ACL Elite Pro
ACL Elite Pro
ACL Elite Pro
Manufacturer
Instrumentation Laboratory Company
113 Hartwell Avenue - P.O. Box 9113
Lexington, MA 02421-3125 U.S.A.
Telephone: (781) 861-0710
EU Authorized Representative
Instrumentation Laboratory SpA
Viale Monza 338 - 20128 Milan, Italy
Telephone: 39-2-25221
ACL Elite / ElitePro Service Manual
Foreword
This Service Manual contains information necessary to install, service, maintain and troubleshoot the
Instrumentation Laboratory ACL Elite / ElitePro system.
This Service Manual is intended for IL field engineers, or service engineers from organizations duly
recognized and authorized by Instrumentation Laboratory, who have been previously trained on how to
use, maintain and troubleshoot the IL ACL Elite / ElitePro model.
For detailed information on Operator’s interface and other user related topics, reference the ACL Elite /
ElitePro Operator’s Manual.
The ACL Elite / ElitePro system is compatible with the diverse requirements for supply voltage and
frequency encountered throughout the world.
The ACL Elite / ElitePro system conforms to the directives and standards of the Community European
89/336/EEC + 92/31EEC + 93/68EEC and certified by CE marking. This system is approved to CE
standards EN55011:1991 (CISPR 11), Group 1, Class A; EN50082-1:1997 and EN61010-1993 +
A2:1995 (IEC 1010-1).
The ACL Elite / ElitePro system also conforms to the directives and standards of the CSA and certified by
CSA marking. This system is approved to CSA standards with licence number LR24215 and produced
under CSA certification number 161648/1121145.
All instruments bear the CE and CSA monograms.
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.
Foreword
Chapter 1
General Information
Chapter 2
Operator Interface Description
Index Page 1 of 5
ACL Elite / ElitePro Service Manual
Chapter 3
General Description
Chapter 4
Parts Replacement
Page 2 of 5 Index
ACL Elite / ElitePro Service Manual
Chapter 5
Installation & Maintenance
5.1 Installation
5.1.1 Site requirements
5.1.2 Unpacking and inspection
5.1.3 Mounting Instrument parts
5.1.4 First turn on cycle
5.1.5 Instrument set-up
5.1.6 Performance tests
5.1.7 Installation Procedure & Checklist
5.2 Maintenance
5.2.1 Daily Maintenance
5.2.2 Weekly Maintenance
5.2.3 Bi-Weekly Maintenance
5.2.4 Monthly Maintenance
5.2.5 Yearly Maintenance
5.2.6 As needed Maintenance
5.2.7 Maintenance schedule
5.3 Shut down & Shipment precautions
5.3.1 Long term shut down
5.3.2 Shipment
Chapter 6
Troubleshooting
Index Page 3 of 5
ACL Elite / ElitePro Service Manual
Chapter 7
Check Out & Adjustment
Page 4 of 5 Index
ACL Elite / ElitePro Service Manual
Chapter 8
System Interfacing
8.1 Keyboard
8.2 External Parallel Printer
8.3 Network
8.4 Modem
8.5 Mouse
8.6 Host Computer
8.7 External Bar Code Reader
Chapter 9
Parts List
Chapter 10
Drawings
Chapter 11
Service Notes
Chapter 12
Appendix
Index Page 5 of 5
ACL Elite/ElitePro Service Manual
Chapter 1
General Information
This chapter of the manual contains general information about the ACL Elite/ElitePro
system(s), including its use, measured parameters, presentation of results, hardware
description and operation, additional features and procedural limitations.
Description and use of the ACL Elite/ElitePro Operator’s Interface is addressed in a
separate chapter of this manual. Following are the specific sections.
Coagulometric Tests
Absorbance Tests
• Antithrombin
• Heparin Xa
• Protein C
• Plasmin Inhibitor (alpha-2-antiplasmin)
• Plasminogen
• Fibrinogen-C (Clauss method)
Immunological Tests
• D-Dimer
• von Willebrand Factor
Special Tests
Note: An (*) indicates that the test is not available in the United States.
Profiles
Tests Groups
Some tests can be run together as a group, thus saving time when the number of
samples to be analyzed is relatively small. Following are some examples:
PT-FIB/APTT
PT-FIB/APTT/TT
Double Tests
The ACL Elite/ElitePro offers the user the capability to set up double tests. Refer to
the Operator’s Manual for additional information on this subject.
• s (seconds)
• R (Ratio)
• NR (Normalized Ratio)
• INR (International Normalized Ratio)
• % (Percent activity)
• U/mL (units/mL)
• mg/dL (for example for Fibrinogen)
• g/L (for example for Fibrinogen)
• ng/mL (for example for D-Dimer)
• microg/L (for example for D-Dimer)
• micromol/L
• IU/mL (International Unit)
• User configurable unit
The ACL Elite/ElitePro systems incorporate a Liquid Crystal Display (LCD) unit that
displays the status of the instrument, permits the user to select desired procedures and,
through the use of menus and options, guides the operator through these procedures.
Information and instructions are entered into the system either via a Touch Screen
device, through a standard PC keyboard or through a serial or USB mouse.
When sample testing is initiated, the samples and reagents are sequentially pipetted
into a 20-cuvette polystyrene rotor (loading process). Sample and reagents are then
mixed by centrifugation process. The mixing is carried out by a combination of rapid
acceleration and braking actions that are effective in thoroughly mixing the liquids.
Reaction measurements (data acquisition) via the photometer are made while the rotor
is spinning.
The ACL Elite/ElitePro analyzers include several hardware components and modules,
which interact with each other to carry out the analytical process.
This section contains descriptions of those components and their functions as well as
the operations that take place during the analytical process.
The figure below highlights some of the main components of the ACL Elite/ElitePro,
as viewed from the front of the system.
1
9
3
10
11
5
14
12
13
4
More information about the other components on the instrument is given in Chapter 3
“General Description”.
Following are the specific sub-sections with the item descriptions.
The ACL Autosampler system includes a rotating sample tray that contains:
40 x 14.2 mm diameter positions for cups and primary tubes and
10 x 23 mm diameter positions to hold accessory materials such as calibrators,
diluents, reagent vials, etc.
Optical sensors located around the tray verify that the tray is correctly positioned, and
also detect the presence of cups, tubes and vials.
Three different sample trays can be used with the ACL system, each one appropriate
for different size primary tubes: 3 mL, 5 mL and S11.5; all of them can be used for
0.5, 2 or 4 mL cups.
Note: The dimensions and volumes mentioned above are all nominal values.
Warning: Do not access sample or reagent area while probe arm is operating.
The ten internal positions of the sample tray - A1 to A10 - are used for placing
materials such as calibrators, diluents or reagents in a choice of containers such as 23
mm vials (10 mL filling volume), 18 mm vials (4 mL filling volume) or cups.
Adapters are needed for the 4 mL vials and cups as seen in the picture below.
The ACL Elite reagent area consists of 8 reservoirs labelled R1 to R8, and the ACL
ElitePro reagent area consists of 12 reservoirs labelled R1 to R12,
designed to hold reagent containers. An area alongside the vial holes is designed to
hold the vial caps while the vials are in use.
Positions R1 to R4 are cooled by a Peltier-effect temperature regulator and are
equipped with a stirring mechanism, (magnetic stirbar).
Positions R5 to R8 are used for reagents at room temperature; these positions do not
have a stirring mechanism.
Positions R9 to R12 (ACL ElitePro), are cooled by a Peltier-effect temperature
regulator however are not equipped with a stirring mechanism, (magnetic stirbar).
The reagents in positions R1 to R6, and R9 to R12 (ACL ElitePro) are aspirated with
the internal needle (reagent needle) while the reagents placed in positions R7 and R8
are aspirated with the external needle (sample needle).
Warning: Do not access sample or reagent area while probe arm is operating.
All twelve reagent positions can hold 28 mm vials (16 mL filling volume). Smaller
diameter vials require the use of color coded adapters.
The rinse / waste system of the ACL Elite/ElitePro consists of a removable Rinse /
Waste Reservoir positioned between reagent positions R4 and R5. A plastic tube is
connected to the reservoir that drains the waste from the reservoir to a waste container
outside the analyzer (left hand side) where the waste is collected.
The Rinse / Waste Reservoir which is always filled with Wash-R emulsion, is used as
a washing basin for the dispensing needles in-between cycles; the liquid waste is then
drained and collected in the waste container on the outside of the analyzer for proper
disposal.
WARNING !
BIOLOGICAL HAZARDS EXIST. Avoid touching, with bare hands, any parts
of the system which may have come in contact with potentially infectious fluids.
ALWAYS wear gloves when performing any type of Maintenance/Service action
on this area.
The area of the analyzer where the reaction cuvettes are loaded and the analysis takes
place is located under the rotor holder cover in the center of the instrument, on the
right side of the reagent area. This area includes:
• The reaction cuvettes (rotors) storage system and mechanisms involved in the
transport of the rotors, (excluded on ACL Elite).
• The plate where the rotor is placed during loading and analysis (Rotor Holder).
• The hardware components responsible for ensuring proper mixing of reagents and
samples in the cuvettes.
• The optical system used to make the analytical measurements.
The Rotor Stack, the Rotor Transport and the Rotor Arm compose this assembly.
(excluded on ACL Elite)
• Rotor stack
Before their use, rotors are stored in the rotor stack that holds up to 12 rotors (240
cuvettes). The rotor stack compartment, which may be accessed from the top of the
analyser on the right side, can be filled at any time (continuous rotor loading) either
manually (one rotor at a time) or using a special rotor refill tool (up to 10 rotors at a
time).
The rotor stack area is thermostatically controlled in order to keep the rotors in a
temperature range between 36°C and 39oC and the rotor stack is insulated to help
thermal-regulation.
The ACL Elite has a smaller rotor storage area thermostatically controlled between
36°C and 39oC. Rotors are manually placed into the storage area.
• Rotor Transport
(excluded on ACL Elite)
Below the rotor stack, a rotor transport mechanism moves the bottom rotor out to
make it available to the rotor arm mechanism.
• Rotor Arm
(excluded on ACL Elite)
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
takes the rotor and discards it into the rotor waste container.
The ACL Elite does not contain the robotic mechanism to place rotors onto the Rotor
Holder. With the ACL Elite rotors are manually placed onto the Rotor Holder prior to
sample loading and analysis, and manually removed when the analysis cycle is
completed.
The Rotor Holder is an aluminium disk that holds the rotor in place during loading
and analysis. The rotor holder is thermostatically controlled to a temperature of 38.5 ±
0.5o C to insure 37 oC inside the cuvette.
The loading of samples and reagents into the reaction cuvettes involves the action of
the sampling / dispensing arm and needles. When starting with a new rotor, cuvette 20
is generally filled with a normal pool of calibration plasma. Cuvette 19 is usually
filled with the Wash-Reference Emulsion aspirated from the one-litre bottle housed
against the back wall of the analyzer. The remaining 18 rotor cuvettes (1-18) are filled
with samples and reagents as required by the programmed request.
The used rotors are dropped inside the Rotor Waste Container. This container is
accessed from a door in the right front area of the analyzer for removal and disposal
of the used rotors, as seen in the figure below. With the ACL Elite rotors are
manually removed from the rotor holder after analysis is complete and may be
disposed of in the Rotor Waste container or other suitable method.
WARNING !
BIOLOGICAL HAZARDS EXIST. Avoid touching, with bare hands, any parts
of the system which may have come in contact with potentially infectious fluids.
ALWAYS wear gloves when performing any type of Maintenance/Service action
on this area.
This module consists of a Liquid Crystal Display, 12-inch active matrix (LCD), which
has Touch Screen capability, allowing all operations to be carried out using the LCD.
The LCD guides the operator during the analytical process and displays calibrator
data and patient results. It is also used to display calibration curves, and to perform
several utility programs that 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:
1.4.7 Keyboard
The ACL Elite/ElitePro 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 USA keyboard layout, the
ACL software itself also supports the layout for the following languages: German,
French, Spanish, Italian and English (UK).
• USB connectors (4) to interface USB mouse, USB External Barcode Scanner,
and/or USB Printer.
The ACL Elite/ElitePro includes an interface for a USB external barcode scanner that
allows reading reagent barcodes. The external barcode scanner is a standard accessory
for the ACL ElitePro system and an optional feature for the ACL Elite system.
The ACL Elite/ElitePro 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 ACL Elite/ElitePro has an output for an optional external printer. Two emulation
protocols are available for printers: ESC/P2 (Epson like printers) and HP-PCL 5 (for
HP like Laser Printers).
• Standard PC keyboard
Parallel Keyboard
USB Ports (4) Ethernet
Host Serial Printer
Mouse
The cooling of the system is insured by the presence of fans mounted on the internal
right and left sides of the analyzer. An air filter prevents dust from entering the
system.
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.
The on-board barcode reader, a standard feature of the ACL Elite/ElitePro, is located
in the sampling area as indicated in the figure below. A small window indicates its
position.
Following are the numerical and alphanumerical readable codes.
• Codabar
• Code 39
• Code 128
• Interleave 2 of 5
When using barcoded sample tubes, it is important to position them in the sample tray
such that the labels are facing towards the outside of the sample tray. This will allow a
correct reading of the labels by the on-board barcode reader.
The external barcode scanner for the ACL Elite/ElitePro is able to read numerical and
alphanumerical IL Reagent bottle labels. The maximum barcode label length readable
is 6 cm with a resolution of 0.2 mm.
Following are the numerical and alphanumerical readable codes.
• Code 128
A floppy disk drive is mounted in the upper right part of the ACL Elite/ElitePro. This
device is used for some of the utility programs.
The floppy disk drive is accessible by pushing both sides of the small door to open it.
If the ACL Elite/ElitePro is left ON for a period longer than 30 minutes without any
operator action, the system moves into the Standby status. The LCD screen goes
blank. Pressing the Touch Screen reactivates the display and allows the system to
resume normal operation.
When the system enters the Standby status, all motors are deactivated to reduce power
consumption and the LED source is switched off. While the instrument is in the
Standby status, an automatic priming cycle of Wash Reference Emulsion solution is
performed every 30 minutes. The Database is saved when the instrument goes into
the Standby status.
At the end of each analytical cycle, an audible signal notifies the operator that the
cycle has been completed.
The ACL contains a Hard Disk Drive to store the database in the event of a power
interruption. The instrument performs an automatic save of the database to retain the
data every entry into standby or when exiting from the main program to power the
system off.
The instrument has an internal clock that keeps track of the date and time.
The instrument incorporates several utility programs that allow certain functions to be
changed or set according to the user’s needs. These programs also help in
troubleshooting.
For additional information, refer to Chapter 2 “Operator Interface Description” in this
manual.
The system automatically monitors faults to ensure accuracy of sample data and
proper system performance. Fault monitoring includes display of alarms and
warnings.
For additional information, refer to Chapter 6 “Troubleshooting” in this manual.
Do Not Actuate
Chapter 2
Operator Interface Description
This chapter is designed to familiarize the service engineer with the Operator
Interface (OI) items used during the process of requesting and performing analytical
and service operations, such as the data input devices, elements within menus, buttons
and icons. Following are the specific sections.
Note: On the screen, any disabled object (menu, check-box, and button) is displayed
dimmed and it cannot be selected.
This is the upper part of the screen that contains the following items.
• IL Logo
• Indication of current instrument status (see section 2.3)
• Date and Time
• Windows like Menu bar (see section 2.5)
This is the central area of the screen, which display windows containing data,
commands or messages.
Within the ACL Elite/ElitePro screens these items are grouped or contained in three
different types of defined windows that are following.
• Standard window
In the analysis menu, this is a larger area that contains sets of related data, which can
be edited by the user by means of command buttons.
In the service menu, or in any common menu, this is an area that contains
configuration and setting options with command buttons.
• Dialogue box
This is a small area used to prompt the user to choose one of several options (OK,
Abort, Retry, Ignore, Cancel, Yes, No).
• Message box
Command buttons allow the user to select options, cause actions and get from one
part of the software to another.
The buttons are positioned in different areas depending on the screen.
Some are identified with text that is self-explanatory of the action.
Some are shown with an icon inside that illustrates an action as defined in the
following table.
Confirm
Cancel
(Dimmed if Edit action not allowed)
Host
Delete
Add
Add an item to the list.
Remove
Remove an item from the list.
Transfer
Transfer an item from one list to another.
Details
Information
Provide information in different languages.
New Sample
Note
Patient Name
Patient Details
Save
Save information to floppy disk.
Inside the standard windows, “Check boxes” may be present which allow the user to
“mark” an item. If a check box or button is in mutual exclusion with another check
box or button, there is a frame wrapping the two, along with “graphic” information.
Icon Meaning
ERROR
To call attention to high priority failures and fault messages.
WARNING !
To deliver different kinds of messages. For example to warn
the user of a “not allowed/wrong” operation, or of
“problems/errors” detected by the instrument during or after
an operation.
QUESTION
To request confirmation by the user before starting an
operation or before cancelling an action.
INFORMATION
To offer general information. In some boxes, but not always,
the message is followed by a request for confirmation.
This is the bottom part of the screen, which contains a series of command buttons for
immediate and easy access to particular functions.
The status of the buttons (Active or Dimmed) is dependent on the instrument status,
but independent from the type of information displayed in the working area.
The buttons are shown with an icon inside that illustrates an action as defined in the
following table.
Instrument Status
Informs the operator about the status of the operation in progress.
Close/Open Cover
This operation is disabled if there is a possible interference with
the instrument operation.
STOP
Confirmation is required.
Resume
Starts the operations paused due to a STAT request.
Host Status
This icon appears only during communication with the Host to
inform the operator about the status of this action.
Printer Status
This icon appears only during printing to inform the operator
about the status of this action.
Warning !
This icon appears when there is at least one warning. Press to
open “Warning List”.
Exit
Allows the operator to exit the Service menu.
Log Out
Allows the operator to exit the Analysis menu.
Confirmation is required. It is mandatory to follow the proper
Log Out sequence (pressing the Log Out Icon), before powering
off the instrument.
Reagent Status
Indicates status of reagents by color change
QC Status
By pressing icon, a screen is displayed indicating the last 100 QC
results. A red ! in the icon indicates a QC error.
The main information input device for the user is the touch screen.
To start an “enter command” or “edit value” action the operator touches the area to be
edited, which results in the immediate display of the numerical keypad (if enabled).
If the information to be entered is strictly numerical, the editing is done directly on
the keypad.
If the information requires alphanumeric characters, the input is done through the
external keyboard.
The editing action may be closed by pressing the "Confirm" or the "Cancel" buttons
or in some cases by touching a different area of the screen (implicit confirmation).
Once the confirmation is done, the system performs an automatic check on the entered
value. If an error situation is detected the user is notified by means of dialogue boxes
and the editing action is reactivated.
The touch screen supports auto-repeat functions in order to make lists easier to scroll.
The main function of the PC keyboard is to enter and edit data in the alphanumeric
fields.
To start the editing action, select the field to be edited. Move the cursor from the
current object (it may be the default object if the window was just opened) to the
desired object by pressing [TAB] or [Shift] [TAB].
To close the editing action 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 conditions by means of a dialogue box. If the editing action has been
implicitly closed (touching a different area of the screen) the fault condition of the
entered value will be changed to the pre-existing one.
Pressing the [ESC] key without activating any control may also close the editing
action; in this case the value returns to the pre-existing one.
Main and secondary menus may be selected using the keyboard. Pressing [ALT]
+Character opens the menus; selections within the secondary menus are done using
the Character key.
The keyboard may also be used to activate the Toolbar functions ( [F 1] to [F 10] ).
Pressing [ALT]-[TAB] allows shifting from an activated window to another visible
window. Pressing [CTRL + F4] will activate the Log Out function.
2.2.3 Mouse
The serial mouse or USB mouse is a device that may be used as a selecting device in
place of touching the screen. If at the instrument turn on the mouse is connected to the
proper port of the Interface Board then the Mouse arrow pointer is displayed.
The external barcode reader is a device used to “read” the information encoded in IL
reagent barcode labels.
• LOG-IN
This indicates that the instrument is inoperative and is waiting for the inputting of the
User Identification and the Password of the operator (see section 2.4).
• READY
This indicates that there have been no blocking errors detected, there are no analytical
operations in progress and the instrument is ready to start.
• OPERATING
This indicates that either an analytical function is in progress (Calibration or Sample
Analysis) or a diagnostic function is being performed.
• HOLD
This identifies a system "pause" reached during an analytical session (STAT request,
no rotors, etc.). In order to continue the current session, select “Resume” (green flag
icon in the Toolbar).
• FAILURE
This indicates that the system has detected a blocking malfunction for a software
problem or mechanical assembly (devices, temperature control, etc.).
• STAND-BY
This is the status into which the instrument moves automatically after 30 minutes of
inactivity. The LCD lamp in the video module is turned off and its status led becomes
green. Both the coagulimetric LED and Halogen Lamp are off and the system
performs a Database check then becomes inoperative.
To exit from the stand by status enter any command (Touch the screen, press any key
etc.).
• SERVICE
This is the status assumed when the instrument is in the Service program or in its
menus. To gain access to the Service program it is necessary to insert the proper
identification password at the LOG-IN prompt, (User: Service, Password: System
Fix) and then select on the windows like menu bar “Diagnostic” and then “Service”.
The Service program contains all the software tools and utilities to allow the Service
Engineer to perform a complete check out and adjustment of the whole instrument.
In the Service program the coagulimetric LED and Halogen Lamp are turned on for
default. To exit from the Service program select the “Exit” button on the Toolbar.
Note: When the “Exit” button is touched, the system performs an initialization of the
instrument.
During this initialization all the motors are moved to the home position and the
instrument attempts to recover from any errors before access to the Analysis program
is allowed.
2.4 Passwords
This section contains the available passwords implemented in the instrument software
together with the description of the allowable functions.
Service System Fix Gain access to all Service and Analysis programs
Note: User name and password are case sensitive. In the User as in the Password
fields pay attention to type correctly the “Upper/Lower Case letters” and the “spaces”.
Otherwise the system shows an “Error” message box.
This sub-section is designed to provide information about the location of the menu in
the Analysis program.
A menu may be opened by selecting the appropriate area of the screen (touch or click
with the mouse) or using the keyboard: [ALT] + Character.
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 (¾).
Selecting a menu item, touching an external area, or pressing [ESC] from the standard
keyboard closes a menu.
The “Analysis Windows Like Menu Expanded Diagrams” is available in the figure
2.5.1 Drawing 1 of the Chapter 10 “Drawings”.
This sub-section is designed to provide information about the location of the menu in
the Service program.
A menu may be opened by selecting the appropriate area of the screen (touch or click
with the mouse) or using the keyboard: [ALT] + Character.
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 (¾).
Selecting a menu item, touching an external area, or pressing [ESC] from the standard
keyboard closes a menu.
The “Service Windows Like Menu Expanded Diagrams” is available in the figure
2.5.2 Drawing 1 of the chapter 10 “Drawings”.
This sub-section is designed to provide information on the menus that are common
and present in both the Analysis and the Service program. More information about
these 3 menus is provided in the Operator’s Manual.
Following are the specific sub-section for these 3 menus.
2.5.3.a Diagnostic
2.5.3.b Setup
2.5.5.c Utility
2.5.3.a Diagnostic
Following is the table with the description of the functionality of each option in the
“Diagnostic” menu.
Option Description
2.5.3.b Setup
Following is the table with the description of the functionality of each option in the
“Setup” menu.
Option Description
Tests This is a second level menu with options that allow the
operator to configure the analytical tests.
Profiles This is a second level menu with options that allow the
operator to configure the analytical profile tests.
Liquids This is an option that allows the operator to configure the
liquids used by the instrument.
Interfaces This is a second level menu, with options that allow the
operator to configure the interface with the internal /
external device.
System Configuration This is an option that allows to the operator to configure the
system.
Date / Time This is an option that allows the operator to set the date and
the internal clock time.
Units This is an option that allows at the operator to select the
measuring units for the data.
2.5.3.c Utility
Following is the table with the description of the functionality of each option in the
“Utility” menu.
Option Description
Upgrade IL Library This option allows the operator to upgrade the IL library
present in the system with new liquids, tests and profiles.
Backup / Restore This option allows the operator to backup or restore the
current system configuration (for Hardware, QC, AR, and
Patients).
Archive This option allows the operator to store the data (QC, AR,
Patients database and Calibration) on floppy disks using the
“.TXT” format. If required these floppy disks are then
readable from a PC.
Software This option allows the operator to check the software ID,
and/or upload and upgrade the instrument software.
Save Last Rotor Map This option allows the operator to save on floppy disk the
raw data of all the rotors analyzed in the last session using
the “.TXT” or “.DAT” formats. If required these raw data
disks can be viewed on a PC.
Save Trace This option allows the operator to save on floppy disk the
file where the instrument stores any operation performed
and any command received. If required, this file may be
delivered to IL for troubleshooting purposes.
Decapper This option is dimmed (the Decapper unit is a feature not
available at this time).
Debug This option is always dimmed (only for R&D purposes).
Testing This option is always dimmed (only for R&D purposes).
Chapter 3
General Description
This chapter of the manual contains general descriptions about the ACL Elite/ElitePro
system, including the use and functionality. Following are the specific sections.
The fluidic functions are sampling, dispensing and flushing the system.
The ACL Elite/ElitePro fluidic system includes the components described in the
following sub-sections.
The Dilutor Chamber is an acrylic block with two cylinders which contain a stainless
steel piston and an O ring / Teflon seal.
A stepping motor and lead screw on which the fork actuator for the piston is mounted
drives each piston.
Volumes up to 140 µl can be aspirated or dispensed. Since the pistons do not touch
the walls of the chambers in which they move, the volume of the liquid dispensed
depends entirely upon the accuracy of the piston and the travel.
The travel is determined by the stepping motor and driving lead screw.
Note: Due to the critical adjustment and burn-in procedure required after the O ring
replacement, no service action must be attempted at sub assy level in the field.
In order to keep different liquids separate in the same fluidic line (ex: The in line
Wash-Reference Emulsion and sample or reagent) the instrument loads a small air
bubble between the two liquids.
The two Electro-Valves are mounted within the Dilutors Chamber, each one
connected to one of the pistons. Two Electro-Valves are electronically controlled and
connect the pistons to the Wash-Reference Emulsion bottle as well as to the two
needles of the Needles Block mounted on the Sample Arm.
The “Instrument Fluidic System Diagram” is provided in figure 3.1.2 Drawing 1 of
the Chapter 10 “Drawings”.
Two stainless steel needles (External for Sample, Auxiliary Material and Reagent and
the Internal for Reagent only) are mounted on the end of the Sample Arm that is
moved by the Sample Arm Movement Assy.
The Sample Arm allows the Needles Block to move in the proper positions and to
perform with the dilutors the following operations.
Two specific capacitive sensors connected to the Needle Block are used to detect the
level of the liquid around the sample (External) and reagent (Internal) needle.
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.
Following is the sequence of the sensor operations during a cycle.
- self-check
- liquid test
- washing
- final sensor self-check
Operators are warned of sensor failures. Results for a sample for which the system
detected insufficient volume will appear with a warning. In the case that all sample
containers in the sample tray are empty the cycle will be aborted after the final self-
check. No other warnings appear on the video or on the printer.
The ACL uses two different optic principles to measure the hemostasis parameters:
Emerging Chromogenic
Light Channel
Scattered
Light
Rotor Sample
Cuvette Coagulimetric
Channel
Incident
Light
The rotor cuvette loading and analysis area also houses two optical systems for
analysis: Coagulimetric (nephelometric method) and Chromogenic (absorbance
method). Following are the specific sub-section.
The coagulimetric channel uses a high efficiency light emitter diode (LED) as light
source (wavelength is 660 nm approx.).
The light radiation coming from the LED is transferred to the Rotor Holder using an
optic fibre system.
Due to the narrow bending radius required connecting the LED output to the rotor
mounting assy, the use of a very flexible optic fibre is required.
For this reason a multiple fibres system, composed by a large number of single fibres
(about 1000), is used.
The optic fibre is locked to both the emitter side and the rotor side, using 2 set screws.
Note: When the optic fibre is locked on the diode side, the applied torque cannot
exceed 90° degrees CW or CCW at the rotor holder side.
A specific circuit, powered by the Switching Mode Power Supply Board with the +12
Vdc, provides a constant current to the diode.
The light emitter is also equipped with a “LED OFF” line, coming from the Motor
Board (Board #5), which de-activates the LED when the instrument enters the Stand-
by status.
The light generated by the light emitter diode is transmitted through the optic fibre
and is scattered by the reaction mixture present in the rotor cuvette. This scattered
light is read by using a solid state optical detector, which is installed below the Rotor
Holder and is directly connected to the Acquisition & Sensors Board (Board #3)
through a coaxial cable.
The Chromogenic Channel uses a Halogen lamp with an effective life of 1000 hours.
