ACL 9000 System: Operator's Manual - P/N 080961-01 - Rev. 2.0 - March 2001

ACL 9000 System
Operator's Manual • P/N 080961-01 • Rev. 2.0 • March 2001
Instrumentation Laboratory
ACL 9000 ■ Operator's Manual Text ■ Rev. 2.0 ■ March 2001
This publication and any and all materials (including software) concerning the products of IL
ACL 9000 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.
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 1.21
1.4.14 External Barcode Scanner (Optional) 1.22
1.4.15 External Printer (Optional) 1.23
1.4.16 Floppy disk drive 1.24
1.5 Additional Features 1.25
1.5.1 Standby Status 1.25
1.5.2 End of the Cycle 1.25
1.5.3 Power Loss 1.25
1.5.4 Setup and Utility Programs 1.26
1.5.5 Fault Detection 1.26
1.5.6 Reverse Video Display 1.26
1.6 Procedural Limitations 1.26
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 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 (Optional) Port 3 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 9000 Software Tree 3.9
3.2 Sample Analysis 3.11
3.2.1 Sample Analysis Procedures - Summarized 3.11
3.2.2 Step-by-Step Sample Analysis 3.14
3.2.3 Profile sesssion 3.15
3.2.4 Analyze Single Test 3.21
3.2.5 Analyze Test Group 3.24
3.2.6 Analysis: Loadlist 3.27
3.2.7 Analysis: Session Report 3.30
3.2.8 Analysis: Add samples function and STAT 3.33
3.2.9 Result list 3.35
3.3 Quality Control 3.43
3.3.1 General QC Procedure - Summary 3.43
3.3.2 Step-by-Step Quality Control 3.44
Addendum: Quality Control Typical SD with IL Reagents
and Controls 3.56
3.4 Calibration 3.57
3.4.1 General Calibration Procedure - Summary 3.58
3.4.2 Saving a Calibration - Summary 3.59
3.4.3 Step-by-Step Calibrations 3.59
3.4.4 Calibration - Review Calibration 3.62
3.4.5 Factor Assays Calibration 3.67
3.5 Analytical Reference 3.75
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
4.1.2.1 Setup - Tests - Description 4.5
4.1.3 Setup - Tests - Sort Tests 4.10
4.1.4 Setup - Tests - Tests Group 4.12
4.1.5 Setup - Tests - Interference Table 4.14
4.1.6 Setup - Tests - Default Tests 4.16
Instrumentation Laboratory II
4.1.7 Setup - Tests - Reflex Tests 4.17
4.1.8 Setup - Profiles - View/Define 4.20
4.1.9 Setup - Profiles - Sort Profiles 4.23
4.1.10 Setup - Liquids 4.24
4.1.11 Setup - Interfaces - Host 4.31
4.1.12 Setup - Interfaces - Printer 4.32
4.1.13 Setup - Interfaces - Barcode 4.34
4.1.14 Setup - Interfaces - Keyboard 4.36
4.1.15 Setup - Interfaces - Network 4.37
4.1.16 Setup - Interfaces - Modem 4.37
4.1.17 Setup - System Configuration 4.37
4.1.18 Setup - Date/Time 4.39
4.1.19 Setup - Units 4.40
4.2.0 Setup - Tests - Define 4.41
4.2.0.1 Copy Test 4.43
4.2.0.2 New Test 4.44
4.2.1 Setup - New Tests 4.48
4.2.2 Analysis: Loading Setup 4.50
4.2.3 Calibration: Loading Setup 4.59
4.2.4 Acquisition Setup 4.69
4.2.5 Calculation Setup 4.71
4.2.6 Ranges Setup 4.94
4.3 Utility 4.98
4.3.1 Utility Submenu 4.98
4.3.2 Utility - Upgrade IL Library 4.98
4.3.3 Utility - Backup/Restore 4.99
4.3.4 Utility - Archive 4.100
4.3.5 Utility - Software - Software Identification 4.101
4.3.6 Utility - Software - Software Upgrade/Upload 4.102
4.3.7 Utility - Save Last Rotor Map 4.103
4.3.8 Utility - Save Trace 4.104
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) 5.16
5.2 Maintenance Procedures 5.17
5.2.1 Introduction 5.17
5.2.2 Daily Preventive Maintenance 5.17
5.2.3 Weekly Preventive Maintenance 5.20
Instrumentation Laboratory III

5.2.4 Bi-weekly Preventive Maintenance 5.21
5.2.5 Monthly Preventive Maintenance 5.22
5.2.6 As-needed Maintenance 5.23
5.2.7 Decontamination Procedure 5.29
5.3 Maintenance Table 5.31
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 6.8
6.1.4 Mechanical Anomalies 6.11
6.1.5 Acquisition Station Anomalies 6.13
6.1.6 Liquids Anomalies 6.14
6.1.7 Optics Anomalies 6.16
6.1.8 Operative Anomalies 6.16
6.1.9 Parsing and Loading Anomalies 6.17
6.1.10 Database Anomalies 6.17
6.2 Data Transmission Failure 6.18
6.3 Data Reduction Error Codes 6.18
6.3.1 Session Error Codes 6.19
6.3.2 Reaction Curve Error Codes 6.20
6.3.3 Calibration Error Codes 6.23
6.3.4 Analytical Reference Error Codes 6.27
6.3.5 QC Error Codes 6.30
6.3.6 Double Test Error Codes 6.32
6.3.7 Ratio and INR Error Codes 6.33
6.3.8 DMS Errors 6.34
6.3.9 Other Miscellaneous Errors 6.35
6.4 Coag Errors 6.35
6.5 Sample ID Errors 6.36
6.6 Data Reduction Diagram for PT, APTT and TT 6.37
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 7.17
7.3.1 Sample Requirements and Positions 7.17
7.3.2 Sample Position in the Rotor 7.19
7.3.3 Coagul0metric Test Volumes 7.20
7.3.4 Chromogenic Test Volumes 7.22
7.3.5 Special Tests Volumes 7.24
7.4 Data Processing Features, Parameters and Analytical
Specifications 7.25
Instrumentation Laboratory IV
7.4.1 Flagging Limits 7.25
7.4.2 Results Format: VDU and Printer 7.28
7.4.3 Dealing with Results Messages 7.28
7.4.4 Calibration Curve Slope (m) 7.31
7.4.5 Calibration Curve Intercept (q) 7.31
7.4.6 Ranges for Calibration Plasma Values 7.32
7.4.7 Reaction Times 7.32
7.4.8 Test Algorithms 7.35
7.5 Assay Performance Characteristics 7.36
7.5.1 Assay Precision Performance, Linearity and
Method Comparison Studies 7.36
7.5.2 Assay Calibration Stability 7.40
7.6 Analytical Limitations 7.41
7.6.1 Carryover 7.41
7.6.2 Cephalin: Needle Self-conditioning 7.42
7.6.3 Lipemic Samples 7.42
7.7 Container Specifications 7.42
7.7.1 Primary Tubes 7.42
7.7.2 Cups and Reagent Containers 7.43
7.8 Instrument Specifications 7.44
7.8.1 Hardware and Operational Specifications 7.44
7.8.2 Dimensions 7.45
7.8.3 Data Bases Specifications 7.45
7.9 Ambient Specifications 7.47
7.10 Electrical Specifications 7.47
7.11 Hazards 7.48
7.11.1 General Warning 7.48
7.11.2 Shock Hazard 7.48
7.11.3 Electrical Hazards 7.48
7.11.4 Biohazards 7.49
7.11.5 Mechanical Hazards 7.49
Addendum: Method Comparison Studies 7.50
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
Instrumentation Laboratory V
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
Instrumentation Laboratory VI
1 General Information
1.0 Introduction
This Operator’s Manual contains the information necessary to operate, maintain and
troubleshoot the Instrumentation Laboratory ACL 9000 system.
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 9000 system,
including its 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 9000 Operator’s Interface is
addressed in separate Sections of this Manual.
ACL 9000 system
Instrumentation Laboratory 1.1

General Information
1.1 Product Use

The IL ACL 9000 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 9000 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 Xa
• Protein C
• Plasmin Inhibitor (alpha-2-antiplasmin)
• Plasminogen
• Fibrinogen-C (Clauss method)
Immunological Tests
• D-Dimer
• von Willebrand Factor (*)
Special Tests
• ProClot (clotting Protein C)
• Protein S
• APCR-V
• Pro-IL-Complex **
• Hepatocomplex **
NOTE:
An (*) indicates that the test is not currently available for the ACL 9000 system
An (**) indicates that the test is not available in the United States.
Profiles
The user may program Profiles 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

ACL 9000 Operator’s Manual
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
Double Tests (Duplicate Testing)
The ACL 9000 offers the user the capability to set up double tests. Section 4.0
contains information that allows you to set up double tests on the system.
1.3 Presentation of Results

The ACL 9000 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)
• g/L (for example for Fibrinogen)
• ng/mL (for example for D-Dimer)
• 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 9000 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 through a mouse.
When sample testing is initiated, the samples and reagents are sequentially
pipetted into a 20-cuvette polystyrene rotor (loading process). Sample and
reagents are then mixed by a centrifugation process. The mixing is carried
out by a 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.

General Information
o o o o
The ACL measures the parameters at 37 C ± 1 C (98.6 F ± 1.8 F), at an
o o o o
ambient temperature from 15 C to 32 C (59 F to 89 F). However, if the
ACL is in a temperature controlled environment where the ambient
temperature is held constant, the measurements are made within a narrower
o o
temperature range: 37 C ± 0.25 C.
The results are displayed on the VDU 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 9000 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 9000,
as viewed from the front of the system.
ACL 9000 system - Components
1. Wash-R Emulsion 5. Sampling Arm 10. Rotor Transport and Rotor Arm
2. Dilutors 6. Floppy Disk Drive 11. Rotor Waste Area
3. Sample Tray 7. LCD 12. Keyboard
4. Reagent Area 8. Rotor Stack Area 13. Adapters Area
9. Rotor Holder Cover 14. Liquid Waste Outlet

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)
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.
3 mL Primary tube, 3 or 3.5 mL total volume (13x75 mm)

5 mL Primary tube, 5 mL total volume (13x75 mm and/or 13x100 mL)
S 11.5 Sarstedt type primary tube, 3 mL volume (11.5x66 mm) and/or
5 mL volume (11.5x92 mm)
The dimensions and volumes mentioned above are all nominal values.

General Information
Sample Tray
Sample Tray Location on the ACL

§ Additional Reagents positions

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

General Information
1.4.4 Reagent Area

The reagent area consists of 8 reservoirs labeled R1 to R8 designed to hold
reagent containers. An area alongside the vial holes is designed to hold the
vial caps while the vials are in use.
o
Positions R1 to R4 are maintained at about 15 C by a Peltier-effect regulator
and 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 are aspirated with the external needle
while the reagents placed in positions R7 and R8 are aspirated with the
internal needle.
Reagent Area
All eight reagent positions can hold 28 mm vials (16 mL filling 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

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 which drains the waste from the cup, and a
waste container outside the analyzer (left side) where the waste is collected.
The cup, which is always filled with Wash-R Emulsion, is used as a washing
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
1.4.6 Sampling/Dispensing System

The sampling/dispensing system of the ACL 9000 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.

General Information
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 mounted
above the acrylic block, each one connected to one of 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 (E) and internal (I), are mounted on the
distal end of an arm which is actuated radially by a stepping motor. Another
stepping 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 internal and external
compartments of the reaction cuvettes within the rotor.
- Washing of the needles in the constant level waste/rinse station.
Sampling Dispensing System
Sensors
Two fluidic sensors connected to the needle block are used to detect the
presence of samples and reagents in the needles.
Through the liquid sensors, the system monitors the presence of samples
and liquid materials (calibrators, deficient plasma, diluents, etc.) in 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.
Operators are warned of sensor failures: results of a sample for which the
system detected insufficient volume will appear with a warning; if the failure
was due to insufficient sample in a cup, the warning message will display
“low level”. In case that 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

General Information
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.
Rotor

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.
Each wedge-shaped cuvette contains two compartments, a small one near
the center to hold the sample and/or reagent and a larger one which holds
reagents only. A partial dam between both 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 large 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 which holds up to
12 rotors (240 cuvettes). 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
special 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
o
between 36 and 39 C; the rotor stack is insulated to help thermal-regulation.
The instrument informs the Operator when the Rotor Stack is empty.
Use of Rotor Refill Tool

General Information
Feeding the Rotor Stack
Rotor Transport - Below the rotor stack, a rotor transport 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

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
o o
temperature of 38.5 ± 0.5 C to insure 37 C inside the cuvette.
Rotor Holder Area
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
o
rotor by an optic fiber system. The scattered light is read at a 90 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,
o
therefore the readings are made at an 180 angle from the light beam.
The optical path width for the chromogenic channel is 0.5 cm (cuvette
height). The absorbance values provided by the analyzer are normalized to 1

General Information
cm. These values are generally double the ones obtained on other ACL
models, for which the absorbance values are strictly 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.
Clot and Chromogenic Detection Systems
Clot channel Chromogenic Channel
Sensor
405 nm filter
LED Rotor
Lenses
Quartz
Quartz optical fiber
Optical fiber Sensor Halogen Lamp
Rotor Waste Area
The used rotors are dropped into a waste container. This container is
accessed from a door in 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.

Rotor Waste Access and Removal
In the sensor 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 command all events in 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 switch-
controlled power supply directly connected to the main power.

General Information
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 all 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 in
three areas as shown in the figure below:
- 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 9000 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 keyboard
layout, the ACL software itself also supports the following languages:
German, French, Spanish and Italian.
Keyboard

1.4.11 Interface Connectors

External Barcode Reader Interface (port 1)
The ACL 9000 includes an interface for an external barcode scanner which
allows additional reading. The external barcode scanner is an optional
feature of the system.
RS-232 C Interface for Host (port 2)
The ACL 9000 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 an optional mouse (port 3)

Modem (port 4) not supported in this software release.
Ethernet (port 5) not supported in this software release.
External Printer Output (port 6)
The ACL 9000 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 7)

General Information
Rear Panel and Fuse
1. External Bar Code (Optional)

2. RS232C 1 (Host - Optional)
3. RS232C 2 (Mouse – Optional)*
4. Modem (NS)
5. Ethernet (NS)
6. Parallel Printer (Optional)
7. Keyboard
NS = Not Supported in this software release

* = The supported mouse protocol is the PS2 compatible
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 9000, 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 and Section 7 of this Manual.
The numerical and alpha-numerical 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, as shown in the picture above. 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 an optional feature of the ACL 9000. This
barcode scanner is able to read numerical and alphanumerical labels. The
maximum barcode label length readable is 6 cm with a resolution of 0.2 mm.
Numerical and alphanumerical readable codes are:
- Code 39
- Code 128
- Code 93
- Codabar
- Interleaved 2 of 5
- MSI/PLESSEY
The scanner is provided with an On/Off trigger. The scanner has a timeout of
10 seconds. If no reading is done in this period the scanner is switched off.
External Barcode Scanner

1.4.15 External Printer (optional)

An external 80-column printer can be interfaced to the ACL 9000.
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 Laser printers.
External Printer

General Information
1.4.16 Floppy Disk Drive

A floppy disk drive is mounted in the upper right part of the ACL 9000.
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.
The floppy disk drive is available to insert the diskette when needed (utility
programs).

1.5 Additional Features
1.5.1 Standby Status

If the ACL 9000 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, all motors are deactivated to
reduce power consumption and the LED source is switched off. While the
instrument is in the Standby status, 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.
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. In the Main menu, the
Warning icon in 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 Reverse Video Display

Certain situations concerning results and calibration parameters are
displayed as follows:
− Violet = out of normal range
− Red = out of scale
For additional information, refer to Section 3 and Section 7 of this Manual.
1.6 Procedural Limitations

o o
The operating range of the ACL 9000 is 15 to 32 C (59 to 89 F) and at up to 85%
Relative Humidity (not condensing). No safety hazards occur in the temperature
o o
range 5 - 40 C (41 to 104 F) and functional performance characteristics are
o o
resumed when the instrument re-enters the range of 15 to 32 C (59 to 89 F).
Sarstedt, Epson and Hewlett Packard are registered Trademarks.

2 Installation
2.0 Introduction
This section contains all the information necessary for installing and setting up the
ACL 9000 system.
NOTE: The ACL 9000 system must only be installed by IL personnel or IL

authorized persons.
Before attempting the installation of the ACL 9000 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 9000
system.
2.1.1 Ambient Conditions

o
The instrument will function correctly in an ambient temperature of 15-32 C
o o
(59 F to 89 F) 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, in 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 on 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.
NOTE: 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.
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.

NOTE: 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 9000. 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 7 connectors.
Connectors
1. External Bar Code (Optional)

2. RS232C 1 (Host - Optional)
3. RS232C 2 (Mouse – Optional) *
4. Modem (NS)
5. Ethernet (NS)
6. Parallel Printer (Optional)
7. Keyboard
NS = Not Supported in this software release

* = The supported mouse protocol is the PS2 compatible

2.2 Instrument Unpacking

Before unpacking the boxes containing the ACL and accessories, visually inspect
them to verify that there has been no damage during shipping and handling.
In case of damage notify the carrier and your IL Representative immediately.
Remove the box containing the rotors and the startup kit. Using the startup kit list
included in the box, confirm that all the 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.).
NOTE: 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 right 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.
NOTE: 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.
CAUTION
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 NCCLS 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 :
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
Different 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 positions

Installation
Reagent Adapters for the Sample Tray A1-A10 positions
Wash-Reference Emulsion
Place a 1-liter bottle of Wash-Reference Emulsion in the appropriate position at the

back of the dilutor fitting and insert the aspiration tube. Make sure that the aspiration
tube connector is properly plugged 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 (internal)
needle and the right hand tubes fits into the upper (external) needle.
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

Installation
External Barcode Scanner (optional)

Connect the external Barcode Scanner, if provided, to its port in the rear panel.
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 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 is reduced
to a minimum. If necessary, pinch the chamber outlet tubes 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 washing chamber to the instrument outlet
and then to the waste container is not impaired.
NOTE: 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 slider 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:
•
o
Rotor Holder 38 to 39 C
•
o
Peltier 10 to 16 C
•
o
Rotor Transport 34 to 40 C
•
o
Rotor Stack 34 to 40 C
As the temperature is continuously checked, the screen is constantly refreshed
showing a blinking effect.
External Barcode Scanner

This is an optional feature for the ACL 9000. Set up the Barcode Scanner according
to the procedure described in the specific setting section of the CCD Barcode
Scanner Operator’s Manual.

