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Access
Immunoassay System
Reference Manual
Revision 101740S
Revised May 2003
Printed in U.S.A.
Ó 2003 Beckman Coulter, Inc.
BECKMAN COULTER, INC. · FULLERTON, CA 92835
Publication Notes
Each page of this manual is identified with its revision and release date. For pages other than
the title page, revision information is located at the bottom of the page.
This manual includes pages from six revision releases. The pages listed below are issued as
revision 101740S, release date 5/03:
• This Title Page
• Pages 7 through 10
• Page 5-32
• Pages 6-8, 6-25, 6-32, 6-34 through 6-36, 6-38 through 6-40, 6-43, 6-45, 6-47, 6-70, and 6-86
The pages listed below are issued as revision 101740R, release date 10/01:
• Pages 2-10 through 2-11
• Pages 5-4 and 5-10
• Pages 7-12 through 7-17
The pages listed below are issued as revision 101740P, release date 04/01:
• Pages 5-3, and 6-21 through 6-22.
The page listed below is issued as revision 101740N, release date 10/00:
• Page 2-6
The pages listed below are issued as revision 101740M, release date 9/00:
• Pages 2-1 through 2-5
All other pages in this manual are issued as revision 101740L, release date 3/00.
This manual is intended for use with the Access Immunoassay System analyzer.
Access and the BECKMAN COULTER logo are trademarks of Beckman Coulter, Inc.
Table of Contents
Table of Contents
• Manual Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
• Safety Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
• Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
• Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
• Ordering Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Figure 1-27 Specifications for Original Bar Code Reader Bar Code Label . . . . 1-40
Figure 1-28 Specifications for Wide Scan Bar Code Reader Bar Code Label . . 1-40
Figure 1-31 Wide Scan Sample ID Bar Code Label Placement . . . . . . . . . . . . . . 1-44
Figure 6-27 Front Panel, Supply Cover, and Hex Screws . . . . . . . . . . . . . . . . . . 6-70
Figure 6-30 Original Incubator Belt, Vessel Holders, and Dovetail. . . . . . . . . . 6-73
Table 7-6 Available Bar Code Parameters Sorted by Bar Code Reader . . . . 7-12
Table 7-8 Configure Bar Code Reader Screen Fields and Functions . . . . . . . 7-14
Table 7-14 Add Calibrator Lot Screen Fields and Functions . . . . . . . . . . . . . . 7-33
Table A-2 Configure LIS Interface Screen Fields and Functions . . . . . . . . . . . . A-4
LIS Interface Figure A-3 Configure LIS Interface Flow Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
(continued) Figure A-4 Manual LIS Test Request Entry Flow Chart . . . . . . . . . . . . . . . . . . . . A-8
Figure A-5 Automatic LIS Test Request Entry Flow Chart . . . . . . . . . . . . . . . . A-10
Figure A-6 Delete All LIS Test Requests Flow Chart . . . . . . . . . . . . . . . . . . . . . A-13
Figure A-7 Print All LIS Test Requests Flow Chart. . . . . . . . . . . . . . . . . . . . . . . A-14
Figure A-9 Manually Selecting and Sending Test Results to LIS Flow Chart . A-19
Preface
This Preface contains the following information:
• Installation
• Definition of System Documentation
• Manual Conventions
• Safety Features
• Warranty Information
• Technical Support
• Ordering Supplies
Definition of The Access Immunoassay System documentation and the system software are
System Docu- provided in four, 3-ring binders:
mentation • Access Immunoassay System Operator’s Guide
• Access Immunoassay System Reference Manual
• Access Immunoassay System Assay Manual (not available in Japan)
• Access System Software (the “LIS Vendor Information Document” and
updates may be distributed in this manual binder, but you would
forward them to your LIS vendor, as applicable)
Operator’s Guide
The Operator’s Guide contains complete day to day operating instructions. Each
section begins with a brief description of the functions included in the chapter. If
appropriate, a flow chart of the steps necessary to complete a task is provided
followed by detailed text instructions.
Reference Manual
The Reference Manual contains detailed information about the Access System
including system specifications, performance characteristics, the theory of
operation, and instructions for configuring the Access System to suit the needs of
your laboratory. In addition, instructions are included for using the system
diagnostics section of the software and troubleshooting information to isolate and
correct system problems.
Assay Manual
The Assay Manual (not available in Japan) contains a product insert for each
Access System assay. The information presented includes a brief methodology
summary, a description of each assay component, reference ranges, and
performance characteristics. As new assays are released, a product insert for each
new assay is automatically sent to each Access System customer.
System Software
A technical support representative will install the system software on the analyzer.
A disk copy of the software is included in the System Software binder. Store this
binder in a safe, dry place away from intense heat and electrical and magnetic
fields.
Manual The Access System manuals follow certain conventions, ensuring consistency
Conventions between the manuals and making the information in each easier for you to find.
Each page lists the chapter or section title at the top of the page, and the manual
title and revision level at the bottom of the page. Each chapter contains a table of
contents and several sections, each of which have a section number (for example,
Section 3.2 is the second section in Chapter 3). The text within sections can be
divided into subsections, indicated by a line separating the text, and a subsection
heading in the margin.
Operator keystrokes are indicated by bold typeface and brackets (for example,
[Enter]). Function keys are indicated in the same way, followed by the title of the
function key in bold typeface (for example, [F1] Test Request). Field and screen
names are capitalized.
Steps to perform a particular function are displayed in the text as either bullet
point steps:
• Perform this step.
or numbered steps:
1 Perform this step.
If a step is required for a function, a numbered box is used. If a step is optional for
a function, a bullet point is used.
Flow charts are integrated into the text to display the steps required to perform a
particular function in a concise, visual format. Arrows lead you through the flow
of steps. Screens are indicated by a rectangle with rounded corners containing the
screen name. Any point at which a decision is required is indicated by a diamond
containing the question to be decided.
WARNING
Warnings are used when there is the possibility of harm to the operator.
CAUTION
Cautions are used when there is the possibility of damaging the analyzer.
NOTE
Notes are used to highlight or provide additional information.
Safety The Access Immunoassay System analyzer is designed to meet U.S. and
Features international safety standards. Safety labels are affixed to the instrument to alert
you to safety considerations, and interlock switches protect you from injury. Some
of the labels and interlock switches are described in the following sections.
A label with an exclamation point (see the following example) calls attention to
important information to read. The information is located either on the label or in
this manual. In this manual, text following the label example provides additional
information regarding safety conditions.
CAUTIONS
• The Access System generates, uses, and can radiate radio frequency
energy and if not installed and operated properly may cause interference
with other equipment. The Access Immunoassay System has been tested
and shown to be compliant with the requirements of part 15 of FCC rules
for a Class A digital device. These requirements are intended to provide
reasonable protection from interference when the instrument is operated
in a commercial environment. If interference with other equipment is
suspected, the operator must take whatever action is required to correct
the interference.
• In addition, other equipment may radiate radio frequency energy to
which the Access System analyzer is sensitive. Some suggested corrective
actions are:
– Move the equipment so there is a larger distance between the
equipment and the Access System analyzer.
– Re-orient the equipment with respect to the Access System
analyzer.
– Ensure the equipment is operating from a different power service
connector than that of the Access System analyzer.
• The Access System contains high leakage electrical current and should
always be plugged into an outlet with a third grounding hole. DO NOT
bypass the grounding prong on the plug.
• The label of the Canadian Standards Association signifies that the Access
Immunoassay System meets all requirements for electrical safety and is
approved for use in the field.
Biohazard Label
• The biohazard symbol indicates areas of the instrument and its associated
fluid handling equipment that may contain potentially infectious human
serum or blood products. Follow good laboratory practices in handling and
disposing of materials from these areas.
CE Mark Label
Interlock Switch
In addition to safety labels, the Access System analyzer is equipped with an
interlock switch to protect the operator from injury. This interlock switch stops
movement, or prevents movement of mechanical parts when the switch is
activated.
The front panel interlock switch is activated when the panel is opened. The
interlock switch does not prevent opening the front panel; however, when the
panel is opened, the switch is activated and mechanical motion inside the
analyzer is stopped immediately. If this panel is opened when samples are being
processed, tests may be automatically cancelled by the system.
WARNING
The analyzer has moving parts and uses high voltage in the ultrasonics, each
of which presents an injury hazard. Therefore, the analyzer should not be
operated with the covers open.
Warranty The Access Immunoassay System is covered by and subject to the provisions of
Information the warranty included in your contractual agreement for the system and/or its
reagents.
Technical For technical assistance regarding the Access Immunoassay System, contact
Support Beckman Coulter Technical Support at 800-854-3633 (in the U.S.A.) or your
technical support representative (outside the U.S.A).
Ordering Table P-2 is a list of Access System manuals and supplies, and their respective
Supplies catalog numbers. Also, available parts and tools that are referred to in the
Operator’s Guide or Reference Manual are included in the list.
Refer to the Quick Reference Guide or individual product inserts for the catalog
numbers for all Access System assay specific reagents.
Catalog
Product
Number
Catalog
Product
Number
Catalog
Product
Number
Catalog
Product
Number
*** In Japan, the Assay Manual and Material Safety Data Sheets are not applicable. See your
local product inserts.
1
Introduction to the Access
Immunoassay System
• Technology Overview (Section 1.1)............................................................ 1-2
1.1
Technology Overview
The Access Immunoassay System automated analyzer features random access
capabilities. The processing protocol allows simultaneous use of instrument
resources to intermix processing various assays. For example, pipetting, washing,
and reading of multiple assays, in various stages, can take place concurrently. To
accomplish this task, the system allocates instrument resources prior to
processing using a real time multi-tasking environment.
The reaction vessel movements between the incubator belt and the wash/read
carousel permit the processing of a variety of assay methodologies. Variable
incubation times and reagent addition sequences allow for high flexibility in
assay development for maximum assay performance.
The Access System assays use paramagnetic particles for separation of free and
bound analyte fractions and a chemiluminescent substrate for light signal
generation. The amount of light produced is proportional or inversely
proportional to the concentration of the analyte being measured. Refer to
Section 1.4 and the individual product inserts for detailed information regarding
the assays.
The Access System consists of six “modules,” which execute the functions
necessary for processing patient samples, controls, calibration controls, and
calibrators. The relationship between the processing, control, and interface
functions and the modules that execute these functions are described in the
following sections and illustrated in Figure 1-1.
Control Control functions, which direct the operation of the processing modules, are
Functions performed by the electronics module. The electronics module contains an
interface circuit board assembly, which connects each of the processing modules
to the control modules. This allows the control modules to direct the actions of the
processing modules.
Interface Interface functions are performed by the system software, directed through the
Functions peripheral module. The peripheral module includes the keyboard, monitor,
printer, external bar code wand, and external bar code scanner, which allow the
operator to request and monitor system functions via the system software.
PROCESSING FUNCTIONS
FLUIDIC MODULE
• Probe Wash Tower
• Wash Pump
• Waste Pump
• Substrate Pump
• Vacuum Pump
• Vacuum Reservoir
• Fluids Tray
CONTROL FUNCTIONS
ELECTRONICS MODULE
• Power Supply
• Printed Circuit Boards
• Floppy Disk Drive
• Hard Disk Drive
• Interlock Switches
INTERFACE FUNCTIONS
PERIPHERAL MODULE
• Keyboard
• Monitor System
• Printer Software
• External Bar Code Wand
• External Bar Code Scanner
1.2
Instrument Description
The Access System is comprised of the following modules:
• Carousel Module
• Main Pipettor Module
• Analytical Module
• Fluidic Module
• Electronics Module
• Peripheral Module
Fluidic Module
Electronics Module
Carousel Module
Main Pipettor Module
Analytical Module
Fluidic Module
Electronics Module
NOTE
There are two different fluids trays available. Refer to the Fluidic Module section
for a description and illustration of each tray.
Revision A There are two different revisions of the fluidic system used in the Access System.
and B The main differences are in the fluidic and main pipettor modules. Some
Fluidics maintenance, support, and troubleshooting procedures are different for revision
A and B fluidics. Refer to Table 1-4 and the illustrations of the main pipettor
(Figure 1-6 and Figure 1-7) and fluidic (Figure 1-2, Figure 1-3, Figure 1-9, and
Figure 1-10) modules to determine if your system has revision A or B fluidics.
400642 400760
400643 400770
400664 400788
400665 400791
Any serial numbers other than those in Table 1-4 are for analyzers with revision A
fluidics. If you cannot determine whether your system has revision A or B
fluidics, call Technical Support. Refer to the Fluidic Module section for a
description of the various components of this module.
Carousel Samples and reagent packs/vials on-board the analyzer are located on two
Module independently rotating carousels. The carousel module (Figure 1-5) is comprised
of these two carousels, the cup/tube detector, and the internal bar code reader.
Cup/Tube Detector
Reagent Carousel
Reagent Packs
Sample Carousel
Sample Tray
Sample Carousel
The sample carousel can hold up to 6 sample trays. Each tray contains 10 sample
positions for a total on-board capacity of 60 patient specimens, quality control
samples, calibrators, and/or calibration controls. Tray positions on the sample
carousel are accessed one at a time for loading and unloading sample trays. The
sample tray bar code labels provide positive sample tracking and indicate to the
system which sample containers are used (refer to Chapter 4 of the Operator’s
Guide for details).
Two different internal bar code readers have been installed in Access Systems: the
original reader and a wide scan reader. The wide scan bar code reader differs from
the original reader with the following features:
• It allows placement of the bar code labels closer to the top of a sample
container.
• It requires a wider quiet zone on either side of the bar code.
• It reads sample containers in 16x75 mm sample trays.
• It accepts configuration of all bar code symbology parameters.
NOTE
For Access software version 3.27 or higher, you can enable available bar
code reader configurations by bar code symbology (refer to Chapter 7,
System Configuration, for detailed information). Successful programming
of available configurations depends on which internal bar code reader you
have.
Access analyzers with a serial number 401029 or higher have the wide scan bar
code reader installed. For analyzers with a serial number less than 401029, the
wide scan bar code reader may be installed by a technical support representative.
Analyzers with the wide scan bar code reader should have the words “Wide
Scan” in the comment line of the Internal Bar Code Reader field of the Configure
System Revisions screen (key sequence from the Main Menu: [F8] System
Config., [F1] System, [F8] Configure System Revisions, [Page Down] and/or
[Down Arrow] to Internal Bar Code Reader field).
Cup/Tube Detector
After a sample tray is loaded onto the analyzer, the sample carousel rotates until
the tray passes the internal bar code reader and the cup/tube detector. The cup/
tube detector scans for sample containers on the tray. If a sample container is not
detected on a scanned tray, but there is a test request entered for that tray position,
the test request is deleted.
Reagent Carousel
The reagent carousel holds up to 24 reagent packs/vial racks.
NOTE
Vials and vial racks are not available in all areas.
For reagent packs, the test name, lot number, expiration date, and serial number
are entered into the system manually or by scanning a bar code label on the
reagent pack. The bar code label is scanned using the external bar code wand as
you load the reagent pack on the carousel.
For reagent vial racks, the rack position, reagent code, reagent name, lot number,
serial number, and the expiration date are entered into the system manually or by
scanning the bar code labels printed on each reagent vial. Using the external bar
code scanner, all the vials on a rack can be scanned at the same time. Alternatively,
the bar code on each vial can be individually scanned using the external bar code
wand.
Main The main pipettor module (Figure 1-6 and Figure 1-7) is comprised of a pipettor
Pipettor gantry, main pipettor, precision pump, and ultrasonic transducer. The main
Module pipettor transfers samples, reagents, and wash buffer (for dilutions if necessary)
to the reaction vessels.
Precision Pump
Pipettor Gantry
Main Pipettor
Top View
Ultrasonic
Transducer
Primary
Probe
Front View Front View
Pipettor Gantry
Top View
Ultrasonic
Transducer
Pipettor Gantry
The pipettor gantry supports the primary pipettor and allows horizontal motion
of the primary pipettor.
Main Pipettor
The main pipettor pipettes sample and reagents into the reaction vessels through
the primary probe. It is also used to prepare on-board sample dilutions. The main
pipettor allows vertical motion of the primary probe.
Precision Pump
The Access System uses a precision (dual resolution delivery) pump to achieve
accurate and precise delivery of both large and small fluid volumes. The precision
pump aspirates samples and assay specific reagents into the probe for delivery to
reaction vessels and delivers wash buffer for washing the probe and for preparing
sample dilutions.
Ultrasonic Transducer
The main pipettor is equipped with an ultrasonic transducer. Ultrasonic
vibrations are applied to the tip of the primary probe to: mix reagents in the
reagent pack before sampling, mix the contents of the reaction vessel, clean the
probe after each use, and detect the sample fluid level. Level sense is used to
determine the depth that the probe is immersed in solution or sample. Probe
immersion is minimized to reduce carryover.
Analytical The analytical module (Figure 1-8) is comprised of the reaction vessel supply,
Module reaction vessel loader, incubator belt, and the wash/read carousel. This module
transports and incubates reaction vessels during processing and washes and
reads the reaction vessels when incubation is complete.
Wash/Read Carousel
Luminometer
Wash Arm
Reaction
Vessel
Waste
Bag
When [F4] Reaction Vessels is pressed from the Supplies or Supplies Required
screen, the interlock switch on the reaction vessel load door is released and the
reaction vessel rake is moved from the load area, allowing a reaction vessel
cartridge to be loaded. When a reaction vessel cartridge is placed in the
instrument and the reaction vessel load door is firmly pressed down on the
cartridge, then reaction vessels are removed from the plastic spine. Then, when
[F1] Done is pressed, the reaction vessel rake moves the vessels into the supply
area. The reaction vessel shuttle moves the vessels from the supply area into
position to allow the main pipettor to add the samples and reagents, then moves
the vessels onto the incubator belt.
Incubator Belt
The reaction vessels are carried on the incubator belt for a specified time period
defined by each assay protocol. The incubator temperature is controlled for
optimal assay conditions. After incubation, the vessel is transferred to the wash
station in the wash/read carousel. Refer to Section 3.2, Reaction Vessel Transport,
for a description of the wash cycle. If more processing is required after a wash
cycle but before the luminometer reading, the vessel is returned to the incubator
belt. After samples are read, the vessels are carried on the incubator belt to the
waste chute. The reaction vessel shuttle pushes the vessel from the incubator belt
and ejects it into the waste chute. The used vessels are collected in a disposable
waste bag. The system monitors the available space in the waste bag and alerts
the operator when the bag must be replaced.
Wash/Read Carousel
The wash/read carousel is comprised of the wash/read area, wash arm, three
aspirate probes, three dispense probes, substrate probe, separation magnets, and
luminometer.
The wash station contains three wash positions to maximize throughput. The
reaction vessels are transferred from the incubator belt to the first wash position
where the paramagnetic particles are washed according to the specific assay
protocol. The vessels are then moved to the second and third positions for
additional wash cycles. If necessary, the reaction vessel is returned to the
incubator belt for further processing.
contents. After the substrate is added, the vessels are incubated for a short period
as they advance to the luminometer.
Luminometer
The luminometer is a photo multiplier tube which measures the amount of light
produced by the chemiluminescent reaction in the reaction vessels. This
measurement is then transmitted as an electronic signal to the electronics module
for conversion into a calculated result in the appropriate units.
Fluidic The fluidic module (Figure 1-9 and Figure 1-10) consists of the wash, waste, and
Module substrate pumps and valves, vacuum pump and reservoir, fluids tray, and probe
wash tower. The function of each component is described as follows.
Substrate Valve
Vacuum
Pump Substrate Pump
Wash Pump Waste Pump
Vacuum Reservoir
Waste Valve
Substrate Heater
Probe Wash
Valve
Fluids Tray
Vacuum Pump
Wash Pump
Vacuum Reservoir
Wash Valve
Substrate Valve,
Pump, and Heater
Probe Wash
Valve
Fluids Tray
Peristaltic Waste
Pump
0051E
Figure 1-10 Fluidic Module–Revision B Fluidics
NOTE
There are two different fluids trays available. Refer to the Fluids Tray section
below for a description and illustration of each tray.
Vacuum Reservoir
The vacuum reservoir provides temporary storage for liquid removed from the
wash tower (both revision A and B fluidics). The waste pump then aspirates the
fluid out of the vacuum reservoir and into the liquid waste bottle.
Vacuum Pump
During probe washing, vacuum is applied to the wash tower to remove wash
buffer. As the primary probe is removed from the wash tower, vacuum is applied
to remove any droplets clinging to the outside of the probe.
Fluids Tray
There are two different fluids trays available for the analyzer, the unibase fluids
tray and the original fluids tray. Both fluids trays are located on the left side of the
analyzer; however, the components contained in the trays and the function of
some features differ. Figure 1-11 and Figure 1-12 are diagrams of the two fluids
trays.
The unibase fluids tray contains the liquid waste bottle, wash buffer bottle, wash
buffer reservoir, substrate bottles, a float level sensor for monitoring the wash
buffer volume, and a scale for monitoring the liquid waste weight. The unibase
fluids tray also contains the waste filter/bottle assembly, which filters
microscopic particles from the waste pump and vacuum pump exhausts.
Substrate
Bottles Float Level Sensor
Waste Filter/Bottle
Assembly
The original fluids tray contains the liquid waste bottle, wash buffer bottle, wash
buffer reservoir, and two capacity level sensors for monitoring the liquid waste
and wash buffer levels. The original fluids tray also contains the waste filter/
bottle assembly, which filters microscopic particles from the waste pump and
vacuum pump exhausts.
Liquid Waste
Bottle
Electronics The electronics module (Figure 1-13) is comprised of printed circuit boards,
Module power supply, hard disk drive, floppy disk drive, reset button, an interlock
switch, and the reaction vessel load door alarm.
Power Supply
(under PCBs)
Printed Circuit
Boards (PCBs)
Reset Button
Reset Button
The reset button is located inside the front panel to the right of the main pipettor.
Pressing the reset button reboots the system (refer to Chapter 6, System Support
Procedures, for instructions on rebooting the system).
Power Supply
The power supply provides and regulates the power for the system computer and
the electronic subsystems. The power supply is located underneath the printed
circuit boards.
Interlock Switch
The analyzer is equipped with an interlock switch to protect the operator from
injury. This interlock switch stops movement, or prevents movement of
mechanical parts when the front panel of the analyzer is opened. If the front panel
is opened while samples are being processed, tests may be automatically
cancelled by the system.
WARNING
The analyzer has moving parts and uses high voltage in the ultrasonics, each
of which presents an injury hazard. Therefore, the analyzer should not be
operated with the covers open.
Peripheral The peripheral module (Figure 1-14) consists of the external system accessories
Module for the analyzer.
Printer
Color Monitor
Articulated Arm
Keyboard
Color Monitor
The color monitor provides high resolution screen text and graphics.
Articulated Arm
The articulated arm allows optimal positioning of the monitor and/or keyboard.
Keyboard
The keyboard is a standard 101 key model with full function key use.
Printer
The single sheet feed printer produces letter quality reports and graphics. Refer to
the printer manufacturer’s manual for details.
NOTE
Vials are not available in all areas.
Peripheral Connections
The following table describes each of the peripheral connections (or ports) located
on the right side panel of the instrument. Each port on the instrument is labeled.
Port Description
1.3
System Software
The Access System software is your interface with the instrument. The software
functions are organized into a logical set of screens, all of which use a similar
format (Figure 1-15 and Table 1-16).
There are eight function keys represented along the bottom of each screen, each of
which corresponds to an active, or soft, function key on the keyboard (labeled [F1]
through [F8]). The functions of these keys change from screen to screen. If a
function is not currently available, the title of the key is displayed on the screen in
gray (instead of black). There are also seven function keys on the keyboard that
are constant throughout all screens (labeled [F9] through [F12], [Print Screen],
[Scroll Lock], and [Pause]). Refer to the Keyboard section later in this section for
detailed descriptions of the function keys.
The system software uses a three dimensional effect to indicate when data can be
entered into a field. If the field is recessed, you can enter information into that
field. If the field is raised, data cannot be entered into that field. For example,
when the Load Reagent Pack screen is displayed, the Reagent Pack Name field is
raised because data cannot be entered into that field. However, the Reagent Pack
Code field is recessed indicating that data may be entered into the field.
All screens have icons in the upper right and left corners of the screen. The icon in
the upper left corner displays the number of sample trays that are currently on-
board the analyzer. The icon in the upper right corner represents the system mode
(refer to Table 1-17 for a description of the system modes).
If the dialog window of the screen contains more information than can be
displayed at one time, a “scroll bar” is displayed along the right side of the dialog
window. The scroll bar contains a box indicating the location of the information
displayed in relation to all the available information. Use the [Page Up],
[Page Down], [End], and [Arrow] keys to “scroll” through the information.
An underlined arrow character ( ) on the right side of a field indicates that the
field has several options which can be viewed and selected using one of two
methods:
• When the cursor is in the field, press the [Space Bar] to scroll through the list
of available options until the desired option is displayed, then press [Enter].
• When the cursor is in the field, press [Shift-F12] to display a Choice List of
available options, use the [Arrow] keys to highlight the desired option, then
press [Enter].
If the Screen Saver Delay option is enabled in system configuration, the system
will blank the screen if the keyboard has not been used for the defined period of
time (the screen will be black). To re-display the screen, press any key. If the
system mode changes, an icon is highlighted, or the reaction vessel load door is
opened while the screen is blank, the system will automatically re-display the
screen for the defined period of time. Refer to Section 7.2, Configure System, for
more information on the Screen Saver Delay option.
On-board
Trays
Screen Title
System Mode
Dialog
Window
Status
Icons
Prompt Line
Active
Function Keys
Onboard Trays The round icon is divided into six sections which represent the sample
tray positions. One section is highlighted in blue for each on-board
sample tray.
System Mode An icon (depicted as a person) which represents the current system
mode. System modes are: READY (in starting block), RUNNING (running),
PAUSED (standing), and NOT READY (tying shoes). Refer to Table 1-17 for
a detailed description of each system mode.
Dialog Window Displays information which requires input and the information entered
in response to an inquiry. If input is required, such as a patient Sample
ID, the response will be displayed in the appropriate field in the Dialog
Window.
Status Icons Nine status icons convey information about various system parameters.
The icons from left to right represent the following:
• Wash Buffer
• Liquid Waste
• Reaction Vessels
• Substrate
• Supply Action Required
• Reaction Vessel Waste Bag
• Reagent Packs
• QC
• Event Log
Refer to Status Icons later in this section for a detailed description of
each icon.
Prompt Line Displays prompts, data entry instructions, and help messages as needed.
Active Function The active function keys, [F1] through [F8], are used to access the
Keys function indicated by their titles. For example, to enter test requests,
press [F1] Test Request/Progress from the Main Menu screen to display
the Test Request/Progress screen. Function keys may specify different
options depending on the screen displayed. These differences are
identified by the function key titles. Unlabeled function keys are not
active on that screen.
NOTE
In addition to the active function keys, there are eight fixed function
keys on the keyboard which perform the same functions from every
screen. For example, press [F9] to display the Main Menu from any
screen. Refer to the Keyboard section later in this section for a detailed
description of each key.
System To keep you informed of the system activities, or system mode, an icon is depicted
Modes in the upper, right-hand corner of each screen using a graphic representation of a
person. Descriptions of each mode follow.
NOT READY The system is not yet ready to process samples. The
system is checking the status of subsystems, initializing
motors, priming fluid lines, homing movable parts,
warming necessary modules, and/or requires
initialization.
Status Icons The status icons (refer to Table 1-18), located just above the function keys
displayed on the screen, convey information about various system parameters.
The background on which the icons are displayed is color coded (gray, yellow, or
red), depending on the icon and according to the urgency of attention required.