The main characteristics of the lamp are the following:
• Voltage: 6 V
• Wattage: 10 W
The lamp is installed into an appropriate socket that allows an easy installation into
the Source Lamp assy. The Halogen Lamp Socket can be replaced by accessing the
area through a removable cover inside the rotor waste area, in the center of the
One end of the optic fibre is secured to the source lamp assembly by means of a
setscrew, while the other end, is secured below the rotor mounting assembly.
The quantity of radiation unabsorbed by the cuvette contents, passes through a 405
nm interference filter and than is detected by an optical sensor (solid state
photodiode).
Both the optical detector and the filter are mounted in the Rotor Holder Cover.
The photodetector is directly connected to the Acquisition & Sensor Board #3 through
a coaxial cable.
Note: The optical path width for the Chromogenic Channel is 0.5 cm (cuvette height).
The absorbance values provided by the analyzer are normalized to 1 cm. These values
are generally double the ones obtained on other ACL models, for which the
absorbance values are strictly the ones obtained for the 0.5 cm cuvette path.
The purpose of this drawing is to clarify the starting point and the route of each major
signal present in the Instrument.
The major modules are logically grouped. An exception is made for the big Module
Interconnection Board which is split for better identification of each single module
driven.
This sub-section is designed to describe the circuits on the main boards and the main
modules and parts driven. Following is the board function table.
The CPU Master Board and the PC104 Board, located between the system Card
Housing and the Dilutor Assembly, are powered through the Switching Power
Supply, which provides a +5Vdc (DGT) and +12Vdc (DGT).
The CPU Master Board (Board #1) has a Personal Computer architecture design.
The “CPU Master Board General Block Diagram” is available in figure 3.3.4 Drawing
1, while the “PC104 Board General Block Diagram” is available in figure 3.3.4
Drawing 2 of the chapter 10 “Drawings”.
The main functions reported in the following outline are further expanded and
presented on specific paragraphs.
• Software runtime.
• Internal devices control.
• External devices control.
• Communication with PC104 Board.
3.3.4.a CPU Master Board General Block Diagram (See figure 3.3.4 Drawing 1)
• Software runtime.
At the instrument power on the CPU Master downloads from the Hard Disk Drive
both the Operating System and the Application software. A local MEMORY BANK
is used during the software runtime. After downloading, the Board #1 starts system
initialization testing the instrument hardware through the Slave Board (Board # 2).
The control of the MEMORY BANK is achieved through the SYSTEM & DRAM
CONTROLLER and the MEMORY CONTROLLER. The Hard Disk Drive control is
performed through the SYSTEM & DRAM CONTROLLER and the PERIPHERALS
STANDARD CONTROLLER.
In addition to the Operating System and Application software the Hard Disk Drive
also allows Patient and Analytical Database storage.
The CPU Master Board reads the internal device configuration, through the SYSTEM
& DRAM CONTROLLER from the BIOS MEMORY.
The internal devices of the instrument controlled from the Board # 1 are:
The active matrix LCD (Liquid Crystal Display) controlled by the VGA
CONTROLLER and the VIDEO MEMORY (through the LCD ACTIVE
MATRIX CONNECTOR CN6). The VGA CONTROLLER can also support
The external devices controlled by Board # 1 (through the Interface Board) are:
The standard PC Keyboard controlled from the SYSTEM & DRAM CONTROLLER
(through the UTILITY CONNECTOR CN21).
An external Ethernet interface controlled from the ETHERNET CONTROLLER
(through the ETHERNET CONNECTOR CN4).
An external Parallel Printer controlled from the PERIPHERAL STANDARD
CONTROLLER (through the PARALLEL PORT CONNECTOR CN26).
A PC serial Mouse controlled from the PERIPHERAL STANDARD CONTROLLER
(through the MOUSE SERIAL PORT CONNECTOR CN30).
Four USB ports (version 1.1) are connected to a integrated USB standard controller
thru connector CN24.
The CPU Master Board communicates with the PC104 Board through the SYSTEM
& DRAM CONTROLLER and the PC104 CONNECTOR CN13 – CN14 – CN29.
The CPU Master Board receives the signal RESET from the Mother Board through
the UTILITY CONNECTOR CN21. This signal is generated from the Slave Board
(Board # 2) and is sent also to the PC104 Board.
The Board # 1 provides to the PC104 Board a +5Vdc (DGT).
3.3.4.b PC104 Board General Block Diagram (See figure 3.3.4 Drawing 2)
The CPU Master Board communicates to the PC104 Board through the connector
CN13 – CN14.
The PC104 Board, through the SERIAL CONTROLLER, controls the MODEM –
HOST – BAR CODE SERIAL PORT CONNECTOR CN7 – CN8 – CN9. These
serial ports though the Interface Board allow the instrument to communicate with the
external devices.
The CPU Master Board communicates to the PC104 Board through the connector
CN13 – CN14.
The PC104 Board through the TOUCH SCREEN CONTROL BOARD SERIAL
LINE CN6 and the TOUCH SCREEN CONTROL BOARD POWER CN3, controls
the Touch Screen Board located inside the Display assembly.
The Slave board (Board #2) is located on the system card housing and powered
through the Switching Power Supply, which provides a +5Vdc (DGT).
The Slave Board is equipped with a microprocessor (MCU U1), a resident memory
bank and a circuitry handling various interrupt signals that are sent to the board.
Multiple data and address busses are employed: (D0 - D15 and A0 - A23) are used to
connect the MCU U1 to the internal bus (DB0 - DB15 and AB0 - AB23). The internal
busses are then buffered to external data and address bus (SLD0 - SLD15 and SLA0 -
SLA23) through which the Slave board communicates with the Boards # 3, # 5 and
# 6.
The “Slave Board General Block Diagram” is available in figure 3.3.5 Drawing 1 of
the Chapter 10 “Drawings”.
The main functions reported in the following outline are further expanded and
presented on specific paragraphs.
• Receives commands forwarded from the CPU Master Board (Board # 1).
• Controls the REM Board (Board #4) and the internal Bar Code Reader.
• Interfaces the Slave board with the external data and address bus.
• Interrupt controller.
3.3.5.a Slave Board General Block Diagram (See figure 3.3.5 Drawing 1)
The RESET CIRCUIT U3 generates the signal RESET used to initialize the whole
system. The RESET CIRCUIT can be triggered by any of the following
devices/signals:
The LED LD1 is illuminated only when the signal RESET is present.
The LED LD4 is illuminated always while the Board # 2 is powered with +5Vdc
(DGT).
• Receives commands forwarded from the CPU Master Board (Board # 1).
The Slave board communicates with the CPU Master Board by means of an Arcnet
connection, using a dedicated cable and connector P6 (P7 could also be used as it
replicates P6 pinout, being parallel connected). The data transmission is handled by
the ARCNET CONTROLLER CIRCUIT U27.
• Controls the REM Board (Board #4) and the internal Bar Code Reader.
The serial ports P8 - P9 - P10 are not used during the normal operations. Use of these
ports is limited to the manufacturing process when the board is connected to external
devices, which program the resident logic.
A few memory devices are employed to support the MCU U1 on the Slave Board,
these are:
The SERIAL EPROM U2 is directly linked to a serial port of the MCU U1.
The RAM STATIC MEMORY BANK U22-25 linked to MCU U1 through the data
bus DB0 - DB15 and the address bus AB0 - AB19.
The FLASH EPROM MEMORY U14 - U21 linked to MCU U1 through the data bus
DB0 - DB15 and the address bus AB0 - AB19.
The MCU U1 is also connected to the BOOT LOADER EPROM U26 from, which
downloads the boot program by sending the command CSBOOT while initializing.
• Interfaces the Slave board with the external data and address bus.
The MCU U1 is connected through the data bus D0 - D15 to the INTERNAL DATA
BUS TRANSCEIVER U4, which outputs DB0 - DB15 as local data bus connecting to
other devices resident on the Slave board.
The local data bus BD0 - DB15, is then linked to the EXTERNAL DATA BUS
TRANSCEIVER U7 – U36. These devices output SLD0 - SLD15 (slave data bus),
which allows MCU U1 to communicate with the Board # 3, # 5 and # 6, located on
the system card housing.
The address bus A0 - A23 links MCU U1 to the INTERNAL ADDRESS BUS
BUFFER U5 – U6 which outputs AB0 - AB23 as local address bus connecting to
other devices resident on the Slave board.
The local address bus AD0 - AD23, is then linked to the EXTERNAL ADDRESS
BUS BUFFER U8 – U9. These devices output SLA0 - SLA23 (slave address bus),
which allows MCU U1 to communicate with the Board # 3, # 5 and # 6, located on
the system card housing.
The control signal R/W is fed to the INTERNAL ADDRESS BUS BUFFER U5 –U6
which outputs a signal BR/W connected to the MAIN LOGIC EPLD U12. The EPLD
generates the individual control signals RD and WR which are routed to the
INTERNAL ADDRESS BUS BUFFER U5 –U6 where they get converted into BRD
and BWR. The EXTERNAL INTERRUPT BUS BUFFER U10 – U11 buffer the
commands and output the commands SLRD and SLWR which become control signals
of the external data and address bus.
The MAIN LOGIC EPLD U12 also handles the chip select signals for the local
devices as well as the board select commands. The board select commands (BS0 -
BS3) are fed to the EXTERNAL INTERRUPT BUS BUFFER U10 – U11 which
provide outputs SLBS0 - SLBS3 to the Board # 3, # 5 & # 6 located on the system
Card Housing.
• Interrupt controller.
Possible interrupts generated outside the Slave board are input via the EXTERNAL
INTERRUPT BUS BUFFER U10 – U11 and then routed to the INTERRUPT
CONTROLLER EPLD U13. The EPDL U13 handles the interrupts following a
scheme of priority and sends signals IRQ1 - IRQ7 to the MCU U1.
The interrupts, which can be generated and logged into the Slave board are as follows:
- POWERFAIL
This signal is raised from the Switching Power Supply, which can detect a lack of
supply voltage, and may lead to a decrease of the dc voltages thus impairing proper
functioning of the logic.
- STS
This can be raised by the Acquisition & Sensor Board (Board # 3) when the A/D
conversion has been accomplished and the data is available on the bus.
- ELETFAIL
This can be raised by the Rotor Exchange Module Board (Board # 4) in case of
malfunction of an electromagnet thus impairing proper rotor displacement.
- ROTFAIL
This can be raised by the Photometric & Temperature Control Board (Board # 6) in
case of a malfunction of the Rotor Motor.
The Acquisition & Sensor Board, is located in the system Card Housing, and powered
through the Switching Power Supply, which provides the +5Vdc (DGT), +15Vdc
(ANA), -15Vdc (ANA) and +12Vdc (PW).
The Acquisition & Sensors Board communicates with the Slave Board (Board # 2)
through the signals SLD0 - SLD15 “slave data bus”, and the signals SLA0 - SLA7
“slave address bus”. This communication is supported by the control signals SLRD,
SLWR, RESET as well as the Board enabling signal SLBS0.
The “Acquisition & Sensors Board General Block Diagram” is available in figure
3.3.6 Drawing 1 of the Chapter 10 “Drawings”.
The main functions reported in the following outline are further expanded and
presented on specific paragraphs.
Acquisition & Sensors Board General Block Diagram (see paragraph 3.3.6.a)
Sample Tray Detectors Emitter & Receiver Sections (see paragraph 3.3.6.d)
3.3.6.a Acquisition & Sensors Board General Block Diagram (See figure 3.3.6
Drawing 1)
The Slave Board (Board # 2) sends to the PARALLEL I/O U5 two control signals for
the Switching Power Supply. The first is the signal LAMPWR that controls the
Halogen Lamp status.
The second is the signal PWROFF that controls the +9Vdc, +12Vdc and +70Vdc
power voltage status.
The Board # 3 uses the multiplexer MPLX CIRCUIT U1 to select that signal will
convert the A/D CONVERTER CIRCUIT U11. This selection is driven by the
PARALLEL I/O U5 that sends the control signals MUX0 - MUX3 to the multiplexer.
The EPLD U6 controls with the start signal ADRC and the end signal ADSTAT the
conversion process of the A/D CONVERTER CIRCUIT U11. The EPLD U6 controls
the timer programmable TIMER PROG. U9 that allows the EPLD of work with the
Rotor Motor’s speed during acquisition at 600 or 1200 Rpm, and introduces a delay in
the acquisition time pre-selected in the Curve Adjustment Service menu (see section
7.2 for Coag. and section 7.3 for Chrom.). The EPLD U6 receives from the
PARALLEL I/O U5 the control signals AACQ to select the static or the dynamic
acquisition and the signals SCALF to select the delay for Coag. Ch. or Chrom. Ch.
The EPLD U6 receives the signals ROTCUV – ROTCUVZ from the Motors Board
(Board # 5) and they are very important signals to synchronise the data acquisition.
• Sends the interrupt signal STS to the Slave Board (Board # 2).
When the new data is ready the EPLD U6 receives the signal ADSTAT from the A/D
CONVERTER CIRCUIT U11, then enables the BUFFER 3-STATE U12 – U13 with
the signal RDADC and sends the interrupt signal STS to the Slave Board (Board # 2).
The timer programmable TIMER PROG. U10 is used to produce the frequency
FREQST for the work of the Magnetic Stirrer Motors drivers on the Motors Board
(Board # 5).
The Optical sensor of the Coagulimetric Channel is located under the Rotor Holder.
This sensor is connected to the Acquisition & Sensors Board through a coaxial cable
that enters in the specific amplifier’s box. The sensor’s signal enters in the
AMPLIFIER CIRCUIT U17 – U21, and the output COAG is one of the most
important signals converted in the Multiplexer & Acquisition Section. This circuit is
composed also by the trimmers RV1 used to adjust the Offset and RV2 used to adjust
the Gain during the instrument testing (see section 7.2).
The Optical sensor of the Chromogenic Channel is located under the Analysis
Compartment Cover. This sensor is connected to the Acquisition & Sensors Board
through a coaxial cable that enters in the specific amplifier’s box. The sensor’s signal
enters in the AMPLIFIER CIRCUIT U20 – U22, and the output CHROM is one of
the most important signals converted in the Multiplexer & Acquisition Section. This
circuit is composed also by the trimmers RV4 used to adjust the Offset and RV3 used
to adjust the Gain during the instrument testing (see section 7.3).
Forty positions are available to load patient samples. Two rings (outermost and
middle ring) can accept twenty cup/tubes each. A third ring (innermost) is available
on the Sample Tray and up to ten positions can be loaded with calibrants, controls
and/or reagents.
Two optical sensors are located in the Autosampler housing with the purpose of
detecting the presence of the containers in the Sample Tray. The internal sensor is
placed in the internal wall while the external sensor is placed in the external wall of
the Autosampler housing. Both the sensors detect the presence of the containers using
the refraction principle.
The power section for the infra red light emitter of the sensors is controlled by the
PARALLEL I/O U5 that sends the enabling signals ESCUV – ESCUVINT –
ESCUVEXT to the EPLD U6.
The Sample cup/tubes can be placed in the Sample Tray on two different rings. As the
sample cup/tubes can be placed on both the outermost and the middle ring, two
different levels of current are needed to drive the external sensor which shall detect
the presence of sample containers located either close (outermost ring) or far (middle
ring).
To select the most appropriate current level, the EPLD U6 sends the AUTOC signal
to the SWITCH CIRCUIT U26 which through the signals SCUVL1 – SCUVL2 set
the current level output at the CURRENT GENERATOR U43A – U46A.
The trimmer RV6 allows the adjustment of the current in the emitter during the
instrument testing (see sub-section 7.5.3). The outputs of the power circuit for the
external sensor are ANLED1 – KD1.
The auxiliary materials containers are placed in the innermost ring of the Sample Tray
and are detected by the internal sensor. The trimmer RV7 allows the adjustment of the
current in the emitter during the instrument testing (see sub-section 7.5.3).
The outputs of the power circuit for the internal sensor are ANLED2 – KD2.
The external sensor receives the refracted light and sends to the receiver circuit the
signal ET1 which is filtered and amplifier to produce the signal SCUVEXT. This
signal is then converted in the Multiplexer & Acquisition Section.
To select the right work’s level, the EPLD U6 sends the controls signal AUTOC to
the SWITCH CIRCUIT U26 that can link the trimmer RV10 to control the gain of the
AMPLIFIER CIRCUIT U27A.
The trimmer RV10 allows, for the outermost ring, the adjustment of the amplifier gain
for the receiver signal during the instrument testing (see sub-section 7.5.3).
Another control signal is BLIVSCUV which is sent to the COMPARATOR CIRCUIT
U48A to select the right work level and produce the logical signal PCUVEXT, then
this signal is read from the PARALLEL I/O U5. The DRIVER CIRCUIT U28
controls the LED DL1 that is lighted when the sample containers are detected during
the Autosampler / BCR Test (see sub-section 7.5.3).
The internal sensor receives the refracted light and sends to the receiver circuit the
signal ET2 witch is filtered and amplified to produce the signal SCUVINT, one of the
most important signals converted in the Multiplexer & Acquisition Section.
The circuit produces also the logical signal PCUVINT which is read from the
PARALLEL I/O U5. The DRIVER CIRCUIT U28 controls the LED DL2 that is
lighted when the auxiliary materials containers are detected during the Autosampler
Test (see sub-section 7.5.3).
The Liquid Level Detector Board, connected to the needles block assembly, sends the
signals AGOSS for the sample needle and AGOSR for the reagent needle to the
Acquisition & Sensors Board. The EPLD U36 selects with the enabling signals
EAGOS - EAGOR the sample/reagent needle sensor signal. The EPLD U36 also
controls with the signals EAUTOZEROS – RAUTOZEROS the reading or the reset
of the auto-zero circuit. The selected signals enter in the specific circuit and produce
the output signal SLIQ, which is then converted in the Multiplexer & Acquisition
Section. The EPLD U36 sends the control signals GXL1 – GXL2 to the SWITCH
CIRCUIT U51 which, according with the cycle in progress, sets the gain of the
AMPLIFIER CIRCUIT U39B by connecting either the trimmer RV11 (for the
Reagent) or RV12 (for the Sample) as appropriate.
The trimmer RV11 and RV12 allow the adjustments of the amplifier gain for the
output SLIQ during the instrument testing (see section 6.3.1). The signal SLIQ is also
compared with one of the three threshold signals SG1 – SG2 – SG3, this selection is
controlled by EPLD U36 to produce the logical signal PSAGO, then this signal is read
from the PARALLEL I/O U5. The DRIVER CIRCUIT U28 controls the LED DL4
that is lit when the liquids are detected during the Needles Sensor Test (see sub-
section 7.4.1). The PARALLEL I/O U5 sends to the EPLD U36 the signal EAGHITIP
aimed at enabling the entire liquid detectors circuit and the signal LGT2 to enables
the timer programmable TIMER PROG. U9.
The trimmer RV9 allows the adjustments of the amplifier gain for the output signal
SFLUSH during the instrument testing (see sub-section 7.4.1). The trimmer RV8
allows the factory adjustment of the amplifier gain for the reference signal CLKSINE.
3.3.6.g Analysis Compartment Cover Sensor Section (See figure 3.3.6 Drawing 8)
3.3.7 Rotor Exchange Module Board (Board # 4) (excluded from ACL Elite)
The Rotor Exchange Module Board, is located in the system Card Housing, and
powered through the Switching Power Supply, which provides the +5Vdc (DGT),
+15Vdc (ANA), -15Vdc (ANA) and +12Vdc (PW).
The R.E.M. Board is equipped with a microprocessor (CPU U1) and a resident
memory bank. The R.E.M. Board communicates with the Slave Board (Board # 2)
through the serial communications line TXD4 – RXD4.
The “Rotor Exchange Module Board General Block Diagram” is available in figure
3.3.7 Drawing 1 of the chapter 10 “Drawings”.
The main functions reported in the following summary are further expanded and
presented on specific paragraphs.
• Resident Memory Bank and communication with the Slave Board (Board # 2).
3.3.7.a Rotor Exchange Module General Block Diagram (See figure 3.3.7
Drawing 1)
The status of the mechanical switch, located inside the Rotors Waste container
compartment, is read through the BUFFER CIRCUIT U27, which outputs the signal
DOOR_WST to the CPU U1.
The CPU U1 through the EPLD U2 controls the LED DL1, which is lit when the CPU
U1 is ready.
The Slave Board sends to the CPU U1 the command relative to the Transport Motor
movement. The CPU U1 controls the TRANSPORT MOTOR DRIVER U14 – DX1,
whose output signals are the motor phases M1A – M1BB. The CPU U1 uses the
demultiplexer DEMPL U29 to send the enable signal M1_PWR_ENA to the driver
circuit, and the multiplexer MPLX U6 to check the presence of the signal MO_CAS
generated by the driver only if there is a malfunction. The TRANSPORT MOTOR
DRIVER U14 – DX1 is powered by the LOCAL GENERATOR +24VPW U10.
The jumpers in M1 are factory pre-set to obtain full or half steps as required.
The Slave Board sends to the CPU U1 the command relative to the Rotor Arm
Vertical Motor movement. The CPU U1 controls the ROTOR ARM VERTICAL
MOTOR DRIVER U18 – DX3, whose output signals are the motor phases M3A –
M3BB. The CPU U1 uses the demultiplexer DEMPL U29 to send the enable signal
M3_PWR_ENA to the driver circuit, and the multiplexer MPLX U6 to check the
presence of the signal MO_HIG generated by the driver only if there is a malfunction.
The ROTOR ARM VERTICAL MOTOR DRIVER U18 – DX3 is powered by the
LOCAL GENERATOR +24VPW U10. The jumpers in M3 are factory pre-set to
obtain the full or half steps as required.
• Resident Memory Bank and communication with the Slave Board (Board # 2).
The CPU U1 controls through the data bus D0 – D7, the address bus A8 – A15, and
the BUFFER 3-STATE CIRCUIT U3, the RAM MEMORY U4 and the ROM
FLASH MEMORY U5, used for the program’s run-time and data storage.
The CPU U1 through the EPLD U2 sends the enable signals to the memories.
The serial communication line of the CPU U1 is linked with the SERIAL I/O
CIRCUIT U8, which handles the serial communication line TXD4 – RXD4 to the
Slave Board (Board # 2).
The upper sensor located inside the Rotors Feed Stack allows the system to detect for
presence of new rotors in the storage area of the Rotor Stack (over the mechanical
movements).
This sensor is powered by the POWER CIRCUIT Q7, which provides the signals
AFCS and CFC.
The sensor receives the refracted light and sends to the receiver circuit the signals
FCS, which is handled by the circuit to produce the signal FC_STR. This signal is
read by the CPU U1 through the multiplexer MPLX CIRCUIT U7. This circuit is
composed also by the trimmer PT1 used to adjust the signal during the instrument
testing (see sub-section 7.5.1).
The lower sensor located inside the Rotors Feed Stack allows the system to detect for
presence of a new rotor on the Rotor Transport plate.
This sensor is powered by the POWER CIRCUIT Q7, which provides the signals
AFCC and CFC.
The sensor receives the refracted light and sends to the receiver circuit the signals
FCC, which is handled by the circuit to produce the signal FC_CAS. This signal is
read by the CPU U1 through the multiplexer MPLX CIRCUIT U7. This circuit is
composed also by the trimmer PT2 used to adjust the signal during the instrument
testing (see sub-section 7.5.1).
The sensor located above the Rotors Waste container allows the system to detect the
conditions of “Waste container full”.
This sensor is powered by the POWER CIRCUIT Q7, which provides the signals
AFCW and CFC.
The sensor receives the refracted light and sends to the receiver circuit the signals
FCW, which is handled by the circuit to produce the signal FC_WST. This signal is
read by the CPU U1 through the multiplexer MPLX CIRCUIT U7. This circuit is
composed also by the trimmers PT3 used to adjust the reading of the signal during the
instrument testing (see sub-section 7.5.2).
The CPU U1 through the EPLD U2 sends the signal CK_LED, which is used to
enable the circuit.
• Sends the interrupt signal ELETFAIL to the Slave Board (Board # 2).
The RESISTIVE CIRCUIT controls the signals for the electromagnets and sends the
warning TEM_CLM for the Caliper, TEM_ST1 for the upper movement, TEM_ST2
for the lower movement, and the signal 24V_MOT for the LOCAL GENERATOR
+24VPW. These signals are read by the CPU U1 through the multiplexer MPLX
CIRCUIT U7. If a warning signal is active the CPU U1 commands the EPLD U2 to
disable the electromagnet with the failure and sends the interrupt signal ELETFAIL to
the Slave Board (Board # 2).
The Motors Board, is located in the system Card Housing, and powered through the
Switching Power Supply, which provides the +5Vdc (DGT), and +12Vdc (PW).
The Motors Board communicates with the Slave Board (Board # 2) through the
signals SLD0 - SLD7 “slave data bus”, and the signals SLA0 - SLA7 “slave address
bus”. This communication is supported by the control signals SLRD, SLWR, RESET
as well as the Board enabling signal SLBS2.
The “Motors Board General Block Diagram” is available in figure 3.3.8 Drawing 1 of
the chapter 10 “Drawings”.
The main functions reported in the following summary are further expanded and
presented on specific paragraphs.
• Reading of the signals originated by the Dual Channel Optical Switch mounted on
the Autosampler Motor, the Sample Arm Motors, the Dilutors Motors, the Rotor
Motor and the Analysis Compartment Cover Motor.
• Sends the interrupt signals ROTCUV – ROTCUVZ to the Slave Board (Board #
2) and to the Acquisition & Sensor Board (Board #3).
• Dilutor Electro Valves control.
• Coagulimetric Channel LED status control.
• Autosampler Motor Section (see paragraph 3.3.8.b).
• Sample Arm Motors Section (see paragraph 3.3.8.c).
• Dilutors Motors Section (see paragraph 3.3.8.d).
• Magnetic Stirrer Motors Section (see paragraph 3.3.8.e).
3.3.8.a Motors Board General Block Diagram (See figure 3.3.8 Drawing 1)
• Reading of the signals originated by the Dual Channel Optical Switch mounted on
the Autosampler Motor, the Sample Arm Motors, the Dilutors Motors, the Rotor
Motor and the Analysis Compartment Cover Motor.
The positions of the motors are coded by Encoder disks or flags located on the
movement assy. The Dual Channel Optical Switch sends to the Board # 5 the signals
read on the Encoders associated. These signals are:
SMALOW – SMAHIGH for the Autosampler Motor
SMOLOW – SMOHIGH for the Sample Arm Horizontal Motor
SMVLOW – SMVHIGH for the Sample Arm Vertical Motor
SMDREAG for the Reagent Dilutor Motor (uses a Single Channel Optical Switch)
SMDSAMP for the Sample Dilutor Motor (uses a Single Channel Optical Switch)
SMRTLOW – SMRTHIG for the Analysis Compartment Cover Motor
SMRLOW – SMRHIGH for the Rotor Motor.
These signals enter in the BUFFER CIRCUIT U7 – U8 then in the PARALLEL I/O
U1, which is controlled through the “slave data and address bus” from the Slave
Board (board # 2).
The motor rotation, sensed by the Dual Channel Optical Switch, allows the Slave
Board to detect possible “motor failures”.
• Sends the interrupt signals ROTCUV – ROTCUVZ to the Slave Board (Board #
2) and to the Acquisition & Sensor Board (Board #3).
The Dual Channel Optical Switch mounted on the Rotor Motor is very important to
achieve a proper reading during the Analysis Acquisition. Its signals SMRLOW –
SMRHIGH through the BUFFER CIRCUIT U7 – U8 enter the EPLD U41, which
sends the signals ROTCUV – ROTCUVZ to the Acquisition & Sensor Board (Board
# 3) and to the Slave Board (Board # 2).
The Slave Board controls through the “slave data and address bus” the PARALLEL
I/O U1, which communicates the request status for the Electro Valves to the DRIVER
CIRCUIT U5. This driver energize/de-energize the Electro Valves through the power
signals EV1 – EV2.
The Slave Board controls through the “slave data and address bus” the PARALLEL
I/O U1, which output enables the power circuit Q1 to send the signal LEDOFF to the
Coagulimetric Channel LED.
The Slave Board sends to the EPLD U42 the command relative to the Reagent Dilutor
Motor movement. The EPLD U42 through the demultiplexer DEMPLX CIRCUIT
U16 controls the REAGENT DILUTOR MOTOR DRIVER U13 – U14, which output
signals are the motor phases MFR1 – MFR4.
The Reagent Dilutor Motor drives circuit is powered from the LOCAL
GENERATOR +5VPW U40. The trimmer RV1 is factory adjusted to sets the
reference voltage to the demultiplexer DEMPLX CIRCUIT U16.
The Slave Board sends to the EPLD U42 the command relative to the Sample Dilutor
Motor movement. The EPLD U42 through the demultiplexer DEMPLX CIRCUIT
U20 controls the SAMPLE DILUTOR MOTOR DRIVER U17 – U18, which output
signals are the motor phases MFS1 – MFS4.
