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This publication and any and all materials (including software) concerning the products of IL ACL
ELITE / ELITE PRO Systems are of proprietary nature and are communicated on a strictly
confidential basis; they may not be reproduced, recorded, stored in a retrieval system, transmitted
or disclosed in any way and by any means whatsoever, whether electronic, mechanical through
photocopying or otherwise, without IL’s prior written consent.
Information contained herein is believed by IL to be accurate: in any event, no responsibility,
whether express or implied, is assumed hereby by IL for or in connection with the use thereof, or for
infringement of any third party rights which might arise therefrom, or from any representation or
omissions contained therein.
Information is subject to change and/or updating without notice.
1 General Information
1.0 Introduction 1.1
1.1 Product Use 1.2
1.2 Measured Parameters 1.2
1.3 Presentation of Results 1.3
1.4 Instrument Description and Operation 1.3
1.4.1 Summary 1.3
1.4.2 Main Hardware Components 1.4
1.4.3 Sample Tray 1.5
1.4.4 Reagent Area 1.8
1.4.5 Rinse/Waste Area 1.9
1.4.6 Sampling/Dispensing System 1.9
1.4.7 Loading and Analysis Area 1.12
1.4.8 Microprocessor and Electronics 1.17
1.4.9 Liquid Crystal Display (LCD) 1.18
1.4.10 Keyboard 1.18
1.4.11 Interface Connectors 1.19
1.4.12 Internal Cooling System 1.20
1.4.13 On-board Barcode Reader 1.20
1.4.14 External Barcode Scanner (Optional) 1.21
1.4.15 External Printer (Optional) 1.22
1.4.16 Floppy disk drive 1.23
1.5 Additional Features 1.24
1.5.1 Standby Status 1.24
1.5.2 End of the Cycle 1.24
1.5.3 Power Loss 1.24
1.5.4 Setup and Utility Programs 1.25
1.5.5 Fault Detection 1.25
1.5.6 Video Display - Colors and Symbols 1.25
1.6 Procedural Limitations 1.25
1.7 Certifications 1.26
1.8 Instrument Disposal 1.28
1.9 Symbols Chart 1.29
2 Installation
2.0 Introduction 2.1
2.1 Installation Requirements 2.1
2.1.1 Ambient Conditions 2.1
2.1.2 Space Requirements 2.2
2.1.3 Electrical Requirements 2.2
2.2 Instrument Delivery and Unpacking 2.5
2.3 Mounting Instrument Parts 2.6
2.4 Turning the System ON 2.10
2.5 ACL - Host Interconnect Cable 2.13
Instrumentation Laboratory I
3 Analytical Operations
3.0 Introduction 3.1
3.1 Components and Use of the Operator Interface 3.1
3.1.1 Touch Screen 3.1
3.1.2 Numerical Keypad 3.2
3.1.3 Standard PC Keyboard 3.3
3.1.4 External Barcode Reader 3.4
3.1.5 Mouse Port 2 3.4
3.1.6 Menus 3.4
3.1.7 Windows and Boxes 3.4
3.1.8 Key Screen Elements/ICONS 3.5
3.1.9 A Special Window for Alarms and Errors 3.9
3.1.10 Screen Saver 3.9
3.1.11 The ACL Elite/Elite Pro Software Tree 3.9
3.2 Sample Analysis 3.11
3.2.1 Sample Analysis Procedures - Summarized 3.11
3.2.2 Sample Analysis Modes 3.14
3.2.3 Material Map 3.23
3.2.4 Analysis: Loadlist 3.25
3.2.5 Analysis: Session Report 3.30
3.2.6 Session Pause Conditions 3.33
3.2.7 Analysis: Pause / STAT Functions 3.34
3.2.8 Results list 3.37
3.2.8.1 Extract Icon 3.39
3.2.8.2 Sample Detail Icon 3.40
3.2.8.3 New Sample (Tubes in folder) Icon 3.43
3.2.8.4 Delete (Trash Can) Icon 3.44
3.2.8.5 Printing Results 3.45
3.2.8.6 Sending Results to Host Computer 3.46
3.3 Quality Control 3.48
3.3.1 Analysing QC Materials using a Loadlist 3.48
3.3.2 Quality Control Setup 3.49
3.3.3 QC Result Review 3.52
3.3.4 QC – Plot and Statistics 3.53
3.3.5 QC – Cumulative Results 3.55
3.3.6 QC – Host Communication 3.59
3.3.7 QC – Extract Results 3.60
3.4 Calibration 3.62
3.4.1 General Calibration Procedure - Summary 3.63
3.4.2 Saving a Calibration - Summary 3.64
3.4.3 Dedicated Calibrations - Details 3.64
3.4.4 Calibration - Review Calibration 3.65
3.4.5 Factor Assays Calibration 3.71
3.4.6 Factor Assay Calibration – Parallelism Tests 3.78
3.4.7 Factor Assay Parallelism Results 3.79
3.5 Analytical Reference 3.81
Instrumentation Laboratory II
3 Analytical Operations (continued)
6 Troubleshooting
6.0 Introduction 6.1
6.1 Failures, Alarms and Warnings 6.1
6.1.1 System Anomalies 6.2
6.1.2 REM (Rotor Exchange Module) Anomalies 6.7
6.1.3 Temperature Anomalies 6.9
6.1.4 Mechanical Anomalies 6.12
6.1.5 Acquisition Station Anomalies 6.14
6.1.6 Liquids Anomalies 6.15
6.1.7 Optics Anomalies 6.18
6.1.8 Operative Anomalies 6.18
6.1.9 Parsing and Loading Anomalies 6.19
6.1.10 Database Anomalies 6.20
6.2 Data Transmission Failure 6.20
6.3 Data Reduction Error Codes 6.20
6.3.1 Session Error Codes 6.21
6.3.2 Reaction Curve Error Codes 6.22
6.3.3 Calibration Error Codes 6.26
Instrumentation Laboratory IV
6 Troubleshooting (continued)
Instrumentation Laboratory V
7 Assay and Instrument Specifications (continued)
10 Warranty
10.0 General Warranty Conditions 10.1
10.1 Disclaimer Regarding Non-IL Brand Product 10.2
11 IL Worldwide Locations
Index
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 ELITE and ELITE PRO. Personnel
responsible for operating and maintaining the instrument should read and understand the
material included here prior to using the system. This Manual should be kept near the
instrument or in a suitable location for reference as required.
This Section of the Manual contains general information about the ACL ELITE/ELITE
PRO systems, including use and measured parameters, description of the hardware
modules as well as their function and operation, methodology, additional features and
procedural limitations. The description and use of the ACL ELITE/ELITE PRO Operator’s
Interface is addressed in separate Sections of this Manual.
Absorbance Tests
• Antithrombin
• Heparin
• Protein C (Chromogenic)
• Plasmin Inhibitor
• Plasminogen
• Fibrinogen
Immunological Tests
• D-Dimer
• von Willebrand Factor – Activity and Antigen
• Free Protein S
Special Tests
• ProClot (clotting)
• Protein S
• Factor V Leiden
• LAC Screen and Confirm
• Silica Clotting Screen and Confirm
• Pro-IL-Complex *
• Hepatocomplex *
• Homocysteine
NOTE:
An (*) indicates test is not available in all countries, contact your local distributor for
availability. Please refer to the library installed on your system for the latest tests list.
The user may program single or multiple tests on patient samples to be performed on a
random access basis. Refer to Section 4 for additional information on this subject.
Tests Groups
Some tests can be run together as a group, thus saving time when the number of
samples to be analyzed is relatively small. Following are some examples:
PT-FIB/APTT
PT-FIB/APTT/TT
Fib-C/ AT/D-Dimer
The ACL ELITE/ELITE PRO offers the user the capability to set up double tests. Chapter
4.0 contains information that allows you to set up double tests on the system.
1.4.1 Summary
The ACL is a family of fully automated computer-controlled, microcentrifugal
analyzers. The ACL ELITE/ELITE PRO system incorporates a Liquid Crystal
Display (LCD) unit that shows the status of the instrument, permits the user to
select desired procedures, and through the use of menus and options guides the
operator through these procedures. Information and instructions are entered into
the system either via the Touch Screen device or through a standard PC
keyboard or mouse.
When sample testing is initiated, the samples and reagents are sequentially
pipetted into a 20-cuvette polystyrene rotor (loading process). A centrifugation
process then mixes sample and reagents. The mixing is carried out by a
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.
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 temperature range: 37
o o
C ± 0.25 C.
The results are displayed on the LCD and optionally printed by the external
printer, and/or sent to a host computer. The ACL performs automatic calibration,
offers a series of utility programs for the operator and manages a complete
quality control program.
The figure below highlights some of the main components of the ACL
ELITE/ELITE PRO, as viewed from the front of the system.
System – Components (ACL ELITE does not have Rotor Transport and Rotor Arm)
5
6
7
2
1
3
8
9 & 10
11
14 13 12
4
Sample Tray
Vial Adapter
Cup Adapter
All reagent positions can hold 28 mm vials (16 mL fill volume). Smaller diameter
vials require the use of color-coded adapters.
Vial Adapters
The cup, which is always filled with Wash-R Emulsion, is used as a wash basin
for the dispensing needles between cycles; the liquid waste is then drained and
collected in the waste container on the outside of the analyzer for proper
disposal.
Rinse/Waste System
Set against the back wall of the analyzer is an acrylic block with two cylinders
each of which has a stainless steel piston. Two electrovalves are connected to
the pistons. The electrovalves are electronically controlled and connect the
pistons to the Wash-Reference Emulsion bottle as well as to the two needles
mounted on the sampling/dispensing arm.
Two stainless steel needles, external (Sample) and internal (Reagent), are
mounted on the distal end of an arm, which is actuated radially by a stepper
motor. Another stepper motor moves the arm in the vertical plane through a
worm screw. The combination of these two movements allows the following
operations:
Reagent Sample
Sensors
Two liquid level sensors connected to the needle block are used to detect the
presence of samples and reagents in the needles.
Through the liquid level sensors, the system monitors the presence of samples
and liquid materials (calibrators, deficient plasma, diluents, etc.) in 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.
External
Internal (Sample)
(Reagent)
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.
Rotor
Inner Well
Outer Well
Rotor stack - Before their use, rotors are stored in a stack that holds up to 12
rotors. The rotor stack compartment, which may be accessed from the top of the
analyzer on the right side, can be filled at any time (continuous rotor loading)
either manually (one rotor at a time) or using a rotor refill tool (up to 10 rotors at a
time). The rotor stack area is thermostatically controlled in order to keep the
o
rotors in a temperature range 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 on the ACL ELITE PRO.
Rotor Transport* - Below the rotor stack, a rotor transport slide mechanism
moves the bottom rotor out to make it available to the rotor arm mechanism.
Rotor Arm* - The robotic arm takes the rotor and inserts it into the rotor holder.
This is the area where the rotor will remain during the loading and analysis
process. Once analysis is completed, if the rotor is fully utilized (or if requested
by the user), the rotor arm discards the rotor into the rotor waste container.
On the ACL ELITE rotors must be manually loaded from the storage area into the
analysis compartment. Press the “Open Lid” icon to raise/lower the analysis
compartment cover. Press the button on the center of the hub in the analysis
compartment to properly seat and remove the rotor. The analyzer will alert the
operator when a rotor exchange is needed.
Rotor Holder and Rotor Loading
The rotor holder is an aluminum disk that holds the rotor in place during loading
and analysis. The rotor holder is thermostatically controlled to a temperature of
o o
38.5 ± 0.5 C to insure 37 C inside the cuvette.
Press this
button to
manually
place and
remove
rotors
Rotor loading: as indicated above, the loading of sample and reagents into the
reaction cuvettes involves the action of the sampling/dispensing arm and
needles.
The Loading and Analysis area also houses the optical system for analysis on
two channels: nephelometric and absorbance.
Nephelometric channel: the light source for this channel is a light emitting diode
(LED); the light (λ = 660 nm) is directed to the reaction cuvettes in the rotor by a
o
fiber optic 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 path width for the absorbance channel is 0.5 cm (cuvette height). The
absorbance values provided by the analyzer are normalized to 1 cm. These
values are generally twice those ones obtained on other ACL models, for which
the absorbance values are not normalized and are thus exactly the ones
obtained for the 0.5 cm cuvette path.
The halogen lamp can be replaced by accessing the area through a removable
cover inside the rotor waste area in the center of the instrument by an IL Service
engineer.
Sensor
405 nm filter
LED Rotor
Lenses
Quartz
Quartz optical fiber
Halogen Lamp
The used rotors are automatically dropped into a waste container on the ACL
ELITE PRO system. On the ACL ELITE system rotors may be manually moved
into the waste bin or discarded immediately into a designated biohazard
container per laboratory protocol. This container is accessed from a door on the
right front area of the analyzer for removal and disposal of the used rotors, as
seen in the figure below. The instrument informs the user when the Rotor Waste
is full.
Warning: Cuvettes within the rotor are intended for use one time only. IL
does not recommend or support the re-use of previously used- washed
cuvettes in a rotor.
In the waste area a switch (sensor) verifies the presence of the waste container.
The LCD guides the operator during the analytical process and displays
calibrator data and patient results. It is also used to display calibration curves and
to perform several utility programs, which are easily accessible through this input
device.
The LCD screen system reproduces 256 colors, and shows numeric and
alphanumeric characters. The interaction with the operator is also made user
friendly by the availability of graphics and icons. The screen is divided into three
areas:
1.4.10 Keyboard
The ACL ELITE/ELITE PRO has a standard computer keyboard with mechanical
keys that allow the user to access the various operating modes of the instrument.
Although the instrument is equipped with and supports the English (US & UK)
keyboard layout, the ACL software itself also supports the following languages:
German, French, Spanish, Japanese (Kanji) and Italian.
Keyboard
The ACL ELITE/ELITE PRO contains an RS-232C interface (DTE Standard) for
the output of data to a central computer (Host) or a personal computer.
Communication to a host computer is via ASTM protocol.
The USB ports can be used for a mouse, printer, optional external reagent
barcode reader or memory device*.
Modem (port 4) not supported in this software release.
The ACL ELITE/ELITE PRO has an output for an optional external printer. Two
emulation protocols are available for printers: ESC/P2 (Epson like printers) and
HP-PCL (for HP like Laser Printers).
1 2 3 4 5 6
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.
- Codabar
- Code 39
- Code 128
- Interleaved 2 of 5
- Material ID
The scanner is attached to one of the USB ports located on the backside of the
analyzer. Connect the scanner with the analyzer off and reboot the system. The
scanner will become active.
The scanner is automatically activated when the material map is displayed.
The ESC P2 is a typical Epson like protocol while the HP-PCL is a typical Hewlett
Packard like protocol for Inkjet and Laser printers.
The printer can use either a USB or Parallel connector. If the USB connection is
used the printer must be connected and turned on prior to the system being
booted up. If the printer is turned off while the instrument is on, the analyzer
must be rebooted in order for printing to occur.
External Printer
This device is used for some of the utility programs (refer to section 4).
The floppy disk is accessible from the cover by pushing both sides of it to open.
3.5” Double sided High Density IBM preformatted disks should be used in the
drive. File storage will be in the root directory on all storage media.
When the system enters the Standby status, the database is saved, all motors
are deactivated to reduce power consumption and the LED source is switched
off. While the instrument is in Standby an automatic priming cycle is performed
every 30 minutes.
1. The rotor holder temperature was within the acceptable range during the
check. The system is ready.
2. The rotor holder temperature was out of range. On the Main menu, the
Warning icon on the lower part of the screen is activated indicating that one or
more temperatures are out of range.
− *** = result out of the Scale range, high, for the assay
− --- = result out of the Scale range, low, for the assay
Defined normal, test and scale range limits can be obtained by detailing the
individual test definitions in the system. Normal ranges must be entered by user.
1.7 Certification
CE Certification
The CE label on the back of the instrument indicates that the ACL ELITE/ELITE PRO
conforms to the European Directives as stated in IL Declaration of Conformity,
EU Directive:
Applicable standards:
• EN 61010-2-04 2001 2nd Edition, Safety requirements for electrical equipment for
measurement, control and laboratory use. Part 1: General Requirements
CSA Certification
The CSA label on the back of the system indicates the Canadian Standards Association
(CSA) certified the ACL ELITE/ELITE PRO to the applicable standards per file #161618.
Applicable standards:
Other Certification
The ACL ELITE/ELITE PRO meet CEI/IEC 61010-1, 2001 Mod, Second Edition, for the
following:
• Flame Resistance
• Fluid Resistance
• Audible Noise
• Product Labeling
The ACL ELITE/ELITE PRO shipping package, US or overseas, complies with the
International Safe Transit Packaging Testing Procedure ISTA 1B (June, 1999) and ASTM
999.
Disposing of this product correctly will help prevent potential negative consequences for
the environment and for human health that could otherwise arise from inappropriate
waste handling. The recycling of materials will help to conserve natural resources.
Penalties may be applicable for incorrect disposal of this waste, in accordance with
national (European) legislation.
Please call your local Instrumentation Laboratory distributor for information regarding the
disposal of any end-of-life instruments.
2.0 Introduction
This section contains all the information necessary for installing and setting up the ACL
ELITE/ELITE PRO system.
Warning: The ACL ELITE/ELITE PRO system must only be installed by IL personnel or
IL authorized persons.
Before attempting the installation of the ACL ELITE/ELITE PRO system in the laboratory,
inspect the site with laboratory personnel to identify the desired location for the system
and to insure that the environment meets all the requirements for its successful
installation.
The instrument should be positioned in an area free from dust, fumes, vibrations
and excessive variations of temperature.
The heat generated by the instrument during normal operation is exhausted from
the bottom, on the front-right and left side of the unit.
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.
The instrument has a power supply that can operate from 100 to 240 V and it
automatically switches to the line voltage required.
Power Consumption
Warning: The average power consumption is about 350 VA, but peak loads
or current surges may exceed this value when turning the instrument on.
Line Frequency
Connectors
The instrument is provided with several connectors located on the back side.
Connectors
1 2 3 4 5 6
Caution: Two persons should lift the instrument using the space below the unit at
the front and at the back as shown on the figure below.
Connect the waste tube to the fitting on the bottom left hand side of the instrument. Cut
the tube to suitable length to fit into the waste container which must be situated below the
instrument waste outlet port, as shown in the figures below.
Caution: The horizontal section of the tube should be kept as short as possible
and the free end should not be immersed in the liquid waste container. Waste
volume is not monitored. Customer is responsible to empty waste when full.
Warning
The liquid waste from the instrument is to be considered contaminated and should
be disposed of according to the waste management procedures of the laboratory
and in compliance with local and state regulations.
• Fit the reagent adapters in their appropriate positions (if needed), as shown in the
figure below. Three color-coded reagent adapters are available for reagent positions
R1 to R8 (ACL ELITE) and R1 to R12 (ACL ELITE PRO ) :
Blue vial adapters are used for the A1 through A10 positions on the sample tray.
• Place the magnetic stirrers inside the reagent vials in reagent positions R1 to R4, if
needed (refer to reagent package insert sheet for stir bar usage).
Reagent Adapters for R1-R8 (ACL ELITE) and R1-R12 (ACL ELITE PRO) positions
Wash-Reference Emulsion
Place a 1-liter bottle of Wash-Reference Emulsion in the appropriate position at the back
of the dilutor block. Insert the aspiration tube. Make sure that the aspiration tube
connector is properly connected to the level-sensing device.
Electrovalve-needle assembly
Verify that the two tubes from the dilutor/electrovalve assembly to the needle block are
tightly connected.
NOTE: The tube from the left hand electrovalve fits into the lower needle connector
and the right hand tube fits into the upper needle connector.
Electrovalve-needle assembly
Connect the LCD display to the appropriate fitting on the right side of the instrument, as
shown in the figure below.
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).
Please refer to Section 5 for information about the Needles Position procedure.
Priming
Select Diagnostic from the main screen menu bar and click the Priming option.
The Priming screen is displayed during the priming cycle:
Priming screen
During priming, check that the number of bubbles in the dilutor chambers are reduced to
a minimum. If necessary, pinch the chamber outlet tubes with your fingers while the
piston is descending and release them before the piston reaches bottom dead center.
Repeat the priming cycle if necessary.
Check that there are no blockages or leaks in the fluid path and that the liquid is flowing
smoothly from the bottle to the dilutors and from the dilutors to the needles.
Check that the discharge of liquid from the rinse cup to the instrument outlet and then to
the waste container is not impaired.
Warning: If the message “SENSOR FAIL” in the Warning area is displayed, the
priming cycle must be repeated.
Locate the ventilation filter holder on the right side of the instrument. Verify that the filter
is clean and that the two fans are operating properly.
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.
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 (N/A ACL Elite)
o
• Rotor Stack 34 to 40 C
*ACL ELITE PRO will display Peltiers for R1 – R4 and R9 – R12.
The temperature display is constantly refreshed showing a blinking effect on the display.
Manufacturer’s Responsibility
The manufacturer is responsible for the defects having an impact on safety, reliability and
performance of the equipment only if:
3.0 Introduction
This Section describes the different procedures associated with sample analysis,
calibration and Quality Control (Q.C.) on the ACL ELITE/ELITE PRO System. Since
these procedures require an interaction between the operator and the ACL, this Section
begins with some general information about the System’s Operator Interface (OI) for easy
referral, as need arises.
The main information input device for the user is the touch screen. To start an
“enter” or “edit” action, the operator touches the area to be edited. If the
information to be entered is strictly numerical, the editing is done directly on the
keyboard or popup keypad (optional system configuration). If the information
requires alphanumeric characters, the input is done through the external
keyboard.
The editing action may be closed by pressing the "Confirm" √ or the "Cancel"
Χ buttons.
3. Toolbar area: bottom part of the screen, which contains a series of buttons
for immediate access to particular functions and easy access to specific
commands. The status of the buttons is dependent on the instrument status, but
independent from the type of information displayed in the working area.
NOTE: On the touch screen, any disabled object (menu, check-box, icon, or
button) is dimmed out and cannot be selected.
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.
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 is closed by touching a different
area of the screen, the entered value will be changed to the pre-existing one.
The editing action, of the present text box, may also be closed by pressing the
[ESC] key without activating any change; in this case the value returns to the
pre-existing one.
Main and secondary menus may be selected using the keyboard. The menus are
opened by pressing [ALT] +underlined Character; selections within the menus
are done using the specific underlined character. Pressing the [ENTER] key
allows access to the secondary menus.
The keyboard function keys (F1 – F10) may also be used to activate the
functions on the bottom row of icons. Use [Ctrl] + F4 for keyboard log off.
3.1.6 Menus
A menu may be opened by selecting the appropriate area of the screen (touch or
click with the mouse) or using the keyboard: [ALT] + underlined letter.
The selection of menus to be opened may be done in all directions: up and down
or right and left.
The displayed items, which have a secondary menu, are identified with a marker
().
Selecting a menu item, touching an external area, or pressing [ESC] from the
standard keyboard closes a menu.
• Standard window: usually a larger area which contains sets of related data
which can be edited by the user
• Dialogue box: a small area used to prompt the user to choose one of
several options (i.e. OK, Abort, Retry, Ignore, Cancel, Yes, No)
• Message box: an area used only to provide information
ICONS are often included in a message box. The table below lists all
possible icons with their corresponding meanings.
Icon Meaning
ERROR. Calls attention to high priority failures and
fault messages.
• 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:
READY: indicates that there have been no errors detected, there are no
analytical operations in progress and the instrument is ready to start
SERVICE: the status assumed when the Service functions are in use.
Buttons allow the user to select options, cause actions and get from one part of
the software to another. The buttons are positioned in different areas depending
on the screen. Buttons are identified with text that is self -explanatory of the
action. Icons, which illustrate an action, are defined below.
If a check box or button is in mutual exclusion with another check box or button,
there is a frame wrapping the two, along with “graphic” information.
• ICONS
Icons can be found either in the middle Working Area of the screen or lining up in
the Toolbar Area at the bottom of the screen.
Below are two lists grouping the standard icons used throughout the ACL
ELITE/ELITE PRO, along with their associated commands. The first one includes
the Window Icons found in the screen’s Working Area, and the second one
includes the Toolbar Icons found in the screen’s Toolbar Area.
NOTES:
1. The same icon may have slightly different meaning depending on the
screen where it is found.
2. One or more of these may be disabled on a specific screen, indicated by
a dimmed representation. Its selection is ignored.
3. “Active” toolbar buttons for each specific screen and their actions are
described within the appropriate section of this Manual.
Cancel
(Host) Transmit
Delete
Details
New Sample
Note
Patient Name
Patient Details
Save information
.
Instrument Status Operating
Status of the operation in Ready
progress. Displays Hold
material map in Ready
STOP Ready
Confirmation is required. Operating
Hold
Reagent Map
Color changes depending Operating
upon the reagent map
status
QC Ready Hold
Press to view the most Operating
recent QC data. Red ! Failure
indicates a QC failure
Database View Ready
Return to the database Operating
view or “Main” screen. Hold
The "File Error History" window contains a list, sorted by time, of the last 100
alarms or error conditions. The “Session Error History” and “File Error File
History” windows are dynamically updated when opened and must be closed
before starting a new operation.
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)
Multi-Tests Profiles
Test Groups
Test Group Profiles
Sort Multi -Tests
Default Multi-Test
Liquids
Interfaces Host
Printer
Internal Barcode
External Barcode
Keyboard
Network (dimmed)
Modem (dimmed)
System Configuration
Security
Audible Alarms
Date/Time
Units
click the Prev Prog button. Press the ▼to move to the next loadlist position
or Confirm when complete.
9. Click the Confirm button: Date and Time is associated to the Loadlist
Number and the system switches to the Loadlist screen.
10. Click the Confirm button: the system switches to the Main screen. The
inserted samples are displayed in the database.
11. Select Analysis; Multi-Tests or Single Test then desired test(s).
12. Click the Loadlist No. box and enter the loadlist number.
13. If tests were not previously ordered on the sample (step 6) or default tests
are not desired, click the Program Sample button. Select the test to be run
and press the ▼to move to the next sample on the Loadlist or Confirm
when complete.
14. Verify that the current test selection is the one of choice confirm the
materials map and click the Runner icon.
15. During Analysis the Session Report screen is shown. Test sequence is
indicated. From this screen the Material Map and the Error History are
available.
Manual Sample ID Entry – Loadlist created during Analysis
1. Select Analysis.
2. Select Multi-Tests Session or Single Test then desired test(s).
3. With cursor on the first tray position of the Loadlist, click the Program
Sample button. QC can be added by clicking on the Add QC button.
4. In the Sample Entry screen enter the Sample ID and select the Tests to be
run.
5. Click the “New Sample” icon to enter the next position and enter the next
Sample ID.
6. If tests to be run are the same as before, click the Prev. Prog. button; if they
are different, select new Tests.
7. Repeat steps 6 and 7 until all samples and tests are entered.
8. Click the Confirm button to accept the changes; the system switches to the
Single Test Pre-Analysis screen (if a single test was selected) or to the
Multi-Tests Pre-Analysis screen (if a Multi-Tests was selected).
9. The tray positions will be displayed in dark blue with the letter P (Pending).
10. Press the Store Loadlist button and enter in a loadlist number.
11. Once the samples are in the sample tray, confirm materials, click the
Runner.
11. An alternate method is to click on Mark Samples and select the Sample
IDs from the database of samples.
12. Click the Confirm button. The system switches back to the Loadlist screen
showing the Date and Time when the loadlist was saved.
13. Click the Confirm button. The system switches back to the Main screen.
14. Select Analysis.
15. Select Multi-Tests Session or Single Test then desired test(s).
16. Click the Loadlist No. box and enter a valid Loadlist number.
17. Once the samples are in the sample tray, confirm materials, press the
Runner.
1. Select Analysis.
2. Select Multi-Tests Session or Single Test then desired test(s).
3. Place the samples on the sample tray
4. Select Read Bar-codes and the instrument will create the loadlist using the
barcode reader.
5. Select first sample then Click Program Sample to select Test(s) to run.
6. Click the “” button to move to the next position sample ID.
7. If tests to be run are the same as before, click the Prev.Prog. button; if they
are different, select a new Test. Repeat step 6 & 7 or when complete click
the Confirm button.
8. Confirm Materials Map and press the Runner icon.
9. During Analysis the Session Report screen is available. Test sequence is
indicated. From this screen the Material Map and the Error History are
available.
Sample ID entry by barcodes - connection to a host computer (Host Query
mode)
1. Place barcoded samples on sample tray. From the main database screen
click the Runner icon. (Instrument will perform Host Query and proceed to
the analysis).
• Single Test: This option will configure the system to only process the single
test selected for analysis. If the samples on the tray have multiple tests
programmed on them, only the selected test will be analyzed and the un-
processed tests will remain pending on a sample.
Notes:
The Current Multi-Test drop down menu will list the available profiles,
test groups and test group profiles in the order selected by the sort multi-
tests function
1. Top left area: the Current Multi-Tests or Single Test window displays the
selection to be run in the current analytical session. The selection can be
changed by pressing the () button on the right of the window and browsing
though the displayed list; the decision must be confirmed by pressing the same
button again. The main objective of this screen is to activate the Materials map,
since the programming of the map is dependent on the Current selection
displayed.
The ( …) displayed prior to the test groups names have the following meaning.
The Deselect Tests button (available when in the Multi-Tests Analysis Screen
only) may be clicked to open the Multi-Tests Details window. This screen allows
the operator to deselect running one (or more) of the tests, on all samples,
included in the Multi-Tests.
Clicking the Material List button at the bottom left of the screen opens the list of
materials required for the analysis.
Clicking the Materials Map button opens the Pre-Analysis: Material Status
window as shown below (for details refer to Section 3.2.3).
2. Middle area: the two windows in the middle of the Selected Pre-Analysis
screen (refer to screen on pages 3.14 and 3.15) contain the sample
programming information. The round circle on the left divided into 4
quadrants is used to select a region on the sample tray. The current
selected quadrant is displayed in yellow and highlighted. The window to the
right displays the status of the 10 samples within the selected quadrant. The
color of the circle provides information on the status of the sample. In
addition to the color, the circle may contain a letter or symbol that provides
further details about the sample type. The following table contains details
about the colors and sample type letters.
Empty Available
Gray
+ Stat
No tests Programmed
Light Blue
Programmed
P Onboard
Sample ID (Hourglass)
Warning or Error
Sample
Yellow processing
The circles will be colored and also will contain a symbol. Examples include:
Clicking on a position circle will display the information about that sample.
The small window on the top left Sample Tray Map enables the Read Bar
Code button to be displayed. The Loadlist No. window allows the operator
to either create a new loadlist or select a stored one. To create a new one
enter the Loadlist number (1-20) not currently defined for samples. Refer to
section 3.2.4 for loadlist details. If you modify a loadlist, press the Store
Loadlist button to save the changes.
The operator chooses how to program samples according to the desired sample
ID entry mode (refer to section 3.2.1):
- Manual Entry into the “Analysis” menu
- Manual Entry in the “Loadlist” menu
- Manual Entry in the “Database” menu
- Use of barcoded samples, no connection with Host Computer
- Use of barcoded samples, connected, Host Query mode
• Clicking the Read Bar Codes button activates rotation of the sample tray.
During the rotation the barcode reader and sample cup/tube position reader
identify a cup/tube placed on the tray along with sample identification by
reading the bar codes. If barcoded samples are present and barcodes are
readable, their corresponding Sample IDs are displayed in the large window.
If a cup or tube is identified to be in place and the system is unable to read
the barcode label a warning of “Error in Sample Identification” is presented
to the operator. If this occurs, check the tube position to ensure the barcode
label was properly oriented, then click on the Read Bar Code button again.
Bar Code read flags: (No_R) - Sample ID missing, (Dpl) - duplicate Sample
ID, (No_C) - truncated Sample ID, (Inv) - invalid Sample ID. A label ID that
cannot be read by the reader may be entered manually by selecting the
Loadlist position and pressing the Edit Sample ID button. Refer to section
6.5 for barcode troubleshooting information.
• The Store Loadlist button will save the changes to the current list.
• Clicking on the ADD QC button on the bottom of the screen will open the
QC screen. Scroll down the list and select the desired QC liquid to be
processed in the current cup position. Press the Confirm (√) to accept.
• Clicking the Edit Sample ID button displays a window that allows the
operator to type the sample identification. For the Sample ID 1 to 16 alpha-
numeric digits must be entered via the standard keyboard or 1 to 16 numeric
digits using the screen keypad. Use the ▼ to enter additional IDs in
subsequent positions on the sample tray.
• Once all the ID numbers have been typed, clicking the Confirm button
accepts all the IDs and returns to the Selected Pre-Analysis Screen. To
return to the Pre-Analysis Screen without accepting the changes, click the
Cancel button. The system does not allow the same SampIe ID to be
loaded twice; if this is attempted, a warning appears: Duplicated Sample ID.
• Clicking the Clear ID button deletes the selected Sample ID, leaving the
space blank to enter another Sample ID. No confirmation is requested.
• Clicking the Program Sample button opens the window that allows you to
program a new sample.
Within this screen the operator types the Sample ID (required field), and enters
the Patient Demographic information (optional) on the top half of the screen. If
the sample is a Stat sample, the Stat icon should be checked. The Test or the
Multi-Tests (shown when in Multi-Tests analysis mode) to run on the sample is
ordered by clicking on the desired selection. If you make a mistake, the scissors
icon can be used to delete the test or Multi-Tests from this sample or you can
uncheck a selection box. Use the New Sample (tubes in folder) icon to save this
request and present a new (blank) order entry screen for your next sample. If the
current sample has the same test or profile as the previous one, you can use the
Prev. Prog. Button. This sequence is repeated for all new samples.
After programming the last sample, click the Confirm (√) button. The system
switches back to the Single test/Multi-Tests or Test group Pre-analysis screen.
Patient demographics: the upper portion of this window displays the patient
demographic information. The displayed fields that are editable fields include:
Patient ID, Patient Name, Department Name or Number (Dept.), Birth Date and
Sex. Note: The sample ID field must contain at least one alphanumeric
character and it cannot be changed once confirmed (√).
Loadlist and Position fields display the current Loadlist and position within the
list for the displayed sample.
Patient Details: clicking this icon allows access to additional fields, such as the
Operator Notes, the Physician’s name and the Entry Date. (see screen below)
Pressing the Materials Map Button will display the Liquids necessary to do the
testing for this session.
The Materials map displays in a graphical format the liquid positions on the
analyzer. The Map shown above applies to the ACL ELITE PRO. The ACL
ELITE does not have positions (R9-R12), which are shown.
This screen displays the status of the reagents currently on-board the system,
along with other information. The color of the position circles can be:
Green: Volume of liquid in position is greater than warning limit and stability ok.
Orange: Volume of liquid in position is less than warning limit or either onboard
or lot number stability has expired.
Note: When you start/resume a run, the materials map is not checked for
volume status. The analysis will proceed regardless of the color of the
reagent position. The colors are only visual alerts to the user.
The operator is able to assess the situation of the ten Sample Tray positions and
the Reagent Tray positions. Clicking on one of the colored liquid positions will
display details about that liquid. This information includes:
• Liquid Level: The remaining volume of liquid in this position. This level is
retained from the last session for which this liquid was used. The system
tracks the level by counting down the volume during the testing. The
operator must enter the initial “start” volume. This is generally done when a
new bottle is placed on board or by the optional barcode reader.
• Expiration Date: The lot number expiration date for this liquid. If this liquid is
used beyond the expiration date, the operator will be alerted with a warning
in the Session Error History list. The Expiration date is predefined in the
Liquids screen.
• On Board Stability: The remaining time left for this liquid on board the
analyzer. The system tracks the time the bottle is on board the analyzer.
The operator must start the clock using the “Start Timer” button when a new
bottle is placed on the analyzer. The “Start Timer All” button will start the
clock for all of the liquids displayed on the current materials map. If a bottle is
removed from the analyzer, the timer countdown may be paused by pressing
the “Pause Timer” button. When the bottle is returned back to the analyzer
the clock may be resumed by pressing the “Pause Timer” button. If this
liquid is used beyond the on board stability time, the operator will be alerted
with the warning “Material on board stability expired in position XX” in the
Session Error History list. The On Board Stability time is predefined in the
Liquids screen. Expired stability will be displayed in orange on the Materials
Map.
Note: The use of the Liquid Level, Expiration Date and On Board Stability
tracking is optional. The operator can track these items offline and does
not have to use the features on board.
Set Volume allows manual volume update for the specific reagent position.
Volume entry less than 1mL should use a leading 0 (i.e. 0 .5).
Reset single will update the volume of the selected reagent position to its
default value (predefined in the Liquids screen).
Reset All will update all volumes of all reagent positions displayed on the
current map to the default values (predefined in the Liquids screen).