Normally, these icons are displayed on a gray background. The icons, from left to
right across the screen, represent the following:
Wash Buffer The system monitors the volume of buffer through a fluid
level sensor. There is no yellow warning status for this
icon. When the buffer level activates the sensor, the icon
background turns red, indicating that wash buffer must be
added. The Event Log icon is yellow and the Event Log
message states that the “scheduler” is paused (i.e., no new
tests are started).
Liquid Waste The system monitors the volume in the waste bottle. There
is no yellow warning status for this icon. When the waste
level activates the sensor, the icon background turns red,
indicating that the liquid waste bottle must be emptied.
The Event Log icon is yellow and the Event Log message
states that the “scheduler” is paused (i.e., no new tests are
started).
Supply The background of this icon turns red if the worklist being
Action initiated cannot run to completion without operator
Required intervention. You can press [F10] Supplies Required to get
more information. This icon may duplicate the warning
information given by the other status icons. Conditions for
the background of this icon to turn red include: insufficient
supply of reaction vessels or substrate and insufficient
space remaining in the reaction vessel waste bag. Test
processing is not affected. The background of this icon
returns to gray after the supply is replenished or the waste
bag is replaced.
Reagent Packs The system monitors the number of tests processed using
each reagent pack and vial. There is no yellow warning
status for this icon. When there are not enough reagents in
the on-board reagent packs and/or vials to process the test
request, the icon background is displayed in red.
Quality Control There is no yellow warning status for this icon. If any
quality control sample is flagged, the icon background is
displayed in red until the QC Data screen is viewed. Test
processing is not affected.
Keyboard The Access System keyboard is a standard computer keyboard. Text and numeric
entries are made by typing the information into the appropriate field. Some keys,
or combination of keys, perform unique Access System functions. These keys and
keystrokes are described in Table 1-19, Table 1-20, and Table 1-21.
Function Keys
[F1] - [F8] The functions these keys initiate will vary, depending on the displayed screen.
Called active (soft) function keys.
[F10] Checks system status and displays the Supplies Required screen if a sample is
on-board the system for which there are insufficient supplies to process the
requested tests, or for which calibration is required.
[Shift - F12] Displays the Choice List. The Choice List contains the available options for the
field containing the cursor. An underlined arrow character is displayed on the
right side of every field for which you can view the Choice List.
[Esc] Exits the current screen and displays the previous screen. A confirmation
message is displayed if data was entered.
[Scroll Lock] Displays the Event Log which includes system messages.
[Pause] Pauses pipetting after pipetting is completed for the current sample. All other
processing continues.
[Shift - Pause] Stops the instrument and places the system in the NOT READY mode if the
system is running. In process tests are cancelled. If the system is not running,
this key sequence exits the user interface.
When this key is pressed, a confirmation screen is displayed. Press [Y] to stop
the instrument and cancel tests in progress or exit the user interface.
[Enter] Moves the cursor one field to the right or one field down, depending on the
screen. This key also initiates actions from several windows.
[Shift- Scrolls the field one character to the left if the entire field entry cannot be
Left Arrow] displayed.
[Up Arrow] Scrolls the field one line up if the entire field entry cannot be displayed.
[Down Arrow] Scrolls the field one line down if the entire field entry cannot be displayed.
[Page Down] Moves the cursor one page down in a scroll region.
[Home] In fields with a scroll region, displays the first page of data. In the Test Request/
Progress screen, moves the cursor to the Tray ID field.
[End] In fields with a scroll region, moves the cursor to the last line of data. In the Test
Request/Progress screen, moves the cursor to the Sample ID field of position 10.
Main Menu The Main Menu (Figure 1-22) is displayed at system startup. All system functions
are available from the Main Menu by pressing the appropriate function key, [F1]
through [F8] (Table 1-23). The system will respond by displaying the
corresponding screen. To return to the Main Menu from any screen, press the
[F9] Main Menu key.
Main Menu
1
Access®
TM
[F1] Test Select this option to enter sample information, select tests, review and edit the
Request/ test requests, load or unload sample trays from the system, select LIS samples
Progress for processing, clear trays, or review testing progress. Refer to Chapter 3 of the
Operator’s Guide for detailed information.
[F2] View Test Select this option to review, print, and archive patient results, and send them to
Results an LIS (refer to Appendix A for more information on the LIS interface). Refer to
Chapter 5 of the Operator’s Guide for detailed information.
[F3] Supplies Select this option to review and update the inventory status of all system
supplies. Refer to Chapter 2 of the Operator’s Guide for detailed information.
[F4] Quality Select this option to review and print quality control results, Levey-Jennings
Control charts, and QC rule analysis of control data. Refer to Section 3.4, Quality
Review Control, of this manual and Chapter 7 of the Operator’s Guide for detailed
information.
[F5] Calibration Select this option to review and print calibration data. Refer to Section 3.3,
Review Calibration, of this manual and Chapter 6 of the Operator’s Guide for detailed
information.
[F6] Maintenance Select this option to perform routine maintenance procedures. Refer to
Chapter 8 of the Operator’s Guide for detailed information.
[F7] Diagnostics Select this option to perform system diagnostic procedures. Refer to Chapter 4,
System Diagnostics, for detailed information.
[F8] System Select this option to customize the Access System for your laboratory. Refer to
Configuration Chapter 7, System Configuration, for detailed information.
1.4
System Assays
All Access System immunoassays employ a paramagnetic particle solid phase
and an enzyme mediated chemiluminescent reaction for signal detection. The
solid phase and detection technologies allow measurement of a broad range
of analytes.
The Access System assays use a variety of protocols, the most common of which
are competitive binding, sandwich, and antibody detection immunoassay
methodologies. Figure 1-24, Figure 1-25, and Figure 1-26 illustrate these assay
types. Individual assays may use different formats; refer to the reagent pack insert
for the specific methodology used for each assay.
Each assay is optimized for rapid time to first result, with most tests completed in
15 - 30 minutes. Total assay time is dependent on incubation time and wash cycles
defined by the assay protocol.
Wash to remove
unbound components.
Legend
= Analyte in sample
Sandwich Assays
Legend
= Analyte in sample
= Wash 3 times
Legend
= Antibodies in sample
= Wash 3 times
Para- Micron size paramagnetic particles are used as the solid phase to separate the
magnetic bound from the unbound analyte. During wash cycles, magnets are used to pull
Particles the particles to the side of the reaction vessel to allow complete aspiration of the
wash fluid. The particles are re-suspended by adding wash buffer and then
spinning the vessel.
Chemilumi- Luminescence is defined as the emission of light associated with the dissipation of
nescence energy from an excited substance. There are different forms of luminescence
based on the excitation mechanism. Natural forms of luminescence include the
following:
• Photoluminescence, or fluorescence, which is caused by a substance
being stimulated by light.
• Bioluminescence, which is caused by an enzyme mediated chemical
reaction in living organisms, such as the firefly.
• Chemiluminescence, which is the product of a specific chemical reaction.
Access The Access reagent pack contains enough reagents to perform up to 50 tests. Refer
Reagent to the product inserts or the reagent pack label to determine the number of tests
Packs included in each pack. The reagent packs are covered with an elastomeric layer to
maintain reagent integrity and prevent evaporation. This layer lightly reseals
after being punctured by the primary probe. However, the seal will not prevent a
punctured reagent pack from leaking if it is turned upside down.
The reagent packs are divided into five compartments or wells, denoted by letters
a - e. The paramagnetic particles are usually in well a. The contents of the
remaining wells and their letter assignments are assay-dependent.
Reagent packs are installed and removed using the Supplies, Reagent Inventory,
or Supplies Required (for loading only) screens. When a reagent pack is installed
on the reagent carousel, the bar code information is entered into the system with
the external bar code wand. Alternatively, the bar code information can be
entered manually. A bar code label on each reagent pack includes the following:
• Assay name
• Reagent pack lot number
• Expiration date
• Unique serial number
The system tracks the number of tests remaining in each reagent pack via the
serial number. A partially used reagent pack may be removed to make room for
other packs and then be re-installed later.
Access Some Access assays require the use of reagents from reagent vials. Each vial
Reagent Vials contains one reagent that is then used in conjunction with reagents from a
(Not “common” reagent pack.
Available in
Like reagent packs, reagent vials are loaded onto the reagent carousel. Before
All Areas) loading the vials onto the carousel, they must first be inserted into a reagent vial
rack that is specially designed to hold the vials. Vials can either be loaded into an
empty rack, or added to a rack that has already been loaded on the system (on-
board rack). After loading an off-board rack, the vials can be scanned as a group
on the external bar code scanner, and then loaded on the carousel.
Refer to the product inserts or the reagent vial label to determine the number of
tests included in each vial. The reagent vials are covered with an elastomeric layer
to maintain reagent integrity and prevent evaporation. This layer reseals after
being punctured by the primary probe. Reagent vials should be stored upright in
a refrigerator.
Because there must always be a common reagent pack installed along with the
reagent vials, 23 reagent vial racks with a maximum of 8 vials per rack can be
stored on the reagent carousel. Refer to the product insert for detailed storage and
handling instructions.
Vial racks are installed and removed by using the Supplies, Reagent Inventory, or
Supplies Required (loading only) screens. When a reagent rack is installed on the
reagent carousel, the bar code information of all the vials on a rack is entered into
the system using the external bar code scanner. Alternatively, the bar code
information can be entered manually or by using the external bar code wand.
A bar code label on each reagent vial includes the following:
• Reagent code
• Reagent vial lot number
• Expiration date
• Unique serial number
The system tracks the number of tests remaining in each reagent vial via the serial
number. A partially used reagent vial may be removed to make room for other
vials and then re-installed later.
The bar codes attached to the vial rack are used by the system to track vial
positions.
1.5
Bar Code Readers/Scanners
This section describes the various ways in which bar codes can be used to enter
information. The Access System can be equipped with three bar code readers/
scanners:
• Internal bar code reader and cup/tube detector — automatically scans the
Tray ID bar code label to verify that the correct tray is loaded. When tubes
are detected on the sample tray, the internal bar code reader scans for
individual Sample ID bar code labels. Each Access System uses either the
original bar code reader or the wide scan bar code reader. Refer to the
Carousel Module heading in Section 1.2 for more information about these
two readers.
• External bar code wand — allows you to scan Tray IDs, Sample IDs, and
calibrator, calibration control, and reagent pack /vial information contained
on bar code labels.
• External bar code scanner (for reagent vials only) — allows you to scan
information contained on the bar code labels of all the reagent vials loaded
on a reagent rack at one time.
The internal bar code reader is configured on and off and bar code reader
parameters are enabled in system configuration (refer to Chapter 7, System
Configuration). The external bar code wand and scanner are always on when they
are connected to the analyzer.
Bar Code Bar code labels consist of vertical black bars (the bar code) and the equivalent
Label characters. Figure 1-27 and Figure 1-28 are illustrations of bar code labels with the
Requirements specifications required for successful reading by the original bar code reader and
the wide scan bar code reader.
Height
(min. 0.39 in. Bar code
or 1 cm) ABC123456789 Bar code characters
Figure 1-27 Specifications for Original Bar Code Reader Bar Code Label
Height
(min. 0.39 in. Bar code
or 1 cm) ABC123456789 Bar code characters
Figure 1-28 Specifications for Wide Scan Bar Code Reader Bar Code Label
The characters received into a field when a bar code label is scanned are identical
to the characters printed below the bar code, excluding bar code check digits or
start and stop characters when those parameters are disabled in system
configuration.
Sample tube bar code labels are not provided, but must adhere to the
specifications illustrated in Figure 1-27 and Figure 1-28. Sample tray bar code
labels matching the specifications above are provided with the sample trays,
allowing you to assign Tray IDs according to the type of sample container you
plan to use. Refer to Chapter 4 of the Operator’s Guide for information on the types
of containers you can use and the Tray IDs associated with each. Refer to Chapter
2, System Specifications and Performance Characteristics, for the bar code
symbologies acceptable for use with the Access System bar code readers.
Internal Bar When you press [F1] Done after loading the sample tray onto the analyzer, the
Code Reader sample carousel rotates the tray to the internal bar code reader. If the bar code
reader/tube detector is configured on, the sample tray is scanned for a Tray ID
bar code. The Tray ID indicates to the system the type of sample container used
(refer to Chapter 4 of the Operator’s Guide for details). If the Tray ID bar code does
not match the Tray ID displayed in the Test Request/Progress screen, a message is
displayed stating that the wrong tray was loaded.
If the Tray ID bar code matches the Tray ID displayed in the Test Request/
Progress screen, the cup/tube detector checks for sample containers loaded on
the tray.
• If a sample container is detected and the Sample ID field is blank, the sample
container is scanned for a bar code label and the bar code value is inserted
into the Sample ID field. Tests that have been requested from the LIS are
downloaded, or you can manually select test IDs for the sample and enter
the remaining sample information.
• If a sample container is not detected, and there is a test request entered for
that tray position, the test request is deleted from the Test Request/Progress
screen.
With the internal bar code reader/tube detector configured on, you can add
samples to on-board trays (refer to Chapter 4 of the Operator’s Guide for details).
External Bar The external bar code wand can be used to enter information provided on bar
Code Wand code labels for the following items:
• Tray IDs
• Sample IDs
• Reagent pack/vial information
• Calibration control information
• Calibrator information
To scan a bar code with the external bar code wand, use the following technique:
1 Place the cursor in the appropriate field of the appropriate screen before
scanning the bar code.
2 Place the tip of the wand at an angle on the quiet zone of the bar code. (Refer
to Figure 1-28 for an illustration of a bar code with quiet zones.) With the
wand at a proper angle, you can see a small, oval pattern of light extending
from the tip of the wand within the quiet zone.
3 Move the tip of the wand smoothly and rapidly across the bar code to the
quiet zone on the other side. The external bar code wand beeps after reading
a bar code.
NOTE
Keep the light focused within the lines of the bar code. If the light extends
across the edge of either side of the bar code, the bar code may not be read
successfully.
4 Look at the screen and verify that the bar code is correctly displayed in the
proper field.
Alternatively for Sample IDs, you can manually enter the Sample ID or use the
internal bar code reader to scan the bar code label. During test request entry,
Sample ID bar codes can be entered for an entire tray at one time using the
internal bar code reader. Refer to Entering Sample IDs for a Tray later in this
section for detailed instructions.
External Bar The external bar code scanner can be used to enter information provided on the
Code bar code labels of reagent vials that have been loaded onto a reagent vial rack,
Scanner eliminating the need to type the information into a field on the Load Vial Rack
(for Reagent screen. Place the cursor in the appropriate field before scanning the bar codes.
Vials Only) Alternatively, scan each bar code with the external bar code wand, or manually
enter the bar code information.
NOTE
The external bar code scanner can only scan vial racks. Do not attempt to use it to
scan reagent packs.
Attaching The sample tray bar code labels must be placed on the tray as follows to ensure
Tray ID Bar that they can be read properly by the internal bar code reader. The Tray ID
Code Labels indicates to the system the type of sample container used (refer to Chapter 4 of the
Operator’s Guide for details).
1 Lay the sample tray on a table so that the ends of the tray curve towards
the table.
2 Locate the center spine of the tray. The center spine is located directly below
the handle of the tray and divides the 10 sample positions into two sets of 5.
3 Locate the indentation on the spine that indicates the correct location for the
bar code label.
4 Align the bar code label with the indentation and attach the label securely to
the tray with the bar code nearest the handle of the tray and the
corresponding number underneath it (refer to Figure 1-29).
05
05
0-1 mm
05
Attaching The Sample ID bar code labels must be placed on the sample containers as follows
Sample ID Bar to ensure that they can be read properly by the internal bar code reader. The
Code Labels procedure for attaching the bar code label to a sample container differs depending
on which internal bar code reader is installed in the system. The internal bar code
reader automatically discriminates between symbologies, so samples with bar
code labels using different symbologies can be included on the same tray.
You may need to enable parameters for the bar code symbologies you use. Refer
to Chapter 7 for bar code configuration information.
3 Place the bar code label on the sample container so that the label is at least
0.25 inches from the bottom of the sample container and is at the same height
as the Tray ID bar code label (refer to Figure 1-30).
ABC123456789
Min. distance = 0.25 in. or 0.6 cm
4 Ensure that the label is aligned vertically on the sample container and is
securely fastened to the tube.
5 Place the sample container in the tray and ensure that the Sample ID bar
code label and the Tray ID bar code label are at the same height in relation
to the tray and that the Sample ID bar code label is centered in the sample
position for maximum visibility.
ABC123456789
2 Place the sample container in the tray and ensure that the Sample ID bar
code label is centered in the sample position for maximum visibility.
Entering The Sample IDs for an entire tray can be entered at one time when the internal bar
Sample IDs code reader is configured and the samples are bar code labeled. Sample IDs can
for a Tray also be entered into the test request using the external bar code wand. Refer to
Chapter 3 of the Operator’s Guide for detailed instructions.
3 Load the samples with bar code labels onto the selected sample tray.
5 Load the sample tray onto the analyzer, then press [F1] Done.
The sample carousel rotates until the sample tray passes the internal bar
code reader and cup/tube detector. The internal bar code reader scans the
Sample ID bar code labels and inserts the Sample IDs into the appropriate
Sample ID field in the Test Request/Progress screen.
2
System Specifications and
Performance Characteristics
• Space and Environmental Requirements (Section 2.1) ............................ 2-2
2.1
Space and Environmental
Requirements
This section describes the spatial, environmental, and electrical requirements for
the Access System.
Electrical The Access System can operate from any line supplying either 115-120 VAC at
Requirements 15 amps or 220-240 VAC at 6 amps, at either 50 or 60 hertz (Hz), single phase
power.
• Line voltage sags not to fall below 90 VAC (115-120 VAC line) or 180
VAC (220-240 VAC line)
• Line voltage surges not to exceed 135 VAC (115-120 VAC line) or 250
VAC (220-240 VAC line)
• Line protection device should be a circuit breaker rated 15 amps (115-120
VAC line) or 6 amps (220-240 VAC line)
• Maximum voltage between the neutral conductor and the safety ground
conductor should not exceed 2 VAC RMS
• Maximum resistance between the safety ground conductor and an
accessible building safety ground should not exceed 0.1 ohms
• The outlet should be located within 1.5 m (5 feet) of the Access System.
• Transient overvoltages, according to UL 3101 Installation Categories
(Overvoltage Categories) I and II.
The line must supply the correct voltage to operate the Hewlett Packard DeskJet
printer used with the Access System, or damage to the printer may occur. The
printer is supplied as either a 115-120 VAC or a 220-240 VAC unit.
• Power consumption and heat production with HP 500, 505J, 520, 540, 560J,
810C, or 840C printer
Device Power (watts) Heat Output (BTU/hour)
Instrument 800 2730
Monitor 120 410
Printer 25 85
TOTAL 945 3225
Surge Suppressors
Beckman Coulter, Inc. does not recommend the use of surge suppressors with the
Access System. The Access System incorporates protection similar to that
provided by a surge suppressor.
If a line conditioning transformer is used, ensure that the specifications meet the
following requirements:
Minimum output capacity: 1300 volt amperes (VA)
Output voltage: 120 or 240 VAC
Output frequency: 50 or 60 Hz, single phase
Output wave form: True sine wave (< 5% distortion)
Output safety ground: Isolated local ground
Approvals: UL 1012, CSA C22.2 107.1 (UL 544, if desired)
If a backup power supply is used, ensure that the specifications meet the
following requirements:
Minimum output capacity: 1300 VA
Output voltage: 120 or 240 VAC
Output frequency: 50 or 60 Hz, single phase
Output wave form: True sine wave (< 5% distortion)
Standby runtime: Minimum 15 minutes at 1000 watts output (low
battery indicator and/or shutdown recommended)
Approvals: UL 1778, CSA C22.2 107.1 (UL 544, if desired)
2.2
Performance Characteristics
This section describes the performance characteristics of the following:
• System Operation
• Temperature Sensor
• Luminometer
• Capacities
• Reaction Vessels
• System Computer
• Peripherals
• External Bar Code Wand
• External Bar Code Scanner
• Original Internal Bar Code Reader
• Wide Scan Internal Bar Code Reader
Capacities The supply status icons displayed on every screen indicate when supplies are
needed. Normally the background of these icons is gray. If the background is red,
current test processing will continue, but no new tests will be initiated.
(Exception: If a reagent supply is needed, and tests are requested that use a
different reagent supply, those tests will be initiated.)
Original • Bar code symbologies CODE 128, with 15 characters or less variable
Internal Bar in order of preference length
Code Reader CODE 39 (ASCII codes 0 through 127 only)
Interleaved 2 of 5, with an even number from 4
to 15 characters fixed length
CODABAR (NW-7), with 4 to 15 characters
variable length
Wide Scan • Bar code symbologies CODE 128, with 15 characters or less variable
Internal Bar in order of preference length
Code Reader CODE 39
Interleaved 2 of 5, with an even number from 4 to
15 characters fixed length
CODABAR (NW-7), with 4 to 15 characters
variable length
• Bar code label Length = 3.00 inches (80 mm) maximum
dimensions (including quiet zones at ends)
3
Theory of Operation
• Sample Processing (Section 3.1) .................................................................. 3-2
3.1
Sample Processing
Continuous access is the ability to process any sample at any time. The Access
Immunoassay System allows samples and most supplies to be loaded, waste
containers to be emptied, and tests to be requested while processing samples.
When test processing is initiated, all supply levels are verified, and if necessary,
the system prompts you for additional supplies. The system evaluates the
calibration, lot, and pack expiration status and, if necessary, prompts you to
perform calibration. If the system status meets requirements, processing begins
immediately. The following sections describe the sample processing sequence.
Test Request A test request is entered for each sample using the Test Request/Progress screen.
Samples can be patient samples, controls, calibration controls, or calibrators. The
samples are placed in sample trays containing 10 sample positions each. Up to 30
trays can be defined, 6 of which can be on-board (loaded onto) the system at one
time. During processing, samples can be added to an empty position on an on-
board tray or they can be placed in an empty tray which is then loaded onto the
system.
If a patient sample is manually diluted prior to testing, the pre-dilution factor can
be added to the test request. The test result will automatically be multiplied by the
dilution factor entered.
There are multiple test request entry procedures. To simplify test request entry,
options such as an automatic Sample ID assignment and batch (or group) test
selection can be activated. The procedural steps can be intermixed to tailor an
entry procedure to fit your laboratory needs. Refer to Chapter 3 of the Operator’s
Guide for detailed test request entry information.
Test After tests are requested and the sample trays are loaded onto the analyzer,
Processing pressing [F11] Run initiates sample processing. The order in which samples will
Order be processed is evaluated; this order is determined by the following criteria:
1. Sample priority:
a. Stat patient samples, then
b. Calibrators and calibration controls, then
c. Controls and routine patient samples
2. Date and time the sample tray was loaded
3. Assay priority (dependent on the assay protocol)
4. Sample position within the sample tray
All stat samples are run first, in the order that they were loaded onto the analyzer.
The calibrators and calibration controls are run next, before routine patient
samples and controls. Routine patient samples and controls are run intermixed, in
the order they were loaded onto the system. All patient samples and controls on a
tray will be run together. Within a tray, all tests of a given type will be run
together, in a specified order, to maximize throughput.
Result reports for each sample are printed when testing is complete.
Sample Testing progress for each sample can be monitored using the sample status which
Status is displayed on the Test Request/Progress screen. Table 3-1 defines each sample
status.
NoTest Sample ID exists, but no tests are requested for the sample.
Test State Generally, the result reports are printed when tests are done. If you print a result
report before a test is done, the report shows the test state in the Flags column,
and N/A in the Result(s) column. Table 3-2 identifies and defines each test state.
For more information on sample results and result reports, refer to Chapter 5,
Sample Results in the Operator’s Guide.
Tray Status Testing progress for all samples on a tray can be monitored using the tray status
which is displayed on the Test Request/Progress screen. The tray status is
dependent on the progress (or status) of each sample on the tray. The sample
which is in the earliest stage of testing determines the tray status. For example,
nine samples on a tray are In Progress but the tenth sample is Requested; the tray
status would be Requested.
The tray status information can be used to determine when a tray can be
unloaded from the system. A tray with the Aspirated status can be unloaded
without affecting testing. If you attempt to unload a tray before the Aspirated
status, a confirmation message is displayed.
Supply Wait At least one test requires a supply to be loaded before the test
can be processed.
Aspirated All samples have been pipetted. The tray can now be
removed without affecting processing.
*Done* All sample processing is complete, but at least one test was
cancelled.
Reagent Pack When the system matches the tests to reagent packs/vials, the following criteria
Usage are applied to determine which reagent pack/vial is used:
• Calibrated reagent packs/vials are used first.
• If there are multiple calibrated reagent packs/vials, the pack/vial which
was punctured first is used first.
• If there are multiple calibrated, punctured reagent packs/vials, the
reagent pack/vial which expires first is used first.
• If there are no punctured reagent packs/vials, the pack/vial which
expires first is used first. If the “unpunctured” packs/vials expiration
dates match, the pack/vial that was loaded onto the analyzer first is used
first.
Supplies All reagent supply levels are verified before the system starts sample processing
to ensure adequate resources are available for the tests requested. Each test is
matched to a reagent pack/vial until all the reagents in the pack/vial are
allocated. The total number of tests requested is compared to the number of tests
which can be processed with the on-board system supplies (i.e., wash buffer,
substrate, reaction vessels). If testing supplies are sufficient, sample processing
begins. If one of the following situations applies, the Supplies Required screen is
displayed requesting the required action:
• Testing supplies are insufficient
• Waste containers need to be emptied or replaced
• A reagent pack/vial is expired
• Calibration is expired
• There is no calibration curve
3.2
Reaction Vessel Transport
During sample processing for one-step assays, the reaction vessels are
transported from the reaction vessel loader into position for pipetting, onto the
incubator belt, to the wash/read carousel, and back onto the incubator belt for
ejection. For some two-step assays, the reaction vessels are transported from the
wash/read carousel back to the incubator belt, then back to the pipetting position
for further pipetting. For other two-step assays, the reaction vessels are
transported unwashed from the incubator belt back to the pipetting position for
additional pipetting. After processing, the RVs are ejected into the reaction vessel
waste bag. Figure 3-4 is a flow chart of the path the reaction vessels travel. The
following section describes the path during these processes.
Sample and • After a reaction vessel cartridge is placed in the supply area, where the RVs
Reagent are pre-heated, the reaction vessel rake moves the RVs into the shuttle 1 row
Additions at a time.
• The reaction vessel shuttle moves the reaction vessels to the pipetting
position on the shuttle so samples and reagents can be pipetted into each
vessel.
• The order in which the sample and reagents are pipetted is dependent on the
assay protocol.
Incubation • The vessel is moved onto the incubator belt where it remains for the time
Stage specified by the assay protocol. The temperature is controlled to ensure
optimal assay conditions.
• At the end of the incubation period, the reaction vessel is transferred from
the incubator belt to the first of three wash positions in the wash/read
carousel, or back to the pipetting position for additional pipetting.
Washing Each wash cycle on the Access System consists of three washes.
Stage
First wash
• Wash buffer is dispensed into the reaction vessel by the first dispense
probe.
• The paramagnetic particles in the test reaction mixture are drawn to the
side of the reaction vessel by magnets located in the wash/read carousel.
• The supernatant is aspirated out of the reaction vessel by the first aspirate
probe.
Second wash
• Wash buffer is dispensed into the reaction vessel by the second dispense
probe.
• The paramagnetic particles are resuspended in the wash buffer by the
dispensed wash buffer and by spinning.
• The paramagnetic particles in the test reaction mixture are drawn to the
side of the reaction vessel by magnets located in the wash/read carousel.
• The supernatant is aspirated out of the reaction vessel by the second
aspirate probe.