The Sample Dilutor Motor drives circuit is powered from the LOCAL GENERATOR
+5VPW U40. The trimmer RV2 is factory adjusted to set the reference voltage to the
demultiplexer DEMPLX CIRCUIT U20.
The Slave Board sends to the EPLD U43 the command relative to the Magnetic
Stirrer Motors movement. The EPLD U43 controls the MAGNETIC STIRRER
MOTOR DRIVER U25 – U26 – U27 – U28, which outputs signals are the motor
phases AGTR1A – AGTR4B. The driver circuit is powered from the LOCAL
SWITCHING POWER SUPPLY +26VPW U7. These driver circuits work with AC
motors, so they need the frequency signal STFREQ (50 Hz) from the Acquisition &
Sensors Board.
The REFERENCE VOLTAGE GENERATOR U39 and the THRESHOLD CIRCUIT
U11 allow to the COMPARATOR CIRCUIT U6 – U12 to detect a possible
malfunction of the magnetic stirrers. In case a malfunction is detected the
COMPARATOR CIRCUIT U6 – U12 outputs the warning signals ALAGTR1 -
ALAGTR4. These warning signals are read through the PARALLEL I/O U1 by the
Slave Board, and by the EPLD U43 that turns off the magnetic stirrer motor raising a
fail warning.
The Photometric & Temperatures Control Board, is located in the system Card
Housing, and powered through the Switching Power Supply, which provides the
+5Vdc (DGT), +15Vdc (ANA), -15Vdc (ANA), +9Vdc (PW), +12Vdc (PW) and
+70Vdc (PW).
The Motors Board communicates with the Slave Board (Board # 2) through the
signals SLD0 - SLD7 “slave data bus”, and the signals SLA0 - SLA7 “slave address
bus”. This communication is supported by the control signals SLRD, SLWR, RESET
as well as the Board enabling signal SLBS3.
The Slave Board through the PARALLEL I/O U4 sends to the EPLD U5 the
command relative to the Rotor Motor movement. The EPLD U5 controls the ROTOR
MOTOR DRIVER U7 – U8 – U10 – U14, which output signals are the motor phases
RF1 – RF4.
The Rotor Motor drive circuits are powered from the LOCAL GENERATOR +5VPW
U13.
• Sends the interrupt signal ROTFAIL to the Slave Board (Board # 2).
The circuits ROTOR MOTOR DRIVER U7 – U8 – U10 – U14 send the signals
VSENSE1 – VSENSE2 to the COMPARATOR CIRCUIT U12, which is aimed to
detect possible motor failure. If a failure is present this circuit outputs the signal
IRFAIL, which enters the BUFFER CIRCUIT U2. The buffer sends the interrupt
signal ROTFAIL to the Slave Board (Board # 2).
The Slave Board disables the interrupt ROTFAIL through the PARALLEL I/O U4,
which sends the signal ROTCLR to the EPLD U5. The EPLD U5 controls with the
signal NROTCLR the SWITCH CIRCUIT U18, which sends the signal CLFAIL to
reset the COMPARATOR CIRCUIT U12.
If there is a warning for high current, the driver circuits output the signals AACHOP –
BBCHOP, which are used to disable the EPLD U5
3.3.9.b Analysis Compartment Cover Motor Section (See figure 3.3.9 Drawing 3)
The Slave Board through the PARALLEL I/O U4 sends to the EPLD U5 the
command relative to the Analysis Compartment Cover Motor movement. The EPLD
U5 through the demultiplexer DEMPLX CIRCUIT U37 controls the COVER
MOTOR DRIVER U15 – U16, which outputs signals are the motor phases MFT1 –
MFT4.
The Analysis Compartment Cover Motor drives circuit is powered from the LOCAL
GENERATOR +5VPW U13.
The trimmer RV6 is factory adjusted to set the reference voltage to the demultiplexer
DEMPLX CIRCUIT U37.
The thermistor located inside the Rotor Holder sends the signal SROT1 – SROT2 to
the Photometric & Temperatures Control Board.
This signal is connected to the jumper JR1, the reference resistance R59 and to the
trimmer RV1. When the jumper JR1 is on the check position the trimmer RV1 allows
the factory adjustment of the circuit. When the jumper JR1 is in the reading position
the signal SROT1 – SROT2 is amplified and outputs as TROT, which is sent to the
Acquisition & Sensor Board (Board # 3).
The Slave Board through the Acquisition & Sensors Board acquires the temperature
of the Rotor Holder, and controls the PARALLEL I/O U4 that sends the enable signal
INCOIL to the EPLD U6. The EPLD U6 controls the thermoregulation circuit, which
provides the signal Z1 – FOTGND to the heating coil of the Rotor Holder. The circuit
that provides the power is also composed of:
The PACKET DELAY CIRCUIT U26A – U21 output signal TASTD, which controls
the timing of the sinusoidal wave signals packet.
The PHASE DISPLACEMENT CIRCUIT U22 output the signal COMROT that, with
the SWITCH CIRCUIT U19, controls the phase of the sinusoidal wave signal
generated by the OSCILLATOR CIRCUIT U23.
The IMPULSE GENERATOR U24 generate the signal that triggers the POWER
CIRCUIT Q11 that activates the LC oscillator circuit providing heating to the rotor
holder. The trimmer RV2 is factory set to obtain the most suitable time shift to the
power signal and avoid overcurrent which may damage the POWER CIRCUIT Q11.
3.3.9.e Transport & Rotors Feed Stack Section (See figure 3.3.9 Drawing 6)
The thermistor located inside the Transport Plate sends the signal SSLITTA to the
Photometric & Temperatures Control Board.
This signal is amplified and outputs as TFSLITTA to the Acquisition & Sensor Board
(Board # 3).
The Slave Board through the Acquisition & Sensors Board acquires the temperature
of the Transport Plate, and controls the PARALLEL I/O U4 that sends the enable
signal INPREH to the SWITCH CIRCUIT U18. This circuit outputs the signal
ONSLITTA to activate the POWER CIRCUIT Q10, which provides the current signal
PSLITTA to the heating pad used to heat the transport plate.
The Transport Plate temperature detection and control is not used on the ACL Elite.
On the ACL Elite a jumper resistor pack is installed to simulate Transport Plate
temperature.
The Switching Power Supply Board, located under the dilutor assembly, provides to
the instrument +5VDGT, +12VDGT, +15VANA, -15VANA, +9VPW, +12VPW,
+70VPW and +6VLAMP.
The Power Entry provides the signal LINE-IN that allows the operation of the
Switching Power Supply. This signal must be in the range from 100-120Vac to 220-
240Vac (50-60 Hz).
The “Switching Power Supply Board General Block Diagram” is available in figure
3.3.10 Drawing 1 of the chapter 10 “Drawings”. The main functions reported in the
following outline are further expanded and presented on specific paragraphs.
Switching Power Supply Board General Block Diagram (see paragraph 3.3.10.a)
• Line filter.
• Automatic identification of the line voltage.
• Control & Protection stage for all the generators.
• Sends the ready signal to the system.
• Control the turn off of the power voltages.
• Chromogenic Lamp drives circuit.
• Communicate warning status to the system.
3.3.10.a Switching Power Supply Board General Block Diagram (See figure
3.3.10 Drawing 1)
• Line filter.
The Switching Power Supply Board has a LINE FILTER integrated on board.
The Board through the POWER FACTOR CORRECTION BOARD PCB1 identifies
the line voltage connected to the instrument, and sets the Switching Power Supply
Board as appropriate. The line voltage acceptable for the Switching Power Supply
Board are100-120Vac to 220-240Vac (50-60 Hz).
At the instrument turn on, the POWER CONTROL BOARD PCB2 controls all the dc
voltage outputs, when all of them are stabilized, sends the signal INIT to the Slave
Board (Board # 2).
When the POWER CONTROL BOARD PCB2 receives the signal POWEROFF from
the Acquisition & Sensors Board (Board # 3), it disables the power voltages
GENERATOR +9VPW, +12VPW and +70VPW.
When the POWER CONTROL BOARD PCB2 receive the signal LAMPWR from the
Acquisition & Sensors Board (Board # 3), enables the GENERATOR +6VLAMP that
turns on the Chromogenic Lamp.
The POWER CONTROL BOARD PCB2 sends three warning signals to the system in
case of malfunction, which are detected as follows:
The signal POWERFAIL is sent to the Slave Board (Board # 2) if the output voltages
are lower than the 80% of the normal value, or in any case before that the Switching
Power Supply is turned off.
The signal THERFAIL is sent to the Acquisition & Sensors Board (Board # 3) if the
environment temperature is over 60 C°. If this temperature rises up to read 75 C°, the
Board sets to “Protection Mode” and turns off the instrument.
The signal MISSLAMP is sent to the Acquisition & Sensors Board (Board # 3) if a
Short Circuit or a no load is detected on the GENERATOR +6VLAMP.
This sub-section provides information about the Instrument Ground System, in order
to help the service engineer in the assembling of the circuit placed in whole the
Instrument.
The diagram of the “Instrument Ground Circuit” is available in figure 3.3.11 Drawing
1 of the chapter 10 “Drawings”.
The interface board provides serial and USB connections to peripheral devices such
as printer, mouse, keyboard and barcode scanner as well as communication to a host
system. A parallel printer port is also supported. The Interface Board connects to the
Pentium CPU.
NOTE: If the USB ports detect an overload the USB Hub disables that port or. To re-
enable the USB ports the instrument must be re-booted. The interface board is also
protected by 2 onboard fuses.
The figure below highlights some of the main hardware components of the ACL
Elite/Elitepro as viewed from the front of the instrument, while the main electronic
boards and system interconnection ports are located on the rear of the system.
At the turn on the instrument shows the CPU Master Board (Board #1) BIOS boot
screen with the CPU Master initialization.
Then the system loads the operating system and the application program from the
Hard Disk Drive and performs the initialization of both the electronic boards and the
modules.
The Hard Disk Drive stores all the software of the instrument, both the application
program (Analytical and Service programs) and backup files of the software working
on the Slave Board (Board #2) and R.E.M. Board (Board #4).
These two specific softwares are stored in the memories located onboard the Slave
Board and the R.E.M. Board where are located two slave microprocessors.
The two microprocessors load the software directly from the memories (Flash Eprom)
at the instrument turn on.
In order to load a new software revison in the instrument or download the software
from the Hard Disk Drive to the boards memories, the software upgrade procedure
has to be performed as described in the sub-section 7.16.
Chapter 4
Parts Replacement
This chapter of the manual contains general descriptions about the operations required
to replace the main assemblies as well as the electronic boards and the covers present
on the ACL Elite/ElitePro system.
Following are the specific sections.
Caution: Prior to any part replacement insure that the unit is turned off
and power cord disconnected.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
The Autosampler Movement Assy P/N 181108-30 includes the following spare parts:
- 1 Dual Channel Optical Switch flat (fixed with 2 screws) P/N 182356-80
- 1 Autosampler Internal Ring Sensor (fixed with 1 strap) P/N 84869-38
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
The Peltier 1 Assembly is located under the Fluidic Plate and is connected to the
system through the Module Interconnection Board.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Remove the connectors P121, P122, P123, P124, P126 and the 2 ground
cables (see “Instrument Ground Circuit” figure 3.3.11 Drawing 1 of the
chapter 10 “Drawings”).
2 Remove the 3 screws that secure the Peltier 1 Assembly.
3 Remove the Peltier 1 Assembly.
The Peltier 1 Assy P/N 181108-34 includes the following spare parts:
- 1 Peltier Temperature Sensor (fixed with 2 screws and 1 strap) P/N 181021-28
- 4 Stirrer Motors (removable after removed the black dissipater, which is fixed
with 3 screws located under the black dissipater) P/N 82433-10
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Follow in the opposite direction the “Procedure to Remove the Peltier 1 Assy”
paying attention to the location of the cables on the rear of the assembly.
2 Verify with a Magnetic Stirrer Bar the functionality of the 4 Stirrer Motors.
3 Verify that the Peltier 1 thermoregulation system works correctly as described
in the sub-section 7.14.
NOTE: It is necessary to remove the Sample Arm Movement Assembly to gain access
to the Peltier 2 Assembly for removal. To remove the Sample Arm Movement
Assembly refer to Section 4.1.3.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1. Follow in the opposite direction the “Procedure to Remove the Peltier 2 Assy”
paying attention to the location of the cables on the rear of the assembly.
2. Replace the Sample Arm Movement Assembly. (Refer to section 4.1.3).
3. Perform all Sample Arm Movement and Sample Arm Assembly alignments as
described in sections 7.6.3, 7.6.4, 7.7.1, and 7.7.4.
4. Verify that the Peltier 1 thermoregulation system works correctly as described in
the sub-section 7.14.
The Sample Arm Assembly is composed of an upper support called Sample Arm and
a lower assembly, located under the Fluidic Plate, called the Sample Arm Movement
Assy. The whole assembly is connected to the system through the Module
Interconnection Board.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Loosen the knob, located on the rear of the Sample Arm, which fixes the
Needles Block.
2 Remove the Needles Block and then remove its connector for the liquid
sensor.
3 Remove the upper cover of the Sample Arm fixed with a screw.
4 Remove the Liquid Level Detection Cable from the Needles & Wash-R
Interconnection Board.
5 Loosen the 3 setscrews located at 120° on the aluminium support.
6 Remove the Sample Arm.
The Sample Arm P/N 181108-95 includes the following spare parts:
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
The Sample Arm Movement Assy P/N 190856-06 includes the following spare parts:
- 2 Dual Channel Optical Switch flat (fixed with 2 screws) P/N 182356-80
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Follow in the opposite direction the “Procedure to Remove the Sample Arm”.
2 Follow the procedure for the module centering of this assembly as described in
the sub-section 7.7.1. and also the procedure to fine adjust the Needles Block
Assy position as described in the sub-section 7.7.4.
3 Perform the Liquid Level Sensor test as described in the sub-section 7.4.
The Rotor Holder Movement Assy is located under the Fluidic Plate. The Rotor
Holder Movement Assy is connected to the system through the Photometer Interface
Board.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
The Rotor Holder Movement Assy P/N 181108-50 includes the following spare parts:
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Follow in the opposite direction the “Procedure to Remove the Rotor Holder
Movement Assy”.
2 Perform the Motor Adjustment test for the Rotor Motor as described in the
sub-section 7.6.1.
3 Follow the procedure for the module centering of the Rotor Holder as
described in the sub-section 7.7.3.
4 Verify that the thermoregulation system for the Rotor Holder works correctly
as described in the sub-section 7.14.
5 Perform the tests for both the Coagulimetric and the Chromogenic Channels as
described in sections 7.2 and 7.3.
The Rotor Arm Assembly is composed of an upper support called Rotor Arm and by a
lower assembly, located under the R.E.M. and a common support under the Fluidic
Plate, called Rotor Arm Movement Assy. The whole assembly is connected to the
system through the R.E.M. Upper and Lower Interconnection Board.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
The Rotor Arm P/N 181108-55 includes the following spare parts:
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Remove the connectors P104, P105, P107, P108 and the ground cable (see
“Instrument Ground Circuit” figure 3.3.11 Drawing 1 of the chapter 10
“Drawings”).
2 Remove the Rotor Exchange Module Assy (Basic) as described in this sub-
section at the paragraph 4.1.5.d.
3 Remove the 3 nuts that fix the Rotor Arm Movement Assy.
4 Remove the Rotor Arm Movement Assy.
The Rotor Arm Movement Assy P/N 181108-54 includes the following spare parts:
- 2 Dual Channel Optical Switch flat (fixed with 2 screws) P/N 182356-80
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Follow in the opposite direction the “Procedure to remove the Rotor Arm
Movement Assy”.
2 Perform the Motor Adjustment tests for the Rotor Arm Horizontal and
Vertical Motor as described in the sub-sections 7.6.8 and 7.6.9.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Follow in the opposite direction the “Procedure to Remove the Rotor Arm”.
2 Follow the module centering procedure to align the Rotor Arm at the Rotor
Transport as described in the sub-section 7.7.6.
3 Follow the module centering procedure to align the R.E.M. at the Rotor
Holder as described in the sub-section 7.7.7.
The Rotor Transport Assembly is composed of a black upper support (like a Rotor
Holder) called Rotor Transport and by a mechanical movement (moved by the
Transport Motor) incorporated in the R.E.M. Assy (Basic) located under the Fluidic
Plate. The whole assembly is connected to the system through the R.E.M. Lower
Interconnection Board.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
The Rotor Stack Assy is located on the right side of the R.E.M. The whole assembly
is connected to the system through the R.E.M. Upper Interconnection Board.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Remove the connectors P113, P114, P116, P117, P118, P119 and the ground
cable (see “Instrument Ground Circuit” figure 3.3.11 Drawing 1 of the chapter
10 “Drawings”).
2 Remove the 3 screws, located under the common support, which fix the Rotor
Stack Assembly (see “Rotor Exchange Module Replacement” figure 4.1.5
Drawing 1 of the chapter 10 “Drawings”).
3 Remove the Rotor Stack Assy.
The Rotor Stack Assy P/N 181108-94 includes the following spare parts:
1 Follow in the opposite direction the “Procedure to Remove the Rotor Stack
Assy”.
2 Verify that the thermoregulation system for the Rotor Stack works correctly as
described in the section 7.14.
3 Follow the module centering procedure to align the Rotor Stack and the Rotor
Transport as described in the sub-section 7.7.5.
4 Perform the Optic Sensor test for the Rotor Stack as described in the sub-
section 7.5.1.
5 Verify that the Rotor Stack Cover Sensor works correctly as described in the
sub-section 7.9.2.
6 Perform the RA – SL – RH test as described in the sub-section 7.7.9 to verify
the proper rotors movements inside the Rotor Stack.
The Rotor Exchange Module Assy (Basic) is an assembly that incorporates the black
R.E.M. Common Support plate, the Rotor Transport mechanical movement and the
Transport Motor.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
The Rotor Exchange Module Assy (Basic) P/N 181108-53 includes the following
spare parts:
- 1 Dual Channel Optical Switch flat (fixed with 2 screws) P/N 182356-80
- 1 Rotor Transport Motor (fixed with 4 screws) P/N 82433-00
- 1 Optical Sensor Rotor Waste Full (fixed with 4 screws) P/N 84869-47
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Secure with the 3 nuts the Rotor Arm Movement Assy in place.
2 Put the whole REM Common Support under the tilted Instrument (See the
“REM Common Support Position 1” in the drawing “R.E.M. Replacement”
available in the figure 4.1.5 drawing 1 of the chapter 10 “Drawings”).
3 Following the arrows lift the right side of the REM Common Support, paying
attention to center the 3 Rotor Stack fixing point holes in the Fluidic Plate
(See the “REM Common Support Position 2” in the drawing “R.E.M.
Note: It’s required to perform the relevant check out procedures for all the other
assemblies that had been removed.
The Rotor Cover Assembly is composed of an upper cover called Rotor Cover, by a
mechanical support called Arm with Pulley and by an assembly, located under the
Fluidic Plate, called Rotor Cover Movement Assy. The whole assembly is connected
to the system through the Photometer Interface Board.
Rotor Cover
Movement Assy
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Remove the 3 screws, located on the lower black side, which fix the upper
white support.
2 Remove the 2 screws, located on the metallic mechanical arm, which fix the
black lower support.
3 Remove the Chromogenic Coaxial Cable.
The Rotor Cover P/N 181108-46 includes the following spare parts:
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Follow in the opposite direction the “Procedure to Remove the Rotor Cover”
paying attention to the clearance of the optic parts.
2 Perform the tests for the Chromogenic Channel as described in the sub section
7.3.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Follow in the opposite direction the “Procedure to Remove the Arm with
Pulley”, paying attention to secure the Chromogenic Coaxial Cable in a proper
position to prevent damage during the Arm with Pulley movement.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
The Rotor Cover Movement Assy P/N 181108-47 (Elite) and P/N 181106-48
(ElitePro)-includes the following spare part:
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Assemble the Rotor Cover Movement Assy (without tightening the 3 screws).
2 Lift the Rotor Cover Movement Assy and, with the Encoder at the top, insert
the Rotor Cover Belt on the Rotor Cover Motor pulley.
3 Using the Rotor Cover Centering Tool in the niche between the support and
the assembly, push down the Rotor Cover Movement Assy until the Rotor
Cover Belt reaches the proper tension (take as example the tension of the other
belts on the assemblies in the instrument). In this condition tighten the 3
screws paying attention to the horizontal positioning of the assembly.
4 Loosen the 2 setscrews that fix the Encoder to the motor shaft, rotate the
Encoder until it is in the middle of the Dual Channel Optical Switch sensor.
5 Lower the Encoder until its upper side is horizontal and about 1 mm above the
upper side of the Dual Channel Optical Switch sensor then tighten the 2
setscrews.
Dual Channel
Optical Switch
Note: If available use the Rotor Cover Encoder Centering Tool P/N 190575-00.
6 Assemble and fix with 2 knobs the bulkhead located inside the rear of the Card
Housing.
7 Insert and connect the 5 Boards in the Card Housing.
8 Assemble the Rotor Holder Movement Assy as described in the sub-section
4.1.4.
9 Connect P143, P144 and the ground (see “Instrument Ground Circuit” figure
3.3.11 Drawing 1 of the chapter 10 “Drawings”).
10 Assemble the Halogen Lamp Assy as described in the sub-section 4.1.7.
11 Perform the Motor Adjustment test for the Rotor Cover Motor as described in
the sub-section 7.6.2.
The Halogen Lamp Assy is located under the Fluidic Plate. The Halogen Lamp
Socket is powered directly through the Switching Power Supply Board.
It is possible, without removing the Front Cover, to change the Halogen Lamp Socket
Assy through the Rotor Waste compartment.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
- 1 Halogen Lamp Socket (fixed with 1 knob and 1 screw) P/N 181021-81
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Follow in the opposite direction the “Procedure to Remove the Halogen Lamp
Assy” paying attention not to damage the Optical Collimator Assy when
tightening the setscrew.
2 Perform the “Chromogenic Channel check out & adjustment” test as described
in the sub-section 7.3.1.
The Dilutor Assy is located under the rectangular Transparent Cover behind the
Sample Tray. The Dilutor Assy is connected to the system through the Module
Interconnection Board.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Remove the connectors P81, P82, P83, P84, P85, P86 and the ground cable
(see “Instrument Ground Circuit” figure 3.3.11 Drawing 1 of the chapter 10
“Drawings”).
2 Remove the fluidic tube that connects the Wash-R Emulsion Bottle to the T
Connector.
3 Remove the 2 fluidic tubes that connect the 2 Dilutor Electro-Valves to the
Needles Block.
4 Remove the 3 screws that fix the Dilutor Assy.
5 Remove the Dilutor Assy.
The Dilutor Assy P/N 181108-58 includes the following spare part:
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Follow in the opposite direction the “Procedure to Remove the Dilutor Assy”.
2 Perform the Motor Adjustment tests for the Sample/Reagent Motors as
described in the sub-section 7.6.6.
3 Perform the Volume Check and the Dilutor Test as described in “Dilutor
Module” test in the section 7.8.
The Display Assembly is located on a tower support on the right side of the
Instrument. The Display Assembly is connected to the CPU Master Board and to the
PC104 Board through the Display Cable.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1. Disconnect the VGA, Power and Serial Cables from the rear of the monitor.
2. While holding the monitor loosen and remove the black knob. Remove the white
and grey washers.
3. Remove the monitor from the support pole. Remove the metallic washer that sits
between the monitor bracket and the support pole.
clamp
Bracket attached
to monitor
Serial cable
Knob with
washers
underneath Power cable
VGA cable
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
The Hard Disk Drive is located under the CPU Master Board #1 and PC104 Board
support in the middle of the rear side of the Instrument. The Hard Disk Drive is
connected to the CPU Master Board through the HDD data flat cable.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Remove all the cables connected to the CPU Master Board #1 and PC104
Board.
2 Remove the Needles & Wash-R Sensor Interconnection Board support that is
fixed with 2 screws, and remove Video Cable connector bracket.
3 Remove the HDD with the CPU Master Board and the PC104 Board removing
the 2 external screws and loosening the 1 internal screw.
4 Remove the HDD power and data cables connectors.
5 Remove the HDD that is fixed with 4 screws.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Follow in the opposite direction the “Procedure to Remove the Hard Disk
Drive”.
2 Perform the procedures described in the section 7.16 “Software Checking and
Loading”.
Note: In order to completely restore the system status on the new Hard Disk Drive as
before the replacement of the damaged one, it is necessary to perform the following
operations.
- Format and partition the new hard disk drive as described in sub-section
7.16.6.
- Perform Software Installation procedure as described in section 7.16.5
- Perform the Upgrade procedure for the IL Library described in the sub-section
7.16.4.
- Perform the Restore procedure of the last Backup of the system configuration
available described in the sub-section 7.16.3.
The ACL Elite Rotor Preheater Assy is located on the right side of the instrument.
The assembly is connected to the system through the R.E.M. Upper Interconnection
Board by connector P117 and the REM Lower Interconnection Board by connector
P111. Three screws mount the Rotor Preheater assembly to the instrument.
Precaution
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
1 Remove the connectors P111 (Lower Interconnection board) and P117 (Upper
Interconnection Board)
2 Remove the 3 screws, located under the common support, which fix the Rotor
Preheater Assembly.
3 Remove the Rotor Preheater Assy.
Make sure that the Instrument has been switched OFF prior to going through the
following procedure.
The table is according with the drawing “Instrument Covers” reported in the figure
4.2 Drawing 1 of the chapter 10 “Drawings”.
Chapter 5
Installation & Maintenance
This section provides information related to the instrument installation, as
recommendation for the unpacking and the various set-up procedures necessary to put
the system in working condition, as well as operator maintenance procedures.
Sub-sections detailing instrument cleaning and decontamination procedures, plus shut
down and shipment precautions complete this section.
5.1 Installation
5.2 Maintenance
5.3 Shut down & Shipment precautions
WARNING !
BIOLOGICAL HAZARDS EXIST. Avoid touching, with bare hands, any parts
of the system which may have come in contact with potentially infectious fluids.
ALWAYS wear gloves when performing any type of Maintenance/Service action
on this area.
Warning: Do not access the sample or reagent area while the probe arm is
operating.
As a reminder for the technical personnel, the above warning is also directly shown in
those sub-sections describing the maintenance / cleaning actions on the fluidic lines of
the instrument.
5.1 Installation
This sub-section contains all the information necessary to install, set-up and place in
working condition the ACL Elite/ElitePro system.
Before attempting the installation of the ACL Elite/ElitePro 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.
In addition ensure that the Coagulimetric Optic Test Kit P/N 97580-50 and the
Chromogenic Optic Test Kit P/N 97579-50 together with the Temperature Probe P/N
70954-00 are available.
Following are the specific sub-sections.
Following are the specific paragraphs with the required condition to install the ACL
Elite/ElitePro system.
• Ambient condition
• Space requirements
• Electrical requirements
• Ambient Condition
• Space requirements
Following are the external dimensions and the weight of the ACL Elite/ElitePro
analyzer.
The heat generated by the instrument during normal operation is exhausted from the
bottom, in the front-right and left side of the unit.
Sufficient space must be allowed around the instrument to permit circulation of air for
cooling.
The instrument must be positioned so that a waste tube can be easily connected on its
left side.
If the operator wishes to work from a sitting position in front of the system, leg-space
should be provided under the front of the instrument.
• Electrical requirements
Voltage
The instrument has been designed to operate correctly with variations of ± 10% on the
nominal line voltage and with line frequencies between 50-60 Hz.
The instrument has a power supply that can operate from 100 to 240 VAC and it
automatically switches to the line voltage required.
Warning:
Check that the nominal line voltage in the laboratory is compatible with the label on
the rear of the instrument as shown in the table below.
Power Consumption
Check that the line is capable of supplying 350 VA.
Note: The average power consumption is about 350 VA, but peak loads or current
surges may exceed this value when turning the instrument on and during the
temperature warm-up.
Line Frequency
The instrument will function at any frequency between 50-60 Hz.
The power cord provided with the system is specifically designed for it and should
not be substituted.
The cord plugs into the Power Entry socket as shown in the figure below.
The Power Entry module includes the ON/OFF switch.
Fuse
The fuses are enclosed in the compartment to the right of the Power Entry socket.
Fuses have to meet the specification 6.3 A – 250 V. Instruments at 100 – 240vac
utilize 2 fuses rated at 6.3 amps.
Caution: Prior to accessing the fuse holder to install / replace fuses insure the
unit is powered off and the power cord disconnected. Only use fuses rated for
the specified current and voltage.
Interface ports
The instrument is provided with several connectors, located on the rear, which are
associated with relevant devices.
NOTE: If the USB ports detect an overload situation the USB ports are disabled. To
re-enable the USB ports the Elite/ElitePro instrument must be powered off and re-
booted.
Following are the connectors and the relevant devices.
