Acl9000 Manual PDF

ACL Elite / Elite Pro System
Operator's Manual • P/N 181121-11 • Rev. 0 December 2005
Manufacturer EU Authorized Representative

Instrumentation Laboratory Company Instrumentation Laboratory SpA
101 Hartwell Avenue - P.O. Box 9113 Viale Monza 338 - 20128 Milan, Italy
Lexington, MA 02421-3125 U.S.A. Telephone: 39-2-25221
Telephone: (781) 861-0710
Instrumentation Laboratory
ACL Elite/Elite Pro Operator’s Manual Text Part No. 181121-11 Rev. 0 December 2005
This publication and any and all materials (including software) concerning the products of IL
ACL Elite / Elite Pro Systems are of proprietary nature and are communicated on a strictly
confidential basis; they may not be reproduced, recorded, stored in a retrieval system,
transmitted or disclosed in any way and by any means whatsoever, whether electronic,
mechanical through photocopying or otherwise, without IL’s prior written consent.
Information contained herein is believed by IL to be accurate: in any event, no responsibility,
whether express or implied, is assumed hereby by IL for or in connection with the use thereof,
or for infringement of any third party rights which might arise therefrom, or from any
representation or omissions contained therein.
Information is subject to change and/or updating without notice.
Sarstedt, Epson and Hewlett Packard are registered Trademarks.

Contents
1 General Information
1.0 Introduction 1.1
1.1 Product Use 1.2
1.2 Measured Parameters 1.2
1.3 Presentation of Results 1.3
1.4 Instrument Description and Operation 1.3
1.4.1 Summary 1.3
1.4.2 Main Hardware Components 1.4
1.4.3 Sample Tray 1.5
1.4.4 Reagent Area 1.8
1.4.5 Rinse/Waste Area 1.9
1.4.6 Sampling/Dispensing System 1.9
1.4.7 Loading and Analysis Area 1.12
1.4.8 Microprocessor and Electronics 1.17
1.4.9 Liquid Crystal Display (LCD) 1.18
1.4.10 Keyboard 1.18
1.4.11 Interface Connectors 1.19
1.4.12 Internal Cooling System 1.20
1.4.13 On-board Barcode Reader 1.20
1.4.14 External Barcode Scanner (Optional) 1.21
1.4.15 External Printer (Optional) 1.22
1.4.16 Floppy disk drive 1.23
1.5 Additional Features 1.24
1.5.1 Standby Status 1.24
1.5.2 End of the Cycle 1.24
1.5.3 Power Loss 1.24
1.5.4 Setup and Utility Programs 1.25
1.5.5 Fault Detection 1.25
1.5.6 Video Display - Colors and Symbols 1.25
1.6 Procedural Limitations 1.25
1.7 Certifications 1.26
1.8 Instrument Disposal 1.28
1.9 Symbols Chart 1.29
2 Installation
2.1 Installation Requirements 2.1
2.1.1 Ambient Conditions 2.1
2.1.2 Space Requirements 2.2
2.1.3 Electrical Requirements 2.2
2.2 Instrument Delivery and Unpacking 2.5
2.3 Mounting Instrument Parts 2.6
2.4 Turning the System ON 2.10
2.5 ACL - Host Interconnect Cable 2.13
Instrumentation Laboratory I
3 Analytical Operations
3.1 Components and Use of the Operator Interface 3.1
3.1.1 Touch Screen 3.1
3.1.2 Numerical Keypad 3.2
3.1.3 Standard PC Keyboard 3.3
3.1.4 External Barcode Reader 3.4
3.1.5 Mouse Port 2 3.4
3.1.6 Menus 3.4
3.1.7 Windows and Boxes 3.4
3.1.8 Key Screen Elements 3.5
3.1.9 A Special Window for Alarms and Errors 3.9
3.1.10 Screen Saver 3.9
3.1.11 The ACL Elite/Elite Pro Software Tree 3.9
3.2 Sample Analysis 3.11
3.2.1 Sample Analysis Procedures - Summarized 3.11
3.2.2 Sample Analysis Modes 3.14
3.2.3 Material Map 3.23
3.2.4 Analysis: Loadlist 3.25
3.2.5 Analysis: Session Report 3.30
3.2.6 Session Pause Conditions 3.33
3.2.7 Analysis: Pause / STAT Functions 3.34
3.2.8 Results list 3.37
3.2.8.1 Extract Icon 3.39
3.2.8.2 Sample Detail Icon 3.40
3.2.8.3 New Sample (Tubes in folder) Icon 3.43
3.2.8.4 Delete (Trash Can) Icon 3.44
3.2.8.5 Printing Results 3.45
3.2.8.6 Sending Results to Host Computer 3.46
3.3 Quality Control 3.48
3.3.1 Analysing QC Materials using a Loadlist 3.48
3.3.2 Quality Control Setup 3.49
3.3.3 QC Result Review 3.52
3.3.4 QC – Plot and Statistics 3.53
3.3.5 QC – Cumulative Results 3.55
3.3.6 QC – Host Communication 3.59
3.3.7 QC – Extract Results 3.60
3.4 Calibration 3.62
3.4.1 General Calibration Procedure - Summary 3.63
3.4.2 Saving a Calibration - Summary 3.64
3.4.3 Dedicated Calibrations - Details 3.64
3.4.4 Calibration - Review Calibration 3.65
3.4.5 Factor Assays Calibration 3.71
3.4.6 Factor Assay Calibration – Parallelism Tests 3.78
3.4.7 Factor Assay Parallelism Results 3.79
3.5 Analytical Reference 3.81
Instrumentation Laboratory II
3 Analytical Operations (continued)
3.5.1 Analytical Reference: Setup 3.81

3.5.2 Analytical Reference: Plot and Statistics 3.83
3.5.3 Analytical Reference: Cumulative Results 3.84
3.5.4 Analytical Reference: Host Communication 3.86
3.5.5 Analytical Reference: Extract Data 3.87
4 Setup and Utility

4.1 Setup 4.1
4.1.1 Setup Submenu 4.1
4.1.2 Setup - Tests – View/Define 4.2
4.1.3 Setup - Tests - Sort 4.4
4.1.4 Setup - Tests –Interference Table 4.6
4.1.5 Setup - Tests – Default Tests 4.8
4.1.6 Setup - Tests –Reflex Tests 4.9
4.1.7 Setup - Multi-Tests Profile 4.13
4.1.8 Setup - Multi-Tests – Test Groups 4.17
4.1.9 Setup - Multi-Tests – Test Group Profiles 4.22
4.1.10 Setup - Multi-Tests – Sort Multi-Tests 4.26
4.1.11 Setup - Default Multi-Tests 4.27
4.1.12 Setup - Liquids 4.27
4.1.13 Setup - Interfaces - Host 4.36
4.1.14 Setup - Interfaces - Printer 4.38
4.1.15 Setup - Interfaces - Internal Barcode 4.40
4.1.16 Setup - Interfaces - External Barcode 4.42
4.1.17 Setup - Interfaces - Keyboard 4.43
4.1.18 Setup - Interfaces - Network 4.43
4.1.19 Setup - Interfaces - Modem 4.44
4.1.20 Setup - System Configuration 4.44
4.1.21 Setup - Security 4.46
4.1.22 Setup - Audible Alarms 4.51
4.1.23 Setup - Date/Time 4.52
4.1.24 Setup - Units (Temperature) 4.53
4.2 Setup - Tests - Define 4.54
4.2.1 Copy Test 4.56
4.2.2 Setup - Tests Details 4.57
4.2.3 Analysis: Loading Setup 4.62
4.2.4 Calibration: Loading Setup 4.72
4.2.5 Acquisition Setup 4.82
4.2.6 Calculation Setup 4.84
4.3 Utility 4.113
4.3.1 Utility Submenu 4.113
4.3.2 Utility - Upgrade IL Library 4.113
4.3.3 Utility - Backup/Restore 4.114
4.3.4 Utility - Archive 4.115
Instrumentation Laboratory III

4 Setup and Utility (continued)
4.3.5 Utility - Software - Software Identification 4.117
4.3.6 Utility - Software - Software Upgrade/Upload 4.117
4.3.7 Utility - Save Rotor Map 4.119
4.3.8 Utility - Save Trace 4.120
4.3.9 Utility – Test/Material – Backup and Upload 4.121
5 Diagnostics and Maintenance

5.1 The Diagnostic Submenu 5.1
5.1.1 Priming 5.2
5.1.2 Cleaning 5.4
5.1.3 Maintenance 5.7
5.1.4 Temperature Control 5.8
5.1.5 Needles Position 5.10
5.1.6 Session Error History 5.11
5.1.7 File Error History 5.12
5.1.8 Logbook 5.14
5.1.9 Service (dimmed) 5.15
5.2 Maintenance Procedures 5.16
5.2.1 Introduction 5.16
5.2.2 Daily Preventive Maintenance 5.16
5.2.3 Weekly Preventive Maintenance 5.19
5.2.4 Bi-weekly Preventive Maintenance 5.20
5.2.5 Monthly Preventive Maintenance 5.21
5.2.6 As-needed Maintenance 5.22
5.2.7 Decontamination Procedure 5.28
5.3 Maintenance Table 5.30
6 Troubleshooting
6.1 Failures, Alarms and Warnings 6.1
6.1.1 System Anomalies 6.2
6.1.2 REM (Rotor Exchange Module) Anomalies 6.7
6.1.3 Temperature Anomalies 6.9
6.1.4 Mechanical Anomalies 6.12
6.1.5 Acquisition Station Anomalies 6.14
6.1.6 Liquids Anomalies 6.15
6.1.7 Optics Anomalies 6.18
6.1.8 Operative Anomalies 6.18
6.1.9 Parsing and Loading Anomalies 6.19
6.1.10 Database Anomalies 6.20
6.2 Data Transmission Failure 6.20
6.3 Data Reduction Error Codes 6.20
6.3.1 Session Error Codes 6.21
6.3.2 Reaction Curve Error Codes 6.22
6.3.3 Calibration Error Codes 6.25
Instrumentation Laboratory IV
6 Troubleshooting (continued)
6.3.4 Analytical Reference Error Codes 6.29

6.3.5 QC Error Codes 6.33
6.3.6 Double Test Error Codes 6.34
6.3.7 Ratio and INR Error Codes 6.35
6.3.8 DMS Errors 6.36
6.3.9 Other Miscellaneous Errors 6.37
6.4 Coag Errors (Data Reduction) 6.37
6.5 Sample ID Errors 6.38
6.6 Data Reduction Diagram for PT, APTT and TT 6.39
7 Assay and Instrument Specifications

7.1 Measured Parameters 7.3
7.2 Calculation of Results 7.5
7.2.1 Coagulometric Tests 7.7
7.2.2 Chromogenic Tests 7.14
7.3 Samples/Reagents Configuration and Specifications 7.18
7.3.1 Sample Requirements and Positions 7.18
7.3.2 Sample Position in the Rotor 7.20
7.3.3 Coagulometric Test Volumes 7.22
7.3.4 Chromogenic Test Volumes 7.24
7.3.5 Special Tests Volumes 7.25
7.4 Data Processing Features, Parameters and Analytical
Specifications 7.26
7.4.1 Flagging Limits 7.26
7.4.2 Results Format: VDU and Printer 7.29
7.4.3 Dealing with Results Messages 7.29
7.4.4 Calibration Curve Slope (m) 7.32
7.4.5 Calibration Curve Intercept (q) 7.32
7.4.6 Ranges for Calibration Plasma Values 7.33
7.4.7 Reaction Times 7.33
7.4.8 Test Algorithms 7.36
7.5 Assay Performance Characteristics 7.37
7.5.1 Assay Precision Performance, Linearity and
Method Comparison Studies 7.37
7.5.2 Assay Calibration Stability 7.41
7.6 Analytical Limitations 7.42
7.6.1 Carryover 7.42
7.6.2 Cephalin: Needle Self-conditioning 7.43
7.6.3 Lipemic Samples 7.43
7.7 Container Specifications 7.43
7.7.1 Primary Tubes 7.43
7.7.2 Cups and Reagent Containers 7.44
7.8 Instrument Specifications 7.45
7.8.1 Hardware and Operational Specifications 7.45
Instrumentation Laboratory V
7 Assay and Instrument Specifications (continued)
7.8.2 Dimensions 7.46

7.8.3 Data Bases Specifications 7.46
7.9 Ambient Specifications 7.48
7.10 Electrical Specifications 7.48
7.11 Hazards 7.49
7.11.1 General Warning 7.49
7.11.2 Shock Hazard 7.49
7.11.3 Electrical Hazards 7.49
7.11.4 Biohazards 7.50
7.11.5 Mechanical Hazards 7.50
Addendum: Method Comparison Studies 7.51
8 Sample Collection and Storage

8.1 Sample Collection 8.1
8.2 Plasma Handling 8.2
8.2.1 Plasma Separation 8.2
8.2.2 Plasma Transport 8.2
8.2.3 Plasma Storage 8.2
8.3 Calibration Plasma 8.2
8.3.1 Description 8.2
8.3.2 Preparation 8.3
8.3.3 Value Assignment 8.3
9 Parts and Expendables

9.1 Startup kit 9.1
9.2 Order Information for Expendables 9.4
10 Warranty
10.0 General Warranty Conditions 10.1
10.1 Disclaimer Regarding Non-IL Brand Product 10.2
11 IL Worldwide Locations
Appendix A Host Communication Protocol

Appendix B Bar Code Label Specification
Appendix C Special Tests Procedures
Appendix D ACL Elite/Elite Pro Printout Examples
Index
Instrumentation Laboratory VI
ACL Elite/Elite Pro Operator’s Manual
INDEX
Calibration Plasma, 8.2
A Calibration Replicates, 3.71, 4.73
Calibration Stability, 7.41
Abort Test, 4.71, 4.81 Calibration Target Values, 4.31, 8.3
Absorbance channel, 1.15 Carryover, 4.6
Absorbance Tests, 1.2 Carryover - User Defined Tests, 4.7
Acquisition Anomalies, 6.14 Carryover Specification, 7.42
Acquisition Delay, 4.83 Check Mark, 3.29
Acquisition Setup, 4.82 Chromogenic Tests, 7.4, 7.14
Acquisition time, 7.33 Chromogenic Test Volumes, 7.24
Adapters, 1.9, 2.7, 9.4 Cleaning -Test Setup, 4.68, 4.78, 5.2
Add QC, 3.18 Cleaning Air Filter, 5.21
Alarms, 6.1, 6.4 Clock, 3.33
Algorithm, 4.87 Clock Symbol, 3.31
Ambient Conditions, 2.1 Clot/Reaction Curve, 3.42
Ambient Specifications, 7.48 Coagulometric tests, 7.3, 7.7
Analytical Reference, 3.82 Coagulometric Tests, 1.2
Analytical Reference Cumulative Results, 3.85 Color codes, 3.17, 3.39
Analytical Reference Data Extract, 3.88 Complete Possible and Signal, 4.71, 4.81
Analytical Reference Error Codes, 6.29 Connectors, 2.4
Analytical Reference Host Transmit, 3.87 Copy Tests, 4.56
Analytical Reference Plots, 3.84 Correct Ratio with 100% Std., 4.109
APCR, 7.8 Correct with AR, 4.108
APTT, 7.8 Cuvettes, 1.18
Archive, 4.115
Assay Performance Characteristics, 7.37 D
Assigned Liquid Volume, 4.29
Audible Alarms, 4.51 Database Anomalies, 6.20
Autolist, 3.27 Database Configuration, 4.44
Database Specifications, 7.46
B Data Reduction Diagram, 6.39
Data Reduction Error, 6.37
Backup, 4.114 Data Reduction Error Codes, 6.20
Backup Test and Material, 4.121 Data Transmission Failure, 6.20
Barcode, External, 1.21 Date/Time, 4.52
Barcode, On-board, 1.20 D Dimer, 7.16
Biohazards, 7.50 Dead Volume- Vials and Cups, 7.44
Decimal places- Result Formats, 7.29
C Decontamination, 5.16, 5.28
Dedicated Calibration, 3.64
Cal Low F, 3.72 Default Liquid Position, 4.34
Calculation of Results, 7.5 Default Multi-Tests, 4.27
Calculation Setup, 4.84 Default Tests, 4.8
Calibration, 3.63 Default Screen, 4.45
Calibration Curve Flagging Limits, 7.27 Delay at Completion, 4.67, 4.77
Calibration Curve Review, 3.66 Delete Icon, 3.44
Calibration Curve limits, 7.30 Delta Algorithm, 4.101
Calibration Curve Setup, 4.107 Dilutor, 2.8
Calibration Error Codes, 6.25 Dimensions of Analyzer, 7.46
Calibration - Factors - Non Parallelism, 3.72 Display, 1.18
Calibration - Factors - with Parallelism, 3.79 DMS Errors, 6.41
Calibration Loading Setup, 4.72 Dots displayed - Multi Tests, 3.15
Calibration Modes, 4.58 Double Test Error Codes, 6.36
Instrumentation Laboratory 1
E INR Setup, 4.60, 4.30

INR Errors, 6.35
Electrical Hazards, 7.49 Installation Requirements, 2.1
Electrical Requirements, 2.2 Instrument Cleaning, 5.19
Electrical Specifications, 7.48 Instrument Description, 1.3
Electronics, 1.17 Instrument Specifications, 7.45
Empty Cups - Analysis, 4.63, 4.66 Instrument Status, 3.5
Error 10, 7.30 Interface Connectors, 1.19
Error 13, 6.38 Interfaces - Setup, 4.36
Error 6, 6.37, 7.30 Interference Table, 4.6
Error 7, 6.38, 7.30 Intermediate Rinse, 4.66, 4.76
Expiration Date, 3.24 Internal Barcode, 4.40
External Barcode Setup, 4.42 Inter-ramp Interval, 4.68, 4.82
External Barcode Reader, 3.24 ISI, 4.30, 4.86
Extract Samples, 3.39 ISI Limits, 4.32, 4.34
Extrapolated Result, 4.109
K
F
Keyboard, 1.18, 3.3, 4.43
Factor assay calibration, 3.72
Factors, 7.9
Failure Status, 3.5, 6.1
L
Fibrinogen - PT based, 7.4, 7.14 Language Setup, 4.44
File Error History, 5.12 Latex tests, 7.4
Filter, 2.11 Letter Code Meaning - 3.17
Filter Cleaning, 5.21 Library Identification, 4.118
First Derivative Algorithm, 3.43, 4.96 Line Frequency, 2.3
Flagging Limits for Results, 7.26 Linearity, 7.39
Floppy Disk Drive, 1.23 Lipemic Samples, 7.43
Flush/Optic Channel Error, 6.21 Liquid Accessing Needle, 4.34
Free Protein S, 7.17 Liquid Anomalies, 6.15
Fuse, 2.3 Liquid ID, 4.28
Liquid Sensor, 4.45
H Liquid Setup, 4.27
Liquid Waste, 5.17
Halogen Lamp, 1.16, 5.27 Loading and Analysis Area, 1.12
hardware components, 1.4 Loading Setup - Analysis, 4.62
Hazards, 7.49 Loading Setup - Calibration, 4.72
Header volumes - Reagent and Sample, 7.22 Loadlist, 3.25
Heparin, 7.16 Loadlist Time Interval, 3.27
Hepatocomplex, 7.12 Logbook, 5.14
High curve (Factor Assay), 3.74 Low curve (Factor Assay) , 3.75
Host, 2.13, 3.46, 4.36
Hourglass, 3.31
M
I Magnetic Stirrer Part Number, 9.4
Maintenance - As Needed, 5.22
Icons, 3.6 Maintenance - Bi-Weekly, 5.20
Immunological Tests, 1.2 Maintenance - Daily, 5.16
Import Calibration Data, 4.58 Maintenance - Monthly, 5.21
Import ISI, 4.86 Maintenance - Weekly, 5.19
Import Raw Data, 4.58 Maintenance menu, 5.7
Import Ref Value, 4.86 Maintenance Overdue Warning, 5.8
In Cup Dilution, 4.65, 4.74 Maintenance Table/Checklist, 5.30
In Line Dilution, 4.65, 4.74 Make Loadlist, 3.25
In Session Calibration, 3.67 Mark Samples - Loadlist, 3.27
Materials Check, 4.70, 4.80 Primary Unit Correction, 4.91, 4.95, 4.96, 4.99
Materials Map, 3.23 Priming, 2.11, 5.2, 5.17
Material Map - Profiles, 4.16 Priming in standby, 5.3
Mean of Results, 4.105 Printer, 1.22, 4.38
Measured Parameters, 1.2 Printer Fail, 6.6
Mechanical Anomalies, 6.12 Printing Results, 3.45
Mechanical Hazards, 7.50 Printout Setup, 4.38
Method Comparison Studies, 7.40, 7.51 Pro Clot, 7.13
Microprocessor, 1.17 Product Use, 1.2
Middle curve (Factor Assay), 3.76 Profiles, 4.13
Miscellaneous Errors, 6.37 Profiles Details screen, 4.15
Mixing Cuvette Contents, 4.68, 4.78 Program Sample, 3.20, 3.35
Mouse, 3.4 Pro IL Complex, 7.11
Multi-Tests, 3.14, 4.13 PT, 7.7
N Q
Needle Alignment, 5.10 QC Error Codes, 6.37
Needle Cleaning, 5.14 QC Cumulative Results, 3.55
Needle Replacement, 5.23, 9.4 QC Data Extract, 3.60
Nephelometric channel, 1.15 QC Host Transmission, 3.59
New Liquid Setup, 4.34 QC Icon/Review Results, 3.52
New Sample - Program, 3.20 QC Plots, 3.53
New User Definition, 4.49 QC Setup, 3.49
Noise Checks- Data Reduction, 4.94 Quality Control, 3.48
Normal Range, 1.25, 3.39, 4.59 Q Prime Checkbox, 4.109
Normalization, 4.85
Numerical Keypad, 3.2, 4.43 R
O r2 check - Parallelism, 3.81
Ramp, 4.82
Omit Calibration Replicate, 3.68 Ratio, 4.60, 4.85, 4.105
On Board Stability- Reagents, 3.24, 4.29 Ratio Errors, 6.33
Operative Anomalies, 6.18 Raw Data - Save to Disk, 4.119
Optical Measuring System, 1.15 Reaction Curve Error Codes, 6.22
Optical Path, 1.15 Reaction Times, 7.33
Optical Path Cleaning, 5.21 Reagent Area, 1.8
Optical Reference, 4.74 Reagent Barcode Setup, 4.42
Optics Anomalies, 6.18 Reagent Priming, 4.65, 4.76
Reagent Vials, 7.44
P Reagents positions, 1.7, 7.18
Reference Value, 4.60
Parallelism - Calibration, 3.79 Reflex Testing Status, 4.44
Parallelism Results, 3.80 Reflex Tests Setup, 4.9
Parsing Anomalies, 6.19 REM Enable, 4.45
Part/Expendable list, 9.4 REM Anomalies, 6.7
Passwords - Security, 4.46 Rerun Tests Setup, 4.9
Patient Demographic Details, 3.21 Restore Configuration, 4.114
Pause System During Run, 3.34 Results, 3.37, 7.26, 7.29
Pause Reagent Timer, 3.25 Result Units - IL Coagulometric Tests, 7.5
Perform Sequentially, 4.69 Results - Units with/without Calibration, 7.6
Piston block and Electrovalves, 1.10 Review Calibrations, 3.66
Plasma Handling, 8.2 Rinse Reservoir Cleaning, 5.17
Power Consumption, 2.2 Rinse/Waste, 1.9
Precision Performance, 7.38 Rotor, 1.12
Presentation of Results, 1.3 Rotor Arm, 1.13
Rotor Holder, 1.15 Stirrers, 1.9, 2.7

Rotor Part Number, 9.4 Symbols Chart, 1.26
Rotor Stack, 1.13 System Anomalies, 6.2
Rotor Transport, 1.13 System Configuration, 4.44
Rotor Waste, 5.18
Rotor Waste Area, 1.16 T
Runner Icon - Main Screen - Setup 4.27
Target Values, 4.29
S Temperature - Limits, 2.12
Temperature Anomalies, 6.9
Sample Analysis Procedures, 3.11 Temperature Display - Real Time, 5.8
Sample Barcode Setup, 4.40 Temperature Units, 4.53
Sample Collection, 8.1 Test Code, 4.57
Sample Cups, 744, 9.4 Test Group ID/Code, 4.20
sample Database, 3.37 Test Group List, 4.22
Sample Details, 3.40 Test Group Profiles, 4.22
Sample ID Errors, 6.38 Test Groups, 4.17
Sample Requirement and Positions, 7.18 Test Group - User Defined, 4.19
Sample Spillage Cleaning, 5.19 Test ID, 4.57
Sample Status, 3.22, 3.31 Test Range, 1.25, 3.39, 4.59
Sample Tubes, 7.43 Test - Save Individual, 4.121
Sampling Rate - Data Acquisition, 4.83 Test volumes, 7.22
Sampling/Dispensing Arm Assembly, 1.10 Tests Details, 4.57
Save Rotor Map, 4.119 Tests Display/Print - Setup, 4.4
Save Trace, 4.120 Tests Execution Status, 3.31
Scale Range, 1.25, 3.39, 4.60 Tests Setup, 4.54
Scope, 4.64, 4.74, 4.82 Thermal Fail, 6.6
Second Derivative, 3.43, 4.98 Threshold, 3.43, 4.86
Security - Setup, 4.46 Threshold/Second Derivative, 3.43, 4.92
Sensors, 1.10 Time/Date Setup, 4.52
Service Menu, 5.15 Timing Constraint, 4.66, 4.77
Session Error Codes, 6.21 Touch Screen, 1.17, 3.1
Session Error History, 5.11 Trace File, 4.120
Session History, 3.32 Trend Algorithm, 4.88
Session Report, 3.31 TT, 7.8
Set Timer, 4.67, 4.77
Set Volume, Reagents, 3.24 U
Setup Tests, 4.2
Shock Hazards, 7.49 Unit Correction, 4.60
Silica Clotting Time, 7.13 Units, 1.3, 4.59
Single Test, 3.14 Upgrade IL Library, 4.113
Slope Check-Parallelism, 3.80 USB Ports, 2.4
Software Identification, 4.117 Used Rotor, 5.118
Software Tree, 3.10 User - Security Setup, 4.50
Software Upgrade, 4.117
Sort Multi-Tests, 4.26 W
Sort Tests, 4.4
Space Requirements, 2.2 Wait Until Timer Expires, 4.67, 4.77
Special Tests, 1.2 Warnings, 6.1, 6.5
Special Test Volumes, 7.25 Wash-R Part Number,9.4
Standby, 1.24, 3.5 Wash R. Checkbox, 4.74, 4.66
Start Reagent Timer, 3.24 Wash-Reference Emulsion, 1.9, 2.8
STAT, 3.34 Waste Line Cleaning Procedure, 5.22
Step Length, 4.66, 4.77 Waste Tube, 2.6
General Information
1.0 Introduction
This Operator’s Manual contains the information necessary to operate, maintain and
troubleshoot the Instrumentation Laboratory ACL Elite and Elite Pro. Personnel
responsible for operating and maintaining the instrument should read and understand
the material included here prior to using the system. This Manual should be kept near
the instrument or in a suitable location for reference as required.
This Section of the Manual contains general information about the ACL Elite/Elite Pro
systems, including use and measured parameters, description of the hardware
modules as well as their function and operation, methodology, additional features and
procedural limitations. The description and use of the ACL Elite/Elite Pro Operator’s
Interface is addressed in separate Sections of this Manual.
ACL Elite Pro system
Instrumentation Laboratory 1.1

General Information
1.1 Product Use

The IL ACL Elite/Elite Pro system is a fully automated, high productivity analyzer
designed specifically for clinical use in the hemostasis laboratory, for coagulation
and/or fibrinolysis testing. The system provides results for both direct hemostasis
measurements and calculated parameters.
1.2 Measured Parameters

The ACL Elite/Elite Pro system is used to perform the following tests:
Coagulometric Tests
• PT-FIB (Prothrombin Time and PT-Based Fibrinogen concentration)
• APTT (Activated Partial Thromboplastin Time)
• TT (Thrombin Time)
• Single Factors (VII, X, V, II, XII, XI, IX, VIII)
Absorbance Tests
• Antithrombin
• Heparin
• Protein C
• Plasmin Inhibitor
• Plasminogen
• Fibrinogen-C (Clauss method)
Immunological Tests
• D-Dimer
• von Willebrand Factor – Activity and Antigen
• Free Protein S
Special Tests
• ProClot (clotting Protein C)
• Protein S
• Factor V Leiden
• LAC Screen and Confirm
• Pro-IL-Complex *
• Hepatocomplex *
NOTE:
An (*) indicates that the test is not available in the United States.
Single Test or Multi-Tests

The user may program single or multiple tests on patient samples to be performed on
a random access basis. Refer to Section 4 for additional information on this subject.
1.2 Instrumentation Laboratory

Tests Groups
Some tests can be run together as a group, thus saving time when the number of
samples to be analyzed is relatively small. Following are some examples:
PT-FIB/APTT
PT-FIB/APTT/TT
Fib-C/ AT/D-Dimer
Double Tests (Duplicate Testing)
The ACL Elite/Elite Pro offers the user the capability to set up double tests. Chapter
4.0 contains information that allows you to set up double tests on the system.
1.3 Presentation of Results

The ACL system offers the following choices to display and print results of testing:
• s (seconds)
• R (Ratio)
• NR (Normalized Ratio)
• INR (International Normalized Ratio)
• % (Percent activity)
• U/mL (units/mL)
• mg/dL (for example for Fibrinogen)
• mg/L
• g/L (for example for Fibrinogen)
• ng/mL (for example for D-Dimer)
• microg/mL
• microg/L (for example for D-Dimer)
• micromol/L
• IU/mL (International Unit)
• User configurable unit
1.4 Instrument Description and Operation
1.4.1 Summary
The ACL is a family of fully automated computer-controlled, microcentrifugal
analyzers. The ACL Elite/Elite Pro system incorporates a Liquid Crystal
Display (LCD) unit that shows the status of the instrument, permits the user
to select desired procedures, and through the use of menus and options
guides the operator through these procedures. Information and instructions
are entered into the system either via a Touch Screen device or through a
standard PC keyboard or mouse.
When sample testing is initiated, the samples and reagents are sequentially
pipetted into a 20-cuvette polystyrene rotor (loading process). A centrifugation
process then mixes sample and reagents. The mixing is carried out by a

General Information
combination of rapid acceleration and braking actions, which are effective in

thoroughly mixing the liquids. Reaction measurements (data acquisition) via
the photometer are made while the rotor is spinning.
The ACL measures the parameters at 37 oC ± 1 oC (98.6 oF ± 1.8 oF), at an
ambient temperature from 15 oC to 32 oC (59 oF to 89 oF). However, if the
ACL is in a temperature-controlled environment where the ambient
temperature is held constant, the measurements are made within a narrower
temperature range: 37 oC ± 0.25 oC.
The results are displayed on the LCD and optionally printed by the external
printer, and/or sent to a host computer. The ACL performs automatic
calibration, offers a series of utility programs for the operator and manages a
complete quality control program.
1.4.2 Main hardware components

The ACL Elite/Elite Pro analyzer includes several hardware components and
modules, which interact with each other to carry out the analytical process.
This section contains descriptions of those components and their functions as
well as the operations that take place during the analytical process.
The figure below highlights some of the main components of the ACL
Elite/Elite Pro, as viewed from the front of the system.
System – Components (ACL Elite does not have Rotor Transport and Rotor Arm)
5
6
1. Wash-R Emulsion 6. Floppy Disk Drive 11. Rotor Waste Area

2. Dilutors 7. LCD 12. Keyboard
3. Sample Tray 8. Rotor Stack Area 13. Adapters Area
4. Reagent Area 9. Rotor Holder Cover 14. Liquid Waste Outlet
5. Sampling Arm 10. Rotor Transport / Arm* *Not Available on ACL Elite
8
9 & 10
11
12
14 13

General Information
The following items will be addressed in the Sections below:

• Sample Tray (Section 1.4.3)
• Reagent Area (Section 1.4.4)
• Rinse/Waste Area (Section 1.4.5)
• Sampling/Dispensing System (Section 1.4.6)
- wash-reference emulsion
- piston block and electrovalves
- Sampling arm assembly
- Sensors
• Loading and Analysis Area (Section 1.4.7)
- Rotors (reaction cuvettes)
- Rotor housing and rotor transport*
- Rotor holder and rotor loading
- Optical measuring system (photometric and nephelometric)
- Rotor waste area
• Microprocessor and Electronics (Section 1.4.8)
• Liquid Crystal Display (LCD) (Section 1.4.9)
• Keyboard (Section 1.4.10)
• Interface Connectors (Section 1.4.11)
• Internal Cooling System (Section 1.4.12)
• On-board Barcode Reader (Section 1.4.13)
• External Barcode Scanner (Section 1.4.14)
• External printer (Section 1.4.15)
• Floppy disk drive (Section 1.4.16)
*Rotor Transport system is not available on the ACL Elite
1.4.3 Sample Tray

The ACL autosampler system includes a rotating sample tray which contains:
- 40 x 14.2 mm diameter positions for cups and primary tubes and
- 10 x 23 mm diameter positions to hold accessory materials such as
calibrators, diluents, reagents vials, etc.
Optical sensors located around the tray verify that the tray is correctly
positioned, and also detect the presence of cups, tubes and vials.
Three different sample trays can be used (with the ACL system) depending
on the instrument configuration. Each is appropriate for a different size of
primary tubes: 3 mL, 5 mL and S11.5; all of them can be used for 0.5, 2 or 4
mL cups.
Short (3 mL) Primary tube (13x75 mm)

Tall (5 mL) Primary tube (13x75 mm and/or 13x100 mm)
Tall (S 11.5) Sarstedt primary tube (11.5x66 mm) and/or (11.5x92 mm)
The dimensions mentioned above are all nominal values.

Sample Tray
Sample Tray Location on the ACL
Press Button to Remove Tray

General Information
§ Additional Reagents positions

The ten internal positions of the sample tray - A1 to A10 - are used to place
materials such as calibrators, diluents or reagents in a choice of containers
such as 23 mm vials (10 mL fill volume), 18 mm vials (4 mL fill volume) or
cups. Adapters are needed for the 4 mL vials and cups as seen in the picture
below.
Normally, position A1 is reserved for a cup containing calibration plasma
(normal pool) and position A2 is reserved for a cup containing IL Factor
Diluent, for use in the calibration procedure.
Adapters for internal positions in the Sample Tray
Vial Adapter
Cup Adapter

1.4.4 Reagent Area

The ACL Elite reagent area consists of 8 reservoirs labeled R1 to R8
designed to hold reagent containers. The ACL Elite Pro has 4 additional non-
stirred cooled positions labeled R9 to R12. An area alongside the vial holes is
designed to hold the vial caps while the vials are in use.
Positions R1 to R4 (all models) and R9 to R12 (ACL Elite Pro only) are
maintained between 10 - 16 oC by a Peltier-effect regulator. Positions R1 to
R4 are equipped with a stirring mechanism.
Positions R5 to R8 are used for reagents at room temperature; these
positions do not have a stirring mechanism.
The reagents in positions R1 to R6 and R9 to R12 are aspirated with the
internal (Reagent) needle while the reagents placed in positions R7 and R8
are aspirated with the external (Sample) needle.
Reagent Area - ACL Elite
All reagent positions can hold 28 mm vials (16 mL fill volume). Smaller
diameter vials require the use of color-coded adapters.
Vial Adapters
Gray: for 10 mL vials requiring magnetic stirrer
Pink: for 10 mL vials not requiring magnetic stirrer
Green: for 4 mL vials not requiring magnetic stirrer

General Information
1.4.5 Rinse/Waste Area

The rinse/waste system of the ACL consists of a removable rinse cup
reservoir positioned between reagents positions R4 and R5, a plastic tube
connected to the cup reservoir drains the waste from the cup, and a waste
container outside the analyzer (left side) collects the waste.
The cup, which is always filled with Wash-R Emulsion, is used as a wash
basin for the dispensing needles between cycles; the liquid waste is then
drained and collected in the waste container on the outside of the analyzer
for proper disposal.
Rinse/Waste System
Rinse Waste Reservoir under Needles External Waste Container

(left side, front of unit)
1.4.6 Sampling/Dispensing System

The sampling/dispensing system of the ACL Elite/Elite Pro includes the
following components:
Wash-Reference Emulsion bottle

This is a plastic bottle containing 1000 mL of silicon emulsion, which is
employed as a wash solution and serves as the optical reference for the
nephelometric channel. A sensor located inside the bottle alerts the user
when the liquid level falls below acceptable values. The cap on the bottle is
removed by lifting it up off the bottle.

Piston block and Electrovalves

Set against the back wall of the analyzer is an acrylic block with two cylinders
each of which has a stainless steel piston. Two electrovalves are connected
to the pistons. The electrovalves are electronically controlled and connect the
pistons to the Wash-Reference Emulsion bottle as well as to the two needles
mounted on the sampling/dispensing arm.
Sampling/Dispensing Arm Assembly
Two stainless steel needles, external (Sample) and internal (Reagent), are
mounted on the distal end of an arm, which is actuated radially by a stepper
motor. Another stepper motor moves the arm in the vertical plane through a
worm screw. The combination of these two movements allow the following
operations:
- Aspiration of sample and/or reagent from their respective locations.

- Dispensing of sample and reagent into the inner and outer
compartments of the reaction cuvettes within the rotor.
- Washing of the needles in the waste/rinse station.
Sampling Dispensing System
Sensors
Two liquid level sensors connected to the needle block are used to detect the
presence of samples and reagents in the needles.
Through the liquid level sensors, the system monitors the presence of
samples and liquid materials (calibrators, deficient plasma, diluents, etc.) in

General Information
the sample tray and reagents in the original reagent vials located in the
reagent area.
These liquid sensors are integrated into the ACL analytical cycles in such a
way that their operation does not affect the throughput of the system. For all
analytical cycles the verification by the sensors is done “in-line” during the
loading phase. The sampling arm stops when the needle is just below the
liquid surface to allow proper aspiration of the programmed amount of liquid.
The liquid sensors become active at the start of each analytical cycle. The
sequence of sensor operations during a cycle is as follows:
- self-check
- liquid test
- washing
- final sensor self-check
- if applicable, reports sensor failures to be displayed in the LCD.
If Operators are warned of sample/reagent sensor failures: results of a

sample for which the system detected insufficient volume will appear with a
warning. For Example, if the failure was due to insufficient sample in a cup,
the warning message will display “low level”. If all sample containers in the
sample tray are empty, the cycle will be aborted after the final self-check. No
other warnings appear on the video or on the printer.
Sampling Arm with sensor
Sample line is on top
External
Internal (Sample)
(Reagent)

Any sensor failure warning due to self-check or to insufficient reagent will:

- disappear at the beginning of the loading phase
- appear during incubation/acquisition in case of self-check error or
insufficient reagent
- remain up to the next loading phase in the following cycle.
Although the sensor test terminates as soon as an error is detected during
the initial self-check, the analytical cycle continues. In this case, the test
results are given and a warning appears in the status line indicating the
sensor failure. No indications will be given about the absence of samples
and/or reagents.
The operator may view the warning condition by pressing the Warning icon.
An equivalent message will be printed out with the results.
Note: No additional amount of liquid (sample or reagent) is aspirated for the

sensor check.
1.4.7 Loading and Analysis Area

The area of the analyzer where the reaction cuvettes are loaded and the
analysis takes place is located under the rotor holder cover in the center of
the instrument, on the right side of the reagent area. This area includes the
reaction cuvettes (rotors) storage system and mechanisms involved in the
transport of these rotors, the plate where the rotor is placed during loading
and analysis (rotor holder), the hardware components responsible for
ensuring proper mixing of reagents and samples in the cuvettes and the
optical system used to make the analytical measurements. The rotor holder
cover can be opened by pressing the rotor cover icon.
Rotor
Inner Well
Outer Well
Caution: Avoid touching

the area of the rotor where
the optical reading occurs.
This includes the top, side
and bottom of the outer
portion on the rotor.

General Information
Rotor (reaction cuvettes)

The disposable reaction cuvettes, precision made of UV-transparent
polystyrene, are radially arranged in groups of 20. The 20-cuvette unit is
called a rotor. Optical readings occur in the outer portion of the rotor.
Each wedge-shaped cuvette contains two compartments, an inner one near
the center to hold the sample and/or reagent and an outer one that holds
reagents only. A partial dam between the compartments maintains the
contents separately during the loading process; as centrifugal action starts,
the sample/reagent in the inside compartment flows over the dam to mix with
the contents in the outer compartment. The reaction and analysis take place
within the large, outside compartment while the rotor is spinning.
Rotor Stack, Rotor Transport and Rotor Arm

Rotor stack - Before their use, rotors are stored in a stack that holds up to 12
rotors. The rotor stack compartment, which may be accessed from the top of
the analyzer on the right side, can be filled at any time (continuous rotor
loading) either manually (one rotor at a time) or using a rotor refill tool (up to
10 rotors at a time). The rotor stack area is thermostatically controlled in
order to keep the rotors in a temperature range between 36 and 39 oC; the
rotor stack is insulated to help thermal-regulation. The instrument informs the
Operator when the Rotor Stack is empty on the ACL Elite Pro.
Use of Rotor Refill Tool
Depress center button to

load and unload rotors

Feeding the Rotor Stack
Rotor Transport* - Below the rotor stack, a rotor transport slide mechanism
moves the bottom rotor out to make it available to the rotor arm mechanism.
Rotor Arm* - The robotic arm takes the rotor and inserts it into the rotor
holder. This is the area where the rotor will remain during the loading and
analysis process. Once analysis is completed, if the rotor is fully utilized (or if
requested by the user), the rotor arm discards the rotor into the rotor waste
container.
Rotor Transport and Arm – (Not Applicable on the ACL Elite)*
On the ACL Elite rotors must be manually loaded from the storage area into
the analysis compartment. Press the “Open Lid” icon to raise/lower the
analysis compartment cover. Press the button on the center of the hub in the
analysis compartment to properly seat and remove the rotor. The analyzer
will alert the operator when a rotor exchange is needed.

General Information
Rotor Holder and Rotor Loading

The rotor holder is an aluminum disk that holds the rotor in place during
loading and analysis. The rotor holder is thermostatically controlled to a
temperature of 38.5 ± 0.5 oC to insure 37 oC inside the cuvette.
Rotor Holder Area
Press this
button to
manually
place and
remove
rotors
Rotor loading: as indicated above, the loading of sample and reagents into
the reaction cuvettes involves the action of the sampling/dispensing arm and
needles.
Optical Measuring System

The Loading and Analysis area also houses the optical system for analysis
on two channels: nephelometric and absorbance.
Nephelometric channel: the light source for this channel is a light emitting
diode (LED); the light (λ = 660 nm) is directed to the reaction cuvettes in the
rotor by a fiber optic system. The scattered light is read at a 90o angle with
respect to the incident beam using a solid state detector located below the
rotor holder.
Absorbance channel: the light source is a halogen lamp, from which the
radiation is directed to the reaction cuvettes in the rotor via a quartz optic
fiber and a focusing system. The selection of the wavelength for analysis is
effected by a narrow-band interference filter centered at λ = 405 nm.
The optical detector is mounted in the cover of the loading/analysis area;
therefore the readings are made at a 180o angle from the light beam.
The optical path width for the absorbance channel is 0.5 cm (cuvette height).
The absorbance values provided by the analyzer are normalized to 1 cm.
These values are generally twice those ones obtained on other ACL models,

for which the absorbance values are not normalized and are thus exactly the
ones obtained for the 0.5 cm cuvette path.
The halogen lamp can be replaced by accessing the area through a
removable cover inside the rotor waste area in the center of the instrument by
an IL Service engineer.
Nephelometric and Absorbance Detection Systems
Clot channel Absorbance Channel
Sensor
405 nm filter
LED Rotor
Lenses
Optical Fiber Sensor
Quartz
Quartz optical fiber
Halogen Lamp
Rotor Waste Area

The used rotors are automatically dropped into a waste container on the ACL
Elite Pro system. On the ACL Elite system rotors may be manually moved
into the waste bin or discarded immediately into a designated biohazard
container per laboratory protocol. This container is accessed from a door on
the right front area of the analyzer for removal and disposal of the used
rotors, as seen in the figure below. The instrument informs the user when the
Rotor Waste is full.
Warning: Cuvettes within the rotor are intended for use one time only.
IL does not recommend or support the re-use of previously used-
washed cuvettes in a rotor.

General Information
Rotor Waste Access and Removal
In the waste area a switch (sensor) verifies the presence of the waste
container.
1.4.8 Microprocessor and Electronics

This ACL analyzer unit is built around three computer microprocessors.
These microprocessors control all actions of the analyzer: mechanical
movements, aspiration and dispensing of samples and fluids, acquisition and
processing of data and operator interface with input (keyboard) and output
(video/printer) devices.
The electronics consist of printed circuit boards held together by a frame
mounted behind the front panel of the analyzer. Three of these boards are
assigned to the microprocessor and logic sections while the other three are
used for the interface modules and the various activation controls. These
circuits and the sub-assemblies of the instrument are supported by a
switching power supply directly connected to the main power

1.4.9 Liquid Crystal Display (LCD)

This module consists of a Liquid Crystal Display, 12-inch active matrix (LCD),
which is fitted with a Touch Screen function, allowing most operations to be
carried out using the LCD.
The LCD guides the operator during the analytical process and displays
calibrator data and patient results. It is also used to display calibration curves
and to perform several utility programs, which are easily accessible through
this input device.
The LCD screen system reproduces 256 colors, and shows numeric and
alphanumeric characters. The interaction with the operator is also made user
friendly by the availability of graphics and icons. The screen is divided into
three areas:
- The upper section displays the submenus
- The central section displays menus, results, graph plots and instructional
guidelines
- The lower section displays instruction icons.
1.4.10 Keyboard
The ACL Elite/Elite Pro has a standard computer keyboard with mechanical
keys that allow the user to access the various operating modes of the
instrument.
Although the instrument is equipped with and supports the English (US & UK)
keyboard layout, the ACL software itself also supports the following
languages: German, French, Spanish, Japanese (Kanji) and Italian.
Keyboard

General Information
1.4.11 Interface Connectors

RS-232 C Interface for Host (port 1)
The ACL Elite/Elite Pro contains an RS-232C interface (DTE Standard) for
the output of data to a central computer (Host) or a personal computer.
Communication to a host computer is via ASTM protocol.
RS-232 C Interface for a serial mouse (port 2)
USB ports (4 receptors)
The USB ports can be used for a mouse, printer or the optional external
reagent barcode reader.
Modem (port 4) not supported in this software release.
External Printer Output (port 5)
The ACL Elite/Elite Pro has an output for an optional external printer. Two
emulation protocols are available for printers: ESC/P2 (Epson like printers)
and HP-PCL (for HP like Laser Printers).
Standard PC keyboard (port 6)
Rear Panel and Fuse
1 2 3 6
1. RS232C 1 (Host - Optional)

2. RS232C 2 (Mouse)
3. USB (4 ports) Mouse, Printer, External barcode
4. Modem (NS)
5. Parallel Printer (Optional)
6. Keyboard
NS = Not Supported in this software release

1.4.12 Internal Cooling System

The cooling of the system is insured by the presence of fans mounted on the
internal right side of the analyzer. An air filter prevents dust from entering the
system (see Maintenance section).
A two-level alarm warns the user when the internal temperature of the
instrument rises above damaging levels. The first level alerts the operator of
the temperature rise and displays a warning. The second level switches off
the instrument.
1.4.13 On-board Barcode Reader

The on-board barcode reader, a standard feature of the ACL Elite/Elite Pro, is
located in the sampling area as indicated in the figure below. A small window
indicates its position. For additional information on the use of the on-board
barcode reader, refer to Section 3, Section 7 and appendix B of this Manual.
The numeric and alpha-numeric readable codes are:
- Codabar
- Code 39
- Code 128
- Interleaved 2 of 5
When using barcoded sample tubes, it is important to position them in the

sample tray such that the labels are facing towards the outside of the sample
tray. This will allow correct reading of the labels by the on-board barcode
reader.
On-Board Barcode Reader

General Information
1.4.14 External Barcode Scanner (optional)

The external barcode scanner is a standard item on the Elite Pro and an
optional feature of the ACL Elite. This barcode scanner is able to read the
alphanumeric information on the HemosIL reagent vials when the material
map is displayed. The vial label includes the following information used by
the ACL Elite/Elite Pro:
- Last 4 digits of the lot number

- Lot number expiration date
- Material ID
The scanner is attached to one of the USB ports located on the backside of
the analyzer. Connect the scanner with the analyzer off and reboot the
system. The scanner will become active.
The scanner is automatically activated when the material map is displayed.
External Barcode Scanner

1.4.15 External Printer (optional)

An external 80-column printer can be interfaced to the ACL Elite/Elite Pro.
Two emulation protocols can be used : ESC P2 or HP-PCL.
The ESC P2 is a typical Epson like protocol while the HP-PCL is a typical
Hewlett Packard like protocol for Inkjet and Laser printers.
The printer can use either a USB or Parallel connector. If the USB
connection is used the printer must be connected and turned on prior to the
system being booted up. If the printer is turned off while the instrument is on,
the analyzer must be rebooted in order for printing to occur.
External Printer

General Information
1.4.16 Floppy Disk Drive

A floppy disk drive is mounted in the upper right area on the ACL Elite/Elite
Pro.
This device is used for some of the utility programs (refer to section 4).
The floppy disk is accessible from the cover by pushing both sides of it to
open.
3.5” Double sided High Density IBM preformatted disks should be used in the
drive.

1.5 Additional Features
1.5.1 Standby Status

If the ACL Elite/Elite Pro is left ON for a period longer than 30 minutes
without any operator action, the system moves into the Standby status. The
LCD screen is “Switched off”. Pressing the Touch Screen reactivates the
display and allows the system to resume normal operation.
When the system enters the Standby status, the database is saved, all
motors are deactivated to reduce power consumption and the LED source is
switched off. While the instrument is in Standby an automatic priming cycle is
performed every 30 minutes.
1.5.2 End of the Cycle

At the end of each analytical cycle, a beep signal notifies the operator that
the cycle has been completed.
1.5.3 Power loss

The ACL contains a non-volatile memory to retain the database in the event
of a power interruption. The instrument performs an automatic save of the
database with every entry in standby or when exiting from the main program
to power off. Failure to log off before shutting the system down may result in
the loss of some results that have not been saved to the database.
The instrument has an internal clock that keeps track of the date and time.
When power returns after an interruption, the instrument performs self-
checks and displays the “login” screen. Entering the main screen, two
situations are possible:
1. The rotor holder temperature was within the acceptable range during the
check. The system is ready.
2. The rotor holder temperature was out of range. On the Main menu, the
Warning icon on the lower part of the screen is activated indicating that one
or more temperatures are out of range.
Note: Selecting the “WARNING” icon a message may be displayed if

temperatures of the reagent cooling system, the rotor holder, the rotor
transport and/or the rotor stack are out of range.

General Information
1.5.4 Setup and Utility Programs

The instrument incorporates several utility programs that allow certain
functions to be changed or set according to the user’s needs. These
programs also help in troubleshooting.
For additional information, refer to Section 4 and Section 6 of this Manual.
1.5.5 Fault Detection

The system automatically monitors faults to ensure accuracy of sample data
and proper system performance. Fault monitoring includes display of alarms
and warnings.
For additional information, refer to Section 6 of this Manual.
1.5.6 Video Display Colors and Symbols

Certain situations concerning results and calibration parameters are
displayed as follows:
− Black = Result within Normal range

− Violet = out of Normal range
− Red = out of Test range
− *** = result out of the Scale range, high, for the assay
− --- = result out of the Scale range, low, for the assay
− ? = No result is available for this ordered test
− * = More than one result is available for this test
For additional information, refer to Section 3.2.2 and Section 7 of this
Manual.
Defined normal, test and scale range limits can be obtained by detailing the
individual test definitions in the system. Normal ranges must be entered by
user.
1.6 Procedural Limitations

The operating range of the ACL Elite/Elite Pro is 15 to 32 oC (59 to 89 oF) and at up to
85% Relative Humidity (not condensing). The system has been tested according to
EN61010-1 to ensure no safety hazards occur in the temperature range 5 - 40 oC (41
to 104 oF) and functional performance characteristics are resumed when the
instrument re-enters the range of 15 to 32 oC (59 to 89 oF).

1.7 Certification
CE Certification
The CE label on the back of the instrument indicates that the ACL Elite/Elite Pro conforms
to the European Directives as stated in IL Declaration of Conformity,
EU Directive:
IVD - 98/79/EC (27/10/1998) , Annex I and III
Applicable standards:
• EN 61326-1: 1998/A2 2001 (Class A)
• EN 61010-2-04 Safety requirements for electrical equipment for measurement,

control and laboratory use. Part 1: General Requirements
• EN 61010-2-101 Part 2: Particular requirements for in-vitro diagnostic laboratory

equipment
• EN 61010-2-081 Part 2: Particular requirements for automatic and semi-automatic

laboratory equipment for analysis and other purposes.
CSA Certification
The CSA label on the back of the instrument indicates that the Canadian Standards
Association (CSA) has certified the ACL Elite/Elite Pro to the applicable standards.
Applicable standards:
• CAN/CSA C22.2 No. 1010.1-92
• UL Std. No. 61010-1, 2nd Edition
LOPD (Data Protection Organic Law)

Directive 95/46/CE of the European Parliament and the Council Directive of October 24th,
1995.

General Information
European regulation on data protection, concerning:
Luxembourg Ireland Greece
United Kingdom Belgium Portugal
Austria Germany Italy
Denmark France Netherlands
Sweden Finland Spain
European parliament and council directives and regulations on data protection.
Spanish Constitution of 1978.
Organic Law 15 of December 13th, 1999, on Personal Data Protection (LOPD).
Royal Decree 994/1999 on Security Measures. Royal Decree 1332/1994.
Regulation of the Computerized Processing of Personal Data.
Spanish Data Protection Agency instructions.
Other Certification
The ACL Elite/Elite Pro meet CEI/IEC 61010-1, 2001 Mod, Second Edition, for the
following:
• External Surface Temperature
• Flame Resistance
• Fluid Resistance
• Internal Air Flow and Temperature
• Audible Noise
• Product Labeling
The ACL Elite/Elite Pro shipping package, US or overseas, complies with the International
Safe Transit Packaging Testing Procedure ISTA 1B (June, 1999) and ASTM 999.

1.8 Instrument Disposal

European Union Directive 2002/96/EC on Waste Electrical and Electrical
Equipment (WEEE)
Instrumentation Laboratory is committed to meeting or exceeding the conditions of

the WEEE Directive, and being a good environmental partner. In compliance with the
Directive, beginning with product shipped after August 13, 2005, all instruments will
be labeled with the wheelie bin symbol.
Please call your local Instrumentation Laboratory distributor for information regarding
the disposal of any end-of-life instruments.

General Information
1.9 Symbols Chart

The following chart displays the various symbols that may be associated with the ACL
Elite/Elite Pro system
Temperature Use By Manufacturer Batch Code

CE Mark Limitation
ATTENTION: CAUTION: NOTE: ATTENTION:

Biological Risk See Risk of electric Important user Consult
Instructions Shock Information Documents
For use
In Vitro Authorized Contains

Catalog Number Serial Number Diagnostic Representative sufficient for
Device <n> tests
Earth Off (supply) On (supply) End of Life

Protective Disposal
Conductor (WEEE)
terminal -Earth

Installation
2.0 Introduction
This section contains all the information necessary for installing and setting up the
ACL Elite/Elite Pro system.
Warning: The ACL Elite/Elite Pro system must only be installed by IL personnel or
IL authorized persons.
Before attempting the installation of the ACL Elite/Elite Pro system in the laboratory,
inspect the site with laboratory personnel to identify the desired location for the
system and to insure that the environment meets all the requirements for its
successful installation.
2.1 Installation Requirements

The following sections detail the specific installation requirements for the ACL
Elite/Elite Pro system.
2.1.1 Ambient Conditions

The instrument will function correctly in an ambient temperature of 15-32 oC
(59 oF to 89 oF) with a relative humidity of up to 85% (non-condensing).
In accordance with the IEC regulations no instrument failures will occur in

presence of short term ambient temperature as low as 5°C or as high as
40°C.
The instrument should be positioned in an area free from dust, fumes,

vibrations and excessive variations of temperature.

Installation
2.1.2 Space Requirements

External dimensions of the analyzer are:
- Height at display level 60 cm 23.6 inches
- Height of analysis surface 27 cm 10.6 inches
- Width (including LCD) 100 cm 39.4 inches

- Depth 60 cm 23.6 inches
- Weight 63 Kg 139 lbs.
The heat generated by the instrument during normal operation is exhausted
from the bottom, on the front-right and left side of the unit.
Sufficient space must be allowed around the instrument to permit circulation
of air for cooling. The instrument must be positioned so that a waste tube can
be easily connected to its left side.
If the operator wishes to work from a sitting position in front of the system,
leg-space should be provided under the front of the instrument.
2.1.3 Electrical Requirements

The instrument has been designed to operate correctly with variations of
±10% on the nominal line voltage and with line frequencies between 50-60
Hz.
The instrument has a power supply that can operate from 100 to 240 V and it
automatically switches to the line voltage required.
Warning: Check that the nominal line voltage in the laboratory is

compatible with the label on the rear of the instrument as shown in the
table below. The electrical installation of the room should comply with
local, state or national requirements (including a power supply circuit
with independent grounding).
Value as shown on the label Values of line voltage for

normal function
100 – 240 V 100, 110, 115, 120, 125 Vac ±10%
220, 230, 240 Vac ±10%
Power Consumption
Check that the line is capable of supplying 350 VA.

Warning: The average power consumption is about 350 VA, but peak
loads or current surges may exceed this value when turning the
instrument on.
Line Frequency
The instrument will function at any frequency between 50-60 Hz.
The power cord provided with the system is specifically designed for use with
the ACL Elite/Elite Pro. No other cord should be substituted. The cord plugs
into the socket as shown in the figure below. The fuses are enclosed in the
compartment to the right of the socket. The power entry module and the
ON/OFF switch are included.
Power Socket and Fuse

Installation
Connectors
The instrument is provided with several connectors located on the back side.
Connectors
1 2 3 4 5 6
1. RS232C 1 (Host - Optional)

2. RS232C 2 (Serial Mouse)
3. USB Ports (4): Mouse, Printer or External Barcode reader
4. Modem (NS)
5. Parallel Printer (Optional)
6. Keyboard
NS = Not Supported in this software release

2.2 Instrument Delivery and Unpacking

An IL-certified representative should unpack the boxes containing the ACL and
accessories, visually inspect them to verify that there has been no damage during
shipping and handling. IL is not responsible for damages resulting from any non IL-
certified representative opening the boxes.
In case of damage notify the carrier and IL immediately.
Remove the box containing the rotors and the startup kit. Using the startup kit list
included in the box, confirm that all the shipping list components are present.
Remove the instrument and place it on the working surface.
Remove the adhesive tape used for transport from the various parts (covers, fan
cover, etc.).
Caution: Two persons should lift the instrument using the space below the unit
at the front and at the back as shown on the figure below.
Instrument carrying points

Installation
2.3 Mounting Instrument Parts

Waste tube
Connect the waste tube to the fitting on the bottom left hand side of the instrument.
Cut the tube to suitable length to fit into the waste container which must be situated
below the instrument waste outlet port, as shown in the figures below.
Caution: The horizontal section of the tube should be kept as short as possible
and the free end should not be immersed in the liquid waste container.
Warning
The liquid waste from the instrument is to be considered contaminated and
should be disposed of according to the waste management procedures of the
laboratory and in compliance with local regulations (see also CLSI GP25-A, Vol.
13 No. 22: Clinical Laboratory Waste Management, Dec. 1993).
Waste tube connection and waste container position

Rinse, Sample and Reagent Accessories

• Verify that the waste-rinse reservoir is placed in its appropriate position.
• Fit the appropriate sample tray on its corresponding support.

• Fit the reagent adapters in their appropriate positions (if needed), as shown in the
figure below. Three color-coded reagent adapters are available for reagent
positions R1 to R8 (ACL Elite) and R1 to R12 (ACL Elite Pro ) :
Gray for 10 mL vials requiring magnetic stirrer (R1 to R4 only)
Pink for 10 mL vials not requiring magnetic stirrer
Green for 4 mL vials not requiring magnetic stirrer
Different blue vial adapters are used for the additional positions on the sample
tray.
• Place the magnetic stirrers inside the reagent vials in reagent positions R1 to R4,
if needed.
Reagent Adapters for the R1-R8 (ACL Elite) and R1-R12(ACL Elite Pro) positions

Installation
Reagent Adapters for the Sample Tray A1-A10 positions
Cup Adaptor Vial Adaptor
Wash-Reference Emulsion
Place a 1-liter bottle of Wash-Reference Emulsion in the appropriate position at the
back of the dilutor block. Insert the aspiration tube. Make sure that the aspiration
tube connector is properly connected to the level-sensing device.
Positioning of the Wash-Reference emulsion bottle
Electrovalve-needle assembly
Verify that the two tubes from the dilutor/electrovalve assembly to the needle block
are tightly connected.

NOTE: The tube from the left hand electrovalve fits into the lower needle
connector and the right hand tubes fits into the upper needle connector.
Electrovalve-needle assembly
Positioning the touch-screen LCD display

Connect the LCD display to the appropriate fitting on the right side of the instrument,
as shown in the figure below.
Position of the LCD display
Monitor can be adjusted for left/right and up/down viewing angle

Installation
2.4 Turning the System On

Before turning the instrument on, check that the line voltage setting of the laboratory
is in accordance with the instrument label. Connect the instrument to the power
supply and switch it on using the power switch on the back panel.
Check that the Warning message “INCUBATION TEMPERATURE OUT OF RANGE”
appears on the screen display by accessing the WARNING icon. Check that the
magnetic stirrers in the reagent vials R1 and R4 are rotating (if needed).
Date/Time
Select Setup from the Main screen menu bar and click the Date/Time option. Choose
the date format. Set date and time. Press Confirm/Cancel to accept or ignore the
changes (refer to Section 4 - Setup Date/Time).
NOTE: The message “INCUBATION TEMPERATURE OUT OF RANGE” in the

Warning list is displayed for approximately 15 minutes, until the rotor holder
has reached the operating temperature.
Needle Arm Assembly

Please refer to Section 5 for information about the Needles Position procedure.
Priming
Select Diagnostic from the main screen menu bar and click the Priming option.
The Priming screen is displayed during the priming cycle:

Priming screen
During priming, check that the number of bubbles in the dilutor chambers are reduced
to a minimum. If necessary, pinch the chamber outlet tubes with your fingers while
the piston is descending and release them before the piston reaches bottom dead
center. Repeat the priming cycle if necessary.
Check that there are no blockages or leaks in the fluid path and that the liquid is
flowing smoothly from the bottle to the dilutors and from the dilutors to the needles.
Check that the discharge of liquid from the rinse cup to the instrument outlet and then
to the waste container is not impaired.
Warning: If the message “SENSOR FAIL” in the Warning area is displayed, the
priming cycle must be repeated.
Air Cooling System Check

Locate the ventilation filter holder on the right side of the instrument. Verify that the
filter is clean and that the two fans are operating properly.

Installation
Temperature Check
Wait until the INCUBATION TEMPERATURE OUT OF RANGE warning has
disappeared and the Main menu is displayed. Click the Diagnostic button in the
menu bar and select the Temperature Control option, which will open the
Temperature Control screen. For details refer to Section 5.
Temperature Control screen

The temperature should be within the following ranges for each area:
• Rotor Holder 38 to 39 oC
• Peltier* 10 to 16 oC
• Rotor Transport 34 to 40 oC (N/A ACL Elite)

• Rotor Stack 34 to 40 oC
*ACL Elite Pro will display two Peltiers for R1 – R4 and R9 – R12.
The temperature display is constantly refreshed showing a blinking effect on the
display.
.

On-Board Barcode Reader

This is a standard feature for the ACL Elite/Elite Pro. Set up the On-Board Barcode
Reader according to the procedure described in Section 4 of this Manual.
For additional information on the On-Board Barcode Reader, refer to Appendix B.
Manufacturer’s Responsibility
The manufacturer is responsible for the defects having an impact on safety, reliability
and performance of the equipment only if:
- assembly operations, extensions, re-adjustments, modifications or repairs are
carried out by manufacturer’s authorized personnel; and
- the electrical installation complies with national requirements; and
- the equipment is used in accordance with these operating instructions.
2.5 ACL - HOST Interconnect Cable

The following table provides information regarding the wiring of the interconnection
cable between the ACL and a PC (Host).
ACL Side PC Side

Interface Type: DTE Interface Type: DTE
9 Pin Female Delta Connector 9 Pin Female Delta Connector
PIN DESCRIPTION PIN DESCRIPTION

1 N.C 1 N.C.
2 TXD 2 TXD
3 RXD 3 RXD
4 DTR 4 DTR
5 Signal GND 5 Signal GND
6 DSR 6 DSR
7 RTS 7 RTS
8 CTS 8 CTS
9 N.C. 9 N.C.

Analytical Operations
3.0 Introduction
This Section describes the different procedures associated with sample analysis,
calibration and Quality Control (Q.C.) on the ACL Elite/Elite Pro System. Since these
procedures require an interaction between the operator and the ACL, this Section
begins with some general information about the System’s Operator Interface (OI) for
easy referral, as need arises.
3.1 Components and Use of the Operator Interface

The following sub-sections are intended to familiarize the operator with the Operator
Interface (OI) items used during the process of requesting and performing analytical
operations, such as the data input devices, menu items, buttons and icons. The ACL
Elite/Elite Pro software tree is also included.
3.1.1 Touch Screen

The basic interaction with the ACL is done through menus that allow access
to sets of related functions (analysis, calibration, QC, set-up, diagnostics,
etc.) and through the use of dialogue or message boxes to input or retrieve
information.
The main information input device for the user is the touch screen. To start
an “enter” or “edit” action, the operator touches the area to be edited. If the
information to be entered is strictly numerical, the editing is done directly on
the keyboard or popup keypad (optional system configuration). If the
information requires alphanumeric characters, the input is done through the
external keyboard.
The editing action may be closed by pressing the "Confirm" √ or the
"Cancel" Χ buttons.
Once confirmation is complete, the system performs an automatic check on
the entered value; if an erroneous entry is detected, the user is notified by
means of dialogue boxes and the editing action is reactivated. The touch
screen supports auto-repeat functions in order to make lists easier to scroll
(e.g. sample lists, test lists, increase/decrease order).
The Main Database screen is divided into 3 main areas:

1. Status area: upper part of the screen which contains:
Instrument status Date and Time
Current user Software revision
IL logo

2. Working area: central area of the screen, which displays windows that
contain data or messages.
3. Toolbar area: bottom part of the screen, which contains a series of
buttons for immediate access to particular functions and easy access to
specific commands. The status of the buttons is dependent on the instrument
status, but independent from the type of information displayed in the working
area.
NOTE: On the touch screen, any disabled object (menu, check-box,

icon, button) is dimmed out and cannot be selected.
3.1.2 Numerical Keypad

The numerical keypad allows the operator to edit numerical data without
using the standard PC keyboard. The numerical keypad can be configured to
automatically display when the user starts an edit action (refer to section
4.1.17). The keypad allows the operator to visualize the edited string while
editing is in progress. The keypad automatically disappears when the
"Confirm” √ or "Cancel" Χ. buttons are selected or the editing action is
implicitly closed.
The keypad displays the name of the field being edited as a window caption,
and information on the accepted range values; it also supports the date
format.
When the numerical keypad is opened, the values shown in the fields are
either the default or the values previously entered. Use the arrow buttons to
select the field to be edited.

3.1.3 Standard PC Keyboard

The main function of the PC keyboard is to enter and edit data in the
alphanumeric fields. The keyboard input is case sensitive.
To start the editing action, select the field to be edited. This is done by
moving the cursor from the current object (it may be the default object if the
window was just opened) to the chosen object by pressing [TAB] or [Shift] +
[TAB].
To close the editing action, of the present text box, press [Enter] or select
another active object or move the cursor by pressing the [TAB] or [Shift]
+[TAB] keys. In all cases, closing the editing action causes the system to
activate checks on the entered data and the user is notified of any error
condition by means of a dialogue box. If the editing action has been closed
(touching a different area of the screen), the entered value will be changed to
the pre-existing one.
The editing action, of the present text box, may also be closed by pressing
the [ESC] key without activating any change; in this case the value returns to
the pre-existing one.
Main and secondary menus may be selected using the keyboard. The menus
are opened by pressing [ALT]+underlined Character; selections within the
menus are done using the specific underlined character. Pressing the
[ENTER] key allows access to the secondary menus.
The keyboard function keys (F1 – F10) may also be used to activate the
functions on the bottom row of icons. Use [Ctrl] + F4 for keyboard log off.