Third wash
• The second wash is repeated using the third dispense probe to dispense
the buffer and the third aspirate probe to aspirate the supernatant out of
the reaction vessel.
Substrate • The Lumi-Phos 530 substrate is dispensed at the substrate position into the
Addition reaction vessel through the substrate probe to initiate the chemiluminescent
reaction.
Luminometer • The reaction vessel is incubated and then is moved to the luminometer
Reading where the amount of light generated is read.
• After the luminometer reading, the reaction vessel is transferred off the
wash/read carousel onto the incubator belt and the vessel is ejected into the
reaction vessel waste bag.
3.3
Calibration
Two types of calibration can be performed with the Access Immunoassay System:
luminometer and assay. The luminometer is calibrated automatically and requires
no operator input. The following subsection, Luminometer Calibration, describes
the theory of luminometer calibration.
Luminometer The luminometer in the Access System analyzer is calibrated against a luminous
Calibration standard when the system is manufactured. The status is periodically verified by
a technical support representative as part of the preventative maintenance
routine. An LED (light emitting diode) is used as an on-board reference standard
to maintain luminometer reading consistency. The LED is located on the wash/
read carousel, directly across from the luminometer and is automatically read at
pre-programmed intervals. A correction factor, based on the LED reading, is
calculated and applied to all raw RLU (relative light unit) measurements.
Assay A current (or Active) assay calibration is required for each assay that is to be
Calibration performed. The Access System provides three types of assay calibration:
• Quantitative calibration provides a multi-point calibration curve that is
used to calculate the concentration of an analyte in a patient sample or
control.
• Qualitative calibration provides a cutoff value to which patient samples
are compared and categorized as reactive or non-reactive for the analyte.
• Semi-quantitative calibration provides a multi-point calibration curve to
which patient samples are compared to calculate a concentration value
and categorized into qualitative classes for the analyte.
Calibrators and calibration controls are packaged in sets appropriate for the assay.
The number of calibrators or calibration controls required is defined by the assay
protocol. Specific information is provided on a calibration card included with
each calibrator set. This data can be entered into the system configuration using
the keyboard or the external bar code wand.
Refer to Chapter 3 and Chapter 6 of the Operator’s Guide for detailed information
on processing calibrators and calibration controls.
Quantitative Quantitative assay calibration is the process by which a set of samples with
Assay known analyte concentrations (i.e., assay calibrators) is tested like patient samples
Calibration to measure the response. A mathematical relationship between the measured
response and the analyte concentration is then derived. This mathematical
relationship is called a “calibration curve.” A calibration curve is used to convert
raw measurements in RLU (relative light unit) to specific analyte concentrations.
The shape of the curve is determined by the mathematical model used. The math
model is defined in the assay protocol. The quantitative calibration math models
used are the following:
• Weighted four parameter logistic (4PLC)
• Weighted smoothing spline
• Straight line
The calibration data and associated curve can be displayed and/or printed using
the Calibration Data and Calibration Curve screens. Refer to Chapter 6 of the
Operator’s Guide for detailed instructions.
The calibration data and associated curve can be displayed and/or printed using
the Calibration Data and Calibration Curve screens. Refer to Chapter 6 of the
Operator’s Guide for detailed instructions.
The procedures for defining calibration controls in the system configuration and
requesting them for processing are virtually identical to the procedures for
defining and requesting calibrators. Therefore, calibrators and calibration controls
are entered into system configuration using the same screen (refer to Chapter 7,
System Configuration).
Confirmatory Some qualitative assays have an associated confirmatory assay which can be used
Assays to confirm reactive patient sample results. The percent (%) suppression of RLUs
for the confirmatory assay is calculated to determine if a reactive result is
confirmed or not confirmed.
If both the screening and confirmatory test are selected in a test request, a
confirmatory result will be automatically reported for reactive samples. When
requested, the confirmatory test is linked with the most recently completed
screening result for that patient sample. There are three scenarios for requesting
and processing screening and confirmatory assays.
Tests run separately: In this situation, the screening assay is processed first.
After reviewing the result, the confirmatory test is
requested. The confirmatory result is calculated using
the previously completed screening test data. The
confirmatory test can be requested ONLY if the
patient sample has not been removed from the
analyzer.
Tests run together: The screening and confirmatory tests are requested at
the same time. The confirmatory result is calculated
using the screening test data processed at the same
time. In this situation, the confirmatory test will be run
on all samples, regardless of the screening test results.
Screening test repeated: The screening test is requested and processed. After
reviewing the results, the confirmatory test, and
another screening test is requested. The confirmatory
result is calculated using the second screening result.
where:
A = Patient sample RLUs obtained in the screening assay
B = Patient sample RLUs obtained in the confirmatory assay (Each
confirmatory assay replicate is evaluated separately)
If the percent suppression is greater than or equal to the pre-set limit defined by
the assay protocol, the result is Confirmed. If the percent suppression is less than
the pre-set limit, the result is Not Conf (Not Confirmed).
The replicate(s) used to calculate the confirmatory result are listed in the
Comments field on the result report.
Stored For quantitative and semi-quantitative assays, up to three sets of calibration data
Quantitative are stored for each calibrator set/reagent pack/vial lot number or calibration
and Semi- control set/reagent pack/vial lot number combination. The following is a
Quantitative description of the stored calibration data:
Calibration Last Run Last Run calibration data to which acceptance criteria were
Data applied. If the Last Run calibration is accepted, it becomes the
Active calibration and the Last Run and Active calibrations are
the same calibration data.
Active The most recently accepted calibration. If the Last Run calibration
is rejected, the current Active calibration remains in use.
Previous When a new calibration is accepted, the old Active calibration
becomes the Previous calibration.
Only the Active calibration is used to evaluate patient samples.
NOTE
A calibration remains active until it is replaced by a new, accepted calibration. An
active calibration may expire, as defined by the assay protocol, but it would still
be used to evaluate patient samples until it is replaced.
Stored For qualitative assays, two sets of calibration data may be stored for each
Qualitative calibrator set/reagent pack/vial lot number or calibration control set/reagent
Calibration pack/vial lot number combination. The following is a description of the stored
Data calibration data:
Last Run Last Run calibration data to which acceptance criteria were
applied. If the Last Run calibration is accepted, it becomes the
Active calibration and the Last Run and Active calibrations are
the same calibrations.
Active The most recently accepted calibration. If the Last Run
calibration is rejected, no Active calibration exits. Calibration
must be repeated.
NOTE
A calibration remains active until it is replaced by a new, accepted calibration. An
active calibration may expire, as defined by the assay protocol, but it would still
be used to evaluate patient samples until it is replaced.
Acceptance The four parameter logistic curve (4PLC), smoothing spline, and straight line
Criteria for math models are used to fit calibration data to a curve.
Quantitative
Weighting constants are used in curve fitting, and are defined by each assay
and Semi-
protocol. Weighting is required because the precision of the assay varies with the
Quantitative analyte concentration. Weighting constants are derived from pooled signal RLU
Assay variance data.
Calibration
For some quantitative and semi-quantitative assays, the assay protocol defines
acceptable limits for the % CV obtained from the replicates of the S0 (or zero)
calibrator. If the % CV obtained is outside these limits, the calibration is rejected.
The acceptance method used by the Access System is called the “precision
profile” method. This method can be used with any fitted curve math model for
which summed squares of the residuals are calculated. The precision profile
method consists of three steps:
• Fitting calibration data using the defined math model for that assay.
• Calculation of predicted precision at various analyte concentrations.
• Comparison of predicted precisions and the defined limits for that assay.
When fitting the calibration data to the math model, the calculation process tries
to minimize the distance of the individual data points from the calculated curve
(residuals). The individual replicates, not the mean, are used to calculate the
curve. The calculations are repeated (iterated) until the “best curve” (i.e., the
curve for which the residuals are the least) is obtained. If the maximum number of
iterations is performed without calculating an acceptable curve, the calibration is
rejected. The system may delete one replicate due to a fatal error in processing the
calibrator. However, if more than one replicate was flagged with a fatal error, the
calibration will automatically be rejected.
After an acceptable curve is obtained, an error band is calculated around the curve
based on the distance of the calibration data points from the curve (Figure 3-5).
The calibration data and the shape of the math model to which the calibration data
are fitted are used to predict the precision at various analyte concentrations. At
analyte concentrations defined by each assay protocol, a predicted precision is
calculated and compared to defined limits. If the result for any analyte
concentration is outside the acceptable limits (i.e., outside the error band), the
calibration is rejected.
Error Band
RLU
Precision
Analyte Concentration
Note: The width of the error band is exaggerated for illustration purposes.
Acceptance The assay protocol defines the limits for each calibration control used to calculate
Criteria for the cutoff value for qualitative assays. Refer to the product insert for the equation
Qualitative used to calculate the cutoff value. The RLU limits for a calibration control are
Assay applied to the following:
Calibration • Each replicate of the reactive calibration control
• Each replicate of the non-reactive calibration control
• Mean of the reactive calibration control replicates
• Mean of the non-reactive calibration control replicates
The assay protocol determines the number of replicates that must be within the
acceptable RLU limits for the assay calibration to be accepted. Two or more
replicates of each calibration control must be within the acceptable limits because
each mean must be calculated using at least 2 replicates. If the mean cannot be
calculated or the calculated mean fails to meet the criteria specified by the assay
protocol, the calibration is rejected.
For some qualitative assays, the assay protocol defines acceptable limits for the
% CV of the RLUs obtained for the replicates of each calibration control. If the
% CV obtained is outside these limits, the assay calibration is rejected.
Reasons for If a calibration is rejected, the reason for rejection is displayed on the Last Run
Calibration Calibration Data screen in the Status field. Table 3-6 outlines the reasons
Rejection calibrations can be rejected.
Bad Fit The calibration data does not meet the limits defined
by the assay protocol.
Insuff Data There was not enough data to perform the calibration
calculations. This occurs if two or more replicates were
not calculated due to an instrument error.
3.4
Quality Control
Quality control samples are tested to ensure the validity of the patient sample
results generated. Control samples should be processed as recommended in the
product insert. To best simulate the characteristics of the patient samples, the
control samples used are prepared from materials similar to the patient sample
being tested. For example, if testing serum, the quality control samples used
should also be serum based. In addition, multiple quality control samples can be
included to cover the entire measuring range of the test method.
Each laboratory should establish the acceptable range for commercially available
quality control materials. The manufacturer’s suggested ranges may be used until
an adequate number of samples have been processed to determine a lot-specific
mean and standard deviation.
The QC rules are dependent on the range of results being viewed in the QC Data
or Levey-Jennings Chart screens. Therefore, if a result fails to meet QC rule
criteria when viewed in one set of results, it may not fail to meet that rule when
viewed in a different set of results. In addition, a result can be omitted from
quality control calculations using the QC Data screen, and is therefore not used in
QC rule calculations. When a quality control result fails to meet an activated QC
rule, the quality control icon background is red until the control results are
reviewed.
Refer to Chapter 3 and Chapter 7 of the Operator’s Guide for detailed information
on processing controls.
4
System Diagnostics
• Introduction (Section 4.1)............................................................................. 4-2
4.1
Introduction
The Access Immunoassay System is designed to help “diagnose” an instrument
problem should one occur. If a system problem is encountered, an entry is made
in the Event Log (Figure 4-1). The information in the Event Log (Table 4-2) assists
in determining when and where the problem occurred.
The Diagnostics screen (Figure 4-3) is accessed by pressing [F7] Diag. from the
Main Menu and can be used to further troubleshoot the problem.
NOTE
Diagnostics cannot be accessed when the analyzer is in the RUNNING mode.
4.2
Event Log
The Access System monitors the status of various system parameters. The Event
Log (Figure 4-1), accessed by pressing the [Scroll Lock] key from any screen,
displays messages and codes to assist with troubleshooting. When a warning
message is entered into the Event Log, the background of the Event Log icon is
displayed in yellow or red, depending on the type of event. Informational
messages (e.g., Special Clean procedure completed) are also entered into the
Event Log, but the background of the Event Log icon remains gray. To print all of
the messages in the Event Log, press the [F7] Print Event Log key.
Event Log
0
System initialized
1996/ 6/14 12:58:10 360002 uiaccess(011) [ 81]
RV pack loaded
1996/ 6/14 12:51:24 7c0010 uiaccess(011) [ 81]
System initialized
1996/ 6/14 12:43:33 360002 uiaccess(011) [ 81]
SHUT error occurred before cleanout
1996/ 6/14 12:40:39 360501 uiaccess(011) [ 81]
RAKE Init Command Err <4 1 1 1000 11 32501 32510>
1996/ 6/14 12:39:25 370403 rake (021) [ 81]
System initialized
1996/ 6/14 12:32:08 360002 uiaccess(011) [ 81]
Print
Event Log
F1 F2 F3 F4 F5 F6 F7 F8
Event Log Each Event Log entry is comprised of two lines of text. The first line contains the
Messages command message and, if appropriate, numbers that describe the error, such as the
minimum, maximum, and actual values. The second line consists of the date, time,
event code, device controller, and the sequence number.
For example, if the substrate temperature is outside the acceptable limits, an entry
is made in the Event Log detailing the system condition. In addition, the
corresponding test result is labeled with a flag to alert you that the result is suspect.
If a sample result is flagged with a system error (SYS), the time at which the error
occurred is displayed in the Test Request/Progress and View Test Results screens
and is printed on the result report. This time can then be matched to the
appropriate Event Log entry to determine the system error that caused the flag.
[F7] Print Event Prints all of the messages in the Event Log.
Log
4.3
Diagnostics Screen
Various system parameters are monitored by the system and can be viewed using
the Diagnostics screen (Figure 4-3 and Table 4-4), which is displayed when you
press [F7] Diag. from the Main Menu.
The [F6] Temp./Voltage/Vacuum and [F7] Print Align. Report keys access
functions you can use to help determine the nature of a system failure or review
the current status of the system.
Diagnostics
1
[F1] System Opens the System Initialization screen and initializes the primary system
Initialization devices. The devices are returned to the start or “home” positions.
[F2] Mechanics Opens the Mechanics screen which allows alignment of specific mechanical
devices on the analyzer. DO NOT use this screen unless so directed by a
technical support representative or if you are following instructions in this
manual or in the Operator’s Guide.
[F3] Luminometer Opens the Luminometer screen which allows verification of the luminometer
calibration. DO NOT use this screen unless so directed by a technical
support representative. If the luminometer calibration is inadvertently
altered, call Technical Support immediately.
[F4] Ultrasonics Opens the Ultrasonics screen which allows alteration and/or verification of
the ultrasonic transducer status. DO NOT use this screen unless so directed
by a technical support representative.
[F5] Digital Devices Opens the Digital Devices screen which allows you to turn off/on certain
digital devices (various pumps, valves, motors and sensors) on the analyzer.
Also provides the status (open/closed) of certain access doors on the
analyzer. DO NOT use this screen unless so directed by a technical support
representative.
[F6] Temp. Voltage Opens the Temperature/Voltage Status screen which provides the current
Vacuum temperature of various areas of the analyzer, voltage of the power supply,
and pressure in the vacuum bottle.
[F7] Print Alignment Prints the run-hour status and the current alignment information for various
Report mechanical devices. The run-hour status is a measure of the time the analyzer
has spent processing samples.
[F8] More Options Opens a menu of options including LIS, Expanded Archive Data, Archive
Service Data, Exerciser, Calib. Incubator Belt, and Print Belt Cal. Report.
The LIS option opens the LIS Diagnostics screen (refer to Appendix A, LIS
Interface). The Expanded Archive Data and Archive Service Data options
save test and system data to disk (refer to Section 6.5, Archiving Data To
Disk). The Exerciser option cycles movement of various mechanical devices
on the analyzer. Selecting the Exerciser option starts the pre-programmed
exercise routine. The Calib. Incubator Belt option re-calibrates the incubator
belt after maintenance, and the Print Belt Cal. Report option prints a report
containing incubator belt calibration data.
DO NOT use either the Exerciser or the Calib. Incubator Belt function
unless so directed by a technical support representative or if you are
following instructions in this manual or in the Operator’s Guide.
Mechanics
CAUTION
DO NOT use this function unless directed to do so by a technical support
representative or if you are following instructions in this manual or in the
Operator’s Guide.
Luminometer
CAUTION
DO NOT use this function unless directed to do so by a technical support
representative.
Ultrasonics
CAUTION
DO NOT use this function unless directed to do so by a technical support
representative.
Digital CAUTION
Devices
DO NOT use this function unless directed to do so by a technical support
representative.
The Digital Devices screen is displayed. The status of various digital devices
can be reviewed.
A report of the run-hour status and all of the alignment values for all
primary system devices is printed (refer to Figure 4-5 for an example of the
report).
Exerciser
CAUTION
DO NOT use this function unless directed to do so by a technical support
representative or if you are following instructions in this manual or in the
Operator’s Guide.
3 Use the [Arrow] keys to move the cursor to Exerciser, then press [Enter].
5 Use the [Arrow] keys to highlight the appropriate exerciser test, then press
[Enter] to select.
NOTES
• The [F8] Stop Cycling key is displayed after [F2] Start Cycling is pressed.
• Pressing [F8] Stop Cycling does not immediately stop the exercise routine.
The test will stop after the present cycle is completed.
Laboratories, Inc.
Laboratory A
123 Lake Street
Townsville, ST 33333
Director
System ID
Technologist
Other Text
Alignment Report
Device: Pipettor
Reagent - X 7
Sample - X 8
Wash - X 6
RV - X 11
Reagent - Z -37
Sample - Z -14
Wash - Z -6
RV - Z 1
Load/Unload -1
Tube Detector 0
Bar Code Reader -5
Aspirate -6
Load/Unload 0
Aspirate -5
Device: RV Shuttle
CW Align 30
CCW Align 25
Device: Rake
RV Inc -19
Page 1 of 3
Technologist _______ 03-25-99 2:24 pm
Laboratories, Inc.
Laboratory A
System ID
Alignment Report
Wash Crsl/Arm -7
CW Align -1
CCW Align 0
CW Align 1
CCW Align 1
CCW Align -6
Backlash Cal. 0
Incubator 0
Laboratories, Inc.
Laboratory A
System ID
Alignment Report
Calibrate
Incubator Belt CAUTION
DO NOT use this function unless directed to do so by a technical support
representative or if you are following instructions in this manual or in the
Operator’s Guide.
3 Use the [Arrow] keys to move the cursor to Calib. Incubator Belt,
then press [Enter].
3 Use the [Arrow] keys to move the cursor to Print Belt Cal. Report, then
press [Enter].
Laboratories, Inc.
Laboratory A
123 Lake Street
Townsville, ST 33333
5
Troubleshooting
• Introduction (Section 5.1)............................................................................. 5-2
5.1
Introduction
This chapter includes troubleshooting procedures for identifying and correcting
problems that might occur during system operation. There are two general types
of system failure:
• Instrument failure
• Assay failure
The following sections describe symptoms, possible causes, and corrective actions
for each of these types of system failure.
The Event Log displays messages and codes which can guide you and/or a
technical support representative during troubleshooting. Various system
parameters are monitored by the system and can be viewed using the Diagnostics
screen. Refer to Chapter 4, System Diagnostics.
Result reports may include fatal or non-fatal flags that can also assist you in
troubleshooting. For information about flags, refer to the Operator’s Guide,
Chapter 5, Sample Results.
5.2
System Check Troubleshooting
System Check results that are out of range of expected values may indicate
operational problems with the instrument. To review System Check expected
values, refer to Table 8-11 in the Operator’s Guide. To review information about
how the System Check works, refer to Section 6.7, System Check Support
Information.
Use the troubleshooting tables in this section to assist you in troubleshooting out-
of-range System Check results. The troubleshooting tables identify symptoms, list
possible causes for the symptoms, and provide the corrective action for each
cause, sorted by the result that is out of range. If you have out-of-range results for
more than one area of the System Check, troubleshoot the problem in the
following order:
• Substrate Check Problems
• Unwashed Check Problems
• Washed Check Problems
• Wash Efficiency Problems
When you have corrected a problem, perform another System Check to confirm
the results and/or further identify the problem. You are done troubleshooting
when you complete the System Check with all results within expected ranges.
Because you troubleshoot problems in sequence, problems in the tables for each
subsequent area of the System Check are limited to problems not ruled out by the
previous area of the System Check.
If you are unable to identify the cause of a problem or if the problem persists after
performing the specified troubleshooting procedure(s), call Technical Support for
assistance.
Substrate If the System Check fails the first time, it should be repeated to rule out
Check procedural problems. Use a new aliquot of undiluted System Check Solution and
Problems a new 1/501 dilution.
If System Check results do not fall within expected ranges, troubleshoot the
Substrate Check problems first. The Substrate Check uses the fewest system
components. When the Substrate Check results from the complete System Check
are within range, the substrate and substrate system generally can be ruled out as
causes for subsequent out-of range results.
NOTE
After troubleshooting, the complete System Check procedure must be run again
to confirm the success of your efforts. If a Substrate Check is run independently,
it will not indicate problems due to plugged or dirty probes.
High substrate Aspirate probes are dirty or Clean the aspirate probes. Refer to the
ratio plugged, causing fluid to adhere Replacing and Cleaning Aspirate Probes
and drip. heading of Section 8.4, Weekly Maintenance
of the Operator’s Guide for instructions.
Revision B fluidics: Inspect the tubing, and the area under the
Fluid dripping from aspirate tubing, from the peristaltic waste pump to
probes due to damaged peristaltic the aspirate probes for crystalline deposits.
waste pump tubing. Deposits may indicate that the tubing is
damaged and should be replaced. Call
Technical Support for assistance. Refer to
the Chapter 6 tubing replacement procedure
only when instructed by Technical Support.
High % CV due to The System Check is not diluted or Use a new aliquot of undiluted System
high values in improperly diluted, or the cups are Check Solution and prepare a new 1/501
only the last one out of order in the maintenance dilution. Run the System Check again. Refer
or two replicates. tray. to Section 8.4, Weekly Maintenance of the
Operator’s Guide to review the correct
System Check procedure.
High % CV with Inconsistent substrate delivery Check the substrate supply bottle and
random due to insufficient supply. replenish, if necessary, using the Supplies or
variability Supplies Required screen. Refer to Section
throughout 2.6, Substrate of the Operator’s Guide for
replicates. more information.
Inconsistent substrate delivery Lift the front panel and inspect the substrate
due to air in fluid lines. tubing. You can expect to see air bubbles.
Close the front panel and prime the
substrate by pressing [F6] Maint. from the
Main Menu, [F4] Fluidics Priming, then
[F3] Substrate. After priming, inspect the
tubing again. You should see no bubbles in
the tubing. If you see bubbles, continue
troubleshooting.
Revision B fluidics:
Visually inspect tubing to and from the
substrate pump/heater assembly, fluid
fittings on the substrate pump (2 fittings),
and valve to pump connections for deposits
(refer to Chapter 1 for part locations).
Deposits may indicate damaged tubing
which should be replaced. Call Technical
Support for further instructions.
Inconsistent substrate delivery or Inspect the substrate probe (left most probe
splashing due to bent substrate on the wash arm - refer to Section 8.3 of the
probe. Operator’s Guide for probe location). If probe
is bent, call Technical Support for further
instruction.
High RLU mean. The System Check is not diluted or Use a new aliquot of undiluted System
improperly diluted, or the cups are Check Solution and prepare a new 1/501
out of order in the maintenance dilution. Run the System Check again. Refer
tray. to Section 8.4, Weekly Maintenance of the
Operator’s Guide to review the correct
System Check procedure.
Substrate pump delivering too Run the Visual Substrate Volume Check
much substrate. procedure and follow the instructions
appropriate to the results. Refer to Section
6.8 of this manual for this procedure. If the
Visual Substrate Volume Check does not
fail, continue troubleshooting.
Low RLU mean. Expired substrate. Check the install date in the event log.
Install a new bottle of substrate, as needed.
Incomplete priming after substrate Prime the substrate by pressing [F6] Maint.
decontamination. from the Main Menu, [F4] Fluidics Priming,
then [F3] Substrate. Repeat the System
Check procedure.
Unwashed Begin troubleshooting the Unwashed Check out-of-range results when the
Check Substrate Check results are within expected ranges. The troubleshooting
Problems information for the Unwashed Check focuses on problems with the pipetting
system and does not provide detail on problems related to the substrate system.
High % CV. A kink in the wash buffer supply Visually inspect tubing for kinks from the
lines. wash buffer supply to the main pipettor.
Straighten kinked tubing if found. Then,
prime the pipetting system by pressing
[F6] Maint. from the Main Menu,
[F4] Fluidics Priming, then [F1]Pipettor.
High % CV Out of wash buffer. Check the wash buffer supply in the fluids
(continued). tray. If empty, replenish the wash buffer as
described in Chapter 2 of the Operator’s
Guide; however, before replenishing the
wash buffer, check the wash buffer icon on
the Main Menu. If it is not red when the
system is out of wash buffer, call Technical
Support.
Revision B fluidics:
Call Technical Support.
Precision pump, valve, fittings, or Examine the precision pump, valve, fittings
tubing damaged and leaking. (2 fittings), and tubing (from the precision
valve to the primary pipettor) for leaks and/
or salt deposits. If any are found, call
Technical Support.
High RLU mean. Improperly prepared or no Use a new aliquot of undiluted System
dilution in the System Check Check Solution and prepare a new 1/501
maintenance tray. dilution. Run the System Check again. Refer
to Section 8.4, Weekly Maintenance of the
Operator’s Guide to review the correct
System Check procedure.
High RLU mean Problems with the substrate If the Substrate Check RLU mean results are
(continued). system that are due to any of the within expected ranges, you can rule out
following causes: these causes. If the Substrate Check results
are not within expected ranges, refer to
• Wash/read carousel or
Substrate Check troubleshooting for high
substrate temperatures that
RLU mean.
are too high.
• A contaminated substrate
supply.
• The substrate pump
delivering too much substrate.
Low RLU mean. Improperly prepared or no Use a new aliquot of undiluted System
dilution in the System Check Check Solution and prepare a new 1/501
maintenance tray. dilution. Run the System Check again. Refer
to Section 8.4, Weekly Maintenance of the
Operator’s Guide to review the correct
System Check procedure.
Problems with the substrate If the Substrate Check RLU mean results are
system that are due to any of the within expected ranges, you can rule out
following causes: these causes. If the Substrate Check results
are not within expected ranges, refer to
• Expired substrate.
Substrate Check troubleshooting for low
• Insufficient substrate supply. RLU mean.
• Wash/read carousel or
substrate temperatures that
are out of range low.
• Incomplete priming after
substrate decontamination.
• Substrate supply
contaminated with Contrad 70
cleaning solution.
• Substrate dispense volume too
low.
Washed Begin troubleshooting the Washed Check out-of-range results when the Substrate
Check Check and the Unwashed Check results are within expected ranges. The
Problems troubleshooting information for the Washed Check focuses on problems with the
reaction vessel wash system, and does not provide detail on problems related to
the substrate or the pipetting system.
High % CV. Incomplete aspiration of reaction Clean the aspirate probes. Refer to the
vessels due to dirty or plugged Replacing and Cleaning Aspirate Probes
aspirate probes. heading of Section 8.4, Weekly Maintenance
of the Operator’s Guide for instructions.
Incomplete aspiration of reaction Inspect the aspirate probes on the wash arm.
vessels due to damaged aspirate Replace bent probes. Refer to Section 8.4,
probes. Weekly Maintenance in the Operator’s Guide
for the identification of, and replacement
procedure for, aspirate probes. If problem
persists, call Technical Support.