On-Board Barcode Reader
This is a standard feature for the ACL 9000. 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
25 Pin Connector 25/9 Pin Connector
PIN DESCRIPTION PIN DESCRIPTION

1 Protective GND 1/1 Protective GND
2 TXD 3/2 RXD
3 RXD 2/3 TXD
4 RTS 5/8 CTS
5 CTS 20/4 DTR
6 DSR N.R.
7 Signal GND 7/5 Signal GND
20 DTR 6/6 DSR

3 Analytical Operations
3.0 Introduction
This Section describes the different procedures associated with sample analysis,
calibration and Quality Control (Q.C.) on the ACL 9000 System. Since these
procedures require an active 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 OI items
used during the process of requesting and performing analytical operations, such as
the data input devices, elements within menus, buttons and icons. The ACL 9000
software tree is also included.
3.1.1 Touch Screen

The basic interaction with the ACL is done through menus which allow
access to sets of related functions (analysis, calibration, QC, set-up,
diagnostics, etc.) and through the use of windows, 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 which
results in the immediate display of the numerical keypad. If the information to
be entered is strictly numerical, the editing is done directly on the keypad. 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 error situation 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 screen is divided into 3 main areas:

1. Status area: upper part of the screen which contains:
IL Logo

Analytical Operations
Indication of current instrument status

Date and Time
Active Menu
2. Working area: central area of the screen, which display windows
containing 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,

button) is displayed dimmed 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 is automatically
displayed when the user starts an edit action. The keypad allows the operator
to visualize the edited string while editing is in progress. The keypad
automatically disappears when the "Confirm" √ , the "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 fault condition of 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 control; 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 may also be used to activate the functions as shown on the
icon, since they usually indicate the character of the functions they represent
(e.g. F1, F12).

3.1.4 External Barcode Reader (Optional) - Port 1

The external barcode reader is used to “read” the information encoded in
sample barcode labels; from that point, the characters are handled exactly as
manual editing from the keyboard and are valid for every editable field.
3.1.5 Mouse (Optional) - Port 3

The mouse may be used as a pointing device in place of touching the screen.
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] + 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
Ø).
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 displayed dimmed. Selecting a

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. To call attention to high priority failures and
fault messages.
WARNING. To deliver different kinds of messages,

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

boxes, but not always, the message is followed by a
request for confirmation.
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" reached during an analytical session (i.e.

STAT request, no rotors, etc.)
FAILURE: indicates that the system has detected a malfunction of internal

mechanisms (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 on.
• Check Boxes and Buttons

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. Some are identified with text that is self -
explanatory of the action. Some are shown as an icon which illustrates an
action as 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.
• Button ICONS
Buttons with 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 button icons used throughout the
ACL 9000 OI, 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 buttons 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)
cancel3d.ico
Cancel
Print
print.ico
(Host) Transmit
Host.ico
Delete
delete-s.ico
Add to the list
Remove an item from the list
Transfer an item from one list to

another
Details
detail-s.ico
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

Toolbar Icons Commands / Instrument Status
Actions (Icon active)
Short Turn Around Time Operating
(STAT) – Urgent sample Hold
din-stat.ico Pressing this button
opens a window that
guides the operator.
Confirmation is required.
Instrument Status O Operating

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

This operation is disabled Hold
open_cover.ico
if there is a possible
interference with the
instrument operation.
close_cover.ico
STOP Ready
Confirmation is required. Operating
stop.ico Hold
Resume Hold
Starts the operations
paused due to STAT
request. Rotor waste full,
Rotor stack empty.
Data Base View Ready

The system goes back to Operating
dbview.ico the database view or Hold
“Main” screen.
Host Status Ready

This icon appears only Operating
host-d.ico during communication Hold
with the Host to inform Failure
the operator about the
status of this action.
Warning Ready
This icon appears when Operating
Exclem.ico There is at least one Hold
Warning. Press to open Failure
“Warning List”.
Log Out Ready
Allows the operator to Failure
logout.ico Exit the screen.
Confirmation is required

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 placed above 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 which 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 after the conclusion of each analytical session so the errors
can be checked between analytical sessions.
The "Error File History" window contains a list, sorted by time, of the last 100
alarms or error conditions. The “Session Error History” and “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 saver is activated after 30 minutes of system inactivity, provided the
ACL system is in the READY status. This time cannot be modified by the
operator. Any action performed on the touch screen, through the keyboard or
the bar code reader will stop the screen saver functions.
3.1.11 The ACL 9000 Software Tree

Shown in the next page is the structure of the ACL 9000 Operator’s Interface
- or system Software Tree - including main menu, first and second-level sub-
menus.

ACL 9000 Software Tree
Menu First-Level Submenu Second-Level Submenu
ANALYSIS Profile Session

Single Test Session
Test Group 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
Profiles View/Define
Sort Profiles
Liquids
Interfaces Host
Printer
Barcode
Keyboard
Network (dimmed)
Modem (dimmed)
System Configuration
Date/Time
Units

UTILITY Upgrade IL Library

Back-up/Restore
Archive
Software SW Identification
SW Upgrade (#)
Save Last Rotor Map
Save Trace
Decapper (dimmed)
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 the ones that follow contain detailed descriptions of the screens,
options and steps involved in the sample analysis process on the ACL 9000.
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 function used before

Analysis
1. Select Analysis.
2. Select Loadlist.
3. Select the first available (empty) Loadlist, click the details icon.
4. Click the Enter/Edit Sample ID button.
5. Type the first Sample ID.
6. Press “t” to move to next position.
7. Repeat steps 5 and 6 until all the samples are entered in the loadlist. At
the end of EDIT click the confirm button.
8. Test default can be programmed using the appropriate check box.
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 with the flag N meaning
“No Test Requests.”
11. Select Analysis; select the desired option from Profile, Single Test or
Test Group.
12. Enter the loadlist number and press ENTER.
13. In the Sample Data screen click the Order Test button. Select the test to
be run and press Program Test.
14. Click the “t” button to display the next sample ID.

15. If tests to be run are the same as before, click the Prev.Prog. button; if
they are different, select a new Test or Profile. At the end press the
Confirm icon.
16. Verify that the current test selection is the one of choice and click the
Start button.
17. 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 prepared in the Analysis

menu
1. Select Analysis.
2. Select Profile Session or Single Test or Test Group.
3. Click the Enter/Edit Sample ID button.
4. Type the first Sample ID; move to the next sample ID position by
pressing “t”.
5. Repeat steps 3 and 4 until all the samples are entered.
6. With cursor on the first line of the Loadlist, click the Order Test button.
7. In the Sample Data screen select the Test or the Profile to be run and
click the Program Test button.
9. If tests to be run are the same as before, click the Prev. Prog. button; if
they are different, select a new Test or Profile.
10. Repeat steps 8 and 9 until tests are assigned to all samples.
11. 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 Profile Pre-Analysis screen (if a profile was selected).
12. The letter P (for Pending) appears in the Status column.
13. Once the samples are in the sample tray, click the Start button.
available.
Manual sample ID Entry – From Database menu
1. Click the New Sample button.

2. Type the Sample ID.
3. Select the Test to be programmed and click the Program Test button.
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. Click the Pending button (all or test selection).
10. Choose the desired option: “All Time Interval” or “From…To…” or …
11. Click the Confirm button and click the OK button. The system switches
back to the Loadlist screen showing the Date and Time when the
loadlist was saved.
12. Click the Confirm button. The system switches back to the Main
screen.

Sample ID entry by barcodes - no connection to a host

computer
1. Select Analysis.
2. Select the desired option from Profile, Single Test and Test Group.
2. Select Read Bar-codes and the instrument will do the loadlist using the
barcode reader.
3. Click on the Order Test and select the Test to be run and click the
Program Test button.
5. If tests to be run are the same as before, click the Prev.Prog. button; if
they are different, select a new Test – Click the Confirm button.
6. Click the Start button.
available.
Sample ID entry by barcodes - connection to a host

computer (Host Query mode)
1. Select Analysis; select the desired Profile.
2. Click the Start button (instrument will perform the Host Query and
proceed to the analysis).
available.

The ACL 9000 can process up to 40 samples in a single session (including

Reflex tests) programmed with a number of tests using as much as possible
rotors position. Reagents and samples (from original containers) are
automatically aspirated and dispensed by the needles arm. Rotors are loaded
and discharged automatically providing a complete walk-away system.
3.2.2 Step-by-step Sample Analysis

The sample analysis process is started from the Main screen by selecting
Analysis on the menu bar. The 5 options given on the Analysis screen
(PROFILE session, SINGLE TEST session, TEST GROUP session,
LOADLIST and SESSION HISTORY) are discussed separately in the
following paragraphs.

3.2.3 Profile Session

Selecting Profile from the Analysis menu opens the Profiles Pre-Analysis
screen:
This screen contains three windows and several associated buttons:
1. Top left area: the Current Profile window displays the profile selected to
be run in the current analytical session. The profile can be changed by
pressing the button on the right of the window (t) 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 window,
since the programming of the tests is independent on the Current Profile
displayed.
The Deselect Tests button may be clicked to open the Profile Details window
to allow the operator to deselect one (or more) of the tests included in the
profile.
2. Bottom left area: the Material window displays all the materials needed to
run the tests and their associated positions on the system. The list changes
according to the selected profiles or tests and their configuration.
Clicking the Liquid Details button at the bottom of the window opens the
Liquid Setup window (for details refer to Section 4).
Clicking the Materials Map button opens the Pre-Analysis: Material Status
window (for details refer to Section 4).

3. Middle area: the large window in the middle of the Profiles Pre-Analysis
screen contains the sample programming information. The actual Sample IDs
and their location in the 40-position sample tray are displayed, along with
three columns for each sample ID (P = Priority, S = Status and F = Flags
during barcode reading). The small window on the top left Sample Tray Map
allows selection of the number of sample tray to be displayed, while the
Loadlist No. window allows the operator either to select an already stored
loadlist or to create a new one using the Store Loadlist button located in the
button column on the right of the screen.
The operator chooses how to use this area according to the desired sample
ID entry mode:
- 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
4. Right side area: The buttons lined up on the right side of the screen are all
related to the sample programming.

• Clicking the Read Bar Codes button turns on the barcode reader and
starts the rotation of the sample tray. If barcoded samples are present
and barcodes are readable, their corresponding Sample IDs are
displayed in the large window.
• Clicking the Enter/Edit Sample ID button displays a window that allows

the operator to type the sample identification, as shown. Up to 15 alpha-
numeric digits can be entered via the standard keyboard or up to 15
numeric digits using the screen keypad.
• Once the number has been typed, clicking the Confirm button accepts
the ID and returns to the Profile Pre-Analysis Screen. To return to the
Profile 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 removes the selected Sample ID, leaving
the space blank to enter another Sample ID. No confirmation is
requested.
• Clicking the Order Test button opens the Sample Data window (see
details below).
• Clicking the Add QC button opens the Add QC Liquid screen:

All the materials that have been defined as Controls are displayed in
the QC Liquids list. Once a control is selected and the Confirm
button is clicked, the material is automatically copied in the sample
tray position where the cursor was placed.
• The Make Loadlist and Store Loadlist buttons are used when the
sample programming choice uses loadlists (refer to Section 3.2.6)
• Clicking the Start button activates the analytical run.
• Clicking the Cancel allows to exit the screen; the system goes back to
the Main 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 turn the
system off; No will cancel the operation.

The SAMPLE DATA window

Clicking the Order Test button in the Profile, Single Test or Test Group Pre-
Analysis screen opens the Sample Data window.
Patient demographics: the upper portion of this window displays the patient
demographic information. The editable fields displayed are: Patient ID,
Patient Name, Department Name or Number (Dept.), Birth Date and Sex.
Patient Details: clicking this button allows access to additional fields, such
as the Operator Notes, the Physician’s name and the Entry Date.

Status: the "status” associated with each sample is selected in the Sample
Data Screen: Transmitted (Transmitted = T or Not Transmitted = L for Local)
and Sample (No test ordered [N]; Pending for at least one test [P]; Completed
[C]).
Priority: clicking this button allows selection of the prioritization of each

sample. During analysis the sample will be extecuted with priority before the
other samples (STAT function)
Tests or Profiles: Test programming may be done from this screen - by test
or profile - for each selected stored sample. Clicking the Delete button
eliminates the test on which the cursor is positioned.
New Sample icon: clicking this button opens the New Sample screen that
allows to insert a new sample in the database.
Within this screen the operator types the Sample ID, selects the Test or the
Profile to be run and clicks the Program Test button. This sequence is
repeated for all new samples.
After programming the last sample, click the Confirm 4 button. The system
switches back to the Single test/Profile test/Test group/Pre-analysis screen.
The inserted samples are displayed and marked with a P (Pending). In the
Sample Data Screen area, the tests requested are marked with a question
mark (?).

3.2.4 Analyze Single Test

After selecting Analysis from the Main screen menu bar, select Single Test
to open the Single Test Pre-Analysis screen.
1. Top left area: the Current Single Test window displays the first test of the
list. The test can be changed by pressing the button on the right of the field
(t) and browsing through 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 window since the programming of the tests is
independent from the Current Single Test displayed.
2. Bottom left area : the Material window displays all the materials needed to
run the test with their associated positions on the system. The list changes
according to the selected test and its configuration.
Clicking the Liquids Details button at the bottom of the window opens the
Liquid Setup window (for details, refer to Section 4).
window (for details, refer to Section 4).

3. Middle area: the large window in the middle of the Single test Pre-Analysis
screen contains the sample programming information. The actual Sample IDs
and their location in the 40-position sample tray are displayed, along with
three columns for each sample ID (P for Priority, S for Status and F for Flags
during barcode reading). The small window on the top left Sample Tray Map
allows selection of the number of sample tray to be displayed, while the
Loadlist No. window allows the operator either to select an already stored
loadlist or to create a new one, using the Loadlist button located in the
button column on the right of the screen.
ID entry mode: (see section 3.2.1)
4. Right side area: The buttons lined up on the right side of the screen are
related to sample programming.
• Clicking the Read Barcodes button turns on the barcode reader and
starts the rotation of the sample tray. If barcoded samples are present
and barcodes are readable, their corresponding Sample IDs are
displayed in the large window.
• Clicking the Enter/Edit Sample ID button displays a window that allows

the operator to type the sample identification as shown below. Up to 15
alpha-numeric digits can be entered via the standard keyboard or up to
15 numeric digits using the keypad on the screen. Once the number has
been typed, clicking the Confirm button accepts the ID and returns to
the Single Test Pre-Analysis Screen. To return to the “Single Test 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 removes the selected Sample ID, leaving
requested.
• Clicking the Order Test button opens the Sample Data window (refer to
details in the Analyze Profiles section above).

All the materials that have been defined as Controls are displayed in the
QC Liquids list. Once a control is selected and the Confirm button is
clicked, the material will be automatically copied into the sample tray
position where the cursor was placed.
• The Loadlist and Store Loadlist buttons are used when the sample
programming choice uses loadlists (refer to Section 3.2.6).
• Clicking the Start button activates the analytical session.
• Clicking Cancel exits the screen; the system goes back to the Single
Test Pre-Analysis screen.



3.2.5 Analyze Test Group

Test Groups are preprogrammed only by IL personnel.
Tests are executed as batch: all sample IDs will be analyzed for all tests
contained in the Test Group selected.
After selecting Analysis from the Main screen menu bar, select Test Group
Session to open the Test Groups Pre-Analysis screen, as seen below.

1. Top left area: the Current Test Group field displays the tests selected to
be run in the current analytical session. The tests can be changed by
pressing the button on the right of the field (t) and browsing through 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 window,
since the programming of the tests is independent from the Current Test
Group displayed.
2. Bottom left area: the Material window displays all the materials needed to
run the tests, with their associated positions on the system. The list changes
according to the selected tests and their configuration.
Liquid Setup window (for details, refer to Section 4).

window (for details, refer to Section 4).
3. Middle area: the large window in the middle of the Test Groups Pre-
Analysis screen contains the sample programming information. The actual
Sample IDs and their location in the 40-position sample tray are displayed,
along with three columns for each sample ID (P for Priority, S for Status and
F for Flags during barcode reading). The small window on the top left
Sample Tray Map allows selection of the number of the sample tray to be
displayed, while the Loadlist No. window allows the operator to select an
already stored loadlist or to create a new one, using the Loadlist button
located in the button column on the right of the screen.
ID entry mode: (see section 3.2.1)
4. Right side: The buttons lined up on the right side of the screen are all
related to the sample programming.
Clicking on the Read Barcodes button turns on the barcode reader and
starts the rotation of the sample tray. If barcoded samples are present and
barcodes are readable, their corresponding Sample IDs will be displayed in
the large window.
When the Enter/Edit Sample ID button is clicked, a window appears to allow

the operator to type the sample identification as shown below. Up to 15
alphanumeric digits can be entered via the standard keyboard. Once the
number has been typed, clicking the Confirm button accepts the ID and
returns to the Test Groups Pre-Analysis Screen. To return to the “Test
Groups 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 window warning appears: Duplicated Sample ID.
• Clicking the Clear ID button will remove the selected Sample ID, leaving
requested.
• Clicking the Order Test button will open the Sample Data window (for
details refer to the Analyze Profile section above).

All the materials that have been defined as Controls are displayed in
the QC Liquids list. Once a control is selected and the Confirm
button is clicked, the material is automatically copied into the sample
tray position where the cursor was placed.
• The Loadlist and Store Loadlist buttons are used when the sample
programming choice uses loadlists (refer to Section 3.2.6).
• Clicking the Start button activates the analytical run.
• Clicking the Cancel exits the screen; the system goes back to the Test
Groups Pre-Analysis screen.


3.2.6 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 of all the available
stored loadlists either blank or defined. Each of the stored loadlists (20
maximum) is identified with a number, a date and a time.
Several options are available:
• Clear Single clears a single Loadlist.
• Clear All clears all Loadlists.
• Make Loadlist prepares a Loadlist automatically.

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

• Confirm or Cancel exits the screen; the system goes back to the
previous screen.
• Clicking the Details button on the top right side of the screen opens the
Loadlist Details screen shown below.
In this screen:
• Clicking the Enter/Edit Sample ID button opens a window for sample
ID editing.
• Clicking the Delete Sample ID button deletes the single sample ID.
• Clicking Delete All Sample ID button deletes all the sample IDs in
the specific Loadlist.


CREATING a LOADLIST
From any screen where the Make Loadlist button is active, proceed as
follows:
• Select the first available (empty) Loadlist.
• Click the Edit Sample ID button.
• Type the first Sample ID and move to the next sample ID.
• Repeat this step until all the samples are entered in the loadlist.
• Click the Confirm button; Date and Time are associated to the Loadlist
Number and the system switches to the Loadlist screen.
• Click the Confirm button; the system switches to the Main screen.

3.2.7 Analysis: Session History

This screen is also automatically presented during a run.
The ACL 9000 allows the user to view the Analytical Session Reports which
include information about the status of the tests and samples for the
analytical runs performed on the system.
In order to reach the screen from which to access the reports, select
Analysis from the Main screen menu bar and Session History from the
Analysis menu. This opens the Analysis: Session Report screen.
The Session Type window at the top of the screen indicates the session is in
process and which test phase is running

Two large windows are seen in the screen containing information pertaining
to the session shown in the Session Type window:
- the Test Execution Status window on the left indicates how many tests
are programmed, how many are already done and if Reflex tests have
been automatically programmed during the run.
- the Samples Status for the Session window on the right indicates the
Status of the samples, the priority and if any sample was Low during
aspiration. A sample found Low in liquid level will stop all testing of that
particular sample.
- Confirm button exits the screen; the system goes back to the Main
screen.
Clicking the Session Error History button at the bottom of the windows
opens the Session Error History screen (see details below).
• ACTIVE BUTTONS on the bottom of this screen are :

Session Error History

The ACL 9000 allows the operator to have access to the information
regarding the errors or warnings generated during the current analytical
session. To access the Session Error History screen click the Session Error
History button in the Analysis: Session Report screen (see below).
ROTOR WASTE FULL
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 “resume” icon.
ROTOR STACK EMPTY
When the rotor stack is empty, the instrument will beep and automatically
pause.
To proceed operator has to refill the rotor stack and press the “resume” icon.