3.1.4 External Barcode Reader (optional on ACL Elite)

The USB ports allow for the connection of an external hand held barcode
reader. This device can be used to identify reagents and indicate the
placement of them onboard the system. Please refer to section 4.1.16
3.1.5 Mouse - Port 2

A serial mouse may be used as a pointing device in place of touching the
screen. The USB ports also provide the capability to connect a USB mouse
to the analyzer.
3.1.6 Menus
A menu may be opened by selecting the appropriate area of the screen
(touch or click with the mouse) or using the keyboard: [ALT] + underlined
letter.
The selection of menus to be opened may be done in all directions: up and
down or right and left.
The displayed items, which have a secondary menu, are identified with a
marker (Ø).
Selecting a menu item, touching an external area, or pressing [ESC] from the
standard keyboard closes a menu.
NOTE: In any menu, an inactive item is dimmed out. Selecting an

inactive item does not elicit a response; therefore, this method cannot
be used to exit the menu.
3.1.7 Windows and Boxes

Within the ACL screens, the data, information, or messages for the user are
grouped or contained in defined units of three different types:
• Standard window: usually a larger area which contains sets of related
data which can be edited by the user
• Dialogue box: a small area used to prompt the user to choose one of
several options (i.e. OK, Abort, Retry, Ignore, Cancel, Yes, No)
• Message box: an area used only to provide information
ICONS are often included in a message box. The table below lists all
possible icons with their corresponding meanings.

Icon Meaning
ERROR. Calls attention to high priority failures and
fault messages.
WARNING. Delivers 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. Requests confirmation by the user before
starting an operation or before canceling an action
INFORMATION. Offers general information. In some

boxes, but not always, the message is followed by a
request for confirmation.
3.1.8 Key Screen Elements

Below are descriptions of the most significant items found within the ACL
screens.
• Instrument Status
Located in the upper part of the screen within the Status area, this item
identifies the current state of the instrument as one of the following:
INIT (BOOT/START-UP): indicates that the instrument is performing startup

operations (Initializing)
READY: indicates that there have been no errors detected, there are no
analytical operations in progress and the instrument is ready to start
OPERATING: indicates that either an analytical function is in progress (i.e.

calibration or sample analysis) or a diagnostic function is being performed
HOLD: identifies a system "pause" condition during an analytical session (i.e.

STAT request, no rotors, etc.)
FAILURE: indicates that the system detected an internal mechanical
malfunction (devices, temperature control, etc.)
STAND-BY: the status into which the instrument moves automatically after
30 minutes of inactivity. LCD display is switched off (screen saver); this
extends LCD life. An orange LED indicates that the instrument is ON.
Touching the screen or any key on the keyboard will cause the instrument to
exit from standby.
NOTE: when the instrument is in standby operation, every 30 minutes an

automatic priming cycle is performed. 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).

SERVICE: the status assumed when the Service functions are in use.
• Check Boxes, Buttons and Icons
Buttons allow the user to select options, cause actions and get from one part
of the software to another. The buttons are positioned in different areas
depending on the screen. Buttons are identified with text that is self -
explanatory of the action. Icons, which illustrates an action, are defined
below.
Check boxes allow the user to “mark” an item.
If a check box or button is in mutual exclusion with another check box or
button, there is a frame wrapping the two, along with “graphic” information.
• ICONS
Icons can be found either in the middle Working Area of the screen or lining
up in the Toolbar Area at the bottom of the screen.
Below are two lists grouping the standard icons used throughout the ACL
Elite/Elite Pro, along with their associated commands. The first one includes
the Window Icons found in the screen’s Working Area, and the second one
includes the Toolbar Icons found in the screen’s Toolbar Area.
NOTES:
1. The same icon may have slightly different meaning depending on the
screen where it is found.
2. One or more of these may be disabled on a specific screen, indicated
by a dimmed representation. Its selection is ignored.
3. “Active” toolbar buttons for each specific screen and their actions
are described at the end of each appropriate section of this Manual.

Table - Window Icons

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

close3d.ico allowed)
Cancel
cancel3d.ico
Print
print.ico
(Host) Transmit
Delete
Add item to the list
Remove an item from the list
Transfer an item from one list to

another
Details
Information in different languages

earth.ico
New Sample
Extract Sample Data

sort.ico
Note
Patient Name
Patient Details
Save information to floppy disk

save.ico

Table - Toolbar icons

T Toolbar Icons C Commands / I Instrument Status
Actions (Icon active)
STAT/Pause O Operating
Pauses the system for Hold
stat or sample entry
R . H
I Instrument Status O Operating
Status of the operation inH Ready
progress. Displays Hold
material map in Ready
Close/Open cover Ready

. Hold
STOP R Ready
Confirmation is required. Operating
stop.ico Hold
Reagent Map
Color changes dependingO Operating
upon the reagent map
status
Q QC R Ready Hold
Press to view the most Operating
recent QC data. Red ! Failure
indicates a QC failure
Database View Ready
Return to the database Operating
dbview.ico view or “Main” screen. Hold
Host Status Ready Hold

Host communication in Operating
host-d.ico process Failure
Warning Ready Hold

This icon indicates Operating
Warnings exist. Press to Failure
open “Warning List”.
Log Out Ready
Allows the operator to Failure
Exit the screen.
A Confirmation is required
Start or Resume Run Ready Hold

3.1.9 A Special Window for Alarms and Errors

If an abnormal situation develops and causes an interruption during the
progress of an operation, the operator is informed through an alarm message
in a specific message box. This message box is displayed in front of all the
other windows present in the working area. After the operator confirms the
message, the information about the alarm can be viewed in this warning
window.
Error conditions that do not affect the in-progress analytical session may be
reviewed accessing the "Session Error History". The operator is able to view
a list of all the warnings and error messages, sorted by time, which pertain to
the last analytical session or to the one in progress. The Session Error
History is saved at the conclusion of each analytical session so the errors can
be checked between analytical sessions.
The "File Error History" window contains a list, sorted by time, of the last 100
alarms or error conditions. The “Session Error History” and “File Error File
History” windows are dynamically updated when opened and must be closed
before starting a new operation.
3.1.10 Screen Saver

A screen blank is activated after 30 minutes of system inactivity, provided the
ACL system is in the READY status. The operator cannot modify this time.
Any action performed on the touch screen, through the keyboard or the bar
code reader will reactivate the system.
3.1.11 The ACL Elite/Elite Pro Software Tree

The next page shows the structure of the ACL Elite/Elite Pro Operator’s
Interface - or system Software Tree - including main menu, first and second-
level sub-menus.

ACL Elite/Elite Pro Software Tree
Menu First-Level Submenu Second-Level Submenu
ANALYSIS Multi Test Session

Single Test Session
Loadlist
Session History
QC QC Review
CALIBRATION Calibrate
Review Calibrations
Analytical Reference
DIAGNOSTIC Priming
Cleaning
Maintenance
Temperature Control
Needles Position
Session Error History
File Error History
Logbook
Service (dimmed)
SET-UP Tests View/Define

Sort Tests
Test Group
Interference Table
Default Tests
Reflex Tests
Multi-Tests Profiles
Test Groups
Test Group Profiles
Sort Multi -Tests
Default Multi-Test
Liquids
Interfaces Host
Printer
Internal Barcode
External Barcode
Keyboard
Network (dimmed)
Modem (dimmed)
System Configuration
Security
Audible Alarms
Date/Time
Units

UTILITY Upgrade IL Library

Back-up/Restore
Archive
Software SW Identification
SW Upgrade (#)
Save Last Rotor Map
Save Trace
Test/Material Backup
Upload
Debug (dimmed)
Testing (dimmed)
(#) SW Upgrade is divided in SW Master, SW Slave and SW REM.
3.2 Sample Analysis

Section 3.2.1 and those that follow it contain detailed descriptions of the screens,
options and steps involved in the sample analysis process on the ACL Elite/Elite Pro.
The ACL provides 2 modes for running samples: Single Test and Multi-Tests. Within
each of these a “session” is considered to be the total of all the individual test “runs”.
For example, you are using the PT-APTT profile and have 20 samples to process.
Each sample contains both tests. The “Session” would therefore be composed of 4
test “Runs”; 2 runs for PT and 2 runs for APTT since the maximum number of
samples per run is 19 for the PT and APTT tests.
The ACL allows a variety of choices to enter the sample ID information into the
system before analysis, depending on the laboratory’s procedures and system setup.
For those users who are already familiar with the ACL Operator Interface, Section
3.2.1 includes summarized sample analysis protocols to be followed depending on
the mode of sample ID entry.
3.2.1 Sample Analysis Procedures - Summarized
Manual Sample ID Entry - Loadlist created before Analysis

1. Select Analysis.
2. Select Loadlist.
3. Select the desired (empty) Loadlist, click the details icon.
4. Click the Enter/Edit Sample ID button.
5. Type the Sample ID, use the ? to move to the next position or Confirm
when all sample IDs have been entered.
6. If Default Tests are desired for the list, do not program tests for individual
samples. Click on the “Set Default Test” button.
7. Click the Program Test button
8. Program Tests/Multi-Tests on the sample by clicking the desired test
selection in the Test matrix. The selection will display in the
Programmed test list. Corrections can be made clicking the test
selection again to deselect if the desired tests/profiles were the same as
the previous sample, click the Prev Prog button. Press the ? to move to
the next loadlist position or Confirm when complete.

9. Click the Confirm button: Date and Time is associated to the Loadlist
Number and the system switches to the Loadlist screen.
10. Click the Confirm button: the system switches to the Main screen. The
inserted samples are displayed in the database.
11. Select Analysis; then chose either: Multi-Tests or Single Test.
12. Click the Loadlist No. box and enter the loadlist number.
13. If tests were not previously ordered on the sample (step 6) or default
tests are not desired, click the Program Sample button. Select the test
to be run and press the ? to move to the next sample on the Loadlist or
Confirm when complete.
14. Verify that the current test selection is the one of choice confirm the
materials map and click the Runner icon.
15. During Analysis the Session Report screen is shown. Test sequence is
indicated. From this screen the Material Map and the Error History are
available.
Manual Sample ID Entry – Loadlist created during Analysis
1. Select Analysis.
2. Select Multi-Tests Session or Single Test.
3. With cursor on the first tray position of the Loadlist, click the Program
Sample button. QC can be added by clicking on the Add QC button.
4. In the Sample Entry screen enter the Sample ID and select the Tests to
be run.
5. Click the “New Sample” icon to enter the next position and enter the
next Sample ID.
6. If tests to be run are the same as before, click the Prev. Prog. button; if
they are different, select a new Test.
7. Repeat steps 6 and 7 until all samples and tests are entered.
8. Click the Confirm button to accept the changes; the system switches to
the Single Test Pre-Analysis screen (if a single test was selected) or to
the Multi-Tests Pre-Analysis screen (if a Multi-Tests was selected).
9. The tray positions will be displayed in dark blue with the letter P
(Pending).
10. Press the Store Loadlist button and enter in a loadlist number.
11. Once the samples are in the sample tray, confirm materials, click the
Runner.
Manual sample ID Entry –Loadlist created from Database menu
1. Click the New Sample icon.

2. Enter the Sample ID.
3. Select the Test to be programmed.
4. Repeat steps 1, 2 and 3 until all samples are entered.
5. After programming the last sample, click the Confirm button. The
system switches back to the Main screen. The inserted samples are
displayed and marked with a P (for Pending); in the “Test Request”
area the tests requested are marked with a ?.
6. Select Analysis.
7. Select Loadlist.
8. Click the Make Loadlist button.
9. Enter the Loadlist Number to start with (1-20), default is 1, and the
Number of samples per Loadlist (1-40), default is 40.
10. Click the Pending button (‘All’ or ‘Test’ selection). You may then select
a certain “Date and Time” range along with a “Sample ID” range.
11. An alternate method is to click on Mark Samples and select the
Sample IDs from the database of samples.

12. Click the Confirm button. The system switches back to the Loadlist
screen showing the Date and Time when the loadlist was saved.
13. Click the Confirm button. The system switches back to the Main
screen.
14. Select Analysis.
16. Click the Loadlist No. box and enter a valid Loadlist number.
17. Once the samples are in the sample tray, confirm materials, press the
Runner.
Sample ID entry by barcodes - no connection to a host computer

1. Select Analysis.
3. Place the samples on the sample tray
4. Select Read Bar-codes and the instrument will create the loadlist using
the barcode reader.
5. Click on the Program Sample and select the Test to be run.
6. Click the “>” button to move to the next position sample ID.
7. If tests to be run are the same as before, click the Prev.Prog. button; if
they are different, select a new Test. Repeat step 6 or when complete
click the Confirm button.
8. Confirm Materials Map and press the Runner icon.
available.
Sample ID entry by barcodes - connection to a host computer (Host
Query mode)
1. Select Analysis; select the desired Multi-Tests or Single test.
2. Confirm the reagent map and Click the Runner icon (instrument will
perform the Host Query and proceed to the analysis).
available.
Sample ID entry by barcodes – connection to a host computer (Host

Query mode) – Default Multi-tests
1. Place barcoded samples on sample tray. From the main database

screen click the Runner icon. (Instrument will perform Host Query and
proceed to the analysis).
Note: It is important to ensure the Reagent positions onboard the
analyzer are setup with the correct reagents placed for this option.
Failure to do so may result in tests running with an inappropriate reagent.
Refer to the Profile Setup screen to view the material map for the default
profile.

The ACL Elite/Elite Pro can process up to 40 samples in a single session

(including Reflex tests) programmed with a number of tests while optimizing
cuvette positions within the rotors. As positions on the sample tray become
complete, new samples may be substituted into these positions. This is
accomplished using the Stat/Pause Icon. Reagents and samples (from cups
or original containers) are automatically aspirated and dispensed by the
needle arm. Rotors are loaded and discharged automatically providing a
complete walk-away system for the ACL Elite Pro. The ACL Elite will prompt
the user when a new rotor for analysis is required.
3.2.2 Sample Analysis Modes

The sample analysis process is started from the Main screen by selecting
Analysis on the menu bar. The 2 options given on the Analysis screen for
processing samples are MULTI-TESTS and SINGLE TEST. In addition, the
“Runner” icon on the main database will start a run using the default Multi-
tests setup.
• Multi-Tests: This option allows you to process multiple tests in a

random access fashion on the samples in the tray. The tests groupings
are user defined and configured under the Setup menu. The multi-tests
grouping can be composed of one or more single tests (profile) or one or
more tests groups (test group profile)
• Single Test: This option will configure the system to only process the
single test selected for analysis. If the samples on the tray have multiple
tests programmed on them, only the selected test will be analyzed and
the un-processed tests will remain pending on a sample.
SINGLE TEST ANALYSIS Screen

MULTI-TESTS ANALYSIS Screen
Notes:
§ The Current Multi-Test drop down menu will list the available
profiles, test groups and test group profiles in the order selected by
the sort multi-tests function
These 2 analysis screens contain multiple windows and associated buttons:
1. Top left area: the Current Multi-Tests or Single Test window displays the
selection to be run in the current analytical session. The selection can be
changed by pressing the (>) button on the right of the window and browsing
though the displayed list; the decision must be confirmed by pressing the
same button again. The main objective of this screen is to activate the
Materials map, since the programming of the map is dependent on the
Current selection displayed.
The ( …) displayed prior to the test groups names have the following
meaning.
… Single Test Group
Multi - Tests session composed of single tests

…
• • Multi – Tests session composed of Test Groups

• •
The Deselect Tests button (available when in the Multi-Tests Analysis

Screen only) may be clicked to open the Multi-Tests Details window. This

screen allows the operator to deselect running one (or more) of the tests, on
all samples, included in the Multi-Tests.
Clicking the Material List button at the bottom left of the screen opens the list
of materials required for the analysis.
Clicking the Materials Map button opens the Pre-Analysis: Material Status
window as shown below (for details refer to Section 3.2.3).
2. Middle area: the two windows in the middle of the Selected Pre-Analysis
screen (refer to screen on pages 3.14 and 3.15) contain the sample
programming information. The round circle on the left divided into 4
quadrants is used to select a region on the sample tray. The current
selected quadrant is displayed in yellow and highlighted. The window to
the right displays the status of the 10 samples within the selected
quadrant. The color of the circle provides information on the status of the
sample. In addition to the color, the circle may contain a letter or symbol
that provides further details about the sample type. The following table
contains details about the colors and sample type letters.

Color Status Letter/Symbol Status
Empty
Gray
Available
+ Stat
No tests Programmed
Light Blue
Programmed
P Onboard
Programmed Complete
but will not
be run in this
C
Dark Blue
session
Sample has Not
Lavender
test that
match
N Programmed
current run
Completed in Quality Control

prior or
current
QC
Green
session
Pending, but Empty cup in

will be position
Orange processed in
session
Sample ID (Hourglass)
Warning or
Sample
Error
Yellow processing
Sample Not
? Identified
The circles will be colored and also will contain a symbol. Examples include:
1-2: Programmed Stats

3-4: Programmed Routine
5: Completed Sample
6: Tests Not Programmed
7: Sample Not Identified
8: QC Sample
9: Empty Position
10: 0.5 Cup in Position

Clicking on a position circle will display the information about that sample.
#: Sample tray position

+: Sample Priority – Stat indicated by !
S: Status of Tests (P, C or N)
• P - Pending: One or more tests is missing a result
• C - Complete: All tests programmed on the sample

have been analyzed
• N - No Test: Sample ID has no tests ordered
F: Flags associated with that sample

Samples that are detected as short will be flagged in yellow with L. No
further testing will be performed on this sample position during this
session. If the sample is replenished, the sample must be moved to a
different position on the tray if processing is desired in the current
session.
The small window on the top left Sample Tray Map enables the Read
Bar Code button to be displayed. The Loadlist No. window allows the
operator to either create a new loadlist or select a stored one. To create
a new one enter the Loadlist number (1-20) not currently defined for
samples. Refer to section 3.2.4 for loadlist details. If you modify a
loadlist, press the Store Loadlist button to save the changes.
The operator chooses how to program samples according to the desired
sample ID entry mode (refer to section 3.2.1):
- Manual Entry into the “Analysis” menu
- Manual Entry in the “Loadlist” menu
- Manual Entry in the “Database” menu
- Use of barcoded samples, no connection with Host Computer
- Use of barcoded samples, connected, Host Query mode
• Clicking the Read Bar Codes button activates rotation of the sample
tray. During the rotation the barcode reader and sample cup/tube
position reader identify a cup/tube placed on the tray along with sample
identification by reading the bar codes. If barcoded samples are present
and barcodes are readable, their corresponding Sample IDs are
displayed in the large window. If a cup or tube is identified to be in place
and the system is unable to read the barcode label a warning of “Error in
Sample Identification” is presented to the operator. If this occurs, check
the tube position to ensure the barcode label was properly oriented, then

click on the Read Bar Code button again. Bar Code read flags:
(No_R) - Sample ID missing, (Dpl) - duplicate Sample ID, (No_C) -
truncated Sample ID, (Inv) - invalid Sample ID. A label ID that cannot be
read by the reader may be entered manually by selecting the Loadlist
position and pressing the Edit Sample ID button. Refer to section 6.5 for
barcode troubleshooting information.
• The Loadlist button will display the status of the 20 Loadlists.
• The Store Loadlist button will save the changes to the current list.
• Clicking on the ADD QC button on the bottom of the screen will open the
QC screen. Scroll down the list and select the desired QC liquid to be
processed in the current cup position. Press the Confirm (v) to accept.
• Clicking the Edit Sample ID button displays a window that allows the
operator to type the sample identification. Up to 16 alpha-numeric digits
can be entered via the standard keyboard or up to 16 numeric digits
using the screen keypad. Use the ? to enter additional IDs in
subsequent positions on the sample tray.
• Once all the ID numbers have been typed, clicking the Confirm button
accepts all the IDs and returns to the Selected Pre-Analysis Screen. To
return to the Pre-Analysis Screen without accepting the changes, click
the Cancel button. The system does not allow the same SampIe ID to
be loaded twice; if this is attempted, a warning appears: Duplicated
Sample ID.
• Clicking the Clear ID button deletes the selected Sample ID, leaving the
space blank to enter another Sample ID. No confirmation is requested.
• Clicking the Program Sample button opens the window that allows you
to program a new sample.

1. Program Sample for NEW SAMPLE
Within this screen the operator types the Sample ID (required field), and
enters the Patient Demographic information (optional) on the top half of the
screen. If the sample is a Stat sample, the Stat icon should be checked.
The Test or the Multi-Tests (shown when in Multi-Tests analysis mode) to
run on the sample is ordered by clicking on the desired selection. If you make
a mistake, the scissors icon can be used to delete the test or Multi-Tests from
this sample or you can uncheck a selection box. Use the New Sample (tubes
in folder) icon to save this request and present a new (blank) order entry
screen for your next sample. If the current sample has the same test or
profile as the previous one, you can use the Prev. Prog. Button. This
sequence is repeated for all new samples.
After programming the last sample, click the Confirm (v) button. The system
switches back to the Single test/Multi-Tests or Test group Pre-analysis
screen.
The samples entered are displayed and marked with a P (Pending).

2. Details for SAMPLE with Previous tests
Patient demographics: the upper portion of this window displays the patient
demographic information. The displayed fields that are editable fields include:
Patient ID, Patient Name, Department Name or Number (Dept.), Birth Date
and Sex. Note: The sample ID field cannot be changed once it has been
confirmed (v).
Loadlist and Position fields display the current Loadlist and position within
the list for the displayed sample.
Patient Details: clicking this icon allows access to additional fields, such as
the Operator Notes, the Physician’s name and the Entry Date. (see screen
below)

If the sample is a Stat sample, the Stat icon should be checked.

Status: the "status” associated with each sample is displayed in the Sample
Data Screen:
o Trans. T = Transmitted and L = Local (Not Transmitted)
o Sample Status: (No test ordered [N]; Pending for at least
one test [P]; Completed [C]).
The tests programmed on the sample will be displayed in the center portion
of the screen. Pending tests will be indicated with a (?). Results for
completed tests will be displayed. Press the Detail Icon to view detailed
information about the test (i.e. clot curve). To delete a test that is either
pending or completed on a sample, move the cursor to the test and press the
Trash (Delete) Icon.
Additional or repeat Tests to be run on the sample are ordered by clicking
the Program Test button. Use the New Sample (tubes in folder) icon to
save this request and present a new (blank) order entry screen for your next
sample. This screen would be the one displayed in option 1 above.
To move to the next sample ID in the list use the (? ? ) to move down or up
in the list. Samples can be printed by pressing the Printer icon.
After programming the last sample, click the Confirm (v) button. The system
switches back to the Single test/Multi-Tests or Test group Pre-analysis
screen.
The samples entered are displayed and marked with a P (Pending).

3.2.3 Materials Map
Pressing the Materials Map Button will display the Liquids necessary to do
the testing for this session.
The Materials map displays in a graphical format the liquid positions on the
analyzer. The Map shown above applies to the ACL Elite Pro. The ACL Elite
does not have positions (R9-R12), which are shown.
This screen displays the status of the reagents currently on-board the
system, along with other information. The color of the position circles can be:
Green: Volume of liquid in position is greater than warning limit
Orange: Volume of liquid in position is less than warning limit or either

onboard or lot number stability has expired.
Red: Analyzer detected a reagent shortage in this position.
Note: When you start a run, the materials map is not checked for
volume status. The analyzer will proceed with the testing regardless of
the color of the reagent position. The colors are only alerts to the user.
The operator is able to assess the situation of the ten Sample Tray positions
and the Reagent Tray positions. Clicking on one of the colored liquid
positions will display details about that liquid. This information includes:
• Liquid ID: The Name of the liquid assigned to this position

• Lot Number: Current lot number entered for the liquid in this position
• Liquid Level: The remaining volume of liquid in this position. This level
is retained from the last session for which this liquid was used. The
system tracks the level by counting down the volume during the testing.

The operator must enter the initial “start” volume. This is generally done
when a new bottle is placed on board or by the optional barcode reader.
• Expiration Date: The lot number expiration date for this liquid. If this
liquid is used beyond the expiration date, the operator will be alerted with
a warning in the Session Error History list. The Expiration date is
predefined in the Liquids screen.
• On Board Stability: The remaining time left for this liquid on board the
analyzer. The system tracks the time the bottle is on board the analyzer.
The operator must start the clock using the “Start Timer” button when a
new bottle is placed on the analyzer. The “Start Timer All” button will
start the clock for all of the liquids displayed on the current materials
map. If a bottle is removed from the analyzer, the timer countdown may
be paused by pressing the “Pause Timer” button. When the bottle is
returned back to the analyzer the clock may be resumed by pressing the
“Pause Timer” button. If this liquid is used beyond the on board stability
time, the operator will be alerted with the warning “Material on board
stability expired in position XX” in the Session Error History list. The On
Board Stability time is predefined in the Liquids screen. Expired stability
will be displayed in orange on the Materials Map.
Note: The use of the Liquid Level, Expiration Date and On Board
Stability tracking is optional. The operator can track these items offline
and does not have to use the features on board.
Three operations can be carried out on the Liquid Level settings:
§ Set Volume will allow the volume update of the specific reagent position
to a customized value (using the keyboard or the keypad on the screen)
§ Reset single will update the volume of the selected reagent position to
its default value (predefined in the Liquids screen).
§ Reset All will update all volumes of all reagent positions displayed on
the current map to the default values (predefined in the Liquids screen).
When the screen is activated, the system also checks and displays
information about the status of the rotor station, status of the waste, number
of available cuvettes in the rotor and the current volume of the Wash-
Reference Emulsion. To start the session with an unused rotor, the operator
must check the Start with a New Rotor box.
Press the Confirm (v) to Accept the changes and return to the Pre-Analytical
screen. Pressing the Cancel (X) will discard any changes you made. Press
the Runner icon and the run will begin.
Liquid Details: This button will display the liquid setup screen for the current
liquid position selected. Refer to section 4.1.13 for further details
The optional External Barcode Reader can be used to identify reagent
placement and validate the lot number and expiration date. When the
material map is displayed, read the vial label using the reader. The lot
number information and expiration is checked and the position to place the

reagent onboard the analyzer will blink. Place the vial in the designated
location. If the lot number or expiration dates are invalid the system will
display a warning box on the screen. You can configure the external
barcode reader to automatically reset the default volume and onboard
stability for the vial when a label is read.
If the “Pause Timer” is checked for a reagent vial, when this vial is read with
the external barcode reader the “Pause Timer” will become unchecked. If the
vial is then read a second time at this point the volume and timer will be reset
if these options are enabled under the external barcode setup.
Refer to section 4.1.16 for information on enabling the external barcode
reader.
3.2.4 Analysis: Loadlist

The Loadlist screen below can be accessed selecting Analysis from the
Main screen menu bar, and then the Loadlist option from the Analysis menu.
This screen gives the operator access to the information on the stored
loadlists, by being either blank or defined. Each of the defined stored loadlists
(20 maximum) is identified with a number, status and date/time.
Several options are available:
• Clear Single clears current highlighted single Loadlist. Clearing a
Loadlist has no impact on the samples in the database. The samples
that were on the loadlist can still be viewed and printed after a Loadlist is
cleared.

• Clear All clears all defined Loadlists.

• Make Loadlist opens the loadlist creation screen.
• Clicking the Clear Single button in the Loadlist screen, displays a
confirmation window: Do you really want to clear the selected loadlist?
OK clears the single selected loadlist; Cancel will cancel the operation.
• Clicking the Clear All button on the bottom right of the screen, displays a
confirmation window Do you really want to clear all loadlists? OK clears
all of the stored loadlists; Cancel will cancel the operation.
• Clicking the Make Loadlist button opens the Make Loadlist screen (see
details below).
Loadlist can be created 4 ways:

1. Time Interval (Date/Time sample was entered into database)
2. Sample ID range
3. Marking or selecting Individual samples
4. Automatic List creation using a predefined Sample ID Prefix or Suffix
Once one of the four list criteria is chosen you then select which tests to
include on the loadlist. Clicking the Pending (all) button will search the
database for all pending tests for the group of samples chosen. Clicking the
Pending (test selection) button will allow you to scroll down the displayed
test list and select the desired tests by pressing Select. If you make a
mistake you can remove a test by clicking on the Deselect button. The
notation in the Select column will then be removed.
Loadlist Creation Process

The first item to define at the top of the screen is the Loadlist Number to
Start with. You must enter in a value between 1-20 in this field. To the right

of this field is the entry location for the Number of Samples per loadlist.
Enter in a value between 1-40.
You then select one of the 4 ways listed above to use for creating the loadlist.
1. Time Interval – Clicking All Time Interval will create the loadlist without
respect to the time that the samples were entered into the database. If
you click on From To you must enter in a Start Date/Time and End
Date/Time.
2. Sample ID Range – Clicking All Samples will select all samples with no
respect to the Sample ID attached to it. If you click on From/To you must
enter in a Starting Sample ID and Ending Sample ID to include in the
loadlist. Only samples within this range will be placed on the loadlist.
3. If you click the Mark Samples button the following screen will appear
This screen will display all the samples along with their current status in the
database. You can scroll down the list and press Select to mark the current
individual sample. If you make a mistake, press the Deselect Single to
remove the notation in the mark column. Pressing Deselect All will remove
the notation in the mark column for all samples. When you are finished press
the Confirm (v) or Cancel (X) to return to the previous screen.
4. Click the Autolist button to display the automatic loadlist creation screen.
This screen will allow you to create one or more loadlists. You can
create the sample IDs for the loadlist using a prefix or suffix.

On this screen you must enter in the number of loadlist you want to prepare.
You can create up to 20 loadlists; each loadlist will contain up to 40 samples.
In the Fixed String field, enter in a character string to attach to each sample
ID. If you want to use the fixed string as a prefix, click on the Use as a prefix
button. If you do not click on this field, then the fixed string will be appended
as a suffix to the ID.
The Variable string field will determine the maximum number of sample IDs
to create. If you select a variable string of 2, the maximum number of
samples will be 99, if you select 3 the maximum number will be 999. The
starting number field will vary in length depending upon the variable string
field entry. The number you enter into the Starting Number field will be used
for the first sample. The remaining sample IDs will then index by one after
this value.
When you are finished press the Confirm (v) or Cancel (X) to return to the
previous screen.
Note: On this screen you determine the number of loadlist to prepare.

On the previous screen you entered in the loadlist number to start with
along with the number of sample IDs each loadlist will contain.

Once the Loadlist/Autoloadlist is created you then program tests for the
sample IDs on the list. Select the Loadlist and then press the Detail Icon.
The sample IDs on this loadlist will be displayed in the left hand column. You
can change the Sample IDs on the list by selecting a particular sample and
pressing Edit Sample ID. If you need to delete samples from the list you can
use the Delete Sample ID or Delete All Sample ID buttons.
To program or change the requested tests, select either a particular sample
ID or the first one on the list.
To program tests for the selected sample, Press the Program Sample
button.

Click on the Prev. Prog to All button to program the previous tests request to
ALL samples on the loadlist. If you press the Prev. Prog button the previous
tests will just be ordered on the current highlighted sample only.
Click on the Set Default tests button to program the Default tests to all
samples on the loadlist.
Highlight a sample and click on the Detail button to view the current sample.
This will display the demographics along with the tests ordered and any
completed results for the sample.
To print a loadlist, click on the Printer Icon.
• Confirm or Cancel exits the screen; the system goes back to the
previous screen.
• ACTIVE BUTTONS at the bottom of this screen are:
- Open/Close opens or closes the rotor holder cover.
- Database View displays the Database View or Main Screen.
- Shutdown followed by a confirmation window Do you really want to
shutdown ACL? Yes closes the session, allowing the operator to log off
and/or turn the system off; No will cancel the operation.
3.2.5 Analysis: Session Report

This screen is automatically displayed during a run.
This screen displays information about the status of the tests and samples for
the analytical runs performed on the system.
The top line displays the current test being analyzed and the current phase
for the test (i.e. loading, waiting, acquisition…)

The middle of the screen displays the 4 sample ring quadrants on the left and
the 10 sample cups included within the quadrant. Please refer to section
3.2.2 for details on the color codes and symbols used for the sample
positions.
The details (results) of a sample can be displayed by selecting the sample
ring quadrant on the left then selecting the desired cup position and clicking
the Details button. If a sample is complete the results will be displayed.
The Materials Map button will display the current reagent map for the
session. Please refer to section 3.2.3 for details on the Materials Map.
The Session Status button will display the Analysis Session report screen
for all samples in the current session.
The Test Execution Status box displays information on the tests in the
session. It displays the tests that may be analyzed in this session along with
the number of samples programmed, number of reflex tests to be processed,
and the number of samples completed. Test groups are considered to be
individual tests and display that way in the box.
The Sample Status for the Session box on the right displays the samples to
be processed in this session. This box is divided into 5 columns:
• # Column: position on sample tray
• +: an ! in this column indicates the sample is designated a stat
sample.
• Status: Displays the current status of this sample. The status
can be indicated by the following symbols
- Hourglass symbol: Sample is in process
- Clock symbol: Sample is in a waiting status
- Check Mark (v): Sample is finished being processed

• Short: This column will display a “low” indicator when a sample

has been detected to be short. A sample found to be low would
stop all further testing on that sample.
• The sample ID column displays the sample IDs on the loadlist.
The Materials Map button will display the current reagent map for the
session.
Note: The bottom row of Icons on the main screen contains one of a reagent
bottle. The color of the bottle indicates the status of the reagents in the map.
If all the reagents have levels above the warning volume the icon will be
displayed in green. While testing is in process if a reagent becomes low the
bottle icon will turn orange. If a reagent runs out during analysis the bottle
icon turns red. Pressing the bottle icon will display the current reagent map.
When a reagent runs short during analysis the system will continue
processing all other tests. When testing is complete the system will display a
message box with the following:
One or more reagents are insufficient to complete all samples. Do you want
to Refill?
Press Yes to refill and then restart.
Press No to close the session.
If the Yes option is selected the operator should replenish the reagents that
are short and press the runner icon to restart the run.
If “No” is selected the system will end the current analytical session. The
run can be restarted later by selecting Analysis à Session History
The Restart this Session button will start the analysis again to process
those samples with a status of “Pending”. This can be useful if a reagent
runs short during analysis.
The Session History Button will normally be dimmed out during analysis. If
an error condition occurs during the analysis the button will illuminate. The
operator should make note of the button status. When the button illuminates,
the operator should press the button to display the Session History List.

The list will display the Date and Time along with the Error that occurred.
The Printing option will print the Session Error History Report followed by a
confirmation window Do you really want to print? Yes allows the operator to
print the Session Error History Report; No will cancel the operation.
Press the Confirm (v) button to return to the previous screen.
If the session has completed, you can return back to the Session History
screen by selecting Analysis from the Main screen menu bar and Session
History from the Analysis menu. This opens the Analysis: Session Report
screen.
• ACTIVE BUTTONS on the bottom of this screen are :

3.2.6 Session Pause Conditions

The following conditions will place the ACL Elite/Elite Pro into a pause status
during analysis. If this occurs, the condition noted should be corrected. The
run can then be resumed by pressing the runner icon
ROTOR WASTE FULL (Elite Pro Only)

When the rotor waste is full the instrument will beep and automatically pause.

To proceed the operator has to empty the rotor waste container and press
the “runner” icon.
ROTOR STACK EMPTY (Elite Pro Only)
When the rotor stack is empty, the instrument will beep and automatically
pause.
To proceed the operator has to refill the rotor stack and press the “runner”
icon.
REAGENT SHORT
A reagent shortage detected during analysis will place the system in the Hold
condition at the end of the session. At this time the operator has the option to
refill the reagents and resume the session.
3.2.7 Analysis: Pause / STAT Functions

During a run the session status is presented showing the number of tests
executed and which test phase is in progress.
It is possible to pause the system during an analytical session using the

Stat/Pause “Ambulance” icon on the bottom left side of the screen.
When this icon is activated a message saying, “Do you really want to hold the
session” will be presented.
Pressing “NO” the session will proceed.
Pressing “YES” the session will pause at an appropriate time in the current
session. You will be notified when it is safe to proceed.
Stat samples cannot be executed during Automatic Host Transmission.
During the Hold state, you can perform the following on the system:

• Add Samples, both STAT and Routine
• Change Priority of a Sample from Routine to Stat

• Add Tests to a sample on the sample tray
• Add QC samples to the session
• Access the Materials Map to Refill reagents

• Substitute Samples on the sample tray. Completed samples
indicated by a green cup position circle (also noted by a C in “S”
column) can be removed and replaced with a new sample.
The “Add Samples/Stats” screen displays the status of the samples on the
tray.
The Status of the samples is displayed using colors and letters/symbols for
the cup positions (refer to section 3.2.2 for details on the colors and
symbols). The sample tray is divided into 4 quadrants of 10 sample positions
each. To change to a different quadrant simply click on the desired segment
in the circle on the left.
Barcode stat samples
Read Barcodes: This button will activate the sample bar code reader and
read the sample IDs on the tray. It will then display the samples IDs. No
host query is performed during this action. Non-barcoded sample IDs (except
QC cups) will be deleted from the list for samples that are currently not active
on the rotor being analyzed. If you are not bi-directionally interfaced, after
reading the barcodes click on the desired sample position to display the
sample-programming screen. Enter the optional demographic information.
To designate the sample as a stat, click the Stat icon. Select the tests by
clicking on the desired test box. To remove a test from the programmed tests

list click on the test name a second time. Use the down arrow to proceed to
the next sample position. When complete press the Confirm button.
Restart with BCR: This button can be selected if you are using host query
and barcoded samples. Click this button then press the resume icon. The
system will read the sample IDs and query the host for the tests to process.
This option is not recommended to be used when a mix of barcoded and
non-barcoded samples are present on the sample tray.
Non-Barcoded stat samples

Programming Non-Barcoded Samples: Click on the desired sample
position to display the sample-programming screen.
To program your samples enter the Sample ID along with any of the other
optional demographic information. To designate the sample as a stat, click
the Stat icon. Select the tests by clicking on the desired test box. To remove
a test from the programmed tests list click on the test name a second time. If
you have additional samples to program click on the New Sample icon. If
you are finished programming samples click on the Confirm button. Press
the Runner run icon to start the analysis.
Enter/Edit Sample ID: This button allows you to manually enter an ID or edit
one that is displayed. Positions that cannot be edited will dim the button.
Clear ID: This button will clear an ID from a position on the sample tray. The
position can then be used to program a new sample onto the tray. This button
will be dimmed if the sample tray does not have positions in which the
sample is complete. Completed samples will be designated as a green cup
position circle with the letter C. Samples with pending tests to be completed
will be designated as an orange cup position circle with the letter P.
Positions that cannot have the ID cleared will dim the button.

Program Sample: Opens the tests order screen. Refer to information in

section 3.2.2 for details on this function.
Add QC Liquids: Displays the QC liquid list. Select the desired liquid and
click on the Confirm button to accept. The QC liquid will then be added to
the samples on the tray. Note: Do not click on the Restart with BCR button
when QC is added to a list. Press the Runner icon only to start the run.
Once the Stats/New Samples have been programmed and added to the
sample tray, the run is restarted using the Runner icon.
Notes:
• When the stat/pause icon is pressed, the system will display a
message indicating when it is safe to add/remove samples from the
tray. Please wait for this message to appear. This is an indication
that the sample arm will not move toward the sample tray.
• If a test is added but not contained in the Multi-Tests or Single Test
presently running the test will only be programmed.
• Default tests will be added to a sample when the next test in the run
is started. Prior to this the circle will be displayed in light blue with
the status of N. After the next test in the run is started the default
tests will be added to the samples and circle will become purple
when processing occurs.
• If a test is contained in the Multi-Tests or Single Test presently

running the test will either interrupt the current session or be
executed in a session after the current one. The current session will
be interrupted if the samples have not been pipetted. If the stat
interrupt occurs during a session whereby the reagent only is being
pipetted, the system will abort the run to process the stat. If you do
not want to abort the current run, wait until the unit begins pipetting
sample before requesting the stat interrupt.

- Confirm exits the screen; the system goes back to the previous screen.
3.2.8 Results list

The main screen of the ACL Elite/Elite Pro is the database or results list. Up
to 1000 sample IDs can be contained in the sample database. The database
is handled in a first in first out (fifo) manner for completed samples. When the

database reaches 1000 samples, the oldest samples with a status of

“Complete” will be permanently deleted. Each sample ID can reference up
to 30 tests. Tests processed in duplicate occupy a minimum of 3 test
positions (first result, second result and mean).
The “Database View” at the top of the screen indicates whether you are
viewing “All Samples” or a “Subset” of the samples. A subset of the
samples in the database is obtained by Extracting results. If you are viewing
a subset of the results and you wish to view all, you must extract again and
select the “All Samples” option.
The numeric values on the right of the screen (i.e. 147/540) indicate how
many samples are currently displayed in the database. If you extract, the first
value indicates how many samples were extracted and the second value
indicates the total number of samples in the entire database. When you are
viewing “All Samples” the two values will be identical.
The results list has several columns:
- + indicates if the sample was run with a (STAT) priority attribute

- S Column indicates the status of the sample ID
• N means no tests are programmed on that sample ID
• P means one or more tests are missing a result
• C means that all tests have been run on the sample and it is
considered complete
- E Column indicates errors are present on at least one test for the
sample ID (refer to section 6.3 for further details)
- Sample ID column (max 16 characters). Each of the 1000 samples in
the database must have a unique Sample ID. Duplicate IDs are not

allowed. If you need to re-use a sample ID, you must delete the original
one first. Highlight ID and click the “trash can” icon to delete.
- Patient Name column (max 25 characters). Using the “Identity Card”
icon this column can be hidden. This will allow more tests to be
displayed across the database screen.
- Test and Unit columns are defined (customized) in the sort test
submenu in the Test Set-up. Please refer to the Test Setup Section
(chapter 4). If a test has a ? in a column, then the result is pending for
the sample. As the test is completed, the ? will be replaced with the
result. If the result is displayed along with a “Snowflake” symbol, then
there is more than one result available for that particular test. Tests with
errors will be noted instead of a result on the screen. Highlight the
sample and press the “detail” icon to view all the results
A result presented in “black” color means it is within the normal range.
A result presented in “violet” color means it is outside the normal range.
A result presented in “red” color means it is outside the test range.
A result presented as “***” means it is outside the scale range high.

A result presented as “---” means it is outside the scale range low.
The Instrument status line also displays the current User logged into the
system and the current revision of the software on the analyzer.
Several functions are available from the test results list:
Extract Results Detail Sample Icon
New Sample Delete Samples
Print Samples Transmit to Host
3.2.8.1 Extract Icon
• Using the Extract icon (Hand in File Drawer) it is possible to filter the
database for desired samples based on several criteria. See screen
below
- Single Sample ID
- Sample ID From … To … (Use the Same number of Characters
when defining the From/To range that you normally have for the
Sample ID)
- Patient ID
- Patient Name
- Loadlist Number

- All samples
- Entry Date From … To …

- Department
It is possible to combine the above Sample ID criteria with the result criteria
checkbox selections on the lower part of the screen.
- Completed / Pending
- Stat / Non Stat

- Transmitted / Not Transmitted
- Flagged / Not Flagged
Note: If you extract into a subset of the database, you must re-extract using
the “All Samples” checkbox to return the database to display all samples.
New samples entered into the database while you are in a subset may not be
shown on the database.
3.2.8.2 Sample Detail Icon

• Using the Details function (magnifying glass) additional information on
the Sample and Tests can be displayed. This information would include
Demographic data, Results, Errors and Reaction curves.

From the Sample Data screen the patient detail icon displays additional
demographic information.
From the Sample Data screen it is possible to view the reaction curve.
Highlight the desired test and press the detail icon to view the curve.

Warnings associated with the test results are displayed in the warning
list. Please review these and take appropriate action if necessary before
reporting the results.
The “Floppy Disk” icon allows you to save the “normalized data
readings” for the curve. The data can then be viewed using another
software program (i.e. Microsoft Excel). The curve as it is presented can
be printed using the print icon. Warnings associated with the results are
displayed in the warning list.
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.
Endpoint
Deceleration
Optical
Readings Delta
Acceleration
Baseline
Acquisition Time

The Baseline readings start after any acquisition delay settings in the
test definition. During the baseline the sample and reagents are
mixing and this continues until the clot has begun to form. In the
acceleration phase the clot continues to form resulting in an increase
in the optical readings. The deceleration phase is the time when the
clot formation begins to slow down. For a clotting based assay, once
all the fibrinogen has been converted to fibrin the endpoint has been
reached and the reading stablizes
Various algorithms are used by the system to select the actual
clotting time. Some examples of these include:
- First Derivative: time at which the maximum speed of clot
formation is noted.
- Second Derivative: time at which the maximum change in

speed (maximum acceleration) of clot formation is noted.
- Threshold: time when a pre-set optical density value is reached.
- Threshold- 2nd Derivative: If the threshold reading is not met,

then the system will use the 2 nd Derivative value.
When viewing clot curves some items you should make note of
include:
- Shape of the curve (Flat curves may indicate no clotting)
- Long baselines indicate a prolonged clotting time
- 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.
- Continual rise in the Acceleration phase with no endpoint

indicates the sample did not clot within the acquisition time.
- A drop in the endpoint may indicate an unstable clot formation
3.2.8.3 New Sample Icon (Tubes in Folder)

• Using the New Sample Icon it is possible to add a new sample to the
database and manually program tests on it. Please refer to page 3.20 for
details.

3.2.8.4 Delete Icon (Trash Can )

• Using the Delete Icon it is possible to delete results using the following
criteria.
- Single Sample ID
- Sample ID From … To …(Use the Same number of Characters

Sample ID)
- Patient ID
- Patient Name
- Loadlist Number
- All samples

- Department
It is possible to combine the above Sample ID criteria with the test criteria
checkbox selections on the lower part of the screen.
- Stat / Non Stat


3.2.8.5 Printing results

Using the Print Icon it is possible to Print results (two types of reports can be
generated: Cumulative and Sample Reports) using the following criteria.
- Single Sample ID
- Sample ID From … To ……(Use the Same number of Characters

Sample ID)
- Patient ID
- Loadlist Number
- All samples
- Patient Name
- Department
It is possible to combine the above Sample ID criteria with the test checkbox
selections in the lower part of the screen.
- Stat / Non Stat


3.2.8.6 Sending results to Host Computer

Using the Host Icon it is possible to download test requests or transmit
results using the following criteria.
- Single Sample ID
- Sample ID From … To ……(Use the Same number of Characters

Sample ID)
- Patient ID
- Loadlist Number (1 through 20)
- All samples
- Patient Name
- Department
It is possible to combine the above Sample ID criteria with the test checkbox
selections on the lower part of the screen.
- Stat / Non Stat

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 the
containers. 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.

3.3 Quality Control

This Section contains all the information needed to perform analysis of quality control
materials and satisfy your laboratory’s quality control program requirements on the
ACL Elite/Elite Pro System. The first subsection presents a summarized procedure
for those users already familiar with the ACL Elite/Elite Pro system. Specific details
about the screens, options, etc. are described later in the step-by-step procedures.
• The QC Materials must be pre-defined in the Liquid Setup screen; refer

to the pertinent information in Section 4 – Setup.
• The QC Material target values must be pre-defined in the QC Setup
screen; refer to the pertinent information in Section 4 – Setup.
• The QC Materials may be run with patient samples during normal routine
testing or alone as a separate run. In the first case, refer to the
“Analysis” section 3.2.1; in the second case, follow the steps below.
3.3.1 Analyzing QC materials using a loadlist

This procedure will describe how to run QC on a loadlist without patient samples.
The loadlist can be saved and recalled each time that you need to run QC. Several
different loadlists can be configured on the system. Each loadlist could contain
different QC materials
• Select Analysis.
• Select Multi-Tests or Single Test.
• Click on the Loadlist No. box. Enter a loadlist number (1-20). If you do
not know which loadlists are available, click on the “Loadlist” button to
display the status of the 20 loadlists.
• Position the cursor on the desired cup position on the sample tray. Click
the Add QC Liquid button.
• Choose the control and click the Confirm (v) button.
• Repeat the last two actions until all materials have been entered.
• Click on the Store Loadlist button to save the loadlist.
• Place the QC sample cups on the sample tray in the respective
positions. Press the Runner icon to begin the analysis.
Note: At the completion of the run, the completed loadlist will still be stored
in memory. If you do not delete it you can recall it the next time you need to
run QC. In this case you would not need to reprogram the sample tray
positions.

3.3.2 Quality Control Setup

The quality control process is started from the Main screen by selecting QC
on the menu bar, and selecting QC Setup/Review. This will open the QC
Review screen shown.

Under the heading LIQUID ID, the window on the left side of this screen lists
all control materials that are configured in the Setup Liquids menu, while the
Configured Test window in the middle of the screen lists the tests that are
associated with each material.
The QC statistics are reported on the right side of the screen:
- Unit
- Actual Mean
- Target Mean
- Actual SD
- Target SD
- Actual CV
- Results in Statistics
- Results in Database (DB)
Clicking on the Show Enabled button will reduce the list of Liquids and
display just the Liquids that have been setup for QC analysis on the system.
This is a toggle type button. With the button not clicked you will always
display all liquids. With the button clicked you will display only the liquids
previously setup.
Clicking the Confirm (v) button exits the screen and the system goes back to
the Main screen.

The QC configuration must be entered into the QC Setup screen shown

below. Select the QC liquid in the left box then press the Setup button under
the middle window.

The top of the screen displays the selected QC material (Liquid ID) and
specific information about it such as Expiration Date, Lot Number, plus a
space for Notes.
The next step is to associate tests to the selected QC Liquid.
To do this, the operator highlights a test from the Enabled Tests list shown on
the left window then clicks on the Arrow icon under the window. This action
causes the selected test to move from the Enabled Tests list to the
Configured Tests list shown in the middle window. By repeating this
sequence, the control material is associated with up to 15 tests.
To remove a test from the Configured Tests list, click the Scissors icon
under the window. This action opens first a confirmation window: Removing
test removes all tests data…Do you really want to remove the selected test?
The Yes or No selection reminds the operator that removing a test means
removing all the results saved for that test.
Once the QC Liquid/Tests association is complete, the next step is to define
the units, target mean, target SD and the SD Range for all tests associated to
the QC material.
Unit: for each test, the selection of units includes only the ones that are
legitimate for that test. Modifying a previously selected unit will not cause a
change in Target Mean and SD values. These would need to be updated if
the unit type is changed.
Target Mean and Target SD: these fields accept any value, which is entered
by touching the field and using the external keyboard or the keypad on the
screen.
SD Range: choose 1, 2 or 3 SD. The typical SD ranges for IL reagents and

controls levels are reported in section 3.3.8. Labs may use these values as
guidelines, but they should establish their own SD.

If the QC Range Check box is activated, the control will be checked and will
be flagged if found to be outside the defined range. Patient results will not be
flagged if only this box is checked.
The Flag Patient Results check box can be activated only after the
activation of the QC Range Check box. If this box is checked and QC is out
of range, then a flag will be noted on the patient samples processed on the
same run as the QC samples. Samples processed on subsequent runs that
do not have QC samples will not be flagged.
The QC Range Check and Flag Patient Results check boxes can be
activated by simple touch, causing a check sign to appear.
The Clear Statistics button deletes, after confirmation, all the results of a
particular Test – QC Material combination.
Warning: Changing the Lot number for a QC liquid under the Liquid
Setup menu will delete all previous QC results for that liquid.
Clicking the Printer icon, followed by a confirmation request Do you really
want to print? Yes allows the operator to print the test Setup; No will cancel
the operation.
Clicking the Confirm button allows the operator to leave this screen and the
system goes back to the QC Review screen.

- Database View display the Database View or Main Screen.
When there is an active association between a QC material and tests, the
Plot and Statistics, Cumulative Results and Host icons are active.
3.3.3 QC Result Review

The Main Database screen has a QC Icon on the bottom row. This icon will
display a separate database of the last 100 QC results processed on the
system. A red exclamation point will be displayed across the icon if there is a
QC failure on the system. Results outside 2SD will display in blue, while
those outside 3SD will display in Red. Results within their range will be
displayed in black. The exclamation point will remain on the icon until the QC
failure is cleared from the list. If all QC liquids and tests have no QC outliers
the exclamation point will not be displayed.

The database displays the following for the QC results: test, QC material,
result, unit for result, and any errors. The number of Results in the database
is displayed in the “Results” box on the top right. The Clear All and Clear
Single buttons will remove the results from the QC database, however they
will still be displayed under the QC Plot and Cumulative result options. The
results on the database can be printed using the Print All QC
o r Print Today QC.
3.3.4 QC - PLOT and STATISTICS

In order to open the QC Plot and Statistics window (shown below), press the
Plot and Statistics button located in the QC Review screen.
This screen displays both the Plot and the Statistics of a selected QC
Material and test pair, displayed at the top of the screen.
The window in the left side of the screen displays the following information,
which is not editable from this screen:
- Start Date
- End Date
- Unit
- Actual Mean
- Target Mean
- Actual SD
- Target SD
- Actual CV
- Results in Statistics
- Results in Database (DB)

The QC plot for a test can be viewed in the window on the right side of the
screen. The chart indicates Days on the X-axis, the unit and target mean on
the left y-axis, and the SD on the right y-axis.
The display covers an interval of 30 days; the default window displays the
results for the last 30-day interval, but the operator may view earlier data and
move about using the scroll bar. The last 500 QC values per liquid and test
can be displayed on the plot. The system will retain the last 65,536 values
for statistical calculations.
QC values will be displayed as follows on the graph:
• Omitted values appear as a blue diamond symbol
• QC values out of SD range (1 or 2 SD) appear as a violet circle

• QC values out of 3 SD range appear as a red triangle
• Valid QC values appear as an asterisk
The statistical calculation is done using all results in database. To obtain the
Statistics and Plot for other selected intervals of time, click the Select
Interval button and enter the specific start and end date (dd.mm.yyyy or
according to the date format selected in the Date/Time configuration) in the
specific fields of the Select Interval screen:

The new interval must be confirmed by clicking the Confirm button, which
results in the system going back to the QC Plot and Statistics screen, or not
confirmed by clicking the Cancel button (this applies only to the selected
interval). The statistical results will be updated based upon the selected
interval.
Clicking the Printer icon, followed by a confirmation window Do you really
want to print? Yes allows the operator to print the plot; No will cancel the
operation.
Clicking the Cumulative Results button opens the QC Cumulative Results
screen (refer to subsection below).
Clicking the Confirm button exits this screen and goes back to the QC
Review screen.


3.3.5 QC - CUMULATIVE RESULTS

Clicking the Cumulative Results button located in both the QC Plot and
Statistics and the QC Review screens opens the QC Cumulative Results
screen:

The top portion of the screen displays the following: the selected QC material
(Liquid ID), the selected test (test ID), the date range (dd.mm.yyyy) and the
time range (hh.mm). This information cannot be edited on this screen.
The larger part of the screen is used to display the results obtained for the
selected pair QC material-test.
“F” column flag – A Q will appear in this field if there is a QC alert.
“S” column indicates the transmission status (L is local, T is transmitted).

“O” column means omitted, designated by a check mark in this column .
Results are displayed using a list that can be scrolled vertically; the columns
show the numeric results in the configured unit and the date/time of the
analysis. Values out of programmed SD range (1 or 2 SD) will be displayed
in violet and those values out of 3 SD will be displayed in red.
There is also a column for notes, and columns for possible flags and
warnings.
Further details about a single result, are accessible by clicking the Details
icon, which opens the QC Single Result Details screen:

On this screen, the identity of the Liquid ID/Test ID pair is displayed on the
first line of the screen.
The windows in the left side of the screen display the QC sample curve, the
measured units and the calculated units.
Additional information about the displayed result is also viewable on the right
side of the screen:
- Transmission status (T: Transmitted to Host or L: Local when result
has not been transmitted to Host)
- Omission status (Yes or No)
- Analysis date and time
- Notes (if any)
- Warning list.
Clicking the Disk icon allows the operator to save the result on a floppy disk
for future use. The action opens the Type File Name screen.
After typing the name of the file and confirming the operation, the Operation
in Progress screen opens and the information is saved on the disk.
The disk save routine saves the raw data point readings and not the actual
clot curve display to disk. The file must be named with a “crv” extension (i.e.
PTQC1.crv)
Clicking the Printer icon, followed by request for confirmation window Do you
really want to print? Yes allows the operator to print the single result; No will
cancel the operation.
Clicking the Confirm button causes the system to go back to the QC
Cumulative Results screen.
The operators may enter their own notes in the Insert Notes screen (shown
below) that is opened by clicking the Notes icon.

The free text note field allows the operator to key in up to 30 alphanumeric
characters. Click the Confirm button after entering the note to save it.
Clicking the Omit Result button allows the operator to permanently omit the
selected result. Before omitting it, confirmation is requested Omitting
result…Do you really want to omit the selected result? Yes or No selections
are possible. When the result is omitted, a check will appear in the O column
beside the result and this result will not be included in the statistical
calculation. Omitted results will be displayed on the QC Plot as a blue
“diamond” symbol. You cannot Un-Omit a result once it has been omitted.
Clicking the Plot and Statistics button allows access to the QC Plot and
Statistics screen (refer to section 3.3.4 above).
Clicking the Host icon opens the QC Host Communication screen (refer to
section 3.3.6 below).
Clicking the Extract Results icon opens the QC Extract Data screen (refer to
section 3.3.7 below).
want to print? Yes allows the operator to print the results; No will cancel the
operation.
Clicking the Confirm button saves any changes and returns back to the QC
Review screen.


3.3.6 QC - HOST COMMUNICATION

Clicking the Host icon found in both QC Cumulative Results and QC Review
screens opens the QC Host Communication screen:
The Host Communication configuration displayed on the screen is needed to

decide which type of QC results are to be sent and for what time interval.
The user first defines the date range, choosing between:
− “All range” (All range would include all results for the selected tests)
− “From…To…” (Specific Date range to send)

If the latter is selected, the starting date/time and the ending date/time must
be defined.
The user can then select if data for a specific test or all tests should be
transmitted by choosing between the following options:
- “Single Test”
- “All Tests”
Once the date range and tests are chosen the user can then narrow down
which results to send from the following choices:
- Valid Results
- Invalid Results
- Not Numeric Results
- Out of Scale Results
- Omitted Results
- “Transmitted” or “Not Transmitted”

- “Flagged” or “Not Flagged”
Touching the check box area close to the option makes the selections; a
check mark appears next to the choice. These options allow the user to
group the transmitted results for ease of handling: i.e. Valid and Not Flagged
results. The second level options can also be combined with them to transmit
groups such as Valid and Not Flagged - but Omitted - results.
Once the transmission criteria are defined, the transmission begins by
clicking the Start Communication button.
Clicking the Cancel button rejects the changes; the system goes back to
either the QC Cumulative Results screen or to the QC Review screen
depending from which screen the Host icon was pressed.
3.3.7 QC - EXTRACT DATA

Clicking the “Cumulative Results” button from the QC Review screen opens
the QC Cumulative Results screen.
Clicking the Extract Results icon will open the QC Extract Data screen
(shown below) that is almost identical to the QC Host Communication screen.

The data configuration displayed on this screen is needed to decide which

type of QC results are to be extracted and at what time intervals. The Liquid
ID/Test ID association is visible on the upper part of the screen.
− “All range” (All range would include all results for the selected tests)
− “From…To…” (Specific Date range to send)

be defined.
Once the date range and tests are chosen the user can then narrow down
which results to view from the following choices:
- Valid Results
- Invalid Results
- Omitted Results
The selections are made by touching the check box area close to the option;
a check mark appears next to the choice. These options allow the user to
group the extracted results for ease of handling: i.e. Valid and Not Flagged
results. The second level options can also be combined with them to view
groups such as Valid and Not Flagged - but Omitted - results.
Once the extraction criteria are defined, the process begins by clicking the
Extract icon. The cumulative data for the selected interval will be displayed.
The statistical results are not updated based upon the selected data. The
statistics will be based upon the default interval data.
- Clicking the Cancel button rejects the changes.


3.4 Calibration
The ACL Elite/Elite Pro system requires that certain tests be calibrated either prior to
or simultaneously with sample analysis. If a test with a dedicated calibration is
requested, and no calibration curve exists in memory, a “missing calibration” warning
will be displayed during the pre-analytical check.
Although calibrations require the use of test-specific reagents and often other specific
materials, the calibration procedure is common to all tests.
This section contains all the information needed to calibrate assays on the ACL
Elite/Elite Pro, starting with a summarized procedure for those users already familiar
with the ACL Elite/Elite Pro system, followed by step-by-step procedures with specific
details about the screens, options, etc.
Calibration Table characteristics by test
Test Dedicated In Session Each Rotor
PT #
Fib-PT Based #
Fibrinogen-C #
Factors* #
Antithrombin #
Heparin #
Protein-C #
Plasminogen #
Plasmin-Inhibitor #
ProClot #
Factor VIII Chrom. #
Free Protein S #
Protein-S #
Pro S #
D-Dimer #
VWF (Ag & Activity) #
*Assays with Parallelism import the calibration from the same factor
assay with a dedicated calibration mode
Dedicated means a separate session is initiated to perform a calibration.
The session is initiated using the calibration menu. The analyser will

store the last executed calibration curve. The curve is viewable under
the calibration review submenu.
In session means the calibration is executed the first time together with
samples and then saved. Subsequent runs for the test in the same
analytical session use the saved curve. For future analytical sessions, if
the calibrators are positioned on the sample tray the calibration will be
executed, if not, the previous calibration is used. The system will store
the last five In-session calibrations per test. The curves are visible using
the calibration review menu. The last curve performed is active and in
use.
Each Rotor means that every time a rotor is loaded with samples the
calibration is executed as well. The calibration material is required to be
placed on the sample tray for each run. If multiple rotors are processed
within an analytical session, a calibration will be performed on each rotor.
3.4.1 Dedicated Calibration Procedure-Summary

1. Select Calibration from the Main screen menu bar and select Calibrate from
the Calibration submenu.
2. Scroll through the list of tests displayed in the Test to Calibrate window on
the top right side of the screen, and select the test to be calibrated.
3. Look at the left side window or Materials Map and make sure that you have
on hand the materials listed to perform the calibration for the test.
4. Press Start to begin the Pre-Analysis phase. The ACL Elite/Elite Pro will
check the presence of the required materials; if all required materials are
present the calibration run will begin.

3.4.2 Saving a Calibration - Summary

At the end of the cycle the Calibration can be viewed prior to being saved.
When the new calibration is accepted the previous calibration will be deleted.
For dedicated calibrations only it is possible to compare results of the new
calibration session with those of the previous calibration before deciding to
save it or not. For non-dedicated calibrations, the system retains the last 5
calibrations in memory. The oldest is automatically cancelled with any new
calibration run.
Note: Calibrations should be reviewed and accepted prior to the system

going into standby
3.4.3 Dedicated Calibration- Details

The calibration process is started from the Main screen by selecting
Calibration on the menu bar and selecting Calibrate from the Calibration
submenu. This will open the Calibration Pre-Analysis screen:
The screen is divided into several areas:
Top right area: The Test to Calibrate window allows the user to scroll through
the list of tests displayed and choose the test to be calibrated. The list
includes all the tests that require a dedicated calibration.
Top left area: A large window displays the list of materials needed to perform
the calibration for the test selected in the Test to Calibrate window. For
example, if a PT test is selected, the Calibration Plasma, Factor Diluent and
Thromboplastin will appear as required materials.
• If you are using a new lot of any of the materials press the Liquid
Details button at the bottom of the window and modify the appropriate
lot number.
• If you are using a new lot of Calibration Plasma, press the Liquid
Details button at the bottom of the window and enter the new assigned
value as shown on the Calibration Plasma package insert sheet.
Note: For the PT calibration, the value entered for the cal plasma is 100.
The window is divided into 4 columns with one row per Material. The
information displayed is the same as that entered when defining the
material’s configuration:
- # Number of the position assigned on the ACL Sample

Tray (A1-10) or Reagent Position (R#)
- Lot Number Number of the specific lot
- Value Assigned value for the FIRST Standard, as indicated
on the package insert sheet

Clicking the Materials Map button at the bottom of the window opens the
Pre-Analysis: Material Status screen:
This screen displays the status of reagents currently on-board the system,
along with other analyser information. Refer to section 3.2.3 for details on
the Materials Map.
Clicking the Start button from the Materials Map starts the calibration run.

shutdown ACL? Yes closes the session, allowing the operator to log out
3.4.4 Calibration - Review Calibrations

The Calibration Review (dedicated and in session calibration) process is
started from the Main screen by selecting Calibration on the menu bar, and
selecting Review Calibration from the Calibration submenu. This will open
the Calibration Review screen:

This screen displays the recorded date and time of all the calibrations
performed for each enabled test.
• Dedicated Calibrations: The ACL will save the last calibration performed.
• In-Session Calibration: The ACL will save the last 5 calibrations. The
most recent one will be the active one in use.
Calibrations may be deleted by selecting the desired Test ID and Calibration

date/time, then clicking the Delete icon.
Clicking the Details icon at the bottom of the screen opens the Calibration
Data screen (shown below).

This screen gives the user the ability to view at a glance the most important
information related to calibration runs:
- Name of the test (ID)
- Date and time when the calibration was performed
- Calibration curve
- Calibration Line Equation coefficients
- Errors (click the Error View button, see below)
- Warnings (click the Warning List button, see below)
- Mean value of the replicates, units of measure and CV%
Clicking the Details icon displays information about each single replicate.
This screen allows the operator to review the clot formation curve (or the
absorbance curve, depending on the test) for each single replicate, along
with the numeric value. For the clotting test curves, the clotting point is also
displayed.
Individual replicates can be omitted by pressing the Omit Replicate button.
The selected replicate will be removed from the calculation of the mean. It
will remain displayed and will have a check in the Omit Column. You may
omit multiple replicates, but must leave at least one for the curve calculation.
The mean value for a calibration is calculated by averaging all replicate

values. The replicate furthest from the mean is eliminated. The
remaining replicates are then averaged. This is the value used to
construct the curve
The raw data for the level and replicates displayed may be saved using
the floppy icon. The curve must be given a name. The .crv extension will
automatically be added to the name.
- ACTIVE BUTTONS at the bottom of this screen are:


- Confirm exits the screen; the system goes back to the Calibration
review screen.
Warning: Changing the target value of a calibrator in the Liquid Setup
screen after a calibration is performed results in the stored calibration
getting automatically updated to reflect the new value. A warning
message is presented informing the user the stored calibration will be
updated. Calibration should still be executed for the test if the
calibration was never performed using this lot of calibrator.
Clicking the Confirm button will allow the operator to exit the screen and the
system goes back to the Calibration Data screen.
Clicking the Printer icon the calibration curve and the calibration data are
printed. If the curve is composed of multiple segments, you must print each
segment individually. If the printer icon is pressed while viewing the replicate
curves, then the curve displayed will be printed.
Clicking the Error View button opens the Error View screen (shown below).

Clicking the Warning List button opens the View Warnings screen:
Clicking the Confirm button exits the screens: the system goes back to the
Calibration Data screen.

Table: Number of calibration points used per test.
Test Calibratio Total Number of Total

n Number of Replicates Number of
Standard Calibration for each Calibration
to be Points Point Points
positioned
PT 1 3 6 18
Fib-PT Based * * * *
Fib-C 1 3 4 12
Factors # 2 6 1 6
Factors $ 1 6 2 12
AT 1 3 4 12
HEP 2 3 4 12
P-C 1 3 1 3
PLG 1 3 1 3
FVIII Chr 1 3 1 3
P-I 1 3 1 3
ProClot 1 3 1 3
ProS 2 3 1 3
D-Dimer 1 3 4 12
VWF(Ag / Act) 1 4 4 16
* same number as the PT tests
# 2 standards are used for Non-Parallelism Factor Assays calibration: the

100% is the Calibration Plasma as it is (neat) and the Low Factor
Calibration Plasma is the same calibration plasma diluted 1+15 with
Factor Diluent (this dilution has to be prepared manually by the operator).
Factors with parallelism utilize Calibration plasma only.
$ Factors with Parallelism tests defined will import the calibration from the
same assay without the parallelism dilutions. The calibration for this test
will require 3 empty cups during the calibration cycle which will be used
to prepare the Low Factor Calibration Plasma dilution.