Parallel Keyboard
USB Ports (4) Ethernet
Host Serial Printer
Mouse
Before unpacking the boxes containing the ACL Elite/ElitePro and accessories,
visually inspect them to verify that there has been no damage done during shipping
and handling.
In case of damage notify the carrier and your IL Representative immediately.
Remove the box containing the rotors and the Start-up kit. Using the Start-up kit list
included in the box, confirm that all the components are present.
Remove the instrument and place it on the working surface.
Remove the adhesive tape used for transport from the various parts.
Note: Two people should lift the instrument using the space below the
unit at the front and at the back as shown on the figure below.
This sub-section provides information about the parts that have to be mounted on the
Instrument before switching it on.
Mount the Barcode Reader bracket onto the rear of the LCD Monitor as follows:
1. Remove the monitor mounting bracket (may be white or black) from the rear
of the monitor (4 screws).
2. Place the barcode reader bracket p/n 282104-00 onto the back of the monitor
followed by the original monitor mounting bracket. Secure both brackets to
the monitor using the 4 screws previously removed.
Monitor bracket (may be black or
Bracket Bracket mounting
white)
mounting screws 4 places
screws 4 places
LCD Monitor
The ACL Elite/ElitePro LCD Monitor must be installed on the instrument during the
installation process. Mount the LCD Monitor as follows.
clamp
Bracket attached
to monitor
Serial cable
Knob with
washers
underneath Power cable
VGA cable
1. Remove cables from plastic bag on support pole and monitor from packaging.
2. Remove clamping knob, white washer, gray washer, and metallic washer from
the monitor support pole.
3. Mount flat metallic washer onto support pole.
4. Mount bracket attached with monitor onto support pole.
5. Mount gray washer so that the outer diameter is touching the surface of the
bracket and the inner diameter raised, then the white washer.
6. Mount clamping knob onto support pole. Tighten securely.
7. Remove clamp from the back of the monitor by loosening screw.
8. Insert the power cable into the clamp. The distance between the clamp and the
end of the power cable connector should be 6 inches. Insert power connector
into receptacle at the base of the monitor. Make sure the orientation of the
power cable is similar to what is shown in the picture above.
9. Mount the clamp to the back of the monitor using screw, split washer, and flat
washer provided. See picture above for location.
10. Connect the serial and VGA cables to the monitor.
Waste tube
Connect the waste tube to the fitting on the bottom left hand side of the Instrument.
Cut the tube to suitable length to fit into the waste container which must be situated
below the instrument waste outlet port, as shown in the figures below.
Note: The horizontal section of the tube should be kept as short as possible and the
free end should not be immersed in the liquid waste container.
CAUTION !
In the figure below are reported the Waste tube connection and waste container proper
position.
Place 4 magnetic stirrers inside the reagent vials in reagent positions R1 to R4.
Different vial adaptors are used for the additional positions on the Sample Tray.
In the figure below are reported the Reagent Adaptors for the Sample Tray A1-A10
positions.
Verify that the two fluidic tubes from the Electro-Valve in the Dilutor Assy to the
Needles Block are tightly connected.
Note: The tube from the left hand Electro-Valve fits into the lower position on the
Needles Block (internal Needle, Reagent). The tube from the right hand Electro-Valve
fits into the upper position on the Needles Block (external needle, Sample).
Mouse
Connect the Serial Mouse or USB Mouse to the appropriate port on the rear panel.
Before turning the Instrument on, check that the line voltage setting of the laboratory
is in accordance with the Instrument label.
Switch the instrument on using the Power Switch on the Power Entry.
The system initializes the instrument with a series of electronics and mechanics self-
checks. During this initialization check that the Sample Arm, the Rotor Arm and the
Rotor Cover may be free to move without obstruction.
Following are some of the messages displayed during the System Init phase.
The Init System phase continues with a progress bar in a window where the following
is displayed.
When the progress bar is full and all the sequence of self-checks is ended, then the
Login window appears.
Touch Utility on the Main Menu Bar then the Software and the Software
Identification option. Check that in the SW Identification screen all the software is at
the lastest revision. The last software revision is also present in the Instrument Start
Up Kit.
Note: Any temperature and liquid level sensors warning may be present. In this case
the yellow Warning button on the Tool Bar is active.
Touch Setup on the Main Menu Bar then the Date/Time option. Choose the date
format and set the current date and time. Press “√” to accept.
Mounting (if needed) the Needles Block and then perform/verify the Needle Position
procedure as described in the sub-section 7.7.4.
Select Diagnostic from the Main Menu Bar and click the Priming option.
The following Priming screen is displayed during the priming cycle:
During the Priming cycle insure that the air bubbles in the dilutor chambers are
removed. If necessary, pinch the chamber outlet tubes while the piston is descending
and release them before the piston reaches bottom dead point. Repeat the Priming
cycle several times if necessary.
If in the end of the Priming the message “SENSOR FAIL” in the Warning area is
displayed, the priming cycle must be repeated.
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 Wash/Rinse Reservoir to the instrument
outlet and then to the liquid waste container is not impaired.
Check the Air Cooling System. Verify that the 2 Instrument Fans in the right hand
side of the instrument are operating properly as also the 2 Secondary Fans on the left
hand side. Locate the ventilation filter slider on the right side of the instrument and
verify also that the filter is clean.
Before checking the Temperatures wait until all the start up temperature warnings
have disappeared, then enter Diagnostic on the Main Menu Bar and select the
Temperature Control option, which will open the Temperature Control screen.
Rotor Holder 38 to 39 °C
Peltier 10 to 16 °C
Rotor Transport (ACL ElitePro) 34 to 40 °C
Rotor Stack (ACL ElitePro) 34 to 40 °C
Rotor Preheater (ACL Elite) 34 to 40 °C
The purpose of this sub-section is to verify that all the main Setup options have been
already set or otherwise to help the customer to make setup selections.
Select Setup from the Main Menu Bar then set the following options.
System Configuration
Patient Database listing
QC Database listing
Reflex Status
Current Language
Sample Tray type
Sensor Enable
HW Enable
Date / Time
Unit
The following test, which we recommend be carried out at the installation, check the
precision and the linearity of the two Optic Channels as well as the precision and the
accuracy of the dilutors.
Perform a Priming cycle then check the Optic Channel precision and accuracy as
described in the sub-sections 7.2.2 (for Coagulimetric) and 7.3.2 (for Chromogenic).
Perform a Priming cycle then check the Dilutors precision as described in the sub-
section 7.8.1 (for Coagulimetric and Chromogenic Channel).
Perform a Priming cycle then carry out the PT-FIB calibration cycle as described in
the Operator’s Manual.
The following Installation Checklist should be used as a guide when installing the
ACL Elite/ElitePro instrument.
5.1.7.1 Initialization
5.1.7.2 Procedure
open position. Verify on the LCD display that there is a minimum of two (2)
and a maximum of five (5) minus signs to the right of the home sensor arrow.
Touch HOME POSITION.
Touch NEXT CW POSITION two (2) times and observe that the rotor cover
closes properly.
Touch the check (√) to exit.
▼
+ + + + + + -- -- --
Home Sensor
Place a magnetic stirrer bar in bottle and place the bottle into each reagent
position R1, R2, R3 and R4.
Check that the bar rotates in each position.
Remove bottles from reagent positions.
3. SYSTEM CONFIGURATION CHECK
Material / tools necessary for this check: 1.44 MB Floppy Disk (formatted)
6. INTERFACE CHECK
Materials / tools necessary: RS 232 Test Connector P/N 199992-01
Make sure the rotor cover is open (touch ROTOR COVER OPEN icon).
Install the needle adjustment tool into the rotor position.
Touch SERVICE→MOTOR ADJUST→SAMPLE ARM
MOTOR→HORIZONTAL ARM MOTOR.
Touch NEXT COUNTERCLOCKWISE POSITION several times to move
the sample arm over the rotor position.
Touch check (√) to exit. Touch NO.
Place cup adaptor and 0.5 mL cup in the A1 position of the sample tray.
Place 0.5mL cups in position 1 and 2 of the sample tray.
Place sample tray in instrument.
Touch ROTOR COVER and remove the stack cover to gain access. Check
that the three (3) set screws on the Rotor Arm are tightened properly.
Place the magnet disk over the sensor board on the stack and secure with a
piece of tape.
Load a stack of fifteen (15) rotors in the rotor stack. Align the notches in the
top five (5) rotors that are above the stack. Empty the rotor waste container
and place it back in the housing.
Touch SERVICE→MODULE POSITIONING→RA-SL-RH TEST.
The instrument initializes the motors of the R.E.M., the rotor holder and the
rotor cover.
Once initialization is completed, the system starts loading / unloading until the
stack of rotors is exhausted.
Check visually that all the rotors in the stack are loaded and removed from the
rotor position. The pliers should secure the rotor around the top of the rotor
when the rotors are being transferred. A message should appear that the waste
container is full. Open the door and remove rotors from container. Reinstall
the waste container and the system should start to load and unload rotors.
Check the bar codes by moving the horizontal scroll bar to the right. Check
that each bar code reported is the same as the bar code in that sample tray
position.
Sample Tray
Remove reference bottle from instrument and place the bottle with 500 mL of
reference solution in its place.
Touch SERVICE→SENSOR TEST→WASH-R EMULSION VOL.
Check that the R-Emulsion value is 500 mL +/- 150 mL.
( adjust RV9, Acquisition & Sensors Board if necessary)
Dispense 150 microliters of reference solution in a 0.5 mL sample cup and
place the cup in position 1 of the Sample Tray.
Dispense 1500 microliters of reference solution in a 4.0 mL bottle and place
the bottle in the R1 position.
Touch SERVICE→SENSOR→NEEDLES SENSOR TEST.
Touch START.
Check expected values: Position 1 liquid value must be ≥ 3.9 volts. ( adj
RV12, Acq & Sen Bd if necessary). Position R1 liquid value must be ≥ 3.5
volts. ( adj RV11, Acq & Sen Bd if necessary)
Touch DOOR EXIT (located in lower right corner, shown with door open and
arrow going out).
Touch CALIBRATION→CALIBRATE.
Touch START. Wait for cycle to complete (arm will stop).
Touch DIAGNOSTIC→TEMPERATURE CONTROL.
Check that the four (4) temperature values are within specification shown on
the LCD Display.
Offset Check
Touch ROTOR COVER (icon that shows cover open) to open the chamber.
Rotate the rotor holder in the analysis compartment to block the LED light’s
optic pathway. Touch ROTOR COVER (icon that shows cover open) to close
rotor cover.
Touch SERVICE→A / D CONVERTER TESTS.
Check that the coagulimetric and the chromogenic channels’ average voltages
are within the specification range of 0.002 to 0.015 volts. (NOTE:
Occasional spikes above this value are allowed.)
Coagulimetric channel: ( Adjust RV 1 Acquisition & Sensors Board if
necessary).
Chromogenic channel: ( Adjust RV 4 Acquisition & Sensors Board if
necessary)
NOTE: It is important to watch the voltage reading for one (1) minute and
observe that the voltage occasionally fluctuates slightly above 0.000.
Curves Check
NOTE: Dispensed volume, temperature, and time are critical to the results of
this test.
Touch SERVICE→OPTICAL MODULE TEST→CURVE ADJUST
(coagulimetric rotation speed set @ 1200 rpm).
Check that the SELECT DELAY (μs) is the same as the value on the
instrument label next to Coag. “1200 DELAY.” (The label is located on the
drawer under the top right hand corner of the keyboard.)
Check that the delay to left of the 1000 value is the same as the SELECT
DELAY value on the LCD display (and the label).
Touch the arrow below SELECT CHANNEL. Touch CHROMOGENIC.
Touch the arrow below SELECT CHANNEL again.
Touch START.
Check the delay to the left of the 1000 value.
Check that the delay to the left of the 1000 value is the same as the SELECT
DELAY value on the instrument label next to Chrom. “1200 DELAY.”
Check that the maximum delay delta (i.e., absolute value of the difference)
between coagulimetric and chromogenic values (@ 1200 rpm) on the
Checklist is ≤ 90.
Volume Check
Note: Use caution in removing the tubes not to disturb the needles
adjustment
Disconnect the capillary from the sample tube and reinstall the tube on the top
of the sample arm. Remove the bottom tube from the sample arm and connect
the capillary to the tube. Hold the tube over the empty 8.0 mL bottle.
If the liquid consistently sets above or below the two lines, a correction is
required. The correction can be entered in the window SELECT
CORRECTION VALUE. First attempt decrementing (or incrementing) the
correction value by 1 unit. The allowable range is –8 to +8. Repeat the test to
ensure that the entered value achieves proper volume dispensing. NOTE: If a
value has changed with respect to the original setting, it is necessary to change
the label when all related tests are completed.
Touch check (√) to replace value and exit.
Disconnect the capillary from the reagent tube and reinstall the tube on the
bottom of the sample arm.
Touch check (√) to exit.
Coagulimetric Check
Note: Use caution in removing the tubes not to disturb the needles
adjustment. Use tubing removal tool to invert the sample and reference
tubes on the sample arm. (Sample tube onto reference and reference
tube onto sample.)
Place deionized water in 4.0 mL bottle and place bottle in position R4. Place
the instrument’s reference solution in a 4.0 mL bottle and place in position R1.
Touch ROTOR COVER icon to open rotor cover. Install a new rotor in
chamber.
Touch ROTOR COVER icon to close rotor cover.
Touch SERVICE→DILUTOR TESTS→DILUTOR TEST.
Touch START MANUAL ROTOR LOADING. Wait for instrument to
complete test.
Check that when the test is completed there are no red values displayed.
If there are red values, repeat the test with a new rotor. If instrument fails
again (red values at the end of the test), corrective action is required. Prime
the dilutors (insure air bubbles are removed from pistons and tubing), check
needle block alignment, repeat dilutor tests volume checks. Repeat the
dilutor test.
Chromogenic Check
Use tubing tool to reinvert sample and reagent tubes on the sample arm.
(Reagent tube on the bottom and sample tube on the top). Remove bottle with
reference solution from position R1 and replace it with PNA 160µmol/l in a
new bottle.
Touch rotor cover icon to open rotor cover.
Replace rotor with a new rotor.
Touch rotor cover icon to close rotor cover.
Touch arrow next to CHANNEL TYPE. Touch the down arrow to choose
CHROMOGENIC.
Touch arrow next to CHANNEL TYPE.
Touch arrow next to LOADING TYPE. Touch the down arrow to choose
REAGENT DILUTOR.
Touch arrow next to LOADING TYPE.
Touch “START IN MANUAL LOADING”
Check that when the test is completed there are no red values displayed,
except for the MEAN value which can be red with the specification of 7.2 to
8.8.
If there are red values (except for the mean), repeat the test with a new rotor.
If instrument fails again (red values at the end of the test), corrective action is
required. Prime the dilutors (insure air bubbles are removed from pistons and
tubing), check needle block alignment, repeat dilutor tests volume checks.
Repeat the dilutor test.
Exit the Service menu by touching the CLOSE DOOR icon, which should
bring you to the “Ready” screen.
Using a fingertip, touch the (vertical) down scroll arrow. The highlighted bar
should move down.
Using a fingertip, touch the (vertical) up scroll arrow. The highlighted bar
should move up.
Perform adjustments as necessary. Set configurations as necessary. Refer to ACL Elite/ElitePro Service Manual.
Check overall instrument appearance. Insure accessory kit is complete.
5.2 Maintenance
In order to keep the ACL Elite/ElitePro analyzer in optimal operating condition it is
recommend that the following procedures be carried out by a trained operator at the
frequency specified.
The Maintenance subsection of the Diagnostic menu allows the user to access and
record dates and notes related to the performance of specific maintenance operations.
If any maintenance action is not performed within the recommended period then the
relevant line will appear in red.
WARNING !
BIOLOGICAL HAZARDS EXIST. Avoid touching, with bare hands, any parts
of the system which may have come in contact with potentially infectious fluids.
ALWAYS wear gloves when performing any type of Maintenance/Service action
on this area.
At the beginning and at the end of each working day perform a Priming cycle to
ensure the complete removal of all sample or reagent residual along the fluidic paths.
While the priming cycle is in progress, the operator should visually inspect three
items:
Note: The instrument has sensors to detect the availability of Wash Reference
Emulsion as well as new and waste rotors. In order to start the working day with the
maximum instrument autonomy it’s advisable to empty the Rotor Waste Container
from used rotors, fill the Rotor Stack with brand new rotors and check the level of the
Wash Reference Emulsion in the bottle.
The weekly preventive maintenance for the ACL Elite/ElitePro consists in cleaning
all the key instrument areas which normally come in contact with sample and reagents
and therefore accumulate residues that will, if allowed to build up, impair the
instrument functionality and affect the tests results. The parts / areas to be cleaned are:
WARNING !
BIOLOGICAL HAZARDS EXIST. Avoid touching, with bare hands, any parts
of the system which may have come in contact with potentially infectious fluids.
ALWAYS wear gloves when performing any type of Maintenance/Service action
on this area.
soaked in a 0.1 N Hydrochloric Acid (HCl) solution (IL Cleaning Solution P/N
98317-00). Rinse using a cloth soaked in distilled water. Wipe dry.
The rotor holder and the optical path components located in the analysis area must be
cleaned every two weeks under normal instrument use.
WARNING !
BIOLOGICAL HAZARDS EXIST. Avoid touching, with bare hands, any parts
of the system which may have come in contact with potentially infectious fluids.
ALWAYS wear gloves when performing any type of Maintenance/Service action
on this area.
Press the “Open/Close Cover” icon to open the Rotor Holder Cover.
Using a cotton tip applicator moistened with distilled water, clean all 20 holes in the
Rotor Holder and the surfaces of the Channels sensors and fibers. Use a clean, dry
cotton tip applicator to remove all moisture from these areas.
Check the filter: if it is dirty or blocked, clean it with compressed air or by washing it
in water and blowing it dry. Do not place a wet filter into its position.
If the filter appears damaged, it should be replaced. Insert the clean or new Air Filter
back in its holder.
The yearly preventive maintenance for the ACL consists of replacing the following
expandable parts.
WARNING !
BIOLOGICAL HAZARDS EXIST. Avoid touching, with bare hands, any parts
of the system which may have come in contact with potentially infectious fluids.
ALWAYS wear gloves when performing any type of Maintenance/Service action
on this area.
WARNING !
BIOLOGICAL HAZARDS EXIST. Avoid touching, with bare hands, any parts
of the system which may have come in contact with potentially infectious fluids.
ALWAYS wear gloves when performing any type of Maintenance/Service action
on this area.
1 Remove the needle from the plastic syringe (if necessary), and fit the PVC
tube on the end on the syringe (the tube’s dimensions must be such that it will
fit onto the syringe on one end and into the waste line at the other end).
2 Fill the syringe with distilled water or 10% bleach.
3 Remove the Rinse / Waste Reservoir and clean it if necessary (refer to Section
5.2.2).
4 Insert the free end of the PVC tube into the waste line, carefully inject the
distilled water or 10% bleach into the waste line and check that the liquid
flows out from the external waste line of the instrument to the waste container.
5 Repeat the procedure several times to ensure removal of any potential
blockage then replace the Rinse / Waste reservoir.
In case of sample / reagent spillage wipe using a clean cloth or cotton tip applicator
soaked in a 0.1N HCl solution (IL Cleaning Solution P/N 98317-00). Follow with
distilled water and dry with a clean cloth or cotton tip applicator.
In case of sample / reagent spillage in the Autosampler or in the Rotor Holder
compartment, it may be required to clean also the 2 sensors in the Autosampler and
the two optical paths in the analysis area (see sub-section 5.2.3).
The procedure to reposition or adjust the Needles Block is necessary after having
dismantled for cleaning, decontamination or changes of the Needles Block.
The procedure is described in sub-section 7.7.4.
This sub-section describes the procedure to decontaminate the ACL Needles Block.
It’s recommended after using the system to test a highly infectious sample and as a
general precaution to prevent and eliminate potential bacterial contamination.
The use of the ACL system for the analysis of known or suspected highly infectious
samples, should be followed by careful disinfecting of the instrument surfaces and
parts which have been in contact with the samples. The disinfecting agent used to
perform the procedure indicated below is a 1:8 dilution of IL Cleaning Agent P/N
98327-00, which is a solution of sodium hypochlorite with a concentration of less
than 0.625% of available chlorine. The 1:8 diluted solution is prepared by mixing 1
part Cleaning Agent with 7 parts of distilled water.
Note!
Use only IL Cleaning Agent (P/N 98327-00) diluted 1:8 with distilled water.
The use of undiluted IL Cleaning Agent may cause corrosion of metal parts.
CAUTION !
Using the Hard Drive Maintenance Diskette part number 000190357-70, perform the
hard drive maintenance as needed. Refer to procedure 000190357-70 included with
the Hard Drive Maintenance Diskette.
Daily At the beginning and at the end of each working day or once per shift,
carry out a priming cycle.
Empty the liquid waste container when needed.
Empty the rotors waste container when needed.
Fill the Rotor Stack with new rotors when needed.
Load a new bottle of Wash – Reference Emulsion when needed.
Weekly Clean the exposed instrument surfaces, inside the Autosampler and
the analysis compartments (with the exception of the Rotor Holder).
Clean the Needles Block carrying out the dedicated cleaning cycle
Clean the Rinse / Waste reservoir
Bi-Weekly Clean the analysis compartment optical parts with a cotton tip
applicator moistened with distilled water:
Clean the LED sensor surface
Clean the LED optic fibre surface
Clean the Halogen Lamp sensor surface
Clean the Halogen Lamp fibre optic surface
Clean the 20 holes of the Rotor Holder
Monthly Check the Air Filter
Yearly Replace the Air Filter
Replace the sample and reagent tubes
Replace the Needles Block
Replace the waste tube
Replace the waste reservoir
As needed Clean the Waste line
Clean the sample spillage
Replace the Needles Block
Position the Needles Block
Decontaminate the Needles Block
Hard Drive Maintenance
For long period of inactivity, more than one week, the following actions should be
carried out.
5.3.2 Shipment
Chapter 6
Troubleshooting
This Chapter is designed to provide the Service Engineer information about the error
messages displayed by the instrument as well as suggestions and tools to fix the problem
during the Instrument Troubleshooting.
The following paragraphs provide information about problems related to the PC like
system present inside the instrument.
Alarm: Slave The CPU Master Following the procedure in the sub-section 7.16.2, make
Absent doesn’t find the the Upload and then the Upgrade of the Slave Software.
Slave. Replace the Slave Board (Board #2).
Alarm: Slave The CPU Master Following the procedure in the sub-section 7.16.2, make
program not doesn’t find the the Upload and then the Upgrade of the Slave Software.
loaded software onboard Replace the Slave Board (Board #2).
of the Slave Bd
Alarm: Flash The CPU Master Following the procedure in the sub-section 7.16.2, make
Memory Error detects a problem the Upload and then the Upgrade of the Slave Software.
on the Flash Replace the Slave Board (Board #2).
Memory on the
Slave Board.
Alarm: Arcnet The Main program Verify the Arcnet interconnection cable.
Connection detects a problem Try also to use the connector CN4 (on the PC104 Board)
Error in the and P7 (on the Slave Board).
communications Replace the Slave Board (Board #2).
with the Slave Replace the PC104 Board.
through Arcnet.
Alarm: A/D
Converter
Error
Alarm: OI
Error
Alarm: Error The Main Program Following the procedure in the sub-section 7.16.2, make
Creating detects a problem the Upload and then the Upgrade of the Master Software.
Window during the creating Replace the CPU Master Board (Board #1).
of a window for the
Operator Interface
graphic program.
Alarm:
Timeout
Expired
Alarm:
Unknown
message
Alarm: Error
sending
message
Alarm: Error The Main Program Following the procedure in the sub-section 7.16.2, make
creating timer detects a problem the Upload and then the Upgrade of the Master Software.
during the creating Replace the CPU Master Board (Board #1).
of a timer.
Alarm: Master The Main Program Following the procedure in the sub-section 7.16.2, make
– Slave detects a problem the Upload and then the Upgrade of the Master Software.
message has in the length of a Replace the CPU Master Board (Board #1).
incorrect message sent from
length the CPU Master to
the Slave.
Alarm: Master The Main Program Following the procedure in the sub-section 7.16.2, make
– Slave detects a problem the Upload and then the Upgrade of the Master Software.
message has in the code of a Replace the CPU Master Board (Board #1).
incorrect code message sent from
the CPU Master to
the Slave.
Alarm: Rotor The Instrument Check for mechanical obstruction during the
Cover Motor detects a problem movement.
Error during the Rotor Check for the plug in of the connectors P144 (for the
Cover Motor motor) and P143 (for DCOS).
movement. Check for the functionality of the Motor and of the
DCOS as described in the sub-section 7.6.2; pay
attention to tension of the Cover movement’ Belt.
Replace the Photometric and Temperatures Control
Board (Board #6).
Replace the Motors Board (Board #5).
Replace the Photometer Interface Board.
Warning: The Instrument Check the presence and the level of the Mandatory
Mandatory detects, during the Liquid “Id” in the Position xxx.
Liquid “Id” loading, a Low Perform any Priming cycles and then check for air
Low Level in Level on the bubbles along the fluidic path.
Position xxx Mandatory Liquid Following the procedure in the sub-section 7.4,
for test yyy “Id” located in the checks for the functionality of the Needles Sensor;
position xxx and pays attention to the correct positioning of the
used for the test Needles Block.
yyy. Replace the Needles Block.
Replace the LLD Board.
Replace the LLD Cable.
Warning: The Instrument Check the presence and the level of the Wash-R
Wash-R detects a Low Emulsion (at least over 100 mL).
Emulsion Low Level on the Wash- Check also the horizontally of the Wash-R
Level R Emulsion. Emulsion’s bottle and for the correct insertion of the
cap sensor.
Following the procedure in the sub-section 7.4.1,
checks for the functionality of the Wash-R Emulsion
Sensor.
Warning: The Instrument Check the presence and the level of the Wash-R
Wash-R detects, during a Emulsion (at least over 100 mL).
Emulsion not analytical cycle, Following the procedure in the sub-section 7.4.1,
absent that the Wash-R checks for the functionality of the Wash-R Emulsion
Emulsion is absent. Sensor.
Replace the Reference Emulsion Sensor.
Replace the Needles & Wash-R Sensor
Interconnection Board.
Replace the Acquisition & Sensors Board (board #3).
Replace the Mother Board
Warning: The Instrument Following the procedure in the sub-section 7.4.2,
Sample sensor detects a problem checks for the functionality of the Needles Sensor.
Error on the Sample Replace the Needles Block.
line’s Liquid Replace the LLD Board.
Sensor. Replace the LLD Cable.
Replace the Needles & Wash-R Sensor
Interconnection Board.
Replace the Acquisition & Sensors Board (board #3).
Replace the Mother Board
Warning: The Instrument Following the procedure in the sub-section 7.4.2,
Reagent sensor detects a problem checks for the functionality of the Needles Sensor.
Error on the Reagent Replace the Needles Block.
line’s Liquid Replace the LLD Board.
Sensor. Replace the LLD Cable.
Replace the Needles & Wash-R Sensor
Interconnection Board.
Replace the Acquisition & Sensors Board (board #3).
Replace the Mother Board
Warning: The Wash-R Solves the problem associated to the Wash-R Sensor,
Wash-R sensor Emulsion Sensor is then enable the sensor in the System Configuration
Off disabled in the menu to restore the normal condition.
System
Configuration
menu’.
Warning: The Sample line’s Solves the problem associated to the Sample Sensor,
Sample sensor Sensor is disabled then enable the sensor in the System Configuration
Off in the System menu to restore the normal condition.
Configuration
menu’.
Warning: The Reagent line’s Solves the problem associated to the Reagent Sensor,
Reagent sensor Sensor is disabled then enable the sensor in the System Configuration
Off in the System menu to restore the normal condition.
Configuration
menu’.
Alarm: Wash- The Instrument Check the presence and the level of the Wash-R
R Emulsion detects, during an Emulsion (at least over 100 mL).
absent analysis, that the Following the procedure in the sub-section 7.4.1,
Wash-R Emulsion checks for the functionality of the Wash-R Emulsion
is absent. Sensor.
The analysis aborts. Replace the Reference Emulsion Sensor.
Replace the Needles & Wash-R Sensor
Interconnection Board.
Replace the Acquisition & Sensors Board (board #3).
Replace the Mother Board
Warning: The Instrument Check that the External Printer is connected and On-
Printer failure detects, before the Line.
document printing, Check in the Interface Setup that the transmission
that the External protocol selected is consistent (ex. ESC/P2).
Printer fails or is Following the procedure in the section 7.13.5, checks
not ready to print. for the functionality of the External Printer.
Replace the Interface Board.
Replace the CPU Master Board.
Warning: The Instrument Check for the presence of the liquids required in the
Cleaning not detects, during the positions R6 and R7.
performed cleaning cycle, that Following the procedure in the sub-section
the cleaning’s 7.4,checks for the functionality of the Needles
liquid is missing in Sensor.
the positions R6 Replace the Needles Block.
and/or R7. Replace the LLD Board.
