value.
Flags R
Remedial First derivative peak is not significant enough to
Action indicate a real clotting reaction point. Review the clot
curve. Repeat the test in extended acquisition time.
Error code – 13
Meaning Coag error
Cause Maximum peak of the second derivative is below the
Flags R
Remedial Second derivative peak is not significant enough to
Action indicate a real clotting reaction point. Review the clot
curve. Repeat the test in extended acquisition time.
Error code - 14
Meaning Offset error (delta algorithm)
Cause Offset value is greater than “First part” value defined in
calculation setup section of test definition or below
scale range low limit.
Flags R
Remedial Review the clot reaction curve “Y” axis scale to
Action determine if value is low or high (turbid). Rerun
Sample.
Error code - 30
Meaning Offset error (delta algorithm)
Cause Offset of the initial part of the curve is below the
Flags R
Remedial Initial reaction turbidity is relatively low. Review the clot
Action reaction curve. Check integrity of reagents, and make
sure no bubbles are present
22
Error code - 31
Meaning Minimum Curve Delta not met
Cause The total delta of the reaction curve is less than the
limit specified in the test setup. (Reaction curve is flat,
and clot formation may not have occurred)
Flags R
Remedial Review the curve and rerun the sample. Sample may
Action have an extended clotting time.
Noisy Baseline/Reaction Curve (Error 32/33)

Meaning Reaction curve baseline readings are erratic
Cause Interference in reaction readings
Flags Q - “Noisy Baseline/Reaction Curve” displayed in
Warning List box when clot curve is displayed
Results Error 32/33 instead of the result
Remedial Review Curve and repeat sample
Action
23

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INSTRUMENTATION LABORATORY

ACL ELITE* / ELITE PRO System

PN 722277 Rev. BB (November 2010)

HAZARDS AND OPERATIONAL PRECAUTIONS AND LIMITATIONS

WARNINGS, CAUTIONS and IMPORTANTS alert you as follows:

WARNING Risk of operator injury if:

PN 722277BB (December 2010) v of vi

ACL ELITE / ELITE PRO Course Map…………………3

How Course Works…………………….…………………6-7

PN 722277BB (December 2010) Page 1of 8

Page 4 of 8 PN 722277BB (November 2010)

PN 722277BB (December 2010) Page 5 of 8

HOW COURSE WORKS

Let’s look at the makeup of this course

Page 6 of 8 PN 722277BB (December 2010)

Personal Progress Summary

Master Progress Chart

PN 722277BB (December 2010) Page 7 of 8

Page 8 of 8 PN 722277BB (December 2010)

REAGENT / CALIBRATOR INSERT REVIEW

P/N 722277BB (December 2010) RI 1 of 6

RI 2 of 6 P/N 722277BB (December 2010)

Sample of a Reagent Insert

NOTE: Linearity (14) is not applicable to the Thrombin Time Test

RI 4 of 6 P/N 722277BB (December 2010)

1 Obtain HemosIL reagent package inserts, from your facilitator.

2 Complete the Skill Check.

P/N 722277BB (December 2010) RI 5 of 6

2. How long is this PT reagent (RecombiPlastin-R2G) stable on the ACL Elite/ElitePro?

6. What is the linearity of the D-Dimer test?

7. Identify recommendation for a D-Dimer test exceeding linearity?

RI 6 of 6 P/N 722277BB (December 2010)

Given an ACL ELITE/ELITE PRO workstation, the Operators Manual, Training

• Locate the Working Area

• ACL ELITE / ELITE PRO System Training Module

PN 722277BB (December 2010) IB 1 of 14

ANALYSIS QC CALIBRATION DIAGNOSTIC SETUP UTILITY

Multi Test Session

IB 2 of 14 PN 722277BB (December 2010)

POWER ON AND LOG ON TO THE SYSTEM

How To Use the Touchscreen

PN 722277BB (December 2010) IB 3 of 14

How To Use the Keyboard

How To Use the Mouse

• A serial mouse is used as a selecting or pointing device, replacing the touch

Note: If the USB mouse is ever disconnected the system must be

IB 4 of 14 PN 722277BB (December 2010)

ACL ELITE/ELITE PRO SYSTEM DATABASE SCREEN

PN 722277BB (December 2010) IB 5 of 14

IB 6 of 14 PN 722277BB (December 2010)

Cancel (dimmed if Edit action not

Remove an item from the list

Transfer an item from one list to

Information in different languages

Extract Sample Data

Save information to floppy disk

PN 722277BB (December 2010) IB 7 of 14

Toolbar Icons Commands / Instrument Status

Instrument Status Operating

Close/Open cover Ready

Host Status Ready

IB 8 of 14 PN 722277BB (December 2010)

QUALITY CONTROL: Indicates a failure in a quality