3.4.5 Factor assay calibration for Non-Parallelism Tests

This information is valid for all 8 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 3 segments:
1. High Curve: Prepared using Cal Plasma with levels at 100%, 50% and
25%.
2. Low Curve: Prepared using Low Cal F with levels ranging from 6.25%,
3.125% and 1.56%.
3. Middle segment connects the 25% from segment one and the 6.25%
from segment three.
*excludes Chromogenic Factor VIII
Preparation of the Calibration standards

For factor assay calibration it is necessary to prepare two calibration
standards:
100% is represented by the reconstituted Calibration Plasma; the specific

assigned value contained in the insert sheet of the calibration plasma needs
to be used as the assigned value for this material and the relative factor
being tested.
Cal Low F (6.25%) is represented by the Calibration Plasma diluted 1 + 15

using Factor Diluent. The assigned value is automatically calculated by the
ACL Elite/Elite Pro from the 100% value entered by the user. The standard is
prepared by pipetting 20 µL Calibration Plasma + 300 µL Factor Diluent into
0.5 mL cup. Mix well prior to use.
The 100% calibration plasma is required to obtain a valid calibration curve.
If the 100% calibration plasma material is not placed, a window will indicate
the missing materials. The options to abort or to continue are given. If the
user chooses to continue, sample analyses are performed although the
calibration cannot be executed. Sample results are calculated based on the
previous calibration. Response and activity (%) values are reported. If no
stored calibration curve exists, the results will only be displayed in seconds.
If the 100% material does not give a valid result, the entire calibration is
automatically rejected. When reviewing the calibration, an error message is
displayed. In addition, no calibration curve or statistics will be displayed.

IL recommends that the 100% material be placed on the sample tray for each
Factor Analysis session.
The Cal Low F (6.25%) material is an optional material. It is used to obtain

the Low and Middle segments of the calibration curve.
Below is a summary of the 6 dilutions used by the ACL Elite/Elite Pro to

perform a Factor Assay calibration when all 3 segments are performed.
Dilution Ratio in % Preparation

100 Undiluted Calibration Plasma
50 Cal Plasma - Dilution done automatically by the
ACL Elite/Elite Pro
25 Cal Plasma - Dilution done automatically by the
ACL Elite/Elite Pro
6.25 Cal Low F - Manually prepared diluting the
Calibration Plasma 1+15 with Factor Diluent
3.12 Cal Low F - Dilution done automatically by the
ACL Elite/Elite Pro
1.56 Cal Low F - Dilution done automatically by the
ACL Elite/Elite Pro
3 Calibration segments: High, Middle and Low
The calibration curve for factor assays is composed by 3 segments:
High segment is obtained connecting the 100, 50 and 25 % points

Middle segment is obtained connecting the 25 and 6.25% points
Low segment is obtained connecting the 6.25, 3.12 and 1.56% points.
Factor Assay Calibration in the IL test library use the criteria of the in-session
calibration mode. If the undiluted calibration plasma is present on the ACL
Elite/Elite Pro sample tray, the High segment calibration is performed during
the analytical session.

If the undiluted calibration plasma is not present, the previous High

calibration stored in memory is used for calculation and reporting of results.
Note: Do not place the Low Cal F cup onboard the analyser without
placing the Cal Plasma cup
An analytical session is defined as beginning with the start of analysis and
ending when the instrument returns to Ready.
Note: All results processed on a calibration curve with an error in one
segment will be flagged with a warning “Invalid adjacent segment”.
High curve
In case the operator needs only the High curve, it is possible to perform the
calibration only using the undiluted calibration plasma.
The ACL Elite/Elite Pro will perform only 3 calibration points: 100%, 50 and
25%.
Linearity varies from factor to factor but the instrument will always flag a
result less than 60% of the lowest calibration point.
In case the lowest calibration point is 25 %, all results below 15 % will be

flagged with a “C” in the Error column and tagged with “Extrapolated Result”
in the Test Details Warning List.
If a result is higher than 150 % of the highest calibration point value, a “C” will
be displayed in the Error column and “Extrapolated Result” will be shown in
the Test Details Warning List.
For example, if the highest point of the calibration is 100 %, all results above
150% will be flagged with a “C” and tagged with “Extrapolated Result”.
If the High curve is not valid (rejected), results on patients will be presented
only in seconds.

If the High calibration curve is rejected but the 100% result is a valid result,
the Low curve and the Middle curve segments will be calculated.
If the 100% gives a non-valid result (i.e. error number xx), the High, Middle
and the Low curve will be rejected.
In both cases listed above the calibration should be repeated along with
Quality Control and patient samples.
It is possible that only two points (including the 100%) are valid and in this
case the instrument will present the "2 point cal” condition.
Low curve
If both High and Low segments are required, both segments must be
calibrated at the same time.
If the High curve is rejected due to a non-valid 100% result, the Low curve is
rejected.
If the Low curve is rejected (invalid, non monotonic, etc.), the High and the
Middle curve segments can be considered valid. The Middle segment curve
should be verified prior to reporting the patient results.
It is possible that only two points (including the 6.25%) are valid and in this
case the instrument will present the "2 point cal” condition.
Any result outside its specified Test Range as defined in the test setup will be
flagged with a “C” in the Error column and “Outside Test Range” will be
displayed in the Test Details Warning List.

Middle curve
The Middle curve will be calculated when both High and Low curve segments
are calibrated at the same time and both 25% and 6.25% points have
produced valid results.
In case the High and Low segment do not produce a valid calibration (i.e.
slope out of range), if both results of the Middle curve segment are valid the
Middle curve segment is calculated. The Middle segment curve should be
verified prior to reporting the patient results.
Any result outside its specified Test Range as defined in the test setup will be
flagged with a “C” in the Error column and “Outside Test Range” will be
displayed in the Test Details Warning List.
Non monotonic check
Another check done on calibration is called “Monotonic”.

This check verifies that the results obtained in seconds are proceeding in the
same direction: low to high or high to low.
If one of the points in seconds is not “monotonic”, the entire segment of the
curve is flagged and rejected.
If the High curve segment is found “non monotonic”, sample results will be
calculated based on the Middle or the Low curve segments if valid.
If the Low curve segment is found “non monotonic”, sample results will be
calculated based on the Middle or the High curve segments if valid.
For the two conditions above, the curve should be verified prior to reporting
the patient results.
If only the 100% calibrator is present and the error “non monotonic” is shown,
the entire curve will be rejected. In this case sample results will be calculated
based on the previous calibration curve. If a previous calibration curve is not
present, only response values will be reported.

Slope check
If the calibration slope exceeds the slope limit specifically defined for the
segment, the segment will be rejected with the Slope out of Range error
message.
Samples run in this condition will be flagged with a “C” together with the
message “Slope out of Range”.
r2 check
If the calibration r2 for a specific segment exceeds the r2 limit specifically

defined for the segment, the r2 will be presented in red and a “C” flag with the
message “r2 out of Range” will be presented together with patient sample
results.

Flags on patient results
Several flags on patient results may be present and they are summarized in
the following table.
Flag Explanation
Out of Test Range = result is Result is outside the Test Range

displayed in violet for that specific test.
Extrapolated result When the result is greater than

150% of the highest calibration
point or less than 60% of the
lowest calibration point. Applies to
high curve or low curve.
Previous calibration Result is calculated using a

previously stored calibration.
Invalid Adjacent Segment Calibration curve has a segment

with an error.
Slope out of Range Result is calculated if at least the

High segment of the curve is valid.
R2 out of Range Result is calculated and an error

message is shown (r2 out of
Range).
Response “non monotonic” Result is calculated and an error

message is shown (response “non
monotonic”)
Recommendation:
If the Low segment fails and results are obtained <25%, repeat the
calibration, Quality Control, and patient samples.
Since calibration can be run simultaneously with patient samples or a

previously stored calibration can be used, the operator should verify that all
calibration segments are valid and no calibration flags are present before
validating any results.

For good laboratory practice, at least two (2) levels of controls should be run
together with patient samples.
If a calibration displays any flags, good laboratory practice suggests

repeating the calibration, Quality Control and patient samples.
In case of Factor VIII and/or IX, patient therapeutic treatment may be

associated to sample results. Perform the Low curve calibration, at the same
time as the High curve calibration, to cover factor concentrations down to the
1.56 % level.
Stability of a stored calibration curve should be monitored by the use of at

least two levels of Quality Control materials each day of testing.
3.4.6 Factor assay calibration for Parallelism Tests
Factor assays for tests with parallelism import the calibration from the same
factor test defined without the parallelism dilutions. This master test is
calibrated using the dedicated calibration mode.
This information is valid for all factor assays with Parallelism when using the
IL tests library. The calibration curve for factors is divided into 3 segments:
o High Curve: Prepared using Cal Plasma with levels at 100%, 50% and
25%.
o Low Curve: Prepared using Low Cal F with levels ranging from 6.25%,
3.125% and 1.56%.
o Middle segment connects the 25% from segment one and the 6.25% from
segment three.
Calibration of the master test will require 3 empty cups on the sample tray
during the calibration cycle. These cups will be used to automatically prepare
the dilution of the Cal Plasma for use as the Low Cal F.
Samples that are processed with the Factor Parallelism will process the
samples at three dilution levels: 100%, 50% and 25%.

3.4.7 Factor assay Parallelism Results
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 definable Flag to alert the operator if a limit has been
exceeded. If an inhibitor is suspected, confirmatory testing is suggested.
Results are obtained by running a series of dilutions of the sample similar to

performing a calibration. Samples run using factor parallelism will be
analyzed at the 100%, 50% and 25% levels. On the cumulative report the
results for all 3 dilutions will be reported as Dil 1 (100%), Dil 2 (50%) and Dil
3 (25%). Each of these levels may display the results in seconds, %
(Uncalculated) and Rec % (Recalculated). The recalculated results will be
the % uncalculated values multiplied by the dilution factor.
In addition to the individual results the system will perform calculations for the
following:
- AVeCR% - Average of the three Corrected Results in % activity.

- CV-CR% - CV% of the three Corrected Results % values. When this
value exceeds the limit in the test setup the results will be displayed in
red on the screen and an error will print on the report.
- Slope – The slope for the 3 parallelism values is calculated. This slope
should coincide with that for the factor test calibration. In the test setup
there is a user definable minimum and maximum allowable Slope limit.
When the recovered slope for the samples is outside the limits in the test
setup the results will be flagged in red and the error “Slope out of range”
will be printed.

- Int – This value is the intercept for the line based upon the 3 factor
parallelism dilutions. In the test setup there is a user definable minimum
and maximum allowable Intercept limit. When the recovered value for
the samples is outside limits the results will be flagged in red and the
error “Intercept out of range” will be printed.
- R2 – This value is the correlation coefficient calculated using the
seconds and the 3 factor parallelism dilution % values (uncorrected). In
the test setup there is a user definable minimum and maximum
allowable R2 limit. When the recovered value for the samples is outside
the limits the results will be flagged in red and the error “R2 out of range”
will be printed.
Sample results with an error on any of the above units should be reviewed for
the presence of a possible factor inhibitor. Additional retesting including off-
line dilutions at higher levels may be required to confirm any questionable
results.
Example 1:
Laboratory Maximum Variance ± 10% of the mean
Concentrations: 100% 50% 25%
Values: 54.7% 51.5% 46.4%
In the above example the results of 54.7% and 51.5%, have a mean of 53.1
with a 10% agreement the range is 47.8% - 58.4%. If the results are outside
that range another dilution should be made, if they are within range they are
close enough to report. If all points are within 10% of their mean then the
100% concentration value should be reported as long as no other flags are
seen.
Parallelism’s sole purpose is to aide in the identification of inhibitors. In the
case of an inhibitor the answer reported should be the result obtained when 2
dilutions (CR’s) agree

3.5 Analytical Reference

Analytical Reference (AR) is the name associated to a control material that is
intended for use as a general check of the system precision.
The AR results are handled just like the results for a Quality Control material.
The plot and cumulative list of results are both available for the AR. These
results may be transferred to a host computer, printed or archived to a floppy
disk.
3.5.1 Analytical Reference: SETUP

To Review the Analytical Reference results, from the Main screen select
Calibration on the menu bar, then select Analytical Reference from the
Calibration submenu. This will open the Analytical Reference Review screen:
This screen is similar to the QC Review screen.

The user may select the desired test from the list of enabled tests. The
following statistics are displayed, but cannot be edited, on the right side of the
screen:
- Unit
- Actual and Target Mean
- Actual and Target SD
- Actual CV
- Results in Statistics and in Database (DB)
If the AR Use box is checked then the system will check for the presence of
the Analytical Reference during the Pre-Analytical check for all assays.
Remove the check from the box to disable the use of the Analytical
Reference for all assays. Default value is for the box to be unchecked.
If the AR Use button is checked (enabled) and profiles are created the
material map for the profile will reflect the need for Cal Plasma. If the AR
Use button is later disabled the profiles that contain tests that use the AR will
need to be deleted and re-created.

Clicking the Setup button opens the Analytical Reference Setup screen (see
details later in this Section).
Clicking the Plot and Statistics button opens the Analytical Reference Plot
and Statistics screen (see details later in this Section).
Clicking the Cumulative Results button opens the Analytical Reference Data
screen (see details later in this Section).
Clicking the Transfer to Host icon opens the AR Host Communication
screen (see details later in this Section).
Clicking the Confirm button exits the screen.
Clicking the Setup button in the Analytical Reference Review screen opens
the Analytical Reference Setup screen:
The selected test ID appears on the top of the screen; below it the operator
can view the following information:
- Unit
- Target Mean and SD
- Target SD
- SD Range
- Results in Database. 10, 100, 500, 1000 is selectable. Any change to
the number of results in the database will delete all AR results for this
test.
- Note

Clicking the Clear Statistics button, followed by a confirmation window

Clearing Cumulative Results for this test? Yes clears the cumulative results;
No will cancel the operation.
Clicking the Confirm button saves the changes, while clicking the Cancel
button rejects the changes; in both cases the system goes back to the
Analytical Reference Review screen.
3.5.2 Analytical Reference: PLOT and STATISTICS

Clicking the Plot and Statistics button in the Analytical Reference Review
screen opens the AR Plot and Statistics screen.
This screen displays both the Plot and the Statistics for the selected test.
The following information is viewable, but not editable, on the far left side of
the screen:
- Start and End Date
- Unit
- Actual and Target Mean
- Actual and Target SD
- Actual CV
- Results in Statistics and in the Database (DB), choices are 10, 100, 500
and 1000 viewable results.

The AR plot is displayed on the far right side of the screen; the axes on the
chart indicate:
- X-axis = days
- left Y-axis = target mean and chosen units
- right y-axis = SD
The display covers an interval of 30 days; the default window displays the
results for the last 30-day interval, but the operator may view earlier data and
move about using the scroll bar.
The statistical calculation is done using all the results in the database. To
obtain the statistics for other selected intervals of time click the Select
Interval button and enter the specific start and end date (dd.mm.yyyy or
according to the date format selected in the Date and Time configuration) in
the specific fields of the Select Interval screen.
The new interval must be confirmed by clicking the Confirm button, which
results in the system going back to the AR Plot and Statistics screen, or not
confirmed by clicking the Cancel button (this applies only to the selected
interval).

want to print? Yes allows the operator to print the test setup; No will cancel
the operation.
Clicking the Cumulative Results button opens the Analytical Reference Data
screen (refer to subsection below).
Clicking the Confirm button allows the operator to leave this screen and go
back to the AR Review screen.

shutdown ACL? Yes closes the session, allowing the operator to turn the
system off; No will cancel the operation.
3.5.3 Analytical Reference: CUMULATIVE

RESULTS
Clicking the Cumulative Results button in either the Analytical Reference
Review or the Analytical Reference Plot and Statistics screen opens the
Analytical Reference Data screen:

In the upper part of the screen, the user views the selected Test ID. The
larger part of the screen is used to display the results obtained. Results can
be displayed using the list that can be scrolled vertically and horizontally; the
columns show the numeric results in all configured units and the date/time of
the analysis.
There is also space for notes, and columns for flags and warnings. The
operator may enter his own notes by clicking the Note icon that opens the
Insert Notes screen (similar to that on the QC screen).
Clicking the Confirm button allows the operator to save the entered or
modified note and to exit this screen, going back to the AR Data screen.
Clicking the Omit Result button allows the operator to permanently omit the
selected result. Before omitting it, confirmation is requested Omitting
result…Do you really want to omit the selected result? Yes or No selections
are possible. When the result is omitted, a check will appear in the O column
beside the result and this result will not be used in the statistical calculation.
Clicking the Plot and Statistics button allows the operator to have access to
the Analytical Reference Plot and Statistics screen (refer to subsection
above).
Clicking the Host icon opens the AR Host Communication screen (refer to
subsection below).
Clicking the Extract Results icon opens the AR Extract Data screen (refer to
subsection below).
Clicking the Printer icon opens the AR Result Report screen with the various
possibilities:
− ALL
− From … to
− Not numeric

− Out of scale
− Omitted
− Transmitted
− Not transmitted
− Flagged
− Not flagged
Clicking the Confirm button exits this screen and goes back to the Analytical
Reference Review screen.
3.5.4 Analytical Reference: HOST

COMMUNICATION
Clicking the Transfer to Host icon in the Analytical Reference Review screen
opens the AR Host Communication screen (similar to the QC functionality).
The Host Communication configuration displayed on this screen is needed to

decide which type of AR results are to be sent and at what time intervals they
should be transferred to the Host Computer.
− “All range”
− “From…To…”
be defined.
The user can select also if a specific test data or all tests data should be
transmitted between the following options:
- “Single Test”
- “All Tests”
The user then makes a second-level choice from each of the following
pairs:

- Omitted Results
Some second-level selections are also available:


Touching the area close to the options makes the selections: a check mark
appears next to the choice. These options allow the user to group the
transmitted results for ease of handling, i.e. Not Numeric and Not Flagged
groups such as Not Numeric and Not Flagged - but Omitted - results. Once
the extraction criteria are defined, clicking the Start Communication button
may activate the transmission.
Clicking the Cancel button rejects the changes and exits the screen.
3.5.5 Analytical Reference: EXTRACT DATA

Selecting Analytical Reference from the Calibration menu, Cumulative
Results and then clicking the Extract Results icon in the Analytical
Reference Data screen opens the AR Extract Data screen (similar to the QC
functionality).
The data configuration displayed on this screen is needed to decide which
type of AR results are to be extracted and at what time intervals they are
extracted.
− “All range”
− “From…To…”
be defined.
The user then makes a second-level choice from each of the following
pairs

- Omitted Results
Some second-level selections are also available:
Touching the area close to the option makes the selections; a check mark
appears next to the choice. These options allow the user to group the
transmitted results for ease of handling, i.e. Not Numeric and Not Flagged

groups such as Not Numeric and Not Flagged - but Omitted - results. Once
the extraction criteria are defined, clicking the Extract icon can activate the
extraction.
Clicking the Cancel button rejects the changes and exit the screen.



Setup and Utility
4.0 Introduction
The intent of this Section is to familiarize the ACL Elite/Elite Pro user with the items
included in the Setup and Utility portions of the Operator Interface. The understanding of
the items and their proper use are key in order to prepare the system for its optimum
analytical operation, to handle data and to work with the system software.
4.1 SETUP
The Setup portion of the ACL Elite/Elite Pro software groups all functions related to
definition or configuration of features or items in order to adapt and optimize the use of
the system to the laboratory needs prior to performing the analytical operations.
4.1.1 SETUP Submenu

Clicking the SETUP button on the Main screen menu bar displays :
TESTS
- View/Define
- Sort Tests
- Interference Table
- Default Tests
- Reflex Tests
MULTI-TESTS
- Profiles
- Test Groups
- Test Group Profiles
- Sort Multi-Tests
- Default Multi-Tests
LIQUIDS
INTERFACES
- Host
- Printer
- Internal Barcode
- External Barcode
- Keyboard
- Network (dimmed) – Not Supported in this version
- Modem (dimmed) – Not supported in this version
SYSTEM CONFIGURATION
SECURITY
AUDIBLE ALARMS
DATE/TIME
UNITS

Setup and Utility
4.1.2 Setup - TESTS – View/Define

This area of the software is used to define and view individual tests. The default
setting for all tests is disabled. The test library can contain up to 300 tests; 200
reserved for IL applications and 100 reserved for customized applications; up to
100 tests can be enabled (active) at the same time independent of the mix.
Selecting Tests from the Setup submenu, and then choosing View/Define
opens the View Tests screen:
Above the test list a rectangular box will show the number of tests present in the
Library Application. The box will show two numbers; the enabled tests followed
by the total number of tests.
The large window on the left of the screen displays a table of all the configured
tests.
Each test is identified by an abbreviated name, Test ID, shown on the right side
column. The Test ID name can be customized in the test details screen. The
Test ID must be unique for each test.

The two columns to the left of the test names contain checks indicating whether
each test is:
- currently Enabled and ready to be run on the ACL
- an IL pre-defined test application.
Note: IL pre-defined tests were developed and tested specifically for

use with IL Test reagents and new supplies (i.e. rotors and
wash-R) for use on the ACL™ Elite/Elite Pro. The proper
performance of other reagents and supplies including washed
rotors has not been fully tested or verified, and the use of them
may cause clinically significant degradation of performance and
results. IL does not assume any obligation or warranty
engagement concerning precision and/or accuracy of the
measurements or for any damage to the instrument directly or
indirectly resulting from the use of reagents, consumables, and
expendable supplies other than those sold by IL.
All responsibility for parameter development and validation
of new or copied tests belongs to the user alone.
The right side of the screen contains the following fields:

TEST CODE
TEST REVISION
TEST CODE FOR HOST
EXTENDED NAME
CALIBRATION MODE
The information shown in these fields can be viewed but not edited from this
screen. Several buttons are found around these fields:
Clicking the Details icon opens the Test Details screen, which allows editing of
the fields (refer to section 4.2.2 for details).
Clicking the Printer icon, followed by a confirmation window Do you really want
to print the Test report? Yes allows the operator to print the Test Setup of the
selected test; No cancels the operation.
Clicking the Enable/Disable button, followed by a confirmation window Yes/No,
erases all information related to the selected test from the Patient Database and
the QC Database. If the test is disabled, clicking the Enable/Disable button will
enable it.
Clicking the Show Enabled check box allows the operator to view only the
enabled tests from the test table. When this checkbox is marked the list
presented displays just the enabled tests. This setting is saved when exiting from
this screen and also at power off.
Clicking the Copy Test button opens the Copy Test screen (refer to section 4.2.1
below).

Setup and Utility
Clicking the New Test button opens the New Test screen (refer to section 4.2.2
for details).
Clicking the Delete icon, followed by a confirmation window, erases all
information related to the currently selected test. IL locked tests cannot be
deleted.
- Database View returns to the Database View or Main Screen.
4.1.3 Setup - TESTS - Sort Tests

This area of the software is used to sort the tests available in the system.
Selecting Tests from the Setup submenu and choosing Sort Tests opens the
Sort Tests screen:
Sorting the tests defines the display order of the tests in the patient database, the
order of the tests list during programming and the order of the tests in the
printouts.
The window on the left side of the screen displays a table of all currently enabled
Tests; a check mark to the left side of a test indicates that it is a Sorted Test.
The window on the right side of the screen displays the order in which the tests
are sorted.
The Arrow and the Scissors icons at the bottom of the windows are used to
create a sorted list.
The default condition is to have the tests in both columns listed in alphabetical
order.
The operator selects the tests from the sorted tests box and presses the scissors
icon; the tests are then removed from the right side window.
This operation is necessary because the tests cannot be moved up and down in
the Sorted Tests list.
The arrow is used to move a test from the left (enabled tests) list to the right
(sorted) list in the desired position.
Tests are added after the cursor. If a mistake is made, the Scissors icon is used
to remove the test from the sorted list. No test can be added above the first test
in the list.
Enabled tests that are not sorted will be printed and viewed after those tests that
are sorted.
Clicking the Confirm button saves the changes and clicking the Cancel button
rejects the changes; in both cases the system goes back to the Database
View/Main screen.

and/or turn the system off; No cancel the operation.

Setup and Utility
4.1.4 Setup - TESTS - Interference Table

Even though the ACL has been designed to minimize reagent carryover between
tests, it was found experimentally that performing an operation called “reagent
priming” might improve the system performance. The Interference Table option is
used to activate this operation between test pairs.
Selecting Tests from the Setup submenu, and choosing Interference Table
opens the Interference Table screen shown below.
This screen contains three windows:

TESTS WITH REAGENT PRIMING on the left side, which lists the tests that
require a preventive needle priming as defined in the test setup.
INTERFERING TESTS in the middle, which displays all tests that interfere with
the current test highlighted in the left window (Test with Reagent Priming).
ENABLED TESTS on the right side displays all the enabled tests in the system.
If an interfering test is executed before a test requiring reagent priming, the
reagent priming is executed before the first reagent dispensation.
The interference tests table is preset for IL-Predefined tests.

The Arrow and the Scissors icons at the bottom of the windows are used to add
or remove a test.
The steps to setup the interference tests table are as follows:

1. Select a test with Reagent Priming defined from the list in the left box.
2. Select the interfering tests that affect the highlighted test selected in step 1
from the Enabled test box.
3. Move the test selected in step 2 to the interfering test column using the
arrow. Use the scissors to delete a test from the center column.
At the bottom of this screen, clicking the Confirm button saves the changes;
clicking the Cancel button rejects the changes; in both cases the system goes
back to the Main screen.
Warning:
After performing any software library upgrades it is important to check the

interference table especially if you have custom tests defined. Custom tests that
interfere with an IL Locked tests (tests with reagent priming defined) will no
longer be linked in the interference table. You will need to re-enter the
interference.
Reagent Prime Defined Interfering Test Status after Upgrade
IL Locked Tests Custom Tests After upgrade – no link
Custom Tests IL Locked Tests After upgrade – still linked

Setup and Utility
4.1.5 Setup - TESTS - Default Tests

The default tests are programmed on sample IDs without a test request from the
internal database or the Host.
If default test is enabled, a sample ID with no tests requested (status of N) will
get the test default automatically programmed. If the tests are included in the
selected Multi-Tests or Single Tests session they will be processed.
The list on the left shows all enabled tests. The list on the right shows the tests
selected as default.
The Arrow and the Scissors icons at the bottom of the windows are used to add
or remove a test.
Select the tests to be added to the Default Tests list from the box on the left
(Enabled Tests) and press the Arrow key. The selected tests will move to the
Default tests box.
The default tests can be disabled/enabled using the Enable Default Tests
checkbox.
Note: Default tests are added to a sample after checking the database and
performing a host query. If neither of these checks result in tests being
programmed on a sample, then the default tests will be added. Default tests will
not be added to a previously run sample with completed results. The default tests
will not be run if they are not included in the current single test or multi-test
session selected.

4.1.6 Setup - TESTS - Reflex Tests

The Reflex Tests allow the user to program and/or execute a test generated by a
condition of the master test. Reflex logics are applied one time on each sample.
Additional logic checking is not performed on results that originated on test
orders from reflex test rules
Up to 60 rules can be defined. A rule is composed of 1 to 3 conditions. A
condition may be either numeric result based (on a specific unit) or dependent
upon errors that occurred on the master test (i.e. error 6, error 7, error 12, etc.).
Each rule can program and/or execute automatically up to 10 tests.
Clicking the Details icon when the cursor is on a specific rule displays all the
conditions and tests. All of these can be modified.
Moving the cursor using the up and down arrows, then clicking the
Enable/Disable button will select or deselect each single rule. When a rule is
enabled a check mark appears close to the rule number. If a rule is checked it
will be applied (see System Configuration for general Reflex Rules activation in
section 4.1.20).

Setup and Utility
Clicking the Delete icon deletes the rule.

Clicking the Print icon prints all the reflex rules.
To insert a rule, use the Insert Icon.
Clicking the Detail icon, the Reflex Rules Details window appears.
The Details icon allows viewing /editing of the conditions for the current reflex
rule.
The upper window allows the insertion of the rule condition by pressing the
Insert Icon.

The Reflex Rule Conditions window appears.
The test generating the reflex test can be chosen from the Test ID List.
For the numeric results class use the appropriate Unit field to select which unit
should be checked by the rule.
Two classes of conditions are available: value, based on numeric results; error-
based on the error that occurred.
For the numeric results, the unit can be selected according to the test and the
units defined in the specific test setup.
Then select the Comparison in terms of >; =; < for the value entered above.
In the Value field, after checking the value check box, enter in the numerical
value for comparison. Press the green check to confirm and save the condition.
The second class includes the result error (data reduction errors), e.g. error 6, error
7, error 12, etc. Most errors are based upon the measured unit; therefore this unit
should be used when defining the logics. See the Troubleshooting section 6 for
additional information on each specific error.
For the error conditions, it is possible to group multiple errors (up to 5) in a single
rule by using the Select icon.
Move the cursor on the error to be selected, and then press the Select button; a
check mark appears close to the selected errors. Press the green check to
confirm and save the condition.

Setup and Utility
Multiple conditions are checked using the “AND / OR” qualifiers.

Up to 3 conditions can be linked to the same rule using the AND/OR option.
If the AND option is selected, both selected conditions must be fulfilled to
generate the reflex test(s).
If the OR condition is selected, only one of the conditions must be fulfilled to
generate the reflex test(s).
The lower part of the Reflex Rules Details screen allows the reflex tests to be
selected by using the Arrow and Scissors icons.
Rules and conditions can be reviewed or deleted by pressing the details or the
delete icons.
The Print icon prints all the relevant information for all rules and conditions stored.
Below are listed some possible examples of reflex rules. These rules do not
represent any particular clinical aspects but only possible selective examples.
Each customer should define his own reflex rules. For the reflex rules execution
please refer to the System Configuration section.
Reflex Rules examples
• PT > 50 seconds then PT-e

• PT (sec) = error 6 then PT-e
• PT (sec) = error 7 then PT-e
• APTT > 110 seconds then APTT-e

• APTT (sec) = error 6 then APTT-e
• APTT (sec) = error 7 then APTT-e
• Fib-C > 600 mg/dL (or g/L) Fib-C H

• Fib-C < 100 mg/dL (or g/L) Fib-C l
• D-Dimer > 1050 ng/mL D-D h
• VWF > 150 % VWF h
Note: Only one level of reflex logic checks is applied to each sample. No
additional reflex logic checks are applied to the results of tests that were added
to a sample from the first level of reflex logic checking.
The following table lists the reaction curve error codes along with the unit
that should be used when defining a reflex logic for that error.

Error Definition Cause Reflex unit

Code
5 Optical ADC Saturation Measured
Failure
6 Not Coag First threshold not passed Measured
7 Coag Error Second threshold not passed Measured
8 Coag Error Delta time between thresholds is Measured
greater than the selected value
9 Coag Error Initial slope of the reaction curve is Measured
higher than the selected value
10 Coag Error Final Slope of the reaction curve is Measured
higher than the selected value
11 Final Delta Final delta of the reaction is higher Measured
Error than the selected value
12 Coag Error Maximum peak of the first derivative Measured
is below the selected limit value
13 Coag Error Maximum peak of the second Measured
derivative is below the selected limit
value
14,30 Offset Error Offset value is outside limits Measured
31 Curve Delta of reaction curve does not meet Measured
Delta Error limit specified for test
32 Noisy Erratic reaction readings Measured
Baseline
33 Noisy Erratic reaction readings Measured
Reaction
45 & Mean not One of the two test results is not valid Reported
46 Calculated (non numeric result)
4.1.7 Setup – Multi-Tests - Profiles

This area of the software allows users to define and view their own choice of
Multi-Tests (Profiles or Test Group Profiles). Multi-Tests Profiles are composed
of single tests and Test Group Profiles are composed of test groups. Refer to
section 4.1.10 for details on setting up Multi-Tests - Tests Group Profiles.
Up to 30 Multi-Tests profiles can be created (code numbers from 1 to 99). The

same number cannot be used for a multi-tests profile and a test group profile.
A multi-tests profile can contain a maximum of 20 tests. A test group profile can
contain a maximum of 20 test groups.
Selecting Multi-tests and Profiles from the Setup submenu and then choosing
View/Define opens the Profiles View screen shown below.
The order in which the tests are entered in the Profile is one of the major
determinants of the analysis sequence of the tests when the profile is selected.

Setup and Utility
The window on the left side of the screen displays a list of Profiles defined, while
the window in the middle displays the individual tests in the Profile highlighted on
the left.
Each Profile is assigned a numeric code (profile code: 1-99), and for each there
is an associated NOTE field. Notes can only be viewed on this screen.
The information shown for these fields can be viewed but not edited from this
screen. Several buttons are found near these fields:
Clicking the Details icon opens the Profiles Details screen, which allows editing
of the fields (refer to the specific section below).
Clicking the Delete icon, followed by a confirmation window Do you want to
delete the current profile? Yes allows the operator to delete the selected profile;
Clicking the Print icon, followed by a confirmation window Do you really want to
print the current profile? Yes prints the selected profile setup; No will cancel the
operation.
Clicking the New Profile button allows the operator to access the New Profile
screen (refer to the specific section below).

The Profiles Details screen:
As mentioned above, any changes to be made to the fields shown in the Profiles
View screen are done through the Profiles Details screen, which opens by
clicking the Details icon.
NOTE: If the user wishes to define a NEW profile, clicking the New Profile
button will open the New Profile screen, which has blank fields to be filled in (see
below). Since the purpose of the New Profile and the Profiles Details screens is
very similar, they have an identical design. When the fields are completed in the
New Profile screen, it becomes a Profiles Details screen.
Two fields in the top part of the screen display the Profile ID and the assigned
Profile Code. Two windows are located below: the window on the left displays all
Enabled Tests and the one on the right contains the tests that make up the
selected profile. Tests that use an in cup dilution or in-session calibration cannot
be placed in a multi-tests profile
The user defines the tests in the profile with the help of the Arrow and the
Scissors icons to add and delete the tests from the enabled tests window to the
tests in profile window. The NOTE field at the far right is open for the user to add
desired comments (free text).
The materials map is automatically created as soon as the tests are inserted
according to the default position of the Setup liquids. If a reagent’s default

Setup and Utility
position for a profile’s material map is already occupied by another reagent, the
next available “like” position is then automatically assigned. If all the positions in
a homogeneous area R1 to R4, R9 to R12 (ACL Elite Pro only), R7 to R8, A1 to
A10 and R5 to R6, are filled, the liquid cannot be placed and a message warns
the user that the test cannot be added to the profile
The large window in the bottom of the screen reports the information currently
stored for this profile in the Materials Map:
- Liquid ID: the name of the materials used to analyze the selected profile
- Position: the selected position (A1…A10 or R1…R12) for the specific liquid
material
- Refrigerated: a check indicates that the selected liquid material must be
kept at 15°C, positions R1 to R4, R9 to R12 (ACL Elite Pro only)
- Stirred: a check indicates that the selected liquid material must be stirred by
the magnetic stir bar (positions R1 to R4)
- Needle: indicates which needle (sample or reagent) dispenses the selected
material.
rejects the changes; in both cases the system goes back to the Profiles View
screen.
The Globe icon allows modification of the profile names in the selected
language.


4.1.8 Setup – Multi-Tests – Test Groups

The Test Group is a combination of tests using the same wavelength, optical
reference and same acquisition cycle.
Test Groups are predefined by IL. A User can create a new test group when
they are logged in at the Lab Manager security level.
Selecting Multi-Tests from the Setup submenu, and then choosing Test Groups
opens the Test Groups screen, shown below.
The window on the left side of the screen displays a list of the current groups of
tests, “Test Groups ID”, while the window on the right side displays the individual
tests in the highlighted Group.
Each Test Group is assigned a numeric code, and on the right there is space to
enter a NOTE for each. Notes can be viewed but not defined on this screen.
Several buttons are located around these windows:
Clicking the Details icon allows the operator access to the Test Group Details
screen (refer to the specific section below).
print Test Group? Yes prints the test group setup; No will cancel the operation.

Setup and Utility
Clicking the Confirm button saves the changes and the system goes back to the
Main screen.
The Test Group Details screen:
Clicking the Details icon in the Group Tests screen opens the Test Group Details
screen shown below.
The test group ID and code are displayed in the upper part of this screen; on the
right there is space for the user to enter notes.
The larger window on the left of the screen is used to describe the sequence of
operations for each of the tests included in the specific test group, while the
smaller window on the right lists the tests enabled.
Clicking the Materials Map button opens the Tests Materials Map screen. This
screen is used to check the number and the characteristics of the positions
where the reagents for these tests are located (refrigerated or not; mixed or not;
use of sample or reagent needle). Note: the setup of the liquid materials is
described in Section 4.1.13.
Clicking the Material Check button, displays the actions to be taken by the
instrument when a low liquid level is detected. The actions can only be changed
after a test group is initially saved.
Clicking the Confirm button saves the changes and the system goes back to the
Test Group Details screen.

Creating a New Test Group
The user can create test groups when they are logged in at the Lab Manager
level. When creating a new group there are several items that need to be
considered for tests to be compatible in the group.
- The test group must have a minimum of one test

- The tests must utilize the same wavelength
- The tests must have similar Acquisition Setup settings. The actual
acquisition time does not have to be the same, however the mixing, ramp
and inter-ramp settings must be the same.
- The time to pipette the second test in the group must be less than the
incubation time for the first test.
- The test group can have one RP (Reagent Prime) and this occurs as the
first aspiration in the group.
- The test group can have one CL (Clean) cycle at the end of the group
- The group can only have one Optical Reference and or Reference step.
- The material check screen can only be modified after a test group is saved.

Setup and Utility
Clicking the New Test Group button will opens a blank Test Group detail screen.
- The Enable Max Samples Value box allows you to limit the number of
samples that can be processed when using this group. For the IL locked
tests this field can be edited at the Service security level.
- The list of available tests is displayed in the Enabled Tests box. Highlight
the desired test and move the test into the group using the arrow icon.
Repeat the step for all desired tests in the group. You will notice that the
second and all subsequent tests that are added into the group are placed
below the previous ones.
- Once all of the tests are placed into the group you then need to modify the
sequence of the pipetting steps. When you are doing this you need to
consider items such as grouping similar operations or moving pipetting
steps so they occur during incubations.
- The next thing you need to consider is the incubation time clocks. For
steps with a “set timer” time constraint you need to have a “wait until timer
expires” to follow it. If you have two simultaneous steps with “set timer” the
system will respect the time for the first step when it encounters the “ wait
until timer expires”. In this case the second timer is ignored if both tests are
run.
- Excessive optical reference steps must be deleted. The group only requires
one.
Test Group ID: Enter an ID name for the group (8 alphanumeric characters)
Test Group Code: Enter a unique numeric value between 501 – 999.
Double Samples: A check in this box will initiate all testing to be performed in
duplicate for this group.
Notes: This field can be used for free text comments about the test group.
Materials Map: Displays the material map for the group
Assign Step No.: Pressing this button displays a window that allows you to
change the step number for the current step highlighted.
Add Step: This button opens the window that allows you to program a new step
for the group.
Refer to the Setup Tests Definition for details on filling in this screen
Clicking the Confirm button saves the changes.

Setup and Utility
The following table contains a list of IL locked Test Groups and the tests
contained within it.
Test Group Name Tests within Test Group

PT SP APTT SP, FIB(g/L), PT
PT_ SP APTT SP,FIB_(mg/dL), PT
HS LYOTT APTT LY, FIBHS(g/L), PTHS, TT-8
HS_LYOTT APTT Ly, FIB HS_(mg/dL), PT HS, TT-8
HS LYO APTT Ly, FIBHS(g/L), PTHS
HS_ LYO APTT Ly, FIB HS_(mg/dL), PTHS
HS+ LYO APTT Ly, FIB HS+(g/L), PT HS+
HS+_ LYO APTT Ly, FIB HS+_(mg/dL), PT HS+
HS+ SP APTT SP, FIB HS+(g/L), PT HS+
HS+_ SP APTT SP, FIB HS+_(mg/dL), PT HS+
RPT SYS APTTSYS, R-FIB(g/L), R-PT
RPT_ SYS APTTSYS, R-FIB _(mg/dL), R-PT
ATDD FIB AT* , DD, DDh, FIB-C(g/L)
ATDDFIB_ AT* ,DD, DDh, FIB-C_(mg/dL)
HS SP APTT SP, FIBHS(g/L), PTHS
HS_ SP APTT SP, FIB HS_(mg/dL), PT HS
4.1.9 Setup – Multi-Tests – Test Group Profiles
This area of the software allows users to define and view their own choice of Test
Groups to be run in Multi-Tests analytical sessions.
Up to 30 Multi-Tests profiles can be created (code numbers from 1 to 99).

Each profile can contain a maximum of 20 tests combinations each. The actual
maximum number of tests you will be able to add will depend on the available
reagent positions.
Selecting Multi-tests and Test Group Profiles from the Setup submenu and
then choosing New Test Group Profile opens the screen shown below.

The window on the left side of the screen displays a list of Test Groups defined,
while the window in the middle displays the tests groups in the current Profile.
Each Profile is assigned a Profile ID (8 alphanumeric characters max.), numeric
code (profile code: 1-99), and for each there is an associated NOTE field.
The user defines the tests groups in the profile with the help of the Arrow and
the Scissors icons to add and delete the groups from the left window to the right
window. The NOTE field at the far right is open for the user to add desired
comments (free text).
The materials map is automatically created as soon as the test group is inserted
according to the default position of the Setup liquids. If the default position for a
reagent is already occupied by another reagent, the next available “like” position
is then automatically assigned. If all the positions in a homogeneous area R1 to
R4, R9 to R12 (ACL Elite Pro only), R7 to R8, A1 to A10 and R5 to R6, are filled,
the liquid cannot be placed and a message warns the user that the tests group
cannot be added to the profile
The large window in the bottom of the screen reports the information for this
profile’s Materials Map:
- Liquid ID: the name of the materials used to analyze the selected profile
- Position: the selected position (A1…A10 or R1…R12) for the specific liquid
material
Setup and Utility
- Refrigerated: a check indicates that the selected liquid material must be

kept at 15°C, positions R1 to R4, R9 to R12 (ACL Elite Pro only)
- Stirred: a check indicates that the selected liquid material must be stirred by
the magnetic stir bar (positions R1 to R4)
- Needle: indicates which needle (sample or reagent) dispenses the selected
material.
rejects the changes; in both cases the system goes back to the Profiles View
screen.
The Globe icon allows modification of the profile names in the selected
language.
The Test Group Profiles Details screen:

As mentioned above, any changes to be made to the fields shown in the Profiles
View screen are done through the Profiles Details screen, which opens by
clicking the Details button.
NOTE: Since the purpose of the New Profile and the Profiles Details screens is
very similar, they have an identical design. When the fields are completed in the
New Profile screen, it becomes a Profiles Details screen.

Clicking the Delete icon, followed by a confirmation window Do you want to

delete the current profile? Yes allows the operator to delete the selected profile;
print the current profile? Yes prints the selected profile setup; No will cancel the
operation.

Setup and Utility
4.1.10 Setup – Multi-Tests - Sort Multi-Tests

This area of the software is used to sort the test profiles defined in the system.
Profiles, Test Groups and Test Group Profiles that are not on the sorted list will
not be visible as run modes under Analysis. The operator only needs to sort the
profiles, test groups and test group profiles they will run.
Selecting Multi-Tests – Sort Multi-Tests from the Setup submenu opens the
Sort Multi-Tests screen, shown below.
The 3-windows 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 in the Sorted
Profile list.
The window on the right part of the screen displays all Sorted Profiles.
The Arrow and Scissors icons are used to sort profiles and groups. As the
operator selects the first entry and presses the Arrow icons, the profile/group is
copied from one position to another of the sorted profiles list in the right side
window. If a mistake is made, the Scissors icon is used to remove the profile
from the sorted list. The profile is inserted below the cursor. Profiles that are not
sorted will not be visible on the Analysis menu drop down selection.
rejects the changes; in both cases the system goes back to the Main screen.



-
4.1.11 Setup – Default Multi-Tests

The Default Multi-Tests Profile selection determines the tests that may be run
and their associated material map setup when a user activates a run using the
“Runner” icon from the main database screen.
Selecting Multi-Tests from the Setup submenu, and then choosing Default
Multi-tests opens the Test Groups screen, shown below.
The box on the left lists all of the Multi-Tests Profiles and Test Group Profiles
created. Select the desired Default selection from the list and move it to the
column on the right using the Arrow. If you want to change the selected Default
Profile, use the scissor icon to remove.
To Enable the Default Multi-Tests place a check in the box. The desired tests to
run still need to be programmed on a sample even though the Default Multi-tests
are enabled.
4.1.12 Setup - LIQUIDS

This area of the software allows the user to define and view the setup for all the
liquid materials needed to run tests on the ACL Elite/Elite Pro. The system will
store 300 liquids of which 200 are reserved for IL use and 100 are available for
the operator to define.
Setup and Utility
Selecting Liquids from the Setup submenu opens the Liquid Setup screen:
A list of IL predefined liquids is already stored in the software.
This screen displays the characteristics of all the liquid materials currently
configured in the system.
- LIQUID ID: the short name of the liquid material. For Control liquids this ID
can be all numeric (1 to 10 characters). This is the control ID sent to the
Host if the analyzer is interfaced. All other liquids must be an alphanumeric
ID
- EXTENDED NAME: the complete name of the liquid material (Max. 15

alphanumeric characters)
- LOT No.: the lot number of the material
- EXPIRATION DATE: the expiration date as it is shown on the vial label. It is

possible to use the expiration date as a function of the Reagent Map
Warnings (see Reagent Map section 3.2.3).

- ON BOARD STABILITY: the stability as claimed in the insert sheet. It is

possible to use the on-board stability value for the real time stability timer as
a function of the Reagent Map Warnings (see Reagent Map section 3.2.3).
Enter number followed by h for hours and d for days.
- CURRENT VOLUME: quantity of liquid (in mL) remaining in the container
depending on the specific reagent used (non-editable from this screen)
- ASSIGNED VOLUME: quantity of liquid (in mL) present in a new container
before starting the analytical session (default volume as defined on the
product label)
- WARNING VOLUME: quantity of liquid (in mL) below which the material
map position and reagent map icon colors will change from green to orange.
This field should be filled in for all reagents to be monitored.
- LIQUID TYPE: calibrator, control, reagent, solution

This screen also displays a “Used By” table showing the tests for which each
material is used. In this table, the user may also record the ISI values. For the
Calibrators, the user may enter the assigned value for the standard as reported
in the product insert sheet.
ISI and Calibration Plasma assigned values can be inserted by clicking the
Assign Value button and entering the value using either the keyboard or the
numerical keypad. The default setting for all assignments is blanked out. The
user must enter the calibrator values and ISI value prior to running the analyzer.
The calibrator value for the PT test run in the laboratory should be set to 100.
The ISI value is found on the PT reagent insert sheet and is lot specific
Note: Whenever the ISI value is modified, all the results will use the new ISI
value to calculate the INR. The ISI value entered must fall within the specified
ISI range as defined in the Liquid details for the PT reagent.
Note: The optional external barcode reader setup allows the operator to
configure the system to automatically reset the onboard stability and/or assigned
volume whenever a vial label is read. Refer to section 4.1.16 for further details.
Note: For the IL locked PT tests the ISI value entered for the primary PT test is
automatically imported into the secondary tests (i.e. extended (e) and double (d)
tests). This option is also available for custom (non-IL locked) PT tests. Refer to
section 4.2.6 for further details.

Setup and Utility
ACL Elite/Elite Pro TECHNICAL BULLETIN IMPORTANT INR NOTICE
INR FORMULA
ISI
INR = (PT Patient / PT Normal)
PT PATIENT = Patient’s PT in seconds
PT NORMAL = Mean* of the Normal Range (on the ACL Elite/Elite Pro this is called the Reference Value)
ISI value = International Sensitivity Index from the current lot # of thromboplastin reagent being used.
To assure appropriate reporting of INR results, you must follow these steps:
1. Make sure instrument is in the READY mode. From the SET UP MENU select the LIQUIDS SUBMENU,
then select the appropriate THROMBOPLASTIN REAGENT (LIQUID ID) from the list in the left upper part
of the screen.
2. Select the PT TEST that uses this Thromboplastin reagent and click on ASSIGN VALUE.
3. Enter the ISI VALUE of the Thromboplastin Lot in use and select Confirm twice to enter value. Make sure
that all PT tests using the same Thromboplastin import the proper ISI assignment. Several PT TESTS using
the same Thromboplastin may be present such as PT extended, PT duplicate standard and PT duplicate
extended acquisition time. These tests will import the value from the standard test.
NOTE: The ISI value is specific for the lot number of prothrombin time reagent being used.
4. From the SET UP MENU select TESTS VIEW/DEFINE. Select the appropriate PT test and click on details.
5. Select CALCULATION SETUP and the instrument will show in the right part of the screen the selection of
the REFERENCE VALUE. This represents the Mean of Normal Population value in SECONDS, which is
used as the DENOMINATOR in the RATIO and INR CALCULATION.
6. Make sure that the value entered in this field represents the MEAN NORMAL POPULATION RANGE of the
local PT population. This value is editable and can be modified to reflect the laboratory established mean
normal range.
7. Confirm all PT Tests using the very same thromboplastin lot for Ratio/INR will be calculated using the same
value in seconds as the denominator (Mean Normal Population Range).
8. The instrument uses the following formula for RATIO CALCULATION.
RATIO CALCULATION = PATIENT PLASMA (seconds)

REFERENCE VALUE (seconds)
Reference Value means MEAN OF NORMAL POPULATION (seconds).

MEAN OF THE NORMAL POPULATION RANGE = Mean Normal PT Time = Mean of Patient Normal
Range in seconds as recommended in the CLSI Document C28-A, Vol. 15, No.4.
9. The INR will then be calculated as follows:
ISI
INR = (PT Patient/PT of Reference Value)
Using the Reference Value feature the denominator used in the Ratio and INR calculation will
accurately reflect the Mean of Normal Population Range.
*or Geometric mean
IMPORTANT WARNINGS:
• If the INR calculation is not properly setup, then erroneous patient results may be reported.
• If the product lot number changes, then the new ISI value from the package insert must be entered.
• In the ACL Elite/Elite Pro both screen and printout show/report Ratio and INR units separately

Note: Whenever the Calibration Plasma target values are modified, the stored
calibrations for the tests are automatically updated and all future results will be
calculated according to the new assigned value.
A “Notes” field is available for the user to enter comments (free text).
Clicking the Details icon opens the Liquid Details screen that provides further
details about the selected material (refer to specific details below).
Clicking the New Liquid button opens the New Liquid screen for the user to
enter the characteristics of a new material (refer to specific details below).
Clicking the Confirm button saves the changes made and clicking the Cancel
button rejects the changes.
Clicking the Print icon and confirming the selection the liquid report is printed.
Clicking the Show Enabled checkbox, the list of liquids on the left will be
reduced to only display the liquids used by the enabled tests.
If the Show Enabled box is checked, QC liquids will not be visible on the list. To
view the QC liquids remove the check in the box.
A warning window opens after a change is made in any field: Liquid parameters
have been changed. Do you want to save them before proceeding? The operator
must select Cancel, Yes or No.
o Cancel: The window is closed; the new value entered is
displayed, but not yet saved.
o Yes: The window is closed and the changes are saved
o No: The window is closed, the changes entered are deleted
and the previous saved value is displayed


Setup and Utility
Liquid Details screen:

Clicking the Details button in the Liquid Setup screen opens the Liquid Details
screen. This allows access to further information about a selected liquid material:
The information in this screen can be viewed but not edited. The only exception
is the Default Position for the IL liquids only. The information provided in this
screen is:
- Liquid ID (maximum 10 alphanumeric character ID)
- Liquid Code (valid numbers for user defined liquid is 501 – 999)
- LIQUID TYPE (calibrator, control, reagent, solution)
- EXTENDED NAME (maximum 15 alphanumeric character name)
- DEFAULT POSITION (Must coincide with following 3 selections)
- ACCESSING NEEDLE
- Sample: Valid for positions A1 – A10 and R 7, 8
- Reagent: Valid for positions R1 – R6 and R9 – R12
- REFRIGERATED (checkbox)- Liquid must use Reagent needle and be
placed in R1-R4 or R9-R12 (ACL Elite Pro only)
- STIRRED (checkbox) – Liquid must use Reagent needle and be placed in
Positions R1- R4
- ISI Minimum and Maximum acceptable values for a Reagent
- IL LIQUID (available for IL use only)
rejects the changes.

New Liquid screen

Clicking the New Liquid button in the Liquid Setup screen opens the New Liquid
screen. This is the screen where the operator enters all information pertaining to
a new liquid material to be used on the ACL system, which will be displayed in
other screens.
The following fields are “open” for the operator to enter the desired alphanumeric
digits (fields with the * are mandatory):
- LIQUID ID*: the abbreviated name of the material (10 characters). For
Control liquids only, this ID can be all numeric.
- EXTENDED NAME*: the complete name of the material (15 alphanumeric
characters)
- LIQUID CODE*: the numeric code of the material (IL codes are reserved
from 1 to 500; user codes are from 501 to 999)
- LOT No.: the lot number of the material (8 characters).
- EXPIRATION DATE: the expiration date as it is shown on the vial label. The
system will monitor this date and alert the operator in the session error
history screen when the liquid date has expired.
- ASSIGNED VOLUME*: quantity of liquid (in mL) present in a new container
before starting the analytical session (default volume as declared on the
product label)

Setup and Utility
- WARNING VOLUME: quantity of liquid (mL) below which the material map
position and the reagent map icon colors will be changed from green to
orange This field should be filled in for all reagents to be monitored.
- ON BOARD STABILITY: the stability as it is claimed in the insert sheet.
Time can be entered using the following abbreviations: h=hours and d=days
(i.e. 24h or 1d).
- ISI Value Minimum: If this liquid is defined as a Reagent the minimum
acceptable ISI value for the reagent can be entered.
- ISI Value Maximum: If this liquid is defined as a Reagent the maximum
acceptable ISI value for the reagent can be entered
In the following fields the operator must make a choice among the given options:
- ACCESSING NEEDLE*: Sample, (external needle) can only aspirate from
A1 to A10 and R7 and R8. The Reagent,(internal needle) can only aspirate
from R1 to R6 and from R9 to R12 (ACL Elite Pro only)
- DEFAULT POSITION*: A1 to A10 or R1 to R8 or (R9 to R12 on the ACL
Elite Pro only). Default position can be modified also for IL liquids,
maintaining liquid requirement characteristics (refrigeration, stirring, needle,
etc.)
- LIQUID TYPE*: Calibrator, Reagent, Control, or Solution
In the following two areas the operator must “check” the checkbox if the liquid
requires the feature onboard (check = YES):
- REFRIGERATED (must use Reagent needle and positions R1 - R4 and R9
– R12)
- MIXED (must use Reagent needle and positions R1 – R4)
- IL LIQUID (dimmed)
Since only the first four positions of the Reagent Area (R1…R4) can be
refrigerated and mixed (on the ACL Elite Pro additional refrigerated only positions
are located in the area from R9 to R12), a warning window appears if the
operator tries to define an improper setup (i.e. a liquid is placed in position R5
and the operator checks the “Refrigerated” check box).
The warning reads:

“Invalid Liquid Setup. The specific liquid setup is invalid and cannot be stored.
Please correct setup before saving “
If the liquid material is an “IL predefined liquid”, another checkbox is

automatically checked; this checkbox cannot be edited, meaning that a “User
Liquid” cannot be identified as an “IL Liquid”.

rejects the changes; in both cases the system goes back to the Liquid Setup
screen.
Clicking the Globe icon allows the user to modify the liquid ID and name in the
selected language.


Setup and Utility
4.1.13 Setup - INTERFACES - Host

This area of the software allows the user to define some characteristics of the
communication between the ACL Elite/Elite Pro and the Host Computer to which
it is interfaced.
Selecting Interfaces from the Setup submenu and selecting Host opens the
Host Setup screen shown below.
Two fields in this screen allow the operator to define:

- BAUD RATE – Choices are: 2400, 4800, 9600, 19200 or 38400.
- AUTOMATIC DATA TRANSMISSION (TX) – Choices are: “Not Required”,
“Patient Samples” or “QC, AR and Patient Samples”.”
Selecting automatic data transmission, the transmission of results is done at the
end of each test run during the analytical session.
Other buttons in the screen are “checked” by the operator if the feature is desired
(check = YES):
- HOST QUERY
- DELETE AUTOMATICALLY AFTER TRANSMISSION (TX)
Selecting automatic deletion will not allow for re-transmission of results at a
later time.
- UNIQUE INSTRUMENT ID (a digit between 1 and 99 can be defined)

Tests downloaded from the LIS that are disabled in the analyzer will not be
displayed on the database.
reject the changes; in both cases the system goes back to the Main screen.

- Open/Close will open or close the rotor holder cover.
- Database View will display the Database View or Main Screen.
shutdown ACL? Yes will close the session, allowing the operator to log out
For additional information on the host communication refer to Appendix A (Host

Communication Protocol) located at the end of this manual. Refer to section 2.5
for details on the cable pin configuration.

Setup and Utility
4.1.14 Setup - INTERFACES - Printer

This area of the software allows the user to configure the ACL Elite/Elite Pro
optional external printer.
Selecting Interfaces from the Setup submenu and selecting Printer opens the
Printer Setup screen:
On the top part of the screen, the operator defines:
- PRINTED SAMPLES: Any tests just analyzed (regardless of sample status)

or just the Completed (sample status is complete)
- REPORT TYPE: Cumulative(multiple samples per page) or Sample Report
(Single Sample per page)
- PRINTER PROTOCOL: ESC/P2 (for Epson-like printers) or HP-PCL (for
HP-like printers)
- PAPER DIMENSION: A4 (210 x 297 mm.) or Letter (216 x 280 mm./ 8½ x

11 inches)
- PAPER FORMAT: Single sheet or Continuous sheet
A check in the Automatic Print-Out box indicates that this feature is desired.
Automatic Printout occurs at the end of each run within a rotor according to the
selected criteria (any analyzed, completed; cumulative or sample report).

The user defines the SAMPLE REPORT DATA area by pressing the
Enable/Disable button. Choices are: the Instrument Name, the Normal Ranges
and the Date/Time.
Clicking the Customize Header button allows further customization of the report
by providing 5 lines of 30 characters each of free text to the user as entered in
the Custom Header screen.
On both screens - Printer Setup and Custom Header Setup, clicking the Confirm
button saves the changes and clicking the Cancel button rejects the changes; in
both cases the system goes back to the Printer Setup screen.

Note: The ACL Elite/Elite Pro support the use of a Parallel or USB connection
for the external printer. If the USB connection is used the printer must be
connected and turned on prior to the system being booted up. If the printer is
turned off while the instrument is on, the analyzer must be rebooted in order for
printing to occur.

Setup and Utility
4.1.15 Setup - INTERFACES – Internal Barcode

This area of the software allows the user to configure the internal barcode reader
used for sample identification on the ACL Elite/Elite Pro system.
Selecting Interfaces from the Setup submenu and selecting Barcode opens the
Barcode Setup screen:
The first step is to activate the Internal Barcode Reader by checking the
checkbox Internal BCR enabled seen on top of the screen.
The four fields visible on the screen correspond to the four families of barcodes
that may be activated on the ACL along with their corresponding subtypes of
barcodes.
For each field, the user must choose one of the options according to the
laboratory’s needs, as shown below.
CODABAR: Disabled
No Checksum
AIM Mod 16
NW7 Mod 11
NW7 Mod 16
CODE 39: Disabled

No Checksum
Mod 43
INTERLEAVED 2 OF 5: Disabled
No Checksum
USS Mod 10
OPCC Mod 10
CODE 128: Disabled

No Checksum

Setup and Utility
4.1.16 Setup - INTERFACES –External Barcode (optional)
The external barcode reader is an option that allows the reagent vial barcodes to
be read when the material map is displayed. Click on the External BCR
Enabled button to enable the feature.
The Code 128 dropdown box provides two selections: Disabled, No Checksum
Reset Reagent Volume when Scanned: Checking this box will

automatically reset the reagent volume on the map to the default
volume defined for the liquid.
Reset Timer when Scanned: Checking this box will automatically

Set the onboard stability timer to the default value defined for the liquid.
If the pause timer is checked for a reagent, when the vial label is read it will
uncheck the pause button. If the vial is read a second time, at this point the timer
and volume will be reset
Onboard stabilities and default liquid volumes must be defined for the two options
listed above to be functional.
When the material map is displayed the external barcode reader is active.
The external barcode reader can be used to read the label on the reagents.
The position to place the vial onboard the system will blink. If the lot number
Expiration date are invalid a warning message will be displayed.
Notes:
- The barcode device has been tested in accordance with EN60825-1 LED
safety, and has been certified to be under the limits of a Class 1 LED
device.
- The scanner’s housing is not water-tight, therefore do not submerge the
scanner in water. The scanner housing and window should be cleaned with
a soft cloth or facial tissue dampened with water or a mild water based
detergent. Do not clean the scanner or window with alcohol or solvents.

4.1.17 Setup - INTERFACES - Keyboard

This area of the software allows the user to configure the ACL Elite/Elite Pro
standard keyboard for the language used in the laboratory and to decide on the
use of the on-screen pop-up numerical keypad.
Selecting Interfaces from the Setup submenu, and selecting Keyboard opens
the Keyboard Setup screen.
The window in this screen selects:
- KEYBOARD TYPE:
English (UK), French, German, Italian, Spanish or USA (English).
- NUMERICAL KEYPAD
Disabled, All numerical fields, or All numerical fields and Sample ID
reject the changes; in both cases the system goes back to the Keyboard Setup
screen.
4.1.18 Setup - INTERFACES - Network

Not supported in this Software Revision.

Setup and Utility
4.1.19 Setup - INTERFACES - Modem

Not supported in this Software Revision.
4.1.20 Setup - SYSTEM CONFIGURATION

This area of the software allows the user to configure some of the system
features of the ACL Elite/Elite Pro.
Selecting System Configuration from the Setup submenu opens the System
Configuration screen:
This screen allows the user to select the preferred options for the following:
PATIENT DATABASE LISTING: defines the order of the patient samples in the
database; 4 options are available.
1. Last sample entered is at the top
2. Last entered is at the end
3. Sample ID order Ascending

4. Sample ID order Descending
Options 1 and 2 are based upon date/time of sample entry and options 3 and 4
are based upon the Sample ID alphanumeric sort.
QC/AR DATABASE LISTING: defines the order of the QC materials in the
database: last material entered is at the top or last entered is at the end.
REFLEX STATUS: if rules are defined in the Setup/Tests/Reflex Tests, three

options are available: Program Reflex only, Execute reflex before closing
session, Disabled. For additional information please refer to section 4.1.7.

s Program Reflex only: add the tests to the sample ID but do not execute the
analysis. Test will remain pending until executed in a subsequent session.
s Execute reflex before closing session: program tests and execute them
during the current session provided the tests are defined within the current
profile session in use.
s Disabled: turn off ALL reflex programming and testing.
CURRENT LANGUAGE: English, French, German, Italian, Spanish or Japanese
(Kanji). Reboot the analyzer after changing the language setup. Entries in the
logbook, File Error and Session Error history are not updated for entries prior to
the language change date and time.
DEFAULT SCREEN: When the system boots up you can select from the
following two screens as the initial screen: Database View or Multi-Tests Pre-
Analysis (pre-analysis of last multi-test session is displayed).
LIQUID SENSOR checkbox: enable/disable the use of the sample and reagent
probe liquid level sensor.
Wash-R emulsion sensor checkbox: enable/disable the use of this sensor.
Warning: If Liquid Sensors and Wash-R Sensor are disabled both a warning
message and a flag on all sample results will be presented. If the Liquid Sensor
is disabled the operator must carefully monitor the volume of liquids and samples
to ensure adequate amounts are present for testing. The automatic host
transmission of results is disabled when the sensors are disabled. At the end of
each session a pop up box will alert the operator to confirm sufficient
sample/reagent remains onboard the analyzer. After confirmation of the
volumes, the operator may initiate a manual upload of the results to the host.
When the sensor is re-enabled the host communication will automatically be re-
activated.
REM Enabled: enable/disable the use of the Rotor Exchange Module. Not
applicable for the ACL Elite. When the REM is disabled the
operator can use the system by manually loading the rotors.


Setup and Utility
4.1.21 Setup – SECURITY
This area of the software allows the Laboratory Manager to configure the
privilege level for the users (Supervisor or Operator) and define IDs and
passwords for all personnel using the ACL Elite/Elite Pro system.
Up to 99 users can be defined in the Security area.
The first operation to be performed by the Laboratory Manager is the definition of

the level of entry for the other two user groups.
The Laboratory Manager, using their password, will have access to the Lab
Manager View button.
Note: It is advisable upon installation of the system to enter a new Lab Manager
ID and password.
Clicking on the Lab Manager View button a screen where both Supervisor and
Operator access definition will appear.

In this screen, for each menu/submenu, the level of entry can be defined by the
Laboratory Manager according to the specific laboratory needs.
LEVEL: From the drop down menu select the level to define: Supervisor, or
Operator
Note: The Lab Manager must define the screen access levels at both the
Supervisor and Operator. Defining no access at the supervisor level for a
submenu does not automatically exclude access at the operator level.
For each menu/submenu the Laboratory Manager has three basic options:
s No Access
s Access, View* only
s Access, Edit*
*The V and E listed under the Environment column stand for View and Edit
No Access means that it will not be possible to enter in a menu or submenu; the
option will be dimmed.
Access-View Only means that access is possible. The screens can be viewed
but no modification can be performed.
Access-Edit means that the access is possible and Edit capability is available
(depending on the type of screen).

Setup and Utility
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 Edit capability for the selected menu/submenu.

When a new user has to be entered in the system the New User button has to be
chosen from the main Security entry screen.
The next screen will appear.

Setup and Utility
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 3 and maximum 15 characters) as it will be used to log in
to the system.
EXTENDED USER NAME: type the extended user name to differentiate between
users. (Maximum 20 characters)
LEVEL: the Laboratory Manager will define for each user the entry level:
s Lab Manager
s Supervisor
s Operator
PASSWORD: the new user will enter his password.
CONFIRM PASSWORD: re-enter the same password for confirmation.
Password has to be minimum 3 and maximum of 9 characters.
When logging onto the system User Name and Password will be required.
It is recommended that when the system is not in use to log-out (using the key
icon) requiring the next user to log-in.
When using the Security/Password system, all-important operations are logged
into the Logbook (see section 5 Diagnostic).

4.1.22 Setup – Audible Alarms

The audible alarms setup screen allows for labs to enable/disable the alarm
sounding for various system conditions.
Selecting Audible Alarms from the Setup menu opens the following screen:
3 Alarm sounds are pre-set by the Analyzer, referred to as: A, B, C.

The audible alarms can be enabled/disabled for the following conditions:
- END OF ANALYTICAL SESSION (Alarm A)

- HOLD STATUS (Alarm B): This condition occurs during a stat interrupt
when the current test in process is complete
- FAILURE STATUS (Alarm C): System error condition encountered
- INSUFFICIENT REAGENT (Alarm B): Reagent Shortage during the
analytical session
- INSUFFICIENT WASH-REFERENCE EMULSION (Alarm B): Wash-
Reference bottle is empty
- QC OUTSIDE SD RANGE (Alarm B): Alert when a QC failure occurs on the
system
- MISSING MATERIAL/CALIBRATION BEFORE ANALYSIS STARTS (Alarm
B): Missing material observed during pre-analytical check
- MISSING MATERIAL/MISSING SAMPLES (Alarm B): Missing material or
samples observed during pre-analytical check
- ROTOR RE-USE (Alarm B): Physical cuvette map for the rotor does not
match the logical map, operator must enter/confirm cuvette positions
Move the cursor to the desired Audible Alarm Condition and press the DeSelect
button to enable/disable the alarm for this condition.
If the alarm is enabled it will sound at a 60 second interval for up to one hour.

Setup and Utility
4.1.23 Setup - DATE/TIME

This area of the software allows the user to configure the format of the Date and
to set the current Date and Time for use on all appropriate screens and printouts
of the ACL Elite/Elite Pro system.
Selecting Date/Time from the Setup submenu opens the Date and Time screen:
DATE FORMAT: in this field the user chooses among the following options:
dd.mm.yyyy (European style)

yyyy.mm.dd (Japanese style)
mm.dd.yyyy (US style)
In order to set date and time, two numeric fields are available.
reject the changes.
ACTIVE BUTTONS at the bottom of this screen are:
Warning: Changing date to a prior date may impact the result (Patient, QC,
Calibration & AR) database FIFO operation. Results processed on dates furthest
from the current system date will be the first ones to be automatically deleted.

4.1.24 Setup - UNITS

This area of the software allows the user to configure the units used for
temperature on the ACL Elite/Elite Pro system.
Selecting Units from the Setup submenu opens the Units screen:
The TEMPERATURE UNIT field has the following options: °C or °F.

rejects the changes; in both cases the system goes back to the Main Screen.

Setup and Utility
4.2 Setup - TESTS - Define

This area of the software is used to view and define tests.
Warning: After defining a new or copied test, the test settings should be printed
and verified to confirm correct entry. IL assumes no responsibility for the
performance of non-IL locked tests on the analyzer. Each laboratory must verify
and confirm the validity and results of the user defined tests definitions.
Selecting Tests from the Setup submenu and then choosing View/Define opens
the View Tests screen:
On top of the test list a rectangular box will show the number of tests present in
the Library Application. The box will show two numbers: the enabled tests and
the total number of tests.
The large window on the left of the screen displays a table of all configured tests.
Each test is identified by an abbreviated name, Test ID, shown on the right side
column. Both columns to the left of the test names contain checks to indicate
whether each test is:
- currently Enabled and ready to be run on the ACL

- an IL pre-defined Locked test.