The screen displays a large window divided into three areas which list the
Dates, Times, and warnings generated, with the latest error or warning
appearing at the top.
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.


- Confirm exits the screen; The system goes back to the previous
screen.

3.2.8 Analysis: Add Samples Function and STAT

During a run the sample status is presented showing the number of tests
executed and which test phase is in progress.
Two large windows are visible in this screen containing information pertaining
to the session shown in the Session Type window:
- the Test Execution Status window on the left indicates how many tests
are programmed, how many are already done and if Reflex tests have
been automatically programmed during the run.
- the Samples Status for the Session window on the right indicates the
Status of the samples, the priority and if any sample was Low during
aspiration. A sample found Low in liquid level will stop all test(s) of that
particular sample.
It is possible to add samples during an analytical session using the “Tube

Running” icon on the left end 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 be paused and it will be possible to add
samples.
The “add samples” screen gives the possibility on the left side to type the
sample IDs in the available positions on the sample tray and on the right side
to program test(s) on the added samples.

Use of the STAT in analysis

It is also possible to assign a priority to the added sample (STAT) as that they
will be processed before the other samples using the appropriate check-box.
Use of the barcode reader during “add sample” function

If barcode labels are used the session can be resumed using the internal
barcode reader to read the labels using the appropriate check-box.
Use of the RESUME function in analysis

When all samples are added the “Resume” icon (green flag) can be pressed
to resume the session.
During sample addition all analyses already loaded in the rotor will proceed to
the end; only the analyses which are not loaded yet in the rotor will wait until
the session is resumed.
The “add sample” function is always available except during some part of the
acquisition phases.
Use of the change priority (STAT) or add test(s) to a sample already on-
board in analysis
The “add sample” icon can be used to change priority to a sample already
on-board or to add test(s) on a sample already on-board.
In these cases after the session has been paused the operator can press the
sample database icon and (can change the priority) of the specific sample in
the database by using the appropriate check-box or add test(s).
It is not possible to delete a test already programmed in the on-going session

on samples already positioned on the sample tray.
If a test is added but not contained in the Profile (or Single Test or Test-
Group) presently running the test will only be programmed.
If a test is contained in the Profile (or Single Test or Test-Group) presently

running the test will be executed in the session after the resume operation.

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

3.2.9 Results list

The main screen of the ACL 9000 is the results list. Up to 1000 sample IDs
can be contained in the sample database. Each sample ID can reference up
to 30 tests. In case of a test in duplicate, 3 positions are occupied in the
single sample ID (first result, second result and mean).
The results list has several columns:
- P indicates if the sample was run with a priority attribute (STAT)
- S indicates the status of the sample ID; N means no tests are

programmed on that sample ID, P means some tests have been
executed but there is at least one test pending, C means that all tests
have been run on the sample and it is considered completed
- E indicates if errors are present on at least one test of the specific

sample ID; R means that data reduction errors may be present, E
means that system errors may be present and Q means that QC,
Calibration or AR errors flags may be present.
- Sample ID column (max 15 characters)
- Patient Name column (max 25 characters). Using the “Identity Card”

icon this column can be hidden. When exiting from the ACL 9000
software the patient name column is shown again (default).
- Test and Unit columns are defined (customized) in the sort test
submenu in the Test Set-up. Please refer to the Test Setup Section.

A result presented in “black” color mean inside the normal range.

A result presented in “blue” color means outside normal range.
A result presented in “red” color means outside linearity range.
Above is the representation of the result list when the Patient Name is hidden
using the “Identity Card” icon.
Several functions are available from the test results list:
• Using the Extract icon it is possible to filter only the needed samples by
several criteria.
- Single Sample ID
- Sample ID From … To …
- Patient ID
- Patient Name
- Loadlist Number
- All samples
- Entry Date From … To …
- Department

It is possible to combine the above criteria with the checkbox selection in the
lower part of the screen.
- Completed / Pending
- Stat / Non Stat

- Transmitted / Not Transmitted
- Flagged / Not Flagged
• Using the details function additional information on the sample ID and

results are available (Demographic, Errors, Reaction Curves, etc.).
When more than one result is available on the same test a “ φ “ (snowflake)
Symbol is presented.

From the Sample Data screen it is possible to view the reaction curve
using the detail button.

From the Sample Data screen it is possible to view additional

demographic information using the patient detail button.
• Using the New Sample Icon it is possible to add a new sample to the
database and program manually tests for it.

• Using the Delete Icon it is possible to delete results using the following
criteria.
- Single Sample ID
- Patient ID
- Patient Name
- Loadlist Number
- All samples

- Department
- Stat / Non Stat

• 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
- Patient ID
- Loadlist Number
- All samples
- Patient Name
- Department
- Stat / Non Stat

• Using the Host Icon it is possible to download tests requests or transmit

results using the following criteria.
- Single Sample ID
- Patient ID
- Loadlist Number
- All samples
- Patient Name

- Department
- Stat / Non Stat

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 9000 System. The first subsection presents a summarized procedure for those
users already familiar with the ACL 9000 system and specific details about the
screens, options, etc. are described later in the step-by-step procedures.
3.3.1 General QC Procedure - Summary

• 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 by themselves as a separate run. In the first case, refer to the
“Analysis” section; in the second case, follow the steps below.
• Select Analysis.
• Select Profile or Single Test or Test Group.
• Click the Add QC Liquid button.
• Choose the control and click the Confirm button.
• Repeat the last two actions until all materials to be run have been
entered.

3.3.2 Step-by-step Quality Control

• QC REVIEW and SETUP
The quality control process is started from the Main screen by selecting QC
on the menu bar, and selecting QC Review. This will open the QC Review
screen:
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
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 the Confirm 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, which is opened by pressing the Setup button under the middle
window.
The top of the screen displays the selected QC material (Liquid ID) and some
specific information about it such as Expiration Date, Lot Number, plus a
space for Notes.
The next step is to associate the selected control material with a test.
To do this, the operator selects a test from the Enabled Tests list shown on
the left window using the Arrow button 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 as many tests as desired.

To remove a test from the Configured Tests list, click the Scissors button
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 association Liquid-Tests is done, the next step is to select the units,
the target mean, the target SD and the SD Range for each test in that
material.
Unit: for each test, the selection of units includes only the ones that are
legitimate for that test. Modifying a unit will not cause a change in Target
Mean and SD values that need to be retyped.
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 or 2 or 3 SD. The expected SD ranges for IL reagents

and controls levels are reported in the Addendum at the end of this section.
The flag Patient Results check box can be activated only after the activation
of the QC Range Check box.
The QC Range Check and Flag Patient Results check boxes can be
activated by simple touch, causing a check sign to appear.
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.
If the Flag Patient Results is activated, all the patients run after a control that
resulted outside the defined range will be flagged.
The Clear Statistics button deletes, after confirmation, all the results of a
particular Test – QC Material combination.
Clicking the Printer button, 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 buttons are active.
• 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, as shown on 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 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).
Clicking the Printer button, 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.


• 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:
In the upper part of the screen the user views, but is not allowed to edit, the
selected QC material (Liquid ID), the selected test (test ID), the date range
(dd.mm.yyyy) and the time range (hh.mm).
The larger part of the screen is used to display the results obtained for the
selected pair QC material-test.
“F” column flag.
“S” column indicates the transmission status (L is local, T is transmitted).
“O” column means omitted.

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.
There is also space for some notes, and columns for possible flags and
warnings.
If the user wishes to know further details about a single result, they are
accessible by clicking the Details button, which opens the QC Single Result
Details screen:
In this screen, the identity of the Liquid ID/Test ID pair is displayed on the
upper part of the screen.
The windows in the left side of the screen display the 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
- Omission status
- Performed date and time
- Notes (if any)
- Warning list.
Clicking the Disk button 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.
Clicking the Printer button, 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 operator may enter his own notes in the Insert Notes screen (shown
below) that is opened by clicking the Notes button.
The free text field allows the operator to key in up to 30 alphanumeric

characters.
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 never be considered in the calculation.
Clicking the Plot and Statistics button allows access to the QC Plot and
Statistics screen (refer to subsection above).

Clicking the Host button opens the QC Host Communication screen (refer to
subsection below).
Clicking the Extract Results button opens the QC Extract Data screen (refer
to subsection below).

want to print? Yes allows the operator to print the results; No will cancel the
operation.
Clicking the Confirm button saves the changes and the system goes back to
the QC Cumulative Results screen.
Clicking the Confirm button allows to leave this screen and go back to the
QC Review screen.

• QC - HOST COMMUNICATION
Clicking the Host button found in both QC Cumulative Results and QC
Review screens opens the QC Host Communication screen:

The Host Communication configuration displayed on this screen is needed to

decide which type of QC results are to be sent and at what time intervals they
must be transferred to the Host Computer.
The user first defines the date range, choosing between:
− “All range”
− “From…To…”
If the latter is selected, the starting date/time and the ending date/time must
be defined.
The user can also select if a specific test data or all tests data should be
transmitted by choosing between the following options:
- “Single Test”
- “All Tests”
The user then makes a second-level choice from each of the following pairs:
- Valid Results
- Invalid Results
- Not Numeric Results
- Out of Scale Results
- Omitted Results
Some second-level selections are also available:
- “Transmitted” or “Not Transmitted”

- “Flagged” or “Not Flagged”
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 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 can be activated
by clicking the Start Communication button.
Clicking the Cancel button rejects the changes; the system goes back either
to the QC Cumulative Results screen or to the QC Review screen depending
from which screen the Host button was pressed.


• QC - EXTRACT DATA
Clicking the “Cumulative Results” button from the QC Review screen opens
the QC Cumulative Results screen.
Clicking the Extract Results button 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
association Liquid ID/Test ID is visible on the upper part of the screen.
− “All range”
be defined.
The user can also select if a specific test data or all tests data should be
extracted by choosing between the following options:
- “Single Test”
- “All Tests”

The user then makes a second-level choice from each of the following pairs
options:
- Valid Results
- Invalid Results
- Omitted Results

The selections are made by touching the 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 extract groups such
as Valid and Not Flagged - but Omitted - results.
Once the extraction criteria are defined, the extraction can be activated by
clicking the Extract button.
Clicking the Cancel button will reject the changes and leave the screen; the
system goes back to the "QC Cumulative Results” screen.


Addendum: Quality Control Typical SD with IL Reagents and Controls
Parameter Reagent Units Normal Abnormal Abnormal Abnormal Abnormal

Control 1 (Low) 2 (High) Chromogenic Controls
Plasma 1/2
PT PT-Fib Sec. 0.4 0.7 1.3

PT-Fib-HS Sec. 0.5 1.5 3.0
PT-Fib-HS Plus Sec. 0.5 1.5 3.0
APTT APTT EA.• Sec. 1.0 1.5 2.0

APTT-C Sec. 1.5 2.0 3.0
APTT-Lyo• Sec. 1.5 2.0 3.0
APTT-SP Sec. 1.5 2.0 3.0
TT 3.0 U/mL Sec. 1.0

1.9 U/mL Sec. 1.5
Fibrinogen PT-Fib mg/dL 30

PT-based PT-Fib-HS mg/dL 30
PT-Fib-HS Plus mg/dL 30
Fibrinogen mg/dL 20 8
Clauss
Factors % 10 8
(F-VIII)
Pro-IL-Complex • % 6 1.5 1.5
Hepatocomplex • % 10 2.0 2.0
Antithrombin Chromogenic % 6 6
Plasminogen Chromogenic % 6 4
Plasmin Inhibitor Chromogenic % 8 6
Protein C Chromogenic % 6 4
Protein C Clotting % 12 4 8
Protein S % 10 2 6
• Tests not available in United States

3.4 Calibration
The ACL 9000 system requires that tests are calibrated either prior to or
simultaneously with sample analysis. Calibration data may also be stored and is valid
for a determined amount of time, which varies for each test.
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 9000,
starting with a summarized procedure for those users already familiar with the ACL
9000 system, and 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 #
Protein-S #
D-Dimer #
VWF #
Dedicated means that a separate session is done to perform a

calibration.
In session means that the calibration is executed the first time together
with samples but later on can be re-used for assays with analysis only. In
case the calibration plasma is positioned on the sample tray the
calibration will be executed, when the calibration plasma is not positioned
on the sample tray the previous calibration is used.

Each Rotor means that every time a rotor is loaded with samples the
calibration is executed together.
3.4.1 General Calibration Procedure - Summary

• Select Calibration from the Main screen menu bar and select Calibrate
from the Calibration submenu. This will open the Calibration Pre-
Analysis screen of the dedicated calibration session.
• Scroll through the list of tests displayed in the Test to Calibrate window
on the top right side of the screen, and choose the test to be calibrated.
• Look in the left side window and make sure that you have on hand the
materials listed, which will be needed to perform the calibration for that
test. Lot Numbers and assigned values for calibrators for these materials
are listed on the left.
• 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.
• Check the status of the materials currently on the system by pressing the
Materials Map button at the bottom right side of the window. Through
this window you are able to reset single material volumes or all of them,
as well as to choose to start the calibration on a brand new rotor. If this
option is not selected, the ACL 9000 will first use all the positions left in
the rotor currently in the rotor holder.
• Press Start to begin the Pre-Analysis phase. The ACL 9000 will check
the presence of the needed materials. If any of them is missing, the
calibration will not start and the cycle will be aborted. If all is in order, the
system will start the Analysis phase of the Calibration.

3.4.2 Saving a Calibration - Summary

At the end of the cycle the Calibration can be saved and the previous
calibration will be deleted. For dedicated calibrations only it is possible to
compare results of the active calibration session with those of the previous
calibration before deciding to save it or not. For not dedicated calibrations,
ACL 9000 retain 5 calibrations in memory, cancelling the oldest with any new
calibration run.
3.4.3 Step-by-step Calibration

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 as described below:
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 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.

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 Reagent

Tray
- Lot Number Number of the specific lot
- Value Assigned value for the FIRST Standard, as indicated
on the package insert sheet
- Material Component ID or short name of the component
Clicking the Start button on the right side of the window starts the calibration
process.
Clicking the Cancel button rejects any changes made and the system goes
back to the Main screen.

Liquid Setup screen (for details, refer to Section 4 - Setup):

This window provides complete current information on every material used to

perform the coagulation assays on the ACL 9000, such as type, lot numbers,
expiration date, volume in the container, and the on-board stability. The user
may modify any of the information as needed, i.e. when starting new lots of
materials or when the assigned value to the Calibration Plasma must be
changed.
Clicking the Materials Map button at the bottom of the window opens the
Pre-Analysis: Material Status screen:
This screen displays the status of the samples and reagents currently on-
board the system, along with other information.
The operator is able to assess the situation of the ten Sample Tray positions
and the eight Reagent Tray positions. For the reagents, the information
includes Liquid ID, Lot Number and Liquid Level.
Three operations can be carried out on the volume settings:
§ Set Volume will allow the update of volume 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 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 calibration with an unused rotor, the operator
must check the Start with a New Rotor box.
The information on this screen is not editable.
Clicking the Confirm button saves the changes and clicking the Cancel
button rejects the changes; in both cases the system goes back to the
“Calibration Pre-analysis screen”.
Clicking the Start button starts the calibration run.

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:

The ACL uses this screen to display the recorded date and time of all the
calibrations performed for each enabled test.
Clicking the Details button 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
- Fit equation used
- Errors (clicking the Error View button, see below)
- Warnings (clicking the Warning List button, see below)
- Mean value of the replicates, units of measure and CV%
Clicking the Details button allows to obtain information about each single
replicate.
- ACTIVE BUTTONS at the bottom of this screen are:


- Confirm exits the screen; the system goes back to the Calibration
review screen.
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 button the calibration curve and the calibration data are
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.
Clicking the Details button from the Calibration Data Screen opens the
Calibration Point Details screen:

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.
Clicking the Disk button, allows the user to store all the raw data onto a floppy
disk.
Clicking the Confirm button allows to exit the screen; the system goes back
to the Calibration Data screen
Clicking the Printer button, the instrument prints the reaction curve.
Number of calibration points used.
Test Calibration Total Number of Total

Standard Number of Replicates Number of
to be Calibration for each Calibration
positioned Points Point Points
PT 1 3 6 18
Fib-PT Based * * * *
Fib-C 1 3 4 12
Factors # 2 6 1 6
AT 1 3 4 12
HEP 2 3 4 12
P-C 1 3 1 3
PLG 1 3 1 3
P-I 1 3 1 3
ProClot 1 3 1 3
P-S § 2 3 1 3
D-Dimer 1 3 4 12
VWF 1 4 4 16
* same number as the PT tests
# 2 standards are used for 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).
§ 50% calibrator is optional

3.4.5 Factor assays calibration

This information is valid for all 8 factor assays (VII, X, V, II, XII, XI, IX and VIII)
when using the IL tests library.
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 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; assigned value is automatically calculated by the ACL
9000 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.
The 100% calibration plasma is required to obtain a valid calibration curve.
If the 100% material is not placed, a window will indicate the missing
materials. The options to stop or to proceed are given. If the user chooses to
proceed, sample analysis are performed although the calibration cannot be
executed. Sample results are calculated based on the previous calibration.
Response and activity (%) values are reported.
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 has to be placed in each Factor

Analysis session.
The Cal Low F (6.25%) material is an optional material and 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 9000 to perform a

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

100 Undiluted Calibration Plasma
50 Dilution done automatically by the ACL 9000
25 Dilution done automatically by the ACL 9000
6.25 Manually prepared diluting the Calibration
Plasma 1+15 with Factor Diluent
3.12 Dilution done automatically by the ACL 9000
1.56 Dilution done automatically by the ACL 9000
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
9000 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.
An analytical session is defined as beginning with the start of analysis and

ending when the instrument returns to Ready.
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 9000 will perform only 3 calibration points: 100%, 50 and 25%.
Linearity varies from factor to factor but the instrument will always flag a result
lower than 60% of the lowest calibration point.
In case the lowest calibration point is 25 %, all results below 15 % will be

flagged with a “Q” in the Error column and as “Extrapolated Result” in the Test
Details Warning List.
If a result is higher than 150 % of the highest calibration point value, a “Q” 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 “Q” and as “Extrapolated Result”.
Any result outside its specified Test Range as defined in the test setup will be
flagged as with a “Q” in the Error column and “Outside Test Range” will be
displayed in the Test Details Warning List.
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, the
Middle and the Low curve will be rejected.
If this occurs, in both cases 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.
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.