Replace the LLD Cable.
Replace the Needles & Wash-R Sensor
Interconnection Board.
Replace the Acquisition & Sensors Board (board #3).
Replace the Mother Board.
Warning: The Instrument Check for the functionality of the Rotor Cover
Forced open detects, during Sensor as described in the sub-section 7.9.1; pay
Rotor Cover loading or attention to the correct positioning of the sensor.
incubation, that the Replace the Rotor Cover Sensor.
Rotor Cover is Replace the Acquisition & Sensors Board (Board #3).
open. Replace the Photometric Interface Board.
Warning: The Instrument Check for the functionality of the Rotor Stack Cover
Rotor Stack detects that the Sensor in the Optic Sensor test.
Cover open Rotor Stack Cover Check for the presence of the Magnet.
is open. Replace the Rotor Stack Cover Sensor.
Replace the REM Upper Interface Board.
Replace the REM Board (Board #4).
Warning: The Instrument Check for the presence of the Floppy Disk in the
Floppy Not detects that the Floppy Disk Drive.
Present Floppy Disk is Replace the Floppy Disk Drive.
missing. Replace the Cable of the Floppy Disk Drive.
Replace the CPU Master Board.
Warning: The Instrument Check that the Floppy Disk in the Floppy Disk Drive
Floppy disk detects, during a is not write protect.
write protected writing operation, Replace the Floppy Disk.
that the Floppy Replace the Floppy Disk Drive.
Disk is write Replace the Cable of the Floppy Disk Drive.
protected. Replace the CPU Master Board.
Warning: The Instrument Check that the Floppy Disk in the Floppy Disk Drive
Floppy disk detects, during a is not full.
full writing operation, Replace the Floppy Disk.
that the Floppy Replace the Floppy Disk Drive.
Disk is full. Replace the Cable of the Floppy Disk Drive.
Replace the CPU Master Board.
Warning: During the loading Following the procedure in the sub-section 7.16.2,
Timeout of the analytical make the Upload and then the Upgrade of the Master
expired during cycle the timeout is and of the Slave Software.
loading expired. Replace the Slave Board (Board #2).
This sub-section is not available in this Service Manual release 2. For reference on the
analytical errors consult the proper section of the Operator’s Manual.
Following is the table with the main information about the Service Tools.
Purpose:
This Tool allows the checking of the actual temperature within the rotor analysis area.
Description:
It consists of a precise thermistor fit into a cuvette of an analysis rotor.
The leads of the thermistor are brought to the upper tool surface in order to allow the
measuring of the thermistor resistance (with a DVM) through the two dispensing holes
on the Rotor Cover. The read resistance value allows through a mathematical calculation
written on the label stuck on the tool upper surface, to know the temperature in °C
present inside the analysis rotor. The value must be between 36 –38 °C.
The procedure to use this tool is very easy but it’s important to pay attention to follow all
TEMPERATURE PROBE
P/N 70954-00
the steps.
Purpose:
This kit allows the checking of the performance of the Coagulimetric Channel (see sub-
section 7.2.2).
Description:
The kit contains four different concentration levels of Wash-Reference Emulsion for a
total of 50 ampoules distributed as follows:
13 ampoules of 2
19 ampoules of 1
12 ampoules of 0.5
6 ampoules of 0.25
Purpose:
This kit allows the checking of the performance of the Chromogenic Channel (see sub-
section 7.3.2).
Description:
The kit contains four different concentration levels of a yellow solution
(ParaNitroAniline, PNA) for a total of 50 ampoules distributed as follows:
13 ampoules of 160
19 ampoules of 80
12 ampoules of 40
6 ampoules of 20
Purpose:
This tool allows the checking of the Sample and Reagent Dilutor lines aspiration and
dispensing (see sub-section 7.8.2).
Description:
The kit contains 3 capillaries.
GRADUATED CAPILLARY
Purpose:
These tools can be plugged together on serial line ports (Modem, Mouse and Host
communication ports) present on the rear Instrument Interface Board to allow ports to be
tested through the relevant Service program (see section 7.13).
Description:
Following is the RS 232 C Interface Check Connector drawing in order to make it if it’s
not available.
13 12 11 10 9 8 7 6 5 4 3 2 1
25 24 23 22 21 20 19 18 17 16 15 14
Following is the drawing of a serial customized 9 Pin Check Connector Male (for the Bar
Code Port) or Female (for Host, Mouse and Modem Port) in order to make it if the RS
232 C Interface Check Connector and its Adapter are not available.
TX RX
5 4 3 2 1
9 8 7 6
DTR D SR
C T S RT S
Purpose:
This tool has to be used to carry out the alignment of the Needles Block in respect to the
analysis rotor position (see sub-section 7.7.4).
Description:
The tool is a plastic block that has to be properly snapped on the Rotor Holder with the
“A” face up. The side “A” of the tool has two Reference Points in order to allow the
proper alignment of the Needles Block tips.
Reference Dots
4.3 mm
Purpose:
This tool has to be used to center the Sample Arm Movement Assy in respect to the
Fluidic Plate (see sub-section 7.7.1).
Description:
The tool has a simple cylindrical shape that fits between the Sample Arm Movement
Assy shaft and its Fluidic Plate hole.
13,6 mm 19,6 mm
66 mm
Purpose:
This tool has to be used to center the Rotor Arm in respect to the Rotor Transport (see
sub-section 7.7.6).
Description:
The tool has a simple cylindrical shape that fits between the Rotor Arm central finger and
the Rotor Transport central hole.
9 mm 12 mm
Purpose:
This tool has to be used to center the Needles Block (and the Sample Arm) in respect to
the Needles Waste/Rinse position on the Fluidic Plate (see sub-section 7.7.1).
Description:
The tool has a shape very similar at the normal Waste Adapter with the addition of 2
tubes that fits in the 2 holes for the Needles.
9 mm 12 mm
Purpose:
This tool has to be used to center the Peltier Assy in respect to its holes in the Fluidic
Plate (see sub-section 4.1.2).
Description:
The tools have a simple cylindrical shape that fits into the reagents adaptor holes of the
Peltier.
28,3 mm 29,8 mm
32 mm
Purpose:
This tool has to be used during the Touch Screen Calibration test (see section 7.12).
Description:
The tools have a simple pencil shape with a rounded tip.
Purpose:
This tool has to be used when is needed to put in tension the Belt of the Rotor Cover
Movement Assy before the final fixing with the 3 screws (see sub-section 7.6.2).
Description:
The tool has a simple flat shape that fits into the niche between the Rotor Cover
Movement Assy and the support. This tool assures the horizontal alignment of the Rotor
Cover Movement Assy.
Purpose:
This tool has to be used to center the Encoder Disk position when the Rotor Cover
Movement Assy is replaced (see sub-section 7.6.2).
Description:
The tool has a simple pencil shape with a thread (M3) at the tip that fits into the setscrew
hole.
M3
Purpose:
Rotor Stack Centering Tool is used to align the Rotor Silo to the Transport Plate (Slider).
Description:
Tool has a handle to allow user to place tool into rotor stack. Tool also has notches to
allow tool to pass by calliper arms in rotor stack. The tool has access holes to access
screws on transport (slider) plate.
Purpose:
Tools are placed into sample and reagent positions on the tray and tray alignment to the
sample arm is verified.
Description:
Tools are sized to fit into sample or reagent positions on the tray. Each tool has an
alignment hole to check position with needle block in arm.
Purpose:
After rotor snap is removed from the rotor holder the Rotor Snap Alignment Tool is used
to insure the 2 pins on the rotor holder are straight vertically. Tool is placed over the pins
on the rotor holder to straighten the pins.
Description:
Rotor Snap Alignment Tool is cylinder shaped with two (2) small holes in the bottom of
the lower end. Align small holes with pins on rotor holder where snap mounts and gently
press down on tool to straighten pins.
Purpose:
Simulates rotor holder thermistor resistance if at approximately 37.5C . A defective
heater coil will cause power supply to shut down due to no load or overcurrent condition.
Using this tool the ACL unit can be powered on to allow further troubleshooting.
Description:
If power supply is in shutdown condition, unplug the rotor holder heater cable and install
the rotor holder temperature simulator tool by plugging it into the heater cable connector.
This will simulate a rotor temperature of approximately 37.5 C possibly allowing the
power supply to power up normally and allow the service personel to further troubleshoot
the unit.
* Note: A special flexible version of these two screwdrivers are both available in
the kit “2.5/3 mm Flex Allen Screw Driver” P/N 99208-10
Chapter 7
Checkout & Adjustment
This chapter is designed to allow the Service Engineer to perform a thorough check
out of the whole Instrument.
The Service software incorporates proper utilities for the entire checkout and
adjustment needed.
Following are the specific sections with the check out procedures.
Warning: Do not access sample or reagent area while probe arm is operating.
Note: For Software version 3.0 to access the Service Menu log on with Username:
Service and Password: System Fix
User names and passwords are case sensitive.
Precaution
Make sure that the instrument has been switched ON for at least 20 minutes (warm-up
of light source and thermoregulation) prior to performing the following procedure.
4 Using the Icon on the screen turn off the LED. Lower the analysis compartment
cover then locate the trimmer RV1 (on Board # 3) see figure below.
5 Adjust RV1 to read between 0 and 15 mV on screen. Then touch “√” to exit.
Note: Turn RV1 CCW to increase offset mV or CW to decrease offset mV.
On the windows like menu enter Service then Optical Module Test and Curve
Adjustment. The instrument shows the screen below:
These two tests are designed to verify the overall performance of the Coagulimetric
Channel:
The Coagulimetric Optic Test Kit (P/N 97580-50) is necessary to perform both tests.
The kit consists of 50 vials (2 mL each):
13 vials 2
19 vials 1
12 vials 0.5
6 vials 0.25
Warning: If one of the tests fail then it is necessary to perform all the other check out
tests of this section 7.2.
1 On the windows like menu enter Service then Optical Module Test and Channel
Optic Test.
2 The instrument shows the screen below. Select in sequence Channel type:
Coagulimetric; Test Type: Precision Loading Type: Reagent.
3 Put the content of two vials (4ml) labelled 1 (taken from the kit P/N 97580-50)
into a clean, empty 4 mL reagent vial with a Green adapter.
Note: For this test it is possible to use the Wash-Reference Emulsion in substitution of
the Silicon Emulsion labelled 1.
4 Position the 4 mL reagent vial with the adapter onto the reagent position R1.
5 Load 200µl of Wash-Reference Emulsion in cuvette number 20 of a new rotor
before placing the rotor onto the Rotor Holder in the analysis compartment.
6 Touch “Start in Manual Rotor Loading”. The instrument will load the rotor
cuvettes picking the Silicon Emulsion from the reagent vial using the reagent
probe.
7 Wait for the acquisition cycle then verify the following parameters :
Note: Acquisition cycle only can be repeated selecting Skip Loading from the
“Loading Type” window.
1 On the windows like menu enter Service then Optical Module Test and Channel
Optic Test.
2 The instrument shows the screen below. Select in sequence Channel type:
Coagulimetric; Test Type: Linearity Loading Type: Reagent.
3 Put the content of two vials (4ml), of each level (1, 0.5 and 0.25 from the kit P/N
97580-50) into three clean, empty 4 mL reagent vials with their Green adapters.
4 Position the 4 mL reagent vials with the adapters on the reagent tray as follows:
Note: Acquisition cycle only can be repeated selecting “Skip Loading” from the
“Loading Type” window.
These two tests are designed to verify the overall performance of the Coagulimetric
Channel LED with fiber:
1 On the windows like menu enter Service then Optical Module and Acquisition
Adjustment. The instrument shows the screen below.
5 Touch Start and then turn RV2 fully clockwise until to read as low as possible on
the Coagulimetric Channel line.
6 Check that in the above conditions the value displayed on the screen is higher than
250 mV. If test fails replace the “Coagulimetric Channel LED with fiber” assy
(see next sub-section). If test passes then adjust RV2 to read 2.6 V ± 0.3V on the
screen.
7 Touch Stop and “√” to exit.
If the LED is replaced follow the procedure here below to adjust the amplifier circuit
and the optic fibre.
1 On the windows like menu enter Service then Optical Module and Acquisition
Adjustment. The instrument shows the screen below.
Optic fibre
Loose this
set screw
Sleeve
7 Move the optic fibre upward to obtain the maximum voltage reading on the
Coagulimetric Channel line. After reaching maximum value, move fibre in
opposite direction until the value decreases by 100mV, then tighten the setscrew.
8 Adjust by means of RV2 the reading to 2.600 ± 0.3 V.
9 Touch Stop then “√” to exit.
1 On the windows like menu enter Service then Optical Module and Fibre
Adjustment.
2 Wait for the initialization of the motors then empty the analysis compartment from
any rotor.
3 Touch Start and verify that (without any rotor in place) no “cuvette” reads a value
higher than 70 mV. See screen below:
• Loose the setscrew that holds the Optic Fibre in place on the Rotor Holder side.
• Rotate the Optic Fibre CW or CCW (max. 90°) until a reading lower than 70 mV
is obtained.
• Tighten the setscrew to lock the Optic Fibre back in place (the Optic Fibre must
be placed in the bottom).
The tests that achieve verification of the Chromogenic Optical Channel are:
Precaution
Make sure that the instrument has been switched on for at least 20 minutes (warm-up
of light source and thermoregulation) prior to going through the following procedure:
3 On the windows like menu enter Service then A/D Converter Test. The instrument
displays the screen below.
4 Using the Icon turn off the Halogen Lamp. Lower the analysis compartment
cover, then locate the trimmer RV4 (on Board # 3), see figure below:
5 Adjust RV4 to read between 0 and 15 mV on screen. Then touch “√” to exit.
Note: Turn RV4 CCW to decrease offset mV and CW to increase offset mV.
6 On the windows like menu enter Service then Optical Module Test and Curve
Adjustment.
7 Load 200 µl of Wash-Reference Emulsion inside cuvette number 20 of a new
rotor. Place rotor onto rotor holder.
8 Select Chromogenic Channels, set rotational speed at 1200 rpm and touch “Start”.
The instrument performs an acquisition cycle. Upon completion of the acquisition
cycle scroll the table of values and delays until you find the delay corresponding
to the value of 1000.
9 Check that the delay is within 60 µsec. from the “current” delay displayed on the
window “Select Delay”. The Chromogenic channel delay cannot be updated, only
viewed and compared to the current Coagulametric channel delay.
10 Change the rotational speed from 1200 to 600 rpm and touch “Start”. The
instrument performs an acquisition cycle. Upon completion of the acquisition
cycle scroll the table of values and delays until you find the delay corresponding
to the value of 1000.
11 Check that the delay is within 120 µsec. from the “current” delay displayed on the
window “Select Delay”.
12 Remove the rotor. On the windows like menu enter Service then Optical Module
Test and Acquisition Adjustment. Touch Start, then adjust RV3 (on board # 3, see
figure on previous page) to read 8.7 ± 0.05 Vdc on the Chromogenic Channel line
(accept any value from 8.65 to 8.75 Vdc). Once adjusted touch “Stop”.
13 Load a new rotor with 200 µl of Wash-Reference Emulsion on cuvette # 6. Place
the loaded rotor in the analysis compartment.
14 Touch “Start” and verify that the reading on Chromogenic Channel line does not
exceed 3.5 Vdc. Otherwise replace the 405 nm Optical Filter and repeat the test.
15 Touch “√” to exit
These three tests allow you to verify the overall performance of the Chromogenic
Channel:
The Chromogenic Optic Test Kit (P/N 97579-50) is necessary to perform both tests.
The kit incorporates 50 vials (2 mL each), having the following concentration of PNA
(ParaNitroAnyline):
1 On the windows like menu enter Service then Optical Module Test and Channel
Optic Test.
2 Select in sequence Channel type: Chromogenic; Test Type: Precision Loading
Type: Reagent. The instrument shows the screen below:
Note: Acquisition cycle only can be repeated selecting Skip Loading from the
“Loading Type” window.
1 On the windows like menu enter Service then Optical Module Test and Channel
Optic Test.
2 The instrument shows the screen below. Select in sequence Channel type:
Chromogenic, Test Type: Linearity and Loading Type: Reagent.
3 Put the content of two PNA vials (4mL), of each level (80, 40 and 20 from the kit
P/N 97579-50) into a clean, empty 4 mL reagent vial with their Green adapters, or
other suitable container.
4 Position the reagent vials on the reagent tray as follows:
Note: Acquisition cycle only can be repeated selecting Skip Loading from the
“Loading Type” window.
1 On the windows like menu enter Service then Optical Module Test and Channel
Optic Test.
2 The instrument shows the screen below. Select in sequence Channel type:
Chromogenic, Test Type: Linearity and Loading Type: Reagent.
3 Put the content of two PNA vials (4 mL), of each level (160, 80 and 40 from the
kit P/N 97580-50) into a clean, empty 4 mL reagent vial with theirs adapters or
other suitable container.
4 Position the reagent vials onto reagent tray according to the following scheme:
7 Wait for the acquisition cycle, then verify that the following results are obtained:
Note: Acquisition cycle only can be repeated selecting Skip Loading from the
“Loading Type” window.
1 On the windows like menu enter Service then Optical Module and Acquisition
Adjustment. Wait for motors initialization then the instrument shows the screen
below.
6 Check that in the above condition the value displayed on the screen is in the range
890 to 4150 mV. If test fails replace the Halogen Lamp Socket Assy and perform
the Chromogenic Channel check out & adjustment as described in the sub-section
7.3.1. If test passes, remove the rotor and then repeat the Acquisition test and re-
adjust RV3 to read 8.7 +/- 0.050 V on the Chromogenic Channel line.
7 Touch Stop and “√” to exit.
This procedure allows the adjustment of the reference solution sensor circuit that shall
determine the volume of the solution left in the bottle.
5 Adjust if necessary RV9 located on the Acquisition & Sensor Board (Board # 3),
see figure below, to obtain a Flush Volume of 500ml displayed.
6 Fill the Wash-R bottle with 1000ml of solution. Install the bottle on board and
cork it completely with the Reference Emulsion Sensor. On the windows like
menu enter Service then Sensors Test and Flush Volume test. The Flush Volume
displayed should be 1000 ± 20% (800 – 1200 ml).
7 Fill the Wash-R bottle with 100ml of solution. Install the bottle on board and cork
it completely with the Reference Emulsion Sensor. On the windows like menu
enter Service then Sensors Test and Flush Volume test. The Flush Volume
displayed should be 100 ± 30% (70 – 130 ml).
This test allows functional verification of the circuitry that fulfils the task of liquid
detection through both the sample and reagent probes.
Warning:
Prior starting procedures execute one or more priming cycles following the route
Diagnostic then Priming. Perform these operations until confident that the fluidic path
is completely filled and without air bubbles.
Verify also that the fluidic lines are smooth and without crimps, etc.
1 On the windows like menu enter Service then Sensors Test and Needle Sensor
Test.
2 Press Start. The Sample Arm moves across the default test positions (1, 2 and A1
on the Sample Tray positions then R1, R5 and R7 on the Reagent Tray) and stops
on the waste position. The system displays the following screen:
3 Verify on the current screen that the value presented on the window “Reference
value” is in the range 4.000 - 6.000 V.
Note: If it’s out of range then perform the procedure “Wash-Reference Emulsion
Volume Test” to adjust the Flush Volume value at 500 mL. If the problem persists
then replace the Acquisition & Sensors Board (Board #3).
4 Prepare and position the suitable containers with distilled water or Wash-R
Solution as for the table below then press Start. The Sample Arm will scan the
positions and system will refresh screen with updated values.
5 Verify that the windows “SENSOR RESULT” display LIQUID. In addition check
that the windows “LIQUID” displays values according to table below. Adjust RV
11 and RV 12 if necessary and repeat the test as many times as needed.
6 Locate trimmer position on Acquisition & Sensors Board (Board # 3) as per figure
below.
7 Repeat the test with the containers positioned and filled as indicated in the table
below then check the results.
Note: If the “LIQUID” value is correct but the “Sensor Result” is “Air” the meaning
is that the liquid level in this position is low. This may indicate a problem with the
Sample Arm and/or the Needles Block.
This happens when the Needles have touched the liquid (LIQUID value in range) but
the mechanical stop has blocked the Sample Arm before the Needles enter 2mm into
the liquid for confidence (Sensor Result “Air”).
To solve the problem correct the Sample Arm assembly then repeat this procedure.
This condition of liquid low level may be present also during the analysis. In this case
perform this test (using the specific test quantity of liquid) to clarify if the liquid is
really insufficient and if the sensor is working properly.
Repeat the test with the containers empty and positioned as indicated in the table
below then press “Start” and check the results.
9 Check also that on each of the six small windows the value for offset is below
300mV. The offset is a reading taken on the sensor once the Sample Arm reaches
each given position prior to lowering into the liquid (circuit autozero).
Note: If the Offset is too high (over 700 mV) we have Sensor Fail. To solve Offset
problem it’s advisable to check for liquid on the Needles, dirt and/or insulating lost in
the Needles Block.
The Rotor Stack is actually equipped with two optical sensors that have the purpose
of detecting the presence of:
4 Access the Service menu then follow the route: Service, Sensor Test and Optic
Sensor Test. The instrument will initialize motors then the screen below is
presented.
5 Manually load one new rotor and leave it seated at the lower position of the Rotor
Stack lined up to the Optical Sensor Rotor Stack Upper.
6 Check that the voltage being displayed with the rotor in place is 5.00 V (higher
than 5 Vdc on the DVM). Last check that the flag on the screen shall indicate the
presence of the rotor. Should above reading be less than 5.00 V adjust, proceeding
as follows.
7 Locate in the system Card Housing the R.E.M. Board (Board #4).
8 Connect a DVM between TP0 (GND) and TP1 (signal) as shown in the figure
below.
11 Manually move the rotor in and out a few times and assess for proper rotor
detection. Check also that the flag toggles on the screen as rotor is being moved in
and out.
6 Check that the voltage being displayed, with the rotor in place is 5.00 V (higher
than 5 Vdc on the DVM). In the meanwhile a flag on the screen shall indicate the
presence of the rotor. Should above reading be less than 5.00 V adjust, proceeding
as follows.
7 Locate in the system Card Housing the R.E.M. Board (Board #4).
8 Connect a DVM between TP0 (GND) and TP2 (signal) as shown in figure below.
10 Manually remove the rotor and observe the voltage value reported on the screen to
drop to less than 1V. The flag that indicates the presence of the rotor shall also
disappear. In case the reading remains above 1.00 V then check for sensor
position and cleanliness.
11 Manually move the rotor in and out a few times and assess for proper rotor
detection. Check also that the flag toggles on the screen as rotor is being moved in
and out.
The Rotor Waste container can accommodate up to eleven used rotors (240 tests).
Following are the two conditions detected by the “Optical Sensor Rotor Waste Full”:
- Rotor Waste container available (until ten rotors pile-up in the Rotor Waste
container).
- Rotor Waste container full (when eleven rotors pile-up in the Rotor Waste
container).
The system provides appropriate warning messages to the User any time that the full
condition is met.
1 Access the Service environment, then follow the route: Service, Sensor Test and
Optic Sensor Test. The instrument will initialize the motors then the screen shown
below is presented.
2 Gain access to the Rotor Waste compartment by lowering the door in bottom front
of the instrument (this test needs to be performed with the Front Cover and the
Lower Support Plate assembled).
3 Remove the Rotor Waste Container from its housing.
4 Fill the waste rotor bag with ten rotors.
5 Place the Rotor Waste Container back into its compartment.
6 Check that, in this condition, the voltage being displayed is 4.25V (accept any
value in the range 3.50 to 5.00). Should above reading be out of the specified
range then adjust, proceeding as follows.
7 Locate in the system Card Housing the R.E.M. Board (Board #4).
8 Connect a DVM between TP0 (GND) and TP3 (signal), as shown in figure below.
9 Turn PT3 until the DVM reads 4.25 Vdc with ten rotors in the waste container.
10 Manually insert another rotor in the pile. Now 11 rotors are the waste container.
11 The System shall detect the “Rotor Waste full” condition and flag it on the screen
as appropriate.
12 Check that the voltage being displayed, with the 11 rotors in place is 5.00 V on
the screen (higher than 8.00Vdc on the DVM).
13 Manually remove two rotors from the pile and leave 9 rotors in the waste
container.
14 Check that, in this condition, the voltage being displayed drops to less than 1.00V.
Accept any value below 1.00 V, the flag that indicates the presence of the rotor
shall also disappear. In case reading remains above 1.000 V check for sensor
position and cleanness.
15 Manually move the rotors in and out a few times and assess for proper rotor
detection. Check also that the flag toggles on the screen as the rotors are being
moved in and out.
16 If any of the above voltages cannot be obtained adjust the position of the optical
sensors and repeat the procedure.
The Autosampler Housing is equipped with two optical sensors used to detect the
presence on the Sample Tray of primary tubes, cups, reagents or calibrator vials. It’s
also equipped with the internal Barcode Assy, used to read the “Patient ID” labels
present on the primary tubes. The two following procedures are required to
completely Check out & Adjust the Autosampler Housing sensors.
This procedure is designed to verify and adjust the sensitivity of the optical sensors
located on the Sample Tray compartment, which detect the presence of cups / primary
tubes or other containers.
The positions on the Sample Tray covered by each sensor are as follows.
Note: Prior to performing this procedure verify that the Autosampler Movement Assy
with its grey Flange Adjustable is properly aligned (see sub-section 7.6.5 and 7.7.1).
1 Take a Sample Tray with all the positions free and place:
Note: Make sure that the cups are new and free from any scratches.
2 Access the Service environment, place the prepared Sample Tray in its
compartment then enter Service, Sensor Test and Optical Sensor test. The system
displays the screen below:
Note: Adjust the 2nd ring first because the adjustment made on the trimmer RV6 will
affect the voltage reading on the 1st ring. The Acquisition & Sensors Board, through
RV6 sets the maximum current in the Outer Sensor, which is used for both the rings,
and RV10 sets the gain of the reading circuit for the 1st ring.
4 Select 2nd ring. Manually rotate the Sample Tray positioning the cup in position
34 in front of the optical sensor. Rotate the Sample Tray, to obtain the maximum
voltage reading on the screen for the 2nd ring. The voltage for the 2nd ring should
read between 2.8 to 4.0V.
5 If not adjust trimmer RV6 located on the Acquisition & Sensors Board (see figure
below), to obtain the specified value. Make sure that the Sample Tray does not
lose its position (at maximum reading) while adjusting.
6 Remove the cup and check that the voltage indicated on the LCD is <1.00V.
7 Select 1st ring. Manually rotate the Sample Tray positioning the cup in position
33 in front of the optical sensor. Rotate the Sample Tray, to obtain the maximum
voltage reading on the screen for the 1st ring. The voltage for the 1st ring should
read >3.5V.
8 If not adjust trimmer RV10 located on the Acquisition & Sensors Board (see
figure below), to obtain the specified value. Make sure that the Sample Tray does
not lose its position (at maximum reading) while adjusting. Note: If the voltage is
too high, such as 10.0V trim it down with RV10.
9 Remove the cup and check that the voltage indicated on the LCD is <1.00V.
10 Insert a 4mL bottle adaptor (p/n 190763-00) into AUX position A9. Place a 4ml
bottle into the adaptor making sure that the glass is facing the adaptor handle and
the label is facing away from the handle.
11 Observe the status line for the Inner Ring. Turn RV7 on the Acquisition &
Sensors Bd, (bd #3) to the maximum value. Manually rotate the autosampler
around the internal ring sensor position and look for the maximum obtainable
value. This has to be ≥ 6V.
If the positioning of the internal ring sensor (sensor touching the tool),
seems to be fine, install a spacer, p/n 190782-02 underneath the sensor.
Install the Adaptor Plate (p/n 190781-02) on top of the sensor (see
diagram). Recheck sensor alignment. Repeat steps 10 and 11.
12 Insert a 4ml bottle without a label filled with DI water into the adaptor in position
A9. Manually move the sample tray around the sensor to get the maximum
voltage displayed on the 3rd ring status line.
13 Adjust RV7 on the Acquisition & Sensor Bd, (bd #3), for an output value on the
LCD between 3.2 to 3.5V.
14 Remove the bottle and verify that the output value is < 2.2V. (See note below).
15 Remove the empty 2mL adaptor (p/n 190764-00) and observe that the output
value is < 2.2V. (See note below).
Note: If obtaining < 2.2V is not possible, remove the autosampler and
flange. Use sensor alignment tool p/n 190782-03 to check the position
of the internal sensor. The front of the sensor should be against the
tool. If the positioning seems to be fine, install spacer p/n 190782-02
underneath the sensor and repeat steps 10 - 15.
16 Place an empty 2mL cup into the adaptor and observe that the output value is ≥
3.6V.