Warning: IL pre-defined tests were developed and tested specifically for

use with HemosIL reagents and IL supported supplies for use
on the ACL™ Elite/Elite Pro.
The proper performance of other reagents and supplies has not
been fully tested or verified, and the use of them may cause
clinically significant degradation of performance and results.
IL does not assume any obligation or warranty engagement
concerning precision and/or accuracy of the measurements or
for any damage to the instrument directly or indirectly resulting
from the use of reagents, consumables (new or washed), and
expendable supplies other than those sold by IL.
All responsibility for parameter development and validation
of new or copied tests belongs to the user alone.
The right side of the screen contains the following fields:

TEST CODE
TEST REVISION
TEST CODE FOR HOST
EXTENDED NAME
CALIBRATION MODE
The information shown in these fields can be viewed but not edited from this
screen. Several buttons are found around these fields:
Clicking the Details icon opens the Test Details screen which allows editing of
the fields (refer to the specific section below).
Clicking the Printer icon followed by a confirmation window “Do you really want
to print?” Yes allows the operator the choice to print the Test Setup of the
selected test; No will cancel the operation.
Clicking the Enable/Disable button followed by a confirmation window Yes/No,
erases all information related to the selected test from the Patient Database and
the QC Database. If the test is disabled, clicking the Enable/Disable button will
enable it.
The test database can contain up to 300 tests; 200 reserved for IL applications
and 100 reserved for customized applications; up to 100 tests can be enabled
(active) at the same time.

Setup and Utility
Clicking the Show Enabled check box allows the operator to view only the
enabled tests from the test table. When this checkbox is marked the list
presented is relative to the enabled tests. This information is saved exiting from
this screen and also at power off.
Clicking Delete erases only the open tests (customized); IL predefined tests
cannot be deleted.
4.2.1 COPY TEST

Clicking the Copy Test button opens the Copy Test screen.
The upper field indicates the “Test to be Copied” ; the list contains all the tests
present in the test database.
The NEW TEST ID field allows the operator to name the new test (8 characters
maximum). This is a mandatory field.
The EXTENDED NAME field allows the operator to name the new test with a
more detailed name (15 characters maximum).
The TEST CODE FOR HOST represents the numeric code for the Host
communication (four characters maximum).
The TEST CODE is a unique numeric field (four characters maximum). This is a
mandatory field. The acceptable test code range for Non-IL locked tests is
between 501 and 999..

The TEST REVISION helps the operator to keep track of the changes in the
application. The number must be keyed in manually (4 characters maximum).
The Confirm/Cancel button saves or rejects the changes and the system returns
to the View Test screen.
4.2.2 Setup – TESTS DETAILS
The Test Details screen is shown below. For new tests the fields will be blank,
while those for copied tests will contain the settings from the original test that was
copied.
In the new test details the following information is accessible.

• TEST ID – 8 characters
This field is editable for all tests including the IL predefined
tests. The TEST ID must be unique for each test. The TEST
ID is used for ordering tests as well as reviewing results
(i.e. TEST ID column).
The TEST ID is printed in the cumulative report.
At least one alpha-numeric character is mandatory.
• TEST CODE - 3 characters
This field is editable in an open test but not in the IL locked tests.
Available numbers for the open assays are from 501 to 999

Setup and Utility
• EXTENDED TEST NAME - 15 characters

This field is editable in the IL and open test.
This field is printed in the sample report.
At least one alpha-numeric character is mandatory.
• TEST CODE FOR HOST - 4 characters (editable)

This field is editable for all tests.
This field represents the Code for Host transmission.
• TEST REVISION - 4 characters
This field is editable in an open test.
Format is from 0.00 to 99.99.
• CALIBRATION MODE - One of the following options may be selected:
- None: No calibration is needed for this test.
- One Time per Session: This test does not have a dedicated
calibration cycle; the calibration is performed with the
analytical session and can be stored and used for further
analysis.
- Each Rotor: This test does not have a dedicated calibration
cycle; the calibration is performed for each analytical session
within the rotor. The previous calibration can be reviewed but
cannot be used for further analysis.
- Dedicated: This test has a dedicated calibration cycle and
that this calibration can be stored.
• IMPORT CALIBRATION – One of the following options may be selected:
- None: No calibration import is needed for this test
- Test List dropdown: If it is necessary to import a calibration,
choose the test from the displayed test list. Only the tests
enabled with a calibration defined will appear.
• IMPORT RAW DATA FROM - The following options may be selected:
- None: This test does not import raw data from any other
test.
- Test List dropdown: if it is necessary to import the raw data,
choose the test from the displayed test list. All tests are
displayed.
Select Ranges from the test setup screen to modify the unit reporting option, the
ranges for the selected unit and the scale of the Y-axis of the reaction curves.
Note: When defining a new test the Ranges should be entered after all of the
subsections (Analysis, Calibration, Acquisition and Calculation) of the test setup
are defined

The Range and Units table contains the following information.
§ Show in sample list If the unit has been checked (Yes), the unit is displayed
in the patient database and printed.
Note: This setting has no impact on transmission of results to a Host system.
All units for a test are always transmitted regardless of the setting in this
checkbox.
§ Correction parameters If any correction factor is applied to a specific unit, an

asterisk will appear.
§ Result Unit Units that are available in the selected test (from 1 to 4).
§ Normal Range Defines the normal range for each unit. Minimum and
Maximum values can be typed in. The normal range is
used to flag patient results. On the screen, the results are
displayed in black when within the Normal Range; the
results are displayed in violet when outside the Normal
Range; on the printout an asterisk will be printed (close to
the results out of normal range).
§ Test Range Defines the test range for each unit (i.e. Linearity Range).
Minimum and Maximum values cannot be edited in IL test
applications but can be edited in the customized
applications. The test range is used to flag patient results.
Values outside the Test Range are displayed in red; on
the printout these results will be in bold print.
Setup and Utility
§ Scale Range Numerical reporting range for the test. Numerical values
outside the scale range high are presented as asterisks
(***), and values outside the range low are presented as
dashes (---). Minimum and Maximum values cannot be
edited in the IL test applications but can be edited in the
customized applications.
§ Reaction Curve Graph Defines the Y-axis of the reaction curve (minimum and
maximum values). If fields are left blank, the system will
auto-scale based on the raw data obtained.
The Reference Value is entered in the Calculation Setup section.

The value is used for R (Ratio) and INR calculation for the tests.
This value is the denominator of the R and INR calculation and it should
represent the mean normal population time for the selected test.
The reference value for the standard test can be automatically imported into the
secondary related tests. For example, the PT (standard test) reference value
will be automatically imported into the Pte, PTd and Pted (secondary) tests. The
automatic import is built into the IL locked tests. For non-IL locked tests this
feature can be used if the tests are setup to do so. Refer to the Calculation
Setup section for more details
Clicking on the Unit Correction button it is possible to correct result units based
on a mathematical equation.
The calculated units for the tests can be corrected on this screen (i.e. %, R, INR,
g/L, mg/dL, U/mL, etc.), while the primary units (i.e. seconds, delta, absorbance,
etc.) can be corrected in the Calculation Section 4.2.6. Test results for IL locked
tests that have correction parameters entered for the primary (measured) unit will
display “Lab correlation applied” in the warning list box when the clot curve is
displayed.
Up to 3 intervals of corrections based on the result range can be activated.
The correction is represented by the following formula:
Y = mX + q
where “m” represents the slope and “q” the intercept on the Y axis.
X is the original result and Y is the corrected results.

Minimum and Maximum Interval values represent the range of unit where the
correction is expected to be active. The values for these fields should be positive
numbers within the test range for the selected test.
For “m” and “q” coefficients both positive and negative value coefficients can be
entered.
Correction Parameters (when not defined by IL in the IL Locked Test
Applications) definition used are the responsibility of the laboratory personnel.
Warning: Modification of the correction parameters for calculated units on the IL

Locked Tests (i.e. D-Dimer High) is not recommended. A message box will
display to alert the user if they attempt to change the settings.
The recommended sequence of operations when a new test is created is the

following.
1. Analysis: Loading setup
2. Calibration: Loading setup

3. Acquisition setup
4. Calculation setup
5. Ranges setup
Warning: When a new application is defined please consider that major changes
to the Analysis step setup (i.e. adding or removing steps), the
Calibration step setup (i.e. adding or removing calibration points) and
the Acquisition setup (i.e. change in acquisition time) will erase all the
Calculation setup conditions. This is done to prevent conditions of
possible test inconsistencies. For this reason it is important to ensure

Setup and Utility
the Analysis loading, Calibration Loading and Acquisition Setup is

correct before defining the Calculation Setup.
It is advisable before any change is done to an open test either new or copied, to
print the parameters in order to have a reference to use when re-entry of
calculation setup is needed.
When a new application is defined please consider that minor changes to the
Analysis step setup (i.e. change of a liquid name or volume in an existing step)
and the Calibration step setup (i.e. change of a liquid name or volume in an
existing step) will not erase the Calculation setup conditions.
4.2.3 Analysis – Loading Setup

Analysis: Loading Setup screen flow
TEST
DETAILS
CLEANING
ANALYSIS:
LOADING
SETUP
REAGENT
PRIMING
STEP SETUP
(single step)
MATERIAL
CHECK
PARAMETERS PARAMETERS
Sample line Reagent Line

Clicking the Analysis: Loading Setup button allows the user to view/edit the
reagents and sample setup in the trays during analysis.
This screen is used to define all the steps needed to carry out the analysis.
Test ID: in this field the test ID previously defined is displayed. This field is
present in all screens of the test setup.
EMPTY CUPS ON OUTER RING STARTING FROM POSITION NUMBER: this
field is used only when it is necessary to place an empty (0.5mL) cup on the
sample tray for pre-dilution purposes.
CALIBRATION POINTS REPLICATES: view field only; defined in calibration

setup.
Double Samples checkbox: check this box to run tests in duplicate mode.
Checking of the mean value is enabled under Calculation Setup
Step: this is the order of the execution of the analysis step by step.
Add button: this button is used to define in detail all the steps of the analysis. A
single step is the action of aspirating/dispensing liquids. A step can be carried out
by the sample needle the reagent needle or by both needles. The final result of a
step is the completion of a scope.

Setup and Utility
Several scopes can be selected:

- Optical Reference (Wash-R Emulsion) to be used with both 660 nm and
405 nm channel definitions.
- Reference (in Absorbance tests) to be used with 405 nm channel definition
only.
- Sample
- Sample a (activated sample as in APCR-V test)
- Sample 1, 2, 3 (For use with factor parallelism)
- Analytical Reference
- Analytical Reference a (activated analytical reference as in APCR-V test)
The Arrow/Scissors icons add or delete a possible scope.
List of “possible scope” presented in this screen is only an example; real

selections of possible scopes are indicated in the text above.
Once the scope is defined, it is necessary to define which needle will be used to
aspirate/dispense the liquids.
The parameters button for entering the Sample or Reagent line opens the Step
Setup Parameters window.

The Loading parameters for the Sample and Reagent needle can be defined as
No Loading, No Dilution, In Line Dilution or In Cup Dilution.
Notes: a head volume of 10 microliters is always automatically added to each
total step condition both on the sample line as well as on the reagent line for all
three conditions: No Dilution, In Line Dilution and In Cup Dilution. All liquid
volumes should be entered as microliter volumes. Wash cycle aspiration is 130
ul of Wash-R per cycle.
No Loading: This line does not aspirate/dispense any liquid in this step.
No Dilution: The liquid is aspirated and dispensed as it is without any dilution.
The following fields must be entered.
• Liquid ID: choose from the liquid list

• Volume: enter the volumes in microliters (minimum 10; maximum = 140)
In Line Dilution: A diluent and the sample are aspirated one after the other and
dispensed together. The following fields must be entered.
• Diluent Liquid ID: choose the diluent liquid from the list
• Diluted Liquid ID: choose the liquid to be diluted from the list
• Volume: enter the volumes for each liquid in microliters (minimum single
liquid=2; maximum total volume is 140).
In Cup Dilution (Sample needle only): Diluent and sample are dispensed in an
empty (0.5mL) cup when a very high dilution is needed.

Setup and Utility
The In Cup Dilution option is not available for the reagent needle as this needle
cannot aspirate/dispense in the sample tray area.
• Pre-dispensed Liquid ID: choose the diluent from the liquid list*
• Diluent Liquid ID: choose the diluent from the liquid list*
• Diluted Liquid ID: choose the liquid to be diluted from the list (i.e. plasma)
• Volume: enter the volumes in microliters (minimum single liquid=2;
minimum total cup volume=150; maximum total cup volume is 250).
The Washing field must be entered if a wash cycle is needed after each cup
dilution is completed. The value refers to the number of cycles and the range is
1-5.
The position of the empty (0.5mL) cup in the sample tray is defined by checking
the Inner Ring (A1- A10) or Outer Ring checkbox.
*When a highly diluted sample is required, the diluent must be added in two
phases. The diluent used in the first phase is called "pre-dispensed liquid". The
diluent used in the second phase, together with the sample, is called "diluent
liquid".
Warning: when a low volume sample needs to be dispensed, it is advisable to
use the In Line Dilution option or the In Cup Dilution option. It is not
recommended to dispense a low sample (below 10 microliters) alone
without any diluent/buffer.
Intermediate Rinse checkbox: if checked, the needle is dipped in the
waste/rinse reservoir to wash the exterior of the probe. This action is
recommended when low volumes are used.
Wash R. checkbox: if checked, the needles are washed in the rinse before
starting the next step. Must be activated to run washing between loading.
Washing between loading: defines how many rinse cycles are performed
between any sample line loading or between any reagent line loading. The
minimum is 0 and the maximum is 5.
Washing at step completion: defines how many rinse cycles are performed at
the end of loading phase for both sample line or reagent line for this step. The
minimum is 0 and the maximum is 5.
Timing constraint: some steps can be more critical on timing than others. For
these it is necessary to define a time interval that must be honored in the defined
step(s).
None: The following step is executed immediately after the completion of
the present liquid dispensation.
Step length: It is possible to define the time interval within which a single
step must be completed. The loading time is included in the total step
length. The system will wait for the remainder of the step length time if
loading is complete before the time limit elapses. Mixing will occur after
the step length time expires.
Delay at Completion: After loading of the liquids in the step, a fixed
delay is added; loading time is not included within the Delay at
Completion time. No mixing occurs before starting the delay timer.
Step length and Delay at Completion are always applied to a single
step definition only
Set timer: At the end of the loading phase of the defined step, a TIMER
is set for a certain amount of seconds; this timer will be used across the
next loading step(s) (i.e.: the Cephalin step incubation time in the APTT
test has to wait for the step of the Calcium Chloride). Subsequent steps,
up to a Wait timer step, are executed immediately, only the timer is set.
Wait until timer is expired: The loading step is executed after the time
of a previously SET TIMER step expires (i.e.: the CaCl2 step in the APTT
test has to close the timer previously opened).
Note: Set Timer and Wait until timer is expired are used when a timer
spans across several steps (minimum of two). In this case the time will go
across multiple steps. When Set Timer is defined in one step, a
subsequent step must have a Wait until timer is expired condition in
order to close the timer opened previously. Both conditions of Set Timer
and Wait until timer is expired have to be used in one application
definition.
Time in seconds for the timing constraint field can be defined from 1 to 999
seconds (0 means disabled).

Setup and Utility
Mixing area: In the current step, if it is necessary to mix the contents of the rotor
cuvette, the ramp checkbox must be checked.
The following fields must be filled in.
Centrifugation Time: rotor may spin from 1 second to 999 seconds. If the value
0 is input, the rotor will not spin.
Inter-ramp Interval: if the rotor is stopped after the first acceleration, this interval
must be defined. The minimum is 1 second and the maximum is 10 seconds. If 0
is input, no inter-ramp will occur.
The Confirm/Cancel button leaves the screen saving or rejecting the changes
and the system goes back to the Main screen.
As soon as one step is entered, the details button becomes active and it can be
pressed to review and edit the fields.
The Delete icon can be used to delete a step in the analysis sequence.
§ CLEANING
From the Analysis: Loading Setup Screen, press the Cleaning button to display
the cleaning setup screen.
This screen is used to define the liquid and its volume used for cleaning the
reagent line and the sample line.
When the cleaning procedure is defined, it is carried out after the last step of the
test cycle.

Liquids can be defined as Diluent Liquid ID and/or Diluted Liquid ID which

means that it is possible to use a single solution or to dilute the solution with
another liquid.
The total volume has to be within 10-140 microliters, independent from Diluent
Liquid only, Diluted Liquid only, both Diluent and Diluted Liquids.
Cycles no.: this is the number of the cycles (minimum 1 – maximum 5). If 0 is
entered no cleaning is performed.
Perform Sequentially: if checked, one line (sample needle line) is cleaned
before the other line (reagent sample needle); if not checked, the cleaning is
performed at the same time.
Washing at completion defines the washing done by the Wash-R Emulsion in

number of cycles at the end of the cleaning cycle (minimum 1 - maximum 5).
§ REAGENT PRIMING
From the Analysis: Loading Setup Screen, press the Reagent Priming button to
display the reagent priming setup screen.
This screen is used to define the liquid and its volume to be used for reagent
priming for the reagent line and/or the sample line.
When the reagent priming procedure is defined, it is carried out at the beginning
of the test cycle (before the first step).
When Reagent Priming is defined, the interfering tests that will trigger it needs to
be activated using the Interference Table setup in section 4.1.5.
Setup and Utility
Washing at startup defines the washing done by the Wash-R Emulsion in

number of cycles at the beginning of the reagent priming cycle.
Liquids can be defined as Diluent Liquid ID and Diluted Liquid ID which means
that it is possible to use a single solution or to dilute the solution with another
liquid.
Cycles no.: This is the number of the cycles (minimum 1 – maximum 5). If 0 is
entered, no reagent priming is performed.
Before and after the reagent priming, a wash (using the Wash-R emulsion)
procedure can take place, a number can be defined (minimum 1-
maximum 5).
Perform Sequentially: If checked, one line (sample needle line) is primed before
the other line (reagent needle line); if not checked, the reagent priming is
performed at the same time.
Washing at completion defines the washing done by the Wash-R Emulsion and
number of cycles at the end of the reagent priming cycle (minimum 1 - maximum
5).
done and the system goes back to the Main screen.
§ MATERIALS CHECK
Once all the liquids are configured, it is possible to define whether the instrument
checks for the presence of the liquid container during the pre-analytical check.

If a liquid is selected to be checked, you can define what actions to take if the
liquid becomes low during the analysis.
The Check in Pre-Analysis option defines if the analysis may start even if the
liquid is not present (optional presence). This applies to materials in positions A1
– A10 on the sample tray.
If the liquid is marked as mandatory, the analysis cannot start without it and the
options of Check and Continue or Abort is presented after the pre-analysis
checks.
If the liquid is not marked as mandatory, the analysis can start without it and the
Continue option is also presented after the pre-analysis checks allowing the
analysis to continue without a specific liquid.
The Check Selected Row box is used to define the liquid as mandatory.
The Check Selected Row option can only be used for the liquids positioned in A1
to A10 (auxiliary sample tray positions).
The available Actions of the system when a liquid is low are as follows:
§ Abort test: In some cases the presence of the liquid is required to
complete the session (i.e. calibration): if the liquid is low, the session will
be aborted. Samples and reagents pipetted into the rotor prior to the
shortage will not be analyzed.
§ Complete possible and signal: In this case if the liquid becomes low
during the session, the samples that had sufficient liquid aspirated and
dispensed will be completed; while those, after the low reagent condition
was detected, will be kept on hold and the system will warn the user.
Tests after the low condition remain pending. The run can be restarted
by refilling the reagents after session completion
§ Just signal: The instrument will only advise the operator that a liquid is
low but it will continue to perform all pipetting operations.

Setup and Utility
4.2.4 Calibration – Loading Setup

Analysis: Loading Setup screen flow
TEST
DETAILS
CLEANING
CALIBRATION
LOADING
SETUP
REAGENT
PRIMING
STEP SETUP
(single step)
MATERIAL
CHECK
PARAMETERS PARAMETERS
Sample line Reagent Line

Click the Calibration: Loading Setup button to view/edit the liquids (reagents,
calibrators) setup in the trays during the test calibration.
This screen is used to define all the steps needed to carry out a calibration.
Test ID: in this field the test ID previously defined is displayed. This field is
present in all the screens of the test setup.
EMPTY CUPS ON OUTER RING STARTING FROM POSITION NUMBER: this
field is used only when it is necessary to place an empty cup (0.5 mL) on the
sample tray for pre-dilution purposes.
Calibration Points Replicates: The maximum number of replicates is 6. Since
the calibration must be performed on a single rotor, the total number of usable
rotor cuvettes is 18; the possible combinations (standard levels/replicates) are as
follows: 2 levels and 3, 4, 5, 6 replicates; 3 levels and 3, 4, 5, 6 replicates; 4
levels and 3, 4 replicates; 5 levels and 3 replicates; 6 levels and 3 replicates.
The Delete icon can be used to delete a step in the calibration sequence.
Add button: This button is used to define in detail a step of the calibration. A
single step is the action of aspirating/dispensing liquids. A step can be carried out
by the sample needle the reagent needle or by both needles. The final result of a
step is the completion of a scope.

Setup and Utility
Step: this is the order of the execution of the calibration run.

Several scopes can be selected:
- Optical Reference (Wash-R Emulsion) to be used with both 660 nm and
405 nm channels definition.
- Reference (in Absorbance tests) to be used with 405 nm channel definition

only.
- Sample
- Standard (1-2-3-4-5-6)
- All (only if all steps have the same conditions)
The Arrow/Scissors icons add or delete a step.
Once the scope is defined, it is necessary to define which needles will be used to
aspirate/dispense the liquids in the step.
The Loading type for the needle of the sample line may be defined; here is the
definition of the Sample and/or Reagent line.
No Loading: This line does not aspirate/dispense any liquid in this step.
No Dilution: The liquid is aspirated and dispensed as it is.
In Line Dilution: A diluent and the sample are aspirated one after the other and
dispensed together.
In Cup Dilution: Diluent and sample are dispensed in an empty cup when a very
high dilution is needed.

The parameters button for either the Sample or Reagent line opens the Step
Setup Parameters window.
No Dilution: The liquid is aspirated and dispensed as it is. The following fields
must be entered:
§ Liquid ID: choose from the liquid list
§ Volume: enter the volumes in microliters (minimum=10; maximum=140)

In Line Dilution: A diluent and the liquid are aspirated one after the other and
dispensed together. The following fields must be entered:
§ Diluent Liquid ID: choose the diluent from the liquid list
§ Diluted Liquid ID: choose the liquid to be diluted from the list (i.e. cal
plasma)
§ Volume: Enter the volumes in microliters (minimum single liquid=2;

maximum total volume is 140).
"In Cup dilution" option (Sample Probe option only) dilutes the material in an
empty 0.5mL cup prior to loading into a cuvette on the rotor. Used when a high
dilution ratio of material is required. The following fields must be entered:
§ Pre-dispensed Liquid ID: choose the diluent from the liquid list*
§ Diluent Liquid ID: choose the diluent from the liquid list*
§ Diluted Liquid ID: choose the liquid to be diluted from the list (i.e. cal
plasma)
§ Volume: enter the volumes in microliters (minimum single liquid=2;
minimum total volume=150; maximum total volume is 250).

Setup and Utility
*In case a highly diluted sample is required, the diluent must be added in two
phases. The diluent used in the first phase is called "pre-dispensed liquid". The
diluent used in the second phase, together with the sample, is called "diluent
liquid".
The In Cup Dilution option is not available for the reagent needle as this needle
cannot aspirate/dispense in the sample tray area.
Note: a head volume of 10 microliters is always automatically added to each total

step condition both on the sample line as well as on the reagent line for all three
conditions: No Dilution, In Line Dilution and In Cup Dilution.
The washing field must be entered if a wash cycle is needed after each cup
dilution is completed. The value refers to the number of cycles and the range is
1-5. Each wash cycle rinses with 130ul of Wash-R.
The position of the empty cup (0.5mL) in the sample tray is defined by checking
the Inner Ring or Outer Ring checkbox. Standard dilutions must use the Outer
Ring.
The Confirm/Cancel button leaves the screen saving or rejecting the changes.
Warning: when a low volume sample needs to be dispensed, it is advisable to

use the In Line Dilution option or the In Cup Dilution option. It is not
recommended to dispense a low sample (below 10 microliters) alone, without
any diluent/buffer.
Intermediate Rinse checkbox: if it is checked, the needle is dipped in the

waste/rinse reservoir to rinse the exterior of the probe. This action is
recommended in case of low volume use.

Wash R. checkbox: if it is checked, the needles are washed in the rinse before
starting the next step.
Washing between loading: It is possible to define how many rinse cycles are to
be performed between any sample line loading or between any reagent line
loading. The minimum is 0 and the maximum is 5. Each wash cycle rinses with
130ul of Wash-R.
Washing at step completion: it is possible to define how many rinse cycles are
to be performed at the end of loading phase for both sample line or reagent line.
The minimum is 0 and the maximum is 5. Each wash cycle rinses with 130ul of
Wash-R.
Timing constraint: since some steps can be more critical than others, it is
necessary to define some time interval that must be honored in the defined
step/s.
None: The following step is executed immediately after the completion of
the present liquid dispensation.
Step length and Delay at Completion are always applied to a single
step definition only.
Step length: It is possible to define the time interval within which a single
step must be completed. The loading time is included in the total step
length. For example, the loading of the substrate in the AT test: activation
time must be respected because it is a critical step in the reaction.
Delay at Completion: After loading of the liquids in the step, a fixed
delay is added; loading time is not included within the Delay at
Completion time. No mixing occurs before starting the delay timer.
Note: Set Timer and Wait until timer is expired are used when a time
has to include several steps (minimum of two). In this case the time will
go across multiple steps. When Set Timer is defined in one step, a
subsequent step must have a Wait until timer is expired condition in
order to close the timer opened previously. Both conditions of Set Timer
and Wait until timer is expired have to be used in one application
definition.
Set timer: At the end of the loading phase of the defined step, a TIMER
is set for a certain amount of seconds; this timer will be used across the
next loading steps (i.e.: the Cephalin step incubation time in the APTT
test has to wait for the step of the Calcium Chloride). Subsequent steps,
up to a Wait Timer step, are executed immediately, only the timer is set.
Wait until timer is expired: The loading step is executed when the time
of a previously SET TIMER step expires (i.e.: the CaCl2 step in the APTT
test has to close the timer previously opened).

Setup and Utility
Time in seconds for the timing constraint field can be defined from 1 to 999
seconds (0 means disabled).
Mixing area: If in the current step is necessary to mix the contents of the rotor
cuvette, the ramp checkbox must be checked.
The following fields must be filled in.
Centrifugation Time: rotor may spin from 1 second to 999 seconds. If the value
0 is input, the rotor will not spin.
Inter-ramp Interval: If the rotor is stopped after the first acceleration, this interval
must be defined. The minimum is 1 second and the maximum is 10 seconds. If 0
is input, no inter-ramp will occur.
The Confirm/Cancel button leaves the screen saving or rejecting the changes.
As soon as one step is entered, the details button becomes active and it can be
pressed to review and edit the fields.
§ CLEANING
From the Calibration Loading setup screen, Press the Cleaning button to display
the cleaning setup.
This screen is used to define the liquid and its volume to be used to clean the
reagent and sample lines.
When the cleaning procedure is defined, it is carried out after the last step of the
test cycle.
Liquids can be defined as Diluent Liquid ID and/or Diluted Liquid ID which

means that it is possible to use a single solution or to dilute the solution with
another liquid.
Cycles no.: this is the number of cycles (minimum 1 – maximum 5). If 0 is
entered, no cleaning is performed.
After the cleaning, a wash (using the Wash-R emulsion) procedure can take
place: a cycle number can be defined (minimum 1 - maximum 5).
Perform Sequentially: if checked, the sample needle line is cleaned before the
reagent line; if not checked, the cleaning is performed at the same time.
Washing at completion defines the washing done by the Wash-R Emulsion in
number of cycles at the end of the cleaning cycle (minimum 1- maximum 5).
Each wash cycle rinses with 130ul of Wash-R.
§ REAGENT PRIMING
From the Calibration: Loading Setup Screen, press the Reagent Priming button
to display the reagent priming setup screen.
This screen is used to define the liquid and its volume to be used for reagent
priming for the reagent and/or sample lines.
When the reagent priming procedure is defined, it is carried out at the beginning
of the test cycle (before the first step).
When Reagent Priming is defined, the interfering tests that will trigger it needs to
be activated using the Interference Table setup in section 4.1.5.

Setup and Utility
Washing at startup defines the washing done by the Wash-R Emulsion in

number of cycles at the beginning of the reagent priming cycle.
Liquids can be defined as Diluent Liquid ID and Diluted Liquid ID which means
that it is possible to use a single solution or to dilute the solution with another
liquid.
The total volume has to be within 10-140 microliters, independent of Diluent
Cycles no.: this is the number of the cycles (minimum 1 - maximum 5). If 0 is
entered, no reagent priming is performed.
Perform Sequentially: if checked, the sample line is primed before the reagent
line; if not checked, the reagent priming is performed at the same time.
Washing at completion defines the washing done by the Wash-R Emulsion and
number of cycles at the end of the reagent priming cycle (minimum 1 – maximum
5). Each wash cycle rinses with 130ul of Wash-R.
§ MATERIALS CHECK
Once all the liquids have been configured, it is possible to define whether the
instrument checks for the presence of the liquid, and also what action to take if
the liquid volume is low.
If a liquid is selected to be checked, you can define what actions to take if the
liquid becomes low during the analysis.

The Check in Pre-Analysis option defines if the analysis may start if the liquid is
not present (optional presence).
If the liquid is marked as mandatory, the analysis cannot start without it and the
message Check and Continue or Abort is presented after the pre-analysis
checks.
If the liquid is not marked as mandatory, the analysis can start without it and the
Continue option is presented after the pre-analysis checks allowing the analysis
to continue without a specific liquid.
The Check Selected Row box is used to define the liquid as mandatory.
The Check Selected Row option can only be used for the liquids positioned in A1
to A10 (auxiliary sample tray positions).
The available Actions of the system when a liquid is low are as follows:
§ Abort test: In some cases the presence of the liquid is required to
complete the session (i.e. calibration); if the liquid is short, the session
will be aborted.
§ Complete possible and signal: In this case if the liquid becomes low
during the session, the samples that had sufficient liquid aspirated and
dispensed will be completed; while those, after the low reagent condition
was detected, will be kept on hold and the system will warn the user
(tests after the low condition will remain pending).
§ Just signal: The instrument will only advise the operator that a liquid is
low but it will continue to perform all pipetting operations.

Setup and Utility
4.2.5 Acquisition Setup

Click the Acquisition: Setup button to open the screen to view/edit the data
acquisition settings for the test.
This screen is used to define all the acquisition parameters.
The acquisition profile is represented in the following drawing.
INTER-RAMP DATA
INTERVAL DELAY ACQUISITION
TIME TIME
RAMP RAMP RAMP
0.4 s 0.4 s # 0.4 s
Each mixing Ramp is fixed at 0.4 seconds.

Inter-Ramp Interval, Delay Time and Acquisition Time are defined according to
the application.
In general terms clotting reactions always have an Inter-Ramp Interval while
chromogenic and latex reactions do not use Inter-Ramp Interval.

If the Ramp checkbox is checked, the other parameters can be entered.
First mixing ramps (ramp up and down) are set at 0.8 seconds total.
INTER-RAMP INTERVAL : time in seconds between the two ramps (0 means no
inter-ramp; or 1 to 10 seconds defines the time between the two ramps).
Second ramp up after the inter-ramp interval and before the acquisition delay is
set at 0.4 seconds.
ACQUISITION DELAY: time where no data points are recorded during the
acquisition (1-60). If 0 is entered, no delay is considered.
SAMPLING RATE: interval between the data points in milliseconds (50 to 1000
milliseconds in 50 millisecond interval)
ACQUISITION TIME: time used to read the reaction (1-1200 seconds)
SPEED: 600 or 1200 rpm
ACQUISITION CHANNEL: 405 (Absorbance) or 660 (nephelometric) nm.

Setup and Utility
4.2.6 Calculation Setup

Calculation: Setup screen flow
TEST
DETAILS
CHECKS
CALCULATION
SETUP
DEFINE
PARAMETERS
CALIBRATION
SETUP
CALCULATION
ALGORITHMS
CALIBRATION DEFINE
CURVE SETUP PARAMETERS
CALCULATION
ALGORITHMS

Click the Calculation: Setup button to view/edit the data calculation settings for
the test.
This screen is used to define all the steps needed to manage the raw data
(calibration and analysis).
Test ID: In this field the test ID that has been previously defined is displayed.
This field is present in all screens of the calculation setup.
Normalization: two criteria may be selected: S/R * 100 or log (R/S). The first
algorithm is commonly used for the clotting assays, while the second is mostly
used for chromogenic assays. S means the value (in mV) of the sample and R
means the value (in mV) of the Wash-R emulsion (for S/R*100) and also the
Optical Reference (for log (R/S)).
Scope: Defines the calculation for all the steps defined in the loading step setup:
- Optical Reference (Wash-R Emulsion)
- Reference (in Absorbance tests)

- Sample, Sample a (activated sample as in APCR-V test)
- Analytical Reference, Analytical Reference a (activated analytical
reference as in APCR-V test)
- ALL
Ratio: Select the formula used to calculate the Ratio. Available options are:
- None (No ratio calculation performed)

- R = S / Ref. Value

Setup and Utility
- R = S / Std 1
- R = S / Std 2
- R = S / Std 3
Import Ref Value from: Select either None or a test from the drop down list.
The reference value entered for the primary test is automatically imported into
the secondary tests (i.e. extended (e) and double (d) tests). This value is the
denominator of the R and INR calculation and should represent the geometric
mean of the normal population time for the selected test.
Normalized Ratio: Select the formula from the drop down list.
- None (no calculation performed)
- INR = R^ISI
- NR = R(S) / Ref
Import ISI Value from: Select either None or a test from the drop down list.
The ISI value entered for the primary test is automatically imported into the
secondary tests (i.e. extended (e) and double (d) tests).
Algorithm Type – Seven selections are available:
None, Trend Algorithm, Threshold, Threshold/Second Derivative, First
Derivative, Second Derivative and Delta.

NONE
TREND
ALGORITHM
Page 4.88
THRESHOLD
Page 4.89
ALGORITHM
TYPE
THRESHOLD
2nd DERIVATIVE
Page 4.92
FIRST
DERIVATIVE
Page 4.96
2nd
DERIVATIVE
Page 4.98
DELTA
Page 4.110

Setup and Utility
Once the Algorithm type has been selected the Define Parameters screen can
be accessed to define the calculation of the selected Algorithm Type.
§ None
No algorithm is applied. Only the raw data will be available.
§ Trend Algorithm
Selecting Trend the following selections are possible:
Two Smoothings can be selected in terms of number of points.

The reaction curve can be analyzed in two areas: the First Part (Offset or Min)
and the Final Part (Final or Max). Number of points to be used to calculate the
average or determine the Min/Max for the trend algorithm can be defined.
Presented Units
The only available units for the Trend algorithm are the first part of reaction curve
Offset/Minimum and the Final/Maximum for the final part of the curve.

Curve Checks
The Check Saturation checkbox activates a monitor on the reaction curve
readings to ensure they are within the hardware limit of the lamp used.
§ Threshold Algorithm
Selecting Threshold the following selections are possible:
Two smoothings can be selected in terms of number of points: 1st Smooth and
2nd Smooth.
Smoothings are calculated using the moving average mean criteria; the criteria to
calculate the moving average mean is defined by the number of points (degree)
used to calculate the new smoothed values.
Delta Check defines the minimum acceptable delta for the normalized data
reaction curve.
The reaction curve can be analyzed in two areas: the First Part (Offset or Min)
and the Final Part (Final or Max). Number of points to be used to calculate the
average or determine the Min/Max for the first and final parts can be defined.
Pressing the Threshold Parameters button will display the following window

Setup and Utility
o
The 1 Threshold Parameters window allows you to set the following
parameters.
The Threshold Search Direction provides the option to search for the threshold
value in the Forward (starting from the beginning of the reaction) or Backward
(starting from the end of the reaction and moving toward the beginning) direction.
Threshold Mode allows selection of Absolute (total) or % of Curve to calculate
the threshold.
st
1 Threshold defines where the clot time should be taken; a numerical value
should be entered. The threshold represents a fix change in turbidity from the
initial offset of the reaction curve.
Backwards Threshold Settings settings not applicable for this algorithm.

Presented Units
Time in seconds (calculated against the first threshold) is in general the

presented unit, other units such as the Initial Reaction Offset/Minimum and the
Final/Maximum part of the reaction can be chosen.
Curve Checks
2 nd Threshold defines where one of the checks on the clot curve should be
taken; a numerical value should be entered. This value is used as a verification
that a real clotting curve is present.
In general the second threshold is used to discriminate between real clotting
curves and noisy or unstable clot curves or low Fibrinogen.
Delta Time is used to check bi-phasic curves; it represents the difference in

seconds between two thresholds.

Initial Slope is used to check non-phasic curves; it represents the initial slope of
the reaction curve at the beginning of the acquisition time. In case the slope
check is not met an error will be generated.
Primary Unit Correction

Accessing the Correction Parameters window it is possible to set value
corrections based on the reaction offset.
Correction Parameters are applied here on the primary unit, in this case seconds.
The Offset Interval can be defined and a correction curve in terms of slope (m)
and intercept (q) can be set.
Y = mX + q
correction is expected to be active.
entered.
For example, this correction is used for the Fibrinogen-PT-Based method in very
lipemic samples.

Setup and Utility
§ Threshold/Second Derivative Algorithm

Selecting Threshold/Second Derivative the following selections are possible:
1st and 2nd Derivative calculation in terms of number of points to be used.

Five smoothings can be selected in terms of number of points: 1st Smooth, 2nd
Smooth and 3rd Smooth are used for the raw data; the 4th and 5th Smoothings
are used for the First Derivative.
The reaction curve can be analyzed in two areas: the First Part (Offset/Min) and
the Final Part (Final/Max). Number of points to be used to calculate the average
or determine the Min/Max for the two parts can be defined.
reaction curve.
Presented Units
Time in seconds (calculated either against the first threshold or on the maximum
peak of the second derivative; see Initial Slope and Delta Time) is in general the
presented unit, other units such as the Initial Reaction Offset/Minimum and the
Final/Maximum Reaction Part can be chosen.
Pressing the Threshold Parameters button displays the following window:

o
The 1 Threshold Parameters window allows you to set the following
parameters.
the threshold.
st
should be entered. The threshold represents a fixed change in turbidity from the
Click on the Backwards Threshold Settings box to enable calculation from the
end of acquisition time moving backwards to the beginning.
the threshold.
Value field defines where the clot time should be taken; a numerical value
should be entered. The threshold represent a fix change in turbidity from the
Curve Check
Accessing the Curve Check Parameters window it is possible to make the
following selections.

Setup and Utility

2 nd Threshold defines where one of the checks on the clot curve should be
that a real clot curve is present.
In general the second threshold is used to discriminate between real clot curves
and noisy, unstable clot curves or low Fibrinogen.

seconds between two thresholds. In case the delta time is not met the raw data
will be analyzed using the Second Derivative criteria
the reaction curve at the beginning of the acquisition time. Number of points and
slope value can be entered (numerical values). In case the slope check is not
met the raw data will be analyzed using the Second Derivative criteria.
Second Derivative calculation in terms of number of points to be used.

Second Derivative represents the acceleration of the reaction and can be used as
criteria to find the clotting point searching for the maximum peak of the second
derivative.
Click on the Noise Check 1 button to activate. If enabled, the system will
determine the clot time searching backwards through the data curve for a value
that is a percentage of the curve delta. The desired percentage is entered in the
Percent field. The delta between the original time (time or threshold) and the
backward calculation time is determined. The Max Time Delta value is the
maximum allowable time delta between the two values.
Click on the Noise Check 2 button to activate. If enabled the system seeks the
next maxima value or time starting from the original value or time. If there is no
further drop in the normalized data curve then the local maxima value and time
will equal the original.
In the Points field enter the minimum number of points the curve must fall in
order for the local maxima to be considered a true peak. The Min Peak Delta is
the percentage of the overall delta of the curve the local max value must exceed
in order for it to be considered a true peak. The Min Decrease is the minimum
difference in signal (absolute) for the local maxima to be considered a true peak.
Click on Coagulation Location Check button to activate. If enabled the system

will check the coagulation point to ensure it falls within the Percent of the total
curve delta.


Y = mX + q
Minimum and Maximum Interval values represents the range of unit where the
entered.
lipemic samples.

Setup and Utility
§ First Derivative Algorithm

Selecting First Derivative the following selections are possible:
1st Derivative calculation in terms of number of points to be used.

It represents the speed of the reaction and can be used as criteria to find the
clotting point searching for the maximum peak of the first derivative.
Smooth and 3rd Smooth are used for the raw data; the 4th and the 5th
Smoothings are used for the First Derivative.
or determine the Min/Max for the first and final parts can be defined.
reaction curve.
Presented Units
Time in seconds (calculated on the maximum peak of the first derivative) is in
general the presented unit, other units such as the Initial Reaction
Offset/Minimum and the Final/Maximum Reaction Part can be chosen.


Y = mX + q
entered.
lipemic samples.
Curve Check

Setup and Utility

First Derivative limit check in terms of absolute value to be used to verify that a
proper clot is occurring.
First Part is the initial turbidity check value of the reaction.

Second Derivative calculation in terms of number of points to be used and check
limit value to be used to verify that a proper clot is occurring.
§ Second Derivative Algorithm

Selecting Second Derivative the following selections are possible:

1st Derivative calculation in terms of number of points to be used.

2nd Derivative calculation in terms of number of points to be used.
It represents the acceleration of the reaction and can be used as criteria to find
the clotting point searching for the maximum peak of the second derivative.
Smooth and 3rd Smooth are used for the raw data; the 4th and the 5th
Smoothings are used for the First Derivative.
reaction curve.
Presented Units
Time in seconds (calculated on the maximum peak of the second derivative) is in

general the presented unit, other units such as the Initial Reaction
Offset/Minimum and the Final/Maximum Reaction Part can be chosen.
Curve Checks
Second Derivative value defines when the maximum peak of the second
derivative should give a result as time in seconds; a numerical value should be
entered.


Setup and Utility

Y = mX + q
Minimum and Maximum Interval values represents the range of unit where the
entered.
lipemic samples.

§ Delta Algorithm
Selecting Delta the following selections are possible:
Two Smoothings (1st and 2nd) can be selected in terms of number of points.
reaction curve.
Presented Units
Delta is in general the presented unit, other units such as the Offset/Minimum
and the Final/Maximum of the reaction can be chosen.
Curve Checks

Setup and Utility
st
1 Threshold defines where one of the checks on the clot curve should be taken;
a numerical value should be entered. This value is used as a verification that a
real clot curve is present.
The threshold represent a fix change in turbidity from the initial offset of the
reaction curve.
Offset Min checks the reaction to see if the offset value is less than this value. If
the offset is less than the value the response is failed.
The Check Saturation checkbox activates a control on the reaction curve

nd
2 Threshold defines where one of the checks on the clot curve should be
that a real clot curve is present. In general the second threshold is used to
discriminate between real clot curves and noisy or unstable clot curves or low
Fibrinogen.

seconds between two thresholds.
the reaction curve at the beginning of the acquisition time. Number of points and
slope value can be entered (numerical values).
Final Slope is used to check non-phasic curves; it represents the final slope of
the reaction curve at the end of the acquisition time. Number of points and slope
value can be entered (numerical values).
First Part checks the initial reaction mixture to be sure it has not exceeded the
value entered (turbid reaction)

Max / Final checks if the final reaction mixture is turbid or not. Maximum
absorbance reading minus the final absorbance reading cannot exceed this limit.
Pressing the Threshold Parameters button will display the following window
The 1o Threshold Parameters window allows you to set the following

parameters.
the threshold.
st
should be entered. The threshold represents a fixed change in turbidity from the
Backwards Threshold Settings - settings not applicable for this algorithm.
Correction Parameters
corrections based on the reaction offset. Correction Parameters are applied here
on the primary unit, in this case seconds.

Setup and Utility

Y = mX + q
entered.
lipemic samples.

Once the Algorithm type is selected and defined some additional settings on the
main calculation setup may be defined.
Delete Parameters: is used to delete the defined parameters with a single

button.
Calculate mean field: if the option to run the test in duplicate (double test field)
was chosen, calculate mean can be used to obtain the mean of the selected
units with each single result of the duplicate.
Check mean field: this field activates the flag of the duplicate values when they
are far from the mean; this unit is represented in % variation of the selected unit.
For example if the inserted value is 10% the check is done as Mean + 10%. A
flag is presented when the Duplicate is out of Range.
Ratio selection: selects the mode for the Ratio Calculation. Either against the
AR (Analytical Reference) on each single sample tray or against the Reference
Value. The Reference Value represents the Mean Normal Range of the Local
Normal Patient Population and each laboratory should establish its own
Reference Value.
The keyboard or the numerical keypad can be used to type the proper value.
If the calculation versus the Reference Value is activated, all Results in Ratio and
INR will be calculated using the Reference Value as denominator.
RATIO = Sample Result / Reference Value
For the Ratio Selection (R) , 3 selections are possible:

- None: no calculation is done.
- R= S/Reference Value: Ratio equals the sample result is divided by the
Reference Value.
Setup and Utility
- R= S/Standard X: Ratio equals the sample result divided by the selected

standard value of the calibration.
X = selected from the standards defined in the calibration.
Normalized Ratio Field: 3 selections are possible.
- None: no calculation is done.

ISI
- INR= R
- NR=R(S)/Reference Value
Pressing the Check button displays the Checks screen.
This screen is used when an Analytical Reference has been set and the user
needs to activate a flag criteria based on the Analytical Reference and the
Analytical Reference Activated value (i.e. APCR-V assay).
The check is done in % versus the measured value of the Analytical Reference.
A % absolute value and the type of Value should be defined.
Several possibility for the AR value can be chosen between the following ones:
s Reference Value (value manually entered by the operator)

s Std 1 (against the first calibration standard point)
s Std 2 (against the second calibration standard point)
s Std 3 (against the third calibration standard point)

Selecting the Calibration curve setup button displays the Calibration Setup
screen.
Algorithm Type: 7 options are available: None, Trend Algorithm, Threshold,

Threshold/Second Derivative, First Derivative, Second Derivative, Delta.
Define Parameters: This option in Calibration Setup has the same selections as
for the test calculation setup; please refer to the previous section in this chapter
(4.2.7).
Delete Parameters: It is used to delete the defined parameters with a single
button.
Response type: the measured unit is displayed in this field

Check CV checkbox: if the user wants to flag the CV of the calibration replicates,
this checkbox should be selected.
Outlier checkbox: If checked, the outlier result is automatically discarded in the

calibration calculation.
The instrument calculates the mean, then discards the furthest value from the
mean, then the new mean is recalculated using the remaining points.
Dilution Ratio %: to be defined according to the calibration loading setup (up to
two decimals may be entered).
CV: when a minimum of three replicates has been configured, the field can be
filled in with the acceptable CV% value. When the obtained CV% value is higher
than the defined limit, the specific calibration standard point is flagged.

Setup and Utility
Final Unit: It represents the calculated unit of the calibration. The unit can be
selected from a list including: mg/dL, g/L, %, ng/mL, U/mL, ug/L, umol/L, IU/mL,
%, mg/mL, ug/mL.
New Unit: If a unit different from those included in the list is configured, the user
can configure a custom unit by typing it in this field (up to 8 characters).
Calibration Curve Setup: pressing this button displays the Calibration Curve
setup screen.
This screen aims to define the mathematical relation between X (measured unit)
and Y (calculated unit).
Normalization of X and Y: X and Y can be recalculated according to the

selected options.
- X (as it is)
- R= X/Std Z (Z = selected from the standards defined in the calibration.)
And for the Y:

- Y (as it is)
- R= Y/Std Z (Z = selected from the standards defined in the calibration.)

Correct with AR in analysis checkbox: the AR result in the run is used to
modify the calibration curve (it represents a single point calibration); all patient
results will be calculated on the basis of the modified calibration, if the checkbox

is checked. This option is valid only for the dedicated calibration sessions and
only for the calibration unit.
Correct Ratio with 100% Std: if the checkbox is activated, the Ratio (and
consequently the INR) is calculated using as denominator the new 100% as it is
obtained from the modification of the curve.
Extrapolated Result
The Extrapolated Result function is automatically executed and it is embedded
into the software. It is not visible on any screen and cannot be modified by the
operator. When a result is above 150% of the highest calibration point or below
60% of the lowest calibration point, it will be flagged.
Define as Mandatory: it defines which calibration point is mandatory.
The calibration curve can use multiple functions to better interpolate the
calibration standards.
The curve can be divided into three different segments and different functions
may be applied to each of them.
In order to define the segments, it is necessary to define start and end points that
correspond to the standards previously defined. For example Factor Assays use
3 segments to cover the entire range.
The end point of the first segment corresponds to the start point of the second;
the end point of the second segment corresponds to the start point of the third.
F(X) and G(y): lists the selectable functions.
1 X Y
2 1/X 1/Y
2
3 X Y2
4 ln (X) ln /Y)
5 ln [ln (X)] ln [ln (Y)]
6 log (X) log (Y)
7 log [log (X)] log [log (Y)]
X Y
8 e e
X Y
9 10 10
q' checkbox: When checked, it is possible to force the curve to pass through the
desired calibration point standard. If multiple segments have been defined, the q'
must correspond to the interconnection point between two segments (end of one
segment - start of the other segment).
Calibration Curve Checks:
A different slope range flag can be attributed to the different calibration curve
segments. Limit is from –99999 to +99999.
If the curve is not divided into segments, only the first line must be filled in.

Setup and Utility
If the slope is outside of the given range, an error is presented.

2
A different r flag can be attributed to different calibration curve segments. If the
2
r value is lower than the given limit presented (format is x.xxxx), a flag is
displayed.
If the curve has not been divided into segments, only the first line must be filled
in.
Clicking the Confirm button saves the changes; clicking the Cancel button
rejects the changes; in both cases the system goes back to the View Tests
screen.
and/or to turn the system off; No will cancel the operation.
Parallelism Setup
Selecting the Parallelism setup button allows definition of the checks used for
factor assays with parallelism.
Three dilutions can be performed on each sample. The Dilution Ratio %

displays the dilution percentage used on the system.

The results for the Parallelism can be selected for display and printouts in various
units using the following checkboxes.
o CR %: the system will take the results in seconds for each dilution,
convert these results to % activity by reading it off the calibration curve,
then multiply the results by the dilution factor.
o Ave CR%: the average of the 3 CR% results.
o CV-CR% : the CV of the CR% results.
Slope*: If enabled, a minimum and maximum acceptable value for the slope of
the line based on the 3 dilution values can be entered. Results outside these
limits will be flagged “out of range” and printed in bold.
Intercept*: If enabled, a minimum and maximum acceptable value for the

intercept of the line based on the 3 dilution values can be entered. Results
outside these limits will be flagged “out of range” and “results printed in bold.
* To enable and enter values you must be at the Lab Manager level
R2 : If enabled, a minimum and maximum acceptable value for the R2 for the
linear regression line (seconds vs. uncorrected % recovery) based on the 3
dilution values can be entered. Results outside these limits will be flagged “out of
range” and results printed in bold.
Maximum % Variance: Maximum allowable difference between the recalculated

results. This check is determined by comparing dilution result 1 to dilution result
2 and also comparing dilution result 2 and dilution result 3.
Maximum % CV: Maximum allowable CV% for the recalculated results.
Pressing the Units button will display the available units for parallelism. You can
select four of the units to display and print.

Setup and Utility
Highlight the desired unit and press the Show in Sample List. A check will be
placed in the left hand column. These units will display on the screen and be
printed. Up to 4 units can be selected.
Available units include:

o AVECR% Average of the recalculated results in %
o CV-CR% CV of the recalculated results in %
o Slope Slope of the parallelism line
o INT Intercept of the parallelism line
2
o r Correlation of the parallelism line based upon
the results versus the dilution %. This is determined
using linear regression analysis.
For Slope and INT you must enter a range to report and flag these units.
Results for factor parallelism can be printed in 3 ways:
1. Sample Report - This report will include 4 of the following selected by the
user:
a. Ave CR%
b. CV CR%
c. Slope
d. Int. (Intercept)
2
e. r
2. Cumulative Report – This report will include:

a. 1 st dilution , 2 nd dilution and 3 rd dilution results expressed in seconds
(s), percent (%) and the corrected result in % (CR%)
st
Note: For the IL locked tests the 1 dilution is 100%, 2nd dilution is
rd
50% and the 3 dilution is the 25%.
b. Ave CR%
c. CV CR%
d. Slope
e. Int. (Intercept)
2
f. r
3. Parallelism Detail Report

This report will include everything that is included on the cumulative report for
a sample along with a list of the errors associated with the sample.

4.3 UTILITY
The Utility portion of the ACL Elite/Elite Pro software groups all functions related to
saving data and handling the ACL software. For ease of use, Section 4.3.1 shows the
Utility submenu, and Sections 4.3.2 and above are labeled as the items in this submenu.
4.3.1 UTILITY Submenu

This group of functions can be accessed from the Main screen by pressing the
UTILITY button on the menu bar:
UPGRADE IL LIBRARY
BACKUP/RESTORE
ARCHIVE
SOFTWARE
- Software Identification
- Software Upgrade
- SW Master Upload-Upgrade
- SW Slave Upload-Upgrade
- SW REM Upload-Upgrade
SAVE LAST ROTOR MAP
SAVE TRACE
4.3.2 UTILITY- Upgrade IL Library

This utility is used to upgrade the IL tests library.
Follow the instructions indicated on the screen.
The screen will indicate to insert the IL Library diskette into the floppy (upper right
side of the instrument) and press continue.

Setup and Utility
At the end of the IL Library Upgrade all modifications are listed on the screen.
The modifications that occurred can also be printed on a report.
4.3.3 UTILITY- Backup/Restore

This utility is used to backup or restore the system configuration.
Backup will save the following information to one or more floppy disks:
instrument configuration in terms of Host, Printer, Barcode and Keyboard; all
tests setup, profiles setup, test group setup, liquids setup, interference table,
default tests, reflex tests; QC setup, AR setup, etc.
Restore will copy the saved setup information from the floppy disks back into the
analyzer.
Note: Patient results, Calibration curves, QC results and AR results cannot be

backed up and restored.
View Backup Date will display the date the backup was created.
The disk used to create the backup should be a preformatted unprotected Double
Sided High Density 3-1/2” floppy disk.
Warning: You can back up an ACL Elite and restore it to an ACL Elite Pro;
however you cannot backup an ACL Elite Pro and restore it to an ACL ELite.

4.3.4 UTILITY- Archive

This utility is used to copy/transfer analytical data to a floppy disk.
Four checkboxes allow selection of the set of data to be copied/transferred.
- PATIENT DATA (Sample Entry date range is selectable)*

- QC DATA (date range, QC liquid, and tests are selectable)
- AR DATA (date range and tests are selectable)
- CAL DATA (tests are selectable)
Setup and Utility
*Patient data is archived based upon the sample entry date and not the date the
sample was analyzed.
Enabling the checkbox Remove Data After Archive will delete the selected data
for completed samples from the ACL database.
To start the archiving procedure, press the START button.

The file name created by the instrument, is composed of two letters and six
numerical characters: the two letters identify the kind of selection made by the
operator (CD = Calibration Data, QC = Quality Control, PD = Patient Data, AR =
Analytical Reference), the numbers correspond to the date when this operation is
carried out (ddmmyy). The file extension is .000. These files are viewable using
common programs capable of reading text data.
The Data archived includes the following: test name, patient name with related
demographics, results, flags and calibration curve parameters, depending on the
selection made.
Warning: Archived data cannot be restored back to the ACL Elite/Elite Pro. The
data can be viewed using a standard PC capable of viewing text data.

4.3.5 UTILITY- SOFTWARE - Software Identification

Selecting the Utility button on the menu bar and selecting Software
Identification opens the SW Identification screen.
The following information can be viewed but not edited on this screen:
MASTER SW IDENTIFICATION
SLAVE SW IDENTIFICATION
REM SW IDENTIFICATION (Not available on the ACL Elite)
IL TEST LIBRARY
The Confirm button leaves the screen and the system goes back to the Main
screen.
4.3.6 UTILITY- SOFTWARE - Software Upload-Upgrade

This option allows upgrade and upload of the major software areas when a
software release becomes available.
To start the upgrading and uploading procedures, select the software to be
upgraded and uploaded (Slave, Master or REM), insert the disk and follow the
instructions on the screen.
The procedure to load a new software revision is done in two steps for each of
the 3 areas of the software (Slave, Master and REM).

Setup and Utility
The software Upload operation copies the entire information to the hard disk.
The software Upgrade operation installs the software from the hard disk through
the system.
Slave Upload and Upgrade*

Second operation is the Slave Upload (copying information to the hard disk).
Insert the disk, select Slave Upload and continue.
When the Upload procedure is completed, please select Slave Upgrade
(software installation from the hard disk) and continue.
Master Upload and Upgrade*
First operation is the Master Upload (copying information to the hard disk).
Insert the disk, select Master Upload and continue.
When the Upload procedure is completed, please select Master Upgrade
(software installation from the hard disk) and continue.
REM Upload and Upgrade*
Third operation is the REM Upload (copying information to the hard disk).
Insert the disk, select REM Upload and continue.

When the Upload procedure is completed, please select REM Upgrade (software
installation from the hard disk) and continue.
At the end of each operation please verify that the Software Identification reports
the correct revision number.
*Warning: each Upgrade kit will include detailed instructions that supersede the
above instructions if they are different.
Please follow the Upgrade package instructions to perform Upload and Upgrade
operations.

4.3.7 UTILITY- Save Rotor Map

Selecting the Utility button on the menu bar and selecting Save Rotor Map,
opens the Save Rotor screen shown below.
This utility is used to save the analysis raw data to a floppy disk.
The system retains the raw data for all testing performed for the last 31 days.
The user can type the file name and select the file format by checking the
appropriate checkbox.
The DAT files are compatible with the Windows Research Program.
Note: the DAT file is only available if one test (up to 19 samples maximum) is
executed on the rotor. If more tests are executed on the same rotor the DAT file
option will not be available.
The TXT files are ASCII files and are compatible with the most common text
editors and spreadsheet (i.e. Word or Excel).
A maximum of 8 characters can be used for file name. Do not enter the filename
extension when entering a file name. The extension will automatically be added
depending upon the checkbox selected (TXT or DAT).
The file name format is: RMdxxhyy
o xx = day of the month the run was performed
o yy = hour of the day the run was performed*

Insert the disk and press Continue.
The Cancel button will exit to the main screen.

Setup and Utility
*Note: If multiple runs are performed within the hour selected, all runs will be
saved on the disk. A run time stamp separates the various run data on the disk.
The end of run time is used for the time stamp.
4.3.8 UTILITY- Save Trace

This utility is used to save all the operations performed by the instrument.
This utility is used for troubleshooting purposes in case a software defect may
appear (i.e. database error, system lockups, etc.).
The system saves a up to 31 trace files, one for each day for the past 31 days
Type the file name using the following format: Trace_XX.txt

Using a file name already on the disk will overwrite the previous file.
XX is the day of the month you want to save the trace on.
th
For example, to save the trace for the 10 day type: Trace_10.txt
In case the system may need to be rebooted, the trace file can still be performed
after restarting the analyzer.
The dimension of the trace file is maximum 1.44 Mb.
Note: The trace file will only monitor internal software or database errors. A
trace file does not include information about abnormal results.

4.3.9 UTILITY- Test/Material – Backup and Upload
This feature allows single material and test definitions to be copied onto disks
and uploaded from disk.
Selecting the Backup option from the menu displays the following screen
The Test/Material drop down box allows you to select a material ID, Test ID or
Test Group to backup.
The Test/Material list below the selection will then display either the material
IDs, Tests or Test Group based upon the above selection.
Check the Comments box to include the internal comments in the backup
In the Filename box enter the filename (8 characters maximum with no

extension needed)
Press the confirm button to start the backup or the cancel button to exit the
screen.
Selecting the Upload option from the menu displays the following screen

Setup and Utility
Select Test/Material from the drop down box.
A check in the Overwrite box will cause the new information uploaded to replace
the information currently defined in the system.
Enter the Filename of the Material or test to be uploaded (8 characters maximum

with no extension needed).
Press the confirm button to start the backup or the cancel button to exit the
screen.

Diagnostics and Maintenance
5.0 Introduction
The purpose of this Section is to familiarize the ACL Elite/Elite Pro user with the
software-driven diagnostics procedures that are performed automatically by the
system at the operator’s request. Through the ACL diagnostics programs, the user
can access the error history and logbooks of the system as well as perform checks on
key hardware items.
In addition, this Section contains all necessary information to perform Preventive
Maintenance procedures, and thus keep the ACL Elite/Elite Pro in top functional
condition.
5.1 The DIAGNOSTIC Submenu

The Diagnostic submenu can be accessed from the Main screen by pressing the
DIAGNOSTIC button on the menu bar:
PRIMING
CLEANING
MAINTENANCE
TEMPERATURE CONTROL
NEEDLES POSITION
SESSION ERROR HISTORY
FILE ERROR HISTORY
LOGBOOK
SERVICE (dimmed). Only accessible to Service
The following sections contain details about each of the items in the
Diagnostic submenu.
5.1.1 Priming
INSTRUCTIONS to perform a PRIMING CYCLE

(from the READY status)
• Click the Diagnostic button on the Main menu bar
• Select Priming from the Diagnostic menu

The ACL starts a priming cycle, washing needles and pistons.
Duration: approximately 50 seconds
The Priming feature of the Diagnostics menu allows the operator to perform
an automatic priming cycle on the ACL in order to wash the loading module’s
pistons and needles. This priming cycle can only be activated if the system is
in the Ready mode.
The priming cycle must be performed at the following times:
- beginning of a working day or a shift
- end of a working day or a shift
- when the ACL has been OFF for a prolonged period of time
- after replacement of the Wash-Reference Emulsion bottle
In order to perform a priming cycle, click the Diagnostic button on the Main
menu bar and select the Priming option from the Diagnostic submenu to
open the Priming screen:
The window in this screen displays a bar that moves during the cycle
activation to show the elapsed time, for a total of approximately 50 seconds.
The two piston dilutors will move up and down priming the tubing line with an
approximate consumption of 6 mL of Wash-R Emulsion (20 strokes per single
piston dilutor – total of 40 strokes; each single stroke of 0.15 mL).

- Stop followed by a confirmation window Do you really want to stop the
current operation? OK confirms the choice of Stop and Cancel cancels
the operation:


and/or turn the system off; No cancels the operation.
NOTE: when the instrument is in standby, an automatic priming cycle is

performed 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).

5.1.2 Cleaning
INSTRUCTIONS to perform a CLEANING CYCLE

(from the READY status)
Before starting the cleaning cycle, place the desired cleaning solutions in
reagent position R6 (for the reagent line) and reagent position R7 (for the
sample line).
• Click the Diagnostic button on the Main menu bar
• Select Cleaning from the Diagnostic menu
The ACL starts a cleaning cycle for the reagent and sample needles.
Duration: dependent upon the cycle configuration (see details below)
The Cleaning feature of the Diagnostic menu allows the operator to perform
an automatic deep cleaning of the ACL needles using selected cleaning
solutions, followed by rinse cycles using the Wash-Reference Emulsion.
Before starting the cycle, the selected cleaning solutions must be placed in
reagent position R6 for the reagent line and reagent position R7 for the
sample line.
For recommendations on cleaning solutions, refer to Section 5.2.3 and 5.2.7.
In order to perform a cleaning cycle, click the Diagnostic button on the Main
menu bar and select the Cleaning option from the Diagnostic submenu to
open the Cleaning screen shown below. Note: This procedure may only be
started when the ACL is in the READY status.
In this screen the operator may define the configuration of the cleaning
operation:

- VOLUME - volume in microliters of cleaning solutions (positions R6 and

R7) to be used in each single cycle to clean the reagent and the sample
lines: default is 130 microliters. Minimum volume is 0 and maximum
volume is 130 microliters.
- CYCLES No.- the number of cleaning cycles using the cleaning

solutions (same for both lines); default is 3 cycle. Minimum is 1 and
maximum is 5 cycles. Selecting 0 no cycles will be executed.
- WASHING AT COMPLETION - number of rinse cycles (defined for each

line) using Wash-Reference Emulsion; default is 5 cycles. Minimum is 1
and maximum is 5 cycles. Selecting 0 no cycles will be executed.
At a minimum either the sample, reagent or both lines need to be defined

prior to pressing “Start” for the cleaning cycle to be performed.
CLEANING PROCEDURE
Materials needed:
§ 4 glass vials (10 mL volume; diameter 23 mm)
§ 16 mL of Cleaning solution
§ 16 mL of Factor Diluent
Place the Cleaning solution in position R6 and R7 using the two glass vials
indicated above (maximum volume 10 mL; 23 mm diameter) filled with 8 mL
each of one of the following solutions:

§ IL Cleaning Solution (P/N 98317-00) for a normal cleaning procedure or

§ IL Cleaning Agent (P/N 98327-00) diluted 1:8 for a Decontamination
procedure.
Clicking the Start button starts the cleaning cycle and opens a window
displaying a bar that moves to show the elapsed time of the procedure.
If no liquid is detected in the vials the cleaning will be aborted.

After the first step using the appropriate cleaning solution substitute the two
vials filled with Factor Diluent in R6 and R7. Re-start the cleaning.
If the liquids are not in the appropriate positions, the cycle will automatically
abort and an error window will appear.
Clicking the Cancel button leaves the screen.

- Stop stops the cleaning procedure.

shutdown ACL ? Yes closes the session, allowing the operator to log off

5.1.3 Maintenance
The Maintenance subsection of the Diagnostic menu allows the user to
access and record dates related to the performance of specific maintenance
operations. This is meant to keep track of the frequency with which the
instrument is maintained and for troubleshooting purposes.
For information about Maintenance Procedures and recommended

frequency guidelines, refer to Section 5.2.
To open the Maintenance screen, click the Diagnostic button on the Main
menu bar and select the Maintenance option from the Diagnostic submenu:
The large window that occupies most of the screen displays a list of the
suggested maintenance operations along with their recommended frequency
in days.
Operation Days (Frequency)
§ CLEANING CYCLE 7
§ RINSE WASTE RESERVOIR 7
§ CLEAN OPTICAL SENSORS AND WINDOWS 14
§ CLEAN AIR FILTER 28

Next to the Maintenance/Operation column there are three other columns

containing the following information relative to each procedure:
LAST DATE: The date does not need to be typed in after performance of a
specific operation. Clicking the Date button causes today’s date to appear
automatically. Items displayed in red indicate that the maintenance is past the
listed frequency and is overdue. If a run is processed with maintenance
overdue, the Session Error History button will illuminate to alert the operator,
and the results will be flagged. The alert icon will also be illuminated when
maintenance is due. The Clear button will delete the date displayed.
DAYS: This number cannot be edited; it is the IL-recommended frequency in
days with which this procedure should be performed.
NOTE icon opens the Insert Notes screen for entry of free text (26 characters
maximum can be printed).
Clicking the Confirm button saves changes in the Notes screen.
Clicking the Cancel button rejects the changes; in both cases the
system goes back to the Main screen.
Clicking the Printer button, followed by a confirmation window Do you really
want to print? Yes/No, prints the maintenance list.
Clicking the Confirm button saves the changes and clicking the Cancel
button rejects the changes; in both cases the system goes back to the Main
screen.

5.1.4 Temperature Control

Through the Temperature Control option of the Diagnostic submenu the
operator is able to check if the temperatures of the system are within their
acceptable ranges. This is a real-time update screen and the display will
flicker as the temperatures are constantly updating.
Clicking the Diagnostic button on the Main menu bar and selecting
Temperature Control open the Temperature Control screen:

The window in this screen contains 3 columns:
- DEVICE - indicates the areas that are checked

- NORMAL RANGE (°C) - indicates the acceptable range for each device:
- Rotor holder: 38 to 39 °C 100.4 to 102.2 °F
- Peltier: 10 to 16 °C 50 to 60.8 °F
- Rotor transport* 34 to 40 °C 93.2 to 104.0 °F
- Rotor stack: 34 to 40 °C 93.2 to 104.0 °F
- TEMPERATURE (°C or °F according to the selected Units in Setup) -
indicates the actual temperature in the area
*Used to monitor Base of Rotor Stack in ACL Elite
want to print? Yes/No, prints the temperature list report.
Clicking the Confirm button exits the screen and the system goes back to the
Main screen.