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.
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: lower to higher or higher to lower.
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.
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 is exceeding the slope limit specifically defined for the
segment, the segment will be rejected with Slope out of Range error
message.
Samples run in this condition will be flagged with a “Q” together with the
message “Slope out of Range”.
r2 check
2 2
If the calibration r for a specific segment exceed the r limit specifically
2
defined for the segment, the r will be presented in red color and a “Q” flag
2
with the message “r 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
“Q” and Out of Test Range = result is Result is outside the Test
presented in violet color Range for that specific test.
“Q” and Extrapolated result When the result is greater

than 150% of the highest
calibration point or less than
60% of the lowest calibration
point.
Previous calibration Result is calculated using a

previously stored calibration.
“Q” and Slope out of Range Result is calculated if at least

the High segment of the
curve is valid.
2
“Q” and r out of Range Result is calculated and an
2
error message is shown (r
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 1.56
% dilution.
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.

3.5 Analytical Reference

Analytical Reference (AR) is the name of a control material which is intended
for use as a general check of the system precision.
The AR results are handled just like the results of 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 or extracted to a floppy disk.
Analytical Reference: REVIEW

The Review of the Analytical Reference results is started from the Main
screen by selecting Calibration on the menu bar, and selecting 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 from the list of enabled tests. The following statistics are
displayed on the right side of the screen, but are not editable:
- Unit
- Actual and Target Mean
- Actual and Target SD
- Actual CV
- Results in Statistics and in Database (DB)

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 button opens the AR Host Communication

screen (see details later in this Section).
Clicking the Confirm button exits the screen.

Analytical Reference: SETUP

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 will
lose results.
- 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
Analytical Reference Review screen.

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 of 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 up to 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.

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 some notes, and columns for possible flags and
warnings. The operator may enter his own notes by clicking the Note button
which opens the Insert Notes screen (similar to QC functionality).
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 never be considered in the 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 button opens the AR Host Communication screen (refer to
subsection below).
Clicking the Extract Results button opens the AR Extract Data screen (refer
to subsection below).
Clicking the Printer button, 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.


Analytical Reference: HOST COMMUNICATION

Clicking the Transfer to Host button 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”
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

The selections are made by touching the area close to the options: a check
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, the transmission may be activated by
clicking the Start Communication button.
Clicking the Cancel button rejects the changes and exits the screen.

Analytical Reference: EXTRACT DATA

Selecting Analytical Reference from the Calibration menu, Cumulative
Results and then clicking the Extract Results button 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”
be defined.
The user then makes a second-level choice from each of the following pairs
- Omitted Results

The selections are made by touching the area close to the option; a check
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, the extraction can be activated by clicking
the Extract button.
Clicking the Cancel button rejects the changes and exit the screen.


4 Setup and Utility
4.0 Introduction
The intent of this Section is to familiarize the ACL 9000 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 9000 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. For ease
of use, Section 4.1.1 shows the Setup submenu, and Sections 4.1.2 and above are
labeled as the items in this submenu.
4.1.1 SETUP Submenu

Clicking the SETUP button on the Main screen menu bar displays :
TESTS
- View/Define
- Sort Tests
- Test Groups
- Interference Table
- Default Tests
- Reflex Tests
PROFILES
- View/Define
- Sort Profiles
LIQUIDS
INTERFACES
- Host
- Printer
- Barcode
- Keyboard
- Network (dimmed) – Not Supported in this version
- Modem (dimmed) – Not supported in this version
SYSTEM CONFIGURATION
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. As
default all tests are disabled. Up to 300 tests can be contained in the
database. Up to 100 tests can be activated together.
Selecting Tests from the Setup submenu, and then choosing View/Define
open the View Tests screen:
The large window on the left of the screen displays a table of all the
configured tests. Each test is identified by a short name, Test ID, shown on
the right side column. Both 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.
Note: IL pre-defined tests were developed and tested specifically

for use with IL Test reagents and supplies for use on the
ACL™ 9000. 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, 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 is viewable but not editable from this
screen. Several buttons are found around these fields:
Clicking the Details button opens the Test Details screen, which allows
editing of the fields (refer to the specific section below).

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.
The test database can contain up to 300 tests; 100 tests can be enabled
(active).
Clicking the Show Enabled button allows the operator to view only the
enabled tests from the test table.
Clicking the Copy Test button opens the Copy Test screen (refer to the
specific section below).
Clicking the New Test button opens the New Test screen (refer to the
specific section below).
Clicking the Delete button, followed by a confirmation window, erases all

information related to the IL predefined tests.

- Database View returns to the Database View or Main Screen.

Setup and Utility
The Test Details screen:
Any changes to the test fields in the View Tests screen are done through the
Test Details screen, which opens by clicking the Details button.

4.1.2.1 Setup - TESTS - Description
The Test Details screen is shown below.
In Test Details the following information is accessible.
• TEST ID – 8 characters
Notes: This field is not editable for an IL predefined test.
This field is printed in the cumulative report.
• TEST CODE - 3 characters
Note: This field is not editable in an IL predefined test.
• EXTENDED TEST NAME - 15 characters
Notes: This field is editable for an IL predefined test.
This field is printed in the sample report.
• TEST CODE FOR HOST - 4 characters (editable)
• TEST REVISION - 4 characters

Note: This field is not editable for an IL predefined test.

Setup and Utility
• CALIBRATION MODE - One of the following options may be displayed

according to the test selected:
- None
- Dedicated
- In session
- Each rotor
• IMPORT CALIBRATION – One of the following options may be
displayed according to the test selected:
- None
- Any from the list of enabled calibrated tests (displayed)
• IMPORT RAW DATA FROM - One of the following options may be
displayed according to the test selected:
- None
- Any from the list of enabled tests (displayed)
The following buttons are present in this screen:
Clicking the Analysis: Loading Setup button allows the user to view/edit the
reagents and sample setup in the trays during analysis (refer to section
4.2.2).
Clicking the Calibration: Loading Setup button allows the user to view/edit
the liquids (reagents, calibrators) setup in the trays during the test calibration
(refer to section 4.2.3).
Clicking the Acquisition: Setup button allows the user to view the data
acquisition scheme for the test (refer to section 4.2.4).
Clicking the Calculation: Setup button allows the user to view the data
calculation scheme for the test (refer to section 4.2.5).
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.

system off; No cancels the operation.

The screen in the middle displays a table with the following information:
Range and Units table
§ Show in sample list Y if the unit has been selected (Yes), it is shown in
the patient database and printed.
§ Correction parameters. If any correction factor is applied to a specific unit, an
asterisk will appear. For the correction Parameters
please refer to Set Up New Test (Section 4.4.0.2).
§ Result Unit Units that are available in the selected test (from 1 to
4).
§ Norm. Range Defines the normal range for each unit. The normal
range is used to flag patient results. On the screen,
the results are displayed in violet (out of 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. The test range is
used to flag patient results. On the screen, the results
are displayed in red (out of test range); on the printout
the results out of test range will be printed in bold.
§ Scale Range Underflow and overflow condition (out of scale). No
results are presented.
From the Test Details screen, clicking the Ranges button opens the Ranges
Setup screen.:

Setup and Utility
§ Show in sample list: when checked, the unit is displayed and printed.
§ Normal range: Minimum and Maximum values can be typed in.
§ Test range: Minimum and Maximum values cannot be edited in IL tests.
§ Scale range: Minimum and Maximum values cannot be edited in the IL
tests.
§ Reaction Curve graph: defines the Y axis scale of the reaction curve
(minimum and maximum values).
If the Calculation Setup button is pressed (from the Test Details screen) the
Reference Value can be typed in. This value is used for Ratio and INR
calculation for tests with R or INR selected. This value is the denominator of
the R and INR calculation and should represent the mean normal population
time for the selected test. For additional information on Analytical Reference
please refer to section 4.2.5 – Calculation Set up.
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 9000 is called
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. From the Set up menu select the Liquids submenu, then select the
appropriate Thromboplastin Reagent (Liquid ID) on the list in the left
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.
4. Make sure that all PT tests using the same Thromboplastin have the
proper ISI assignment.
5. Several PT tests using the same Thromboplastin may be present such as
PT standard, PT extended, PT duplicate standard and PT duplicate
extended acquisition time.
6. From the Set up menu select Tests View/Define. Select the PT test and
click on Details.
7. Then select Calculation and the instrument will show in the right part of
the screen the selection of the Reference Value and the value in seconds
used as a denominator in the Ratio and INR Calculation.
8. Make sure that the value entered in this field represents the Mean Normal
Range of the local normal PT population. This value is editable and can be
modified to reflect the real local situation.
9. Repeat the steps from 6 to 8 for all PT tests using the very same
thromboplastin lot in order that Ratio/INR will be calculated using the same
value in seconds as denominator.
The instrument uses the following formula for the Ratio Calculation.
RATIO CALCULATION = Patient Plasma (seconds)

Reference Value (seconds)
Reference value means Mean of Normal Range (seconds).
Mean of the Normal Range = Mean Normal PT Time = Mean of Patient

Normal Range in seconds as recommended in NCCLS Document C28 – A,
Vol. 15, No. 4.
The INR will be then calculated as follows:
ISI
INR = (PT of Patient Plasma (seconds) / PT of Reference Value (seconds))
Using the Reference Value feature the denominator used in the Ratio and
INR calculation will accurately reflect the Mean of Normal Range.
IMPORTANT:
In the ACL 9000 both screen and Printout show/report Ratio and INR
units separately.
WARNING:
When a thromboplastin lot is changed all the Procedure mentioned

above must be repeated.
If the INR calculation is not properly setup erroneous patient results

may be reported.

Setup and Utility
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:
This will define the order of the test columns of the patient database.
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 buttons at the bottom of the windows are used
to create a sorted list. The default condition is to have on the right and on the
left column Tests Enabled in alphabetical order. As the operator selects the
first test (sorted tests box) and presses the scissors and the arrow buttons,
the test is removed from the right side window. The arrow is used to move a
test from the left list to the right list in the desired position. Test is added after
the cursor. If a mistake is made, the Scissors button is used to cut the test
from the list. This operation is necessary because the tests cannot be moved
up and down in the Sorted Tests list.

Database View/Main screen.

system off; No cancel the operation.

Setup and Utility
4.1.4 Setup - TESTS – Test Groups

The Test Group is a combination of tests using the same wavelength and
same acquisition cycle.
A sample ID selected for a Test Group will be analyzed for all tests pertaining
to the selected Test Group.
Test Groups are predefined by IL.
Selecting 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.
Several buttons are located around these windows:
Clicking the Details button allows the operator access to the Test Group
Details screen (refer to the specific section below).
Clicking the Print button, followed by a confirmation window Do you really

want to print Test Group? Yes prints the test group setup; No will cancel the
operation.
the Main screen.


The Test Group Details screen:
Clicking the Details button 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 4.1.10.

Setup and Utility
Clicking the Material Check button, the actions to be taken by the instrument
when a low level is detected are listed.
the Test Group Details screen.

4.1.5 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 “needle conditioning” or “reagent priming” may improve the system
performance. The Interference Table option is used to configure this feature.
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 the tests that interfere
with the test highlighted in the left window.

ENABLED TESTS on the right side which 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.
to add or remove a test.
On the left there is the list of tests with reagent priming, in the middle there is
the list of the interfering tests and on the right the list of the Enabled tests.
The Operator has to choose the test that needs the reagent priming by
moving the cursor in the box on the left. Then he chooses the interfering tests
on the right, presses the arrow key to move the selected test to the interfering
tests box.
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.

Setup and Utility
4.1.6 Setup - TESTS - Default Tests

The default tests are used to program sample IDs without a request from the
internal database or the Host.
The list on the left shows all enabled tests. The list on the right shows the
tests selected as default.
to add or remove a test.
Select the test to be added to the Default Tests list from the box on the left
(Enabled Tests) and press the Arrow key. The selected test will move to the
Default tests box.
The default tests can be disabled/enabled using the appropriate checkbox.

4.1.7 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.
Up to 60 rules can be defined. A rule is composed of up to 3 conditions. A

condition may be either numeric (based on a specific unit) or dependent on
errors which occurred on the master test (i. e. error 7).
Each rule can program and/or execute up to 10 tests.
Clicking the Details button when the cursor is on a specific rule displays all
the conditions and tests and they can be modified.
Clicking the Delete button deletes the rule.
Clicking the Print button prints all the reflex rules.
To insert a rule, use the insert icon.

Setup and Utility
Clicking the Details button, the Reflex Rules Details window appears.
The Details button allows to view/change the conditions of the current reflex
rule.
The upper window allows the insertion of the rule condition by pressing the
insert button.
The Reflex Rule Conditions window appears.

The tests generating the reflex test can be chosen from the Test ID List.
Two classes of conditions are available: value, based on numeric results, or

error, based on the error that occurred.
For the numeric results, the following selections are available:: S, Sa, R and
NR >; =; < with a value to be entered; for this class of condition, the unit has
to be selected.
The second class includes the result error (data reduction errors), e.g. error 7.
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 two 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 buttons.
Rules and conditions can be reviewed or deleted by pressing the details or

the delete buttons.
The Print button 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 = error 6 then PT-e
• PT = error 7 then PT-e
• APTT > 110 seconds then APTT-e

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

• Fib-C < 100 mg/dL (or 6 g/L) Fib-C l
• D-Dimer > 1050 ng/mL D-D h
• vWF > 150 % vWF h

Setup and Utility
4.1.8 Setup - PROFILES - View/Define

This area of the software allows users to define and view their own choice of
test profiles.
Up to 99 profiles can be created (code from 1 to 99).
Selecting Profiles from the Setup submenu and then choosing View/Define
opens the Profiles View screen shown below.
The window on the left side of the screen displays a Profiles List if 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), and for each there is
an associated NOTE field.
The information shown for these fields is viewable but not editable from this
screen. Several buttons are found near these fields:
Clicking the Details button opens the Profiles Details screen, which allows
Clicking the Delete button, followed by a confirmation window Do you want to
delete the current profile? Yes allows the operator to delete the selected
profile; No will cancel the operation.
Clicking the Print button, 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 in the fields shown in the

Profiles View screen are done through the Profiles Details screen, which
opens when clicking the Details button.
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.

Setup and Utility
The user defines the tests in the profile with the help of the Arrow and the
Scissors buttons to add and delete the tests 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 programmed as soon as the test is

inserted according to the default position of the Setup liquids. If a default
position is already programmed for another reagent, the next available
position is automatically filled. If all the positions in a homogeneous area (R1
to R4; 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…R8) for the specific
liquid material
- Refrigerated: a check indicates that the selected liquid material must be
kept at 15°C (positions R1 to R4)
- 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.
Profiles View screen.
The Globe button allows modification of the profile names in the selected
language.


4.1.9 Setup - PROFILES - Sort Profiles

This area of the software is used to sort the test profiles defined in the
system.
Selecting Profiles from the Setup submenu and then choosing Sort Profiles
opens the Profiles List screen, shown below.
The window on the left side of the screen lists all the enabled Profiles; a
check mark on the left side indicates that it is a Sorted Profile.
The window on the right part of the screen displays all Sorted Profiles.
The Arrow and the Scissors buttons are used to sort profiles. As the
operator selects the first Profile and presses the scissors and the Arrow
buttons, the profile is copied from one position to another of the sorted
profiles list in the right side window. If a mistake is made, the Scissors button
is used to cut the profile from the list. The profile is inserted below the cursor.
button rejects the changes; in both cases the system goes back to the Main
screen.


4.1.10 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 9000.
Liquid IDs from 1 to 500 are reserved for IL material. From 501 to 999 liquid
IDs are available to the user.
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
- EXTENDED NAME: the complete name of the liquid material
- LOT No.: the lot number of the material
- EXPIRATION DATE: the expiration date as it is shown on the vial label

- ON BOARD STABILITY: the stability as it is claimed in the insert sheet
- CURRENT VOLUME: quantity of liquid (in mL) remaining in the

container
- ASSIGNED VOLUME: quantity of liquid (in mL) present in the 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 column will be changed from green to orange
- LIQUID TYPE: calibrator, control, reagent, solution
This screen also displays a table - “Used By” - 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 first
standard as reported in the product insert sheet.
ISI and Calibration Plasma assigned values can be inserted by clicking the
Assign Value button and using either the keyboard or the numerical keypad.
Whenever the ISI value is modified, all the results will use the new ISI value
to calculate the INR.
INR FORMULA
ISI
Reference Value)
Assign Value.
click on Details.

Setup and Utility


Vol. 15, No. 4.
ISI
IMPORTANT:
units separately.
WARNING:


may be reported.

Whenever the Calibration Plasma is modified, the calibration target values

are automatically updated and all 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 button opens the Liquid Details screen which 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 button and confirming the selection the liquid report is
printed.
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.


Setup and Utility
The Liquid Details screen:
Clicking the Details button in the Liquid Setup screen opens the Liquid
Details screen that 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 and Liquid Code

- LIQUID TYPE
- EXTENDED NAME
- ACCESSING NEEDLE
- DEFAULT POSITION
- REFRIGERATED (checkbox)
- MIXED (checkbox)
- IL LIQUID (checkbox)
button rejects the changes.


The 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 type the desired alpha-
numeric digits:
- LIQUID ID: the short name of the material (10 digits)
- EXTENDED NAME: the complete name of the material (15 digits)
- 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 digits)
- EXPIRATION DATE: the expiration date as it is shown on the vial label

- ASSIGNED VOLUME: quantity of liquid (in mL) present in the container
before starting the analytical session (default volume as declared on the
product label)
- WARNING VOLUME: quantity of liquid (mL) below which the material
map color will changed from green to orange

Setup and Utility
- ON BOARD STABILITY: the stability as it is claimed in the insert sheet

In the following fields the operator must make a choice among the given
options:
- ACCESSING NEEDLE: Sample (external needle only for A1..A10 and

R7 and R8) or Reagent (internal needle only for R1..R6)
- DEFAULT POSITION: A1…A10 or R1…R8. Default position can be

modified also for IL liquids, maintaining consistency characteristics
(refrigeration, agitation, needle, etc.)
- LIQUID TYPE: Calibrator, Reagent, Control, or Solution
In the following two areas the operator must just “check” the checkbox if he
wants to use this feature (check = YES):
- REFRIGERATED
- MIXED
- IL LIQUID (dimmed)
Since only the first four positions of the Reagent Area (R1…R4) can be
refrigerated and mixed, 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”.
button rejects the changes; in both cases the system goes back to the Liquid
Setup screen.
Clicking the Globe button allows the user to modify the liquid ID and name in
the selected language.


4.1.11 Setup - INTERFACES - Host

This area of the software allows the user to define some characteristics of the
communication between the ACL 9000 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”.”
Other buttons in the screen are used by the operator if the feature is desired
(check = YES):
- HOST QUERY
- DELETE AUTOMATICALLY AFTER TRANSMISSION (TX)
- UNIQUE INSTRUMENT ID (a digit between 1 and 99 can be defined)
button reject the changes; in both cases the system goes back to the Main
screen.

Setup and Utility

- 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 turn
the system off; No will cancel the operation.
4.1.12 Setup - INTERFACES - Printer

This area of the software allows the user to configure the ACL 9000 optional
external printer.
Selecting Interfaces from the Setup submenu and selecting Printer opens
the Printer Setup screen:
In the top part of the screen, the operator defines:
- PRINTED SAMPLES: Any (all the analyzed) or Just Completed

- REPORT TYPE: Cumulative or Sample Report
- 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.
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 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.


Setup and Utility
4.1.13 Setup - INTERFACES - Barcode

This area of the software allows the user to configure the barcode reader of
the ACL 9000 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 which is done 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
screen.