Revision B fluidics: Inspect the tubing, and the area under the
Incomplete aspiration of reaction tubing, from the peristaltic waste pump to
vessels due to damaged peristaltic the aspirate probes for crystalline deposits.
waste pump tubing. Deposits may indicate that the tubing is
damaged and should be replaced. Call
Technical Support for assistance. Refer to
the Chapter 6 tubing replacement procedure
only when instructed by Technical Support.
One or more aspirate probes stuck Verify up and down movement of the
in “up” position. aspirate probes. Refer to Section 8.4, Weekly
Maintenance in the Operator’s Guide for
identification of the aspirate probes. Lightly
grasp the probe below the wash arm. The
probes are spring loaded and should move
SLIGHTLY up and down. If not moving
freely, replace the probe(s). Refer to Section
8.4 of the Operator’s Guide.
High % CV Insufficient wash buffer volume Visually inspect tubing for kinks from the
(continued). due to kinks in tubing or air in wash buffer supply to the dispense probes.
wash pump system. Straighten kinked tubing if found. Then,
prime the dispense probes by pressing
[F6] Maint. from the Main Menu,
[F4] Fluidics Priming, then
[F2] Dispense Probes.
High RLU mean. Incomplete aspiration of reaction Clean the aspirate probes. Refer to the
vessels due to dirty or plugged Replacing and Cleaning Aspirate Probes
aspirate probes. heading of Section 8.4, Weekly Maintenance
of the Operator’s Guide for instructions.
Incomplete aspiration of reaction Inspect the aspirate probes on the wash arm.
vessels due to damaged aspirate Replace bent probes. Refer to Section 8.4,
probes. Weekly Maintenance in the Operator’s Guide
for the identification of, and replacement
procedure for, aspirate probes. If problem
persists, call Technical Support.
One or more aspirate probes stuck Verify up and down movement of the
in “up” position. aspirate probes. Refer to Section 8.4, Weekly
Maintenance in the Operator’s Guide for
identification of the aspirate probes. Lightly
grasp the probe below the wash arm. The
probes are spring loaded and should move
SLIGHTLY up and down. If not moving
freely, replace the probe(s). Refer to Section
8.4 of the Operator’s Guide.
Problems with the substrate If the Substrate Check RLU mean results are
system that are due to any of the within expected ranges, you can rule out
following causes: these causes. If the Substrate Check results
are not within expected ranges, refer to
• Wash/read carousel or
Substrate Check troubleshooting for high
substrate temperatures that
RLU mean.
are too high.
• A contaminated substrate
supply.
• The substrate pump
delivering too much substrate.
Low RLU mean. Diluted System Check solution Reload sample cup number one with neat
used instead of neat. Sample cup System Check solution and number four
number one may have been with 1/501 diluted System Check, and
prepared with the incorrect repeat the System Check procedure.
solution, or cup numbers one and
four may have been switched
when placed in the tray.
Low RLU mean Main pipettor not delivering If the Unwashed Check % CV results are
(continued). sufficient volume. within expected ranges, you can rule out
this cause. If the Unwashed Check results
are not within expected ranges, refer to
Unwashed Check troubleshooting for high
% CV.
Problems with the substrate If the Substrate Check % CV and RLU mean
system that are due to any of the results are within expected ranges, you can
following causes: rule out these causes. If the Substrate Check
• Air in substrate lines. results are not within expected ranges, refer
to Substrate Check troubleshooting for high
• A leak in the substrate system. % CV and low RLU mean.
• A kink in the substrate lines.
• A bent substrate probe.
• Substrate pump or valve
failure.
• Expired substrate.
• Insufficient substrate supply.
• Wash/read carousel or
substrate temperatures that
are out of range low.
• Incomplete priming after
substrate decontamination.
• Substrate supply
contaminated with Contrad 70
cleaning solution.
• Substrate dispense volume too
low.
Wash Efficiency Washed Check mean RLUs or Refer to Washed Check troubleshooting for
ppm fail to meet % CV too high. high % CV and high RLU mean.
criteria.
5.3
Instrument Troubleshooting
Instrument troubleshooting information can help you identify and correct
instrument problems that are not resolved during System Check troubleshooting.
The troubleshooting tables identify symptoms, list possible causes for the
symptoms, and provide the corrective action for each cause.
If you are unable to identify the cause of a problem or if the problem persists after
performing the specified troubleshooting procedure(s), call Technical Support for
assistance.
The background A fatal system event has occurred Print the Event Log by pressing
of the Event Log and a test was cancelled. [Scroll Lock], then [F7] Print Event Log. The
icon is red. Event Log message identifies the exact
problem. Refer to the related symptom in
this chapter for instructions.
The background A non-fatal system event has Review the Event Log, by pressing
of the Event Log occurred, test results were [Scroll Lock], and identify the problem.
icon is red calculated, and no tests were Typical problems with corrective actions:
(continued). cancelled.
• If an RV ejected with no waste bag
present, properly install the waste bag.
• If the dark count is too high, perform the
test again. If high dark counts occur
with increasing frequency, call Technical
Support.
NOTE
Dark counts measure the background
light in the instrument in RLUs when
no transmission is occurring. When
dark counts exceed expected results,
an error is posted to the event log.
High dark counts would affect
results.
The background Memory allocation error. Reboot the system. Refer to Section 6.6 in
of the Event Log this manual for detailed information.
icon is red and the
“Unable to
allocate memory”
message is
recorded in the
Event Log.
The background The software has encountered an Reboot the system. Refer to Section 6.6 in
of the Event Log unexpected condition. this manual for detailed information.
icon is red and the
“Assertion error
‘xyz = = NULL’ in
file abc, line n”
message is
recorded in the
Event Log (letters
in italics are
variables).
The background A fatal system event has occurred Prepare a fresh aliquot of the patient sample
of the Event Log because of insufficient sample or maintenance solution and perform the
icon is yellow and quantity. test or System Check again.
a “level sense”
error is logged. A
test result is
flagged QNS or a
maintenance
result is cancelled.
There is A fatal system event has occurred Print the Event Log by pressing
apparently because of level sense failure or [Scroll Lock], then [F7] Print Event Log. The
enough fluid in sample carousel positioning error. Event Log message identifies the exact
the sample problem. Typical corrective actions:
container, yet the
• Change to the correct sample container
background of the
and/or sample tray. Ensure that the
Event Log icon is
sample containers are placed only in a
yellow and a
sample tray with the appropriate Tray
“level sense” error
ID. Refer to Chapter 4 of the Operator’s
is logged. A test
Guide for detailed sample container and
result is flagged
tray information.
QNS or a
maintenance • Ensure that the sample container is fully
result is cancelled. seated in the sample tray.
• Ensure that the sample tray is properly
installed on the carousel. Refer to
Section 4.3, Sample Trays, of the
Operator’s Guide for installation
instructions.
For other problems or further instructions,
call Technical Support.
A fatal system event has occurred Ensure that the fluid in the sample container
because the fluid level exceeds the does not exceed the top of the container and
top of the sample container. perform the test or System Check again.
The background A non-fatal system event has Review the Event Log, by pressing
of the Event Log occurred because of a supply [Scroll Lock] to confirm the problem. Add
icon is yellow and shortage. supplies or empty waste containers as
one or more described in the appropriate section of the
supply status Operator’s Guide, Chapter 2, Supplies. For
icons are red. The other problems or further instructions, call
scheduler is Technical Support.
paused and no
new tests are
started.
The background A non-fatal system event has Review the Event Log, by pressing
of the Event Log occurred that is not related to [Scroll Lock]. The Event Log message
icon is yellow, needed supplies or the available identifies the exact problem. The result of
there is no QNS waste area. the test being performed when the non-
flag, and no fatal event occurred may be flagged.
supply status Review the result to determine if the test
icons are red. should be repeated. For information about
result flags, refer to the Operator’s Guide,
Chapter 5, Sample Results. If necessary, call
Technical Support for assistance.
Start-Up Problems
Symptom Possible Causes Corrective Action
Data diskette in the floppy disk Remove diskette from floppy drive and
drive. reboot.
Hardware (power supply, hard Reboot the system. Refer to Section 6.6 in
disk drive, CPU printed circuit this manual for detailed information.
board) or software failure.
System fails Interlock switch detects the front Close the front panel of the analyzer and
during system panel of the analyzer is open. perform system initialization (refer to
initialization. Section 4.3, Diagnostics Screen, in this
manual).
A device motion error (i.e., device Display the Event Log, by pressing
failed to home or return to its [Scroll Lock], then press [F7] Print Event
starting position) or the system Log to obtain a copy of the entry. Call
software is defective. Technical Support.
Power Problems
Symptom Possible Causes Corrective Action
No power to Faulty power outlet. Plug the analyzer and printer into a
analyzer or different power outlet. If problem persists,
printer. perform Power Problems troubleshooting
for analyzer and printer individually, then
call Technical Support.
No power to Analyzer power switch not turned Turn on power switch located on the right
analyzer. on. side of the analyzer.
Power cord connector loose on Ensure that the power cord connections to
either end. outlet and to analyzer are secure.
No power to Printer power switch not turned Turn on printer power switch located on the
printer. on. lower left front corner of the printer.
Printer power cord connector Ensure that the power cord connections to
loose on either end. outlet and to printer are secure.
Keyboard Problems
Symptom Possible Causes Corrective Action
No response from Connector loose. Ensure that the cable connections (located
keyboard. on the right side of the analyzer) between
the keyboard, bar code wand, and the
analyzer are secure.
System software is not responding. Reboot the system. Refer to Section 6.6 in
this manual for detailed information.
Tray bar code not Internal bar code reader Configure the internal bar code reader on,
read by internal configured off. according to procedures in Section 7.2,
bar code reader. Configure System.
Bar code label not correctly placed Reapply the bar code label correctly on the
on the tray. tray, according to procedures in Section 1.5,
Bar Code Readers/Scanners.
System software version 3.27 or New tray labels, which can be identified by
higher is installed, and the tray has the line under the tray number (refer to
an obsolete tray label. Figure 1-29 for an example), must be used
with system software version 3.27 or higher.
Remove the obsolete tray label and apply a
current label.
Bar code reader not operating Call Technical Support. Until the problem is
properly. corrected, you can configure the reader off
and type the Tray IDs and Sample IDs or
scan the labels with the external bar code
reader. Refer to Section 7.2, Configure
System for configuration procedures.
Sample bar code Sample container not correctly Turn the sample container in the tray until
not read by placed in the tray. its bar code label faces the same direction as
internal bar code the tray bar code label, and the bar code is
reader. fully is visible through the slot in the tray.
Bar code label not correctly placed Verify that the bar code label is placed
on the sample. correctly on the sample container, according
to procedures in Section 1.5, Bar Code
Readers/Scanners. Reapply if needed.
Internal bar code reader not Configure the internal bar code reader
configured properly for the parameters to match the bar code
sample bar code symbology. symbology you are using. Refer to Section
7.3, Configure Internal Bar Code Reader for
configuration information.
Bar code symbology not Verify that the bar code symbology used on
supported. the sample label is supported, according to
Section 2.2, Performance Characteristics. If
the symbology is not supported, consult
with Technical Support to identify a
solution.
No response from Incorrect scanning technique. Verify that the correct screen is displayed for
external bar code the item you are scanning, and that the
wand. cursor is in the correct field. Review
scanning procedures in Section 1.5, Bar
Code Readers/Scanners. Try scanning
again.
You are trying to add more than You can add only one calibrator lot (with
one calibrator lot on the same any related levels) on the Add Calibrator
screen. Lot screen. After saving the information,
press [Esc] to return to the Configure
Calibrator screen and press [F1] Add Lot to
add another calibrator lot.
System software is not responding. Reboot the system. Refer to Section 6.6 in
this manual for detailed information.
Air in System
Symptom Possible Causes Corrective Action
Air in fluid lines. Insufficient priming. Prime the system by pressing [F6] Maint.
from the Main Menu, [F4] Fluidics Priming,
(use the default number of cycles displayed
for each component), then press [F5] All. If
problem persists, call Technical Support.
Air in fluid lines Kinked tubing at fluids tray. Visually inspect tubing for kinks to and
(continued). from the substrate pump/ heater assembly
(refer to Chapter 1 for part locations).
Straighten kinked tubing if found. Then,
prime the system by pressing [F6] Maint.
from the Main Menu, [F4] Fluidics Priming,
then [F5] All.
Increased pressure in system due Check the waste filter bottle for fluid; if
to plugged waste filter. present, empty the bottle as described in
Section 6.16, Replacing the Waste Filter
Bottle.
Fluid dispensed Probe partially clogged. Run the Special Clean procedure. Refer to
from primary Section 6.13 for instructions. If problem
probe with excess persists, call Technical Support for further
pressure. instructions.
Primary probe Primary probe tip is partially Run the Special Clean procedure. Refer to
leaking. clogged. Section 6.13 for instructions. If problem
persists, call Technical Support for further
instructions.
Revision B fluidics:
Visually inspect the fittings between the
primary probe and precision pump valve
for fluid leaks or deposits (refer to Chapter 1
for part locations). Inspect all the fluid
fittings to the manifold. Call Technical
Support for assistance.
5.4
Assay Troubleshooting
The following troubleshooting tables are provided to help you identify and
correct assay problems. The information is organized by calibration, quality
control, and patient sample problems. The troubleshooting tables identify
symptoms, list possible causes for the symptoms, and provide the corrective
action for each cause.
Various system parameters are monitored by the system and can aid in
troubleshooting. Refer to Chapter 4, System Diagnostics, for a description of the
Event Log and the Diagnostics screen.
If you are unable to identify the cause of a problem or if the problem persists after
performing the specified troubleshooting procedure(s), call Technical Support for
assistance.
Calibration When calibration results are rejected, rejection codes are displayed on the Last
Run Calibration screen. Use the following table to assist you in troubleshooting
rejected calibrations. Additional information about calibration is available
through the following references:
• For calibration theory, refer to Chapter 3, Theory of Operation.
• For reviewing calibrations, refer to Chapter 6, Assay Calibration, of the
Operator’s Guide.
• For doing calibrations, refer to Section 7.6, Configure Calibrators and
Calibration Controls, of this manual, and Section 3.9, Calibrator/Calibration
Control Test Request Entry in the Operator’s Guide.
Calibration Problems
Symptom Possible Causes Corrective Action
Two or more replicates were not Review the event log for device errors prior
calculated due to an instrument to the calibration rejection. Troubleshoot the
error. device errors. Contact Technical Support for
assistance.
Calibration is For qualitative assay (reason Be sure that the calibrators or calibration
rejected. Reason displayed: Limits), calibrators or control set are loaded in the proper order,
displayed in Last calibration control set out of order. then recalibrate.
Run Calibration
screen: No Fit, Calibrator or control set expired. Unload expired calibrator or calibration
Max Iter, Bad Fit, Check expiration date in the control set, load new set, then recalibrate.
Resp. Delta, CV Request Calibrator screen.
Std 0, or Limits. Unstable/contaminated calibrator Unload calibrator or calibration control set,
Precision is or calibration control set due to load new set, then recalibrate.
generally good. improper handling.
Substrate supply depleted. Check that the substrate bottle is not empty.
Replenish substrate supply as necessary,
then recalibrate.
Quality When a quality control result fails to meet the criteria for an applied QC rule, the
Control background of the Quality Control icon turns red. The icon background remains
red until the QC Data screen is viewed. For information about reviewing quality
control results, refer to Section 7.2, Reviewing Assay Quality Control Data, in the
Operator’s Guide.
Before using this section to troubleshoot a quality control problem, run the
System Check procedure. If the System Check fails, troubleshoot the problem as
described in Section 5.2, System Check Troubleshooting. Running the System
Check will rule out or help identify QC problems such as:
• Inadequate washing due to aspirate probes not aspirating fluid—detect with
the Substrate Check or the Washed Check results
• Expired or contaminated substrate—detect with the Substrate Check, the
Washed Check, or the Wash Efficiency calculation results
• Inaccurate substrate delivery due to air in the line—detect with the Substrate
Check results
• Inaccurate sample or reagent delivery due to leak in main pipettor lines—
detect with the Unwashed Check results
Controls do not Daily maintenance not performed Perform daily maintenance before running
meet applied QC today. controls. Refer to Section 8.3, Daily
rule. Maintenance, in the Operator’s Guide.
Wrong control loaded onto sample Unload incorrect control, load correct
tray. control, then repeat test(s).
Wrong lot number selected for test. Repeat test with correct lot number.
Wrong sample type. Verify that the sample type matches the type
indicated in the test request, and also
matches the sample type configured for the
control. If not, correct and repeat test(s).
Controls expired, lots expired. Unload expired controls, load new controls,
then repeat test(s).
Controls do not Controls improperly reconstituted. Unload controls, reconstitute new controls
meet applied QC (as directed by the manufacturer) and load,
rule (continued). then repeat test(s).
Quantity of control was not Ensure that enough control is pipetted into
sufficient for the sample container each sample container. (If using 2.0 mL
used. sample cups, ensure that at least 500 mL is
pipetted into each container. If using other
containers, refer to Chapter 4 of the
Operator’s Guide for the correct minimum
volume.)
Wrong reagent pack loaded or Verify the location of all on-board reagent
reagent pack placed in wrong packs by unloading each, checking that the
position on reagent carousel. reagent pack code on the screen matches
that on the label and reloading the reagent
pack. If the reagent pack is on-board but is
not presented during this process, call
Technical Support for assistance.
Reagent pack expired. Check Unload expired reagent pack, load new
reagent pack expiration date in the reagent pack, then repeat test(s).
Reagent Inventory screen.
Controls do not Quantity of sample is not Ensure that enough sample is pipetted into
meet applied QC sufficient for testing. Level sense each sample container, then repeat test(s).
rule (continued). error or results flagged QNS.
Increasing values Sample evaporation. Load a fresh aliquot of each sample, then
across the run. repeat test(s). Ensure 2 mL sample cups and
all insert cups are on board no longer than 1
hour before the sample is aspirated. Ensure
that 3 mL sample containers are on board no
longer than 2 hours before the sample is
aspirated.
Sample values not Inappropriate sample type used. Refer to the product insert for appropriate
as expected. sample types.
Sample improperly handled. Ensure that the sample was stored and
handled according to proper laboratory
procedures. Refer to individual assay inserts
for proper sample handling instructions.
If serum, sample microclots Spin the sample again or use a serum filter.
present. Repeat test.
Quantity of sample was not Ensure that enough sample is pipetted into
sufficient for the sample container each sample container. (If using 2.0 mL
used. sample cups, ensure that 500 mL is pipetted
into each container. If using other
containers, refer to Chapter 4 of the
Operator’s Guide for the correct minimum
volume.)
Sample values not Samples have evaporated. Load a fresh aliquot of each sample, then
as expected repeat test(s). Ensure 2 mL sample cups and
(continued). all insert cups are not on board longer than 1
hour before the sample is aspirated. Ensure
that 3 mL sample containers are not on
board longer than 2 hours before the sample
is aspirated.
Wrong reagent pack loaded or Verify the location of all on-board reagent
reagent pack placed in wrong packs by unloading each, checking that the
position on reagent carousel. reagent pack code on the screen matches
that on the label and reloading the reagent
pack. If the reagent pack is on-board but is
not presented during this process, call
Technical Support for assistance.
Reagent pack expired. Check Unload expired reagent pack, load new
reagent pack expiration date in the reagent pack, then repeat test(s).
Reagent Inventory screen.
Assay calibration expired. Check Recalibrate assay and run controls, then
calibration expiration date in the repeat test(s).
Reagent Inventory screen.
Partial bottles of substrate have Replace and prime a new, full bottle of
been combined. substrate by pressing [F6] Maint. from the
Main Menu, [F4] Fluidics Priming, then
[F3] Substrate. Repeat test(s).
Access instrument problem, such Run the System Check procedure. Refer to
as inadequate washing, poor main Section 8.4, Weekly Maintenance of the
pipettor precision, dirty aspirate Operator’s Guide to review the procedure
probes, substrate expired or and expected results. For out of range
contaminated. results, refer to the Section 5.2, System
Check Troubleshooting tables.
High sample Sample evaporation. Load a fresh aliquot of each sample, then
values. repeat test(s). Ensure 2 mL sample cups and
all insert cups are not on board longer than 1
hour before the sample is aspirated. Ensure
that 3 mL sample containers are not on
board longer than 2 hours before the sample
is aspirated.
LOW sample Sample was diluted If the sample was diluted prior to testing,
value flag. inappropriately prior to testing. repeat testing on the sample undiluted. If
the sample was generated using a diluted
assay format (for example, Diluted Beta
Human Chorionic Gonadotropin), repeat
the sample in the standard assay format (for
the example, Total Beta Human Chorionic
Gonadotropin assay).
Increased assay System not operating within Run System Check procedure and if results
variability/poor expected ranges. are not within expected ranges, refer to
precision. Section 5.2, System Check Troubleshooting.
Wrong reagent pack loaded or Verify the location of all on-board reagent
reagent pack placed in wrong packs by unloading each, checking that the
position on reagent carousel. reagent pack code on the screen matches
that on the label and reloading the reagent
pack. If the reagent pack is on-board but is
not presented during this process, call
Technical Support for assistance.
An unexpected Reagent pack expired. Check Unload expired reagent pack, load new
shift in assay reagent pack expiration date in the reagent pack, then repeat test(s).
results. Reagent Inventory screen.
An unexpected Contaminated wash buffer. Replace wash buffer supply with new
shift in assay buffer, prime the dispense probes by
results pressing [F6] Maint. from the Main Menu,
(continued). [F4] Fluidics Priming, then
[F2] Dispense Probes. Repeat test(s).
UNR Fatal Flag The measured sample signal 1. Review the Event Log for error events
(RLU) is less than an RLU with a similar date and time to this
threshold limit for the least event .
concentrated calibrator/ • If events occurred, troubleshoot.
calibration control for a positive
slope assay, or is greater than the 2. Run controls, then repeat the test.
least concentrated calibrator for a • If the controls are not in range,
negative slope assay, as defined in troubleshoot according to the Quality
the assay protocol file. Control Problems information.
• If you have questions about the result,
or if the problem persists, call Technical
support.
IND Fatal Flag For competitive assays only, at the 1. Review the Event Log for error events
high dose end of the curve. The with a similar date and time to this
measured sample signal (RLU) is event.
so low that the result cannot be
• If events occurred, troubleshoot.
distinguished from a system
failure. 2. Run controls, then repeat the test.
• If the controls are not in range,
troubleshoot according to the Quality
Control Problems information .
• If you have questions about the result,
or if the problem persists, call Technical
Support.
6
System Support Procedures
• Introduction (Section 6.1)............................................................................. 6-2
• Opening and Closing the Top Cover (Section 6.9) ................................. 6-49
6.1
Introduction
This chapter contains system support procedures for the Access Immunoassay
System performed to isolate or correct a system problem. Many of these
procedures should be performed only when instructed by a technical support
representative. In these cases, a caution is included in the introductory section of
the procedure.
CAUTIONS
• Unless you have an emergency problem with the instrument, do not
press [F8] Cancel to stop a maintenance procedure. Cancelling the
procedure may cause damage to the instrument and may compromise the
integrity of results for subsequent tests.
• If you have an emergency problem with the instrument while a
maintenance procedure is running, press [F8] Cancel, but do not initialize
the system. Call Technical Support for assistance.
6.2
Substrate Decontamination
CAUTION
This procedure should be performed only when instructed by a technical
support representative.
If contamination occurs, all system components that come into direct contact with
substrate solution must be decontaminated. Symptoms of substrate system
contamination include the following:
• High Substrate Check values (> 9000 RLUs) in System Check procedure
(refer to Chapter 8, Routine Maintenance, of the Operator’s Guide).
• Increase in zero calibrator RLUs for sandwich assays.
• Increased variability of results, especially low signal calibrators.
NOTE
The substrate used in this procedure must be equilibrated to room temperature
for the time specified in the product insert before you load it on the analyzer.
Refer to the product insert for detailed information.
Procedure
CAUTIONS
• Unless you have an emergency problem with the instrument, do not
press [F8] Cancel to stop a maintenance procedure. Cancelling the
procedure may cause damage to the instrument and may compromise the
integrity of results for subsequent tests.
• If you have an emergency problem with the instrument while a
maintenance procedure is running, press [F8] Cancel, but do not initialize
the system. Call Technical Support for assistance.
• Some steps in this procedure vary, depending on which revision of the
fluidics module is installed. Refer to Section 1.2, Instrument Description
in this manual to determine if your system has revision A or B fluidics.
WARNING
Contrad 70 cleaning solution is alkaline and may cause severe eye irritation or
mild skin irritation. Refer to the manufacturer's label for details.
Use the [Arrow] keys to move the cursor to the Substrate field and type 1.
7 Remove the cap and tubing from the substrate container and thoroughly
wipe down the surfaces of the substrate cap that are exposed to the substrate
and the exterior of the draw tube with the lint-free cloth saturated with
Contrad 70 cleaning solution.
Refer to Section 2.6, Substrate of the Operator’s Guide for detailed instructions
on removing the substrate.
NOTE
To avoid contaminating the substrate again, do not touch the supply line
or inside of the substrate cap, or allow the supply line to come in contact
with any surface.
8 Press [F3] Substrate to begin the priming cycle and then wait for the cycle to
complete, which will create an air gap in the substrate fluid tubing.
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
9 Place the substrate tubing into the container of diluted Contrad 70 cleaning
solution.
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
NOTE
To avoid contaminating the substrate again, do not touch the supply line
or inside of the substrate cap, or allow the supply line to come in contact
with any surface.
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
Allow completion of the entire priming cycle to create a sufficient air gap in
the tubing.
14 Load a new bottle of substrate using the Supplies screen. However, do NOT
prime the substrate after loading the new bottle, because you prime it later
in this procedure.
Refer to Section 2.6, Substrate of the Operator’s Guide for detailed instructions
on replacing the substrate. Key sequence from the Main Menu:
[F3] Supplies, [F5] Substrate, load bottle, [F1] Done, respond YES to
Substrate bottle replaced? (i.e., highlight YES, then press [Enter]), respond
NO to Prime Substrate? (i.e., highlight NO, then press [Enter]).
Key sequence from the Supplies screen: [F9] Main Menu, [F6] Maint.,
[F4] Fluidics Priming.
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
18 Change the number of substrate priming cycles as follows and press [F3]
Substrate:
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
6.3
Precision Pump Seal
Replacement
CAUTION
This procedure should be performed only when instructed by a technical
support representative.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
This section describes the procedure for replacing the piston seals on the precision
pump of a system with revision A fluidics. A technical support representative will
replace your precision pump seals if your system has revision B fluidics. If fluid is
leaking from the precision pump, there may be deposits around the exterior of the
pump and the seal may need to be replaced.
Items • Replacement top and bottom seals (do not remove seals from their
Required individual bags until ready to use)
• Phillips screwdriver
• Flat-blade screwdriver
• Hemostat
• Clean, lint-free cloth
• Deionized water
4 Use the [Arrow] keys to highlight Precision Pump, then press [Enter].
Precision Pump is displayed in the Primary Device field, the current pump
piston position is displayed in the Current Position field, and 4 piston
position options are displayed in the middle section of the screen.
6 Open the front panel of the analyzer to expose the precision pump, which is
located behind the smoked plastic window on the front panel.
Lower Piston
Upper Piston Lower Piston Housing
Top Seal
Pump Barrel
Mounting Block
Bottom Seal
7 Unscrew the top fluid fitting from the mounting block on the right side of
the pump barrel. (The fittings connect the fluid lines from the precision
valve to the precision pump.) Do not remove the fitting from the fluid line,
or the fluid line from the precision valve.
8 Unscrew the bottom fluid fitting from the mounting block. Do not remove
the fitting from the fluid line, or the fluid line from the precision valve.
9 Use the [Tab] key to highlight the Low Res. Max. option, then press
[F3] Move to Position.