5.1.5 Needles Position

The Needles Position option of the Diagnostic submenu is used to center the
needles after changing or removing the needle block.
The needle position has to be verified with the rotor cover open, therefore
press the Open/Close Cover button to open the Rotor cover. Install
alignment tool.
Clicking the Diagnostic button on the Main menu bar and selecting Needles
Position causes a very quick self-initialization. After a reminder to open the
cover, the arm moves over the rotor holder area.
The Raise/Lower Arm button will raise/lower the arm over the rotor holder
area.
The Rotate button will move the rotor holder 90° (1/4 turn).
If the needles position procedure has to be carried out, the needle adjustment
tool must be placed on the rotor holder. For details on this operation, refer to
Section 5.2.6.
Remember to remove the tool at the end of the procedure.

Clicking the Stop button, followed by a confirmation window Do you really
want to stop the current operation? OK the system goes back to the main
screen; Cancel will cancel the operation.
In order to verify the needle centering with the rotor cover closed, repeat the
operation described in 5.2.6.


5.1.6 Session Error History

Any error or alarm occurring during an analytical session is recorded in the
system.
Up to 200 errors can be stored in the error file. The file is handled
automatically using the first in first out approach.
If the user wants to view the errors and alarms while the session is active,
clicking the Diagnostic button on the Main menu bar and then selecting the
Session Error History option will open the Session Error History screen:
The window in this screen contains descriptions of all the errors and warnings
that occurred during the current session along with the date and time. The
latest error or warning appears at the top of the list.
want to print? Yes/No, prints the error list.

Main screen.
As soon as a new session starts, the previous session errors are
automatically erased and the permanent errors are transferred to the File
Error History database.

5.1.7 File Error History

The ACL Elite/Elite Pro software records, stores and displays all the errors
and warnings that occurred since the system was first turned on.
Up to 100 errors can be stored in the error file. The file is handled
The error history may be viewed in the Error File History screen (shown
below), which opens by first clicking the Diagnostic button on the Main menu
bar and then selecting File Error History from the Diagnostic submenu.

This screen displays descriptions of all the errors and warnings along with the
date and time when they occurred. The latest error or warning appears at the
top of the list.
want to print? Yes/No, prints the error list.
Clicking the Clear button followed by a confirmation window deletes all the
messages in the file. Available at the IL-Service Level only.
Main screen.

5.1.8 Logbook
The ACL Elite/Elite Pro software records, stores and displays information on
all the actions performed on the system since it was first turned on.
Actions traced in the Logbook are all the conditions in which an operator
decision is taken. For example, a Liquid entry, a change in assigned value, a
modification in the setup and/or in the configuration, etc. are recorded.
Up to 200 messages can be stored in the logbook file. The file is handled
The logbook may be viewed in the Logbook screen, which opens by first
clicking the Diagnostic button on the Main menu bar and then selecting
Logbook from the Diagnostic submenu.
This screen displays descriptions of all the actions and the login level along
with the date and time when they occurred. The latest action appears at the
top of the list.
§ DATE/TIME: date and time when the action occurred

§ LEVEL: password level
§ USER NAME: user
§ ACTION: description of the action performed

§ NOTE: user editable field for comments
Clicking the Notes button the operator is allowed to enter comments for each
logbook message. (26 characters maximum)


want to print? Yes/No, prints the logbook records.
Main screen.

5.1.9 Service (dimmed)

This section is not accessible at the user level.
The procedures listed in the Service section of the software are to be
performed only by trained IL Service Engineers and therefore are not
included in this Operator’s Manual.

5.2 MAINTENANCE PROCEDURES
5.2.1 Introduction
The ACL is a precision instrument. In order to keep it in functional condition
IL recommends that a trained operator, at the minimum frequency specified,
carry out the following operations.
Warning:
The instrument should be decontaminated before performing any
maintenance procedure and/or service. For instructions related to
Decontamination Procedures, refer to Section 5.2.7 below.
While performing maintenance procedures, the operator should wear
protective clothing and gloves to prevent direct contact with items
potentially contaminated with blood. Hands should also be washed
immediately after gloves are removed and before leaving the laboratory.
Also refer to NCCLS GP25-A Vol. 13 No. 22: Clinical Laboratory Waste
Management, Dec. 1993.
5.2.2 Daily Preventive Maintenance

The following checks and procedures should be performed on the ACL
before starting the daily testing or once per shift.
IMPORTANT NOTE: The ACL will perform optimally if it is left ON at all

times. The complex electronic circuit is most reliable if the number of ON/OFF
cycles is kept to a minimum. Leaving the instrument in the Standby mode
guarantees minimum power consumption and maximum readiness for
operation at any time. For additional information refer to Section 1.
• Check Wash-Reference Emulsion

The Wash Reference Emulsion bottle is fitted with a liquid level sensor that,
reports in real time the amount of solution left in the bottle (mL). This sensor
also produces a warning to alert the operator when the solution in the bottle
is insufficient for additional testing.
If the sensor is switched off in the Setup Configuration option, the operator
must check that the level of liquid in the bottle is at least 1.5 to 2 cm from the
bottom.

If the level is lower, replace the Wash-Reference Emulsion bottle with a full
one and perform the priming procedure before using the system for testing
(refer to Section 5.1.1 or to Priming Procedure below).
NOTE: at a level of 2 cm, there is enough solution to perform testing in one

or two more rotors (taking into account the bottle dead volume).
• Check Waste Liquid Container

Check the level of the waste container and empty if necessary. Also verify
visually that the waste flows freely into the container. For correct installation,
please refer to Section 2.
Warning: The liquid waste of the instrument should be considered a

source of contamination and should therefore be discarded following
the laboratory’s waste procedures, in compliance with the local
regulations. Also refer to: NCCLS GP25-A , Vol. 13, No. 22: Clinical
Laboratory Waste Management, Dec. 1993.
• Perform Priming Procedure

The priming procedure is used to flush the liquid flow path of the system, thus
ensuring removal of sample or reagent residues that may accumulate during
sample analysis. The priming procedure is an effective way to maintain the
ACL’s needle assembly and the rinse reservoir in good working condition.
The ACL automatic priming procedure should be performed at the beginning
and at the end of each working day.
In order to perform the priming cycle, click the Diagnostic button on the Main
Menu bar and select the Priming option from the Diagnostic submenu. The
Priming screen opens with a message “Priming in progress” and priming
begins immediately. When the dispenser system finishes flushing the sample
and reagent needles, the instrument returns automatically to the Main menu.
For additional details, refer to Section 5.1.1.
Important: While the priming cycle is in progress, the operator should
visually inspect three items:
- The number of bubbles in the dilutor chamber is reduced to a minimum.

If bubbles are still present, pinch the chamber outlet tubes while the
piston is descending and release them before the piston reaches the
bottom dead center. Repeat the priming cycle as needed until all
bubbles are gone.
- There are no blockages or leaks in the liquid flow path and the liquid is
flowing smoothly from reservoir to dilutors and from dilutors to needles.
- There is free flow of the liquid waste from the washing chamber to the
instrument outlet tube and then to the waste container.

• Empty Rotor Waste

To access the container with the used rotors, open the small door on the front
of the analyzer body, to the right of the reagent area. Grab the handle of the
container and pull outwards to remove it.
Properly discard the used rotors found in the rotor waste container.
Location of Rotor Waste and Rotor Waste Container
Warning: Rotors contain potentially contaminated materials; discard

and incinerate used rotors according to the proper local regulations.
Note: A partially used rotor may be left in the rotor housing. A 24-hour
timer is set when a new rotor is introduced. After 24hours the user will
be prompted to enter the open cuvette positions for subsequent runs in
the rotor. In order to remove a rotor from the rotor holder, press the
Open/Close icon to open the rotor-holder cover and manually retrieve the
rotor, making sure not to spill its contents while transporting it to the waste
container. Close the rotor holder cover by pressing the Open/Close icon on
the screen. A partially used rotor may be placed back on the rotor housing to
use the remaining cuvettes. Prior to placing a rotor back on the analyzer, the
last used cuvette in the rotor should be filled with 200ul of Wash –R.
Warning: Do not return a partially used rotor to the rotor preheater.

5.2.3 Weekly Preventive Maintenance

Weekly preventive maintenance for the ACL consists of cleaning all the key
instrument areas that normally come in contact with sample and reagents
and therefore accumulate residues that will, if allowed to build up, impair the
instrument functionality and affect test results.
The parts/areas to be cleaned are:

- The instrument body, including autosampler and rotor holder area
- The needle assembly
- The rinse reservoir
• General Instrument Cleaning Procedure

Wipe down all exposed surfaces of the analyzer body, the inside of the auto-
sampler compartment and the rotor compartment (excluding the rotor holder)
using a cloth soaked in a 0.1 N Hydrochloric Acid (HCl) solution (IL Cleaning
Solution P/N 98317-00). Rinse using a cloth soaked in deionized water. Wipe
dry.
• Cleaning of Sample Spillage

In case of sample spillage in the auto-sampler or in the rotor compartment, it
may be required to clean the cup/tube sensor and the two optical paths in the
analysis area.
Cup/Tube sensor inside the sample tray area: wipe the two vertical faces of
the sensor using a clean cloth or cotton tip applicator soaked in a 0.1 N HCl
solution. Spills in the rotor compartment should be clean using dilute (1:8)
cleaning agent P/N 98327-00. Follow with deionized water and dry with a
clean cloth or cotton tip applicator.
Optical paths in the analysis area: refer to Section 5.2.4 below.
• Needle Cleaning Procedure
Although the daily priming procedure helps in maintaining the
sampling/dispensing needles in good working order, after a while protein and
other deposits will accumulate in the inside and the outside of the
sampling/dispensing needles. The following cleaning procedure should be
performed on a weekly basis in order to remove those deposits.
The procedure requires interaction between the operator and the ACL
software. For additional details, refer to Section 5.1.2 - Cleaning.

ACL setup:
Place 8 mL of a 0.1 N HCl solution in 2 vials.
Place the filled vials in reagent positions R6 and R7
For more detailed information please refer to 5.1.2 Cleaning.
Cleaning cycle
Click the Diagnostic button on the Main menu bar and select the Cleaning
option of the Diagnostic submenu to display the Cleaning screen.
In this screen the operator defines the configuration of the cleaning operation,
according to the needs of the instrument (refer to Section 5.1.2).
Clicking the Start button starts the cleaning cycle and opens a window
displaying a bar that moves to show the elapsed time of the procedure.
WARNING: If suspect infectious samples have been tested on the

system, refer to Section 5.2.7 to proceed with the appropriate
Decontamination Procedure.
• Rinse Reservoir Cleaning Procedure

Follow the steps below to clean the rinse reservoir:
Click the Diagnostic button on the Main menu bar and select Needles
Position.
This will cause the needle arm to move to the top of the rotor holder.
Remove the rinse reservoir, wash it thoroughly with a 0.1N HCl solution and
rinse it with deionized water.
Return the rinse reservoir to its position. Press the STOP icon and confirm
with OK. The needle arm goes back to the home position into the waste rinse
reservoir. The instrument returns to the Ready State.
5.2.4 Biweekly Preventive Maintenance

The rotor holder and the optical path components found in the analysis area
must be cleaned every two weeks under normal instrument use.
Rotor Holder and Optical Path Cleaning Procedure
Press the Open/Close Rotor icon to open the rotor holder cover.
Proceed as follows using the figure below as a reference:

Cleaning the Optical Path
- Using a cotton tip applicator moistened with deionized water, clean all 20
holes in the rotor holder and the surface of the channel sensor. Use a clean,
dry cotton tip applicator to remove all moisture from these areas. The cotton
swab should not be pushed down below the rotor holder assembly
- Clean the LED sensor surface (under the rotor holder) and the LED fiber
optic surface using a cotton tip applicator moistened with deionized water.
Use a clean, dry cotton tip applicator to dry these areas well.
- Using a cotton tip applicator moistened with deionized water, clean the
halogen lamp fiber outlet below the rotor holder and the chromogenic channel
sensor filter surface mounted in the rotor holder cover, as seen in the figure
above.
Use a clean, dry cotton tip applicator to dry the areas after cleaning.
Press the Open/Close Rotor icon to close the rotor holder cover.
5.2.5 Monthly Preventive Maintenance

• Checking and Cleaning the Air Filter
In order to clean the analyzer air filter, it must first be removed from its
location on the right side of the instrument. Insert a finger in the holder slot;
pull up and slide the filter out (see figure below).

Removing the Fan Filter
Check the filter. If it is dirty or blocked, clean it with compressed air or by

washing it in water and blowing it dry.
If the filter appears damaged, it should be replaced.

Do not place a wet filter back into the analyzer position.
Insert the clean or new filter back in its holder.
5.2.6 As-needed Maintenance

• Waste Line Cleaning Procedure
This procedure is performed to prevent formation of clots or to clean any
possible blockages (due to clotting) in the waste line. The frequency with
which this procedure should be done depends on the daily workload; once a
day may be necessary for heavy sample loads and less frequently for lighter
loads.
NOTE: This procedure may have to be performed more often

than as needed, depending on instrument use.

Materials required:
-
- a 20 mL plastic syringe
- a 20 cm PVC tube, 4 mm ID, 6 mm OD (this tube dimensions must be
such that it will fit onto the syringe on one end and into the waste line at
the other end)
- 20 mL deionized water
- a container for the deionized water
Preparation
Remove the needle from the plastic syringe (if necessary) and fit the PVC
tube on the end on the syringe. Fill the syringe with deionized water.
Procedure
Click the Diagnostic button on the Main menu bar and select Needles
Position for the Diagnostic submenu. This will cause the arm to move to the
top of the rotor holder.
Remove the rinse reservoir and clean it if necessary (refer to Section 5.2.3).
Insert the free end of the PVC tube into the waste line (hole in the rinse
reservoir area). Carefully inject the deionized water into the waste line and
check that the liquid flows from the external waste line of the instrument to
the waste container.
Repeat the procedure several times to ensure removal of any potential
blockage.
Replace the rinse reservoir. Click the Stop icon and confirm it with OK ; the
arm goes back to waste position and ACL returns to the Ready Status.
• Replacing the Needle
- Press the Open/Close Rotor Cover icon to open the rotor cover.
- Click the Diagnostic button on the Main menu bar and select Needles
Position from the Diagnostic submenu. The needle arm moves over the
rotor holder.
- Label the two tubings that connect to the needle assembly (i.e. top and
bottom).
- Loosen the white knob on the back of the needle, disconnect the tubing,
disconnect the sensor cable and remove the needle block.
- Insert the new needle block, connect the sensor cable, connect the two
tubings and position the block higher than the arm top surface.
Follow the needle positioning procedure as described in the next section.

• Needle Positioning Procedure

The procedure to reposition or adjust the ACL sampling/dispensing needles
is necessary in the following situations:
- after having dismantled the needles block for cleaning or
decontamination of the needles
- after having changed the needles block
Procedure
- In order to verify needle centering with the cover open, press the
Open/Close Rotor Cover icon to open the rotor cover.
- Insert the “needle alignment tool” (a special tool in the shipping kit) into
the rotor holder with side A facing up (refer to figures on next pages).
- Click the Diagnostic button on the Main menu bar and select Needles
Position from the Diagnostic submenu. An Open Cover? Yes/No screen
will display if you did not open the cover beforehand. Click Yes to open
the cover. The needle arm moves over the rotor holder.
- Loosen the white knob on the back of the needle arm and move the
needle block (or insert a new one) so that its top surface is higher than
the arm top surface.
- Click the Raise/Lower Arm button to lower the arm to the rotor holder
over the tool.

- Adjust the height of the needle block so that the needles touch the upper
surface of the tool and confirm that the two needles match the two white
reference dots on the tool surface.
- Tighten the needles using the white arm knob, making sure that the
position has not changed after the tightening.
- Click the Raise/Lower Arm button to raise the arm.

- Remove the tool and insert an ACL rotor; manually push the center of
the rotor snap to fit the rotor properly.
- Click the Raise/Lower Arm button to lower the arm and verify that the
needles enter the rotor holes (cuvette position 1) without touching the
edges of the holes.
- Click the Raise/Lower Arm button to raise the arm.

- Click the Rotate button to move the rotor to the next position (cuvette 6
of the rotor) and repeat the same procedure (as for cuvette position 1).
- Repeat as above for cuvettes position number 11, 16 and 1.
- If the centering of the needles is correct, as shown in examples A and B

of the Needle Alignment figure, proceed to the next step. If the needles
are not centered, correct the position.
- Remove the rotor manually.
- Click the Stop icon and confirm it with OK.
- The arm returns to the waste rinse reservoir position.
- In order to verify the needle centering with the cover closed, click the
Diagnostic button and select again Needles Position.
- The needles arm moves over the rotor holder.
- Verify that needles are contained in the rotor cover holes.

- Press STOP and confirm with 4 and the arm returns to the waste
reservoir position.
- Perform a Priming cycle (see Section 5.1.1).
NOTE: The alignment of the needles may not be identical for the four tested
rotor cuvettes. If a needle/needles do not enter the rotor port/ports or if the
sample needle is positioned to the right of the center in any one cuvette (as in
example C of the figure below), the needles must be re-adjusted in the
cuvette where it is furthest to the right, and the entire procedure must be
repeated.

Needle Positioning Tool: Top view
Needle Positioning Tool: Side view

Needles Alignment
• Replacing the Halogen Lamp

This operation should be done by an IL Representative Service Engineer.

5.2.7 Decontamination Procedure

Introduction
This section describes the procedure to be used to decontaminate the ACL
Elite/Elite Pro, either as a general precaution to prevent and eliminate
potential bacterial contamination, or after using the system to test a highly
infectious sample (i.e. from known or suspected Australia Antigen positive
and/or HIV positive subjects, etc.).
Warning: if spillage of a non-infected sample should occur during the course

of normal system use, clean the affected areas following the procedure
indicated in Section 5.2.3.
The use of the ACL system for the analysis of known or suspected highly
infectious samples should be followed by careful disinfecting of the
instrument surfaces and parts which have been in contact with the samples.
The disinfecting agent used to perform the procedure indicated below is a 1:8
dilution of IL Cleaning Agent P/N 98327-00, which is a solution of sodium
hypochlorite with a concentration of less than 0.625% of available chlorine.
The 1:8 diluted solution is prepared by mixing 1 part Cleaning Agent with 7
parts of distilled water.
WARNING: Use only IL Cleaning Agent (P/N 98327-00) diluted 1:8 with
distilled water.
CAUTION: The use of undiluted IL Cleaning Agent may cause corrosion

of metal parts.
Decontamination procedure
Materials required
- 2 glass vials (23 mm diameter, 10 mL maximum volume)
- Prepare approximately 16 mL of diluted Cleaning Agent solution (mix 1
part of IL Cleaning Agent and 7 parts distilled water; e.g. 2 mL of
Cleaning agent and 14 mL of distilled water)
Load the ACL reagent position R6 and R7:
- Reagent position R6 – Place the glass vial filled with 8 mL of diluted
Cleaning Agent solution
- Reagent position R7 – Place the glass vial filled with 8 mL of diluted
Cleaning Agent solution
- Select Diagnostic, then select Cleaning
- Press Start

At the end of the cleaning cycle the ACL returns to the cleaning screen.
Replace the Clean solution with Factor Diluent and repeat the procedure.
Press the cancel button to return to the main screen.
Refer to section 5.1.2 for further details on the cleaning cycle
Remove the vials in position R6 and R7.
Perform a Priming cycle.
Replace the external waste tube and the waste container.
NOTES:
The discarded items must be placed in an appropriate container for further
incineration, according to proper local regulations.
In case of suspected severe contamination, replace the tubing and discard

the old one in an appropriate container for further incineration, according to
proper local regulations

5.3 Maintenance Table
Maintenance Procedure
Daily - Empty, if necessary, the liquid waste container
- At the beginning and at the end of each working day or
once per shift, carry out a priming cycle
- Remove and discard used rotors from the rotor holder at
the end of the operation
Weekly - Perform an instrument cleaning procedure by cleaning
all exposed surfaces and the inside of the autosampler
and rotor compartments, with the exception of the rotor
holder, with a cloth soaked in a diluted solution of IL
Cleaning Solution (P/N 98317-00) and rinse with
deionized water (clean the rotor holder with diluted
IL Cleaning Agent (P/N 98327-00)
- Perform a cleaning procedure for needles carrying
out a dedicated cleaning cycle
- Perform a rinse waste reservoir cleaning procedure
Bi Weekly - Clean with a cotton tip applicator:
- the halogen lamp optic fiber surface
- the LED sensor
- the LED fiber optic surface
- the 20 holes of the rotor holder
4 Weeks - Check the air filter
Annual - Replace the air filter

- Replace the sample and reagent tubes
- Replace the waste tube
- Replace the needle block
- Replace the waste reservoir
As needed - Perform a waste line cleaning procedure at the end of
each working day, or more frequently if the number of
samples makes it necessary
- Perform a needle position procedure

ACL ELITE
ACL ELITE PRO Serial Number: 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
Daily
Perform System Prime
Empty Liquid and
Rotor Waste
Weekly
Perform Clean Cycle
Clean Rinse Reservoir
Bi-Weekly
Clean Optical Sensors
Monthly
Clean Air Filter
Troubleshooting
6.0 Introduction
Following the Maintenance guidelines described in Section 5 of this Manual is of
paramount importance to keep the ACL Elite/Elite Pro system in good working order
and to minimize instrument failures.
In the event of a malfunction, the ACL automatically notifies the user of the situation
through a system of warnings and alarms. With the help of built-in system checks and
the guidelines offered in this Section, the user would be able to resolve most of the
problems that may arise.
6.1 Failures, Alarms and Warnings

The following general definitions apply to the types of messages that the ACL
Elite/Elite Pro displays in case of system problems:
• A WARNING, displayed in the form of a yellow ICON on the bottom part of the
screen, announces a problem to the user. Clicking on the icon allows viewing of
text that describes the problem. As a general rule, the instrument may continue to
be used with some limitations, depending on the problem.
• An ALARM warns the user of a problem that needs immediate attention. Some
system sub-functions and operations will still be available. If the failure persists
after the operator switches the instrument off and on again (in case this is
suggested), the problem should be referred to a Service Engineer.
• A FAILURE message indicates a problem serious enough to prevent further use

of the instrument and requires the intervention of a Service Engineer.
All Warnings, Alarms and Failures are grouped in the following 10 categories
depending on the their origin. Each group is addressed in the Sections indicated
below:
- System anomalies Section 6.1.1
- REM (Rotor Exchanger Module) anomalies Section 6.1.2
- Temperature anomalies Section 6.1.3

- Mechanical anomalies Section 6.1.4
- Acquisition station anomalies Section 6.1.5
- Liquids anomalies Section 6.1.6

- Optics anomalies Section 6.1.7
- Operative anomalies Section 6.1.8
- Parsing and loading anomalies Section 6.1.9

- Database anomalies Section 6.1.10
Troubleshooting
6.1.1 System Anomalies

FAILURES
Error Message Possible Explanation Remedial Action
ACL thermal shut Temperature inside the Contact Service.
down analyzer is higher than
75 oC. The instrument
shuts down automatically.
ACL shut down The output current of the Contact Service.
+5 V supply is higher
than 11 A. The instrument
shuts down automatically.
Hard disk failure Problem with the Contact Service.
controller or damaged
hard disk.
Floppy disk failure Problem with the Contact Service.
controller or damaged
floppy disk.
RAM memory failure Bios finds RAM problem. Contact Service.
Full Hard disk The hard disk is full. Contact Service.
Opening File Missed critical opening Reload the main
file. software. If the failure
persists, contact
Service.
File length alarm Wrong length of a critical Reload the main
persists, contact
Service.
File read alarm Missed reading of a Reload the main
critical file. software. If the failure
persists, contact
Service.
File write alarm Missed writing of a critical Reload the main
persists, contact
Service.
File close alarm Missed closing of a Reload the main
critical file. software. If the failure
persists, contact
Service.
Exhausted memory Exhausted master Reload the main
memory. software. If the failure
persists, contact
Service.

Error opening window Error while opening a Reload the main

window on the master. software. If the failure
persists, contact
Service.
Master manager error Error on the master error Reload the main
manager. software. If the failure
persists, contact
Service.
Unexpected internal Unexpected internal Reload the main
message message on the master. software. If the failure
persists, contact
Service.
Internal sending failed Internal sending failed on Reload the main
the master. software. If the failure
persists, contact
Service.
Queue/semaphore Error while creating a Reload the main
creating error queue or semaphore on software. If the failure
the master. persists, contact
Service.
Driver installation Error while installing. Reload the main
error software. If the failure
persists, contact
Service.
Timer allocation error Error while allocating Reload the main
timer on master. software. If the failure
persists, contact
Service.
Internal library error Internal error in the library Reload the main
on master. software. If the failure
persists, contact
Service.
Len parse error Error in the message Reload the main
length from master to software. If the failure
slave. persists, contact
Service.
Subtype parse error Error in the message Reload the main
code (subtype) from software. If the failure
master to slave. persists, contact
Service.
Type parse error Error in the message Reload the main
code (type) from master software. If the failure
to slave. persists, contact
Service.
Invalid parameter Error in the parameter Reload the main
message from master to software. If the failure
slave. persists, contact
Service.

Troubleshooting
Database failure Major error in the Reload the main

database handling. software. If the failure
persists, contact
Service.
Coded SW failure Major error in code Reload the main
handling. software. If the failure
persists, contact
Service.
ALARMS
Master and slave do not
Slave communication Reload the main
communicate.
failure software. If the failure
persists, contact
Service.
A/D converter failure Periodic error while Reload the main
handling the ADC. software. If the failure
persists, contact
Service.
Slave code absent Missing slave code. Reload the main
software. If the failure
persists, contact
Service.
Slave download error Failed loading the slave Reload the main
code. software. If the failure
persists, contact
Service.
Check DB error Consistency error in the Reload the main
data base. software. If the failure
persists, contact
Service.
Check parameters Error in consistency of Reload the main
error the parameters. software. If the failure
persists, contact
Service.

WARNINGS
ACL thermal warning* The temperature inside Switch the system off,
the analyzer is higher wait a few seconds
than 60oC. and switch it back on.
If the error persists,
contact Service.
REM communication Missing communication Switch the system off,
error with REM. Either the wait a few seconds
(N/A on the ACL Elite) software is missing or and switch it back on.
REM is not working. If the error persists,
contact Service.
REM command error Command not executed Switch the system off,
correctly. wait a few seconds
(N/A on the ACL Elite)
and switch it back on.
contact Service.
REM download error Download not executed Switch the system off,
correctly. wait a few seconds
(N/A on the ACL Elite)
contact Service.
DB restoring Error Failure to restore Switch the system off,
database. wait a few seconds
contact Service.
DB backup Error Failure to backup Switch the system off,
database. wait a few seconds
contact Service.
File open warning Missed opening a non- Switch the system off,
critical file. wait a few seconds
contact Service.
File length warning Incorrect length of a non- Switch the system off,
contact Service.
File read warning Missed reading a non- Switch the system off,
contact Service.
File write warning Missed writing a non- Switch the system off,
contact Service.
Troubleshooting
File close warning Missed closing a non- Switch the system off,
contact Service.
Floppy disk full The current floppy disk is Replace with a new
full. floppy disk or Disk
drive.
Floppy disk missing# The current floppy disk is Check the floppy disk
missing. on disk drive.
Floppy disk write The current floppy disk is Replace with a new
protected# write protected. floppy disk.
Printer fail **# Printer is not connected Check printer and
or not working. connection.
Paper end No more paper in printer. Reload printer paper.
Internal BCR failure The internal barcode Switch the system off,
reader is not working. wait a few seconds
Reload the main
software. If the error
persists, contact
Service.
* Thermal Fail
This warning indicates the instrument is overheating internally which may
have an effect on the temperature of the measuring chamber. The reason
may be a clogged air filter obstructing the airflow in and out of the analyzer.
Check the air filter on the right side of the analyzer; clean or replace it as
necessary following the instructions in Section 5 (Maintenance). Make sure
that there is free airflow and that the ambient air temperature is below 35oC.
NOTE: The ACL Elite/Elite Pro works optimally when the ambient
o
temperature is in the range of 15 to 32 C, and does not fail in the range
o
of 10 to 40 C.
If cleaning the air filter does not resolve the warning and the ambient
temperature is within limits, contact Service.
** Printer Fail
If the printer does not produce a printout due to a printer failure, the results
may be obtained from the video. Results transmitted via the RS232 C data
link (if connected and enabled) are also correct.
In order to troubleshoot the printer, verify that the paper is correctly loaded.
Also verify that the proper transmission protocol has been selected in the
ACL Elite/Elite Pro Setup (ESCP2 or PCL), and that the printer supports the
selected emulation protocol.
#
The actual error displayed will vary depending upon the submenu where the
request was made. If the failure persists, contact Service.

6.1.2 REM (Rotor Exchange Module) Anomalies*

*(N/A on the ACL Elite)
FAILURES
REM elect fail REM electrical failure. Please logout.
Switch the system off,
wait a few seconds
contact Service.
REM voltage out of REM voltage out of Please logout. Switch
range range. the system off, wait a
few seconds and
switch it back on. If
the error persists,
contact Service.
Verify that there is no
REM vertical alarm Robotic vertical arm
obstruction interfering
motor failure.
with movement. If
there is no
obstruction, but the
error persists, the
system may be used
in the manual mode
by disabling the REM.
contact Service.
REM horizontal alarm Robotic horizontal arm
motor failure.
with movement. If
there is no
error persists, the
system may be used
in the manual mode
contact Service.
REM transport alarm Transport motor failure.
with movement. If
there is no
error persists, the
system may be used
in the manual mode
contact Service.

Troubleshooting

REM CPU failure REM CPU failure.
with movement. If
there is no
error persists, the
system may be used
in the manual mode
contact Service.
The system may be
REM arm EM fault Arm EM failure.
used in the manual
mode by disabling the
REM. If the error
persists, contact
Service.
The system may be
REM arm EM driver Arm circuit failure.
used in the manual
fault
REM. If the error
persists, contact
Service.
The system may be
REM transport EM Transport EM failure.
used in the manual
fault
REM. If the error
persists, contact
Service.
The system may be
REM transport EM Transport circuit failure.
used in the manual
driver fault
REM. If the error
persists, contact
Service.
The system may be
REM stack EM fault Stack EM failure.
used in the manual
REM. If the error
persists, contact
Service.
The system may be
REM stack EM driver Stack circuit failure.
used in the manual
fault
REM. If the error
persists, contact
Service.
REM errors can be generated if the Rotor Waste door is

opened while the analyzer is executing a rotor exchange.

6.1.3 Temperature Anomalies

ALARMS (also see notes at the end of this table)
Thermal power off Power circuit is off. Please logout. Switch
the system off, wait a
few seconds and
the error persists,
contact Service.
Incubation Incubation temperature Allow 30 minutes after
temperature out of out of range after power powering on to allow
range at startup on. temperature
stabilization. If the
error persists, contact
Service.
Incubation Incubation temperature Message may appear
temperature out of out of range during for a few seconds if
range normal operation the rotor cover has
been left open. If the
warning persists after
the rotor cover has
been closed for
several minutes,
contact Service.
Peltier out of range at Peltier temperature out of Wait 30 minutes after
startup range after power on. turning power on. If
the warning persists,
See Note 1.
contact Service.
Although the reagent
refrigeration is not
working correctly, the
system may continue
to be used as long as
the reagents are left
on the analyzer only
for the time required
for the testing.
Peltier out of range Peltier temperature out of If the warning
range during normal persists, contact
operation. Service.
Although the reagent
See Note 1.
refrigeration is not
working correctly, the
system may continue
to be used as long as
the reagents are left
on the analyzer only
for the time required
for the testing.

Troubleshooting
Transport out of Transport temperature Wait 30 minutes after

range at startup out of range at startup. turning power on. If
(N/A on the ACL Elite) See Note 2.
contact Service.
In the meantime,
although the thermal
regulation of the rotor
transport is not
operating correctly,
the system may be
used.
Transport out of Transport temperature If the warning
range out of range. persists, contact
Service.
(N/A on the ACL Elite) See Note 2.
In the meantime,
transport is not
operating correctly,
the system may be
used.
Stack out of range at Rotor stack temperature Wait 30 minutes after
startup out of range at startup. turning power on. If
See Note 2.
contact Service.
In the meantime,
stack is not operating
correctly, the system
may be used.
If the temperature is
Stack out of range Rotor stack temperature
out of range the
out of range.
system may be used
See Note 2. provided Q.C. is
processed during the
session and the
results are within
established limits. If
the error persists,
contact Service.
NOTES:
1. Error Message: Peltier Temperature out of Range
Explanation: Temperature is outside the 10-16oC range.

Remedial Action: Select DIAGNOSTIC from the Main Menu, and then
select TEMPERATURE CONTROL.
- If the video displays ------ or **** for the Peltier, the temperature may be
very high or very low. The instrument may continue to be used provided

that the reagents are left on board only for the duration of the testing, and
are refrigerated afterwards. Contact Service.
- If the video displays a temperature value from 4 to 12 oC for the Peltier,
the system is fully operational and precautions need to be taken.
However, the Service Engineer should be called to rectify the situation.
- If the video displays a low temperature value (from 20 to 36 oC), check
that the ambient temperature is not higher than 32 oC. If the problem is
not corrected, contact Service.
NOTE: As noted above, a high temperature may be caused by dirty

filters or ambient temperatures outside the optimal operational range.
2. Error Message: Transport or Stack Temperature out of Range

Explanation: Temperature is outside the 36-39oC range.
Remedial Action: Select DIAGNOSTIC from the Main Menu, and then
select TEMPERATURE CONTROL.
- If the video displays ------ or **** for the transport or stack temperatures
and the instrument has been properly warmed up, contact Service.
- If the video displays a high temperature value (from 36 to 50 oC), check

the air filter and ambient conditions as indicated in 6.1.1 (page 6.7). If the
problem is not corrected, contact Service.
- If the video displays a low temperature value (from 20 to 36 oC), check

that the instrument has been properly warmed up and that the ambient
temperature is higher than 15 oC. If the problem is not corrected, contact
Service.
NOTE: The system is fully operational even when the pre-heater

temperature is out of range, unless the message “INCUBATION TEMP
OUT OF RANGE” appears at the start of analysis.

Troubleshooting
6.1.4 Mechanical Anomalies

ALARMS
Please logout. Switch
Autosampler alarm Autosampler problem.
few seconds and
the error persists,
contact Service.
Rotor alarm Rotor holder problem.
few seconds and
the error persists,
contact Service.
Horizontal motor Horizontal motor arm
alarm problem.
few seconds and
the error persists,
contact Service.
Vertical motor alarm Vertical motor arm
problem.
few seconds and
the error persists,
contact Service.
Reagent dilutor alarm Reagent dilutor problem.
few seconds and
the error persists,
contact Service.
Sample dilutor alarm Sample dilutor problem.
few seconds and
the error persists,
contact Service.
Cover alarm Rotor cover problem.
few seconds and
the error persists,
contact Service.

WARNINGS
Autosampler warning Autosampler intermittent
problem.
few seconds and
the error persists,
contact Service.
Rotor warning Intermittent problem with
rotor holder.
with movement. If the
Service.
Horizontal motor Intermittent problem with
warning horizontal motor arm.
Service.
Vertical motor Intermittent problem with
warning vertical motor arm.
Service.
Reagent dilutor Intermittent problem with
warning reagent dilutor.
Service.
Sample dilutor Intermittent problem with
warning sample dilutor.
Service.
Cover warning Intermittent problem with
rotor cover.
Service.
The system may be
Stirrer fail Magnetic stirrer not
used without reagent
working.
stirring. In this case
the reagent should be
well mixed before
each run. If the error
persists, contact
Service.

Troubleshooting
6.1.5 Acquisition Station Anomalies

FAILURES
Acquisition timeout Acquisition running for Switch the system off,
alarm more than 30 minutes. wait a few seconds
contact Service.
WARNINGS
Acquisition start error Home position not found
at start.
error persists, switch
few seconds and
the error persists,
contact Service.
Acquisition sync error Home position not found
during acquisition.
error persists, switch
few seconds and
the error persists,
contact Service.
adc int error Unexpected ADC Log out, switch the
interruption system off, wait a few
seconds and switch it
back on.
contact Service.
Cuv int error Unexpected cuvette Log out, switch the
interruption system off, wait a few
back on.
contact Service.
Acq centrifuge error Rotor holder blocked Verify no obstruction
exist. Log out, switch
few seconds and
switch it back on.
contact Service.

Acq tx error Unable to Transmit data Log out, switch the

system off, wait a few
back on.
contact Service.
Acq rot fail error Rotor fail Log out, switch the
back on.
contact Service.
Acq opt ref error Optical reference fail Log out, switch the
back on.
contact Service.
Acq ref error Reference emulsion fail Log out, switch the
back on.
contact Service.
Verify that the rotor
Acq cover open error Cover open during
cover is closed. If the
acquisition
cover is closed, but
the error persists,
please logout. Switch
few seconds and
the error persists,
contact Service.
6.1.6 Liquids Anomalies

ALARMS
Verify the Wash-R
Flush short Reference Emulsion not
bottle liquid level. If
present.
the liquid level is low,
replace with a new
bottle. If sufficient
liquid is present, the
user may temporarily
disable the Wash-R
sensor. It is then the
operators'
responsibility to verify
the Wash-R level. If
the error persists with
the sensor enabled,
contact Service.

Troubleshooting
WARNINGS
Verify the Wash-R
Flush warning Reference Emulsion
bottle liquid level. If
below 100 mL level.
the liquid level is low,
replace with a new
bottle. If sufficient
liquid is present, the
user may temporarily
disable the Wash-R
sensor. It is then the
operators'
the Wash-R level. If
the error persists with
the sensor enabled,
contact Service.
Sample liquid sensor External needle (sample) If the sensor is
off sensor disabled. disabled, it is the
operator's
appropriate liquid
levels. If the error
persists with the
sensor enabled,
contact Service.
Reagent liquid sensor Internal needle (reagent) If the sensor is
off sensor disabled. disabled, it is the
operator's
appropriate liquid
persists with the
sensor enabled,
contact Service.
Sample liquid sensor External needle (sample) If the sensor is
fail circuit sensor error. disabled, it is the
operator's
appropriate liquid
persists with the
sensor enabled,
contact Service.
Reagent liquid sensor Internal needle (reagent) If the sensor is
fail circuit sensor error. disabled, it is the
operator's
appropriate liquid
persists with the
sensor enabled,
contact Service.

Sample short in Insufficient sample in An insufficient sample

position xxx position xxx. level was detected. If
using a tube transfer
the remaining sample
to a sample cup and
repeat the test. If
sufficient sample is
present, but the error
persists, contact
Service.
If the error appeared
Cleaning not Cleaning not performed
during an analysis,
performed due to insufficient or no
check the cleaning
cleaning solution present.
material level and
perform a cleaning
cycle. If sufficient
material is present,
but the error persists,
contact Service.
Material onboard Timer for a material
Replace the material
stability expired in onboard has expired.
and reset the onboard
position “XX” This material will be
timer.
displayed in orange on
the material map.
Liquid “ID” short A specific non-mandatory An insufficient
liquid “ID” is absent or in material level was
insufficient amount. detected. Make sure
that the material level
is sufficient. If
sufficient material is
persists, contact
Service.
Mandatory Liquid “ID” A specific mandatory An insufficient
short liquid “ID” is absent or in material level was
insufficient amount. detected. Make sure
that the material level
is sufficient. If
sufficient material is
persists, contact
Service.
Error Message: Flush/Optic Channel Error

Explanation: Problem with Reference Emulsion dispensing
Remedial Actions:
- Check the level of the Reference Emulsion in the bottle. If the level is
lower than 1 cm, replace the bottle with a new one. Mix by gentle
inversion before placing in the instrument.
- Check that the Reference Emulsion was correctly dispensed into the
rotor cuvettes for the rotor in the analysis cycle. The positions of the
Reference Emulsion depend on the test (further details in Section 7).
Troubleshooting
- If the Reference Emulsion bottle is in place and it has sufficient liquid,

check that the fluidic path is free of obstructions.
NOTE: a quick way to check the fluidic path is to remove the needle
assembly from the sample arm. Using a beaker to collect the liquid,
perform an automatic PRIMING cycle and check that the liquid is
coming out of both needles. Remember to perform a NEEDLES
POSITION ADJUSTMENT after this check (refer to Section 5).
- Check that the LED is ON.
- If the LED is ON, perform the optic path cleaning as described in the
Maintenance Section 5.
- If none of the above resolves the problem, contact Service.
6.1.7 Optics Anomalies

WARNING
Halogen lamp fail Halogen lamp is not
working.
few seconds and switch
it back on. The system
may be used without the
halogen lamp for
clotting-based tests
only. If the error
persists, contact
Service.
6.1.8 Operative Anomalies

WARNINGS
Waste full Rotor waste is full. Empty the rotor waste container. If
the error persists after emptying the
container, contact Service.
Waste open Rotor waste cover is Close the rotor waste container door.
open. If the error persists after this action,
contact Service.
No rotors (REM No more rotors in the Refill the rotor stack. If the error
active) rotor stack. persists after this action, contact
Service.
No rotors No more rotors in the Refill the rotor stack. If the error
(REM not rotor stack. persists after this action, contact
active) Service.
Rotor station No more rotors in the Refill the rotor stack. If the error
empty rotor stack. persists after this action, contact
Service.

Rotor refill Only one or two rotors Refill the rotor stack. If the error
left in the rotor stack. persists after this action, contact
Service.
Cover open Rotor cover was Close rotor cover. If the error persists
during loading / opened during the after this action, contact Service.
incubation loading or incubation
operation.
Time out Time out not met Log out, switch the instrument off,
expired during during loading. wait a few seconds and switch it back
loading on again. If the error persists, contact
Service.
No test to No test to perform Check the programmed tests in the
perform programmed in the database match the tests in the multi-
database and after tests session. Verify that the
host query. connection to the host is working
properly. If they are both OK, contact
Service.
? No tests performed Verify the presence of necessary
due to missing liquids. liquids. If they are all on-board,
contact Service.
6.1.9 Parsing and Loading Anomalies

WARNINGS
Parsing error xxx Error found in the Verify the test definition
parameters during setup is accurate and
loading. complete. Switch the
instrument off, wait a
few seconds and
switch it back on. If the
Service.
Run error xxx Error found during the Log out, switch the
run. instrument off, wait a
few seconds and
Service.
Session error xxx Error found during the Log out, switch the
session. instrument off, wait a
few seconds and
Service.

Troubleshooting
6.1.10 Database Anomalies

WARNINGS
Database warning Patient database at 95% Remove data from the
or higher. database
Database full Patient database at 100%. Remove data from the
database
6.2 Data Transmission Failure

The error Data Transmission is displayed when there has been an error in the
transmission of the data over the RS232 C interface.
Attempt to re-transmit the data as follows:
- Select SETUP from the Main Menu, select INTERFACE STATUS to view the
Data Transmission characteristics to the Host Computer
- Select Data Transmission connection (ACL-computer)
- Repeat the transmission from the Database.
If the fault persists, contact Service. For additional information please refer to
Appendix (Host Communication Protocol).
6.3 Data Reduction Error Codes

Any error that occurs during the data reduction process will be reported as a code
number. The following subsections describe all the error code numbers and their
meanings. Possible sources for the errors, identified by letter codes, are shown as
flags according to the following list:
Error Code Abbreviation Priority

Data reduction errors R 1 (Highest)
Temperature Errors T 2
Instrument errors (i.e. Sensor error) 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
Material Errors ((i.e. expiration) M 9 (Lowest)
Error Codes, that will not generate a valid result, are represented by an Error Number.
The Error Number is presented instead of a valid result.

Error codes that will generate a result plus an additional flag are indicated with a
message that explains the error.
Results with more than one error display the highest priority error.
6.3.1 Session Error Codes

Error 1 - No flush/optical error
Meaning No flush/optical error
Cause Nephelometric optical reference channel out of range
(above 4.0 V or below 1.5 V).
Flags Cycle aborted
Results No results in database.
Remedial Replace Reference Emulsion bottle and clean optics.
Action
Error 2 - Optical error

Meaning Optical error
Cause Absorbance optical reference channel out of range
Flags Cycle aborted
Remedial Clean optics.
Action
Error 3 - No flush
Meaning No flush
Cause Absorbance channel Reference Emulsion out of range
Flags Cycle aborted
Action
Error 4 - Optical failure

Meaning Optical failure
Cause Acquisition data check (signal above 10 V).
Flags Cycle aborted
Action

Troubleshooting
6.3.2 Reaction Curve Error Codes

Warning: For any sample, if you are unsure about the result after reviewing
the error code and clot curve, it is recommended the sample be rerun using
an alternate method.
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.
* = See more details in section 6.4

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.
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.

Troubleshooting
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
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 Numeric Result displayed
Remedial Review Curve and repeat sample
Action
6.3.3 Calibration Error Codes

Error code - 15
Meaning No cal - Insufficient data (curve with a single segment)
Cause Less than 2 calibration standards gave valid results in
the specific curve segment.
Flags on C – No cal - insufficient data
samples
Cal Results Error 15 instead of the result.
Remedial Invalid result. Review the reaction curve. Repeat the
Action calibration with freshly prepared materials.
Error code - 16
Meaning Invalid curve - Insufficient data (curve with more than
one segment)
Cause Less than 2 calibration standards gave valid results.
Flags on C – Invalid curve - insufficient data
samples
Remedial Invalid result. Review the reaction curve. Repeat the
Error code - 17
Meaning Lower No. of standards
Cause A number of standards points are less than the ones
defined in the setup.
Flags on - C – n-1 Standard points
samples
Remedial Invalid results. Review the reaction curve. Repeat the

Troubleshooting
Error code - 18
Meaning No cal - No mandatory standard/s
Cause A mandatory calibration standard does not give a valid
result (single curve segment).
Flags C – no cal no Standard
Remedial Invalid curve. Review the reaction curve. Repeat the
Error code - 19
Meaning Invalid curve segment - No mandatory standards
Cause A mandatory calibration standard does not give a valid
result (curve with more than one segment).
Flags on C – invalid curve no Standard
samples
Remedial Invalid curve. Review the reaction curve. Repeat the
Error code - 20
Meaning Invalid standards replicates
Cause One or more of the replicates for a defined calibration
standard does not give a valid result.
Flags on C– Invalid Standard n
samples
Cal Results Error 20. Mean is flagged. CV is shown flagged (in
red).
Remedial Invalid standard. Review the reaction curve. Repeat
Action the calibration with freshly prepared materials.
Error code - 21
Meaning CV not shown – Insufficient replicates
Cause One or more of the replicates for a defined calibration
standard does not give a valid result. CV cannot be
calculated (replicates below or = 2).
Flags on C – Insufficient replicates
samples
Cal Results Error 21. CV is not shown.
Remedial Invalid standard. Review the reaction curve. Repeat

Error code - 22
Meaning Invalid replicate
Cause One replicate for a defined calibration standard does
not give a valid result.
Flags C – Invalid replicates
Results Error 22. Mean value is flagged.
0Remedial Invalid replicate. Review the reaction curve. Repeat
Error code - 23
Meaning CV out of range
Cause CV of the replicates higher than the selected limit.
Flags on C – CV out of range
samples
Cal Results Error 23. CV is flagged.
Remedial Result out of range. Review the reaction curve. Repeat
Error code - 24
Meaning No cal - slope out of range
Cause The slope of the curve (curve composed by a single
equation) is out of the defined range (single segment).
Flags on C – No Calibration: slope out of range
samples
Cal Results Error 24. Calibration curve not displayed.
Remedial Review the reaction curve. Repeat the calibration with
Action freshly prepared materials.
Error code - 25
Meaning Invalid curve - slope out of range
Cause One of the slopes of the curve (curve composed by
several segments) is out of the defined range.
Flags on C – Invalid segment - slope out of range
samples
Cal Results Error 25. Calibration curve is displayed.

Troubleshooting
Error code - 26
Meaning R2 R2 out of range
Cause R2 The R 2 of the calibration is outside the selected limit.
Flag on C - R2 out of range
samples
Cal Results Error 26. Calibration curve is displayed. R2 value is
flagged.
Error code - 27
Meaning No Calibration - No valid curve
Cause The calibration curve does not have any valid
segment.
Flags on No Calibration – no valid curve
samples
Cal Results Error 27. Calibration curve is not presented.
Error code - 28
Meaning Curve non monotonic
Cause Invalid calibration due to a result not in sequence
compared to the other calibration points.
Flags on C – invalid segment
samples
Cal Results Error 28. Non monotonic curve.
Remedial Repeat calibration.
Action
Error - Extrapolated data

Meaning Extrapolated data.
Cause Test result is above 150% as compared to the highest
calibration standard or below 60% as compared to the
lowest calibration standard.
Flags on C - Extrapolated result.
samples
Cal Results None
Remedial None
Action

Error – Invalid Adjacent Segment (Factor Assays)
Meaning One Segment of Calibration Curve contains an error.

Flags on C – Invalid Adjacent Segment
samples
Remedial Review results before reporting. Repeat any samples
Action if the results are suspicious.
6.3.4 Analytical Reference Error Codes

Error - AR invalid
Meaning AR invalid (using Reference Value for Ratio/INR
calculation)
Cause AR does not give a valid result.
Flags on A – AR invalid
samples
AR Results AR is flagged with an R that indicates the specific Error
code number.
Remedial Review the reaction curves. Repeat the test with
Error - AR out of range

Meaning AR out of range (using Reference Value for Ratio/INR
calculation)
Cause AR gives a result out of range.
Flags on A – AR out of range
samples
AR Results AR is flagged in blue.
Error - AR invalid
Meaning AR invalid (AR used as reference for Ratio/INR
calculation)
Cause AR does not give a valid calculated result.
Flags on A – AR invalid. Ratio/INR on samples is not presented
samples
AR Results AR is flagged.

Troubleshooting

Meaning AR out of range (AR used as reference for Ratio/INR
calculation)
Cause AR gives a result out of range.
Flags on A – AR out of range. Ratio/INR on samples is not
samples presented

Meaning AR out of range (compared to a Calibration standard)
Cause AR does not have a valid Ratio result.
Flags on A – AR out of range, Ratio/INR on samples is not
samples presented
AR Results AR has no ratio calculated.
Error - AR not checked

Meaning AR not checked (compared to a Calibration standard
not defined)
Cause AR not checked.
Flags on A – AR not checked. Ratio/INR is given on samples
samples

Meaning AR out of range (no check on AR selected)
Cause AR gives an invalid result.
Flags on none
samples

Error - ARa invalid

Meaning ARa invalid (check on ARa selected)
Cause ARa is invalid.
Flags on A - ARa invalid
samples
ARa Results ARa flagged.
Remedial Repeat the test with freshly prepared materials.
Action
Error - ARa out of range

Meaning ARa out of range (check on ARa selected)
Cause ARa is out of range.
Flags on A - ARa is cut of range
samples
ARa Results ARa is presented in blue.
Action
Error - ARa invalid

Meaning ARa invalid (check on ARa not selected)
Cause ARa invalid.
Flags on none
samples
ARa Results ARa flagged.
Action
Error - AR invalid
Meaning AR invalid (Ratio defined versus one Calibration
Standard)
Cause AR gives an invalid calculated unit.
Flags on A – AR invalid. Ratio/INR is presented on samples
samples

Troubleshooting

Meaning AR out of range (Ratio defined versus one Calibration
Standard)
Cause AR gives a calculated out of range result.
Flags on A – AR out of range. Ratio/INR is presented on
samples samples.
AR Results AR is calculated and presented in blue.
Error - AR invalid
Meaning AR invalid (No check on AR is selected)
Cause AR gives an invalid result.
Flags on none
samples

Meaning AR out of range (Check on AR is selected)
Cause AR gives an out of range result.
Flags on A – AR out of range. Ratio/INR are not given if AR is
samples defined for Ratio/INR calculation

Meaning AR out of range (Check on AR is selected on
Calibration standard)
Cause AR gives an out of range result.
Flags on A - AR out of range. Ratio/INR are given but flagged
samples

6.3.5 QC Error Codes

Error - QC Invalid
Meaning QC not valid (Check QC – Not selected)
Cause QC gives a non-valid result.
Flags on No flag on samples
samples
QC Results QC result is not displayed and the specific code
number is presented.
Error - QC Invalid
Meaning QC not valid (Check QC -selected, flag samples - not
selected)
samples
Error - QC out of range

Meaning QC out of range (Check QC - selected, flag samples -
not selected)
Cause QC gives a result out of range.
samples
QC Results Flagged with QC Invalid and appear in violet or red.
Error - QC invalid
Meaning QC invalid (Check QC - selected, flag samples -
selected)
Flags on Q – QC Invalid, Flag on samples is present
samples

Troubleshooting
Error - QC out of range

Meaning QC out of range (Check QC - selected, flag samples -
selected)
Cause QC gives a result out of range.
Flags Q – QC out of range flag on samples is present
Results QC result is flagged in violet or red
6.3.6 Double Test Error Codes

Error code - 45
Meaning Mean not calculated (No check selected on mean)
Cause One of the two tests is not valid (non numeric result).
samples
Results Error 45. Mean is not displayed.
Error code - 46
Meaning Mean not calculated (Check selected on mean)
Cause One of the two results is not valid.
Flags on W – Mean not calculated. Flag on samples
samples
Results Error 46. Mean is not displayed.
Error - Mean out of range

Meaning Mean out of range (Check selected on mean)
Cause One of the two results is out of normal range or
linearity range.
Flags on W -- Mean is flagged on samples
samples
Results Mean is presented in relation to the violated result
range.

Error - Mean out of range

Meaning Duplicate out of range (Check selected on mean)
Cause Difference between Replicates exceeds limit
Flags on W - Mean is flagged on samples
samples
Results Mean is flagged in violet.
6.3.7 Ratio and INR Error Codes

Error code – 52/53/54/55/56/59/60/62/63/65
Meaning Ratio calculation error (i.e. Ratio for PT, APTT, TT,
etc.)
Cause One of the results needed for the calculation is not
valid.
Flags on W - Ratio calculation error. Flag on samples
samples
Results Error 52 = sample
Error 53 = Standard
Error 54 = AR
Error 55 = Sa
Error 56 = ARa
Error 59 = AR invalid
Error 60 = Standard invalid
Error 62 = sample invalid
Error 63 = Reference invalid*
Error 65 = ARa invalid
*Reference Value is set to 0
Error code - 50
Meaning Ratio : S or Sa out of range (i.e. Ratio for APCR-V)
Cause S or Sa out of normal range.
Flags on W – Ratio: S, Sa out of range.
samples
Results Error 50. Ratio is not calculated.

Troubleshooting
Error code - 58
Meaning NR: AR or ARa out of range (i.e. NR for APCR-V)
Cause AR or ARa out of range.
Flags on W – R: AR, ARa out of range.
samples
Results Error 58. Ratio is not calculated.
Error code – 57/64/66

Meaning NR error
Cause Ratio not available to calculate the NR
Flags on W – NR error.
samples
Results Error 57 = Ratio not found*
Error 64 = AR Ratio invalid.
Error 66 = AR Delta invalid.
*Reference Value is set to 0
6.3.8 DMS Errors
Error message Possible explanation

Data base full More than 1000 Sample IDs in the
DMS. Sample IDs must be deleted to
allow space for programming.
More than 30 tests Trying to program test # 31 for a
programmed per sample sample. Tests must be deleted to allow
space for programming.
Duplicated sample ID A duplicate sample ID has been
entered when editing a loadlist.
Duplicate sample ID must be deleted.
Control ID already used ID already used for a QC material.
Sample ID must be changed.
Control ID already used ID already used for another patient
for patient sample. Sample ID must be changed.
Invalid range selection One of the two IDs in the selected
range does not exist.
Sample ID not found ID requested does not exist in the
database.

6.3.9 Other Miscellaneous Errors
Error message Possible explanation

Unidentified sample in Sample does not have an associated
position X ID in the loadlist.
Check sample tray Material is missing from the sample
tray.
Low Sample was found missing during
aspiration or liquid level detection
check.
Test X is not calibrated Test does not have a calibration
associated with it.
Added sample in position A sample that was not in the previous
X loadlist was found during the sample
tray check.
Used rotor Rotor is partially used. Enter the
unused cuvette positions (open the
rotor cover to check the first available
empty cuvette number).
Load rotors Rotor is insufficient to perform the
requested analysis. Add more rotors to
the rotor stack.
AR out of range NP out of range (± 9% for PT, ± 15%
for APTT or ± 20% for FIB-PT based).
QC out of range QC material out of range according to
the selected SD limit in the QC setup.
6.4 “Classic Data Reduction Error”

“Error” appears when there are anomalies in the data generated during the clotting of
the sample. The number that accompanies the error - 6, 7 or 13 - refers to the criteria
algorithm that detected the problem.
For additional details, refer to the diagram in Section 6.6 that graphically describes
the data reduction process.
Error 6
Failing criteria: The clot curve does not pass the first threshold before the end of the
acquisition time.
Possible causes: The sample may not have clotted during the acquisition time, or
the variation in the turbidity is insufficient to trigger the reading of the clotting point.
Run it in extended acquisition time.

Troubleshooting
Coag Error 7
Failing criteria: The clot curve passes the first threshold, but not the second
threshold, before the end of the acquisition time.
Possible causes: The sample may not have clotted during the acquisition time, or
the variation in the turbidity is insufficient to trigger the reading of the clotting point.
Run it in extended acquisition time.
Error 13
Failing criteria: When the initial slope of the reaction curve is too high, the criteria
used to decide the clotting point is the Maximum of the Second Derivative. If the limit
of the Maximum of the Second Derivative is not passed, it means that the
acceleration of the reaction is not significant enough.
Possible causes: The reaction curve may not be a real clotting curve, likely
indicating a curve that exhibits an unusual biphasic shape.
6.5 Sample ID Errors (using the internal barcode reader)

When using barcoded samples and sample identification is done with the ACL
internal barcode reader, the following errors may be generated:
- No_R = Sample ID missing
- Dpl = duplicated Sample ID
- No_C = truncated Sample ID
- Inv = invalid Sample ID
If any of these errors occur, the operator may enter the sample ID manually into the
system.

6.6 Data Reduction Diagram for PT, APTT and TT
CLOT CURVES
(after smoothing)
Below 1st threshold Threshold Algorithm Between

(part 1) 1st and 2nd
thresholds
ERROR 6 ERROR 7
Above 2 nd threshold
( above∆ time)
∆ time in seconds
Below ∆ time
Slope check control
Above limit Below limit
2nd derivative Threshold

algorithm Algorithm
(part 2)
Below limit ERROR 13 Above 2nd threshold

Above D2 limit Result (#)
Result (*)
(#) Time is calculated at the correspondence of the Maximum Second Derivative of

the clotting curve.
(*) Time is calculated at the intersection between the clotting curve and the first
threshold.

Assay and Instrument Specifications
7.0 Introduction
This Section includes specifications related to many assays performed on the ACL
Elite/Elite Pro system, as well as specifications related to the instrument and its
accessory items.
The following abbreviations are used throughout this Section:
• D-D h D-Dimer high
• APCR-V Activated Protein
• FPS Free Protein S
C Resistance - Factor V test
• LAC LAC Screen and
• AT Antithrombin
Confirm
• PLG Plasminogen
• SCT Silica Clot Time
• PCX Pro-IL-Complex*
• VWF von Willebrand
• HPX Hepatocomplex*
Factor
• PCL ProClot
• F8 chr H/L Factor VIII
• PC Protein C
chromogenic
• PS Protein S
High/Low
• FIB-C Fibrinogen Clauss
• DP Deficient Plasma
• FIB-C h Fib Clauss High
• AR Analytical
• FIB-C l Fib Clauss Low
Reference
• HEP Heparin
• PI Plasmin Inhibitor
* Not currently available in the U.S.
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.
The information provided in this Section is organized as follows:
Measured Parameters Section 7.1
Calculation of Results Section 7.2

Coagulometric Tests 7.2.1
Chromogenic Tests 7.2.2
Samples/Reagents Configuration and Specifications Section 7.3

Sample Requirements and Positions 7.3.1
Sample Positions in the Rotor 7.3.2
Coagulometric Test Volumes 7.3.3
Chromogenic Test Volumes 7.3.4
Special Test Volumes 7.3.5
Data Processing Features, Parameters and Analytical Specifications

Section 7.4
Flagging Limits 7.4.1
Results Format: VDU and Printer 7.4.2
Dealing with Result Messages 7.4.3

Calibration Curve Slope (m) 7.4.4

Calibration Curve Intercept (q) 7.4.5
Ranges for Calibration Plasma Values 7.4.6
Reaction Times 7.4.7
Coagulometric and Special Tests
Chromogenic Tests
Test Algorithms 7.4.8
Assay Performance Characteristics Section 7.5

Assay Precision Performance, Linearity and Method Comparison Studies
7.5.1
Assay Calibration Stability 7.5.2
Analytical Limitations Section 7.6

Carryover 7.6.1
Assaying a contaminating sample
Assaying a contaminated sample
Cephalin: needle self-conditioning 7.6.2
Lipemic Samples 7.6.3
Container Specifications Section 7.7

Primary Tubes 7.7.1
Cup and Reagent Containers 7.7.2
Instrument Specifications Section 7.8

Hardware and Operational Specifications 7.8.1
Dimensions 7.8.2
Data Bases Specifications 7.8.3
Ambient Specifications Section 7.9
Electrical Specifications Section 7.10
Hazards Section 7.11

General Warning 7.11.1
Shock Hazards 7.11.2
Electrical Hazards 7.11.3
Biohazards 7.11.4
Mechanical Hazards 7.11.5
Addendum: Method Comparison Studies
Note: Please refer to the individual test definitions in the Setup menu
on the analyzer for the latest test library settings for each assay.

7.1 Measured Parameters

This section describes the parameters that are measured by the ACL Elite/Elite Pro
assays to determine the test results. The tests are grouped according to their common
methodology. A brief explanation (text and graphics) of the methods is given.
Some of these parameters may also be one of the reporting units used by the ACL,
such as “seconds” for the coagulometric tests. All measurements are used in the
internal calculation of test results, either related to calibration curves or processed in
various ways to report other useful parameters as described in Section 7.2.
All parameters are measured on the ACL Elite/Elite Pro at 37oC ± 1 oC, provided the
ambient temperature is kept within the range of 15oC to 32oC.
COAGULOMETRIC TESTS: PT, APTT, TT, Factors, Pro-IL-Complex*,

Hepatocomplex*,SCT, ProClot, and Protein S
The ACL monitors clot formation by light scatter (LS), measuring the time (t)
expressed in seconds (s) required to reach a selected point in the clot formation
curve.

FIBRINOGEN (PT-Based)
This Fibrinogen test is based on clot monitoring measurements as it records the light
scattered before and after the formation of the clot and calculates the difference
between the two readings (delta light scatter = ∆LS).
CHROMOGENIC and LATEX TESTS: Antithrombin, Heparin, Plasmin

Inhibitor, Plasminogen, Protein C (Chromogenic), D-Dimer,vWF and Free
Protein S
The ACL monitors photometrically the color development of the reaction, and
calculates the difference between the light absorbed at the beginning of the reaction
and the light absorbed at a defined point during the reaction (∆OD).

FIBRINOGEN-C
This Fibrinogen test is measured by photometry, measuring the time in seconds that it
takes for the absorbance to change by a predefined amount; this time is then further
related to Fibrinogen concentration.
In case of patient results higher than 600 mg/dL (6 g/L), the test can be executed
using the FIB-C h. In case of patient results lower than 100 mg/dL (1 g/L), the test can
be executed using the FIB-C l. The FIB-C h test will automatically dilute the sample 2
fold and the FIB-C l test will concentrate the sample by half using a reduced volume.
7.2 Calculation of Results

This Section describes the ACL choices for calculation of results from the parameters
measured for each test. Some parameters are reported directly, such as “seconds” for
the coagulometric tests. For other tests, such as the chromogenic ones, the results
are calculated based on the fit of optical measurements to calibration curves, built by
performing similar measurements on calibrators. The ACL offers unit result choices
for many of the tests, as it is capable of using the basic measurements for one sample
and processing them in different ways to derive several other values which are
clinically significant (i.e. ratios).
The table below summarizes the tests, the ACL measured parameters and the result
formats that can be reported by the ACL. The choice of the reported results is
dependent on the instrument and analytical conditions (i.e. pre-calibration, presence
of AR in the run, units selection) as seen in the table below.
Tests Measured parameters Reported Results

PT Seconds s, %, R or INR
FIB (PT-based) Delta Light Scattering mg/dL or g/L
APTT Seconds s, R
Silica Clotting Time Seconds S, offset, final
TT Seconds S, R
Single Factor Seconds s, %
Antithrombin ∆ O. D. %
Heparin ∆ O. D. U/mL
Plasminogen ∆ O. D. %
Plasmin Inhibitor ∆ O. D. %
Pro-IL-Complex* Seconds s, %, R or INR
Hepatocomplex* Seconds s, %, R or INR
ProClot Seconds s, %, R
FIB-C Seconds mg/dL or g/L
Protein C (Chromogenic) ∆ O. D. %
*Not currently available in the U.S.

Tests Measured parameters Reported Results

Protein S Seconds s, %
Free Protein S ∆ O. D. %
LAC Screen and Confirm Seconds S, R
VWF ∆ O. D. Offset #, Max, %
F8 Chromogenic High/Low ∆ O. D. %
D-Dimer ∆ O. D. ng/mL, Offset #
APCR-V Seconds (S and Sa) s, R or INR
* Initial average absorbance reading for the reaction
Test Normal Plasma Stored calibration Not calibrated

(AR) in run
PT (Correct ON) with AR s, %, R, INR * s, R/INR *
without AR seconds seconds
PT (Correct OFF) with AR s, %, R, INR * seconds
without AR seconds, % ** seconds
Fibrinogen with AR mg/dL, g/L test must be
without AR calibrated
APTT with AR this test does not seconds, Ratio

without AR require calibration seconds **
TT with AR this test does not seconds, Ratio
without AR require calibration seconds **
Silica Clotting Time this test does not seconds
require calibration
LAC Screen/Confirm this test does not seconds, Ratio
require calibration
Antithrombin % , ∆ OD ∆ OD
Heparin Xa U/mL, ∆ OD ∆ OD
Plasmin Inhibitor %, ∆ OD ∆ OD
Plasminogen % , ∆ OD ∆ OD
Protein C Chromogenic % , ∆ OD ∆ OD
D-Dimer ng/mL, ∆ OD ∆ OD
F8 Chromogenic H/L % , ∆ OD this test MUST be
calibrated each run
Free Protein S % , ∆ OD ∆ OD
Factors s, % seconds
ProClot s , %, R seconds
Fib-C s, mg/dL or g/L seconds
Protein S s,% this test MUST be
calibrated each run
Pro-IL-Complex *** s, %, INR seconds
Hepatocomplex *** s, %, INR seconds
APCR-V # this test does not seconds (s and sa),
require calibration R, NR
* Thromboplastin ISI value is entered in Liquid Setup ** only in case R = S/AR

*** Not currently available in the U.S. # AR is required for NR calculation

7.2.1 Coagulometric Tests
PT (Prothrombin Time)
PT is measured in seconds. If Normal Plasma (AR) or a calibration curve is
run, the ACL can perform different calculations in order to report results in
other formats: % activity, R (ratio using AR) or INR (International Normalized
Ratio).
In the example below, the (100% calibrator) is measured at 11 seconds
(R=1), the 50% dilution of Calibration Plasma measured at 15 seconds
(R=1.36) and the 25% dilution is measured at 21 seconds (R=1.9).
The Calibration Plasma (100% calibrator) value - in seconds - is used as
denominator to calculate the Ratio (R).
100% NP : 11 s → 11 ÷ 11 = 1 (R)
50% NP : 15 s → 15 ÷ 11 = 1.36 (R)
25% NP : 21 s → 21 ÷ 11 = 1.9 (R)
1/A
PT
0.04
0.02
0.01
R
1 1.36 1.9
NOTE: If the PT test is run with “Correct with AR in Analysis” checked 4, the
Analytical Reference value in seconds is used to modify the calibration curve.
The modified curve is used for the calculation of the sample value.
If the PT test is run with “Correct with AR in Analysis” not checked, the
Calibration Plasma value in the original calibration curve (100% point) is used
for the calculation of the sample value.
Recalibrate the PT test when the lot of Wash-R or rotor lot (alpha character)
changes.
For more details, refer to Section 4 -Test Setup

• Result as % activity: The prothrombin activity of the sample is expressed

as % calculated from the calibration curve based on the R-value.
• Result as R: R is the ratio between the sample value in seconds and the
value in seconds for either the AR, the Reference Value or one of the
calibration standards (see NOTE above).
Sample PT (in seconds)

R (ratio) = ———
AR or Reference Value or Calibration Standard (in seconds)
• Result as INR: is the R-value normalized according to the ISI (Sensitivity

Index). To obtain this value, the ISI must be entered in the ACL software.
INR = RISI
APTT, TT
APTT and TT are measured in seconds. These tests do not require
calibration. Normal Plasma may be placed along with the samples in each
analysis run, or a reference value may be stored in the software. For
additional information, refer to Section 4 (Test Setup).
value in seconds for AR or a Reference Value.
Sample APTT/TT in seconds

R (ratio) = —
AR or Reference Value (in seconds)
APCR-V
This test is measured in seconds. Sa is the “activated time” and S is the “base
time”.
• Result as R: R is the ratio between the value in seconds for Sa and the
value in seconds for S.
Sa in seconds
R (ratio) = ———————
S in seconds
• Result as NR: NR is the normalized ratio, the sample ratio value divided by
the Normal Plasma (AR) ratio value.
Sample Ratio value

NR = ————————
AR Ratio value

FACTORS
Factors are measured in seconds; the ACL also calculates the % activity
based on a calibration curve.
The calibration curves for Factor assays are composed of three segments:
one High Curve segment with higher concentration calibrators; one Low
Curve segment with lower concentration calibrators and one Medium segment
which connects the high curve 25 % calibration point with the Low curve
6.25% calibration point.
The Calibration Plasma (100% calibrator) value - in seconds - is used as the
denominator to calculate the Ratio (R).
- For the High Calibration Curve segment:
100% NP : 40 s → 40 ÷ 40 = 1 (R)
50% NP : 50 s → 50 ÷ 40 = 1.25 (R)
25% NP : 60 s → 60 ÷ 40 = 1.50 (R)
The curve is constructed with Ratios (from seconds) on the x-axis and %
Activity on the y-axis, using a log-log scale.
Lg A
2.0
HIGH CURVE SEGMENT
1.69
1.39
Lg R
0 0.09 0.18

- For the Low Calibration Curve segment:

6.25% NP (log = 0.80) : 70 s → 70 ÷ 40 = 1.75 (R)
3.12% NP (log = 0.50) : 80 s → 80 ÷ 40 = 2.00 (R)
1.56% NP (log = 0.20) : 90 s → 90 ÷ 40 = 2.25 (R)
Lg A
0.80 LOW CURVE SEGMENT
0.50
0.20 Lg R
0.24 0.30 0.35
The MEDIUM SEGMENT connects the 25% and the 6.25% points.
• Result as % activity: for the whole range of Multilinear Calibration Curve

the ratio between the sample value in seconds and the Calibration Plasma
100% value in seconds is calculated and then used to read the value of
Activity from the calibration curve.
Refer to section 3.4 for preparation of 6.25% dilution used to calibrate low
curve.
Note: All samples run for factor analysis are automatically diluted (x5) by the
ACL system during the analysis.