Setup and Utility
4.1.14 Setup - INTERFACES - Keyboard

This area of the software allows the user to configure the ACL 9000 standard
keyboard for the language used in the laboratory and to decide on the use of
the on-screen keypad.
Selecting Interfaces from the Setup submenu, and selecting Keyboard

opens the Keyboard Setup screen.
The window in this screen selects:
- KEYBOARD TYPE:
English, French, German, Italian or Spanish.
- NUMERICAL KEYPAD
Disabled, All numerical fields, or All numerical fields and Sample ID
button reject the changes; in both cases the system goes back to the
Keyboard Setup screen.


4.1.15 Setup - INTERFACES - Network

Not supported in this Software Revision.
4.1.16 Setup - INTERFACES - Modem

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

This area of the software allows the user to configure some of the system
features of the ACL 9000.
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
features:
PATIENT DATABASE LISTING: defines the order of the patient samples in

the database: last entered is at the top or last entered is at the end.
QC DATABASE LISTING: defines the order of the QC materials in the

database: last 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
sessions, Disabled.

Setup and Utility
CURRENT LANGUAGE: English, French, German, Italian or Spanish
SAMPLE TRAY TYPE: 5 mL tubes, 3 mL tubes, S 92 tubes, S66 tubes (for

Sarstedt 92 mm and Sarstedt 66 mm)
Liquid Sensor checkbox: enable/disable the use of this sensor.
Wash-R emulsion sensor checkbox: enable/disable the use of this sensor.
REM Enable checkbox: enable/disable the use of the Rotor Exchanger

Module.
Decapper Enabled checkbox: not supported in this SW/HW version.
screen.


4.1.18 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 9000 system.
Selecting Date/Time from the Setup submenu opens the Date and Time
screen:
DATE FORMAT: in this the field the user chooses among the following
options:
dd.mm.yyyy
yyyy.mm.dd
mm.dd.yyyy
In order to set date and time, two numeric fields are available.
button reject the changes.
ACTIVE BUTTONS at the bottom of this screen are:


Setup and Utility
4.1.19 Setup - UNITS

This area of the software allows the user to configure the units used for
temperature on the ACL 9000 system.
Selecting Units from the Setup submenu opens the Units screen:
The TEMPERATURE UNIT field has the following options: °C or °F.
Screen.


4.2.0 Setup - TESTS - Define

This area of the software is used to define a new test.
Selecting Tests from the Setup submenu and then choosing View/Define
opens the View Tests screen:
The large window on the left of the screen displays a table of all configured
tests. Each test is identified by a short 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 test.

Setup and Utility
Note: IL pre-defined tests were developed and tested specifically

for use with IL Test reagents and supplies for use on the
ACL™ 9000. 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, 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 is viewable but not editable from this
screen. Several buttons are found around these fields:
Clicking the Details button opens the Test Details screen which allows

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; 100 tests can be enabled
(active).
Clicking the Show Enabled button allows the operator to view only the
enabled tests from the test table, but not all the configured tests. Operator
has to click the same icon again to visualize all tests.
Clicking Delete erases only the open tests (customized); IL predefined tests
cannot be deleted.

4.2.0.1 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). Once saved, the Test ID cannot be edited. In order to
change the ID, it is necessary to remove the test and repeat the copy option.
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 numeric field (four characters maximum). This is a

mandatory field. The test code must be unique.
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.

Setup and Utility
4.2.0.2 NEW TEST

Clicking the New Test button opens the New Test screen.
Test ID from 1 to 500 are reserved for IL test. Test ID from 501 to 999 are
available for the user.
This screen contains the same fields of the Test Details screen, but they are
all empty.
TEST ID
HOST CODE
EXTENDED TEST NAME
TEST CODE
TEST REVISION
Further explanations of the fields are reported in the Setup-New Test section.
In the New Test screen the following information is accessible:

§ CALIBRATION MODE:
None: it means that this test does not require calibration.
One time per session: it means that 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: it means that this test does not have a dedicated calibration
cycle; the calibration is performed with the analytical session in each rotor.
The previous calibration can be reviewed but cannot be used for further
analysis.
Dedicated: it means that this test has a dedicated calibration cycle and that
this calibration can be stored.
§ IMPORT CALIBRATION FROM:

None: it means that this test does not import calibration from any other test.
List of tests: if it is necessary to import a calibration, choose the test from

the displayed test list. Only the tests with a defined calibration will appear.
This function is used in some IL-predefined tests. For example, the PT
Extended cycle imports the calibration from the PT cycle.
§ IMPORT RAW DATA:
None: it means that this test does not import raw data from any other test.
List of tests: if it is necessary to import the raw data, choose the test from
the displayed test list. All tests are displayed.
This function is used in some IL-predefined tests. For example, the PT based
Fibrinogen imports the raw data from the PT cycle.


Setup and Utility
Selecting Ranges from the first test setup screen it is possible to modify the
ranges for all the units and the scale of the Y-axis of the reaction curves.
Clicking on the correction button it is possible to correct results unit based on

a mathematical equation.
For the IL tests, only the calculated units can be corrected, while for the open
test all units can be corrected.
3 intervals of corrections based on the result range can be activated.


Setup and Utility
4.2.1 Setup – New TESTS
The Test Details screen is shown here below.
In the new test details the following information are accessible.
• TEST ID – 8 characters
Notes: This field is editable in an open test.
This field is printed in the cumulative report.
At least one alpha-numeric character is mandatory.
• TEST CODE - 3 characters
Note: This field is editable in an open test.
Available code numbers are from 500 to 999.
• EXTENDED TEST NAME - 15 characters

Notes: This field is editable in an 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)
• TEST REVISION - 4 characters

Note: 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
- One Time per Session
- Each Rotor
- Dedicated
• IMPORT CALIBRATION – One of the following options may be selected:
- None
- Any from a list of enabled calibrated tests (displayed)
that have a calibration defined.
• IMPORT RAW DATA FROM - One of the following options may be
selected:
- None
- Any from a list of enabled tests (all tests are displayed).
ANALYSIS:
LOADING
SETUP
CALIBRATION:
LOADING
SETUP
ACQUISITION
SETUP
TEST
DETAILS
CALCULATION
SETUP
RANGES
SETUP

Setup and Utility
4.2.2 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 a secondary 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 test in duplicate mode
Step: this is the order of the execution of the analysis.
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 or by 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)
- 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)
The use of the Arrow/Scissors buttons adds or deletes 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.
First the Loading type for the needle of the sample line is defined; here is the
definition of the sample 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 a secondary cup when
a very high dilution is needed.
Then the Loading type for the reagent needle line is defined; here is the
definition of the 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
The In Cup Dilution option is not available for the reagent needle as this
needle cannot aspirate/dispense in the sample tray area.
Intermediate Rinse checkbox: if it is checked, the needle is dipped in the
waste/rinse reservoir. 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 flushing 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.
Washing at step completion: it is possible to define how many flushing

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.
Timing constraint: since some steps can be more critical than other, it is
necessary to define some time interval that must be honored in the defined
step.
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 the
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.
Set timer: At the end of the loading phase of the defined step, a
TIMER is set for "XX" that will be used in one of the next loading
steps (for example the Cephalin step in the APTT test).
Wait timer is expired: The loading step is executed using the time of
a previously SET TIMER step (for example CaCl2 in the APTT test).

Setup and Utility
Time in seconds for the timing constraint field can be defined from 1 to 999
seconds (0 means disabled).
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 parameters button opens the Step Setup Parameters window.
According to the loading type selected, the type of liquid and the volumes
must be defined.
If the "No Dilution" option has been defined, the following fields must be
entered:
Liquid ID: choose from the liquid list
Volume: enter the volumes in microliters (minimum = 3; maximum = 140)

If the "In Line Dilution" option has been defined, the following fields must be
entered:
Diluent Liquid ID: choose from the liquid list
Diluted Liquid ID: choose from the liquid list

Volume: enter the volumes in microliters (minimum single liquid=3; maximum
total volume is 140).
If the "In Cup Dilution" option has been defined, then the following fields
must be entered:
Pre-dispensed Liquid ID: choose from the liquid list

Diluted Liquid ID: choose from the liquid list (usually plasma)
Volume: enter the volumes in microliters (minimum single liquid=3; minimum

total volume=150; maximum total volume is 250).
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 Washing field must be entered if a washing cycle is needed after each
dispensation. The value refers to the number of cycles and the range is 1-5.
The position of the secondary cup check box in the sample tray is defined
checking the Inner Ring or Outer Ring checkbox.
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 button can be used to delete a step in the analysis sequence.

Setup and Utility
§ CLEANING
From the Analysis: Loading Setup Screen, pressing the Cleaning button
displays the cleaning setup screen.
This screen aims to define the liquid and its volume to be used as cleaning
for the reagent line and the sample line. This cleaning procedure is carried
out at the end of the test 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 cleaning is performed.
After the cleaning, a washing (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 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.

§ REAGENT PRIMING
From the Analysis: Loading Setup Screen, pressing the Reagent Priming
button displays the reagent priming setup screen.
This screen aims to define the liquid and its volume to be used as reagent
priming either for the reagent line and the sample line. This reagent priming
procedure is carried out at the beginning of the test cycle.
Washing at startup defines the washing done by the Wash-R Emulsion in

number of cycles at the beginning of the reagent priming cycle.

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 (minimum1-maximum 5).
Perform Sequentially: If checked, one line (sample needle line) is primed

before the other line (reagent sample needle); if not checked, the reagent
priming is performed at the same time.

in number of cycles at the end of the reagent priming cycle.

Setup and Utility

changes done and the system goes back to the Main screen.
§ MATERIALS CHECK
Once the liquids have been configured, it is possible to define whether the
instrument must check the presence of the liquid or not and also what action
to take if the liquid volume is low.
The Check in Pre-Analysis option defines if the analysis may start even if the
liquid is not present (optional presence). If the liquid is marked as mandatory,
the analysis cannot start without it. The Check Selected Row box can be
used to define the liquid mandatory.
The Action If Low Level defines the behavior of the system when the liquid
is low.
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 other cases the liquid can be depleted
during the session. In this case the first samples will be completed, while
those without reagent will be kept on hold and the system will warn the user.
Just signal: The instrument will only advise the operator that a liquid is low
but it will continue to perform all operations.

4.2.3 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

Setup and Utility
Clicking the Calibration: Loading Setup button allows the user 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 that has been 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 a secondary cup 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 (dilutions/replicates)
are as follows: 2 dilutions and 3 or 4 or 5 or 6 replicates; 3 dilutions and 3 or
4 or 5 or 6 replicates; 4 dilutions and 3 or 4 replicates; 5 dilutions and 3
replicates; 6 dilutions and 3 replicates.
Add button: This button is used to define in detail all the steps of the
calibration. A single step is the action of aspirating/dispensing liquids. A step
can be carried out by the sample needle or by the reagent needle or by both
needles. The final result of a step is the completion of a scope.

Step: this is the order of the execution of the calibration run.
Several scopes can be selected:
- Optical Reference (Wash-R)
- Reference (in Absorbance tests)
- Sample
- Standard (1-2-3-4-5-6)
- All (only if all steps have the same conditions)
The use of the Arrow/Scissors buttons adds or deletes a step.
Once the scope is defined, it is necessary to define which needle will be used
to aspirate/dispense.
The Loading type for the needle of the sample line must be defined; here is
the definition of the sample line.

Setup and Utility
In Cup Dilution: Diluent and sample are dispensed in a secondary cup when
a very high dilution is needed.
Then the Loading type for the reagent needle line must be defined; here is
the definition of the reagent line.
The In Cup Dilution option is not available for the reagent needle as this
needle cannot aspirate/dispense in the sample tray area.
Intermediate Rinse checkbox: if it is checked, the needle is dipped in the
waste/rinse reservoir. 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 flushing 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.
Washing at step completion: it is possible to define how many flushing

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.
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.
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 the
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.
Set timer: At the end of the loading phase of the defined step, a
TIMER is set for "XX" that will be used in one of the next loading
steps (for example the Cephalin step in the APTT test).
Wait timer is expired: The loading step is executed using the time of
a previously SET TIMER step (for example CaCl2 in the APTT test).

Time in seconds for the timing constraint field can be defined in a range 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 parameters button opens the Step Setup Parameters window.
According to the loading type selected, the type of liquid and the volumes
must be defined for all the calibration standards.
If the "No Dilution" option has been defined, the following fields must be
entered:
Liquid ID: choose from the liquid list

Volume: enter the volumes in microliters (minimum = 3; maximum = 140)
If the "In Line dilution" option has been defined, the following fields must be
entered:

Setup and Utility

Diluted Liquid ID: choose from the liquid list
Volume: Enter the volumes in microliters (minimum single liquid=3; maximum

total volume is 140).
If the "In Cup dilution" option has been defined, the following fields must be
entered:
Pre-dispensed Liquid ID: choose from the liquid list

Diluted Liquid ID: choose from the liquid list (usually plasma)
Volume: enter the volumes in microliters (minimum single liquid=3; minimum

total volume=150; maximum total volume is 250).
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 washing field must be entered if a washing cycle is needed after each
dispensation. The value refers to the number of cycles and the range is 1-5.
The position of the secondary cup check box in the sample tray is defined by
checking the Inner Ring or Outer Ring checkbox.

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 button can be used to delete a step.

§ CLEANING
Pressing the Cleaning button, the cleaning setup will appear.
This screen aims to define the liquid and its volume to be used as cleaning
for the reagent line and the sample line. This cleaning procedure is carried
out at the end of the test cycle.

another liquid.
Cycles no.: this is the number of the cycles (minimum 1 – maximum 5). If 0 is
entered, no cleaning is performed.
After the cleaning, a washing (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 cleaned

before the other line (reagent sample needle); if not, the cleaning is

in number of cycles at the end of the cleaning cycle.


Setup and Utility
§ REAGENT PRIMING
Pressing the Reagent Priming button, the reagent priming setup will appear.
This screen aims to define the liquid and its volume to be used as reagent
priming for the reagent line and the sample line. This reagent priming
procedure is carried out at the beginning of the test cycle.
Washing at startup defines the washing done by the Wash-R Emulsion in

number of cycles at the beginning of the reagent priming cycle..

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 washing (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 sample needle); if not, the reagent priming is


in number of cycles at the end of the reagent priming cycle.

§ MATERIALS CHECK
Once the liquids have been configured, it is possible to define whether the
instrument must check the presence of the liquid or not and also what action
to take if the liquid volume is low.
The Check in Pre-Analysis option defines if the analysis may start even if the
liquid is not present (optional presence). If the liquid is marked as mandatory,
the analysis cannot start without it. The Check Selected Row box can be
used to define the liquid mandatory.
The Action If Low Level defines the behavior of the system when the liquid
is low.
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.

Setup and Utility
Complete possible and signal: In other cases the liquid can be depleted
during the session. In this case, the first samples will be completed, while
those without reagent will be kept on hold and the system will warn the user.
Just signal: The instrument will only advise the operator that a liquid is low
but it will continue to perform all operations.


4.2.4 Acquisition Setup

Acquisition Setup screen flow
TEST
DETAILS
ACQUISITION
SETUP
Clicking the Acquisition: Setup button opens the screen to view the data
acquisition scheme for the test.
This screen is used to define all the acquisition parameters.

Setup and Utility
If the Ramp checkbox is checked, the other parameters can be entered.
INTER-RAMP INTERVAL : time in seconds between the two ramps (0

means no inter-ramp; from 1 to 10 seconds defines the time between the two
ramps).
ACQUISITION DELAY: time where no data points are recorded during the
acquisition (1-999). If 0 is entered, the delay is not considered.
SAMPLING RATE: interval between the data points in milliseconds (50, 100,
150….1000)
ACQUISITION TIME: time used to read the reaction (1-999 seconds)
SPEED: 600 or 1200 rpm
ACQUISITION CHANNEL: 405 (Absorbance) or 660 (nephelometric) nm.
Inter-ramp plus acquisition delay plus acquistion time cannot be higher than
1800 seconds (30 minutes).


4.2.5 Calculation Setup

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

Setup and Utility
Clicking the Calculation: Setup button opens the screen to view the data
calculation scheme for the test.
This screen is used to define all the steps needed to elaborate 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 and 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 (in case of
S/R*100) and of the Optical Reference (in case of log (R/S)).
Scope: It 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) or ALL.

7 possible choices are available in the Algorithm Type selection:

None, Trend Algorithm, Threshold, Threshold/Second Derivative, First
Derivative, Second Derivative and Delta.
NONE
TREND
ALGORITHM
THRESHOLD
ALGORITHM
TYPE
THRESHOLD
SECOND
DERIVATIVE
FIRST
DERIVATIVE
SECOND
DERIVATIVE
DELTA

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.
§ Trend
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 and the
Final Part. Number of points to be used to calculate the trend algorithm can
be defined.
In the presented unit, the Initial Offset and Final Part of the reaction can be
chosen.
The Check Saturation checkbox activates a control on the reaction curve

that must be within the hardware limit of the lamp used.

§ Threshold
Selecting Threshold the following selections are possible:
st
1 Threshold defines where the clot time should be taken; a numerical value
should be entered.
Two smoothings can be selected in terms of number of points: First

Smoothing and Second Smoothing.
be defined.
The presented unit, the Initial Offset and Final Part of the reaction can be
chosen.
nd
2 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.
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.

Setup and Utility
Accessing the Correction Parameters window it is possible to set value

corrections based on the reaction offset.
The Offset Interval can be defined and a correction curve in terms of slope
(m) and intercept (q) can be set.
For example, this correction is used for the Fibrinogen-PT-Based method in

very lipemic samples.


§ Threshold/Second Derivative
Selecting Threshold/Second Derivative the following selections are possible:
st
1 Threshold defines where the clot time should be taken; a numerical value
should be entered.
First Derivative calculation in terms of number of points to be used.
Five smoothings can be selected in terms of number of points: First

Smoothing, Second Smoothing and Third Smoothing are used for the raw
data; the Fourth and the Fifth Smoothings are used for the First Derivative.
be defined.
chosen.

Setup and Utility
Accessing the Curve Check Parameters window it is possible to make the

following selections.

nd


slope of the reaction curve at the beginning of the acquisition time. Number of
points and slope value can be entered (numerical values).
Second Derivative calculation in terms of number of points to be used.




Setup and Utility
§ First Derivative
Selecting First Derivative the following selections are possible:

be defined.
choosen.




Setup and Utility


nd



§ Second Derivative
Selecting Second Derivative the following selections are possible:

be defined.
chosen.

Second Derivative value defines if the maximum peak the derivative should
have to give a time; a numerical value should be entered.


Setup and Utility


§ Delta
Selecting Delta the following selections are possible:
Two Smoothings can be selected in terms of number of points.
be defined.
chosen.


Setup and Utility


st
nd


Final Slope is used to check non-phasic curves; it represents the initial slope
of the reaction curve at the beginning of the acquisition time. Number of
Offset / Min checks if the initial reaction mixture is turbid or not.
Max / Final checks if the final reaction mixture is turbid or not.




Setup and Utility
Delete Parameters: is used to delete the defined parameters with a single

button.
Calculate mean field: in case 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.
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, 3 selections are possible:
- None: no calculation is done.
- R= S/Reference Value: the sample result is divided by the Reference

Value.
- R= S/Standard X: the sample result is 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 value.
The check is done in % versus the measured value of the Analytical

Reference.
% and Reference Value must be defined.
Selecting the Calibration setup button displays the Calibration Setup screen.

Setup and Utility
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 (4.2.5).
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 check the CV of the calibration

points, this box should be selected.
Outlier checkbox: If checked, the outlier result is discarded in the calibration

calculation.
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 CV% value is higher
than expected, that calibration standard point is flagged.
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, microg/L,
micromol/L, IU/mL, %.
New Unit: If a unit different from those included in the list is confugured, the
user can type it in this field (up to 8 characters).

Calibration Curve Setup: pressing this button displays the Calibration Curve
setup screen.
The button “Flag Extrapolated result” is not shown on this screen but it is
present in the real software. Please refer to the next page for additional
explanation.
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.

Setup and Utility
And for the Y:

- X (as it is)
- R= X/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 (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
When a result is above 150% of the highest calibration point or below 60% of
the lowest calibration point 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, in 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 2
3 X Y
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 (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 has not been divided into segments, only the first line must be
filled in.
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
2
the r value is lower than the given limit presented (format is x.xxxx), an error
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.


Setup and Utility
4.2.6 Ranges Setup

From the test details screen it is possible to access the Range and Units
screen.
The Range and Units table contains the following information.
§ Show in : Y (Yes) if the unit has been selected, it is shown in

sample list the patient database and is printed.
§ Unit Correction: If any correction factor is applied to a specific unit, an

asterisk will appear.
§ Res. Units: Units that are available in the selected test (from 1 to 4)
§ Norm. Range: Define the normal range for each unit. The normal range
is used to flag patient results. On the screen, the results
are displayed in violet (out of normal range); on the
printout an asterisk close to the results out of normal
range will be printed.
§ Test Range: Define the test range for each unit. The test range is
used to flag patient results. On the screen, the results
are displayed in red (out of test range); on the printout
the results out of test range will be printed in bold.
§ Scale Range: Underflow and overflow condition (out of scale). No
results are presented.

Accessing the Range button the following options are available:

§ Show in Sample List: When checked, the unit is displayed and printed.
§ Normal Range: Minimum and Maximum values can be typed in.
§ Test Range: Minimum and Maximum values cannot be edited in the IL
tests.
§ Scale Range: Minimum and Maximum values cannot be edited in the IL
tests.
§ Reaction Curve Graph: It defines the Y axis scale of the reaction curve
(minimum and maximum values).
If the Calculation Setup button is pressed from the Test Details screen the
Reference Value can be typed in. This value is used for Ratio and INR
calculation for the tests with R or INR selected. This value is the denominator
of the R and INR calculation and it should represent the mean normal
population time for the selected test.

Setup and Utility
INR FORMULA
ISI
Reference Value)
Assign Value.
click on Details.



Vol. 15, No. 4.
ISI
IMPORTANT:
units separately.
WARNING:


may be reported.

Setup and Utility
4.3 UTILITY
The Utility portion of the ACL 9000 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 IL tests library.
Follow the instructions indicated on the screen.

At the end of the IL Library Upgrade all modifications are listed.
Modification occurred can also be printed.
4.3.3 UTILITY- Backup/Restore

This utility is used to backup or restore the system configuration.
View backup data allows to verify the integrity of the backup.

Setup and Utility
4.3.4 UTILITY- Archive

This utility is used to copy/transfer the data to a floppy disk.
Four checkboxes allow selection of the set of data to be copied/transferred.
- PATIENT DATA (date range is selectable)
- QC DATA (date range, liquid materials, tests are selectable)
- AR DATA (date range and tests are selectable)
- CAL DATA (tests are selectable)
Enabling the checkbox Remove Data After Archive will delete the selected
data 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 electronic page programs (*.txt or *.xls)
The Data that are archived are the following: test name, patient name with
relative demographics, results, flags and calibration curve parameters,
depending on the selection made.

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 is viewable but not editable on this screen:
MASTER SW IDENTIFICATION
SLAVE SW IDENTIFICATION
REM SW IDENTIFICATION
IL TEST LIBRARY
The Confirm button leaves the screen and the system goes back to the Main
screen.

Setup and Utility
4.3.6 UTILITY- SOFTWARE - Software Upgrade-Upload

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 (Master or Slave 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 (Master, Slave and REM).
Master Upload and Upgrade
First operation is the Master Upload.
Insert the disk, select Master Upload and continue.
When the Upload procedure is completed select Master Upgrade and

continue.
Slave Upload and Upgrade
Second operation is the Slave Upload.
Insert the disk, select Slave Upload and continue.
When the Upload procedure is completed select Slave Upgrade and

continue.
REM Upload and Upgrade

Third operation is the REM Upload.
Insert the disk, select REM Upload and continue.
When the Upload procedure is completed select REM Upgrade and continue.
At the end of each operation please verify that the Software Identification
reports the correct revision number.

4.3.7 UTILITY- Save Last Rotor Map

Selecting the Utility button on the menu bar and selecting Save Last Rotor
Map, opens the Save Last Rotor screen shown below.
This utility is used to save the raw data of the latest executed rotor on a
floppy disk. The user can type the file name and select the file format by
checking the checkbox. The DAT files are compatible with the Windows
Research Program. The TXT files are ASCII files and are compatible with the
most common text editors.
A maximum of 8 characters can be used for file name.
Insert the disk and press Continue.
The Cancel button will exit to the main screen.

Setup and Utility
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.
Type the file name using the .txt extension, maximum 8 characters.

5 Diagnostics and Maintenance
5.0 Introduction
The purpose of this Section is to familiarize the ACL 9000 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.
Additionally, this Section contains all necessary information to perform Preventive

Maintenance procedures, and thus keep the ACL 9000 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.

Diagnostics and Maintenance
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:

NOTE: when the instrument is in standby operation, 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.
NOTE: 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 100 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 1 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.
CLEANING PROCEDURE
Materials needed:
§ 4 glass vials (10 mL volume; diameter 23 mm)

§ 16 mL of the needed Cleaning solution
§ 16 mL of Factor Diluent
Place the needed 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 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.
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 needed liquids are not in the appropriate positions, the cycle will
automatically be aborted 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 turn
the system off; No cancels the operation.

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.
NOTE: 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 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 the date to appear
automatically.
FREQUENCY: This number cannot be edited; it is the IL-recommended

frequency in days with which this procedure should be performed.
NOTE: Operator’s own notes about the procedure. Clicking the Note button
to open the Insert Notes screen allows entry of free text. Operator can insert
text using the standard PC keyboard.
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.

want to print? Yes/No, prints the maintenance list.
screen.

5.1.4 Temperature Control

Through the Temperature Control option of the Diagnostic submenu the
operator is able to check if the temperatures in some areas of the system are
within their acceptable ranges.
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 60.8.0 °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

want to print? Yes/No, prints the temperature list report.
Main screen.



5.1.5 Needles Position

The Needles Position option of the Diagnostic submenu is used to center the
needles after changing the needle block or after having dismantled to clean it.
As the needle position has to be verified first with the rotor cover open, press
the Open/Close Cover button to open the Rotor cover.
Clicking the Diagnostic button on the Main menu bar and selecting Needles
Position causes a very quick self-initialization. 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 of 90°.
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
which 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 9000 software records, stores and displays all the errors and
warnings which 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.
Main screen.



5.1.8 Logbook
The ACL 9000 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 their 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 (not supported in this software revision)
§ 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.
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 the following operations be carried out by a trained
operator at the frequency specified.
CAUTION:
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.
CAUTION: 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 flowpath 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.
While the priming cycle is in progress, the operator should visually inspect
three items:
- that 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.
- that 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.

- that 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
NOTE: Rotors contain potentially contaminated materials; discard and

incinerate used rotors according to the proper local regulations.
A partially used rotor may be left in the rotor housing only if it is used during
the following working shift, otherwise the rotor should be discarded. 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.
NOTE: 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 which 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 cuvette sensor and the two optical paths in the
analysis area.
Cuvette sensor inside the sample tray area: wipe the two vertical faces of the
cuvette sensor using a clean cloth or cotton tip applicator soaked in a 0.1 N
HCl solution. 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 2 empty glass vials in reagent positions R6 and R7
Place 8 mL of a 0.1 N HCl solution in vial position R6.
Place 8 mL of a 0.1 N HCl solution in vial position 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.
- 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;
the filter slides out when pulled (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 into its 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.
- 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.
- 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.
- 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.
- Insert the “needle positioning 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 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

9000, 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.).
NOTE: 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
- Press Start

At the end of the cleaning cycle the ACL returns to the cleaning screen.
Press the cancel button to return to the main screen.
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

6 Troubleshooting
6.0 Introduction
Following the Maintenance guidelines described in Section 5 of this Manual is of
paramount importance to keep the ACL 9000 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 will 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 9000
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

Troubleshooting
- 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
6.1.1 System Anomalies

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

File close alarm Missed closing of a Reload the main

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

Troubleshooting
Type parse error Error in the message Reload the main

code (type) from master software. If the failure
to slave. persists, call the
Service Engineer.
Invalid parameter Error in the parameter Reload the main
message from master to software. If the failure
slave. persists, call the
Service Engineer.
Database failure Major error in the Reload the main
database handling. software. If the failure
persists, call the
Service Engineer.
Coded SW failure Major error in code Reload the main
handling. software. If the failure
persists, call the
Service Engineer.
ALARMS
Master and slave do not
Slave communication Reload the main
communicate.
failure software. If the failure
persists, call the
Service Engineer.
A/D converter failure Periodic error while Reload the main
handling the ADC. software. If the failure
persists, call the
Service Engineer.
Slave code absent Missing slave code. Reload the main
software. If the failure
persists, call the
Service Engineer.
Slave download error Failed loading the slave Reload the main
code. software. If the failure
persists, call the
Service Engineer.
Check DB error Consistency error in the Reload the main
data base. software. If the failure
persists, call the
Service Engineer.
Check parameters Error in consistency of Reload the main
error the parameters. software. If the failure
persists, call the
Service Engineer.

WARNINGS
ACL thermal warning* The temperature inside Switch the system off,
the analyzer is higher wait a few seconds
o
than 60 C. and switch it back on.
If the error persists,
call Service Engineer.
REM communication Missing communication Switch the system off,
error with REM. Either the wait a few seconds
software is missing or and switch it back on.
REM is not working. If the error persists,
REM command error Command not executed Switch the system off,
correctly. wait a few seconds
and switch it back on.
REM download error Download not executed Switch the system off,
correctly. wait a few seconds
DB restoring Error Failure to restore Switch the system off,
database. wait a few seconds
DB backup Error Failure to backup Switch the system off,
database. wait a few seconds
File open warning Missed opening a non- Switch the system off,
critical file. wait a few seconds
File length warning Incorrect length of a non- Switch the system off,
File read warning Missed reading a non- Switch the system off,
File write warning Missed writing a non- Switch the system off,
Troubleshooting
File close warning Missed closing a non- Switch the system off,
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, call Service
Engineer.
* Thermal Fail
This warning indicates that the instrument is overheating internally which may
have an effect on the temperature of the measuring chamber. The reason
may be a partially clogged air filter that is obstructing the airflow in and out of
the analyzer. Check the condition of 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
o
temperature is below 35 C.
NOTE: The ACL 9000 works optimally when the ambient temperature is
o o
in the range of 15 to 32 C, and does not fail in the range of 10 to 40 C.
If cleaning the air filter does not resolve the warning and the ambient
temperature is within limits, call the Service Engineer.
** Printer Fail
If the printer does not produce a printout due to a printer failure, the results
may be obtained from the video, since the analyzer continues to function
correctly. 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 9000 Setup (ESCP2 or PCL), and that the printer supports the selected
emulation protocol.
If no reason can be found for the failure, call the Service Engineer.

6.1.2 REM (Rotor Exchange Module) Anomalies

FAILURES
REM elect fail REM electrical failure. Call Service Engineer
REM voltage out of REM voltage out of Call Service Engineer
range range.
REM vertical alarm Robotic vertical arm Switch the system off,
motor failure. wait a few seconds
REM horizontal alarm Robotic horizontal arm Switch the system off,
motor failure. wait a few seconds
REM transport alarm Transport motor failure. Switch the system off,
wait a few seconds
REM CPU failure REM CPU failure. Switch the system off,
wait a few seconds
REM arm EM fault Arm EM failure. Switch the system off,
wait a few seconds
REM arm EM driver Arm circuit failure. Switch the system off,
fault wait a few seconds
REM transport EM Transport EM failure. Switch the system off,
REM transport EM Transport circuit failure. Switch the system off,
driver fault wait a few seconds

Troubleshooting
REM stack EM fault Stack EM failure. Switch the system off,

wait a few seconds
REM stack EM driver Stack circuit failure. Switch the system off,
6.1.3 Temperature Anomalies

ALARMS (also see notes at the end of this table)
Thermal power off Power circuit is off. Call Service Engineer
Incubation Incubation temperature Wait 30 minutes after
temperature out of out of range after power turning power on. If
range at startup on. the warning persists,
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, call
Service Engineer.
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.
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, call Service
operation. Engineer.
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.
Transport out of Transport temperature Wait 30 minutes after
range at startup out of range at startup. turning power on. If
See Note 2.
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, call Service
Engineer.
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.
In the meantime,
stack is not operating
correctly, the system
may be used.
Stack out of range Rotor stack temperature If the warning
out of range. persists, call Service
Engineer.
See Note 2.
In the meantime,
stack is not operating
correctly, the system
may be used.

Troubleshooting
NOTES:
1. Error Message: Peltier Temperature out of Range

o
Explanation: Temperature is outside the 12-15 C 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. Call the Service Engineer.
o
- If the video displays a temperature value from 4 to 12 C 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.
o
- If the video displays a low temperature value (from 20 to 36 C), check
o
that the ambient temperature is not higher than 32 C. If the problem is
not corrected, call the Service Engineer.
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

o
Explanation: Temperature is outside the 36-39 C 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, call the Service
Engineer.
o
- If the video displays a high temperature value (from 36 to 50 C), check
the air filter and ambient conditions as indicated in 6.1.1 (page 6.7). If the
problem is not corrected, call the Service Engineer.
o
- If the video displays a low temperature value (from 20 to 36 C), check
that the instrument has been properly warmed up and that the ambient
o
temperature is higher than 15 C. If the problem is not corrected, call the
Service Engineer.
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.

6.1.4 Mechanical Anomalies

ALARMS
Autosampler alarm Autosampler problem. Switch the system off,
wait a few seconds
Rotor alarm Rotor holder problem. Switch the system off,
wait a few seconds
Horizontal motor Horizontal motor arm Switch the system off,
alarm problem. wait a few seconds
Vertical motor alarm Vertical motor arm Switch the system off,
problem. wait a few seconds
Reagent dilutor alarm Reagent dilutor problem. Switch the system off,
wait a few seconds
Sample dilutor alarm Sample dilutor problem. Switch the system off,
wait a few seconds
Cover alarm Rotor cover problem. Switch the system off,
wait a few seconds

Troubleshooting
WARNINGS
Autosampler warning Autosampler intermittent Switch the system off,
problem. wait a few seconds
Rotor warning Intermittent problem with Switch the system off,
rotor holder. wait a few seconds
Horizontal motor Intermittent problem with Switch the system off,
warning horizontal motor arm. wait a few seconds
Vertical motor Intermittent problem with Switch the system off,
warning vertical motor arm. wait a few seconds
Reagent dilutor Intermittent problem with Switch the system off,
warning reagent dilutor. wait a few seconds
Sample dilutor Intermittent problem with Switch the system off,
warning sample dilutor. wait a few seconds
Cover warning Intermittent problem with Switch the system off,
rotor cover. wait a few seconds
Stirrer fail Magnetic stirrer not Switch the system off,
working. wait a few seconds
The system may still
be used without the
reagent magnetic
stirring. The reagents
should be mixed well
before placing them
on board and they
should be left on the
instrument only for the
duration of the testing.

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
WARNINGS
Acquisition start error Home position not found Switch the system off,
at start. wait a few seconds
Acquisition sync error Home position not found Switch the system off,
during acquisition. wait a few seconds
adc int error Unexpected ADC Switch the system off,
interruption wait a few seconds
Cuv int error Unexpected cuvette Switch the system off,
interruption wait a few seconds
Acq centrifuge error Rotor holder blocked Switch the system off,
wait a few seconds
Acq tx error Unable to Transmit data Switch the system off,
wait a few seconds
Acq rot fail error Rotor fail Switch the system off,
wait a few seconds

Troubleshooting
Acq opt ref error Optical reference fail Switch the system off,
wait a few seconds
Acq ref error Reference emulsion fail Switch the system off,
wait a few seconds
Acq cover open error Cover open during Switch the system off,
acquisition wait a few seconds
6.1.6 Liquids Anomalies

ALARMS
Replace the bottle
Flush short Reference Emulsion not
with a new one. If the
present.
error persists, call
Service Engineer.
WARNINGS
Replace the bottle
Flush warning Reference Emulsion
with a new one. If the
below 100 mL level.
error persists, call
Service Engineer.
Sample liquid sensor External needle (sample) IL strongly recommends
off sensor disabled. the advice of the Service
Engineer for solving this
problem. The use of the
system without sample
or reagent sensors may
lead to questionable
results in case of liquid
shortage in the
containers.
Reagent liquid sensor Internal needle (reagent) Same as above.

off sensor disabled.
Sample liquid sensor External needle (sample) Same as above.
fail circuit sensor error.
Reagent liquid sensor Internal needle (reagent) Same as above.
fail circuit sensor error.

Sample short in Insufficient sample in Try placing remaining

position xxx position xxx. sample in a 0.5 mL
cup. If the error
persists when sample
amount is OK, call the
Service Engineer.
Cleaning not Cleaning not performed If cleaning is not
performed due to insufficient or no performed, carryover
cleaning solution present. is possible. Refer to
maintenance section
for cleaning operation.
If error persists when
liquid amount is OK,
call the Service
Engineer.
Liquid “ID” short A specific non-mandatory The tests associated
liquid “ID” is absent or in with this liquid are put on
insufficient amount. hold. Tests can be
resumed after the liquid
is replenished and
testing re-started. If error
persists when liquid
amount is OK, call the
Service Engineer.
Mandatory Liquid “ID” A specific mandatory Same as above.

short liquid “ID” is absent or in
insufficient amount.
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).
- 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, call the Service Engineer.
Troubleshooting
6.1.7 Optics Anomalies

WARNING
Halogen lamp fail Halogen lamp is not Switch the system off,
working. wait a few seconds and
switch it back on.
If the error persists, call
the Service Engineer.
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, call the Service Engineer.
Waste open Rotor waste cover is Close the rotor waste container door.
open. If the error persists after this action,
call the Service Engineer.
No rotors (REM No more rotors in the Refill the rotor stack. If the error
active) rotor stack. persists after this action, call the
Service Engineer.
No rotors No more rotors in the Refill the rotor stack. If the error
(REM not rotor stack. persists after this action, call the
active) Service Engineer.
Rotor station No more rotors in the Refill the rotor stack. If the error
empty rotor stack. persists after this action, call the
Service Engineer.
Rotor refill Only one or two rotors Refill the rotor stack. If the error
left in the rotor stack. persists after this action, call the
Service Engineer.
Cover open Rotor cover was Close rotor cover. If the error persists
during loading / opened during the after this action, call the Service
incubation loading or incubation Engineer.
operation.
Time out Time out not met Switch the instrument off, wait a few
expired during during loading. seconds and switch it back on again.
loading If the error persists, call the Service
Engineer.
No test to No test to perform Check the programmed tests in the
perform programmed in the database. Verify that the connection
database and after to the host is working properly. If they
host query. are both OK, call the Service
Engineer.
? No tests performed Verify the presence of necessary
due to missing liquids. liquids. If they are all on-board, call

6.1.9 Parsing and Loading Anomalies

WARNINGS
Parsing error xxx Error found in the Switch the instrument
parameters during off, wait a few seconds
loading. and switch it back on. If
the error persists, call
Run error xxx Error found during the Switch the instrument
run. off, wait a few seconds
and switch it back on. If
Session error xxx Error found during the Switch the instrument
session. off, wait a few seconds
and switch it back on. If
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

Troubleshooting
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, call the Service Engineer. For additional information please refer
to Appendix 4 (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:
Data reduction errors R (no measured result is available)

Instrument errors E
QC errors Q
Calibration errors Q
Analytical Reference errors Q
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 explain the error.

6.3.1 Session Error Codes

Error - 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 - Optical error

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

Error code - 1
Meaning Data Error
Cause One data is equal to “0”.
Flags R
Results Error 1 instead of result.
Remedial Retest sample.
Action
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.
* = See more details in section 6.4

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.
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
Cause Final delta of the reaction curve 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.

Troubleshooting
Error code - 12
Meaning Coag error
Cause Maximum peak of the first derivative is below the
selected limit value.
Flags R
Remedial First derivative peak is not significant enough to
Action indicate a real clotting reaction point. Review the clot
curve. Repeat the test in extended acquisition time.
Error code – 13 *
Meaning Coag error
Cause Maximum peak of the second derivative is below the
Flags R
Remedial Second derivative peak is not significant enough to
Action indicate a real clotting reaction point. Review the clot
curve. Repeat the test in extended acquisition time.
Error code - 14
Meaning Offset error (delta algorithm)
Cause Offset of the initial part of the curve is above the
Flags R
Remedial Initial reaction turbidity is relatively high. Review the
Action clot reaction curve.
* = See more details in section 6.4

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 Q – 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 Q – 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 Q – n-1 Standard points
samples
Remedial Invalid results. Review the reaction curve. Repeat the
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 Q – no cal no Standard
Remedial Invalid curve. Review the reaction curve. Repeat the

Troubleshooting
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 Q – 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 Q – 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 Q – 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 Q – Invalid replicates
Results Error 22. Mean value is flagged.
Remedial 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 Q – 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 Q – 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 Q – Invalid segment - slope out of range
samples
Cal Results Error 25. Calibration curve is displayed.
Error code - 26
2 2
Meaning R R out of range
2 2
Cause R The R of the calibration is outside the selected limit.
2
Flag on Q - R out of range
samples
2
Cal Results Error 26. Calibration curve is displayed. R value is
flagged.

Troubleshooting
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 Q – 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 Q - Extrapolated result.
samples
Cal Results None
Remedial None
Action

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 Q – 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 Q – 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 Q – AR invalid. Ratio/INR on samples is not presented
samples
AR Results AR is flagged.

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

Meaning AR out of range (compared to a Calibration standard)
Cause AR does not have a valid Ratio result.
Flags on Q – 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 Q – 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 Q - 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 Q - 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 Q – AR invalid. Ratio/INR is presented on samples
samples

Meaning AR out of range (Ratio defined versus one Calibration
Standard)
Cause AR gives a calculated out of range result.
Flags on Q – AR out of range. Ratio/INR is presented on
samples samples.
AR Results AR is calculated and presented in blue.

Troubleshooting
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 Q – 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 Q - AR out of range. Ratio/INR are given but flagged
samples
6.3.5 QC Error Codes

Error - QC not valid
Meaning QC not valid (No check QC selected)
Cause QC gives a not 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 not valid

Meaning QC not valid (Check on QC selected, flag on samples
not selected)
Cause QC gives a non valid result.
samples
Error - QC out of range

Meaning QC out of range (Check on QC selected, flag on
samples not selected)
Cause QC gives a result out of range.
samples
QC Results QC result is flagged in blue.
Error - QC invalid
Meaning QC invalid (Check on QC selected, flag on samples
selected)
Cause QC gives a non valid result.
Flags on Q – QC invalid, Flag on samples is present
samples
Error - QC out of range

Meaning QC out of range (Check on QC selected, flag on
samples is 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 blue.

Troubleshooting
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 R – 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 Mean is flagged on samples
samples
Results Mean is presented in relation to the selected range.
Error - Mean out of range

Meaning Mean out of range (Check selected on mean)
Cause One of the two results is out of the specified range.
Flags on Mean is flagged on samples
samples
Results Mean is flagged in blue.

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 Q - 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
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 Q – Ratio: S, Sa out of range.
samples
Results Error 50. Ratio is not calculated.
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 Q – R: AR, ARa out of range.
samples
Results Error 58. Ratio is not calculated.

Troubleshooting
Error code – 57/64/66

Meaning NR error
Cause Ratio not available to calculate the NR
Flags on Q – NR error.
samples
Results Error 57 = Ratio not found.
Error 64 = AR Ratio invalid.
Error 66 = AR Delta invalid.
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)
st
Below 1 threshold Threshold Algorithm Between
(part 1) st
1 and 2
nd
thresholds
ERROR 6 ERROR 7
nd
Above 2 threshold
( above∆ time)
Slope check control
Below ∆ time
∆ time in seconds
Above limit Below limit

nd
2 derivative Threshold
algorithm Algorithm
(part 2)
nd
Below limit ERROR 13 Above 2 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.

7 Assay and Instrument Specifications
7.0 Introduction
This Section includes specifications related to the assays that are performed on the
ACL 9000 system, as well as specifications related to the instrument and its
accessory items.
The following abbreviations are used throughout this Section:
• APCR-V Activated Protein C Resistance - Factor V test

• AT Antithrombin
• PLG Plasminogen
• PCX Pro-IL-Complex*
• HPX Hepatocomplex*
• PCL ProClot
• PC Protein C (Chromogenic)
• PS Protein S
• FIB-C Fibrinogen Clauss
• FIB-C h Fibrinogen Clauss high
• FIB-C l Fibrinogen Clauss low
• HEP Heparin
• PI Plasmin Inhibitor (alpha-2-antiplasmin)
• D-D h D-Dimer high
• DP Deficient Plasma
• AR Analytical Reference
* Not currently available in the U.S.
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

Assay and Instrument Specifications
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

7.1 Measured Parameters

This section describes the parameters that are measured by the ACL 9000 assays to
determine the test results. The tests are grouped according to their common
methodology. A brief explanation (text and graphical) of the methods used is given.
Some of these parameters may also be one of the result choices reported 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.
o o
All parameters are measured on the ACL 9000 at 37 C ± 1 C, provided the ambient
o o
temperature is kept within the range of 15 C to 32 C.
COAGULOMETRIC TESTS: PT, APTT, TT, Factors, Pro-IL-Complex*,

Hepatocomplex*, ProClot and Protein S
The ACL monitors clot formation by light scattering (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 scattering = ∆LS).
CHROMOGENIC and LATEX TESTS: Antithrombin, Heparin, Plasmin

Inhibitor, Plasminogen, Protein C (Chromogenic) and D-Dimer
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.
7.2 Calculation of Results

This Section describes the ACL approaches to 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 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 choices of
result units 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
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. %

Tests Measured parameters Reported Results
Protein S Seconds s, %
D-Dimer ∆ O. D. ng/mL
APCR-V Seconds (S and Sa) s, R or INR
Test Normal Plasma Pre-calibrated 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 **
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
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
* The 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) 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
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 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 calibration curve (100% point) is used for the
calculation of the sample value.
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 value in seconds for the sample
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 already be entered in the ACL
software.
ISI
INR = R
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 value for AR may be stored in the software. For additional
information, refer to Section 4 (Test Setup).
• Result as R: R is the ratio between the value in seconds for the sample
and the 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
“basal 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 25 % calibration point with the 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) in 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.
Reference section 3.4 for preparation of 6.25% dilution.

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 compared 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) in 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) in the
x-axis and % Activity on the y-axis, using a log-log scale.
The sample activity is obtained calculating the ratio between sample value in
seconds and 100% Calibration Plasma in seconds to read the value of %
Activity directly on the calibration curve.

HEPATOCOMPLEX *
Hepatocomplex is measured in seconds; the ACL also calculates the %
Below are some typical calibration data and a graphical example of an

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 calculating the ratio between sample value in
seconds and the 100% Calibration Plasma in seconds to read the value of %
Activity directly on the calibration curve.

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 between
sample value in seconds and 0% calibratior value in seconds) to read the %
Activity on 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 are 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 calibrators delta OD values
and their respective concentrations in ng/mL.
In case of patients results higher than 1050 ng/dL, test can be executed using
the D-D h test (linearity from 1050 to 5250 ng/dL).

An example of D-Dimer Calibration curve is shown below:
D-Dimer (ng/dL)
1000
500
250
0.12 0.24 0.48 OD

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
9000 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 that any sample tray position from A1 to A10 may
be used for Calibrators, Diluents, Buffer, Deficient Plasma, etc. These
positions are defined in the Setup submenu of the ACL 9000 software.
For details, refer to Section 4 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
TT/APTT 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

CHROMOGENIC and SPECIAL TESTS

Test POSITIONS
Ax Ax Ax Ax Samples
AT Normal Factor empty empty empty cups
Calibration Pool Diluent cup cup 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 Calibrator Working Normal Pool empty empty cups
Calibration Diluent cup positions
1-12
Heparin -- Working -- -- 1 – 20;
Analysis Diluent empty cups
positions
21-40
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
D-Dimer Calibrator Buffer Factor empty --
Calibration Pool diluent cups
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
NOTE: 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 18 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-FIB -- 1 2 - 19 20 --
APTT -- 1 2 - 19 20 --
TT -- 1 2 - 19 20 --
SINGLE 100% 1 -- 7 - 19 20 --
FACTOR 50% 2
(Cal+Anal) 25% 3
6.25% 4
3.12% 5
1.56% 6
SINGLE -- -- 1 - 19 20
FACTOR
Analysis
DOUBLE -- 1 2 - 19 20 --
TEST
(PT-FIB,
APTT, TT)
AT Cal. 100% 2-5 -- -- 14 1
50% 6-9
25% 10-13
AT Analysis -- -- 2-9 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
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

TEST Cal Curve NP Samples Reference Optical

Emulsion Reference
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
D-Dimer Cal. 1000 2 - 5 -- -- 14 1
ng/mL 500 6 - 9
250 10 - 13
D-Dimer Anal -- -- 2 - 19 20 1
APCR-V -- 1 and 2 3 - 10 (s) 19 --
11-18 (Sa)
NOTE: 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 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 cephalin 50 µL
Head 10 µL per sample per rotor
10 µL 50 µL CaCl2 /rotor
Reagent 100 µL 100 µL 53 µL cephalin 75 µL
Dispensed 100 µL 50 µL CaCl2
100 µL

NOTE: Conditioning of the needle for cephalin (APTT)

When the APTT test is preceeded 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, followed by an 80 µL air
bubble. The cephalin 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.
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%
rd
3 Standard 25% 1.56%
The MEDIUM SEGMENT connects the 25% and the 6.25% points.

7.3.4 Chromogenic Test Volumes

and dispensed for each chromogenic test, including “head” volumes.
PLG / PI PC
Sample Std 10 µL Std 10 µL

Sample 100% Std. 3 µL 100% Std. 14 µL
Dispensed 50% Std. 1.5 µL 50% Std. 7 µL
0% Std. -- 0% Std. --
Samples 3 µL Samples 14 µL
Diluent Std 10 µL Std 10 µL
Diluent 100% Std 60 µL 100% Std 42 µL
Dispensed 50% Std 61.5 µL 50% Std 49 µL
0% Std 63 µL 0% Std 56 µL
samples 60 µL samples 42 µL
Enzyme Std 10 µL Std 10 µL
Enzyme 60 µL per Standard/Sample 56 µL per Standard/Sample
Dispensed 80 µL for Optical Reference 80 µL for Optical Reference
Substrate 50 µL per rotor 50 µL per rotor
Head
Substrate 50 µL per Standard/Sample 50 µL per Standard/Sample
Dispensed
Note: The “Optical Reference” is the reference for the chromogenic tests,
and it consists of 80 µL diluted buffer + 80 µL enzyme.
Liophilized Antithrombin Calibration Antithrombin Analysis

Sample Head 10 µL 10 µL
Sample Dispensed 50 µL 50 µL
Enzyme Head 10 µL 10 µL
Enzyme Dispensed 50 µL 50 µL
Substrate Head 50 µL per rotor 50 µL per rotor
Substrate Dispensed 50 µL 50 µL

Liquid Antithrombin Calibration Antithrombin Analysis

Std/Sample Head 10 µL 10 µL
Std/Sample Dispensed 3 µL 3 µL
Diluent Head 10 µL 10 µL
Diluent Dispensed 92 µL 92 µL
Heparin Calibration Heparin Analysis

FIB-C Calibration FIB-C Analysis

150% - 100% - 50%
Std/Sample Dispensed 16.2 µL – 10.8 µL – 5.4 µL 10.8 µL
Diluent Head 50 µL 50 µL
Diluent Dispensed 84.6 µL - 90µL – 95.4 µL 90 µL
Reagent Head 10 µL 10 µL
Reagent Dispensed 50 µL 50 µL
D-Dimer Calibration D-Dimer Analysis

1000 - 500 – 250 ng/mL
Buffer Head 50 µL 50 µL
Buffer Dispensed 70 µL 70 µL
Latex Head 10 µL 10 µL
Latex Dispensed 90 µL 90 µL

7.3.5 Special Test Volumes

and dispensed for each Special Test, including “head” volumes.
APCR-V
Head Dispensed
Factor V DP 50 µL 42 µL
Plasma 10 µL 10.5 µL
APTT Cephalin 10 µL 52.5 µL
Calcium Chloride 50 µL 52.5 µL
APC/CaCl2 50 µL 52.5 µL
Pro-IL-Complex** Hepatocomplex** ProClot
Sample Std. 10 µL 100% Std. 10 µL Std. 10 µL

Head Samples 10 µL Samples 10 µL Samples 10 µL
Sample 100% Std. 10.8 µL 100% Std. 10.8 µL 100% Std. 4 µL
Dispensed 25% Std. 10.8 µL 50% Std. 10.8 µL 50% Std. 4 µL
12.5% Std. 10.8 µL 25% Std. 10.8 µL 0% Std. 4 µL
6.25% Std. 10.8 µL Samples 10.8 µL Samples 4 µL
Samples 10.8 µL
Diluent -- -- Standard 10 µL
Head Samples 10 µL
Diluent -- -- Standard 40 µL
Dispensed Samples 40 µL
DP Head 50 µL* 50 µL* 50 µL*
DP Position 50 µL 50 µL 32 µL
18 for each sample for each sample for each sample
Dispensed
Reagent 10 µL 10 µL 10 µL
Head for each sample for each sample for each sample
Reagent 140 µL 140 µL 64 µL Cephalin
Dispensed 61 µL CaCl2
* Head aspirated the first time only.
** Not currently available in the U.S.

Protein S
Sample Head Std 10 µL
Samples 10 µL
Sample Dispensed 100% Std. 4 µL
* 50% Std. 4 µL
0% Std. 4 µL
Samples 4 µL
DP Head 10 µL
DP Dispensed 76 µL
Reagent Head 10 µL
Reagent Dispensed 80 µL
* Optional (to be prepared manually)
7.4 Data Processing Features, Parameters and

Analytical Specifications
7.4.1 Flagging Limits
When some types of results are outside acceptable limits, the ACL flags them
by displaying them in a different color. There are three types of results that
are flagged in this manner:
1. test results outside the instrument 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 (Linearity)
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 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% > 500%
Fibrinogen < 40 mg/dL 40-800 mg/dL > 800 mg/dL > 1500 mg/dL
< 0.4 g/L 0.4-8.0 g/L > 8.0 g/L > 15 g/L
Factors < 1% 1-150% > 150% > 900%
Lyophilized < 15% 15-150% > 150% > 900%
Antithrombin
Liquid < 15% 15-150% > 150% > 900%
Antithrombin
PI < 10% 15-150% > 150% > 500%
PLG < 10% 15-150% > 150% > 500%
PC < 15% 15-150% > 150% > 500%
Heparin <0.1 U/mL 0.1-1 U/mL > 1 U/mL > 90 U/mL
Pro-IL-Complex* < 4% 4-150% > 150% > 900%
Hepatocomplex* < 8% 8-120% > 120% > 500%
ProClot < 10% 10-150% > 150% > 500%
Protein S < 10% 10-150% > 150% > 500%
FIB-C < 60 mg/dL 60-550 mg/dL >550 mg/dL > 900 mg/dL
< 0.6 g/L 0.6-5.5 g/L >5.5 g/L > 9.0 g/L
D-Dimer <200 ng/mL 200-1050 ng/mL >1050 ng/mL >9999 ng/mL
D-Dimer offset - 0-2 >2 shown as >>

*** Represents the higher operating limit of the system (scale range)
2. Linearity of calibration curves outside acceptable limits

Given that the most reliable results are obtained when the linearity coefficient
2
r of a calibration curve is between 0.980 and 1.000, the ACL offers helpful
2
“visual” help by flagging r outside relative acceptable limits.
•
2
r < 0.980 - displayed in Red
•
2
r < 0.970 - displayed in red for Factors Tests only when the Low Curve
segment is considered (6.25 – 1.56%)
• 0.980 < r ≤ 1.000 - displayed in Black

2

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

cycles
In this case, when the calibration %CV values are larger than relative
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

2
system if the %CV is up to 1% larger than the limit but the r 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
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 numerical fields depends on values according to
the following rules:
Value Range Format Example
X<1 x.yyy Concentration (U/mL)

1 ≤ X < 10 x.yy Time
10 ≤ X < 100 xx.y 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
Already clotted sample
Normal plasma value Normal Plasma out of range with respect

displayed in blue to the reference data (range ± 9% of the
reference value). Results are flagged
depending on calculation setup.
FIB *** on the sample The FIB value is > 1500 mg/dL.
Dilute the sample 1:2 with Factor DIL to
fit into the instrument operating range.
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 blue ± 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
- Already clotted sample
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 tests 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
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 9000 requires that the user defines 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 9000, 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 each coagulometric and
special test.
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) 119
standard 4 100 115 249
extended 4 250 245
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

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
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 9000.
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
2
PROCLOT Quadratic Activity R
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

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 9000. 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 9000.
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 9000 for the following IL
Test 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 9000. Results are shown in the table below:
Reagent No. of Slope Intercept r Sample

Sample Range
Levels
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

9000 results were similar to the predicate device’s (ACL 6000) 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 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
IL Test Fibrinogen-C 5 days
IL Test Antithrombin 5 days
IL Test Liquid Antithrombin 30 days
IL Test Heparin 5 days
IL Tests Plasminogen 5 days
IL Test 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.
WARNING: 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 minima 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 30 µL of cephalin from reagent reservoir
#2, followed by an 80 µL air bubble;
- the reagent is discarded into the waste reservoir.