10 While holding the upper piston housing down with 1 hand, use a small
Phillips screw driver to remove the 2 screws securing the upper piston
housing to the analyzer. Place the screws and washers in a safe place. When
both screws are removed, the upper piston housing tends to spring upward.
Gently allow the housing to move upward.
11 Hold the pump barrel stationary and carefully pull straight up on the upper
piston housing to separate the upper piston housing from the pump barrel.
Set the upper piston housing aside with the piston extending upward.
12 Wrap a lint-free cloth around the lower piston housing to absorb any fluid
remaining in the pump, then carefully pull straight up on the pump barrel
to separate the pump barrel from the lower piston.
13 Press upward on the bottom of the brown plastic piston flange (supporting
the lower piston) to remove it from the lower piston assembly. Wipe the
flange with a clean, lint-free cloth moistened with deionized water to
remove any deposits.
CAUTION
Remove the seals carefully in the following steps to ensure that the pump
barrel is not scratched or scored. Should this occur, call Technical Support for
assistance.
14 Remove the top and bottom seals from the pump barrel by gently lifting the
inner edge of the seal (away from the pump barrel wall) using a hemostat or
your fingernail or a small flat-blade screw driver until the seal is completely
free from the barrel. If using a screw driver, do not allow the screw driver
to come in contact with the inside of the pump barrel.
15 Rinse the pump barrel with deionized water, then shake the barrel to
remove any excess water. Dry the area where the upper and lower seals seat
with a lint-free cloth.
16 Using a damp, lint-free cloth, wipe the upper piston, upper piston housing,
lower piston, and outside of the pump barrel to remove any deposits.
17 Remove the new top seal from the plastic bag. Do not remove both seals at
the same time because they are difficult to differentiate. Place the new top
seal, with the spring side down, on a flat surface such as a table top.
18 Align the top of the barrel (the fluid fitting mounting block is nearest the top)
with the seal and press down until the barrel contacts the table top.
19 Turn the barrel upright (with the seal inside) and use your finger to press the
seal completely down into the barrel until you feel the seal snap into place.
20 Repeat steps 17 through 19 using the bottom seal and the bottom of the
pump barrel.
21 Slide the top of the brown plastic piston flange over the top of the lower
piston, then press down firmly until it is completely seated in the metal
support bracket on the analyzer.
22 Slide the barrel and upper piston housing (with the fluid fitting mounting
block to the right), down onto the lower piston housing (the lower piston
housing is still connected to the analyzer). Press firmly to seat the pump
barrel onto the lower piston housing.
23 Align the upper piston with the top seal in the pump barrel, ensuring that
the fluid fitting mounting block is on the top and to the right and that the
piston will enter the seal squarely. Slide the upper piston completely into the
barrel. Press firmly to seat the upper piston housing onto the top of the
barrel and hold it in place with 1 hand.
24 Insert and tighten each Phillips screw into the upper piston housing. Push
down on the upper piston housing to align the screws with the screw
positioning holes on the analyzer.
NOTE
If you cannot align the screws with the holes in the analyzer, turn the brown
knurled (scored) portion of the upper piston housing from left to right until the
screws and the screw positioning holes are aligned (approximately 1/2 to 1 turn).
If the problem persists, call Technical Support for assistance.
25 Using only your fingers, turn but do not force, the knurled (scored) portion
of the upper piston housing from right to left to tighten the upper piston
housing down onto the pump barrel. The assembly should be snug enough
that the barrel resists movement, but can still be manually rotated.
CAUTION
DO NOT over-tighten the fluid fittings in the following steps. Gently tighten
the fluid fittings using only your fingers.
26 Locate the fluid line coming off the lower left fitting of the precision valve.
Gently screw the fluid fitting on the “loose” end of the fluid line into the
bottom opening of the mounting block on the right side of the precision
pump barrel.
27 Locate the fluid line coming off the upper left fitting of the precision valve.
Gently screw the fluid fitting on the “loose” end of the fluid line into the top
opening of the mounting block on the right side of the precision pump
barrel.
31 Ensure that the front panel and top cover are closed, then press
[F1] System Init.
32 When the system initialization process is complete, press [F9] Main Menu.
35 Press [F1] Pipettor. Four priming cycles are performed. Watch through the
plastic window on the front panel to ensure that all air is removed from the
precision pump during priming. If you see bubbles, repeat the priming.
36 When priming is complete, open the front panel and check for fluid leaking
from the fittings and for air bubbles in the pump or the main pipettor.
• If you do not see fluid leaks or air bubbles, close the front panel.
Verification 37 Run the System Check procedure (refer to Section 8.4, Weekly Maintenance
of the Operator’s Guide). Troubleshoot if results are not within expected
ranges (refer to Section 5.2, System Check Troubleshooting).
NOTE
After successfully completing a precision pump seal replacement, Beckman
Coulter recommends that you:
• Run quality control samples for all assays you are using to report patient
results.
• Recalibrate any assay with out-of-range results.
6.4
System Priming
This section describes the procedure for priming various components of the
Access System. The following components can be primed individually or
simultaneously:
• Main pipettor
• Dispense probes
• Substrate
The number of priming cycles can be selected for each component. The default
setting is recommended unless otherwise specified by a procedure in an Access
manual or by Technical Support.
CAUTIONS
• Unless you have an emergency problem with the instrument, do not
press [F8] Cancel to stop a maintenance procedure. Cancelling the
procedure may cause damage to the instrument and may compromise the
integrity of results for subsequent tests.
• If you have an emergency problem with the instrument while a
maintenance procedure is running, press [F8] Cancel, but do not initialize
the system. Call Technical Support for assistance.
The Fluidics Priming screen is displayed with the cursor in the No. Cycles
field for the pipettor.
• To change the number of cycles from the default, type the desired number
of cycles.
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
The main pipettor is primed. The Pipettor Priming screen is displayed while
priming is in process.
The Fluidics Priming screen is displayed with the cursor in the No. Cycles
field for the pipettor.
• To change the number of cycles from the default, use the [Arrow] keys to
move the cursor to the No. Cycles field for dispense probes, then type the
desired number of cycles.
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
The dispense probes are primed. The Dispense Probes screen is displayed
while priming is in process.
The Fluidics Priming screen is displayed with the cursor in the No. Cycles
field for the pipettor.
• To change the number of cycles from the default, use the [Arrow] keys to
move the cursor to the No. Cycles field for substrate, then type the desired
number of cycles.
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
The Fluidics Priming screen is displayed with the cursor in the No. Cycles
field for the pipettor.
• To change the number of cycles for any component, use the [Arrow] keys to
move the cursor to the No. Cycles field for that component, then type the
desired number of cycles.
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
All system components are primed. The Prime All screen is displayed while
priming is in process.
6.5
Archiving Data To Disk
This section describes the procedure for archiving test and system data to a
3.5” High Density disk formatted for DOS (Figure 6-5 is a flow chart of this
procedure). The archived information is then used by a technical support
representative for troubleshooting. There are 2 data archiving options:
• Expanded Archive Data archives detailed testing information in a
comma separated field format, which can then be imported into a
PC-based spreadsheet program.
• Archive Service Data archives detailed system information in the
OS9000 database format.
Test results can also be archived from the View Test Results screen. For more
information on archiving test results, refer to Chapter 5 of the Operator’s Guide.
NOTE
Archiving on the Access Immunoassay System means copying data to disk.
Archiving does not mean copying and removing data. Data is removed when the
data storage capacity is reached. Then, the oldest data is automatically removed
(overwritten) as new data is added.
The maximum information that can be archived at one time is equivalent to the
data storage capacity.
NOTE
Data cannot be archived when the system is in the RUNNING or PAUSED mode.
Archive Data
Main Menu
[F7] Diag.
Diagnostics
Main Menu
3 Press the [Down Arrow] key to highlight the desired data archiving option,
then press [Enter].
4 Insert a 3.5” disk formatted for DOS into the disk drive, then press [Enter].
A message informs you when the archival process is complete.
• If you are prompted to insert additional disks, remove the current disk and
insert a new DOS formatted disk into the drive, then press [Enter].
5 Remove the disk from the drive and label it with the file number displayed
in the prompt line.
6.6
System Reboot
This section describes the various procedures for rebooting, or restarting the
system. There are 2 ways by which the system may be rebooted. The preferred
method is using the reset button and therefore, is described first.
Rebooting The system may be rebooted by pressing the reset button. This method is also
Using the called a “warm boot.”
Reset Button
1 Open the front panel of the analyzer.
2 Locate the reset button which is located just to the right of the pipettor
gantry (refer to Figure 6-6).
NOTE
If the front panel is not closed, the system will not be able to home the
mechanical devices. Should this occur, press the reset button a second time and
then close the front panel immediately.
Several screens are displayed as the software “boots.” Do not press any keys
on the keyboard until the reboot is complete. When the Main Menu is
displayed, the system mode is NOT READY and system initialization begins.
Rebooting The system may be rebooted using the on/off switch as described below. This
Using the method is also called a “cold boot.”
On/Off Switch
1 Ensure the front panel of the analyzer is closed.
NOTE
If the front panel is not closed, the system will not be able to home the
mechanical devices. Should this occur, close the front panel, then turn the power
off and on a second time.
2 Locate the power switch on the lower, back part of the right side of the
analyzer (refer to Figure 6-7).
Power Switch
3 Press the bottom part of the switch to turn the power off.
4 Wait approximately 20 seconds and then press the top part of the switch to
turn the power on.
Several screens are displayed as the software “boots.” Do not press any keys
on the keyboard until the reboot is complete. When the Main Menu is
displayed, the system mode is NOT READY and system initialization begins.
6.7
System Check Support
Information
This section includes information about the System Check procedure, which is
performed as part of weekly maintenance and/or when troubleshooting the
system. A better understanding of this procedure may assist you in diagnosing
and fixing a problem. Refer to Section 8.4, Weekly Maintenance, of the Operator’s
Guide for instructions on performing the System Check procedure. If any of the
System Check results fail to meet the specified criteria, refer to Chapter 5,
Troubleshooting for further instructions. Troubleshooting procedures or Technical
Support may refer you to individual tests of the System Check procedure, which
are provided later in this section.
Table 6-8 correlates the part of the System Check procedure with the function or
component that is tested.
Reaction vessel (RV) wash system Washed Check, Clean Check, Wash
(various components involved in Efficiency
washing the RVs during testing)
Luminometer All
Washed Check
During the Washed Check, the main pipettor dispenses 150 mL of undiluted
System Check Solution into 10 RVs on which 3 wash cycles are then performed.
Next, 200 mL of substrate is pipetted into each RV, and the RLUs are measured
with the luminometer.
Each wash cycle should reduce the concentration of the System Check Solution by
a factor of at least 100. Therefore, the final concentration of System Check Solution
should be at least 1/1,000,000 of the original concentration. The mean RLUs for
the Washed Check should be between 5,000–20,000, and the % CV should be £ 12.
If the results are outside the acceptable limits, the performance of the RV wash
and/or mixing systems may be impaired.
Clean Check
The 5 RVs used in the Clean Check are processed similarly to the RVs for the
Washed Check. The differences are that 150 mL of wash buffer is added to the RVs
instead of the undiluted System Check Solution, and only 5 RVs are used.
These results should be examined to ensure that there is not a significant decline
in the RLUs from the first to the last replicate. This type of a decrease in the RLUs
indicates that there may be carryover occurring in the wash/read carousel due to
poor washing of the aspirate probes.
Substrate Check
In the Substrate Check, no sample (i.e., no wash buffer or System Check Solution)
is added to the RVs, and the RVs are not washed. For this test, 200 mL of substrate
is pipetted into 10 RVs, then the RLUs are measured with the luminometer.
The mean, SD, and % CV are calculated from the RLU readings on the last 6 RVs.
This is because during the Clean Check as the wash arm is lowered, the aspirate
probe touches the bottom of the first 4 Substrate Check RVs. A small amount of
residual fluid from the probe could remain in the RV and increase the RLU
reading.
The highest RLU single reading from the first 4 RVs is divided by the mean of the
RLUs measured for the last 6 RVs to obtain the substrate ratio. This ratio should
be £ 1.4. If the ratio is > 1.4, the function of the waste system could be
compromised.
The mean RLU value for the Substrate Check should be between 5,000 and 9,000
and the % CV should be £ 5. If the results are outside of the acceptable limits, the
performance of the substrate dispense system or the luminometer could be
suspect.
Unwashed Check
The Unwashed Check is performed similarly to the Substrate Check, except that
the main pipettor dispenses 50 mL of diluted System Check Solution into 10 RVs.
The RVs are not washed, and 200 mL of substrate is added. The RLUs for the
Unwashed Check are significantly higher because of the chemical reaction
between the substrate and the System Check Solution.
The % CV should be 2. If the Substrate Check results are acceptable but the
Unwashed Check % CV results fail to meet specifications, the precision of the
main pipettor may be compromised.
Although not a system specification, the RLU mean result for the Unwashed
Check can be used as a reference guideline. If results are not in the range of
4–10 million, there may have been an error made in preparing the 1/501 dilution
of the System Check Solution. Prepare the dilution again and repeat the System
Check procedure.
Wash Efficiency
The Wash Efficiency is calculated using the results from the Washed, Substrate,
and Unwashed Checks as described below. The result prints on the System Check
Report.
2. Using the result from step 1, the Unwashed RLUs per RV (RLUs/RV) is
calculated as shown:
3. The Mean RLUs Washed reduced by the Mean RLUs Substrate is divided by
the RLUs per RV from step 2 also reduced by the Mean RLUs Substrate, as
shown in ratio form:
4. The Wash Efficiency ppm (parts per million) is obtained by multiplying the
result from step 3 by 1,000,000.
NOTE
If the Wash Efficiency result is a negative number, due to either low RLUs
for the Washed Check or high RLUs for the Substrate Check, the substrate
system may be contaminated. For more information, refer to the
troubleshooting information in Chapter 5.
Individual Following is a description of how to run each of the 3 tests that comprise the
System System Check procedure. Each of the tests can be performed alone to pinpoint
Checks problems indicated by failed System Check results:
• Washed Check
• Substrate Check
• Unwashed Check
NOTES
• To obtain the Wash Efficiency result, you must run the complete System
Check procedure described in Section 8.4, Weekly Maintenance in the
Operator’s Guide.
• Use only 2.0 mL sample cups for the System Check tests.
CAUTIONS
• Unless you have an emergency problem with the instrument, do not
press [F8] Cancel to stop a maintenance procedure. Cancelling the
procedure may cause damage to the instrument and may compromise the
integrity of results for subsequent tests.
• If you have an emergency problem with the instrument while a
maintenance procedure is running, press [F8] Cancel, but do not initialize
the system. Call Technical Support for assistance.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
NOTE
The tray preparation instructions (step 2) assume that the default of 10
replicates is used (a minimum of 10 replicates must be performed to assure
statistically valid results). If the number of replicates is increased, add 1
sample cup with 2 mL of undiluted System Check Solution for each 10
replicates and place the sample cups in sequential positions on the tray
(maximum of 10 replicates per sample cup). For example, if running 25
replicates, fill 3 sample cups with solution and place the cups in sample
positions 1, 2, and 3.
5 Load the tray onto the system, then press [F1] Done and [Enter] to confirm
that the maintenance tray is loaded.
• To change the number of replicates to be run, press the [Tab] key to move
the cursor to the No. Reps field, type the desired number of replicates, then
press [Enter].
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
9 Compare the obtained results with the expected results listed in Table 6-9. If
the results are outside the acceptable limits, contact Technical Support.
Expected % CV 12%
Expected RLU Mean 5,000–20,000
NOTE
The maintenance tray must be unloaded before patient samples, quality
control samples, calibrators, or calibration controls can be processed.
13 Unload the maintenance tray, then press [F1] Done and [Enter] to confirm
that the maintenance tray is unloaded.
NOTE
The tray preparation instructions (step 2) assume that the default of 10
replicates is used. If the number of replicates is increased, add another
empty sample cup for each 10 replicates and place the sample cups in
sequential positions on the tray (maximum of 10 replicates per sample
cup). For example, if running 25 replicates, place 3 empty sample cups in
sample positions 1, 2, and 3.
The Load Maintenance Tray screen is displayed with the cursor in the Tray
ID field.
5 Load the tray onto the system, then press [F1] Done and [Enter] to confirm
that the maintenance tray is loaded.
• To change the number of replicates to be run, press the [Right Arrow] key
to move the cursor to the No. Reps field, type the desired number of
replicates, then press [Enter].
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
9 Compare the obtained results with the expected results listed in Table 6-10.
If the results are outside the acceptable limits, contact Technical Support for
assistance.
Expected % CV 5%
Expected RLU Mean 5,000–9,000
NOTE
The maintenance tray must be unloaded before patient samples, quality
control samples, calibrators, or calibration controls can be processed.
13 Unload the maintenance tray, then press [F1] Done and [Enter] to confirm
that the maintenance tray is unloaded.
NOTE
The tray preparation instructions (step 3) assume that the default of 10
replicates is used (a minimum of 10 replicates must be performed to assure
statistically valid results). If the number of replicates is increased, add 1
sample cup with 2 mL of diluted System Check Solution for each 10
replicates and place the sample cups in sequential positions on the tray
The Load Maintenance Tray screen is displayed with the cursor in the Tray
ID field.
6 Load the tray onto the system, then press [F1] Done and [Enter] to confirm
that the maintenance tray is loaded.
• To change the number of replicates to be run, press the [Right Arrow] key
to move the cursor to the No. Reps field, type the desired number of
replicates, then press [Enter].
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
10 Compare the obtained results with the expected results listed in Table 6-11.
If the results are outside the acceptable limits, contact Technical Support for
assistance.
Expected % CV 2%
Expected RLU Mean 4-10 million *
NOTE
The maintenance tray must be unloaded before patient samples, quality
control samples, calibrators, or calibration controls can be processed.
14 Unload the maintenance tray, then press [F1] Done and [Enter] to confirm
that the maintenance tray is loaded.
6.8
Volume Checks
This section describes how to perform volume check tests on the Access System.
These tests require external measurement by the operator and are designed to
quantitatively measure the dispense precision and accuracy of the various parts
of the fluidic module using gravimetric measurements. However, qualitative
assessment of the performance is also possible by visual examination. Procedures
for visual volume checks are included after the analytical volume check
procedures.
Due to the small volumes used by the Access System, an analytical balance is
required for most gravimetric measurements. Discrimination to the nearest
hundredth of a milligram (0.01 mg) is recommended for optimal performance.
When handling and weighing reaction vessels:
• Wear gloves to prevent transferring oils onto the vessels.
• Use forceps to remove the vessels from the instrument and balance.
• Weigh vessels immediately after dispensing to minimize evaporation.
• Take at least 9 replicates of the measurements to obtain a meaningful
representation of the system precision and accuracy.
• Number the vessels before weighing to ensure correct sequences.
You may be instructed to perform 1 or more of the volume check tests as part of
troubleshooting.
CAUTIONS
• Unless you have an emergency problem with the instrument, do not
press [F8] Cancel to stop a maintenance procedure. Cancelling the
procedure may cause damage to the instrument and may compromise the
integrity of results for subsequent tests.
• If you have an emergency problem with the instrument while a
maintenance procedure is running, press [F8] Cancel, but do not initialize
the system. Call Technical Support for assistance.
Running
Analytical WARNING
Substrate
You will come in contact with potentially infectious materials during this
Volume
procedure. Handle and dispose of biohazard materials according to proper
Check
laboratory procedures. Proper hand, eye, and facial protection is required.
Position 2
Position 3 Position 1
To reaction
vessel
waste bag
8 Weigh the vessels using an analytical balance, and record the weights.
NOTE
After weighing the reaction vessels, handle them with the forceps, not with
your hands.
9 Place the 3 weighed reaction vessels into the vacated shuttle positions.
10 Close the front panel of the instrument, then press [F1] Done.
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
The substrate is dispensed and the reaction vessels are returned to shuttle
positions 1, 2, and 3.
14 Weigh the reaction vessels using the analytical balance, and record the
weights.
16 Convert vessel weight to volume using the equation in Table 6-13, then
calculate the mean, standard deviation, and % CV of the replicates.
17 Compare the obtained results with the expected results listed in Table 6-14.
If the results are outside the acceptable limits, contact Technical Support for
assistance.
Expected % CV 2%
Table 6-14 Substrate Volume Expected Results
Running The visual volume check is used to detect gross volume errors.
Visual
Substrate WARNING
Volume
You will come in contact with potentially infectious materials during this
Check procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
NOTE
A message is displayed prompting you to remove and weigh 3 RVs. For
this procedure, you do NOT have to perform this step.
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
The substrate is dispensed and the reaction vessels are returned to the
shuttle.
7 Using the forceps, remove the reaction vessels from shuttle positions 1, 2,
and 3 (refer to Figure 6-12).
10 Place the reference vessel and the 3 dispensed vessels on a level surface.
NOTE
Only gross volume discrepancies will be visible.
• If you see a significant volume difference in any of the vessels, call Technical
Support.
12 Inspect the dispensed vessels for air bubbles. Proper substrate dispense will
leave no bubbles on the surface, or sometimes a few small, regularly sized
bubbles around the surface edge.
Running The procedure for running a 50 mL pipettor volume check is the same as that for
Analytical running both 200 and 350 mL volume checks, except for the volume selected.
Main Pipettor
Volume WARNING
Checks (50/
200/350 mL) You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
• Pipette at least 1.5 mL of wash buffer into a sample cup and place the cup
in sample position 1.
NOTE
When performing repeated dispense checks, verify that the sample cup
contains sufficient volume to complete the 3 aspirations. For the 200 and
350 mL volumes, it is recommended that you remove and refill the sample cup
after each group of 3 vessels.
The Load Maintenance Tray screen is displayed with the cursor in the Tray
ID field.
5 Load the tray onto the system, then press [F1] Done and [Enter] to confirm
that the maintenance tray is loaded.
8 Press [F2] Pipettor 50 mL, [F3] Pipettor 200 mL, or [F8] Low Res. Dispense
350 mL.
12 Weigh the vessels using an analytical balance, and record the weights.
NOTE
After weighing the reaction vessels, handle them with the forceps, not with
your hands.
13 Place the 3 weighed reaction vessels into the vacated shuttle positions.
14 Close the front panel of the instrument, then press [F1] Done.
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
The wash buffer is dispensed and the reaction vessels are returned to shuttle
positions 1, 2, and 3.
18 Weigh the reaction vessels using the analytical balance, and record the
weights.
NOTE
Be sure that the sample cup contains sufficient wash buffer to complete the
aspirations.
20 Convert vessel weight to volume using the equation in Table 6-15, then
calculate the mean, standard deviation, and % CV of the replicates.
21 Compare the obtained results with the expected results listed in Table 6-16.
If the results are outside the acceptable limits, contact Technical Support for
assistance.
Expected % CV 2%
Table 6-16 Pipettor Volume Expected Results
Expected % CV £ 1%
Target Volume - Low Res. Dispense 350 mL
Expected % CV £ 1%
Table 6-16 Pipettor Volume Expected Results (continued)
22 When you are done with this procedure, press [Esc] twice to return to the
Maintenance screen.
25 Press [F1] Done and then [Enter] to confirm that the maintenance tray is off-
board.
Running The visual volume check is used to detect gross volume errors.
Visual Main
Pipettor WARNING
Volume
You will come in contact with potentially infectious materials during this
Checks (50/ procedure. Handle and dispose of biohazard materials according to proper
200/350 mL) laboratory procedures. Proper hand, eye, and facial protection is required.
NOTE
When performing repeated dispense checks, verify that the sample cup
contains sufficient volume to complete the 3 aspirations. For the 200 and
350 mL volumes, it is recommended that you remove and refill the
sample cup after each group of 3 vessels.
5 Load the tray onto the system, then press [F1] Done and [Enter] to confirm
that the maintenance tray is loaded.
8 Press [F2] Pipettor 50 mL, [F3] Pipettor 200 mL, or [F8] Low Res. Dispense
350 mL.
The appropriate Pipettor Volume screen is displayed.
NOTE
A message is displayed prompting you to remove and weigh 3 RVs. For
this procedure, you do NOT have to perform this step.
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
The wash buffer is dispensed and the reaction vessels are returned to the
shuttle.
11 Using the forceps, remove the reaction vessels from shuttle positions 1, 2,
and 3 (refer to Figure 6-12).
13 Manually pipette 50 mL, 200 mL, or 350 mL of wash buffer (the same amount
selected in step 8) into a reference reaction vessel.
14 Place the reference vessel and the 3 dispensed vessels on a level surface.
NOTE
Only gross volume discrepancies will be visible.
• If you see a significant volume difference in any of the vessels, call Technical
Support.
16 Inspect the dispensed vessels for air bubbles. Proper main pipettor dispense
will leave no bubbles on the surface, or sometimes a few small, regularly
sized bubbles around the surface edge.
17 When you are done with this procedure, press [Esc] twice to return to the
Maintenance screen.
20 Press [F1] Done and then [Enter] to confirm that the maintenance tray is off-
board.
Running This procedure is done on 1 dispense probe at a time. The function key pressed in
Analytical step 4 determines which dispense probe is tested.
Dispense
Probe Volume WARNING
Check You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
Tubing Clip
(Revision A fluidics only) Barbed Fittings
7
6
1
5 4 3 2
Dispense Probe 1
(Probe # 1)
8 Weigh the vessels using an analytical balance, and record the weights.
NOTES
• After weighing the reaction vessels, handle them with the forceps,
not with your hands.
• The 3 reaction vessels will all be filled by the probe selected in step 4.
9 Place the 3 weighed reaction vessels into the vacated shuttle positions.
10 Close the front panel of the instrument, then press [F1] Done.
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
The wash buffer is dispensed and the reaction vessels are returned to shuttle
positions 1, 2, and 3.
14 Weigh the reaction vessels using the analytical balance, and record the
weights.
16 Convert vessel weight to volume using the equation in Table 6-18, then
calculate the mean, standard deviation, and % CV of the replicates.
17 Compare the obtained results with the expected results listed in Table 6-19.
If the results are outside the acceptable limits, contact Technical Support for
assistance.
Expected % CV 3%
Target Volume - Dispense Probe 2 500 mL
Expected % CV 2%
Table 6-19 Dispense Probe Volume Expected Results
Expected % CV £ 2%
Table 6-19 Dispense Probe Volume Expected Results (continued)
Running This procedure is done on 1 dispense probe at a time. The function key pressed in
Visual step 4 determines which dispense probe is tested.
Dispense
Probe Volume WARNING
Check You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
NOTE
A message is displayed prompting you to remove and weigh 3 RVs. For
this procedure, you do NOT have to perform this step.
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
The wash buffer is dispensed and the reaction vessels are returned to shuttle
positions 1, 2, and 3.
9 Pipette the appropriate volume of wash buffer into an empty reaction vessel.
10 Place the reference vessel and the 3 vessels removed from the shuttle upright
on a level surface.
NOTE
Only gross volume discrepancies will be visible.
• If you see a significant volume difference in any of the vessels, call Technical
Support.
12 Inspect the dispensed vessels for air bubbles. Proper dispense probe
dispense will leave no bubbles on the surface, or sometimes a few small,
regularly sized bubbles around the surface edge.
Running
Analytical WARNING
Aspirate You will come in contact with potentially infectious materials during this
Probe Volume procedure. Handle and dispose of biohazard materials according to proper
Check laboratory procedures. Proper hand, eye, and facial protection is required.
8 Weigh the vessels using an analytical balance, and record the weights.
NOTES
• After weighing the reaction vessels, handle them with the forceps,
not with your hands.
• The 3 reaction vessels will each be aspirated by a different probe.
9 Place the 3 weighed reaction vessels into the vacated shuttle positions
according to their numbers.