Pro-IL-Complex*
Pro-IL-Complex is measured in seconds; the ACL also calculates the %
Activity based on a calibration curve.
Below are some typical calibration data and a graphical example of a Pro-IL-
Complex calibration curve – 25% - 6.25 segment.
Lg A
1.40
PCX
1.10
0.80
0.21 0.38 0.57 Lg R
Ratio values are calculated using the 100% Standard as denominator.

Therefore the Calibration plasma must be placed on the sample tray when the
Pro-IL-complex calibration is run.
100% NP : 40s → 40 ÷ 40 = 1
25% NP (log = 1.40) : 65s → 65 ÷ 40 = 1.63 (log = 0.21)
12.5% NP (log = 1.10) : 95s → 95 ÷ 40 = 2.4 (log = 0.38)
6.25% NP (log = 0.80) : 150s →150 ÷ 40 = 3.75 (log = 0.57)
The 100% - 25% segment is constructed with Ratios (from seconds) on the
x-axis and 1/% Activity on the y-axis, using a linear scale.
The 25% - 6.25% segment is constructed with Ratios (from seconds) on the
x-axis and % Activity on the y-axis, using a log-log scale.
The sample activity is obtained by calculating the ratio between the sample
value in seconds and the 100% Calibration Plasma in seconds. This value is
then read off of the calibration curve to obtain the value of % Activity.

HEPATOCOMPLEX *
Hepatocomplex is measured in seconds; the ACL also calculates the %
Below are some typical calibration data and a graphical example of a
Hepatocomplex calibration curve.
100% NP : 18 s → 18 ÷ 18 = 1 (R)
50% NP : 27 s → 27 ÷ 18 = 1.5 (R)
25% NP : 36 s → 36 ÷ 18 = 2 (R)
The Calibration curve is constructed with Ratio on the x-axis and 1/Activity on
the y-axis, on a linear scale.
1/A
0.04
HPX
0.02
0.01
1 1.5 2.0
The sample activity is obtained by calculating the ratio between the sample
value in seconds and the 100% Calibration Plasma in seconds. This value is
then read off of the calibration curve to obtain the value of % Activity.

Silica Clotting Time –Screen and Confirm

SCT is measured in seconds. These tests do not require calibration. Normal
Plasma may be placed along with the samples in each analysis run, or a
reference value may be stored in the software. For additional information,
refer to Section 4 (Test Setup).
value in seconds for a Reference Value.
Sample screen result in seconds

Screen R (ratio) = —
Mean of Screen Normal Range (in seconds)
Sample confirm result in seconds

Confirm R (ratio) = —
Mean of confirm Normal Range (in seconds)
Sample screen ratio

Normalized SCT (ratio) = —
Sample confirm ratio
ProClot
ProClot is measured in seconds; the ACL also calculates the ProClot %
Below are some typical calibration data and a graphical example of ProClot
calibration curve.
100% NP : 165 s → 165 ÷ 60 = 2.75 (R)

50% NP : 120 s → 120 ÷ 60 = 2.0 (R)
0% NP : 60 s → 60 ÷ 60 = 1.0 (R)
The calibration curve is constructed with squared Ratio on the x-axis and
Activity on the y-axis, on a linear scale.
A PCL
100.0
50.0
0.00
1.00 4.0 7.6 R
The sample activity is obtained using the squared Ratio (calculated using the
sample value in seconds and 0% calibrator value in seconds) to read the %
Activity off the calibration curve.

FIBRINOGEN (PT-Based)
The ACL records the light scattered before and after the formation of a clot
and calculates the difference (∆LS) between the two readings.
The ACL calculates the fibrinogen value of the sample in mg/dL using a
calibration curve. The curve correlates the fibrinogen concentration of 3
calibrators with their ∆LS Ratios.
Below is some typical fibrinogen calibration data and the calibration curve
constructed with them.
Cal. Conc. (mg/dL) Delta LS Ratio (R)

300 60 60 ÷ 60 = 1
150 30 30 ÷ 60 = 0.5
75 15 15 ÷ 60 = 0.25
The Calibration curve is constructed with Ratio on the x-axis and Fibrinogen
concentration on the y-axis, on a linear scale.
C(mg/dL)
300
150
75
0.25 0.5 1.0 R

The ACL calculates the ratio between the fibrinogen sample values (in delta
LS) and the first point of Calibration Plasma (in delta LS) to obtain the
corresponding value in mg/dL from the calibration curve.
7.2.2 Chromogenic Tests

Antithrombin, Plasmin Inhibitor, Plasminogen,
Protein C (Chromogenic)
For these chromogenic tests, the ACL measures the difference between the
light absorbed at the beginning and at a defined point during the reaction
(∆OD). The % activity of the sample is calculated from a calibration curve
built with 3 calibrators of known activity and measured ∆OD. Below are

examples of calibration curves for Antithrombin, Plasmin Inhibitor

Plasminogen and Protein C.
A% AT/Plasmin Inhibitor A% Plasminogen/Protein C

100 100
50 50
25 25
OD OD

Heparin
For Heparin, the ACL calculates the concentration of the samples in U/mL
based on a calibration curve. The calibration curve is built with 3 calibrators of
known concentration and measured ∆OD.
An example of a Heparin Calibration Curve is shown below.
U/mL Heparin High Curve

0.8
0.4
0.0 ∆OD
1.05 1.45 1.86
NOTE: For Antithrombin and Heparin, the delta OD is measured throughout

the reaction acquisition time of 30 seconds. For Plasmin Inhibitor,
Plasminogen and Protein C (Chromogenic) the acquisition time is 60
seconds.
D-Dimer
For the D-Dimer test, the ACL measures the difference between the light
absorbed at the beginning and at a defined point during the reaction (∆OD).
The concentration of D-Dimer in the sample, in ng/mL, is calculated from a
calibration curve constructed by correlating the calibrator’s delta OD values
and their respective concentrations in ng/mL.
In case of patient results higher than 1050 ng/mL, the test can be rerun using
the D-Dimer high (D-D h) test which has a linearity from 1000 to 5250 ng/mL.
Note: The D-Dh test should only be run on patients with a D-Dimer sample
concentration greater than 1000 ng/mL.

An example of D-Dimer Calibration curve is shown below:

D-Dimer (ng/mL)
1000
500
250
0.12 0.24 0.48 OD
Free Protein S
For the Free Protein S test, the ACL measures the difference between the
light absorbed at the beginning and at a defined point during the reaction
(∆OD). The concentration of Free Protein S in the sample, in %, is calculated
from a calibration curve constructed by correlating the calibrator’s delta OD
values and their respective concentrations in %. The calibration curve for the
Free Protein S is constructed of 3 segments:
Segment 1: 100% to 50%

Segment 2: 50% to 25%
Segment 3: 25% to 12.5%
An example of Free Protein S Calibration curve is shown below:
98.0
49.9
24.5
12.25
0 .06 0.10 0.20 0.34

7.3 Samples/Reagents Configuration

and Specifications
7.3.1 Sample Requirements and Positions
The following tables indicate the materials that must be placed on the ACL
Elite/Elite Pro sample tray in order to perform each test, along with their
respective positions. The tables group the different types of tests.
In the Tables, Ax indicates the material map positions on the sample tray for
positions A1 to A10 to be used for Calibrators, Diluents, Buffer, Deficient
Plasma, etc. The default positions are defined in the Setup submenu of the
ACL Elite/Elite Pro software.
For details, refer to Section 4 and Appendix C of this Manual.
COAGULOMETRIC TESTS
Test POSITIONS
Ax Ax Ax Ax 1-40
PT-FIB CAL Normal Factor -- -- --
Pool Diluent
PT-FIB Normal -- -- -- Samples
Pool
APTT Normal -- -- -- Samples
Pool
TT Normal -- -- -- Samples
Pool
PT-FIB/APTT Normal -- -- -- Samples
Pool
SCT Normal -- -- -- Samples
Pool
FACTORS Normal Factor Diluted Deficient Samples
(Calibration + Pool Diluent Normal Plasma
Analysis) (100%) Pool*
(6.25%)
DOUBLE TESTS
Test POSITIONS
Ax Ax Ax Ax 1-40
DOUBLE TEST Normal -- -- -- Samples
(PT-FIB, APTT, TT) Pool
Normal Pool = Calibration Plasma

* Diluted Normal Pool is prepared by placing 300ul of Factor Diluent + 20ul of
Calibration Plasma in a 0.5mL cup. Mix cup well prior to use.

CHROMOGENIC and SPECIAL TESTS

Test POSITIONS
Ax Ax Ax Ax Samples
AT Normal Factor Empty Empty empty cups
Calibration Pool Diluent cup cup in positions
1-12
AT Analysis -- Factor -- -- 1 – 20;
Diluent empty cups
positions
21-40
AT * Normal Factor Empty Empty --
Calibration Pool Diluent cup cup
AT* -- Factor -- -- 1 - 40
Analysis Diluent
Heparin Empty Calibrator Calibrator Working
Calibration Cup Dil.
Heparin -- -- -- Working 1 – 40
Analysis Dil.
PI Normal Diluted -- -- 1 - 40
Pool Buffer
PLG Normal Factor Substrate -- 1 - 40
Pool Diluent
PCX Cal.** Normal Factor DP # Empty --
Pool Diluent cups
PCX Anal.** -- -- DP # -- 1 - 40
HPX Cal.** Normal Factor Empty cups DP # --
Pool Diluent
HPX Anal.** -- -- DP # 1 - 40
PCL Normal Working Protein C Empty 1 - 40
Pool Diluent DP # cup
FIB-C Cal. Normal Factor -- -- --
Pool Diluent
FIB-C Anal. -- Factor -- -- 1 – 40
Diluent
PS Normal PS Activated PS 50% 1 - 40
Pool DP # DP # Std.
PC Normal Diluted Substrate -- 1 - 40
Pool Diluent
FPS Cal. Normal Factor Empty -- --
Pool Diluent Cups
FPS Anal. -- Factor -- -- 1 - 40
Diluent
F8 chr H Normal Empty Cup Empty Cup F8 Chr 1 – 20;
Cal/Anal. Pool Buffer empty cups
positions
21-40
F8 Chr L Empty Empty Cup Diluted F8 Chr 1 – 20;
Cal/Anal. Cup Normal Pool Buffer empty cups
positions
21-40
LAC Screen & Normal 1- 40
Confirm Pool
vWF Cal Normal Factor Dil Empty Cups vWF --
Pool Buffer
vWF Anal. -- Factor Dil vWF
Buffer

D-Dimer Calibrator Buffer Factor -- --

Calibration Pool diluent
D-Dimer -- Buffer -- -- 1 - 40
Analysis
APCR-V Normal Factor V -- -- 1 - 40
Pool DP #
* Liquid Antithrombin
** Not currently available in the U.S.
# = Deficient Plasma
The Normal Pool can either be the IL Calibration Plasma or a

laboratory’s pooled plasma.
7.3.2 Sample Positions in the Rotor (unused case)

The following table indicates, for each different test (or test combination in the
case of double tests), the positions occupied in the rotor by the materials
needed to perform the assay. A maximum of 19 samples are used.
TEST Cal Curve NP Samples Reference Optical

Emulsion Reference
PT-FIB Cal. 100% 1-6 -- -- 19 --
50% 7-12
25% 13-18
PT /APTT -- 1 2 - 19 20 --
SCT -- -- 1 - 19 20 --
TT -- 1 2 - 19 20 --
FACTOR 100% 1 -- 7 - 19 20 --
(Cal+Anal) 50% 2
25% 3
6.25% 4
3.12% 5
1.56% 6
FACTOR -- -- 1 - 19 20
Analysis
DOUBLE -- 1 2 - 19 20 --
TEST
(PT-FIB,
APTT, TT)
Liquid - AT 100% 2-5 -- -- 14 1
Cal. 50% 6-9
25% 10-13
Liquid - AT -- -- 2-9 20 1
Analysis
AT Cal. 100% 2-5 -- -- 14 1
50% 6-9
25% 10-13
AT. Analysis -- -- 2 - 19 20 1
Heparin 0.8 2-5 -- -- 14 1
Calibration 0.4 6-9
0.0 10-13
Heparin -- -- 2 - 19 20 1
Analysis
PI / PLG 100% 2 -- 5 - 19 20 1
50% 3
0%4
TEST Cal Curve NP Samples Reference Optical

Emulsion Reference
PCX 25% 5-8 -- -- 17 --
Calibration *. 12.5% 9-12
6.25% 13-16
100% 1-4
PCX Analysis * -- -- 1 – 19 20 --
HPX 100% 1-4 -- 13 --
Calibration *. 50% 5-8
25% 9-12
HPX* Anal. -- -- 1 - 19 20 --
PCL 100% 1 -- 4 - 19 20 --
50% 2
0% 3
FIB-C Cal. 150% 2-5 -- -- 14 1
100% 6-9
50% 10-13
FIB-C Anal. -- -- 2 - 19 20 1
PROTEIN-S 100% 1 -- 4 - 19 20 --
50% 2
0% 3
PROTEIN-C 100% 2 -- 5 - 19 20 1
50% 3
0% 4
FPS Cal. 100% 2-4 -- 14 1
50% 5-7
25% 8-10
12.5% 11-13
FPS Analysis -- -- 2 - 19 20 1
F8 Chr H/L 100% 2 -- 5-19 20 1
Cal./Anal. 50% 3
25% 4
LAC Screen/ -- 1 2 - 19 20 --
Confirm
vWF Cal. 100% 2-5 -- -- 18 1
50% 6-9
25% 10-13
12.5% 14-17
vWF Anal. -- -- 2 - 19 20 1
D-Dimer Cal. 1000 2 - 5 -- -- 14 1
ng/mL 500 6 - 9
250 10 - 13
D-Dimer -- -- 2 - 19 20 1
Anal
APCR-V -- 1 and 2 3 - 10 (s) 19 --
11-18 (Sa)
In the chromogenic cycles, the Reference Emulsion serves as a check to

verify complete washing between samples and from rotor to rotor.

7.3.3 Coagulometric Test Volumes

The following tables summarize the sample and reagent volumes aspirated
and dispensed for each coagulometric test, including “head” volumes.
PT-FIB Cal
100% PT-FIB APTT & SCT TT
50% Analysis
25%
Sample 10 µL/sample 10 µL/sample 10 µL/sample 10 µL/sample
Head 0
0
Sample 50 µL 50 µL 53 µL 75 µL
Dispensed 25 µL
12.5 µL
Diluent -- -- -- --
Head 10 µL/sample
10 µL/sample
Diluent -- -- -- --
Dispensed 25 µL
37.5 µL
Reagent 10 µL 10 µL/sample 10 µL reagent 50 µL
Head 10 µL per sample per rotor
10 µL 50 µL CaCl 2 /rotor
Reagent 100 µL 100 µL 53 µL reagent 75 µL
Dispensed 100 µL 50 µL CaCl 2
100 µL

NOTE: Conditioning of the needle for cephalin (APTT)

When the APTT based test is proceeded by a cycle using thromboplastin -
PT, Factors of Extrinsic Pathway, Pro-IL-Complex*, Hepatocomplex* and
Protein S, the internal needle aspirates 90 µL of cephalin or Clean A followed
by an 80 µL air bubble. The cephalin or Clean A is then dispensed into the
waste reservoir. This step is repeated three times.
EXTRINSIC PATHWAY INTRINSIC PATHWAY

FACTORS FACTORS
Sample NP Std 1 - 6 10 µL NP Std. 1 - 6 10 µL
Head Samples 10 µL Samples 10 µL
Sample NP Std 1,4** 8 µL NP Std 1,4** 8 µL
Dispensed NP Std 2,5 4 µL NP Std 2,5 4 µL
NP Std 3,6 2 µL NP Std 3,6 2 µL
Samples 8 µL Samples 8 µL
Diluent NP Std 1 – 6 10 µL NP Std 1 – 6 10 µL
Head
Diluent NP Std 1,4 32 µL NP Std 1,4 32 µL
Dispensed NP Std 2,5 36 µL NP Std 2,5 36 µL
NP Std 3,6 38 µL NP Std 3,6 38 µL
Reagent 10 µL 50 µL 10 µL 50 µL 50 µL
Head Standards DP Standards CaCl2 DP
and samples Per each and samples per rotor per each factor
Factor
Reagent 80 µL 40 µL 40 µL 40 µL 40 µL
Dispensed Thrombopl. DP Cephalin CaCl2 DP
Per sample per sample
• NP is the abbreviation for Normal Plasma.

• Std. is the abbreviation for Standard.
** Std 4 to be prepared manually (20ul Cal plasma + 300ul factor diluent).
Standards for Single Factor assays

For Single Factor assays of the Extrinsic and Intrinsic Pathways, the
Standards are as indicated below:
HIGH CURVE segment LOW CURVE segment
st
1 Standard 100% 6.25%
nd
2 Standard 50% 3.12%
3rd Standard 25% 1.56%
The MEDIUM SEGMENT connects the 25% and the 6.25% points.

7.3.4 Chromogenic/405 filter Test Volumes

The following table lists the tests use the 405nm filter on the ACL Elite/Elite
Pro. Details for each test can be either viewed on the screen or printed. The
test information can be obtained under the Setup, Tests, View Define menu.
Once you highlight the test you can either print the information by pressing
the print Icon or you can press the detail Icon to view the test.
The test volumes can be found in the Calibration Setup and Analysis Setup
sections for each test. The volume listed defined for each test do not include
any header volumes. The head volumes are as follows:
Sample Head: 10ul/Sample
Reagent Head: 10ul/cuvette when pipetted along with
the sample (i.e. APTT Cephalin).
Reagent Head: 50ul/rotor when pipetted by itself into the
rotor (i.e. APTT Ca/Cl).
Chromogenic/405 filter
Channel Tests
Test Abbreviation Test Name Test Code Number
PLG Plasminogen 212
PI Plasmin Inhibitor 213
PC Protein C 214
F8 Chr H Chromogenic VIII High 220
D-D D-Dimer 250
AT Anti-Thrombin 200
AT* Anti-Thrombin Liquid 199
HepXa Heparin-UHF 210
Fib-C Fibrinogen Clauss 202
vWF Von Willebrand Factor 400
Free PS Free Protein S 160
Note: The “Optical Reference” is the reference for the chromogenic tests. It
consists of 80 µL diluted buffer + 80 µL enzyme.

7.3.5 Special Test Volumes
The following table list the Special tests on the ACL Elite/Elite Pro. Details for
each test can be either viewed on the screen or printed. The test information
can be obtained under the Setup, Tests, View Define menu. Once you
highlight the test you can either print the information by pressing the print Icon
or you can press the detail Icon to view the test.
The test volumes can be found in the Calibration Setup and Analysis Setup
sections for each test. The volume listed defined for each test do not include
any header volumes. The head volumes are as follows:
Sample Head: 10ul/Sample
Reagent Head: 10ul/cuvette when pipetted along with
the sample (i.e. APTT Cephalin).
Reagent Head: 50ul/rotor when pipetted by itself into the
rotor (i.e. APTT Ca/Cl).
Special Tests
Test Abbreviation Test Name Test Code Number
APCR-V Activated Protein C 225

Resistance
LAC-S, LAC-C LAC Screen/Confirm 410/411
SCT-S, SCT-C SCT Screen/Confirm 155/156
PCX* Pro-IL Complex 150
HPX* Hepatocomplex 151
P-ClotSP Proclot SP 153
PS Protein S 159

7.4 Data Processing Features, Parameters and

Analytical Specifications
7.4.1 Flagging Limits
When results are outside acceptable limits, Low or High, the ACL flags them
by displaying them as --- / *** respectively or in a different color. There are
three types of results that are flagged in this manner:
1. test results outside the instrument numeric reading scale capabilities

2. linearity of calibration curves outside acceptable limits
3. percent CV (%CV) for calibration cycles outside relative acceptable limits.
1. Tests Results Outside the Instrument Reading Scale

Capabilities
These limits are imposed by the instrument electro-mechanical capabilities
they are not necessarily the same as the limits of the assay range.
NOTE: Check the Instrument settings and package insert included with the
assay’s reagents to obtain information about the range and the limitations of
the assay, and the procedure to follow when the assay results are outside the
linear range.
The table below indicates, for each test, which results are displayed in Black
and which results are outside the limits and therefore displayed in Red.

TEST Red Black Red --- / ***

PT < 15% 15-150% > 150% <0 - >500%
Fibrinogen < 40 mg/dL 40-800 mg/dL > 800 mg/dL <0 - >3000
< 0.4 g/L 0.4-8.0 g/L > 8.0 g/L mg/dL
<0 - >30 g/L
Factors < 1% 1-150% > 150% <0 ->900%
Lyophilized < 15% 15-150% > 150% <0 ->900%
Antithrombin
Liquid < 15% 15-150% > 150% <0 ->900%
Antithrombin
PI < 10% 15-150% > 150% <0 ->500%
PLG < 10% 15-150% > 150% <0 ->500%
PC < 15% 15-150% > 150% <0 ->500%
Heparin <0.1 U/mL 0.1-1 U/mL > 1 U/mL <0 ->90 U/mL
Pro-IL-Complex* < 4% 4-150% > 150% <0 ->900%
Hepatocomplex* < 8% 8-120% > 120% <0 ->500%
ProClot < 10% 10-150% > 150% <0 ->500%
Protein S < 10% 10-150% > 150% <0 ->500%
FIB-C < 60 mg/dL 60-550 mg/dL >550 mg/dL <0 ->900 mg/dL
< 0.6 g/L 0.6-5.5 g/L >5.5 g/L <0 ->9.0 g/L
Free Protein S < 10 % 10- 140% > 140% <0 ->999%
F8 Chr H < 10 % 10- 120% > 120% <0 ->500%
F8 Chr L <0% 0- 10% > 10% <0 ->500%
LAC S/C < 12 s 12.0- 165.0 s > 165 s 10- 999 s
< 0.5 R 0.5- 5.0 R > 5.0 R <0 ->99.0 R
SCT S/C <6.640 s 24 – 35 s >247.5 s <0 - >300
vWF < 10% 10- 150% > 150% <0 ->999%
D-Dimer <200 ng/mL 200-1050 ng/mL >1050 ng/mL <0 ->9999
ng/mL
*** Represents the operating limit of the system (scale range)
2. Linearity of calibration curves outside acceptable limits

The most reliable results are obtained when the linearity coefficient r2 of a
calibration curve is close to 1.000. The ACL offers helpful “visual” help by
flagging r2 outside relative acceptable limits. For example, If a test had the
acceptable limit set as > 0.980, results outside the limit would display as:
• r2 < 0.980 - displayed in Red
• 0.980 < r2 ≤ 1.000 - displayed in Black

Refer to the Calculation setup parameters for specific limits on each
test.

3. Percent CV (%Coefficient of Variation) for calibration

cycles
When the calibration replicates %CV values are greater than programmed
acceptable limits, they are flagged in red. The table below lists the acceptable
limits for each test.
NOTE: for PT and Fibrinogen, calibrations are considered acceptable by the

system if the %CV is no more than 1% higher than the limit and the r2 is within
the acceptable limits.
TEST Calibrator %CV limit

PT NP (100%) 1.5
NP (50%) 2.0
NP (25%) 2.0
FIB NP (100%) 8.0

NP (50%) 12.0
NP (25%) 12.0
Lyophilized AT NP (100%) 8.0

NP (50%) 6.0
NP (25%) 4.0
Liquid AT NP (100%) 8.0

NP (50%) 6.0
NP (25%) 4.0
Heparin NP (100%) 8.0

NP (50%) 6.0
NP (25%) 4.0
HPX* NP (100%) 1.5

NP (50%) 2.0
NP (25%) 6.0
PCX* NP (100%) 2.0

NP (25%) 3.0
NP (12.5%) 4.0
NP (6.25%) 6.0
FIB-C NP (150%) 1.5

NP (100%) 2.0
NP (50%) 2.5
FPS NP (100%) 8
NP (50%) 8
NP (25%) 8
NP (12.5%) 20
vWF NP (100%) 5
NP (50%) 5
NP (25%) 7
NP (12.5%) 10

D-Dimer NP (1000 ng/mL) 4.0

NP (500 ng/mL) 6.0
NP (250 ng/mL) 10.0
7.4.2 Results Format: VDU and Printer

The format used to display and print numerical fields is dependent upon the
value obtained. The format cannot be changed. The following rules are used:
Value Range Format Example

X<1 x.yyy (3 decimal places) Concentration (U/mL)
1 ≤ X < 10 x.yy (2 decimal places) Time
10 ≤ X < 100 xx.y (1 decimal place) Activity
X ≥ 100 XXX (or greater, Concentration (mg/dL)

depending on field size)
7.4.3 Dealing with Result Messages

One table is presented below which is related to result messages that appear
on the VDU or printer.
• This table contains a list of the most common messages that may appear
on the ACL in place of results, ordered by test, along with explanation and
suggestions to obtain a numerical result.

General Messages Table
TEST MESSAGE Possible Explanation

PT Error 6 The sample does not clot within the
programmed acquisition time.
Read the sample in Extended Time
Error 7 Fibrinogen< 60 mg/dL
Clotted sample analyzed
Normal plasma value Normal Plasma out of range with respect
displayed in violet to the reference data (range ± 9% of the
reference value). Results are flagged
depending on calculation setup.
FIB *** on the sample The FIB value exceeds the high scale
range limit.
Dilute the sample 1:2 with Factor DIL for
high samples and repeat.
value > 800 mg/dL on Dilute the sample 1:2 to fit into the
the sample, in red instrument operating range.
Normal Plasma value Normal Plasma out of range (Range ±
displayed in violet 20% of the reference value).
Error 10 The clot may not be completely
stabilized. Read the sample in the
Extended Acquisition Time
No FIB is given for the Light scatter exceeds the maximum
sample. readable limit of the amplifier.
1. Analysis mixture is very turbid and
initially exceeds the readable limit.
2. During clot formation the curve
exceeds the readable limit.
Dilute the sample 1:2. to fit into the
instrument operating range and multiply
results by 2.

TEST MESSAGE Possible Explanation

APTT Error 6 The sample does not clot within the
maximum end time. Read the sample in
Error 7 - Fibrinogen < 60 mg/dL
- Clotted sample analyzed
Normal Plasma value Normal Plasma out of range with respect
reference value).
Results are flagged depending on
calculation setup.
TT Error 6 The sample does not clot within the
acquisition time. Read the sample in
Error 7 - Fibrinogen < 60 mg/dL
- Already clotted sample
Normal Plasma value Normal Plasma out of range with respect
reference value). Results are flagged
depending on calculation setup.

7.4.4 Calibration Curve Slope (m)

The table below lists the expected slopes (m) for the calibration lines.
TEST range of slope m

PT 0 - 0.2
FIB - mg/dL 0 – 1000
- g/L 0 – 10
Factors 100% - 25% -20 – 0
25% - 6.25% -30 – 0
6.25% - 1.56% -30 – 0
Lyophilized Antithrombin -2000 – 0
Liquid Antithrombin -2000 – 0
Plasmin Inhibitor -2000 – 0
Heparin -200 – 0
Plasminogen 0 – 1000
Pro-IL-Complex* -12 – 0
25%-6.25% segment
Pro-IL-Complex* 0 - 0.17
100%-25% segment
Hepatocomplex* 0 - 0.35
ProClot 0 – 200
FIB-C -10 – 0
PC 0 – 1000
Protein-S 0 – 10
Free Protein S 0 – 1000
vWF: Ag 0 – 1000
D-Dimer 0 – 6000
7.4.5 Calibration Curve Intercept (q)

In tests that require calibration (PT-FIB, Factors, Chromogenic Tests and
Special Tests), the calibration curve is best fitted to the measured points such
that the first point (first dilution) lays on the calibration line.
The following graphs illustrate the situation before and after the fitting to the
first point.
The equation for a line is: Y = mX + q
Therefore: q = Y - mX
The graph displayed uses this first intercept “q”, as seen below.
•
q
•
•

The curve is then transported so it passes through the first point, and a new
intercept q’ is calculated: q’ = Y’ - mX’
The sample results for these calibrated tests are calculated from this new
calibration curve, which has an identical slope to the original one, but a
different intercept.
q’ •←
•
•
7.4.6 Ranges for Calibration Plasma Values

Before analyzing samples, the ACL Elite/Elite Pro requires the user define the
corresponding value of the Calibration Plasma for each test. This is done in
the Liquid setup area of the software (for details refer to Section 4).
When this area is accessed, a default value is displayed; the user enters the
corresponding value for the lot of Calibration Plasma in use.
7.4.7 Reaction Times

This section contains information about the different timings within the
reactions for each test measured by the ACL Elite/Elite Pro, including the
details of the data acquisition process. The tests have been divided into two
groups which are treated separately: Coagulometric/Special tests and
Chromogenic tests.
COAGULOMETRIC TESTS and SPECIAL TESTS

The following diagram represents the general reaction for a Coagulometric
and a Special test:
INTER-RAMP DATA
INTERVAL DELAY ACQUISITION
TIME TIME
RAMP RAMP RAMP
0.4 s 0.4 s # 0.4 s

The table below shows the specific reaction times for coagulometric and
special test. Please refer to the individual tests on the system for more details.
NOTES related to table below:

1. BLANKING TIME = RAMP + INTER-RAMP INTERVAL (seconds)
2. TOTAL ACQUISITION TIME = BLANKING TIME + ACQUISITION TIME
(seconds) or BLANKING TIME + DELAY + ACQUISITION TIME (seconds)
3. EXTENDED time is available for PT-FIB, APTT and TT in single and

double tests mode.
COAGULOMETRIC Blank. Acq. Acq. Total Acq.

Time time per time time
TESTS (sec) point (sec) (seconds)§
(msec)
PT/FIB Calibration* 4 100 58 62
PT/FIB Analysis*
(single, double)
standard 4 100 58 62
extended 4 150 165 169
APTT (single, double)*
standard 4 100 115 119
extended 4 250 245 249
SCT S/C
4 250 245 245
TT 2 mL
extended 2 150 165 167
TT 5 mL
extended 4 150 165 169
TT 8 mL
extended 4 150 165 169
FACTORS
Extrinsic Pathway
Calibration + Analysis 4 150 165 169
FACTORS
Intrinsic Pathway
Calibration + Analysis 4 150 165 169
FACTORS -
Ext.Pathway Analysis 4 150 165 169
FACTORS -
Int.Pathway Analysis 4 150 165 169
*Check individual test definitions in the system for specific values

SPECIAL Blank. time Acq. time Acq. time Total Acq.

(sec) per point (sec) time
TESTS Ramp, delay (msec) (seconds)
Pro-IL-Complex # 4 + 20 250 275 299
Hepatocomplex # 4 200 220 224
ProClot 4 + 20 250 275 299
Protein-S 4 200 220 224
APCR-V 4 200 220 224
# Calibration and Analysis; not currently available in the U.S.
CHROMOGENIC TESTS
The following diagram represents the reaction for a chromogenic assay:
ACQUISITION TIME
RAMP RAMP
0.4 s 0.4 s 0.4 s
The table below summarizes the reaction times:
CHROMOGENIC TESTS Blank. time Acq. time Acq. Time Total Acq. time
(sec) per point
Ramp, delay (msec) (seconds) (seconds)
Antithrombin 1 100 30 31
Liquid Antithrombin 1 50 20 21
Heparin 1 100 30 31
Plasminogen 1 100 60 61
Plasmin Inhibitor 1 100 60 61
Protein C (Chromogenic) 0 100 90 90
Fibrinogen-C 2 100 90 92
Factor VIII (chromogenic) 1 100 120 121
vWF : Antigen 1 250 300 301
Free Protein S 1 250 300 301
D-Dimer 2+1 250 300 303

7.4.8 Test Algorithms

The following table shows the algorithms that relate the Y-axis and X-axis for
the parameter measurements done on the ACL Elite/Elite Pro.
TEST CORRELATION Y X
PT Linear 1/Activity Ratio
FIBRINOGEN Linear C (mg/dL or g/L) Ratio
FACTORS Log Activity Ratio
AT, PLG, PC, PI Linear Activity ∆OD
HEPARIN Linear C (U/mL) ∆OD
PRO-IL-Complex* Log/Log Activity R
(25%-12.5%-6.25%)
PRO-IL-Complex* Linear 1/Activity R
(100% -25%)
HEPATOCOMPLEX* Linear 1/Activity R
PROCLOT Quadratic Activity R2
FIBRINOGEN-C Log-Log/Log C (mg/dL or g/L) seconds
PROTEIN-S Linear Activity seconds
D-DIMER Linear 1/C (ng/mL) ∆OD
VWF Linear Activity ∆OD
Free Protein S Linear Activity ∆OD

7.5 Assay Performance Characteristics
7.5.1 Assay Precision Performance, Linearity and Method

Comparison Studies
This section contains information about the analytical precision performance
of several assays on the ACL Elite/Elite Pro. The tables displayed below
include data obtained during performance studies (for the purpose of system
evaluation) conducted at IL laboratories or in the field.
The data presented should be used as an example of typical precision
performance of the assays on the ACL Elite/Elite Pro.
Precision studies
The table below shows the within-run precision data obtained for 2 or 3 levels
of controls, during studies performed at IL on an ACL Elite/Elite Pro for the
following IL reagents.
Within Run Precision

Within run precision assessed over multiple runs (10) using multiple levels of
control plasma gave the following results:

Precision Performance
Reagent Control Level n Mean %CV

Normal 30 112.3 2.33
Antithrombin Abnormal 1 30 58.3 3.23
(%) Abnormal 2 30 25.7 3.42
Level1 40 0.98 1.82
APCR-V Level 2 40 0.62 1.96
(Normalized Ratio)
Normal 60 29.3 1.27
APTT-SP Abnormal 1 60 49.2 0.98
(seconds) Abnormal 2 60 61.3 1.72
Level 1 90 263 6.54
D-Dimer Level 2 90 673 3.00
(ng/mL)
Normal 40 78.9 3.32
Factor VII (%) with Abnormal 1 40 55.7 3.01
PT-Fibrinogen Abnormal 2 40 24.4 4.04
Normal 40 77.0 8.39
Factor VIII (%) with Abnormal 1 40 84.0 6.67
APTT-SP Abnormal 2 40 39.2 6.67
Normal 80 269.3 3.20
Fibrinogen-C Low Fibrinogen 80 97.2 2.09
(mg/dL)
0.85 LMW Heparin 30 0.8 2.02
Heparin Low Heparin 30 0.3 4.33
(U/mL) High Heparin 30 0.7 2.65
Normal 50 110 1.21
Plasmin Inhibitor Abnormal 1 50 68.4 2.52
(%) Abnormal 2 50 35.3 3.82
Normal 50 106.2 2.78
Plasminogen
Abnormal 1 50 69.2 2.94
(%) Abnormal 2 50 31.3 3.31
ProClot (%) Normal 80 83.0 3.71
APTT-SP Abnormal 80 48.6 5.12
Normal 40 95.4 1.68
Protein -C (%) Abnormal 1 40 51.1 1.77
Abnormal 2 40 22.8 3.31
Normal 70 103.1 2.60
Protein -S (%) Abnormal 2 70 50.7 4.36
Normal 60 12.8 1.30
PT Abnormal 1 60 19.2 1.75
(seconds) Abnormal 2 60 29.1 2.07
Normal 90 243.0 7.06
PT-FIB Low Fibrinogen 90 106.4 7.14
(mg/dL)
Normal 90 17.9 3.39
TT 8 mL Heparin sample 90 22.8 3.57
(seconds)

Linearity Studies
Linearity studies were performed over multiple sample levels with each level
run in duplicate on an ACL Elite/Elite Pro. Results are shown in the table
below:
Reagent No. of Slope Intercept r Sample

Levels Range
Antithrombin 7 0.94 5.958 0.999 14-140
(%)
D-Dimer 10 0.97 6.229 0.998 56-1192
(ng/mL)
Factor VII (%) with 9 1.01 -4.036 0.997 1.9-132
PT-Fibrinogen
Factor VIII (%) with 9 0.87 -0.508 1.000 2.3-127.5
APTT-SP
Fibrinogen-C 7 1.10 -25.713 0.999 91-528
(mg/dL)
Heparin 7 0.97 -0.007 0.999 0.00-1.07
(U/mL)
Plasmin Inhibitor (%) 7 0.94 6.677 0.997 0-115
Plasminogen (%) 7 0.95 3.500 0.994 0-137
ProClot (%) 8 0.92 -0.129 1.000 0-171
APTT-SP
Protein -C 7 1.04 -0.338 1.000 0.5-173.5
(%)
Protein -S 11 1.00 -0.221 1.000 0-120
(%)
PT 6 0.96 0.565 1.000 12-35
(seconds)
PT-Based Fibrinogen 9 0.95 15.621 0.997 0-567
(mg/dL)

Method Comparison Studies
In method comparison studies evaluating citrated plasma samples, the ACL

Elite/Elite Pro results were similar to the predicate device’s (ACL 9000) results
as supported by the summary of linear regression statistics below. The graphs
are reported in the Addendum at the end of this chapter.
Reagent No. of Slope Intercept r Sample

Sample Range
Levels
Antithrombin 48 1.08 -3.031 0.995 14-125
(%)
APCR-V 57 0.97 0.021 0.993 0.457-1.105
(Normalized Ratio)
APTT-SP 54 1.04 -1.471 0.998 27.5-96.2
(seconds)
D-Dimer 46 0.91 86.596 0.996 56-1083
(ng/mL)
Factor VII (%) with 48 1.02 -2.605 0.996 2.4-170
PT-Fibrinogen
Factor VIII (%) with 47 0.96 0.6184 0.990 0.96-199.2
APTT-SP
Fibrinogen-C 54 1.10 -14.032 0.998 74-766
(mg/dL)
Heparin 50 1.03 -0.002 0.996 0.00-1.21
(U/mL)
Plasmin Inhibitor 57 0.91 8.642 0.990 49.6-125.0
(%)
Plasminogen 57 0.99 3.525 0.989 18.4-150.8
(%)
ProClot (%) 54 0.98 1.912 0.995 10.7-199.1
APTT-SP
Protein -C 52 1.10 -5.781 0.998 22-317
(%)
Protein -S 54 0.92 2.935 0.993 12-117
(%)
PT 52 1.07 -0.838 0.999 10.4-25.1
(seconds)
PT-Based Fibrinogen 51 0.93 35.038 0.990 49.7-844.7
(mg/dL)
Thrombin Time-8 mL 54 1.01 1.010 0.998 15.5-43.5
(seconds)
Please refer to the end of this chapter for the Method Comparison Graphs.

7.5.2 Assay Calibration Stability

Calibration stability studies were done at IL with a full range of controls in
order to determine the minimum amount of time that a calibration curve can
be used for each assay. The results are shown in the table below.
TEST Calibration Stability

Factor II 5 days
Factor V 5 days
Factor VII 5 days
Factor VIII 5 days
Factor IX 5 days
Factor X 5 days
Factor XI 5 days
Factor XII 5 days
Fibrinogen-C 5 days
Antithrombin 5 days
Liquid Antithrombin 30 days
Heparin 5 days
Plasminogen 5 days
Plasmin Inhibitor 5 days
These time intervals should be used as guideline only. Use of Quality Control materials
is the best determinant of stability in your laboratory.

7.6 Analytical Limitations

7.6.1 Carryover
Studies performed on all members of the ACL family have shown sample
carryover to be less than 0.5% by volume.
In most cases, the inaccuracy contributed by the carryover factor is well within
the expected imprecision of the method; therefore, it is not statistically or
clinically significant.
The following exception cases were found to be statistically significant,
although not clinically significant (the amount of contamination will not shift an
abnormal sample result into the normal range):
1. When testing a plasma sample (PT or APTT) from a patient with a severe
Factor Deficiency (factor < 10%) immediately after a normal sample.
2. When testing an unusually high heparinized sample (> 10 U/mL) or
samples from patients undergoing aggressive factor replacement therapy,
immediately after a normal sample.
Assaying a Contaminating Sample

The following procedure is recommended in order to deal with a sample that
is suspected of containing high levels of Factors or Heparin and avoid
carryover into others:
Testing mode for APTT or PT/FIB: place the suspect sample in cup #1. Place
Reference Emulsion or Factor Diluent in the pool position. Place Hydrochloric
Acid (HCl 0.1 N) in cup positions #2 and #4. Place deionized water in
positions #3 and #5. Use cups in positions 6-9 to place the other samples to
be assayed.
Note: No calculated results will be reported in this situation (i.e. Ratio,

INR, % activity or fibrinogen).
Assaying a Contaminated Sample

The following procedure is recommended in order to re-assay samples which
are suspect of having been contaminated by the sample preceding them in
the run (with high Factors or Heparin):
Note: because the contamination is caused by carryover, it affects
mostly the aspirated sample and has minimal effect on the sample
remaining in the cup.
Testing mode for APTT or PT/FIB: place the sample to be re-assayed in cup
#1. Use cups in positions 2-9 to place the other samples to be assayed.

7.6.2 Cephalin: needle self-conditioning

The reagent aspiration/dispensing needle does its own “self-conditioning”
prior to using the cephalin reagent.
When a test which uses cephalin is preceded by a cycle using thromboplastin
(i.e. PT, Single Factors of the Extrinsic Pathway, Pro-IL-Complex*,
Hepatocomplex* or Protein-S), the following procedure is repeated three
times before aspirating the cephalin:
- the internal needle aspirates 90 µL of reagent or Clean A, followed by
an 80 µL air bubble;
- the liquid is discarded into the waste reservoir.
7.6.3 Lipemic Samples

If a lipemic sample is tested on the ACL Elite/Elite Pro, the turbidity caused by
the lipemia may interfere with the fibrinogen measurement that is done by
light scattering.
Lipemic specimens should preferably be cleared before testing on the ACL.
However, since studies have shown that there is a linear relationship between
turbidity and fibrinogen values, a correction factor has been introduced in the
calculation of fibrinogen results based on the initial offset of the sample in
order to compensate for lipemic interference.
7.7 Container Specifications

7.7.1 Primary Tubes
The ACL Elite/Elite Pro sample tray accepts several kinds of primary tubes, in
different sizes and filling volumes, as specified in the table below.
Primary glass Anticoagulant Drawn Blood Total Volume

tube size (mm) Volume (mL) Volume (mL) (mL)
13 x 75 - Type a 0.50 4.5 5.0
13 x 75 - Type b 0.35 3.15 3.5
13 x 64 0.30 2.7 3.0
11.5 x 64 0.30 2.7 3.0
11.5 x 92 0.50 4.5 5.0
13 x 100 0.50 4.5 5.0

Specifications for ACL drawing from Types a and b primary tubes

Type a
For drawn blood volumes of 4.5 mL (nominal value), the ACL can aspirate
plasma with tolerances of +10 to -20%.
For maximum sample collection (4.5 mL + 10%), the ACL can aspirate the
correct amount of sample if the hematocrit is ≤ 70%.
Type b
For drawn blood volumes of 3.15 mL (nominal value), the ACL can aspirate
plasma with tolerances of +10 to -20%.
For maximum sample collection (3.15 mL + 10%), the ACL can aspirate the
correct amount of sample if the hematocrit is ≤ 70%.
NOTE:
The specifications above may be affected by the following variables:
- Lot and manufacturer variations of internal tube diameter.
- Time remaining to expiration date (level of vacuum decreases close to the
end of the tube life).
7.7.2 Cup and Reagent Containers

The following charts detail the specifications for the sample cups and reagent
containers that may be used on the ACL Elite/Elite Pro.
Sample Tray
Container Usable Volume Usable Volume
Type Volume Diameter Positions 1-40 Positions A1-A10
Sample Cup 0.5 mL 14 mm 0.4 mL In cup dilution only
Sample Cup 2 mL 14 mm 1.8 mL 1.9 mL
Sample Cup 4 mL 14 mm 3.8 mL 3.9 mL
Reagent Vial 4 mL 18 mm NA 3.6 mL
Reagent Area
Container Usable Volume Usable Volume
Type Volume Diameter Stirred Reagents Non-Stirred
Reagents
Reagent Vial 10 mL 23 mm 8.3 mL 9.4 mL
Reagent Vial 16 mL 28 mm 13.2 mL 14.1 mL
NOTE: The reagent vials partially filled with PT-FIB and APTT reagents may
be topped with fresh reagent ONLY IF the reagent in the vial is still within the
on-board stability at 15 oC and the ratio between old reagent and fresh
reagent does not exceed 1:2 (suggestion is to use one part of old reagent
plus two parts of new reagents).

7.8 Instrument Specifications

7.8.1 Hardware and Operational Specifications
Temperature of the reagent reservoirs: 10 - 16 oC
Temperature of the analysis area: 37 ± 1 oC at ambient temperatures
from 15 to 32oC
Coagulometric channel light source: Light emitting diode, λ=660 nm
Chromogenic channel light source: Halogen lamp, λ=405 nm w/filter
Chromogenic channel optical path: 0.5 cm
Analytical cuvettes: rotor units contain 20 cuvettes/each
Number of rotors in rotor stack: 12 maximum
Sample trays available:
1. for cups and primary tubes (13x75 mm - 5 mL & 13x64 mm - 3 mL)
2. for cups and primary tubes (13x100 mm - 5 mL)
3. for cups and Sarstedt primary tubes (11.5x64 mm - 5 mL and
11.5x92 mm - 3 mL)
Sample tray adapters: for 4 mL reagent containers and
cups
Reagent containers: 4 mL, 10 mL and 16 mL vials, cups
Reagent reservoir adapters: for 10 mL vial with stirrer (gray)
for 10 mL vial w/o stirrer (pink)
for 4 mL vial w/o stirrer (green)
Stirrer magnet reagent R1-R4: size - 10x5 mm diameter
rotation speed - 250 rpm
Sample/reagent dispensing: stainless steel pistons contained in
an acrylic structure
Waste tube: PVC, 12 mm diameter
Cooling fans: two, with five blades and dust filter
Fuses: Two, T 6.3 A (for 100-240 Vac nom.)
PC keyboard: Standard
Video Display Unit: 12.1” color LCD, with touch screen
Interface for data transmission to Host: RS 232C
Additional interfaces: one for optional Barcode Scanner
one for optional External Printer
Instrument structure: expanded polyurethane designed for
direct mounting of internal elements

7.8.2 Dimensions
Total height: 60 cm
Height of analysis surface: 33 cm
Width: 100 cm
Depth: 60 cm
Weight: 63 Kg
7.8.3 Data Base Specifications

The table below provides specifications related to the maximum size of all
Data Bases included in the ACL Elite/Elite Pro software.

Description Maximum Type of

Size Handling
N° of Patient IDs in Data Base 1000 FIFO
Number of Tests per Patient * 30 N/A
Number of Reaction Curves in Patients Data Base 800 FIFO
Number of Results in Each Single QC file 500 FIFO
Total number of QC Results in each Statistic file 65536 FIFO
Number of Reaction Curves in QC Data Base 200 FIFO
Total Number of QC Materials 50 N/A
Number of IL QC Materials 30 N/A
Number of Customized QC Materials 20 N/A
Number of Tests for each Single QC Material 20 N/A
N° of QC results in QC Data base 100 FIFO
Number of Results in AR Data Base 10-50-100- Selectable
500-1000
Number of Reaction Curves in AR Data Base 100 FIFO
Total Number of Operators 100 N/A
Total Number of Profiles 30 N/A
Number of Tests in a Single Profile 20 N/A
Total Number of Tests in the Library 300 N/A
Number of IL Tests in the Library 200 N/A
Number of Customized Tests in the Library 100 N/A
Total Number of Test Groups 60 N/A
Number of IL Test Groups 30 N/A
Number of Customized Test Groups 30 N/A
Number of Tests in a Single Test Group 6 N/A
Total Number of Materials (Liquids) in the Data Base 300 N/A
Number of IL Materials (Liquids) in the Data Base 200 N/A
Number of Customized Materials (Liquids) in the Data Base 100 N/A
Number of Definable Loadlist 20 N/A
Number of Sample IDs in a Loadlist 40 N/A
Number of Steps used in a Test Application 30 N/A
Number of Materials (Liquids) used in a Test Application 36 N/A
Number of Reflex Rules 60 N/A
Number of Criteria in each Single Reflex Rule 3 N/A
Number of Tests that can be generated by each Single Reflex Rule 10 N/A
Number of Calibrations for Dedicated Session 1 FIFO
Number of Calibrations for In Session and In Run 5 FIFO
Number of Messages in the Session Error History 200 FIFO
Number of Messages in the File Error History 100 FIFO
Number of Messages in the Logbook 200 FIFO
Number of Messages in the Trace file Up to 1.4 MB Automatic
* Test in duplicate count for 3 results (first result, second result and mean)
FIFO = First In First Out

7.9 Ambient Specifications

The ACL Elite/Elite Pro pertains to the following class of instruments:
CATEGORY: II
POLLUTION DEGREE: 2
USE: indoors
The following ambient conditions apply to the ACL Elite/Elite Pro:
• Ambient conditions for transport and storage
Temperature: 4 - 45 oC
RH: maximum 95%, non-condensing
• Functional ambient conditions

BP: 500 to 1060 mbar
Altitude: maximum 2000 meters
• Safety limit ambient conditions

BP: 500 to 1060 mbar

Altitude: maximum 2000 meters
7.10 Electrical Specifications

FREQUENCY: 50 and 60 Hz (nominal)
Frequency range: 50 - 60
VOLTAGE: 100 V to 240 V
Voltage tolerance: ± 10%
Power Consumption: 350 VA
Fuses: 2 x T 6.3 A

7.11 HAZARDS
7.11.1 General Warnings

The ACL Elite/Elite Pro analyzer can be used with a main voltage of 90 to 240
VAC (50/60 Hz). An automatic power supply unit is provided with the
instrument which allows the use of the local 90-240 V power supply.
The analyzer must be plugged into a grounded power outlet.
In order to allow proper cooling around the analyzer, allow at least 15 cm (6
inches) of clearance on the sides, back and top of the unit.
The ACL Elite/Elite Pro has been tested and found to comply with national
and international EMC and RFI requirements. These requirements are
designed to provide reasonable protection against harmful interference when
the equipment is operated in a commercial environment. This instrument
generates, uses and can radiate radio frequency energy. If harmful
interference is produced as a result of installation and use other than that
recommended by the manufacturer, the user will be required to correct the
interference at his own expense.
7.11.2 Shock Hazards

Operators and maintenance personnel of the ACL Elite/Elite Pro analyzer are
urged to follow sound electrical safety practices when using the instrument.
Although all exposed metal parts of the analyzer are at ground potential (0
volts), it should never be touched with one hand while the other hand is
touching a plumbing fixture, radiator, AC operated device or other grounded
object.
7.11.3 Electrical Hazards

• Unplug the analyzer from the power outlet before opening the body of the
analyzer.
• Turn the analyzer OFF before replacing components or attempting any

repair.
• Do not operate the analyzer in an atmosphere containing explosive
gases, as the components of the analyzer may generate sparks.
Earth Ground: Identifies an Protective Ground: Identifies

Earth Ground terminal any terminal intended for connection
to an external conductor

7.11.4 Biohazards
Since the ACL is used to work with products derived from human blood, all
operator-accessible parts of the analyzer should be considered potentially
bio-hazardous. For this reason, gloves and protective clothing should be worn
during system operation.
When carrying sample trays loaded with samples, exercise caution to avoid
spillage of samples. Also avoid spilling fluids on the analyzer, and clean
immediately if this occurs.
The surface of the analyzer should be inspected frequently for visible spills
and decontaminated if necessary following the instructions in Section 5.
Follow the recommendations given in Section 5 for preventive and routine
maintenance of the instrument.
For additional information, refer to NCCLS document 117-P No. 15:
Protection of Laboratory Workers from Instruments Biohazards, 1991.
Instrumentation Laboratory complies with the Directive 2002/96/EC of the

European Parliament on Waste, Electrical and Electrical equipment (WEEE) .
For instructions on End of Life Disposal please contact your local distributor
for further details.
7.11.5 Mechanical Hazards

The operator should pay attention to the moving parts of the instrument during
normal operation.
In particular the sample tray area should be accessed only in Ready state or
using the STAT (Pause) function to avoid mechanical hazard due to the
needles arm movement.
Disclaimers
Instrumentation Laboratory, Inc. (IL) is responsible for the safety and electrical
performance of this equipment if and only if:
• Assembly operations, extensions, adjustments, modifications or repairs
are carried out by persons authorized by IL;
• The electrical installation of the room complies with the local, state or
national requirements (including a power supply circuit with independent
grounding);
• The equipment is used in accordance with these instructions for use.
Bibliography
For additional information, refer to NCCLS document 117-P No. 15:
Protection of Laboratory Workers from Instruments Biohazards, 1991.

ADDENDUM: Method Comparison Studies
Note: Analytical performance for the ACL 8/9/10000 and ELITE/ ELITE
PRO are comparable
Antithrombin(%):
Antithrombin: ACL 9000 (Test)

vs. ACL 6000 (Reference)
140
ACL 9000 (AT% Activity)
120 y = 1.0817x - 3.0311

100 r = 0.9947
n = 48
80
60
40
20
0
0 20 40 60 80 100 120 140
ACL 6000 (AT% Activity)
APC Resistance V
(Normalized Ratio):
APCR V: ACL 9000 EM5 (Test)

1,2 vs. ACL 6000 (Reference)
1,1
Normalized Ratio)
ACL 9000 EM5
1 y = 0.9725x + 0.0214
0,9 r = 0.9934
0,8 n = 57
0,7
0,6
0,5
0,4
0,4 0,5 0,6 0,7 0,8 0,9 1 1,1 1,2
ACL 6000 (Normalized Ratio)

APTT-SP
(Seconds):
APTT: ACL 9000 (Test)

110
100 y = 1.0416x - 1.4706
ACL 9000 (seconds)
90 r = 0.9979
80 n = 54
70
60
50
40
30
20
20 30 40 50 60 70 80 90 100
ACL 6000 (seconds)
D-Dimer
(ng/mL):
D-Dimer: ACL 9000 EM6 (Test)

1200
1000 y = 0.9114x + 86.596
ACL 9000 EM6
r = 0.9955
800
n = 46
(ng/mL)
600
400
200
0
0 200 400 600 800 1000 1200
ACL 6000 (ng/mL)

Factor VII (%)

with PT-Fibrinogen:
180 Factor VII: ACL 9000 EM5 (Test)

160 vs. ACL 6000 (Reference)
140
y = 1.0194x - 2.6046
ACL 9000 EM5
120
(% Activity)
r = 0.9961
100 n = 48
80
60
40
20
0
0 20 40 60 80 100 120 140 160 180
ACL 6000 (% Activity)
Factor VIII (%)

with APTT-SP:
Factor VIII: ACL 9000 EM3 (Test)

200
y = 0.9598x + 0.6184
ACL 9000 EM3
(% Activity)
r = 0.9896
150 n = 47
100
50
0
0 50 100 150 200 250

Fibrinogen-C
(mg/dL):
Fib-C: ACL 9000 EM6 (Test)

600 y = 1.0994x - 14.032

ACL 9000 EM6
r = 0.9982
(mg/dL)
n = 54
400
200
0
0 200 400 600 800
ACL 6000 (mg/dL)
Heparin
Heparin: ACL 9000 EM3 (Test)

1,4 vs. ACL 6000 (Reference)
1,2
y = 1.0286x - 0.0017
ACL 9000 EM3
1 r = 0.9961
(U/mL)
0,8 n = 50
0,6
0,4
0,2
0
0 0,2 0,4 0,6 0,8 1 1,2 1,4
ACL 6000 (U/mL)
(U/mL):

Plasmin Inhibitor
(%):
Plasmin Inhibitor: ACL 9000 (Test)

140
130
120
y = 0.9084x + 8.6423
r = 0.9899
110
n = 57
100
90
80
70
60
50
40
40 50 60 70 80 90 100 110 120 130 140
Plasminogen
(%):
Plasminogen: ACL 9000 EM3 (Test)

140
120 y = 0.9864x + 3.525
ACL 9000 EM3
(% Activity)
r = 0.9894
100
n = 57
80
60
40
20
0
0 20 40 60 80 100 120 140 160

ProClot (%)
with APTT-SP:
Proclot (with APTT-SP): ACL 9000 EM5 (Test)

250
200
ACL 9000 EM5
y = 0.982x + 1.9116
(% Activity)
150 r = 0.9954
n = 54
100
50
0
0 50 100 150 200 250
Protein-C
(%):
Protein C: ACL 9000 EM7 (Test)

350
300
ACL 9000 EM7
y = 1.095x - 5.7806
(% Activity)
250
r = 0.9982
200 n = 52
150
100
50
0
0 50 100 150 200 250 300 350

Protein S (%):
Protein S: ACL 9000 (Test)

140
120
y = 0.923x + 2.9345
100
r = 0.9930
80 n = 54
60
40
20
0
0 20 40 60 80 100 120 140
PT (Seconds):
PT: ACL 9000 (Test)

30
ACL 9000 (Seconds)
25 y = 1.0659x - 0.8383
r = 0.9985
20
n=52
15
10
5
0
0 5 10 15 20 25 30
ACL 6000 (Seconds)

PT-Based Fibrinogen (mg/dL):
PT-Based Fibrinogen: ACL 9000 EM7 (Test)

1000
800 y = 0.9331x + 35.038

ACL 9000 EM7
r = 0.9901
(mg/dL)
600 n = 51
400
200
0
0 200 400 600 800 1000
ACL 6000 (mg/dL)
Thrombin Time - 8 mL
(Seconds)
TT - 8 mL: ACL 9000 (Test)

vs ACL 6000 (Reference)
50
45
y = 1.0103x + 1.0097
40 r = 0.998
ACL 9000 (Seconds)
35 n = 54
30
25
20
15
10
5
5 10 15 20 25 30 35 40 45 50
ACL 6000 (Seconds)

8 Sample Collection and Storage
8.0 Introduction
Given the importance of coagulation tests in making diagnostic and therapeutic
decisions, it is essential to follow a detailed procedure for the collection and transport
of blood specimens as well as for the preparation of plasma used for these tests.
Many variables such as the type of anticoagulant, the storage of the sample, and the
type of container used to draw blood will have an effect on the analytical results.
The general procedures described below - which concern the collection of human
blood samples from the patient, their transport from the collection site to the
laboratory, and their handling and storage in the laboratory - are considered standard
for any coagulation test.
8.1 Sample Collection

Venous blood must be drawn with minimal stasis using a plastic syringe or a vacuum
filled test tube, as recommended by CLSI Document H21-A3.
For all tests concerning control of hemostasis, with the exception of the platelet count,
the preferred anticoagulant is trisodium citrate at the concentration recommended in
CLSI Document H21-A3, using a ratio of 1 volume of citrate to 9 volumes of blood.
The correct concentration of the anticoagulant is of utmost importance for precision of
the results. The Document mentioned above must be referenced when adjustments
to the citrate concentration are required.

Sample, Collection and Storage
8.2 Plasma Handling
8.2.1 Plasma Separation

The samples should be centrifuged at 2500 g for 15 minutes as soon as
possible after collection.
Hemolysis must be avoided during collection and centrifugation of the sample
due to the presence of red cells, which have phospholipid surfaces with
thromboplastin activity that will affect clotting times.
8.2.2 Plasma Transport

For recommendations on transporting plasma, please refer to CLSI
Document H21-A3.
8.2.3 Plasma Storage

For recommendations on storage of plasma, please refer to CLSI Document
H21-A3.
8.3 Calibration Plasma
8.3.1 Description
The operative conditions of the ACL Elite/Elite Pro system use a reference plasma
pool (calibration plasma) to check the system as a whole (analyzer plus reagents).
The IL Test Calibration Plasma consists of a lyophilized pool of normal plasma,
having the same characteristics of a fresh pool of normal human plasma. The
lyophilized material offers the advantages of easier storage and longer stability.
The ACL Elite/Elite Pro uses the Calibration Plasma as follows:
1. To generate a calibration curve as needed.
2. To check and follow assay conditions during sample analysis within the entire
system (optional for certain assays).
For the PT, PT-based Fibrinogen, APTT and TT assays, the Calibration Plasma value
should be within the reference range stored in the ACL memory. If this is not the
case, message flags will be given to the operator. Result flagging is optional.

8.3.2 Preparation
Please refer to the printed package insert sheet that accompanies each product.
8.3.3 Value assignment

The Calibration Plasma differs from normal control plasma in that it is used to
generate a calibration curve and to monitor the precision and accuracy of the system
(analyzer plus reagents).
This means that the Calibration Plasma has a known target value – or reference
value - for the tests. Normal control plasma may have a range of acceptable values,
not a single target value, for the tests.
The Calibration Plasma should have an activity close to 100% of expected values,
while the normal control plasma activity should only be within an assigned reference
range.
The normal and abnormal control plasmas can be used randomly as part of an
internal quality control program to verify the analytical performance of the system.
The target value of the Calibration Plasma indicated on the package insert sheet is
assigned by using a number of determinations carried out on different instruments.
In order to eliminate any possible laboratory-to-laboratory variation, it is advisable to

calculate PT, APTT and TT times (in seconds) for each lot of Calibration Plasma,
which can then be used as the reference value for the laboratory’s own conditions.
IL suggests the following procedure to determine your laboratory’s value for the
Calibration Plasma:
• For APTT and TT, perform a minimum of 5, and a maximum of 10

determinations. Calculate the mean value for each assay and enter it in the
ACL’s Test Setup “checks” frame.
• For PT, the titer will correspond to the value, in seconds, of the 100% solution.
Once the calibration is accepted, enter the value obtained for the 100%
standard in the Test Setup “checks” frame.
• For Fibrinogen, when performing a Fibrinogen calibration, enter the value

reported in the Calibration Plasma package insert sheet. Enter this value also
in the Test Setup “checks” frame.
NOTE: The procedure outlined above should be performed any time there is a
change - such as new Calibration Plasma lot, new reagent lot, new rotor lot, etc.
- requiring a new calibration of the ACL Elite/Elite Pro system.

Sample, Collection and Storage
References
1. CLSI Document (latest revision) Collection, Transport and Processing of
Blood Specimens for Coagulation Testing and General Performance of
Coagulation Assays.
2. ECCLS Vol. No. 1 Standard for Specimen Collection
3. CLSI Document (latest revision. Procedure for the Collection of
Diagnostic Blood Specimens by Venipuncture.

9 Parts and Expendables
9.0 Introduction
This section contains information about the expendable materials that are available for
use with the ACL Elite/Elite Pro System. These items may be ordered from IL or its
representative whenever they are needed using the Catalog Numbers as shown in the
table, Section 9.2. One or more of these items are shipped in the “Startup Kit” included
with the ACL Elite/Elite Pro system, as indicated in Section 9.1.
9.1 Startup Kit

The following expendable materials are contained in the Startup Kit that is shipped with
the ACL Elite/Elite Pro System:
Sample Trays
Three types of sample trays are available as shown below. The startup kit includes two of
them. The user chooses the desired system configuration between the Short and Tall
configuration. Trays for the Sarstedt tubes must be ordered separately..
Tray type Used for

Short Primary tube, 3 or 3.5 mL total volume (13x75 mm)
Tall Primary tube, 5 mL total volume (13x75 or 13x100 mm)
S 11.5 Sarstedt type tube, 3 mL (11.5x66 mm) or 5 mL (11.5x92 mm)
Sample Tray Adapters
- for plastic cups - 4 pieces

- for 4 mL glass vials - 6 pieces
Reagent Vial Adapters
- for 10 mL vials, reagents requiring magnetic stirring (gray) - 4 pieces

- for 10 mL vials, reagents not requiring magnetic stirring (pink) - 6 pieces
- for 4 mL vials, reagents not requiring magnetic stirring (green) - 4 pieces

Parts and Expendables
Magnetic Stirrers
- for reagent stirring - one package containing 6 pieces
Small Sample Cups
- 0.5 mL sample cups - one package containing 1000 pieces
Large Sample Cups
- 2.0 mL sample cups - one package containing 1000 pieces

Diluent/Buffer/Reagent Cups
- 4.0 mL cups, with labels - one package containing 100 pieces
Diluent/Buffer/Reagent Glass Vials

- 10 mL glass vials - one package containing 10 pieces
Block and Probes Assembly
- an assembly consisting of an acrylic block with the sample and reagent needles and
their associated liquid sensors
Sample and Reagent Tubing
- a 1.5 meter piece of tubing to be cut and used as needed
Insertion Tool for Sample and Reagent Tubing
- a tool to be used when replacing sample and reagent tubing
Wash/Reference Emulsion
- a 1-liter bottle of Emulsion
Waste/Rinse Reservoir
- a reservoir for needle wash and rinse

Waste Bottle
- a 5-liter bottle to collect ACL waste
Waste Tubing
- a 1.5 meter piece of tubing to be used for collection of liquid waste
Adjustment Tool for Aspiration/Dispensing Needles
- a tool to be used to adjust the position of the needles in the arm

Rotors
- 20-Cuvette Rotors - package containing 100 pieces

Rotor Insertion Tool

- a tool used to insert rotors into the system
Rotor Waste Container
- a removable container used inside the system to hold the used rotors
Molded Air Filter
- One air filter for the analyzer body

Fuses 6.3 AT
- 2 fuses for the system
Power Cord
- a power cord for the system: the cord included is consistent with the voltage with
which the system will be used, either 100-115 V or 220-240 V
External Printer Cable

- a cable to connect the optional external printer
Host Computer Cable
- a cable to connect the optional host computer
Software System Disk Kit
- kit containing the main system software
Test Library Disk Kit

- kit containing the test library software
Operator’s Manual
- the Operator’s Manual for the use of the ACL Elite/Elite Pro system
Two-Button mouse pointing device
External Barcode Reader (ACL Elite Pro Only)
Compliance Certificate
- a specific system compliance certificate

Parts and Expendables
9.2 Order Information for Expendables
Catalog Item Description # Pieces in

Number Package Unit
181108-90 * Sample Tray for 13x75 mm, (3-3.5 mL) tubes 1
181108-98 * Sample Tray for 13x75 & 13x100 mm, (5 mL) tubes 1
181812-85 Sample Tray for Sarstedt 11.5x66 mm (3 mL) 1
& 11.5x92 mm (5 mL) tubes
190764-00 Sample Tray adapter for plastic cup 4
190763-00 Sample Tray adapter for 4 mL vials 6
181812-65 Adapter for 10 mL reagent vials with magnetic 4
stirring (gray)
190762-00 Adapter for 10 mL reagent vials without magnetic 6
stirring (pink)
190761-00 Adapter for 4 mL reagent vials without magnetic 4
stirring (green)
97466-06 Magnetic Stirrer 6
189241-00 Glass Vials, 10 mL 10
67992-00 Sample Cups, 0.5 mL 1000
55751-00 Sample Cups, 2 mL 1000
67994-00 Cups, 4 mL, plus Labels 100
68000-00 Rotors- 20 cuvettes 100
181812-77 Rotor Refill Tool 1
181108-97 Rotor Waste Container 1
181108-43 Block Probe Assembly 1
181039-41 Needles Adjustment Tool 1
73289-01 Sample and Reagent Tubing, 1.5 m 1
181080-65 Sample and Reagent Tubing Extractor Tool 1
181812-72 Waste Reservoir, for needles wash 1
181057-69 Liquid Waste Bottle 1
99095-03 Waste Tube, 1.5 m 1
181812-71 Air Filter, molded 1
68931-02 Fuses 6.3 AT 2
148821-00 Power Cord, 100-115 V 1
71992-00 Power Cord, 220-240 V 1
84864-50 External Printer Cable 1
181812-74 Host Computer Cable (9 pin – 9 pin) 1
200024-00 Wash/Reference Emulsion, 1 liter 1
181951-XX Software System Disk Kit 1
181963-XX Test Library Disk Kit 1
97627-50 Compliance Certificate 1
181121-11 Operator’s Manual, English version 1
* 2 sample trays are included in each start-up kit

XX = depending on software revision

10 Warranty
10.0 General Warranty Conditions

IL declares to the original Purchaser that each instrument manufactured and/or sold
by IL shall be free from defects in material workmanship and, under normal and
proper use conditions, warrants it for a period of one year from installation and no
more than 13 months from the shipping date.
IL's obligation is limited to repairing, replacing or modifying (at IL's undisputed
judgment) at IL's factory - or elsewhere - the material whose defects have been
verified, on condition that the Purchaser has informed IL of any defects found within 8
days from receipt or from discovery in case of defects which may not be identified in
the normal inspection.
Damages caused by or connected to transport are excluded. Transport to and from

IL’s Factory will be at Purchaser's charge and risk and shall be paid also for
reshipment.
These replacements, repairs or alterations will in no case determine extension to the

above specified warranty period.
This warranty does not cover those parts which deteriorate or which are considered
consumables or those parts or items which by their nature are normally required to be
replaced periodically consistent with normal maintenance (including without limitation
lamps, and tubes).
Those instruments or accessories, which are supplied by IL but are not of IL

manufacture will only benefit from the warranty conditions offered by the
manufacturer.
It's also understood that, following the purchase and delivery of the instrument, the
Purchaser shall be deemed liable for any losses, damages or complaints concerning
persons or things incurred by the use or misuse of the instrument on behalf of the
Purchaser, his employees, co-operators or others.
IL does not assume any obligation or warranty engagement concerning precision
and/or accuracy of the measurements as well as for any damage to the instrument
directly or indirectly resulting from the use of reagents and/or consumables different
from those produced by IL specifically for its own instruments on the same properly
tested.