7.6.3 Lipemic Samples

If a lipemic sample is tested on the ACL 9000, the turbidity caused by the
lipemia may interfere with the fibrinogen measurement which 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 9000 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 9000.
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 14.1 mL 13.2 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
o
on-board stability at 15 C 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: 13.5 ± 1.5 C
o
37 ± 1 C at ambient temperatures
o
Temperature of the analysis area:
o
from 15 to 32 C
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 magnetic stirrer

for 10 mL vial w/o magnetic stirrer
for 4 mL vial w/o magnetic stirrer
Stirrer magnet reagent R1-R4: size - 10x5 mm diameter
rotational 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 Bases Specifications

Here below the summary specifications related to the maximum size of all
Data Bases included in the ACL 9000 software.

Description Maximum Type of

Size Handling
N° of Patient IDs in Data Base 1000 Manual
Number of Results by 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 15 N/A
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 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 150 N/A
Number of IL Materials (Liquids) in the Data Base 100 N/A
Number of Customized Materials (Liquids) in the Data Base 50 N/A
Number of 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 9000 pertains to the following class of instruments:
CATEGORY: II
POLLUTION DEGREE: 2
USE: indoors
The following ambient conditions apply to the ACL 9000:
• Ambient conditions for transport and storage

o
Temperature: 4 - 45 C
RH: maximum 95%, non-condensing
• Functional ambient conditions

o
BP: 500 to 1060 mbar
Altitude: maximum 3000 meters
• Safety limit ambient conditions

o
BP: 500 to 1060 mbar
Altitude: maximum 3000 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 9000 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 9000 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 9000 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.

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.
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.
Bibliography
For additional information, refer to NCCLS document 117-P No. 15:
Protection of Laboratory Workers from Instruments Biohazards, 1991.

ADDENDUM: Method Comparison Studies

Antithrombin
(%):
Antithrombin: ACL 9000 (Test)

vs. ACL 6000 (Reference)
140
y = 1.0817x - 3.0311
ACL 9000 (AT% Activity)
120
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
(U/mL):
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)

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
r = 0.9894
(% Activity)
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
250
(% Activity)
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 minimum stasis using a plastic syringe or a
vacuum filled test tube, as recommended by NCCLS 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
NCCLS 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 NCCLS 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 and will affect clotting times.
8.2.2 Plasma Transport

For recommendations on transporting plasma, please refer to NCCLS
Document H21-A3.
8.2.3 Plasma Storage

For recommendations on storage of plasma, please refer to NCCLS
Document H21-A3.
8.3 Calibration Plasma
8.3.1 Description
The operative conditions of the ACL 9000 system require the use of 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 9000 uses the Calibration Plasma as follows:

1. To generate a calibration curve when needed.
2. To check and follow assay conditions during sample analysis within the entire
system.
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.

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 all tests. A normal control plasma will have a range of acceptable values,
not a single target value, for all 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 should 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 9000 system.

Sample, Collection and Storage
References
1. NCCLS Document H21-A3. Collection, Transport and Processing of Blood
Specimens for Coagulation Testing and General Performance of
Coagulation Assays. Third Edition, Vol.18, No. 20, December 1998.
2. ECCLS Vol. No. 1

Standard for Specimen Collection
3. NCCLS Document H3-A3. Procedure for the Collection of Diagnostic Blood

Specimens by Venipuncture. Third Edition, Vol. 11, No.10, July 1991.

9 Parts and Expendables
9.0 Introduction
This section contains information about the expendable materials that are available for
use with the ACL 9000 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
9000 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 9000 System:
Sample Trays
Three types of sample trays are available as shown below. The startup kit includes two of
them, chosen by the user according to the desired system configuration.
Tray type Used for

3 mL Primary tube, 3 or 3.5 mL total volume (13x75 mm)
5 mL 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 9000 system
Compliance Certificate
- a specific system compliance certificate

Parts and Expendables
9.2 Order Information for Expendables
Catalog Item Description # Pieces in

Number Package Unit
181812-80 * Sample Tray for 13x75 mm, (3-3.5 mL) tubes 1
181812-79 * 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
181812-73 Rotor Waste Container 1
181812-70 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
84853-00 Power Cord, 100-115 V 1
71992-00 Power Cord, 220-240 V 1
84864-50 External Printer Cable 1
184202-38 Host Computer Cable (9 pin – 9 pin) 1
200024-00 Wash/Reference Emulsion, 1 liter 1
181951-XX Software System Disk Kit 1
181952-XX Test Library Disk Kit 1
97627-50 Compliance Certificate 1
80961-01 Operator’s Manual, English version 1
* 2 sample trays of a single type 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,
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
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Fax: 44-01925-826708

APPENDIX A
ACL 9000
Host Communication Protocol

Appendix A
Instrumentation Laboratory 2
Index 3
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 11
3.5.2 Host Query 13
3.5.3 Test Request Message 15
3.5.4 Test Order Message 15
3.6 Rejected Test Order 16
3.7 Download Session Volumes 17
4.0 Test Results Uploading 18
4.1 Test Result Message 19
4.1.1 Patient Information Record 19
4.1.2 Test Order Record 20
4.1.3 Result Record 21
4.1.4 Comment Record 22
4.1.5 Error Codes 23
4.2 Upload Session Volumes 25
5.0 Not Supported Records 25
6.0 Transmission Abort 25
7.0 Appendix - ACL 9000 Test Codes 27
8.0 Appendix - ACL 9000 Supported Characters 30
8.1 Supported Characters for Sample ID 30
8.2 Supported Characters for Patient name and Department 30
8.3 Supported Characters for delimiters 30
9.0 Appendix - ACL 9000 Supported Units 31
Appendix A
1.0 Introduction
1.1 Purpose
This document is a guide to integrate a Laboratory Information Management system with the
Instrumentation Laboratory ACL 9000 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 ACL6000/7000 Host Communication Protocol.
Specification E-1394 defines the logical layer of ASTM standard; all significant information for ACL
9000 instruments application can be found in chapters Specific Requirements and following.
Specification E-1381 refers to low level protocol; significant information for ACL 9000 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 ACL 9000 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 ACL 9000 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 ACL 9000 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 ACL 9000 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.
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.
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 cannot exceed 240 bytes. 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 ACL 9000 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.
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
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
Appendix A
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.
ACL 9000 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 ACL 9000 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 ACL 9000 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 ACL 9000 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 ACL 9000 limits the size of handled records (independently from
the record type supported by ASTM) to 1024 byte during downloading session.
3.5.1.1 Test Request Message

The Test Request Message is used by ACL 9000 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.
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 not provided
Time
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>
Appendix A
Q|1|ALL||||||||O<CR>
L|1|N<CR>
3.5.1.2 Test Order Message
To answer the ACL 9000 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 ACL 9000.
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.
Mother’s maiden Name Ignored
Birth date Stored, if available. The data will be converted
and displayed in the following in according to
ACL 9000 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
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:
Record Type ID Must be ‘O’ (letter)

Sequence Number Must begin with ‘1’ and then must increment by
one for each new test order record for the same
patient
Specimen ID This is the ACL 9000 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 ACL 9000 supported
characters.
Instrument Specimen ID Ignored
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.
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.
Requested/Ordered Date and Time Ignored
Specimen Collection Date and Time Ignored
Collection End Time Ignored
Collection Volume Ignored
Collector ID Ignored
Action Code Ignored
Appendix A
Danger Code Ignored
Relevant Clinical Information Ignored
Date and Time Specimen Received Ignored
Specimen Descriptor Ignored both fields
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.
Physician’s Telephone Number Ignored
User Field #1 Ignored
User Field #2 Ignored
Laboratory Field #1 Ignored
Laboratory Field #2 Ignored
Date/time Results Reported or Last Ignored
Modified
Instrument Charge to Computer System Ignored
Instrument Section Ignored
Report Type Set to O (letter); other codes will cause records
rejection
Reserved Field Ignored
Location of Ward of specimen Collection Ignored
Hospital Information Flag Ignored
Specimen Service Ignored
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||^^^001|S||||||||||^|DR. VERDI||||||||||O||||||<CR>
O|5|SMP02||^^^001|||||||||||^|||||||||||O||||||<CR>
O|6|SMP03||^^^001|||||||||||^|||||||||||O||||||<CR>
O|7|SMP04||^^^001|||||||||||^|||||||||||O||||||<CR>
O|8|SMP05||^^^001|||||||||||^|||||||||||O||||||<CR>
P|2||PTNT2||GIALLI^GIANLUCA^^^||19551028|F||||||||||||||||||DEP 2||||||||||<CR>
O|1|SMP10||^^^001|||||||||||^|||||||||||O||||||<CR>
O|2|SMP10||^^^005|||||||||||^|||||||||||O||||||<CR>
O|3|SMP10||^^^009|||||||||||^|||||||||||O||||||<CR>
O|4|SMP10||^^^022|||||||||||^|||||||||||O||||||<CR>
P|3||PTNT3||VERDI^P.^^^||19580821|U||||||||||||||||||DEP 3||||||||||<CR>
O|1|SMP11||^^^001|||||||||||^|||||||||||O||||||<CR>
L|1|N<CR>
3.5.2 Host Query

The 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
ACL 9000 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.
ACL 9000 will process each received test order validating the fields that ACL 9000 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 ACL 9000 it will be rejected. The
instrument will inform the host computer using a record containing the list of rejected test orders.
Appendix A
During a download session the listed error conditions can be detected, the associated ACL 9000
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 ACL 9000 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 ACL 9000 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 ACL 9000 limits the size of handled records (independently from
the record type supported by ASTM) to 1024 byte during downloading session.
3.5.3 Test Request Message

The Test Request Message is used by ACL 9000 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.
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 not provided
Time
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>
3.5.4 Test Order Message

As an answer to the ACL 9000 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.
Appendix A
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, ACL 9000 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’
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’
To summarize the possible values for the rejection reason and identification fields are reported in
the following table:
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|1|M_TEST_E|SMP01 ^010|I<CR>
C|2|1|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 ACL 9000 and host computer) are
not considered.
The minimal session would occur if the host has no test orders available for ACL 9000. In this
condition ACL 9000 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 ACL 9000 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 data base or AR data base, or the data in a specified interval for
the QC material present in the load-list.
Considering that ACL 9000 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 ACL 9000, 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.
ACL 9000 does not accept inquiries for test results.
4.1 Test Result Message

The Test Result Message is used by ACL 9000 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 is composed by 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 begin with ‘1’ and then
must increment by one for must increment by one for
each new Patient Information each new Patient
record Information record
Practice Assigned Patient Not provided not provided
ID
Laboratory Assigned Provided if defined as a string not provided
Patient ID 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 Not provided not provided
Suspected 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 Not provided not provided

Diagnostic Code and
Classifiers
Alternative Diagnostic Code Not provided not provided
and 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
each new test order record for each new test order record for
the same patient the same patient
Specimen ID Provided, is the ACL 9000 Provided, is the ACL 9000 QC
sample ID. material ID for QC data; or is
See Appendix for ACL 9000 the ‘AR’ keyword for AR data.
supported characters. See Appendix for ACL 9000
supported characters.
Instrument Specimen ID Not provided Not provided
Universal Test ID The field is composed of 4 The field is composed by 4
parts, only the Manufacturer’s parts, only the Manufacturer’s
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).
Priority Provided if set as a ‘S’ char for Not provided
priority samples.
Requested/Ordered Date Not provided Not provided
and Time
Specimen Collection Date Not provided Not provided
and 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 Not provided Not provided
Information
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 Not provided Not provided
or 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 Not provided Not provided
specimen 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
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
Appendix A
parts, only the Manufacturer’s parts, only the Manufacturer’s
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 The field contains the obtained The field contains the obtained
Value numeric value or qualitative numeric value or qualitative
message (***, ---, Error xx). message (***, ---, Error xx).
Units Provided if the previous field is Provided if the previous field is
a numeric value; is a free 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 Not provided Not provided
Instrument 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
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
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_IN_ONE_SEGMENT = 218,
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 FOR ONE SEGMENT = 224,
SLOPE OUT OF RANGE: INVALID CALIBRATION CURVE = 225,
R2_OUT_OF_RANGE = 226,
NO_VALID_SEGMENTS: INVALID CALIBRATION CURVE = 227,
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,
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,
N.B. Out of range indications referring to normal or test ranges are not transmitted to the host
computer.
An example for a complete test uploading sequence is given by:

H|\^&||||||||ACL9000||P|1|19982110134700<CR>
P|1||PTNT1||BLU^^^^||19391127|M|||||||||||||||||DEP 1||||||||||<CR>
R|1|^^^001|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|^^^001|14.5|s||||F||||19960119114215|<CR>
C|1|I|31^ Invalid for QC |I<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 ACL 9000 and host
computer) are not considered.
The minimal session would occur if ACL 9000 has no test results to be transmitted; no data is sent
and the data volume is zero.
In conditions in which the ACL 9000 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: ACL 9000 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.
5.0 Not Supported Records

The Scientific record and the Manufacturer Information record are not supported by ACL 9000
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.
Appendix A
ACL 9000 family instruments behavior in each of the listed conditions is described in the following:
Condition Action
ACL 9000’s operator ACL 9000 will signal the end of transmission to the host and will discard
requested stop download any following messages. The host must consider the interrupt request.
process It must be emphasized that ACL 9000 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.
ACL 9000 ’s operator ACL 9000 will complete the message in progress with the message
requested stop upload terminator and will not transmit any further test results.
process
Host computer is not During download and upload transmission sessions, operation by ACL
responding 9000 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 ACL 9000 is
EOT 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- ACL 9000 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 Test ID Extended Test Name

Code Code for (8 char. (15 char. max)
host 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 PLUS PT PLUS
010 0010 PT + e PTPLUS Extended
011 0011 PT + d PT PLUS Double
012 0012 PT + ed PTPLUS Ext. Db.
913 0913 PT R PT Rec.
914 0914 PT R e PT Rec Extended
915 0915 PT R d PT Rec. Double
916 0916 PT R ed PT Rec 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)
954 0954 FIB R_ FIB (Rec)
955 0955 FIB R FIB (Rec)
956 0956 FIB Re_ FIB (Rec e)
957 0957 FIB Re FIB (Rec e)
958 0958 FIB Rd_ FIB (Rec d)
959 0959 FIB Rd FIB (Rec d)
960 0960 FIB Red_ FIB (Rec ed)
961 0961 FIB Red FIB (Rec ed)
080 0080 APTT Ly APTT Ly

081 0081 APTT Lye APTT Ly Ext.
Appendix A

host max)
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.
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
520 0520 Free PS Free 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 UHFh Heparin UHF-h
811 0811 Hep UHFl Heparin UHF-l
210 0210 Hep LMWh Heparin LMW-h
810 0810 Hep LMWl Heparin LMW-l
212 0212 PLG Plasminogen
213 0213 PL-IN Plasmin Inhib.
214 0214 P-C Protein C
250 0250 D-Dimer D-Dimer
251 0251 D-Dh D-Dimer high
400 0400 vWF:Ag vWF Antigen
401 0401 vWF:AgH vWF Antigen Hig

host max)
300 0300 FVIII Ly F VIII - Ly
302 0302 FVIII SP F VIII - SP
304 0304 FVIII C F VIII - C
310 0310 FIX Lyo F IX - Ly

312 0312 FIX SP F IX - SP
314 0314 FIX C F IX - C
320 0320 FXI Lyo F XI - Ly

322 0322 FXI SP F XI - SP
324 0324 FXI C F XI - C
330 0330 FXII Lyo F XII - Ly

332 0332 FXII SP F XII - SP
334 0334 FXII C F XII - C
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
350 0350 FX PT F X - PT
352 0352 FX HS F X - HS
354 0354 FX HSP F X - HS Plus
356 0356 FX R FX-R
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
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
Appendix A
8.0 Appendix – ACL 9000 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 and Department

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.
9.0 Appendix - ACL 9000 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
Delta Optical Absorbance ∆ Abs

Delta ∆
Curve behavior offset

min
max
final
User defined free string containing up to 8
chars
APPENDIX B
ACL 9000
Bar Code Label Specification

Appendix B
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 9000 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 9000 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
Appendix B
2. General Description
The WA is a fixed mount CCD bar code scanner with integrated decoder for easy integration into
host equipment (ACL 9000 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.
Appendix B
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.
Appendix B
2.5 Appendix - Decoder Zone Map
2.6 Appendix - Barcode Label Dimensions
Appendix B

ACL 9000 System: Operator's Manual - P/N 080961-01 - Rev. 2.0 - March 2001

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ACL 9000 System

Operator's Manual • P/N 080961-01 • Rev. 2.0 • March 2001

4 Setup and Utility

5 Diagnostics and Maintenance

Instrumentation Laboratory III

7 Assay and Instrument Specifications

8 Sample Collection and Storage

Appendix A Host Communication Protocol

Appendix B Bar Code Label Specification

ACL 9000 system

Instrumentation Laboratory 1.1

1.1 Product Use

1.2 Measured Parameters

The user may program Profiles on patient samples to be performed on a random

1.2 Instrumentation Laboratory

Double Tests (Duplicate Testing)

1.3 Presentation of Results

1.4 Instrument Description and Operation

Instrumentation Laboratory 1.3

1.4.2 Main hardware components

ACL 9000 system - Components

1.4 Instrumentation Laboratory

The following items will be addressed in the Sections below:

1.4.3 Sample Tray

3 mL Primary tube, 3 or 3.5 mL total volume (13x75 mm)

Instrumentation Laboratory 1.5

Sample Tray Location on the ACL

1.6 Instrumentation Laboratory

§ Additional Reagents positions

Adapters for internal positions in the Sample Tray

Instrumentation Laboratory 1.7

1.4.4 Reagent Area

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

1.8 Instrumentation Laboratory

1.4.5 Rinse/Waste Area

Rinse Waste Reservoir under Needles External Waste Container

1.4.6 Sampling/Dispensing System

This is a plastic bottle containing 1000 mL of silicon emulsion which is

Instrumentation Laboratory 1.9

Piston block and Electrovalves

Sampling/Dispensing Arm Assembly

- Aspiration of sample and/or reagent from their respective locations.

Sampling Dispensing System

1.10 Instrumentation Laboratory

Sampling Arm with sensor

Instrumentation Laboratory 1.11

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

Although the sensor test terminates as soon as an error is detected during

Note: No additional amount of liquid (sample or reagent) is aspirated for the

1.4.7 Loading and Analysis Area

1.12 Instrumentation Laboratory

Rotor (reaction cuvettes)

Rotor Stack, Rotor Transport and Rotor Arm

Use of Rotor Refill Tool

Instrumentation Laboratory 1.13

Feeding the Rotor Stack

Rotor Transport and Arm

1.14 Instrumentation Laboratory

Rotor Holder and Rotor Loading

Rotor Holder Area

Optical Measuring System