17 Remove the adaptor and cup. Insert an 8mL bottle filled with water in AUX
position 9 and observe that the output value is ≥ 3.6V.
To thoroughly assess the proper functioning of sensors through all available positions
of the Sample Tray, it is advisable to perform the “Autosampler / BCR test”. This is
the next test described in this sub-section.
The Autosampler / BCR (Bar Code Reader) test is designed to verify the proper
reading of Autosampler Optical Sensors and BCR under dynamic conditions.
These conditions replicate the real use during the analysis cycles. Specific Offset can
be entered to trigger an early/late reading on the optical sensors. This will compensate
for some mechanical play that may produce a small shift of the Sample Tray during
rotation.
1 On the windows like menu enter Service then Autosampler / BCR test. The
system shows the screen below and positions at home the Sample Tray.
2 Prepare a Sample Tray with all the even positions (2nd, middle ring) loaded with
new empty 2 mL cups. Make sure that the cups are new, free from any scratches.
Place the prepared Sample Tray onboard.
3 Touch key “START WITHOUT BCR”. The system will perform a complete turn
of the Autosampler reporting on the screen cups presence (1 present; 0 not
present) and position.
Note: There are 3 other columns in the result area of the screen.
The first is the “Offset” column.
The second is the “ADC Value” column, read on each position during the test. The
last is the “Bar Code Values” column where is reported the value read by the BCR on
the Patient ID Barcode Label. This column is compiled only when the test starting by
touching the button “START WITH BCR”.
4 Assess that all the even positions on the screen report “1” for presence.
5 If any positions fail then check that the relevant cup is in good condition, replace
the cup and repeat test. Checks also in the “ADC Value” column that the highest
value read for this position is close to the set point of the sensor (see the test
“Autosampler Sensors Check out & Adjustment” described above in this sub-
section).
6 If the problem persist then enter on the window “CENTRAL RING OFFSET” a
new value close to zero (the value suggested are –5 to +5) and repeat the test a
few times until confident that the proper value is found.
Once achieved, unload cups from mid ring, place them on outer ring and perform this
test for the outer ring. Set “OUTER RING OFFSET” if necessary and enter an offset
value close to zero (the value suggested are –5 to +5) and repeat the test a few times
until confident that the proper offset value is found. Also, install bottles without labels
on the Auxiliary Ring (inner ring) and perform the test again. Set “INNER RING
OFFSET” if necessary and enter an offset value close to zero (the value suggested are
–5 to +5) and repeat the test a few times until confident that the proper offset value is
found.
Test functionality of the internal Bar Code Reader performing the following
procedure. Make sure internal BCR is enabled and appropriate symbologies selected.
1 On the windows like menu enter Service then Autosampler / BCR test. The
system shows the screen below and positions at home the Sample Tray.
2 Prepare a Sample Tray with primary tubes equipped with Bar Code Labels. Place
tubes in both the middle and outer rings. (It is not necessary to place tubes in
every position, but make sure tubes are in both the middle and outer ring). Make
sure that the labels are valid, in good condition (see also Appendix B Bar Code
Label specification) and positioned toward the Bar Code Reader.
3 Place the prepared Sample Tray onboard.
4 Touch key “START WITH BCR”. The system will perform a complete turn of the
Autosampler reporting on the “Bar Code Values” column the value read by the
BCR on the Patient ID Barcode Label.
5 Confirm that all positions containing tubes indicate a “1” for presence.
6 If any position fails check that the relevant primary tube label is in good
condition, replace the primary tube and repeat the test. If any position continues
to fail repeat the Autosampler Sensor Adjustment procedure and cup Offset
Procedure.
7 Confirm that the barcode value read matches the barcode label and that the bar
code value is displayed in the correct tray position.
8 If the barcode values are not in the correct tray positions, then enter on the
window “BCR OFFSET” a new value and repeat the test (move the Offset value +
or – 1 at any repetition). Repeat several times until confident that the BCR reads
correctly all primary tube labels.
Note: The value reported in the “Offset” column is approximately the cup presence
Optic Sensors output.
Operator interface for each motor adjustment screen is very similar. Some exceptions
exist for the Rotor Holder Cover Motor. The functionality of the commands available
and the most common dynamic labels are described in the following sub- section.
PRESENT PHASE
COVER SENSOR
HOME SENSOR
POSITION SENSOR
STEP DONE
Home position
Brings the stepper motor to the Encoder Home Position.
Motor Off
De-energizes the motor. The motor status reported on the relevant window “MOTOR
STATUS” changes from “Energized” to “De-energized”.
Cautions !
Listed are descriptions of the dynamic labels that are available inside each of the
Motors Adjustment screens.
This procedure is designed to verify and adjust (if required) the central phase of the
Home Position of the motor. This is to match the motor phases with the optical sensor
reading on the encoder disk. It’s also possible to use it to verify the functionality of
the stepper motor and of the optical sensor.
1 Turn the Instrument On. Then access the Service program main menu.
2 On the windows like menu enter Service then Motor Adjust and Rotor Motor. The
system displays the screen below.
3 On the tool bar touch the small icon of the analysis compartment cover to raise the
cover (the icon acts as a toggle switch to raise/lower the Rotor Cover).
4 Home the Rotor Motor by touching the Home Position button on the screen. The
system moves to the Home Position the Rotor Motor. The Rotor Holder cuvette
#20 is in front of the Coagulimetric Channel Optic Fibre.
5 Verify that the dynamic labels “HOME SENSOR” and “POSITION SENSOR” are
both ON.
6 With the Step Increment set to 1, repeatedly press cw arrow (or ccw arrow) button
on the screen. The status bars of both the home and position sensors show the
actual condition of optical switch (+: light; -: dark).
7 Continue to press cw (or ccw) arrow until both the status changes from light to
dark then reverse motion by touching the opposite key until the status of optical
sensors becomes dark again after the light window.
8 It is now possible to determine the width of the optical window (notch on the
encoder disk).
9 Pressing on the cw (or ccw) arrow keys move to the middle of the window
(- - - - + + + + + - - - -).
10 Check that the present phase matches the stored phase on the dynamic labels. If
phases are equal then the Rotor Motor is centered on the encoder and the test is
over. Press “√” to exit.
11 Or, press “STORE PHASE” if active. Unavailability of the “STORE PHASE” key
indicates an illegal condition of the Rotor Motor phase exist. Touch the cw (or
ccw) arrow key to restore a legal motor phase condition.
12 Visually inspect the Rotor Holder and confirm that the middle of the cuvette
position #20 is in front of the coagulation optic fibre.
13 If yes and if the present and stored phase are still in disagreement, touch “STORE
PHASE”.
14 Press “√” to return to the Service main menu.
This procedure is designed to verify and adjust (if necessary), the alignment of the
Rotor Cover Encoder Disk and the Optical Sensor. It is also possible to use it to
verify the functionality of the stepper motor and the optical sensor. The encoder disk
identifies three rotor cover positions which are closed, intermediate and home (fully
open).
1 Turn the Instrument On. Then access the Service program main menu.
2 If the Rotor Cover Movement Assy was replaced or in any case removed and then
assembled, verify that when the Cover is closed the Encoder is in the position
indicated in the following drawing (the top edge of the encoder disk should be
approximately 1mm above the top edge of the dual channel optical sensor). If the
Encoder is not in the correct position then adjust it by loosening the two setscrews
that fix the Encoder to the motor shaft and adjust the encoder up or down as
necessary. Tighten the encoder set screws after adjustment.
Note: On a properly adjusted encoder the upper side of the encoder has to be about 1
mm above the upper side of the Dual Channel Optical Switch Sensor when the Rotor
Holder Cover is in the closed position. If available use the Rotor Cover Encoder
Centering Tool P/N 190575-00.
Encoder Disk
Dual Channel
Optical Sensor
3 On the windows like menu enter Service then Motor Adjust and Rotor Holder
Cover. The system displays the LCD screen below.
4 The Rotor Holder Cover sets to its intermediate position (automatic loading
position).
5 Touch the ”HOME POSITION” key, and the Cover Motor opens the cover until
the –36 Step (ACL Elite) or –51 Step (ACL ElitePro) is reached. Cover is fully
open.
6 The Home and the Position Sensors are ON.
7 Touch the ”STEP UP ARROW” key and verify that the Home and the Position
Sensors go to OFF (indicated by minus (--) signs on the relevant status bar) at
least 2 to a maximum of 5 steps before the cover hits the mechanical stop.
Home | - - - - - + + + Pass
Position | - - - - + + + +
Note: If there are too many minus signs (greater than 5) loosen the setscrews and
rotate the encoder downward. If there are too few minus signs (less than 2) loosen the
setscrews and rotate the encoder upward. Repeat steps 3 thru 7 above.
8 Touch the ”HOME POSITION” key and then the “NEXT CW POSITION” key.
Step count should be 0.
9 Press “NEXT CW POSITION” key. The cover should close to form a hermetic
seal against the fluidic plate. Touch the “STEP UP” or “STEP DOWN” key as
necessary to insure a hermetic seal of the cover and fluidic plate.
10 Once closed verify that the position sensor is ON (+ on the relevant status bar). It
is not necessary to set in the middle of the optical window.
11 Touch the “STORE STEP” key, the system will update the value.
12 Touch once the “NEXT CCW POSITION” to raise the cover back to the
intermediate position.
13 Once the intermediate position is reached verify that the dynamic label “STEP
DONE” sets to a value of 0. The dynamic labels of cover, home and position
sensor should be set as specified (see table below).
14 Touch any time the “NEXT CCW POSITION” and the “NEXT CW POSITION”
until confidant that the adjustment is acceptable.
15 Touch “√” to return at the Service main menu screen.
This procedure is designed to verify and adjust (if required) the central phase of the
Home Position of the motor. This is to match the motor phases with the optical sensor
reading on the encoder disk. It’s also possible use it to verify the functionality of the
stepper motor and of the optical sensor.
1 Turn the Instrument On. Then access the Service program main menu.
2 On the windows like menu enter Service then Motor Adjust then Sample Arm
Motors and Horiz. Sample Arm Motor. The system displays the screen below.
This procedure is designed to verify and adjust (if required) the central phase of the
Home Position of the motor. This is to match the motor phases with the optical sensor
reading on the encoder disk. It’s also possible use it to verify the functionality of the
stepper motor and of the optical sensor.
1 Turn the Instrument On. Then access the Service program main menu.
2 On the windows like menu enter Service then Motor Adjust then Sample Arm
Motors and Vert. Sample Arm Motor. The system displays the screen below.
Note: The Sample Arm Vertical Motor doesn’t require phases to be stored.
6. Press “ Next CCW Position” key until the arm is over R1 position. Press
“√” then NO to exit.
7. Select Service/Motor Adjust/Sample Arm/Vert. Arm Motor.
8. Select “R1-R4” from the menu under “Horizontal Arm Logical Area” on
the screen.
9. Press “Home Position” key. Then “Next Down Position” key once.
10. Increment downwards by pressing the “down arrow” icon until the needle
hits the bottom of the glass bottle, or the +++ signs change to - - - signs on
the position sensor display line.
11. If the probe hits the glass bottle bottom press the “up arrow “ icon to raise
the probe 5 to 7 steps. If the +++ signs changed to - - - signs on the
position sensor display line, press the “up arrow” icon to display at least 3
+++ signs on the position sensor display line.
12. Make a note of the value displayed in the “Step Done” box.
13. Press “√” then YES to exit.
14. Select Service/Motor Adjust/Sample Arm/Vert. Arm Motor
15. Press “Home Position” key
16. Select Service/Motor Adjust/Sample Arm/Horiz. Arm Motor.
17. Press “Home Position” key
18. Press “ Next CCW Position” key until the arm is over R4 position. Press
“√” then NO to exit.
19. Select Service/Motor Adjust/Sample Arm/Vert. Arm Motor.
20. Select “R1-R4” from the menu under “Horizontal Arm Logical Area” on
the screen.
21. Press “Home Position” key. Then “Next Down Position” key once.
22. Increment downwards by pressing the “down arrow” icon until the needle
hits the bottom of the glass bottle, or the +++ signs change to - - - signs on
the position sensor display line.
23. If the probe hits the glass bottle bottom press the “up arrow “ icon to raise
the probe 5 to 7 steps. If the +++ signs changed to - - - signs on the
position sensor display line, press the “up arrow” icon to display at least 3
+++ signs on the position sensor display line.
24. Observe the value indicated in the “Step Done” box. If the value is the
same as the value noted for the R1 position press the “Store Position”
button on the screen. If the value in the “Step Done” box is larger for the
R4 position than the R1 position press the “up arrow” icon until the R4
value equals the R1 value and press the “Store Position” button on the
screen. If the value in the “Step Done” box is lower for R4 position than
the value for the R1 position press the “Store Position” button on the
screen.
Note: If plus signs are not present in the “position sensor” row when
attempting to store position, continue to press “up arrow” key until at
least 3 plus signs appear then store position.
Note: If plus signs are not present in the “position sensor” row when
attempting to store position, continue to press “up arrow” key until at
least 3 plus signs appear then store position.
R12 position than the R9 position press the “up arrow” icon until the R12
value equals the R9 value and press the “Store Position” button on the
screen. If the value in the “Step Done” box is lower for R12 position than
the value for the R9 position press the “Store Position” button on the
screen.
Note: If plus signs are not present in the “position sensor” row when
attempting to store position, continue to press “up arrow” key until at
least 3 plus signs appear then store position.
This procedure is designed to verify and adjust (if required) the central phase of the
Home Position of the motor. This is to match the motor phases with the optical sensor
reading on the encoder disk. It’s also possible to use it to verify the functionality of
the stepper motor and of the optical sensor.
1 Turn the Instrument On. Then access the Service program main menu.
2 On the windows like menu enter Service then Motor Adjust then Autosampler
Motor. The system displays the screen below.
3 Touch the Home Position button on the screen. The system moves the
Autosampler motor until the Home Position is achieved.
4 Verify that the dynamic labels “HOME SENSOR” and “POSITION SENSOR” are
both in ON condition.
5 With the step increment set to 1, repeatedly press cw (or ccw) arrow button on the
screen. The status bars of both the home and position sensors show the actual
condition of optical switch (+: light; -: dark).
6 Continue to press cw (or ccw) until status changes from light to dark, then reverse
motion by touching the opposite key until the status of the optical sensors
becomes dark again after the light window.
7 It is now possible to determine the width of the optical window (notch on the
encoder disk).
8 Press the arrow keys cw (or ccw) to set the middle of the optical window
(- - - - + + + + + - - - -).
9 Check that the present phase matches the stored phase on the dynamic labels. If
phases are equal then the Autosampler Motor is centered on the encoder and the
test is over. Press “√” to exit.
10 If not press “STORE PHASE” if active. Unavailability of the “STORE PHASE”
key indicates an illegal condition of the current motor phase exist. Touch once cw
(or ccw) arrow key to restore legal motor phase condition and then touch “STORE
PHASE”.
11 Press “√” to return to the Service main menu.
NOTE: Check the Autosampler Movement Assembly “Backlash” (lag between the
belt, pulley and motor). Check the backlash as follows.
From the windows like menu, enter Service, then select Motors Adjust,
Autosampler. Touch the Home button on the screen to Home the
Autosampler. Press the cw or ccw arrow buttons until the “Home Position”
sensor status changes from “+” light, to “-“ dark. While observing the status
of the Home Sensor press the oppsite direction arrow and continue pressing
the arrow until the Home Sensor status changes from “-“ dark to “+” light.
There should be 5 or less minus signs “-“ prior to the status changing for the
Home Sensor. If there is greater than 5 minus signs the autosampler has
excessive play between the belt, pulley and motor and the autosampler should
be replaced.
This procedure is designed to verify and adjust (if required) the central phase of the
Home Position of the motor. This is to match the motor phases with the optical sensor
reading on the encoder disk. It’s also possible use it to verify the functionality of the
stepper motor and of the optical sensor.
1 Turn the Instriment On. Then access the Service program main menu.
2 On the windows like menu enter Service then Motor Adjust then Dilutor Motors
and Sample / Reagent Dilutor Motor. The system displays the screen below.
3 Touch the Home Position button on the screen. The system moves the
Sample/Reagent Dilutor Motor fully upward.
4 Verify that the dynamic labels that the “HOME SENSOR” is in ON condition.
5 Touch the “NEXT DOWN POSITION” to lower the Sample/Reagent Dilutor
Motor to the full down position.
6 Verify that the dynamic labels that the “HOME SENSOR” is in OFF condition.
7 Press “√” to return to the Service main menu.
This procedure is designed to verify and adjust (if required) the central phase of the
Home Position of the motor. This is to match the motor phases with the optical sensor
reading on the encoder disk. It’s also possible to use it to verify the functionality of
the stepper motor and of the optical sensor.
1 Turn the Instrument On. Then access the Service program main menu.
2 On the windows like menu enter Service then Motor Adjust and Slider Motor. The
system displays the screen below.
3 Touch the Home Position button on the screen. The system moves the Rotor
Transport (slider) under the Rotor Stack.
4 Verify that the dynamic labels “HOME SENSOR” and “POSITION SENSOR” are
both in the ON condition.
5 Touch the “NEXT CCW POSITION” to move the Rotor Transport (slider) to the
left (rotor picking position).
6 Verify that the dynamic labels “HOME SENSOR” and “POSITION SENSOR” are
respectively in OFF and ON condition.
7 Press “√” to return to the Service main menu.
This procedure is designed to verify and adjust (if required) the central phase of the
Home Position of the motor. This is to match the motor phases with the optical sensor
reading on the encoder disk. It’s also possible use it to verify the functionality of the
stepper motor and of the optical sensor.
1 Turn the Instrument On. Then access the Service program main menu.
2 On the windows like menu enter Service then Motor Adjust then Rotor Arm
Motors and Horiz. Rotor Arm Motor. The system displays the screen below.
This procedure is designed to verify and adjust (if required) the central phase of the
Home Position of the motor. This is to match the motor phases with the optical sensor
reading on the encoder disk. It’s also possible use it to verify the functionality of the
stepper motor and of the optical sensor.
1 Turn the Instument On. Then access the Service program main menu.
2 On the windows like menu enter Service then Motor Adjust then Rotor Arm
Motors and Vert. Rotor Arm Motor. The system displays the screen below.
Horizontal Arm
Logical Area Current Value
Waste Position T 0
3 Touch the Home Position button on the screen. The system raises the Rotor Arm
to the rotation height.
4 Verify that the dynamic labels “HOME SENSOR” and “POSITION SENSOR” are
respectively in OFF and ON condition.
5 Touch the “NEXT DOWN POSITION” to lower the rotor arm to the bottom
position.
6 Verify that the dynamic labels “HOME SENSOR” and “POSITION SENSOR” are
both in ON condition.
7 Press “√” to return to the Service main menu.
Note: The Rotor Arm Vertical Motor doesn’t require phases to be stored.
• Autosampler assy.
• Sample Arm assy.
• Rotor Holder assy.
• Rotor Arm assy.
• Rotor Transport assy.
The Module Positioning Tests options are available under the service programs main
menu. On the windows like menu, the sequence Service - Module Positioning Test
gives access to the following operational tests:
• ST – SA – RH Test
• RA – SL Test
• RA – RH Test
• RA – SL – RH Test
To perform a complete alignment of all the modules in the instrument the following
sequence must be followed. Note that the Sample Arm is the “Reference Point”. The
sample arm drive assy vertical shaft must be centered in the fluidic plate opening and
the arm must be aligned to the rinse/waste reservoir prior to performing any other
alignments. All other alignments are referenced to the Sample Arm. Also, verify that
all motor phase settings are correct prior to performing module alignments. The
module alignment sequence is:
Sample Arm
Autosampler
Rotor Module
REM
NOTE: Sample Arm vertical shaft must be centered in the fluidic plate prior to
performing any further alignments. Use alignment tool to center shaft to fluidic plate.
All above modules have to properly match to each other to insure proper picking and
delivery of samples and reagents as well as rotors for the analysis. Should any module
loose its pre-set position (e.g. due to the fact it was dismantled and re-fitted for
service purposes) it must be re-adjusted. The following table provides a summary of
tests to be done based upon the module that was replaced/adjusted, to restore the
proper working conditions.
The Sample Arm must be aligned with respect to the needles Wash/Waste Pot and
represents the mechanical reference to the other major assemblies. It is recommended
to verify the proper positioning of the Sample Arm prior to starting any position
adjustment on other modules.
In case the Sample Arm module was adjusted/replaced the following procedure needs
to be completely carried out, in other situations follow it only for verification.
Materials / tools necessary for the test: - Needles Waste Centring Tool
P/N 190515-00
- Sample Arm centring tool
P/N 190513-00
- Needles Position Tool
P/N 181039-41
1 Position the Sample Arm module in place from the bottom of the system and
secure it by using the 3 black column screws but without tightening completely.
2 Re-connect cables as required.
3 Insert the Sample Arm Centering Tool (P/N 190513-00) on the shaft of the
Sample Arm Movement assy, between the shaft and the Fluidic Plate hole.
4 Tighten the 3 black column screws making sure that the Sample Arm Movement
shaft is in the middle of the Fluidic Plate hole.
5 Remove the Sample Arm Centering Tool (P/N 190513-00).
6 Carefully tilt up the Instrument by holding the keyboard drawer guides and fold
back the two stands and then lower the instrument on the bench.
7 Replace the needles Wash/Waste Pot adapter with the Needles Waste Centring
Tool (P/N 190515-00).
8 Turn On the Instrument then access at the Service program main menu.
9 On the windows like menu enter Service then Module Positioning test and (ST –
SA – RH Test). Upon entry the system performs motors initialization and displays
the screen below.
10 Put the Sample Arm on the Sample Arm Movement shaft (at the bottom) using
caution not to lose the current shaft position.
11 Manually move the Sample Arm (with the needle block assembled) over the
needles Waste/Rinse Reservoir.
12 Lower the Sample Arm Movement shaft to allow the Needles Block to enter the
Waste Centering tool.
13 Adjust the Sample Arm (rotational and horizontal adjustment) to match the 2
needles with the 2 reference points on the Waste Centering tool.
Note: Use the 2 screws located on the top of the aluminium support to set the depth of
the Needles Block assy (if required).
14 Tighten the 3 setscrews located at 120° on the aluminium support that holds the
Sample Arm in place. Tighten the 2 allen head screws that secure the horizontal
movement of the arm.
15 Place the Needles Position Centring Tool (P/N 181039-41) on the Rotor Holder.
16 Raise the Sample Arm Movement assy. Touch the key “NEXT POSITION”, the
Sample Arm moves over the Rotor Holder and lowers to dispensing position.
17 Adjust the Needles Block height by setting the needles tip on the 2 white points of
the Needles Centring tool surface.
Note: Loosen and secure the Needles Block by using the white knob located on the
rear of the Sample Arm. If during this check out it is necessary to move the Rotor
Holder module position then perform the R.E.M. module positioning as described in
the section 7.7.7.
18 Remove the Wash Centering tool from the Wash/Waste Pot and install the
Waste/Rinse Reservoir.
19 Raise the Sample Arm Movement assy. Touch the key “NEXT POSITION”, the
Sample Arm moves over the Autosampler to position #1of the Sample Tray.
20 Remove the Needles Position Tool P/N 181039-41 from the Rotor Holder.
21 Touching the key “NEXT POSITION” the Sample Arm raises, moves over the
Rinse Waste Pot and lowers on the Rinse Waste Reservoir.
22 Visually inspect that needless are centered with respect to the Rinse Waste
Reservoir.
23 Touch the icon “STOP” and then “Ok” to return at the Service main menu.
Note: Before resume normal operation it is advisable to perform a Needle Sensor Test
as detailed in section 7.4.1.
The Autosampler must be aligned with respect to the Sample Arm. It is recommended
to verify the proper positioning of the Sample Arm prior to starting any position
adjustment on other modules.
If the Autosampler module was repaired/replaced the following procedure needs to be
completely carried out, in other situations follow it only for verification.
Materials / tools necessary for the test: - 0.5 mL disposable sample cups or
primary tubes
1 Position the Autosampler assy in place from the bottom of the system. Secure it
by using the 4 black column screws but without tightening completely.
2 Re-connect cables as required.
3 Tighten the 4 black column screws making sure that the Autosampler shaft is in
the middle of the fluidic plate hole.
4 Install the inner ring optical sensor and lock it in place.
5 Carefully tilt up the Instrument by holding the keyboard drawer guides folding
back the two stands and then lower the instrument on the bench.
6 Put the grey Flange Adjustable in place on the top of the Autosampler movement.
Secure it by the 2 screws but not completely tightened (it shall still be possible to
turn it by hand).
7 Turn On the Instrument then access the Service program main menu.
8 On the windows like menu enter Service then Module positioning test and (ST –
SA – RH Test). Upon entry the system performs modules initialization and
displays the screen below.
9 Touch the key “NEXT POSITION”, the Sample Arm moves over to the Rotor
Holder and lower to dispensing position.
10 Load a Sample Tray with a 0.5 mL cup in the position #1. Put it on the Flange
Adjustable.
11 Touch the key “NEXT POSITION” again, the Sample Arm raises, moves over to
the Autosampler housing and lowers on the position #1 of the Sample Tray.
12 Visually inspect that Sample Needle is centered in the cup. If off-center gently
turn the Sample Tray to achieve best fit.
Note: May be necessary to adjust the Autosampler assy if the Sample Needle is not in
the middle of the cup. In this case, to adjust the Autosampler Movement position
loosen the 4 black column screws, move the Autosampler to achieve best fit and then
tighten the 4 black column screws again.
Visually inspect that (with the Sample Tray inside) the distance between the Sample
Tray and the external wall of the Autosampler housing circumference is at least 2mm.
It’s also advisable to test the middle and inner rings positions (#2 and A1) by using
together the Motor Adjust options for the Autosampler and for the Sample Arm
Horizontal Motor. During this test on #1, #2 and A1 it is not possible to align all 3
positions perfectly, so obtain a best fit alignment.
13 Touch the toggle key “TO RAISE / LOWER ARM”, the Sample Arm moves up
and down. Repeat the operation to verify proper centering.
14 With the Sample Arm fully raised and paying attention that you are not moving
the Flange Adjustable from current position, remove the Sample Tray and tighten
the two fixing screws.
15 Refit the Sample Tray with the cup in position #1 and verify that the Sample
Needle is centered.
16 Once proper matching is achieved touch the icon “STOP” and then “OK” to
return at the Service main menu.
The Rotor Holder must be aligned with respect to the Sample Arm. It is recommended
to verify the proper positioning of the Sample Arm prior starting any position
adjustment on other modules.
If the Rotor Holder module was repaired/replaced the following procedure needs to be
completely carried out, in other situations follow it only for verification.
Materials / tools necessary for the test: - Needles Position Tool P/N 181039-41
- Disposable rotor
1 Put the Rotor Holder assy in place from the bottom of the system. Secure it by
using the 3 black column screws but without tightening completely.
2 Re-connect cables and optic fibres as required.
3 Carefully tilt up the Instrument by holding the keyboard drawer guides and
folding back the two stands then lower the instrument on the bench.
4 Turn On the Instrument then access at the Service program main menu.
5 On the windows like menu enter Service then Module Positioning test and (ST –
SA – RH Test). Upon entry the system performs the modules initialization and
displays the screen below.
6 Place the Needles Position Tool (P/N 181039-41) on the Rotor Holder.
7 Touch the key “NEXT POSITION”, the Sample Arm raise, moves over the Rotor
Holder and lower to dispensing position.
8 Adjust the Rotor Holder position to achieve best fit between the needles tip and
the 2 white points on the Needles Centering tool surface then tighten the 3 black
column screws.
9 Touch the toggle key “TO RAISE / LOWER ARM”, the Sample Arm will move up
and down. Repeat this operation to insure proper centering.
10 Once proper matching is achieved Touch the icon “STOP” and then “OK” to
return at the Service main menu.
Note: Once Rotor Holder has been centered with respect to the Sample Arm then
perform verification against the R.E.M. (see section 7.7.7. for the details).
Before normal operation is resumed it is advisable to perform a Needle Sensor Test as
detailed in the sub-section 7.4.1 and a Needles Position test available in the
Diagnostic menu using a plastic rotor.
This test has the purpose to Adjust/Verify the Needles Block Position every time that
is needed (Replacement, Maintenance, accidental hit or for service action).
WARNING !
BIOLOGICAL HAZARDS EXIST. Avoid touching, with bare hands, any parts
of the system which may have come in contact with potentially infectious fluids.
ALWAYS wear gloves when performing any type of Maintenance/Service action
on this area.
1 Turn the Instrument On. Then access the Analytical Main Program.
2 On the tool bar touch the small icon of the Analysis Compartment Cover to
raise the cover (the icon acts as a toggle switch to raise/lower the Rotor
Cover).
3 On the windows like menu enter Diagnostic then Needles Position. The
system initializes the Sample Arm, the Rotor Holder and displays the screen
below.