Warranty
Warranty will not apply to those defective instruments or materials showing defects or
damage arising from the following causes:
a. Insufficient or negligent care by the Purchaser.
b. Insufficient or negligent maintenance by the Purchaser in relation to the instructions
contained in the Manuals prepared by IL for this purpose, tampering or alterations of
the instruments or in any case intervention or repairs made by any person not duly
authorized by IL.
c. Misuse due to carelessness, negligence or inexperience.
d. Employment of materials under heavier conditions than those for which they had
been designed and manufactured and use of the same in combination with
incompatible or dangerous products.
e. Non-observance of regulations relative to installation, power supply and operation

of the instruments (with particular regard to the regulations for accident prevention).
10.1 Disclaimer regarding non-IL brand products

IL brand reagents, consumable and expendable supplies (including, for example,
wash reference emulsion and rotors) were developed specifically for the ACL's
centrifugal, nephelometric clot detection system. IL's ACL system products are tested
to assure proper performance when using plasma samples in accordance with the
protocol described in Section 8. Each lot of IL brand ACL reagents is tested against
these criteria. Verification of other brands of reagent or supplies to ascertain their
suitability for the ACL's methodology or their level of performance on the IL ACL
instruments is not performed. The use of non-IL brand reagents or supplies for testing
which is not done in accordance with IL protocols may cause a clinically significant
degradation of performance and results.
IL does not assume any obligation or warranty engagement concerning precision
and/or accuracy of the measurements as for any damage to the instrument directly or
indirectly resulting from the use of reagents, consumables and expendable supplies
different from those produced by IL.

THIS WARRANTY IS GIVEN EXPRESSLY AND IN LIEU OF ALL OTHER
WARRANTIES, EXPRESSED OR IMPLIED. PURCHASER AGREES THAT THERE
IS NO WARRANTY OR MERCHANTABILITY AND THAT THERE ARE NO OTHER
REMEDIES OR WARRANTIES, EXPRESSED OR IMPLIED, WHICH EXTEND
BEYOND THE CONTENTS OF THIS AGREEMENT.
No agent or employee of IL is authorized to extend any other warranty or to assume
for IL any liability except as above set forth.
IL does not test other manufacturer reagents to ascertain their suitability for the ACL's
methodology or their level of performance on the IL ACL instruments.
ACL Warranty
The following items are considered as consumable parts:
Fluidic Tubing
Sample Probe

11 IL Worldwide Locations
Corporate Headquarters
Aragón 90 - 08015 Barcelona, Spain
P.O. Box 35027 (08080)
Telephone: 34-3-4010101
Fax: 34-3-4513745
US, Canada, Latin America,

Headquarters
Instrumentation Laboratory Company
101 Hartwell Avenue - P.O. Box 9113
Lexington, MA 02421-3125 U.S.A.
Telephone: (781) 861-0710
Fax: (781) 861-1908
Mexico
Instrumentation Laboratory Diagnostics, S.A. DE C.V.
Londres 47 - Colonia Juarez - Mexico, D.F. 06600
Telephone: 525-8639
Fax: 525-8539
Pacific Headquarters
Yoshiu Building 1F
6-7-5 HigashiKasai
Edogawa-ku, Tokyo 134 - Japan
Telephone: 81-3-5658-3041
Fax: 81-3-5658-3043
Japan
Yoshiu-Sangyo Building 1F
6-7-5 Higashi-Kasai
Edogawa-ku, Tokyo 134 - Japan
Telephone: 81-3-5658-3041
Fax: 81-3-5658-3043

Worldwide Location
Europe, Middle East, Africa

Headquarters
Instrumentation Laboratory SpA
Viale Monza 338 - 20128 Milan, Italy
Telephone: 39-2-25221
Telex: 330112 ILSpA I
Fax: 39-2-2575250
Austria
Instrumentation Laboratory Ges. m. b. H.
Business Park Vienna - Wienerbergstraβe 3
A-1100 Vienna, Austria
Telephone: 43-1-60213300
Fax: 43-1-6022317
Belgium
Instrumentation Laboratory (Belgium) N.V. / S.A.
Excelsiorlaan 81 bus 1
1930 Zaventem (Brussel) - Belgium
Telephone: 32-2-7252052
Fax: 32-2-7212409
Federal Republic of Germany

Instrumentation Laboratory GmbH
Klausnerring 4
D-85551 Kirchheim bei München
Federal Republic of Germany
Telephone: 49-89-909070
Telex: 5215032 ILFD
Fax: 49-89-90907116
France
32, avenue de Saint- Mandé
B.P. 35 - 75562 Paris Cedex 12 France
Telephone: 33-1-43461144
Telex: 670652 PULMO-PARIS
Fax: 33-1-43460701

Italy
Instrumentation Laboratory SpA
Divisione Commerciale Italia
Viale Monza 338 - 20128 Milan, Italy
Telephone: 39-2-25221
Telex: 330112 ILSpA I
Fax: 39-2-2575250
Switzerland
Instrumentation Laboratory AG
Giessenstrasse 15 - Postfach
CH-8952 Schlieren (ZH), Switzerland
Telephone: 41-1-7423030
Fax: 41-1-7423035
The Netherlands
Instrumentation Laboratory (Netherlands) B.V.
Moskesbaan 2
4823 AH BREDA - The Netherlands
Telephone: 31-76-5480100
Fax: 31-76-5480102
United Kingdom
Instrumentation Laboratory (U.K.) Ltd.
Kelvin Close - Birchwood Science Park
Warrington, Cheshire WA3 7PB England
Telephone: 44-01925-81-0141
Fax: 44-01925-826708

ACL Elite/Elite Pro TECHNICAL BULLETIN IMPORTANT INR NOTICE
INR FORMULA
INR = (PT Patient / PT Normal) ISI
PT PATIENT = Patient’s PT in seconds
PT NORMAL = Mean* of the Normal Range (on the ACL Elite/Elite Pro this is called the Reference Value)
ISI value = International Sensitivity Index from the current lot # of thromboplastin reagent being used.
To assure appropriate reporting of INR results, you must follow these steps:
1. Make sure instrument is in the READY mode. From the SET UP MENU select the LIQUIDS
SUBMENU, then select the appropriate THROMBOPLASTIN REAGENT (LIQUID ID) from the list
in the left upper part of the screen.
2. Select the PT TEST that uses this Thromboplastin reagent and click on ASSIGN VALUE.
3. Enter the ISI VALUE of the Thromboplastin Lot in use and select Confirm twice to enter value.
Make sure that all PT tests using the same Thromboplastin import the proper ISI assignment.
Several PT TESTS using the same Thromboplastin may be present such as PT extended, PT
duplicate standard and PT duplicate extended acquisition time. These tests will import the value
from the standard test.
NOTE: The ISI value is specific for the lot number of prothrombin time reagent being used.
4. From the SET UP MENU select TESTS VIEW/DEFINE. Select the appropriate PT test and click on
details.
5. Select CALCULATION SETUP and the instrument will show in the right part of the screen the
selection of the REFERENCE VALUE. This represents the Mean of Normal Population value in
SECONDS, which is used as the DENOMINATOR in the RATIO and INR CALCULATION.
6. Make sure that the value entered in this field represents the MEAN NORMAL POPULATION
RANGE of the local PT population. This value is editable and can be modified to reflect the
laboratory established mean normal range.
7. Confirm all PT Tests using the very same thromboplastin lot for Ratio/INR will be calculated using
the same value in seconds as the denominator (Mean Normal Population Range).
8. The instrument uses the following formula for RATIO CALCULATION.
RATIO CALCULATION = PATIENT PLASMA (seconds)

REFERENCE VALUE (seconds)
Reference Value means MEAN OF NORMAL POPULATION (seconds).

MEAN OF THE NORMAL POPULATION RANGE = Mean Normal PT Time = Mean of Patient
Normal Range in seconds as recommended in the CLSI Document C28-A, Vol. 15, No.4.
9. The INR will then be calculated as follows:
INR = (PT Patient/PT of Reference Value)ISI
Using the Reference Value feature the denominator used in the Ratio and INR calculation will
accurately reflect the Mean of Normal Population Range.
*or Geometric mean
IMPORTANT WARNINGS:
• If the INR calculation is not properly setup, then erroneous patient results may be reported.
• If the product lot number changes, then the new ISI value from the package insert must be
entered.
• In the ACL Elite/Elite Pro both screen and printout show/report Ratio and INR units separately
CO# 400342 P/N 181121-12 Rev.00

Appendix A
ACL Elite/Elite Pro
Host Communication Protocol
Revision 2.3
Dec 2005
Appendix A
Revision Date Comments

December 07-2002 Added transmission examples
Specified ASTM field numbers
Add Notes for information
Total number of pages
Reviewed Test Codes
December 16-2002 Review some Notes
April 2004 Error code update
December 2005 Elite/Elite Pro update
Instrumentation Laboratory 2 of 33
ELITE/ELITE PRO Operator’s Manual
Index
1.0 Introduction 4
1.1 Purpose 4
2.0 General Description 5
2.1 Product Perspective 5
3.0 Specific Requirements 6
3.1 Protocol Specification 6
3.2 Low Level Interface 6
3.3 Data Link and Logical Layer 6
3.4 Sessions 6
3.4.1 Message Header and Message Terminator Records 7
3.5 Test Order Downloading 8
3.5.1 Receive Session from DMS 8
3.5.1.1 Test Request Message 9
3.5.1.2 Test Order Message 10
3.5.1.2.1 Patient Information Record 10
3.5.1.2.2 Test Order Record 12
3.5.2 Host Query 14
3.5.3 Test Request Message 15
3.5.4 Test Order Message 16
3.6 Rejected Test Order 17
3.7 Download Session Volumes 18
4.0 Test Results Uploading 19
4.1 Test Result Message 20
4.1.1 Patient Information Record 20
4.1.2 Test Order Record 21
4.1.3 Result Record 22
4.1.4 Comment Record 23
4.1.5 Error Codes 24
4.2 Upload Session Volumes 26
5.0 Not Supported Records 27
6.0 Transmission Abort 27
7.0 Appendix - ACL Elite/Elite Pro Test Codes 28
8.0 Appendix - ACL Elite/Elite Pro Supported Characters 31
8.1 Supported Characters for Sample ID 31
8.2 Supported Characters for Patient name and Department 31
8.3 Supported Characters for delimiters 31
9.0 Appendix - ACL Elite/Elite Pro Supported Units 32
Appendix A
1.0 Introduction
1.1 Purpose
This document is a guide to integrate a Laboratory Information Management system with the
Instrumentation Laboratory ELITE/ELITE PRO family instruments using the ASTM (American
Society for Testing and Materials) specification to transfer information between clinical instruments
and computer systems.
ASTM specification E-1394-91 Standard Specification for Transferring Information between Clinical
instruments and Computer Systems and E-1381-91 Standard Specification for the Low Level
Protocol to transfer Messages between Clinical Laboratory Instruments and Computer Systems
have been used as standard to develop ELITE/ELITE PRO Host Communication Protocol.
Specification E-1394 defines the logical layer of ASTM standard; all significant information for
ELITE/ELITE PRO instruments application can be found in chapters Specific Requirements and
following.
Specification E-1381 refers to low level protocol; significant information for ELITE/ELITE PRO
family instruments application can be found later on in this document.
2.0 General Description
2.1 Product Perspective
Communication sessions with host computer can be started on ELITE/ELITE PRO family
instruments by operator request or automatically at session completion.
If the operator requires a manual download session, the instrument will open communication with
the host computer that will provide transmission of all test orders.
If the operator requires an upload session, the instrument will transmit a subset of sample results
(identified by the user) stored in the instrument patient database or QC database or Analytical
Reference database.
If the instrument is properly configured, automatic downloading or uploading sessions can be

started by ELITE/ELITE PRO instrument.
Automatic downloading will occur at session start if host query is configured. In this condition the
instrument will request test orders for specific sample IDs recognized on the sample tray.
The second condition will occur, if automatic uploading has been requested, at session completion.
In case the communication session is not generated from the instrument, any host computer
message is ignored.
All information received by the host computer must be associated with a Sample ID which is the
primary key of the database. In addition to programmed tests a certain amount of information can
be associated with a Sample ID (patient data) and stored in ELITE/ELITE PRO database. This
information is optional.
The sample ID is the primary key to access information in the database.

If the checks fail, any downloading operations will be aborted. See Test Order Downloading
section.
At most 1000 samples can be stored in ELITE/ELITE PRO database; each sample can have a
maximum of 30 tests associated (double tests are considered as 3 tests).
The system behavior when these limits are exceeded is explained in the paragraph Test Order
Downloading.
If 1000 samples are present in the database, the FIFO (First In First Out) will not accept additional
samples during a Manual Downloading.
The test ordering operation, to identify the type of ordered test, by host computer must refer to a
computer code that is instrument specific. Refer to Test Order Downloading for further details and
to the Appendix at the end of this document for the test codes table.
Note: for the downloading the Host should send to the ELITE/ELITE PRO string information in
single frame (single line) during the transmission or up to 240 bytes maximum during the
transmission.
.
Appendix A
3.0 Specific Requirements
3.1 Protocol Specification
3.2 Low Level Interface
Low level interface conforms to ASTM specification E-1381-91. The following characteristics are
supported and are configurable by Operator Interface:
Baud Rate 2400, 4800, 9600, 19200, 38600
Character Length 8 bit
Parity No parity
Stop Bits 1
3.3 Data Link and Logical Layer
For the Data Link and Logical Layer the ASTM specification E-1381-91 has been maintained as a
reference. Protocol limits and constraints are those declared by the standard.
To mention some of them, the data part of the frames exchanged between the instrument and the
host computer should be done as single frame. As a consequence during transmission sessions
specific routines provide the ability to divide large records into multiple frames and during a
reception session they re-build partial frames in a single record. The application level has no
evidence of this mechanism.
According to ASTM standard the following characters cannot be part of data records: <SOH>,
<STX>, <ETX>, <EOT>, <ENQ>, <ACK>, <DLE>, <NAK>, <SYN>, <ETB>, <LF>, <DC1>,
<DC2>, <DC3>, <DC4>.
Timeout and retry logic are those specified by the standard; the Low Level Clinical Message State
Diagram representing the implemented automatic is the reference.
In interrupt request status the instrument accept remote EOT.
3.4 Sessions
There are two types of sessions that the instrument handles with the ASTM interface: the test
orders download and the test results upload. These sessions can be initiated by the operator or
automatically activated by the instrument.
When the user/operator requests a download operation (Receive Command), the instrument will
send a request to the host for available test orders (all) or for test orders requested for specific
samples, and the host will answer with the test orders available for the instrument.
Test results upload (Transmit Command) are initiated by the user or automatically by the
instrument at the same way. The host is not allowed to transmit unsolicited messages, any type of
inquiries or test orders not explicitly required by the instrument.
3.4.1 Message Header and Message Terminator Records
Following ASTM specification, each type of transaction between the instrument (DTE) and the host
computer (DCE) has two common records that are the Message Header record and the Message
Terminator record. These records open and close data transmission between ELITE/ELITE PRO
instruments and host computer.
Their fields are described in the following:
Message Header Record:
Record Type ID Always set to ‘H’

Delimiter Definition The 5 ASCII characters composing this field define the type
of delimiters that will be used in the following records. See
Appendix B for supported delimiters.
Message Control ID Not provided
Access Password Not provided
Sender Name or ID Set to ‘ACL9000’ when transmitting to host or receiving. As
an option, the ability to identify univocally the instrument by
means of an extension to the instrument name is also
supported: the name syntax becomes ‘ACL9000-xx’ where
xx is a two digit code in the range 01-99.
The extension to the instrument name is user configurable in
the set-up environment.
The instrument ID is always ACL9000 independently from
the model; ELITE/ELITE PRO.
Sender Street Address Not provided
Reserved Fields Not provided
Sender Telephone Number Not provided
Characteristics of Sender Not provided
Receiver ID Must be set to ‘ACL9000’ when receiving from host.
Depending on the instrument set-up, the ability to identify
univocally the instrument by means of the extension to the
instrument name is also supported: the name syntax
becomes ‘ACL9000-xx’ where xx is a two digit code in the
range 01-99.
If the ID is different from the expected one, the session is
interrupted.
Comment or special Instructions Not provided
Processing ID Always set to ‘P’ meaning Production
Version No. Set to the current ASTM standard version = ‘1’
Date and Time of Message Format is YYYYMMDDHHMMSS
Example of message sent from the ELITE/ELITE PRO :
H|\^&|||ACL9000|||||||P|1|20021205123956<CR>
Example of message sent from Host:
H|\^&||||||||ACL9000||P|1|20021205123956<CR>
Appendix A
Message Terminator Record:
Record Type ID always set to ‘L’

Sequence Number always set to ‘1’
Termination Code set to ‘N’ for normal termination and to ‘E’ for abnormal
termination while transmitting to host;
not considered for received data
Example of Terminator:
L|1|N<CR>
3.5 Test Order Downloading
Test order downloading is used to request test orders available on the host and to have them on
the instrument. This operation can be obtained in two ways: manually opening a download session
from the DMS environment or enabling on the instrument the host query function.
In the first case the host will have to transmit to the instruments all pending test requests; in the
second case the instrument will automatically require specific information for the samples placed
on the sample tray and without any test requests.
Details for both modalities are explained in Receive Session from DMS and Host Query
paragraphs.
3.5.1 Receive Session from DMS
The operator manually initiates the test order download from the DMS environment.
The host will provide to the instrument all available test requests. The host can send zero or more
test orders in one or more messages, but all messages will be part of the same transmission
session.
During a transmission session more test orders can be required for the same sample.
The host sends usually all test orders for which it has not yet received results even if they have
been previously transmitted.
ELITE/ELITE PRO instruments will process each received test order to validate fields supported;
some information will be extracted from the received record while other information will be ignored.
Only test orders related to patient samples are considered, if the required sample ID does not exist
in the patient database and the required sample ID is not used in the QC database, a new record is
created. If the database is full, the transmission session will be aborted.
If the test orders are for a sample already existing in the sample data base, the new orders will be
added to the existing tests but all tests already ordered or performed will remain unchanged.
If a test order with more than the maximum number of programmable tests is sent, the request is
rejected. The limit is 30 single tests or 10 double tests.
If the test order is not recognized as one of those supported by ELITE/ELITE PRO family
instruments, it is rejected. The instrument will inform the host computer using a record containing
the list of rejected test orders.
During a downloading session the listed error conditions can be detected, the associated
instrument behavior and actions are listed as well:
Error Condition Action User Message
Sample ID used in the QC data base Abort communication Sample ID already used
in the QC data base
Bad Sample ID (long, unsupported Abort communication Invalid Sample ID
characters)
Data Base full Abort communication Patient Data Base is full
Patient record has no associated test Abort communication Not identified sample ID
order record for patient data
Test order has no associated patient Abort communication No patient record for
record ordered tests
Instrument Identifier different from Abort communication Invalid instrument
ACL9000 or extended name identifier
Too many test requests for the same Reject test order -
sample ID
Unknown test request Reject test order -
Bad Test Reject test orders -
Illegal record format Abort communication Incorrect record format

in host messages
All abort conditions imply that ELITE/ELITE PRO family instruments will send to the host computer
a message with the reason for transmission interruption (see Reject Test Order) while a message is
presented to the user on the instrument. When transmission abort is not implied, at transmission
completion one or more records will follow (see Reject Test Order) with an indication of rejected
test orders.
Information rejected is typically unknown test requests or test requests exceeding the sample
record size in ELITE/ELITE PRO Data Management System. It must be observed that if any of this
information is rejected, it does not imply that all sample data have been rejected.
The set of legal test requests are normally stored while the illegal requests for the same sample ID
will be rejected.
It also must be underscored that ELITE/ELITE PRO limits the size of handled records
(independently from the record type supported by ASTM) to 1024 byte during downloading session.
Note: for the downloading the Host should send to the ELITE/ELITE PRO string information in
single frame (single line) during the transmission or up to 240 bytes maximum during the
transmission.
3.5.1.1 Test Request Message
The Test Request Message is used by ELITE/ELITE PRO to start the test order download session.
It is composed from a Message Header record, a Request Information record and a Message
Terminator record.
The “Request Information record” requests from the host ALL test orders available for the specific
instrument.
Following the ASTM specification the fields composing the Request Information are described in
the following.
Appendix A
Request Information Record:
Record Type ID always set to ‘Q’

Sequence Number as defined by the standard set to ‘1’ when query is sent
Starting Range ID Number set to the string ‘ALL’
Ending Range ID Number not provided
Universal Test ID not provided
Nature of Request Time Limit not provided
Beginning request Results Date and Time not provided
Requesting Physician Name not provided
User Field #1 not provided
Request Information Status Code always set to ‘O’ (requesting test orders and
demographics only)
An example for the complete message (composed by header message, request information record
and message terminator record) is given by:
H|\^&|||ACL9000|||||||P|1|19960210103227<CR>
Q|1|ALL||||||||O<CR>
L|1|N<CR>
3.5.1.2 Test Order Message
To answer the ELITE/ELITE PRO Test Request Message, the host computer sends the Test Order
Message. It contains the records specifying which tests are being requested for each specified
sample. The host computer may answer with one or more message; each one contains one or
more test order specifications. The test order specification consists of a Patient Information record
followed by one or more Test Order records.
The host can send for the same sample ID a Patient Information record followed by many Test
Order records or, for each test to be ordered, a pair composed by the Patient Information record
followed the Test Order record.
Comment Record messages during downloading operations are ignored by ELITE/ELITE PRO.
3.5.1.2.1 Patient Information Record
The fields characterizing this record are specified in the following:
Patient Information Record:
Record Type ID Must be ‘P’

Sequence Number Must begin with ‘1’ and then must increment by
one for each new Patient Information record
Practice Assigned Patient ID Ignored
Laboratory Assigned Patient ID Stored, if available, as a string in the Patient ID
field of the sample record.
No checks are performed for this field and the
string will be truncated to 15 characters.
Patient ID #3 Ignored
Patient Name Stored, if available, as a unique string in the
‘name’ field of sample record considering only the
first two sub fields in this data field (second and
first name). The string will be truncated to 30
characters. If a character not supported is found
(see Appendix for supported characters), the
patient name and all the other strings in the same
patient record will be ignored.
If the patient name is not available 4 separators
must be transmitted: ^^^^.
Mother’s maiden Name Ignored
Birth date Stored, if available. The data will be converted and
displayed in the following in according to
ELITE/ELITE PRO supported format.
Expected format, conforming to ASTM standard, is
YYYYMMDD
Patient Sex Stored if available. Allowed characters are ‘M’, ‘m’,
‘F’, ‘f’, ‘U’, ‘u’; any other character is interpreted as
‘U’.
Patient Race-Ethnic Origin Ignored
Patient Address Ignored
Reserved Field Ignored
Patient Telephone Number Ignored
Attending Physician ID Ignored
Special Field #1 Ignored
Special Field #2 Ignored
Patient Height Ignored
Patient Weight Ignored
Patient’s Known or Suspected Diagnosis Ignored
Patient Active Medications Ignored
Patient’s Diet Ignored
Practice Field #1 Ignored
Practice Field #2 Ignored
Admission and Discharged Dates Ignored
Admission Status Ignored
Location Stored if available as a free string in the
‘department’ field of sample record. The string will
be truncated to 30 characters. See Appendix B for
supported characters.
Nature of Alternative Diagnostic Code Ignored
and Classifiers
Alternative Diagnostic Code and Ignored
Classifiers
Patient Religion Ignored
Marital Status Ignored
Appendix A
Isolation Status Ignored

Language Ignored
Hospital Service Ignored
Hospital Institution Ignored
Dosage Category Ignored
3.5.1.2.2 Test Order Record
Test Order Record:
1. Record Type ID Must be ‘O’ (letter)

2. Sequence Number Must begin with ‘1’ and then must increment
by one for each new test order record for the
same patient
3. Specimen ID This is the ELITE/ELITE PRO sample ID; the
field must be less than or equal to 15
characters and must be consistent with rules
on sample ID (ID already in use for QC
database are not legal). Non conforming
sample IDs will cause an abort of the
download process.
See Appendix B for ELITE/ELITE PRO
supported characters.
4. Instrument Specimen ID Ignored
5. Universal Test ID The field is composed of 4 parts; only the
Manufacturer’s Code component is used as a
4 character code (user configurable on board);
unknown test ID will be rejected.
6. Priority If the field contains in any of the sub fields the
S char the sample ID will be considered a
priority sample; any additional flag will be
ignored. If the field does not contain the S char
or it is empty, the sample will be identified as a
routine sample.
7. Requested/Ordered Date and Time Ignored
8. Specimen Collection Date and Time Ignored
9. Collection End Time Ignored
10. Collection Volume Ignored
11. Collector ID Ignored
12. Action Code Ignored
13. Danger Code Ignored
14. Relevant Clinical Information Ignored
15. Date/Time Specimen Received Ignored
16. Specimen Descriptor Ignored both fields
17. Ordering Physician Stored if available as a free string in the
‘physician’ field of sample record. The string
will be truncated to 30 characters. See
Appendix for supported characters.
18. Physician’s Telephone Number Ignored
19. User Field No. 1 Ignored
20. User Field No. 2 Ignored
21. Laboratory Field No. 1 Ignored
22. Laboratory Field No. 2 Ignored

23. Date/Time Results Reported or Last Ignored
Modified
24. Instrument Charge to Computer System Ignored
25. Instrument Section ID Ignored
26. Report Types Set to O (letter); other codes will cause
records rejection
27. Reserved Field Ignored
28. Location of Ward of Specimen Collection Ignored
29. Hospital Information Flag Ignored
30. Specimen Service Ignored
31. Specimen Institution Ignored
An example for a complete test ordering is given by:
H|\^&||||||||ACL9000||P|1|19982110134700<CR>
P|1||PTNT1||ROSSI^MARIO^^^||19391127|M|||||||||||||||||DEP
1||||||||||<CR>
O|1|SMP01||^^^0001|S||||||||||^|DR. VERDI||||||||||O||||||<CR>
O|5|SMP02||^^^0001|||||||||||^|||||||||||O||||||<CR>
P|2||PTNT2||GIALLI^LUCA^^^||19551028|F||||||||||||||||||DEP
2||||||||||<CR>
O|1|SMP10||^^^0001|||||||||||^|||||||||||O||||||<CR>
L|1|N<CR>
Example of download without patient name:
H|\^&||||||||ACL9000||P|1|20021205123956<CR>
P|1||||^^^^|||||||||||||||||||||||||||||<CR>
O|1|LAURA01||^^^0001|||||||||||^|||||||||||O||||||<CR>
L|1|N<CR>
Note: Separators are always expected from Host and are always transmitted independently from
the information contained in the string.
Appendix A
3.5.2 Host Query
Host query is automatically activated by the instrument each time the system is properly
configured. Beginning the pre-analysis phase of a single test or profile or test group, one or more
samples have no type of test requests associated.
The instrument will send, using the requested information record, the sample IDs requiring test
programming and will accept only test orders for those sample IDs.
The instrument will accept for the queried samples any test orders independently by the type of test
which will be executed in the starting session.
The mechanism supported by ASTM requires sending to the host a Request Information record for
each sample ID or sending to the host a range of queried sample IDs. The mechanism supported
by ELITE/ELITE PRO is the first option, so will be independent of the sorting system used by
instrument or host computer on the samples.
As a consequence the instrument will send a query for the first sample, will wait for the host
information and will send later a new query for the next samples (if any). All the host query
sessions will be organized in this manner.
Because the instrument is asking for information regarding a specific sample ID, it will reject any
type of information associated with different sample IDs.
The host will provide to the instrument all available test requests. The host can send zero or more
test orders in one or more messages, but all messages will be part of the same transmission
session.
During a transmission session more test orders can be required for the same sample.
ELITE/ELITE PRO will process each received test order validating the fields that ELITE/ELITE
PRO supports; some information will be extracted from the received record while other information
will be ignored.
If the test order is not recognized as one of those supported by ELITE/ELITE PRO it will be
rejected. The instrument will inform the host computer using a record containing the list of rejected
test orders.
Host Query is only performed if the Sample ID is not located in the database for the ACL system.
During a download session the listed error conditions can be detected, the associated ELITE/ELITE
PRO action is listed as well:
Error Condition Action User Message
Sample ID used in the QC data base Abort communication Sample ID already used
in the QC data base
Bad Sample ID (long, unsupported Abort communication Invalid Sample ID
characters)
Data Base full Abort communication Patient Data Base is full
Patient record has no associated test Abort communication Not identified sample ID
order record for patient data
Test order has no associated patient Abort communication No patient record for
record ordered tests
Instrument Identifier different from Abort communication Invalid instrument
ACL9000 or extended name identifier
Too many test requests for the same Reject test order -
sample ID
Unknown test request Reject test order -
Bad Test Reject test orders -
Illegal record format Abort communication Incorrect record format
in host messages
All abort conditions imply that ELITE/ELITE PRO family instruments will send to the host computer
a message with the reason of transmission interruption (see Reject Test Order) while a message is
presented to the user on the instrument. When transmission abort is not implied, at transmission
completion one or more records will follow (see Reject Test Order) with an indication of rejected
test orders.
Information rejected is typically unknown test requests or test requests exceeding the sample
record size in ELITE/ELITE PRO Data Management System. It must be observed that if any of this
information is rejected, it does not imply that all the sample data have been rejected.
The set of legal test requests are normally stored while the illegal requests for the same sample ID
will be rejected.
It also must be underscored that ELITE/ELITE PRO limits the size of handled records
(independently from the record type supported by ASTM) to 1024 byte during downloading session.
Note: If the Sample ID is not present at the Host level during the Host Query, the Host will return
only the Header and the terminator.
H|\^&||||||||ACL9000||P|1|20021205123956<CR>
L|1|N<CR>
Note: If the Host requests a test that is disabled on the ELITE/ELITE PRO, the test will not be
programmed on the ELITE/ELITE PRO and a reject message of this type will be returned back to
the Host.
C|1|I|UKNOWN_T|PatientID^0080|I<CR>
3.5.3 Test Request Message
The Test Request Message is used by ELITE/ELITE PRO to require information for each specific
sample that has no test orders in the instrument database. It is composed from a Message Header,
a Request Information and a Message Terminator record.
Appendix A
The Request Information record requests in this case information for one specific ID at time. The
ASTM protocol limits the number of Request Information records to one. As a consequence the
instrument will wait for the host answer before sending a second Request Information record for a
second sample.
Following the ASTM specification the fields composing the Request Information are described in
the following.
Request Information Record:
Record Type ID always set to ‘Q’

Sequence Number as defined by the standard set to ‘1’ when query is
sent
Starting Range ID Number set to the specific sample ID to require information on;
the meaningful component is the second one
Ending Range ID Number not provided
Universal Test ID not provided
Nature of Request Time Limit not provided
Beginning request Results Date and Time not provided
Requesting Physician Name not provided
Request Information Status Code always set to ‘O’ (requesting test orders and
demographics only)
An example for the complete message (composed by header message, request information record
and message terminator record) is given by:
H|\^&|||ACL9000|||||||P|1|19960210103227<CR>
Q|1|^S001^||||||||O<CR>
L|1|N<CR>
Answer from Host:
H|\^&||||||||ACL9000||P|1|19960210103256<CR>
P|1||||ROSSI^MARIO^^^||19391127|M|||||||||||||||||DEP 1||||||||||<CR>
O|1|S001||^^^0001|||||||||||^| DR. VERDI ||||||||||O||||||<CR>
O|5|S001||^^^0002|||||||||||^|||||||||||O||||||<CR>
L|1|N<CR>
3.5.4 Test Order Message
As an answer to the ELITE/ELITE PRO Test Request Message the host computer sends the Test
Order Message. It contains the records specifying which tests are being requested for the queried
Sample ID.
See Test Order Message for details.
3.6 Rejected Test Order
At completion of download operations, or at completion of the download operation for a single

sample in the host query mechanism, ELITE/ELITE PRO can transmit a message to inform host
computer about rejected test orders and samples or about the reasons for transmission interrupt.
The Rejected Test Order Message consists of a Message Header record followed by one or more
Comment records and completed by the Message Terminator Record. A comment record will be
transmitted for each rejected information.
It must be observed that if no legal information has been received, the download process is
interrupted and the rejected test order message will signal the reason for the interruption.
If the download process has been completed normally, the possible following rejected test order
message will report no legal test orders.
Comment Record structure is described in the following table:
Record Type ID Always set to ‘C’

Sequence Number Must begin with ‘1’ and then it will increment by one for each new
comment record
Comment Source Always set to ‘I’ (as ASTM: clinical instrument system)
Comment Text This field indicates the reason of the test order rejection. It is a string with
two components, each one can assume the reported values:
Rejection Reason:
BAD_TEST: the transmitted test code is invalid
QC_MA_ID: the specified ID is already used as a material in the QC
data base
BAD_S_ID: the specified ID is invalid
WRONG_ID: the host is sending information for a sample ID different
from the expected one
PDB_FULL: patient data base is full
M_TEST_E: more tests than expected
UKNOWN_T: unknown test requested
INSTR_ID: invalid instrument identifier
NO_TESTS: no test ordered for patient record
NO_PATIE: no patient record for ordered test
BAD_RECO: incorrect record format
Identification: This string contains the identification of the sample causing
the problem; if a test order caused the problem the sample ID and test ID
are transmitted sequentially. The character used to separate the rejection
reason, and the two strings used for the identification field is ‘|‘.
Lacking information will be signaled as “UNKNOWN”.
If BAD_RECO is the reason of the rejection the field will contain the
record number and the field number caused the failure.
Comment Type Always set to ‘I’ (as ASTM: instrument flag comment)
To summarize the possible values for the rejection reason and identification fields are reported in
the following table:
Appendix A
Rejection Reason Transmission Identification: first sub_field Identification: second sub_field

Interrupted
QC_MA_ID yes sample ID (causing the problem) UNKNOWN
BAD_S_ID yes sample ID (causing the problem) UNKNOWN
PDB_FULL yes sample ID (causing the problem) test_ID
NO_TESTS yes UNKNOWN UNKNOWN
NO_PATIE yes sample ID (causing the problem) test_ID
INSTR_ID yes UNKNOWN UNKNOWN
M_TEST_E no sample ID test ID (causing the problem)
UNKWOWN_T no sample ID test ID (causing the problem)
BAD_TEST no sample ID test ID (causing the problem)
BAD_RECO yes Record No. (debug purpose) Field No. (debug purpose)
An example for a complete rejection phase is given by:
H|\^&|||ACL9000|||||||P|1|19982110103227<CR>
C|1|I|M_TEST_E|SMP01 ^010|I<CR>
C|2|I|BAD_TEST|SMP01 ^000|I<CR>
L|1|N<CR>
3.7 Download Session Volumes
Approximate data volumes for download sessions is provided as a guide for estimating the time
required completing typical sessions. System latencies (both in ELITE/ELITE PRO and host
computer) are not considered.
The minimal session would occur if the host has no test orders available for ELITE/ELITE PRO. In
this condition ELITE/ELITE PRO sends the test request message, the host would respond with a
message containing no test orders (only message header and message terminator record).
In conditions in which the host has test orders for the instrument, the estimated data volume is:
Test Request Message = Message Header (41) +17 + Message Terminator Record (6) = 64
Test Order Message = Message Header (41) +

Number of patient records (82 + 55 *number of ordered test)
+ Message Terminator Record (6)
Test Order Rejected = Message Header (41) +

+ 41 * number of rejected records
+ Message Terminator Record (6)
So considering the following situation: the host has 50 sample IDs to be download, each one with 4
tests, consider 10 rejected records the data volume can be estimated in:
Test Request Message = 64

Test Order Message = 41+ 50 (82 + 55 *4) + 6 = 15147
Test Order Rejected = 41 + (41 * 10) + 6 = 457
Total = 15668 characters
At 9600 “baud rate” and with no system overhead it would take approximately 17 seconds and
considering a system efficiency of 60% it becomes about 27 seconds.
All estimations have been done using the maximum expected length for string fields.
Appendix A
4.0 Test Results Uploading

Test Result Uploading allows transmission of results of the tests performed on ELITE/ELITE PRO
to the host computer. Results, related to patient, QC samples and Analytical Reference materials,
are transmitted on explicit user request or automatically at session completion.
In the first case the user must require the transmission command in the DMS or in the QC or in the
AR environment, select the patient samples or QC samples or AR set of data to be transmitted (in
according with one of the supported selection criteria) and start operation.
In the second case the transmission will happen automatically at session completion and the
instrument will provide to upload patient and/or QC samples data and/or AR data.
The type of data to be transferred during an automatic upload session depends upon the
instrument set-up (the automatic data transmission can be set to “patient samples only” or “QC and
patient samples” or “QC and AR patient samples”).
If upload is manually requested, all data are transmitted independently from the transmission flag.
If transmission is performed automatically at session completion, the instrument will upload for
patient samples all the data available for the sample IDs just analyzed and will upload, for QC
data, the results just obtained.
From a general point of view the automatic data transmission of the patient samples is equivalent
to the manual data transmission, requested in DMS, of patient samples belonging to a specific
load-list. While the automatic data transmission of the QC data or AR data is equivalent to the
manual data transmission, requested in QC database or AR database, or the data in a specified
interval for the QC material present in the load-list.
Considering that ELITE/ELITE PRO fills the strings used for Sample ID, department and patient
name with space characters (to align data), the host computer must ignore space characters on the
right of these fields.
If uploading is completed successfully for patient, QC samples and AR data, the transmission flag
associated to the single record will be updated from ‘L’ to ‘T’ (transmitted).
It must also to be underscored that on ELITE/ELITE PRO, modifications to sample data already
transmitted (such as adding of a new test result or modifications of sample data) cause the
transmission flag to change from ‘T’ to ‘L’.
It does not apply to QC or AR data because the only modification the user can request on these
data is to omit or to clear statistic. The effect of omit operation is to exclude the data from the
statistic but the data is not modified.
Modifications in the set-up values and note field do not modify the transmission status of QC data
and AR data.
While transmission is in progress the user will be updated on the number of the sample being
transmitted.
ELITE/ELITE PRO does not accept inquiries for test results.
4.1 Test Result Message
The Test Result Message is used by ELITE/ELITE PRO to transmit any available test results for a
sample. All available test results will be transmitted for patient samples even if data have been
already transmitted partially.
The message consist of a Message Header record, a Patient Information record, one or more pair
Test Order records followed by one or more Results records (depending upon the number of
available test results and the number of results for each specific test).
The Result record can be completed with a Comment record containing flags associated to the
executed test.
Tests are uploaded using the same sorting used on board. The complete set of available test
results is globally uploaded to the host computer independently by the set of results defined as to
show in the sample list.
In some conditions, depending by the instrument status (i.e. calibrated, not calibrated, AR used,
etc.) only a subset of the results supported by the test will be transmitted to the host computer.
The Message Terminator record completes the transmitted data.
The same structure is used also to upload QC and AR data. In the following paragraphs any
differences in the way to treat patient, QC and AR data will be underlined.
4.1.1 Patient Information Record
This information is transmitted to the host only if available on the instrument. The Patient
Information structure is:
Patient Information Record:
File Type Patient Sample QC Sample or AR
Record Type ID Must be ‘P’ must be ‘P’

Sequence Number Must begin with ‘1’ and then must must begin with ‘1’ and
increment by one for each new then must increment by
Patient Information record one for each new Patient
Information record
Practice Assigned Patient ID Not provided not provided
Laboratory Assigned Patient ID Provided if defined as a string not provided
containing up to 15 characters.
Patient ID #3 Not provided not provided
Patient Name Provided if known as a single not provided
string containing up to 30
characters
Mother’s Maiden Name Not provided not provided
Birth date Provided if known as a single not provided
string without any checks
Patient Sex Provided if known as a single not provided
character
Patient Race-Ethnic Origin Not provided not provided
Patient Address Not provided not provided
Reserved Field Not provided not provided
Patient Telephone Number Not provided not provided
Attending Physician ID Not provided not provided
Special Field #1 Not provided not provided
Appendix A
Special Field #2 Not provided not provided

Patient Height Not provided not provided
Patient Weight Not provided not provided
Patient’s Known or Suspected Not provided not provided
Diagnosis
Patient Active Medications Not provided not provided
Patient’s Diet Not provided not provided
Practice Field #1 Not provided not provided
Practice Field #2 Not provided not provided
Admission and Discharged Not provided not provided
Dates
Admission Status Not provided not provided
Location Provided if known as a 30 not provided
characters free string
Nature of Alternative Diagnostic Not provided not provided

Code and Classifiers
Alternative Diagnostic Code and Not provided not provided
Classifiers
Patient Religion Not provided not provided
Marital Status Not provided not provided
Isolation Status Not provided not provided
Language Not provided not provided
Hospital Service Not provided not provided
Hospital Institution Not provided not provided
Dosage Category Not provided not provided
4.1.2 Test Order Record
Test Order Record:
File Type Patient Sample QC Sample or AR data
Record Type ID Must be ‘O’ Must be ‘O’

Sequence Number Must begin with ‘1’ and then Must begin with ‘1’ and then
must increment by one for each must increment by one for
new test order record for the each new test order record for
same patient the same patient
Specimen ID Provided, is the ELITE/ELITE Provided, is the ELITE/ELITE
PRO sample ID. PRO QC material ID for QC
See Appendix for ELITE/ELITE data; or is the ‘AR’ keyword for
PRO supported characters. AR data. See Appendix for
ELITE/ELITE PRO supported
characters.
Instrument Specimen ID Not provided Not provided
Universal Test ID The field is composed of 4 The field is composed of 4
parts, only the Manufacturer’s parts; only the Manufacturer’s
Code component is used as a 4 Code component is used as a
character code (host codes are 4 character code (host codes
user configurable on board). are user configurable on
board).
Priority Provided if set as a ‘S’ char for Not provided
priority samples.
Requested/Ordered Date/Time Not provided Not provided
Specimen Collection Date and Not provided Not provided
Time
Collection End Time Not provided Not provided
Collection Volume Not provided Not provided
Collector ID Not provided Not provided
Action Code Not provided Set to ‘Q’
Danger Code Not provided Not provided
Relevant Clinical Information Not provided Not provided
Date and Time Specimen Not provided Not provided
Received
Specimen Descriptor Not provided both fields Not provided both fields
Ordering Physician Provided, if available, as a Not provided
string containing up to 30 chars
Physician’s Telephone Not provided Not provided
Number
User Field #1 Not provided Not provided
User Field #2 Not provided Not provided
Laboratory Field #1 Not provided Not provided
Laboratory Field #2 Not provided Not provided
Date/time Results Reported or Not provided Not provided
Last Modified
Instrument Charge to Not provided Not provided
Computer System
Instrument Section Not provided Not provided
Report Type Set to F Set to F
Reserved Field Not provided Not provided
Location of Ward of specimen Not provided Not provided
Collection
Hospital Information Flag Not provided Not provided
Specimen Service Not provided Not provided
Specimen Institution Not provided Not provided
4.1.3 Result Record
The fields characterizing this record are specified in the following table.
A result record is send to the host computer for each available test result. For double tests all
available single values will be transmitted to the host computer (no mean values). Each result
record will contain one of available test results.
Result Record:
File Type Patient Sample QC Sample or AR data
Record Type ID Set to ‘R’ Set to ‘R’

Sequence Number Must begin with ‘1’ and then Must begin with ‘1’ and then
must increment by one for must increment by one for
each result record for the each result record for the
same patient test record for same patient test record for
the same patient record the same patient record
Universal Test ID The field is composed of 4 The field is composed of 4
parts, only the Manufacturer’s parts, only the Manufacturer’s
Appendix A
Code component is used as a Code component is used as a

4 character code (host codes 4 character code (host codes
are user configurable on are user configurable on
board). board).
Data or Measurement Value The field contains the obtained The field contains the obtained
numeric value or qualitative numeric value or qualitative
message (Error xx). All message (Error xx). All
numerical results are sent. * numerical results are sent. *
Units Provided if the previous field Provided if the previous field
is a numeric value; is a free is a numeric value; is a free
string (see Appendix C for string (see Appendix C for
standard units) maximum standard units) maximum
number of characters is 8). number of characters is 8).
Reference range Not provided Not provided
Result Abnormal Flag Not provided Not provided
Nature of Abnormality Flag Not provided Not provided
Result Status Set to ‘F’ Set to ‘F’
Data of Change in Instrument Not provided Not provided
Normative Values or Units
Operator Identification Not provided Not provided
Date/Time Test Started Not provided Not provided
Date/Time Test Completed Execution time, string of the Execution time, string of the
type YYYYMMDDHHMMSS type YYYYMMDDHHMMSS
Instrument Identification Not provided Not provided
* Specific ranges must be set at the Host level.
4.1.4 Comment Record
The Comment record allows integration of the transmitted test results with possible error
messages.
One or more comment records can follow the result records. Fields characterizing this record are
specified in the following.
Comment Record:
Record Type ID set to ‘C’

Sequence Number must begin with ‘1’ and then must increment by one for
each comment record
Comment Source set to ‘I’
Comment Text this field specifies the instrument errors (see table) as a
numeric code (2 characters) plus the associated message
Comment Type set to ‘I’
4.1.5 Error Codes
TEMPERATURE WARNING
ROTOR STACK TEMPERATURE Out of Range = 41,

SLIDER TEMPERATURE Out of Range = 43,
REAGENT TEMPERATURE Out of Range = 45,
INCUBATION TEMPERATURE Out of Range = 49,
MECHANICAL WARNING
AUTOSAMPLER WARNING = 50,

ROTOR MOTOR WARNING = 51,
HORIZONTAL MOTOR WARNING = 52,
VERTICAL MOTOR WARNING = 53,
REAGENT DILUTOR WARNING = 54,
SAMPLE DILUTOR WARNING = 55,
PHOTOMETRIC COVER WARNING = 56,
STIRRER1_FAIL = 57,
STIRRER2_FAIL = 58,
STIRRER3_FAIL = 59,
STIRRER4_FAIL = 60,
LIQUID WARNING
LIQUID_SENSOR OFF (SAMPLE) = 73,

LIQUID_SENSOR OFF (REAGENT) = 74,
LIQUID_SENSOR_FAIL (SAMPLE) = 75,
LIQUID_SENSOR_FAIL (REAGENT) = 76,
MATERIAL_SHORT = 77,
MANDATORY_MATERIAL_SHORT = 78,
FLUSH_PRE_WARNING = 79,
FLUSH WARNING = 80,
CLEANING_NOT_PERFORMED = 83,
MISCELLANEOUS WARNING
COVER_OPEN_DURING_LOADING_OR_INCUBATION = 86,
TIMEOUT_EXPIRED_DURING_LOADING = 87,
ERRORS ON RESPONSE
OUTSIDE SCALE RANGE LOW = 98

OUTSIDE SCALE RANGE HIGH = 99
SATURATION_ERROR = 205,
FIRST_THRESHOLD_ERROR = 206,
SECOND_THRESHOLD_ERROR = 207,
DELTA_ERROR = 208,
INITIAL_SLOPE_ERROR = 209,
FINAL_SLOPE_ERROR = 210,
FINAL_REACTION CURVE ERROR = 211,
FIRST_DERIVATIVE_ERROR = 212,
SECOND_DERIVATIVE_ERROR = 213,
FIRST_PART_REACTION CURVE ERROR = 214,
Appendix A
ERRORS ON CALIBRATION CURVES
INSUFFICIENT_STANDARD POINTS IN ONE_SEGMENT = 215,

INVALID CURVE INSUFFICIENT DATA = 216,
NUMBER OF_STANDARD OUT OF RANGE = 217,
INVALID_TRANSLATION_OR_MANDATORY_STANDARD = 219,
INVALID_STD_INSUFFICIENT_REPLICATES = 220,
INSUFFICIENT_REPLICATES = 221,
INVALID_REPLICATES = 222,
CV_OUT_OF_RANGE = 223,
SLOPE OUT OF RANGE: INVALID CALIBRATION CURVE = 225,
R2_OUT_OF_RANGE = 226,
NOT MONOTONIC CURVE = 228,
ERRORS ON ANALYTICAL REFERENCE, QC, RATIO AND NORMALIZED RATIO
AR_INVALID = 229,
AR_OUT_OF_RANGE = 230,
AR_NOT_CHECKED = 233,
DUPLICATE OUT OF RANGE = 239,
QC_INVALID = 240,
QC_OUT_OF_RANGE = 242,
RATIO_CALCULATION_ERROR = 249,
RATIO_CALCULATION_ERROR: S/Sa out of range = 250,
NORMALIZED RATIO ERROR: AR/Ara out of range = 251,
NORMALIZED RATIO: CALCULATION ERROR = 252,
STD_NOT_FOUND = 253,
AR_NOT_FOUND = 254,
ACTIVATE SAMPLE NOT_FOUND = 255,
ARa_NOT_FOUND = 256,
RATIO_NOT_FOUND = 257,
AR_OUT_OF_RANGE = 258,
AR_NULL = 259,
STD_NULL = 260,
SAMPLE_NULL = 262,
REF_NULL = 263,
AR_RATIO_ NULL_ = 264,
ACTIVATED_AR NULL_ = 265,
NULL_DIFFERENCE = 266,
Out of range indications referring to normal or test ranges are not transmitted to the host computer.
The * symbol (outside Normal Range) is presented only on the Cumulative and Sample Reports.
An example for a complete test uploading sequence is given by:
Sample
H|\^&||||||||ACL9000||P|1|19982110134700<CR>
P|1||PTNT1||BLU^^^^||19391127|M|||||||||||||||||DEP 1||||||||||<CR>
R|1|^^^0001|12.8|||||F||||19960119114215|<CR>
C|1|I|31^ Invalid for QC |I<CR>
P|2||PTNT1||Gialli^^^^||19391127|M|||||||||||||||||DEP 1||||||||||<CR>
R|1|^^^0001|14.5|s||||F||||19960119114215|<CR>
C|1|I|31^ Invalid for QC |I<CR>
L|1|N<CR>
QC
H|\^&|||ACL9000|||||||P|1|20021205123956<CR>
P|1||||||||||||||||||||||||||||||||||<CR>
O|1|Normal C.||^^^0001|||||||Q||||^|||||||||||F||||||<CR>
L|1|N<CR>
AR
H|\^&|||ACL9000|||||||P|1|20021205123956<CR>
P|1||||||||||||||||||||||||||||||||||<CR>
O|1|AR||^^^0001|||||||Q||||^|||||||||||F||||||<CR>
L|1|N<CR>
4.2 Upload Session Volumes
Approximate data volumes for upload sessions is provided as a guide for estimating the time
required to complete typical sessions. Obviously, system latencies (both in ELITE/ELITE PRO and
host computer) are not considered.
The minimal session would occur if ELITE/ELITE PRO has no test results to be transmitted; no
data is sent and the data volume is zero.
In conditions in which the ELITE/ELITE PRO has results to be transmitted, the data volume can be
estimated on the Test Order and Test Result record size base.
Test Order Message = Message Header (41) +

Number of patient records (82 + Results) + Message Terminator Record (6)
Results = number of ordered test (55 + 60*number of test result + 56* number of error messages)
Consider the following situation: ELITE/ELITE PRO has 50 sample IDs to be uploaded each with 4
tests, each test with 3 results and each test with 2 flags, the data volume can be estimated in:
Test Result Message = 41+ 50 (82 + 4(55 + 60*3 + 56*2)) + 6

Total = 69547 characters
At 9600 “baud rate” and with no system overhead it would take approximately 73 seconds and
considering a system efficiency of 60% it becomes about 116 seconds.
Appendix A
5.0 Not Supported Records
The Scientific record and the Manufacturer Information record are not supported by ELITE/ELITE
PRO protocol.
As a consequence the instrument ignores any type of information they contain.
6.0 Transmission Abort
The download or upload transmission session can be interrupted for an explicit user request
detected on the instrument, because the host computer is not responding or because the host
computer required interruption of the transmission process.
Further, as reported above, the download process can be interrupted because an illegal sample
Identifier has been received. Instrument behavior in this particular condition was defined in and
Reject Test Orders.
ELITE/ELITE PRO family instruments behavior in each of the listed conditions is described in the
following:
Condition Action
ELITE/ELITE PRO’s ELITE/ELITE PRO will signal the end of transmission to the host and
operator requested stop will discard any following messages. The host must consider the
download process interrupt request.
It must be emphasized that ELITE/ELITE PRO will signal the
transmission interruption with a message that is a rejected test order
message if any information has been rejected or with a message
header plus a message terminator record if no information has been
rejected.
ELITE/ELITE PRO ’s ELITE/ELITE PRO will complete the message in progress with the
operator requested stop message terminator and will not transmit any further test results.
upload process
Host computer is not During download and upload transmission sessions, operation by
responding ELITE/ELITE PRO is stopped. If download was in progress, no rejected
test messages will be transmitted.
A message will inform the user that the transmission has been
interrupted: “Host Computer not responding”
Host computer required Both during download and upload sessions, operation by ELITE/ELITE
EOT PRO is stopped. If download was in progress, no rejected test
messages will be transmitted.
It must be emphasized that the host computer must request the
transmission interruption with a message composed by a message
header plus a message terminator record.
A message will inform the user that the transmission has been
interrupted: “Host Computer required interrupt transmission”
Incorrect record format Transmission/reception is aborted and the user is informed:
“Incorrect format in host messages”
7.0 Appendix- ELITE/ELITE PRO Test Codes
Test codes are user definable. Codes from 1 to 500 are assigned to IL pre-defined tests. Codes
greater than 500 are assigned to the user definable tests. IL Library proposes the default test codes
reported in the following table.
Test Test Code Test ID Extended Test Name

Code for host (8 char. max) (15 char. max)
001 0001 PT PT
002 0002 PT e PT Extended
003 0003 PT d PT Double
004 0004 PT ed PT Ext. Db.
005 0005 PT HS PT HS
006 0006 PT HS e PT HS Extended
007 0007 PT HS d PT HS Double
008 0008 PT HS ed PT HS Ext. Db.
009 0009 PT HS + PT PLUS
010 0010 PT HS + e PTPLUS Extended
011 0011 PT HS + d PT PLUS Double
012 0012 PT HS + ed PT PLUS Ext. Db.
013 0013 R-PT Recombipl-PT
014 0014 R-PTe Recombipl-PTex
015 0015 PT R PT Rec.
016 0016 PT R e PT Rec Extended
017 0017 PT R d PT Rec. Double
018 0018 PT R ed PT Rec Ext. Db.
023 0023 R-PT d Rec-PT Double
024 0024 R-PT ed Rec-PT Ext Db
030 0030 FIB_ FIB (PT)

031 0031 FIB FIB (PT)
032 0032 FIB e_ FIB (PT e)
033 0033 FIB e FIB (PT e)
034 0034 FIB d_ FIB (PT d)
035 0035 FIB d FIB (PT d)
036 0036 FIB ed_ FIB (PT ed)
037 0037 FIB ed FIB (PT ed)
038 0038 FIB HS_ FIB (PT HS)
039 0039 FIB HS FIB (PT HS)
040 0040 FIB HSe_ FIB (PT HS e)
041 0041 FIB HSe FIB (PT HS e)
042 0042 FIB HSd_ FIB (PT HS d)
043 0043 FIB HS d FIB (PT HS d)
044 0044 FIBHSed_ FIB (PT HS ed)
045 0045 FIB HSed FIB (PT HS ed)
046 0046 FIB HS+_ FIB (PT PLUS)
047 0047 FIB HS+ FIB (PT PLUS)
048 0048 FIB HS+e_ FIB (PLUS e)
049 0049 FIB HS+e FIB (PLUS e)
050 0050 FIB HS+d_ FIB (PLUS db)
051 0051 FIB HS+d FIB (PLUS db)
052 0052 FIB+ed_ FIB (PLUS ed)
053 0053 FIB+ed FIB (PLUS ed)
054 0054 R-FIB_ Recombipl-FIB
055 0055 R-FIB Recombipl-FIB
056 0056 R-FIBe_ Recombipl-FIBex
Appendix A

057 0057 R-FIBe Recombipl-FIBex

058 0058 FIB R_ FIB (Rec)
059 0059 FIB R FIB (Rec)
060 0060 FIB Re_ FIB (Rec e)
061 0061 FIB Re FIB (Rec e)
062 0062 FIB Rd_ FIB (Rec d)
063 0063 FIB Rd FIB (Rec d)
064 0064 FIB Red_ FIB (Rec ed)
065 0065 FIB Red FIB (Rec ed)
074 0074 R-Fibd_ Recombipl-FIBd
075 0075 R-Fibd Recombipl-FIBd
076 0076 R-Fibed_ Recombipl-FIBed
077 0077 R-Fibed Recombipl-FIBed
080 0080 APTT Ly APTT Ly

081 0081 APTT Lye APTT Ly Ext.
082 0082 APTT Lyd APTT Ly Db.
083 0083 APTTLyed APTT Ly Ext.Db.
084 0084 APTT-SP APTT-SP
085 0085 APTT-SPe APTT-SP Ext.
086 0086 APTT-SPd APTT-SP Db.
087 0087 APTTSPed APTT-SP Ext.Db.
088 0088 APTT-C APTT-C
089 0089 APTT-C e APTT-C Ext.
090 0090 APTT-C d APTT-C Db.
091 0091 APTT-Ced APTT C-Ext.Db.
092 0092 APTTSYS APTT SynthASil
093 0093 APTTSYSe APTT SynthASile
094 0094 APTTSYSd APTT SynthASild
095 0095 APTTSSed APTTSynthASiled
096 0096 APTTSYF APTT SynthAFax
097 0097 APTTSYFe APTT SynthAFaxe
098 0098 APTTSYFd APTT SynthAFaxd
099 0099 APTTSFed APTT SynthAFaxed
102 0102 FVIII SF FVIII SynthAFax

107 0107 FIX SF FIX SynthAFax
112 0112 FXI SF FXI SynthAFax
117 0117 FXII SF FXII SynthAFax
120 0120 TT-5 TT - 5

121 0121 TT e-5 TT Ext. 5
122 0122 TT d-5 TT Dbl. 5
123 0123 TT ed-5 TT Ext. Dbl. 5
124 0124 TT-8 TT - 8
125 0125 TT e-8 TT Ext. 8
126 0126 TT d-8 TT Dbl. 8
127 0127 TT ed-8 TT Ext. Dbl. 8
128 0128 TT-2 TT - 2
129 0129 TT e-2 TT Ext. 2
130 0130 TT d-2 TT Dbl. 2
131 0131 TT ed-2 TT Ext. Dbl. 2
150 0150 PCX Pro-IL-Complex

151 0151 HPX Hepatocomplex
152 0152 P-ClotLy Pro-Clot Ly

153 0153 P-ClotSP Pro-Clot SP

154 0154 P-ClotC Pro-Clot C
159 0159 PS Protein S
160 0160 Free PS Free Protein S
161 0161 Pro S Protein S
199 0199 AT* Antithr. Liquid
200 0200 AT Antithr. In cup
201 0201 FIB-C_ Fib. Clauss

202 0202 FIB-C Fib. Clauss
203 0203 FIB-C l_ Fib. Clauss low
204 0204 FIB-C l Fib. Clauss low
205 0205 FIB-C h_ Fib Clauss high
206 0206 FIB-C h Fib. Clauss high
225 0225 APCR-V APCR V

208 0208 HEP LMW Heparin LMW
210 0210 HEP UHF Heparin UHF
212 0212 PLG Plasminogen
213 0213 PL-IN Plasmin Inhib.
214 0214 P-C Protein C
220 0220 F8 Chr H F8Chr High
221 0221 F8 Chr L F8Chr Low
225 0225 APCR V APCR V
250 0250 D-Dimer D-Dimer
251 0251 D-Dh D-Dimer high
275 0275 F8SP-P FVIII SP Par
276 0276 F9SP-P FIX SP Par
300 0300 FVIII Ly F VIII - Ly

302 0302 FVIII SP F VIII - SP
304 0304 FVIII C F VIII – C
305 0305 FVIII SS FVIII SynthASil
310 0310 FIX Lyo F IX - Ly

312 0312 FIX SP F IX - SP
314 0314 FIX C F IX - C
315 0315 FIX FIX SynthASil
320 0320 FXI Lyo F XI - Ly

322 0322 FXI SP F XI - SP
324 0324 FXI C F XI - C
325 0325 FXI SS FXI SynthASil
330 0330 FXII Lyo F XII - Ly

332 0332 FXII SP F XII - SP
334 0334 FXII C F XII - C
335 0335 FXII SS FXII SynthASil
336 0336 FVII PT F VII - PT

338 0338 FVII HS F VII - HS
340 0340 FVII HSP F VII - HS Plus
342 0342 FVII R F VII - R
343 0343 R FVII FVII RecombPT
350 0350 FX PT F X - PT
Appendix A

352 0352 FX HS F X - HS
354 0354 FX HSP F X - HS Plus
356 0356 FX R FX-R
357 0357 R FX FX RecombPT
360 0360 FV PT F V - PT
362 0362 FV HS F V - HS
364 0364 FV HSP F V - HS Plus
366 0366 FV R FV-R
367 0367 R FV FV RecombPT
370 0370 FII PT F II - PT

372 0372 FII HS F II – HS
374 0374 FII HSP F II - HS Plus
376 0376 FII R F II – R
377 0377 R FII FII RecombPT
155 155 SCT-S SCT Screen

156 156 SCT-C SCT Confirm
400 0400 VWF:Ag vWF Antigen
401 0401 vWF:AgH vWF Antigen Hig
410 0410 LAC_S LAC_S

411 0411 LAC_C LAC Confirm
Note: This table represents the situation for the IL Library 7.
8.0 Appendix – ELITE/ELITE PRO Supported Characters
8.1 Supported Characters for Sample ID
The ASCII set of characters considered is in the decimal range 32 to 126, because a Sample ID
can be accepted only if it contains at least one character different from a space.
8.2 Supported Characters for Patient name, Department and Units
Is the ASCII set of characters considered in the decimal range 32 to 255.
8.3 Supported Characters for delimiters
! “ # $ %
& ‘ ( ) *
+ / : ; =
@ [ \ ] ^
_ { | } ~
ASCII character 127 is not allowed as delimiter.
Note: Separators are always expected from Host and are always transmitted independently from
the information contained in the string.
Appendix A
9.0 Appendix - ELITE/ELITE PRO Supported Units
Unit Abbreviation
Time s
Activity %
Ratio R
International Normalized Ratio INR
NR
Concentration mg/dL
g/L
ng/mL
U/mL
µg/L
µmol/L
IU/mL
mg/L
ug/mL
Delta Optical Absorbance ∆ Abs

Delta ∆ (∆ ASCII code is 7F)
Activated Sample Sa Sa (Hex code EC)
Curve behavior offset
min
max
Final
User defined free string containing up to 8

chars
Notes: For duplicate (d) and extended duplicate (ed) tests only the individual replicate results are
sent to the host system. The mean value is not sent from the ACL8/9/10000 system. This applies
to all sample types including patient, QC and Analytical reference.
APPENDIX B
ACL Elite/Elite Pro
Bar Code Label Specification

Appendix B ACL Elite/Elite Pro Operator’s Manual
Index
1. INTRODUCTION............................................................................................................... 3
1.1 PURPOSE .......................................................................................................................... 3
1.2 DEFINITIONS, ACRONYMS AND ABBREVIATIONS ..................................................................... 3
1.3 REFERENCES .................................................................................................................... 3
2. GENERAL DESCRIPTION................................................................................................ 4
2.1 SUPPORTED CODES AND CHECKSUM TYPE ........................................................................... 4
2.2 BAR CODE SYMBOL SPECIFICATIONS ................................................................................... 4
2.3 BARCODE PARAMETERS ..................................................................................................... 5
2.4 BARCODE LABEL POSITIONING ............................................................................................ 6
2.5 APPENDIX A - DECODER ZONE MAP..................................................................................... 7
2.6 APPENDIX B - BARCODE LABEL DIMENSIONS......................................................................... 8
1.0 Introduction
In the following sections the characteristics of the bar code labels that can be read with the
Welch Allyn SCANTEAM 3700 scanner installed on ACL Elite/Elite Pro family instruments are
described.
1.1 Purpose
Purpose of this document is to give indication of the scanner characteristics in terms of readable
codes, identify the requirements the barcode labels must satisfy and define constraints in terms
of label positioning within ACL Elite/Elite Pro instrument.
1.2 Definitions, Acronyms and Abbreviations
WA Welch Allyn SCANTEAM 3700
Near Distance is the nearest distance that a scanner can accurately digitize a given
bar code.
Far Distance is the farthest distance that a scanner can accurately digitize a given
bar code.
Scan Width is the length of the widest bar code that can be successfully
interpreted by the scanner.
Quiet Zone is the blank area located just before and just after the bar space
pattern.
1.3 References
Ref. 1 SCANTEAM 3700 - Technical Manual - Welch Allyn
2. General Description
The WA is a fixed mount CCD bar code scanner with integrated decoder for easy integration into
host equipment (ACL Elite/Elite Pro family instruments in our case).
The 3700 features Welch Allyn’s time-proven decoding algorithms in a micro-processor-

controlled bar code scanner/decoder and offers configurable operating parameters.
The following mean features are available with every WA:
• High scan rate per second (100 is the standard)
• Flexible scan trigger configurations
• Decoder configurable for high security
• Scan voting to ensure bar code data integrity
• Ease of configuration through RS-322 interface
2.1 Supported Codes and Checksum type
Code Type Checksum Type Data Digits

Code 128 No checksum up to 15
Code 39 Modulus 43 up to 15
No Checksum up to 15
Interleaved 2 of 5 USS - Modulus 10 up to 15
OPCC - Modulus 10 up to 15
No checksum up to 15
Codabar AIM - Modulus 16 with start/stop digits up to 15
NW7 - Modulus 11 up to 15
NW7 - Modulus 16 with start/stop digits up to 15
No Checksum up to 15
2.2 Bar Code Symbol Specifications
All bar code symbols have to satisfy the appropriate AIM Uniform Symbology Specification.
In particular the following characteristics have to considered:
• Background substrate: the barcode symbol should be printed on a material type which is
reflective and has a matte (not glossy) finish. A background diffuse reflectance of at least
70% to 80% is suggested for optimum contrast.
• Ink color and type: the ink type must be compatible with 660 nm LEDs used in the scanner.
The barcode symbols inked bars should not exceed 10% reflectance at 660 nm which is
being used for reading, whether printed with black ink or colored ink.
• Voids and Specks: the code has to be printed clearly, free of voids, specks, blemishes and
lines which could “fool” the scanner.
• Definition: the bars in the barcode symbols should be well defined. Their edges should not
be rough or fuzzy, so that bar and spaces have the proper widths intended for the used
barcode symbology used. Definition should be sharp and consistent.
• Tolerance: the ratio of the widths and spaces in a barcode sysmbol must conform to the
appropriate AIM barcode specifications and can cause problems if not correct throughout the
barcode. Problems can occur if bar edges are smeared or rough, or when they exhibit voids.
2.3 Barcode Parameters
Parameters have to be considered in that context are:
• Density (bar code): refers to the number of cheracters in a linear inch of bar code.
• Ratio: refers to the ratio of the nominal wide element width to the nominal narrow element
width.
In order to ensure a good bar code reading (in addition to that indicated in section 2.2), the
parameters above mentioned should be as follows:
• Density: not less 10 Mils
• Ratio: not less 2.5
These values are valid for all the above mentioned bar code types.
The relationship between reading distances, scan width and bar code density are displayed in the
following:
Near Distance Far Distance Scan Width Scan Width Density

(near distance) (far distance) (bar code)
63.5 mm 114.5 mm 101.6 mm 152.4 mm 7.5 MIL
(161.29’’) (290.83’’) (258.064’’) (387.096’’)
34.3 mm 130.3 mm 82.3 mm 178.3 mm 13 MIL
(87.122’’) (330.962’’) (209.042’’) (452.882’’)
In Appendix Decoder Zone Map the attached drawing defines the “decoder zone map” for the
data displayed above. The displayed graph has been experimentally obtained from Welch Allyn
Laboratories because the WA equipped for the IL requirements does not have standard optics.
2.4 Barcode Label Positioning
In Appendix Barcode Label Dimension the attached drawing defines the barcode label
dimensions and identifies constraints in positioning labels on Vacutainers ® #. The 13x75
vacutainers have been considered. The proposed barcode label dimensions and positioning
apply to all sample tray models.
The following measurements are reported:
Barcode label feature Dimension

Maximum label length (global label size) 52.6 mm (2.071”)
Maximum barcode length (printed area) 39.6 mm (1.559”)
Quiet zone (white area before and after the printed area) 6.35 mm (0.256”)
Label position (it is identified as the label edge measured 58 mm (2.283”)
starting from the Vacutainer lower edge)
# ® Vacutainer is a registered trademark of Becton Dickinson.
2.5 Appendix - Decoder Zone Map
2.6 Appendix - Barcode Label Dimensions
APPENDIX C
ACL Elite/Elite Pro
Special Tests Procedures
Revision 3
.
2 Instrumentation Laboratory
Specialty Testing on the ACL Elite/Elite Pro
• APCR-V Page 4 • Plasminogen Page 52
• Antithrombin (Liquid) Page 8 • Plasmin Inhibitor Page 56
• D-Dimer Page 12 • Pro-IL-Complex Page 60
• Factor Assays Page 18 • ProClot Page 64
• Chromogenic Fact. VIII Page 24 • Protein C Page 68
• Fib-C Page 28 • Pro S Page 72
• Free Protein S Page 34 • Silica Clotting Time Page 76
• Heparin Page 38 • Thrombin Time Page 80
• Hepatocomplex Page 44 • vWF Activity Page 84
• LAC- Screen/Confirm Page 48 • vWF Antigen Page 88
APCR-V
Reagent Preparation
Enable the test within the

analyzer
SetupàTestsà View /Define
Edit the Test Reference

Range/Cutoff
SetupàTestsàView/Define
Setup the QC for APCR-V

QC à Setup/Review
Analyze Patient / QC Samples
APCR-V – ACL Elite/Elite Pro
1. Materials Needed
• APCR-V Reagent Kit Cat. No. 20008700

• Calibration Plasma Cat No. 20003700
APCR-V Reagent Kit Configuration

Kit Contents Stability Preparation
o
2 x 4mL APTT Reagent 1 Month at 2-8 C Mix Thoroughly before Use
1 Week at 15-25 oC
8 hours at 15 oC on ACL
**Note: Do Not Freeze
2 x 4 mL Factor V Reagent Plasma 8 hours at 15-25 oC Add 4.0 mL H2O.
o
24 hours at 2-8 C Swirl, let sit for 30 min at
3 months at -20 oC in original 15 – 25oC.
vial Invert. Do Not Shake!
o
(Thaw at 37 C and mix before
use. Do Not Refreeze)
2 x 2 mL APC Ca/Cl2 8 hours at 15-25 oC Add 2.0 mL H2O.
5 Days at 2-8 oC Swirl, let sit for 30 min at
Note: Default position on the 3 months at -20 oC in original 15 – 25oC.
analyzer is R7 (APC Ca Act) vial Invert. Do Not Shake!
(Do Not Refreeze)
2 x 2 mL Ca/Cl2 1 Month at 2-8oC Mix Thoroughly before Use
Note: Default position on the 1 Week at 15-25 oC
analyzer is R8 (APC CaCl2) 3 Days at 15 oC on ACL
2 x 1 mL APC Control Plasma 6 hours at 15-25 oC Add 1.0 mL H2O.
Level 1 6 hours at 2-8 oC Swirl, let sit for 30 min at
3 months at -20 oC original vial 15 – 25oC.
o
(Thaw at 37 C and mix before Invert. Do Not Shake!
2 x 1 mL APC Control Plasma 6 hours at 15-25 oC Add 1.0 mL H2O.
Level 2 6 hours at 2-8 oC Swirl, let sit for 30 min at
3 months at -20 oC in original 15 – 25oC.
vial Invert. Do Not Shake!
(Thaw at 37 oC and mix before
2. Enabling the Test in the Analyzer
- Setup à Tests à View Define

- Click on the Show Enabled button to display all the tests
- Scroll down the test list and highlight the APCR-V Test. Click on the Enable/Disable
button to enable the test. A check mark will appear in the Enabled test column for this
test.
- Press the Green Check to Save and return to main database screen.
3. Editing the Test Reference Range/Cutoff

- Scroll down the list, highlight the APCR-V test, and press the Detail Icon.
- Scroll down to the row for desired reporting units, and click on the Ranges button.
- Enter in the Min and Max values for the normal range.
- The reaction curve min and max may also be set. If the values are unknown, clear the
min and max to zoom the curve display to full scale.
4. Setting up Liquid Positions
- The liquid positions for APTT Reagent, Factor V Reagent Plasma, APC/CaCl2 and
CaCl2 are automatically assigned when the test is placed in a profile or run as a single
assay. Refer to the Materials map screen when running the assay for placement.
5. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined The APCR-V test can utilize the following
control materials to verify assay performance:
- APC Control Plasma Level 1
- APC Control Plasma Level 2
On the ACL Elite/Elite Pro this is defined in Setup à Liquids menu. Refer to section 4.1.11 in
the ACL Elite/Elite Pro Operator’s manual for Detailed instructions on defining new liquids.
- QC à QC Review and Setup

- Scroll down the Liquid ID list and select the appropriate QC liquid. Press the Setup
button to define.
- Configure the tests from the Enabled tests list. Define the Units, Target Mean, Target
SD and SD range for the test. If the Mean and SD is not known, then initially leave it
set to zero. Once the ranges are known, then you can re-define and click on the QC
Range check button for control result flagging. Refer to the ACL Elite/Elite Pro
Operator’s Manual section 3 for details on QC setup.
6 . Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37 oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
Results are reported in either seconds or a Ratio of the Seconds. The ratio is calculated as follows:
APCR-V = APTT (with APC) / APTT (without APC)
Each laboratory should establish its own normal cutoff value for the ratio.
Refer to the HemosIL APC Resistance V package insert sheet for a procedure to establish the
cut-off value.
L (Liquid)
Antithrombin
Reagent Preparation

analyzer
SetupàTestàView/Define

Range/Cutoff
Setup the QC for Liquid AT

QCà Review/Setup
Calibrate the Liquid AT test

CalibrationàCalibrate
Validate Calibration and

Analyze Patient samples
Liquid Antithrombin – ACL Elite/Elite Pro
1. Materials Needed
• Liquid Antithrombin Kit Cat. No. 20002500

• HemosIL Calibrator Cat. No. 20003700
• HemosIL Normal Unassayed Control Cat. No. 20003120
• HemosIL Normal Assayed Control* Cat No. 20003110
• HemosIL Low Abnormal Unassayed Control Cat. No. 20003220
• HemosIL Low Abnormal Assayed Control* Cat. No. 20003210
• HemosIL High Abnormal Unassayed Control Cat. No. 20003320
• HemosIL High Abnormal Assayed Control* Cat. No. 20003310
• Special Test Control Level 1 Cat. No. 20010100
• Factor Diluent Cat. No. 09757600
• Cleaning solution (Clean A) Cat. No. 09831700
Liquid Antithrombin Reagent Kit Configuration

4 x 4mL Factor Xa Reagent Until Expiration when not opened Invert to mix before use.
and stored at 2-8oC
5 weeks in original vial at 2-8oC
2 Days on ACL, when opened
2 x 2 mL Chromogenic Substrate Until Expiration when not opened Invert to mix before use.
and stored at 2-8oC
5 weeks in original vial at 2-8oC
2 Days on ACL, when opened

- Scroll down the test list and highlight the AT* Test. Click on the Enable/Disable
test.