When the screen is activated, the system also checks and displays information
about the status of the rotor station, status of the waste, number of available
cuvettes in the rotor and the current volume of the Wash-Reference Emulsion. To
start the session with an unused rotor, the operator must check the Start with a
New Rotor box.
Press the Confirm (√) to Accept the changes and return to the Pre-Analytical
screen. Pressing the Cancel (X) will discard any changes you made. Press the
Runner icon and the run will begin.
Liquid Details: This button will display the liquid setup screen for the current
liquid position selected. Refer to section 4.1.13 for further details
map is displayed, read the vial label using the reader. The lot number
information and expiration is checked and the position to place the reagent
onboard the analyzer will blink. Place the vial in the designated location. If the
lot number or expiration dates are invalid the system will display a warning box
on the screen. You can configure the external barcode reader to automatically
reset the default volume and onboard stability for the vial when a label is read.
If the “Pause Timer” is checked for a reagent vial, when this vial is read with the
external barcode reader the “Pause Timer” will become unchecked. If the vial is
then read a second time at this point the volume and timer will be reset if these
options are enabled under the external barcode setup.
Refer to section 4.1.16 for information on enabling the external barcode reader.
This screen gives the operator access to the information on the stored loadlists,
by being either blank or defined. Each of the defined stored loadlists (20
maximum) is identified with a number, status and date/time.
• Clicking the Clear All button on the bottom right of the screen, displays a
confirmation window Do you really want to clear all loadlists? OK clears all of
the stored loadlists; Cancel will cancel the operation.
• Clicking the Make Loadlist button opens the Make Loadlist screen (see
details below).
2. Sample ID range
3. Marking or selecting Individual samples
Once one of the four list criteria is chosen you then select which tests to include
on the loadlist. Clicking the Pending (all) button will search the database for all
pending tests for the group of samples chosen. Clicking the Pending (test
selection) button will allow you to scroll down the displayed test list and select
the desired tests by pressing Select. If you make a mistake you can remove a
test by clicking on the Deselect button. The notation in the Select column will
then be removed.
Loadlist Creation Process
The first item to define at the top of the screen is the Loadlist Number to Start
with. You must enter in a value between 1-20 in this field. To the right of this
field is the entry location for the Number of Samples per loadlist. Enter in a
value between 1-40.
You then select one of the 4 ways listed above to use for creating the loadlist.
1. Time Interval – Clicking All Time Interval will create the loadlist without
respect to the time that the samples were entered into the database. If you
click on From To you must enter in a Start Date/Time and End Date/Time.
2. Sample ID Range – Clicking All Samples will select all samples with no
respect to the Sample ID attached to it. If you click on From/To you must
enter in a Starting Sample ID and Ending Sample ID to include in the loadlist.
Only samples within this range will be placed on the loadlist.
3. If you click the Mark Samples button the following screen will appear
This screen will display all the samples along with their current status in the
database. You can scroll down the list and press Select to mark the current
individual sample. If you make a mistake, press the Deselect Single to remove
the notation in the mark column. Pressing Deselect All will remove the notation
in the mark column for all samples. When you are finished, press the Confirm (√)
or Cancel (X) to return to the previous screen.
4. Click the Autolist button to display the automatic loadlist creation screen.
This screen will allow you to create one or more loadlists. You can create
the sample IDs for the loadlist using a prefix or suffix.
On this screen you must enter in the number of loadlist you want to prepare. You
can create up to 20 loadlists; each loadlist will contain up to 40 samples. In the
Fixed String field, enter in a character string to attach to each sample ID. If you
want to use the fixed string as a prefix, click on the Use as a prefix button. If
you do not click on this field, then the fixed string will be appended as a suffix to
the ID.
The Variable string field will determine the maximum number of sample IDs to
create. If you select a variable string of 2, the maximum number of samples will
be 99, if you select 3 the maximum number will be 999. The starting number
field will vary in length depending upon the variable string field entry. The
number you enter into the Starting Number field will be used for the first sample.
The remaining sample IDs will then index by one after this value.
When you are finished, press the Confirm (√) or Cancel (X) to return to the
previous screen.
Once the Loadlist/Autoloadlist is created, you then program tests for the sample
IDs on the list. Select the Loadlist and then press the Detail Icon.
The sample IDs on this loadlist will be displayed in the left hand column. You
can change the Sample IDs on the list by selecting a particular sample and
pressing Edit Sample ID. If you need to delete samples from the list you can
use the Delete Sample ID or Delete All Sample ID buttons.
To program tests for the selected sample, Press the Program Sample button.
Click on the Prev. Prog to All button to program the previous tests request to
ALL samples on the loadlist. If you press the Prev. Prog button the previous
tests will just be ordered on the current highlighted sample only.
Click on the Set Default tests button to program the Default tests to all samples
on the loadlist.
Highlight a sample and click on the Detail button to view the current sample.
This will display the demographics along with the tests ordered and any
completed results for the sample.
• Confirm or Cancel exits the screen; the system goes back to the previous
screen.
• ACTIVE BUTTONS at the bottom of this screen are:
This screen displays information about the status of the tests and samples for the
analytical runs performed on the system.
The top line displays the current test being analyzed and the current phase for
the test (i.e. loading, waiting, acquisition…)
The middle of the screen displays the 4 sample ring quadrants on the left and the
10 sample cups included within the quadrant. Please refer to section 3.2.2 for
details on sample position color codes and symbols.
The details (results) of a sample can be displayed by selecting the sample ring
quadrant on the left then selecting the desired cup position and clicking the
Details button. If a sample is complete the results will be displayed.
The Materials Map button will display the current reagent map for the session.
Please refer to section 3.2.3 for details on the Materials Map.
The Session Status button will display the Analysis Session report screen for all
samples in the current session.
The Test Execution Status box displays information on the tests in the session. It
displays the tests that may be analyzed in this session along with the number of
samples programmed, number of reflex tests to be processed, and the number of
samples actually completed. Test groups are considered to be individual tests
and display that way in the box.
The Sample Status for the Session box on the right displays the samples to be
processed in this session. This box is divided into 5 columns:
• Status: Displays the current status of this sample. The status can
be indicated by the following symbols
• Short: This column will display a “low” indicator when a sample has
been detected to be short. A sample found to be low would stop all
further testing on that sample.
The Materials Map button will display the current reagent map for the session.
Note: The bottom row of Icons on the main screen contains one of a reagent
bottle. The color of the bottle indicates the status of the reagents in the map. If
all the reagents have levels above the warning volume the icon will be displayed
in green. While testing is in process if a reagent becomes low the bottle icon will
turn orange. If a reagent runs out during analysis the bottle icon turns red.
Pressing the bottle icon will display the current reagent map.
When a reagent runs short during analysis the system will continue processing
all other tests. When testing is complete the system will display a message box
with the following:
One or more reagents are insufficient to complete all samples. Do you want to
Refill? Press
Yes to refill and then restart. Press No
to close the session.
If the Yes option is selected the operator should replenish the reagents that are
short and press the runner icon to restart the run.
If “No” is selected the system will end the current analytical session. The run
can be restarted later by selecting Analysis Session History
The Restart this Session button will start the analysis again to process those
samples with a status of “Pending”. This can be useful if a reagent runs short
during analysis.
The Session History Button will normally be dimmed out during analysis. If an
error condition occurs during the analysis the button will illuminate. The operator
should make note of the button status. When the button illuminates, the operator
should press the button to display the Session History List.
The list will display the Date and Time along with the Error that occurred.
The Printing option will print the Session Error History Report followed by a
confirmation window Do you really want to print? Yes allows the operator to print
the Session Error History Report; No will cancel the operation.
If the session has completed, you can return back to the Session History screen
by selecting Analysis from the Main screen menu bar and Session History from
the Analysis menu. This opens the Analysis: Session Report screen.
When the rotor waste is full the instrument will beep and automatically pause.
To proceed the operator has to empty the rotor waste container and press the
“runner” icon.
When the rotor stack is empty, the instrument will beep and automatically pause.
To proceed the operator has to refill the rotor stack and press the “runner” icon.
REAGENT SHORT
A reagent shortage detected during analysis will place the system in the Hold
condition at the end of the session. At this time the operator has the option to
refill the reagents and resume the session.
During the Hold state, you can perform the following on the system:
The “Add Samples/Stats” screen displays the status of the samples on the tray.
The Status of the samples is displayed using colors and letters/symbols for the
cup positions (refer to section 3.2.2 for details on the colors and symbols). The
sample tray is divided into 4 quadrants of 10 sample positions each. To change
to a different quadrant simply click on the desired segment in the circle on the
left.
Read Barcodes: This button will activate the sample bar code reader and read
the sample IDs on the tray. It will then display the samples IDs. No host query is
performed during this action. Non-barcoded sample IDs (except QC cups) will be
deleted from the list for samples that are currently not active on the rotor being
analyzed. If you are not bi-directionally interfaced, after reading the barcodes
click on the desired sample position to display the sample-programming screen.
Enter the optional demographic information. To designate the sample as a stat,
click the Stat icon. Select the tests by clicking on the desired test box. To
remove a test from the programmed tests list click on the test name a second
time. Use the down arrow to proceed to the next sample position. When
complete press the Confirm button.
Restart with BCR: This button can be selected if you are using host query and
barcoded samples. Click this button then press the resume icon. The system
will read the sample IDs and query the host for the tests to process. This option
is not recommended to be used when a mix of barcoded and non-barcoded
samples are present on the sample tray.
Non-Barcoded stat samples
To program your samples enter the Sample ID along with any of the other
optional demographic information. To designate the sample as a stat, click the
Stat icon. Select the tests by clicking on the desired test box. To remove a test
from the programmed tests list click on the test name a second time. If you have
additional samples to program click on the New Sample icon. If you are finished
programming samples click on the Confirm button. Press the Runner run icon
to start the analysis.
Enter/Edit Sample ID: This button allows you to manually enter an ID or edit
one that is displayed. Positions that cannot be edited will dim the button.
Clear ID: This button will clear an ID from a position on the sample tray. The
position can then be used to program a new sample onto the tray. This button will
be dimmed if the sample tray does not have positions in which the sample is
complete. Completed samples will be designated as a green cup position circle
with the letter C. Samples with pending tests to be completed will be designated
as an orange cup position circle with the letter P. Positions that cannot have the
ID cleared will dim the button.
Program Sample: Opens the tests order screen. Refer to information in section
3.2.2 for details on this function.
Add QC Liquids: Displays the QC liquid list. Select the desired liquid and click
on the Confirm button to accept. The QC liquid will then be added to the
samples on the tray. Note: Do not click on the Restart with BCR button when QC
is added to a list. Press the Runner icon only to start the run.
Once the Stats/New Samples have been programmed and added to the sample
tray, the run is restarted using the Runner icon.
Notes:
• When the stat/pause icon is pressed, the system will display a message
indicating when it is safe to add/remove samples from the tray. Please
wait for this message to appear. This is an indication that the sample
arm will not move toward the sample tray.
• Default tests will be added to a sample when the next test in the run is
started. Prior to this the circle will be displayed in light blue with the
status of N. After the next test in the run is started the default tests will
be added to the samples and circle will become purple when processing
occurs.
- Confirm exits the screen; the system goes back to the previous screen.
The “Database View” at the top of the screen indicates whether you are viewing
“All Samples” or a “Subset” of the samples. A subset of the samples in the
database is obtained by Extracting results. If you are viewing a subset of the
results and you wish to view all, you must extract again and select the “All
Samples” option.
The numeric values on the right of the screen (i.e. 147/540) indicate how many
samples are currently displayed in the database. If you extract, the first value
indicates how many samples were extracted and the second value indicates the
total number of samples in the entire database. When you are viewing “All
Samples” the two values will be identical.
The results list has several columns:
• C means that all tests have been run on the sample and it is
considered complete
- E Column indicates errors are present on at least one test for the sample ID
(refer to section 6.3 for further details)
- Patient Name column (max 25 characters). Using the “Identity Card” icon
this column can be hidden. This will allow more tests to be displayed across
the database screen.
- Test and Unit columns are defined (customized) in the sort test submenu in
the Test Set-up. Please refer to the Test Setup Section (chapter 4). If a test
has a ? in a column, then the result is pending for the sample. As the test is
completed, the ? will be replaced with the result. If the result is displayed
along with a “Snowflake” symbol, then there is more than one result
available for that particular test. Tests with errors will be noted instead of a
result on the screen. Highlight the sample and press the “detail” icon to
view all the results
The Instrument status line also displays the current User logged into the system
and the current revision of the software on the analyzer.
• Using the Extract icon (Hand in File Drawer) it is possible to filter the
database for desired samples based on several criteria. See screen below
- Single Sample ID
- Sample ID From … To … (Use the Same number of Characters when
defining the From/To range that you normally have for the Sample ID)
- Patient ID
- Patient Name
- Loadlist Number
- All samples
- Department
It is possible to combine the above Sample ID criteria with the result criteria
checkbox selections on the lower part of the screen.
- Completed / Pending
Note: If you extract into a subset of the database, you must re-extract using the
“All Samples” checkbox to return the database to display all samples. New
samples entered into the database while you are in a subset may not be shown
on the database.
From the Sample Data screen the patient detail icon displays additional
demographic information.
From the Sample Data screen it is possible to view the reaction curve.
Highlight the desired test and press the detail icon to view the curve.
Warnings associated with the test results are displayed in the warning list.
Please review these and take appropriate action if necessary before
reporting the results.
The “Floppy Disk” icon allows you to save the “normalized data readings”
for the curve. The data can then be viewed using another software program
(i.e. Microsoft Excel). The curve as it is presented can be printed using the
print icon. Warnings associated with the results are displayed in the warning
list.
Endpoint
Deceleration
Optical
Readings Delta
Acceleration
Baseline
Acquisition Time
The Baseline readings start after any acquisition delay settings in the test
definition. During the baseline the sample and reagents are mixing and this
continues until the clot has begun to form. In the acceleration phase the clot
continues to form resulting in an increase in the optical readings. The
deceleration phase is the time when the clot formation begins to slow down.
For a clotting based assay, once all the fibrinogen has been converted to
fibrin the endpoint has been reached and the reading stablizes
Various algorithms are used by the system to select the actual clotting
time. Some examples of these include:
When viewing clot curves some items you should make note of include:
- Single Sample ID
- Patient ID
- Patient Name
- Loadlist Number
- All samples
- Entry Date From … To …
- Department
It is possible to combine the above Sample ID criteria with the test criteria
checkbox selections on the lower part of the screen.
- Completed / Pending
- Single Sample ID
- Patient ID
- Loadlist Number
- All samples
- Patient Name
It is possible to combine the above Sample ID criteria with the test checkbox
selections in the lower part of the screen.
- Completed / Pending
- Single Sample ID
- Patient ID
- All samples
- Patient Name
- Entry Date From … To …
- Department
It is possible to combine the above Sample ID criteria with the test checkbox
selections on the lower part of the screen.
- Completed / Pending
Note: If the liquid and/or Wash-R sensors are disabled, the system will not
automatically transmit the results to the host. At the end of each run, a warning
message will appear, instructing the operator to check the material and sample
levels to ensure there is sufficient residual volume in the containers. Once the
check is performed then the results can be manually transmitted to the host.
When the sensors are re-enabled, the auto transmission will resume.
• The QC Materials may be run with patient samples during normal routine
testing or alone as a separate run. In the first case, refer to the “Analysis”
section 3.2.1; in the second case, follow the steps below.
The loadlist can be saved and recalled each time that you need to run QC. Several
different loadlists can be configured on the system. Each loadlist could contain different
QC materials
• Select Analysis.
• Click on the Loadlist No. box. Enter a loadlist number (1-20). If you do not
know which loadlists are available, click on the “Loadlist” button to display
the status of the 20 loadlists.
• Position the cursor on the desired cup position on the sample tray. Click the
Add QC Liquid button.
• Repeat the last two actions until all materials have been entered.
• Place the QC sample cups on the sample tray in the respective positions.
Press the Runner icon to begin the analysis.
Note: At the completion of the run, the completed loadlist will still be stored in
memory. If you do not delete it you can recall it the next time you need to run
QC. In this case you would not need to reprogram the sample tray positions.
Under the heading LIQUID ID, the window on the left side of this screen lists all
control materials that are configured in the Setup Liquids menu, while the
Configured Test window in the middle of the screen lists the tests that are
associated with each material.
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.
Select the QC liquid in the left box then press the Setup button under the middle
window.
The top of the screen displays the selected QC material (Liquid ID) and specific
information about it such as Expiration Date, Lot Number, plus a space for Notes.
To do this, the operator highlights a test from the Enabled Tests list shown on the
left window then clicks on the Arrow icon under the window. This action causes
the selected test to move from the Enabled Tests list to the Configured Tests list
shown in the middle window. By repeating this sequence, the control material is
associated with up to 15 tests.
To remove a test from the Configured Tests list, click the Scissors icon under
the window. This action opens first a confirmation window: Removing test
removes all tests data…Do you really want to remove the selected test? The Yes
or No selection reminds the operator that removing a test means removing all the
results saved for that test.
Once the QC Liquid/Tests association is complete, the next step is to define the
units, target mean, target SD and the SD Range for all tests associated to the
QC material.
Unit: for each test, the selection of units includes only the ones that are
legitimate for that test. Modifying a previously selected unit will not cause a
change in Target Mean and SD values. These would need to be updated if the
unit type is changed.
Target Mean and Target SD: these fields accept any value, which is entered by
touching the field and using the external keyboard or the keypad on the screen.
If the QC Range Check box is activated, the control value before rounding (see
section 7.4.2) is checked and flagged if found to be outside the defined range.
Patient results will not be flagged if only this box is checked.
The Flag Patient Results check box can be activated only after the activation of
the QC Range Check box. If this box is checked and QC is out of range, then a
flag will be noted on patient samples processed until valid QC results are
obtained for all QC materials defined for the test.
The QC Range Check and Flag Patient Results check boxes can be activated
by simple touch, causing a check sign to appear.
The Clear Statistics button deletes, after confirmation, all the results of a
particular Test – QC Material combination.
Warning: Changing the Lot number for a QC liquid under the Liquid Setup
menu will delete all previous QC results for that liquid.
Clicking the Printer icon, followed by a confirmation request Do you really want
to print? Yes allows the operator to print the test Setup; No will cancel the
operation.
Clicking the Confirm button allows the operator to leave this screen and the
system goes back to the QC Review screen.
When there is an active association between a QC material and tests, the Plot
and Statistics, Cumulative Results and Host icons are active.
The database displays the following for the QC results: test, QC material, result,
unit for result, and any errors. The number of Results in the database is
displayed in the “Results” box on the top right. The Clear All and Clear Single
buttons will remove the results from the QC database, however they will still be
displayed under the QC Plot and Cumulative result o pt i ons . T h e r es u lts o n
th e d at a bas e c a n b e p r i nt ed us in g t he Pr in t Al l Q C or P r in t
Today QC.
This screen displays both the Plot and the Statistics of a selected QC Material
and test pair, displayed at the top of the screen.
The window in the left side of the screen displays the following information, which
is not editable from this screen:
- Start Date
- End Date
- Unit
- Actual Mean
- Target Mean
- Actual SD
- Target SD
- Actual CV
- Results in Statistics (results for current selected date interval)
- Results in Database (DB) (all results for all dates)
The QC plot for a test with results can be viewed in the window on the right side
of the screen. The chart indicates Days on the X-axis, the unit and target mean
on the left y-axis, and the SD on the right y-axis.
The display covers an interval of 30 days; the default window displays the results
for the last 30-day interval, but the operator may view earlier data and move
about using the scroll bar. The last 500 QC values per liquid and test can be
displayed on the plot. The system will retain the last 65,536 values for statistical
calculations.
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) to view results on the screen
for the selected interval:
The new interval must be confirmed by clicking the Confirm button, which results
in the system going back to the QC Plot and Statistics screen, or not confirmed
by clicking the Cancel button (this applies only to the selected interval). The
statistical results will be updated based upon the selected interval.
Clicking the Printer icon, followed by a confirmation window Do you really want
to print? Yes allows the operator to print the plot; No will cancel the operation.
Enter a “From … To” date range interval to print results for a certain time interval.
Selecting “All Results” will print entire QC list for all dates.
Clicking the Confirm button exits this screen and goes back to the QC Review
screen.
The top portion of the screen displays the following: the selected QC material
(Liquid ID), the selected test (test ID), the date range (dd.mm.yyyy) and the time
range (hh.mm). This information cannot be edited on this screen.
The larger part of the screen is used to display the results obtained for the
selected pair QC material-test.
Results are displayed using a list that can be scrolled vertically; the columns
show the numeric results in the configured unit and the date/time of the analysis.
Values out of programmed SD range (1 or 2 SD) will be displayed in violet and
those values out of 3 SD will be displayed in red.
There is also a column for notes, and columns for possible flags and warnings.
Further details about a single result, are accessible by clicking the Details icon,
which opens the QC Single Result Details screen:
On this screen, the identity of the Liquid ID/Test ID pair is displayed on the first
line of the screen.
The windows in the left side of the screen display the QC sample curve, the
measured units and the calculated units.
Additional information about the displayed result is also viewable on the right side
of the screen:
- Transmission status (T: Transmitted to Host or L: Local when result has
not been transmitted to Host)
- Omission status (Yes or No)
- Analysis date and time
- Notes (if any)
- Warning list.
Clicking the Disk icon allows the operator to save the results 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.
The curve save routine saves the raw data point readings and not the actual clot
curve display. The file name must have at least one alpha-numeric character
and be named with a “crv” extension (i.e. PTQC1.crv)
Clicking the Printer icon, followed by request for confirmation window Do you
really want to print? Yes allows the operator to print the single result; No will
cancel the operation.
Clicking the Confirm button causes the system to go back to the QC Cumulative
Results screen.
The operators may enter their own notes in the Insert Notes screen (shown
below) that is opened by clicking the Notes icon.
The free text note field allows the operator to key in up to 30 alphanumeric
characters. Click the Confirm button after entering the note to save it.
Clicking the Omit Result button allows the operator to permanently omit the
selected result. Before omitting it, confirmation is requested Omitting result…Do
you really want to omit the selected result? Yes or No selections are possible.
When the result is omitted, a check will appear in the O column beside the result
and this result will not be included in the statistical calculation. Omitted results
will be displayed on the QC Plot as a blue “diamond” symbol. You cannot Un-
Omit a result once it has been omitted.
Clicking the Plot and Statistics button allows access to the QC Plot and
Statistics screen (refer to section 3.3.4 above).
Clicking the Host icon opens the QC Host Communication screen (refer to
section 3.3.6 below).
Clicking the Extract Results icon opens the QC Extract Data screen (refer to
section 3.3.7 below).
Clicking the Printer icon, followed by a confirmation window Do you really want
to print? Yes allows the operator to print the results; No will cancel the operation.
Enter a “From … To” date range interval to print results for a certain time interval.
Selecting “All Results” will print entire QC list for all dates.
Clicking the Confirm button saves any changes and returns back to the QC
Review screen.
− “All range” (All range would include all results for the selected tests)
If the latter is selected, the starting date/time and the ending date/time must be
defined.
The user can then select if data for a specific test or all tests should be
transmitted by choosing between the following options:
- “Single Test”
- “All Tests”
Once the date range and tests are chosen the user can then narrow down which
results to send from the following choices:
- Valid Results
- Invalid Results
- Not Numeric Results
- Out of Scale Results
- Omitted Results
- “Transmitted” or “Not Transmitted”
- “Flagged” or “Not Flagged”
Touching the check box area close to the option makes the selections; a check
mark appears next to the choice. These options allow the user to group the
transmitted results for ease of handling: i.e. Valid and Not Flagged results. The
second level options can also be combined with them to transmit groups such as
Valid and Not Flagged - but Omitted - results.
Once the transmission criteria are defined, the transmission begins by clicking
the Start Communication button.
Clicking the Cancel button rejects the changes; the system goes back to either
the QC Cumulative Results screen or to the QC Review screen depending from
which screen the Host icon was pressed.
Extracting QC will allow the user to display data for a particular date range. The
date range entered will impact the data displayed however it will not apply to QC
Host Communication or Printing. Each of these two additional functions has its
own fields whereby you can limit what is transmitted or printed.
The data configuration displayed on this screen is needed to decide which type
of QC results are to be extracted and at what time intervals. The Liquid ID/Test
ID association is visible on the upper part of the screen.
− “All range” (All range would include all results for the selected tests)
Once the date range and tests are chosen the user can then narrow down which
results to view from the following choices:
- Valid Results
- Invalid Results
- Not Numeric Results
- Out of Scale Results
- Omitted Results
- “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 extracted results for ease of handling: i.e. Valid and Not Flagged results. The
second level options can also be combined with them to view groups such as
Valid and Not Flagged - but Omitted - results.
Once the extraction criteria are defined, the process begins by clicking the
Extract icon. The cumulative data for the selected interval will be displayed. The
statistical results are not updated based upon the selected data. The statistics
will be based upon the default interval data.
3.4 Calibration
The ACL ELITE/ELITE PRO system requires that certain tests be calibrated either prior
to or simultaneously with sample analysis. If a test with a dedicated calibration is
requested, and no calibration curve exists in memory, a “missing calibration” warning will
be displayed during the pre-analytical check.
Although calibrations require the use of test-specific reagents and often other specific
materials, the calibration procedure is common to all tests.
This section contains all the information needed to calibrate assays on the ACL
ELITE/ELITE PRO, starting with a summarized procedure for those users already familiar
with the ACL ELITE/ELITE PRO system, followed by step-by-step procedures with
specific details about the screens, options, etc.
PT #
Fib-PT Based #
Fibrinogen #
Factors* #
Antithrombin #
Heparin #
Homocysteine #
Protein-C #
Plasminogen #
Plasmin-Inhibitor #
ProClot #
Free Protein S #
Pro S #
D-Dimer #
*Assays with Parallelism import the calibration from the same factor assay
with a dedicated calibration mode
store the last executed calibration curve. The curve is viewable under the
calibration review submenu.
In session means the calibration is executed the first time together with
samples and then saved. Subsequent runs for the test in the same analytical
session use the saved curve. For future analytical sessions, if the calibrators
are positioned on the sample tray the calibration will be executed, if not, the
previous calibration is used. The system will store the last five In-session
calibrations per test. The curves are visible using the calibration review
menu. The last curve performed is active and in use.
Each Rotor means that every time a rotor is loaded with samples the
calibration is executed as well. The calibration material is required to be
placed on the sample tray for each run. If multiple rotors are processed
within an analytical session, a calibration will be performed on each rotor.
2. Scroll through the list of tests displayed in the Test to Calibrate window on the
top right side of the screen, and select the test to be calibrated.
3. Look at the left side window or Materials Map and make sure that you have on
hand the materials listed to perform the calibration for the test.
4. Press Start to begin the Pre-Analysis phase. The ACL ELITE/ELITE PRO will
check the presence of the required materials; if all required materials are present
the calibration run will begin.
Note: Calibrations should be reviewed and accepted prior to the system going
into standby
• If you are using a new lot of any of the materials press the Liquid Details
button at the bottom of the window and modify the appropriate lot number.
• If you are using a new lot of Calibration Plasma, press the Liquid Details
button at the bottom of the window and enter the new assigned value as
shown on the Calibration Plasma package insert sheet.
Note: For the PT calibration, the value entered for the cal plasma is 100.
The window is divided into 4 columns with one row per Material. The information
displayed is the same as that entered when defining the material’s configuration:
Clicking the Materials Map button at the bottom of the window opens the Pre-
Analysis: Material Status screen:
This screen displays the status of reagents currently on-board the system, along
with other analyser information. Refer to section 3.2.3 for details on the Materials
Map.
Clicking the Start button from the Materials Map starts the calibration run.
This screen displays the recorded date and time of all the calibrations
performed for each enabled test.
• Dedicated Calibrations: The ACL will save the last calibration performed.
• In-Session Calibration: The ACL will save the last 5 calibrations. The most
recent one will be the active one in use.
Clicking the Details icon at the bottom of the screen opens the Calibration Data
screen (shown below).
This screen gives the user the ability to view at a glance the most important
information related to calibration runs:
- Name of the test (ID)
- Date and time when the calibration was performed
- Calibration curve
- Calibration Line Equation coefficients
- Errors (click the Error View button, see below)
- Warnings (click the Warning List button, see below)
- Mean value of the replicates, units of measure and CV%
Clicking the Details icon displays information about each single replicate.
This screen allows the operator to review the clot formation curve (or the
absorbance curve, depending on the test) for each single replicate, along with
the numeric value. For the clotting test curves, the clotting point is also displayed.
Individual replicate values can be omitted by pressing the Omit Replicate button.
The selected replicate will be removed from the calculation of the mean. It will
remain displayed and will have a check in the Omit Column. You may omit
multiple replicates, but must leave at least one for the curve calculation.
The mean value for a calibration is calculated by averaging all replicate numeric
values. The replicate furthest from the mean is eliminated. The remaining
replicates are then averaged. This is the value used to construct the curve
The raw data for the level and replicates displayed may be saved using the
floppy icon. The curve must be given a name. The .crv extension will
automatically be added to the name.
- 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 icon the calibration curve and the calibration data are
printed. If the curve is composed of multiple segments, you must print each
segment individually. If the printer icon is pressed while viewing the replicate
curves, then the curve displayed will be printed.
Clicking the Error View button opens the Error View screen (shown below).
Clicking the Warning List button opens the View Warnings screen:
Clicking the Confirm button exits the screens: the system goes back to the
Calibration Data screen.
PT 1 3 6 18
Fib-PT Based 1 3 6 18
Fib* 1 3/4 4 12
Factors # 2 6 1 6
$
Factors 1 6 2 12
AT 1 3 4 12
HEP 2 3 4 12
HEP Liquid 3 3 3 9
Homocysteine 1 4 3 12
P-C 1 3 1 3
PLG 1 3 1 3
FVIII Chr 1 3 1 3
P-I 1 3 1 3
ProClot 1 3 1 3
ProS 2 3 1 3
D-Dimer 1 3 4 12
VWF(Ag / Act) 1 4 4 16
1. High Curve: Prepared using Cal Plasma with levels at 100%, 50% and 25%.
2. Low Curve: Prepared using Low Cal F with levels ranging from 6.25%,
3.125% and 1.56%.
3. Middle segment connects the 25% from segment one and the 6.25% from
segment three.
If the 100% calibration plasma material is not placed, a window will indicate the
missing materials. The options to abort or to continue are given. If the user
chooses to continue, sample analyses are performed although the calibration
cannot be executed. Sample results are calculated based on the previous
calibration. Response and activity (%) values are reported. If no stored
calibration curve exists, the results will only be displayed in seconds.
If the 100% material does not give a valid result, the entire calibration is
automatically rejected. When reviewing the calibration, an error message is
displayed. In addition, no calibration curve or statistics will be displayed.
IL recommends that the 100% material be placed on the sample tray for each
Factor Analysis session.
The Cal Low F (6.25%) material is an optional material. It is used to obtain the
Low and Middle segments of the calibration curve.
Low segment is obtained connecting the 6.25, 3.12 and 1.56% points.
Factor Assay Calibration in the IL test library uses the criteria of the in-session
calibration mode. If the undiluted calibration plasma is present on the ACL
ELITE/ELITE PRO sample tray, the High segment calibration is performed during
the analytical session.
If the undiluted calibration plasma is not present, the previous High calibration
stored in memory is used for calculation and reporting of results.
Note: Do not place the Low Cal F cup onboard the analyser without placing
the Cal Plasma cup
High curve
In case the operator needs only the High curve, it is possible to perform the
calibration only using the undiluted calibration plasma.
The ACL ELITE/ELITE PRO will perform only 3 calibration points: 100%, 50 and
25%.
Linearity varies from factor to factor but the instrument will always flag a result
less than 60% of the lowest calibration point.
In case the lowest calibration point is 25 %, all results below 15 % will be flagged
with a “C” in the Error column and tagged with “Extrapolated Result” in the Test
Details Warning List.
If a result is higher than 150 % of the highest calibration point value, a “C” will be
displayed in the Error column and “Extrapolated Result” will be shown in the Test
Details Warning List.
For example, if the highest point of the calibration is 100 %; all results above
150% will be flagged with a “C” and tagged with “Extrapolated Result”.
If the High curve is not valid (rejected), results on patients will be presented only
in seconds.
If the High calibration curve is rejected but the 100% result is a valid result, the
Low curve and the Middle curve segments will be calculated.
If the 100% gives a non-valid result (i.e. error number xx), the High, Middle and
the Low curve will be rejected.
In both cases listed above the calibration should be repeated along with Quality
Control and patient samples.
It is possible that only two points (including the 100%) are valid and in this case
the instrument will present the "2 point cal” condition.
Low curve
If both High and Low segments are required, both segments must be calibrated
at the same time.
If the High curve is rejected due to a non-valid 100% result, the Low curve is
rejected.
If the Low curve is rejected (invalid, non monotonic, etc.), the High and the
Middle curve segments can be considered valid. The Middle segment curve
should be verified prior to reporting the patient results.
It is possible that only two points (including the 6.25%) are valid and in this case
the instrument will present the "2 point cal” condition.
Any result outside its specified Test Range as defined in the test setup will be
flagged with a “C” in the Error column and “Outside Test Range” will be displayed
in the Test Details Warning List.
Middle curve
The Middle curve will be calculated when both High and Low curve segments are
calibrated at the same time and both 25% and 6.25% points have produced valid
2
results. “R ” value for middle curve will always be 1.00 since it is composed of 2
points and therefore is a straight line.
In case the High and Low segment do not produce a valid calibration (i.e. slope
out of range), if both results of the Middle curve segment are valid the Middle
curve segment is calculated. The Middle segment curve should be verified prior
to reporting the patient results.
Any result outside its specified Test Range as defined in the test setup will be
flagged with a “C” in the Error column and “Outside Test Range” will be displayed
in the Test Details Warning List.
This check verifies that the results obtained in seconds are proceeding in the
same direction: low to high or high to low.
If one of the points in seconds is not “monotonic”, the entire segment of the curve
is flagged and rejected.
If the High curve segment is found “non monotonic”, sample results will be
calculated based on the Middle or the Low curve segments if valid.
If the Low curve segment is found “non monotonic”, sample results will be
calculated based on the Middle or the High curve segments if valid.
For the two conditions above, the curve should be verified prior to reporting the
patient results.
If only the 100% calibrator is present and the error “non monotonic” is shown, the
entire curve will be rejected. In this case sample results will be calculated based
on the previous calibration curve. If a previous calibration curve is not present,
only response values will be reported.
Slope check
If the calibration slope exceeds the slope limit specifically defined for the
segment, the segment will be rejected with the Slope out of Range error
message.
Samples run in this condition will be flagged with a “C” together with the message
“Slope out of Range”.
r2 check
2 2
If the calibration r for a specific segment exceeds the r limit specifically defined
2
for the segment, the r will be presented in red and a “C” flag with the message
2
“r out of Range” will be presented together with patient sample results.
Flag Explanation
Recommendation:
If the Low segment fails and results are obtained <25%, repeat the calibration,
Quality Control, and patient samples.
For good laboratory practice, at least two (2) levels of controls should be run
together with patient samples.
In case of Factor VIII and/or IX, patient therapeutic treatment may be associated
to sample results. Perform the Low curve calibration, at the same time as the
High curve calibration, to cover factor concentrations down to the 1.56 % level.
Factor assays for tests with parallelism import the calibration from the same
factor test defined without the parallelism dilutions. This master test is calibrated
using the dedicated calibration mode.
This information is valid for all factor assays with Parallelism when using the IL
tests library. The calibration curve for factors is divided into 3 segments:
o High Curve: Prepared using Cal Plasma with levels at 100%, 50% and 25%.
o Low Curve: Prepared using Low Cal F with levels ranging from 6.25%,
3.125% and 1.56%.
o Middle segment connects the 25% from segment one and the 6.25% from
segment three.
Calibration of the master test will require 3 empty(0.5mL) cups on the sample
tray during the calibration cycle. These cups will be used to automatically
prepare the dilution of the Cal Plasma for use as the Low Cal F.
Samples that are processed with the Factor Parallelism will process the samples
at three dilution levels: 100%, 50% and 25%.
Introduction
Factor Parallelism is a technique used to determine the influence or effect
inhibitors have on a sample’s Factor Assay activity result. The possible presence
of an inhibitor and its effect may be determined by assaying the Factor using a
series of dilutions. The impact of the dilutions on the factor activity can then be
observed.
The purpose of the Parallelism function on the ACL ELITE / ELITE PRO is to
assist with the identification of an inhibitor in an easy, automated fashion. The
Parallelism test mode is a means to create operator definable dilutions. The
instrument will execute all dilutions, perform testing on the dilutions, and will
provide evaluation data on the results to assist in determining the presence of an
inhibitor.
The software provides multiple checks of the data generated and provides the
operator with valuable information to assist in identifying the presence of an
inhibitory pattern. Some of the checks include comparison to the original
undiluted result and precision data of the additional dilutions.