10 Close the front panel of the instrument, then press [F1] Done.
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
Three RVs will be loaded onto the wash/read carousel and 1 wash cycle is
performed on each RV (i.e., 500 mL of wash buffer is dispensed into the RVs,
then the buffer in each reaction vessel is aspirated by a different probe).
After the wash cycle is complete, the RVs are returned to shuttle positions 1,
2, and 3.
11 Open the front panel of the instrument.
12 Using the forceps, remove the RVs from positions 1, 2, and 3 (refer to Figure
6-12).
NOTE
When performing an aspirate volume evaluation, ensure that the vessels are
weighed as quickly as possible because the small remaining volume is
especially susceptible to evaporation.
14 Weigh the reaction vessels using the analytical balance, and record the
weights.
16 Convert vessel weight to volume using the equation in Table 6-20, then
calculate the mean, standard deviation, and % CV of the replicates.
17 Compare the obtained results with the expected results listed in Table 6-21.
18 If the results are outside the acceptable limits, use Table 6-22 to determine
which aspirate probe should be cleaned/replaced.
CAUTION
If there is a plugged aspirate probe, do NOT run the Clean Wash Probes
procedure or prime any component of the system until the problem is
resolved.
Running
Visual WARNING
Aspirate You will come in contact with potentially infectious materials during this
Probe Volume procedure. Handle and dispose of biohazard materials according to proper
Check laboratory procedures. Proper hand, eye, and facial protection is required.
NOTE
A message is displayed prompting you to remove and weigh 3 RVs. For
this procedure, you do NOT have to perform this step.
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
Three RVs will be loaded onto the wash/read carousel and 1 wash cycle is
performed on each RV (i.e., 500 mL of wash buffer is dispensed into the RVs,
then the buffer in each reaction vessel is aspirated by a different probe).
After the wash cycle is complete, the RVs are returned to shuttle positions 1,
2, and 3.
7 Using the forceps, remove the RVs from positions 1, 2, and 3 (refer to Figure
6-12). Note the position from which each RV is removed.
NOTE
You must remember the position from which each RV was removed
because this information is used to determine which aspirate probe is
malfunctioning.
NOTE
To assist you in identifying whether a drop of fluid is within the guideline,
turn the RV upside down. An amount of 4 mL or less will not run out of an
RV when the RV is turned upside down.
10 If the Visual Aspirate Probe Volume Check results fail, (i.e., there is a
significant amount (> 4 mL) of fluid remaining in a vessel), use Table 6-22 to
determine which aspirate probe should be cleaned/replaced.
CAUTION
If there is a plugged aspirate probe, do NOT run the Clean Wash Probes
procedure or prime any component of the system until the problem is
resolved.
6.9
Opening and Closing the Top
Cover
CAUTION
This procedure should be performed only when instructed by a technical
support representative.
This section describes the procedure to open and close the top cover of the
analyzer. You may need to open this cover when troubleshooting or performing a
system support procedure. Do not leave the top cover open when samples are
being processed.
Procedures for opening and closing both types of top covers are included in this
section.
Front Panel
3 Close the front panel of the analyzer. (Or, you may leave it open if you have
the captive screw design and you are opening the top cover.)
Refer to the appropriate procedure following this section for detailed instructions
on opening and closing the top cover.
Opening the 1 Open the front panel of the analyzer by grasping the lower portion of the left
Top Cover and right sides of the front panel, pulling the bottom of the panel towards
(Captive you, then lifting the panel upwards (refer to Figure 6-23).
Screw Design)
2 Loosen the “captive” screw located at the top of the pipettor gantry to
release the top cover. The captive screw can be loosened or tightened, but
cannot be removed from its position.
4 Slide both sides of the top cover back toward the rear of the analyzer
approximately 1/4”, or 6 mm (refer to Figure 6-24).
Top Cover
CAUTION
Do not attempt to lift the top cover before the cover is retracted.
Closing the 1 Gently pull the top cover down until the cover is horizontal.
Top Cover
2 Press down firmly on both rear corners of the top cover to ensure that the
(Captive
cover is in the correct position.
Screw Design)
3 Pull the top cover forward until the edge of the top cover meets the edge of
the front panel.
5 Tighten the captive screw located at the top of the pipettor gantry to secure
the top cover. If necessary, gently push the screw into place while turning it.
1 Hold the cover open with your right hand and push one side of the brace
away from you until it unlocks.
2 Pull the top cover toward you until the cover is horizontal.
6.10
Peristaltic Waste Pump Tubing
Replacement
CAUTION
This procedure should be performed only when instructed by a technical
support representative. This section contains instructions for replacing all the
tubing. The technical support representative will help determine which
tubing needs to be replaced.
This section describes the procedure for replacing the tubing on the peristaltic
waste pump (revision B fluidics only) that draws waste fluids from either the
vacuum reservoir or the aspirate probes. This tubing may need to be changed if
you have high % CV values, the reaction vessels are not being fully aspirated, or
waste is not being cleared from the vacuum reservoir bottle.
Items • Replacement peristaltic pump tubing for vacuum reservoir or aspirate probe
Required tubing connection
• 3/32” hex wrench
• Rubber gloves
• Biohazard eye, hand, and facial protection
Procedure
WARNING
Any liquid in the tubing should be considered potentially infectious. Handle
and dispose of the liquid waste in accordance with proper laboratory
procedures.
1 Open the front panel of the analyzer to expose the peristaltic waste pump,
located in the front, left side of the analyzer.
• If the tubing being removed in step 2 goes to an aspirate probe, the aspirate
probe needs to be removed and placed in a cup. This will keep any fluid in
the line or probe from dripping into the wash/read carousel. Refer to
Section 8.4, Weekly Maintenance, of the Operator’s Guide.
2 Using both hands, pull the opaque waste pump tubing from the connector
that attaches either to the right side of the pump (opaque vacuum tubing) or
to the clear tubing connected to the aspirate probe (opaque aspirate tubing).
Refer to Figure 6-25.
NOTES
• The tubing which must be disconnected in step 2 depends on which tubing
must be replaced. Contact Technical Support for assistance in determining
what tubing should be replaced.
• If a metal connector on the base of the pump pulls out of its plastic fitting
while removing the tubing, pull the metal connector free from the tubing.
Loosen the plastic fitting on the pump base, and insert the metal connector
into the fitting. Tighten the fitting to the base before proceeding.
Clear tubing to
aspirate probe
Opaque Aspirate
Tubing
Lever Guard
Plastic Fittings with
Metal Connectors
3 Pull the other end of the tubing off of the waste pump base to the left of the
pump.
4 Using a 3/32” hex wrench, loosen the screws that secure the lever guard and
remove the guard.
5 Push the lever on the cassette you are removing the tubing from as far to the
right as possible. This will release the cassette from the pump.
6 Pull the cassette toward you and slide it free of the waste pump (refer to
Figure 6-26).
Cassette
8 Using the tubing that you removed as a measurement guide, cut the new
tubing to the correct length.
9 Push the new tubing into the cassette, keeping the retainer clips positioned
as shown in Figure 6-26.
10 Slide the cassette back into its position in the waste pump and push its lever
about 90 to the left.
11 Push the left end of the new tubing onto the correct metal tubing on the left
side of the pump.
12 Push the other end of the tubing onto the connector attaching it to either the
right side of the pump (for vacuum tubing) or to the clear aspirate probe
tubing (for opaque aspirate tubing).
• If an aspirate probe was removed, reinstall the probe into its proper location
on the wash arm. Refer to Section 8.4, Weekly Maintenance, of the Operator’s
Guide.
13 Repeat steps 2-12 for each piece of tubing that needs to be replaced.
15 Prime the system using the Dispense Probes option from the Fluidics
Priming screen.
Use the default number of cycles for each component. Refer to Section 6.4,
System Priming, in this manual.
Refer to Section 6.8, Volume Checks, of this chapter. If the results of this
procedure fail, call Technical Support.
Refer to Section 6.8, Volume Checks, of this chapter. If the results of this
procedure fail, call Technical Support.
6.11
System Shut Down and Restart
This section describes the procedures for shutting down and restarting the Access
System. You should shut down the analyzer to move the system or whenever it
will be turned off for an extended period of time (approximately 5 to 7 days). The
Access System does not require periodic shut down. Before shutting down the
system, confirm your decision with Technical Support.
The shut down procedure is the same for revision A and B fluidics, but the restart
procedures are different. In addition, the restart procedure for revision A fluidics
varies depending on the type of wash and waste valves installed in the system.
Refer to Section 1.2, Instrument Description in this manual to determine which
restart procedure to follow.
3 Turn the power switch on the right side of the analyzer to the Off (O)
position.
Restarting
Analyzers CAUTION
with Revision
Use this procedure only on systems with revision A fluidics. Do not use this
A Fluidics
procedure for revision B fluidics. Refer to Section 1.2, Instrument Description
to determine if your system has revision A or B fluidics.
NOTE
The substrate used in this procedure must be equilibrated to room temperature
for the time specified in the product insert before you load it on the analyzer.
Refer to the product insert for detailed information.
• If necessary, replenish the wash buffer supply. Refer to Section 2.9, Wash
Buffer, of the Operator’s Guide.
2 Turn the power switch on the right side of the analyzer to the On (|)
position.
NOTE
Steps 3 through 13 only need to be performed if the analyzer has the ceramic
valves. Refer to Fluidic Module in Section 1.2, Instrument Description, in this
manual to locate the waste and wash valves. The original valves are blue. The
ceramic valves have a clear body and black screw-on cap. If you cannot
determine which valves are installed on your system, please call Technical
Support.
For systems with the original (blue) wash and waste valves, skip to step 14.
Each time, the wash valve will move slightly away from, and then back to,
its home position.
Each time, the waste valve will move slightly away from, and then back to,
its home position.
Use the default number of cycles for each component. Refer to Section 6.4,
System Priming in this manual.
Refer to Section 6.8, Volume Checks, of this chapter. If the results of this
procedure fail, call Technical Support.
Refer to Section 6.8, Volume Checks, of this chapter. If the Visual Aspirate
Probe Volume Check results fail, the procedure may refer you to clean and/
or replace appropriate aspirate probes, according to procedures in Section
8.4, Weekly Maintenance, of the Operator’s Guide, and then run the Visual
Aspirate Probe Volume Check procedure again.
CAUTION
If the Visual Aspirate Probe Volume Check results fail again, do not proceed
with the Special Clean procedure. Contact Technical Support.
• If the System Check results fail, repeat the procedure. If the results fail again,
refer to Chapter 5, Troubleshooting for further instructions.
Restarting
Analyzers CAUTION
with Revision Use this procedure only on systems with revision B fluidics. Do not use this
B Fluidics procedure for revision A fluidics. Refer to Section 1.2, Instrument Description
to determine if your system has revision A or B fluidics.
NOTE
The substrate used in this procedure must be equilibrated to room temperature
for the time specified in the product insert before you load it on the analyzer.
Refer to the product insert for detailed information.
• If necessary, replenish the wash buffer supply. Refer to Section 2.9, Wash
Buffer, of the Operator’s Guide.
2 Turn the power switch on the right side of the analyzer to the On (|)
position.
Each time, the wash valve will move slightly away from, and then back to,
its home position.
Each time, the precision valve will move slightly away from, and then back
to, its home position.
Use the default number of cycles for each component. Refer to Section 6.4,
System Priming, in this manual.
Refer to Section 6.8, Volume Checks, in this manual. If the results of this
procedure fail, call Technical Support.
Refer to Section 6.8, Volume Checks. If the volume check results fail, the
procedure may refer you to Replacing and Cleaning Aspirate Probes in
Section 8.4 of the Operator’s Guide.
• If you replace and clean the aspirate probes, run the Visual Aspirate Probe
Volume Check procedure again. If the results fail again, call Technical
Support. Only when directed by Technical Support, refer to Section 6.10,
Peristaltic Waste Pump Tubing Replacement for continued troubleshooting.
CAUTION
If the Visual Aspirate Probe Volume Check results fail after replacing the
waste pump tubing, do not proceed with this procedure. Contact Technical
Support.
• If the System Check results fail, repeat the procedure. If the results fail again,
refer to Chapter 5, Troubleshooting for further instructions.
6.12
Establishing Control Ranges
This section provides a recommendation to establish control ranges for the Access
Immunoassay System. This information is a recommendation ONLY and is not
intended to replace your existing laboratory procedure(s); use this procedure in
conjunction with your standard laboratory practices and/or the manufacturer’s
recommendations for the quality control materials you use.
NOTES
• Use fresh control materials to ensure accurate results (refer to Section 4.4,
Sample Processing, of the Operator’s Guide for the time limitation for on-
board samples).
• Do not reuse controls by pooling into sample cups or storage containers.
• Refer to Chapter 4, System Processing, of your Operator’s Guide for more
information regarding sample processing.
Collecting 1 Run 1 or 2 replicates of each control once per day. From day to day, vary the
Data Points sequence in which the control samples are processed.
4 Calculate the mean, % CV, 1SD, 2SD, and 3SD values, and the 3SD range for
each control level/analyte combination.
• Remove any values outside of the 3SD range (outliers), then recalculate
the mean, % CV, 1SD, 2SD and 3SD values. Proceed to step 6.
• If no outliers are detected, use the data calculated in step 4 and proceed
to step 7.
• If the % CV < 6, you may consider widening the ranges by multiplying the
stated SD by 1.5, then recalculating the 1SD, 2SD, and 3SD ranges.
8 The values and ranges should be periodically recalculated during the life of
the control lot.
5 Verify that the calculated mean is within the manufacturer assigned range
provided in the control sera product insert (if more than 1 range is listed, use
the 2SD range).
• If the mean is within the assigned range, calculate a temporary range for
each control level.
• If the mean is not within the assigned range, contact Technical Support.
• If no manufacturer assigned ranges are listed in the product insert,
contact Technical Support.
6.13
Special Clean Procedure
The special clean procedure prevents buildup of debris on the primary, dispense,
and aspirate probes of the Access System. Perform the Special Clean procedure
when:
• Shutting down or restarting the Access System (refer to Section 6.11, System
Shut Down and Restart for more information).
• Troubleshooting procedures in an Access manual advise you to perform it.
• Technical Support instructs you to perform it.
NOTE
Beckman Coulter recommends that if you use the Access System to process the
B12 assay, you perform the Special Clean procedure at the end of each day, or
whenever the instrument will be idle for 8 hours or more.
CAUTIONS
• Unless you have an emergency problem with the instrument, do not
press [F8] Cancel to stop a maintenance procedure. Cancelling the
procedure may cause damage to the instrument and may compromise the
integrity of results for subsequent tests.
• If you have an emergency problem with the instrument while a
maintenance procedure is running, press [F8] Cancel, but do not initialize
the system. Call Technical Support for assistance.
Materials • 13 mm sample tray for 2 mL Sample Cups—a sample tray used for a
Required maintenance procedure is also called a maintenance tray
• Six Access 2.0 mL Sample Cups
NOTE
Use only the 2.0 mL Sample Cup when performing routine maintenance
procedures. Using any other sample container may result in level sensing
errors and cancellation of the maintenance routine.
WARNINGS
• Contrad 70 cleaning solution is alkaline and may cause severe eye
irritation or mild skin irritation. Refer to the manufacturer’s label for
details.
• Citranox cleaning solution is acidic and may cause eye or skin irritation.
Refer to the manufacturer’s label for details.
4 Pipette 2.0 mL of deionized water or wash buffer into the 2.0 mL Sample
Cup in sample position 3.
5 Pipette 2.0 mL of 70% methanol into each of the cups in sample positions 6,
7, and 8.
The Load Maintenance Tray screen is displayed with the cursor in the Tray
ID field.
9 When the tray loading position is presented, load the maintenance tray (for
instructions on placing a tray onto the sample carousel, refer to Section 4.3,
Sample Trays in the Operator’s Guide).
10 Press [F1] Done and then [Enter] to confirm that the maintenance tray is
loaded.
11 Ensure the system is in the READY mode, then press [F6] Special Clean.
CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.
Messages in the prompt line inform you of the cleaning status. The
procedure takes about 35 minutes to complete with revision B fluidics, and
about 45 minutes with revision A fluidics.
13 When the maintenance tray is presented, unload the tray (for instructions on
removing a tray from the sample carousel, refer to Section 4.3, Sample Trays
in the Operator’s Guide).
14 Press [F1] Done and then [Enter] to confirm that the maintenance tray is off-
board.
6.14
Incubator Belt Procedures
This section describes these incubator belt procedures:
• Replacing vessel holders (also called incubator belt clips)
• Calibrating the incubator belt
• Running the system exerciser test
Calibrating the incubator belt corrects for slight variations in the distance from the
center of one dovetail to the center of the next dovetail on the incubator belt (refer
to Figure 6-30). Incubator belt calibration is required when:
• Any vessel holder is replaced
• The home vessel holder (a vessel holder with a magnet attached to its top) is
moved to a position other than its original position
Materials • Original (no hole through the top) or chamfered (hole through the top)
Required vessel holders; original vessel holders are shown in Figure 6-30
• Original “home” vessel holder with magnet or chamfered “home” vessel
holder with magnet
• Small screwdriver
• Hemostat
• Hex wrench, 9/64”
• Black felt-tip marker
NOTES
• Remember to reorder any CARE kit parts that you use. Please contact
Technical Support for ordering information.
• If the instrument has original vessel holders, you must replace them with
original vessel holders. If the instrument has chamfered vessel holders, you
must replace them with chamfered vessel holders.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
Removing NOTE
Covers
Before beginning this procedure, ensure that no samples are being processed and
that the analyzer is in the READY or NOT READY mode.
• If the Event Log icon at the bottom of the screen is red before you begin
these procedures, press [Scroll Lock] to check the Event Log for error
messages. Checking the Event Log clears the icon and aids you in detecting
any future errors.
• If the Event Log icon turns red at any time during the following procedures,
check the Event Log messages before proceeding.
1 Open the front panel of the instrument by grasping the lower portion of the
left and right sides of the front panel, pulling the bottom of the panel
towards you, then lifting the panel upwards (refer to Figure 6-27).
Front Panel
Supply Cover
Hex Screws
(under Front Panel)
2 Remove the 9/64” hex screw from each end of the supply cover. The screws
are located where the supply cover meets the instrument frame (refer to Figure
6-27).
3 Remove the reaction vessel waste bag and the 9/64” hex screw in the bottom
of the waste bag well.
4 Lift off the supply cover (refer to Figure 6-27) and set it aside.
• If the substrate bottle is onboard the analyzer (not in the fluids tray), remove
the substrate bottle and set it aside without disconnecting the supply line
from the substrate bottle.
5 Release the RV load door latch using a small screwdriver, and raise the RV load
door slightly (refer to Figure 6-28).
6 At the front corners of the incubator cover, pull lightly outward on the cover
release tabs and lift the cover up and forward until it is off (refer to Figure 6-
28). Set the cover aside.
Incubator Cover
Release Tabs RV Load Door Frame
Retainers
RV Load Door RV Load Door Latch
Removing 7 Use the hemostat to remove all reaction vessels (RVs) and any broken vessel
Failed Vessel holder legs (refer to Figure 6-30) from the visible area of the incubator track.
Holders and Save all removed broken vessel holder legs.
Fallen RVs
8 Remove any vessel holders that have broken or bent legs by pulling up on
the tab at the top of the vessel holder (refer to Figure 6-30). Save all vessel
holders with broken legs.
CAUTION
If the incubator belt resists movement during step 12, stop rotating it and
remove any visible vessel holders that might have been damaged. Call
Technical Support for assistance.
12 Attempt to rotate the incubator belt clockwise by hand and remove all
visible RVs and any broken vessel holder legs.
Move the belt by turning the incubator belt pulleys (refer to Figure 6-29)
or by pulling horizontally on the dovetails or vessel holders (refer to
Figure 6-30).
Incubator
13 Match the number of broken vessel holders removed in steps 8 and 12 to the
number of broken legs retrieved from the instrument to ensure there are no
vessel holder pieces left in the instrument.
CAUTION
If there are still vessel holder legs or pieces missing, call Technical Support for
assistance. Leaving them in the instrument may damage the analyzer.
Replacing 14 Replace any broken or damaged vessel holders with new ones.
Vessel
Holders The vessel holders should gently “snap” into place when they are fully
seated in the downward direction.
NOTES
• If the home vessel holder (with magnet) is broken, be sure to replace it with
another home vessel holder.
• If the instrument has original vessel holders, replace them with original
vessel holders. If the instrument has chamfered vessel holders (hole in top),
replace them with chamfered vessel holders.
Incubator Belt
Tab
Dovetail
Leg
Vessel Holder
16 Use the [Up Arrow] or [Down Arrow] key to highlight RV Shuttle, then
press [Enter].
• If the round LED indicator labeled Index is light green, proceed to step 17.
CAUTION
If the Index indicator is dark green, call Technical Support for assistance. The
RV shuttle is not fully retracted from the incubator belt area. Any movement
of the incubator belt might damage the instrument.
18 Use the [Up Arrow] or [Down Arrow] key to highlight Wash Carousel, then
press [Enter].
• If the round LED indicator labeled Index is light green, proceed to step 19.
CAUTION
If the Index indicator is dark green, call Technical Support for assistance. The
wash carousel could be encroaching on the incubator belt area. Any movement
of the incubator belt might damage the instrument.
20 Rotate the incubator belt clockwise by hand until the RV placed in step 19
has moved 1 revolution.
CAUTION
If the belt resists movement, stop rotating it. Call Technical Support for
assistance.
CAUTION
If the belt resists movement, stop rotating it. Call Technical Support for
assistance.
25 Use the [Up Arrow] or [Down Arrow] key to highlight Incubator Belt, then
press [Enter].
,I 7KHQ
The Event Log icon did not turn red and The incubator belt was homed
there are no error messages successfully.
The Event Log icon turned red Check the Event Log messages
and call Technical Support
before proceeding.
27 Press [Esc].
The Mechanics screen is displayed with Incubator Belt shown in the Primary
Device field.
The incubator belt moves rapidly back and forth between the wash out
transfer location and the home positions. Allow it to continue moving for 1
minute.
The [F8] Stop Cycling key is displayed after [F6] Start Cycling is pressed.
• If the Event Log icon background is gray, proceed to the next section.
• If the Event Log icon background is yellow or red, review the Event Log and
call Technical Support for assistance.
Calibrating
Incubator Belt CAUTION
Before proceeding, verify that the incubator belt is not obstructed and that all
vessel holders are fully seated, or the system may be damaged. Ensure there is
only 1 home vessel holder on the belt. (Refer to Figure 6-30 for an illustration
of the home vessel holder with the magnet.)
4 Use the [Up Arrow] or [Down Arrow] key to highlight Calib. Incubator
Belt, then press [Enter].
The system immediately begins a 45-second calibration routine. The belt will
move clockwise, then counterclockwise. When the belt has stopped moving,
the calibration routine is complete.
• If the icon is red, please call Technical Support immediately. The message
posted in the Event Log (accessed by pressing [Scroll Lock]) indicates that
the calibration routine has failed.
3 Use the [Up Arrow] or [Down Arrow] key to highlight Exerciser, then press
[Enter].
5 Use the [Up Arrow] or [Down Arrow] key to highlight Vessel Holder, then
press [Enter].
The system immediately begins an exercise routine to ensure that the system
is functioning properly.
7 Press [F8] Stop Cycling after 2 is displayed in the Cycles Completed field.
The [F8] Stop Cycling key is displayed after [F2] Start Cycling is pressed.
The test will stop after the 3rd cycle is completed.
• If you are running this system exerciser test at the request of Technical
Support, this procedure is complete.
• If you are performing this procedure after replacing vessel holders, continue
to the next steps to prepare the instrument for processing.
9 Reinstall the incubator cover by raising the RV load door slightly using a
small screwdriver, moving the load door through the large opening in the
cover, and sliding the cover retaining slots under the load door frame
retainers (refer to Figure 6-28).
10 Hook both cover release tabs over the front corners of the incubator housing
(refer to Figure 6-28).
• If the substrate bottle is kept onboard the analyzer (not in the fluids tray),
reinstall the substrate bottle.
11 Reinstall the supply cover and the 9/64” hex screws in the bottom of the
waste bag well and at each end of the supply cover.
12 Reinstall the reaction vessel waste bag by sliding the plastic tab on the bag
fully into the slot on the waste chute.
6.15
Main Pipettor Procedures
This section describes the procedures for:
• Replacing the primary probe and properly using the pipettor torque tool.
• Inspecting and cleaning the pipettor gantry.
Replacing the The primary probe must be replaced if it is plugged, bent, or otherwise damaged.
Primary Probe
Materials Required
• Pipettor torque tool
• 5/16” open end wrench
• 1/4” open end wrench
• Primary probe
NOTE
Remember to reorder any parts of your CARE kit that you use.
WARNING
The primary probe is considered to be contaminated and should be handled
according to proper laboratory procedure. Proper hand, eye, and facial
protection is required.
NOTE
Do not use the pipettor torque tool to remove the primary probe. The tool may
be damaged if used in a manner other than that described in the Installing
Primary Probe section of this chapter.
1 Ensure that the system is in either the READY or NOT READY mode.
2 Open the front panel to disable the system motors and access the main
pipettor.
3 Move the main pipettor just to the left of the probe wash tower (refer to
Figure 6-31).
Main Pipettor
Lower end
Fit the 5/16" of Ultrasonic
wrench here Transducer
Probe Nut
Primary Probe
4 Place the 5/16” wrench on the flat sides of the lower end of the ultrasonic
transducer above the probe nut, as shown in Figure 6-31.
This wrench is used to keep the main pipettor from rotating when the probe
nut is loosened.
CAUTION
Do not exert pressure with the 5/16” wrench or the pipettor may be damaged.
5 Place the 1/4” wrench on the probe nut so that the handle is on the right
hand side of the probe nut (refer to Figure 6-31).
6 Loosen the probe nut by holding the 5/16” wrench in place and moving the
1/4” wrench to the left.
8 Continue to turn the nut by hand until you have removed the nut (with the
probe inside) from the lower end of the ultrasonic transducer.
9 Separate the primary probe from the probe nut. Dispose of the probe
according to proper laboratory procedures.
Retain the probe nut for use when installing the new primary probe.
2 Insert the new primary probe into the probe nut (refer to Figure 6-32) and
install the probe and nut onto the lower end of the ultrasonic transducer
(refer to Figure 6-31).
Probe Nut
Primary Probe
4 Place the 5/16” wrench on the flat sides of the lower end of the ultrasonic
transducer above the probe nut, as shown in Figure 6-31.
This wrench is used to keep the main pipettor from rotating when the probe
nut is tightened.
CAUTION
Do not exert pressure with the 5/16” wrench or the pipettor may be damaged.
5 With the stationary bar toward the left side of the instrument, fit the 1/4”
hex opening of the pipettor torque tool (refer to Figure 6-33) on the probe
nut.
NOTE
Do not touch the tension bar (refer to Figure 6-33) while rotating the pipettor
torque tool in step 6.
CAUTION
Do not overtighten the probe nut. Overtightening the probe nut could severely
damage the ultrasonic transducer.
6 While holding the 5/16” wrench in place, place a finger or thumb in the
notch on the pipettor torque tool (refer to Figure 6-33) and press the
stationary bar to the right (toward the reagent/sample carousel) until the
stationary bar touches the tension bar.
7 Remove the 5/16” wrench and torque tool and close the front panel.
Verification
1 Press [F7] Diag. from the Main Menu.
Expected Outcome
1 The System Check results must meet all specifications.
If the controls are not within the acceptable ranges, recalibrate the assay(s)
and rerun the controls.
CAUTIONS
• Wipe ONLY the lower pipettor gantry shaft to remove debris. The lower
shaft is not lubricated.