- Scroll down the list, highlight the AT* test, and press the Detail Icon.
- Scroll down to the row for units in % and click on the Ranges button.
4. Entering in the Calibrator concentration
- Setup à Liquids
- Scroll down the Liquid ID column and highlight Cal Plasma
- Scroll down the Used by column and highlight the AT* test
- Click on the Assign Value button, and enter in the value for the Calibrator. This value
can be found on the Cal Plasma package insert.
- The liquid positions for the Cal Plasma, Factor Xa, Chromogenic Substrate, Factor
Diluent and Clean A are automatically assigned when the test is placed in a profile or
run as a single assay. Refer to the Materials map screen when calibrating or running
the assay for placement.
6. Setting up QC
system has the appropriate QC liquid defines. The AT* test can utilize the following
- Normal Control Plasma
- Abnormal Chromogenic Control Plasma Level 1
- Abnormal Chromogenic Control Plasma Level 2
On the ACL Elite/Elite Pro these liquids are defined in Setup à Liquids menu. Refer to
section 4.1.11 in the ACL Elite/Elite Pro Operator’s manual for Detailed instructions on
defining new liquids.
- Scroll down the Liquid ID list and select the appropriate QC liquid. Press the Setup button
to define.
- Configure the tests from the Enabled tests list. Define the Units, Target Mean, Target SD
and SD range for the test. If the Mean and SD range is not known, then initially leave it
set to zero. Once the ranges are known, then you can re-define and click on the QC Range
check button for control result flagging. Refer to the ACL Elite/Elite Pro Operator’s
Manual section 3 for details on QC setup.
8. Calibrating the Assay
All reagents, calibrators must be reconstituted according to directions and allowed to sit for 30
minutes prior to calibration.
- Calibration à Calibrate
- From the calibrate screen, select the AT* test from the drop down menu in the Test to
Calibrate window.
- Confirm the necessary liquids are in place according to the Material Map.
- Place 2 empty 0.5 mL sample cups in the appropriate “A” positions according to the
Material Map.
- Press the Start key to begin the calibrate cycle.
- When the calibration is complete the graph and cal curve data will be visible. If the curve
data is acceptable, click on the check to accept the use of the curve.
9. Sample Processing
Linearity: 10 – 150 % activity
D-Dimer
Reagent Preparation

analyzer

Range/Cutoff
Setup the Auto-Rerun for

D-Dimer High
SetupàTestàReflex Tests
Setup the QC for D-Dimer

QCà Review/Setup
Calibrate the D-Dimer test


D-Dimer / D-Dimer High – ACL Elite/Elite Pro
1. Materials Needed
• D-Dimer Reagent Kit Cat. No. 20008500

• D-Dimer Bi-level Control kit Cat. No. 20008610
D-Dimer Reagent Kit Configuration

o
4 x 3mL Latex Reagent 1 Month at 2-8 C Add 3.0 mL H2O.
1 Day on ACL at 15 oC Swirl, let sit for 30 min at
**Note: Do Not Freeze 15 – 25 oC.
Invert. Do Not Shake!
3 x 9 mL Reaction Buffer 1 Month at 2-8oC Ready to use.
1 Day on ACL at 15 oC Invert to mix prior to placing vial
on instrument
o
2 x 1mL D-Dimer Calibrator 1 Month at 2-8 C Add 1.0 mL H2O.
3 Days at 15-25oC Swirl, let sit for 30 min at
2 Months at –20oC 15 – 25 oC.
**Freeze and thaw only 1 time. Invert. Do Not Shake!
Thaw at 37oC & mix prior to Avoid foam formation.
use.
D-Dimer Controls
5 x 1.0 mL Low D-Dimer 1 Month at 2-8oC Add 1.0 mL H2O.
Control 3 Days at 15-25 oC Swirl, let sit for 30 min at
Approximate Level: Border line 2 Months at –20oC 15 – 25 oC.
value **Freeze and thaw only 1 time. Invert. Do Not Shake!
Thaw at 37oC & mix prior to use.
5 x 1.0 mL High D-Dimer 1 Month at 2-8oC Add 1.0 mL H2O.
Control 3 Days at 15-25 oC Swirl, let sit for 30 min at
Approximate Level: Abnormal 2 Months at –20oC 15 – 25 oC.
value **Freeze and thaw only 1 time. Invert. Do Not Shake! Avoid
Thaw at 37oC & mix prior to use. foam formation.

- Scroll down the test list and highlight the D-Dimer Test. Click on the Enable/Disable
test.
- Repeat the above step for the D-D h test (D-Dimer High assay)

- Scroll down the list, highlight the D-Dimer test, and press the Detail Icon.
- Scroll down to the row for units in ng/mL and click on the Ranges button.
- The reaction curve min and max may also be set. If the desired values are unknown,
clear both the min and the max to zoom curve display to full scale.
- Setup à Liquids
- Scroll down the Liquid ID column and highlight D-D Cal
- Scroll down the Used by column and highlight the D-Dimer test
- Click on the Assign Value button, and enter in the value for the D-Dimer Calibrator.
This value can be found on the package insert included in the kit.
Note: The D-Dh (D-Dimer High) test uses the calibration curve for the regular D-Dimer
test. It is not necessary to enter in the calibrator value into the D-D h test.
- The liquid positions for the D-D Cal, D-Dimer Latex, Buffer reagent and Factor
Diluent are automatically assigned when the test is placed in a profile or run as a single
assay. Refer to the Materials map screen when running the assay for placement.
6. Setting up the Autorerun feature
Note: The D-Dimer assay is linear from 200 to 1050 ng/mL. The ACL Elite/Elite Pro
system can rerun patient samples that exceed the 1050ng/mL limit using the D-Dimer high
test. This will increase the linearity of the assay 5-fold up to 5250 ng/mL. Values above
5250 ng/mL from the D-D h (D-Dimer high) test will need manual dilution (1:25 or 1:125)
with factor diluent and repeated using the D-Dimer test. Multiply the printed results by 5,
25 or 125 (depending upon the number of dilution steps performed) to correct for the
dilution. Do Not run the D-Dimer high test on samples with a D-Dimer less than 1000
ng/mL
- Setup à Tests àReflex Tests

- Define a new Reflex rule for the following:
- If D-Dimer > 1050 à Add test D-Dh (D-Dimer High)
- Refer to section 4.1.8 in the ACL Elite/Elite Pro Operator’s manual for detailed
instructions on setting up Reflex rules.
- To Enable the reflex testing: Setup à System Configuration
- The drop down menu for Reflex Status provides 3 choices
1. Program Test only
2. Execute before closing session
3. Disabled
- Select either option 1 or 2 to enable the programming and/or testing.
- Press the Green Check to Save and return to main database screen
7. Setting up QC
system has the appropriate QC liquid defined. The D-Dimer test can utilize the following
- Low Dimer Control
- High Dimer Control
On the ACL Elite/Elite Pro this is defined in the Setup à Liquids menu. Refer to section
4.1.11 in the ACL Elite/Elite Pro Operator’s manual for Detailed instructions on defining new
liquids.
button to define.
SD and SD range for the test. If the Mean and SD range is not known, then initially
leave it set to zero. Once the ranges are known, then you can re-define and click on the
QC Range check button for control result flagging.
- Refer to the ACL Elite/Elite Pro Operator’s Manual section 3 for details on QC setup.
- From the calibrate screen, select the D-Dimer test from the drop down menu in the Test
to Calibrate window.
- When the calibration is complete the graph and cal curve data will be visible. If the
curve data is acceptable, click on the check to accept the use of the curve.
Linearity: 200 – 1050 ng/mL
Factor XII
Reagent Preparation

analyzer

Range/Cutoff
Setup the QC for Factors

QC à Setup/Review
Calibrate and
Factor Analysis– ACL Elite/Elite Pro
This protocol is setup for the FXII SP test. All factors are processed the same way on the ACL Elite/Elite
Pro, therefore these guidelines can be used to run any clotting factor test on the analyzer. Ordering
information for the materials needed to run additional factor tests is located at the end of the document.
1. Materials Needed
• Factor XII Deficient Plasma Cat. No. 20201200

• APTT SP #
Cat. No. 20006300
# Kit can also be run using other APTT formulations (refer to section 10)
* For use in selected countries
Factor Deficient Reagent Kit Configuration
5 x 1mL Factor XII Deficient 4 Hours at 2 - 8oC original vial Add 1.0 mL H2O.
Plasma Swirl, let sit for 30 min at
15 – 25 oC.
o
5 x 9mL APTT Reagent 1 Month at 2-8 C Shake for 15 seconds or Vortex
5 Days at 15 oC on ACL for 5 seconds before Use
5 x 8mL Calcium Chloride 1 Month at 2-8oC Ready for Use

- Scroll down the test list and highlight the FXII SP Test. Click on the Enable/Disable
test.

- Scroll down the list, highlight the FXII SP test, and press the Detail Icon.
- Setup à Liquids
- Scroll down the Used by column and highlight the FXII SP test
Notes: The FXII SP assay is Calibrated Once per Session onboard the ACL Elite/Elite
Pro. The test calibration occurs during the analysis cycle. The test cannot be calibrated
under the Calibration Menu.
Parallelism tests utilize a Dedicated calibration and are calibrated under the Calibration
menu.
- The liquid positions for the Cal Plasma, Cal Low F, FXII Def, Factor Diluent, APTTSP
and APTT Ca/Cl2 are automatically assigned when the test is run as a single assay.
Refer to the Materials map screen when running the assay for placement.
6. Setting up QC
system has the appropriate QC liquid defines. The FXII SP test can utilize the following
control material to verify assay performance:
- Special Test Control Level 2
On the ACL Elite/Elite Pro these liquids are defined in the Setup à Liquids menu. Refer to

button to define.
QC Range check button for control result flagging. Refer to the ACL Elite/Elite Pro
Non Parallelism Factor Assays

Calibration is performed during the Analysis Run for FXII SP. The Calibration utilizes 2
calibrators: Cal Plasma and Cal Low F. The Cal Low F is a 1:16 dilution of the cal plasma.
This is prepared by taking 20µL of Cal Plasma and diluting it with 300µL of Factor diluent in a
0.5mL cup. When the ACL Elite/Elite Pro sees both of these calibrators onboard during its pre-
analytical check it will do a complete calibration curve. The calibration curve will cover
between 100% down to 1.56% activity.
If the ACL detects only the Cal Plasma onboard during the pre-analytical
check, then it will execute a calibration and construct a curve from 100% down to 25%
activity. Low results below 25% will be extrapolated from the curve. In either case the
calibration curve will be stored and utilized again on subsequent runs if during the pre-
analytical check for FXII SP the instrument does not detect the presence of the Cal Plasma in
position A1.
Note: Do Not place the Low Cal F onboard without having Cal Plasma onboard as well.
Calibration for the Factor Parallelism tests is defined as dedicated and performed using the
Calibration Menu.
Expected Values: 50 – 150 % activity
10. Ordering information for Factor Assays
APTT Based Factors
Factor VIII Deficient Plasma Cat. No. 08466450

Factor IX Deficient Plasma Cat. No. 08466550
Factor XI Deficient Plasma Cat. No. 08466650
Factor XII Deficient Plasma Cat. No. 20201200
PT Based Factors
Factor II Deficient Plasma Cat. No. 08466050
Factor V Deficient Plasma Cat. No. 08466150
Factor VII Deficient Plasma Cat. No. 08466250
Factor X Deficient Plasma Cat. No. 08466350
Clotting Reagents
APTT SP Cat. No. 20006300
APTT Lyophilized Silica Cat. No. 08468710
PT - Fib Cat. No. 09756710
PT - Fib Recombinant Cat. No. 20005000
PT- Fib HS Cat. No. 08468210
PT- Fib HS PLUS Cat. No. 08469810
HemosIL SynthasIL Cat. No.20006800
HemosIL RecombiPlasTin Cat. No.20002900 or 20003000
Chromogenic Factor VIII
Reagent Preparation

analyzer
Edit the Test

Reference Range
Setup the QC
QCà Review/Setup
Run Samples/Calibrate
Chromogenic Factor VIII – ACL Elite/Elite Pro
The Chromogenic Factor VIII test has a High and Low tests defined in the system. The High test linear
range is 10 – 120% and the Low test is 0 – 10%.
1. Materials Needed
• Electrachrome Factor VIII Cat. No. 49730503

• Clean A Cat. No. 09831700
Reagent Kit Configuration

2 x 3mL Factor Reagent 12 Hours at 2 - 8oC original vial Add 3.0 mL H2O.
30 days at -70oC Swirl, let sit for 30 min at
15 – 25 oC.
1 x 6mL Factor VIII Chromogenic 1 Month at 2-8oC original vial Add 6.0 mL H2O.
Substrate Reagent Swirl, let sit for 30 min at
15 – 25 oC.
1 x 24mL Factor VIII Buffer 1 Month at 2-8oC (after diluting) Working buffer: dilute 2 mL
Buffer with 18 mL H2O.

- Scroll down the test list and highlight the F8 Chr H / F8 Chr L Tests. Click on the
Enable/Disable button to enable the test. A check mark will appear in the Enabled test
column for this test. You can select to run either the High test, Low test or both. The
selected test must be run in single test mode and cannot be placed in a profile.

- Scroll down the list, highlight the F8 Chr H / F8 Chr L test, and press the Detail Icon.
- Setup à Liquids
- Scroll down the Used by column and highlight the F8 Chr H / F8 Chr L test.
Notes: The FVIII SP assay is Calibrated “Each Rotor” onboard the ACL Elite/Elite Pro.
The test calibration occurs during the analysis cycle. The test cannot be calibrated under
the Calibration Menu. The assay must be calibrated each time it is run.
- The liquid positions for the Cal Plasma, Cal Low F, F8 Chr Buf, F8 Chr Act, F8 Chr
Sub, Clean A, and Factor Diluent are automatically assigned when the test is run as a
single assay. Refer to the Materials map screen when running the assay for placement.
6. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined.

Verify that your system has the appropriate QC liquid defined. The FVIII SP
test can utilize the following control material to verify assay performance:
On the ACL Elite/Elite Pro these liquids are defined in the Setup à Liquids
menu. Refer to section 4.1.11 in the ACL Elite/Elite Pro Operator’s manual
for Detailed instructions on defining new liquids.
button to define.
QC Range check button for control result flagging. Refer to the ACL Elite/Elite Pro
8. Calibrating the Assay (performed each rotor during analysis)
All reagents and calibrators must be reconstituted according to directions and allowed to sit for 30
The Cal Low F is a 1:16 dilution of the cal plasma.

This is prepared by taking 20µL of Cal Plasma and diluting it with 300µL of Factor diluent in a
0.5mL cup.
This calibrator is used for the F8 Chr L (Low Chromogenic Factor VIII) test.
Calibration for the Factor Parallelism tests is defined as “Each Rotor” and performed during the
analysis.
Note: When the assay is run 2 empty (0.5 mL) cups will be required in the displayed “A”
positions on the tray along with one empty (0.5 mL) cup for each sample. The empty cups in the
sample position should be placed starting with position 21. One cup per patient sample needs to
be placed.
Expected Values: 50 – 150 % activity
Clauss Fibrinogen
Reagent Preparation

analyzer

Range/Cutoff
Setup the Auto-Rerun for

Fib-High/Low
SetupàTestàReflex Tests
Setup the QC for Fib-C

QCà Review/Setup
Calibrate the Fib-C test


Fibrinogen –C ACL Elite/Elite Pro
1. Materials Needed
• Fibrinogen-C Reagent Kit Cat. No. 8469110

• Low Fibrinogen Control Cat. No. 20004200
• Cleaning solution Clean A Cat. No. 09831700
* For use in selected countries
Fibrinogen-C Reagent Kit Configuration

8 x 2mL Bovine Thrombin 3 Days at 2-8 oC Add 2.0 mL H2O.
Reagent 8 hours at 15oC on ACL Swirl, let sit for 30 min at
1 Month at –20 oC original vial 15 – 25 oC.
o
2 x 1mL Abnormal Control 4 Hours at 15-25 C Add 1.0 mL H2O.
7 Days at –20oC original vial Swirl, let sit for 30 min at
15 – 25 oC.

- Scroll down the test list and highlight the Fib-C_ Test. Click on the Enable/Disable
test.
- Repeat the above step for the Fib-C h_test (Fib Clauss High assay) and the Fib-C l_
(Fib Clauss Low assay)

- Scroll down the list, highlight the Fib-C_ test, and press the Detail Icon.
- Scroll down to the row for units in mg/dL and click on the Ranges button.
- Repeat the above steps for the Fib-C h_ test (Fib Clauss High assay) and the Fib-C l_
(Fib Clauss Low assay)
- Setup à Liquids
- Scroll down the Liquid ID column and highlight Cal Plasm
- Scroll down the Used by column and highlight the Fib-C_ test
- Click on the Assign Value button, and enter in the value for the Cal Plasma. This value
Note: The Fib-C h_ (Fib Clauss High) and the Fib-C l_ (Fib Clauss Low) tests use the
calibration curve for the regular Fib Clauss test. It is not necessary to enter the calibrator
value into these additional tests.
- The liquid positions for the Cal Plasm, FIB-C Thr., Factor Diluent, and Clean A are
automatically assigned when the test is placed in a profile or run as a single assay.
Refer to the Materials map screen when running or calibrating the assay for placement.
6. Setting up the Autorerun feature
Note: The Fib-C_ assay range is from 60 to 550 mg/dL. The ACL Elite/Elite Pro system
can rerun patient samples that exceed the lower and upper range using the Fib Clauss Low
and High tests. The Fib-Clauss Low test range is 30-550 mg/dL and the Fib Clauss high
test range is 60-1100mg/dL.
Setup à Tests àReflex Tests
- Define Reflex rules for the following:

- If Fib-C_ > 550 mg/dL à Add test Fib-C h_ (Fib Clauss High)
- If Fib-C_ < 60 mg/dL à Add test Fib-C l_ (Fib Clauss Low)
- Refer to section 4.1.7 in the ACL Elite/Elite Pro Operator’s manual for detailed
instructions on setting up Reflex rules.
- To Enable the reflex testing: Setup à System Configuration
- The drop down menu for Reflex Status provides 3 choices
4. Program Test only
5. Execute before closing session
6. Disabled
- Select either option 1 or 2 to enable the programming and/or testing.
- Press the Green Check to Save and return to main database screen
7. Setting up QC
system has the appropriate QC liquid defined. The Fib Clauss test can utilize the following
- Normal Control
- Abnormal Control (packaged in kit)
- Low Fibrinogen control
On the ACL Elite/Elite Pro these are defined in the Setup à Liquids menu.
Refer to section 4.1.11 in the ACL Elite/Elite Pro Operator’s manual for detailed instructions
on defining new liquids.

button to define.
Refer to the ACL Elite/Elite Pro Operator’s Manual section 3 for details on QC setup.
- From the calibrate screen, select the Fib-C_ test from the drop down menu in the Test to
Calibrate window.
- Confirm the necessary liquids (Fib-C Thr., Factor Diluent and Clean A) are in place
according to the Material Map.
Assay Ranges:
Fib-C_ : 60 – 550 mg/dL
Fib-C l_: 30 – 550 mg/dL
Fib-C h_: 60 – 1100 mg/dL
Free Protein S
Reagent Preparation

analyzer

Range/Cutoff
Setup the QC for Free PS

QCà Review/Setup
Calibrate the Free PS test


Free Protein S – ACL Elite/Elite Pro
1. Materials Needed
• Free Protein S Reagent Kit Cat. No. 20002700

• HemosIL Calibration Plasma Cat. No. 20003700
*Not available in all countries
Free Protein S Reagent Kit Configuration

3 x 2mL Anti PS Latex Until Expiration when not Invert to mix before use.
Reagent opened and stored at 2-8 oC Do Not Shake! Avoid Foam
o
1 Month at 2-8 C ,1 Week on Formation!
ACL, when opened
3 x 4 mL C4BP Latex Post Reconstitution: Add 1 vial of C4BP Buffer into
1 Month at 2-8oC Latex, swirl gently 20 seconds
1 Week on ACL Let sit for 30 min at
15 – 25 oC.

- Scroll down the test list and highlight the Free PS Test. Click on the Enable/Disable
test.

- Scroll down the list, highlight the Free PS test, and press the Detail Icon.
- Setup à Liquids
- Scroll down the Used by column and highlight the Free PS test
- The liquid positions for the Cal Plasma, Anti PS Latex, C4BP Latex reagent and Factor
Diluent are automatically assigned when the test is placed in a profile or run as a single
assay. Refer to the Materials map screen when calibrating or running the assay for
placement.
6. Setting up QC
system has the appropriate QC liquid defines. The Free PS kit can utilize the following
- Special Test Control Plasma Level 2
to define.
check button for control result flagging.
- From the calibrate screen, select the Free PS test from the drop down menu in the Test to
Calibrate window.
Linearity: 10 – 135 %
Heparin
Reagent Preparation

analyzer

Range/Cutoff
Setup the QC for Heparin

QCà Review/Setup
Calibrate the Heparin test

Analyze Patient/QC samples
Heparin– ACL Elite/Elite Pro
1. Materials Needed
• Heparin Reagent Kit Cat. No. 20009400

• Low Heparin Control Plasma Cat. No. 20004000
• High Heparin Control Plasma Cat. No. 20004100
• Cleaning Solution (Clean A)# Cat. No. 09831700
# Clean A is used for the automatic clean cycle incorporated into the Heparin assay test definition.
Heparin Reagent Kit Configuration

1 x 4mL Chromogenic Substrate 3 Months at 2-8oC Add 4.0 mL H2O.
(Hep Sub) 7 Days at 15oC original vial Swirl, let sit for 30 min at
15 – 25 oC.
Invert.
o
1 x 5 mL Factor Xa Reagent 3 Months at 2-8 C Add 5.0 mL H2O.
(Hep_F(Xa) 7 Days at 15oC original vial Swirl, let sit for 30 min at
15 – 25 oC.
Invert.
1 x 3 mL Antithrombin 3 Months at 2-8oC original vial Add 3.0 mL H2O.
Swirl, let sit for 30 min at
15 – 25 oC.
Invert.
o
1 x 8mL Buffer 3 Months at 2-8 C original vial Dilute 1:10 (1 part Buffer + 9
parts H2O)
Prepare the reagents as directed above, then prepare the working reagents for the Heparin
assay after the reagents above have reconstituted and stabilized (30 minutes)
Heparin Working Reagent Preparation

Working Buffer 7 Days at 2-8oC Add 1.0 mL Antithrombin to 24.0
(Hep W.D.) 7 Days at 15oC mL of Diluted Buffer
0.8 Calibrator Add 1.0 mL of 0.8 U/mL diluted

Heparin* to 1 vial of Lyophilized
Cal Plasma
0.0 Calibrator Add 1.0 mL of H2O to a vial of
Cal Plasma, let sit 30 minutes
*0.8 Heparin Calibrator Preparation
Stock Heparin Dilution Dilution

Concentration (to create a 20 U/mL heparin standard) Ratio
25,000 units/mL Step 1: 100 µL heparin +2.4 mL water 1:25
Step 2: 100 µL of Step 1 dilution + 4.9 mL 1:50
water
10,000 units/mL Step 1: 100 µL heparin + 900 µL water 1:10
water
5,000 units/mL Step 1: 100 µL heparin + 400 µL water 1:5
water
1,000 units/mL 100 µL of heparin + 4.9 mL water 1:50
50 units/mL 1.0 mL heparin + 1.5 mL water 1:2.5
Dilute 100 µL of the 20 U/mL heparin prepared above with 2.4 mL of the recommended water.
This will result in a 0.8 U/mL solution of heparin. Use 1.0mL of this solution to dilute one vial of
Cal Plasma.
Note: There are 2 Heparin assays defined within the ACL Elite/Elite Pro.
1. Hep UHFl: Unfractionated Heparin
2. Hep LMWl: Low Molecular Wt Heparin

- Scroll down the test list and highlight the desired Heparin Test (see list above). Click
on the Enable/Disable button to enable the test. A check mark will appear in the
Enabled test column for this test.

- Scroll down the list, highlight the desired Heparin test, and press the Detail Icon.
- Scroll down to the row for units in U/mL and click on the Ranges button.
- Setup à Liquids
- Scroll down the Liquid ID column and highlight HEPCAL 0.8
- Scroll down the Used by column and highlight the desired Heparin test
- Click on the Assign Value button, and enter in the value for the Calibrator (0.8).
- Do Not enter a cal value for the HEPCAL 0.0 (zero heparin calibrator)
- The liquid positions for the HEP W.D., HEP_F(Xa), HEP Sub, Cleaning A, HepCal 0.0
and HEPCal 0.8 are automatically assigned when the test is either calibrated or run as
a single assay. HEPCal 0.0 and HEPCal 0.8 are only needed during the calibration
cycle. Refer to the Materials map screen when running the assay for placement.
6. Setting up QC
system has the appropriate QC liquid defines. The Heparin test can utilize the following
control materials, for Unfractionated Heparin testing only, to verify assay performance:
- Low Heparin Control Plasma
- High Heparin Control Plasma
section 4.1.11 in the ACL Elite/Elite Pro Operator’s manual for Detailed instructions on d

to define.
The Heparin assay utilizes the dedicated Calibration mode and therefore is calibrated under the
Calibration menu.
Empty cups for the calibration must be placed onboard the analyzer as follows:
- HepUHFl test: Position A1
- Hep LMWl test: Position A1
The Hep UHFl and the Hep LMWl tests do not need empty cups during analysis.
Linearity: 0 – 1.0 U/mL
HPX
Reagent Preparation

analyzer
Edit the Test Normal Range

Setupà Testà View/Define
Enter in ISI and Cal Value
Setup the QC for HPX

QCà Setup/Review
Calibrate the HPX test

Analyze QC and Patient

samples
Hepatocomplex – ACL Elite/Elite Pro**
** Kit not available in USA
1. Materials Needed
• Hepatocomplex Reagent Kit Cat. No. 09758710

• PCX/HPX Thromboplastin diluent Cat. No. 08469600
Hepatocomplex Reagent Kit Configuration

5 x 7mL Rabbit Calcium Until Expiration when not Add 7mL of PCX/HPX
Thromboplastin opened and stored at 2-8 oC Thromboplastin diluent, Swirl, let
5 days in original vial at 2-8 oC sit for 30 min at 15 – 25oC.
8 Hours on ACL, when opened Invert. Do Not Shake!
5 x 3 mL Bovine Plasma Until Expiration when not Add 3.0 mL NCCLS Type II
opened and stored at 2-8 oC water.
24 hours in original vial at 2-8 oC Swirl, let sit for 30 min at 15 –
, when opened 25oC.
5 days stability at -20oC Invert. Do Not Shake!
**Note: Do Not Re-Freeze

- Scroll down the test list and highlight the HPX Test. Click on the Enable/Disable
test.

- Scroll down the list, highlight the HPX test, and press the Detail Icon.
- Scroll down to the row for desired unit and click on the Ranges button.
- Enter in the Min and Max values for the range.
4. Entering in the Reagent ISI value
- Setup à Liquids
- Scroll down the Liquid ID column and highlight the Rabbit Calcium Thromboplastin
(HPX Thromb.)
- Scroll down the Used by column and highlight the HPX test
- Click on the Assign Value button, and enter in the ISI value. This value can be found
on the Hepatocomplex package insert.
- Press the Green Check to Save and return to the main database screen.
- Setup à Liquids
- Scroll down the Used by column and highlight the HPX test
- The liquid positions for the Cal Plasma, HPX Plasma, HPX Thromb (Rabbit Ca
Thromboplastin) , and Factor Diluent are automatically assigned when the test is
calibrated or run in a profile or as a single assay. Refer to the Materials map screen
when calibrating or running the assay for placement.
7. Setting up QC
system has the appropriate QC liquid defines. The HPX test can utilize the following
- Abnormal Control Plasma Low/Level 1
- Abnormal Control Plasma High/Level 2

to define.
- From the calibrate screen, select the HPX test from the drop down menu in the Test to
Calibrate window.
- Place 2 empty 0.5 mL sample cups in the appropriate “A” positions (A3 and A4) according
to the Material Map.
LAC Screen and/or
LAC Confirm
Reagent Preparation

analyzer
Edit the Test

Reference Range
Setup the QC for LAC

QC à Setup/Review
LAC Screen/Confirm – ACL Elite/Elite Pro
1. Materials Needed
• LAC Screen Reagent Kit Cat. No. 20008000

• LAC Confirm Reagent Kit Cat. No. 20008200
LAC Screen/Confirm Reagent Kit Configuration

o
10 x 2mL LAC Screen Reagent 1 month at -20 C, Add 2.0 mL NCCLS Type II water.
10 x 2mL LAC Confirm Reagent 48 Hours at 2-8oC or Swirl, let sit for 30 min at 15 – 25 oC.
o
24 Hours at 15-25 C in the Invert. Do Not Shake!
original vial*
*Note: Do Not Refreeze

- Scroll down the test list and highlight the LAC* Test. Click on the Enable/Disable
test.
* LAC-S is the LAC Screen assay and LAC-C is the LAC Confirm.

- Scroll down the list, highlight the desired LAC test, and press the Detail Icon.
- Scroll down to the row for units in seconds (S) or ratio (R) and click on the Ranges
button.
- The liquid positions for the LAC Reagent are automatically assigned when the test is
run as a single assay or in a 4.1.11 in the Operator’s manual for Detailed instructions
on defining new liquids.

to define.
Refer to the Operator’s Manual section 3 for details on QC setup.
7. Results
The following procedure should be used to calculate the LAC Screen and
LAC Confirm ratios:
1. For each new lot of LAC Screen and LAC Confirm kit a new Normal Range
should be determined according to NCCLS Document H21-A3, Vol. 18, No. 20.
2. Determine the Mean of each Normal Range in seconds.
3. The mean of each normal range will be used as a constant denominator in the calculations of
ratios.
LAC Screen
1. The patient sample result in seconds is divided by the Mean of the LAC Screen normal range.
Screen Ratio = Patient Screen results (seconds) / Mean of Screen Normal Range (seconds)
2. If test plasma LAC Screen clotting time is 20% longer than the Mean of the Screen Normal
Range (i.e. ratio >1.2), the presence of LA should be confirmed with IL LAC Confirm.
LAC Confirm
1. The patient sample result in seconds is divided by the Mean of the LAC Confirm normal range.
Confirm Ratio = Patient Confirm results (seconds) / Mean of Confirm Normal Range (seconds)
2. The ratio result from the LAC Screen is divided by the ratio result from LAC Confirm.
Normalized LAC Ratio = Screen Ratio / Confirm Ratio
Interpretation
1. The final result should be expressed as the Normalized LAC Ratio:
Ratio greater than 2.0 LA is strongly present.
Ratio between 1.5 - 2.0 LA is moderately present.
Ratio between 1.2 - 1.5 LA is weakly present.
2. If ratio < 1.2 and LAC Screen and LAC Confirm clotting times are prolonged, then mixing
studies should be performed to investigate factor II, V and X deficiencies or inhibitors. If the
mixing test is still prolonged, it indicates that some anticoagulant other than LA
(e.g. anti-Factor V) may be present in the test plasma.
Plasminogen
Reagent Preparation

analyzer

Setup the QC liquid for PLG

QCà Review / Setup
Calibrate and
Plasminogen – ACL Elite/Elite Pro
1. Materials Needed
• Plasminogen Reagent Kit Cat. No. 20009000

Plasminogen Reagent Kit Configuration

2 x 2mL Chromogenic Substrate 3 Months at 2-8oC original vial Add 2.0 mL H2O.
7 Days at 15oC original vial Swirl, let sit for 30 min at
6 Months at -20oC original vial 15 – 25 oC.
Mix before use.
2 x 2.5 mL Streptokinase 3 Months at 2-8oC original vial Add 2.5 mL H2O.
o
6 Months at -20 C original vial 15 – 25 oC.
Mix before use.

- Scroll down the test list and highlight the PLG Test. Click on the Enable/Disable
test.

- Scroll down the list, highlight the PLG test, and press the Detail Icon.
- Setup à Liquids
- Scroll down the Used by column and highlight the PLG test
Notes: The PLG assay is Calibrated Once per Session onboard the ACL Elite/Elite Pro.
the Calibration Menu.
- The liquid positions for the Cal Plasma, Streptokinase (PLG Strept) and Chromogenic
substrate (PLG Sub) are automatically assigned when the test is run. The test can be
run in the Single Test or Profile mode on the analyzer. Refer to the Materials map
screen when running the assay for proper placement.
6. Setting up QC
system has the appropriate QC liquid defines. The PLG test can utilize the following
- Abnormal Chromogenic Control Plasma Level 1and 2
On the ACL Elite/Elite Pro these liquids are defined in the Setup à Liquids menu.
Refer to section 4.1.11 in the ACL Elite/Elite Pro Operator’s manual for Detailed
instructions on defining new liquids.

button to define.
Calibration is performed during the Analysis Run for PLG. The calibration curve will be
saved and utilized again on subsequent runs if, during the pre-analytical check for PLG, the
instrument does not detect the presence of the Cal Plasma in position A1.
Plasmin Inhibitor
Reagent Preparation

analyzer

Setup the QC liquid for PL-IN

QCà Review / Setup
Calibrate and
Plasmin Inhibitor – ACL Elite/Elite Pro
1. Materials Needed
• Plasmin Inhibitor Reagent Kit Cat. No. 20009200

Plasmin Inhibitor Reagent Kit Configuration

1 x 4mL Chromogenic Substrate 5 Days at 2-8 oC original vial Add 4.0 mL H2O.
Mix before use.
o
2 x 2.5 mL Plasmin Reagent 5 Days at 2-8 C original vial Add 2.5 mL Diluted Buffer.
Mix before use.
2 x 9mL Buffer Undiluted Buffer: Until Dilute as needed 1:10 by adding
(Buffer must be diluted prior to Expiration when not opened and 1 part Buffer + 9 part H2O
use) stored at 2-8oC
Diluted Buffer: 24 Hours at 15oC

- Scroll down the test list and highlight the PL-IN Test (test no. 213). Click on the
column for this test.

- Scroll down the list, highlight the PL-IN test, and press the Detail Icon.
- Setup à Liquids
- Scroll down the Used by column and highlight the PL-IN test
Notes: The PL-IN assay is Calibrated Once per Session onboard the ACL Elite/Elite Pro.
- The liquid positions for the Cal Plasma, PI Buffer, PI Plasmin, and Chromogenic
substrate (PI Sub) are automatically assigned when the test is run. The test can be run
in the Single Test or Profile mode on the analyzer. Refer to the Materials map screen
when running the assay for proper placement.
6. Setting up QC
system has the appropriate QC liquid defines. The PL-IN test can utilize the following
On the ACL Elite/Elite Pro these liquids are defined in the Setup à Liquids menu.
Refer to section 4.1.11 in the ACL Elite/Elite Pro Operator’s manual for Detailed
instructions on defining new liquids.

button to define.
Calibration is performed during the Analysis Run for PL-IN. The calibration curve will be
saved and utilized again on subsequent runs if, during the pre-analytical check for PL-IN, the
PCX
Reagent Preparation

analyzer

Enter in ISI and Cal Value
Setup the QC for PCX

QCà Setup/Review
Calibrate the PCX test

Analyze QC and Patient

samples
Pro-IL- Complex– ACL Elite/Elite Pro**
** Kit not available in USA
1. Materials Needed
• Pro-IL-Complex Reagent Kit Cat. No. 09758810

• PCX/HPX Thromboplastin diluent Cat. No. 08469600
Pro-IL-Complex Reagent Kit Configuration

5 x 7mL Bovine Calcium Until Expiration when not Add 7mL of PCX/HPX
Thromboplastin opened and stored at 2-8 oC Thromboplastin diluent, Swirl, let
5 days in original vial at 2-8 oC sit for 30 min at 15 – 25oC.
8 Hours on ACL, when opened Invert. Do Not Shake!
5 x 3 mL Bovine Plasma Until Expiration when not Add 3.0 mL NCCLS Type II
opened and stored at 2-8 oC water.
24 hours in original vial at 2-8 oC Swirl, let sit for 30 min at 15 –
when opened 25oC.
5 days stability at -20oC Invert. Do Not Shake!
**Note: Do Not Re-Freeze

- Scroll down the test list and highlight the PCX Test. Click on the Enable/Disable
test.

- Scroll down the list, highlight the PCX test, and press the Detail Icon.
- Scroll down to the row for desired unit and click on the Ranges button.
- Enter in the Min and Max values for the range.
4. Entering in the Reagent ISI value
- Setup à Liquids
- Scroll down the Liquid ID column and highlight the Bovine Calcium Thromboplastin
(PCX Thromb.)
- Scroll down the Used by column and highlight the PCX test
- Click on the Assign Value button, and enter in the ISI value. This value can be found
on the Pro-IL-Complex package insert.
- Press the Green Check to Save and return to the main database screen.
- Setup à Liquids
- Scroll down the Used by column and highlight the PCX test
- The liquid positions for the Cal Plasma, PCX Plasma, PCX Thromb (Bovine Ca
Thromboplastin) , and Factor Diluent are automatically assigned when the test is
calibrated or run in a profile or as a single assay. Refer to the Materials map screen
when calibrating or running the assay for placement.
7. Setting up QC
system has the appropriate QC liquid defines. The PCX test can utilize the following
- Abnormal Control Plasma Low/Level 1
- Abnormal Control Plasma High/Level 2
Section 4.1.11 in the ACL Elite/Elite Pro Operator’s manual for detailed instructions on

to define.
- From the calibrate screen, select the PCX test from the drop down menu in the Test to
Calibrate window.
- Place 3 empty 0.5 mL sample cups in the appropriate “A” positions (A3, A4 and A6)
according to the Material Map.
ProClot
Reagent Preparation

analyzer

Range/Cutoff
Setup the QC for ProClot

QCà Review/Setup
Calibrate and Analyze

Patient/QC samples
ProClot– ACL Elite/Elite Pro
1. Materials Needed
• ProClot Reagent Kit Cat. No. 08468310

• ProClot Diluent Cat. No. 08468600
• APTT SP #
Cat. No. 20006300
# Kit can also be run using APTT-Lyophilized silica
* Not available in all countries
ProClot Reagent Kit Configuration

4 x 1mL Protein C Deficient 4 Hours at 15-25 oC Add 1.0 mL H2O.
Reagent 7 Days at –20oC in the original Swirl, let sit for 30 min at
vial 15 – 25 oC.
o
4 x 1.5 mL Protein C Activator 15 Days at 2-8 C Add 1.5 mL H2O.
(Protac®) 60 Days at –20 oC in the original Swirl, let sit for 30 min at
vial 15 – 25 oC.
Protein C Working Diluent 8 Hours at 2-8oC Mix 4.3 Parts of ProClot Diluent
with 1 Part Protein C Activator
5 x 9mL APTT Reagent 1 Month at 2-8oC Shake for 15 seconds or Vortex
5 Days at 15 oC on ACL for 5 seconds before Use
5 x 8mL Calcium Chloride 1 Month at 2-8oC Ready for Use
2 x 1 mL Protein C Control 4 Hours at 15-25 oC Add 1.0 mL H2O.

Plasma 7 Days at –20oC in the original Swirl, let sit for 30 min at
vial 15 – 25 oC.

- Scroll down the test list and highlight the ProClotSP Test. Click on the Enable/Disable
test.

- Scroll down the list, highlight the ProClotSP test, and press the Detail Icon.
- Setup à Liquids
- Scroll down the Used by column and highlight the ProClotSP test
Notes: The ProClot assay is Calibrated Once per Session onboard the ACL Elite/Elite Pro.
the Calibration Menu. The Calibration under analysis utilizes an empty cup for the
calibration, therefore the test must be run as a single test and cannot be run in the profile
mode.
- The liquid positions for the Cal Plasma, Protein C Deficient, Working Diluent,
APTTSP and APTT Ca/Cl are automatically assigned when the test is run as a single
assay. Refer to the Materials map screen when calibrating or running the assay for
placement.
6. Setting up QC
system has the appropriate QC liquid defines. The ProClotSP test can utilize the following
- Abnormal Control Plasma Level 1
- Protein C Control Plasma – packaged in reagent kit
section 4.1.11 in the ACL Elite/Elite Pro Operator’s manual for detailed instructions on

to define.
Refer to the ACL Elite/Elite Pro Operator’s Manual section 3 for details on QC
setup.
Calibration is performed during the Analysis Run for ProClot. The calibration curve will be
saved and utilized again on subsequent runs if during the pre-analytical check for Pro-Clot the
The Calibration during analysis requires an empty cup to be placed in position A2 on the
sample tray.
Protein C
Reagent Preparation

analyzer
Edit the Test

Reference Range
Setup the QC for Protein C

QCà Review/Setup
Calibrate and Analyze

Patient/QC samples
Protein C – ACL Elite/Elite Pro
1. Materials Needed
• Protein C Reagent Kit Cat. No. 20009100

Protein C Reagent Kit Configuration

2 x 2mL Chromogenic Substrate 3 Months at 2-8oC and Add 2.0 mL H2O.
15 – 25 oC.
Invert.
o
2 x 2.5 mL Protein C Activator 3 Months at 2-8 C and Add 2.5 mL H2O.
15 – 25 oC.
Invert.
1 x 8mL Diluent Store at 2-8 oC in original vial Mix 1 Part of Diluent with 9 Parts
Water. Mix before use.

- Scroll down the test list and highlight the P-C Test. Click on the Enable/Disable button
to enable the test. A check mark will appear in the Enabled test column for this test.

- Scroll down the list, highlight the P-C test, and press the Detail Icon.
- Setup à Liquids
- Scroll down the Used by column and highlight the P-C test
Notes: The P-C assay is Calibrated Once per Session onboard the ACL Elite/Elite Pro.
- The liquid positions for the Cal Plasma, PC Activ., PC Sub., and Pchrom Dil are
automatically assigned when the test is run as a single assay. Refer to the Materials
map screen when running the assay for placement.
6. Setting up QC
system has the appropriate QC liquid defines. The P-C test can utilize the following

to define.
Refer to the ACL Elite/Elite Pro Operator’s Manual section 3 for details on QC
setup.
Calibration is performed during the Analysis Run for P-C. The calibration curve will be
saved and utilized again on subsequent runs if, during the pre-analytical check for P-C, the
Pro S
Reagent Preparation

analyzer
Edit the Test Reference Range

Setup the QC for ProS

QCà Review/Setup
Calibrate the ProS test


ProS– ACL Elite/Elite Pro
1. Materials Needed
• HemosIL ProS Reagent Kit Cat. No. 20002800

• Prot S Ctrl (included in ProS Reagent Kit) Cat. No. 20002830
*For use in selected countries
ProS Reagent Kit Configuration

o
3 x 3mL Protein S 2 Days at 2-8 C Add 3.0 mL H2O.
Reagent 4 Hours at 15oC on board Swirl gently, let sit for 30 min at
*15 Days at –20oC original vial 15 – 25 oC.
No stirring required Invert. Do Not Shake!
5 x 1 mL Protein S After Reconstitution: Add 1.0 mL H2O.
Deficient Plasma 4 Hours at 15oC original vial Swirl gently, let sit for 30 min at
o
*7 Days at –20 C 15 – 25 oC.
o
2 x 1 mL Protein S 4 Hours at 15-25 C original vial Add 1.0 mL H2O.
Control Plasma *7 Days at –20 oC Swirl, let sit for 30 min at
15 – 25 oC.
* Frozen reagent and plasmas should be thawed at 37oC and gently mixed before. Before freezing they
can be aliquoted using plastic tubes and stoppers. DO NOT REFREEZE.

- Scroll down the test list and highlight the ProS Test. Click on the Enable/Disable
test.
3. Editing the Test Reference Range

- Scroll down the list, highlight the ProS test, and press the Detail Icon.
- Scroll down to the row for units in seconds (s) and click on the Ranges button.
- Setup à Liquids
- Scroll down the Used by column and highlight the ProS test
- DO NOT enter any value for ProS 50% C.
Notes: The ProS assay must be Calibrated One Time per Session. The test calibration
occurs during the analysis cycle. The test cannot be calibrated under the Calibration Menu
but you can view the calibration report after analysis run.
- The liquid positions for the Cal Plasma, ProS 50% C (Cal Plasma diluted 1:1 with
Protein S Def Plasma), Protein S Reagent, Protein S Deficient Plasma and Factor
Diluent are automatically assigned when the test is run as a single assay. Refer to the
Materials map screen when calibrating or running the assay for placement.
6. Setting up QC
system has the appropriate QC liquid defines. The ProS test can utilize the following control
materials to verify assay performance:
- Low Abnormal Control Plasma
- High Abnormal Control Plasma
- Protein S Control Plasma – packaged in reagent kit

button to define.
The ProS assay must be Calibrated One Time per Session. The test calibration occurs during
the analysis cycle. The test cannot be calibrated under the Calibration Menu but you can view
the calibration report after analysis run.
plasma prior to testing.
SCT- Screen/Confirm
Reagent Preparation

analyzer

Range/Cutoff
Setup the QC for SCT-S/C

QC à Setup/Review
SCT-Screen/Confirm – ACL Elite/Elite Pro
1. Materials Needed
• Silica Clotting Time Reagent Kit Cat. No. 20004800

• HemosIL Calibrator Cat No. 20003700
Silica Clotting Time Reagent Kit Configuration

3 x 5mL SCT Screen Reagent 20 Days at 2-8oC – Original vial Add 50 uL of mixed SCT
5 Days at 15 oC on ACL Confirm reagent to one vial of
**Note: Do Not Freeze SCT Screen reagent.
Invert to mix before use.
3 x 5 mL SCT Confirm Reagent 20 Days at 2-8oC – Original vial Invert to mix before use.
5 Days at 15 oC on ACL
3 x 10 mL SCT Ca/Cl2 20 Days at 2-8 oC – Original vial Invert to mix before use.

- Scroll down the test list and highlight the SCT-S / SCT-C Test. Click on the
column for this test.

- Scroll down the list, highlight the SCT-S / SCT-C -V test, and press the Detail Icon.
- Scroll down to the row for desired reporting units, and click on the Ranges button.
- The reaction curve min and max may also be set. If the values are unknown, clear the
min and max to zoom the curve display to full scale.
- The liquid positions for SCT Screen, SCTConfirm and SCT CaCl2 are automatically
assigned when the test is placed in a profile or run as a single assay. Refer to the
Materials map screen when running the assay for placement.
5. Setting up QC
system has the appropriate QC liquid defined The SCT Screen/Confirm test can utilize the
following control materials to verify assay performance:
Materials

On the ACL Elite/Elite Pro this is defined in Setup à Liquids menu. Refer to section 4.1.11 in
the ACL Elite/Elite Pro Operator’s manual for Detailed instructions on defining new liquids.

button to define.
SD and SD range for the test. If the Mean and SD is not known, then initially leave it
set to zero. Once the ranges are known, then you can re-define and click on the QC
Range check button for control result flagging. Refer to the ACL Elite/Elite Pro
6 . Sample Processing
trisodium citrate. Freezing of the plasma releases residual platelet phospholipids which can
shorten the SCT screen clotting times. Double centrifuge or filter plasma through a 0.2micron
filter to remove platelets before freezing.Frozen samples should be thawed at 37 oC for 15 minutes.
Centrifuge the plasma prior to testing. Samples should be analyzed within 2 hours.
SCT Screen
1. The patient sample result in seconds is divided by the Mean of the SCT Screen normal range.
Screen Ratio = Patient Screen results (in seconds)

Mean of Screen Normal Range (in seconds)
SCT Confirm
1. The patient sample result in seconds is divided by the Mean of the SCT Confirm normal range.
Confirm Ratio = Patient Confirm results (in seconds)

Mean of Confirm Normal Range (in seconds)
2. The ratio result from the SCT Screen is divided by the ratio result from SCT Confirm.
Normalized SCT Ratio = Screen Ratio

Confirm Ratio
Interpretation
1. The final result should be expressed as the Normalized SCT Ratio:
ACL Elite/Elite Pro Ratio > 1.20 indicates Lupus Anticoagulant is present
2. If ratio = 1.20 and SCT Screen and SCT Confirm clotting times are prolonged, then mixing
studies should be performed to investigate factor deficiencies or inhibitors. If the mixing
test is still prolonged, it indicates that some anticoagulant other than LA may be present in
the test plasma.
Each laboratory should establish its own normal cutoff value for the ratio.
Refer to the HemosIL Silica Clotting Time package insert sheet for a procedure to
establish the cut-off value.
Thrombin Time
Reagent Preparation

analyzer
Edit the Test

Reference Range
Setup the QC for TT

QC à Setup/Review
Thrombin Time (TT) – ACL Elite/Elite Pro
1. Materials Needed
• Thrombin Time Reagent Kit Cat. No. 09758515

• Cleaning solution Clean A Cat. No. 09831700
Thrombin Time Reagent Kit Configuration

4 x 2, 5 or 8mL Bovine Thrombin 15 Days at 2-8oC original vial Add 2.0 / 5.0 or 8.0* mL Diluted
8 Hours at 15 oC onboard ACL Diluent.
Swirl, let sit for 30 min at 15 –
25oC.
1 x 9mL Diluent 1 month after preparation at 15- Dilute necessary amount 1:5
25 oC using 1 part Diluent + 4 part H2O
*Heparin Therapy: 2.0 mL, Screening Test: 5.0 or 8.0mL reconstitution

- Scroll down the test list and highlight the TT-* Test. Click on the Enable/Disable
test.
* Refers to reconstitution volume 2, 5, or 8mL. Select the appropriate test based upon your
reconstitution volume for the Thrombin Reagent.

- Scroll down the list, highlight the TT-* test, and press the Detail Icon.
- Scroll down to the row for units in seconds (s) and click on the Ranges button.
- The liquid positions for the Cal Plasma, and Thrombin Reagent (TT Thr.) are
automatically assigned when the test is run as a single assay*. Refer to the Materials
map screen when running the assay for placement.
*It is recommended to run the Thrombin Time in the Single test mode and not within a
profile. A Clean-A procedure needs to be performed after the Thrombin Time is
complete prior to running additional test on the analyzer.
5. Setting up QC
system has the appropriate QC liquid defines. The TT* test can utilize the following

to define.
vonWillebrand Factor
Activity
Reagent Preparation

analyzer
Edit the Test

Reference Range
Setup the QC for VWFACT

QCà Review/Setup
Calibrate the VWFACT test


von Willebrand Factor Activity– ACL Elite/Elite Pro
1. Materials Needed
• vWF Activity Reagent Kit Cat. No. 20004700

VWF Reagent Kit Configuration

2 x 4.5mL Latex Reagent 1 month at 2-8°C Pour entire contents of 1 vial of
3 days on Elite/Elite Pro Buffer into Latex bottle. Cap,
**Note: Do Not Freeze Swirl for 20 seconds. Allow to
sit at room temperature for 25-30
minutes. Invert to mix prior to
use.
2 x 4.5 mL Buffer

- Scroll down the test list and highlight the VWFACT Test. Click on the Enable/Disable
test.

- Scroll down the list, highlight the VWFACT test, and press the Detail Icon.
- Setup à Liquids
- Scroll down the Liquid ID column and highlight Cal Plasma.
- Scroll down the Used by column and highlight the VWFACT test
- Click on the Assign Value button, and enter in the value for the Cal Plasma.
This value can be found on the Cal Plasma package insert.
- The liquid positions for the Cal Plasma, VWFACT Latex and Factor Diluent are
automatically assigned when the test is calibrated, placed in a profile or run as a single
assay. Refer to the Materials map screen when running or calibrating the assay for
placement.
6. Setting up QC
system has the appropriate QC liquid defined. The VWFACT test can utilize the following
- Normal Control
On the ACL Elite/Elite Pro this is defined in the

Setup à Liquids menu. Refer to section 4.1.11 in the ACL Elite/Elite Pro Operator’s manual
for detailed instructions on defining new liquids.

to define. Recommended controls are Normal and the Special Test controls levels 1 & 2.
Cal Plasma must be reconstituted according to directions and allowed to sit for 30 minutes
prior to calibration.
- From the calibrate screen, select the VWFACT test from the drop down menu in the Test
to Calibrate window.
Linearity: 10 – 150 % (VWFACT)
vonWillebrand Factor
Antigen
Reagent Preparation

analyzer
Edit the Test

Reference Range
Setup the QC for VWF:Ag

QCà Review/Setup
Calibrate the VWF:Ag test


von Willebrand Factor Antigen– ACL Elite/Elite Pro
1. Materials Needed
• vWF Activity Reagent Kit Cat. No. 20002300

VWF Reagent Kit Configuration

2 x 3 mL Latex Reagent 3 month at 2-8°C – original Invert to mix prior to use. Avoid foam
vial formation in reagent when mixing.
1 week at 15°C on ACL
Elite/Elite Pro
2 x 4 mL Buffer 3 month at 2-8°C – original Invert to mix prior to use. Avoid foam
vial formation in reagent when mixing.
1 week at 15°C on ACL
Elite/Elite Pro

- Scroll down the test list and highlight the VWF:Ag Test. Click on the Enable/Disable
test.

- Scroll down the list, highlight the VWF:Ag test, and press the Detail Icon.
- Setup à Liquids
- Scroll down the Liquid ID column and highlight Cal Plasma.
- Scroll down the Used by column and highlight the VWF:Ag test
- Click on the Assign Value button, and enter in the value for the Cal Plasma. This value
- The liquid positions for the Cal Plasma, VWF:AgBuf, VWF:AgLx and Factor Diluent
are automatically assigned when the test is calibrated, placed in a profile or run as a
single assay. Refer to the Materials map screen when running or calibrating the assay
for placement.
6. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined.

Verify that your system has the appropriate QC liquid defined. The VWFACT
test can utilize the following control materials to verify assay performance:
- Normal Control
On the ACL ACL Elite/Elite Pro this is defined in the Setup à Liquids menu.
Refer to section 4.1.11 in the ACL ACL Elite/Elite Pro
Operator’s manual for detailed instructions on defining new liquids.

to define. Recommended controls are Normal and the Special Test controls levels 1 & 2.
Refer to the ACL ACL Elite/Elite Pro Operator’s Manual section 3 for details on QC
setup.
Cal Plasma must be reconstituted according to directions and allowed to sit for 30 minutes
prior to calibration.
- From the calibrate screen, select the VWF:Ag test from the drop down menu in the Test to
Calibrate window.
- Confirm the necessary liquids are in place according to the Material Map. The calibration
will require 3 empty 0.5 mL sample cups.
trisodium citrate. Frozen samples should be quickly thawed at 37oC. Gently mix the plasma prior
to testing. Samples should be analyzed within 2 hours.
Linearity: 10 – 150 % (VWF Antigen)

High Samples that exceed 150 % can be reprocessed using the VWF:AgH test. This assay dilutes
the sample and extends the linearity by a factor of 4 (40 – 600 %).
APPENDIX D
ACL Elite/Elite Pro
Printout Examples
Appendix D ACL Elite/Elite Pro Operator’s Manual
Contents
1. Analytical Reference – Cumulative Report.................................... 3

2. Analytical Reference – Plot and Statistics...................................... 4
3. Calibration Printout – PT Assay..................................................... 5
4. Calibration Printout – Factor Assay............................................... 6
5. Calibration Replicate – Curve Details............................................ 7
6. File Error History............................................................................ 8
7. Liquid Setup.................................................................................... 9
8. Logbook Report.............................................................................. 10
9. Maintenance Report........................................................................ 11
10. Parallelism Cumulative Report...................................................... 12
11. Parallelism Sample Report………………………………………. 13
12. Parallelism Detail Report………………………………………… 14
13. Profile Report................................................................................. 15
14. Quality Control – Cumulative Report............................................ 16
15. Quality Control – Plot and Statistics.............................................. 17
16. Quality Control – Daily Printout..................................................... 18
17. Reflex Test Logics......................................................................... 19
18. Sample Report – Single.................................................................. 20
19. Sample Report – Cumulative.......................................................... 21
20. Session Error History Report.......................................................... 22
21. Temperature Report........................................................................ 23
22. Test Detail Report........................................................................... 24
1. Analytical Reference – Cumulative Report
2. Analytical Reference – Plot and Statistics
3. Calibration Printout – PT Assay
4. Calibration Printout – Factor Assay
5. Calibration Replicate – Curve Details
6. File Error History
7. Liquid Setup
8. Logbook Report
9. Maintenance Report
10. Parallelism Cumulative Report
11. Parallelism Sample Report
12. Parallelism Detail Report
13. Profile Report
14. Quality Control Cumulative Report
15. Quality Control Plot and Statistics
16. Quality Control – Daily Printout
17. Reflex Test Logics
18. Sample Report
19. Sample Report Cumulative
20. Session Error History Report
21. Temperature Report
22. Test Detail Report
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ACL Elite / Elite Pro System

Operator's Manual • P/N 181121-11 • Rev. 0 December 2005

Manufacturer EU Authorized Representative

Sarstedt, Epson and Hewlett Packard are registered Trademarks.

3.5.1 Analytical Reference: Setup 3.81

4 Setup and Utility

Instrumentation Laboratory III

5 Diagnostics and Maintenance

6.3.4 Analytical Reference Error Codes 6.29

7 Assay and Instrument Specifications

7.8.2 Dimensions 7.46

8 Sample Collection and Storage

9 Parts and Expendables

Appendix A Host Communication Protocol

E INR Setup, 4.60, 4.30

Rotor Holder, 1.15 Stirrers, 1.9, 2.7

ACL Elite Pro system

Instrumentation Laboratory 1.1

1.1 Product Use

1.2 Measured Parameters

Single Test or Multi-Tests

1.2 Instrumentation Laboratory

1.3 Presentation of Results

1.4 Instrument Description and Operation

Instrumentation Laboratory 1.3

combination of rapid acceleration and braking actions, which are effective in

1.4.2 Main hardware components

1.4 Instrumentation Laboratory

1. Wash-R Emulsion 6. Floppy Disk Drive 11. Rotor Waste Area

Instrumentation Laboratory 1.5

The following items will be addressed in the Sections below:

1.4.3 Sample Tray

Short (3 mL) Primary tube (13x75 mm)

1.6 Instrumentation Laboratory

Sample Tray Location on the ACL

Press Button to Remove Tray

Instrumentation Laboratory 1.7

§ Additional Reagents positions

Adapters for internal positions in the Sample Tray

1.8 Instrumentation Laboratory

1.4.4 Reagent Area

Reagent Area - ACL Elite

Gray: for 10 mL vials requiring magnetic stirrer

Pink: for 10 mL vials not requiring magnetic stirrer

Green: for 4 mL vials not requiring magnetic stirrer

Instrumentation Laboratory 1.9

1.4.5 Rinse/Waste Area

Rinse Waste Reservoir under Needles External Waste Container

1.4.6 Sampling/Dispensing System

Wash-Reference Emulsion bottle

1.10 Instrumentation Laboratory

Piston block and Electrovalves

- Aspiration of sample and/or reagent from their respective locations.

Sampling Dispensing System

Instrumentation Laboratory 1.11

If Operators are warned of sample/reagent sensor failures: results of a

Sampling Arm with sensor

Sample line is on top

1.12 Instrumentation Laboratory

Any sensor failure warning due to self-check or to insufficient reagent will:

Note: No additional amount of liquid (sample or reagent) is aspirated for the

1.4.7 Loading and Analysis Area

Caution: Avoid touching