In addition to the individual results the system will perform calculations for the
following:
- CV-CR% - CV% of the three Corrected Results % values. When this value
exceeds the limit in the test setup the results will be displayed in red on the
screen and an error will print on the report.
- Slope – The slope for the 3 parallelism values is calculated. This slope
should coincide with that for the factor test calibration. In the test setup
there is a user definable minimum and maximum allowable Slope limit.
When the recovered slope for the samples is outside the limits in the test
setup the results will be flagged in red and the error “Slope out of range” will
be printed.
- Int – This value is the intercept for the line based upon the 3 factor
parallelism dilutions. In the test setup there is a user definable minimum and
maximum allowable Intercept limit. When the recovered value for the
samples is outside limits the results will be flagged in red and the error
“Intercept out of range” will be printed.
2
- R – This value is the correlation coefficient calculated using the seconds
and the 3 factor parallelism dilution % values (uncorrected). In the test setup
2
there is a user definable minimum and maximum allowable R limit. When
the recovered value for the samples is outside the limits the results will be
2
flagged in red and the error “R out of range” will be printed.
Sample results with an error on any of the above units should be reviewed for the
presence of a possible factor inhibitor. Additional retesting including off- line
dilutions at higher levels may be required to confirm any questionable results.
Example 1:
Laboratory Maximum Variance ± 10% of the mean
In the above example the results of 54.7% and 51.5%, have a mean of 53.1 with
a 10% agreement the range is 47.8% - 58.4%. If the results are outside that
range another dilution should be made, if they are within range they are close
enough to report. If all points are within 10% of their mean then the 100%
concentration value should be reported as long as no other flags are seen.
The AR results are handled just like the results for a Quality Control material. The
plot and cumulative list of results are both available for the AR. These results
may be transferred to a host computer, printed or archived.
The user may select the desired test from the list of enabled tests. The following
statistics are displayed, but cannot be edited, on the right side of the screen:
- Unit
- Actual and Target Mean
- Actual and Target SD
- Actual CV
- Results in Statistics and in Database (DB)
If the Mandatory AR Use box is checked then the system will check for the
presence of the Analytical Reference during the Pre-Analytical check. If the AR
is required for any tests in the session and it is not present the run will not
proceed. Remove the check from the box to disable the use of the Analytical
Reference for all assays.
If the Mandatory AR Use button is checked (enabled) and profiles are created the
material map for the profile will reflect the need for Cal Plasma. If the AR Use
button is later disabled the profiles that contain tests that use the AR will need to
be deleted and re-created.
Clicking the Setup button opens the Analytical Reference Setup screen (see
details later in this Section).
Clicking the Plot and Statistics button opens the Analytical Reference Plot and
Statistics screen (see details later in this Section).
Clicking the Cumulative Results button opens the Analytical Reference Data
screen (see details later in this Section).
Clicking the Transfer to Host icon opens the AR Host Communication screen
(see details later in this Section).
Clicking the Confirm button exits the screen.
Clicking the Setup button in the Analytical Reference Review screen opens the
Analytical Reference Setup screen:
The selected test ID appears on the top of the screen; below it the operator can
view the following information:
- Unit
- Target Mean and SD
- Target SD
- SD Range
- Results in Database. 10, 100, 500, 1000 is selectable. Any change to the
number of results in the database will delete all AR results for this test.
- Note
Clicking the Confirm button saves the changes, while clicking the Cancel button
rejects the changes; in both cases the system goes back to the Analytical
Reference Review screen.
This screen displays both the Plot and the Statistics for the selected test.
The following information is viewable, but not editable, on the far left side of the
screen:
- Start and End Date
- Unit
- Actual and Target Mean
- Actual and Target SD
- Actual CV
- Results in Statistics and in the Database (DB), choices are 10, 100, 500 and
1000 viewable results.
The AR plot is displayed on the far right side of the screen; the axes on the chart
indicate:
- X-axis = days
- left Y-axis = target mean and chosen units
- right y-axis = SD
The display covers an interval of 30 days; the default window displays the results
for the last 30-day interval, but the operator may view earlier data and move
about using the scroll bar.
The statistical calculation is done using all the results in the database. To obtain
the statistics for other selected intervals of time click the Select Interval button
and enter the specific start and end date (dd.mm.yyyy or according to the date
format selected in the Date and Time configuration) in the specific fields of the
Select Interval screen.
The new interval must be confirmed by clicking the Confirm button, which results
in the system going back to the AR Plot and Statistics screen, or not confirmed
by clicking the Cancel button (this applies only to the selected interval).
Clicking the Printer icon, followed by a confirmation window Do you really 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.
In the upper part of the screen, the user views the selected Test ID. The larger
part of the screen is used to display the results obtained. Results can be
displayed using the list that can be scrolled vertically and horizontally; the
columns show the numeric results in all configured units and the date/time of the
analysis.
There is also space for notes, and columns for flags and warnings. The operator
may enter his own notes by clicking the Note icon that opens the Insert Notes
screen (similar to that on the QC screen).
Clicking the Confirm button allows the operator to save the entered or modified
note and to exit this screen, going back to the AR Data screen.
Clicking the Omit Result button allows the operator to permanently omit the
selected result. Before omitting it, confirmation is requested Omitting result…Do
you really want to omit the selected result? Yes or No selections are possible.
When the result is omitted, a check will appear in the O column beside the result
and this result will not be used in the statistical calculation.
Clicking the Plot and Statistics button allows the operator to have access to the
Analytical Reference Plot and Statistics screen (refer to subsection above).
Clicking the Host icon opens the AR Host Communication screen (refer to
subsection below).
Clicking the Extract Results icon opens the AR Extract Data screen (refer to
subsection below).
Clicking the Printer icon opens the AR Result Report screen with the various
possibilities:
− ALL
− From … to
− Not numeric
− Out of scale
− Omitted
− Transmitted
− Not transmitted
− Flagged
− Not flagged
Clicking the Confirm button exits this screen and goes back to the Analytical
Reference Review screen.
− “All range”
− “From…To…”
If the latter is selected, the starting date/time and the ending date/time must 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:
Touching the area close to the options makes the selections: a check mark
appears next to the choice. These options allow the user to group the transmitted
results for ease of handling, i.e. Not Numeric and Not Flagged results. The
second level options can also be combined with them to transmit groups such as
Not Numeric and Not Flagged - but Omitted - results. Once the extraction criteria
are defined, clicking the Start Communication button may activate the
transmission.
Clicking the Cancel button rejects the changes and exits the screen.
• ACTIVE BUTTONS at the bottom of this screen are:
The data configuration displayed on this screen is needed to decide which type
of AR results are to be extracted and at what time intervals they are extracted.
− “All range”
− “From…To…”
If the latter is selected, the starting date/time and the ending date/time must be
defined.
The user then makes a second-level choice from each of the following pairs
Not Numeric and Not Flagged - but Omitted - results. Once the extraction criteria
are defined, clicking the Extract icon can activate the extraction.
Clicking the Cancel button rejects the changes and exits from the screen.
4.0 Introduction
The intent of this Section is to familiarize the ACL Elite/Elite Pro user with the items
included in the Setup and Utility portions of the Operator Interface. The understanding of
the items and their proper use are important in order to prepare the system for its optimal
analytical operation, to handle data and to work with the system software.
4.1 SETUP
The Setup portion of the ACL Elite/Elite Pro software groups all functions related to
definition or configuration of features or items in order to adapt and optimize the use of
the system to the laboratory needs prior to performing the analytical operations.
SYSTEM CONFIGURATION
SECURITY
AUDIBLE ALARMS
DATE/TIME
UNITS
Selecting Tests from the Setup submenu, and then choosing View/Define
opens the View Tests screen:
Above the test list a rectangular box will show the number of tests present in the
Library Application. The box will show two numbers; the enabled tests followed
by the total number of tests.
The large window on the left of the screen displays a table of all the configured
tests.
Each test is identified by an abbreviated name, Test ID, shown on the right side
column. The Test ID name can be customized in the test details screen. The
Test ID must be unique for each test.
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The two columns to the left of the test names contain checks indicating whether
each test is:
- currently Enabled and ready to be run on the ACL
TEST CODE
TEST REVISION
TEST CODE FOR HOST
EXTENDED NAME
CALIBRATION MODE
The information shown in these fields can be viewed but not edited from this
screen. Several buttons are found around these fields:
Clicking the Details icon opens the Test Details screen, which allows editing of
the fields (refer to section 4.2.2 for details).
Clicking the Printer icon, followed by a confirmation window Do you really want
to print the Test report? Yes allows the operator to print the Test Setup details of
the selected test; No cancels the operation.
Clicking the Show Enabled check box allows the operator to view only the
enabled tests from the test table. When this checkbox is marked the list
presented displays just the enabled tests. This setting is saved when exiting from
this screen and also at power off.
Clicking the Copy Test button opens the Copy Test screen (refer to section 4.2.1
below).
Clicking the New Test button opens the New Test screen (refer to section 4.2.2
for details).
Clicking the Delete icon, followed by a confirmation window, erases all setup
details and result data related to the currently selected test. IL locked tests
cannot be deleted.
• ACTIVE BUTTONS at the bottom of this screen are:
Selecting Tests from the Setup submenu and choosing Sort Tests opens the
Sort Tests screen:
Sorting the tests defines the display order of the tests in the patient database, the
order of the tests list during programming and the order of the tests in the
printouts.
The window on the left side of the screen displays a table of all currently enabled
Tests; a check mark to the left side of a test indicates that it is a Sorted Test.
The window on the right side of the screen displays the order in which the tests
are sorted.
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The Arrow and the Scissors icons at the bottom of the windows are used to
create a sorted list.
The default condition is to have the tests in both columns listed in alphabetical
order.
The operator selects the tests from the sorted tests box and presses the scissors
icon; the tests are then removed from the right side window.
This operation is necessary because the tests cannot be moved up and down in
the Sorted Tests list.
The arrow is used to move a test from the left (enabled tests) list to the right
(sorted) list in the desired position.
Tests are added below the cursor. If a mistake is made, the Scissors icon is used
to remove the test from the sorted list. No test can be added above the first test
in the list.
Enabled tests that are not sorted will be printed and viewed after those tests that
are sorted.
Clicking the Confirm button saves the changes and clicking the Cancel button
rejects the changes; in both cases the system goes back to the Database
View/Main screen.
Selecting Tests from the Setup submenu, and choosing Interference Table
opens the Interference Table screen shown below.
TESTS WITH REAGENT PRIMING on the left side displays the list of tests
containing a preventive needle priming defined within their test setup.
INTERFERING TESTS in the middle displays all tests that interfere with the
current test highlighted in the left window (Test with Reagent Priming).
ENABLED TESTS on the right side displays all the enabled tests in the system.
If an interfering test is executed prior to a test with reagent priming defined, the
reagent priming cycle is executed before the first reagent dispensation.
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The Arrow and the Scissors icons at the bottom of the windows are used to add
or remove a test.
1. Select a test with Reagent Priming defined from the list in the left box.
2. Select the interfering tests that affect the highlighted test selected in step 1
from the Enabled test box.
3. Move the test selected in step 2 to the interfering test column using the
arrow. Use the scissors to delete a test from the center column.
At the bottom of this screen, clicking the Confirm button saves the changes;
clicking the Cancel button rejects the changes; in both cases the system goes
back to the Main screen.
Warning:
The list on the left shows all enabled tests. The list on the right shows the tests
selected as default.
The Arrow and the Scissors icons at the bottom of the windows are used to add
or remove a test.
Select the tests to be added to the Default Tests list from the box on the left
(Enabled Tests) and press the Arrow key. The selected tests will move to the
Default tests box.
The default tests can be disabled/enabled using the Enable Default Tests
checkbox.
Note: Default tests are added to a sample after checking the database and
performing a host query. If neither of these checks result in tests being
programmed on a sample, then the default tests will be added. Default tests will
not be added to a previously run sample with completed results. The default tests
will not be run if they are not included in the current single test or multi-test
session selected. For samples added during a pause/stat request the default
tests will be added after the run is resumed if the criteria for default tests are met.
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Clicking the Details icon when the cursor is on a specific rule displays all the
conditions and tests. All of these can be modified.
Moving the cursor using the up and down arrows, then clicking the
Enable/Disable button will select or deselect each single rule. When a rule is
enabled a check mark appears close to the rule number. If a rule is checked it
will be applied (see System Configuration for general Reflex Rules activation in
section 4.1.20).
Clicking the Detail icon, the Reflex Rules Details window appears.
The Details icon allows viewing /editing of the conditions for the current reflex
rule.
The upper window allows the insertion of the rule condition by pressing the
Insert Icon.
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The test generating the reflex test can be chosen from the Test ID List.
For the numeric results class use the appropriate Unit field to select which unit
should be checked by the rule.
Two classes of conditions are available: value- based on numeric results; error-
based on the error that occurred.
For the numeric results, the unit can be selected according to the test and the
units defined in the specific test setup.
Then select the Comparison in terms of >; =; < for the value entered above.
In the Value field, after checking the value check box, enter in the numerical
value for comparison. Press the green check to confirm and save the condition.
The second class includes the result error (data reduction errors), e.g. error 6, error
7, error 12, etc. Most errors are based upon the measured unit; therefore this unit
should be used when defining the logics. See the Troubleshooting section 6 for
additional information on each specific error.
For the error conditions, it is possible to group multiple errors (up to 5) in a single
rule by using the Select icon.
Move the cursor on the error to be selected, and then press the Select button; a
check mark appears close to the selected errors. Press the green check to
confirm and save the condition.
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).
The lower part of the Reflex Rules Details screen allows the reflex tests to be
selected by using the Arrow and Scissors icons.
Rules and conditions can be reviewed or deleted by pressing the details or the
delete icons.
The Print icon prints all the relevant information for all rules and conditions stored.
Below are listed some possible examples of reflex rules. These rules do not
represent any particular clinical aspects but only possible selective examples.
Each customer should define his own reflex rules. For the reflex rules execution
please refer to the System Configuration section.
Note: Only one level of reflex logic checks is applied to each sample. No
additional reflex logic checks are applied to the results of tests that were added
to a sample from the first level of reflex logic checking.
The following table lists the reaction curve error codes along with the unit
that should be used when defining a reflex logic for that error.
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Selecting Multi-tests and Profiles from the Setup submenu and then choosing
View/Define opens the Profiles View screen shown below.
The order in which the tests are entered in the Profile is one of the major
determinants of the analysis sequence of the tests when the profile is utilized.
The window on the left side of the screen displays a list of Profiles defined, while
the window in the middle displays the individual tests in the Profile highlighted on
the left.
Each Profile is assigned a unique numeric code (profile code: 1-99), and for each
there is an associated NOTE field. Notes can only be viewed on this screen.
The information shown for these fields can be viewed but not edited from this
screen. Several buttons are found near these fields:
Clicking the Details icon opens the Profiles Details screen, which allows editing
of the fields (refer to the specific section below).
Clicking the Print icon, followed by a confirmation window Do you really want to
print the current profile? Yes prints the selected profile setup; No will cancel the
operation.
Clicking the New Profile button allows the operator to access the New Profile
screen (refer to the specific section below).
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As mentioned above, any changes to be made to the fields shown in the Profiles
View screen are done through the Profiles Details screen, which opens by
clicking the Details icon.
NOTE: If you want to define a NEW profile, click the New Profile button to open
the New Profile screen, which has blank fields to be filled in (see below). Since
the purpose of the New Profile and the Profiles Details screens is very similar,
they have an identical design. When the fields are completed in the New Profile
screen, it becomes a Profiles Details screen.
Two fields in the top part of the screen display the Profile ID and the assigned
Profile Code. Two windows are located below: the window on the left displays all
Enabled Tests and the one on the right contains the tests that make up the
selected profile. Tests with an in cup dilution or in-session calibration cannot be
placed in a multi-tests profile, and must be run in the Single Test mode.
The user defines the tests in the profile with the help of the Arrow and the
Scissors icons to add and delete the tests from the enabled tests window to the
tests in profile window. The NOTE field at the far right is open for the user to add
desired comments (free text).
The materials map is automatically created as the tests are inserted according to
the default position defined in the Setup liquids. If a reagent’s default position for
a profile’s material map is already occupied by another reagent, the next
available “like” position is then automatically assigned. If all the positions in a
particular area R1 to R4, R9 to R12 (ACL Elite Pro only), R7 to R8, A1 to A10
and R5 to R6, are occupied, 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…R8/12) for the specific
liquid material
- Refrigerated: a check indicates that the selected liquid material must be
kept at 15°C, positions R1 to R4, R9 to R12 (ACL Elite Pro only)
- Stirred: a check indicates that the selected liquid material must be stirred by
the magnetic stir bar (positions R1 to R4)
- Needle: indicates which needle (sample or reagent) dispenses the selected
material.
Clicking the Confirm button saves the changes and clicking the Cancel button
rejects the changes; in both cases the system goes back to the Profiles View
screen.
The Globe icon allows modification of the profile names in the selected
language.
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Test Groups are predefined by IL. A User can create a new test group when
they are logged in at the Lab Manager security level.
Selecting Multi-Tests from the Setup submenu, and then choosing Test Groups
opens the Test Groups screen, shown below.
The window on the left side of the screen displays a list of the current groups of
tests, “Test Groups ID”, while the window on the right side displays the individual
tests in the highlighted Group.
Each Test Group is assigned a numeric code, and on the right there is space to
enter a NOTE for each. Notes can be viewed but not defined on this screen.
Clicking the Print icon, followed by a confirmation window Do you really want to
print Test Group? Yes prints the test group setup; No will cancel the operation.
For complete details it is recommended the Test Groups and individual Tests
parameters within the Test group be printed.
Clicking the Confirm button saves the changes and the system goes back to the
Main screen.
Clicking the Details icon in the Test Group screen opens the Test Group Details
screen shown below.
The test group ID and code are displayed in the upper part of this screen; on the
right there is space for the user to enter notes.
The larger window on the left of the screen is used to describe the sequence of
operations for each of the tests included in the specific test group, while the
smaller window on the right lists the tests enabled.
Clicking the Materials Map button opens the Tests Materials Map screen. This
screen is used to check the number and the characteristics of the positions
where the reagents for these tests are located (refrigerated or not; mixed or not;
use of sample or reagent needle). Note: the setup of the liquid materials is
described in Section 4.1.13.
Clicking the Material Check button, displays the actions to be taken by the
instrument when a low liquid level is detected. The actions can only be changed
after a test group is initially saved.
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Clicking the Confirm button saves the changes and the system goes back to the
Test Group Details screen.
The user can create test groups when they are logged in at the Lab Manager
level. When creating a new group there are several items that need to be
considered for tests to be compatible in the group.
Clicking the New Test Group button will opens a blank Test Group detail screen.
- The Enable Max Samples Value box limits the number of samples in a run
using this group. For IL locked groups users can edit (lower) the value at the
Lab Manager security level if “timeout expired during loading” errors occur.
- The list of available tests is displayed in the Enabled Tests box. Highlight
the desired test and move the test into the group using the arrow icon.
Repeat the step for all desired tests in the group. You will notice that the
steps for the second and all subsequent tests that are added into the group
are placed below the previous ones.
- Once all of the tests are placed into the group you then need to modify the
sequence of the pipetting steps. When you are doing this you need to
consider items such as grouping similar operations or moving pipetting
steps so they occur during incubations.
- The next thing you need to consider is the incubation time clocks. For
steps with a “set timer” time constraint you need to have a “wait until timer
expires” follow it. If you have two simultaneous steps with “set timer” the
system will respect the time for the first step when it encounters the “wait
until timer expires”. In this case the second timer is ignored if both tests are
run.
- Excessive optical reference steps must be deleted. The group only requires
one.
Test Group ID: Enter an ID name for the group (8 alphanumeric characters)
Test Group Code: Enter a unique numeric value between 501 – 999.
Double Samples: A check in this box will initiate all testing to be performed in
duplicate for this group.
Notes: This field can be used for free text comments about the test group.
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Assign Step No.: Pressing this button displays a window that allows you to
change the step number for the current step highlighted.
Add Step: This button opens the window that allows you to program a new step
for the group.
Refer to the Setup Tests Definition for details on filling in this screen
The following table contains a list of IL locked Test Groups and the tests
contained within it.
This area of the software allows users to define and view their own choice of Test
Groups to be run in Multi-Tests analytical sessions.
Selecting Multi-tests and Test Group Profiles from the Setup submenu and
then choosing New Test Group Profile opens the screen shown below.
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The window on the left side of the screen displays a list of Test Groups defined,
while the window in the middle displays the tests groups in the current Profile.
The user defines the tests groups in the profile with the help of the Arrow and
the Scissors icons to add and delete the groups from the left window to the right
window. The NOTE field at the far right is open for the user to add desired
comments (free text).
The materials map is automatically created when the test groups are inserted
according to the default position of the Setup liquids. If the default position for a
reagent is already occupied by another reagent, the next available “like” position
is then automatically assigned. If all the positions in a homogeneous area R1 to
R4, R9 to R12 (ACL Elite Pro only), R7 to R8, A1 to A10 and R5 to R6, are filled,
the liquid cannot be placed and a message warns the user that the tests group
cannot be added to the profile
The large window in the bottom of the screen reports the information for this
profile’s Materials Map:
- Liquid ID: the name of the materials used to analyze the selected profile
- Position: the selected position (A1…A10 or R1…R12) for the specific liquid
material
- Refrigerated: a check indicates that the selected liquid material must be
kept at 15°C, positions R1 to R4, R9 to R12 (ACL Elite Pro only)
- Stirred: a check indicates that the selected liquid material must be stirred by
the magnetic stir bar (positions R1 to R4)
- Needle: indicates which needle (sample or reagent) dispenses the selected
material.
Clicking the Confirm button saves the changes and clicking the Cancel button
rejects the changes; in both cases the system goes back to the Profiles View
screen.
If a Test Group profile needs to be modified after it is created and saved, the
original test group profile should be deleted and a new one created.
As mentioned above, any changes to be made to the fields shown in the Profiles
View screen are done through the Profiles Details screen, which opens by
clicking the Details button.
NOTE: Since the purpose of the New Profile and the Profiles Details screens is
very similar, they have an identical design. When the fields are completed in the
New Profile screen, it becomes a Profiles Details screen.
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Clicking the Print icon, followed by a confirmation window Do you really want to
print the current profile? Yes prints the selected profile setup; No will cancel the
operation.
Selecting Multi-Tests – Sort Multi-Tests from the Setup submenu opens the
Sort Multi-Tests screen, shown below.
The 3-windows on the left side of the screen list defined Profiles, Test Groups
and Test Group Profiles. A check mark on the left side of a defined item indicates
that item is in the Sorted Profile list.
The window on the right part of the screen displays all Sorted Profiles.
The Arrow and Scissors icons are used to sort profiles and groups. As the
operator selects the first entry and presses the Arrow icons, the profile/group is
copied from one position to another of the sorted profiles list in the right side
window. If a mistake is made, the Scissors icon is used to remove the profile
from the sorted list. The profile is inserted below the cursor. Profiles that are not
sorted will not be visible on the Multi-Tests Analysis menu drop down selection.
Clicking the Confirm button saves the changes and clicking the Cancel button
rejects the changes; in both cases the system goes back to the Main screen.
• ACTIVE BUTTONS at the bottom of this screen are:
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Selecting Multi-Tests from the Setup submenu, and then choosing Default
Multi-tests opens the Test Groups screen, shown below.
The box on the left lists all of the Multi-Tests Profiles and Test Group Profiles
created. Select the desired Default selection from the list and move it to the
column on the right using the Arrow. If you want to change the selected Default
Profile, use the scissor icon to remove.
To Enable Default Multi-Tests place a check in the box. The desired tests to
run still need to be programmed on a sample even though the Default Multi-tests
are enabled.
Selecting Liquids from the Setup submenu opens the Liquid Setup screen:
This screen displays the characteristics of all the liquid materials currently
configured in the system.
- LIQUID ID: the short name of the liquid material. For Control liquids this ID
can be all numeric (1 to 10 characters). This is the control ID sent to the
Host if the analyzer is interfaced. All other liquids must be an alphanumeric
ID
- LOT No.: the lot number of the material. Modification of the lot number will
automatically delete the currently stored ISI value, if applicable for the
reagent
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- WARNING VOLUME: quantity of liquid (in mL) below which the material
map position and reagent map icon colors will change from green to orange.
This field should be filled in for all reagents to be monitored. Volumes less
than 1 should be entered with a leading 0 (i.e. 0.5)
This screen also displays a “Used By” table showing the tests for which each
material is used. In this table, the user may also record the ISI values. For the
Calibrators, the user may enter the assigned value for the standard as reported
in the product insert sheet.
ISI and Calibration Plasma assigned values can be inserted by clicking the
Assign Value button and entering the value using either the keyboard or the
numerical keypad. The default setting for all assignments is blanked out. The
user must enter the calibrator values and ISI value prior to running the analyzer.
The calibrator value for the PT test run in the laboratory should be set to 100.
The ISI value is found on the PT reagent insert sheet and is lot specific
Note: Whenever the ISI value is modified, all the results will use the new ISI
value to calculate the INR. The ISI value entered must fall within the specified
ISI range as defined in the Liquid details for the PT reagent.
Note: The optional external barcode reader setup allows the operator to
configure the system to automatically reset the onboard stability and/or assigned
volume whenever a vial label is read. Respective data for these fields must be
entered into the liquid setup for this function to operate. Refer to section 4.1.16
for further details.
Note: For the IL locked PT tests the ISI value entered for the primary PT test is
automatically imported into the secondary tests (i.e. extended (e) and double (d)
tests). This option is also available for custom (non-IL locked) PT tests. Refer to
section 4.2.6 for further details.
INR FORMULA
ISI
INR = (PT Patient / PT Normal)
PT NORMAL = Mean* of the Normal Range (on the ACL ELITE/ELITE PRO this is called the Reference Value)
ISI value = International Sensitivity Index from the current lot # of thromboplastin reagent being used.
To assure appropriate reporting of INR results, you must follow these steps:
1. Make sure instrument is in the READY mode. From the SET UP MENU select the LIQUIDS SUBMENU,
then select the appropriate THROMBOPLASTIN REAGENT (LIQUID ID) from the list in the left upper part
of the screen.
2. Select the PT TEST that uses this Thromboplastin reagent and click on ASSIGN VALUE.
3. Enter the ISI VALUE of the Thromboplastin Lot in use and select Confirm twice to enter value. Make sure
that all PT tests using the same Thromboplastin import the proper ISI assignment. Several PT TESTS using
the same Thromboplastin may be present such as PT extended, PT duplicate standard and PT duplicate
extended acquisition time. These tests will import the value from the standard test.
NOTE: The ISI value is specific for the lot number of prothrombin time reagent being used.
4. From the SET UP MENU select TESTS VIEW/DEFINE. Select the appropriate PT test and click on details.
5. Select CALCULATION SETUP and the instrument will show in the right part of the screen the selection of
the REFERENCE VALUE. This represents the Mean of Normal Population value in SECONDS, which is
used as the DENOMINATOR in the RATIO and INR CALCULATION.
6. Make sure that the value entered in this field represents the MEAN NORMAL POPULATION RANGE of the
local PT population. This value is editable and can be modified to reflect the laboratory established mean
normal range.
7. Confirm all PT Tests using the very same thromboplastin lot for Ratio/INR will be calculated using the same
value in seconds as the denominator (Mean Normal Population Range).
8. The instrument uses the following formula for RATIO CALCULATION.
Using the Reference Value feature the denominator used in the Ratio and INR calculation will
accurately reflect the Mean of Normal Population Range.
*or Geometric mean
IMPORTANT WARNINGS:
• If the INR calculation is not properly setup, then erroneous patient results may be reported.
• If the product lot number changes, then the new ISI value from the package insert must be entered.
• In the ACL ELITE/ELITE PRO both screen and printout show/report Ratio and INR units separately
Note: Whenever the Calibration Plasma target values are modified, the stored
calibrations for the tests are automatically updated and all future results will be
calculated according to the new assigned value.
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A “Notes” field is available for the user to enter comments (free text).
Clicking the Details icon opens the Liquid Details screen that provides further
details about the selected material (refer to specific details below).
Clicking the New Liquid button opens the New Liquid screen for the user to
enter the characteristics of a new material (refer to specific details below).
Clicking the Confirm button saves the changes made and clicking the Cancel
button rejects the changes.
Clicking the Print icon and confirming the selection the liquid report is printed.
Clicking the Show Enabled checkbox, the list of liquids on the left will be
reduced to only display the liquids used by the enabled tests.
If the Show Enabled box is checked, QC liquids will not be visible on the list. To
view the QC liquids remove the check in the box.
A warning window opens after a change is made in any field: Liquid parameters
have been changed. Do you want to save them before proceeding? The operator
must select Cancel, Yes or No.
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:
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The following fields are “open” for the operator to enter the desired alphanumeric
digits (fields with the * are mandatory):
- LIQUID ID*: the abbreviated name of the material (10 characters). For
Control liquids only, this ID can be all numeric.
- LIQUID CODE*: the numeric code of the material (IL codes are reserved
from 1 to 500; user codes are from 501 to 999)
- EXPIRATION DATE: the expiration date as it is shown on the vial label. The
system will monitor this date and alert the operator in the session error
history screen when the liquid date has expired.
- WARNING VOLUME: quantity of liquid (mL) below which the material map
position and the reagent map icon colors will be changed from green to
orange This field should be filled in for all reagents to be monitored.
In the following fields the operator must make a choice among the given options:
In the following two areas the operator must “check” the checkbox if the liquid
requires the feature onboard (check = YES):
- REFRIGERATED (must use Reagent needle and positions R1 - R4 and R9
– R12)
- MIXED (must use Reagent needle and positions R1 – R4)
- IL LIQUID (dimmed)
Since only the first four positions of the Reagent Area (R1…R4) can be
refrigerated and mixed (on the ACL Elite Pro additional refrigerated only positions
are located in the area from R9 to R12), a warning window appears if the
operator tries to define an improper setup (i.e. a liquid is placed in position R5
and the operator checks the “Refrigerated” check box).
Clicking the Confirm button saves the changes and clicking the Cancel button
rejects the changes; in both cases the system goes back to the Liquid Setup
screen.
Clicking the Globe icon allows the user to modify the liquid ID and name in the
selected language.
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Other buttons in the screen are “checked” by the operator if the feature is desired
(check = YES):
- HOST QUERY
- DELETE AUTOMATICALLY AFTER TRANSMISSION (TX)
Selecting automatic deletion will not allow for re-transmission of results at a
later time.
- UNIQUE INSTRUMENT ID (a digit between 1 and 99 can be defined)
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Tests downloaded from the LIS that are disabled in the analyzer will not be
displayed on the database.
Clicking the Confirm button saves the changes and clicking the Cancel button
reject the changes; in both cases the system goes back to the Main screen.
Selecting Interfaces from the Setup submenu and selecting Printer opens the
Printer Setup screen:
A check in the Automatic Print-Out box indicates that this feature is desired.
Automatic Printout occurs at the end of each run within a rotor according to the
selected criteria (any analyzed, completed; cumulative or sample report).
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The user defines the SAMPLE REPORT DATA area by pressing the
Enable/Disable button. Choices are: the Instrument Name, the Normal Ranges
and the Date/Time.
Clicking the Customize Header button allows further customization of the report
by providing 5 lines of 30 characters each of free text to the user as entered in
the Custom Header screen.
On both screens - Printer Setup and Custom Header Setup, clicking the Confirm
button saves the changes and clicking the Cancel button rejects the changes; in
both cases the system goes back to the Printer Setup screen.
Note: The ACL ELITE?ELITE PRO support the use of a Parallel or USB
connection for the external printer. If the USB connection is used the printer must
be connected and turned on prior to the system being booted up. If the printer is
turned off while the instrument is on, the analyzer must be rebooted in order for
printing to occur.
The first step is to activate the Internal Barcode Reader by checking the
checkbox Internal BCR enabled seen on top of the screen.
The four fields visible on the screen correspond to the four families of barcodes
that may be activated on the ACL along with their corresponding subtypes of
barcodes.
For each field, the user must choose one of the options according to the
laboratory’s needs, as shown below.
CODABAR: Disabled
No Checksum
AIM Mod 16
NW7 Mod 11
NW7 Mod 16
INTERLEAVED 2 OF 5: Disabled
No Checksum
USS Mod 10
OPCC Mod 10
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Clicking the Confirm button saves the changes and clicking the Cancel button
rejects the changes; in both cases the system goes back to the Main screen.
The external barcode reader is an option that allows the reagent vial barcodes to
be read when the material map is displayed. Click on the External BCR
Enabled button to enable the feature.
The Code 128 dropdown box provides two selections: Disabled, No Checksum
Onboard stabilities and default liquid volumes must be defined for the two options
listed above to be functional.
When the material map is displayed the external barcode reader is active.
The external barcode reader can be used to read the label on the reagents.
The position to place the vial onboard the system will blink. If the lot number
Expiration date are invalid a warning message will be displayed.
Notes:
- The barcode device has been tested in accordance with EN60825-1 LED
safety, and has been certified to be under the limits of a Class 1 LED
device.
- The scanner’s housing is not water-tight; therefore do not submerge the
scanner in water. The scanner housing and window should be cleaned with
a soft cloth or facial tissue dampened with water or a mild water based
detergent. Do not clean the scanner or window with alcohol or solvents.
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Clicking the Confirm button saves the changes and clicking the Cancel button
reject the changes; in both cases the system goes back to the Keyboard Setup
screen.
Selecting System Configuration from the Setup submenu opens the System
Configuration screen:
This screen allows the user to select the preferred options for the following:
PATIENT DATABASE LISTING: defines the order of the patient samples in the
database; 4 options are available.
Options 1 and 2 are based upon date/time of sample entry and options 3 and 4
are based upon the Sample ID alphanumeric sort.
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Execute reflex before closing session: program tests and execute them
during the current session provided the tests are defined within the current
profile session in use.
Warning: If Liquid Sensors or the Wash-R Sensor are disabled both a warning
message and a flag on all sample results will be presented. If the Liquid Sensor
is disabled the operator must carefully monitor the volume of liquids and samples
to ensure adequate amounts are present for testing. The automatic host
transmission of results is disabled when the sensors are disabled. At the end of
each session a pop up box will alert the operator to confirm sufficient
sample/reagent remains onboard the analyzer. After confirmation of the
volumes, the operator may initiate a manual upload of the results to the host.
When the sensor is re-enabled the host communication will automatically be re-
activated.
REM Enabled: enable/disable the use of the Rotor Exchange Module. Not
applicable for the ACL ELITE. When the REM is disabled the
operator can use the system by manually loading the rotors.
Clicking the Confirm button saves the changes and clicking the Cancel button
rejects the changes; in both cases the system goes back to the Main screen.
This area of the software allows the Laboratory Manager to configure the
privilege level for the users (Supervisor or Operator) and define IDs and
passwords for all personnel using the ACL ELITE/ELITE PRO system.
The Laboratory Manager, using their password, will have access to the Lab
Manager View button.
Note: It is advisable upon installation of the system to enter a new Lab Manager
ID and password.
Clicking on the Lab Manager View button a screen where both Supervisor and
Operator access definition will appear.
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In this screen, for each menu/submenu, the level of entry can be defined by the
Laboratory Manager according to the specific laboratory needs.
LEVEL: From the drop down menu select the level to define: Supervisor, or
Operator
Note: The Lab Manager must define the screen access levels available to both
the Supervisor and Operator. Defining no access at the supervisor level for a
submenu does not automatically exclude access at the operator level.
For each menu/submenu the Laboratory Manager has three basic options:
No Access
Access, Edit*
*The V and E listed under the Environment column stand for View and Edit
No Access means that it will not be possible to enter in a menu or submenu; the
option will be dimmed.
Access-View Only means that access is possible. The screens can be viewed
but no modification can be performed.
Access-Edit means that the access is possible and Edit capability is available
(depending on the type of screen).
Selecting the Details icon after choosing the menu/submenu the above screen
will appear.
In the Access Mode box the Laboratory Manager can define the Access/No
Access for the specific menu/submenu.
If the Access option is chosen the Laboratory Manager can then define either
View Only or Edit capability for the selected menu/submenu.
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Press the New User button from the main Security entry screen to define new
users within the system.
USER NAME: type the user name (it must be unique). It is advisable to keep the
name short (minimum 3 and maximum 15 characters) as it will be used to log in
to the system.
EXTENDED USER NAME: type the extended user name to differentiate between
users. (Maximum 20 characters)
LEVEL: the Laboratory Manager will define for each user the entry level:
Lab Manager
Supervisor
Operator
When logging onto the system User Name and Password will be required.
It is recommended that when the system is not in use to log-out (using the key
icon) requiring the next user to log-in.
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Selecting Audible Alarms from the Setup menu opens the following screen:
Move the cursor to the desired Audible Alarm Condition and press the DeSelect
button to enable/disable the alarm for this condition.
If the alarm is enabled it will sound at a 60 second interval for up to one hour.
DATE FORMAT: in this field the user chooses among the following options:
In order to set date and time, two numeric fields are available.
Clicking the Confirm button saves the changes and clicking the Cancel button
rejects the changes.
Warning: Changing date to a prior date may impact the result (Patient, QC,
Calibration & AR) database FIFO operation. Results processed on dates furthest
from the current system date will be the first ones to be automatically deleted.
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Selecting Units from the Setup submenu opens the Units screen:
Clicking the Confirm button saves the changes and clicking the Cancel button
rejects the changes; in both cases the system goes back to the Main Screen.
Warning: After defining a new or copied test, the test settings should be printed
and verified to confirm correct entry. IL assumes no responsibility for the
performance of non-IL locked tests on the analyzer. Each laboratory must verify
and confirm the validity and results of the user defined tests definitions.
Selecting Tests from the Setup submenu and then choosing View/Define opens
the View Tests screen:
On top of the test list a rectangular box will show the number of tests present in
the Library Application. The box will show two numbers: the enabled tests and
the total number of tests. The system can store 100 user defined and 200 IL
locked tests.
The large window on the left of the screen displays a table of all configured tests.
Each test is identified by an abbreviated name, Test ID, shown on the right side
column. Both columns to the left of the test names contain checks to indicate
whether each test is:
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TEST CODE
TEST REVISION
TEST CODE FOR HOST
EXTENDED NAME
CALIBRATION MODE
The information shown in these fields can be viewed but not edited from this
screen. Several buttons are found around these fields:
Clicking the Details icon opens the Test Details screen which allows editing of
the fields (refer to the specific section below).
Clicking the Printer icon followed by a confirmation window “Do you really want
to print?” Yes allows the operator the choice to print the Test Setup of the
selected test; No will cancel the operation.
The test database can contain up to 300 tests; 200 reserved for IL applications
and 100 reserved for customized applications; up to 100 tests can be enabled
(active) at the same time.
Clicking the Show Enabled check box allows the operator to view only the
enabled tests from the test table. When this checkbox is marked the list
presented is relative to the enabled tests. This information is saved exiting from
this screen and also at power off.
Clicking Delete erases only the open tests (customized); IL predefined tests
cannot be deleted.
The upper field indicates the “Test to be Copied”; the list contains all the tests
present in the test database.
The NEW TEST ID field allows the operator to name the new test (8 characters
maximum). This is a mandatory field.
The EXTENDED NAME field allows the operator to name the new test with a
more detailed name (15 characters maximum).
The TEST CODE FOR HOST represents the numeric code for the Host
communication (four characters).
The TEST CODE is a unique numeric field (four characters maximum). This is a
mandatory field. The acceptable test code range for Non-IL locked tests is
between 501 and 999.
The TEST REVISION helps the operator to keep track of the changes in the
application. The number must be keyed in manually (4 characters maximum).
The Confirm/Cancel button saves or rejects the changes and the system returns
to the View Test screen.
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The Test Details screen is shown below. For new tests the fields will be blank,
while those for copied tests will contain the settings from the original test that was
copied.
• TEST ID – 8 characters
This field is editable for all tests including the IL predefined
tests. The TEST ID must be unique for each test. The TEST
ID is used for ordering tests as well as reviewing results
(i.e. TEST ID column).
The TEST ID is printed in the cumulative report.
At least one alpha-numeric character is mandatory.
• TEST CODE - 3 characters
This field is editable in an open test but not in the IL locked tests.
Available numbers for the open assays are from 501 to 999
The IL Test box indicates this test is locked with minimal user modifications
allowed when the box is checked.
The Parallelism ( // ) box indicates parallelism is defined for this test when the
box is checked.
Note: When defining a new test the Ranges should be entered after all of the
subsections (Analysis, Calibration, Acquisition and Calculation) of the test setup
are defined.
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Show in sample list If the unit has been checked (Yes) the selected unit is
displayed in the patient database and printed.
Note: This setting has no impact on transmission of results to a Host system.
All units for a test are always transmitted regardless of the setting in this
checkbox.
Result Unit Units that are available in the selected test (from 1 to 4).
Normal Range Defines the normal range for each unit. Minimum and
Maximum values can be typed in. The normal range is
used to flag patient results. On the screen, the results are
displayed in black when within the Normal Range; the
results are displayed in violet when outside the Normal
Range; on the printout an asterisk will be printed (close to
the results out of normal range).
Test Range Defines the test range for each unit (i.e. Linearity Range).
Minimum and Maximum values cannot be edited in IL test
applications but can be edited in the customized
applications. The test range is used to flag patient results.
Values outside the Test Range are displayed in red; on
the printout these results will be in bold print.
Scale Range Numerical reporting range for the test. Numerical values
outside the scale range high are presented as asterisks
(***), and values outside the range low are presented as
dashes (---). Minimum and Maximum values cannot be
edited in the IL test applications but can be edited in the
customized applications.
Reaction Curve Graph Defines the Y-axis of the reaction curve (minimum and
maximum values). If fields are left blank, the system will
auto-scale based on the raw data obtained.
The value is used for R (Ratio) and INR calculation for the tests.
This value is the denominator of the R and INR calculation and it should
represent the mean normal population time for the selected test.
The reference value for the standard test can be automatically imported into the
secondary related tests. For example, the PT (standard test) reference value will
be automatically imported into the Pte, PTd and Pted (secondary) tests. The
automatic import is built into the IL locked tests. For non-IL locked tests this
feature can be used if the tests are setup to do so. Refer to the Calculation
Setup section for more details
Clicking on the Unit Correction button it is possible to correct result units based
on a mathematical equation.
The calculated units for the tests can be corrected on this screen (i.e. %, R, INR,
g/L, mg/dL, U/mL, etc.), while the primary units (i.e. seconds, delta, absorbance,
etc.) can be corrected in the Calculation Section 4.2.6. Test results for IL locked
tests that have correction parameters entered for the primary (measured) unit will
display “Lab correlation applied” in the warning list box when the clot curve is
displayed.
Y = mX + q
where “m” represents the slope and “q” the intercept on the Y axis.
X is the original result and Y is the corrected results.
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Minimum and Maximum Interval values represent the range of unit where the
correction is expected to be active. The values for these fields should be positive
numbers within the test range for the selected test.
For “m” and “q” coefficients both positive and negative value coefficients can be
entered.
Correction Parameter (when not defined by IL in the IL Locked Test Applications)
definitions used are the responsibility of the laboratory personnel.
3. Acquisition setup
4. Calculation setup
5. Ranges setup
Warning: When a new application is defined please consider that major changes
to the Analysis step setup (i.e. adding or removing steps), the
Calibration step setup (i.e. adding or removing calibration points) and
the Acquisition setup (i.e. change in acquisition time) will erase all the
Calculation setup conditions. This is done to prevent conditions of
possible test inconsistencies. For this reason it is important to ensure
the Analysis loading, Calibration Loading and Acquisition Setup is
correct before defining the Calculation Setup.
It is advisable before any change is done to an open test either new or copied, to
print the parameters in order to have a reference to use when re-entry of
calculation setup is needed.
When a new application is defined please consider that minor changes to the
Analysis step setup (i.e. change of a liquid name or volume in an existing step)
and the Calibration step setup (i.e. change of a liquid name or volume in an
existing step) will not erase the Calculation setup conditions.
TEST
DETAILS
CLEANING
ANALYSIS:
LOADING
SETUP
REAGENT
PRIMING
STEP SETUP
(single step)
MATERIAL
CHECK
PARAMETERS PARAMETERS
Sample line Reagent Line
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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.
Double Samples checkbox: check this box to run tests in duplicate mode.
Checking of the mean value is enabled under Calculation Setup
Step: this is the order of the execution of the analysis step by step.
Add button: this button is used to define in detail all the steps of the analysis. A
single step is the action of aspirating/dispensing liquids. A step can be carried out
by the sample needle the reagent needle or by both needles. The final result of a
step is the completion of a scope.
Note: Cuvette volume for a reaction must be no less than 150ul and no greater
than 250ul.
Once the scope is defined, it is necessary to define which needle will be used to
aspirate/dispense the liquids.
The parameters button for entering the Sample or Reagent line opens the Step
Setup Parameters window.
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The Loading parameters for the Sample and Reagent needle can be defined as
No Loading, No Dilution, In Line Dilution or In Cup Dilution.
In Line Dilution: A diluent and the sample are aspirated one after the other and
dispensed together. The following fields must be entered.
• Diluent Liquid ID: choose the diluent liquid from the list
• Diluted Liquid ID: choose the liquid to be diluted from the list
• Volume: enter the volumes for each liquid in microliters (minimum single
liquid=2; maximum total volume is 140).
In Cup Dilution (Sample needle only): Diluent and sample are dispensed in an
empty (0.5mL) cup when a very high dilution is needed.
The In Cup Dilution option is not available for the reagent needle as this needle
cannot aspirate/dispense in the sample tray area.
• Pre-dispensed Liquid ID: choose the diluent from the liquid list*
• Diluent Liquid ID: choose the diluent from the liquid list*
• Diluted Liquid ID: choose the liquid to be diluted from the list (i.e. plasma)
• Volume: enter the volumes in microliters (minimum single liquid=2;
minimum total cup volume=150; maximum total cup volume is 250).
The Washing field must be entered if a wash cycle is needed after each cup
dilution is completed. The value refers to the number of cycles and the range is
1-5.
The position of the empty (0.5mL) cup in the sample tray is defined by checking
the Inner Ring (A1- A10) or Outer Ring checkbox.
*When a highly diluted sample is required, the diluent must be added in two
phases. The diluent used in the first phase is called "pre-dispensed liquid". The
diluent used in the second phase, together with the sample, is called "diluent
liquid".
Warning: when a low volume sample needs to be dispensed, it is advisable to
use the In Line Dilution option or the In Cup Dilution option. It is not
recommended to dispense a low sample (below 10 microliters) alone
without any diluent/buffer.
Intermediate Rinse checkbox: if checked, the needle is dipped in the
waste/rinse reservoir to wash the exterior of the probe. This action is
recommended when low volumes are used.
Wash R. checkbox: if checked, the needles are washed in the rinse before
starting the next step. Must be activated to run washing between loading.
Washing between loading: defines how many rinse cycles are performed
between any sample line loading or between any reagent line loading. The
minimum is 0 and the maximum is 5.
Washing at step completion: defines how many rinse cycles are performed at
the end of the loading phase for both the sample line and reagent line for this
step. The minimum is 0 and the maximum is 5.
Timing constraint: some steps can be more critical on timing than others. For
these it is necessary to define a time interval that must be honored in the defined
step(s).
Step length: It is possible to define the time interval within which a single
step must be completed. The loading time is included in the total step
length. The system will wait for the remainder of the step length time if
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loading is complete before the time limit elapses. Mixing will occur after
the step length time expires.
Set timer: At the end of the loading phase of the defined step, a TIMER
is set for a certain amount of seconds; this timer will be used across the
next loading step(s) (i.e.: the Cephalin step incubation time in the APTT
test has to wait for the step of the Calcium Chloride). Subsequent steps,
up to a Wait timer step, are executed immediately, only the timer is set.
Wait until timer is expired: The loading step is executed after the time
of a previously SET TIMER step expires (i.e.: the CaCl2 step in the APTT
test has to close the timer previously opened).
Note: Set Timer and Wait until timer is expired are used when a timer
spans across several steps (minimum of two). In this case the time will go
across multiple steps. When Set Timer is defined in one step, a
subsequent step must have a Wait until timer is expired condition in
order to close the timer opened previously. Both conditions of Set Timer
and Wait until timer is expired have to be used in one application
definition.
Time in seconds for the timing constraint field can be defined from 1 to 999
seconds (0 means disabled).
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 Confirm/Cancel button leaves the screen saving or rejecting the changes
and the system goes back to the Main screen.
As soon as one step is entered, the details button becomes active and it can be
pressed to review and edit the fields.
The Delete icon can be used to delete a step in the analysis sequence.
CLEANING
From the Analysis: Loading Setup Screen, press the Cleaning button to display
the cleaning setup screen.
This screen is used to define the liquid and its volume used for cleaning the
reagent line and the sample line.
When the cleaning procedure is defined, it is carried out after the last step of the
test cycle.
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The total volume has to be within 10-140 microliters, independent from Diluent
Liquid only, Diluted Liquid only, both Diluent and Diluted Liquids.
Cycles no.: this is the number of the cycles (minimum 1 – maximum 5). If 0 is
entered no cleaning is performed.
The Confirm/Cancel button leaves the screen saving or rejecting the changes
and the system goes back to the Main screen.
REAGENT PRIMING
From the Analysis: Loading Setup Screen, press the Reagent Priming button to
display the reagent priming setup screen.
This screen is used to define the liquid and its volume to be used for reagent
priming for the reagent line and/or the sample line.
When the reagent priming procedure is defined, it is carried out at the beginning
of the test cycle (before the first step).
When Reagent Priming is defined, the interfering tests that will trigger the prime
need to be activated using the Interference Table setup in section 4.1.5.
Liquids can be defined as Diluent Liquid ID and Diluted Liquid ID which means
that it is possible to use a single solution or to dilute the solution with another
liquid.
The total volume has to be within 10-140 microliters, independent from Diluent
Liquid only, Diluted Liquid only, both Diluent and Diluted Liquids.
Cycles no.: This is the number of the cycles (minimum 1 – maximum 5). If 0 is
entered, no reagent priming is performed.
Before and after the reagent priming, a wash (using the Wash-R emulsion)
procedure can take place; a number can be defined (minimum 1- maximum 5).
Perform Sequentially: If checked, one line (sample needle line) is primed before
the other line (reagent needle line); if not checked, the reagent priming is
performed at the same time.
Washing at completion defines the washing done by the Wash-R Emulsion and
number of cycles at the end of the reagent priming cycle (minimum 1 - maximum
5).
The Confirm/Cancel button leaves the screen saving or rejecting the changes
done and the system goes back to the Main screen.
MATERIALS CHECK
Once all the liquids are configured, it is possible to define whether the instrument
checks for the presence of the liquid container during the pre-analytical check.
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If a liquid is selected to be checked, you can define what actions to take if the
liquid becomes low during the analysis.
The Check in Pre-Analysis option defines if the analysis may start even if the
liquid is not present (optional presence). This applies to materials in positions A1
– A10 on the sample tray.
If the liquid is marked as mandatory, the analysis cannot start without it and the
options of Check and Continue or Abort are presented after the pre-analysis
checks.
If the liquid is not marked as mandatory, the analysis can start without it and the
Continue option is also presented after the pre-analysis checks allowing the
analysis to continue without a specific liquid.
The Check Selected Row box is used to define the liquid as mandatory.
The Check Selected Row option can only be used for the liquids positioned in A1
to A10 (auxiliary sample tray positions).
The available Actions of the system when a liquid is low are as follows:
Complete possible and signal: In this case if the liquid becomes low
during the session, the samples that had sufficient liquid aspirated and
dispensed will be completed; while those, after the low reagent condition
was detected, will be kept on hold and the system will warn the user.
Tests after the low condition remain pending. The run can be restarted
by refilling the reagents after session completion
Just signal: The instrument will only advise the operator that a liquid is
low but it will continue to perform all pipetting operations.
The Confirm/Cancel button leaves the screen saving or rejecting the changes
and the system goes back to the Main screen.
TEST
DETAILS
CLEANING
CALIBRATION
LOADING
SETUP
REAGENT
PRIMING
STEP SETUP
(single step)
MATERIAL
CHECK
PARAMETERS PARAMETERS
Sample line Reagent Line
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Click the Calibration: Loading Setup button to view/edit the liquids (reagents,
calibrators) setup in the trays during the test calibration.
This screen is used to define all the steps needed to carry out a calibration.
Test ID: in this field the test ID previously defined is displayed. This field is
present in all the screens of the test setup.
The Delete icon can be used to delete a step in the calibration sequence.
Add button: This button is used to define in detail a step of the calibration. A
single step is the action of aspirating/dispensing liquids. A step can be carried out
by the sample needle the reagent needle or by both needles. The final result of a
step is the completion of a scope.
- Sample
- Standard (1-2-3-4-5-6)
Once the scope is defined, it is necessary to define which needles will be used to
aspirate/dispense the liquids in the step.
The Loading type for the needle of the sample line may be defined; here is the
definition of the Sample and/or Reagent line.
In Line Dilution: A diluent and the sample are aspirated one after the other and
dispensed together.
In Cup Dilution: Diluent and sample are dispensed in an empty cup when a very
high dilution is needed.
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The parameters button for either the Sample or Reagent line opens the Step
Setup Parameters window.
No Dilution: The liquid is aspirated and dispensed as it is. The following fields
must be entered:
In Line Dilution: A diluent and the liquid are aspirated one after the other and
dispensed together. The following fields must be entered:
Diluent Liquid ID: choose the diluent from the liquid list
Diluted Liquid ID: choose the liquid to be diluted from the list (i.e. cal
plasma)
"In Cup dilution" option (Sample Probe option only) dilutes the material in an
empty 0.5mL cup prior to loading into a cuvette on the rotor. Used when a high
dilution ratio of material is required. The following fields must be entered:
Pre-dispensed Liquid ID: choose the diluent from the liquid list*
Diluent Liquid ID: choose the diluent from the liquid list*
Diluted Liquid ID: choose the liquid to be diluted from the list (i.e. cal
plasma)
*In case a highly diluted sample is required, the diluent must be added in two
phases. The diluent used in the first phase is called "pre-dispensed liquid". The
diluent used in the second phase, together with the sample, is called "diluent
liquid".
The In Cup Dilution option is not available for the reagent needle as this needle
cannot aspirate/dispense in the sample tray area.
The position of the empty cup (0.5mL) in the sample tray is defined by checking
the Inner Ring or Outer Ring checkbox. Standard dilutions must use the Outer
Ring.
The Confirm/Cancel button leaves the screen saving or rejecting the changes.
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Wash R. checkbox: if it is checked, the needles are washed in the rinse before
starting the next step.
Washing between loading: Defines how many rinse cycles are performed
between any sample line loading or between any reagent line loading. The
minimum is 0 and the maximum is 5. Each wash cycle rinses with 130ul of Wash-
R.
Washing at step completion: it is possible to define how many rinse cycles are
to be performed at the end of loading phase for both sample line or reagent line.
The minimum is 0 and the maximum is 5. Each wash cycle rinses with 130ul of
Wash-R.
Timing constraint: since some steps can be more critical than others, it is
necessary to define some time interval that must be honored in the defined
step/s.
Step length: It is possible to define the time interval within which a single
step must be completed. The loading time is included in the total step
length. For example, the loading of the substrate in the AT test: activation
time must be respected because it is a critical step in the reaction.
Note: Set Timer and Wait until timer is expired are used when a time
has to include several steps (minimum of two). In this case the time will
go across multiple steps. When Set Timer is defined in one step, a
subsequent step must have a Wait until timer is expired condition in
order to close the timer opened previously. Both conditions of Set Timer
and Wait until timer is expired have to be used in one application
definition.
Set timer: At the end of the loading phase of the defined step, a TIMER
is set for a certain amount of seconds; this timer will be used across the
next loading steps (i.e.: the Cephalin step incubation time in the APTT
test has to wait for the step of the Calcium Chloride). Subsequent steps,
up to a Wait Timer step, are executed immediately, only the timer is set.
Wait until timer is expired: The loading step is executed when the time
of a previously SET TIMER step expires (i.e.: the CaCl2 step in the APTT
test has to close the timer previously opened).
Time in seconds for the timing constraint field can be defined from 1 to 999
seconds (0 means disabled).
Mixing area: If in the current step is necessary to mix the contents of the rotor
cuvette, the ramp checkbox must be checked.
The following fields must be filled in.
Centrifugation Time: rotor may spin from 1 second to 999 seconds. If the value
0 is input, the rotor will not spin.
Inter-ramp Interval: If the rotor is stopped after the first acceleration, this interval
must be defined. The minimum is 1 second and the maximum is 10 seconds. If 0
is input, no inter-ramp will occur.
The Confirm/Cancel button leaves the screen saving or rejecting the changes.
As soon as one step is entered, the details button becomes active and it can be
pressed to review and edit the fields.
CLEANING
From the Calibration Loading setup screen, Press the Cleaning button to display
the cleaning setup.
This screen is used to define the liquid and its volume to be used to clean the
reagent and sample lines.
When the cleaning procedure is defined, it is carried out after the last step of the
test cycle.
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The total volume has to be within 10-140 microliters, independent from Diluent
Liquid only, Diluted Liquid only, both Diluent and Diluted Liquids.
The Confirm/Cancel button leaves the screen saving or rejecting the changes
and the system goes back to the Main screen.
REAGENT PRIMING
From the Calibration: Loading Setup Screen, press the Reagent Priming button
to display the reagent priming setup screen.
This screen is used to define the liquid and its volume to be used for reagent
priming for the reagent and/or sample lines.
When the reagent priming procedure is defined, it is carried out at the beginning
of the test cycle (before the first step).
When Reagent Priming is defined, the interfering tests that will trigger it need to
be activated using the Interference Table setup in section 4.1.5.
Liquids can be defined as Diluent Liquid ID and Diluted Liquid ID which means
that it is possible to use a single solution or to dilute the solution with another
liquid.
The total volume has to be within 10-140 microliters, independent of Diluent
Liquid only, Diluted Liquid only, both Diluent and Diluted Liquids.
Cycles no.: this is the number of the cycles (minimum 1 - maximum 5). If 0 is
entered, no reagent priming is performed.
Perform Sequentially: if checked, the sample line is primed before the reagent
line; if not checked, the reagent priming is performed at the same time.
Washing at completion defines the washing done by the Wash-R Emulsion and
number of cycles at the end of the reagent priming cycle (minimum 1 – maximum
5). Each wash cycle rinses with 130ul of Wash-R.
The Confirm/Cancel button leaves the screen saving or rejecting the changes
and the system goes back to the Main screen.
MATERIALS CHECK
Once all the liquids have been configured, it is possible to define whether the
instrument checks for the presence of the liquid, and also what action to take if
the liquid volume is low.
If a liquid is selected to be checked, you can define what actions to take if the
liquid becomes low during the analysis.
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The Check in Pre-Analysis option defines if the analysis may start if the liquid is
not present (optional presence).
If the liquid is marked as mandatory, the analysis cannot start without it and the
message Check and Continue or Abort is presented after the pre-analysis
checks.
If the liquid is not marked as mandatory, the analysis can start without it and the
Continue option is presented after the pre-analysis checks allowing the analysis
to continue without a specific liquid.
The Check Selected Row box is used to define the liquid as mandatory.
The Check Selected Row option can only be used for the liquids positioned in A1
to A10 (auxiliary sample tray positions).
The available Actions of the system when a liquid is low are as follows:
Complete possible and signal: In this case if the liquid becomes low
during the session, the samples that had sufficient liquid aspirated and
dispensed will be completed; while those, after the low reagent condition
was detected, will be kept on hold and the system will warn the user
(tests after the low condition will remain pending).
Just signal: The instrument will only advise the operator that a liquid is
low but it will continue to perform all pipetting operations.
The Confirm/Cancel button leaves the screen saving or rejecting the changes
and the system goes back to the Main screen.
INTER-RAMP DATA
TIME TIME
Inter-Ramp Interval, Delay Time and Acquisition Time are defined according to
the application.
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First mixing ramps (ramp up and down) are set at 0.8 seconds total.
Second ramp up after the inter-ramp interval and before the acquisition delay is
set at 0.4 seconds.
ACQUISITION DELAY: time where no data points are recorded during the
acquisition (1-60). If 0 is entered, no delay is considered.
SAMPLING RATE: interval between the data points in milliseconds (50 to 1000
milliseconds in 50 millisecond interval)
The Confirm/Cancel button leaves the screen saving or rejecting the changes
and the system goes back to the Main screen.
TEST
DETAILS
CHECKS
CALCULATION
SETUP
DEFINE
PARAMETERS
CALIBRATION
SETUP
CALCULATION
ALGORITHMS
CALIBRATION DEFINE
CURVE SETUP PARAMETERS
CALCULATION
ALGORITHMS
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Click the Calculation: Setup button to view/edit the data calculation settings for
the test.
This screen is used to define all the steps needed to manage the raw data
(calibration and analysis).
Test ID: In this field the test ID that has been previously defined is displayed.
This field is present in all screens of the calculation setup.
Normalization: two criteria may be selected: S/R * 100 or 2 * log (R/S). The first
algorithm is commonly used for the clotting assays, while the second is mostly
used for chromogenic assays. S means the value (in mV) of the sample and R
means the value (in mV) of the Wash-R emulsion (for S/R*100) and also the
Optical Reference (for 2 * log (R/S)).
Scope: Defines the calculation for all the steps defined in the loading step setup:
Ratio: Select the formula used to calculate the Ratio. Available options are:
- R = S / Std 1
- R = S / Std 2
- R = S / Std 3
Import Ref Value from: Select either None or a test from the drop down list.
The reference value entered for the primary test is automatically imported into
the secondary tests (i.e. extended (e) and double (d) tests). This value is the
denominator of the R and INR calculation and should represent the geometric
mean of the normal population time for the selected test.
Normalized Ratio: Select the formula from the drop down list.
- INR = R^ISI
Import ISI Value from: Select either None or a test from the drop down list.
The ISI value entered for the primary test is automatically imported into the
secondary tests (i.e. extended (e) and double (d) tests).
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NONE
TREND
ALGORITHM
Page 4.88
THRESHOLD
Page 4.89
ALGORITHM
TYPE
THRESHOLD
2nd DERIVATIVE
Page 4.92
FIRST
DERIVATIVE
Page 4.96
2nd
DERIVATIVE
Page 4.98
DELTA
Page 4.101
Once the Algorithm type has been selected the Define Parameters screen can
be accessed to define the calculation of the selected Algorithm Type. To clear
parameter settings for a test select the Delete Parameters button.
None
No algorithm is applied. Only the raw data will be available.
Trend Algorithm
Selecting Trend the following selections are possible:
Presented Units
The available units for the Trend algorithm are the first part of reaction curve
Offset/Minimum and the Final/Maximum for the final part of the curve.
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Curve Checks
The Confirm/Cancel button leaves the screen saving or rejecting the changes
and the system goes back to the Main screen.
Threshold Algorithm
Selecting Threshold the following selections are possible:
Two smoothings can be selected in terms of number of points: 1st Smooth and
2nd Smooth.
Smoothings are calculated using the moving average mean criteria; the criteria to
calculate the moving average mean is defined by the number of points (degree)
used to calculate the new smoothed values.
Delta Check defines the minimum acceptable delta for the normalized data
reaction curve.
The reaction curve can be analyzed in two areas: the First Part (Offset or Min)
and the Final Part (Final or Max). Number of points to calculate the Offset/Final
value or determine the Min/Max for the two parts of the curve can be defined.
Pressing the Threshold Parameters button will display the following window
o
The 1 Threshold Parameters window allows you to set the following
parameters.
The Threshold Search Direction provides the option to search for the threshold
value in the Forward (starting from the beginning of the reaction) or Backward
(starting from the end of the reaction and moving toward the beginning) direction.
Curve Checks
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Initial Slope checks for non-phasic curves. It represents the initial slope of the
reaction curve at the beginning of the acquisition time. If the minimum slope
check is not met an error will be generated.
Three correction intervals can be defined and a corresponding slope (m) and
intercept (q) value can be entered.
Five smoothings can be selected in terms of number of points: 1st Smooth, 2nd
Smooth and 3rd Smooth is used for the raw data; the 4th and 5th Smoothings
are used for the First Derivative.
Smoothings are calculated using the moving average mean criteria; the criteria to
calculate the moving average mean is defined by the number of points (degree)
used to calculate the new smoothed values.
The reaction curve can be analyzed in two areas: the First Part (Offset/Min) and
the Final Part (Final/Max). Number of points used to calculate the Offset/Final
values or determine the Min/Max for the two curve areas can be defined.
Delta Check defines the minimum acceptable delta for the normalized data
reaction curve.
Presented Units
Time in seconds (calculated from the first threshold or the maximum peak of the
second derivative) is usually the presented unit. Other available units include the
First Part Offset/Minimum and the Final Part Final/Maximum values.
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o
The 1 Threshold Parameters window allows you to set the following
parameters.
The Threshold Search Direction provides the option to search for the threshold
value in the Forward (starting from the beginning of the reaction) or Backward
(starting from the end of the reaction and moving toward the beginning) direction.
Click on the Backwards Threshold Settings box to enable calculation from the
end of acquisition time moving backwards to the beginning.
Threshold Mode allows selection of Absolute (total) or % of Curve to calculate
the threshold.
Value field defines where the clot time should be taken; a numerical value
should be entered. The threshold represents a fixed change in turbidity from the
initial offset of the reaction curve.
Curve Check
Accessing the Curve Check Parameters window it is possible to make the
following selections.
Initial Slope checks for non-phasic curves. It represents the initial slope of the
reaction curve at the beginning of the acquisition time. Number of points and
slope value can be entered. If the slope check is not met the raw data will be
analyzed using the Second Derivative criteria.
st
1 and 2nd Derivative can be enabled and minimum acceptable delta limits
defined.
Noise Check 1 - If enabled, the system will determine the clot time searching
backwards through the data curve for a value that is a percentage of the curve
delta. The desired percentage is entered in the Percent field. The delta
between the original time (time or threshold) and the backward calculation time is
determined. The Max Time Delta value is the maximum allowable time delta
between the two values.
Noise Check 2 - If enabled the system seeks the next maxima value or time
starting from the original value or time. If there is no further drop in the
normalized data curve then the local maxima value and time will equal the
original.
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In the Points field enter the minimum number of points the curve must fall in
order for the local maxima to be considered a true peak. The Min Peak Delta is
the percentage of the overall delta of the curve the local max value must exceed
in order for it to be considered a true peak. The Min Decrease is the minimum
difference in signal (absolute) for the local maxima to be considered a true peak.
Three Correction Intervals can be defined and a corresponding slope (m) and
intercept (q) value can be entered.
Five smoothings can be selected in terms of number of points: 1st Smooth, 2nd
Smooth and 3rd Smooth are used for the raw data; the 4th and the 5th
Smoothings are used for the First Derivative.
Smoothings are calculated using the moving average mean criteria; the criteria to
calculate the moving average mean is defined by the number of points (degree)
used to calculate the new smoothed values.
The reaction curve can be analyzed in two areas: the First Part (Offset/Min) and
the Final Part (Final/Max). Number of points used to calculate the Offset/Final
values or determine the Min/Max for the two curve areas can be defined.
Delta Check defines the minimum acceptable delta for the normalized data
reaction curve.
Presented Units
Time in seconds is usually the presented unit. Other available units include the
First Part Offset/Minimum and the Final Part Final/Maximum values.
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Three Correction Intervals can be defined and a corresponding slope (m) and
intercept (q) value can be entered.
The correction is represented by the formula Y = mX + q where “m” represents
the slope and “q” the intercept on the Y axis.
Minimum and Maximum Interval values represent the result range where the
correction is applied.
For “m” and “q” coefficients both positive and negative value coefficients can be
entered.
The Confirm/Cancel button leaves the screen saving or rejecting the changes
and the system goes back to the Main screen.
Curve Check
Accessing the Curve Check Parameters window it is possible to make the
following selections.
First Derivative limit check in terms of absolute value to be used to verify that a
proper clot is occurring.
First Part - the initial turbidity check value of the reaction versus the value
Second Derivative – enter the number of points to use and check limit value to
verify that a proper clot is occurring.
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st
1st Derivative calculated using number of points entered. 1 derivative is the
velocity of the reaction
nd
2nd Derivative calculated using number of points entered 2 derivative is the.
acceleration of the reaction and can be used to find the clotting point searching
for the maximum peak of the second derivative.
Five smoothings can be selected in terms of number of points: 1st Smooth, 2nd
Smooth and 3rd Smooth are used for the raw data; the 4th and the 5th
Smoothings are used for the First Derivative.
Smoothings are calculated using the moving average mean criteria; the criteria to
calculate the moving average mean is defined by the number of points (degree)
used to calculate the new smoothed values.
The reaction curve can be analyzed in two areas: the First Part (Offset/Min) and
the Final Part (Final/Max). Number of points to be used to calculate the average
or determine the Min/Max for the first and final parts can be defined.
Delta Check defines the minimum acceptable delta for the normalized data
reaction curve.
Presented Units
Second Derivative value defines when the maximum peak of the second
derivative should give a result as time in seconds; a numerical value should be
entered.
Three Correction Intervals can be defined and a corresponding slope (m) and
intercept (q) can be entered.
Delta Algorithm
Two Smoothings (1st and 2nd) can be selected in terms of number of points.
Smoothings are calculated using the moving average mean criteria; the criteria to
calculate the moving average mean is defined by the number of points (degree)
used to calculate the new smoothed values.
The reaction curve can be analyzed in two areas: the First Part (Offset/Min) and
the Final Part (Final/Max). Number of points to be used to calculate the average
or determine the Min/Max for the first and final parts can be defined.
Delta Check is the minimum acceptable delta for the normalized curve data.
Presented Units
Delta is in general the presented unit, other units such as the Offset/Minimum
and the Final/Maximum of the reaction can be chosen.
The Confirm/Cancel button leaves the screen saving or rejecting the changes
and the system goes back to the Main screen.
Curve Checks
Accessing the Curve Check Parameters window it is possible to make the
following selections.
st
1 Threshold defines where one of the checks on the clot curve should be taken;
a numerical value should be entered. This value is used as verification that a real
clot curve is present. The threshold represents a fix change in turbidity from the
initial offset of the reaction curve.
Offset Min checks the reaction to see if the offset value is less than this value. If
the offset is less than the value the response is failed.
The Check Saturation checkbox activates a control on the reaction curve
readings to ensure they are within the hardware optical limit.
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 verification
that a real clot curve is present. The second threshold is used to discriminate
between real clot curves and noisy or unstable clot curves or low Fibrinogen.
Initial Slope checks non-phasic curves; it represents the initial slope of the
reaction curve at the beginning of the acquisition time. Number of points and
slope value can be entered (numerical values).
Final Slope checks non-phasic curves; it represents the final slope of the
reaction curve at the end of the acquisition time. Number of points and slope
value can be entered (numerical values).
First Part checks the initial reaction to be sure it has not exceeded the value
entered (turbid reaction)
Max / Final checks if the final reaction is turbid or not. Maximum absorbance
reading minus the final absorbance reading cannot exceed this limit.
Pressing the Threshold Parameters button will display the following window
o
The 1 Threshold Parameters window allows you to set the following
parameters.
The Threshold Search Direction provides the option to search for the threshold
value in the Forward (starting from the beginning of the reaction) or Backward
(starting from the end of the reaction and moving toward the beginning) direction.
Correction Parameters
Correction Parameters allows you to set primary unit corrections based on the
reaction.
Three Correction Intervals can be defined and a corresponding slope (m) and
intercept (q) can be defined.
***************************************************************************************
Check Mean: flags the duplicate values when they exceed the mean by the
entered value. This unit is represented in % variation for the selected unit.
Pressing the Checks button displays the Analytical Reference Checks screen.
Limits to flag the Analytical Reference and/or the Analytical Reference Activated
(ARa) values can be defined
The check is done in % versus the measured value of the Analytical Reference.
Options for the AR/ARa values can be chosen from the following selections:
Reference Value (value manually entered by the operator)
Pressing the Acq. Data Checks button displays the following screen
Click the box to select the Baseline By Moving SD. In the Points field enter the
number of raw data points to use. The Segment field allows you to enter the
portion of the total curve time.
Click the box to select the Curve Sequence. In the Curve Type field select
either Max follows Min or Min follows Max.
Click the box to select the Spike Removal. In the Percent field enter the
minimum deviation (1-99%) from the curve sequence for a point to be considered
a spike. In the Limit field enter the maximum number of spikes allowed.
Click the box to select the Baseline SD. In the Points field enter the number of
data points to use. In the Max SD field enter the maximum allowable Standard
Deviation used to establish whether the baseline is smooth or not
Derivative Checks
Click the box to select the Normalized Signal to ensure the reported clot time
coincides with the curve sequence selection.
st
Click the box to select the 1 Derivative Boundary check. This will ensure the
nd st
2 derivative max peak occurs before (in time) the 1 derivative max peak.
Selecting the Calibration Curve Setup button displays the Calibration Setup
screen.
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
(Calculation Setup).
Delete Parameters: Used to delete the defined parameters for the selected
Algorithm type.
CV: when a minimum of three replicates is configured, the field can be filled in
with the maximum acceptable CV% value. When the obtained CV% value is
higher than the defined limit, the specific calibration standard point is flagged.
Final Unit: Represents the calculated unit of the calibration. The unit can be
selected from a list including: mg/dL, g/L, %, ng/mL, U/mL, ug/L, umol/L, IU/mL,
%, mg/mL, ug/mL.
New Unit: If a unit different from those included in the list is desired, the user can
configure a custom unit by typing it in this field (up to 8 characters).
The Confirm/Cancel button leaves the screen saving or rejecting the changes
and the system goes back to the Main screen.
Calibration Curve Setup: pressing this button displays the Calibration Curve
setup screen.
This screen aims to define the mathematical relation between X (measured unit)
and Y (calculated unit).
Correct Ratio with 100% Std: if the checkbox is activated, the Ratio (and
consequently the INR) is calculated using for the denominator the 100% as it is
obtained from the modification of the calibration curve.
Extrapolated Result
The Extrapolated Result function is automatically executed. It is not visible on any
screen and cannot be modified by the operator. When a result exceeds 150% of
the highest calibration point or is below 60% of the lowest calibration point, it will
be flagged if this option is enabled.
Define as Mandatory: defines which calibration points are mandatory.
The calibration curve can use multiple functions to better interpolate the
calibration standards.
The curve can be divided into three different segments and different functions
may be applied to each of them.
In order to define the segments, it is necessary to define start and end points that
correspond to the standards previously defined. For example Factor Assays use
3 segments to cover the entire range.
The end point of the first segment corresponds to the start point of the second;
the end point of the second segment corresponds to the start point of the third.
Calibration Curve (X) and (Y) axis 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 between two segments (end of one
segment - start of the other segment).
A different slope range flag can be attributed to the different calibration curve
segments. Limit is from –99999 to +99999.
If the curve is not divided into segments, only the first line must be filled in.
If the slope is outside of the given range, an error is presented.
2
A different r flag can be attributed to different calibration curve segments. If the
2
r value is lower than the given limit presented (format is x.xxxx), a flag is
displayed.
If the curve has not been divided into segments, only the first line must be filled
in.
The Confirm/Cancel button leaves the screen saving or rejecting the changes
and the system goes back to the Main screen.
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.
Parallelism Setup
Selecting the Parallelism setup button allows definition of the checks used for
factor assays with parallelism.
The results for the Parallelism can be selected for display and printouts in various
units using the following checkboxes.
o CR %: the system will take the results in seconds for each dilution;
convert these results to % activity by reading it off the calibration curve,
then multiply the results by the dilution factor.
o Ave CR%: the average of the 3 CR% results.
o CV-CR% : the CV of the CR% results.
Slope*: If enabled, a minimum and maximum acceptable value for the slope of
the line based on the 3 dilution values can be entered. Results outside these
limits will be flagged “out of range” and printed in bold.
* To enable and enter values you must be at the Lab Manager level
2 2
R : If enabled, a minimum and maximum acceptable value for the R for the
linear regression line (seconds vs. uncorrected % recovery) based on the 3
dilution values can be entered. Results outside these limits will be flagged “out of
range” and results printed in bold.
Pressing the Units button will display the available units for parallelism. You can
select four of the units to display and print.
Highlight the desired unit and press the Show in Sample List. A check will be
placed in the left hand column. These units will display on the screen and be
printed. Up to 4 units can be selected.
For Slope and INT you must enter a range to report and flag these units.
1. Sample Report - This report will include 4 of the following selected by the
user:
a. Ave CR%
b. CV CR%
c. Slope
d. Int. (Intercept)
2
e. r
4.3 UTILITY
The Utility portion of the ACL Elite/Elite Pro software groups all functions related to
saving data and handling the ACL software. For ease of use, Section 4.3.1 shows the
Utility submenu, and Sections 4.3.2 and above are labeled as the items in this submenu.
UPGRADE IL LIBRARY
BACKUP/RESTORE
ARCHIVE
SOFTWARE
- Software Identification
- Software Upgrade
- SW Master Upload-Upgrade
- SW Slave Upload-Upgrade
- SW REM Upload-Upgrade
SAVE TRACE
TESTS / MATERIALS
- Backup/Upload
The screen will indicate to insert the IL Library diskette into the floppy (upper right
side of the instrument) and press continue.
At the end of the IL Library Upgrade all modifications are listed on the screen.
View Backup Date will display the date the backup was created.
Warning: You can back up an ACL Elite and restore it to an ACL Elite Pro;
however you cannot backup an ACL Elite Pro and restore it to an ACL ELite.
*Patient data is archived based upon the sample entry date and not the date the
sample was analyzed.
Enabling the checkbox Remove Data After Archive will delete the selected data
for completed samples from the ACL database.
The file name created by the instrument is composed of two letters and six
numerical characters: the two letters identify the kind of selection made by the
operator (CD = Calibration Data, QC = Quality Control, PD = Patient Data, AR =
Analytical Reference), the numbers correspond to the date when this operation is
carried out (ddmmyy). The file extension is .000. These files are viewable using
common programs capable of reading text data.
The Data archived includes the following: test name, patient name with related
demographics, results, flags and calibration curve parameters, depending on the
selection made.
Warning: Archived data cannot be restored back to the ACL Elite/Elite Pro. The
data can be viewed using a standard computer capable of viewing text data.
The following information can be viewed but not edited on this screen:
MASTER SW IDENTIFICATION
SLAVE SW IDENTIFICATION
IL TEST LIBRARY
The Confirm button leaves the screen and the system goes back to the Main
screen.
The software Upload operation copies the entire information to the hard disk.
The software Upgrade operation installs the software from the hard disk through
the system.
First operation is the Master Upload (copying information to the hard disk).
Insert the disk, select Master Upload and continue.
Third operation is the REM Upload (copying information to the hard disk).
When the Upload procedure is completed, please select REM Upgrade (software
installation from the hard disk) and continue.
At the end of each operation please verify that the Software Identification reports
the correct revision number.
*Warning: each Upgrade kit will include detailed instructions that supersede the
above instructions if they are different.
Please follow the Upgrade package instructions to perform Upload and Upgrade
operations.
This utility is used to save the analysis raw data to an external storage media.
The system retains the raw data for all testing performed for the last 31 days.
The user can type the file name and select the file format by checking the
appropriate checkbox.
DAT files are only compatible for use with the Windows Research Program.
Note: the DAT file is only available if one test (up to 19 samples maximum) is
executed on the rotor. If more tests are executed on the same rotor the DAT file
option can not be used.
TXT files (recommended selection) are ASCII files compatible with text editors
and spreadsheet (i.e. Word or Excel).
A maximum of 8 characters can be used for file name. Do not enter the filename
extension when entering a file name. The extension will automatically be added
depending upon the checkbox selected (TXT or DAT).
*Note: If multiple runs are performed within the hour selected, all runs will be
saved. A run time stamp separates the various run data. The end of run time is
used for the time stamp.
This utility is used for troubleshooting purposes in case a software defect may
appear (i.e. database error, system lockups, etc.).
The system saves up to 31 trace files, one for each day for the past 31 days
XX is the day of the month you want to save the trace on.
th
For example, to save the trace for the 10 day type: Trace_10.txt
In case the system may need to be rebooted, the trace file can still be performed
after restarting the analyzer.
Select available storage media for your system
Note: The trace file will only monitor internal software or database errors. A
trace file does not include information about abnormal results.
This feature allows single material and test definitions to be saved and uploaded.
Selecting the Backup option from the menu displays the following screen
The Test/Material drop down box allows you to select a material ID, Test ID or
Test Group to backup.
The Test/Material list below the selection will then display either the material
IDs, Tests or Test Group based upon the above selection.
Press the confirm button to start the backup or the cancel button to exit the
screen.
Selecting the Upload option from the menu displays the following screen
Note: Only user defined Materials, Tests and Test Groups can be backed up.
Users cannot backup IL defined Materials, Tests and Test Groups.
A check in the Overwrite box will cause the new information uploaded to replace
the information currently defined in the system.
Press the confirm button to start the backup or the cancel button to exit the
screen.
Note: After uploading Test Groups verify the “Max Sample Value” is set correctly
for the uploaded test groups in the Test Group Definition screen.
5.0 Introduction
The purpose of this Section is to familiarize the ACL ELITE/ELITE PRO user with the
software-driven diagnostics procedures that are performed automatically by the system at
the operator’s request. Through the ACL diagnostics programs, the user can access the
error history and logbooks of the system as well as perform checks on key hardware
items.
PRIMING
CLEANING
MAINTENANCE
TEMPERATURE CONTROL
NEEDLES POSITION
SESSION ERROR HISTORY
FILE ERROR HISTORY
LOGBOOK
SERVICE (dimmed). Only accessible to Service
The following sections contain details about each of the items in the Diagnostic
submenu.
5.1.1 Priming
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.
- when the ACL has been OFF for a prolonged period of time
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).
5.1.2 Cleaning
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.
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:
- CYCLES No. - the number of cleaning cycles using the cleaning solutions
(same for both lines); default is 3 cycle. Range for number of cycles
performed is 0 to 5. Selecting 0 no cycles will be executed. Recommended
setting is 3 cycles
At a minimum either the sample, reagent or both lines need to be defined prior to
pressing “Start” for the cleaning cycle to be performed.
CLEANING PROCEDURE
Materials needed:
4 glass vials (10 mL volume; diameter 23 mm)
After the procedure is complete with Cleaning solution, replace the vials with a
second set filled with 8mL of Factor Diluent and Start the clean cycle a second
time.
After the cleaning cycle is complete with Factor Diluent, perform a system
priming cycle.
IL Cleaning Agent (Clean B) (P/N 98327-00) diluted 1:8 with distilled water
may be substituted for Cleaning Solution for decontamination or resolution of
control/sample accuracy/precision issues. Diluted Clean B should be
prepared daily.
Clicking the Start button executes the cleaning cycle and opens a window
displaying a bar that moves to show the elapsed time of the procedure.
If the liquids are not in the appropriate positions, the cycle will automatically abort
and an error window will appear.
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.
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.
CLEANING CYCLE 1
LAST DATE: The date does not need to be typed in after performance of a
specific operation. Clicking the Date button causes today’s date to appear
automatically. Items displayed in red indicate that the maintenance is past the
listed frequency and is overdue. If a run is processed with maintenance overdue,
the Session Error History button will illuminate to alert the operator, and the
results will be flagged. The alert icon will also be illuminated when maintenance
is due. The Clear button will delete the date displayed.
Clicking the Confirm button saves changes in the Notes screen. Clicking
the Cancel button rejects the changes; in both cases the system goes
back to the Main screen.
Clicking the Printer button, followed by a confirmation window Do you really want
to print? Yes/No, prints the maintenance list.
Clicking the Confirm button saves the changes and clicking the Cancel button
rejects the changes; in both cases the system goes back to the Main screen.
Clicking the Diagnostic button on the Main menu bar and selecting
Temperature Control opens the Temperature Control screen:
Clicking the Confirm button exits the screen and the system goes back to the
Main screen.
The needle position has to be verified with the rotor cover open, therefore press
the Open/Close Cover button to open the Rotor cover. Install alignment tool.
Clicking the Diagnostic button on the Main menu bar and selecting Needles
Position causes a very quick self-initialization. After a reminder to open the
cover, the arm moves over the rotor holder area.
The Raise/Lower Arm button will raise/lower the arm over the rotor holder area.
The Rotate button will move the rotor holder 90° (1/4 turn).
If the needles position procedure has to be carried out, the needle adjustment
tool must be placed on the rotor holder. For details on this operation, refer to
Section 5.2.6.
In order to verify the needle centering with the rotor cover closed, repeat the
operation described in 5.2.6.
Up to 200 errors can be stored in the error file. The file is handled automatically
using the first in first out approach.
If the user wants to view the errors and alarms while the session is active,
clicking the Diagnostic button on the Main menu bar and then selecting the
Session Error History option will open the Session Error History screen:
The window in this screen contains descriptions of all the errors and warnings
that occurred during the current session along with the date and time. The latest
error or warning appears at the top of the list.
Clicking the Printer button, followed by a confirmation window Do you really want
to print? Yes/No, prints the error list.
Clicking the Confirm button exits the screen and the system goes back to the
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.
Note: If the language on the system is changed entries in the log prior to the
change will remain in the original language. New entries in the log after the
change will be in the new language
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 error code number and descriptions of the errors/ warnings
along with the date and time when they occurred. The latest error or warning
appears at the top of the list.
Clicking the Printer button, followed by a confirmation window Do you really want
to print? Yes/No, prints the error list.
Clicking the Clear button followed by a confirmation window deletes all the
messages in the file. Available at the IL-Service Level only.
Clicking the Confirm button exits the screen and the system goes back to the
Main screen.
Note: If the language on the system is changed entries in the log prior to the
change will remain in the original language. New entries in the log after the
change will be in the new language
5.1.8 Logbook
The ACL ELITE/ELITE PRO software records, stores and displays information on
all the actions performed on the system since it was first turned on.
Actions traced in the Logbook are all the conditions in which an operator decision
is taken. For example, a Liquid entry, a change in assigned value, a modification
in the setup and/or in the configuration, etc. are recorded.
Up to 200 messages can be stored in the logbook file. The file is handled
automatically using the first in first out approach.
The logbook may be viewed in the Logbook screen, which opens by first clicking
the Diagnostic button on the Main menu bar and then selecting Logbook from
the Diagnostic submenu.
This screen displays descriptions of all the actions and the login level along with
the date and time when they occurred. The latest action appears at the top of the
list.
Clicking the Notes button the operator is allowed to enter comments for each
logbook message. (26 characters maximum)
Clicking the Printer button, followed by a confirmation window Do you really want
to print? Yes/No, prints the logbook records.
Clicking the Confirm button exits the screen and the system goes back to the
Main screen.
Note: If the language on the system is changed entries in the log prior to the
change will remain in the original language. New entries in the log after the
change will be in the new language
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.
5.2.1 Introduction
The ACL is a precision instrument. In order to keep it in functional condition IL
recommends that a trained operator, at the minimum frequency specified, carry
out the following operations.
Warning:
The instrument should be decontaminated before performing any
maintenance procedure and/or service. For instructions related to
Decontamination Procedures, refer to Section 5.2.7 below.
While performing maintenance procedures, the operator should wear
protective clothing and gloves to prevent direct contact with items
potentially contaminated with blood. Hands should also be washed
immediately after gloves are removed and before leaving the laboratory.
Please refer to local and state regulations for disposal of potentially
hazardous material.
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.
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).
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.
ACL setup:
Place 8 mL of Cleaning solution (Clean A) in 2 vials.
Place the filled vials in reagent positions R6 and R7and execute
For more detailed information please refer to 5.1.2 Cleaning.
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.
The priming procedure is used to flush the liquid flow path of the system, thus
ensuring removal of sample or reagent residues that may accumulate during
sample analysis. The priming procedure is an effective way to maintain the ACL’s
needle assembly and the rinse reservoir in good working condition.
In order to perform the priming cycle, click the Diagnostic button on the Main
Menu bar and select the Priming option from the Diagnostic submenu. The
Priming screen opens with a message “Priming in progress” and priming begins
immediately. When the dispenser system finishes flushing the sample and
reagent needles, the instrument returns automatically to the Main menu. For
additional details, refer to Section 5.1.1.
Important: While the priming cycle is in progress, the operator should visually
inspect three items:
- The number of bubbles in the dilutor chamber is reduced to a minimum. If
bubbles are still present, pinch the chamber outlet tubes while the piston is
descending and release before the piston reaches the bottom dead center.
Repeat the priming cycle as needed until all bubbles are gone.
- There are no blockages or leaks in the liquid flow path and the liquid is
flowing smoothly from reservoir to dilutors and from dilutors to needles.
- There is free flow of the liquid waste from the washing chamber to the
instrument outlet tube and then to the waste container.
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.
Note: A partially used rotor may be left in the rotor housing. A 24-hour
timer is set when a new rotor is introduced. After 24hours the user will be
prompted to enter the open cuvette positions for subsequent runs in the
rotor. In order to remove a rotor from the rotor holder, press the Open/Close icon
to open the rotor-holder cover and manually retrieve the rotor, making sure not to
spill its contents while transporting it to the waste container. Close the rotor
holder cover by pressing the Open/Close icon on the screen. A partially used
rotor may be placed back on the rotor housing to use the remaining cuvettes.
Prior to placing a rotor back on the analyzer, the last used cuvette in the rotor
should be filled with 200ul of Wash –R.
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 moistened with 0.1 N Hydrochloric Acid (HCl) solution (IL Cleaning
Solution P/N 98317-00). Rinse using a cloth moistened with distilled water. Wipe
dry.
• Cleaning of Sample Spillage
Cup/Tube sensor inside the sample tray area: wipe the two vertical faces of the
sensor using a clean cloth or cotton tip applicator soaked in a 0.1 N HCl solution.
Spills in the rotor compartment should be clean using dilute (1:8) cleaning agent
P/N 98327-00. Follow with distilled water and dry with a clean cloth or cotton tip
applicator.
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 (Clean
A) and rinse it with distilled water.
• Note: for additional cleaning/decontamination you may substitute 0.625%
®
Bleach solution - HemosIL Cleaning Agent PN 9832700 (Clean B) diluted
1:8 with distilled water in place of the 0.1 N HCL solution. Rinse well with
distilled water to remove all residual cleaning material.
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.
- Using a cotton tip applicator moistened with distilled water, clean all 20 holes
in the rotor holder and the surface of the channel sensor. Use a clean, dry cotton
tip applicator to remove all moisture from these areas. The cotton swab should
not be pushed down below the rotor holder assembly
- Clean the LED sensor surface (under the rotor holder) and the LED fiber optic
surface using a cotton tip applicator moistened with distilled water. Use a clean,
dry cotton tip applicator to dry these areas well.
- Using a cotton tip applicator moistened with distilled 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.
In order to clean the analyzer air filter, it must first be removed from its location
on the right side of the instrument. Insert a finger in the holder slot; pull up and
slide the filter out (see figure below).
Check the filter. If it is dirty or blocked, clean it with compressed air or by washing
it in water and blowing it dry.
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 distilled water
- a container for the distilled 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 distilled 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 distilled 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.
- Press the Open/Close Rotor Cover icon to open the rotor cover.
- Click the Diagnostic button on the Main menu bar and select Needles
Position from the Diagnostic submenu. The needle arm moves over the
rotor holder.
- Label the two tubings that connect to the needle assembly (i.e. top and
bottom).
- Loosen the white knob on the back of the needle, disconnect the tubing,
disconnect the sensor cable and remove the needle block.
- Insert the new needle block, connect the sensor cable, connect the two
tubings and position the block higher than the arm top surface.
Procedure
- In order to verify needle centering with the cover open, press the
Open/Close Rotor Cover icon to open the rotor cover.
- Insert the “needle alignment tool” (a special tool in the shipping kit) into the
rotor holder with side A facing up (refer to figures on next pages).
- Click the Diagnostic button on the Main menu bar and select Needles
Position from the Diagnostic submenu. An Open Cover? Yes/No screen will
display if you did not open the cover beforehand. Click Yes to open the
cover. The needle arm moves over the rotor holder.
- Loosen the white knob on the back of the needle arm and move the needle
block (or insert a new one) so that its top surface is higher than the arm top
surface.
- Click the Raise/Lower Arm button to lower the arm to the rotor holder over
the tool.
- Adjust the height of the needle block so that the needles touch the upper
surface of the tool and confirm that the two needles match the two white
reference dots on the tool surface.
- Tighten the needles using the white arm knob, making sure that the position
has not changed after the tightening.
- 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 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).
- In order to verify the needle centering with the cover closed, click the
Diagnostic button and select again Needles Position.
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.
Needles Alignment
Material needed:
1. Click the Diagnostic button on the Main menu bar and select Needles
Position from the Diagnostic submenu. This will cause the arm to
move to the top of the rotor holder.
2. Remove the rinse reservoir and clean thoroughly with a 0.1N HCL
solution and rinse with distilled water.
3. Clamp off the External Waste Tubing from the side of the ACL
ELITE/ELITE PRO.
5. With the Waste/Rinse reservoir still out of the instrument, insert the
syringe into the hole at the bottom of the reservoir and slowly push the
0.625% bleach solution through the waste tubing being careful that the
bleach solution does not overflow into the well.
Problems that may be resolved by this “as needed” waste line bleaching:
− Waste not flowing properly due to a clot stuck in the line that will not
dislodge by flushing with distilled water.
− High or low control recovery. There may be a blockage in the waste line
causing insufficient cleaning of the needles due to a backup in the
rinse/waste reservoir.
WARNING: Use only IL Cleaning Agent (P/N 98327-00) diluted 1:8 with
distilled water (1 part cleaning agent with 7 parts distilled water).
Decontamination procedure
Materials required
- Press Start
At the end of the cleaning cycle the ACL returns to the cleaning screen.
Replace the Clean solution with Factor Diluent and repeat the procedure.
NOTES:
The discarded items must be placed in an appropriate container for further
disposal, according to proper state and local regulations.
In case of suspected severe contamination, replace the tubing and discard the
old one in an appropriate container for further disposal, according to proper
state and local regulations
Maintenance Procedure
Daily - Check Wash-R level and empty liquid waste container
- Perform the Cleaning cycle for the probes
- At the beginning of each shift/day and at the end of each
day, perform a priming cycle
- Check level of Rotors onboard and empty rotor waste bin
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 moistened with a diluted solution of IL
Cleaning Solution (P/N 98317-00) and rinse with
distilled water (clean the rotor holder with diluted
IL Cleaning Agent (P/N 98327-00)
- 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 -
Reboot the system (if not performed during last 14 days
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Daily
Weekly
Bi-Weekly
Monthly
As Needed
6.0 Introduction
Following the Maintenance guidelines described in Section 5 of this Manual is of
paramount importance to keep the ACL ELITE/ELITE PRO system in good working order
and to minimize instrument failures.
In the event of a malfunction, the ACL automatically notifies the user of the situation
through a system of warnings and alarms. With the help of built-in system checks and the
guidelines offered in this Section, the user would be able to resolve most of the problems
that may arise.
• 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.
ALARMS
Error Message Possible Explanation Remedial Action
Slave communication Master and slave do not Reload the main
failure communicate. software. If the failure
persists, contact
Service.
A/D converter failure Periodic error while Reload the main
handling the ADC. software. If the failure
persists, contact
Service.
Slave code absent Missing slave code. Reload the main
software. If the failure
persists, contact
Service.
Slave download error Failed loading the slave Reload the main
code. software. If the failure
persists, contact
Service.
Check DB error Consistency error in the Reload the main
data base. software. If the failure
persists, contact
Service.
Check parameters Error in consistency of Reload the main
error the parameters. software. If the failure
persists, contact
Service.
Error Code 1019 Internal system out of If this occurs during
specification the initial 30 minutes
of startup, allow time
for temperatures to
stabilize
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,
contact Service.
REM communication Missing communication Switch the system off,
error with REM. Either the wait a few seconds
(N/A on the ACL ELITE) software is missing or and switch it back on.
REM is not working. If the error persists,
contact Service.
REM command error Command not executed Switch the system off,
correctly. wait a few seconds
(N/A on the ACL ELITE)
and switch it back on.
If the error persists,
contact Service.
REM download error Download not executed Switch the system off,
correctly. wait a few seconds
(N/A on the ACL ELITE)
and switch it back on.
If the error persists,
contact Service.
DB restoring Error Failure to restore Switch the system off,
database. wait a few seconds
and switch it back on.
If the error persists,
contact Service.
DB backup Error Failure to backup Switch the system off,
database. wait a few seconds
and switch it back on.
If the error persists,
contact Service.
File open warning Missed opening a non- Switch the system off,
critical file. wait a few seconds
and switch it back on.
If the error persists,
contact Service.
File length warning Incorrect length of a non- Switch the system off,
critical file. wait a few seconds
and switch it back on.
If the error persists,
contact Service.
File read warning Missed reading a non- Switch the system off,
critical file. wait a few seconds
and switch it back on.
If the error persists,
contact Service.
File write warning Missed writing a non- Switch the system off,
critical file. wait a few seconds
and switch it back on.
If the error persists,
contact Service.
File close warning Missed closing a non- Switch the system off,
critical file. wait a few seconds
and switch it back on.
If the error persists,
contact Service.
Floppy disk full The current floppy disk is Replace with a new
full. floppy disk or Disk
drive.
Floppy disk missing
#
The current floppy disk is Check the floppy disk
missing. on disk drive.
Floppy disk write The current floppy disk is Replace with a new
protected
#
write protected. floppy disk.
#
Printer fail ** Printer is not connected Check printer and
or not working. connection.
Paper end No more paper in printer. Reload printer paper.
Internal BCR failure The internal barcode Switch the system off,
reader is not working. wait a few seconds
and switch it back on.
Reload the main
software. If the error
persists, contact
Service.
* Thermal Fail
This warning indicates the instrument is overheating internally which may have
an effect on the temperature of the measuring chamber. The reason may be a
clogged air filter obstructing the airflow in and out of the analyzer. Check the air
filter on the right side of the analyzer; clean or replace it as necessary following
the instructions in Section 5 (Maintenance). Make sure that there is free airflow
o
and that the ambient air temperature is below 35 C.
NOTE: The ACL ELITE/ELITE PRO works optimally when the ambient
o
temperature is in the range of 15 to 32 C, and does not fail in the range of
o
10 to 40 C.
If cleaning the air filter does not resolve the warning and the ambient temperature
is within limits, contact Service.
** Printer Fail
If the printer does not produce a printout due to a printer failure, the results may
be obtained from the video. Results transmitted via the RS232 C data link (if
connected and enabled) are also correct.
In order to troubleshoot the printer, verify that the paper is correctly loaded. Also
verify that the proper transmission protocol has been selected in the ACL
ELITE/ELITE PRO Setup (ESCP2 or PCL), and that the printer supports the
selected emulation protocol.
#
The actual error displayed will vary depending upon the submenu where the
request was made. If the failure persists, contact Service.
NOTES:
1. Error Message: Peltier Temperature out of Range
o
Explanation: Temperature is outside the 10-16 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. Contact Service.
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 that
o
the ambient temperature is not higher than 32 C. If the problem is not
corrected, contact Service.
- If the video displays ------ or **** for the transport or stack temperatures and
the instrument has been properly warmed up, contact Service.
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, contact Service.
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, contact
Service.
WARNINGS
Error Message Possible Explanation Remedial Action
Autosampler warning Autosampler intermittent Please logout. Switch
problem. the system off, wait a
few seconds and
switch it back on. If
the error persists,
contact Service.
Rotor warning Intermittent problem with Verify that there is no
rotor holder. obstruction interfering
with movement. If the
error persists, contact
Service.
Horizontal motor Intermittent problem with Verify that there is no
warning horizontal motor arm. obstruction interfering
with movement. If the
error persists, contact
Service.
Vertical motor Intermittent problem with Verify that there is no
warning vertical motor arm. obstruction interfering
with movement. If the
error persists, contact
Service.
Reagent dilutor Intermittent problem with Verify that there is no
warning reagent dilutor. obstruction interfering
with movement. If the
error persists, contact
Service.
Sample dilutor Intermittent problem with Verify that there is no
warning sample dilutor. obstruction interfering
with movement. If the
error persists, contact
Service.
Cover warning Intermittent problem with Verify that there is no
rotor cover. obstruction interfering
with movement. If the
error persists, contact
Service.
Stirrer fail Magnetic stirrer not The system may be
working. used without reagent
stirring. In this case
the reagent should be
well mixed before
each run. If the error
persists, contact
Service.
WARNINGS
Error Message Possible Explanation Remedial Action
Acquisition start error Home position not found Verify that there is no
at start. obstruction interfering
with movement. If the
error persists, switch
the system off, wait a
few seconds and
switch it back on. If
the error persists,
contact Service.
Acquisition sync error Home position not found Verify that there is no
during acquisition. obstruction interfering
with movement. If the
error persists, switch
the system off, wait a
few seconds and
switch it back on. If
the error persists,
contact Service.
adc int error Unexpected ADC Log out, switch the
interruption system off, wait a few
seconds and switch it
back on.
If the error persists,
contact Service.
Cuv int error Unexpected cuvette Log out, switch the
interruption system off, wait a few
seconds and switch it
back on.
If the error persists,
contact Service.
Acq centrifuge error Rotor holder blocked Verify no obstruction
exists. Log out, switch
the system off, wait a
few seconds and
switch it back on.
If the error persists,
contact Service.
WARNINGS
Error Message Possible Explanation Remedial Action
Flush warning Reference Emulsion Verify the Wash-R
below 100 mL level. bottle liquid level. If the
liquid level is low,
replace with a new
bottle. If sufficient liquid
is present, the user
may temporarily
disable the Wash-R
sensor. It is then the
operators'
responsibility to verify
the Wash-R level. If the
error persists with the
sensor enabled,
contact Service.
Sample liquid sensor External needle If the sensor is
off (sample) sensor disabled, it is the
disabled. operator's
responsibility to verify
appropriate liquid
levels. If the error
persists with the
sensor enabled,
contact Service.
Reagent liquid sensor Internal needle (reagent) If the sensor is
off sensor disabled. disabled, it is the
operator's
responsibility to verify
appropriate liquid
levels. If the error
persists with the
sensor enabled,
contact Service.
Sample liquid sensor External needle If the sensor is
fail (sample) circuit sensor disabled, it is the
error. operator's
responsibility to verify
appropriate liquid
levels. If the error
persists with the
sensor enabled,
contact Service.
Reagent liquid sensor Internal needle (reagent) If the sensor is
fail circuit sensor error. disabled, it is the
operator's
responsibility to verify
appropriate liquid
levels. If the error
persists with the
sensor enabled,
contact Service.
- 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).
- If the LED is ON, perform the optic path cleaning as described in the
Maintenance Section 5.
- If none of the above resolves the problem, contact Service.
Rotor station No more rotors in the Refill the rotor stack. If the error
empty rotor stack. persists after this action, contact
Service.
Rotor refill Only one or two rotors Refill the rotor stack. If the error
left in the rotor stack. persists, contact Service.
Cover open Rotor cover was Close rotor cover. If the error persists
during loading / opened during the contact Service.
incubation loading or incubation
operation.
Time out Time out not met Max Sample limit in test group set to
expired during during loading. high, lower limit by one. Repeat run.
loading If the error persists, contact Service.
- Select SETUP from the Main Menu, select INTERFACE STATUS to view the Data
Transmission characteristics to the Host Computer
If the fault persists, contact Service. For additional information please refer to Appendix
(Host Communication Protocol).
Error Codes, that will not generate a valid result, are represented by an Error Number.
The Error Number is presented instead of a valid result.
Error codes that will generate a result plus an additional flag are indicated with a
message that explains the error.
Results with more than one error display the highest priority error.
Error 3 - No flush
Meaning No flush
Cause Absorbance channel Reference Emulsion out of range
(above 3.5 V or below 0.0 V).
Flags Cycle aborted
Results No results in database.
Remedial Replace Reference Emulsion bottle and clean optics.
Action
Error code – 6 *
Meaning Not coag
Cause First threshold not passed.
Flags R
Results Error 6 instead of the result.
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
Results Error 7 instead of the result.
Remedial Sample clot curve is noisy and does not give a normal clot
Action signal within the acquisition time. Repeat the test in extended
acquisition time.
Error code - 8
Meaning Coag error
Cause Delta time between the two thresholds is higher than the
selected value.
Flags R
Results Error 8 instead of the result.
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
Results Error 9 instead of the result.
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
Results Error 10 instead of the result.
Remedial Unstable endpoint of the clotting curve. Review the clot
Action curve. Possible sample interference with the clotting
reaction. Repeat the test in extended acquisition time.
Error code - 11
Meaning Final delta error is a check that the curve is not
dropping too much after reaching its maximum reading
Cause Final delta of the reaction curve (maximum abs reading
– final abs. reading) is higher than the selected value.
Flags R
Results Error 11 instead of the result.
Remedial If this is a nephelometric reaction, it may be an
Action indication of an unstable endpoint in the clotting curve.
Review the clot curve. Possible sample interference
with the clotting reaction. Repeat the test in extended
acquisition time.
If this is an absorbance test, it may be an indication of
an absorbance value outside the specified limit.
Error code - 12
Meaning Coag error
Cause Maximum peak of the first derivative is below the
selected limit value.
Flags R
Results Error 12 instead of the result.
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
selected limit value.
Flags R
Results Error 13 instead of the result.
Remedial Second derivative peak is not significant enough to
Action indicate a real clotting reaction point. Review the clot
curve. Repeat the test in extended acquisition time.
Error code - 14
Meaning Offset error (delta algorithm)
Cause Offset value is greater than “First part” value defined in
calculation setup section of test definition or below
scale range low limit.
Flags R
Results Error 14 instead of the result.
Remedial Review the clot reaction curve “Y” axis scale to
Action determine if value is low or high (turbid). Rerun
Sample.
Error code - 30
Meaning Offset error (delta algorithm)
Cause Offset of the initial part of the curve is below the
selected limit value.
Flags R
Results Error 30 instead of the result.
Remedial Initial reaction turbidity is relatively low. Review the clot
Action reaction curve. Check integrity of reagents, and make
sure no bubbles are present
Error code - 31
Meaning Minimum Curve Delta not met
Cause The total delta of the reaction curve is less than the
limit specified in the test setup. (Reaction curve is flat,
and clot formation may not have occurred)
Flags R
Results Error 31 instead of the result.
Remedial Review the curve and rerun the sample. Sample may
Action have an extended clotting time.
Error code - 71
Meaning Too Many Spikes Error
Cause Reaction curve has excessive reading spikes
Flags on R
samples
Cal Results Error 71 instead of the result.
Remedial Review the curve, check sample, and rerun. Sample
Action may have an extended clotting time. Invalid result.
Error code - 72
Meaning Baseline SD Error
Cause Baseline SD reading is greater than limit
Flags on R
samples
Cal Results Error 72 instead of the result.
Remedial Review the curve, check sample, and rerun. Sample
Action may have an extended clotting time. Invalid result.
Error code - 73
Meaning SyX Value greater than Maximum SD
Cause Linear regression SyX value exceeds limit
Flags on R
samples
Cal Results Error 73 instead of the result.
Remedial Review the curve, check sample, and rerun. Sample
Action may have an extended clotting time .Invalid result.
Error code - 16
Meaning Invalid curve - Insufficient data (curve with more than
one segment)
Cause Less than 2 calibration standards gave valid results.
Flags on C – Invalid curve - insufficient data
samples
Cal Results Error 16 instead of the result.
Remedial Invalid result. Review the reaction curve. Repeat the
Action calibration with freshly prepared materials.
Error code - 17
Meaning Lower No. of standards
Cause A number of standards points are less than the ones
defined in the setup.
Flags on - C – n-1 Standard points
samples
Cal Results Error 17 instead of the result.
Remedial Invalid results. Review the reaction curve. Repeat the
Action calibration with freshly prepared materials.
Error code - 18
Meaning No cal - No mandatory standard/s
Cause A mandatory calibration standard does not give a valid
result (single curve segment).
Flags C – no cal no Standard
Results Error 18 instead of the result.
Remedial Invalid curve. Review the reaction curve. Repeat the
Action calibration with freshly prepared materials.
Error code - 19
Meaning Invalid curve segment - No mandatory standards
Cause A mandatory calibration standard does not give a valid
result (curve with more than one segment).
Flags on C – invalid curve no Standard
samples
Cal Results Error 19 instead of the result.
Remedial Invalid curve. Review the reaction curve. Repeat the
Action calibration with freshly prepared materials.
Error code - 20
Meaning Invalid standards replicates
Cause One or more of the replicates for a defined calibration
standard does not give a valid result.
Flags on C– Invalid Standard n
samples
Cal Results Error 20. Mean is flagged. CV is shown flagged (in
red).
Remedial Invalid standard. Review the reaction curve. Repeat
Action the calibration with freshly prepared materials.
Error code - 21
Meaning CV not shown – Insufficient replicates
Cause One or more of the replicates for a defined calibration
standard does not give a valid result. CV cannot be
calculated (replicates below or = 2).
Flags on C – Insufficient replicates
samples
Cal Results Error 21. CV is not shown.
Remedial Invalid standard. Review the reaction curve. Repeat
Action the calibration with freshly prepared materials.
Error code - 22
Meaning Invalid replicate
Cause One replicate for a defined calibration standard does
not give a valid result.
Flags C – Invalid replicates
Results Error 22. Mean value is flagged.
0Remedial Invalid replicate. Review the reaction curve. Repeat
Action the calibration with freshly prepared materials.
Error code - 23
Meaning CV out of range
Cause CV of the replicates higher than the selected limit.
Flags on C – CV out of range
samples
Cal Results Error 23. CV is flagged.
Remedial Result out of range. Review the reaction curve. Repeat
Action the calibration with freshly prepared materials.
Error code - 24
Meaning No cal - slope out of range
Cause The slope of the curve (curve composed by a single
equation) is out of the defined range (single segment).
Flags on C – No Calibration: slope out of range
samples
Cal Results Error 24. Calibration curve not displayed.
Remedial Review the reaction curve. Repeat the calibration with
Action freshly prepared materials.
Error code - 25
Meaning Invalid curve - slope out of range
Cause One of the slopes of the curve (curve composed by
several segments) is out of the defined range.
Flags on C – Invalid segment - slope out of range
samples
Cal Results Error 25. Calibration curve is displayed.
Remedial Review the reaction curve. Repeat the calibration with
Action freshly prepared materials.
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 C - R out of range
samples
2
Cal Results Error 26. Calibration curve is displayed. R value is
flagged.
Remedial Review the reaction curve. Repeat the calibration with
Action freshly prepared materials.
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.
Remedial Review the reaction curve. Repeat the calibration with
Action freshly prepared materials.
Error code - 28
Meaning Curve non monotonic
Cause Invalid calibration due to a result not in sequence
compared to the other calibration points.
Flags on C – invalid segment
samples
Cal Results Error 28. Non monotonic curve.
Remedial Repeat calibration.
Action
Error - AR invalid
Meaning AR invalid (AR used as reference for Ratio/INR
calculation)
Cause AR does not give a valid calculated result.
Flags on A – AR invalid. Ratio/INR on samples is not presented
samples
AR Results AR is flagged.
Remedial Review the reaction curves. Repeat the test with
Action freshly prepared materials.
Error - AR invalid
Meaning AR invalid (Ratio defined versus one Calibration
Standard)
Cause AR gives an invalid calculated unit.
Flags on A – AR invalid. Ratio/INR is presented on samples
samples
AR Results AR is flagged.
Remedial Review the reaction curves. Repeat the test with
Action freshly prepared materials.
Error - AR invalid
Meaning AR invalid (No check on AR is selected)
Cause AR gives an invalid result.
Flags on none
samples
AR Results AR is flagged.
Remedial Review the reaction curves. Repeat the test with
Action freshly prepared materials.
Error - QC Invalid
Meaning QC not valid (Check QC -selected, flag samples - not
selected)
Cause QC gives a non-valid result.
Flags on No flag on samples
samples
QC Results QC result is not displayed and the specific code
number is presented.
Remedial Review the reaction curves. Repeat the test with
Action freshly prepared materials.
Error - QC invalid
Meaning QC invalid (Check QC - selected, flag samples -
selected)
Cause QC gives a non-valid result.
Flags on Q – QC Invalid, Flag on samples is present
samples
QC Results QC result is not displayed and the specific code
number is presented.
Remedial Review the reaction curves. Repeat the test with
Action freshly prepared materials.
Error code - 46
Meaning Mean not calculated (Check selected on mean)
Cause One of the two results is not valid.
Flags on W – Mean not calculated. Flag on samples
samples
Results Error 46. Mean is not displayed.
Remedial Review the reaction curves. Repeat the test with
Action freshly prepared materials.
Error code - 50
Meaning Ratio : S or Sa out of range (i.e. Ratio for APCR-V)
Cause S or Sa out of normal range.
Flags on W – Ratio: S, Sa out of range.
samples
Results Error 50. Ratio is not calculated.
Remedial Review the reaction curves. Repeat the test with
Action freshly prepared materials.
Error code - 58
Meaning NR: AR or ARa out of range (i.e. NR for APCR-V)
Cause AR or ARa out of range.
Flags on W – R: AR, ARa out of range.
samples
Results Error 58. Ratio is not calculated.
Remedial Review the reaction curves. Repeat the test with
Action freshly prepared materials.
Flags on W – NR error.
samples
Results Error 57 = Ratio not found*
Error 64 = AR Ratio invalid.
Error 66 = AR Delta invalid.
Remedial Review the reaction curves. Repeat the test with
Action freshly prepared materials.
*Reference Value is set to 0
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.
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.
If any of these errors occur, the operator may enter the sample ID manually into the
system.
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)
∆ time in seconds
Below ∆ time
nd
Below limit ERROR 13 Above 2 threshold
Above D2 limit Result (#)
Result (*)
7.0 Introduction
This Section includes specifications related to many assays performed on the ACL
ELITE/ELITE PRO system, as well as specifications related to the instrument and its
accessory items.
The following abbreviations are used throughout this Section:
• APCR-V Activated Protein • D-D h D-Dimer high
C Resistance - Factor V test • FPS Free Protein S
• AT Antithrombin • LAC LAC Screen and
• PLG Plasminogen Confirm
• PCX Pro-IL-Complex* • SCT Silica Clot Time
• HPX Hepatocomplex* • VWF von Willebrand
• PCL ProClot Factor
• PC Protein C • F8 chr H/L Factor VIII
• Pro S Protein S chromogenic
• FIB-C Fibrinogen Clauss High/Low
• FIB-C h Fib Clauss High • DP Deficient Plasma
• FIB-C l Fib Clauss Low • AR Analytical
• HEP Heparin Reference
• PI Plasmin Inhibitor
* Not currently available in the U.S.
Note: The ACL ELITE/ELITE PRO and the ACL8, 9 and 10000 use identical
analytical systems. Reagents, Calibrators, Controls and their assigned values are
interchangeable between the two systems.
Note: Please refer to the individual test definitions in the Setup menu on
the analyzer for the latest test library settings for each assay.
Some of these parameters may also be one of the reporting units used by the ACL, such
as “seconds” for the coagulometric tests. All measurements are used in the internal
calculation of test results, either related to calibration curves or processed in various
ways to report other useful parameters as described in Section 7.2.
o o
All parameters are measured on the ACL ELITE/ELITE PRO at 37 C ± 1 C, provided the
o o
ambient temperature is kept within the range of 15 C to 32 C.
FIBRINOGEN (PT-Based)
This Fibrinogen test is based on clot monitoring measurements as it records the light
scattered before and after the formation of the clot and calculates the difference between
the two readings (delta light scatter = ∆LS).
Fibrinogen-C results above 600 mg/dL (6 g/L) can be reflexed to the FIB-C h (high test).
Fibrinogen QFA is linear to 1000 mg/dL (10 g/L) and has no High test. Fibrinogen C
results below 100 mg/dL (1 g/L) can be reflexed to the FIB-C l (low test), while FIB QFA
results below 150mg/dL (1.5 g/L) can be reflexed to the FIB QFA L (low test).
PT (Prothrombin Time)
PT is measured in seconds. If Normal Plasma (AR) or a calibration curve is run,
the ACL can perform different calculations in order to report results in other
formats: % activity, R (ratio using AR) or INR (International Normalized Ratio).
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” selected, the
Analytical Reference value in seconds is used to modify the calibration curve.
The modified curve is used for the calculation of the sample value.
If the PT test is run with “Correct with AR in Analysis” not checked, the
Calibration Plasma value in the original calibration curve (100% point) is used for
the calculation of the sample value.
Recalibrate the PT test when the lot of Wash-R or rotor lot (alpha character)
changes.
• Result as R: R is the ratio between the sample value in seconds and the value
in seconds for either the AR, the Reference Value or one of the calibration
standards (see NOTE above).
APTT, TT
APTT and TT are measured in seconds. These tests do not require calibration.
Normal Plasma may be placed along with the samples in each analysis run, or a
reference value may be stored in the software. For additional information, refer to
Section 4 (Test Setup).
• Result as R: R is the ratio between the sample value in seconds and the value
in seconds for AR or a Reference Value.
APCR-V
This test is measured in seconds. S a is the “activated time” and S is the “base
time”.
• Result as R: R is the ratio between the value in seconds for Sa and the value
in seconds for S.
S a 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.
FACTORS
Factors are measured in seconds; the ACL also calculates the % activity based
on a calibration curve.
The calibration curves for Factor assays are composed of three segments: one
High Curve segment with higher concentration calibrators; one Low Curve
segment with lower concentration calibrators and one Medium segment which
connects the high curve 25 % calibration point with the Low curve 6.25%
calibration point.
100% NP : 40 s → 40 ÷ 40 = 1 (R)
50% NP : 50 s → 50 ÷ 40 = 1.25 (R)
25% NP : 60 s → 60 ÷ 40 = 1.50 (R)
The curve is constructed with Ratios (from seconds) on the x-axis and % Activity
on the y-axis, using a log-log scale.
Lg A
2.0
1.69
1.39
Lg R
0 0.09 0.18
Lg A
0.50
0.20 Lg R
0.24 0.30 0.35
The MEDIUM SEGMENT connects the 25% and the 6.25% points.
• Result as % activity: for the whole range of Multilinear Calibration Curve the
ratio between the sample value in seconds and the Calibration Plasma 100%
value in seconds is calculated and then used to read the value of Activity from
the calibration curve.
Refer to section 3.4 for preparation of 6.25% dilution used to calibrate low curve.
Note: All samples run for factor analysis are automatically diluted (x5) by the
ACL system during the analysis.
Factors VIII and IX using either HemosIL SynthASil or HemosIL SP reagent can
be processed in the Parallelism mode. The system will perform 3 dilutions
(100%, 50% and 25%) on these samples.
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
Ratio values are calculated using the 100% Standard as denominator. Therefore
the Calibration plasma must be placed on the sample tray when the Pro-IL-
complex calibration is run.
100% NP : 40s → 40 ÷ 40 = 1
25% NP (log = 1.40) : 65s → 65 ÷ 40 = 1.63 (log = 0.21)
12.5% NP (log = 1.10) : 95s → 95 ÷ 40 = 2.4 (log = 0.38)
6.25% NP (log = 0.80) : 150s →150 ÷ 40 = 3.75 (log = 0.57)
The 100% - 25% segment is constructed with Ratios (from seconds) on the
x-axis and 1/% Activity on the y-axis, using a linear scale.
The 25% - 6.25% segment is constructed with Ratios (from seconds) on the
x-axis and % Activity on the y-axis, using a log-log scale.
The sample activity is obtained by calculating the ratio between the sample value
in seconds and the 100% Calibration Plasma in seconds. This value is then read
off of the calibration curve to obtain the value of % Activity.
HEPATOCOMPLEX *
Hepatocomplex is measured in seconds; the ACL also calculates the % Activity
based on a calibration curve.
100% NP : 18 s → 18 ÷ 18 = 1 (R)
50% NP : 27 s → 27 ÷ 18 = 1.5 (R)
25% NP : 36 s → 36 ÷ 18 = 2 (R)
The Calibration curve is constructed with Ratio on the x-axis and 1/Activity on the
y-axis, on a linear scale.
1/A
0.04
HPX
0.02
0.01
1 1.5 2.0
The sample activity is obtained by calculating the ratio between the sample value
in seconds and the 100% Calibration Plasma in seconds. This value is then read
off of the calibration curve to obtain the value of % Activity.
• Result as R: R is the ratio between the sample value in seconds and the value
in seconds for a Reference Value.
ProClot
ProClot is measured in seconds; the ACL also calculates the ProClot % Activity
based on a calibration curve.
Below are some typical calibration data and a graphical example of ProClot
calibration curve.
A
100.0
50.0
0.00
The sample activity is obtained using the squared Ratio (calculated using the
sample value in seconds and 0% calibrator value in seconds) to read the %
Activity off the calibration curve.
FIBRINOGEN (PT-Based)
The ACL records the light scattered before and after the formation of a clot and
calculates the difference (∆LS) between the two readings.
The ACL calculates the fibrinogen value of the sample in mg/dL using a
calibration curve. The curve correlates the fibrinogen concentration of 3
calibrators with their ∆LS Ratios.
Below is some typical fibrinogen calibration data and the calibration curve
constructed with them.
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
100 100
50 50
25 25
OD OD
0.4
0.0 ∆OD
NOTE: For Antithrombin and Heparin, the delta OD is measured throughout the
reaction acquisition time of 30 seconds. For Plasmin Inhibitor, Plasminogen and
Protein C (Chromogenic) the acquisition time is 60 seconds.
D-Dimer
For the D-Dimer test, the ACL measures the difference between the light
absorbed at the beginning and at a defined point during the reaction (∆OD). The
concentration of D-Dimer in the sample, in ng/mL, is calculated from a calibration
curve constructed by correlating the calibrator’s delta OD values and their
respective concentrations in ng/mL.
In case of patient results higher than 1050 ng/mL, the test can be rerun using
the D-Dimer high (D-D h) test which has a linearity from 1000 to 5250 ng/mL.
Note: The D-Dh test should only be run on patients with a D-Dimer sample
concentration greater than 1000 ng/mL.
D-Dimer (ng/mL)
1000
500
250
Free Protein S
For the Free Protein S test, the ACL measures the difference between the light
absorbed at the beginning and at a defined point during the reaction (∆OD). The
concentration of Free Protein S in the sample, in %, is calculated from a
calibration curve constructed by correlating the calibrator’s delta OD values and
their respective concentrations in %. The calibration curve for the Free Protein S
is constructed of 3 segments:
98.0
49.9
24.5
12.25
COAGULOMETRIC TESTS
Test POSITIONS
Ax Ax Ax Ax 1-40
PT-FIB CAL Normal Factor -- -- --
Pool Diluent
PT-FIB Normal -- -- -- Samples
Pool
APTT Normal -- -- -- Samples
Pool
TT Normal -- -- -- Samples
Pool
PT-FIB/APTT Normal -- -- -- Samples
Pool
SCT Normal -- -- -- Samples
Pool
FACTORS Normal Factor Diluted Deficient Samples
(Calibration + Pool Diluent Normal Plasma
Analysis) (100%) Pool*
(6.25%)
DOUBLE TESTS
Test POSITIONS
Ax Ax Ax Ax 1-40
DOUBLE TEST Normal -- -- -- Samples
(PT-FIB, APTT, TT) Pool
PT-FIB Cal
100% PT-FIB APTT & SCT TT
50% Analysis
25%
Sample 10 µL/sample 10 µL/sample 10 µL/sample 10 µL/sample
Head 0
0
Sample 50 µL 50 µL 53 µL 75 µL
Dispensed 25 µL
12.5 µL
Diluent -- -- -- --
Head 10 µL/sample
10 µL/sample
Diluent -- -- -- --
Dispensed 25 µL
37.5 µL
Reagent 10 µL 10 µL/sample 10 µL reagent 50 µL
Head 10 µL per sample per rotor
10 µL 50 µL CaCl 2 /rotor
Reagent 100 µL 100 µL 53 µL reagent 75 µL
Dispensed 100 µL 50 µL CaCl 2
100 µL
The MEDIUM SEGMENT connects the 25% and the 6.25% points.
The test volumes can be found in the Calibration Setup and Analysis Setup
sections for each test*. The volume listed defined for each test do not include
any header volumes. The head volumes are as follows:
Chromogenic/405 filter
Channel Tests
Test Abbreviation Test Name Test Code Number
PLG Plasminogen 212
PI Plasmin Inhibitor 213
PC Protein C 214
F8 Chr H Chromogenic VIII High 220
D-D D-Dimer 250
AT Anti-Thrombin 200
AT* Anti-Thrombin Liquid 199
HepXa Heparin-UHF 210
Hep Liq Liquid Heparin 218
Fib-C Fibrinogen Clauss 202
Fib QFA Fibrinogen QFA 290 (g/L), 294 (mg/dL)
*Refer to the test library installed for the latest test detail information
The following table list the Special tests on the ACL ELITE/ELITE PRO. Details
for each test can be either viewed on the screen or printed. The test information
can be obtained under the Setup, Tests, View Define menu. Once you highlight
the test you can either print the information by pressing the print Icon or you can
press the detail Icon to view the test.
The test volumes can be found in the Calibration Setup and Analysis Setup
sections for each test*. The volume listed defined for each test do not include
any header volumes. The head volumes are as follows:
Special Tests
PS Protein S 159
*Refer to the test library installed for the latest test detail information
#
Not currently available in the U.S.
Refer to the Calculation setup parameters for the most current limits on
each test.
NOTE: Check the Instrument settings and package insert included with the
assay’s reagents to obtain information about the range and the limitations of the
assay.
The table below provides examples, for some common tests, which results are
displayed in Black and which results are outside the limits and therefore
displayed in Red. Refer to the current library installed on your system for the
latest settings for all tests.
• This table contains a list of the common messages that may appear on the
ACL ELITE/ELITE PRO in place of results, ordered by test, along with an
explanation and suggestions to obtain a numerical result.
The following graphs illustrate the situation before and after the fitting to the first
point.
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’ •←
•
•
When this area is accessed, a default value is displayed; the user enters the
corresponding value for the lot of Calibration Plasma in use.
The following diagram represents the general reaction for a Coagulometric and a
Special test:
INTER-RAMP DATA
TIME TIME
The table below shows the specific reaction times for coagulometric and special
test. Please refer to the individual tests on the system for more details.
3. EXTENDED time is available for PT-FIB, APTT and TT in single and double
tests mode.
CHROMOGENIC TESTS
The following diagram represents the reaction for a 405 nm chromogenic assay:
ACQUISITION TIME
RAMP RAMP
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
Liquid Heparin 0 100 60 60
Homocysteine 1 250 300 301
Plasminogen 1 100 60 61
Plasmin Inhibitor 1 100 60 61
Protein C (Chromogenic) 0 100 90 90
Fibrinogen-C 1 100 90 91
Fibrinogen QFA 1 100 90 91
Factor VIII (Chromogenic) 1 100 120 121
vWF : Antigen 1 250 300 301
Free Protein S 1 250 300 301
D-Dimer 2 250 300 303
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
Liquid Heparin Log/Log IU/mL ∆OD
Homocysteine Log umol/L ∆OD
PRO-IL-Complex* Log/Log Activity R
(25%-12.5%-6.25%)
PRO-IL-Complex* Linear 1/Activity R
(100% -25%)
HEPATOCOMPLEX* Linear 1/Activity R
PROCLOT Quadratic Activity R2
FIBRINOGEN C or QFA Log-Log/Log C (mg/dL or g/L) seconds
PROTEIN-S Linear Activity seconds
D-DIMER Linear 1/C (ng/mL) ∆OD
VWF Linear Activity ∆OD
Free Protein S Linear Activity ∆OD
Precision Performance
Linearity Studies
Linearity studies were performed over multiple sample levels with each level run
in duplicate on an ACL ELITE/ELITE PRO. Results are shown in the table below:
Please refer to the end of this chapter for the Method Comparison Graphs.
These time intervals should be used as guideline only. Use of Quality Control materials is
the best determinant of stability in your laboratory.
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 condition and cleanliness of the sample probe are key
factors in minimizing carryover.
1. When testing a plasma sample (PT or APTT) from a patient with a severe
Factor Deficiency (factor < 10%) immediately after a normal sample.
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).
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 Vial 10 mL 23 mm NA 9.2 mL
Reagent Area
Container Usable Volume Usable Volume
Type Volume Diameter Stirred Reagents Non-Stirred
Reagents
Reagent Vial 4 mL 18 mm NA 3.5 mL
Reagent Vial 10 mL 23 mm 8.3 mL 9.4 mL
Reagent Vial 16 mL 28 mm 13.2 mL 14.1 mL
NOTE: The reagent vials partially filled with PT-FIB and APTT reagents may be
topped with fresh reagent ONLY IF the reagent in the vial is still within the on-
o
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).
PC keyboard: Standard
Video Display Unit: 12.1” color LCD, with touch screen
7.8.2 Dimensions
Total height: 60 cm
Height of analysis surface: 33 cm
Width: 100 cm
Depth: 60 cm
Weight: 63 Kg
Frequency range: 50 - 60
Fuses: 2 x T 6.3 A
7.11 HAZARDS
The ACL ELITE/ELITE PRO has been tested and found to comply with national
and international EMC and RFI requirements. These requirements are designed
to provide reasonable protection against harmful interference when the
equipment is operated in a commercial environment. This instrument generates,
uses and can radiate radio frequency energy. If harmful interference is produced
as a result of installation and use other than that recommended by the
manufacturer, the user will be required to correct the interference at his own
expense.
7.11.4 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.
For additional information, refer to NCCLS document 117-P No. 15: Protection of
Laboratory Workers from Instruments Biohazards, 1991.
In particular the sample tray area should be accessed only in Ready state or
using the STAT (Pause) function to avoid mechanical hazard due to the needles
arm movement.
Disclaimers
Instrumentation Laboratory, Inc. (IL) is responsible for the safety and electrical
performance of this equipment if and only if:
• Assembly operations, extensions, adjustments, modifications or repairs are
carried out by persons authorized by IL;
• The electrical installation of the room complies with the local, state or
national requirements (including a power supply circuit with independent
grounding);
• The equipment is used in accordance with these instructions for use.
Bibliography
For additional information, refer to NCCLS document 117-P No. 15: Protection of
Laboratory Workers from Instruments Biohazards, 1991.
Note: Analytical performance for the ACL 8/9/10000 and ELITE/ ELITE PRO
are comparable
Antithrombin(%):
140
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):
1
ACL 9000 EM5
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):
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):
1200
1000 y = 0.9114x + 86.596
r = 0.9955
ACL 9000 EM6
800
n = 46
(ng/mL)
600
400
200
0
0 200 400 600 800 1000 1200
ACL 6000 (ng/mL)
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)
200
y = 0.9598x + 0.6184
ACL 9000 EM3
r = 0.9896
(% Activity)
150 n = 47
100
50
0
0 50 100 150 200 250
ACL 6000 (% Activity)
Fibrinogen-C
(mg/dL):
r = 0.9982
(mg/dL)
n = 54
400
200
0
0 200 400 600 800
ACL 6000 (mg/dL)
Heparin
1 r = 0.9961
(U/mL)
0,8 n = 50
0,6
0,4
0,2
0
0 0,2 0,4 0,6 0,8 1 1,2 1,4
ACL 6000 (U/mL)
(U/mL):
Plasmin Inhibitor
(%):
140
130
120
y = 0.9084x + 8.6423
ACL 9000 (% Activity)
r = 0.9899
110
n = 57
100
90
80
70
60
50
40
40 50 60 70 80 90 100 110 120 130 140
ACL 6000 (% Activity)
Plasminogen
(%):
r = 0.9894
(% Activity)
100
n = 57
80
60
40
20
0
0 20 40 60 80 100 120 140 160
ACL 6000 (% Activity)
ProClot (%)
with APTT-SP:
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
ACL 6000 (% Activity)
Protein-C
(%):
250
(% Activity)
r = 0.9982
200 n = 52
150
100
50
0
0 50 100 150 200 250 300 350
ACL 6000 (% Activity)
Protein S (%):
140
120
ACL 9000 (% Activity)
y = 0.923x + 2.9345
100
r = 0.9930
80 n = 54
60
40
20
0
0 20 40 60 80 100 120 140
ACL 6000 (% Activity)
PT (Seconds):
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)
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)
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)
8.0 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.
For all tests concerning control of hemostasis, with the exception of the platelet count, the
preferred anticoagulant is trisodium citrate at the concentration recommended in CLSI
Document H21-A3, using a ratio of 1 volume of citrate to 9 volumes of blood.
The correct concentration of the anticoagulant is of utmost importance for precision of the
results. The Document mentioned above must be referenced when adjustments to the
citrate concentration are required.
References
1. CLSI Document (latest revision) Collection, Transport and Processing of
Blood Specimens for Coagulation Testing and General Performance of
Coagulation Assays.
2. ECCLS Vol. No. 1 Standard for Specimen Collection
3. CLSI Document (latest revision). Procedure for the Collection of
Diagnostic Blood Specimens by Venipuncture.
9.0 Introduction
This section contains information about the expendable materials that are available for
use with the ACL ELITE/ELITE PRO System. These items may be ordered from IL or its
representative whenever they are needed using the Catalog Numbers as shown in the
table, Section 9.2. Many of these items are shipped in the “Startup Kit” included with the
ACL ELITE/ELITE PRO system, as indicated in Section 9.1.
Three sample trays configurations are available. The startup kit includes one tray with
conversion adaptors. The user chooses the desired system configuration between the
Short and Tall configuration. Trays for the Sarstedt tubes must be ordered separately.
Magnetic Stirrers
Diluent/Buffer/Reagent Cups
Wash-R Emulsion
Waste/Rinse Reservoir
Waste Bottle
Rotors
- a removable container used inside the system to hold the used rotors
Molded Air Filter
Fuses 6.3 AT
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
Operator’s Manual
- the Operator’s Manual for the use of the ACL ELITE/ELITE PRO system
Compliance Certificate
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.
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 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.
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).
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.
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
Instrumentation Laboratory
Corporate Headquarters
Aragón 90 - 08015 Barcelona, Spain
P.O. Box 35027 (08080)
Telephone: 34-93-4010101
Fax: 34-3-4513745
Mexico
Instrumentation Laboratory Diagnostics, S.A. DE C.V.
Lago Victoria 80, 11520 - Col. Granada Mexico DF
Mexico
phone:+52 55 5262 1760
fax:+52 55 5262 1763
Pacific Headquarters
I.L. Japan Co. Ltd.
Hamamatsucho General, Bldg. 9F
105-0013 - Minato-ku Tokyo, Japan
phone:+81 3 3437 635
fax:+81 3 3437 635
Japan
I.L. Japan Co. Ltd.
Hamamatsucho General, Bldg. 9F
105-0013 - Minato-ku Tokyo, Japan
phone:+81 3 3437 635
fax:+81 3 3437 635
Austria
Instrumentation Laboratory Gesellshaft m.b.H.
Tillmanngasse 5, 12201 - Wien
Austria
phone:+43 1 2565800-0
fax:+43 1 2565800-88
Belgium
Instrumentation Laboratory (Belgium) N.V. / S.A.
Excelsiorlaan 48-50, Bus 8
1930 Zaventem (Brussel) - Belgium
Telephone: 32-02-7252052
Fax: 32-02-7212409
France
Instrumentation Laboratory
32, avenue de Saint- Mandé
B.P. 35 - 75560 Paris Cedex 12 France
Telephone: 33-1-53338600
Fax: 33-1-53338601
Italy
Instrumentation Laboratory SpA
Divisione Commerciale Italia
Viale Monza 338 - 20128 Milan, Italy
Telephone: 39-2-25221
Fax: 39-02-2575250
The Netherlands
Instrumentation Laboratory (Netherlands) B.V.
Moskesbaan 2
4823 AH BREDA - The Netherlands
Telephone: 31-076-5480100
Fax: 31-076-5480102
United Kingdom
Instrumentation Laboratory (U.K.) Ltd.
Kelvin Close - Birchwood Science Park
Warrington, Cheshire WA3 7PB UK
Telephone: 44-1925-81-0141
Fax: 44-1925-826708
Revision 2.4
January 2010
Appendix A
Instrumentation Laboratory 2 of 33
ELITE/ELITE PRO Operator’s Manual
Index
1.0 Introduction 4
1.1 Purpose 4
2.0 General Description 5
2.1 Product Perspective 5
3.0 Specific Requirements 6
3.1 Protocol Specification 6
3.2 Low Level Interface 6
3.3 Data Link and Logical Layer 6
3.4 Sessions 6
3.4.1 Message Header and Message Terminator Records 7
3.5 Test Order Downloading 8
3.5.1 Receive Session from DMS 8
3.5.1.1 Test Request Message 9
3.5.1.2 Test Order Message 10
3.5.1.2.1 Patient Information Record 10
3.5.1.2.2 Test Order Record 12
3.5.2 Host Query 14
3.5.3 Test Request Message 15
3.5.4 Test Order Message 16
3.6 Rejected Test Order 17
3.7 Download Session Volumes 18
4.0 Test Results Uploading 19
4.1 Test Result Message 20
4.1.1 Patient Information Record 20
4.1.2 Test Order Record 21
4.1.3 Result Record 22
4.1.4 Comment Record 23
4.1.5 Error Codes 24
4.2 Upload Session Volumes 26
5.0 Not Supported Records 27
6.0 Transmission Abort 27
7.0 ACL ELITE/ELITE PRO Test Codes 28
8.0 ACL ELITE/ELITE PRO Supported Characters 31
8.1 Supported Characters for Sample ID 31
8.2 Supported Characters for Patient name and Department 31
8.3 Supported Characters for delimiters 31
9.0 ACL ELITE/ELITE PRO Supported Units 32
Instrumentation Laboratory 3 of 33
Appendix A
1.0 Introduction
1.1 Purpose
This document is a guide to integrate a Laboratory Information Management system with the
Instrumentation Laboratory ELITE/ELITE PRO family instruments using the ASTM (American
Society for Testing and Materials) specification to transfer information between clinical instruments
and computer systems.
ASTM specification E-1394-91 Standard Specification for Transferring Information between Clinical
instruments and Computer Systems and E-1381-91 Standard Specification for the Low Level
Protocol to transfer Messages between Clinical Laboratory Instruments and Computer Systems
have been used as standard to develop ELITE/ELITE PRO Host Communication Protocol.
Specification E-1394 defines the logical layer of ASTM standard; all significant information for
ELITE/ELITE PRO instruments application can be found in chapters Specific Requirements and
following.
Specification E-1381 refers to low level protocol; significant information for ELITE/ELITE PRO family
instruments application can be found later on in this document.
Instrumentation Laboratory 4 of 33
ELITE/ELITE PRO Operator’s Manual
If the instrument is properly configured, automatic downloading or uploading sessions can be started
by ELITE/ELITE PRO instrument.
Automatic downloading will occur at session start if host query is configured. In this condition the
instrument will request test orders for specific sample IDs recognized on the sample tray.
The second condition will occur, if automatic uploading has been requested, at session completion.
In case the communication session is not generated from the instrument, any host computer
message is ignored.
All information received by the host computer must be associated with a Sample ID which is the
primary key of the database. In addition to programmed tests a certain amount of information can be
associated with a Sample ID (patient data) and stored in ELITE/ELITE PRO database. This
information is optional.
At most 1000 samples can be stored in ELITE/ELITE PRO database; each sample can have a
maximum of 30 tests associated (double tests are considered as 3 tests).
The system behavior when these limits are exceeded is explained in the paragraph Test Order
Downloading.
If 1000 samples are present in the database, the FIFO (First In First Out) will not accept additional
samples during a Manual Downloading.
The test ordering operation, to identify the type of ordered test, by host computer must refer to a
computer code that is instrument specific. Refer to Test Order Downloading for further details and to
section 7 at the end of this document for the test codes table.
Note: for the downloading, the Host should send to the ELITE/ELITE PRO string information in
single frame (single line) during the transmission, or up to 240 bytes maximum during the
transmission.
.
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Appendix A
Parity No parity
Stop Bits 1
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.
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ELITE/ELITE PRO Operator’s Manual
H|\^&|||ACL9000|||||||P|1|20021205123956<CR>
H|\^&||||||||ACL9000||P|1|20021205123956<CR>
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Appendix A
Example of Terminator:
L|1|N<CR>
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.
ELITE/ELITE PRO instruments will process each received test order to validate fields supported;
some information will be extracted from the received record while other information will be ignored.
Only test orders related to patient samples are considered, if the required sample ID does not exist
in the patient database and the required sample ID is not used in the QC database, a new record is
created. If the database is full, the transmission session will be aborted.
If the test orders are for a sample already existing in the sample data base, the new orders will be
added to the existing tests but all tests already ordered or performed will remain unchanged.
If a test order with more than the maximum number of programmable tests is sent, the request is
rejected. The limit is 30 single tests or 10 double tests.
If the test order is not recognized as one of those supported by ELITE/ELITE PRO family
instruments, it is rejected. The instrument will inform the host computer using a record containing
the list of rejected test orders.
During a downloading session the listed error conditions can be detected, the associated instrument
behavior and actions are listed as well:
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ELITE/ELITE PRO Operator’s Manual
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 -
All abort conditions imply that ELITE/ELITE PRO family instruments will send to the host computer a
message with the reason for transmission interruption (see Reject Test Order) while a message is
presented to the user on the instrument. When transmission abort is not implied, at transmission
completion one or more records will follow (see Reject Test Order) with an indication of rejected test
orders.
Information rejected is typically unknown test requests or test requests exceeding the sample record
size in ELITE/ELITE PRO Data Management System. It must be observed that if any of this
information is rejected, it does not imply that all sample data have been rejected.
The set of legal test requests are normally stored while the illegal requests for the same sample ID
will be rejected.
It also must be underscored that ELITE/ELITE PRO limits the size of handled records
(independently from the record type supported by ASTM) to 1024 byte during downloading session.
Note: for the downloading the Host should send to the ELITE/ELITE PRO string information in single
frame (single line) during the transmission or up to 240 bytes maximum during the transmission.
Following the ASTM specification the fields composing the Request Information are described in the
following.
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Appendix A
An example for the complete message (composed by header message, request information record
and message terminator record) is given by:
H|\^&|||ACL9000|||||||P|1|19960210103227<CR>
Q|1|ALL||||||||O<CR>
L|1|N<CR>
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Appendix A
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ELITE/ELITE PRO Operator’s Manual
H|\^&||||||||ACL9000||P|1|19982110134700<CR>
P|1||PTNT1||ROSSI^MARIO^^^||19391127|M|||||||||||||||||DEP
1||||||||||<CR>
O|1|SMP01||^^^0001|S||||||||||^|DR. VERDI|||||||||O||||||<CR>
O|2|SMP02||^^^0001|||||||||||^||||||||||O||||||<CR>
P|2||PTNT2||GIALLI^LUCA^^^||19551028|F||||||||||||||||||DEP
2||||||||||<CR>
O|1|SMP10||^^^0001|||||||||||^||||||||||O||||||<CR>
L|1|N<CR>
H|\^&||||||||ACL9000||P|1|20021205123956<CR>
P|1||||^^^^|||||||||||||||||||||||||||||<CR>
O|1|LAURA01||^^^0001|||||||||||^||||||||||O||||||<CR>
L|1|N<CR>
Note: Separators are always expected from Host and are always transmitted independently from the
information contained in the string.
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Appendix A
The instrument will send, using the requested information record, the sample IDs requiring test
programming and will accept only test orders for those sample IDs.
The instrument will accept for the queried samples any test orders independently by the type of test
which will be executed in the starting session.
The mechanism supported by ASTM requires sending to the host a Request Information record for
each sample ID or sending to the host a range of queried sample IDs. The mechanism supported by
ELITE/ELITE PRO is the first option, so will be independent of the sorting system used by
instrument or host computer on the samples.
As a consequence the instrument will send a query for the first sample, will wait for the host
information and will send later a new query for the next samples (if any). All the host query sessions
will be organized in this manner.
Because the instrument is asking for information regarding a specific sample ID, it will reject any
type of information associated with different sample IDs.
The host will provide to the instrument all available test requests. The host can send zero or more
test orders in one or more messages, but all messages will be part of the same transmission
session.
During a transmission session more test orders can be required for the same sample.
ELITE/ELITE PRO will process each received test order validating the fields that ELITE/ELITE PRO
supports; some information will be extracted from the received record while other information will be
ignored.
If the test order is not recognized as one of those supported by ELITE/ELITE PRO it will be rejected.
The instrument will inform the host computer using a record containing the list of rejected test
orders.
Host Query is only performed if the Sample ID is not located in the database for the ACL system.
During a download session the listed error conditions can be detected, the associated ELITE/ELITE
PRO action is listed as well:
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Sample ID used in the QC data base Abort communication Sample ID already used
in the QC data base
Bad Sample ID (long, unsupported Abort communication Invalid Sample ID
characters)
Data Base full Abort communication Patient Data Base is full
Patient record has no associated test Abort communication Not identified sample ID
order record for patient data
Test order has no associated patient Abort communication No patient record for
record ordered tests
Instrument Identifier different from Abort communication Invalid instrument
ACL9000 or extended name identifier
Too many test requests for the same Reject test order -
sample ID
Unknown test request Reject test order -
Bad Test Reject test orders -
Illegal record format Abort communication Incorrect record format
in host messages
All abort conditions imply that ELITE/ELITE PRO family instruments will send to the host computer a
message with the reason of transmission interruption (see Reject Test Order) while a message is
presented to the user on the instrument. When transmission abort is not implied, at transmission
completion one or more records will follow (see Reject Test Order) with an indication of rejected test
orders.
Information rejected is typically unknown test requests or test requests exceeding the sample record
size in ELITE/ELITE PRO Data Management System. It must be observed that if any of this
information is rejected, it does not imply that all the sample data have been rejected.
The set of legal test requests are normally stored while the illegal requests for the same sample ID
will be rejected.
It also must be underscored that ELITE/ELITE PRO limits the size of handled records
(independently from the record type supported by ASTM) to 1024 byte during downloading session.
Note: If the Sample ID is not present at the Host level during the Host Query, the Host will return
only the Header and the terminator.
H|\^&||||||||ACL9000||P|1|20021205123956<CR>
L|1|N<CR>
Note: If the Host requests a test that is disabled on the ELITE/ELITE PRO, the test will not be
programmed on the ELITE/ELITE PRO and a reject message of this type will be returned back to
the Host.
C|1|I|UKNOWN_T|PatientID^0080|I<CR>
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Appendix A
The Request Information record requests in this case information for one specific ID at time. The
ASTM protocol limits the number of Request Information records to one. As a consequence the
instrument will wait for the host answer before sending a second Request Information record for a
second sample.
Following the ASTM specification the fields composing the Request Information are described in the
following.
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>
H|\^&||||||||ACL9000||P|1|19960210103256<CR>
P|1||||ROSSI^MARIO^^^||19391127|M|||||||||||||||||DEP 1||||||||||<CR>
O|1|S001||^^^0001|||||||||||^| DR. VERDI |||||||||O||||||<CR>
O|2|S001||^^^0002|||||||||||^||||||||||O||||||<CR>
L|1|N<CR>
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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.
To summarize the possible values for the rejection reason and identification fields are reported in
the following table:
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Appendix A
H|\^&|||ACL9000|||||||P|1|19982110103227<CR>
C|1|I|M_TEST_E|SMP01 ^010|I<CR>
C|2|I|BAD_TEST|SMP01 ^000|I<CR>
L|1|N<CR>
The minimal session would occur if the host has no test orders available for ELITE/ELITE PRO. In
this condition ELITE/ELITE PRO sends the test request message, the host would respond with a
message containing no test orders (only message header and message terminator record).
In conditions in which the host has test orders for the instrument, the estimated data volume is:
Test Request Message = Message Header (41) +17 + Message Terminator Record (6) = 64
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:
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.
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If upload is manually requested, all data are transmitted independently from the transmission flag.
If transmission is performed automatically at session completion, the instrument will upload for
patient samples all the data available for the sample IDs just analyzed and will upload, for QC data,
the results just obtained.
From a general point of view the automatic data transmission of the patient samples is equivalent to
the manual data transmission, requested in DMS, of patient samples belonging to a specific load-
list. While the automatic data transmission of the QC data or AR data is equivalent to the manual
data transmission, requested in QC database or AR database, or the data in a specified interval for
the QC material present in the load-list.
Considering that ELITE/ELITE PRO fills the strings used for Sample ID, department and patient
name with space characters (to align data); the host computer must ignore space characters on the
right of these fields.
If uploading is completed successfully for patient, QC samples and AR data, the transmission flag
associated to the single record will be updated from ‘L’ to ‘T’ (transmitted).
It must also be noted that on the ELITE/ELITE PRO, modifications to sample data already
transmitted (such as adding of a new test result or modifications of sample data) cause the
transmission flag to change from ‘T’ to ‘L’.
It does not apply to QC or AR data because the only modification the user can request on these data
is to omit or to clear statistic. The effect of omit operation is to exclude the data from the statistic but
the data is not modified.
Modifications in the set-up values and note field do not modify the transmission status of QC data
and AR data.
While transmission is in progress the user will be updated on the number of the sample being
transmitted.
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Appendix A
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.
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Appendix A
Result Record:
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board). board).
Data or Measurement Value The field contains the obtained The field contains the obtained
numeric value or qualitative numeric value or qualitative
message (Error xx). All message (Error xx). All
numerical results are sent. * numerical results are sent. *
Units Provided if the previous field is Provided if the previous field is
a numeric value; is a free a numeric value; is a free
string (see Section 9 for string (see Section 9 for
standard units) maximum standard units) maximum
number of characters is 8). number of characters is 8).
Reference range Not provided Not provided
Result Abnormal Flag Not provided Not provided
Nature of Abnormality Flag Not provided Not provided
Result Status Set to ‘F’ Set to ‘F’
Data of Change in Instrument Not provided Not provided
Normative Values or Units
Operator Identification Not provided Not provided
Date/Time Test Started Not provided Not provided
Date/Time Test Completed Execution time, string of the Execution time, string of the
type YYYYMMDDHHMMSS type YYYYMMDDHHMMSS
Instrument Identification Not provided Not provided
Comment Record:
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Appendix A
MECHANICAL WARNING
LIQUID WARNING
MISCELLANEOUS WARNING
COVER_OPEN_DURING_LOADING_OR_INCUBATION = 86,
TIMEOUT_EXPIRED_DURING_LOADING = 87,
ERRORS ON RESPONSE
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AR_INVALID = 229,
AR_OUT_OF_RANGE = 230,
AR_NOT_CHECKED = 233,
DUPLICATE OUT OF RANGE = 239,
QC_INVALID = 240,
QC_OUT_OF_RANGE = 242,
RATIO_CALCULATION_ERROR = 249,
RATIO_CALCULATION_ERROR: S/Sa out of range = 250,
NORMALIZED RATIO ERROR: AR/Ara out of range = 251,
NORMALIZED RATIO: CALCULATION ERROR = 252,
STD_NOT_FOUND = 253,
AR_NOT_FOUND = 254,
ACTIVATE SAMPLE NOT_FOUND = 255,
ARa_NOT_FOUND = 256,
RATIO_NOT_FOUND = 257,
AR_OUT_OF_RANGE = 258,
AR_NULL = 259,
STD_NULL = 260,
SAMPLE_NULL = 262,
REF_NULL = 263,
AR_RATIO_ NULL_ = 264,
ACTIVATED_AR NULL_ = 265,
NULL_DIFFERENCE = 266,
Out of range indications referring to normal or test ranges are not transmitted to the host computer.
The * symbol (outside Normal Range) is presented only on the Cumulative and Sample Reports.
Instrumentation Laboratory 25 of 33
Appendix A
Sample
H|\^&||||||||ACL9000||P|1|19982110134700<CR>
P|1||PTNT1||BLU^^^^||19391127|M|||||||||||||||||DEP 1||||||||||<CR>
O|1|SMP01||^^^0001|S||||||||||^|DR. VERDI|||||||||O||||||<CR>
R|1|^^^0001|12.8|||||F||||19960119114215|<CR>
C|1|I|31^ Invalid for QC |I<CR>
P|2||PTNT1||Gialli^^^^||19391127|M|||||||||||||||||DEP 1||||||||||<CR>
O|1|SMP10||^^^0001|S||||||||||^|DR. VERDI|||||||||O||||||<CR>
R|1|^^^0001|14.5|s||||F||||19960119114215|<CR>
C|1|I|31^ Invalid for QC |I<CR>
L|1|N<CR>
QC
H|\^&|||ACL9000|||||||P|1|20021205123956<CR>
P|1||||||||||||||||||||||||||||||||||<CR>
O|1|Normal C.||^^^0001|||||||Q||||^||||||||||F||||||<CR>
L|1|N<CR>
AR
H|\^&|||ACL9000|||||||P|1|20021205123956<CR>
P|1||||||||||||||||||||||||||||||||||<CR>
O|1|AR||^^^0001|||||||Q||||^||||||||||F||||||<CR>
L|1|N<CR>
Results = number of ordered test (55 + 60*number of test result + 56* number of error messages)
Consider the following situation: ELITE/ELITE PRO has 50 sample IDs to be uploaded each with 4
tests, each test with 3 results and each test with 2 flags, the data volume can be estimated in:
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.
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Further, as reported above, the download process can be interrupted because an illegal sample
Identifier has been received. Instrument behavior in this particular condition was defined in and
Reject Test Orders.
ELITE/ELITE PRO family instruments behavior in each of the listed conditions is described in the
following:
Condition Action
ELITE/ELITE PRO’s ELITE/ELITE PRO will signal the end of transmission to the host and will
operator requested stop discard any following messages. The host must consider the interrupt
download process request.
It must be emphasized that ELITE/ELITE PRO will signal the
transmission interruption with a message that is a rejected test order
message if any information has been rejected or with a message header
plus a message terminator record if no information has been rejected.
ELITE/ELITE PRO ’s ELITE/ELITE PRO will complete the message in progress with the
operator requested stop message terminator and will not transmit any further test results.
upload process
Host computer is not During download and upload transmission sessions, operation by
responding ELITE/ELITE PRO is stopped. If download was in progress, no rejected
test messages will be transmitted.
A message will inform the user that the transmission has been
interrupted: “Host Computer not responding”
Host computer required Both during download and upload sessions, operation by ELITE/ELITE
EOT PRO is stopped. If download was in progress, no rejected test
messages will be transmitted.
It must be emphasized that the host computer must request the
transmission interruption with a message composed by a message
header plus a message terminator record.
A message will inform the user that the transmission has been
interrupted: “Host Computer required interrupt transmission”
Incorrect record format Transmission/reception is aborted and the user is informed:
“Incorrect format in host messages”
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Appendix A
001 0001 PT PT
002 0002 PT e PT Extended
003 0003 PT d PT Double
004 0004 PT ed PT Ext. Db.
005 0005 PT HS PT HS
006 0006 PT HS e PT HS Extended
007 0007 PT HS d PT HS Double
008 0008 PT HS ed PT HS Ext. Db.
009 0009 PT HS + PT PLUS
010 0010 PT HS + e PTPLUS Extended
011 0011 PT HS + d PT PLUS Double
012 0012 PT HS + ed PT PLUS Ext. Db.
013 0013 R-PT Recombipl-PT
014 0014 R-PTe Recombipl-PTex
015 0015 PT R PT Rec.
016 0016 PT R e PT Rec Extended
017 0017 PT R d PT Rec. Double
018 0018 PT R ed PT Rec Ext. Db.
023 0023 R-PT d Rec-PT Double
024 0024 R-PT ed Rec-PT Ext Db
030 0030 FIB_ FIB (PT)
031 0031 FIB FIB (PT)
032 0032 FIB e_ FIB (PT e)
033 0033 FIB e FIB (PT e)
034 0034 FIB d_ FIB (PT d)
035 0035 FIB d FIB (PT d)
036 0036 FIB ed_ FIB (PT ed)
037 0037 FIB ed FIB (PT ed)
038 0038 FIB HS_ FIB (PT HS)
039 0039 FIB HS FIB (PT HS)
040 0040 FIB HSe_ FIB (PT HS e)
041 0041 FIB HSe FIB (PT HS e)
042 0042 FIB HSd_ FIB (PT HS d)
043 0043 FIB HS d FIB (PT HS d)
044 0044 FIBHSed_ FIB (PT HS ed)
045 0045 FIB HSed FIB (PT HS ed)
046 0046 FIB HS+_ FIB (PT PLUS)
047 0047 FIB HS+ FIB (PT PLUS)
048 0048 FIB HS+e_ FIB (PLUS e)
049 0049 FIB HS+e FIB (PLUS e)
050 0050 FIB HS+d_ FIB (PLUS db)
051 0051 FIB HS+d FIB (PLUS db)
052 0052 FIB+ed_ FIB (PLUS ed)
053 0053 FIB+ed FIB (PLUS ed)
054 0054 R-FIB_ Recombipl-FIB
055 0055 R-FIB Recombipl-FIB
056 0056 R-FIBe_ Recombipl-FIBex
057 0057 R-FIBe Recombipl-FIBex
058 0058 FIB R_ FIB (Rec)
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360 0360 FV PT F V - PT
362 0362 FV HS F V - HS
364 0364 FV HSP F V - HS Plus
366 0366 FV R FV-R
367 0367 R FV FV RecombPT
370 0370 FII PT F II - PT
372 0372 FII HS F II – HS
374 0374 FII HSP F II - HS Plus
376 0376 FII R F II – R
377 0377 R FII FII RecombPT
155 155 SCT-S SCT Screen
156 156 SCT-C SCT Confirm
400 0400 VWF:Ag vWF Antigen
401 0401 vWF:AgH vWF Antigen Hig
410 0410 LAC_S LAC_S
411 0411 LAC_C LAC Confirm
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Appendix A
Note: Separators are always expected from Host and are always transmitted independently from the
information contained in the string.
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Unit Abbreviation
Time S
Activity %
Ratio R
International Normalized Ratio INR
NR
Concentration mg/dL
g/L
ng/mL
U/mL
µg/L
µmol/L
IU/mL
mg/L
ug/mL
Notes: For duplicate (d) and extended duplicate (ed) tests only the individual replicate results are
sent to the host system. The mean value is not sent from the ACL ELITE/ELITE PRO system. This
applies to all sample types including patient, QC and Analytical reference.
Instrumentation Laboratory 33 of 33
APPENDIX B
Index
1. INTRODUCTION .................................................................................................................... 3
Instrumentation Laboratory 2
Appendix B ACL ELITE/ELITE PRO Operator’s Manual
1.0 Introduction
In the following sections the characteristics of the bar code labels that can be read with the
internal scanner installed on ACL ELITE/ELITE PRO family instruments are described.
1.1 Purpose
Purpose of this document is to give indication of the scanner characteristics in terms of readable
codes, identify the requirements the barcode labels must satisfy and define constraints in terms of
label positioning within ACL ELITE/ELITE PRO instrument.
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.
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Appendix B ACL ELITE/ELITE PRO Operator’s Manual
2. General Description
The scanner is a fixed mount CCD bar code scanner with integrated decoder for easy integration
into the ACL ELITE/ELITE PRO instruments
The following mean features are available with the internal scanner:
All bar code symbols have to satisfy the appropriate AIM Uniform Symbology Specification.
In particular the following characteristics have to be 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.
Instrumentation Laboratory 4
Appendix B ACL ELITE/ELITE PRO Operator’s Manual
• 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 symbol 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.
• 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:
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:
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 the OEM vendor
because the scanner equipped for the IL requirements does not have standard optics.
Instrumentation Laboratory 5
Appendix B ACL ELITE/ELITE PRO Operator’s Manual
In sections 2.5 & 2.6 attached drawings define 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.
Instrumentation Laboratory 6
Appendix B ACL ELITE/ELITE PRO Operator’s Manual
Instrumentation Laboratory 7
Appendix B ACL ELITE/ELITE PRO Operator’s Manual
Instrumentation Laboratory 8
APPENDIX C
Revision 5
.
2 Instrumentation Laboratory
Specialty Testing on the ACL ELITE/ELITE PRO
• APCR-V Page 4
• Plasminogen Page 59
• Antithrombin (Liquid) Page 8
• Plasmin Inhibitor Page 63
• D-Dimer/DD500 Page 12
• Pro-IL-Complex Page 67
• Factor Assays Page 21
• ProClot Page 71
• Chromogenic Fact. VIII Page 26
• Protein C Page 75
• Fib Clauss or QFA Page 30
• Pro S Page 79
• Free Protein S Page 35
• Silica Clotting Time Page 83
• Heparin Page 39
• Thrombin Time Page 87
• Hepatocomplex Page 44
• vWF Activity Page 90
• Homocysteine Page 48
• vWF Antigen Page 94
• LAC- Screen/Confirm Page 52
3 Instrumentation Laboratory
APCR-V
Reagent Preparation
4 Instrumentation Laboratory
APCR-V – ACL ELITE/ELITE PRO
1. Materials Needed
5 Instrumentation Laboratory
2. Enabling the Test in the Analyzer
- The liquid positions for APTT Reagent, Factor V Reagent Plasma, APC/CaCl2 and
CaCl2 are automatically assigned when the test is placed in a profile or run as a single
assay. Refer to the Materials map screen when running the assay for placement.
5. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined The APCR-V test can utilize the following
control materials to verify assay performance:
- APC Control Plasma Level 1
- APC Control Plasma Level 2
On the ACL ELITE/ELITE PRO this is defined in Setup Liquids menu. Refer to section 4.1.11
In the ACL ELITE/ELITE PRO Operator’s manual for Detailed instructions on defining new
liquids.
6 Instrumentation Laboratory
Range check button for control result flagging. Refer to the ACL ELITE/ELITE PRO
Operator’s Manual section 3 for details on QC setup.
- Press the Green Check to Save and return to main database screen.
6 . Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
Results are reported in either seconds or a Ratio of the Seconds. The ratio is calculated as follows:
APCR-V = APTT (with APC) / APTT (without APC)
Each laboratory should establish its own normal cutoff value for the ratio.
Refer to the HemosIL APC Resistance V package insert sheet for a procedure to establish the
cut-off value.
7 Instrumentation Laboratory
L (Liquid)
Antithrombin
Reagent Preparation
8 Instrumentation Laboratory
Liquid Antithrombin – ACL ELITE/ELITE PRO
1. Materials Needed
9 Instrumentation Laboratory
- Scroll down to the row for units in % and click on the Ranges button.
- Enter in the Min and Max values for the normal range.
- Press the Green Check to Save and return to main database screen.
- Setup Liquids
- Scroll down the Liquid ID column and highlight Cal Plasma.
- Scroll down the Used by column and highlight the AT* test.
- Click on the Assign Value button, and enter in the value for the Calibrator. This value
can be found on the Cal Plasma package insert.
- Press the Green Check to Save and return to main database screen.
- The liquid positions for the Cal Plasma, Factor Xa, Chromogenic Substrate, Factor
Diluent and Clean A are automatically assigned when the test is placed in a profile or
run as a single assay. Refer to the Materials map screen when calibrating or running
the assay for placement.
6. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined. The AT* test can utilize the following
control materials to verify assay performance:
- Normal Control Plasma
- Abnormal Chromogenic Control Plasma Level 1
- Abnormal Chromogenic Control Plasma Level 2
On the ACL ELITE/ELITE PRO these liquids are defined in Setup Liquids menu. Refer to
section 4.1.11 in the ACL ELITE/ELITE PRO Operator’s manual for Detailed instructions on
defining new liquids.
10 Instrumentation Laboratory
7. Calibrating the Assay
All reagents, calibrators must be reconstituted according to directions and allowed to sit for 30
minutes prior to calibration.
- Calibration Calibrate
- From the calibrate screen, select the AT* test from the drop down menu in the Test to
Calibrate window.
- Confirm the necessary liquids are in place according to the Material Map.
- Place 2 empty 0.5 mL sample cups in the appropriate “A” positions according to the
Material Map.
- Press the Run key to begin the calibrate cycle.
- When the calibration is complete the graph and cal curve data will be visible. If the curve
data is acceptable, click on the check to accept the use of the curve.
8. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
11 Instrumentation Laboratory
D-Dimer/DD500
Reagent Preparation
12 Instrumentation Laboratory
D-Dimer / D-Dimer High – ACL ELITE/ELITE PRO
1. Materials Needed
D-Dimer Controls
Kit Contents Stability Preparation
5 x 1.0 mL Low D-Dimer 1 Month at 2-8oC Add 1.0 mL H2O.
Control 3 Days at 15-25oC Swirl, let sit for 30 min at
Approximate Level: Border line 2 Months at –20oC 15 – 25oC.
value **Freeze and thaw only 1 time. Invert. Do Not Shake!
Thaw at 37oC & mix prior to use.
5 x 1.0 mL High D-Dimer 1 Month at 2-8oC Add 1.0 mL H2O.
Control 3 Days at 15-25oC Swirl, let sit for 30 min at
Approximate Level: Abnormal 2 Months at –20oC 15 – 25oC.
value **Freeze and thaw only 1 time. Invert. Do Not Shake! Avoid
Thaw at 37oC & mix prior to use. foam formation.
13 Instrumentation Laboratory
2. Enabling the Test in the Analyzer
- Setup Liquids
- Scroll down the Liquid ID column and highlight D-D Cal.
- Scroll down the Used by column and highlight the D-Dimer test.
- Click on the Assign Value button, and enter in the value for the D-Dimer Calibrator.
This value can be found on the package insert included in the kit.
- Press the Green Check to Save and return to main database screen.
Note: The D-Dh (D-Dimer High) test uses the calibration curve for the regular D-Dimer
test. It is not necessary to enter in the calibrator value into the D-D h test.
- The liquid positions for the D-D Cal, D-Dimer Latex, Buffer reagent and Factor
Diluent are automatically assigned when the test is placed in a profile or run as a single
assay. Refer to the Materials map screen when running the assay for placement.
Note: The D-Dimer assay is linear from 200 to 1050 ng/mL. The ACL ELITE/ELITE
PRO system can rerun patient samples that exceed the 1050ng/mL limit using the D-Dimer
high test. This will increase the linearity of the assay 5-fold up to 5250 ng/mL. Values
above 5250 ng/mL from the D-D h (D-Dimer high) test will need manual dilution (1:25 or
1:125) with factor diluent and repeated using the D-Dimer test. Multiply the printed results
14 Instrumentation Laboratory
by 5, 25 or 125 (depending upon the number of dilution steps performed) to correct for the
dilution. Do Not run the D-Dimer high test on samples with a D-Dimer less than 1000
ng/mL
7. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined. The D-Dimer test can utilize the following
control materials to verify assay performance:
- Low Dimer Control
- High Dimer Control
On the ACL ELITE/ELITE PRO this is defined in the Setup Liquids menu. Refer to section
4.1.11 in the ACL ELITE/ELITE PRO Operator’s manual for Detailed instructions on defining
new liquids.
All reagents, calibrators must be reconstituted according to directions and allowed to sit for 30
minutes prior to calibration.
15 Instrumentation Laboratory
- Calibration Calibrate
- From the calibrate screen, select the D-Dimer test from the drop down menu in the Test
to Calibrate window.
- Confirm the necessary liquids are in place according to the Material Map.
- Press the Run key to begin the calibrate cycle.
- When the calibration is complete the graph and cal curve data will be visible. If the
curve data is acceptable, click on the check to accept the use of the curve.
9. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
16 Instrumentation Laboratory
D-Dimer 500 / D-Dimer 500 High – ACL ELITE/ELITE PRO
1. Materials Needed
D-Dimer Controls
Kit Contents Stability Preparation
5 x 1.0 mL Low D-Dimer 1 Month at 2-8oC Add 1.0 mL H2O.
Control 3 Days at 15-25oC Swirl, let sit for 30 min at
Approximate Level: Border line 2 Months at –20oC 15 – 25oC.
value **Freeze and thaw only 1 time. Invert. Do Not Shake!
Thaw at 37oC & mix prior to use.
5 x 1.0 mL High D-Dimer 1 Month at 2-8oC Add 1.0 mL H2O.
Control 3 Days at 15-25oC Swirl, let sit for 30 min at
Approximate Level: Abnormal 2 Months at –20oC 15 – 25oC.
value **Freeze and thaw only 1 time. Invert. Do Not Shake! Avoid
Thaw at 37oC & mix prior to use. foam formation.
17 Instrumentation Laboratory
2. Enabling the Test in the Analyzer
- Setup Liquids
- Scroll down the Liquid ID column and highlight DD500 Cal.
- Scroll down the Used by column and highlight the DD500 test.
- Click on the Assign Value button, and enter in the value for the DD500 Calibrator.
This value can be found on the package insert included in the kit.
- Press the Green Check to Save and return to main database screen.
Note: The DD500h (D-Dimer 500 High) test uses the calibration curve from the D-
Dimer-500 test. It is not necessary to enter in the calibrator value into the DD500h test.
- The liquid positions for the DD500 Cal, DD500 Latx, DD500 Bufr reagents and Factor
Diluent are automatically assigned when the test is placed in a profile or run as a single
assay. Refer to the Materials map screen when running the assay for placement.
Note: The DD500 assay is linear from 453 to 2283 ng/mL. The ACL ELITE/ELITE PRO
system can rerun patient samples that exceed the 2283ng/mL limit using the DD500h test.
This will increase the linearity of the assay 5-fold up to 11413ng/mL. Values above 11413
ng/mL from the DD500h (DDimer500 high) test will need manual dilution (1:25 or 1:125)
with factor diluent and repeated using the DD500 test. Multiply the printed DD500 results
18 Instrumentation Laboratory
by the manual dilution factor to correct for the dilution. Do Not run the DD500h (DDimer
500 high) test on samples with a D-Dimer less than 2283 ng/mL
7. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined. The D-Dimer test can utilize the following
control materials to verify assay performance:
- Low Dimer Control
- High Dimer Control
On the ACL ELITE/ELITE PRO this is defined in the Setup Liquids menu. Refer to section
4.1.11 in the ACL ELITE/ELITE PRO Operator’s manual for Detailed instructions on defining
new liquids.
19 Instrumentation Laboratory
8. Calibrating the Assay
All reagents, calibrators must be reconstituted according to directions and allowed to sit for 30
minutes prior to calibration.
- Calibration Calibrate
- From the calibrate screen, select the DD500 test from the drop down menu in the Test
to Calibrate window.
- Confirm the necessary liquids are in place according to the Material Map.
- Press the Run key to begin the calibrate cycle.
- When the calibration is complete the graph and cal curve data will be visible. If the
curve data is acceptable, click on the check to accept the use of the curve.
9. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
20 Instrumentation Laboratory
Factor XII
Reagent Preparation
Calibrate and
Analyze Patient / QC Samples
21 Instrumentation Laboratory
Factor Analysis– ACL ELITE/ELITE PRO
This protocol is setup for the FXII SP test. All factors are processed the same way on the ACL
ELITE/ELITE PRO, therefore these guidelines can be used to run any clotting factor test on the analyzer.
Ordering information for the materials needed to run additional factor tests is located at the end of the
document.
1. Materials Needed
22 Instrumentation Laboratory
- Press the Green Check to Save and return to main database screen.
- Setup Liquids
- Scroll down the Liquid ID column and highlight Cal Plasma.
- Scroll down the Used by column and highlight the FXII SP test.
- Click on the Assign Value button, and enter in the value for the Calibrator. This value
can be found on the Cal Plasma package insert.
- Press the Green Check to Save and return to main database screen.
Notes: The FXII SP assay is Calibrated Once per Session onboard the ACL
ELITE/ELITE PRO. The test calibration occurs during the analysis cycle. The test cannot
be calibrated under the Calibration Menu.
Factor assays with parallelism tests utilize a Dedicated calibration and are calibrated under
the Calibration menu. These include FVIII and FIX for APTT SP and SynthASil.
- The liquid positions for the Cal Plasma, Cal Low F, FXII Def, Factor Diluent, APTTSP
and APTT Ca/Cl2 are automatically assigned when the test is run as a single assay.
Refer to the Materials map screen when running the assay for placement.
6. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined. The FXII SP test can utilize the following
control material to verify assay performance:
- Normal Control Plasma
- Special Test Control Level 2
On the ACL ELITE/ELITE PRO these liquids are defined in the Setup Liquids menu.
Refer to section 4.1.11 in the ACL ELITE/ELITE PRO Operator’s manual for Detailed
instructions on defining new liquids.
23 Instrumentation Laboratory
7. Calibrating the Assay
All reagents, calibrators must be reconstituted according to directions and allowed to sit for 30
minutes prior to calibration.
If the ACL detects only the Cal Plasma onboard during the pre-analytical
check, then it will execute a calibration and construct a curve from 100% down to 25%
activity. Low results below 25% will be extrapolated from the curve. In either case the
calibration curve will be stored and utilized again on subsequent runs if during the pre-
analytical check for FXII SP the instrument does not detect the presence of the Cal Plasma in
position A1.
Note: Do Not place the Low Cal F onboard without having Cal Plasma onboard as well.
Calibration for the tests with Factor Parallelism are defined as “dedicated” and performed using
the Calibration Menu. These tests include FVIII and FIX for APTT SP and SynthASil.
8. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
PT Based Factors
Factor II Deficient Plasma Cat. No. 20012200
Factor V Deficient Plasma Cat. No. 20011500
Factor VII Deficient Plasma Cat. No. 20011700
Factor X Deficient Plasma Cat. No. 20010000
24 Instrumentation Laboratory
Clotting Reagents
APTT SP Cat. No. 20006300
APTT Lyophilized Silica Cat. No. 08468710
SynthasIL Cat. No.20006800
PT - Fib Cat. No. 09756710
PT- Fib HS PLUS Cat. No. 08469810
RecombiPlasTin 2G Cat. No.20002950(8mL) or 20003050(20mL)
25 Instrumentation Laboratory
Chromogenic Factor VIII
Reagent Preparation
Setup the QC
QC Review/Setup
Run Samples/Calibrate
26 Instrumentation Laboratory
Chromogenic Factor VIII – ACL ELITE/ELITE PRO
The Chromogenic Factor VIII test has a High and Low tests defined in the system. The High test linear
range is 10 – 120% and the Low test is 0 – 10%.
1. Materials Needed
1 x 24mL Factor VIII Buffer 1 Month at 2-8oC (after diluting) Working buffer: dilute 2 mL
Buffer with 18 mL H2O.
27 Instrumentation Laboratory
- Scroll down to the row for units in % and click on the Ranges button.
- Enter in the Min and Max values for the normal range.
- Press the Green Check to Save and return to main database screen.
- Setup Liquids
- Scroll down the Liquid ID column and highlight Cal Plasma.
- Scroll down the Used by column and highlight the F8 Chr H / F8 Chr L test.
- Click on the Assign Value button, and enter in the value for the Calibrator. This value
can be found on the Cal Plasma package insert.
- Press the Green Check to Save and return to main database screen.
- The liquid positions for the Cal Plasma, Cal Low F, F8 Chr Buf, F8 Chr Act, F8 Chr
Sub, Clean A, and Factor Diluent are automatically assigned when the test is run as a
single assay. Refer to the Materials map screen when running the assay for placement.
6. Setting up QC
On the ACL ELITE/ELITE PRO these liquids are defined in the Setup Liquids
menu. Refer to section 4.1.11 in the ACL ELITE/ELITE Pro Operator’s manual
for Detailed instructions on defining new liquids.
All reagents and calibrators must be reconstituted according to directions and allowed to sit for 30
minutes prior to calibration.
28 Instrumentation Laboratory
The Cal Low F is a 1:16 dilution of the cal plasma.
This is prepared by mixing 20µL of Cal Plasma with 300µL of Factor diluent in a 0.5mL cup.
This calibrator is used for the F8 Chr L (Low Chromogenic Factor VIII) test.
8. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
Note: When the assay is run 2 empty (0.5 mL) cups for calibration will be required in the
displayed “A” positions on the tray along with one empty (0.5 mL) cup for each sample. The
empty cups in the sample position should be placed starting with position 21. One cup per patient
sample needs to be placed.
29 Instrumentation Laboratory
Fibrinogen (Clauss or QFA)
Reagent Preparation
30 Instrumentation Laboratory
Fibrinogen –C ACL ELITE/ELITE PRO
1. Materials Needed
Note: The Fib Clauss test is designated as Fib-C (g/L) and Fib-C_ (mg/dL)
The QFA Fib test is designated as QFA (g/L) and QFA_ (mg/dL)
31 Instrumentation Laboratory
3. Editing the Test Reference Range/Cutoff
- Setup Liquids
- Scroll down the Liquid ID column and highlight Cal Plasm
- Scroll down the Used by column and highlight the desired Fib-C or QFA test
- Click on the Assign Value button, and enter in the value for the Cal Plasma. This value
can be found on the Cal Plasma package insert.
- Press the Green Check to Save and return to main database screen.
Note: The Fib-C h (Fib Clauss High) and the Fib-C l (Fib Clauss Low) tests use the
calibration curve for the regular Fib Clauss test. The QFA L test uses the calibration from
the QFA test. It is not necessary to enter the calibrator value into these additional tests.
- The liquid positions for the Cal Plasm, FIB/QFA Thr., Factor Diluent, and Clean A are
automatically assigned when the test is placed in a profile or run as a single assay.
Refer to the Materials map screen when running or calibrating the assay for placement.
Note: The Fib-C assay range is from 70 - 700 mg/dL (0.7 – 7.0g/L). The system can rerun
samples that exceed the lower and upper range using the Fib Clauss Low and High tests.
The Fib-Clauss Low test range is 30-700 mg/dL (0.3 – 7.0g/L) and the Fib Clauss high test
range is 70-1100mg/dL (0.7-11 g/L). The QFA_ test assay range is 150 to 1000mg/dL (1.5
– 10g/L). The system can rerun samples that are below the lower limit using the QFA L
test. The test range for the QFA_Low test is 30 – 150 mg/dL (0.3 – 1.5g/L).
Define Reflex rules for the Fib test(s) used in your laboratory. For Example,
- If Fib-C_ > 700 mg/dL Add test Fib-C h_ (Fib Clauss High)
- If Fib-C_ < 70 mg/dL Add test Fib-C l_ (Fib Clauss Low)
- If QFA_ < 150 mg/dL Add test QFA L_ (Fib QFA Low)
32 Instrumentation Laboratory
- If using g/L instead of mg/dL the above equations use the test ID without the
underscore (i.e. Fib C and QFA) and enter the values in g/L.
- Refer to section 4.1.7 in the ACL ELITE/ELITE PRO Operator’s manual for detailed
instructions on setting up Reflex rules.
- To Enable the reflex testing: Setup System Configuration
- The drop down menu for Reflex Status provides 3 choices
• Program Test only
• Execute before closing session
• Disabled
- Select desired option to enable the programming and/or testing.
- Press the Green Check to Save and return to main database screen
7. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined.
On the ACL ELITE/ELITE PRO these are defined in the Setup Liquids menu.
Refer to section 4.1.11 in the ACL ELITE/ELITE PRO Operator’s manual for detailed
instructions on defining new liquids.
All reagents, calibrators must be reconstituted according to directions and allowed to sit for 30
minutes prior to calibration.
- Calibration Calibrate
- From the calibrate screen, select the desired Fib-C/QFA test from the drop down menu in
the Test to Calibrate window.
- Confirm the necessary liquids (Fib-C/QFA Thr., Factor Diluent and Clean A) are in place
according to the Material Map.
- Press the Run key to begin the calibrate cycle.
- When the calibration is complete the graph and cal curve data will be visible. If the curve
data is acceptable, click on the check to accept the use of the curve.
33 Instrumentation Laboratory
9. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
Assay Ranges:
Fib-C 70 – 700 mg/dL 0.7 – 7.0 g/L
Fib-C l 30 – 700 mg/dL 0.3 – 7.0 g/L
Fib-C h 70 – 1100 mg/dL 0.7 – 11.0 g/L
QFA 150 – 1000 mg/dL 1.5 – 10.0 g/L
QFA L 30 – 150 mg/dL 0.3 – 1.5 g/L
NOTE: tests with underscore in the test ID (i.e. Fib-C_) indicate the test is defined in mg/dL.
Test ID without the underscore (i.e. Fib-C) indicate the test is defined in g/L.
34 Instrumentation Laboratory
Free Protein S
Reagent Preparation
35 Instrumentation Laboratory
Free Protein S – ACL ELITE/ELITE PRO
1. Materials Needed
36 Instrumentation Laboratory
4. Entering in the Calibrator concentration
- Setup Liquids
- Scroll down the Liquid ID column and highlight Cal Plasma.
- Scroll down the Used by column and highlight the Free PS test.
- Click on the Assign Value button, and enter in the value for the Calibrator. This value
can be found on the Cal Plasma package insert.
- Press the Green Check to Save and return to main database screen.
- The liquid positions for the Cal Plasma, Anti PS Latex, C4BP Latex reagent and Factor
Diluent are automatically assigned when the test is placed in a profile or run as a single
assay. Refer to the Materials map screen when calibrating or running the assay for
placement.
6. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined. The Free PS kit can utilize the following
control materials to verify assay performance:
- Normal Control Plasma
- Special Test Control Level 1
- Special Test Control Plasma Level 2
On the ACL ELITE/ELITE PRO these liquids are defined in the Setup Liquids menu.
Refer to section 4.1.11 in the ACL ELITE/ELITE PRO Operator’s manual for Detailed
instructions on defining new liquids.
All reagents, calibrators must be reconstituted according to directions and allowed to sit for 30
minutes prior to calibration.
37 Instrumentation Laboratory
- Calibration Calibrate
- From the calibrate screen, select the Free PS test from the drop down menu in the Test to
Calibrate window.
- Confirm the necessary liquids are in place according to the Material Map.
- Press the Run key to begin the calibrate cycle.
- When the calibration is complete the graph and cal curve data will be visible. If the curve
data is acceptable, click on the check to accept the use of the curve.
8. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
Linearity: 10 – 135 %
38 Instrumentation Laboratory
Heparin
Reagent Preparation
39 Instrumentation Laboratory
Heparin– ACL ELITE/ELITE PRO
1. Materials Needed
# Clean A is used for the automatic clean cycle incorporated into the Heparin assay test definition.
Prepare the reagents as directed above, then prepare the working reagents for the Heparin
assay after the reagents above have reconstituted and stabilized (30 minutes)
40 Instrumentation Laboratory
*0.8 Heparin Calibrator Preparation
Dilute 100 µL of the 20 U/mL heparin prepared above with 2.4 mL of the recommended water.
This will result in a 0.8 U/mL solution of heparin. Use 1.0mL of this solution to dilute one vial of
Cal Plasma.
Note: There are 2 Heparin assays defined within the ACL ELITE/ELITE PRO.
1. Hep UHF: Unfractionated Heparin
2. Hep LMW: Low Molecular Wt Heparin
- Setup Liquids
- Scroll down the Liquid ID column and highlight HEPCAL 0.8.
- Scroll down the Used by column and highlight the desired Heparin test.
- Click on the Assign Value button, and enter in the value for the Calibrator (0.8).
41 Instrumentation Laboratory
- Do Not enter a cal value for the HEPCAL 0.0 (zero heparin calibrator)
- Press the Green Check to Save and return to main database screen.
- The liquid positions for the HEP W.D., HEP_F(Xa), HEP Sub, Cleaning A, HepCal 0.0
and HEPCal 0.8 are automatically assigned when the test is either calibrated or run as
a single assay. HEPCal 0.0 and HEPCal 0.8 are only needed during the calibration
cycle. Refer to the Materials map screen when running the assay for placement.
6. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined. The Heparin test can utilize the following
control materials, for Unfractionated Heparin testing only, to verify assay performance:
- Low Heparin Control Plasma
- High Heparin Control Plasma
On the ACL ELITE/ELITE PRO these liquids are defined in the Setup Liquids menu.
Refer to section 4.1.11 in the ACL ELITE/ELITE PRO Operator’s manual for Detailed
instructions on defining new liquids.
All reagents, calibrators must be reconstituted according to directions and allowed to sit for 30
minutes prior to calibration.
The Heparin assay utilizes the dedicated Calibration mode and therefore is calibrated under the
Calibration menu.
Empty cups for the calibration must be placed onboard the analyzer as follows:
- HepUHF test: Position A1
- Hep LMW test: Position A1
42 Instrumentation Laboratory
8. Sample Processing
The Hep UHF and the Hep LMW tests do not need empty cups during analysis.
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
43 Instrumentation Laboratory
HPX
Reagent Preparation
44 Instrumentation Laboratory
Hepatocomplex – ACL ELITE/ELITE PRO**
** Kit not available in All Countries
1. Materials Needed
5 x 3 mL Bovine Plasma Until Expiration when not Add 3.0 mL NCCLS Type II
opened and stored at 2-8oC water.
24 hours in original vial at 2-8oC Swirl, let sit for 30 min at 15 –
, when opened 25oC.
5 days stability at -20oC Invert. Do Not Shake!
**Note: Do Not Re-Freeze
45 Instrumentation Laboratory
- Press the Green Check to Save and return to main database screen.
- Setup Liquids
- Scroll down the Liquid ID column and highlight the Rabbit Calcium Thromboplastin
(HPX Thromb.)
- Scroll down the Used by column and highlight the HPX test
- Click on the Assign Value button, and enter in the ISI value. This value can be found
on the Hepatocomplex package insert.
- Press the Green Check to Save and return to the main database screen.
- Setup Liquids
- Scroll down the Liquid ID column and highlight Cal Plasma
- Scroll down the Used by column and highlight the HPX test
- Click on the Assign Value button, and enter in the value for the Calibrator. This value
can be found on the Cal Plasma package insert.
- Press the Green Check to Save and return to main database screen.
- The liquid positions for the Cal Plasma, HPX Plasma, HPX Thromb (Rabbit Ca
Thromboplastin) , and Factor Diluent are automatically assigned when the test is
calibrated or run in a profile or as a single assay. Refer to the Materials map screen
when calibrating or running the assay for placement.
7. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined. The HPX test can utilize the following
control materials to verify assay performance:
- Normal Control Plasma
- Abnormal Control Plasma Low/Level 1
- Abnormal Control Plasma High/Level 2
On the ACL ELITE/ELITE PRO these liquids are defined in the Setup Liquids menu.
Refer to section 4.1.11 in the ACL ELITE/ELITE PRO Operator’s manual for Detailed
instructions on defining new liquids.
46 Instrumentation Laboratory
set to zero. Once the ranges are known, then you can re-define and click on the QC Range
check button for control result flagging.
Refer to the ACL ELITE/ELITE PRO Operator’s Manual section 3 for details on QC
setup.
- Press the Green Check to Save and return to main database screen.
All reagents, calibrators must be reconstituted according to directions and allowed to sit for 30
minutes prior to calibration.
- Calibration Calibrate
- From the calibrate screen, select the HPX test from the drop down menu in the Test to
Calibrate window.
- Confirm the necessary liquids are in place according to the Material Map.
- Place 2 empty 0.5 mL sample cups in the appropriate “A” positions (A3 and A4) according
to the Material Map.
- Press the Run key to begin the calibrate cycle.
- When the calibration is complete the graph and cal curve data will be visible. If the curve
data is acceptable, click on the check to accept the use of the curve.
9. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
47 Instrumentation Laboratory
Homocysteine
Reagent Preparation
48 Instrumentation Laboratory
Homocysteine– ACL ELITE/ELITE PRO
1. Materials Needed
• Homocysteine Reagent Kit Cat. No. 20007800
• Homocysteine Controls Cat. No. 20007900
2 x 2.5 mL Conjugate 2 months at 2-8oC in the original Invert to mix before use
vial
8 Hours at 15oC onboard
Do Not Freeze
2 x 2 mL SAH Latex Reagent 2 months at 2-8oC in the original Add 2.0 mL H2O.
vial Swirl, let sit for 30 min at
8 Hours at 15oC onboard 15 – 25oC.
Do Not Freeze Invert. Do Not Shake!
49 Instrumentation Laboratory
2. Enabling the Test in the Analyzer
- Setup Liquids
- Scroll down the Liquid ID column and highlight HCY Calibrator.
- Scroll down the Used by column and highlight the HCY test.
- Click on the Assign Value button, and enter in the value for the Calibrator.
- Press the Green Check to Save and return to main database screen.
- The liquid positions for the HCY Cal , HCY Buffer, HCY Red, HCY Enz, HCY Conj.
And HCY Latex are automatically assigned when the test is run as a single assay.
Refer to the Materials map screen when calibrating or running the assay for placement.
6. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined. The Homocysteine test utilizes the following
control material to verify assay performance:
- Homocysteine Controls
On the ACL ELITE/ELITE PRO these liquids are defined in the Setup Liquids menu.
Refer to section 4.1.11 in the ACL ELITE/ELITE PRO Operator’s manual for detailed
instructions on defining new liquids.
50 Instrumentation Laboratory
set to zero. Once the ranges are known, then you can re-define and click on the QC Range
check button for control result flagging.
Refer to the ACL ELITE/ELITE PRO Operator’s Manual section 3 for details on QC
setup.
- Press the Green Check to Save and return to main database screen.
All reagents, calibrators must be reconstituted according to directions and allowed to sit for 30
minutes prior to calibration.
The Homocysteine assay utilizes the dedicated Calibration mode and therefore is calibrated
under the Calibration menu. In addition to the reagents, 3 empty 0.5mL cups will need to be
placed in the designated A positions on the sample tray
8. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
51 Instrumentation Laboratory
LAC Screen and/or
LAC Confirm
Reagent Preparation
52 Instrumentation Laboratory
LAC Screen/Confirm – ACL ELITE/ELITE PRO
1. Materials Needed
- The liquid positions for the LAC Reagent are automatically assigned when the test is run
as a single assay.
- QC QC Review and Setup
- Scroll down the Liquid ID list and select the appropriate QC liquid. Press the Setup button
to define.
- Configure the tests from the Enabled tests list. Define the Units, Target Mean, Target SD
and SD range for the test. If the Mean and SD range is not known, then initially leave it
53 Instrumentation Laboratory
set to zero. Once the ranges are known, then you can re-define and click on the QC Range
check button for control result flagging.
Refer to the Operator’s Manual section 3 for details on QC setup.
- Press the Green Check to Save and return to main database screen.
6. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
7. Results
The following procedure should be used to calculate the LAC Screen and
LAC Confirm ratios:
• For each new lot of LAC Screen and LAC Confirm kit a new Normal Range
should be determined according to local and state regulations.
• Determine the Mean of each Normal Range in seconds.
• The mean of each normal range will be used as a constant denominator in the calculations of
ratios.
LAC Screen
• The patient sample result in seconds is divided by the Mean of the LAC Screen normal range.
Screen Ratio = Patient Screen results (seconds) / Mean of Screen Normal Range (seconds)
• If test plasma LAC Screen clotting time is 20% longer than the Mean of the Screen Normal
Range (i.e. ratio >1.2), the presence of LA should be confirmed with IL LAC Confirm.
LAC Confirm
• The patient sample result in seconds is divided by the Mean of the LAC Confirm normal
range.
Confirm Ratio = Patient Confirm results (seconds) / Mean of Confirm Normal Range (seconds)
• The ratio result from the LAC Screen is divided by the ratio result from LAC Confirm.
Interpretation
1. The final result should be expressed as the Normalized LAC Ratio:
Ratio greater than 2.0 LA is strongly present.
Ratio between 1.5 - 2.0 LA is moderately present.
Ratio between 1.2 - 1.5 LA is weakly present.
2. If ratio < 1.2 and LAC Screen and LAC Confirm clotting times are prolonged, then mixing
studies should be performed to investigate factor II, V and X deficiencies or inhibitors. If the
mixing test is still prolonged, it indicates that some anticoagulant other than LA
(e.g. anti-Factor V) may be present in the test plasma.
54 Instrumentation Laboratory
Liquid Heparin
Reagent Preparation
55 Instrumentation Laboratory
Liquid Heparin– ACL ELITE/ELITE PRO
1. Materials Needed
56 Instrumentation Laboratory
- Press the Green Check to Save and return to main database screen.
- Setup Liquids
- Scroll down the Liquid ID column and highlight HepCal3 .
- Scroll down the Used by column and highlight the LiqHep test.
- Click on the Assign Value button, and enter in the value of 2.0. HepCal 1 and HepCal
2 values are automatically calculated and do not need to be entered.
- The liquid positions for the Hep Cals, LHepFXa, and LHepSub are automatically
assigned when the test is calibrated, placed in a profile or run as a single assay. Refer
to the Materials map screen when running or calibrating the assay for placement.
6. Setting up QC
On the ACL ELITE/ELITE PRO this is defined in the Setup Liquids menu.
Refer to section 4.1.11 in the ACL ELITE/ELITE PRO Operator’s manual for detailed
instructions on defining new liquids.
Heparin Calibrators must be reconstituted according to directions and allowed to sit for 30
minutes prior to calibration.
- Calibration Calibrate
57 Instrumentation Laboratory
- From the calibrate screen, select the Liq Hep test from the drop down menu in the Test to
Calibrate window.
- Confirm the necessary liquids are in place according to the Material Map.
- Press the Run key to begin the calibrate cycle.
- When the calibration is complete the graph and cal curve data will be visible. If the curve
data is acceptable, click on the check to accept the use of the curve.
8. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be quickly thawed at 37oC. Gently mix the plasma prior
to testing. Samples should be analyzed within 2 hours.
58 Instrumentation Laboratory
Plasminogen
Reagent Preparation
Calibrate and
Analyze Patient / QC Samples
59 Instrumentation Laboratory
Plasminogen – ACL ELITE/ELITE PRO
1. Materials Needed
- Setup Liquids
- Scroll down the Liquid ID column and highlight Cal Plasma.
- Scroll down the Used by column and highlight the PLG test.
60 Instrumentation Laboratory
- Click on the Assign Value button, and enter in the value for the Calibrator. This value
can be found on the Cal Plasma package insert.
- Press the Green Check to Save and return to main database screen.
Notes: The PLG assay is Calibrated Once per Session onboard the ACL ELITE/ELITE
PRO. The test calibration occurs during the analysis cycle. The test cannot be calibrated
under the Calibration Menu.
- The liquid positions for the Cal Plasma, Streptokinase (PLG Strept) and Chromogenic
substrate (PLG Sub) are automatically assigned when the test is run. The test can be
run in the Single Test or Profile mode on the analyzer. Refer to the Materials map
screen when running the assay for proper placement.
6. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined. The PLG test can utilize the following
control materials to verify assay performance:
- Normal Control Plasma
- Abnormal Chromogenic Control Plasma Level 1and 2
On the ACL ELITE/ELITE PRO these liquids are defined in the Setup Liquids menu.
Refer to section 4.1.11 in the ACL ELITE/ELITE PRO Operator’s manual for Detailed
instructions on defining new liquids.
All reagents, calibrators must be reconstituted according to directions and allowed to sit for 30
minutes prior to calibration.
Calibration is performed during the Analysis Run for PLG. The calibration curve will be
saved and utilized again on subsequent runs if, during the pre-analytical check for PLG, the
instrument does not detect the presence of the Cal Plasma in position A1.
61 Instrumentation Laboratory
8. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
62 Instrumentation Laboratory
Plasmin Inhibitor
Reagent Preparation
Calibrate and
Analyze Patient / QC Samples
63 Instrumentation Laboratory
Plasmin Inhibitor – ACL ELITE/ELITE PRO
1. Materials Needed
64 Instrumentation Laboratory
4. Entering in the Calibrator concentration
- Setup Liquids
- Scroll down the Liquid ID column and highlight Cal Plasma.
- Scroll down the Used by column and highlight the PL-IN test.
- Click on the Assign Value button, and enter in the value for the Calibrator. This value
can be found on the Cal Plasma package insert.
- Press the Green Check to Save and return to main database screen.
Notes: The PL-IN assay is Calibrated Once per Session onboard the ACL ELITE/ELITE
PRO. The test calibration occurs during the analysis cycle. The test cannot be calibrated
under the Calibration Menu.
- The liquid positions for the Cal Plasma, PI Buffer, PI Plasmin, and Chromogenic
substrate (PI Sub) are automatically assigned when the test is run. The test can be run
in the Single Test or Profile mode on the analyzer. Refer to the Materials map screen
when running the assay for proper placement.
6. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined. The PL-IN test can utilize the following
control materials to verify assay performance:
- Normal Control Plasma
- Abnormal Chromogenic Control Plasma Level 1and 2
On the ACL ELITE/ELITE PRO these liquids are defined in the Setup Liquids menu.
Refer to section 4.1.11 in the ACL ELITE/ELITE PRO Operator’s manual for Detailed
instructions on defining new liquids.
65 Instrumentation Laboratory
7. Calibrating the Assay
All reagents, calibrators must be reconstituted according to directions and allowed to sit for 30
minutes prior to calibration.
Calibration is performed during the Analysis Run for PL-IN. The calibration curve will be
saved and utilized again on subsequent runs if, during the pre-analytical check for PL-IN, the
instrument does not detect the presence of the Cal Plasma in position A1.
8. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
66 Instrumentation Laboratory
PCX
Reagent Preparation
67 Instrumentation Laboratory
Pro-IL- Complex– ACL ELITE/ELITE PRO**
** Kit not available in All Countries
1. Materials Needed
5 x 3 mL Bovine Plasma Until Expiration when not Add 3.0 mL NCCLS Type II
opened and stored at 2-8oC water.
24 hours in original vial at 2-8oC Swirl, let sit for 30 min at 15 –
when opened 25oC.
5 days stability at -20oC Invert. Do Not Shake!
**Note: Do Not Re-Freeze
68 Instrumentation Laboratory
- Press the Green Check to Save and return to main database screen.
- Setup Liquids
- Scroll down the Liquid ID column and highlight the Bovine Calcium Thromboplastin
(PCX Thromb.).
- Scroll down the Used by column and highlight the PCX test.
- Click on the Assign Value button, and enter in the ISI value. This value can be found
on the Pro-IL-Complex package insert.
- Press the Green Check to Save and return to the main database screen.
- Setup Liquids
- Scroll down the Liquid ID column and highlight Cal Plasma.
- Scroll down the Used by column and highlight the PCX test.
- Click on the Assign Value button, and enter in the value for the Calibrator. This value
can be found on the Cal Plasma package insert.
- Press the Green Check to Save and return to main database screen.
- The liquid positions for the Cal Plasma, PCX Plasma, PCX Thromb (Bovine Ca
Thromboplastin) , and Factor Diluent are automatically assigned when the test is
calibrated or run in a profile or as a single assay. Refer to the Materials map screen
when calibrating or running the assay for placement.
7. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined. The PCX test can utilize the following
control materials to verify assay performance:
- Normal Control Plasma
- Abnormal Control Plasma Low/Level 1
- Abnormal Control Plasma High/Level 2
On the ACL ELITE/ELITE PRO these liquids are defined in the Setup Liquids menu.
Refer to Section 4.1.11 in the ACL ELITE/ELITE PRO Operator’s manual for detailed
instructions on defining new liquids.
69 Instrumentation Laboratory
set to zero. Once the ranges are known, then you can re-define and click on the QC Range
check button for control result flagging.
Refer to the ACL ELITE/ELITE PRO Operator’s Manual section 3 for details on QC
setup.
- Press the Green Check to Save and return to main database screen.
All reagents, calibrators must be reconstituted according to directions and allowed to sit for 30
minutes prior to calibration.
- Calibration Calibrate
- From the calibrate screen, select the PCX test from the drop down menu in the Test to
Calibrate window.
- Confirm the necessary liquids are in place according to the Material Map.
- Place 3 empty 0.5 mL sample cups in the appropriate “A” positions (A3, A4 and A6)
according to the Material Map.
- Press the Run key to begin the calibrate cycle.
- When the calibration is complete the graph and cal curve data will be visible. If the curve
data is acceptable, click on the check to accept the use of the curve.
9. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
70 Instrumentation Laboratory
ProClot
Reagent Preparation
71 Instrumentation Laboratory
ProClot– ACL ELITE/ELITE PRO
1. Materials Needed
72 Instrumentation Laboratory
2. Enabling the Test in the Analyzer
- Setup Liquids
- Scroll down the Liquid ID column and highlight Cal Plasma.
- Scroll down the Used by column and highlight the ProClotSP test.
- Click on the Assign Value button, and enter in the value for the Calibrator. This value
can be found on the Cal Plasma package insert.
- Press the Green Check to Save and return to main database screen.
Notes: The ProClot assay is Calibrated Once per Session onboard the ACL ELITE/ELITE
PRO. The test calibration occurs during the analysis cycle. The test cannot be calibrated
under the Calibration Menu. The Calibration under analysis utilizes an empty cup for the
calibration, therefore the test must be run as a single test and cannot be run in the profile
mode.
- The liquid positions for the Cal Plasma, Protein C Deficient, Working Diluent,
APTTSP and APTT Ca/Cl are automatically assigned when the test is run as a single
assay. Refer to the Materials map screen when calibrating or running the assay for
placement.
6. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined. The ProClotSP test can utilize the following
control materials to verify assay performance:
- Normal Control Plasma
- Abnormal Control Plasma Level 1
- Protein C Control Plasma – packaged in reagent kit
73 Instrumentation Laboratory
On the ACL ELITE/ELITE PRO these liquids are defined in the Setup Liquids menu.
Refer to section 4.1.11 in the ACL ELITE/ELITE PRO Operator’s manual for detailed
instructions on defining new liquids.
All reagents, calibrators must be reconstituted according to directions and allowed to sit for 30
minutes prior to calibration.
Calibration is performed during the Analysis Run for ProClot. The calibration curve will be
saved and utilized again on subsequent runs if during the pre-analytical check for Pro-Clot the
instrument does not detect the presence of the Cal Plasma in position A1.
The Calibration during analysis requires an empty cup to be placed in position A2 on the
sample tray.
8. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
74 Instrumentation Laboratory
Protein C
Reagent Preparation
75 Instrumentation Laboratory
Protein C – ACL ELITE/ELITE PRO
1. Materials Needed
76 Instrumentation Laboratory
4. Entering in the Calibrator concentration
- Setup Liquids
- Scroll down the Liquid ID column and highlight Cal Plasma.
- Scroll down the Used by column and highlight the P-C test.
- Click on the Assign Value button, and enter in the value for the Calibrator. This value
can be found on the Cal Plasma package insert.
- Press the Green Check to Save and return to main database screen.
Notes: The P-C assay is Calibrated Once per Session onboard the ACL ELITE/ELITE
PRO. The test calibration occurs during the analysis cycle. The test cannot be calibrated
under the Calibration Menu.
- The liquid positions for the Cal Plasma, PC Activ., PC Sub., and Pchrom Dil are
automatically assigned when the test is run as a single assay. Refer to the Materials
map screen when running the assay for placement.
6. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined. The P-C test can utilize the following
control materials to verify assay performance:
- Normal Control Plasma
- Special Test Control Plasma Level 1and 2
On the ACL ELITE/ELITE Pro these liquids are defined in the Setup Liquids menu. Refer
to section 4.1.11 in the ACL ELITE/ELITE Pro Operator’s manual for detailed instructions on
defining new liquids.
77 Instrumentation Laboratory
7. Calibrating the Assay
All reagents, calibrators must be reconstituted according to directions and allowed to sit for 30
minutes prior to calibration.
Calibration is performed during the Analysis Run for P-C. The calibration curve will be
saved and utilized again on subsequent runs if, during the pre-analytical check for P-C, the
instrument does not detect the presence of the Cal Plasma in position A1.
8. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
78 Instrumentation Laboratory
Pro S
Reagent Preparation
79 Instrumentation Laboratory
ProS– ACL ELITE/ELITE PRO
1. Materials Needed
* Frozen reagent and plasmas should be thawed at 37oC and gently mixed before. Before freezing they
can be aliquoted using plastic tubes and stoppers. DO NOT REFREEZE.
80 Instrumentation Laboratory
3. Editing the Test Reference Range
- Setup Liquids
- Scroll down the Liquid ID column and highlight Cal Plasma.
- Scroll down the Used by column and highlight the ProS test.
- Click on the Assign Value button, and enter in the value for the Calibrator. This value
can be found on the Cal Plasma package insert.
- DO NOT enter any value for ProS 50% C.
- Press the Green Check to Save and return to main database screen.
Notes: The ProS assay must be Calibrated One Time per Session. The test calibration
occurs during the analysis cycle. The test cannot be calibrated under the Calibration Menu
but you can view the calibration report after analysis run.
- The liquid positions for the Cal Plasma, ProS 50% C (Cal Plasma diluted 1:1 with
Protein S Def Plasma), Protein S Reagent, Protein S Deficient Plasma and Factor
Diluent are automatically assigned when the test is run as a single assay. Refer to the
Materials map screen when calibrating or running the assay for placement.
6. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined. The ProS test can utilize the following control
materials to verify assay performance:
- Normal Control Plasma
- Low Abnormal Control Plasma
- High Abnormal Control Plasma
- Protein S Control Plasma – packaged in reagent kit
On the ACL ELITE/ELITE PRO these liquids are defined in the Setup Liquids menu.
Refer to section 4.1.11 in the ACL ELITE/ELITE PRO Operator’s manual for Detailed
instructions on defining new liquids.
81 Instrumentation Laboratory
- Scroll down the Liquid ID list and select the appropriate QC liquid. Press the Setup
button to define.
- Configure the tests from the Enabled tests list. Define the Units, Target Mean, Target
SD and SD range for the test. If the Mean and SD range is not known, then initially
leave it set to zero. Once the ranges are known, then you can re-define and click on the
QC Range check button for control result flagging.
Refer to the ACL ELITE/ELITE PRO Operator’s Manual section 3 for details on QC
setup.
- Press the Green Check to Save and return to main database screen.
All reagents, calibrators must be reconstituted according to directions and allowed to sit for 30
minutes prior to calibration.
The ProS assay must be Calibrated One Time per Session. The test calibration occurs during
the analysis cycle. The test cannot be calibrated under the Calibration Menu but you can view
the calibration report after analysis run.
8. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing.
82 Instrumentation Laboratory
SCT- Screen/Confirm
Reagent Preparation
83 Instrumentation Laboratory
SCT-Screen/Confirm – ACL ELITE/ELITE PRO
1. Materials Needed
84 Instrumentation Laboratory
4. Setting up Liquid Positions
- The liquid positions for SCT Screen, SCTConfirm and SCT CaCl2 are automatically
assigned when the test is placed in a profile or run as a single assay. Refer to the
Materials map screen when running the assay for placement.
5. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined The SCT Screen/Confirm test can utilize the
following control materials to verify assay performance:
Materials
On the ACL ELITE/ELITE PRO this is defined in Setup Liquids menu. Refer to section 4.1.11
in the ACL ELITE/ELITE PRO Operator’s manual for Detailed instructions on defining new
liquids.
6 . Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Freezing of the plasma releases residual platelet phospholipids which can
shorten the SCT screen clotting times. Double centrifuge or filter plasma through a 0.2micron
filter to remove platelets before freezing.Frozen samples should be thawed at 37oC for 15 minutes.
Centrifuge the plasma prior to testing. Samples should be analyzed within 2 hours.
85 Instrumentation Laboratory
SCT Screen
• The patient sample result in seconds is divided by the Mean of the SCT Screen normal range.
SCT Confirm
• The patient sample result in seconds is divided by the Mean of the SCT Confirm normal range.
• The ratio result from the SCT Screen is divided by the ratio result from SCT Confirm.
Interpretation
• The final result should be expressed as the Normalized SCT Ratio:
ACL ELITE/ELITE PRO Ratio > 1.20 indicates Lupus Anticoagulant is present
• If ratio ≤ 1.20 and SCT Screen and SCT Confirm clotting times are prolonged, then mixing
studies should be performed to investigate factor deficiencies or inhibitors. If the mixing
test is still prolonged, it indicates that some anticoagulant other than LA may be present in
the test plasma.
Each laboratory should establish its own normal cutoff value for the ratio.
Refer to the HemosIL Silica Clotting Time package insert sheet for a procedure to
establish the cut-off value.
86 Instrumentation Laboratory
Thrombin Time
Reagent Preparation
87 Instrumentation Laboratory
Thrombin Time (TT) – ACL ELITE/ELITE PRO
1. Materials Needed
88 Instrumentation Laboratory
4. Setting up Liquid Positions
- The liquid positions for the Cal Plasma, and Thrombin Reagent (TT Thr.) are
automatically assigned when the test is run as a single assay. Refer to the Materials
map screen when running the assay for placement.
5. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined. The TT tests can utilize the following
control materials to verify assay performance:
- Normal Control Plasma
On the ACL ELITE/ELITE PRO these liquids are defined in the Setup Liquids menu.
Refer to section 4.1.11 in the ACL ELITE/ELITE PRO Operator’s manual for detailed
instructions on defining new liquids.
6. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
89 Instrumentation Laboratory
vonWillebrand Factor
Activity
Reagent Preparation
90 Instrumentation Laboratory
von Willebrand Factor Activity– ACL ELITE/ELITE PRO
1. Materials Needed
2 x 4.5 mL Buffer
91 Instrumentation Laboratory
4. Entering in the Calibrator concentration
- Setup Liquids
- Scroll down the Liquid ID column and highlight Cal Plasma.
- Scroll down the Used by column and highlight the VWFACT test.
- Click on the Assign Value button, and enter in the value for the Cal Plasma.
This value can be found on the Cal Plasma package insert.
- Press the Green Check to Save and return to main database screen.
- The liquid positions for the Cal Plasma, VWFACT Latex and Factor Diluent are
automatically assigned when the test is calibrated, placed in a profile or run as a single
assay. Refer to the Materials map screen when running or calibrating the assay for
placement.
6. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your
system has the appropriate QC liquid defined. The VWFACT test can utilize the following
control materials to verify assay performance:
- Special Test Control Plasma Level 1
- Special Test Control Plasma Level 2
- Normal Control
Cal Plasma must be reconstituted according to directions and allowed to sit for 30 minutes
prior to calibration.
92 Instrumentation Laboratory
- Calibration Calibrate
- From the calibrate screen, select the VWFACT test from the drop down menu in the Test
to Calibrate window.
- Confirm the necessary liquids are in place according to the Material Map.
- Press the Run key to begin the calibrate cycle.
- When the calibration is complete the graph and cal curve data will be visible. If the curve
data is acceptable, click on the check to accept the use of the curve.
8. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be thawed at 37oC for 15 minutes. Centrifuge the
plasma prior to testing. Samples should be analyzed within 2 hours.
93 Instrumentation Laboratory
vonWillebrand Factor
Antigen
Reagent Preparation
94 Instrumentation Laboratory
von Willebrand Factor Antigen– ACL ELITE/ELITE PRO
1. Materials Needed
2 x 4 mL Buffer 3 month at 2-8°C – original Invert to mix prior to use. Avoid foam
vial formation in reagent when mixing.
1 week at 15°C on ACL
ELITE/ELITE PRO
**Note: Do Not Freeze
95 Instrumentation Laboratory
- The reaction curve min and max may also be set. If the desired values are unknown,
clear both the min and the max to zoom curve display to full scale.
- Press the Green Check to Save and return to main database screen.
- Setup Liquids
- Scroll down the Liquid ID column and highlight Cal Plasma.
- Scroll down the Used by column and highlight the VWF:Ag test.
- Click on the Assign Value button, and enter in the value for the Cal Plasma. This value
can be found on the Cal Plasma package insert.
- Press the Green Check to Save and return to main database screen.
- The liquid positions for the Cal Plasma, VWF:AgBuf, VWF:AgLx and Factor Diluent
are automatically assigned when the test is calibrated, placed in a profile or run as a
single assay. Refer to the Materials map screen when running or calibrating the assay
for placement.
6. Setting up QC
On the ACL ELITE/ELITE PRO this is defined in the Setup Liquids menu.
Refer to section 4.1.11 in the ACL ELITE/ELITE PRO Operator’s manual for detailed
instructions on defining new liquids.
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7. Calibrating the Assay
Cal Plasma must be reconstituted according to directions and allowed to sit for 30 minutes
prior to calibration.
- Calibration Calibrate
- From the calibrate screen, select the VWF:Ag test from the drop down menu in the Test to
Calibrate window.
- Confirm the necessary liquids are in place according to the Material Map. The calibration
will require 3 empty 0.5 mL sample cups.
- Press the Run key to begin the calibrate cycle.
- When the calibration is complete the graph and cal curve data will be visible. If the curve
data is acceptable, click on the check to accept the use of the curve.
8. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part
trisodium citrate. Frozen samples should be quickly thawed at 37oC. Gently mix the plasma prior
to testing. Samples should be analyzed within 2 hours.
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APPENDIX D
Printout Examples
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7. Liquid Setup
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8. Logbook Report
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9. Maintenance Report
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INDEX
Calculation Setup, 4.84
A Calibration, 3.62
Calibration Curve Checks, 4.109
Abort Test, 4.71, 4.81 Calibration Curve Flagging Limits, 7.27
Absorbance channel, 1.15 Calibration Curve Review, 3.65
Absorbance Tests, 1.2 Calibration Curve Limits, 7.30
Acquisition Anomalies, 6.14 Calibration Curve Segments, 3.72
Acquisition Channel, 4.83 Calibration Curve Setup, 4.107
Acquisition Delay, 4.83 Calibration Error Codes, 6.26
Acquisition Data Checks, 4.105 Calibration - Factors - Non Parallelism, 3.71
Acquisition Setup, 4.82 Calibration - Factors - with Parallelism, 3.78
Acquisition time, 7.33 Calibration Loading Setup, 4.72
Adapters, 1.9, 2.7, 9.4 Calibration Modes, 4.58
Add QC, 3.19, 3.48 Calibration R Square Check, 3.76
Air Filter Cleaning, 5.21 Calibration Replicates, 3.71, 4.73
Alarms, 6.1, 6.4 Calibration Slope Check, 3.76
Algorithm, 4.87, 7.36 Calibration Stability, 7.41
Ambient Conditions, 2.1 Calibration Target Values, 4.31, 8.3
Ambient Specifications, 7.48 Carryover, 4.6
Analysis Area, 1.12 Carryover - User Defined Tests, 4.7
Analysis Loading Setup, 4.62 Carryover Specification, 7.42
Analytical Reference Setup, 3.81 Certification, 1.26
Analytical Reference Checks, 4.105 Check CV%, 4.107
Analytical Reference Cumulative Results, 3.84 Check Mark, 3.29
Analytical Reference Data Extract, 3.87 Check Mean, 4.104
Analytical Reference Error Codes, 6.30 Checks - Analytical Reference, 4.105
Analytical Reference Host Transmit, 3.86 Chromogenic Tests, 7.4, 7.14
Analytical Reference Plots, 3.83 Chromogenic Test Volumes, 7.24
APCR, 7.8 Clean Cycle, 5.4
APTT, 7.8 Cleaning -Test Setup, 4.68, 4.78, 5.2
AR Use, 3.81 Cleaning Air Filter, 5.21
Archive, 4.115 Clear ID Button, 3.19
As Needed Maintenance, 5.22 Clear Loadlist, 3.25
Assay Performance Characteristics, 7.37 Clear Statistics, 3.52
Assigned Liquid Volume, 4.29 Clock, 3.33
Audible Alarms, 4.51 Clock Symbol, 3.31
Autolist, 3.27 Clot/Reaction Curve, 3.42
Coagulometric Tests, 1.2, 7.3, 7.7
B Color codes, 3.17, 3.39
Color codes - Results, 1.25
Backup Configuration, 4.114 Complete Possible and Signal, 4.71, 4.81
Backup Test and Material, 4.121 Connectors, 2.4
Barcode, External, 1.21 Copy Tests, 4.56
Barcode, On-board, 1.20 Correct Ratio with 100% Std., 4.109
Baseline SD, 4.106 Correct with AR, 4.108
Beeps-Audible, 4.51 Cups, 7.44
Biohazards, 7.50 Cuvettes, 1.18
BiWeekly Maintenance, 5.20
D
C
Daily Maintenance, 5.16
Cal Low F, 3.71 Database Anomalies, 6.20
Calculation of Results, 7.5 Database Configuration, 4.44
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L N
Language Setup, 4.44 Needle Alignment, 5.10, 5.24
Latex tests, 7.4 Needle Cleaning, 5.19
LCD, 1.18 Needle Replacement, 5.23, 9.4
Letter Code Meaning - 3.17 Nephelometric channel, 1.15
Library Identification, 4.118 New Liquid Setup, 4.33
Line Frequency, 2.3 New Sample - Program, 3.20, 3.43
Linearity, 7.39 New User Definition, 4.49
Lipemic Samples, 7.43 Noise Checks- Data Reduction, 4.94
Liquid Accessing Needle, 4.34 Non-Monotonic Check, 3.75
Liquid Anomalies, 6.15 Normal Range, 1.25, 3.39, 4.59
Liquid Details, 4.32 Normalization, 4.85, 4.108
Liquid ID, 4.28 Normalized Data Checks, 4.106
Liquid Sensor, 4.45 Normalized Ratio, 4.86
Liquid Setup, 4.27, 4.33 Numerical Keypad, 3.2, 4.43
Liquid Waste, 5.17
Loading and Analysis Area, 1.12 O
Loading Setup - Analysis, 4.62
Loading Setup - Calibration, 4.72 Omit Calibration Replicate, 3.67
Loadlist, 3.25 On Board Stability- Reagents, 3.24, 4.29
Loadlist Time Interval, 3.27 Operative Anomalies, 6.18
Logbook, 5.14 Optical Measuring System, 1.15
Low curve (Factor Assay) , 3.74 Optical Path, 1.15
Optical Path Cleaning, 5.20
Optical Reference, 4.74
M Optics Anomalies, 6.18
Magnetic Stirrer Part Number, 9.4 Outlier, 4.107
Maintenance - As Needed, 5.22
Maintenance - Bi-Weekly, 5.20 P
Maintenance - Daily, 5.16
Maintenance - Monthly, 5.21 Parallelism - Calibration, 3.78
Maintenance - Weekly, 5.19 Parallelism Results, 3.79
Maintenance menu, 5.7 Parallelism Setup, 4.110
Maintenance Overdue Warning, 5.8 Parsing Anomalies, 6.19
Maintenance Table/Checklist, 5.31, 5.33 Part/Expendable list, 9.4
Make Loadlist, 3.26 Passwords - Security, 4.46
Mark Samples - Loadlist, 3.27 Patient Demographic Details, 3.21
Material Backup/Upload, 4.121 Pause System During Run, 3.34
Materials Check, 4.70, 4.80 Pause Reagent Timer, 3.24
Materials Map, 3.23 Perform Sequentially, 4.69
Material Map - Profiles, 4.16 Piston block and Electrovalves, 1.10
Mean of Results, 4.104 Plasma Handling, 8.2
Mean - Target, 3.51 Power Consumption, 2.2
Measured Parameters, 1.2, 7.3 Precision Performance, 7.38
Mechanical Anomalies, 6.12 Presentation of Results, 1.3
Mechanical Hazards, 7.50 Primary Unit Correction, 4.91,4.95,4.96, 4.99,
Menu - Selecting, 3.4 Priming, 2.11, 5.2, 5.17
Method Comparison Studies, 7.40, 7.51 Priming in standby, 5.3
Microprocessor, 1.17 Printer, 1.22, 4.38
Middle curve (Factor Assay), 3.75 Printer Fail, 6.6
Miscellaneous Errors, 6.38 Printing Results, 3.45
Mixing Cuvette Contents, 4.68, 4.78 Printout Setup, 4.38
Monthly Maintenance, 5.21 Pro Clot, 7.13
Mouse, 3.4 Product Use, 1.2
Multi-Tests, 3.14, 4.13 Profiles, 4.13
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