• A special lubricant is applied to the upper pipettor gantry shaft to protect
it from corrosion. DO NOT wipe the upper shaft, nor touch, nor remove
the lubricant. A thin film of lubricant on the upper shaft is normal. A
small amount of surface dust may accumulate on the upper shaft, but it is
not harmful.
Material Required
• Lint-free cloth
2 Inspect the upper pipettor gantry shaft for corrosion (refer to Figure 6-34). If
you notice significant corrosion, or suspect that fluid or some other material
came in contact with the pipettor gantry, call Technical Support.
3 Wipe the lower pipettor gantry shaft to either side of the main pipettor
carriage with a clean, lint-free cloth to remove debris (refer to Figure 6-34).
Lower Pipettor
Gantry Shaft
4 Move the main pipettor carriage a few inches to the right or left to expose the
section of the lower pipettor gantry shaft that was covered by the carriage.
5 Wipe the remaining section of the lower pipettor gantry shaft with the cloth.
6.16
Replacing the Waste Filter
Bottle
Replace the waste filter bottle when:
• You find fluid in the bottle during the weekly maintenance inspection.
• Troubleshooting procedures in an Access manual advise you to replace it.
• Technical Support instructs you to replace it.
Top of the
Waste Filter/Bottle Assembly
Replace the 1 Unscrew the waste filter bottle from the top of the waste filter/bottle
Waste Filter assembly (refer to Figure 6-35).
Bottle
2 Place the top of the waste filter/bottle assembly in a clean waste filter bottle
and screw-tighten the bottle.
WARNINGS
• The filter is a biohazard. Therefore, do not lay the filter down on
any surface. Immediately place the filter in a clean waste bottle.
• You will come in contact with potentially infectious materials during
this procedure. Handle and dispose of biohazard materials according
to proper laboratory procedures. Proper hand, eye, and facial
protection is required.
3 Decontaminate the contents of the removed waste filter bottle in accordance
with proper laboratory procedures before disposing of the liquid.
5 Rinse the bottle thoroughly by filling it with tap water and discarding the
contents.
6 Rinse the bottle a second time with tap water and allow the bottle to air dry.
NOTE
If desired, the waste filter bottle can be autoclaved.
7 Retain the clean bottle for the next time you need to replace the waste filter
bottle.
7
System Configuration
• Introduction (Section 7.1)............................................................................. 7-2
7.1
Introduction
Access System configuration consists of setting the system default values and
formats, and selecting the tests, calibrators, and controls to be used. System
configuration consists of the following:
• System parameters
• Laboratory information
• Tests
• Calibrators (and calibration controls)
• Controls
• Laboratory Information System (LIS) interface parameters (refer to
Appendix A, LIS Interface)
NOTES
• The Configure LIS Interface screen can be accessed at any time.
• New lots of calibrators/calibration controls and quality control samples can
be entered when the system is either in the READY or RUNNING modes.
However, lot information cannot be edited or deleted in the RUNNING mode.
• Excluding the above exceptions, all other system configuration screens can
only be accessed when the analyzer is in the READY or NOT READY mode.
System Configuration
1
F1 F2 F3 F4 F5 F6 F7 F8
[F1] System Displays the Configure System screen. Refer to Section 7.2.
[F2] Laboratory Displays the Laboratory Information screen. Refer to Section 7.4.
Information
[F3] Tests Displays the Configure Tests screen. Refer to Section 7.5.
[F4] Calibrators Displays the Configure Calibrators screen, which is used for entering
calibrators and calibration controls. Refer to Section 7.6.
[F5] Controls Displays the Configure Controls screen. Refer to Section 7.7.
[F6] LIS Displays the Configure LIS Interface screen. Refer to Appendix A, LIS
Interface Interface, for detailed information.
[F8] About Displays the About Access screen, which contains copyright and license
Access information about the Access Immunoassay System.
7.2
Configure System
The first step in system configuration consists of configuring the following items
on the Configure System screen:
• Date and time formats
• Screen saver delay
• System date and time
• Auto Print Result Report option
• Free Thyroxine Index (FTI) ratio option
• Bar code reader/tube detector
• Language
• Printer (configure only for Japanese language).
NOTES
• To configure parameters for bar code reader symbologies, also refer to
Section 7.3, Configure Internal Bar Code Reader.
• The system supports Japanese language printers, which can be selected only
when the Language option is Japanese.
Configure System
1
Date The current date, which shows on displays and reports. This date conforms
to the format selected in the Date Format field.
Auto Print Result Indicates whether result reports automatically print when tests are
Report complete. Options are:
• After Samples, which sets the Sample Report to print when all tests for
a sample are either completed or cancelled
• After Trays, which sets the Tray Report to print when all tests for all
samples on a tray are either completed or cancelled
• Off, which prevents automatic printing of result reports. You can
manually print reports instead.
Refer to Section 5.3 in the Operator’s Guide for details on the result reports.
Time The current time, which shows on displays and reports. This date conforms
to the format selected in the Time Format field.
FTI Ratio Indicates whether or not the system calculates the FTI ratio for samples with
valid Total T4 and Thyroid Uptake results. If configured on, the ratio
displays on the View Test Results screen and prints on reports.
Date Format The format in which dates are displayed and entered throughout the
system. Options are MM-DD-YYYY, DDMMMYYYY, or DD-MM-YYYY,
where D represents the numeric day, M represents the numeric month, and
Y represents the numeric year.
Bar Code Reader Configures the internal bar code reader and tube detector on or off. When
/Tube Detector the Bar Code Reader/Tube Detector is configured on, the internal bar code
reader scans the loaded sample tray for the Tray ID and for Sample IDs. To
enable available parameters for the CODABAR, Interleaved 2 of 5, or
CODE 39 bar code symbologies, press [F7] Configure Bar Code Reader.
Time Format The format in which time is displayed and entered throughout the system.
Options are 12 hour (with am and pm) or 24 hour.
Language The Language in which the system displays and prints. In addition to the
default language of English, you can configure the Access System in other
available languages, including:
• French
• German
• Italian
• Japanese
• Spanish
Screen Saver The number of minutes of system inactivity after which the screen saver
Delay activates, turning the screen black. The Access screen displays again and the
delay timer is reset when you press any key or when the system mode
changes, an icon is highlighted, or the reaction vessel load door is opened. If
the delay is set to 0 minutes, the screen saver does not activate.
Printer The system supports Japanese language printers, which can be selected only
when the Language option is Japanese.
[F1] Save Saves changes made on this screen. To activate some changes, you also need
to reboot the system.
[F7] Configure Displays the Configure Bar Code Reader screen. This key is available only
Bar Code when the Bar Code Reader/Tube Detector is configured on. Refer to Section
Reader 7.3, Configure Internal Bar Code Reader, for detailed information.
[F8] Configure Displays the Configure System Revisions screen. This screen is reserved for
System use by your technical support representative.
Revisions
Configure System
Main
Menu
System
Configuration
[F1] System
Configure
System
[Space Bar] to scroll to desired Auto Print Result Report option, then [Enter]
[Space Bar] to toggle Bar Code Reader/Tube Detector on or off, then [Enter] *
Type desired number of minutes for screen saver delay (1 to 99), then [Enter]
[Space Bar] to scroll to desired Japanese printer (for Japanese language only)**
[F1] Save
Save window opens. Ensure YES is highlighted, then [Enter]
System
Configuration
Main
Menu
Entering Verify that the date displayed is correct. To change the date:
Current Date
1 Press [F8] System Config.
The Configure System screen is displayed with the cursor in the Date field.
3 Type the current date using the format displayed in the Date Format field,
then press [Enter].
The new date is automatically saved and the cursor moves to the Auto Print
Result Report field.
Selecting 4 Press the [Space Bar] to scroll to the desired option, then press [Enter] to
Auto Print select.
Result Report
The cursor moves to the Time field.
Entering Verify that the time displayed is correct. To change the time:
Current Time
5 Type the current time using the time format displayed in the Time Format
field, then press [Enter].
The new time is automatically saved and the cursor moves to the FTI Ratio
field.
Selecting FTI 6 Press [Space Bar] to toggle the FTI Ratio option ON or OFF, then press
Ratio [Enter] to select.
Selecting 7 Press [Space Bar] to scroll to the desired date format, then press [Enter] to
Date Format select.
Selecting
Bar Code NOTE
Reader/Tube The bar code reader should always be on, unless it is malfunctioning. If it is
Detector malfunctioning, call Technical Support immediately.
8 Press [Space Bar] to toggle the Bar Code Reader/Tube Detector option on or
off, then press [Enter] to select.
Selecting 9 Press [Space Bar] to scroll to the desired time format (12- or 24-hour format),
Time Format then press [Enter] to select.
Selecting 10 Press [Space Bar] to scroll to the desired language, then press [Enter] to
Language select.
NOTES
• To implement a new language, the system must be rebooted after the
system is configured (refer to Section 6.6, System Reboot for
instructions).
• If you select and configure a language in error and cannot determine
which language you want, call Technical Support for assistance in
changing to an appropriate language.
• The system displays screen and field names and prints report fields in
the language selected. However, regardless of the language selected,
the operator enters information using a standard English keyboard.
Defining 11 Type the desired number of minutes (1-99), or type 0 to disable the option,
Screen Saver then press [Enter] to select.
Delay
The cursor moves to the Printer field.
Selecting a This option is available only when Japanese is selected in the Language field.
Japanese When any other language is selected in the Language field, the default HP Deskjet
Language printer is displayed, and cannot be changed.
Printer
12 Press [Space Bar] to scroll to the desired Japanese language printer, then
press [Enter] to select.
NOTES
• To implement a new Japanese language printer, the system must be
rebooted after the system is configured (refer to Section 6.6, System
Reboot for instructions).
The cursor moves to the Date field.
Saving The date and time are automatically saved when they are entered. To save
Changes changes to the remainder of the configure system options:
7.3
Configure Internal Bar Code
Reader
When the internal bar code reader is configured on, it reads supported bar code
symbologies on sample tubes and trays. You can choose what encoded
information is included in the sample ID, such as check digits or start/stop
characters, by enabling or disabling available bar code parameters. Available
parameters and their successful programming depend on the
• Bar code symbology used.
• Internal bar code reader installed.
The Access System uses bar code symbology CODE 128 for tray labels. No
parameter choices are available for CODE 128 symbology.
Table 7-6 identifies available choices for supported bar code symbologies, sorted
by installed bar code reader. If you are not sure which parameters you need to
enable, consult the manufacturer’s bar code printer documentation or contact the
supplier of your printed bar code labels.
When you have identified your configuration choices, use the Configure Bar Code
Reader screen to configure the internal bar code reader.
NOTE
The bar code parameters configured for the Access System must match the
parameters of the printed bar code labels you use. If, after consulting your bar
code printer information, you cannot identify which bar code or bar code
parameters you need to configure, contact Technical Support.
Bar Code Table 7-6 lists the available parameters for supported internal bar code
Symbology symbologies, sorted by internal bar code reader. Definitions of the bar code
Parameters parameters are included below the table.
Table 7-6 Available Bar Code Parameters Sorted by Bar Code Reader
* For all symbologies with the original bar code reader, the send feature cannot
be disabled by configuration. If either a check digit or start/stop characters are
used in the bar code, the check digit or start/stop characters are sent. Disabling
the send parameter has no effect.
† For Interleaved 2 of 5, the bar code must be an even number of characters.
However, with the wide scan bar code reader, if you enable the Check Digit, but
do not enable the Check Digit Send field, an odd number of characters are
required, from 5 to 15.
WARNING
Avoid using the combination of no check digit with the less accurate
symbologies, such as Interleaved 2 of 5 and CODABAR.
Press the [Space Bar] to toggle the sending of the start/stop chars.
Save
F1 F2 F3 F4 F5 F6 F7 F8
Interleaved 2 of 5 The two bar code symbology parameters that can be enabled or disabled,
and the number of characters to send for Interleaved 2 of 5 symbology.
CODABAR The three bar code symbology parameters that can be enabled or disabled
for CODABAR symbology.
CODE 39 The three bar code symbology parameters that can be enabled or disabled
for CODE 39 symbology.
Table 7-8 Configure Bar Code Reader Screen Fields and Functions
Enabling Bar The Configure Bar Code Reader screen is displayed when the internal bar code
Code reader is configured on and you press [F7] Configure Bar Code Reader on the
Symbology Configure System screen. You can enable parameters for three available
Parameters symbologies.
The cursor begins in the Interleaved 2 of 5 column. If you do not need to enable or
change the Interleaved 2 of 5 parameters, press [Enter] or [Tab] to move the
cursor to the column of your choice. When you are done enabling parameters,
save the configuration.
1 Press the [Space Bar] to toggle the Check Digit Enable field to Yes. Then
press the [Down Arrow] key to move the cursor to the next
Interleaved 2 of 5 field.
2 Press the [Space Bar] to toggle the Check Digit Send Enable field to Yes.
Then press the [Down Arrow] key to move the cursor to the next
Interleaved 2 of 5 field.
NOTES
• The Check Digit Send Enable field can only be enabled if the Check
Digit Enable field is enabled.
• The original internal bar code reader sends the check digit if it is
included in the bar code. Disabling the field does not prevent the
check digit from being sent.
3 Type the number of characters of the bar code to show on screens and
reports in the Number of Characters field.
NOTE
For Interleaved 2 of 5, the bar code must be an even number of characters.
However, for the wide scan bar code reader only, the number of characters
must be an odd number if the check digit is not sent.
1 Press the [Space Bar] to toggle the Check Digit Enable field to Yes. Then
press the [Down Arrow] key to move the cursor to the next CODABAR field.
2 Press the [Space Bar] to toggle the Check Digit Send Enable field to Yes.
Then press the [Down Arrow] key to move the cursor to the next CODABAR
field.
NOTES
• The Check Digit Send Enable field can only be enabled if the Check
Digit Enable field is enabled.
• The original internal bar code reader sends the check digit if it is
included in the bar code. Disabling the field does not prevent the
check digit from being sent.
3 Press the [Space Bar] to toggle the Start/Stop Send Enable field to Yes.
NOTE
The original internal bar code reader sends the start/stop characters if they
are included in the bar code. Disabling the field does not prevent the
characters from being sent.
Configuring CODE 39
You can enable one or more of the CODE 39 parameters. To enable CODE 39
parameters:
1 Press the [Space Bar] to toggle the Check Digit Enable field to Yes. Then
press the [Down Arrow] key to move the cursor to the next CODE 39 field.
2 Press the [Space Bar] to toggle the Check Digit Send Enable field to Yes.
Then press the [Down Arrow] key to move the cursor to the next CODE 39
field.
NOTES
• The Check Digit Send Enable field can only be enabled if the Check
Digit Enable field is enabled.
• The original internal bar code reader sends the check digit if it is
included in the bar code. Disabling the field does not prevent the
check digit from being sent.
3 Press the [Space Bar] to toggle the Start/Stop Send Enable field to Yes.
2 Be sure that YES is highlighted, then press [Enter] to save the configuration.
The system takes 40 seconds to program the internal bar code reader
changes and when done, the Configure Bar Code Reader screen is displayed.
1 Press [Enter] or [Tab] or the [Arrow] keys to move the cursor to the field of
the bar code symbology parameter to be disabled.
3 Save the configuration (press [F1] Save as described in the previous section).
7.4
Configure Laboratory
Information
Laboratory information can be entered into System Configuration for inclusion on
reports. Figure 7-9 is a flow chart of this procedure. The laboratory information is
included at the top (in the header) of every report generated.
All fields in the Laboratory Information screen are optional. If a field is left blank,
reports will not contain that information. Refer to Chapter 5 of the Operator’s
Guide for an example of a report containing laboratory information.
Main
Menu
System
Configuration
Laboratory
Information
System
Configuration
Main
Menu
Entering Lab 4 Type the name of the laboratory (maximum 40 alphanumeric characters),
Name then press [Enter].
Entering 5 Type the first line of the address (maximum 40 alphanumeric characters),
Address then press [Enter].
Entering 8 Type the system identification number such as the instrument serial number
System ID (maximum 40 alphanumeric characters), then press [Enter].
7.5
Configure Tests
Tests can be configured for use in your laboratory. Figure 7-12 is a flow chart of
this procedure. The Configure Tests screen allows you to:
• Determine which tests are enabled (these tests are displayed in the Test
Menu window)
• Assign each test a Test ID that is used to select the test
• Define the following for each test: default sample type, reference and critical
ranges (quantitative and semi-quantitative assays only), units (quantitative
assays only), and gray zone (qualitative assays only).
Refer to Figure 7-10 and Table 7-11 for an example and description of the
Configure Tests screen.
The system sorts tests in the Configure Tests screen according to whether they are
enabled or disabled, then by Test ID. A test that has a reagent pack lot number
defined (i.e., in reagent inventory) cannot be disabled. The Test ID also affects the
test result printing order on tray reports. Test results are printed from lowest to
highest Test ID within each sample position. Therefore, you can assign Test IDs in
the order you want the test results to be printed on the tray report.
When assigning Test IDs, the system verifies that each Test ID is unique when you
press [F1] Save, [F2] Sort, or [Esc]. If you have two tests with the same Test ID
assigned, a message will be displayed, and you will not be allowed to save
changes until all Test IDs are unique.
For each quantitative test/sample type, units can be selected. If the units are
changed, the system automatically updates stored data (i.e., results, reference
ranges, critical ranges, control limits) to reflect the changes for that test/sample
type combination.
Reference range checking and critical range checking are only performed for
quantitative and semi-quantitative assays. Reference ranges are used to flag a
result that does not fall within the expected range. Upper and/or lower range
limits may be specified for each test/sample type combination, and the results
that are outside of these limits are flagged. When only one limit (for example, the
upper limit) is defined, the system checks the result against that limit, but does
not perform checking on a lower limit. When neither limit is defined, reference
range checking is not performed for that test/sample type combination. A result
that is below the lower limit is flagged ORL on reports. A result that is above the
upper limit is flagged ORH on reports.
Gray zone checking is performed only for qualitative assays. The gray zone is
used to flag a result that falls between the reactive low limit and the non-reactive
high limit. A result that is within the gray zone is flagged GRY on reports. If a
gray zone is recommended for an assay, the appropriate information is included
in the product insert. The gray zone limits for qualitative assays are entered as
decimal percentages of the cutoff value (for example, 0.95 is 95% of the cutoff).
The range of acceptable values is 0.8 to 1.2. To turn off gray zone checking, set
both limits to 1.0.
Some of the semi-quantitative assays support both a quantitative result and semi-
quantitative class scoring. The quantitative result will always be reported, but the
semi-quantitative class scoring can be suppressed. The assay protocol file defines
for what tests this option is available. If the option is available for a test, the
[F7] Toggle Result Type function key in the Configure Tests screen is displayed in
black when that test is highlighted. If the option is not available, the function key
is displayed in gray.
CAUTION
The Special Configuration option is intended for Beckman Coulter support
personnel and for future applications. Do not access this option unless
instructed by a technical support representative.
Some assays allow you to configure specific parameters. The Assay Protocol File
defines which tests support this option. If the option is available for a test, the [F8]
Special Config key is displayed in black when the test is highlighted on the
Configure Tests screen. If the option is not available, the [F8] Special Config key
is displayed in gray.
Configure Tests
1
Contact your Access representative for test availability.
Enabled Tests The number of tests that are enabled and will be displayed in the
system.
Test Enabled Yes (enabled) or No (disabled). Disabled tests are not displayed
on the Test Menu screen and cannot be selected during test
request entry.
Test ID The number assigned to the test for test selection during test
request entry.
Default Sample The sample type that is automatically displayed when the test is
Type selected during test request entry. The default may be overridden.
Antigen Excess This column is blank. Antigen excess testing is currently not
implemented.
Reflex Testing This column is blank. Reflex testing is currently not implemented.
[F2] Sort Sorts the tests according to Test ID. Any changes to the Test ID will
be reflected.
[F5] Units (Cursor on a quantitative test name) - Opens the Configure Units
screen which allows the units and number of decimal places to be
defined for each test/sample type combination.
(Cursor not on a quantitative test name) - Key is light gray (non-
selectable).
[F6] Gray Zone (Cursor on a qualitative test name) - Opens the Configure Gray
Zone screen which allows gray zone limits to be defined for
qualitative tests.
(Cursor not on a qualitative test name) - Key is light gray (non-
selectable).
[F7] Toggle Result (Cursor on a test name of a semi-quantitative test for which class
Type scoring can be suppressed) - Allows reporting or suppressing of
class scoring for some semi-quantitative tests.
(Cursor not on a test name of a semi-quantitative test for which
class scoring can be suppressed) - Key is light gray (non-
selectable).
[F8] Special Config This option is intended for authorized Beckman Coulter support
personnel and for future applications. Do not access this option
unless instructed by a technical support representative.
Configure Tests
Main Menu
[F3] Tests
Configure Tests
[Space Bar] to toggle test enabled (Yes) or disabled (No), then [Enter]
Type unique Test ID, then [Enter]—Or, [Enter] to accept default Test ID
3 Use the [Up Arrow] or [Down Arrow] keys to highlight the desired test.
4 Use the [Space Bar] to toggle the test enabled (YES) or disabled (NO), then
press [Enter] to select.
NOTE
A test cannot be disabled if a reagent pack is defined for that test. Remove the
reagent pack from inventory, then disable the test.
Entering Test 5 Type the unique Test ID (1-999), then press [Enter].
ID
The cursor moves to the Default Sample Type field.
Entering 6 Use the [Space Bar] to scroll to the desired sample type, then press [Enter]
Default to select.
Sample Type
The cursor moves to the Test Enabled field of the next test.
The system sorts the test list. Any changes you have made will be reflected
in the new test list.
Selecting 7 Use the [Up Arrow] or [Down Arrow] keys to highlight the desired
Units for quantitative test.
Quantitative
8 Press [F5] Units.
Tests
The Units Setup screen is displayed.
9 Use the [Up Arrow] or [Down Arrow] keys to highlight the Units field for
the desired sample type.
10 Use the [Space Bar] to scroll to the desired units, then press [Enter] to select.
11 Type the desired number of decimal places (0, 1, 2, or 3) to display for the
result value, then press [Enter].
12 When all sample types display the desired units and decimal places, press
[F1] Save.
Entering 13 Use the [Up Arrow] or [Down Arrow] keys to highlight the desired
Reference quantitative or semi-quantitative test.
Ranges
14 Press [F3] Ref. Ranges.
The Reference Ranges Setup screen for the test is displayed with the cursor
in the Sample Type field.
15 Use the [Space Bar] to scroll to the desired sample type, then press [Enter]
to select.
18 When reference ranges are defined for all desired sample types, press
[F1] Save.
Entering 19 Use the [Up Arrow] or [Down Arrow] keys to highlight the desired
Critical quantitative or semi-quantitative test.
Ranges 20 Press [F4] Critical Ranges.
The Critical Ranges Setup screen for the test is displayed with the cursor in
the Sample Type field.
21 Use the [Space Bar] to scroll to the desired sample type, then press [Enter]
to select.
22 Type the lower limit of the critical range (maximum 10 numeric characters,
decimal point counts as 1 character), then press [Enter].
23 Type the upper limit of the critical range (maximum 10 numeric characters,
decimal point counts as 1 character), then press [Enter].
24 When critical ranges are defined for all desired sample types, press
[F1] Save.
Entering Gray 25 Use the [Up Arrow] or [Down Arrow] keys to highlight the desired
Zone for qualitative test.
Qualitative
26 Press [F6] Gray Zone.
Tests
The Gray Zone Setup screen is displayed.
27 Type the upper limit of the gray zone (maximum 1.2 which is 120%), then
press [Enter]. The value must be a maximum of 6 numeric characters where
a decimal point is 1 character.
28 Type the lower limit of the gray zone (minimum 0.8 which is 80%), then
press [Enter]. The value must be a maximum of 6 numeric characters where
a decimal point is 1 character.
Enabling (or 30 Use the [Up Arrow] or [Down Arrow] keys to highlight the desired semi-
Disabling) quantitative test.
Optional The current selection (i.e., Quantitative or Semi-Quantitative) for the test is
Semi- displayed in the Selected Test Result Type field.
Quantitative
Class Scoring 31 Press [F7] Toggle Result Type to toggle the selection to Quantitative or
Semi-Quantitative.
7.6
Configure Calibrators and
Calibration Controls
Each new lot of a calibrator (for quantitative and semi-quantitative assays) or a
calibration control (for qualitative assays) is entered into the system in System
Configuration before it can be selected during test request entry. Figure 7-15 is a
flow chart of this procedure. Calibrators and calibration controls are added in the
Add Calibrator Lot screen (refer to Figure 7-13 and Table 7-14), which is accessed
by pressing [F4] Calib. from the System Configuration screen, then [F1] Add Lot
from the Configure Calibrator screen.
Each calibrator has a “calibrator set” bar code which contains the following
information:
• Calibrator set name (test ID)
• Calibrator set lot number
• Calibrator set expiration date
In addition, calibrator sets have one or more “calibrator levels,” each of which has
a calibrator level bar code containing the following information:
• Calibrator level (i.e., S0, S1, S2)
• Stated concentration
• Test name (test ID)
Calibrator set bar codes and calibrator level bar codes are located on the
“calibration card” included in each calibrator kit.
Each calibration control has a calibration control bar code which contains the
following information:
• Calibration control name (test ID)
• Calibration control lot number
• Calibration control expiration date
Calibration control levels are included in the assay protocol. Therefore, when the
calibration control bar code is entered, the system automatically assigns all
appropriate calibration control levels. The calibration control bar code is located
on the “calibration card,” which is included with each calibration control set.
The calibrator set/level bar codes and calibration control bar codes can be
scanned into the system using the external bar code wand or they can be
manually entered by typing the bar code characters (letters and/or numbers
printed under the bar code) into the Bar Code Entry field of the Add Calibrator
Lot screen.
NOTE
If your system is configured in a language other than English or Japanese, it may
not always accept the bar coded calibrator card expiration date. The last 5
characters of the bar coded information are the expiration month and year,
formatted MMMYY, where MMM are the first three letters of the month in
English. To enter the information in your configured language, type the bar
coded calibrator information, substituting the first three letters of the month in
the configured language for the English letters. No substitution is required when
the first three letters of the month are the same in English and in the configured
language.
S0 0.000 pg/mL
S1 100.000 pg/mL
S2 250.000 pg/mL
S3 500.000 pg/mL
S4 900.000 pg/mL
Calibrator Set Name VitCal S5 1500.000 pg/mL
Lot Number 900772
Expiration Date 28FEB00
Test VitB12
Save
F1 F2 F3 F4 F5 F6 F7 F8
Bar Code Entry The characters received from the external bar code wand when a bar
code label is scanned for the calibrator set bar code, calibrator level bar
code, or calibration control bar code. These characters can also be typed
into the field.
Calibrator Set The abbreviation of the calibrator name or calibration control name is
Name displayed automatically when the calibrator set bar code or calibration
control bar code is entered.
Lot Number The lot number of the calibrator or calibration control is displayed
automatically when the calibrator set bar code or calibration control bar
code is entered.
Expiration Date The date on which the calibrator or calibration control expires is
displayed automatically when the calibrator set bar code or calibration
control bar code is entered.
Test The test name is displayed automatically when the calibrator level bar
code or calibration control bar code is entered.
Level The calibrator level is displayed when the calibrator level bar code is
entered. The calibration control levels are displayed automatically
when the calibration control bar code is entered.
Units The units in which the concentration was calculated are displayed
automatically when the calibrator level bar code is entered.
Table 7-14 Add Calibrator Lot Screen Fields and Functions (continued)
Configure Calibrators
Main
Menu
System
Configuration
[F4] Calib.
Configure
Calibrator
Add
Calibrator Lot
Scan calibration control bar code* Scan calibrator set bar code*
Scan calibration control level bar code* Scan calibrator level bar code*
* The calibration control bar code, calibrator set bar code, and individual
calibration control level/calibrator level bar code(s) are located on the
calibrator/calibration card included in the calibration control/calibrator kit.
Alternatively, type the number under the bar code into the Bar Code Entry
field, then press [Enter].
The Add Calibrator Lot screen is displayed with the cursor in the Bar Code
Entry field.
4 Scan the calibrator or calibration control set bar code located on the
calibration card.
Alternatively, the calibrator or calibration control set bar code may be manually
entered:
• Type the characters located directly under the bar code, then press [Enter].
NOTES
• The system will not accept entry of an expired calibrator or calibration
control.
• If your system is configured in a language other than English or Japanese, it
may not always accept the bar coded calibrator card expiration date. The last
5 characters of the bar coded information are the expiration month and year,
formatted MMMYY, where MMM are the first three letters of the month in
English. To enter the information in your configured language, type the bar
coded calibrator information, substituting the first three letters of the month
in the configured language for the English letters. No substitution is
required when the first three letters of the month are the same in English and
in the configured language.
Entering A bar code must be entered for each calibration control level/calibrator level.
Calibration Repeat the following steps until all levels are entered. The calibration control
Control Level/ levels/calibrator levels may be entered in any order.
Calibrator
5 Scan the calibration control level/calibrator level bar code located on the
Level Bar calibration card.
Code(s)
The system automatically displays the calibration control level/calibrator
level, concentration, units, and test.
• Type the number located under the calibration control level/calibrator level
bar code on the calibration card, then press [Enter].
9 Press [Esc].
7.7
Configure Controls
Quality control system configuration consists of entering the following control
sample information:
• Control name
• Lot number
• Expiration date
• Sample type
• Expected mean (test specific)
• Expected standard deviation (test specific)
Control information is entered into system configuration for each new lot of a
control. Figure 7-18 is a flow chart of this procedure. Use a different control name
for each new lot number. The system does not limit the number of lots entered for
a control.
Quality control samples are tested like patient samples to assure the validity of
the patient sample results. Each laboratory should establish the acceptable range
for commercially available quality control materials. The manufacturer's
suggested ranges may be used until an adequate number of samples have been
processed to determine a lot specific mean and standard deviation.
QC rules are additional quality control functions that may be enabled to evaluate
and, if necessary, flag results. For example, you may choose to flag results that are
more than 3 SD from the mean. Refer to Figure 7-16 and Table 7-17 for an example
and explanation of the Add Control screen. Use of QC rules should be determined
by the laboratory supervisor before entering quality control information in
System Configuration. Refer to Section 3.4, Quality Control in this manual for a
description of the available QC rule selections.
If you are using a multi-level control, each level is entered as a separate control. A
maximum of 250 control name/control lot number/Test ID combinations can be
entered into System Configuration. For example, if three tests are assigned to one
lot number of one control, three of the 250 available combinations are used. If a
second lot number of the control is added, and the three tests are assigned to that
lot number also, three more of the 250 available combinations are used.
Enter the control name exactly as you want it to appear on reports (maximum of 8
alphanumeric characters; spaces are not accepted). This control name can be
typed into the Sample ID field during test request entry to select the control for
processing. Control names must be unique; one control name cannot differ from
another only by upper or lower case (for example, if CONTROL1 exists as a
control name, Control1 will not be accepted as a different control). Control names
must also be unique for each lot number of the same control.
The expected, or fixed, mean and standard deviation are used to calculate the
standard deviation interval (SDI):
Add Control
1
QC Rules
Test Mean SD Units 1-2s 2-2s 1-3s 4-1s 10X
Ferritin 102.00 3.00 ng/mL on on on on off
Save Add/
Delete
Test
F1 F2 F3 F4 F5 F6 F7 F8
Control The control name that is entered during test request entry.
Lot The control lot number.
Exp. Date The date on which the control expires.
Sample The sample type for the control. Serum, Urine, CSF, Blood, Plasma, or Other.
Test The abbreviation of the test name.
Mean The expected mean for the test.
SD The expected standard deviation for the test.
Units The units used for the test/sample type combination.
QC Rules QC rules (statistical analysis rules) selected for a test. Use the [Space Bar] to
toggle the rules on or off.
[F1] Save Saves any changes made to the screen.
[F2] Add/ Opens the Control Tests screen which allows you to specify the tests assigned to
Delete the control. When these tests are selected during test request entry, quality
Test control data and Levey-Jennings charts are generated for the tests.
Configure Controls
Main
Menu
[F8] System Config.
System
Configuration
[F5] Controls
Configure
Control
[F1] Add Control
Add
Control
Type control expiration date (accepted format displayed in prompt line), then [Enter]
Verify sample type. To change, press [Space Bar] to scroll to desired sample type,
then [Enter]
[F2] Add/Delete Test
Control
Tests
Type Test ID, then press [+]. Repeat until all tests are entered.
[Esc]
Add
Control
Main
Menu
The Add Control screen is displayed with the cursor in the Control field.
Entering 5 Type the control sample expiration date (the accepted format is displayed in
Control the prompt line), then press [Enter].
Expiration
The cursor moves to the Lot field.
Date
Entering 6 Type the control sample lot number (maximum of 10 numeric characters),
Control Lot then press [Enter].
Number
The cursor moves to the Sample field.
Selecting 7 Press [Space Bar] to scroll to the desired sample type, then press [Enter] to
Control select.
Sample Type
The cursor remains in the Sample field.
Entering 8 Press [F2] Add/Delete Test to display the Control Tests screen.
Control Tests
9 Type the Test ID associated with the test, then press [+] to select the test.
10 Repeat until all desired tests are selected, then press [Esc].
The Add Control screen is displayed with the test(s) and units filled in and
the cursor in the first empty Mean field.
Entering The expected mean for the control can be any decimal number (maximum of 10
Control Test numeric characters), but the number will be displayed with two decimal places.
Mean Negative numbers and zero are not accepted.
Entering The expected standard deviation (SD) for the control can be any decimal number
Control (maximum of 10 numeric characters), but the number will be displayed with two
Standard decimal places. Negative numbers and zero are not accepted.
Deviation
12 Type the expected standard deviation, then press [Enter].
Selecting QC The QC Rules are selected in the five QC Rules fields. The available QC rules
Rules options are the following:
• 12s (1-2s) - Flag when one point is more than 2 SD from the mean.
• 22s (2-2s) - Flag when 2 consecutive points of a given control are more
than 2 SD from the mean in the same direction. Only the
second point is flagged.
• 13s (1-3s) - Flag when one point is more than 3 SD from the mean.
• 41s (4-1s) - Flag when 4 consecutive points of a given control are more
than 1 SD from the mean in the same direction. Only the
fourth point is flagged.
• 10x (10x) - Flag when 10 consecutive points of a given control are on the
same side of the mean (for example, 10 points are above the
mean). Only the tenth point is flagged.
13 Use the [Left Arrow] and/or [Right Arrow] to highlight the desired QC rule
field.
14 Use the [Space Bar] to toggle the QC rule ON (enabled) or OFF (disabled),
then press [Enter].
The cursor moves to the next QC rule field, or if the cursor is in the last QC
rule field and the next line contains a test, the cursor moves to the Mean field
on the next line.
Saving When the mean, SD, and QC rules are entered for all selected tests:
Changes
15 Press [F1] Save.
Editing Control information is edited in the Edit Control screen. The Edit Control screen
Controls allows you to add or delete tests, and edit the mean, SD, units, and QC rules for
each test.
3 Use the [Arrow] keys to highlight the desired control, then press
[F2] Edit Control.
The Edit Control screen is displayed with the cursor in the first empty
Mean field.
4 To change the mean, SD, units, or QC rules, use the [Arrow] keys to move
the cursor to the desired field, then type the new value or change the
selection as described in the appropriate section above.
5 To add or delete a test, press [F2] Add/Delete Test and change the test
selections as described in the Entering Control Tests section above.
Deleting When you delete a control from system configuration, any individual tests
Controls selected for the control are also deleted.
3 Use the [Arrow] keys to highlight the control to delete, then press
[F8] Delete Control. A confirmation message is displayed.
7.8
System Configuration
Worksheets
The following worksheets are included for documentation of the system
configuration settings. Use the worksheets on the following pages as originals
and make photocopies for use with each individual Access System. Retain the
completed worksheets.
Tests
Reference
Default? Range Critical Range Gray Zone
Abrv. No. of
Test Test Sample Dec.
Name ID Type * Y/N Units Places Low High Low High Upper Lower
* Record the units, decimal places, and/or ranges for the default sample type and for other sample types as applicable for each test.
Calibrators/Calibration Controls
Calibrator/Calibration
Control Set Name Lot No. Exp. Date Test Name Level Concentration Units
Controls
QC Rules Applied
Control Name/ Exp. Test ID/
Level Lot No. Date Type Name Mean SD 12s 22s 13s 41s 10x
A
LIS Interface
• Introduction (Section A.1)........................................................................... A-2
A.1
Introduction
The Laboratory Information System (LIS) Interface allows the Access System to
communicate with an LIS. Refer to Section A.7, LIS Connection, for information
on connecting the Access System to an LIS. Your LIS vendor configures the LIS to
communicate with the Access System using ASTM 1394-91 and ASTM 1381-95
standard protocols and the Access System LIS Vendor Information document. The
LIS Vendor Information document is included in the Access System Software binder;
provide this information to your LIS vendor. If your LIS vendor needs the ASTM
standards, contact Beckman Coulter Technical Support.
The LIS Interface option must be enabled in system configuration before data can
be transmitted between the two systems (refer to Section A.2, Configure LIS
Interface, for detailed information). Test requests can then be entered at the LIS
and transmitted to the Access System for processing. The test requests are sent to
a request file by the Access System, where they reside until the Sample ID is
assigned to a sample tray. When a Sample ID is entered in the Test Request/
Progress screen, the system automatically inserts the test request information
associated with that Sample ID into the appropriate fields. If bar code labeled
tubes are used, the test request information can be retrieved by simply loading the
bar code labeled samples onto the analyzer. Refer to Section 7.2, Configure
System, and Section 7.3, Configure Internal Bar Code Reader, for information
about configuring the internal bar code reader to read the bar code symbology.
Refer to Section A.3, Entering LIS Test Requests and Section A.4, Processing LIS
Samples, for information on processing the samples.
After processing is complete, patient sample results and any associated flags can
be automatically sent to the LIS. Alternatively, each result can be reviewed and
manually selected for transmission to the LIS. Quality control samples and
calibrators cannot be requested from the LIS, but if controls are requested via the
Access System, the control results can be transmitted to the LIS. Calibrator results
are not transmitted to the LIS. Refer to Section A.5, Sending Test Results to the
LIS, for detailed information.
A.2
Configure LIS Interface
The Access System LIS interface can be configured to receive and send data
according to laboratory preference. Figure A-3 is a flow chart of this procedure.
Refer to Figure A-1 and Table A-2 for an example and description of the
Configure LIS Interface screen.
When an LIS is connected to the Access System, the LIS Interface should be
enabled (On) to receive test requests from and send test results to the LIS. If an LIS
connection is used, but the LIS is temporarily disabled, the LIS Interface field
selection should be Off-Line, which prevents the actual transmission of data to the
LIS; any data to be sent to the LIS are “held” until the LIS Interface field selection
is returned to On, at which time the results can be manually transmitted to the LIS
(refer to Section A.5). If an LIS is not connected to the Access System, the LIS
Interface field selection should be Off.
The baud rate determines the speed at which data is transmitted between the LIS
and the Access System. The baud rate entered in system configuration must
match the LIS baud rate. Refer to your LIS documentation or contact your LIS
vendor to determine the correct baud rate.
When the Automatically Send to LIS option is enabled (field selection is Yes), all
test results for patient samples and controls are automatically sent to the LIS upon
sample completion. All test results, whether requested through the LIS or from
the keyboard, are transmitted. When the Automatically Send to LIS option is
disabled, each test result to be sent to the LIS must be transmitted manually (refer
to Section A.5).
If a Sample ID is entered in the Test Request/Progress screen with the Host Query
Capability and no matching Sample ID is located, the Access System
automatically queries the LIS for any un-sent test requests after the tray is loaded
on the System.
LIS Interface On
Press the [Space Bar] to turn the LIS interface on, off or off-line.
Save
F1 F2 F3 F4 F5 F6 F7 F8
LIS Interface On, Off, or Off-Line (on hold). This option must be On for data to be
transmitted between the Access System and the LIS.
Baud Rate The speed at which data is transmitted between the Access System
and the LIS. Available options are 1200 and 2400.
Host Query Capability On or Off. This option allows the Access System to query (ask) the LIS
for specific test requests.
[F1] Save Saves any changes made to the LIS interface configuration.
Main Menu
System
Configuration
Configure LIS
Interface
Main Menu
Enabling LIS The LIS interface can be enabled (On), disabled (Off), or placed “on hold”
Interface (Off-Line). When the LIS is temporarily unavailable, the off-line selection stores
any results to be sent to the LIS until the LIS Interface option is re-enabled.
The Configure LIS Interface screen is displayed with the cursor in the LIS
Interface field.
3 Press the [Space Bar] to scroll to the desired option, then press [Enter] to
select.
Selecting The available options for the baud rate (the speed at which data is transmitted)
Baud Rate are 1200 and 2400. The baud rate for the Access System must match the baud rate
for the LIS.
4 Press the [Space Bar] to toggle to the desired option, then press [Enter] to
select.
Selecting When the Automatically Send to LIS option is enabled (Yes), test results are
Automatic automatically sent to the LIS upon sample completion. When the option is
Send to LIS disabled (No), each result must be manually transmitted to the LIS.
5 Press the [Space Bar] to toggle to the desired option, then press [Enter] to
select.
Selecting Host When the Host Query Capability option is enabled (On), the Access System can
Query query (ask) the LIS for specific test requests.
Capability
6 Press [Space Bar] to toggle to the desired option, then press [Enter] to select.
8 Ensure that YES is highlighted, then press [Enter] to save the changes.
A.3
Entering LIS Test Requests
Test request information previously transmitted from the LIS can be retrieved from
the Access System by selecting or entering a Sample ID in the Test Request/Progress
screen. After selecting or entering the Sample ID, the appropriate field in the Test
Request/Progress screen will be filled. Figure A-4 is a flow chart of this procedure.
Alternatively, if bar code labeled tubes or sample cups are used, the Sample IDs
and all previously downloaded test request information are automatically
retrieved when the samples are loaded onto the analyzer. The internal bar code
reader scans each bar code label, and the system inserts the appropriate
information into the Test Request/Progress screen. Using this method, test
request information can be entered into the Test Request/Progress screen simply
by loading the sample tray. Figure A-5 is a flow chart of this procedure.
If the Host Query Capability in the Configure LIS screen is turned on, the system
can send a query to the LIS to retrieve test request information for each Sample ID
with a status of No Test. To initiate the querying process, you must load the tray
containing the samples that need test request information. After loading the tray,
the Access System automatically sends queries to the LIS to obtain the missing
test information. After the LIS sends a response to each query, the Test Request/
Progress screen is automatically updated.
NOTE
If you add a sample to a loaded tray, the system will not query for the test request
information. To automatically query for an added sample, you must reload the
tray. If you must send the query and cannot reload the tray, send the query using
the [F5] key from the LIS Diagnostics screen. For information on the LIS
Diagnostics screen, refer to Section A.6, LIS Diagnostics.
After the test request information has been entered, process the samples as
described in Section A.4, Processing LIS Samples.
Main Menu
Test Request/
Progress
Sample ID
All
samples No
entered for [Enter]
tray?
Yes
*This key reads Get Tray X (where X is the Tray ID) when the tray is on-board.
The key reads Load Tray X (where X is the Tray ID) when the tray is not loaded
on the system.
Manual LIS Use the following procedure to enter LIS test requests for samples without bar
Test Request code labels:
Entry
1 Press [F1] Test Request/Progress from the Main Menu.
Any test requests assigned to the tray are displayed, and the cursor is
positioned in the first available sample position.
If necessary, use the [Arrow] keys to move the cursor to the Sample ID field
for the desired sample position.
4 Use the [Arrow] keys to highlight the desired Sample ID, then press [Enter].
The selected Sample ID appears in the Sample ID field where you placed the
cursor in the Test Request/Progress screen.
5 Press [Enter].
NOTE
Instead of using the process described in steps three through five, you could also
type the Sample ID in the appropriate field and press [Enter]. The Sample ID must
be entered exactly as it was entered at the LIS, including upper or lower case.
6 Repeat steps three through five for each Sample ID on the tray.
8 Ensure that the samples are placed in their assigned sample positions, then
load the sample tray onto the analyzer as described in Section 4.3, Sample
Trays, of the Operator’s Guide.
Main Menu
Test Request/
Progress
System scans bar code labels and fills in test request information
*This key reads Get Tray X (where X is the Tray ID) when the tray is on-board.
The key reads Load Tray X (where X is the Tray ID) when the tray is not loaded
on the system.
Automatic LIS If bar code labeled tubes or sample cups are used, test requests for LIS samples
Test Request can be retrieved from the Access System using the Sample IDs read by the internal
Entry bar code reader. The internal bar code reader must be configured on and the
correct parameters of the bar code reader must be enabled. Refer to Section 7.2
and Section 7.3 for information about configuring the internal bar code reader.
The Test Request /Progress screen is displayed with the cursor in the
Tray ID field.
3 Load the bar code labeled samples into empty sample positions on the
sample tray. Ensure that no Sample IDs are entered for those sample
positions in the Test Request/Progress screen.
Refer to Section 4.3, Sample Trays, of the Operator’s Guide and Section 1.5,
5 Load the sample tray onto the analyzer as described in Section 4.3, Sample
Trays, of the Operator’s Guide.
The internal bar code reader/tube detector scans the tray and inserts the
Sample IDs into the appropriate Sample ID fields. The test request
information for each sample is then automatically inserted into the
appropriate fields on the Test Request/Progress screen.
NOTES
• If the Sample ID in the Test Request/Progress screen does not match the
Sample ID on the bar code labeled sample, the bar coded Sample ID is
ignored and the Sample ID entered in the Test Request/Progress screen is
used to identify the results.
• If the Sample ID that is entered from the bar code labeled tubes has leading
or trailing digits/characters, you may need to configure the internal bar
code reader. Refer to Section 7.2, Configure System and Section 7.3,
Configure Internal Bar Code Reader.
Editing Test Tests can be added to or deleted from the test request via the LIS or the Access
Requests via System keyboard.
LIS
When the test request is edited via the LIS, a message is sent from the LIS
requesting that a test be added to or deleted from an existing test request. This
ensures that the list of tests processed by the Access System and the list of tests for
which the LIS expects results are identical.
If a change to the test list is requested by the LIS after processing has begun
(i.e., [F11] Run was pressed to begin processing the sample to be edited), you
must pause the Access System, then press [F11] Run for the new tests to be
scheduled for processing.
When an edited test request is received from the LIS after processing has begun:
Editing Test The LIS expects results to be sent back for all tests included in the transmitted test
Requests via request; if a test is deleted by typing the test code and pressing the [ - ] key, the LIS
Access continues to expect a result for that test. If a test is added by typing the test code
System and pressing the [ + ] key, the results for the test are sent, but may or may not be
Keyboard recognized by the LIS, depending on the individual LIS. Refer to your LIS
documentation or contact your LIS vendor for details.
Main Menu
Test Request/
Progress
Deleting All All test requests received from the LIS and not yet assigned to a sample tray can
LIS Test be deleted from the Access System. Figure A-6 is a flow chart of this procedure.
Requests
1 Press [F1] Test Request/Progress from the Main Menu.
The Test Request/Progress screen is displayed with the cursor in the Tray
ID field.
3 Use the [Arrow] keys to highlight the Delete All LIS Requests option, then
press [Enter].
All LIS test requests not yet assigned to a sample tray are deleted.
Main Menu
Test Request/
Progress
Printing an LIS All test requests received from the LIS and not yet assigned to a sample tray can
Request be printed from the Access System. Figure A-7 is a flow chart of this procedure.
Report
1 Press [F1] Test Request/Progress from the Main Menu.
The Test Request/Progress screen is displayed with the cursor in the Tray
ID field.
3 Use the [Arrow] keys to highlight the Print LIS Request Report option, then
press [Enter].
All LIS test requests currently residing in the LIS Request file are printed in
a report.
A.4
Processing LIS Samples
As the tests are processed, the sample status progresses from Reqstd, through
intermediary states, to Done.
The LIS status can be viewed after results have been sent using the [F8] Display
Tray ID/LIS key from the View Test Results screen.
Figure A-8 charts the flow of sample processing when entering tests through an
LIS. For more information about general sample processing, refer to Section 4.4,
Sample Processing, of the Operator’s Guide.
Main Menu
Test Request/
Progress
System scans bar code labels and fills in test request information
All
samples No Continue loading
loaded up to 6 trays
?
Yes
[F11] Run
Yes
Processing begins
*This key reads Get Tray X (where X is the Tray ID) when the tray is on-board.
The key reads Load Tray X (where X is the Tray ID) when the tray is not loaded
on the system.
A.5
Sending Test Results to the LIS
Patient and quality control sample results and any associated flags can either be
sent to the LIS automatically or manually. As the LIS receives each test result, a
confirmation message is sent back to the Access System. When the message is
received by the Access System, the LIS status changes to OK.
When the Automatically Send to LIS option is disabled, each test result must be
manually selected and sent to the LIS. Figure A-9 is a flow chart of this procedure.
After all desired test results are selected for transmission, the results can be sent to
the LIS using the [F5] Selected Results to LIS key in the View Test Results screen.
Pressing the [F5] Selected Results to LIS key also re-sends results that were
included in a failed transmission or were on hold while the LIS was off-line.
When the LIS successfully receives results, the LIS status changes to OK. If the test
result does not successfully reach the LIS, the LIS status changes to Fail.
Auto- To automatically send patient test results and any associated flags to the LIS upon
matically sample completion, the Automatically Send to LIS option must be enabled and
Sending the LIS Interface option must be configured On in system configuration. When
Results to the the sample status is Done, the test results are automatically transmitted to the LIS.
LIS As the LIS successfully receives the results, the LIS status in the View Test Results
screen changes to OK.
If any test results do not successfully reach the LIS, the LIS status changes to Fail.
Use the procedure for manually sending results to the LIS to transmit failed
transactions.
Main Menu
View Test
Results
Figure A-9 Manually Selecting and Sending Test Results to LIS Flow Chart
Manually When the Automatically Send to LIS option is disabled in the system
Sending Test configuration, or when transmissions fail, you must select the test results you
Results to the want to send or resend to the LIS.
LIS
1 Press [F2] View Test Results from the Main Menu.
2 Use the [Arrow] keys to highlight the desired sample, then press
[Space Bar].
• If you are resending failed results, you only need to highlight one sample
to send all results with an LIS status of Fail. Continue to step three.
• If you are manually sending other individual results, repeat step two until
all samples to be sent have been selected.
All selected results are transmitted to the LIS. When the LIS confirms that
the results were received, the LIS status in the View Test Results screen
changes to OK. If the test results do not successfully reach the LIS, the LIS
status changes to Fail.
A.6
LIS Diagnostics
Various LIS Interface parameters are monitored by the system and can be viewed
using the LIS Diagnostics screen (Figure A-10). Press [F8] More Options from the
Diagnostics screen, then select LIS from the list of options to display the LIS
Diagnostics screen. The LIS Diagnostics screen monitors the status of data
transmissions to and from the LIS, and can be used to help diagnose a problem
with the connection between the LIS and the Access System.
NOTE
Refer to the LIS Vendor Information for the definition of terms used in this section.
LIS Diagnostics
1
Since Since
07:52 pm Current 07:52 pm Current
08-01-1999 Transfer 08-01-1999 Transfer
Messages Sent 1 1 Queries 2
Results Sent 0 0 Message Errors 0 0
Frames Sent 11 11 Frame Errors 0 0
Messages Sent The number of messages sent to the LIS since the totals were last
cleared (Since field), and within the message currently being sent
(Current Transfer field).
Results Sent The number of results sent to the LIS since the totals were last cleared
(Since field), and within the message currently being sent (Current
Transfer field).
Frames Sent The number of frames sent to the LIS since the totals were last cleared
(Since field), and within the message currently being sent (Current
Transfer field).
Queries The number of queries sent to the LIS since the totals were last cleared
(Since field).
Message Errors The number of message errors that occurred in data transmissions
between the Access System and the LIS since the totals were last
cleared (Since field), and within the message currently being sent or
received (Current Transfer field).
Frame Errors The number of frame errors that occurred in data transmissions
between the Access System and the LIS since the totals were last
cleared (Since field), and within the message currently being sent or
received (Current Transfer field).
Messages Received The number of messages received from the LIS since the totals were
last cleared (Since field), and within the message currently being
received (Current Transfer field).
Tests Received The number of test requests received from the LIS since the totals
were last cleared (Since field), and within the message currently being
received (Current Transfer field).
Frames Received The number of frames received from the LIS since the totals were last
cleared (Since field), and within the message currently being received
(Current Transfer field).
Track Status Indicates which data transmissions are tracked (which fields will
increment when data is transmitted): All, None (only queries are
tracked), or Some (tracks the Error Messages, Messages Sent, and
Messages Received fields).
Sending The status button is illuminated (bright green) when the Access
System is sending data to the LIS.
Receiving The status button is illuminated (bright green) when the Access
System is receiving data from the LIS.
[F2] Clear Status Clears all fields on the screen and resets the time displayed at the top
Totals of the Since field to the current time.
[F3] Check LIS Checks the two LIS processes that must function for data to be
Process transmitted between the Access System and the LIS. A message is
displayed stating the status of the processes. Do not press this key
while the system is processing samples.
[F5] Query LIS for Queries (asks) the LIS for specific test requests. This key is disabled
Test Requests (gray) if the Host Query Capability option or the LIS Interface option
is Off in system configuration. Do not press this key while the system
is processing samples.
[F6] View Last Opens the View Last Received Message screen, which displays the
Received last data message received from the LIS.
[F7] View Last Sent Opens the View Last Sent Message screen, which displays the last
data message sent to the LIS.
The LIS Diagnostics screen is displayed with the cursor in the Track Status
field.
4 Use the [Space Bar] to select All from the list of options. Then press [Enter].
All fields are cleared and the current time is displayed at the top of the
Since field.
Check LIS There are two LIS “processes” that must be functioning for data to be transmitted
Process between the Access System and the LIS: “lis” and “lisagent.” The Check LIS Process
option checks these LIS processes to ensure that they are functioning properly.
CAUTION
DO NOT use this function unless directed to do so by a technical support
representative.
Query LIS for Test requests can be manually requested from the LIS. This key is disabled (gray)
Test Requests when Host Query Capability option or the LIS Interface option is Off in system
configuration.
The Access System queries the LIS for test request information for the
entered Sample ID.
The Last Received Message screen is displayed, listing the last data message
received from the LIS. The individual pieces of data are separated by
characters that represent the end of a field or line.
View Last Sent 1 Press [F7] Diag. from the Main Menu.
The Last Sent Message screen is displayed, listing the last data message sent
to the LIS. The individual pieces of data are separated by characters that
represent the end of a field or line.
A.7
LIS Connection
The Access System LIS connection port is located on the right side of the analyzer
near the power switch. The port is labeled “LIS” and is the top, right port (refer to
Figure A-12).
The LIS cable can be connected directly to the port. The LIS pin designations
should be as follows:
2 RXD TXD
3 TXD RXD
5 Ground Ground
If you have any questions regarding the LIS connection, contact Technical Support
for assistance.
LIS