4 Pushing the Rotor Holder Snap Button, properly insert the Needles Centering
Tool with the side “A” facing up.
Reference Dots
A
5 Press Raise/Lower Arm. The Sample Arm is lowered over the Rotor Holder.
6 Using the knob located on the rear of the Sample Arm adjust the height of the
Needles Block so that the needle tips come in contact with the upper surface
of the Needles Position Tool. During this operation pay attention to put them
in a vertical position.
7 Secure the Needles Block by tightening the relevant knob without losing the
current position.
8 Make sure that the needle tips match with the 2 reference dots of the tool. If
the needle tips don’t match then verify the Sample Arm and the Rotor Holder
positioning as described in the section 7.7.
9 Once the Needles Block adjustment with the tool is achieved, press the
Raise/Lower Arm button. The arm is raised. Remove the Needles Centering
Tool.
10 Pushing the Rotor Holder Snap Button, properly insert a brand new plastic
rotor.
11 Press Raise/Lower Arm. The Sample Arm is lowered over the plastic rotor on
the Rotor Holder.
12 Visually inspect for the proper position of the needles in the center of the 2
holes of the cuvette.
13 Press Raise/Lower Arm. The Sample Arm is raised. By touching the Rotate
button (now active) the plastic rotor on the Rotor Holder is rotated 90°.
14 Repeat steps 11 thru 13 to be sure that in the 4 test positions the Needles
Block adjustment is acceptable.
Note: The needles alignment may not be identical in the 4 rotor cuvettes. However
insure that the needles enter the cuvette holes without touching the edges, etc. for
each test position.
A B C
Sample probe centred
or biased Left
15 When the needles adjustment is acceptable press the red “Stop” icon on the
tool bar and confirm the operation with OK to end the test.
The Rotor Stack must be aligned with the Rotor Transport (slider). Both the Rotors
Stack and the Rotor Transport (slider) are sub-assemblies of the R.E.M. (Rotor
Exchange Module). The R.E.M. itself is aligned with the Rotor Holder assy.
This procedure is designed to center the Rotor Stack (silos) to the Rotor Transport
(slider).
1. Turn On the Instrument then access the Service program main menu.
2. Fill the Rotor Stack with new rotors.
3. On the windows like menu enter Service then Module Positioning Test. Select
RA-SL-RH test.
4. During the test visually inspect for the proper feeding of rotors from the Rotor
Stack to the Rotor Transport (slider). Rotors should drop freely and align on the
slider.
5. If the Rotor Transport (slider) is not aligned then loosen the 3 locking screws that
secure the Rotor Stack (located below the R.E.M. support Plate).
6. Gently move the Rotor Stack assembly to obtain best alignment. Also, the slider
“Home” sensor and/or flag may be adjusted left or right to set the stop position of
the slider under the rotor stack.
7. Secure the Rotors Stacks in place by tightening the 3 locking screws again.
8. Verify the proper position of the Rotor Stack repeating the RA-SL-RH test until
confident that adjustment is acceptable.
Note: The Rotor Stack Cover Sensor needs to detect the presence of the magnet in the
cover to perform the test correctly (use an external magnet).
The Rotor Arm assy must be aligned with respect to the Rotor Transport assy. Both
the Rotor Arm assy and the Rotor Transport are sub-assemblies of the R.E.M. (Rotor
Exchange Module). The R.E.M. must be aligned to the Rotor Holder assy.
If the Rotor Arm was repaired/replaced the following procedure needs to be
completely carried out, in other case follow it only for verification.
Materials / tools necessary for the test: - Rotor Arm Centring Tool
P/N 190503-00
- Disposable rotor
1 Turn On the Instrument and access the Service program main menu.
2 On the windows like menu enter Service then Motor Adjust and Slider Motor.
Touch in sequence “Home Position” then “Next CCW Position”. Touch “√” to
return at Service main menu and touch “NO” on the dialog box “De-energize
motor?”
3 Put the Rotor Arm alignment bushing on Rotor Transport.
4 On the windows like menu perform the sequence Service – Motor Adjust – Rotor
Arm Motors – Rotor Arm Horiz. Motor. Touch in sequence “Home Position”,
then touch “√” to return to service main menu and “NO” on the dialog box “De-
energise motor?”
5 On the windows like menu enter Service then Motor Adjust then Rotor Arm
Motors and Rotor Arm Vert. Motor. The system displays the screen below.
Horizontal Arm
Logical Area Current Value
Waste Position T 0
6 Touch the key “Home Position”. Now both the Rotor Arm and the Transport
motors are initialized.
7 Install now the Rotor Arm on its shaft (do not tighten the 3 setscrews). Raise the
analysis compartment cover by touching the relevant icon on the screen tool bar.
8 Touch on the current value of the window “Chose Step Increment”. The value
goes in reverse video.
9 Press “Canc/Delete” on the main keyboard to delete the value. Key in 40 as new
value.
10 Press the cw arrow in the left bottom side of the screen. The Rotor Arm will lower
by 40 steps.
11 Repeat last operation as many times as necessary to lower the Rotor Arm to the
Rotor Arm alignment bushing (in the meantime visually inspect for best fit, if
necessary manually guide the Rotor Arm paying attention to don’t move the shaft
from the previously set position).
12 Once the Rotor Arm is lowered and matching achieved tighten the 2 screws on the
Rotor Arm aluminium support.
13 Gently tighten the 3 setscrews paying attention not to move the shaft from the
previously set position.
14 The adjustment is now complete, press “√” to return to service main menu. Touch
“YES” on the dialog box “De-energize motor?”
15 Remove the alignment bushing and place a new rotor on the Rotor Transport.
16 On the windows like menu enter Service then Module Positioning Test and RA –
SL – RH Test.
17 The instrument exercises the Rotor Arm and Rotor Transport in sequence. Let the
system operate for a suitable number of cycles and verify for proper matching,
touch “Abort” once confident that adjustment is acceptable.
Horizontal Arm
Logical Area Current Value
Waste Position T 0
rotor holder. Switch between “next up position” and “next down position” buttons
as needed.
Note: To center the pliers onto the rotor, you may need to loosen the five set
screws located on top of the REM assembly and move the REM assembly left or
right, forwards or backwards to achieve perfect centering.
25. With a rotor seated on the rotor holder and the pliers in home position, open pliers
manually by pushing solenoid pin in.
26. Press “next down position”. Verify that the pliers arms do not lift the rotor from
the plate (pliers are too low) or sit on the edge of the rotor (pliers are too high).
Use the “up arrow” or “down arrow” buttons to make appropriate adjustment.
Note: Over the Rotor Position the arm may be adjusted +/- 7 steps.
27. Press “Store position” key, then YES.
28. Press “home position”.
29. Press “√” then NO to exit.
30. Select Service/Motor Adjust/Rotor Arm Motor/Horiz. Arm Motor.
31. Press “home position”. Verify that the pliers do not make contact with the fluidic
plate during movement. If contact is made, make the necessary adjustments and
verify the stored positions for the vertical motor.
The Rotor Exchange Module is a major assembly that incorporates Rotor Stack, Rotor
Transport and Rotor Arm assy. The R.E.M. must be aligned with respect to the Rotor
Holder.
1 Turn On the Instrument then access the Service program main menu.
2 On the windows like menu enter Service then Motor Adjust then Rotor Arm
Motors and Rotor Arm Vert. Motor. Touch “Home Position”, and then touch “√”
to return to service main menu. Touch “NO” on the dialog box “De-energize
motor?”
3 Raise the Rotor Cover by touching the relevant icon on the screen tool bar.
4 On the windows like menu enter Service then Motor Adjust then Rotor Motor.
Touch “Home Position”, and then touch “√” to return to service main menu.
Touch “NO” on the dialog box “De-energize motor?”
5 On the windows like menu enter Service then Motor Adjust then Rotor Arm
Motors and Rotor Arm Horiz. Motor. Touch in sequence “Home Position”, “Next
CCW Position”. Touch “√” to return to service main menu. Touch “NO” on the
dialog box “De-energize motor?”
6 On the windows like menu enter Service then Motor Adjust then Rotor Arm
Motors and Rotor Arm Vert. Motor. The system displays the screen below.
Horizontal Arm
Logical Area Current Value
Waste Position T 0
7 Touch “Home Position” and then on the current value of the window “Chose Step
Increment”. The value goes in reverse video.
8 Press “Canc/Delete” on the main keyboard to delete the value. Key in 40 as new
value.
9 Press the cw arrow in the left bottom side of the screen. The Rotor Arm will lower
by 40 steps.
10 Repeat last operation as many times as necessary to lower the Rotor Arm down
until it actuates the Rotor Holder Snap mechanism located in the center of the
Rotor Holder. Visually inspect for best matching. Set “Step Incerment” back to 1.
11 If off center loosen the 5 R.E.M. locking screws located over the Fluidic Plate,
gently move the whole R.E.M. assembly to obtain the best matching then secure
the R.E.M. in place again.
12 The adjustment is now complete, press “√” to return to service main menu. Touch
“YES” on the dialog box “De-energize motor?”.
13 Manually load a new rotor on the Rotor Holder.
14 On the windows like menu enter Service then Module Positioning Test and RA –
RH Test.
15 The instrument exercises the Rotor Arm performing repeated picking/loading of
rotor from/to the Rotor Holder. Let the system operate for a suitable number of
cycles and verify for proper operation, touch “Abort” once confident that
adjustment is acceptable.
Note: While performing RA-RH test check that rotor is carried freely to/from the
Rotor Holder. Should the rotor touch the fluidic plate during the motion then follow
the “Rotor Arm Tilt Adjustment” procedure as detailed in section 7.7.8.
If during the Rotor Arm movement the rotor carried touches the Fluidic Plate, it is
necessary to repeat the Rotor Arm Centring procedure as described in the sub-section
7.7.6 with an additional operation at point 13. Before tightening the 3 setscrews put
the aluminium support at the top of the shaft housing (about 2 mm over) to lift up the
Rotor Arm.
If the problem persists it can be solved also with the tilt up of the Rotor Arm through
the setscrew located below the electromagnet pin.
To tilt up the Rotor Arm proceed as follows:
Setscrew
located under
electromagnet shaft
3 Loosen a little the 2 cap screws that hold the Rotor Arm in place.
4 Turn cw the setscrew to raise the Rotor Arm and obtain best condition (inserting a
rotor in the Rotor Arm and then, with the vertical motor raised, inspecting the
distance from the bottom of the rotor and the Fluidic Plate).
5 Tighten the 2 cap screws that hold the Rotor Arm on the aluminium support.
6 Replace the Rotor Arm Electromagnet paying attention to the distance of the
magnet and the run of the pin (too close won’t open enough; too far jam and won’t
close).
7 Perform the R.E.M. self test as detailed in section 7.7.9. to insure proper fit.
NOTE: Also insure that the Hex Nut securing the two rotor arms is tightened
sufficiently to allow the arms to securely grasp the rotor edge in the arm slot. If the
Hex Nut is loose one arm may be lower or higher than the other and may ride above
the rotor edge preventing the rotor from being picked up.
7.7.9 R.E.M. (Rotor Exchange Module) self test (ACL ElitePro only)
The Rotor Exchange Module is a major assembly that incorporates the Rotor Stack,
Rotor Transport and Rotor Arm. The R.E.M. must be aligned to the Rotor Holder.
The procedure is detailed in section 7.7.7.
This test is designed to verify the proper alignment of the major sub-assembles of the
Rotor Exchange Module and the Rotor Holder.
1. Turn On the Instrument then access the Service program main menu.
2. Load a stack of 10 new rotors in the Rotor Stack. Empty the Rotor Waste
container and place it back onto its housing.
3. On the windows like menu enter Service then Module positioning test and RA
– SL – RH test.
4. The instrument initializes the motors of the R.E.M., the Rotor Holder and the
Rotor Cover.
5. Once initialization is completed the system starts loading / unloading rotors
until the stack of rotors is exhausted.
Note: If the R.E.M. cover is open or is out of place then the Rotor Stack Cover Sensor
detects this condition and the system, for safety purposes, won’t allow opening of the
Rotor Stack Upper Electro-Magnet. To override this situation and achieve a good
visual inspection without the R.E.M. Cover, put a little magnet on the magnetic sensor
(try both the 2 sides of the magnet to find the proper polarization).
Visually inspect for proper movement of rotors. If any problem is present then
perform the relevant check out and adjustment procedure.
This test is designed to verify the overall system precision. The test is automatically
performed by the instrument and performs three series of six replicates with each
solution at three different concentrations (undiluted, diluted 1/2 and diluted 1/4).
CV % are then calculated for each series, and reported on the screen. The test can be
configured for one Channel (Coagulimetric / Chromogenic) and one dilutor (sample /
reagent) at a time. Any imprecision of the system could be generated either by the
fluidics system (Fluidic parts obstruction, Electro-Valves, air bubbles and/or dilutors
compensation value) or by the optical system (light sources and/or detectors).
Note: Should this test fail, it would be advisable to perform the “Optical channel
check out and adjustment procedure” to verify the system optics. If the system optics
pass the tests then troubleshoot the fluidic system.
Following are described the procedures to test the Reagent Dilutor with both the
Coagulimetric and Chromogenic Channels.
Note: To test the Sample Dilutor with both Channels, set the Loading Type with
“Sample Dilutor”. The only additional operation required is to temporarily exchange
(only for the duration of the test with the Sample Dilutor) the two fluidic tubes that
are connected to the Needles Block.
Precaution
Make sure that the instrument has been turned On for at least 20 minutes (warm-up of
light source and thermoregulation) prior going through the following procedure:
4 Select on the screen “Coagulimetric” on the left window and “Reagent Dilutor”
on the right window.
5 Load 4 ml of Wash-Reference Emulsion into a clean, empty 4 mL reagent vial and
place it with its adapter in the reagent position R1.
6 Load 4 ml of distilled water into a clean, empty 4 mL reagent vial and place it
with its adapter in the reagent position R4.
7 Place a brand new rotor into the analysis compartment.
8 Press “Start in Manual Rotor Loading”. The instrument will load the rotor
cuvettes picking the Wash-Reference Emulsion and the distilled water from the
reagent vials by using the reagent needle and the Reagent Dilutor.
9 Wait for the completion of rotor loading and acquisition cycle then verify that the
following results are obtained.
Precaution
Make sure that the instrument has been turned On for at least 20 minutes (warm-up of
light source and thermoregulation) prior going through the following procedure:
4 Select on the screen “Chromogenic” on the left window and “Reagent Dilutor” on
the right window.
5 Take the content of two vials (4 mL) with PNA concentration 160 µmol/L (taken
from the kit P/N 97579-50) into a clean, empty 4 mL reagent vial with their Green
adapters and place it in reagent position R1.
6 Load 4 ml of distilled water into a clean, empty 4 mL reagent vial and place it
with its adapter in reagent position R4.
7 Place a new rotor into the analysis compartment.
8 Press “Start in Auto Rotor Loading. The instrument will load the rotor cuvettes
picking the PNA and the distilled water from the reagent vials, by using the
reagent needle and Reagent Dilutor.
9 Wait for the completion of rotor loading and acquisition cycle, then verify that the
following results are obtained:
This test is designed to verify and/or adjust the overall accuracy of the dispensation of
the dilution system. The accuracy of the dispensation is verified by means of a special
tool called “Graduated Capillary”. It allows a visual verification of the volumes being
delivered.
The test can be performed using distilled water, however as the results are based on
visual inspection of liquid being actually drawn into the capillary, a dye based
Materials / tools necessary for the test: - Graduated Capillary Kit P/N 8258900
- Small beaker (10 ml) or other suitable
container.
- Distilled water (or dye based aqueous
solution).
1 Prepare a small beaker with a few ml of either distilled water or a dye based
aqueous solution (if available).
2 Gain access to the service program menu.
3 On the windows like menu enter Diagnostic then Priming. The system performs a
fluidic priming cycle.
4 Once the priming is over go through the sequence Service then Dilutors Test then
Volume Check and Sample Dilutor/Reagent Dilutor. The system presents the
screen below.
5 Disconnect the Sample/Reagent needle tubing (the tubes on the Needles Block)
and connect it to a Graduated Capillary (connect the capillary to the upper tubing
to test the Sample Dilutor line or to the lower tubing to test the Reagent Dilutor
line).
6 While holding the capillary above a small beaker out of the liquid press “Start”.
The system will perform a short prime cycle (to fill the capillary) followed by a
re-aspiration. At this time an air bubble is withdrawn in the Graduated Capillary
and a dialogue box is presented on the screen
7 Immerse the Graduated Capillary into the distilled water, or a dye based aqueous
solution then press “OK“.
8 The system aspirates about 10 μL of water or a dye based aqueous solution (if
available) into the capillary. Verify that the head of the liquid sets between the
two upper marks of the Graduated Capillary.
9 After 10 seconds the instrument will automatically deliver most of the content out
of the Graduated Capillary.
10 Check that the liquid that remains sets between the two lower marks of the
Graduated Capillary (more close to the middle as possible). In this condition
(dispensed volume within range) no adjustments are needed, but if the liquid sets
above or below the two lines then a correction is required. The correction can be
entered in the window “Select Correction Value”.
11 Increase value if too much water stays in the Graduated Capillary at the end of
step 9 (dispensed volume insufficient), while decrease value if the water is too
close or below the lowest mark on the Graduated Capillary (dispensed volume too
high).
12 Repeat test to assure that entered value achieves proper volume dispensing.
13 If value has changed with respect to the original setting, record the new value on
the paper label located on the right side of the instrument.
14 Press “√” to exit, remove the Graduated Capillary and refit tubing to the
Sample/Reagent needle.
U p p e r R e fe re n c e lin e s
Lo w e r R e fe re n c e lin e s
A s p ira tio n Le v e l
D is p e n s e d D is p e n s e d D is p e n s e d .
V o lu m e V o lu m e V o lu m e
IN S U F F IC IE N T W IT H IN R A N G E TO O H IG H
This procedure is designed to verify the functionality of the Rotor Holder Cover
Sensor.
1 Remove the side and rear covers to gain access to the cardcage.
2 Connect a DVM between TP21 on the Acquisition & Sensors board (bd#3), and
ANA GND, TP0 on board #4.
3 From the Service menu select Optical Module Test, Acquisition Adjustment.
4 Push “Start”. The rotor cover will close. While the rotor module is rotating adjust
VR5 on the Acquisition & Sensors Board (Bd #3) to read 2700mv +/- 10mv on
the DVM. Also check that LED DL3 is “ON”.
5 Push the “Stop” key to end the acquisition cycle. When the rotor cover opens,
check that the voltage indicated on the DVM is between 1400mv to 1900mv.
Also, check that LED DL3 is “OFF”.
6 If the values are not met check the position of the Hall Sensor (located
underneath the rotor module), with respect to the magnet (located in the rotor
cover). If necessary loosen and move the Hall Sensor and repeat procedure.
7 Press “√” to exit.
Note: To work properly, this sensor needs correct assembly and the presence of its
permanent magnet. This is placed inside the Rotor Cover Assembly and must be
correctly polarized.
This procedure is designed to verify the functionality of the Rotor Stack Cover
Sensor.
Note: To work properly, this sensor needs the presence of a permanent magnet. It’s
placed inside the Rotor Stack Cover and must be correctly polarized.
This sensor doesn’t need adjustment because it works with a digital output signal (On
or Off).
3 Open the Rotor Waste compartment door and verify the presence of the Rotor
Waste Container (if absent put it in place) then close the door.
4 Check that on the “Rotor Waste Presence Switch” line there is displayed a “√”.
5 Open the Rotor Waste compartment door and remove the Rotor Waste Container
then close the door.
6 Check that on the “Rotor Waste Presence Switch” line the “√” disappears.
7 Press “√” to exit.
Note: This sensor doesn’t need electronic adjustments because it works with a digital
output signal (On or Off).
Note: Prior to starting this procedure it’s advisable to remove the Metallic Drip Tray
located between the Dilutors Module and the Switching Power Supply.
Note: The trimmers are located on the Switching Power Supply in the zone under the
CPU Master Board. To gain access to them it is required that the Instrument is Turned
Off and is necessary to remove the entire CPU Master package (CPU Master, PC104
and HDD).
6 If there are voltages Out of Range, try to check the S.P.S. Board without loads. If
without loads the problem persists then replace the S.P.S. Board.
Note: The S.P.S. Board has many protection circuits on board (see sub-section
3.3.10). When one of them is activated the S.P.S. enters into “Protection Mode” (Turn
Off all the voltages and put the LED DL1 On).
Materials / tools necessary for the test: - Touch Screen Calibration Tool
P/N190574-00
Note: If the Touch Screen Calibration Tool is not available then it’s advisable use an
object with the tip rounded. Don’t use any object that can damage the Touch Screen
surface.
1. The serial Connection COM1 must be disconnected from the PC104 Board
(connector CN-6) and reconnected to the CPU Mother Board connector CN-
25. To gain access to CN-25 on the Main CPU board it is also necessary to
disconnect COM2 (CN-7), COM3 (CN-8) and COM4 (CN-9) from the PC104
Board. Leave COM 2, COM 3 and COM4 connectors disconnected for this
procedure.
2. Insert the DOS 6.2 Boot Diskette into the floppy drive and power the
instrument ON.
3. At the C:\ prompt type cd touch (and press ENTER) to get to the Touch
directory. From the Touch directory type Smartset (and press ENTER) to
open the Series Setup Utility.
5. The Touch Screen has to be configured as follows, (use the arrow keys to
move to items and ENTER to change options).
• Communication:
o Hardware Handshaking: select Disabled
• Touch Mode:
o Stream Touches: select Disabled
o Calibration: select Enabled
o Scaling: select Enabled
• Touch Reporting:
o Report Delay (x 10ms): select 15
• Scaling:
o X high: select 800
o Y high: select 600
6. With the proper pointed tool (IL part number 190574-00), touch the following
corners of the display screen.
Upper Left Corner
Lower Right Corner
Several lines of touch screen communication data should be displayed
after each successful touch.
7. Save the calibration by typing: N$01$07 and press ENTER then press
ESCAPE (Esc) to save the calibration and exit.
8. To check the calibration select Touch Testing and press ENTER. The
following Touch Testing screen will appear.
Press ESCAPE to get back to main Menu.
Touch packet format: Smartset Binary
X Y Z Status: Touch Flag:
9. Touch the top left and then the bottom right corners of the display screen with
the pointed tool (IL part number 190574-00) and confirm that the displayed
coordinates for X and Y are approximate to the theoretical values 0 to 800 for
X, and 0 to 600 for Y. The maximum acceptable tolerance for these readings
is +/-2.
For example:
Note: If the touch screen cannot be set within the specified tolerance, return to
the Main Menu and repeat steps 5. thru 8.
10. Upon successful completion press ESCAPE to return to the Main Menu.
12. After the configuration has been saved, select EXIT to exit the Smartset
program. Remove the boot disk and power off the ACL.
13. The serial Connection COM1 must be reconnected to the PC104 Board.
Disconnect the COM1 cable from the CPU Mother Board connector CN-25
and connect it to the PC104 Board connector CN-6. Reconnect COM2 (CN-
7), COM3 (CN-8) and COM4 (CN-9) to the PC104 Board.
14. Reboot the ACL. Confirm touch screen operation using the ACL system
software by pressing the selection buttons and pull down menus on the screen.
Using your finger, confirm that pressing the center of the icon, button or pull
down menu tab, the function is activated.
Note: During the calibration procedure any error may occur or the time out to touch
the proper red rectangle on the screen has expired (15 seconds). In this case a
windows appears with inside the information that the touch screen calibration is
aborted. In this condition the Touch Screen is “out of order” and is needed to use the
TAB key (or the mouse if available) to select the Retry button and then press the
Enter key. Repeat the entire procedure until the Touch Screen is successfully
calibrated.
This test is designed to verify the functionality of the Mouse interface serial port.
Materials / tools necessary for the test: - RS 232 C Interface Check Connector
P/N 99211-01
- RS 232 C Interface Check Connector
Adapter P/N 71467-70
Note: If the RS 232 C Interface Check Connector and its Adapter are not available
then it’s advisable use the customised 9 Pin Check Connector (Female) as reported in
the section 6.2 “Service Tools”.
3 Touch the little arrow on the side of test name then select the “RS 232 Mouse HW
loop” option.
4 Press “Continue”.
5 A window appears with inside the instruction “Please install RS 232 Check
Connector on Mouse serial port”.
6 Properly install the RS 232 C Check Connector with the RS 232 C Check
Connector Adapter on the Mouse serial port.
7 Press “Start”.
8 The next window with the results may be “Test Passed” or “Test Failed”. If the
test failed then it is necessary to troubleshoot the Mouse serial line.
9 Press “OK” to exit.
Note: In case of the result “Test Failed” then investigate the Interface Board, the Flat
Cable, and the CPU Master & PC104 Boards.
This test is designed to verify the functionality of the Host interface serial port.
Materials / tools necessary for the test: - RS 232 C Interface Check Connector
P/N 99211-01
- RS 232 C Interface Check Connector
Adapter P/N 71467-70
Note: If the RS 232 C Interface Check Connector and its Adapter are not available
then it’s advisable use the customised 9 Pin Check Connector (Female) as reported in
the section 6.2 “Service Tools”.
3 Touch the little arrow on the side of test name then select the “RS 232 Host HW
loop” option.
4 Press “Continue”.
5 A window appears with inside the instruction “Please install RS 232 Check
Connector on Host serial port”.
6 Properly install the RS 232 C Check Connector with the RS 232 C Check
Connector Adapter on the Host serial port.
7 Press “Start”.
8 The next window with the results may be “Test Passed” or “Test Failed”. If the
test failed then it is necessary to troubleshoot the Host serial line.
9 Press “OK” to exit.
Note: In case of the result “Test Failed” then investigate the Interface Board, the Flat
Cable, and the CPU Master & PC104 Boards.
7.13.3 USB
There is no Diagnostic test available for the USB ports. To test a USB port connect a
USB device such as a USB mouse and verify system operation.
This test is designed to verify the functionality of the Parallel Printer interface parallel
port.
Before turn on the Instrument connect through the External Printer Cable the PC
Standard Parallel Printer.
1 Turn on the Instrument then gain access to the Service program menu.
2 On the windows like menu enter Service then Interfaces Test. The instrument
shows the screen below.
3 Touch the little arrow on the side of test name then select the “Parallel Printer”
option.
4 Press “Continue”.
5 A window appears with inside the instruction “Please connect an external printer
on the parallel printer port”.
6 Turn on the printer and verify the presence of the paper inside then put the printer
“On Line”.
7 Press “Continue”.
8 The next window with the results may be “Printer Test Passed” or “Printer Test
Failed”. If the test failed then it is necessary to troubleshoot the Parallel Printer
line.
9 Visually inspect the print out of the External Printer in order to detect data
transmission problem.
10 Press “OK” to exit.
Note: In case of the result “Test Failed” or “Wrong” print out then investigate the
Interface Board, the Flat Cable and the CPU Master & PC104 Boards.
Materials / tools necessary for the test: - Temperature Probe P/N 70954-00
Note: Before performing this check procedure make sure that the Instrument is turn
on at least for 30 minutes.
3 Verify that all the devices are in the proper range of Temperature.
Note: If the System detects a temperature out of range, after few seconds a warning is
displayed and the temperature is displayed in red color. If the instrument has been
turned on for only a few minutes or there is a problem on a specific device then the
temperature may be out of its range. In this case the temperature is displayed with “–
– –“ when the temperature is too low or with “* * *” when the temperature is too high
in respect to its working range.
Important: For Rotor Holder temperature verification use the Temperature Probe P/N
70954-00 to measure temperature inside the analysis plastic rotor. The relevant test is
described with the tool in the section 6.2 “Service Tools”.
The Instrument is provided with an internal cooling system. This is composed of the
Instrument Fan Assy, located on the rear-right side of the instrument, that forces
airflow inside the instrument and cleans it from dust through the Air Filter.
A Secondary Fans system, located on the left side of the instrument, forces the heated
air outside.
A specific Fan Control Board with onboard a temperature detector is also present.
This board provides power to the Peltier Fan that is always working and turns on the
Auxiliary Fan when the temperature of the air around the board exceeds 36 °C (over
36 °C turn on the Auxiliary Fan, under the 34 °C turn off the Auxiliary Fan).
The functionality of this board may be tested using a hair-drier.
The maintenance of the Air Filter is very important for the maximum efficiency of the
internal air cooling system.
Note: The inefficiency of the internal air cooling system may be critical for the
Switching Power Supply Board. The SPS is provided with a temperature control
circuit which displays a temperature warning (over 60 °C) and then shuts down the
instrument if the temperature exceeds 75 °C.
Materials / tools necessary for the test: - 1,44 MB Floppy Disk formatted
Note: If a 1,44 MB Floppy Disk formatted is not available it’s possible to format a
new one with a Personal Computer with standard operative system (DOS / Windows).
3 At the beginning of the floppy presence test verify that there is no floppy disk
in the Floppy Disk Drive.
4 Press “Continue”.
5 A window appears with inside the message “Operation in progress. Please
wait”.
6 In case of test failure, a window appears with inside the message “Disk
present in drive. Extract floppy before proceeding”.
7 At the beginning of the floppy write protected test insert a write protected
floppy disk in the Floppy Disk Drive.
8 Press “Continue”.
9 A window appears with inside the message “Operation in progress. Please
wait”.
10 In case of test failure, a window appears with inside the message “The inserted
Floppy disk is not write protected”.
11 At the beginning of the floppy usability test insert a formatted blank floppy
disk in the Floppy Disk Drive.
12 Press “Continue”.
13 A window appears with inside the message “Operation in progress. Please
wait” then another window with the test progress bar is displayed. At the end
another window appears with inside the message “Floppy disk drive test
successfully completed”.
14 In case of test failure, a window appears with inside the message “Usability
floppy disk test failed (on creating file)!”.
15 Press “OK” and then “Cancel” to exit.
Note: In any of the tests fail then investigate the Floppy Disk Drive, the Flat Cable
and the CPU Master Board.
3 Verify that all the Software releases are in the latest versions available.
4 Press “√” to exit.
Note: The Master and the IL Library software version displayed are the software
version stored on the HDD, while the Slave and the REM software version displayed
are the software version stored in the boards Flash EPROMS memories (Boards #2
and #4).
If for troubleshooting purposes the current Slave Board #2 or REM Board #4 are
replaced it’s required to perform the Upgrade procedure. This will program the new
board memories with the last software revision that is Uploaded (stored) on the Hard
Disk Drive. Only after the Upgrade procedure will the last software revision be
written to the boards Flash EPROM memory.
The “Upgrade” program allows the software to be loaded from the Hard Disk Drive to
the specific board memory.
This sub-section is designed to clarify the actions that are possible when a Database
Error is encountered.
If the Checking Database during the Init System phase (at Turn On) detects a problem
then the system shows the following menu.
Database check reported some errors. Please select one of these options.
If this option is selected then the system proceeds with the restore of the last valid
database saved.
Caution! That means that all the data and modifications stored from the last self-
backup (on “date” and “time”) to now will be lost!
If this option is selected then the system proceeds showing the message “System
halted. You can safely turn off ACL.”
Caution! It is possible that after the Init System the instrument is halted with a
database failure message. This may result in the instrument database being corrupted
and the access to the Operator Main Program is denied. In this case the only option is
to turn off and then on again the instrument, and choose 1 (Restore last saved
database) in the menu.
Caution! If, after the Init System, is possible gain access to the Service Program then
it’s advisable try to perform an “Archive” of all the data not saved yet (QC, AR,
Calibrations and Patient data) and also a Backup of the system configuration (if an
other one is not available) as described in the sub-section 7.16.3.
After this, on the windows like menu enter Service then DataBases Check.
The system shows a window where it is possible to select one of the four following
options.
If also through this menu it’s impossible to recover Data and/or Setup configuration
then Log-Out, switch off and then On the Instrument and in the menu select the option
“1 – Restore last saved Database”.
This sub-section is designed to provide information about the Backup / Restore of the
system configuration.
The following procedure allows the service engineer to save on a floppy disk the
current configuration of the instrument with the purpose to create a backup copy that
may be restored in the future on the same but also on other instruments.
The databases that will be saved contain information about the setup of:
• Liquids
• Tests
• Profile
• QC
• AR
• Interface configuration
• System configuration
Following is the procedure is to restore the backup data file on the instrument.
Touching the button “View Backup Date” it is also possible to check the date of the
Backup file on the floppy disk without proceeding with the Restore.
For all the tests updated in the databases with a new revision the calibration, AR, QC
and patients data will be lost. In the end of the operation the system provides to the
service engineer / customer the list of all the data erased.
Software Re-install
The Slave software upgrade must be selected before the application software
is installed. To select Slave Upgrade and install software perform the
following steps:
10. Insert the floppy disk labeled “ACL Elite/ElitePro SW DISK 1” into
the floppy drive and power on the ACL.
11. The “Scandisk” program will start automatically. When completed it
will be followed by the “Defrag” program.
12. Wait until “Defrag” is completed.
13. You will be prompted to insert the last disk of the set, insert the disk
titled “ACL Elite/ElitePro SW DISK 4”, then the disks “ACL
Elite/ElitePro SW DISK 1”, “ACL Elite/ElitePro SW DISK 2”,
“ACL Elite/ElitePro SW DISK 3” and “ACL Elite/ElitePro SW
DISK 4” when prompted..
14. When the following prompt appears:
“Do you want to install a new database?” with the following options:
“Press “Y” if you want to install a new Data Base”
“Press “N” if you want to maintain the actual Database”
Press “N” to keep the database. (If upgrading existing software or
reloading software onto an existing Hard Drive).
Press “Y” if loading software onto a New or Re-Formatted Hard
Drive or if the Database is suspect of corruption).
Automatically the “Scandisk” program will start, when completed it
will be followed by the “Defrag” program.
15. Wait for the instrument to finish with the disks as indicated by the
C:\TEMP> prompt and remove “ACL Elite/ElitePro SW DISK 4”
from the floppy drive.
16. Power Off and then Power On the ACL to start the SLAVE
UPGRADE procedure.
17. Several screens appear before the ACL initialization. During the
machine initialization, the message “Erase Flash Memory in progress. .
.Please wait!” is displayed, followed by “Slave Code Upgrade in
progress. . .Please wait!”
18. At the end of the SLAVE UPGRADE procedure the ACL is upgraded
at new release of software for the Slave and the Master boards.
19. At the end of the start-up the “ACL Login” window should be
displayed. Log into the machine using the user “Service” and
password “System Fix”.
from the main menu. Verify that all tests recorded are enabled, and if
they are not, enable them.
Once logged onto the ACL, you must make sure that the machine knows if
it is an Elite or ElitePro. To do this, use the following steps:
• Select the “Utility” menu option and click “Software”, then
“Software Identification”
• Verify that the correct versions of software for the Master, Slave,
REM and IL Test Library are displayed: Select the confirm button
to exit the window.
• Select the “Diagnostic” menu option and click on the “Service”
option.
• If you did not log onto the machine as user name “Service” you
will be asked to now, the password is “System Fix” and is case
sensitive.
• Once you are logged in as “Service”, select “Service” menu option
and click on the “Hardware Configuration” option.
• If the instrument is an ACL Elite, the box labeled “Additional
Reagents” should be de-selected, and the box labeled “REM
Installed” should be de-selected.
• If the instrument is an ACL ElitePro, the box labeled “Additional
Reagents” should be selected, and the box labeled “REM
Installed” should be selected.
• The “Instrumentation Model” text box will display the type of
instrument that has been selected.
• Press the “Confirm” button to save this setting.
Note: Replacement Hard Disk Drives will not have the ACL Application
Software installed. Replacement Hard Disk Drives must be prepared to accept
the ACL Application Software. Preparation of the hard disk drive includes
partitioning and formatting the drive.
1 Insert the floppy disk labelled “Boot Disk & DOS 6.2 SW” into the floppy drive
and turn the instrument on to boot up in the DOS environment.
2 To partition the hard disk drive, at the A:\ prompt type the “fdisk” command and
press the Enter key.
3 A Menu is displayed indicating 4 options. Select option 1 “Create DOS Partition
or Logical DOS Drive”, and press “Enter”.
4 A new Menu is displayed with 3 options. Select option 1 “Create Primary DOS
Partition” and press “Enter”.
5 The system will display “Do you want to use the maximum available size for a
Primary DOS Partition and make the Partition active?” Select “Y” and press
“Enter”.
6 The Partition routine will start. When finished the partition status will be
displayed as follows:
7 When the partition has been created press ESC to exit from the “fdisk” command.
8 With the Boot Disk & DOS 6.2 SW disk in the floppy drive power the instrument
off and on again to reboot.
9 At the A:\ prompt type “format c:” and press the Enter key. Confirm the
message “Warning: All data will be lost. Non-Removable Disk Drive C will be
lost” by pressing “Y” and press the Enter key. This will start the formatting
routine.
10 After format completion the display will indicate “Volume Label (11 characters,
Enter for none)”. Press “Enter” for no volume label.
11 When the formatting is complete press the Enter or ESC key to finish.
12 Remove the Boot Disk & DOS 6.2 SW disk from the floppy drive and power the
instrument off.
13 To install the application software follow the procedure outlined in section 7.16.5.
14 After formatting harddrive and loading software the motor phases, instrument
configuration, (ie Interfaces, Barcodes, etc.) must be performed.
If the Main CPU board is replaced the System BIOS Setup should be checked.
To check System BIOS Setup perform the following.
1 To enter the BIOS Setup environment turn the instrument power on and hold
down the [Del] or [Canc] key.
2 When you are in the BIOS Setup environment the following options will be
displayed:
6 CHIPSET CONFIGURATION
Internal VGA Boot On: CRT + FP
Internal COM 1: Enabled
Internal COM 2: Enabled
Internal COM 3: Disabled
Internal COM 4: Disabled
Internal COM 5: Disabled
Internal Audio: Disabled
7 After confirming or modifying BIOS Setup, select “Write to CMOS and Exit”
and press the Enter key.
1. Disconnect cables CN7, CN8 and CN9 form the PC 104 Board. Leave these
cables disconnected.
2. Disconnect the video cable, CN6 from the PC 104 Board and connect it to
CN25 on the Main CPU Board.
3. Insert the Boot Disk & DOS 6.2 SW disk into the floppy drive and boot the
instrument.
4. From the C:\ prompt type “new_set4” command and press the Enter key.
Instructions to configure the system with the following options will be shown:
Check that the system is configured as indicated below.
5. To exit from the “new_set4” environment saving the configuration, press the
“End” or “Fine” key.
6. Remove the disk from the floppy drive and power off the instrument. Connect
all cables (CN6, CN7, CN8 and CN9) to their original positions.
7. Power on the instrument and confirm system boots. (Note: If the touch screen
is inoperative it may be necessary to perform the touch screen calibration
described in section 7.12).
Chapter 8
System Interfacing
This chapter provides the main information related to the configuration of the instrument
interface for the communication with external devices.
The devices that are possible connecting to the instrument are following.
8.1 Keyboard
8.2 External Parallel Printer
8.3 Network
8.4 Modem
8.5 Mouse
8.6 Host Computer
8.7 Internal Bar Code Reader
8.8 External Bar Code Reader
8.1 Keyboard
On the windows like menu select “Setup” then “Interfaces” and “Keyboard”. The system
displays the screen below.
The window in this screen allows configuring the ACL Elite/ElitePro PC standard
keyboard for the language and layout used. Also the enabling of the on-screen keypad is
configurable by selecting:
8.3 Network
Not supported in this Software Revision.
8.4 Modem
Not supported in this Software Revision.
8.5 Mouse
The mouse may be used as a selecting device in place of touching the screen.
At instrument turn on, during the “Init. System” phases, the instrument checks the proper
serial port or USB port for the presence of a mouse.
If the mouse is detected then the cursor arrow appears on the display.
If the mouse is connected after the “Init. System” phases then the instrument will not
detect it until the next time the instrument is powered off and on.
The window in this screen allows configuring of Host Computer interface selecting:
The following table provides information regarding the wiring of the interconnection
cable between the ACL and Host Computer.
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. Choose
for each field one of the options below according to the laboratory’s needs.
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
The External Bar Code Reader is used to Identify IL Reagent Bar Code labels. Enable
the external barcode reader by selecting the box labelled External BCR Enabled. Select
additional fields as appropriate.
Chapter 9
Part List
This chapter contains information about the service parts as well as the expendable
materials that are available for use with the ACL Elite/ElitePro System. A large number
of the expendable materials are shipped in the “Startup Kit” included with the ACL
Elite/ElitePro system. These items may be ordered using their Part Numbers as shown in
the tables.
Following are the specific sections.
• Sample Trays
Three types of sample trays are available as shown below. The startup kit includes two of
them, chosen by the user according to the desired system configuration.
• Sample and Reagent Tubing 1.5 meter piece of tubing to be cut and used as
needed
• Insertion Tool for Tubing a tool to be used when replacing sample and
reagent tubing
• Adjustment Tool for Needles a tool to be used for adjusting the position of the
needles in the arm
• Rotor Insertion Tool a tool used for inserting rotors into the system
• Moulded Air Filter One air filter for the analyzer body
• Power Cord a power cord for the system: the cord included is
consistent with the voltage with which the
system will be used
• Software System Disk Kit kit containing the main system software
• Test Library Disk Kit kit containing the test library software
• Operator’s Manual the Operator’s Manual for use of the ACL system
• Hand Held Barcode Scanner USB Hand held barcode scanner with mounting
hardware (ElitePro only)
Note: The Hard Disk Drive Kit, part number 065033-01 does not contain software.
After replacement of the hard drive the hard drive must be partitioned and
formatted prior to the application software being loaded. Refer to section 7.16.
Chapter 10
Drawings
This chapter is designed to group all the main drawings related to the specific chapters
included in this service manual. The drawings are organized by section number (chapters
where referenced) and then for number of drawing used in the section (chapter).
Chapter 11
Service Notes
This chapter is designed to allow the service engineer to add to the service manual
any service product information (service notes) that will be released in the future
This is to allow the service engineer to add all the notes in a specific place or
otherwise to move the service notes to the specific chapter where the notes need to be
added.
Chapter 12
Revision 2.3
Dec 2005
Index
1.0 Introduction 4
1.1 Purpose 4
2.0 General Description 5
2.1 Product Perspective 5
3.0 Specific Requirements
ERROR! BOOKMARK NOT DEFINED.
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 10
3.5.1.2 Test Order Message 11
3.5.1.2.1 Patient Information Record 10
3.5.1.2.2 Test Order Record 12
3.5.2 Host Query 15
3.5.3 Test Request Message 15
3.5.4 Test Order Message 16
3.6 Rejected Test Order 18
3.7 Download Session Volumes 19
4.0 Test Results Uploading 20
4.1 Test Result Message 21
4.1.1 Patient Information Record 20
4.1.2 Test Order Record 23
4.1.3 Result Record 24
4.1.4 Comment Record 23
4.1.5 Error Codes 24
4.2 Upload Session Volumes 26
5.0 Not Supported Records 27
6.0 Transmission Abort 27
7.0 Appendix - ACL Elite/Elite Pro Test Codes 28
8.0 Appendix - ACL Elite/Elite Pro Supported Characters 31
8.1 Supported Characters for Sample ID 31
8.2 Supported Characters for Patient name and Department 31
8.3 Supported Characters for delimiters 31
9.0 Appendix - ACL Elite/Elite Pro Supported Units 32
1.0 Introduction
1.1 Purpose
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.
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 the Appendix at the end of this document for the test codes
table.
Note: for the downloading the Host should send to the ELITE/ELITE PRO string
information in single frame (single line) during the transmission or up to 240 bytes
maximum during the transmission.
.
Parity No parity
Stop Bits 1
For the Data Link and Logical Layer the ASTM specification E-1381-91 has been
maintained as a reference. Protocol limits and constraints are those declared by the
standard.
To mention some of them, the data part of the frames exchanged between the
instrument and the host computer should be done as single frame. As a consequence
during transmission sessions specific routines provide the ability to divide large
records into multiple frames and during a reception session they re-build partial
frames in a single record. The application level has no evidence of this mechanism.
According to ASTM standard the following characters cannot be part of data records:
<SOH>, <STX>, <ETX>, <EOT>, <ENQ>, <ACK>, <DLE>, <NAK>, <SYN>,
<ETB>, <LF>, <DC1>, <DC2>, <DC3>, <DC4>.
Timeout and retry logic are those specified by the standard; the Low Level Clinical
Message State Diagram representing the implemented automatic is the reference.
In interrupt request status the instrument accept remote EOT.
3.4 Sessions
There are two types of sessions that the instrument handles with the ASTM interface:
the test orders download and the test results upload. These sessions can be initiated by
the operator or automatically activated by the instrument.
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.
H|\^&|||ACL9000|||||||P|1|20021205123956<CR>
H|\^&||||||||ACL9000||P|1|20021205123956<CR>
Example of Terminator:
L|1|N<CR>
Test order downloading is used to request test orders available on the host and to have
them on the instrument. This operation can be obtained in two ways: manually
opening a download session from the DMS environment or enabling on the
instrument the host query function.
In the first case the host will have to transmit to the instruments all pending test
requests; in the second case the instrument will automatically require specific
information for the samples placed on the sample tray and without any test requests.
Details for both modalities are explained in Receive Session from DMS and Host
Query paragraphs.
The operator manually initiates the test order download from the DMS environment.
The host will provide to the instrument all available test requests. The host can send
zero or more test orders in one or more messages, but all messages will be part of the
same transmission session.
During a transmission session more test orders can be required for the same sample.
The host sends usually all test orders for which it has not yet received results even if
they have been previously transmitted.
ELITE/ELITE PRO instruments will process each received test order to validate fields
supported; some information will be extracted from the received record while other
information will be ignored.
Only test orders related to patient samples are considered, if the required sample ID
does not exist in the patient database and the required sample ID is not used in the QC
database, a new record is created. If the database is full, the transmission session will
be aborted.
If the test orders are for a sample already existing in the sample data base, the new
orders will be added to the existing tests but all tests already ordered or performed
will remain unchanged.
If a test order with more than the maximum number of programmable tests is sent, the
request is rejected. The limit is 30 single tests or 10 double tests.
If the test order is not recognized as one of those supported by ELITE/ELITE PRO
family instruments, it is rejected. The instrument will inform the host computer using
a record containing the list of rejected test orders.
During a downloading session the listed error conditions can be detected, the
associated instrument behavior and actions are listed as well:
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.
The Test Request Message is used by ELITE/ELITE PRO to start the test order
download session. It is composed from a Message Header record, a Request
Information record and a Message Terminator record.
The “Request Information record” requests from the host ALL test orders available
for the specific instrument.
Following the ASTM specification the fields composing the Request Information are
described in the following.
H|\^&|||ACL9000|||||||P|1|19960210103227<CR>
Q|1|ALL||||||||O<CR>
L|1|N<CR>
To answer the ELITE/ELITE PRO Test Request Message, the host computer sends the
Test Order Message. It contains the records specifying which tests are being requested
for each specified sample. The host computer may answer with one or more message;
each one contains one or more test order specifications. The test order specification
consists of a Patient Information record followed by one or more Test Order records.
The host can send for the same sample ID a Patient Information record followed by
many Test Order records or, for each test to be ordered, a pair composed by the
Patient Information record followed the Test Order record.
Comment Record messages during downloading operations are ignored by
ELITE/ELITE PRO.
standard, is YYYYMMDD
Patient Sex Stored if available. Allowed characters are
‘M’, ‘m’, ‘F’, ‘f’, ‘U’, ‘u’; any other character
is interpreted as ‘U’.
Patient Race-Ethnic Origin Ignored
Patient Address Ignored
Reserved Field Ignored
Patient Telephone Number Ignored
Attending Physician ID Ignored
Special Field #1 Ignored
Special Field #2 Ignored
Patient Height Ignored
Patient Weight Ignored
Patient’s Known or Suspected Ignored
Diagnosis
Patient Active Medications Ignored
Patient’s Diet Ignored
Practice Field #1 Ignored
Practice Field #2 Ignored
Admission and Discharged Dates Ignored
Admission Status Ignored
Location Stored if available as a free string in the
‘department’ field of sample record. The string
will be truncated to 30 characters. See
Appendix B for supported characters.
Nature of Alternative Diagnostic Ignored
Code and Classifiers
Alternative Diagnostic Code and Ignored
Classifiers
Patient Religion Ignored
Marital Status Ignored
Isolation Status Ignored
Language Ignored
Hospital Service Ignored
Hospital Institution Ignored
Dosage Category Ignored
H|\^&||||||||ACL9000||P|1|19982110134700<CR>
P|1||PTNT1||ROSSI^MARIO^^^||19391127|M|||||||||||||||||DEP
1||||||||||<CR>
O|1|SMP01||^^^0001|S||||||||||^|DR. VERDI||||||||||O||||||<CR>
O|5|SMP02||^^^0001|||||||||||^|||||||||||O||||||<CR>
P|2||PTNT2||GIALLI^LUCA^^^||19551028|F||||||||||||||||||DEP
2||||||||||<CR>
O|1|SMP10||^^^0001|||||||||||^|||||||||||O||||||<CR>
L|1|N<CR>
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.
Host query is automatically activated by the instrument each time the system is
properly configured. Beginning the pre-analysis phase of a single test or profile or test
group, one or more samples have no type of test requests associated.
The instrument will send, using the requested information record, the sample IDs
requiring test programming and will accept only test orders for those sample IDs.
The instrument will accept for the queried samples any test orders independently by the type
of test which will be executed in the starting session.
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:
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>
The Test Request Message is used by ELITE/ELITE PRO to require information for
each specific sample that has no test orders in the instrument database. It is composed
from a Message Header, a Request Information and a Message Terminator record.
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.
H|\^&|||ACL9000|||||||P|1|19960210103227<CR>
Q|1|^S001^||||||||O<CR>
L|1|N<CR>
Answer from Host:
H|\^&||||||||ACL9000||P|1|19960210103256<CR>
P|1||||ROSSI^MARIO^^^||19391127|M|||||||||||||||||DEP
1||||||||||<CR>
O|1|S001||^^^0001|||||||||||^| DR. VERDI ||||||||||O||||||<CR>
O|5|S001||^^^0002|||||||||||^|||||||||||O||||||<CR>
L|1|N<CR>
As an answer to the ELITE/ELITE PRO Test Request Message the host computer
sends the Test Order Message. It contains the records specifying which tests are being
requested for the queried Sample ID.
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:
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.
If upload is manually requested, all data are transmitted independently from the
transmission flag.
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.
While transmission is in progress the user will be updated on the number of the
sample being transmitted.
The Test Result Message is used by ELITE/ELITE PRO to transmit any available test
results for a sample. All available test results will be transmitted for patient samples
even if data have been already transmitted partially.
The message consist of a Message Header record, a Patient Information record, one
or more pair Test Order records followed by one or more Results records (depending
upon the number of available test results and the number of results for each specific
test).
The Result record can be completed with a Comment record containing flags
associated to the executed test.
Tests are uploaded using the same sorting used on board. The complete set of
available test results is globally uploaded to the host computer independently by the
set of results defined as to show in the sample list.
In some conditions, depending by the instrument status (i.e. calibrated, not calibrated,
AR used, etc.) only a subset of the results supported by the test will be transmitted to
the host computer.
The 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.
This information is transmitted to the host only if available on the instrument. The
Patient Information structure is:
Dates
Admission Status Not provided not provided
Location Provided if known as a 30 not provided
characters free string
Date/Time
Specimen Collection Date Not provided Not provided
and Time
Collection End Time Not provided Not provided
Collection Volume Not provided Not provided
Collector ID Not provided Not provided
Action Code Not provided Set to ‘Q’
Danger Code Not provided Not provided
Relevant Clinical Not provided Not provided
Information
Date and Time Specimen Not provided Not provided
Received
Specimen Descriptor Not provided both fields Not provided both fields
Ordering Physician Provided, if available, as a Not provided
string containing up to 30
chars
Physician’s Telephone Not provided Not provided
Number
User Field #1 Not provided Not provided
User Field #2 Not provided Not provided
Laboratory Field #1 Not provided Not provided
Laboratory Field #2 Not provided Not provided
Date/time Results Reported Not provided Not provided
or Last Modified
Instrument Charge to Not provided Not provided
Computer System
Instrument Section Not provided Not provided
Report Type Set to F Set to F
Reserved Field Not provided Not provided
Location of Ward of Not provided Not provided
specimen Collection
Hospital Information Flag Not provided Not provided
Specimen Service Not provided Not provided
Specimen Institution Not provided Not provided
The fields characterizing this record are specified in the following table.
A result record is send to the host computer for each available test result. For double
tests all available single values will be transmitted to the host computer (no mean
values). Each result record will contain one of available test results.
Result Record:
The Comment record allows integration of the transmitted test results with possible
error messages.
One or more comment records can follow the result records. Fields characterizing this
record are specified in the following.
Comment Record:
MECHANICAL WARNING
LIQUID WARNING
MISCELLANEOUS WARNING
COVER_OPEN_DURING_LOADING_OR_INCUBATION = 86,
TIMEOUT_EXPIRED_DURING_LOADING = 87,
ERRORS ON RESPONSE
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.
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>
Approximate data volumes for upload sessions is provided as a guide for estimating
the time required to complete typical sessions. Obviously, system latencies (both in
ELITE/ELITE PRO and host computer) are not considered.
The minimal session would occur if ELITE/ELITE PRO has no test results to be
transmitted; no data is sent and the data volume is zero.
In conditions in which the ELITE/ELITE PRO has results to be transmitted, the data
volume can be estimated on the Test Order and Test Result record size base.
Results = number of ordered test (55 + 60*number of test result + 56* number of error
messages)
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.
The Scientific record and the Manufacturer Information record are not supported by
ELITE/ELITE PRO protocol.
The download or upload transmission session can be interrupted for an explicit user
request detected on the instrument, because the host computer is not responding or
because the host computer required interruption of the transmission process.
Further, as reported above, the download process can be interrupted because an illegal
sample Identifier has been received. Instrument behavior in this particular condition
was defined in and Reject Test Orders.
Condition Action
ELITE/ELITE PRO’s ELITE/ELITE PRO will signal the end of transmission to the host
operator requested stop and will discard any following messages. The host must consider
download process the interrupt request.
It must be emphasized that ELITE/ELITE PRO will signal the
transmission interruption with a message that is a rejected test
order message if any information has been rejected or with a
message header plus a message terminator record if no
information has been rejected.
ELITE/ELITE PRO ’s ELITE/ELITE PRO will complete the message in progress with
operator requested stop the message terminator and will not transmit any further test
upload process results.
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
EOT ELITE/ELITE PRO is stopped. If download was in progress, no
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”
Test codes are user definable. Codes from 1 to 500 are assigned to IL pre-defined
tests. Codes greater than 500 are assigned to the user definable tests. IL Library
proposes the default test codes reported in the following table.
350 0350 FX PT F X - PT
352 0352 FX HS F X - HS
354 0354 FX HSP F X - HS Plus
356 0356 FX R FX-R
357 0357 R FX FX RecombPT
360 0360 FV PT F V - PT
362 0362 FV HS F V - HS
364 0364 FV HSP F V - HS Plus
366 0366 FV R FV-R
The ASCII set of characters considered is in the decimal range 32 to 126, because a
Sample ID can be accepted only if it contains at least one character different from a
space.
! “ # $ %
& ‘ ( ) *
+ / : ; =
@ [ \ ] ^
_ { | } ~
Note: Separators are always expected from Host and are always transmitted
independently from the information contained in the string.
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
ACL8/9/10000 system. This applies to all sample types including patient, QC and
Analytical reference.
Chapter 12
Appendix B
(REV 0.0)
Index
1.0 Introduction
1.1 Purpose
1.2 Definitions, Acronyms and Abbreviations
1.3 References
2.0 General Description
2.1 Supported Codes and Checksum type
2.2 Barcode Symbol Specifications
2.3 Barcode Parameters
2.4 Barcode Label Positioning
2.5 Barcode Label Dimensions
1.0 Introduction
In the following sections the characteristics of the bar code labels that can be read
with the Welch Allyn SCANTEAM 3700 scanner installed on ACL 9000 family
instruments are described.
1.1 Purpose
Near Distance is the nearest distance that a scanner can accurately digitize a
given bar code.
Far Distance is the farthtest distance that a scanner can accurately digitize a
given bar code.
Scan Width is the length of the widest bar code that can be successfully
interpreted by the scanner.
Quiet Zone is the blank area located just before and just after the bar space
pattern.
1.3 References
The WA is a fixed mount CCD bar code scanner with integrated decoder for easy
integration into host equipment (ACL 9000 family instruments in our case).
All bar code symbols have to satisfy the appropriate AIM Uniform Symbology
Specification. In particular the following characteristics have to considered:
• Background substrate
The barcode symbol should be printed on a material type that is reflective and has a
matte (not glossy) finish. A background diffuse reflectance of at least 70% to 80% is
suggested for optimum contrast.
The ink type has to be compatible with 660 nm LEDs used in the scanner. The
barcode symbols inked bars should not exceed 10% reflectance at 660 nm that is
being used for reading, whether printed with black ink or colored ink.
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 what indicated in the 2.2
section) 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 above displayed. The displayed graph has been experimentally obtained
from Welch Allyn Laboratories because the WA equipped for the IL requirement has
not a standard optics.
In Appendix Barcode Label Dimension the attached drawing defines the barcode
labels dimensions and identifies constraints in positioning labels on vacutainers. The
13x75 vacutainers have been considered. The proposed barcode labels dimension and
positioning apply to all sample tray models. The following measurements are
reported: