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Reference Manual: C42385 January 2020
Reference Manual: C42385 January 2020
Reference Manual: C42385 January 2020
C42385
January 2020
Printed in U.S.A.
© 2020 Beckman Coulter, Inc.
BECKMAN COULTER, INC. • 250 S. KRAEMER BLVD. • BREA, CA 92821 • U.S.A.
Publication Notes
This manual, P/N C42385, release date 2020-01, supports:
• Access 2 published system software version 3, including full versions 3.4.2, 3.4.3, 3.5.0, 3.6.0, and
3.7.0.
• Access 2i published software version 6, including full versions 6.2.2, 6.2.3, and 6.3.0.
Changes to this Revision
Chapter Page(s) Change Description
Title Page Publication Notes Added software version 3.7.0. Updated the Revision History table.
4 4-16 Depending on the version of your PC, you may need the system password to restart the
7 7-13, 7-15 PC.
Revision History
C30217, December 2018 Access 2 software versions 3.4.2, 3.4.3, 3.5.0, and 3.6.0
Access 2i software verrsions 6.2.2 , 6.2.3, and 6.3.0
C02061-AA, April 2017 Access 2 software versions 3.4.2, 3.4.3, and 3.5.0
Access 2i software verrsions 6.2.2 and 6.2.3
B14253E, July 2016 Access 2 software versions 3.4.2 and 3.4.3
Access 2i software versions 6.2.2 and 6.2.3
B14253D, February 2015 Access 2 software version 3.4.2
Access 2i software version 6.2.2
This manual is intended for use with the Access 2 Immunoassay System. This manual also can be used as
supplemental material for the UniCel DxC 600i system, which consists of an Access 2 system integrated with a
UniCel DxC 600 system.
© 2020 Beckman Coulter, Inc.
Beckman Coulter, Inc. grants a limited non-exclusive license to the Access 2 system owner or operator to make
a copy of all or a portion of this book solely for laboratory use.
Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks
of Beckman Coulter, Inc. in the United States and other countries.
Microsoft, Windows, and the Windows logo are either registered trademarks or trademarks of Microsoft Corporation in the United States and/or
other countries.
Citranox is a trademark of Alconox, Inc.
Contrad is a trademark of Decon Laboratories, Inc.
All other trademarks are the property of their respective owners.
Access 2 Reference Manual Table of Contents
Table of Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-1
5 Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.1 Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
5.2 Initialize System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
5.3 Prime Fluidics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
5.4 Volume Checks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
5.5 Mechanics and Device Diagnostics . . . . . . . . . . . . . . . . . . . . . 5-46
5.6 Analog and Digital Device Diagnostics . . . . . . . . . . . . . . . . . . 5-58
5.7 Luminometer Device Diagnostics . . . . . . . . . . . . . . . . . . . . . . 5-71
5.8 Advanced Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-76
5.9 LIS Diagnostics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-89
5.10 Diagnostic Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-94
5.11 Individual System Checks . . . . . . . . . . . . . . . . . . . . . . . . . . 5-101
A Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
A.1 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
A.2 System Check Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . A-9
A.3 Instrument Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . A-24
A.4 Assay Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-35
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Glossary-1
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Index-1
Preface
About the Reference Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-2
About the Ref- The Reference Manual provides background, theory, troubleshooting, and advanced
erence Man- maintenance information. The Reference Manual contains the following chapters:
ual
Preface • A listing of the Access 2 system documentation
• Information about contacting Technical Support
Chapter 1 • Technical overviews of the Access 2 system and its
Technology hardware modules
Overview • Overview of the immunoassay technology used by the
system to detect and measure analytes
Chapter 2 • Access 2 system spatial requirements, operating
System environment requirements, and electrical requirements
Specifications • Component performance characteristics, system and
supply capacities, bar code sample requirements, and
other specifications
Chapter 3 • Theory of sample processing, including typical
Theory of movement of an RV through the system and
Operation obstruction detection
• Theory of luminometer and assay calibrations, quality
controls, and how the System Check routine can be
used to verify system performance
Chapter 4 • How to configure general system parameters for your
System laboratory, including report, printer, back up
Configuration scheduling, and LIS (laboratory information system)
information
• How to set up the bar code reader for the symbologies
you use
• How to configure tests, result information, test panels,
and reflex tests
Chapter 5 • How to initialize the system, prime the fluidics, and
Diagnostics perform dispense and aspirate volume checks
• How to view and perform diagnostic checks on
mechanical, analog, and digital devices, and the LIS
Chapter 6 • How to review and troubleshoot caution and warning
Event Log events
• Numeric list of cautions and warnings by system
module
Notes, Cau- The Access 2 system documentation uses notes, cautions, and warnings to draw your
tions, and attention to important information, instrument operation instructions, and safety
Warnings information.
Help Manual
Description
Icon Graphic
NOTE
Be prepared to provide your system ID.
1 Technology Overview
1.1 System Technology Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Workgroups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Chemiluminescence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20
The system processes calibration, quality control, and patient samples in individual,
disposable plastic tubes called reaction vessels (RVs) with reagents from up to 24
onboard reagent packs.
The system uses six instrument hardware modules to perform processing, control, and
interface functions (see Figure 1-1). The carousel, main pipettor, analytical, and
fluidic modules provide sample processing functions. The electronics module
connects each of the processing modules to control mechanisms, including the
operating system software. The peripherals module provides the software that you use
to direct and monitor the system.
For information about the instrument hardware, see Section 1.2: Instrument
Technology.
For information about how to use the system interface, see Chapter 1: System
Overview in the Operator's Guide.
Processing Functions
Carousel Module Main Pipettor Module Analytical Module
Sample Carousel Precision Pump and Valve Reaction Vessel Loader
Internal Sample Bar Code Pipettor Gantry Incubator Belt
Reader Ultrasonic Transducer Wash/Read Carousel
Cup/Tube Detector Primary Probe Luminometer
Reagent Carousel
Internal Reagent Bar Code
Reader (if equipped)
Fluidic Module
Probe Wash Tower
Vacuum Pump
Vacuum Reservoir
Substrate Pump, Valve, and
Heater
Wash Pump and Valve
Peristaltic Waste Pump
Fluids Tray
Control Functions
Electronics Module
Power Supply
Printed Circuit Boards
Reset Button
Internal Hard Drive
3.5-Inch Disk Drive
Interlock Switch
RV Load Door Alarm
Status Light Bar (if equipped)
Instrument Software
0501F.wmf
Figure 1-1 Access 2 System Functional Overview
The workgroup database can store large amounts of lot, ID, and test result
information. The database capacity is usually shared over the 1-4 instruments in the
workgroup, but is sometimes limited per instrument. For example, the workgroup can
store 400 rack IDs, but a single instrument can only store 100 of them.
LIS Interface The Laboratory Information System (LIS) interface allows your Access 2 system to
communicate with an external LIS. When the LIS interface is switched on through the
software, it can communicate with the server PC in your workgroup. The LIS links to
the workgroup through an LIS connection port located on the server computer.
You must set up the LIS interface before you try to transmit data. You set up the LIS
interface in the LIS Setup window. When the interface is on, you can enter sample
demographic information and test requests at the LIS, and transmit them to the
workgroup. When a sample ID is entered into the system, the rest of the test request
information is supplied by the LIS transmission.
Once processing is complete, test results and associated flags are transmitted to the
LIS either automatically or manually. When the LIS receives a test result, it transmits
a confirmation to the workgroup server.
For more information about setting up the LIS interface, see Section 4.9: LIS Setup.
The Access 2 system uses the following six instrument hardware modules to execute
processing, control, and interface functions.
• Carousel module
• Main pipettor module
• Analytical module
• Fluidic module
• Electronics module
• Peripherals module
The carousel module contains onboard racks, samples, and reagent packs on two
independently rotating carousels. This module also includes the cup/tube detector that
detects containers in sample positions, and the internal sample bar code reader that
reads the rack and sample container bar code labels. The internal reagent bar code
reader (on instruments with serial numbers ≥570000) reads the printed bar code label
on the reagent packs.
The main pipettor module transfers samples, reagents, and wash buffer (for dilutions,
if necessary) to the reaction vessels (RVs).
The analytical module transports RVs through six stages: pipetting, incubation,
washing, addition of substrate, luminometer reading, and ejection into the RV waste
bag. The luminometer reading is transmitted to the electronics module.
The fluidic module acts in concert with the main pipettor module and the analytical
module to dispense reagents and samples, wash samples and the primary probe,
dispense substrate, and remove liquid waste into the liquid waste bottle.
The electronics module contains an interface circuit board assembly that connects
each of the processing modules to control mechanisms. A hard disk stores the portions
of the instrument software that interface with the instrument’s control mechanisms to
direct the actions of the processing modules. The status light bar (on instruments with
serial numbers ≥570000) changes color to indicate the operational status of the
instrument.
The peripherals module includes the external computer (PC) and other auxiliary
devices, such as the monitor and printer. The user interface software (UI) is stored on
the hard drive of the PC. You use the touch screen monitor, the UI software, mouse,
and keyboard to direct and monitor the system.
Carousel The carousel module holds the samples to be processed and the specific assay reagent
Module packs. The carousel module (see Figure 1-2) includes the internal bar code reader,
cup/tube detector, reagent carousel, and sample carousel.
2
3
4
6
0048C.eps
Sample Carousel
You load samples onto the Access 2 instrument in racks. Each rack is capable of
holding ten samples. The sample carousel holds up to six racks for a total onboard
capacity of 60 patient, quality control, or calibration samples. When loading or
unloading sample racks, positions on the sample carousel are accessed one at a time.
The sample racks are fitted with bar code labels that represent the rack identification
number (ID). The system uses the bar code label to track a rack’s location and the
samples it contains.
The rack ID indicates the type of sample container used in the rack. The system
verifies the rack ID, and then scans the bar code labels on the sample containers. For
each position on the rack, the system automatically adds scanned sample IDs to test
requests.
If the system cannot read a sample container bar code label, you can enter the sample
ID manually or scan it with an external bar code reader.
For information on how to configure the internal sample bar code reader, see
Section 4.3: Bar Code Reader Setup.
For information about racks and corresponding sample containers, see Appendix A:
Racks and Sample Containers in the Operator's Guide.
For a list of supported bar code symbologies and bar code label specifications, see
Section 2.2: Performance Characteristics.
Cup/Tube Detector
The cup/tube detector determines if a sample container is present in each position on
the rack. If a sample container is detected and there is no test request for that position
in the rack, the system will scan the sample container for a sample ID bar code label.
If a sample container is not detected on a scanned rack, but a test request has been
entered for that rack position, the system deletes the test request. The cup/tube
detector cannot be disabled.
Reagent Carousel
The reagent carousel refrigerator temperature is maintained at 1 °C to 5 °C. This
temperature range ensures that the air and onboard reagent pack temperatures will be
within 3 °C to10 °C. The reagent carousel holds up to 24 reagent packs. When loading
or unloading reagent packs, positions on the reagent carousel are accessed one at time.
You define each reagent pack in the system by entering the pack name, lot number,
expiration date, and serial number from the bar code label on the reagent pack. This
information can be entered by typing the bar code information or manually scanning
the information using an external bar code reader before loading the reagent pack.
If the instrument is equipped with an internal reagent bar code reader (available on
instruments with serial numbers ≥ 570000) and the reagent bar code reader is enabled,
you load the reagent packs first and then the instrument reads the information from
the reagent pack bar code and loads the packs that are valid.
Main Pipettor The main pipettor module (see Figure 1-3) transfers measured volumes of samples
Module and reagents to the reaction vessels (RVs) in the analytical module, and prepares
onboard sample dilutions (if necessary). The main pipettor module includes the
precision pump and valve, pipettor gantry, and the main pipettor. The main pipettor
includes the electronic transducer and the primary probe.
2 3a
3
4
1
6
0055E.eps
1 Precision Pump
2 Precision Valve
3 Pipettor Gantry
3a Pressure Monitor (When Installed)
4 Main Pipettor (Top View)
5 Ultrasonic Transducer (Front View)
6 Primary Probe (Front View)
Pipettor Gantry
The pipettor gantry supports the main pipettor and allows it to move horizontally and
vertically.
Pressure Monitor
Access 2 instruments equipped with pressure monitoring have a device mounted on
the pipettor gantry. The pressure monitor is used to detect obstructions in the primary
probe.
Ultrasonic Transducer
The main pipettor is equipped with an ultrasonic transducer. The transducer applies
ultrasonic vibrations to the tip of the primary probe to mix reagents in the reagent
pack before sampling, mix the contents in the RV, clean the probe after each use, and
sense the level of the sample fluid. Level sensing determines the depth that the
primary probe is immersed in a solution or sample. At an optimal depth, the primary
probe can aspirate the correct amount of fluid, and carryover of fluid on the probe is
minimized. Level sensing also helps the instrument determine if there is enough
sample in the container to perform the assay.
Primary Probe
The primary probe transfers appropriate volumes of samples and reagents into RVs,
and dispenses wash buffer to prepare onboard sample dilutions.
Analytical The analytical module transports and incubates reaction vessels during processing,
Module and washes and reads the reaction vessels when the processing is complete. The
analytical module (see Figure 1-4) includes the wash/read carousel, luminometer,
incubator belt, and the RV loader.
1
2
3
4
7 6
0046D.eps
1 Wash/Read Carousel
2 Luminometer
3 Incubator Track and Belt
4 Wash Arm
5 RV Waste Bag
6 RV Loader (Includes Rake and Shuttle)
7 RV Load Door
The RV loader includes the rake and shuttle. After you load an RV cartridge, the rake
moves the vessels into the supply area. The shuttle moves the vessels from the supply
area to a position where the main pipettor adds the samples and reagents. Then the
shuttle moves the vessels onto the incubator belt.
Incubator Belt
The incubator belt carries RVs for the incubation time defined in the assay protocol
file (APF). To provide optimal assay conditions the system maintains the incubator
temperature within a specific range.
When incubation is complete, the system transfers the RVs from the incubator belt to
the wash/read carousel for washing, addition of substrate, and luminometer reading.
After the system reads the samples, the RVs are transferred to the incubator belt,
which carries the RVs to the waste chute. The shuttle ejects the RVs from the
incubator belt into the waste chute, which leads to the disposable RV waste bag. If the
available space in the waste bag is low, the system displays a caution. If not enough
space is available, the system will not allow you to schedule more tests.
Wash/Read Carousel
The wash/read carousel includes the wash/read area, the wash arm, three aspirate
probes, three dispense probes, the substrate probe, separation magnets, and the
luminometer.
The wash/read carousel contains three wash positions. After incubation, the system
transfers each RV to the first wash position. After washing the paramagnetic particles,
the system moves the RV to the second and third positions for additional wash cycles.
If defined in the APF, the system returns the RV to the incubator belt for further
processing.
Luminometer
The luminometer is a photomultiplier tube (PMT) that measures the amount of light
produced by the chemiluminescent reaction occurring in the RVs. This measurement
is transmitted as an electronic signal to the user interface (UI) software, where it is
converted to a calculated test result.
Fluidic Mod- The fluidic module acts in concert with the main pipettor module and the analytical
ule module to dispense reagents and samples, wash the samples and the primary probe,
and dispense substrate. The fluidic module (see Figure 1-5) includes the vacuum and
wash pumps, vacuum reservoir bottle, wash valve, substrate pump, substrate valve,
substrate heater, probe wash tower and wash valve, peristaltic waste pump, and the
fluids tray.
1
2
3
4
5
7
9
8
0051E.eps
1 Vacuum Pump
2 Wash Pump
3 Vacuum Reservoir Bottle
4 Wash Valve
5 Substrate Pump, Valve, and Heater
6 Probe Wash Tower
7 Probe Wash Valve
8 Peristaltic Waste Pump
9 Fluids Tray
Vacuum Pump
During primary probe washing, the vacuum pump removes wash buffer from the
probe wash tower. As the primary probe is lifted from the wash tower, the vacuum
pump also removes any droplets clinging to the outside of the probe.
Fluids Tray
The fluids tray includes the wash buffer bottle, a float level sensor for monitoring the
wash buffer volume, wash buffer reservoir, waste filter/bottle assembly for filtering
microscopic particles from the waste and vacuum pump exhausts, substrate bottles,
and the liquid waste bottle. The tray holds up to two substrate bottles. One bottle
supplies substrate during processing, and the second equilibrates at room temperature
until it is needed. The liquid waste bottle is positioned in the tray over a scale for
monitoring the weight of the liquid waste.
Two fluids trays are available (see Figure 1-6).
1060A.eps
Electronics The electronics module performs control functions that direct the operation of the
Module instrument’s carousel, main pipettor, analytical, and fluidic modules. The electronics
module (see Figure 1-7) includes the power supply, printed circuit boards (PCBs),
reset button, internal hard drive, 3.5-inch disk drive (in some instruments), interlock
switch, and RV load door alarm.
1
2
4 5
0049C.bmp
1 Power Supply (Located Under the PCBs)
2 Printed Circuit Boards (PCBs)
3 Reset Button
4 One Internal Hard Drive (Either Attached to a PCB or Positioned
Further Forward in the Module)
5 3.5-Inch Disk Drive (Not Available in Some Instruments)
Power Supply
The power supply provides and regulates the power for the operating system and the
electronic subsystems. The power supply is located underneath the printed circuit
boards.
Reset Button
The reset button is located inside the front panel to the right of the main pipettor.
Pressing the reset button reboots the instrument.
For information about rebooting the instrument, see Section 7.3: Rebooting, Shutting
Down, and Restarting Procedures.
Interlock Switch
The instrument is equipped with an interlock switch to protect you from injury. When
you open the front panel of the instrument, the interlock switch stops the movement of
the main pipettor. Other mechanical devices will continue to operate with the front
panel open. If the front panel of the instrument is opened while samples are being
processed, the system may cancel tests.
WARNING
The Access 2 instrument has moving parts and uses high voltage in the ultrasonic
transducer. Both present an injury hazard. You should not operate the
instrument with the covers open.
NOTE
RVs can fall between the rake and the wall of the incubator if you do not load
RVs properly by selecting Load RVs F4 from the Supplies or Supplies Required
screen.
For the proper procedure for loading RVs, see Section 2.5: Reaction Vessels (RVs) in
the Operator's Guide.
Peripherals The peripherals module provides the software interface you use to direct and monitor
Module the Access 2 system. The peripherals module consists of the instrument’s external
devices. This includes the touch screen monitor, external computer (PC), articulated
arm, keyboard, an external bar code reader, mouse, and printer.
Printer
The single-sheet printer produces letter quality reports and screen printouts. For more
information about the printer, see the documentation provided by the manufacturer.
Mouse
You can use the mouse as an alternative to touching the monitor to navigate screens
and select system functions.
Keyboard
The keyboard is a standard, 101 key model with a full set of function keys from F1 to
F12.
Articulated Arm
The articulated arm elevates the monitor and keyboard off of the surface of your work
area, allowing you to place both devices in a comfortable position. The arm moves
horizontally and vertically, and can swivel to the left or right.
The external bar code readers are enabled whenever they are connected to the external
computer. You use the external bar code readers to scan bar-coded substrate, reagent
pack, and calibrator information into the system. As a backup to the internal bar code
reader, you can also scan sample IDs, and rack IDs with the handheld bar code reader
and bar code wand. Do not scan sample container and rack IDs if your handheld
reader is operating in the hands-free mode.
NOTE
Technological advances and availability may determine the specific external
computer components of your instrument.
The PC is equipped with a 3.5-inch disk and/or USB flash drive, PC hard drive, and
CD-ROM or DVD drive. You use the CD-ROM or DVD drive to load system
software and APF software upgrades.You can use the 3.5-inch disk or USB flash
drive to copy diagnostic, quality control, or test result data. The PC is also equipped
with a tape or USB flash drive for backing up the system’s database. The PC can link
to an LIS system and interface with up to three other Access 2 systems. In a
workgroup of more than one Access 2 system, one PC is designated as the server
which controls more functions than the client PCs.
For more information about server functions, see Appendix B: System and Mode
Availability Tables.
NOTE
The number of processing steps for each assay format are defined in the assay
protocol file (APF), and can differ from assay-to-assay. The text and illustrations
describing each format are meant to provide you with an overview of the
technology, not to represent a specific assay format.
Each assay format uses reagents that react with a specific analyte to form immune
complexes. Assay reagents include an enzyme-labeled antigen or antibody
(conjugate), coated paramagnetic particles, and other assay-specific reagents (such as
antigens or antibodies specific for the analyte being detected, stripping agents, or
buffered protein solutions).
Analyte in the sample reacts with the conjugate and assay-specific reagents to create
immune complexes. These complexes bind to the paramagnetic particles. A magnetic
field separates the particle-bound components from the unbound, and washing
removes the unbound material from the system.
The total assay time depends on the incubation time and number of wash cycles
defined in the APF. Assays are optimized for rapid time to first result. Most tests are
completed in 15-30 minutes. The system can process up to 100 tests per hour for
one-step assays (assays with one processing stage), or up to 50 tests per hour for
two-step assays (two processing stages).
For more information about specific assays, see the reagent instructions for use.
Paramagnetic Access Immunoassay Systems assays use micron-sized paramagnetic particles, either
Particles directly or indirectly coated with antigen or antibody, to detect analyte in the sample.
After the analyte binds to the particles, a magnetic field pulls the particles to the side
of the RV to allow for complete aspiration of the wash fluid containing the unbound
analyte. The system resuspends the particles by adding wash buffer and then spinning
the RV.
Chemilumi- Luminescence is the emission of light associated with the dissipation of energy from
nescence an excited substance.
A luminometer measures the relative light units (RLUs) of light emitted from the
chemiluminescent reaction. Depending on the assay format, the amount of light
produced is either proportional or inversely proportional to the amount of analyte in
the sample. If proportional, as more analyte is present in the sample, more
enzyme-labeled conjugate can bind to the captured analyte, and more RLUs are
produced. If inversely proportional, as more analyte is present, less enzyme-labeled
conjugate can bind to the particles, and fewer RLUs are produced. Based on the APF
for each assay, the system converts the measured RLUs into a test result.
Competitive Competitive binding assays (see Figure 1-8) use coated paramagnetic particles to
Binding measure antigen in a sample. The particles can be either directly or indirectly coated
Assays with capture antibody. A sample is mixed with the particles, an antigen-specific
antibody, and an enzyme-labeled antigen (conjugate). The sample antigen competes
with the conjugate for antibody binding sites. The antibody and conjugate form
immune complexes that bind to the particles. Magnets separate the particle-bound
immune complexes from the unbound components, and washing removes the
unbound components. After adding chemiluminescent substrate, the measured RLUs
are inversely proportional to the amount of antigen in the sample.
0156Bc.bmp
Figure 1-8 Competitive Binding Assays
Sandwich Sandwich assays (see Figure 1-9) use coated paramagnetic particles to measure
Assays antigen in a sample. The particles can be either directly or indirectly coated with
capture antibody. A sample is mixed with the particles and an enzyme-labeled
antibody (conjugate). The sample analyte and conjugate form immune complexes that
bind to the particles. Magnets separate the particle-bound immune complexes from
the unbound components, and washing removes the unbound components. After
adding chemiluminescent substrate, the measured RLUs are directly proportional to
the amount of antigen in the sample.
0158Bc.bmp
Figure 1-9 Sandwich Assays
Antibody Antibody detection assays (see Figure 1-10) use paramagnetic particles coated with
Detection antigen to detect antibody in a sample. A sample is mixed with the particles, forming
Assays immune complexes. Magnets separate the particle-bound immune complexes from
the unbound antibody, and washing removes the unbound components. An
enzyme-labeled antibody (conjugate) is added. The conjugate binds to the antibody
captured on the particle to form immune complexes. Magnets separate the bound
immune complexes from the unbound antibody, and washing removes the unbound
components. After adding chemiluminescent substrate, the measured RLUs are
directly proportional to the amount of antibody in the sample.
0154Bc.bmp
Figure 1-10 Antibody Detection Assays
Reagent Reagent packs contain assay-specific paramagnetic particles, conjugate, and other
Packs reagents within five wells. Most reagent packs contain enough reagents to perform up
to 50 tests.
Reagent packs are sealed with an elastomeric coating to maintain reagent integrity
and prevent evaporation. The coating will reseal after a well is punctured by the
primary probe.
Reagent packs loaded on the instrument are maintained at 3 °C to 10 °C. You should
store unused reagent packs upright in a refrigerator. To dislodge particles from the
underside of the seal, invert unpunctured pack several times immediately before
loading. It is not necessary to remix packs after loading. Do not invert a punctured
pack.
NOTE
Do not shake packs or use a vortex mixer, except for the Access 25(OH)
Vitamin D Total assay. For the Access 25(OH) Vitamin D Total assay, see the
reagent IFU for pack mixing instructions.
For information about reagent pack contents and storage, see the reagent instructions
for use or the reagent pack label.
For information about loading reagent packs and reagent pack inventory, see
Chapter 2: Supplies in the Operator's Guide.
If sufficient reagent is not dispensed from a reagent pack, one or more events are
reported in the Event Log. Some events are informational. Troubleshooting is
provided for caution and warning events.
If the system detects a pattern of reagent pack monitoring failures, the main pipettor
may be set to disabled or the pack may be rejected.
2 System Specifications
2.1 Space and Environmental Requirements . . . . . . . . . . . . . . . . . . . . 2-2
To operate properly, the Access 2 system requires certain spatial, environmental, and
electrical conditions.
Space The dimensions of the instrument and the peripheral devices as of the date of this
Requirements document are listed in the following table. The Access 2 system operates from a
bench top. Be sure that the surface and surrounding area designated for these
components is large enough to accommodate the system. For information about the
external computer, monitor, and printer, see the documentation provided by the
manufacturer.
Instrument The weight of the instrument is listed in the following table. Be sure that the surface
and Periph- where the instrument, external computer, monitor, and printer will reside can support
eral Device the system.
Operating The Access 2 system is for indoor use only and requires the following environmental
Environment conditions to operate properly:
Requirements
Humidity Operational: 20% to 80%
Exposure: 10% to 80%
Maximum altitude Operational: 6,500 ft (2,000 m)
Exposure: 40,000 ft (12,200 m)
Temperature Operational*,**: 64 °F to 82 °F (18 °C to 28°C)
Exposure: -22 °F to 122 °F (-30 °C to 50 °C)
Maximum ambient 3.6 °F per 30 min (2 °C)
temperature change
rate
Ambient light Results not affected by ambient light levels of 0–200
foot-candles (0–2150 lx)
Pollution degrees 2
Electrical The electrical line and any surge suppressors, backup power supplies (UPS units), and
Requirements line conditioning transformers you use with the instrument must meet specific
requirements.
Electrical Line
The electrical line supplies power to the Access 2 instrument. To avoid damaging the
instrument, the electrical line should meet the following requirements:
NOTE
The Access 2 system may be
connected to a line conditioner. In
this case, locate the line conditioner
within 5 ft (1.5 m) of the outlet.
Line protection device Circuit breaker rated:
• 15 A (115–120 V AC line)
• 6 A (220–240 V AC line)
Line voltage fluctuations Not to exceed ±10 V AC per cycle
Line voltage sags Not to fall below:
• 90 V AC at 15 A
• 180 V AC at 6 A
Line voltage surges Not to exceed:
• 135 V AC at 15 A
• 250 V AC at 6 A
Line voltage supplied to printer See documentation provided by the
manufacturer
Electrical
Power
Current Heat Production
Consumption
Consumption
Surge Suppressors
Beckman Coulter recommends that you do not use a surge suppressor with the
Access 2 instrument. The instrument has built-in protection similar to that provided
by a surge suppressor.
Beckman Coulter does recommend that you use a surge suppressor with the external
computer, monitor, and printer. You should connect the surge suppressor to an outlet,
not a line conditioner.
If you use a line conditioning transformer, it should meet the following requirements:
STAT access You can add STAT samples at any time during routine
operation. The instrument automatically reprioritizes the
remaining test requests for the onboard samples to run the
STAT sample first.
Continuous You can enter new test requests while other samples are in
access process. Some system supplies can be loaded during
processing.
Instrument The Access 2 instrument keeps temperature-sensitive devices and reagents within the
Temperatures following ranges:
Luminometer The luminometer provides the following read precision and drift characteristics:
Performance
Read precision within a ≤0.2% CV
single reaction vessel
Drift ≤5% in 4 weeks
Reaction Ves- The Access 2 system reaction vessels (RVs) have the following properties:
sel Properties c
Database The Access 2 system database stores lot, ID, and test result data, as well as some
Capacities additional information. The system has a defined capacity for each item stored in the
database. The capacity is usually shared over the 1 to 4 instruments in the workgroup,
but is sometimes limited per instrument.
The following table lists the capacities of the system database:
.
Supply and The Access 2 instrument can hold a defined amount of supplies, reagents, RVs, liquid
Sample waste, and samples for processing. The system status buttons for supplies change
Capacities color when supplies are needed or a waste container is full. When the supply
capacities have been reached, you should replenish the depleted supplies, and empty
or replace full waste containers.
The following table lists the supply and sample capacities of the system:
For more information about system status buttons, see Section 1.3: Software
Overview in the Operator's Guide.
Bar Code The Access 2 system has an external handheld bar code reader and an internal sample
Hardware Per- bar code reader. For some Access 2 systems the handheld bar code reader also
formance operates in a hands-free mode.
Bar Code A bar code label consists of vertical black bars (the bar code), the equivalent
Label Specifi- characters printed underneath the bar code, and the quiet zones at either end of the bar
cations code. For a bar code label illustration, see Figure 2-16.
2
ABC123456789 3
0122E.eps
1 Quiet Zones
2 Bar Code
3 Bar Code Characters
The characters received into a field when you scan a bar code label are identical to the
characters printed below the bar code. However, if you disable the bar code check
digits, or start and stop characters during system configuration, the system does not
receive those characters into the field.
Sample tube bar code labels must meet the following specifications. Unless noted, the
label specifications for the internal bar code reader and the external bar code reader
are the same.
Quiet zones 10 x (ten times) the element width of the bar code,
with a minimum of 0.2 in (5 mm) at either end of label
Bar code length 3.0 in (80 mm) maximum, including quiet zones at
either end
Bar code height 0.39 in (10 mm) minimum
Minimum bar width 7.5 mils (0.2 mm) at high resolution
Symbology Must meet the requirements for the internal bar code
reader:
Interleaved 2 of 5
CODABAR
CODE 39
CODE 128 (symbology supported, but no parameter
choices available)
Print Quality Quality B or better, as specified in CLSI standard
AUTO2-A, Laboratory Automation: Bar Codes for
Specimen Container Identification
Label angular skew ≤±7.5° tilt
Bar code label Label should be printed on reflective, matte finish
background with a background diffuse reflectance of 70–80%
Bar code label ink 10% for internal bar code reader
color and type
25% for handheld bar code reader
(Maximum allowed
reflectance at the
reading wavelength)
Beckman Coulter does not provide sample tube bar code labels. Sample rack bar code
labels matching the specifications listed above are provided with the racks, so you can
assign rack IDs according to the type of sample container you intend to use.
For information on the types of containers you can use and the rack IDs associated
with each, see Appendix A: Racks and Sample Containers in the Operator's Guide.
For information about how to configure the internal bar code reader and enable or
disable the bar code reader parameters, see Chapter 4: System Configuration.
3 Theory of Operation
3.1 Sample Processing Theory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
For sample processing, the system provides random, continuous, and STAT access.
• Random access allows you to run any test on any sample, using the onboard
reagent packs.
• Continuous access allows you to schedule additional samples, replenish most
supplies, and change waste containers while the instrument is processing
samples.
• STAT access allows you to add or change the status of a test for immediate
processing.
Once the tests have been requested, the system schedules the tests as defined in the
assay protocol file (APF). The system processes samples in the following order:
• STAT patient samples
• Calibrators
• Quality controls and patient samples
Before the system begins processing samples, it automatically verifies the quantities
of onboard supplies and their expiration dates. The system prompts you if additional
supplies are required.
The system also verifies the calibration curve and reagent pack lot expiration date. If
either component is past its expiration, the system alerts you to replace the reagent
pack or recalibrate the assay.
For more detailed information about sample processing, and verifying or overriding
supplies, see Chapter 4: Sample Processing in the Operator's Guide.
For more information about supplies, see Chapter 2: Supplies in the Operator's
Guide.
For more information about entering and editing test requests, or loading racks, see
Chapter 3: Sample Management in the Operator's Guide.
Reaction Ves- The chemical reaction between patient sample and assay-specific reagents occurs in
sel Transport the reaction vessel (RV). During sample processing, the RV shuttle and incubator belt
move the RV along an assay-specific path through the instrument (see Figure 3-1).
The RV stops at various locations, depending on the processing stage and type of
assay. The assay protocol file (APF) for each assay determines how long the RV
remains at a location and what happens at that location.
Pipetting
RV moves from RV
supply to pipetting
position
Substrate Addition
RV moves from wash
position to substrate
addition position
Luminometer
Reading
RV moves from
substrate to
luminometer position
Ejection
RV moves from
luminometer to inc. belt
and is ejected into RV
waste bag
0506A.wmf
Figure 3-1 RV Transport Flowchart
Pipetting
• The RV shuttle moves the preheated RV from the RV supply area to the
pipetting position.
• The main pipettor pipettes sample and reagents into the RV in an order
defined by the APF.
• The RV shuttle moves the RV from the pipetting position onto the incubator
belt.
For more information about the main pipettor module, see Section 1.2: Instrument
Technology.
Incubation
• The RV is incubated in the analytical module.
• The RV remains on the incubator belt for the time specified by the APF. The
system controls the module temperature to ensure optimal assay conditions.
• At the end of the incubation period, the incubator belt moves the RV to the
first of three wash positions on the wash/read carousel. For some two-step
assays, the incubator belt moves the RV back onto the RV shuttle, and from
the RV shuttle to the pipetting position for additional pipetting.
For more information about the analytical module, see Section 1.2: Instrument
Technology.
Washing
The RV is washed in the analytical module. Every wash cycle on the system consists
of the following three stages:
First Stage
• The first dispense probe dispenses wash buffer into the RV.
• Magnets draw the paramagnetic particles in the test reaction mixture to the side
of the RV.
• The aspirate probe aspirates the liquid out of the RV.
Second Stage
• The second dispense probe dispenses wash buffer into the RV.
• A mixer assembly spins the RV. These two actions resuspend the paramagnetic
particles in the wash buffer.
• Magnets draw the paramagnetic particles in the test reaction mixture to the side
of the RV.
• The second aspirate probe aspirates the liquid out of the RV.
Third Stage
• The system repeats the second wash cycle, using the third dispense probe to
dispense the wash buffer, and the third aspirate probe to aspirate the liquid out of
the RV.
• For some two-step assays, the incubator belt and RV shuttle move the RV back
to previous positions for additional pipetting, incubation, and washing.
• The wash/read carousel moves the RV to the substrate addition position.
Substrate Addition
• The substrate probe dispenses substrate into the RV in the wash/read
carousel.
• A mixer assembly spins the RV, which helps to resuspend the magnetic
particles and start the chemiluminescent reaction.
• The RV is incubated a short time as the wash wheel moves the RV to the
luminometer position on the wash/read carousel.
For more information about chemiluminescence, see Section 1.3: Assay Technology.
Luminometer Reading
• The luminometer reading occurs in the analytical module.
• The luminometer reads the RLUs generated by the chemiluminescent
reaction occurring in the RV.
For more information about the luminometer, see Section 1.2: Instrument
Technology.
Ejection
• The incubator belt removes the RV from the wash/read carousel.
• The RV shuttle ejects the RV from the incubator belt into the RV waste bag.
The luminometer is part of the analytical module. To calibrate the luminometer, the
instrument uses a light emitting diode (LED) as an onboard reference standard to
maintain luminometer reading consistency. The LED, located on the wash/read
carousel directly across from the luminometer, is automatically read at
preprogrammed intervals. The system calculates a correction factor based on the LED
reading and applies this factor to all RLU measurements.
For a diagram of the luminometer and analytical module, see Section 1.2: Instrument
Technology.
Assay calibrations are used to establish values that the system uses to report test
results for patient and quality control samples on an instrument.
The Access 2 system supports three types of assay calibrations. The calibrations differ
in the way they calculate and report test results.
• Quantitative
• Semi-quantitative
• Qualitative
To report a test result, the system requires a current calibration for each requested test.
The number of calibrators required, the math model, and all other calibration
parameters are defined in the assay protocol file (APF) for each assay, and by the
information you enter into the system when you set up a new calibrator set.
A calibration should be performed when:
• The current calibration has expired.
• A new reagent pack lot is used.
• Preventive maintenance has been performed on the system, or a major system
component has been repaired or replaced.
• Quality control data indicates a new calibration may be necessary.
For assay-specific calibration information, see the calibrator reagent instructions for
use.
For more information about setting up calibrators, see Section 6.4: Setting Up
Calibrators in the Operator's Guide.
For more information about entering calibration test requests, see Section 3.3:
Calibration Test Requests in the Operator's Guide.
For more information about reviewing calibration test results, see Section 6.2:
Reviewing Calibration Data in the Operator's Guide.
For more information about interpreting a failed calibration,
see Appendix A: Troubleshooting.
Assay Cali- The Access 2 system performs the following types of assay calibrations:
bration Types
Quantitative Calibrator test results provide a multi-point calibration
curve.
The system uses the calibration curve to convert a
measured response in RLUs to an analyte concentration
and then expresses the result in numerical units.
Semi-Quantitative Calibrator test results provide a multi-point calibration
curve.
The system uses the calibration curve to convert a
measured response in RLUs to an analyte concentration
and then expresses the result in numerical units.
These assays may report their quantitative result as a
qualitative interpretation, such as reactive, non-reactive,
or equivocal.
Qualitative Calibrator test results provide a cutoff value based on a
predefined formula.
The system compares a test result to the cutoff value and
then classifies the result as reactive or non-reactive for
the analyte.
Quantitative To calibrate these assays, calibrators with known analyte concentrations are tested
and Semi- and the instrument measures the RLU response. The Access 2 system derives a
Quantitative mathematical relationship between the measured response and the analyte
concentration. This mathematical relationship is called a calibration curve. The shape
Calibration
of the curve is determined by the math model used.
Acceptance Criteria
For quantitative and semi-quantitative assays, the system uses the precision profile
method to determine if the calibration meets acceptance criteria. The precision profile
method consists of three steps:
1. Fitting calibration data using the defined math model for that assay.
3. Comparing predicted precisions and the defined limits for that assay.
Because the precision of an assay varies at each analyte concentration, the system
uses weight constants when fitting calibration curve data.
Individual calibrator replicates are used to calculate the calibration curve. As the
system fits the calibration data to the math model, it tries to minimize the distance of
the individual calibrator data points from the calculated curve by adjusting the curve
parameters. If the system reaches a maximum number of tries without calculating an
acceptable curve, the calibration fails. During processing, if a single calibrator
replicate is flagged with a fatal error, the system can ignore it and fit the remaining
data to a curve. If more than one replicate is flagged with a fatal error, the calibration
fails.
Another method for fitting calibration data compares the coefficient of variation
(%CV) of the zero (S0) calibrator RLU replicates to a predefined limit. If the %CV is
outside this limit, the calibration fails.
2
1
0125B.eps
1 Precision
2 Error Band (the Width of the Error Band is Exaggerated for
Illustration Purposes)
3 X Axis: Analyte Concentration
4 Y Axis: RLUs
Qualitative To calibrate a qualitative assay, calibrators with known analyte reactivity are tested
Calibration and the instrument measures the response in RLUs. A calibrator set will contain both
a reactive and non-reactive calibrator. A qualitative assay calibration is accepted if all
of the individual calibrator replicates and replicate means are within the defined
limits. The system uses the calibrator results to calculate a cutoff. The cutoff is used to
classify test results.
The APF determines the number of replicates that must be within the RLU limits for
the system to accept the assay calibration. Two or more replicates of each calibrator
must be within the acceptable limits, because each mean must be calculated using at
least two replicates. If the system cannot calculate the mean, or the calculated mean
fails to meet the specified criteria, the calibration fails.
For some qualitative assays, the APF defines acceptable limits for the %CV of the
RLUs obtained for replicates of each calibrator. If the %CV obtained is outside these
limits, the calibration fails.
Confirmatory Assays
For some qualitative assays, a reactive test result must be confirmed with a
confirmatory assay. The confirmatory assay may consist of one or two tests. For a one
test confirmatory assay, the results of both the screening test and the confirmatory test
are evaluated together to determine whether the reactive result is confirmed. For a two
test confirmatory assay, the results of the two confirmatory tests are evaluated
together.
The formula for evaluating a test result is provided in the reagent instructions for use.
To protect against the possibility of erroneous results due to events such as sample
contamination, dilution, and evaporation, the system will not calculate confirmatory
result ratios for any sample in a rack if the Get Selected Rack F6 command is used
between the times the tests used in the calculation are aspirated.
To be sure that a confirmatory result is calculated by the system, use one of the
following methods.
• Load the sample and request both tests needed for the confirmatory result at
the same time.
• Load the sample, run the first test needed for the confirmatory result, then run
the second test without using the Get Selected Rack F6 command between
the first and second tests.
For more information about entering test requests, see Section : Test Requests Screen
in the Operator's Guide.
Quality controls are samples of known reactivity. You run quality controls along with
patient samples to monitor analytical variation on your Access 2 instrument, and to
ensure the validity of the patient results. Quality controls are also run following
instrument maintenance or repair to verify the assay calibration.
To simulate the characteristics of true patient samples, quality controls are prepared
from materials similar to the patient samples being tested. For example, if an assay
specifies serum as the patient sample type to test, the controls should be serum based.
Several quality controls of varying levels of reactivity should be included in a run to
cover the entire measuring range of the assay.
A laboratory should establish its own acceptable performance ranges for each control
level. The manufacturer's suggested ranges may be used until an adequate number of
tests have been processed to determine a lot-specific mean and standard deviation for
each level.
The Access 2 system monitors the performance of quality controls that you have
defined in the QC Setup screen. When you set up a quality control lot, you enter the
expected mean test result value and the expected standard deviation (SD) from the
mean. The system uses statistical analysis to compare quality control test results to the
acceptable range of expected values configured in the system.
You can also set up the system to apply Westgard QC rules to quality control test
results. The system alerts you if a quality control test result is not within the
acceptable range of expected values, or if it violates an applied QC rule.
For more information about setting up quality controls, establishing QC ranges, and
enabling QC rules, see Chapter 7: Quality Controls in the Operator's Guide.
For more information about entering quality control test requests, see Section 3.4:
Quality Control Test Requests in the Operator's Guide.
For more information about reviewing quality control test results, see Section 7.2:
Reviewing Quality Control Charts and Data in the Operator's Guide.
For more information about interpreting a failed quality control test result,
see Appendix A: Troubleshooting.
The System Check routine is designed to verify system performance. You run the
System Check routine weekly to confirm that system performance is within expected
parameters. You run the routine or individual system checks when troubleshooting
system performance.
A better understanding of the System Check routine may assist you in diagnosing and
fixing a problem.
The following table correlates the individual system check with the function or
component that it verifies:
Washed The washed check evaluates the performance of the RV wash and mixing systems.
Check
During the washed check, the main pipettor:
• Pipettes 150 µL of undiluted System Check Solution into ten RVs.
• Performs three wash cycles on each RV.
• Pipettes 200 µL of substrate into each RV.
• Measures the RLUs of each RV with the luminometer.
Each wash cycle should reduce the final concentration of System Check Solution in
the RV by a factor of at least 100. After washing, the mean for all ten RVs should be
within 5,000-20,000 RLUs, and the %CV should be <12%.
If the results are not within the acceptable limits, the performance of the RV wash
and/or mixing systems may be compromised.
Substrate The substrate check evaluates the performance of the substrate dispense system and
Check the luminometer.
The mean, standard deviation (SD), and %CV results for the substrate check are
calculated from the RLU readings of the last six RVs. This is because the aspirate
probe touches the bottom of the first four RVs when the wash arm is lowered during
the clean check. If the probe is dirty, or if there are other problems with the aspirate
system, the probe could leave behind a small amount of fluid in each of these RVs,
increasing the RLU reading. Therefore, these RVs are not included in the statistical
calculations.
The acceptable range for the substrate check is 5,000-9,000 RLUs. The %CV should
be <5%. If either of these two results are not within the specified limits, the
performance of the substrate dispense probe or the luminometer may be
compromised.
Substrate Ratio
The substrate ratio is a calculation based upon the results from the substrate check. To
obtain a substrate ratio result you must run the entire System Check routine.
The substrate ratio is calculated by dividing the highest RLU reading from the first
four RVs by the mean RLU result for the last six RVs. The calculated ratio should be
<1.4. If the ratio is >1.4, the performance of the aspirate probes may be compromised.
Unwashed The unwashed check evaluates the precision of the main pipettor module.
Check
During the unwashed check, the main pipettor:
• Pipettes 50 µL of diluted System Check Solution into ten RVs. The RVs are
not washed.
• Pipettes 200 µL of substrate into each RV.
• Measures the RLUs of each RV with the luminometer.
The RLUs for the unwashed check will be significantly higher than the washed check
because of the chemical reaction that occurs between the System Check Solution and
the substrate.
The %CV for all ten RVs should be <2%. If the substrate check results are acceptable,
but the unwashed check %CV result fails to meet specifications, the precision of the
main pipettor may be compromised.
The expected range for the unwashed check is 4-10 million RLUs. This range is not a
system specification, but it can be used as a reference guideline. If the mean RLU
result is not within this range, there may have been an error in preparing the diluted
System Check Solution.
Clean Check The clean check evaluates the performance of the pipetting, washing, and substrate
delivery functions. This check is performed as part of the System Check routine, and
cannot be requested as an individual check.
The clean check results should be examined to ensure that there is no significant
decline in RLU value from the first to the last RV. This type of RLU decrease could
be caused by carryover occurring in the wash/read carousel.
Substrate: The substrate:washed ratio is a calculation based upon the results from the substrate
Washed Ratio and washed checks. To obtain a substrate:washed ratio result you must run the entire
System Check routine.
The substrate:washed ratio is calculated by dividing the substrate check mean RLU
value by the washed check mean RLU value. The calculated ratio should be
within 0 and 1.25. If the ratio is outside this range, it is possible that System Check
Solution was not used when running the washed check, or the substrate supply is
contaminated.
Wash Effi- Wash efficiency is a calculation based upon the results from the washed, substrate,
ciency and unwashed checks. To obtain a wash efficiency result you must run the entire
System Check routine.
The wash efficiency result is calculated as follows:
If the wash efficiency result from step 4 is >-1.0 and <1.0 ppm, the result is
acceptable. If the result is <-1.0 or >1.0 ppm, the performance of the wash system
may be compromised.
NOTE
If the washed check RLUs are low, or if the substrate check RLUs are high, the
wash efficiency result could result in a number <-1. This could mean that the
substrate system is contaminated.
If the pressure required to draw a sample exceeds an accepted threshold, the test is
cancelled and flagged with the CLT (obstruction) fatal flag, and an event is logged. If
two consecutive failures occur on the same sample, any remaining tests for that
sample are cancelled. If five consecutive failures occur, the system stops scheduling
tests and goes to the Not Ready mode when the tests in progress are completed. The
operator must then initialize the system and inspect, clean, or replace the probe as
necessary. For an overview of the obstruction detection process, see Figure 3-4.
For more information, see Determining a Reference Curve for Obstruction Detection
in Section 5.6: Analog and Digital Device Diagnostics.
NOTE
The reference curve has no impact on reagent pack monitoring, which is also a
function of the pressure monitor.
Was an
obstruction No Process the sample.
detected?
Yes
Two
consecutive Five
CLT flags for the No consecutive CLT No Continue processing with the next test.
same sample? flags?
Yes Yes
Cancel all remaining tests for the Log a fatal warning event. Stop
sample, wash the probe, log a warning scheduling new tests. Complete any
event, and apply the CLT flag to the tests in progress, then go to the
sample. Not Ready mode.
1030A.wmf
Figure 3-4 Obstruction Detection Flowchart
4 System Configuration
4.1 System Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Once the system is installed, you will configure other system parameters from time to
time using the setup procedures in this chapter. You can configure the following
system parameters:
• System (see Section 4.2: System Setup)
• Bar Code Reader (see Section 4.3: Bar Code Reader Setup)
• Tests (see Section 4.4: Test Setup)
• Test panels (see Section 4.5: Test Panels Setup)
• Derived results (see Section 4.6: Derived Result Setup)
• Ranges (see Section 4.7: Ranges Setup)
• Reflex tests (see Section 4.8: Reflex Test Setup)
• Laboratory Information Systems (LIS) (see Section 4.9: LIS Setup)
• PC Admin (see Section 4.10: PC Administration Setup)
NOTE
With the exception of the PC Admin parameters, the bar code reader, and the
system time, you can configure system parameters when the system is in any of
the four modes (Ready, Running, Paused, or Not Ready).
You can document any changes to the system setup by printing the updated screen or
window using [Print Screen] on the keyboard.
Serial Number
Server and Workgroup Settings
System Setup System ID, Date, Time, and Language
Bar Code Reader and Password
Laboratory Information for Reports
System Backup
Schedule Setup
LIS
Available? No
Yes
Configure LIS
0845b.wmf
Figure 4-1 System Configuration Flowchart
To get to this menu from the Main Menu, select Configure F8.
0793B.bmp
Figure 4-2 Configure Menu
System Setup F1 (Button) Select to display the System Setup screen. You use this screen to set the
Access 2 system values for the date and time, language, password administration,
laboratory information, and print options.
For more information about system setup, see Section 4.2: System Setup.
Tests F2 (Button) Select to display the Tests screen. You use this screen to enable, disable, and
define tests.
For more information about tests, see Section 4.4: Test Setup.
Test Panels F3 (Button) Select to display the Test Panels screen. You use this screen to enable,
disable, and define test panels of two or more tests to be performed on a sample.
For more information about test panels, see Section 4.5: Test Panels Setup.
Derived (Button) Select to display the Derived Results screen. You use this screen to enable,
Results F4 disable, and define the mathematical formulas that operate on test results to report
additional derived results.
For more information about derived results, see Section 4.6: Derived Result Setup.
Reflex Tests F5 (Button) Select to display the Reflex Tests screen. You use this screen to enable,
disable, and define reflex tests, which are tests automatically requested, based on
preceding test results.
For more information about reflex tests, see Section 4.8: Reflex Test Setup.
LIS F6 (Button) Select to display the LIS Setup window. If your laboratory has an LIS, you
use this window to set up interface parameters between the LIS and the system.
For more information about the LIS, see Section 4.9: LIS Setup.
PC Admin F7 (Button) Select to display the PC Admin screen. You use this screen to backup and
restore system data, and shut down the PC.
For more information about PC Admin, see Section 4.10: PC Administration Setup.
About (Button) Select to display the About Access 2 window. You use this window to view
Access 2 F8 license and Technical Support information about the Access 2 system.
You can customize the operation of your Access 2 instrument for your laboratory
using the setup procedures in this section. Unless otherwise noted, your changes
affect only the system you are working on, not the entire workgroup. You can change
the following system parameters:
• System settings: Date, time, date and time formats, language, and password
• Laboratory information: Name, address, and telephone number
• Print options: Printer selection and automatic report printing
You access the System Setup screen from the Configure menu.
0794C.bmp
Figure 4-4 System Setup Screen
System ID (Field) Displays the system ID. You can also use the field to change the system ID.
The system ID identifies the system in screens, windows, or reports that show
individual system information for the workgroup.
Language (Field) Displays the language for the information on the screen, in the Help system,
and in reports. You can also use this field to select the language that is appropriate for
your laboratory.
Instrument Serial (Field) Displays the serial number of the Access 2 instrument.
Number The serial number cannot be changed. It is defined by Beckman Coulter at the factory
and is unique for each instrument.
Reagent Bar (Field) Displays the status of the internal Reagent Bar Code Reader.
Code Reader Values are: Enabled, or Disabled
NOTE: This field is available only on instruments with an internal reagent bar code
reader (available on instruments with serial numbers ≥570000).
Date Format (Field) Displays the date format used by the system. Date formats indicate the order
that the day, month, and year are entered and displayed. Formats also indicate the
separator used between the day, month, and year. Changing the date format affects
the way the date displays and prints on the screens and reports. You can use this field
to select the date format that is appropriate for you laboratory.
Values are: MM/DD/YY, MM-DD-YY, YY.MM.DD, DD/MM/YY, DD.MM.YY,
DD-MM-YY, YY/MM/DD, YYMMDD, DD MON YY, and DDMMYY
System (Button) Select to display the System Revisions window. The window displays the
Revisions F1 system software and hardware revisions.
Bar Code Reader (Button) Select to display the Bar Code Reader Setup window. You use the window
Setup F2 to enable or disable the internal reagent bar code reader or the internal sample bar
code reader and to configure the internal sample bar code reader to read the
symbologies you use in your lab.
Set Workgroup (Button) Select to display the Set Workgroup Time window. You use the window to
Date/Time F3 set the time and date for the workgroup.
NOTES:
• This button is displayed on the server system only.
• Changing the date and time on the server changes the date and time on the
workgroup systems.
• Changing the date and time may affect derived results or reflex tests, which
function on results generated within a time frame.
Password (Button) Select to display the Password Setup window. You use the window to
Setup F5 change the system password, if you are authorized.
Changing the Use this procedure to change the system ID, for the individual system you are
System ID working on, not for the workgroup.
1. Go to the System Setup screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select System Setup F1.
NOTE
Changing the system ID of an instrument in a workgroup may change the selected
instruments in some quality control and test result filters. Test and update the
filters that you have applied or defined to be sure that the filters operate as
expected.
Selecting the Use this procedure to select the language used on the screens, Help system, and
Language reports, only for the individual system you are working on, not for the workgroup.
NOTES
• Each system in a workgroup may display and print a different language.
• When either the Japanese or Simplified Chinese language option is selected,
some fields accept data entry using Japanese Katakana or Simplified Chinese
characters.
1. Go to the System Setup screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select System Setup F1.
2. Write down the current date and time format settings. When you change the
language setting, these formats revert to the default settings. For more
information, see the Setting the Date and Time Formats procedure.
3. Select the Language list to display the language options. Select the language that
is appropriate for your laboratory.
The screen text is displayed in the new language.
NOTES
• If you select an unrecognizable language, contact Technical Support to help
you select the appropriate language.
• If you changed the language to or from the Chinese (Simplified) or Japanese
languages, you must configure Microsoft® Windows® options to allow the
system to display and print language-specific characters properly. Refer to
the documentation that shipped with your system software for instructions on
configuring Windows® options.
1. Go to the System Setup screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select System Setup F1.
Setting the Use this procedure to set the date and time for the workgroup.
Date and Time
NOTES
• The Date/Time Settings fields are displayed on the server system only.
• To set the date and time formats, see the Setting the Date and Time Formats
procedure.
• If your lab is in an area with seasonal time changes such as daylight saving
time, remember to reset the workgroup time when the changes occur.
WARNINGS
• If you set the date forward one or more days, the Auto-Delete function may
delete unexpected patient test and QC results from the database. For more
information about deleting results, see the Setting the Auto-Delete Function
procedure in Section 4.10: PC Administration Setup.
• Changing the date and time may affect derived results or reflex tests, which
function on results generated within a time frame.
2. Go to the System Setup screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select System Setup F1.
4. In the Date field, enter the current date in the format for your system.
5. In the Time field, enter the current time in the format for your system.
6. Select OK F1 to save and apply the changes and exit the window.
Setting the Use this procedure to set the date and time formats for the system.
Date and Time
NOTES
Formats
• Each system in a workgroup may display and print a different date and time
format.
• If you change the language setting, the date and time formats revert to the
default settings.
• When you enter dates and times elsewhere in the system, you must follow the
format set on the System Setup screen.
1. Go to the System Setup screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select System Setup F1.
2. Select the Date Format list to display the list of date format options. Select the
date format that is appropriate for your laboratory.
3. Select the Time Format list to display the list of format options. Select the time
format that is appropriate for your laboratory.
NOTES
• The Password Setup F5 button is available only on the server system.
• Your password is case sensitive.
• The password you set on the server system is valid on all of the systems in
the workgroup.
• To keep your password private, asterisks display in the field when you type
your password.
1. Go to the System Setup screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select System Setup F1.
NOTES
• If you do not know the current password, contact the lab supervisor.
• The default password is Access2Admin. However, you should change this
password immediately after your system is installed.
• If you cannot remember or find the current password, contact Technical
Support.
4. In the New Password field, enter the new password.
5. In the Confirm New Password field, enter the new password again.
6. Select OK F1 to save and apply the changes and exit the window.
Setting Up Use this procedure to define general laboratory information. The system prints the
Reports general laboratory information in the headers of all reports for this instrument. You
can set up different header information on different instruments in the workgroup.
NOTES
• All fields on the Reports Setup window are optional. If you leave a field
blank, the corresponding line on the report is skipped and the next line rises
in its place.
• Do not use double quotation marks (" ") in the Reports Setup window fields.
• Your report header information changes take effect immediately and will
appear on all subsequent reports.
2249B.bmp
Figure 4-6 Reports Setup Window
Report Header (6 Fields) You use the Report Header Information fields to
Information type the information for your laboratory. The information
appears at the top of all reports printed from the system.
Auto Print (4 Boxes) Select the reports to print automatically when the
corresponding tests are complete or cancelled.
If the Continuous Sample Report box is selected, you can
select another box to add the patient name to the report.
For examples of the reports, see Figure 5-35, Figure 5-37,
and Figure 6-12 in the Operator's Guide.
Printer (Field) Select the printer connected to your system from the
list.
1. Go to the System Setup screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, thenselect System Setup F1,
3. Fill in the appropriate information for your lab in the Report Header Information
fields. You can enter a maximum of 56 alphanumeric characters in each field.
(Optional) In the Address 1 field, type the first line of the laboratory address.
(Optional) In the Address 2 field, type the second line of the laboratory address.
4. Select OK F1 to save and apply the changes and exit the window.
3. In the Auto Print boxes, select the reports that you want to print automatically
when the samples are complete or cancelled.
For information about the Sample Report or Continuous Sample Report, see
Section 5.4: Test Result Reports in the Operator's Guide.
For information about the Calibration Report, see Section 6.3: Calibration Reports in
the Operator's Guide.
4. Select OK F1 to save and apply the changes and exit the window.
Selecting a One or more printers are configured for your system during installation of the
System Access 2 system. Use this procedure to select the printer from which to print reports
Printer or to print what is displayed on the monitor (using the [Print Screen] key) for this
instrument only.
1. Go to the System Setup screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select System Setup F1,
4. Select OK F1 to save and apply the changes and exit the window.
The internal sample bar code reader reads the printed bar code labels on sample tubes
and racks. The bar code reader can read the following bar code symbologies:
• Interleaved 2 of 5 (Sample IDs only)
• CODABAR (Sample IDs only)
• CODE 39 (Sample IDs only)
• CODE 128 (Racks and Sample IDs)
You can select what encoded information is included in the sample ID by enabling or
disabling the available bar code parameters.
The internal reagent bar code reader (available on instruments with serial numbers
≥570000) reads the printed bar code label on the reagent packs. There are no
parameters to set for the reagent bar code reader. The bar code reader is programmed
to read the bar code symbology used on the reagent pack labels. The internal reagent
bar code reader must be enabled before it can read the reagent pack bar code labels.
Sample Bar Enabling or disabling the available sample bar code reader parameters changes the
Code Reader information that is encoded in the sample ID. Parameters include check digits,
Parameters start/stop characters, and the number of bar code characters to send to the system.
NOTE
No parameter choices are available for CODE 128 symbology.
If you are not sure which parameters to enable, consult the manufacturer's bar code
printer documentation or contact the supplier of your printed bar code labels.
NOTE
The bar code parameters that are configured for the Access 2 system must match
the available parameters for the bar code symbology that is used on your printed
bar code labels. 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.
Table 4-8 lists the available parameters for the bar code symbologies that are
supported by the sample bar code reader.
Available Parameters
Check Digit On
Some bar code technologies can add a check digit to the bar code. The system
calculates the check digit using a standard formula applied to the characters or digits
encoded in the bar code. When you use a check digit, a higher degree of data integrity
is supplied to the system than when a check digit is not used. When it is used, the bar
code reader also calculates the check digit and verifies that the scanned bar code
matches the calculation. If the scanned bar code does not match, the system does not
accept the scanned bar code.
WARNING
Avoid using the combination of no check digit with the less accurate symbologies,
such as Interleaved 2 of 5 and CODABAR.
Send Start/Stop
Some bar code symbologies add characters to the bar code to indicate where the bar
code information starts and stops. If the start and stop characters are sent, they are
displayed on screens and reports as part of the Sample ID.
Bar Code You use the Bar Code Reader Setup window to:
Reader Setup • Enable or disable the internal reagent bar code reader (available on
Window instruments with serial numbers ≥570000) to read reagent pack labels
• Configure the internal sample bar code reader to read sample IDs and to use
the selected parameters for the selected bar code symbologies
NOTE
You can configure the sample bar code reader to not read sample IDs, but the bar
code reader will continue to read the bar code labels on the racks.
You access the Bar Code Reader Setup window from the System Setup screen.
0795C.bmp
Figure 4-9 Bar Code Reader Setup Window
Read Sample IDs (Box) Select to enable the internal sample bar code reader
to read the bar codes on the sample tubes. If you clear the
box, the sample bar code reader will not read the bar codes
on the sample tubes, but will continue to read the bar codes
on the racks.
Enable Reagent (Box) Select to enable the internal reagent bar code reader
Bar Code Reader to read the bar codes on the reagent packs. If you clear the
box, the reagent bar code reader will not read the reagent
pack and you must enter the reagent pack information
manually.
NOTE: This field is available only on instruments with an
internal reagent bar code reader.
Interleaved 2 of 5 Select from the listed options to configure the
parameters used by the sample bar code reader for
Interleaved 2 of 5 bar code symbologies.
Check Digit On —(Box) Select to enable the check digit to
improve data integrity.
Send Check Digit—(Box) Select to send an enabled check
digit to the system.
Characters—(Field) Displays the number of characters in
the bar code range to send. You can also use the field to
change the number of characters in the bar code range.
CODABAR Select from the listed options to configure the
parameters used by the sample bar code reader for
CODABAR bar code symbologies.
Check Digit On—(Box) Select to enable the check digit to
improve data integrity.
Send Check Digit—(Box) Select to send an enabled check
digit to the system.
Send Start/Stop—(Box) Select to send start/stop
characters to the system.
Setting Up the Use this procedure to configure the internal sample bar code reader for the individual
Sample Bar instrument you are working on. You can configure the internal sample bar code reader
Code Reader to read sample IDs and to use the selected parameters based on the bar code
symbologies in use. You can configure the sample bar code reader for more than one
symbology. Also, you can set up each instrument in a workgroup with a unique
sample bar code reader configuration.
CAUTION
A misread label can cause one sample ID to be mistaken for another
sample ID. Use correct bar code label placement and follow bar code
symbology and configuration recommendations to keep the rate of misread
labels to a minimum. For more information, see Sample Bar Code Reader
Parameters in this section.
2. Go to the System Setup screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select System Setup F1.
3. Select Bar Code Reader Setup F2 to display the Bar Code Reader Setup
window.
4. Select the Read Sample IDs box to enable the sample bar code reader to scan the
bar codes on the sample tubes.
NOTE
The default for this option is enabled. You should leave the sample bar code
reader enabled unless it is malfunctioning. If it is malfunctioning, contact
Technical Support immediately.
5. Select (enable) or clear (disable) the boxes as appropriate to configure the sample
bar code reader.
For more information see the following procedures:
• Enabling Interleaved 2 of 5 Parameters
• Enabling CODABAR Parameters
• Enabling CODE 39 Parameters
• Disabling Bar Code Symbology Parameters
NOTE
Occasionally, the system will stall (the progress message remains on the screen
for more than two minutes). If this happens, reboot the PC. Rebooting the PC
saves and applies the bar code reader changes. For information on rebooting the
PC, see Section 7.3: Rebooting, Shutting Down, and Restarting Procedures.
2. Select the Send Check Digit box to send the check digit to the system, and
display it on the screens and reports, as part of the sample ID.
NOTE
Send check digit is only available if the Check Digit On box is selected.
3. Type the number of characters of the bar code to show on screens and reports in
the Interleaved 2 of 5 Characters field.
NOTE
The valid values for the Characters field are 4 to 15. You should type an even
number if you did not select the Check Digit On box, or if you selected both the
Check Digit On and the Send Check Digit boxes. You should type an odd
number if you selected the Check Digit On box, but not the Send Check Digit
box.
2. Select the Send Check Digit box to send the check digit to the system, and
display it on the screens and reports, as part of the sample ID.
3. Select the Send Start/Stop box to send the start and stop characters to the
system, and display them on the screens and reports, as part of the sample ID.
2. Select the Send Check Digit box to send the check digit to the system, and
display it on the screens and reports, as part of the sample ID.
NOTE
Send check digit is only available if the Check Digit On box is enabled.
3. Select the Send Start/Stop box to send the start and stop characters to the
system, and display them on the screens and reports, as part of the sample ID.
Setting Up the If an instrument has an internal reagent bar code reader (available on instruments with
Internal serial numbers ≥570000), the status is displayed on the System Setup screen (see
Reagent Bar Figure 4-4). Use this procedure to configure the internal reagent bar code reader for
the individual instrument you are working on. The reagent bar code reader can be
Code Reader
enabled or disabled. There are no additional parameters to set for the reagent bar code
reader.
2. Go to the System Setup screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select System Setup F1.
3. Select Bar Code Reader Setup F2 to display the Bar Code Reader Setup window
(see Figure 4-4).
4. Select the Enable Reagent Bar Code Reader box on the Bar Code Reader Setup
window (see Figure 4-9) to enable the reagent bar code reader to scan the bar
codes on the reagent packs.
NOTE
The Enable Reagent Bar Code Reader box is visible only on instruments that
have an internal reagent bar code reader.
Available tests on the Access 2 Immunoassay System are distributed in the assay
protocol file (APF). Before you can run an available test on the Access 2 instrument,
the test must be enabled on the Tests screen. Also on the Tests screen you can
configure the following test parameters for your laboratory situation:
• Test ID (assign a unique number for each test)
• Sample type (select the usual sample type for the test, such as serum, blood,
or urine)
• Decimal precision (change the number of digits that are shown after the
decimal point when the results are displayed)
• Unit of measure (select the usual unit of measure for quantitative tests only)
• Gray zones (range of values [up to 20%] above and/or below the cutoff
value)
• Special (set special features for tests, such as a dilution factor)
You can also enable and disable tests, set most test parameters, print reports, and
update APFs using the Test Setup procedures.
NOTE
You enable tests individually on each instrument in the workgroup. Your test
configurations apply to all of the available tests on the Access 2 instruments in
your workgroup.
0796B.bmp
Figure 4-11 Tests Screen
Filter (Field) Displays the filter and sort order applied to the Tests screen.
APF Revision (Field) Displays the revision of the assay protocol file.
Test Name (Field) Displays the test name, which is defined by the APF.
Test ID (Field) Displays the unique test ID for the test in the Test Name field. You can
change the test ID.
Values are: 1 through 999.
Enabled (Box) Select to enable and disable tests for the individual system you are working on.
Enabled tests display on the Test menu from the Test Requests screen.
If you disable a test, it cannot be run from the instrument, and all of the test panels,
derived results, and reflex tests related to the test are also disabled.
Default Sample (Field) Displays the default sample type for the test. The default sample type is
Type displayed when you select the test on the Test Requests screen. You can change the
sample type by selecting a new type from the list.
Values are: Serum, Plasma, Blood, Urine, CSF (cerebrospinal fluid), Amniotic,
Urethral, Saliva, Cervical, Synovial, and Other (any sample type that does not
appear in this list).
Default Units (Field) Displays the unit of measure corresponding to the default sample type that is
selected for the test.
Decimal Places (Field) Displays the decimal precision that the system displays when reporting the
test result value. You can also change the number of digits that the system displays
after the decimal point from this field.
Values are: 0 through 4.
Revision (Field) Displays the revision number of the assays loaded on the system.
Pipettor (Column) Displays N/A. This column is reserved for future use.
Filter F1 (Button) Select to display the Filter window. You use the Filter window to select the
filter and sort order for the tests displayed on the Tests screen.
Edit Units F2 (Button) Select to display the Edit Units window. You use the window to change the
default unit of measure for the selected sample type.
Ranges F3 (Button) Select to display the Ranges menu. You use the menu to configure the
following ranges.
• Reference Range F1: Displays the Reference Ranges window
• Critical Range F2: Displays the Critical Ranges window
• LIS Range F3: Displays the LIS Ranges window
For more information about ranges, see Section 4.7: Ranges Setup.
Gray Zone F4 (Button) Select to display the Gray Zone window. You use the window to define
upper and lower gray zone limits for the selected test.
The button is only available for qualitative assays.
Special F5 (Button) Select to display the Special menu. The menu contains special features you
can configure for some assays that support those features.
The button is not available if the test does not support special features.
Print F7 (Button) Displays the Print window. You use this window to print the following
reports:
• Tests Setup Report
• Reference, Critical, and LIS Ranges Reports
For more information, see the Printing Tests Setup and Ranges Reports procedure in
Section 4.4: Test Setup.
Update APF F8 (Button) Displays the Update APF window. You use the window to install the APF
on the system.
Assigning Each test is assigned a unique test ID in the APF. However, some laboratories prefer
Unique Test to assign their own test IDs.
IDs to Tests Use this procedure to change a test ID for the workgroup.
NOTE
When assigning test IDs, the system verifies that each test ID is unique in the
workgroup. If two tests or test panels have the same test ID, the system displays a
message and prevents you from duplicating the ID.
1. Go to the Tests screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select Tests F2.
4. In the Test ID field, enter a unique test ID (1 through 999). The test ID change
takes effect immediately.
(Optional) Document your changes by printing the updated screen using [Print
Screen] on the keyboard.
Enabling and Tests must be enabled before they can be run on an instrument. Use this procedure to
Disabling enable and disable tests on the individual instrument only. (For information about
Tests requesting tests, see Section 3.2: Patient Test Requests in the Operator's Guide.)
NOTE
New tests received in an updated APF are disabled.
1. Go to the Tests screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select Tests F2.
2. Select the Enabled box for the tests you want to be able to request on this
instrument. The tests are enabled immediately.
(Optional) To disable a test, clear the Enabled box. The test and any test panels,
derived results, and reflex tests that include the test are disabled immediately.
Changing Use this procedure to change the default sample type for tests in your workgroup.
Default Sam-
NOTE
ple Types
You can also change the default sample type while editing the units of
measurement in the Edit Units window.
1. Go to the Tests screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select Tests F2.
3. Select a default sample type from the list in the Default Sample Type field. The
default sample type changes immediately.
(Optional) Document your changes by printing the updated screen using [Print
Screen] on the keyboard.
Changing the Use this procedure to change the number of digits the system displays after the
Decimal Pre- decimal point when it displays a test result.
cision of Test 1. Go to the Tests screen. To get to this screen from the Main Menu, select
Results Configure F8 to display the Configure menu, then select Tests F2.
4. Type the number of digits to display after the decimal point for results from
0 through 4. The new decimal precision value takes effect immediately.
(Optional) Document your changes by printing the updated screen using [Print
Screen] on the keyboard.
Applying Fil- A tests filter is a set of parameters you apply to the Tests screen to reduce or expand
ters and Sort the number of tests displayed on the Tests screen, and to change the order in which the
Orders for tests are displayed. Use this procedure to apply a different filter and sort order for the
tests on the Tests screen.
Tests
1. Go to the Tests screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select Tests F2.
0828B.bmp
Figure 4-13 Filter (Test Setup) Window
Filter (Options) Select a filter that limits the tests that display on
the Tests screen.
Sort Order (Options) Select to change the default sort order of the
tests.
Ascending (Box) Select the box to sort the tests on the Tests screen in
ascending order and clear the box to sort the tests in
descending order.
3. Select a filter.
4. Select a sort order.
5. Select the Ascending box to sort the tests in ascending sort order.
(Optional) Clear the Ascending box to sort the tests in descending sort order.
6. Select OK F1 to save and apply the changes and exit the window.
The system displays the tests that meet the selected filter parameters on the Tests
screen.
Editing a Unit Use this procedure to edit a unit of measure for a single sample type that is associated
of Measure with a single test. For example, you can change the serum unit of measure for
reporting TSH test results from ng/dL to mg/mL. Units are used to calculate and
report results.
NOTES
• You can only change the units for quantitative tests.
• If you change the units, the system automatically updates the stored
ranges data (including reference ranges, critical ranges, LIS ranges, and
quality control limits) for that test and sample type with the new unit of
measure.
• The system records the change in the Event Log.
• Changing units may create problems in derived result formulas because the
system cannot automatically adjust the derived result formulas. When you
change the units, a message displays to remind you that the software will not
automatically adjust derived result formulas.
• Changing units may cause certain reference, LIS, and control ranges to
become invalid. For example, if you change the unit of measure for serum
from nanograms to milligrams, 1.0 ng becomes 0.001 mg. If the decimal
precision is only one decimal place, the range becomes zero, which may be
invalid. For more information about defining ranges, see Section 4.7: Ranges
Setup.
1. Go to the Tests screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select Tests F2.
0829A.bmp
Figure 4-15 Edit Units Window
Test Name (Field) Displays the name of the test you selected on the
Tests screen.
Test ID (Field) Displays the test ID of the test you selected on the
Tests screen.
Default (Option) Select the default sample type for the selected test.
Sample Type (Column) Displays the available sample types for the
selected test.
Units (Field) Displays the units of measure for the selected test.
4. Select a new unit of measure from the list in the Units field for one or more of the
listed sample types.
(Optional) To select a different default sample type for this test, select the default
option to the left of the listed sample type.
5. Select OK F1 to save and apply the changes and exit the window.
A message displays to warn you that the system will not automatically adjust derived
result formulas for unit changes.
6. Select OK F1 to acknowledge the message and exit the window.
(Optional) Document your changes by printing the updated screen or window
using [Print Screen] on the keyboard.
Setting a Gray A gray zone defines a range of values (up to 20%) above and/or below the cutoff
Zone value. The system may be configured so that it flags results in the gray zone (GRY).
The GRY flag indicates that the result is near the cutoff and may require further
interpretation.
Gray zone applies to qualitative tests only. If a gray zone is recommended for a test,
the appropriate information is included in the reagent instructions for use.
For information about the gray zone (GRY) or other non-fatal flags, see Test Result
Flags in Section A.4: Assay Troubleshooting.
Use this procedure to set a gray zone for a qualitative test in your workgroup.
1. Go to the Tests screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select Tests F2.
2. Select the qualitative test for which you are defining a gray zone.
NOTE
The button is only available for qualitative tests.
0798b.bmp
Figure 4-17 Gray Zone Window
(Optional) To turn off gray zone checking, set both upper and lower limits to
1.000, or leave the fields blank. The value 1.000 represents the cutoff value.
6. Select OK F1 to save and apply the changes and exit the window.
(Optional) Document your changes by printing the updated window using [Print
Screen] on the keyboard.
Setting a Dilu- The Dilution Factor window is only available for tests that are defined in the APF to
tion Factor support this special feature. If the test does not support any special features, the
Special menu is not available.
The dilution factor range of values is defined in the APF. The system accounts for the
dilution factor and displays the results of the test like the undiluted tests.
NOTES
• Contact Technical Support before performing this procedure. A dilution
factor should only be determined by Technical Support.
• The dilution factor applies only to the instrument you are working on, not to
the workgroup.
• The dilution factor for a test is listed on the Alignment Report.
• When you set or change the dilution factor, the system records the change in
the Event Log.
• The TSH3d assay is available on the Special menu, but you cannot set or
change the dilution factor.
1. Go to the Tests screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select Tests F2.
3. Select Special F5 to display the Special menu, then select Dilution Factor F1.
The Dilution Factor window is displayed.
0825B.bmp
Figure 4-19 Dilution Factor Window
4. In the Dilution Factor field, type a number that is between the numbers in the
Upper Limit and Lower Limit fields.
5. Select OK F1 to save and apply the changes and exit the window.
A message notifies you that the change will affect future results.
(Optional) Document your changes by printing the updated window using [Print
Screen] on the keyboard.
Printing Tests Use this procedure to print one or more of the Tests Setup and ranges reports.
Setup and
For more information about ranges and ranges reports, see Section 4.7: Ranges Setup.
Ranges
Reports NOTES
• The report information is limited to tests in the current filter and sort order.
• The Reference Ranges, Critical Ranges, and LIS Ranges Reports are very
similar. Therefore, only the Reference Ranges Report is displayed in this
section (see Figure 4-22 for an example).
1. Go to the Tests screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select Tests F2.
Laboratories, Inc.
Laboratory A
123 Lake Street
Tests Setup Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 501240 Jane Smith
Test Name Test ID Enabled Default Sample Default Decimal Revision Pipettor
Type Units Places
Prog 114 X Serum ng/mL 2 2 N/A
Dig 117 X Serum ng/mL 2 23 N/A
Ferritin 125 X Serum ng/mL 1 17 N/A
TotT4 134 X Serum ug/dL 2 3 N/A
TT3 150 X Serum ng/mL 2 2 N/A
MYO 162 X Serum ng/mL 1 3 N/A
CK-MB 163 X Serum ng/mL 1 3 N/A
FOL2 167 X Serum ng/mL 2 2 N/A
RBC2 168 X Serum ng/mL 2 2 N/A
freePSA 169 X Serum ng/mL 2 2 N/A
PSA-Hyb 170 X Serum ng/mL 2 4 N/A
VitB12 190 X Serum pg/mL 0 2 N/A
IFAb 194 X Serum AU/mL 2 3 N/A
Testo 195 X Serum ng/mL 2 4 N/A
Tg 197 X Serum ng/mL 2 3 N/A
TgAb 198 X Serum IU/mL 1 3 N/A
IL-6 210 X Serum pg/mL 2 1 N/A
Dil-Fer 218 X Serum ng/mL 0 2 N/A
aTnI 220 X Serum ng/mL 2 1 N/A
FRT4 226 X Serum ng/mL 2 1 N/A
Page 1 of 1
Technologist ________________________________________ Printed 04-04-07 10:10
0878D.bmp
Figure 4-21 Tests Setup Report
Laboratories, Inc.
Laboratory A
123 Lake Street
Reference Ranges Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 501240 Jane Smith
Page 1 of 1
Technologist ________________________________________ Printed 10/10/10 14:52
0879D.bmp
Figure 4-22 Reference Ranges Report
Updating an To update an APF, follow the software installation instructions included with the APF
APF CD. Updating an APF adds new assays to your system, revises existing assays, and
removes assays that are no longer available.
WARNING
Interrupting the APF installation before the APF Load Successful window is
displayed may result in an incomplete APF update, potentially leading to invalid
results. If the APF Load Successful window is not presented, contact
Beckman Coulter Technical Support before testing samples.
NOTES
• If the APF includes a new test with a test ID that is not unique for your
workgroup, the system automatically renumbers the new test. The system
records the change in the Event Log.
• If the APF includes a new test with a test name that matches a test panel or
derived result name, the system changes the test panel or derived result name
to begin with the letter X. The system records the change in the Event Log.
• If any of the instruments in your workgroup are in the Running or Paused
mode, the APF cannot be loaded, and the system displays a message
indicating that one or more of the systems in the workgroup is running.
• When you install a new APF that removes a test that is no longer available,
the system removes the test and all system data that relates to the test. The
system records the change in the Event Log.
• You will install the APF on only one system in a workgroup.
A test panel is made up of two or more tests. When a test panel is requested, all of the
tests in the test panel are run on the patient sample. The results of the individual tests
in the panel report individually.
You set up a test panel by naming the panel, assigning it a unique test ID, and adding
tests to the panel. For example, you could set up a panel named Thyroid, assign the
test ID 803, and add the tests TSH and FRT4 to the panel.
NOTE
When you set up a test panel, it is available on all Access 2 instruments in your
workgroup. However, you must enable the test panel on each instrument on
which you plan to run the test panel.
For more information about entering test requests, see Section 3.2: Patient Test
Requests in the Operator's Guide.
You access the Tests Panels screen from the Configure menu.
0800D.bmp
Figure 4-23 Test Panels Screen
Filter (Field) Displays the filter and sort order applied to the list of test panels displayed on
the screen.
Panel Name (Field) Displays the name of the test panel which is described across the row.
Test ID (Field) Displays the test ID for the named test panel. You can change the test ID by
selecting this field and typing a unique number.
Values are: 1 through 999.
Enabled (Box) Select to enable, or clear to disable, the test panel for the individual system.
Enabled test panels displayed on the Test Menu window (see Chapter 3: Sample
Management in the Operator's Guide).
Tests in Panel (Field) Displays the list of individual tests that make up the test panel.
Filter F1 (Button) Select to display the Filter window. You use the Filter window to select the
filter and sort order for the test panels displayed on the Test Panels screen.
Add Panel F4 (Button) Select to display the Add Panel window. You use this window to create new
test panels.
Edit Panel F5 (Button) Select to display the Edit Panel window. You use this window to edit a
selected test panel.
Delete Panel F6 (Button) Select to delete a selected test panel.
NOTE: Only disabled panels can be deleted.
Print F7 (Button) Select to print the Test Panels Setup Report. Test panel information prints
for the current filter in the current sort order.
Enabling and Test panels must be enabled before they can be run on an instrument. In addition, all
Disabling Test tests in a test panel must be enabled before you can enable a test panel on the
Panels individual system you are working on. Use this procedure to enable and disable test
panels.
1. Go to the Test Panels screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select Test Panels F3.
2. Select the Enabled box for the test panels you want to be able to request on the
instrument. The test panels are enabled immediately.
(Optional) To disable a test panel, clear the Enabled box. The test panels are
disabled immediately.
Applying a A test panel filter is a set of parameters you can apply to reduce or expand the number
Test Panels of test panels displayed on the Test Panels screen, and to change the order in which
Filter the test panels are displayed. Use this procedure to apply a different filter and sort
order to the test panels on the Test Panels screen.
1. Go to the Test Panels screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select Test Panels F3.
0833B.bmp
Figure 4-25 Filter (Test Panels) Window
Filter (Options) Select a filter that limits the test panels that display
on the Test Panels screen.
Sort Order (Options) Select to change the default sort order of the test
panels.
Ascending (Box) Select the box to sort the test panels on the Tests Panels
screen in the ascending order and clear the box to sort the test
panels in descending order.
3. Select a filter.
4. Select a sort order.
5. Select the Ascending box to sort the tests in ascending sort order.
(Optional) Clear the Ascending box to sort the tests in descending sort order.
6. Select OK F1 to save and apply the changes and exit the window.
The system displays the test panels that meet the selected filter parameters on the Test
Panels Screen.
Adding a Test
Panel Main Menu
Yes
Tests
Configure
F8
Test Panels Enable all tests
F3 for test panel
Test Panels
Add Panel
F4
Add Panels
Assign a unique
name and test ID
Add
F3
All tests
Added? No
Yes
OK
F1
0867A.wmf
Figure 4-27 Adding a Test Panel
Use this procedure to add a test panel to all instruments in the workgroup. Any tests
that are enabled within the workgroup can be included in the Test Panel.
NOTE
You can add up to 100 test panels in your Access 2 workgroup. When the
maximum number of test panels exist, the Add Panel F4 key is no longer
available on the Test Panels screen. To add more test panels, you must delete
existing test panels.
1. Go to the Test Panels screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select Test Panels F3.
0801B.bmp
Figure 4-28 Add Panel Window
Panel Name (Field) Displays the name of the test panel you are editing.
You can also enter a new panel name into this field.
Test ID (Field) Displays the test ID of the test panel you are
editing. You can also enter a new test into this field.
Enabled Tests (Field) Displays all of the tests that are enabled on the Tests
screen. The test can be enabled on any instrument in the
workgroup.
Tests in Panel (Field) Displays the tests that make up the test panel.
Add F3 (Button) Moves the selected test names from the Enabled
Tests field to the Tests in Panel field, which adds the test
to the test panel.
Remove F4 (Button) Moves the selected test names from the Tests in
Panel field to the Enabled Tests field, which removes the
test from the test panel.
3. In the Panel Name field, enter a unique name for the test panel.
NOTES
• A test panel name must start with a letter and can contain up to eight
characters.
• A test panel name cannot share the name of another test, test panel, or
derived result.
5. From the Enabled Tests list, select a test to add to the panel, then select Add F3.
The test is added to the Tests in Panel list.
(Optional) To add a replicate for the test, add the same test again.
6. To add more tests to the panel, repeat step 4 for each test and the optional step for
each replicate.
You can add from 2 to 24 tests to a test panel, not including replicates.
7. Select OK F1 to save and apply the changes and exit the window.
The system displays the new test panel on the Test Panels screen.
(Optional) Document your test panel configuration by printing the updated screen
or window using [Print Screen] on the keyboard.
Editing a Test Use this procedure to edit a test panel for all instruments in the workgroup.
Panel
NOTE
If you are going to add a test to a panel, be sure that the test is enabled before
editing the test panel.
1. Go to the Test Panels screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select Test Panels F3.
(Optional) To change the test ID, select the Test ID field and type a unique
number, from 1 to 999.
4. To add a test to the panel, select a test from the Enabled Tests list, then select
Add F3.
5. To remove a test from the panel, select a test from the Tests in Panel field, then
select Remove F4.
NOTE
If the test panel includes replicates, selecting Remove F4 removes one replicate.
7. Select OK F1 to save and apply the changes and exit the window.
Deleting a Use this procedure to delete a test panel from all instruments in the workgroup.
Test Panel
1. Go to the Test Panels screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select Test Panels F3.
2. On the Test Panels screen, select the test panel to delete and clear the Enabled
box.
(Optional) Document your changes by printing the updated screen using [Print
Screen] on the keyboard.
Printing the Use this procedure to print the Test Panels Setup Report.
Test Panels
1. Go to the Test Panels screen. To get to this screen from the Main Menu, select
Setup Report Configure F8 to display the Configure menu, then select Tests Panels F3.
Laboratories, Inc.
Laboratory A
123 Lake Street
Test Panels Setup Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 501240 Jane Smith
Page 1 of 1
Technologist ________________________________________ Printed 10-10-10 10:10
0880D.bmp
Figure 4-30 Test Panels Setup Report
The system calculates a derived result using a mathematical formula that you define
or one that is included with the APF. The formulas contain numeric constants,
arithmetic operators, and test results from a single patient sample. A derived result
formula must also contain two or more elements that are operated on to create a new
result. For example, the PSA Ratio, which is used to help determine the presence of
prostate cancer, is calculated using the following formula:
You define a derived result formula in the Formula field of the Add Derived Result
window. Derived result formulas contain any of the following elements.
• Test names, representing the numeric results of the tests.
NOTE
You may include spaces between the elements in the formula to improve
readability. Spaces have no effect on the expressions. However, do not include
line returns in the formula, because line returns cause formatting problems with
the Derived Results Setup Report.
By rearranging a formula, you can change the result by causing the system to evaluate
the operators in a different order. For example:
• 1 + 2 * 3 = 7, because multiplication is done before addition
• (1 + 2) * 3 = 9, because the operation within the parentheses is done before
the multiplication
The derived result formulas use these variables to represent the elements:
A = TestA, B = TestB, C = TestC, and N = Numeric constant
NOTE
To enable the system to wrap long formulas on to the following line, you may
need to add extra spaces to the formula. The system ignores the spaces.
NOTE
You can override the adjoining operands error check by using parentheses. For
example, the system evaluates 2(3 + 4) as 7 (not 14). The system ignores the 2
because it is not separated by the * multiplication operator, as in 2 * (3 + 4).
It is possible to create a formula that contains other errors that the system considers to
be correct. To avoid generating erroneous results, Beckman Coulter recommends that
you verify your derived result formula prior to running patient samples. You can
verify your formula by running tests and generating the derived result using known
samples, such as controls and calibrators.
Derived result formulas use the mean numeric portions of the following results:
• Quantitative and semi-quantitative tests use the concentration value (the
system uses the unit of measure that is defined for the test)
• Qualitative tests use the sample-to-cutoff ratio (the calculation cannot
distinguish between reactive and non-reactive results)
NOTE
Your derived result configurations apply to all of the derived results available to
run on the Access 2 instruments in your workgroup.
Derived results report automatically for the instruments that ran the tests when the
following conditions are met:
• Tests in the derived result formula can be run for the patient sample on any
combination of workgroup instruments.
• A derived result is only calculated when the results for all tests in the derived
result formula are less than 48 hours old.
• The systems generate valid results for the tests.
NOTE
If there is a problem with the calculation of the derived result, the derived result
reports with the CCR flag.
For more information about entering test requests, see Section 3.2: Patient Test
Requests in the Operator's Guide.
You access the Derived Results screen from the Configure menu.
0802A.bmp
Figure 4-33 Derived Results Screen
Name (Field) Displays the name of the derived result, which is described across the row.
Enabled (Option) Select to enable or clear to disable a derived result for the instrument.
If you disable a derived result, it will not be calculated on the instrument.
Formula (Field) Displays the formula the system uses to obtain the derived result.
Units (Field) Displays the reporting units for the derived result.
Decimal Places (Field) Displays the decimal precision that the system displays when reporting the
derived result value. You can change the number of digits that the system displays
after the decimal point from this field.
Values are: 0 through 4.
Predefined (Field) Indicates if the formula is predefined in the Assay Protocol File (APF). If the
formula is predefined, "Yes" is displayed in the field.
If a Derived Result is predefined, you cannot edit the derived result formula.
Ranges F3 (Button) Select to display the Ranges menu for the selected derived result.
• Reference Range F1: Select to add or edit a range of expected result values for a
normal demographic population.
• Critical Range F2: Select to add or edit a range of expected result values defined
by your laboratory.
• LIS Range F3: Select to add or edit a range of result values to be sent to the LIS.
For more information, see Section 4.7: Ranges Setup.
Add Derived (Button) Select to display the Add Derived Result window. You use the window to
Result F4 create new derived result formulas.
Edit Derived (Button) Select to display the Edit Derived Result window. You use the window to
Result F5 edit the selected derived result formula. This button is unavailable if the selected
derived result is enabled or predefined.
Delete F6 (Button) Select to delete the selected derived result. This button is unavailable if the
selected derived result is enabled or predefined.
Print F7 (Button) Select to print one or more of the derived result reports:
• Derived Results Setup Report
• Reference, Critical, and LIS Ranges Reports
Enabling and Derived results must be enabled before they can be calculated. Use this procedure to
Disabling a enable or disable a derived result for the instrument.
Derived 1. Go to the Derived Results screen. To get to this screen from the Main Menu,
Result select Configure F8 to display the Configure menu, then select Derived
Results F4.
2. Select the Enabled box for the derived result you want to enable.
The derived result is enabled immediately.
Changing the Use this procedure to change the number of digits the system displays after the
Decimal Pre- decimal point when it displays a derived result.
cision of a 1. Go to the Derived Results screen. To get to this screen from the Main Menu,
Derived select Configure F8 to display the Configure menu, then select Derived
Result Results F4.
2. Locate the derived result that contains the decimal precision to change.
4. Type he number of digits to display after the decimal points for results from
0 through 4. The new decimal precision value takes effect immediately.
(Optional) Document your changes by printing the updated screen using [Print
Screen] on the keyboard.
Adding a Use this procedure to add a derived result formula for your Access 2 workgroup.
Derived
NOTE
Result
You can create up to 100 derived results. After 100 derived results are
configured, the Add Derived Result button is no longer available.
1. Go to the Derived Results screen. To get to this screen from the Main Menu,
select Configure F8 to display the Configure menu, then select Derived Results
F4.
2. Select Add Derived Result F4 to display the Add Derived Result window.
0803b.bmp
Figure 4-35 Add Derived Result Window
Derived Result (Field) Displays the unique name for the derived result.
Name
Units (Optional) (Field) Displays the unit of measure for the derived result.
A unit of measure is optional.
Formula (Field) Displays the formula for the derived results. You
fill the field with the conditions that are listed in the Tests
and Operators fields. The values can be numeric
constants, test name variables, and relational operators.
3. In the Derived Result Name field, type a unique name for the derived result.
NOTES
• A derived result name must begin with a letter and can contain up to eight
characters.
• A derived result name cannot share the name of another test, test panel, or
derived result that is configured for the workgroup.
• If a test name is received in a new version of the APF which matches a
derived result name, the derived result name will change to begin with the
letter X. The system records the change in the Event Log.
4. In the Formula field, enter a derived result formula. You can use numeric
constants, tests included in the Tests list, and operators included in the
Operators list.
NOTE
You may include spaces between the elements in the formula to improve
readability. Spaces have no effect on the expressions. However, do not include
line returns in the formula, because line returns cause formatting problems with
the Derived Results Setup Report.
5. Select OK F1 to save and apply the changes and exit the window.
NOTE
If the formula contains a syntax or logic error, the system will display an error
message. You must fix the error before you can add the derived result.
Editing a Use this procedure to edit a derived result for your Access 2 workgroup.
Derived
NOTES
Result
• You cannot edit derived results that are defined in the APF.
• If you edit a derived result, previously calculated results will not be
recalculated. Also, if you edit a derived result, the new results may have
different meanings than previously calculated results.
1. Go to the Derived Results screen. To get to this screen from the Main Menu,
select Configure F8 to display the Configure menu, then select Derived
Results F4.
NOTES
• You must disable a derived result before you can edit it.
• When you edit a derived result, the changes affect all instruments in the
workgroup.
3. Select Edit Derived Result F5 to display the Edit Derived Result window.
The Edit Derived Result window is basically the same as the Add Derived Result
window (see Figure 4-35).
4. In the Formula field, change the derived result formula. You can use the numeric
constants, tests included in the Tests list, and operators included in the
Operators list.
NOTE
You may include spaces between the elements in the formula to improve
readability. Spaces have no effect on the expressions. However, do not include
line returns in the formula, because line returns cause formatting problems with
the Derived Results Setup Report.
(Optional) You can change the formula by selecting the text and typing or
pressing the [Delete] key.
(Optional) You can change the unit of measure by selecting the text in the
Units (Optional) field and typing or pressing the [Delete] key. A unit of measure
can contain up to eight characters.
NOTE
Elements of mathematical equations are calculated based on the order of
operation rules (see Table 4-31).
5. Select OK F1 to save and apply the changes and exit the window.
NOTE
If the formula contains a syntax or logic error, the system will display an error
message. You must fix the error before you can save the edited derived result.
Deleting a Use this procedure to delete a disabled derived result. Only disabled derived results
Derived can be deleted.
Result NOTES
• A predefined derived result formula cannot be deleted. If it is the only
formula on the Derived Results screen, the Delete F6 button is unavailable.
• When you delete a derived result, it is deleted from all instruments in a
workgroup.
1. Go to the Derived Results screen. To get to this screen from the Main Menu,
select Configure F8 to display the Configure menu, then select Derived
Results F4.
(Optional) Document your changes by printing the updated screen using [Print
Screen] on the keyboard.
Printing Use this procedure to print one or more of the Derived Results Setup and ranges
Derived reports.
Results Setup For more information about ranges and ranges reports, see Section 4.7: Ranges Setup.
Reports
1. Go to the Derived Results screen. To get to this screen from the Main Menu,
select Configure F8 to display the Configure menu, then select Derived
Results F4.
3. Select the box for one or more reports to print. For an example of the Derived
Results Setup Report, see Figure 4-37. For an example of the Reference Range,
Critical Range, and LIS Range reports, see Figure 4-22.
• Derived Results Setup Report (Lists the information for derived results
displayed on the Derived Results screen)
• Reference Range Report (Lists all reference ranges by derived result)
Laboratories, Inc.
Laboratory A
123 Lake Street
Derived Results Setup Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 501240 Jane Smith
Decimal
Name Enabled Formula Units Places Predefined
FTIndex X TotT4 * TU/40 ug/dL 2 Yes
FreePSA% X (freePSA/PSA-Hyb)*100 % 1 No
Page 1 of 1
Technologist ________________________________________ Printed 10/10/01 08:42 AM
0881C.bmp
Figure 4-37 Derived Results Setup Report
A result may be compared to multiple ranges. The ranges are determined by various
factors, including patient demographics (age or sex). Some ranges are defined in the
APF. You can also add multiple ranges manually by using the Ranges windows.
When you define ranges and demographic conditions manually, you set the
parameters in the Reference, Critical, or LIS Ranges windows. The three ranges
windows are very similar.
• Reference Ranges: Used to define the range of expected values for a normal
demographic population.
• Critical Ranges: Used to define a range determined by your laboratory,
which may depend on environmental, lab policy, or other factors.
• LIS Ranges: Used to define the ranges of results to be sent directly to the
LIS. The system holds out-of-range results for your review.
You can edit the Sex, Age, and Sample Type values for the selected test or derived
result on any of the Ranges windows. The ranges display in rows on the Ranges
windows.
For information about tests, see Section 4.4: Test Setup.
For information about derived results, see Section 4.6: Derived Result Setup.
For information about non-fatal flags, see Section A.4: Assay Troubleshooting.
However, you can define additional demographic conditions that include this patient.
For example:
• Additional demographic conditions for example TestA are defined as female
patients, between 35 and 45 years old.
If multiple ranges exist for the same test or derived result, the system compares the
results to all of the demographic ranges and flags the results as necessary.
NOTE
Because of their similarity, only one of the three range windows is displayed in
this manual (see Figure 4-38).
You access a range window to define a test range from the Tests screen.
You access a range window to define a derived result range from the Derived Results
screen.
0797A.bmp
Figure 4-38 Reference Ranges Window
Test Name (Field) Displays the name of the test or derived result you
selected on the Tests or Derived Results screen. To view or
change the ranges information for a different test, return to
the Tests screen. To view or change the ranges information
for a different derived result, return to the Derived Results
screen.
Test ID (Field) Displays the test ID for the selected test or derived
result.
Units (Field) Displays the unit of measure for the sample type.
Sample Type (Field) Displays the sample type of the displayed range. To
display or change ranges for a different sample type, select
that sample type from the list.
Values are: Serum, Plasma, Blood, Urine, CSF,
Amniotic, Urethral, Saliva, Cervical, Synovial, and
Other.
Range Type (Field) Displays the type of range displayed in the window.
To display or change the range information for a different
range type, select that range from the list.
Values are: Reference, Critical, and LIS.
Sex (Field) Select to set the sex demographic conditions for the
corresponding range from the list.
Values are: Male, Female, Unknown, or Either.
Age Range (Fields) Displays the minimum and maximum patient age
Low Units and range, and the corresponding age units. You use these
fields to set the age demographic conditions for the
High Units corresponding range.
Units values are: Days, Weeks, Months, and Years.
Range Low and (Fields) Enter the lower and/or upper limits of the
Range High Reference, Critical, or LIS ranges. The default values for
reference ranges may be defined in the APF.
Clear F3 (Button) Select to delete a selected range in the window.
2. Be sure that Unknown is selected in the Sex field for the first row and the Age
Range Low and High fields are blank.
You must define a generic range (does not include demographic information) before
you can define a specific range for a set of demographics.
3. Enter the low and high values in the Range Low and Range High fields.
NOTE
The Range Low and Range High fields must contain a value. However, if a test
does not have a low range, you can set the value to zero.
4. To select the next row, select the white space below the first row.
You can now define a specific range for a set of demographics in the second and
subsequent rows.
6. Enter the low value in the Age Range Low field. Type a number from 0 to 150.
The ages must not overlap, and must also be contiguous. For example, 1-20, 20-40,
40-80. An error message displays if the upper and lower limits are not contiguous, or
if they overlap another range.
7. Select a value from the list in the Units field. This is the unit of measure for the
low age range.
The minimum and maximum age units do not need to be the same. For example,
6 weeks to 2 years.
8. Enter the high value in the Age Range High field. Type a number from 0 to 150.
The ages must not overlap, and must also be contiguous. For example, 1-20, 20-40,
40-80. An error message displays if the upper and lower limits are not contiguous, or
if they overlap another range.
9. Select a value from the list in the Units field. This is the unit of measure for the
high age range.
The minimum and maximum age units do not need to be the same. For example,
6 weeks to 2 years.
10. Enter the low and high values in the Range Low and Range High fields.
NOTE
The Low and High fields must contain a value. However, if a test does not have a
low range, you can set the value to zero.
(Optional) You can continue adding ranges for this sample type, select a different
sample type and add ranges, or select a different range type and add ranges.
11. Select OK F1 to save and apply the changes and exit the window.
(Optional) To edit the sex, select a value from the list in the Sex field.
(Optional) To edit the low age range, select the Age Range Low field. Enter a
value from 0 to 150.
The ages must not overlap, and must also be contiguous. For example, 1-20, 20-40,
40-80. An error message displays if the upper and lower limits are not contiguous, or
if they overlap another range.
(Optional) To edit the unit of measure for the low age range, select a value from
the list in the Units field.
(Optional) To edit the high age range, select the Age Range High field. Enter a
number from 0 to 150.
The ages must not overlap, and must also be contiguous. For example, 1-20, 20-40,
40-80. An error message displays if the upper and lower limits are not contiguous, or
if they overlap another range.
(Optional) To edit the unit of measure for the high age range, select a value from
the list in the Units field.
(Optional) Enter the low and high values for the range in the Low and High fields.
NOTE
The Low and High fields must contain a value. However, if a test does not have a
low range, you can set the value to zero.
3. Select OK F1 to save and apply the changes and exit the window.
4. Select OK F1 to save and apply the changes and exit the window.
When you run tests on the Access 2 instrument, the system reports the results for
evaluation. You can set up the system to automatically run other tests based on the
results. For example, if the test results are out of range, the system can request
additional tests to be run on the sample. The additional tests that are requested by the
system are called reflex tests. You define reflex tests and the conditions under which
reflex tests are requested.
NOTES
• Your reflex test configurations apply to all of the tests available to run on the
Access 2 instruments in your workgroup.
• If a result that requests a reflex test generates a fatal flag, the system
generates an Event Log message and the reflex test will not run.
• Sufficient sample must be available to allow all reflex tests to be processed.
If there is insufficient sample, the tests are added to work pending.
• If a test is run STAT, the reflex tests also run STAT.
When the system requests a reflex test, it tries to find the sample onboard any
instrument in the workgroup. If the sample is located, the reflex test is scheduled. If
the system cannot find the sample onboard any instrument in the workgroup, the
reflex test becomes work pending in the work pending list, and the Work Pending
button turns yellow. You must load the sample before the system can process the
downloaded test requests.
Reflex Test You define reflex conditions in the Add Reflex Condition window, and edit
Conditions conditions in the Edit Reflex Condition window. To define a reflex condition, you can
use the following elements:
• Tests: Test names that represent their results. These are the results that order
the reflex test.
• Keywords: Keywords indicate patient sex and age, qualitative assay
interpretation, and result flags (the keywords will not be translated into the
local language). For example: MALE, FEMALE, REACTIVE,
NONREACTIVE, LOW, and ORL.
• Operators: Operators show the relationship between elements.
NOTES
• The system assumes that concentrations are in the unit of measure of the
sample test.
• You may include spaces between the elements in the conditions to improve
readability. Spaces have no effect on the expressions.
• You can change the order of evaluation of the condition by grouping an
expression within parentheses.
• Elements of mathematical equations are calculated based on the order of
operation rules (see Table 4-42).
• You can combine two or more reflex conditions by using the AND or OR
operators.
• If a number follows the test name and operators, it is taken to be the
concentration in the case of a quantitative or semi-quantitative assay, or the
sample-to-cutoff ratio (S/CO) in the case of a qualitative assay. For example,
for the quantitative assay AFP, < 2.5 would mean the concentration and for
the qualitative assay IgM-Toxo, > 1.00 would mean the S/CO.
By rearranging a condition, you can change the result by causing the system to
evaluate the operators in a different order.
Reflex
Example Explanation
Conditions
Reflex
Example Explanation
Conditions
Reflex
Example Explanation
Conditions
Sex Expression SEX = MALE If the patient is male, then run the
SEX = MALE reflex test.
SEX = FEMALE NOTE: Sex expressions are usually
included in a compound expression
(an expression of two or more reflex
conditions combined with AND or
OR).
Compound (SEX = MALE) If the patient is male, over 10 years
Expressions AND (AGE > 10) old, and under 30 years old, run the
(Simple Expression) AND (AGE < 30) reflex test.
AND (Simple and YEARS is in NOTE: Two or more reflex
Expression) the Age Units conditions may be combined with
field AND or OR. Open and closing
(Simple Expression)
OR (Simple parentheses may be used to change
Expression) the order of operations.
NOTES
• VariableA and VariableB may be a constant value, such as 10, or the result of
a previously run test.
• The Reflex Test is displayed in the Reflex Test field, and the Expression
appears in the Conditions field in the Add Reflex Condition window.
It is possible to create a formula that contains other errors that the system considers to
be correct. To avoid generating erroneous results, Beckman Coulter recommends that
you verify your reflex test condition prior to running patient samples. You can verify
your condition by running tests and generating the reflex test result using known
samples, such as controls and calibrators.
For more information about test requests, see Section 3.2: Patient Test Requests in the
Operator's Guide.
For more information about work pending, see Section 4.3: Work Pending in the
Operator's Guide.
Reflex Test To ensure that the reflex conditions you define perform correctly, take note of the
Condition following special considerations.
Special Con- Precision of Results
siderations
Use the equal sign (=) cautiously when defining reflex conditions. A numeric result
will not usually be identical to a defined numeric condition. For example, a result of
1.0001 does not meet the condition Test = 1.0000.
You access the Reflex Tests screen from the Configure menu.
0805B.bmp
Figure 4-45 Reflex Tests Screen
Reflex Test (Field) Displays the name of the reflex test. When the conditions of the reflex test are
met, this test is requested by the system.
Enabled (Box) Select to enable, or clear to disable, reflex tests for the workgroup. Enabled
reflex tests are requested automatically when the conditions for the reflex test are met.
Replicates (Field) Enter the number of replicates of the reflex test to run when the conditions for
the reflex test are met.
Values are: 1 through 99.
Conditions (Field) Displays the conditions the system uses to determine when to run a reflex test.
You configure these conditions in the Add Reflex Condition window.
Suppress (Box) Select to suppress a reflex test. You suppress the reflex test when the test is
already ordered for that sample. When you select this option, the reflex test will not
run, even when the conditions for the reflex test are met.
Age Units (Field) Displays the age unit of measure only if the conditions use age as a variable.
The field is blank, or the values are: Days, Weeks, Months, and Years.
Add Reflex (Button) Select to display the Add Reflex Condition window. You use this window to
Test F4 define reflex tests.
Edit Reflex (Button) Select to display the Edit Reflex Condition window. You use the window to
Test F5 edit existing reflex test conditions.
Delete F6 (Button) Select to delete the selected reflex test for all instruments in the workgroup.
Print F7 (Button) Select to print the Reflex Tests Setup Report.
Enabling and Use this procedure to enable or disable a reflex test for the workgroup.
Disabling
1. Go to the Reflex Tests screen. To get to this screen from the Main Menu, select
Reflex Tests Configure F8 to display the Configure menu, then select Reflex Tests F5.
2. Select the Enabled box of the reflex test you want to enable.
The reflex test is enabled for the workgroup immediately.
(Optional) To disable a reflex test, clear the appropriate option in the Enabled
field.
The reflex test is enabled for the workgroup immediately.
Selecting Use this procedure to select the number of times you want a reflex test to run.
Replicates for
1. Go to the Reflex Tests screen. To get to this screen from the Main Menu, select
a Reflex Test Configure F8 to display the Configure menu, then select Reflex Tests F5.
2. Select the Replicates field of the reflex test you want to replicate.
(Optional) Document your changes by printing the updated screen using [Print
Screen] on the keyboard.
Suppressing You suppress a reflex test to prevent it from running when that test is already ordered
a Reflex Test for the patient sample. You need to suppress the test because the system cannot detect
when you manually ordered a test that matches the reflex test.
1. Go to the Reflex Tests screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select Reflex Tests F5.
Adding a Use this procedure to add a reflex test to your Access 2 workgroup.
Reflex Test
1. Go to the Reflex Tests screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select Reflex Tests F5.
2. Select Add Reflex Test F4 to display the Add Reflex Condition window.
2122A.bmp
Figure 4-47 Add Reflex Condition Window
Reflex Test (Field) Select the name of the reflex tests to be requested.
Age Units (Field) Select an age unit of measure to include an age
(Optional) condition for the reflex test. Otherwise leave the field
blank.
Conditions (Field) Enter the conditions for requesting the reflex test.
Conditions are one or more expressions containing the
values listed in the Tests, Keywords, and Operators
fields.
For more information about conditions, see Reflex Test
Conditions.
Tests (Field) Displays the tests that are enabled for the
workgroup, and can also be included in the Conditions
field.
NOTE: You cannot include the reflexed test in the
conditions.
Keywords (Field) Displays the keyword options that can be added to
the Conditions field. For a list of keywords, see Table
4-40.
Operators (Field) Displays the relational and logical operators that
can be added to the Conditions field. For a list of
operators, see Table 4-40.
NOTE: NOT is listed as an operator in the Add Reflex
Test and Edit Reflex Test windows, but NOT is an
unrecognized entry and will not be accepted in a reflex test
condition.
Clear (Button) Clears the Conditions field.
Conditions F3
3. Select a test from the Reflex Test field. The list contains the tests you enabled on
the Tests screen of any instrument in your workgroup.
(Optional) To include an age condition for the reflex test, select age units from
the list in the Age Units (Optional) field.
4. Define the conditions for the reflex test in the Conditions field. The valid values
are listed in the Tests, Keywords, and Operators fields.
NOTES
• NOT is listed as an operator in the Add Reflex Test and Edit Reflex Test
windows, but NOT is an unrecognized entry and will not be accepted in a
reflex test condition.
• You can add integer or decimal numbers.
• You may include spaces between the elements in the conditions to improve
readability.
• You can change the order of evaluation of the condition by grouping an
expression within parentheses.
• Elements of mathematical equations are calculated based on the order of
operation rules (see Table 4-42).
• You must enter ages as positive integers. For example, AGE > 15.
• More than one row on the Reflex Tests screen may show the same reflex test
to be run. In this case, an OR operator is assumed between the conditions.
Therefore, you can set up multiple conditions to run the same reflex test.
• You can combine two or more reflex conditions by using the AND or OR
operators.
5. Select OK F1 to save and apply the changes and exit the window.
The system checks the formula for errors (such as syntax), and displays a message if it
finds errors.
Editing a Use this procedure to edit a reflex test for your workgroup.
Reflex Test
1. Go to the Reflex Tests screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select Reflex Tests F5.
3. Select Edit Reflex Test F4 to display the Edit Reflex Condition window.
The Edit Reflex Condition window is basically the same as the Add Reflex Condition
window (see Figure 4-47).
4. In the Conditions field, change the conditions for the reflex test. The valid values
are listed in the Tests, Keywords, and Operators fields.
NOTE
NOT is listed as an operator in the Add Reflex Test and Edit Reflex Test
windows, but NOT is an unrecognized entry and will not be accepted in a reflex
test condition.
5. Select OK F1 to save and apply the changes and exit the window.
The system checks the formula for errors (such as syntax), and displays a message if it
finds errors.
3. Select Delete F6 to delete the reflex test. The system displays a confirmation
message.
4. Select OK F1 to delete the selected reflexed test and exit the window.
(Optional) Document your changes by printing the updated screen using [Print
Screen] on the keyboard.
Printing the Use this procedure to print the Reflex Tests Setup Report.
Reflex Tests
1. Go to the Reflex Tests screen. To get to this screen from the Main Menu, select
Setup Report Configure F8 to display the Configure menu, then select Reflex Tests F5.
Laboratories, Inc.
Laboratory A
123 Lake Street
Reflex Tests Setup Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 501240 Jane Smith
Page 1 of 1
Technologist ________________________________________ Printed 10-10-2005 10:10
0882B.bmp
Figure 4-49 Reflex Tests Setup Report
The laboratory information system (LIS) interface allows your Access 2 system to
communicate with an LIS. Your LIS vendor configures the LIS to communicate with
the Access 2 system using ASTM E1394-97 and ASTM E1381-95 standard protocols
and the LIS Vendor Information document. The LIS Vendor Information document is
available on CD from Beckman Coulter. Provide the document to your LIS vendor.
An LIS interface, which is configured on for the workgroup, can be configured off for
individual instruments in the workgroup. Other LIS settings must be configured the
same for all instruments in the workgroup, and can only be configured on the server
PC. The server PC is the only system in the workgroup physically connected to the
LIS.
When the LIS interface is on, test requests can be entered at the LIS and transmitted to
the Access 2 system for processing. Received test requests are stored in the LIS
workpool until the corresponding sample IDs are assigned to racks. Sample IDs are
assigned to racks when the system scans barcoded sample containers in the racks or
when you manually enter sample IDs in a test request. When a sample ID is entered,
the system automatically adds the test request information associated with that sample
ID to the test request.
After sample processing, patient sample results and any associated flags can be
automatically sent to the LIS. Alternatively, each result can be reviewed and then
manually selected for transmission to the LIS.
To further define the test results that are automatically sent to the LIS, see
Section 4.7: Ranges Setup.
Quality control and calibration tests cannot be requested from the LIS, but quality
control test results can be transmitted to the LIS. Calibration results cannot be
transmitted to the LIS.
For more information about sample processing and the LIS, see Section 4.1: Sample
Processing in the Operator's Guide.
You access the LIS Setup window from the Configure menu.
0806B.bmp
Figure 4-50 LIS Setup Window
Local LIS (Field) Select a value from the list to switch the data
Interface transmission on or off between the PC that you are working
on and the LIS.
NOTE: You can only select On if the server's global LIS
interface is On.
Values are: On or Off.
Auto Send to LIS (Field) Select which results the system will send
automatically to the LIS. When you select Off, you can
send the results manually.
Values are: Send All Results, Send Only Auto-Verified
Results, and Off.
Host Query On (Box) Select to enable, or clear to disable, the system from
querying the LIS for specific test requests.
Port (Field) Displays the name of the port where the LIS is
connected to the current system.
This field is available on the server only.
Baud Rate (Field) Select the speed of the data transmission that
matches the LIS. The speeds are listed in baud rates.
Values are: 1200, 2400, 4800, 9600, 14400, and 19200.
This field is displayed on the server system only.
Data Bits (Field) Displays the number of bits that actually contain
information and are being transmitted through the RS232
data connection.
This field is available on the server system only.
Global LIS (Field) Select On to turn the LIS interface on for all
Interface instruments in the workgroup. When the interface is on for
the workgroup, the interface can be turned off for
individual instruments using the local LIS interface. When
the interface is off for the workgroup, the interface cannot
be turned on for the individual instruments. The setting
must be on in order to transfer data to the LIS.
Values are: On, Off, or Off-Line.
This list is available on the server system only and is set up
by the technical support representative when your system is
installed.
LIS Send Mode (Field) Select a mode for sending results to the LIS.
Values are: By Sample Container and By Test.
Parity (Field) Displays the parity for the data connection, which is
used to determine the validity of the data during the
transmission.
This field is available on the server system only and is set
up by the technical support representative when your
system is installed.
Stop Bits (Field) Displays the stop bits for the data transmission. A
stop bit indicates to the LIS that a byte of data has just been
transmitted.
This field is available on the server system only and is set
up by the technical support representative when your
system is installed.
Start Bits (Field) Displays the start bits for the data transmission. The
start bit indicates to the LIS that a byte of data will be
transmitted.
This field is available on the server system only and is set
up by the technical support representative when your
system is installed.
Connecting You can configure an individual system in the workgroup to send or receive LIS data.
One PC and Use this procedure to set the connection.
Instrument to 1. Go to the LIS Setup window. To get to this window from the Main Menu, select
the LIS Configure F8 to display the Configure menu, then select LIS F6.
NOTE
The actual transmission of data between an Access 2 workgroup and the LIS only
occurs at the Access 2 instrument that is the server. The interface that you
configure in the Local LIS Interface field is the interface between an individual
Access 2 instrument and the Access 2 server.
2. In the Local LIS Interface field, select an item from the list.
• Select On to enable the system to receive test requests from and send test results
to the LIS. The connection can be configured on only if the global interface is
configured on. For more information about configuring the global LIS interface
on, see the Configuring the Global LIS Settings procedure.
• Select Off to disable data communication between the system and the LIS. The
connection can be configured off for this system, and be configured on for the
workgroup.
3. Select OK F1 to save and apply the changes and exit the window.
Transmitting Use this procedure to select data transmission parameters for the connection between
Data to the the PC that you are working on and the LIS.
LIS 1. Go to the LIS Setup window. To get to this window from the Main Menu, select
Configure F8 to display the Configure menu, then select LIS F6.
2. In the Auto Send to LIS field, select an item from the list.
• Select Send All Requests to automatically send test results to the LIS as soon as
results are generated.
• Select Send Only Auto-Verified Results to automatically send only verified
results to the LIS. For information about setting up verification criteria, see
Section 4.7: Ranges Setup.
• Select Off to prevent automatic sending of results to the LIS. You can manually
send results to the LIS. For more information about manually sending test results,
see Section 5.3: Managing Test Results in the Operator's Guide.
3. Select OK F1 to save and apply the changes and exit the window.
Enabling and If a sample ID is entered in the Test Requests screen, and no matching sample ID is
Disabling found in the LIS workpool, the Access 2 system can automatically query the LIS for
Host Query any unsent test requests.
Use this procedure to enable the host query capability.
1. Go to the LIS Setup window. To get to this window from the Main Menu, select
Configure F8 to display the Configure menu, then select LIS F6.
2. Select the Host Query On box to enable the system to query the LIS for specific
test requests.
(Optional) Clear the Host Query On box to disable host query capability. Disable
host query if your system is not connected to an LIS.
3. Select OK F1 to save and apply the changes and exit the window.
Configuring Use this procedure to configure the global LIS settings for your workgroup.
the Global LIS
NOTE
Settings
This option is only available on the server system.
1. Go to the LIS Setup window. To get to this window from the Main Menu, select
Configure F8 to display the Configure menu, then select LIS F6.
NOTE
The baud rate you enter must match the LIS baud rate. Refer to your LIS
documentation or contact your LIS vendor to determine the correct baud rate.
3. Select On, Off, or Offline from the Global LIS Interface field.
• Select On to enable the system to communicate with the LIS. When an LIS is
connected to the Access 2 system, the Local LIS Interface field also should be
enabled (On) to receive test requests from and send test results to the LIS.
• Select Off to disable data communication between the current system and the
LIS. You use this option if your system is not connected to an LIS.
• Select Offline to temporarily suspend the transmission of data to the LIS
interface. When the LIS interface is offline, the system stores any data waiting to
be sent to the LIS. The results are sent to the LIS when you set the Global LIS
Interface field to On.
4. Select OK F1 to save and apply the changes and exit the window.
Configuring Use this procedure to configure how your workgroup sends results to the LIS.
the LIS Send
NOTE
Mode
If you have multiple Access 2 systems, be sure that the server and client systems
are all in the Ready or Not Ready mode. All of the remaining steps in this
procedure refer to the server system only.
1. Go to the LIS Setup window. To get to this window from the Main Menu, select
Configure F8 to display the Configure menu, then select LIS F6.
2. Set the Global LIS Interface field to Off. For more information about setting the
Global LIS Interface, see the Configuring the Global LIS Settings procedure.
NOTE
The system will not transmit results to the LIS while the Global LIS Interface
field is set to Off. If results are generated while the LIS interface is Off, you must
manually send those results to the LIS. For more information about manually
sending test results, see Section 5.3: Managing Test Results of the Operator's
Guide.
3. Select OK F1 to save and apply the changes and exit the window.
4. From the Main Menu, select Configure F8 to display the Configure menu, then
select LIS F6 to return to the LIS Setup window.
5. Select a mode from the LIS Send Mode field.
• Select By Sample Container to send the test results to the LIS when all of the
requested tests for the sample container are complete.
• Select By Test to send the test result to the LIS as soon as the test is complete.
6. Enter your system password.
NOTES
• If you do not know the current password, contact the lab supervisor.
• If you cannot remember or find the current password, contact Technical
Support.
7. Select OK F1 to exit the window.
8. Select OK F1 to confirm the change and exit the LIS Setup window.
A message displays for you to confirm your choice.
9. Select Yes F1 to change the LIS send mode.
10. Set the Global LIS Interface field to On. For more information about setting the
Global LIS Interface, see the Configuring the Global LIS Settings procedure.
The Access 2 workgroup database stores large amounts of data. This information is
critical to your laboratory. Manage it carefully. Data stored in electronic storage
media is susceptible to corruption and loss. To prevent catastrophic losses caused by a
failure, back up your data regularly. Backing up the data saves system related files,
including test results data, configuration settings, and utilities. Also, when the
database becomes very large, it can affect the efficiency of the system. To keep your
system running at peak efficiency, store only current patient test and QC results on the
database.
When the system stores data on the USB flash drive, the system stores the same
backup data on the disk drive of the external computer, which maintains several of the
most recent backups. This provides redundancy of backups and enables quick
restoration of data in most cases.
You can schedule the system to back up the data automatically, or you can manually
back up the data. Determining the appropriate backup schedule is a matter of
laboratory preference. You will establish a backup schedule with the technical support
representative when your system is installed.
NOTES
• To limit the amount of data that is lost in the event of catastrophic
failure, Beckman Coulter recommends that you back up your data daily.
• If using tape, keep at least three backup tapes. Cycle the tapes to be sure that
at least three backup cycles are available. Store the backup tapes in a safe
place.
• When you back up your system data, the current data overwrites the contents
of the tape or USB flash drive.
• Your PC administration setup applies to all Access 2 instruments in the
workgroup.
If a catastrophic data loss occurs, Technical Support can help you restore the system
with the most recent backup. All data generated since the last backup will be lost.
Also, the supply counts will be lost; therefore, to prevent invalid results, you must
discard all punctured reagent packs.
After running many tests on your Access 2 Immunoassay System, the amount of data
stored in the database can become very large and can affect the efficiency of the
system. If your Access 2 system performance is slow, you can use the Auto-Delete
function to delete patient test and QC results from the database.
You can set up the Auto-Delete function to run at scheduled intervals. Determining
the appropriate schedule is a matter of laboratory preference.
0841C.bmp
Figure 4-52 PC Admin Screen
Last Backup Status — (Field) Displays the status of the last system backup, which is either
Succeeded, Failed, Aborted, or Not Available.
Began — (Field) Shows the date and time that the last system backup began.
Completed — (Field) Shows the date and time that the last system backup
completed.
Next Backup Status — (Field) Displays the status of the next scheduled system backup, which is
either Scheduled or Not Scheduled.
Begin — (Field) Shows the date and time that the next scheduled system backup will
begin.
Frequency — (Field) Shows how frequently the system backup is scheduled to
occur.
Scheduled (Button) Select to display the Scheduled Backup window. You use the window to
Backup F1 schedule system backups. Scheduled backups occur weekly or daily at the date and
time you select in the window.
This button is only available on the server system.
NOTE: You must enter a password to use this feature.
Immediate (Button) Select to display the Immediate Backup window. You use the window to run
Backup F2 an immediate backup.
This button is only available on the server system.
NOTE: You must enter a password to use this feature.
Eject Tape F3 (Button) Select to remove a backup tape from the instrument.
Restore F4 (Button) Select to restore backed up data only as instructed by Technical Support.
Auto-Delete (Button) Select to display the Auto-Delete Setup window. You use the window to
Setup F5 schedule the deletion of patient test results, QC results, and expired off-board reagent
packs from the database.
NOTE: You must enter a password to use this feature.
Remote Select to set up instrument control sharing. Use this function only as directed by your
Management F6 technical support representative.
Shut Down PC F8 (Button) Select to shut down the PC.
For information on shutting down the PC, see Section 7.3: Rebooting, Shutting
Down, and Restarting Procedures.
Scheduling
System Back- Confirm that backup
ups media is present to
receive data
Main Menu
Configure
F8
PC Admin
F7
PC Admin
Scheduled Backup
F1
Password
Enter your
system password
OK
F1
Scheduled Backup
1. Select the Enable automatic backup box
2. Select Daily Backup or Weekly Backup
3. For a weekly backup, select the day of the week
4. Select a time to run the backup
OK
F1
Back up runs at
scheduled time and
date
Yes*
OK
F1 * Initial the Maintenance Log
0921C.wmf
Figure 4-54 Scheduling System Backups Flowchart
Use this procedure to schedule system data backups to a backup tape or USB flash
drive.
• Be sure to label the tape or flash drive either before or after the backup is
made.
• You can only schedule backups on the server system.
• The backup is postponed if there are pending tests in the workgroup, or if one
or more systems is in the Running or Paused mode. If those conditions are
present, the scheduled backup is postponed for five minutes. After 100 failed
attempts (approximately eight hours), the scheduled backup is aborted, and
the system displays a message.
3. Go to the PC Admin screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select PC Admin F7.
NOTES
• If you do not know the current password, contact the lab supervisor.
• If you cannot remember or find the current password, contact Technical
Support.
6. Select OK F1.
The Scheduled Backup window is displayed.
2156A.bmp
Figure 4-55 Scheduled Backup Window
7. Select the Enable Automatic Backup box to enable the scheduled backup.
8. Select the Daily Backup or Weekly Backup option to set the backup frequency.
9. If you selected the Weekly Backup box, select the day from the list that you want
the backup to run.
10. Select a backup start time from the list in the Start Time field.
11. Select OK F1 to save and apply the changes and exit the window.
12. When the backup is complete, the system displays a message that notifies you if
the backup succeeded, aborted, or failed. Select OK F1 to exit the backup status
message.
• If the backup aborted or failed, manually back up the system (see the Performing
Immediate System Backups procedure).
• If the backup aborts or fails again, contact Technical Support.
13. When the backup is successful, initial the appropriate section of the Maintenance
Log (see Section 8.6: Maintenance Log in the Operator's Guide).
Performing Use this procedure to perform a system data backup to a backup tape or USB flash
Immediate drive on demand.
System Back- NOTES
ups
• Be sure to label the tape or flash drive either before or after the backup is
made.
• You can only schedule backups on the server system.
3. Go to the PC Admin screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select PC Admin F7.
NOTES
• If you do not know the current password, contact the lab supervisor.
• If you cannot remember or find the current password, contact Technical
Support.
6. Select OK F1.
The Immediate Backup window is displayed.
NOTES
• If you attempt to run a backup when the system is in the Running or Paused
mode, the system displays a message.
• If you attempt to run an immediate backup while a scheduled backup is
running, a message is displayed and the immediate backup is not run.
7. When the backup is complete, the system displays a message to notify you if the
backup succeeded, aborted, or failed.
• If the backup aborted or failed, repeat this procedure.
• If the backup aborts or fails again, contact Technical Support.
When the backup is successful, initial the appropriate section of the Maintenance Log
(see Section 8.6: Maintenance Log in the Operator's Guide).
8. Select OK F1 to exit the backup status message.
Replacing the If you back up to tape, use this procedure to replace the backup tape after a scheduled
Backup Tape or immediate backup. If you back up to a USB flash drive, skip this procedure.
2. Go to the PC Admin screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select PC Admin F7.
4. Remove the tape from the tape drive on the external PC.
5. Label the tape according to laboratory policy. At a minimum, mark the tape with
the backup date and time and the system ID.
NOTE
For both scheduled and immediate backups, it is your responsibility to label the
tape and make sure the correct tape is in the drive.
6. Place another tape in the tape drive for the next backup. Push the tape until it is
properly seated.
Restoring Contact Technical Support for instructions on how to perform this procedure.
System Data
CAUTION
Beckman Coulter, Inc. strongly recommends that you contact Technical
Support before running restore because critical data will be erased during
the procedure.
Setting the Use this procedure to set up the auto-delete database size management function.
Auto-Delete
NOTE
Function
You can only set the Auto-Delete function from the server system.
1. Go to the PC Admin screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select PC Admin F7.
NOTES
• If you do not know the current password, contact the lab supervisor.
• If you cannot remember or find the current password, contact Technical
Support.
4. Select OK F1.
The Auto-Delete Setup window is displayed.
5. Select the boxes for the types of database deletions you intend to automate:
• Select the Automatically delete patient samples after box to schedule the
deletion of patient test results from the database.
• Select the Automatically delete QC samples after box to schedule the deletion
of QC results from the database.
• Select the Automatically delete off-board reagent packs 30 days after
expiration box to schedule deletion of expired off-board reagent packs.
6. In the Days field for each box you selected in step 5, enter the number of days
that must elapse before the test results are deleted from the database.
7. Select OK F1.
A confirmation window is displayed.
8. Select OK F1.
The Auto-Delete function deletes results when one of the following conditions occur:
• Immediately after you perform this procedure.
• One hour after the scheduled system backup. If no system backup is set, the
Auto-Delete function runs at a default time that does not conflict with other
system operations. For more information about scheduled system backups, see
the Scheduling System Backups procedure.
• Ten minutes after the server PC is rebooted. For information about rebooting the
PC, see the Rebooting the PC procedure in Section 7.3: Rebooting, Shutting
Down, and Restarting Procedures.
5 Diagnostics
5.1 Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
5.1 Diagnostics
The Access 2 system includes features to help diagnose an instrument problem if one
occurs. Using the Diagnostics menu, you can monitor the instrument hardware,
perform diagnostic actions, and verify the effectiveness of troubleshooting steps
taken. You can print four different diagnostic reports and copy diagnostic data to a
disk or USB flash drive.
When performing diagnostic procedures, be sure to pay careful attention to the notes
and cautions in the procedures to avoid injury to yourself or damage to the instrument.
For more information about Event Log troubleshooting, in Section 6.4: List of Events.
NOTES
• Some diagnostic procedures should be used only as directed by a technical
support representative or when you are following instructions in the Help
system system or in an Access 2 manual.
• Except for LIS F5 and Diagnostic Reports F7, Diagnostics menu options
cannot be selected while the system is in the Running mode.
To get to this menu from the Main Menu, select Diagnostics F7.
0733D.bmp
Figure 5-1 Diagnostics Menu
Initialize (Button) Select to initialize the primary system devices. The Initialize System
System F1 window is displayed, confirming whether you want to initialize the system.
For more information about how to use this option, see the Initializing the System
procedure in this chapter.
NOTE: The system must be in the Ready or Not Ready mode to display this
window.
Prime Fluidics F2 (Button) Select to prime the pipettor, dispense probes, or substrate fluidics. The
Prime Fluidics window is displayed, from which you select the fluidic components to
prime and the number of cycles for each component.
For more information about how to use this option, see the Priming the Fluidics
procedure in this chapter.
NOTE: The system must be in the Ready mode to display this window.
Volume (Button) Select to display the Volume Checks screen. You can check the accuracy of
Checks F3 the volumes dispensed or aspirated through the fluidic system probes.
For more information about volume checks, see Section 5.4: Volume Checks in this
chapter.
NOTE: The system must be in the Ready mode to display this screen.
Device (Button) Select to display the Device Diagnostics screen. You can perform advanced
Diagnostics F4 device diagnostic or service procedures from this screen.
For more information about what you can do from the Device Diagnostic screen, see
Section 5.5: Mechanics and Device Diagnostics in this chapter.
NOTE: The system must be in the Ready or Not Ready mode to display this screen.
LIS F5 (Button) Select to display the LIS Diagnostics screen. You can view the contents of
the LIS messages in real time and you can diagnose LIS problems.
Save Data F6 (Button) Select to display a menu of storage options for diagnostic data.
NOTE: The system must be in the Ready or Not Ready mode to display the Copy to
Disk or Export Logs windows.
• Copy to Disk F1 — (Button) Select to copy information to a disk or USB flash
drive. The Copy to Disk window is displayed.
For more information about how to use this option, see the Copying Diagnostic
Data to a Disk or USB Flash Drive procedure in this chapter.
• Export Logs F2 — (Button) Select to collect and save system status logs to a
single location. Use this function only as directed by a technical support
representative or when you are following instructions in the system documentation.
When you initialize the system, a routine brings all devices to their home states. This
routine is known as initialization, and it prepares the system for further processing.
The following primary system devices move to home position:
• Main pipettor
• Precision pump
• Incubator belt
• RV rake
• RV shuttle
• Wash/read carousel
• Reagent carousel
• Sample carousel
• Wash valve
• Other mechanical devices
Priming fills the lines with fluid in preparation for operating the instrument. You can
prime one or more components and you can select the number of priming cycles for
each component. Use the default setting for the number of priming cycles unless an
Access 2 manual or a technical support representative directs you to change the
number.
Priming the Use this procedure to prime the pipettor, dispense probes, or substrate fluidic lines.
Fluidics
1. Confirm that the system is in the Ready mode.
2. Go to the Prime Fluidics window. To get to this window from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Prime
Fluidics F2.
0729D.bmp
Figure 5-3 Prime Fluidics Window
Volume checks measure the precision and accuracy of the dispense and aspirate
components of the fluidic module. You may need to perform one or more of the
following volume checks as part of diagnostics or troubleshooting:
• Substrate
• Pipettor volumes 50 µL, 200 µL, or 350 µL
• Dispense Probes 1, 2, or 3
• Aspirate Probes
You can use either visual or analytical procedures when performing a volume check:
• Visual volume checks rely on what you see to detect gross volume
discrepancies or dispense irregularities.
• Analytical volume checks require an analytical balance to discriminate
gravimetric volumes to the nearest hundredth (0.01) of a milligram.
You access the Volume Checks screen from the Diagnostics menu.
0730B.bmp
Figure 5-5 Volume Checks Screen
Substrate F1 (Button) Select to run the substrate volume check test. The Substrate Volume Check
window is displayed, from which you can start the test.
Pipettor 50 µL F2 (Button) Select to check the aspirated and dispensed volume of the main pipettor. The
Pipettor 50 µL window is displayed, from which you can load a rack and start the
volume test.
Pipettor (Button) Select to check the aspirated and dispensed volume of the main pipettor. The
200 µL F3 Pipettor 200 µL window is displayed, from which you can load a rack and start the
volume test.
Pipettor (Button) Select to check the aspirated and dispensed volume of the main pipettor. The
350 µL F4 Pipettor 350 µL window is displayed, from which you can load a rack and start the
volume test.
Dispense (Button) Select to check the dispensed volume of the dispense probe in position 1.
Probe 1 F5 The Dispense Probe 1 window is displayed, from which you can run the dispense
probe volume test.
Dispense (Button) Select to check the dispensed volume of the dispense probe in position 2.
Probe 2 F6 The Dispense Probe 2 window is displayed, from which you can run the dispense
probe volume test.
Dispense (Button) Select to check the dispensed volume of the dispense probe in position 3.
Probe 3 F7 The Dispense Probe 3 window is displayed, from which you can run the dispense
probe volume test.
Aspirate (Button) Select to check the aspirated volume of the three aspirate probes. The
Probes F8 Aspirate Probe window is displayed, from which you can run the aspirate probe
volume test.
Access to When performing a volume check, you access the RVs in shuttle positions 1, 2, and 3.
RVs for Vol-
1
ume Checks
2
3
00371.eps
1 Position 1
2 Position 2
3 Position 3
4 To RV Waste Bag
Evaluating The substrate check, dispense probe checks, and main pipettor checks measure
Visual Volume dispensed volumes. You visually evaluate dispensed volumes for all three checks the
Checks same way. Refer to the following guide when comparing dispensed volumes to the
manually pipetted reference RV.
Evaluating Properly dispensed fluids leave no bubbles on the surface, or only a few small,
and Trouble- regularly sized bubbles around the edge of the surface. Refer to the following
shooting Dis- illustration when evaluating dispense characteristics.
pense
1 2 3
Characteris-
tics
0892b.eps
1 Irregular
2 Regular
3 Regular
If the dispense characteristics are irregular, take the following actions with the system
in the Ready or Not Ready mode.
1. Look for splashing up the sides of the RVs. Contact Technical Support if
splashing is noted.
2. Open the front panel, inspect the lines, and straighten any kinks. Close the front
panel.
For more information, see Section 7.2: Instrument Cover Procedures.
Performing
Substrate or Main Menu
Dispense
Probe Visual
Diagnostics
Volume F7
Volume Checks
Checks
F3
Volume Checks
OK
F1
Significant
volume No Inspect Dispense
difference? Characteristics
Yes
Normal
characteristics No Troubleshoot
Call Technical Support ?
Done
0734b.wmf
Figure 5-10 Performing Visual Substrate or Dispense Probe Volume Checks
Use this procedure to detect gross volume errors or irregular dispense characteristics
of the substrate or dispense fluidic system. This procedure checks the substrate probe
or one dispense probe. Repeat the procedure to check another probe, as needed.
WARNINGS
• 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.
• Wash buffer contains a preservative, which may cause sensitization by skin
contact. After contact with skin, wash immediately with soap and water.
Wear suitable gloves.
Required Materials
• Forceps
• Empty rack
• Empty reaction vessel (RV)
• Pipettor to dispense from 150 µL to 500 µL
• Wash Buffer
2. Go to the Volume Checks screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Volume
Checks F3.
7
6
1
5 4 3 2
1
6
3 2
5
4
0195Hc.eps
4. From the Volume Checks screen, select the probe to check from the following
buttons:
• Substrate F1
• Dispense Probe 1 F5
• Dispense Probe 2 F6
• Dispense Probe 3 F7
The appropriate substrate volume check or dispense probe volume check window is
displayed.
5. Select Start Test F2 to begin the procedure.
The instrument dispenses the substrate or wash buffer and returns the RVs to their
shuttle positions. The system displays progress messages.
2. With forceps, remove the dispensed RVs from shuttle positions 1, 2, and 3 and
place them in an empty rack. To locate shuttle positions, see Figure 5-7.
5. Align the reference RV and the dispensed RVs so they are level with each other
and visually compare the volumes for gross volume discrepancies.
For a guide to evaluating the volume results, see Table 5-8.
6. If you see a significant volume difference between the reference RV and any of
the test RVs, contact Technical Support.
7. Inspect the fluid in the dispensed RVs for irregularities and troubleshoot as
needed.
For a guide to evaluating and troubleshooting dispense characteristics, see the
Evaluating and Troubleshooting Dispense Characteristics procedure in this section.
Performing
Main Pipettor Main Menu
Visual Volume
Checks
Diagnostics
F7
Volume Checks
F3
Volume Checks
Done
F1
Start Test
F2
Unload Rack
F1
Significant
Inspect Dispense
volume No Characteristics
difference?
Yes
Normal
characteristics No Troubleshoot
Call Technical Support ?
Refer to Evaluating
Yes and Troubleshooting
Dispense Characteristics
Done
0874b.wmf
Figure 5-12 Performing Visual Main Pipettor Volume Checks
Use this procedure to detect gross volume aspirate or dispense errors or irregular
dispense characteristics of the main pipettor fluidic system. This procedure checks
one volume. Repeat the procedure to check another volume, as needed.
WARNINGS
• 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.
• Wash buffer contains a preservative, which may cause sensitization by skin
contact. After contact with skin, wash immediately with soap and water.
Wear suitable gloves.
Required Materials
• 2 mL sample cup
• Pipettors to dispense from 50 µL to 1.5 mL fluid
• Wash buffer
• 13 mm rack for 2 mL sample cups
• Forceps
• Empty reaction vessel (RV)
2. Go to the Volume Checks screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Volume
Checks F3.
3. From the Volume Checks screen, select the pipettor volume to check from the
following buttons:
• Pipettor 50 µL F2
• Pipettor 200 µL F3
• Pipettor 350 µL F4
0731b.bmp
Figure 5-13 Pipettor Volume Check Window
Load a Rack F1 (Button) Select Load a Rack F1 to load the rack prepared
or for the pipettor volume check. When the rack is onboard,
Unload Rack F1 the button changes to Unload Rack F1.
Select Unload Rack F1 to unload the rack when the
volume check is done.
Start Test F2 (Button) Select to start the check when the rack is onboard.
4. Manually pipette at least 1.5 mL of wash buffer into a sample cup and place the
cup in sample position 1 of a rack.
NOTE
When performing repeated dispense checks, verify that the sample cup contains
sufficient volume to complete the three aspirations. For the 200 and 350 µL
volumes, be sure to refill the sample cup before repeating the check.
9. When prompted by the system message, open the front panel of the instrument.
For information about opening and closing the front panel, (see
Section 7.2: Instrument Cover Procedures).
10. With forceps, remove the dispensed RVs from shuttle positions 1, 2, and 3 and
place them in an empty rack. To locate shuttle positions, see Figure 5-7.
11. Close the front panel of the instrument, then select OK F1.
3. Select Done F1 to confirm that the rack is not onboard the instrument.
Performing
Aspirate Main Menu
Probes Visual
Volume
Check Diagnostics
F7
Volume Checks
F3
Volume Checks
Aspirate Probes
F8
Aspirate Probes
Done
F1
Start Test
F2
Significant
amount of fluid No Done
remaining?
Yes
Clean or replace
aspirate probe
0875b.wmf
Figure 5-15 Performing Visual Aspirate Probe Volume Check
Use this procedure to detect gross volume errors of the aspirate fluidic system. This
procedure checks all three aspirate probes at the same time. A different probe
aspirates from each of three dispensed RVs.
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.
Required Materials
• Forceps
• Marker to number the dispensed RVs
0877b.bmp
Figure 5-16 Aspirate Probes Volume Check Window
Start Test F2 (Button) Select to start the aspirate probe visual volume
check.
4. When prompted by the system message, open the front panel of the instrument.
For information about opening and closing the front panel, see
Section 7.2: Instrument Cover Procedures.
6. Number the RV based on its shuttle position, and return the RV to its shuttle
position.
NOTE
If the volume check results fail, you will need to know the shuttle position to
determine which aspirate probe to service.
7. Repeat step 3 and step 4 for the RVs in shuttle positions 2 and 3.
9. When prompted by the system message, open the front panel of the instrument.
10. With forceps, remove the aspirated RVs from shuttle positions 1, 2, and 3.
11. Close the front panel of the instrument, then select OK F1.
The shuttle advances three positions. The Volume Checks screen is displayed when
the instrument completes this movement.
NOTE
To determine if a drop of fluid is within the guideline, turn the RV upside down.
An amount of 4 µL or less will not run out of an RV when the RV is turned upside
down.
2. If there is a significant amount (more than 4 µL) of fluid remaining in a RV, its
corresponding aspirate probe failed the volume check. To determine which
aspirate probe failed, see Table 5-18.
3. If an aspirate probe fails the check, clean or replace the aspirate probe as
described in see Section 8.3: Weekly Maintenance in Chapter 8: Routine
Maintenance of the Operator's Guide.
CAUTION
If an aspirate probe is plugged, disable the Utility Assay and do not run the
Daily Clean System routine or prime any component of the system until you
resolve the problem.
Handling RVs Follow the guidelines for handling and weighing RVs when performing analytical
for Analytical substrate probe, dispense probe, main pipettor, and aspirate probes volume checks.
Volume When handling and weighing RVs:
Performing
Substrate Main Menu
Probe Analyti-
cal Volume
Check Diagnostics
F7
Volume Checks
F3
Volume Checks
Substrate
F1
Substrate
Continue dispensing
substrate and weighing
results until you have
enough replicates
Is range within
limits?
No Call Technical Support
Yes
Done
0876b.wmf
Figure 5-19 Performing Analytical Substrate Volume Check
Use this procedure to quantitatively determine the dispense precision and accuracy of
the substrate fluidic system.
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.
Required Materials
• Forceps
• Marker to number the dispensed RVs
• Analytical balance
5. With forceps, remove the empty RV from shuttle position 1. To locate shuttle
positions, see Figure 5-7.
NOTE
After weighing an RV, handle it only with forceps, not with your hands.
9. Repeat step 5 through step 8 for the RVs in shuttle positions 2 and 3.
10. Close the front panel of the instrument, then select Start Test F2.
The instrument dispenses the substrate and returns the RVs to shuttle positions 1, 2,
and 3. The system displays a message about status of the procedure.
2. With forceps, remove the RV from shuttle position 1. To locate shuttle positions,
see Figure 5-7.
3. Weigh the RV using the analytical balance, and record the weight.
7. Select OK F1.
The Volume Checks screen is displayed.
10. Calculate the mean, the standard deviation, and the %CV of the replicates.
11. Compare the substrate volume check results to the following expected results.
Performing
Dispense Main Menu
Probe Analyti-
cal Volume
Check Diagnostics
F7
Volume Checks
F3
Volume Checks
Dispense Probe 1
F5
Continue dispensing
from dispense probe
and weighing until you
have enough replicates
Subtract RV weight
from dispensed weight, Weight / Wash Buffer Density = Volume
then convert remaining mg / (l.007 mg/µL) = µL
RV weights to volumes
Is
range within No Call Technical Support
limits?
Yes
Done
0918b.wmf
Figure 5-22 Performing Analytical Dispense Probe Volume Checks
Use this procedure to quantitatively assess the precision and accuracy of the dispense
probes. This procedure checks one dispense probe. Repeat the procedure to check
another dispense probe, as needed.
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.
Required Materials
• Forceps
• Marker to number the dispensed RVs
• Analytical balance
2. Go to the Volume Checks screen. To get to this screen from the Main Menu.
select Diagnostics F7 to display the Diagnostics menu, then select Volume
Checks F3.
4. From the Volume Checks screen, select the dispense probe to check from the
following buttons:
• Dispense Probe 1 F5
• Dispense Probe 2 F6
• Dispense Probe 3 F7
6. With forceps, remove the empty RV from shuttle position 1. To locate shuttle
positions, see Figure 5-7.
NOTE
After weighing an RV, handle it only with forceps, not with your hands.
10. Repeat step 6 through step 9 for the RVs in positions 2 and 3.
11. Close the front panel of the instrument, then select Start Test F2.
The dispense probe you selected in step 3 dispenses the wash buffer into the three
RVs and then the RVs are returned to shuttle positions 1, 2, and 3. The system
displays a progress message.
2. With forceps, remove the RV from shuttle position 1. To locate shuttle positions,
see Figure 5-7.
3. Weigh the RV using the analytical balance, and record the weight.
6. Select OK F1.
The Volume Checks screen is displayed.
mg / (1.007 mg/µL) = µL
4. Compare the dispense probe volume check results to the following expected
results.
Performing
Main Pipettor Main Menu
Analytical
Volume
Checks Diagnostics
F7
Volume Checks
F3
Volume Checks
Done
F1 Subtract RV weight
from dispensed weight, Weight / Wash Buffer Density = Volume
then convert remaining mg / (l.007 mg/µL) = µL
RV weights to volumes
Expected Results:
Target Volume 50 µL Compare results with
Expected Volume Range 47.5 - 52.5 µL expected results
Expected %CV <2%
Yes
Done
0917b.bmp
Figure 5-25 Performing Analytical Main Pipettor Volume Checks
Use this procedure to quantitatively assess the main pipettor dispense volume at
50 µL, 200 µL, and 350 µL. This procedure checks one volume. Repeat the procedure
to check another volume, as needed.
WARNINGS
• 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.
• Wash buffer contains a preservative, which may cause sensitization by skin
contact. After contact with skin, wash immediately with soap and water.
Wear suitable gloves.
Required Materials
• 2 mL sample cup
• Pipettor to dispense 1.5 to 2 mL of fluid
• Wash buffer
• 13 mm rack for 2 mL sample cups
• Forceps
• Marker to number the dispensed RVs
• Analytical balance
2. Go to the Volume Checks screen. To get to this screen from the Main Menu.
select Diagnostics F7 to display the Diagnostics menu, then select Volume
Checks F3.
3. From the Volume Checks screen, select the pipettor volume to check from the
following buttons:
• Pipettor 50 µL F2
• Pipettor 200 µL F3
• Pipettor 350 µL F4
4. Manually pipette at least 1.5 mL of wash buffer into a sample cup and place the
cup in sample position 1 of a rack.
NOTE
When performing repeated dispense checks, verify that the sample cup contains
sufficient volume to complete the three aspirations. For the 200 and 350 µL
volumes, remove and refill the sample cup after each group of three RVs.
2. With forceps, remove the empty RV from shuttle position 1. To locate shuttle
positions, see Figure 5-7.
NOTE
After weighing an RV, handle it only with forceps, not with your hands.
7. Close the front panel of the instrument, then select Start Test F2.
The instrument dispenses the wash buffer and returns the RVs to shuttle positions 1, 2,
and 3. The system displays a message about the status of the procedure.
2. With forceps, remove the RV from shuttle position 1. To locate shuttle positions,
see Figure 5-7.
3. Weigh the RV using the analytical balance, and record the weight.
mg / (1.007 mg/µL) = µL
Target Volume 50 µL
Expected Volume Range 47.5 - 52.5 µL
Expected %CV ≤ 2%
Target Volume 200 µL
Performing
Aspirate Main Menu
Probes Ana-
lytical Vol-
ume Check Diagnostics
F7
Volume Checks
F3
Volume Checks
Aspirate Probes
F8
Continuing aspirating
with aspirate probes
and weighing until there
are enough replicates
Subtract RV weight
from dispensed weight, Weight / Wash Buffer Density = Volume
then convert remaining mg / (l.007 mg/µL) = µL
RV weights to volumes
Yes
Done
0919b.wmf
Figure 5-28 Performing Analytical Aspirate Probe Volume Check
Use this procedure to quantitatively assess the precision and accuracy of the aspirate
fluidic system. This procedure checks all three aspirate probes at the same time. A
different probe aspirates from each of the three dispensed RVs.
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.
Required Materials
• Forceps
• Marker to number the dispensed RVs
• Analytical balance
5. With forceps, remove the empty RV from shuttle position 1. To locate shuttle
positions, see Figure 5-7.
NOTE
After weighing an RV, handle it only with forceps, not with your hands.
10. Close the front panel of the instrument, then select Start Test F2.
The instrument transports the RVs from positions 1 through 3 of the shuttle to the
wash/read carousel and dispenses 500 µL of wash buffer into each RV. A different
aspirate probe aspirates the wash buffer from each RV. The instrument then returns
the RVs to their original shuttle positions. A progress message is displayed.
2. With forceps, remove the RV from shuttle position 1. To locate shuttle positions,
see Figure 5-7.
3. Weigh the RV using the analytical balance, and record the weight.
NOTE
When performing an analytical aspirate volume check, weigh the aspirated RVs
as quickly as possible. The small remaining volume is especially susceptible to
evaporation.
7. Select OK F1.
The Volume Checks screen is displayed.
2. Subtract the RV weight from the aspirated RV weight for each replicate. Then,
convert the remaining RV weights (in mg) to volumes (in µL).
For the wash buffer conversion equation, see Table 5-26.
3. Compare the aspirate probe volume check results to the following expected
results.
4. If a result is outside of the expected range, see Table 5-18 to determine which
aspirate probe should be cleaned or replaced.
CAUTION
If an aspirate probe is plugged, disable the Utility Assay and do not run the
Daily Clean System routine or prime any component of the system until you
resolve the problem.
When an Access 2 instrument is in the Ready mode, mechanical devices are aligned
properly to their sensors and to their intersecting mechanical devices.
When technical support representatives service the instrument, they often align
devices as part of their verification routine. Occasionally during troubleshooting, you
may need to view alignments, home or cycle devices, or adjust alignments.
CAUTION
Use this function only as directed by a technical support representative or if
you are following instructions in Help system or in an Access 2 manual.
You access the Device Diagnostics screen from the Diagnostics menu.
0911C.bmp
Figure 5-30 Device Diagnostics Screen
Mechanics F1 (Button) Select to display the Mechanics screen (see Figure 5-33 in this section). You
can use the Mechanics screen to:
• View the alignment of devices in real-time
• View the status of device sensors in real-time
• Align devices using the System Software
• View the step count and cycle data in real-time
For help on using the Mechanics screen, see Figure 5-33 in this section.
Analog (Button) Select to display a menu of the following options:
Devices F2 Analog Data F1—Select to display the Analog Devices window. You can use this
window to review the current temperatures in the instrument, the duty cycles of
temperature controllers, or the voltage of power supplies.
Pressure Monitor F2—Select to display the Pressure Monitor screen. You can use
this screen to enable and disable obstruction detection, generate a new obstruction
detection reference curve, or review the status of obstruction detection.
For help on using the Analog Devices window or the Pressure Monitor screen, see
Section 5.6: Analog and Digital Device Diagnostics.
Digital (Button) Select to display the Digital Devices window. You can use the Digital
Devices F3 Devices window to:
• View information provided by various instrument sensors, including sensed supply
levels (wash buffer and liquid waste), and open access doors.
• Turn various digital devices (pumps, valves, and motors) off or on.
For help on using the Digital Devices window, see Section 5.6: Analog and Digital
Device Diagnostics.
Luminometer F4 (Button) Select to display the Luminometer screen. You can use the Luminometer
screen to:
• View luminometer information
• Load a vessel and read the relative light units (RLUs) in the vessel
• Save the light emitting diode (LED) calibration value
• Set the high voltage control value
For help on using the Luminometer screen, see Section 5.7: Luminometer Device
Diagnostics.
Ultrasonics F5 (Button) Select to display the Ultrasonics window. You can use the Ultrasonics
window to:
• View ultrasonic information
• Perform the ultrasonic level sense test (wet and dry mode)
For help on using the Ultrasonics window, see Section 5.8: Advanced Diagnostics.
Exerciser F6 (Button) Select to display the Exerciser window. You can use the Exerciser window
to cycle the movement of mechanical devices by starting a programmed exercise
routine.
For help on using the Exerciser window, see Section 5.8: Advanced Diagnostics.
Calibrate (Button) Select to display the Calibrate Incubator Belt window. You can use the
Incubator Belt F7 Calibrate Incubator Belt window to:
• Calibrate the incubator belt
• Print the Incubator Belt Report automatically after the procedure
For help on using the Calibrate Incubator Belt window, see Section 5.8: Advanced
Diagnostics.
Reset Pipettor F8 (Button) Select to display the Reset Pipettor window. You can use the Reset Pipettor
window to prepare to continue processing after resolving a reagent pack monitoring
failure.
For help on using the Reset Pipettor window, see the Resetting the Pipettor procedure
in this section.
Resetting the Use this procedure to reset the main pipettor after troubleshooting a specific sequence
Pipettor of reagent pack monitoring problems which disabled the pipettor.
CAUTION
Use this function only as directed by a technical support representative or if
you are following instructions in Help system or in an Access 2 manual.
1057A.bmp
Figure 5-32 Reset Pipettor Window
4. To confirm that you have completed troubleshooting for the events which
disabled the pipettor and that you are ready to reset the pipettor, select OK F1.
• If you have not completed troubleshooting, select Cancel F8 or Help F12 and
continue troubleshooting.
6. Initialize the system to bring the instrument back to the Ready mode. For more
information about initializing the system, see Section 5.2: Initialize System.
• If initialization fails, contact Technical Support.
You access the Mechanics screen from the Device Diagnostics screen.
0737C.bmp
Figure 5-33 Mechanics Screen
Device (Field) Select a device from the alphabetical list of devices. The name of the selected
device is repeated at the top of the middle section of the screen, which contains
alignment information about the device.
Listed devices: Incubator Belt, Pipettor, Precision Pump, Precision Valve, Rake,
Reagent Carousel, RV Shuttle, Sample Carousel, Substrate Pump, Substrate
Valve, Wash Arm, Wash Carousel, Wash Pump, and Wash Valve.
Position (List) Select an alignment position for the device named in the Device field. Some
alignment positions are intersecting devices, while other positions indicate states such
as high resolution, off, or empty. If the position is a device, the name of the device is
repeated at the top of the right section of the screen and the section contains
alignment information about the device. If the position is only an alignment position,
the right section is empty.
Selected Device (2 Indicators) Displays a black dot to indicate the device selected for alignment. Only
one device can be aligned at a time. The homing and positioning buttons at the
bottom of the screen relate to the selected device.
• By default, the selected device is the one named in the Device field.
• If a device is also selected in the position field, you can select the other indicator to
prepare to align that device.
Offset (Field and Arrows) The offset indicates the number of steps in a positive or negative
direction that the device is positioned from a default offset of 0. Some devices have
more than one offset, such as the pipettor's X-axis (horizontal) and Z-axis (vertical)
offsets.
CAUTION
Perform alignments only as directed by a technical support representative
or if you are following instructions in Help system or in an Access 2 manual.
Position/Status (Indicator) Displays the status of one or more of the following device sensors for the
Indicators selected device:
• Home, Home - X, or Home - Z
• Index
• RV Sensor 1, RV Sensor 2
• Top Tube Detector, Middle Tube Detector, Bottom Tube Detector
• Left End
The indicator turns or stays bright green when the device is in that position or when
the sensor is activated.
Home Device F1 (Button) Select to move the device to the home position. When homing is complete,
the Home indicator turns bright green.
Move X to (Button) Select to move the device to an alignment position. If the device is not
Position F2 homed, the system first homes the device and then moves the device to the alignment
or position.
Move Z to Both a device and a position must be selected for the button to be available. The
Position F3 Move X to Position F2 button is available for most devices. The Move Z to Position
F3 button is available for some devices.
Advance CW F4 (Button) Select to move the device clockwise (CW) to the next position.
This button displays only when one of the following devices is named in the Device
field:
• Sample carousel
• Reagent carousel
• Incubator belt
• RV rake
• RV shuttle
• Wash carousel
Advance CCW F5 (Button) Select to move the device counterclockwise (CCW) to the next position.
This button displays only when one of the following devices is named in the Device
field:
• Sample carousel
• Reagent carousel
• Incubator belt
• RV rake
• RV shuttle
• Wash carousel
Start Cycling F6 (Button) Select Start Cycling F6 to start cycling the device named in the Device field
or between home position and the alignment position. Cycling continues until you select
Stop Cycling F6 Stop Cycling F6, and the device reaches a known state at which to stop. Available for
all devices except the rake and RV shuttle.
The button name switches between Stop Cycling and Start Cycling each time you
select it.
Save Offsets F7 (Button) Select to save the offsets changed for the selected device. If you try to exit
the screen without saving offsets, a confirmation message is displayed.
Disable (Button) Select Disable Motors F8 to disable all of the mechanical device motors.
Motors F8 The motors remain disabled until you select Enable Motors F8.
or The button name switches between Disable Motors and Enable Motors each time you
Enable Motors F8 select it.
4. Select the device for which you want to view alignments from the alphabetical
list in the Device field.
Alignment information about the device is displayed in the middle section of the
Mechanics screen.
(Optional) Select one of the device positions from the Position list and view the
alignments.
Position alignment information is displayed in the right hand section of the Mechanics
screen.
5. When you are done viewing an alignment for a device, select another device or
select an appropriate button or tab to exit this screen.
4. Select the device to home from the alphabetical list in the Device field.
Alignment information about the device is displayed in the middle section of the
Mechanics screen.
4. Select the device to be cycled from the alphabetical list in the Device field.
Alignment information about the device is displayed in the middle section of the
Mechanics screen.
5. If positions are available, select the end position for cycling from the Position
list.
8. Wait until the number in the Number of Cycles field for the device reaches 6, or
until the number of cycles or the amount of time directed by your technical
support representative or in the procedure you are following is reached.
9. Select Stop Cycling F6 to end the cycling procedure. Cycling stops after the
present cycle is complete.
Disabling or Use this procedure to disable motors and prevent the instrument from running, and
Enabling then to enable motors again when you are ready to run the instrument.
Motors CAUTION
Use this function only as directed by a technical support representative or if
you are following instructions in Help system or in an Access 2 manual.
4. Select Disable Motors F8 to disable all of the mechanical device motors. The
motors remain disabled until you select Enable Motors F8.
Aligning a You must contact Technical Support if a device on the instrument needs alignment.
Device
The Access 2 instrument has several analog and digital devices. Analog devices are
controlled by the System Software, which displays device information (temperature,
power supply, voltage, obstruction detection status) in the Analog Devices window or
on the Pressure Monitor screen where you can view it. The system updates the Analog
Devices window in one second increments.
The digital devices control the hardware-related actions that take place within the
instrument. Through the System Software, you can turn the following digital devices
on and off:
• Vacuum pump
• Probe wash valve
• Mixer motor
• Stepper motor
• Peristaltic pump
You can also view the status of some of these devices (wash buffer level, waste bottle
level) or view whether something is present (waste bag present).
CAUTION
Use these procedures only as directed by a technical support representative
or if you are following instructions in Help system or in an Access 2 manual.
Viewing Ana- Use this procedure to review the temperatures of various system zones and the voltage
log Device of the related power supply.
Tempera- 1. Confirm that the system is in the Ready mode.
tures and
Voltage 2. Go to the Analog Devices window.
0738b.bmp
Figure 5-35 Analog Devices Window
0739b.bmp
Figure 5-37 Raw Voltage Data Window
You access the Pressure Monitor screen from the Analog Devices menu.
1029B.bmp
Figure 5-39 Pressure Monitor Screen
Curve (Field) Displays the date that the reference curve was determined.
Determined on:
Intercept (Field) Displays the intercept of the reference curve.
Slope (Field) Displays the slope of the reference curve.
Determine (Button) Select to determine a new reference curve. For more information about
Curve F1 determining a new curve, see Determining a Reference Curve for Obstruction
Detection in this section.
Service Reset F6 (Button) Used by Technical Support after servicing the instrument to reset devices for
reagent pack monitoring (secured by password).
Enable (Button) Select Enable Detection F8 to enable obstruction detection. Obstruction
Detection F8 detection continues until you select Disable Detection F8.
or NOTE: Obstruction detection can only be enabled if the pressure sensor is installed
Disable and a reference curve is determined.
Detection F8
The button name switches between Enable Detection and Disable Detection each
time you select it.
Determining a Use this procedure to determine a reference curve for obstruction detection.
Reference
CAUTION
Curve for
Use this procedure only as directed by a technical support representative or
Obstruction if you are following instructions in Help system or in an Access 2 manual.
Detection
1. Confirm that the system is in the Ready mode.
4. Select OK F1 to return to the Pressure Monitor screen and review the reference
curve information.
If the curve fails, prime the pipettor for four cycles and then repeat this procedure. For
more information on priming the pipettor, see the Priming the Fluidics procedure in
Section 5.3: Prime Fluidics. If the curve fails again, contact Technical Support.
Turning Digi- Use this procedure to turn various digital devices (pumps, valves, and motors) off or
tal Devices on.
Off and On CAUTION
Use this procedure only as directed by a technical support representative or
if you are following instructions in Help system or in an Access 2 manual.
2. Go to the Device Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4.
0740c.bmp
Figure 5-41 Digital Devices Window
Stepper Motor (Box) Select to turn the stepper motor power off or on,
Driver PCB On depending on the current status. If the box is selected, the
stepper motor is on and the instrument is in the Ready
mode. If the box is not selected, the stepper motor power is
off and the instrument is in the Not Ready mode.
NOTE
If the stepper motor is off (box not selected), you must
turn the stepper motor power on before you can
initialize the system to bring the instrument back to the
Ready mode.
4. Select or clear the boxes for the following devices to turn them on or off:
• Vacuum Pump On
• Peristaltic Pump On
(Optional) Select a mode from the Select Mode list to cause the status light bar to
display the color associated with the chosen mode. For more information, see
Section 1.3: Software Overview in the Operator's Guide.
The Select Mode list is only available on systems equipped with a status light.
Viewing Digi- Use this procedure to view the information provided by various digital sensors,
tal Device including measured supply levels and open access doors.
Sensor Infor- 1. Confirm that the system is in the Ready or Not Ready mode.
mation
2. Go to the Device Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4.
3. Select Digital Devices F3 to display the Digital Devices window (see Figure
5-41).
4. You can view information provided by digital sensors about the status of the
following items:
• Wash Buffer Level
• Waste Bottle Level
• Waste Bag Present
• RV Load Door
• Front Panel
Running the Use this procedure to run the automated vacuum test. This test is sometimes
Automated recommended by Technical Support to help diagnose vacuum over limit conditions.
Vacuum Test CAUTION
Use this procedure only as directed by a technical support representative or
if you are following instructions in Help system or in an Access 2 manual.
3. Go to the Device Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4.
4. Select Digital Devices F3 to display the Digital Devices window (see Figure
5-41).
NOTE
If the test fails, the test stops and an error message is displayed indicating the
error. Record the error message and contact Technical Support.
Running the Use this procedure to perform a manual, step by step vacuum test. This procedure is
Manual Vac- sometimes recommended by Technical Support to help diagnose vacuum under limit
uum Test conditions. You should stop the test at the first sign of failure.
CAUTION
Use this procedure only as directed by a technical support representative or
if you are following instructions in Help system or in an Access 2 manual.
3. Go to the Device Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4.
5. From the Digital Devices window, select the Pump On and the Probe Wash
Valve On boxes to turn on the vacuum pump and the probe wash valve. For more
information about turning digital devices off and on, see Section 5.6: Analog and
Digital Device Diagnostics.
6. Watch the vacuum level rise in the mm Hg field of the Digital Devices window.
The vacuum level should rise to a value of 450 mm Hg (60 kPa) or higher.
• If the vacuum level does not rise to 450 mm Hg (60 kPa) or higher, clear the
Pump On and the Probe Wash Valve On boxes to turn the vacuum pump and
probe wash valve off. Do not continue with this procedure. Contact Technical
Support for assistance.
7. Clear the Pump On box to turn the vacuum pump off. Leave the probe wash
valve on.
8. Watch the vacuum level fall in the mm Hg field of the Digital Devices window.
The vacuum level should not fall more than 50 mm Hg (6.7 kPa) over a
30 second time span.
• If the vacuum level falls more than 50 mm Hg (6.7 kPa) over 30 seconds, clear
the Probe Wash Valve On box to turn off the probe wash valve. Do not
continue with this procedure. Contact Technical Support for assistance.
9. Clear the Probe Wash Valve On box to turn off the probe wash valve.
10. With both the vacuum pump and the probe wash vacuum valve off, watch the
vacuum level fall in the mm Hg field in the Digital Devices window. The vacuum
level should rapidly fall to a value of nearly 0 mm Hg.
• If the vacuum level does not rapidly fall to nearly 0 mm Hg, do not continue
with this procedure. Contact Technical Support for assistance.
11. If the mm Hg level for each of the steps was within the given parameters, the
vacuum test was successful and the vacuum system is operating within normal
parameters.
Confirm that both pumps are off prior to performing other diagnostic activities or to
continuing processing.
The Access 2 system generates test results by measuring the amount of light produced
in a chemiluminescent reaction between the sample, the Access 2 assay specific
reagents, and the substrate. Within the analytical module of the system, the
luminometer measures the light produced.
High voltage can affect the luminometer reading. A technical support representative
may need to adjust the high voltage control value during troubleshooting.
CAUTION
Use this function only as directed by a technical support representative or if
you are following instructions in Help system or in an Access 2 manual.
For more information about luminometer calibration, see Section 3.2: Luminometer
Calibration Theory.
You access the Luminometer screen from the Device Diagnostics screen.
0741B.bmp
Figure 5-43 Luminometer Screen
Enable LED (Box) Select to turn on the light emitting diode (LED).
Default value: Not Selected
High Voltage (Field) Select to adjust the high voltage reading for the luminometer power supply.
Control You can enter a new value in this field and then select Save High Volt Control F4.
CAUTION
Use this function only as directed by a technical support representative or if
you are following instructions in Help system or in an Access 2 manual.
High Voltage (Field) Displays the power supply output of the luminometer.
Reading
LED Target Value (Field) Displays the LED target value either established during system installation, or
subsequently saved from this screen. This value is included on the Alignment Report.
Current RLU (Field) Displays the current RLU reading based on the results of a luminometer
reading.
For more information, see the Taking a Luminometer Reading procedure in this
section.
Current Mean (Field) Displays the current mean based on the last 20 luminometer readings (one
second each).
For more information, see the Taking a Luminometer Reading procedure in this
section.
Current %CV (Field) Displays the current coefficient of variation (%CV) of the mean based on the
results of a luminometer reading.
For more information, see the Taking a Luminometer Reading procedure in this
section.
Read F1 (Button) Select to begin readings to establish values for the Current Mean and the
Current %CV fields.
Load/Read (Button) Select to transport the vessel in RV shuttle position 1 to the luminometer.
Vessel F2 The system takes luminometer readings until you select Cancel F8.
For more information, see the Taking a Luminometer Reading procedure in this
section.
Save LED (Button) Select to save the LED reading as the LED target value. An informational
Reading F3 message is sent to the Event Log.
Save High Volt (Button) Select to save a new entry in the High Voltage Control field. After you
Control F4 select this button, an informational message is sent to the Event Log.
Cancel F8 (Button) Select to end a luminometer reading that is in progress. This button is only
available when the system is taking a luminometer reading.
Viewing Lumi- Use this procedure to view information about the luminometer calibration.
nometer Infor-
CAUTION
mation
Perform luminometer readings and save values only as directed by a
technical support representative or if you are following instructions in Help
system or in an Access 2 manual.
2. Go to the Device Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4.
4. You can view the high voltage reading and the LED target calibration value
displayed on the luminometer screen.
CAUTION
Use this procedure only as directed by a technical support representative or
if you are following instructions in Help system or in an Access 2 manual.
2. Go to the Device Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4.
CAUTION
Use these procedures only as directed by a technical support representative
or if you are following instructions in Help system or in an Access 2 manual.
Viewing Ultra- Use this procedure to view the information about the ultrasonic transducer and level
sonics sensor.
CAUTION
Turn devices off and on and change values in the Ultrasonics window only as
directed by a technical support representative or if you are following
instructions in Help system or in an Access 2 manual.
2. Go to the Device Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4.
0742b.bmp
Figure 5-45 Ultrasonics Window
PCB Power On (Box) Displays the on/off state of the ultrasonics printed
circuit board (PCB). The default state is selected (power
on). Clear the box to turn the PCB power off.
Sonicator On (Box) Displays the on/off state of the sonicator. The default
state is not selected (sonicator off).
4. You can view ultrasonics information in various fields in the Ultrasonics window.
Provide information as requested to your technical support representative.
Performing a Use this procedure to test the level sensing of the ultrasonic transducer. The test
Level Sense follows the steps the system and main pipettor perform before aspirating samples
Test during sample processing.
WARNINGS
• 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.
• Wash buffer contains a preservative, which may cause sensitization by skin
contact. After contact with skin, wash immediately with soap and water.
Wear suitable gloves.
CAUTION
Use this procedure only as directed by a technical support representative or
if you are following instructions in Help system or in an Access 2 manual.
Required Materials
• 13 mm rack for 2 mL sample cups
• 2 mL sample cup
• Wash buffer
• Pipettor for pipetting 200 µL of fluid
Steps
1. Confirm that the system is in the Ready mode.
2. Go to the Device Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then.select Device
Diagnostics F4.
4. Be sure that Low is selected for the Sonicator Power field, then select
Level Sense Test F2.
0743A.bmp
Figure 5-47 Ultrasonic Level Sense Test Window
Test Mode (Field) Select the test mode you want to run from the list.
The test values refer to the following tests:
• Dry -Tests for fluid being detected when no fluid is
present.
• Wet - Tests for fluid not being detected when fluid is
present.
• Dry and Wet
Test Repetitions (Field) Type the number of repetitions you want to run.
You can type a value from 1-999.
Dry Failure (Field) Displays the number of repetitions in which
Count ultrasonics sensed fluid when no fluid was present.
Dry Z Step Range (Field) Displays the minimum and maximum steps that the
probe was lowered during the dry test.
Dry %CV (Field) Displays the percent coefficient of variation for the
dry z step range.
Current Test (Field) Displays the type of test that the system is currently
performing.
Values are: Dry, Wet
Steps this (Field) Displays the number of steps for the current
Repetition repetition.
Wet Failure (Field) Displays the number of repetitions in which the
Count ultrasonics did not sense fluid when fluid was present.
Wet Z Step (Field) Displays the minimum and maximum steps that the
Range probe was lowered during the wet test.
Wet %CV (Field) Displays the percent coefficient of variation for the
wet z step range.
Print report at (Box) Select to print the Level Sense Report automatically
end of Test when the level sense test is complete.
Load a Rack F1 (Button) Select to load a rack. The button text changes
or from Load a Rack F1 to Unload Rack F1 when you select
Unload Rack F1 the button.
Start Test F2 (Button) Select to start or stop the level sense test. The
or button text changes from Start Test F2 to Stop Test F2
Stop Test F2 when you select the button.
5. Select the test or tests to run from the Test Mode list. Wet and dry refer to the
following tests:
• Dry - Tests for fluid being detected when no fluid is present.
• Wet - Tests for fluid not being detected when fluid is present.
6. Type the number of repetitions to run in the Test Repetitions field. You can run
up to 999 repetitions. A typical number of repetitions is 25 - 50. Fifty repetitions
can take approximately one hour to run.
(Optional) To print the Level Sense Report automatically, select the Print Report
at End of Test box.
NOTE
If Technical Support requests that you use a different sample container for the
test, the technical support representative also will inform you of the minimum fill
level.
9. Place the rack on the sample carousel, then select Done F1.
For more information about loading racks, see Section 3.1: Sample Management of
the Operator's Guide.
The progress of the test or tests, and then the results, are reported in the fields of the
Ultrasonics Level Test window.
12. When you are finished with the level sense testing, select Unload Rack F1.
Remove the rack from the sample carousel, then select Done F1.
For more information about unloading racks, see Section 3.1: Sample Management of
the Operator's Guide.
Exercising Use this procedure to cycle the movement of various mechanical devices by starting
Devices the preprogrammed exercise routine.
CAUTION
DO NOT use this function unless directed to do so by a technical support
representative or if you are following instructions in Help system or in an
Access 2 manual.
0744A.bmp
Figure 5-49 Exerciser Window
Selected Test (Field) Select the device to run the exercise procedure on
from the list of devices:
• Wash Arm
• Wash Carousel Transfer
• Incubator Track
• Reaction Vessel Holders
• Wash Carousel Mixer
Default device: Wash Arm
NOTE
Selecting Stop Cycling F2 does not immediately stop the exercise routine. The
test stops after the present cycle is complete.
2. Go to the Device Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4.
(Optional) If you want a report to print when calibration is complete, select the
Print Report at End of Calibration box.
NOTE
If the calibration fails, then the calibration stops, the system changes to the Not
Ready mode, and an event is generated in the Event Log. For information about
troubleshooting an event, see Section 6.3: Troubleshooting Events.
Copying Diag- Use this procedure to copy test result data, QC data, event log information, system
nostic Data to configuration information, and other diagnostic information to a 3.5-inch high density
a Disk or USB disk or a USB flash drive.
NOTE
If your instrument has USB flash drive technology, a Drive field is displayed
beneath the File name field.
0898C.bmp
Figure 5-52 Copy to Disk (Diagnostics) Window
File Name (Field) Type a unique file name in this field and the system
adds the file extension. If you do not enter a file name, the
system automatically assigns one (based on date and time).
Start Date (Field) Type a date indicating the starting point of the data
you want copied. If you do not type a date, the system uses
the default date of 90 days ago.
Drive (List) For a USB flash drive, select the external computer
drive to which data should be copied.
Data Copied (Field) Displays the console (PC) and instrument
information to be copied.
Format Disk (Box) Select to format a 3.5-inch high density disk.
Formatting a disk prepares it for reading and writing data.
NOTES
• If you do not specify a file extension, the system automatically adds the .csv
file extension.
• If you do not enter a file name, the system supplies a unique file name based
on the date and time.
4. Type a start date into the Start Date field. A default date (90 days ago) is
displayed, unless you type a different date.
(Optional) If your instrument has USB flash drive technology, confirm that the
correct drive is selected from the Drive list, or select a different drive.
NOTE
Unless directed by Technical Support, do not copy data to the C: Console PC
drive or any drive labeled BACKUPDRIVE.
NOTE
Be sure you insert the disk into the A: drive of the PC, not of the Access 2
instrument.
• To copy data to a USB flash drive, insert a flash drive into a port on the front
of the PC. If the front of the PC does not contain a USB port, use a port on the
back of the PC.
(Optional) If the 3.5-inch disk you are using is not formatted, select the Format
Disk box, then OK F1.
A confirmation window is displayed, advising you that if the disk contains data, it will
be overwritten when it is formatted.
6. Select OK F1.
The system begins to copy the data. A progress window is displayed and you may
select Cancel F8 at any time to end the copy process.
7. If the disk or flash drive becomes full before the copy process is complete, the
system displays a status message.
• For a 3.5-inch disk:
- Remove the disk from the drive. Label it with the data file name.
8. Remove the disk or flash drive from the PC when copying is complete. Label it
with its data file name.
The Access 2 system monitors the data transmissions to and from the LIS and
displays this coded information on the LIS Diagnostics screen. With the assistance of
Technical Support, you can use the LIS Diagnostics screen to help diagnose a
problem with the connection between the LIS and the Access 2 system.
You can view the LIS information in real time. To print the information, use the [Print
Screen] key.
You cannot access LIS information if the LIS is not connected or if the LIS is
disabled. If you have any questions about how to connect the LIS, contact Technical
Support.
LIS Diagnos- You use the LIS Diagnostics screen with the assistance of Technical Support to:
tics Screen • View the data transmissions that occur between the LIS and the system in
real-time
• Access the LIS Setup screen to verify settings
• Perform a loopback check (if requested by a technical support representative)
• Query the LIS for an individual test request by its sample ID
• Copy the data transmissions displayed on the LIS Diagnostics screen
You access the LIS Diagnostics screen from the Diagnostics menu.
0865D.bmp
Figure 5-54 LIS Diagnostics Screen
Legend (Field) Displays a color key for the messages on the communication monitor.
Messages originating from the Access 2 system are black, while messages originating
from the LIS are blue.
Baud Rate (Field) Displays the speed of the data transmission between the LIS and the
Access 2 system. You can change the baud rate setting on the server system only by
selecting LIS Setup F1.
Default: 9600
For more information about how to configure the baud setting, see Section 4.9: LIS
Setup.
Communication (List) Displays up to the most recent 100 data transmissions between the LIS and the
Monitor Access 2 system for all instruments in the workgroup.
The most recent transmissions are located at the bottom of the screen. You can use the
scroll bar to view the older transmissions.
Messages originating from the Access 2 system are black, while messages originating
from the LIS are blue.
LIS Setup F1 (Button) Select to display the LIS Setup window. This is the same window that
displays when you select the Configure F8 from the Main Menu, then LIS Setup F6.
For more information about how to use the LIS Setup window, see Section 4.9: LIS
Setup in this manual.
Loopback (Button) Select to run a loopback check, which verifies that the communication
Check F3 between your instrument and the LIS is working properly.
NOTE: Use this procedure only as directed by a technical support representative.
Query for Test (Button) Select to request test information for a specific sample, using the sample ID.
Requests F4
Copy to Disk F6 (Button) Select to copy all of the information from the LIS Diagnostics screen. This
button is unavailable when there are no transmissions.
For more information about how to use this option, see the Copying Data
Transmissions procedure in this section.
Clear Screen F8 (Button) Select to clear all of the information from the LIS Diagnostics screen.
Performing a Use this procedure with the assistance of Technical Support to query the LIS for test
Query for Test request information for a specific sample.
Requests NOTE
You can only use this procedure if the system is configured with host query
capability. For more information about enabling or disabling host query, see
Section 4.9: LIS Setup.
1. Go to the LIS Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select LIS F5.
4. Select OK F1.
The system asks the LIS for the test request information of the sample ID you entered.
Printing a When the LIS host replies to a query for test requests, you can view the data
Reply from transmission on the LIS Diagnostics screen. Technical Support may request that you
the LIS Host send a copy of the transmission for diagnostic interpretation. Use the [Print Screen]
key to print a copy to send.
Copying Data Use this procedure to copy the data transmissions displayed on the LIS Diagnostics
Transmis- screen to the C:\ directory of the PC.
sions 1. Go to the LIS Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select LIS F5.
2. Select Copy to Disk F6.
The LIS Copy to Disk window is displayed.
3. The window indicates the data that will be copied to the C:\ directory of the PC.
4. Select OK F1.
The system displays a progress message during the copy process and assigns a file
name based on the date and the time.
5. For assistance in retrieving the data, contact Technical Support.
Clearing the Use this procedure to clear the LIS Diagnostics screen of all data transmissions to and
Data Trans- from the LIS.
missions NOTE
If you clear the screen, the record of all transmissions (up to 100) on the LIS
Diagnostics screen are deleted.
1. Go to the LIS Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select LIS F5.
There are four types of reports you can print from the Diagnostics screen. Reports
must be selected individually for printing. As a report is being prepared for printing,
the system displays progress messages.
Alignment Report Select to print all of the alignment values for all
primary system devices. This report also includes
total instrument run time (in hours), luminometer
information, and hardware and software versions.
Level Sense Report Select to print the ultrasonic transducer status. This
report also can be automatically printed after you run
the level sense test.
For more information about the level sense test, see
Section 5.8: Advanced Diagnostics.
Incubator Belt Select to print the incubator belt calibration data.
Calibration Report This report also can be automatically printed after
you run the incubator belt calibration procedure.
For more information about setting up reports, see
Section 4.2: System Setup.
Temperature Report Select to print the temperatures, duty cycle, and
status displayed in the Analog Devices window (see
Section 5.6: Analog and Digital Device
Diagnostics). You can also print the Temperature
Report from the Maintenance screen.
• Temperature Report
3. Select OK F1.
The system begins to print the report. Progress messages are displayed in the status
line while the system transfers information to the printer.
Laboratories, Inc.
Laboratory A
123 Lake Street
Alignment Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 500135 T. Nguyen
Device: Pipettor
Reagent Carousel - X -1
Reagent Carousel - Z -15
Sample Carousel - X 12
Sample Carousel - Z -23
Wash Tower - X 0
Wash Tower - Z 25
RV Shuttle - X 12
RV Shuttle - Z -23
Device: Rake
RV Shuttle -10
Laboratories, Inc.
S/N 500135 Laboratory A
Hardware Versions:
Model Number
Instrument Serial Number 500135
SMC Firmware 03
Stepper Driver PCB 48
Power Driver PCB 33
Ultrasonic PCB 38
Backplane PCB 34
I/O PCB 48
Software Versions:
Instrument Software Version 0.386
Instrument Operating System 2.2
Assay Protocol File 1.9.18
PC Software version 0.386.338.1
PC Operating System 4.0, Service Pack 4
Bar Code:
External Bar Code Reader
Internal Bar Code Reader Read Sample IDs
Interleaved 2 or 5, Characters = 10
CODABAR
CODE 39
Page 2 of 2
Technologist __________________________________________ Printed 09-09-05
0902D.bmp
Figure 5-58 Alignment Report, Page 2 of 2
Laboratories, Inc.
Laboratory A
123 Lake Street
Level Sense Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 500135 T. Levasseur
Dry Failure Dry Z Step Dry %CV Wet Failure Wet Z Step Wet %CV
Count Range Count Range
0 275-275 0.00 0 70-90 2.08
Page 1 of 1
Technologist ___________________________________________ Printed 09-09-05 12:43 PM
0906C.bmp
Figure 5-59 Level Sense Report
Laboratories, Inc.
Laboratory A
123 Lake Street
Incubator Belt Calibration Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 500135 O. Wagner
0904C.bmp
Figure 5-60 Incubator Belt Calibration Report
Laboratories, Inc.
Laboratory A
123 Lake Street
Temperature Report Townsville, ST 33333
Access 2 Immunoassay System 101- 555 -2323 ext. 109
S/N 500035 Jane Smith
Page 1 of 1
Technologist __________________________________________ Printed 11-11-11
0905C.bmp
Figure 5-61 Temperature Report
When you select the System Check routine as part of weekly maintenance, you run all
of the individual checks together. With information from these checks, you can
identify instrument problems and begin troubleshooting.
You can also run the individual checks to troubleshoot individual components of the
system.
For more information about troubleshooting the system with results from the System
Checks, see Section A.2: System Check Troubleshooting.
For information about the theory behind individual checks, see Section 3.5: System
Check Theory.
For information on how to run the complete system check routine, see Section 8.4:
System Check of the Operator's Guide.
Required Materials
WARNING
System Check Solution contains a preservative, which may cause sensitization by
skin contact. After contact with skin, wash immediately with soap and water.
Wear suitable gloves.
NOTE
Use only the 2.0 mL sample cups when performing the maintenance routines.
Using any other sample containers may result in level sensing errors and
cancellation of the maintenance routine.
Steps
1. Pipette 2.0 mL of undiluted System Check Solution into the sample cup in
position 7 of a rack. The sample cup should be full, but the solution level
should not be higher than the top of the cup.
2. Be sure that the system is in the Ready mode. Go to the Sample Manager screen.
To get to this screen from the Main Menu, select Sample Manager F1.
3. Be sure that the Rack ID field is selected, then type the rack ID and press [Enter].
The new rack is displayed in the Inventory list on the Sample Manager screen.
NOTE
Load the rack after requesting the maintenance routine. If you load the rack first,
the system recognizes the rack as a patient sample rack, and will not accept the
maintenance request. If the rack is already onboard, unload the rack, clear it, and
load the rack again after requesting the maintenance routine.
NOTE
When you select Maintenance Request F4, the Sample Manager screen is no
longer displayed.
5. Select the System Check box, then select Washed from the System Check list.
6. Select OK F1.
The Maintenance Requests screen is displayed.
7. Select Load Rack X F1. (The X represents the number of the rack that you
entered into the Rack ID field.)
The system displays the Done window and presents a rack position.
WARNINGS
• Unless there is an emergency, let the maintenance routine run to completion.
Cancelling the routine may damage the instrument and compromise the
integrity of subsequent test results.
• If you stop the routine, do not initialize the system. Contact Technical
Support for assistance.
9. Select Run.
The system displays the test results as the samples are processed. When processing is
complete, the system runs the Utility Assay.
NOTE
To print the System Check Report, select Print Report F7 from the System
Check screen.
10. When the washed check is complete, unload the rack and select Done F1.
For more information on unloading a rack, see Section 3.1: Sample Management of
the Operator's Guide.
11. Compare the obtained results with the expected results listed on the report or in
Table 5-62.
• If you need assistance, contact Technical Support.
Required Materials
• 13 mm rack for 2 mL sample cups
• 2 mL sample cup
NOTE
Use only the 2.0 mL sample cups when performing the maintenance routines.
Using any other sample containers may result in level sensing errors and
cancellation of the maintenance routine.
Steps
1. Place an empty sample cup in position 9.
2. Be sure that the system is in the Ready mode. Go to the Sample Manager screen.
To get to this screen from the Main Menu, select Sample Manager F1.
3. Be sure that the Rack ID field is selected, then type the rack ID and press [Enter].
The new rack is displayed in the Inventory list on the Sample Manager screen.
NOTE
Load the rack after requesting the maintenance routine. If you load the rack first,
the system recognizes the rack as a patient sample rack, and will not accept the
maintenance request. If the rack is already onboard, unload the rack, clear it, and
load the rack again after requesting the maintenance routine.
NOTE
When you select Maintenance Request F4, the Sample Manager screen is no
longer displayed.
5. Select the System Check box, then select Substrate from the System Check
list.
6. Select OK F1.
The Maintenance Requests screen is displayed.
7. Select Load Rack X F1. (The X represents the number of the rack that you
entered into the Rack ID field.)
The system displays the Done window and presents a rack position.
WARNINGS
• Unless there is an emergency, let the maintenance routine run to completion.
Cancelling the routine may damage the instrument and compromise the
integrity of subsequent test results.
• If you stop the routine, do not initialize the system. Contact Technical
Support for assistance.
9. Select Run.
The system displays the test results as the samples are processed. When processing is
complete, the system runs the Utility Assay.
NOTE
To print the System Check Report, select Print Report F7 from the System
Check screen.
10. When the substrate check is complete, unload the rack and select Done F1.
For more information on unloading a rack, see Section 3.1: Sample Management of
the Operator's Guide.
11. Compare the obtained results with the expected results listed on the report or in
Table 5-63.
• If you need assistance, contact Technical Support.
Expected %CV ≤ 5%
Expected RLU Mean 5,000–9,000
Required Materials
WARNING
System Check Solution and wash buffer contain a preservative, which may cause
sensitization by skin contact. After contact with skin, wash immediately with
soap and water. Wear suitable gloves.
NOTE
Use only the 2.0 mL sample cups when performing the maintenance routines.
Using any other sample containers may result in level sensing errors and
cancellation of the maintenance routine.
Steps
1. Prepare a 1/501 dilution of System Check Solution. Mix 20 µL System Check
Solution with 10.0 mL of wash buffer.
2. Pipette 1 mL of the 1/501 diluted System Check Solution into a sample cup and
place the cup in sample position 10.
3. Be sure that the system is in the Ready mode. Go to the Sample Manager screen.
To get to this screen from the Main Menu, select Sample Manager F1.
4. Be sure that the Rack ID field is selected, then type the rack ID and press [Enter].
The new rack is displayed in the Inventory list on the Sample Manager screen.
NOTE
Load the rack after requesting the maintenance routine. If you load the rack first,
the system recognizes the rack as a patient sample rack, and will not accept the
maintenance request.If the rack is already onboard, unload the rack, clear it, and
load the rack again after requesting the maintenance routine.
NOTE
When you select Maintenance Request F4, the Sample Manager screen is no
longer displayed.
6. Select the System Check box, then select Unwashed from the System Check
list.
7. Select OK F1.
The Maintenance Requests screen is displayed.
8. Select Load Rack X F1. (The X represents the number of the rack that you
entered into the Rack ID field.)
The system displays the Done window and presents a rack position.
WARNINGS
• Unless there is an emergency, let the maintenance routine run to completion.
Cancelling the routine may damage the instrument and compromise the
integrity of subsequent test results.
• If you stop the routine, do not initialize the system. Contact Technical
Support for assistance.
The system displays the test results as the samples are processed. When processing is
complete, the system runs the Utility Assay.
NOTE
To print the System Check Report, select Print Report F7 from the System
Check screen.
11. When the unwashed check is complete, unload the rack and select Done F1.
For more information on unloading a rack, see Section 3.1: Sample Management of
the Operator's Guide.
12. Compare the obtained results with the expected results. The results are listed in
the report and in Table 5-64.
• If you need assistance, contact Technical Support.
Expected %CV ≤ 2%
Expected RLU Mean 4 to 10 million*
6 Event Log
6.1 Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
The Event Log is a list of events the Access 2 system generates as it monitors the
status of various system parameters. You can use these events to keep informed of
system operations and to assist with troubleshooting.
The Event Log screen displays up to 10 events, based on the current filter settings and
sort option. If more than 10 events fit the filter criteria, you can use the scroll bar to
view additional events.
NOTE
If you have a workgroup with more than one instrument, you can view only the
events that are specific for the instrument attached to the PC displaying the Event
Log.
The Event Log contains a maximum of 2,400 events for a single system or for a
workgroup, regardless of the number of instruments in the workgroup. The oldest
event is overwritten when the maximum is exceeded.
You can access the Event Log screen from any screen by selecting the Event Log
button or pressing [Scroll Lock].
0607B.bmp
Figure 6-1 Event Log Screen
Filter Status (Indicator) Displays the current status of the filter. The default status is Filter Off.
Indicator Values are: Filter On and Filter Off.
Type (Column) Identifies the type of event by the following icons:
Date/Time (Column) Displays the date and time when the event occurred.
Event (Column) Displays a brief description of the event.
Filter F1 (Button) Select to choose a filter to apply to the event list. With the default filter
settings, the event list includes all events.
Troubleshoot F2 (Button) Select to view troubleshooting Help system information for the selected
event.
This function is not available for information events.
Details F4 (Button) Select to view the Details window for the selected event.
The window displays technical information about the event, which may be useful for
Technical Support during troubleshooting.
Find F5 (Button) Select to search the event list for a specific event by text in the event
description. If a filter is applied, the search is limited to the events that fit the filter
criteria.
Sort F6 (Button) Select to sort the event list in ascending or descending chronological order.
Print F7 (Button) Select to print all events that fit the filter criteria or only the events currently
displayed on the screen. You can also choose to print details.
Under normal conditions, the Event Log button is neutral in color. The button turns
red when a warning event occurs or yellow when a caution event occurs. The button
returns to neutral when you display the Event Log screen.
If a new event occurs while you are viewing the Event Log screen, the new event is
displayed in real-time. If a caution or warning event occurs, the Event Log button
changes color accordingly.
When you display the Event Log screen, the currently selected event is highlighted.
Any events you did not previously view are displayed in blue.
Any Screen
OK
F1
Desired set
Filter
of events No F1
displayed?
Yes
Display events in
Search to find a
ascending or Print Event Log Report
specific event
descending order
OK OK OK
F1 F1 F1
0659A.wmf
Figure 6-3 Reviewing Events Flowchart
Applying an An Event Log filter is a set of parameters you can change to reduce or expand the
Event Log Fil- number of events displayed on the Event Log screen.
ter The Event Log screen default is Filter Off. When the filter is off, you can view all
events.
Use this procedure to apply a different filter to the Event Log screen.
1. Go to the Filter window. To get to this window from any screen, select the Event
Log button to display the Event Log screen, then select Filter F1.
0608A.bmp
Figure 6-4 Filter (Event Log) Window
Date Range (Option) Select a date range to include in the filter. Options
are: View All Dates, Last 24 Hours, Last 7 Days, or
Specify.
Start Date and (Fields) If you select the Specify option, Start Date and
End Date End Date default to the current date.
Select the field and enter the starting and ending dates you
want to include in the filter.
The date format selected during system setup determines
the acceptable format for Start Date and End Date. The
following date entry rules apply:
• You can enter a zero in front of single-digit months and
days (not required).
• You can enter two or four digits for the year. If you do
not enter the year, the system assumes the current year.
If you enter a two-digit year that is less than 60, the
system assumes the year is after 1999.
• If the End Date is prior to the Start Date, or if you enter
an invalid date format, a message is displayed. You must
correct the dates before you continue.
Type (Boxes) Select Information to include information events
in the filter, Caution to include caution events in the filter,
and Warning to include warning events in the filter.
You must select at least one type of event.
View All (Button) Select to turn the filter off and include all events
Events F2 in the Event Log.
3. Select OK F1.
The system displays the events that fit the selected filter parameters on the Event Log
screen. The system uses the selected filter until you apply a new one.
Finding an Use this procedure to search the Event Log for a specific event.
Event If a filter is applied, the search is limited to the events that fit the filter criteria.
1. Go to the Event Log screen. To get to this screen from any screen, select the
Event Log button.
0628A.bmp
Figure 6-6 Find (Event Log) Window
3. In the Find What field, enter the text you want to find.
For example, you can type “pipettor” to find events related to the main pipettor.
(Optional) To change the direction of the search, select the Up or Down option.
4. To find an event that fits the search criteria, select Find Next F1.
The closest match to the search parameters you entered becomes the selected event.
If the system does not find a match, it displays a message.
(Optional) To find the next event that fits the search criteria, select Find Next F1.
Sorting Use this procedure to sort the Event Log into ascending order (most recent events at
Events the bottom) or descending order (most recent events at the top).
If a filter is applied, the list is limited to the events that fit the filter criteria.
1. Go to the Sort window. To get to this window from any screen, select the Event
Log button to display the Event Log screen, then select Sort F6.
3. Select OK F1.
The Event Log screen is displayed in the selected sort order. The system uses the
selected sort order until you apply a different one.
Printing Event Use this procedure to print the Event Log Report.
Log Reports If a filter is applied, the report is limited to the events that fit both the filter criteria and
the print range.
1. Go to the Event Log screen. To get to this screen from any screen, select the
Event Log button.
(Optional) To locate a group of events to print a report for, apply a filter to reduce
the number of events. For information about how to apply a filter, see the
Applying an Event Log Filter procedure in this chapter.
(Optional) To find a specific event, select Find F2. For information about how to
find an event, see the Finding an Event procedure in this chapter.
0624A.bmp
Figure 6-8 Print (Event Log) Window
Print Range (Option) Select a print range for the Event Log Report.
If the filter is off, the All option prints the all events. If the
filter is on, the All option pints the events that fit the filter
criteria.
The Current Page option prints the displayed events.
Print Details (Box) Select to include the details for each event.
(Optional) To change the print range, select the All or Current Page option.
• To print all events that fit the filter criteria, select the All option.
• To print the displayed events, select the Current Page option.
(Optional) To print details for each event, select the Print Details box. For more
information about event details, see the Viewing and Printing Event Details
procedure in this chapter.
3. Select OK F1.
• If you selected the All option, and there are more than 50 events in the Event Log,
a confirmation message is displayed. Select Yes F1.
The system sends the report to the printer.
Laboratories, Inc.
Laboratory A
123 Lake Street
Event Log Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 500035 Jane Smith
Filter: Off
0838B.bmp
Figure 6-10 Event Log Report
If a system error or potential problem generates an event in the Event Log, you can
view troubleshooting information for the event. This troubleshooting information
includes:
• Possible causes for the event.
• Brief outline of troubleshooting instructions.
• Links to detailed procedures. Always review the detailed procedures if you
are not completely familiar with them.
You can view technical information about an event in the Details window. The event
details, particularly the event code, can be useful for troubleshooting. If you contact
Technical Support for assistance, the representative may request the details for one or
more events.
For more information about troubleshooting information in the Help system system,
see the Viewing Troubleshooting Help procedure.
For more information about the Help system system, see the Preface.
Any Screen
Event Log
Review events
Yes
Event Log
Troubleshoot
F2
Access 2 Help
Yes
Yes
Details
F4
Details
Print
F7
0840B.wmf
Figure 6-11 Troubleshooting Events Flowchart
Viewing Trou- Use this procedure to view troubleshooting information for an event.
bleshooting
1. Go to the Event Log screen. To get to this screen from any screen, select the
Help Event Log button.
2. Select the caution or warning event you want to get troubleshooting information
for.
NOTE
Troubleshooting Help system is not available for information events.
0847C.bmp
Figure 6-12 Example Troubleshooting Help Window
Viewing and Use this procedure to view the details for an event.
Printing Event
1. Go to the Event Log screen. To get to this screen from any screen, select the
Details Event Log button.
2. Select the caution or warning event you want to view details for.
0630C.bmp
Figure 6-13 Details (Event Log) Window
Event (Field) Displays the event selected from the Event Log
screen.
Code (Field) Displays a system-generated number that identifies
the event.
The first two digits of the code are zeros and are not
included in the numeric List of Events.
Date/Time (Field) Displays the date and time when the event occurred.
A troubleshooting Help system topic is displayed. You can display the same topic for
this event from the Event Log screen.
The List of Events provides an alphabetical listing of caution and warning events
(also referred to as error events) that can appear in the Event Log.
The List of Events includes the following information for caution and warning events.
A/D Converter • Failure detected in reading ADC 1. Print the event details (see Section 6.3).
Reading Failure data. 2. Reboot the instrument (see Section 7.3).
• Defective I/O board. • If the problem persists, contact Technical Support. The I/O
board may need replacement or system software may need to
be re-installed.
3. Continue normal operation. Contact Technical Support to
report the event.
Analog Device Error detected in the control of 1. Print the event details (see Section 6.3).
Error analog devices. 2. Record instrument operations preceding the event; for
example, waste bag was changed.
3. Reboot the instrument (see Section 7.3).
• If rebooting fails, contact Technical Support.
4. Continue normal operation. Contact Technical Support to
report the event.
APF Update APF or AAF disk is not for this 1. Remove the disk from the CD-ROM/DVD drive.
Attempt with a immunoassay system. • If the removed disk is not for the Access 2 immunoassay
Disk from system, begin the update APF procedure again (see
Another System Section 4.4) with the correct system disk.
Failed
• If the disk is for the correct system, contact Technical
Support for assistance.
APF Update APF disk is from a previous APF. 1. Remove the disk from the CD-ROM/DVD drive.
Attempt to a 2. From the Main Menu, select Configure F8, then Tests F2 to
Previous display the Test screen. Compare the APF revision number to
Revision Failed the number on the removed CD-ROM.
• If the removed disk is for a revision number lower than the
current APF, begin the update APF procedure again (see
Section 4.4) with the disk with the same or a higher revision
number.
• If the disk is for the same or a higher revision number,
contact Technical Support for assistance.
Bar Code Defective CPU board. 1. Print the event details (see Section 6.3).
Initialization 2. Reboot the instrument (see Section 7.3).
Error
3. Contact Technical Support to report the event.
Calibration • Insufficient calibrator volume. 1. Review the Event Log and troubleshoot according to any
Failed For • Insufficient substrate. device error event with a date and time shortly before this
Assay XXX event.
• Expired calibrator or reagent pack.
2. If there are no device error events shortly before this event,
• Calibrators not in correct order on
follow the assay calibration troubleshooting instructions in
sample rack.
Appendix A.4: Assay Troubleshooting.
• Reagent pack in wrong slot.
3. Repeat the calibration. If you need assistance or if the problem
• Unstable or contaminated persists, contact Technical Support.
calibrator or reagent.
• Level sense failure.
• Inadequate particle washing.
Cannot XXX Device driver failed to configure or 1. Print the event details (see Section 6.3).
Luminometer disable the luminometer counter. 2. Contact Technical Support.
Counter
Cannot Fork Error detected in the system 1. Print the event details (see Section 6.3).
Database software. 2. Record instrument operations preceding the event; for
Update Process example, waste bag was changed.
3. Reboot the instrument (see Section 7.3).
• If rebooting fails, contact Technical Support.
4. Continue normal operation. Contact Technical Support to
report the event.
Cannot Move - Software timing error. 1. Print the event details (see Section 6.3).
Intersecting 2. From the Mechanics screen, check if the Incubator Belt, RV
Device Moving Shuttle, and Wash Carousel (Devices) are at the home or
index position (see Section 5.5).
3. Follow the steps for the appropriate situation below.
If the incubator belt and shuttle are at home or index and the wash
carousel is not:
1. Home the Wash Carousel (see Section 5.5).
• If homing fails, contact Technical Support.
2. Reboot the instrument (see Section 7.3).
3. Continue normal operation. Contact Technical Support to
report the event.
If the incubator belt and wash carousel are at home or index and
the shuttle is not:
1. Home the RV Shuttle (see Section 5.5).
• If homing fails, review the Event Log and troubleshoot
according to the error events with a similar date and time to
this event.
2. Reboot the instrument (see Section 7.3).
3. Continue normal operation. Contact Technical Support to
report the event.
If neither the incubator belt nor the wash carousel are at home or
index:
1. Clear the shuttle path (see Section 7.5).
2. Select Disable Motors F8, then manually rotate the incubator
belt until the index sensor is lit, then select Enable Motors F8.
3. Clear the wash carousel (see Section 7.8).
4. Home the Incubator Belt (see Section 5.5).
5. Be sure all covers are closed and reboot the instrument (see
Section 7.3).
6. Calibrate the incubator belt (see Section 5.8).
7. Continue normal operation. Contact Technical Support to
report the event.
Communication Error in communication between the 1. Go to the screen that was displayed when the error occurred.
Error instrument and the PC. Exit and re-enter the screen.
• If the problem persists, continue troubleshooting.
2. Reboot the PC (see Section 7.3).
• If the problem persists, continue troubleshooting.
3. Reboot the instrument (see Section 7.3).
• If the problem persists, contact Technical Support.
CPU Timeout CPU cannot process the transmitted 1. Print the event details (see Section 6.3).
Error information within the allotted time. 2. Record instrument operations preceding the event; for
example, waste bag was changed.
3. Allow time for all tests in process to complete and listen for
processing sounds to stop.
4. Reboot the instrument (see Section 7.3).
• If rebooting fails, contact Technical Support.
5. Repeat tests if necessary. Contact Technical Support to report
the event.
Crosstalk Leakage light from one RV to an 1. Review the event details for the date and time of the event and
Counts Outside adjacent RV exceeded 10,000 the crosstalk counts (see Section 6.3).
Limits RLUs. • If the crosstalk counts for the event are >21,000, repeat the
tests completed just before and after the event to verify the
results.
• If the crosstalk counts are <21,000, continue normal
operation. Crosstalk counts of <21,000 do not have a marked
effect on adjacent sample results.
• If you cannot find the crosstalk counts or the tests completed
just before and after the event, contact Technical Support.
Dark Counts • Improperly closed covers 1. From the Digital Devices window, turn on the vacuum pump
Outside Limits • Bright lighting near instrument. and probe wash valve (see Section 5.5).
• Electrical noise. 2. From the Luminometer screen, select Load/Read Vessel F2
(see Section 5.7).
• Fluid spill in wash carousel.
3. Observe the Current RLU field for 2 - 3 minutes, then select
Cancel F8. Typical values are below 50 and should be below
100.
4. Turn off the vacuum pump and probe wash valve.
5. Check if all covers are closed tightly to prevent light from
entering the instrument (see Section 7.2).
• If covers are not closed tightly, close them properly and
repeat step 1 through step 4.
– If RLU values decrease, continue normal operation.
• If all covers were closed tightly, check if bright lighting,
such as a lamp or window, is located near the instrument.
– If bright lighting is present, shield the instrument or
remove the light source and repeat step 1 through step 4.
– If RLU values decrease, remove the light source
permanently if possible, or contact Technical Support
for assistance with relocating the instrument.
• If all covers were closed tightly and there is no bright
lighting present, repeat step 1 through step 3.
– Continue to observe the Current RLU field for 5 - 10
minutes, and record atypical RLU values. Turn off the
vacuum pump and probe wash valve.
– If values were above 100, or if they began low and
increased or spiked, contact Technical Support.
6. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
Device Failed Device motion sequence failure. 1. Review the Event Log and troubleshoot according to the error
During Motion events with a similar date and time to this event.
Sequence 2. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
Device Failed Error received from device 1. Review the Event Log and troubleshoot according to the error
During Timing controller or from another process. events with a similar date and time to this event.
Pitch 2. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
Drift Correction Significant change occurred within 1. Print the event details (see Section 6.3).
Factor Outside the luminometer circuit. 2. Contact Technical Support.
Limits
Error Recovery Exceeded maximum attempts 1. Review the Event Log and troubleshoot according to the error
Failed - No New allowed for device error recovery. events with a similar date and time to this event.
Tests Started 2. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
FATAL Device Fatal instrument error. 1. Review the Event Log and troubleshoot according to the error
Error - Tests In events with a similar date and time to this event.
Progress 2. Run QC (see Section 3.4 in the Operator's Guide) for all
Cancelled assays and evaluate any out-of-range results
(see Appendix A.4).
3. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
FATAL System Fatal error detected within the 1. Print the event details (see Section 6.3).
Software Error system software. 2. Record instrument operations preceding the event; for
example, waste bag was changed.
3. Reboot the instrument (see Section 7.3).
• If rebooting fails, contact Technical Support.
4. Continue normal operation. Contact Technical Support to
report the event.
Incubator Belt Minor deviation detected during 1. Calibrate the incubator belt (see Section 5.8).
Calibration incubator belt calibration. • If calibration fails or if the error recurs, continue
Error - Belt May Note: troubleshooting.
Need Service
The system is operable, but the 2. Switch the vessel holder positions (see Section 7.5).
incubator belt may need service 3. Be sure all covers are closed and initialize the system (see
soon. Try to improve the incubator Section 5.2). If you need assistance or if the problem persists,
belt calibration results by contact Technical Support.
troubleshooting.
Incubator Belt Defective incubator belt. 1. Print the event details (see Section 6.3).
Calibration 2. Contact Technical Support.
Error - Belt
Needs Service
Incubator Belt • Missing or damaged vessel holder 1. From the Maintenance Review screen, select Disable Utility
Calibration or sensor flag. Assay F6 (see Section 8.1 in the Operator's Guide).
Error - Check • Incubator jam. 2. Replace any missing or damaged vessel holders (see
Belt Section 7.5).
3. Home the Incubator Belt (see Section 5.5).
4. Be sure all covers are closed and initialize the system (see
Section 5.2).
5. Calibrate the incubator belt (see Section 5.8).
6. Cycle the belt for 1 minute (see Section 5.5).
7. Exercise the belt for 2 cycles (see Section 5.8).
8. Enable the Utility Assay and continue normal operation. If you
need assistance or if the problem persists, contact Technical
Support.
Incubator Belt Mechanical or electrical failure. 1. Print the event details (see Section 6.3).
Motion Error 2. Review the Event Log and troubleshoot according to any error
event with a date and time shortly before this event.
3. From the Maintenance Review screen, select Disable Utility
Assay F6 (see Section 8.1 in the Operator's Guide).
4. From the Mechanics screen, check if the RV Shuttle and Wash
Carousel (Devices) are at the home or index position (see
Section 5.5).
• If the shuttle is not at home:
a. Clear the shuttle path (see Section 7.5).
b. Home the RV Shuttle. If homing fails, review the Event
Log and troubleshoot according to the error events with
a similar date and time to this event.
• If the wash carousel is not at home or index:
a. Open the front panel.
b. Select Disable Motors F8, then manually rotate the
incubator belt until the index sensor is lit, then select
Enable Motors F8.
c. Clear the wash carousel (see Section 7.8).
4. Check for fallen RVs in the shuttle transfer position and in the
front corners of the analytical module (see Section 7.5).
5. Replace missing or damaged vessel holders (see Section 7.5).
6. Home the Incubator Belt (see Section 5.5).
7. Be sure all covers are closed and reboot the instrument (see
Section 7.3).
• If you replaced any vessel holders, calibrate the incubator
belt (see Section 5.8), cycle the belt for 1 minute (see
Section 5.5), and exercise the belt for 2 cycles (see
Section 5.8).
8. Enable the Utility Assay and continue normal operation.
Contact Technical Support to report the event.
Incubator Belt Incubator belt has not been Calibrate the incubator belt (see Section 5.8). If you need
Not Calibrated calibrated since software was assistance or if the problem persists, contact Technical Support.
loaded.
IND flag is • For sandwich assays, which use 1. For IND flagged results which meet the following criteria,
associated with positive slope calibration curves, dilute and rerun the sample:
the result the result is at the low end of the • The result is on a competitive assay, and
concentration curve and cannot be
• Sample dilution is allowed for the assay, and
distinguished from a system
failure because the RLU reading is • The sample RLU is low.
too low. See the reagent instructions for use to determine the assay type
• For competitive assays, which and whether sample dilution is allowed.
use negative slope calibration 2. Rule out a system problem by reviewing the Event Log for
curves, the result is at either: error events with a date and time shortly before this event.
• The high end of the Troubleshoot accordingly.
concentration curve and 3. If you have ruled out a system problem and the IND flag event
cannot be distinguished from a is the only issue, recalibrating the affected assay may resolve
system failure because the the problem.
RLU reading is too low, or • Recalibrate the assay using a new reagent pack and a new set
• The low end of the of calibrators.
concentration curve and • Run QC.
cannot be distinguished from a
system failure because the • Repeat the test on the affected sample.
RLU reading is too high. If IND flags persist, contact Technical Support.
Invalid Invalid firmware revision for a 1. Print the event details (see Section 6.3).
Firmware On device axis detected on the SMC 2. Contact Technical Support. The SMC board may need
SMC Board board. replacement.
Invalid Sensor Invalid sensor input detected on the 1. Print the event details (see Section 6.3).
Input On SMC SMC board. 2. Contact Technical Support. The SMC board may need
Board replacement.
Luminometer Device driver did not receive 1. Print the event details (see Section 6.3).
Read Failed acknowledgement from the 2. Contact Technical Support.
luminometer.
Main Pipettor • Fluid leak. 1. Visually inspect the tubing leading from the precision pump
Detected an • Sensor failure. valve to the pressure monitor, and from the pressure monitor to
Abnormal the main pipettor (see Figure 1-3). If you see leaks, bubbles, or
Pressure crystalline deposits, contact Technical Support for assistance.
2. Print the event details (see Section 6.3).
3. Contact Technical Support. The pressure sensor may need
replacement.
Main Pipettor Obstruction detected due to: 1. Be sure the sample is free of clots or other solids.
Detected an • Solid matter in sample, or highly 2. Be sure the ID of the rack you are using is appropriate for the
Obstruction viscous sample. sample container (see Section A.2 in the Operator's Guide).
While
• Incorrect sample container for 3. Review the Event Log and troubleshoot any other events with
Aspirating
rack ID. a similar date and time to this event.
Sample
• Plugged primary probe. 4. Repeat the test. If you need assistance or if the problem
persists, contact Technical Support.
Main Pipettor Pressure monitor detected five or 1. Prime the pipettor twice (see Section 5.11), determine a new
Detected Too more obstructions in multiple reference curve for obstruction detection (see Section 5.5), be
Many samples due to: sure the sample is free of clots or other solids, and repeat the
Consecutive • Plugged primary probe. test.
Obstructions 2. If the failure recurs, run the Special Clean routine (see
• Damaged primary probe.
Section 8.5 in the Operator's Guide), run the System Check
• Mechanical problem or alignment.
routine, and determine a new reference curve for obstruction
detection. Repeat the test.
3. If the failure recurs, contact Technical Support to verify the
need to replace the primary probe.
Main Pipettor • Missing reagent packs. 1. If reagent packs might have been removed from the reagent
Disabled after • Leak in the fluidic system. carousel without using the user interface, look for packs using
Repeated the Retrieving Misplaced Packs procedure (see Section 2.7 in
• Precision pump failure.
Dispensing the Operator's Guide).
Failures • Pressure monitor failure.
• If there are missing or misplaced packs, unload and reload
all reagent packs according to the Retrieving Misplaced
Packs procedure. Then, continue troubleshooting with step
2.
• If the carousel contains the correct reagent packs in the
correct slots, contact Technical Support before continuing
troubleshooting.
2. Reset the pipettor and initialize the system (see Section 5.5).
• If initialization fails, contact Technical Support.
3. Continue normal operation. Run canceled tests again.
Main Pipettor • Obstruction in vertical path of the 1. Open the front panel (see Section 7.2).
Motion Error main pipettor. 2. Inspect the primary probe for damage (see Section 8.3 of the
• Obstruction in horizontal path of Operator's Guide).
the main pipettor. 3. Check for obstructions in the main pipettor pathway:
• Debris buildup on lower pipettor • In the vertical path, such as caps left on sample containers or
gantry shaft. reagent packs improperly seated in the reagent carousel.
• Mechanical or electrical failure. • In the horizontal path.
• If you find an obstruction, remove it.
4. Close the front panel (see Section 7.2).
5. From the Mechanics screen, home the Pipettor (see
Section 5.5).
• If homing fails, review the Event Log and troubleshoot
according to the error events listed.
6. Open the front panel.
7. Carefully slide the main pipettor from left to right. Check if the
probe touches the wash tower or incubator cover.
• If the probe touches the wash tower, contact Technical
Support.
• If the probe touches the incubator cover, be sure the
incubator cover is positioned correctly (see Section 7.2).
• If the probe does not touch the wash tower or incubator
cover, clean the lower pipettor gantry shaft (see Section 7.6).
8. Close the front panel and initialize the system (see
Section 5.2).
9. If the probe is damaged, or if you found an obstruction in the
vertical or horizontal path of the probe, contact Technical
Support.
10. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
Main Pipettor • Front panel not completely closed. 1. Be sure the front panel is completely closed (see Section 7.2).
Motion Error - • Defective interlock switch. 2. Initialize the system (see Section 5.2).
Front Panel
3. Continue normal operation. If you need assistance or if the
Open
problem persists, contact Technical Support.
Main Pipettor Defective main pipettor Z-axis home 1. Test the pipettor Z-axis home sensor (see Section 7.6).
X-Axis Motion sensor. 2. From the Mechanics screen, home the Pipettor (see
Error - Pipettor Section 5.5).
Z-Axis Not
• If homing fails, review the Event Log and troubleshoot
Home
according to the error events listed.
3. Select any Position except the Wash Tower. Select Move X to
Position F2, then Start Cycling F6 for 10-15 cycles, then
Stop Cycling F6. Select Home Device F1.
• If cycling or homing fails, contact Technical Support.
4. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
Mixer Belt • Broken mixer belt. 1. Open the front panel (see Section 7.2).
Speed Error - • Defective sensor. 2. Check the mixer belt to verify that it is intact (see Figure 7-35).
Outside Limits
• Defective motor. • If the mixer belt is broken, contact Technical Support.
3. From the Digital Devices window, turn on the mixer motor,
then verify the RPM field reads 2500 +/- 20 (see Section 5.6).
• If the RPM is not within 2500 +/- 20, contact Technical
Support.
4. Turn the motor off.
5. Close the front panel and continue normal operation. If you
need assistance or if the problem persists, contact Technical
Support.
Mixer Belt Mixer speed measurement not 1. Print the event details (see Section 6.3).
Break Detection supported by I/O board. 2. Contact Technical Support. The I/O board may need
Not Supported replacement.
No Empty Instrument sequencer was unable to 1. Print the event details (see Section 6.3).
Position Found find an empty position for an RV on 2. Record instrument operations preceding the event; for
On Incubator the incubator belt. example, waste bag was changed.
Belt
3. Reboot the instrument (see Section 7.3).
• If rebooting fails, contact Technical Support.
4. Continue normal operation. Contact Technical Support to
report the event.
No RV In • Missing RV from RV cartridge. 1. Check for fallen or missing RVs in the shuttle and shuttle
Pipetting • Dirty or defective RV sensor. transfer position (see Section 7.5).
Position 1 Or 2 • If no RVs are fallen or missing, test the RV sensors and
clean them if necessary (see Section 7.5).
• If RVs are fallen or missing, remove all the RVs in the
shuttle and continue troubleshooting.
2. Close the front panel.
3. From the Mechanics screen, home the RV Shuttle (see
Section 5.5).
4. Select Rake (Device) at RV Shuttle (Position). Select Home
Device F1, then Move Z to Position F3.
• If RVs are still fallen or missing in the shuttle, repeat step 1
through step 4 (omit the first bullet under step 1) until no
RVs are missing.
5. Be sure all covers are closed and initialize the system (see
Section 5.2).
6. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
NVRAM Test NVRAM test failure during software 1. Print the event details (see Section 6.3).
Failed During installation. 2. Contact Technical Support. The I/O board may need
Installation replacement.
Peristaltic Movement of peristaltic pump 1. Open the front panel (see Section 7.2).
Pump Running detected when the pump should be 2. From the Digital Devices window, turn on the peristaltic pump
Error stopped. (see Section 5.5).
3. Verify that the peristaltic pump status is Running and the
peristaltic pump is rotating (see Figure 1-5).
• If the pump is not in Running status and rotating, contact
Technical Support.
4. Turn off the peristaltic pump.
5. Verify that the peristaltic pump status is Stopped and the
peristaltic pump stops rotating.
• If the pump is not in Stopped status and it continues
rotating, contact Technical Support.
6. Close the front panel and continue normal operation. If you
need assistance or if the problem persists, contact Technical
Support.
Peristaltic No movement of peristaltic pump 1. Open the front panel (see Section 7.2).
Pump Stopped detected when the pump should be 2. From the Digital Devices window, turn on the peristaltic pump
Error running. (see Section 5.6).
3. Verify that the peristaltic pump status is Running and the
peristaltic pump is rotating (see Figure 1-5).
• If the pump is not in Running status and rotating, contact
Technical Support.
4. Turn off the peristaltic pump.
5. Verify that the peristaltic pump status is Stopped and the
peristaltic pump stops rotating.
• If the pump is not in Stopped status and it continues
rotating, contact Technical Support.
6. Close the front panel and continue normal operation. If you
need assistance or if the problem persists, contact Technical
Support.
PMT H.V. • Failure to write in DAC setup 1. Print the event details (see Section 6.3).
Supply - DAC values. 2. Contact Technical Support.
XXX • Corrupted data within NVRAM.
Possible Rake • Fallen RVs in RV loader. 1. Check for fallen or missing RVs in the shuttle (see
Motion Error • Missing or extra RVs in the RV Section 7.5).
During Row loader. • If RVs are fallen or missing, remove all the RVs in the
Advance shuttle and continue troubleshooting.
• RVs improperly loaded.
2. Close the front panel.
3. From the Mechanics screen, home the RV Shuttle (see
Section 5.5).
4. Select Rake (Device) at RV Shuttle (Position). Select Home
Device F1, then Move Z to Position F3.
• If RVs are still fallen or missing in the shuttle, repeat step 1
through step 4 until no RVs are missing.
5. Be sure all covers are closed and initialize the system (see
Section 5.2).
6. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
Precision • Debris buildup on valve. 1. Clean the precision valve (see Section 7.7).
Valve/Pump • Utility Assay disabled and 2. Continue normal operation. If you need assistance or if the
Motion Error instrument idle for extended time. problem persists, contact Technical Support.
• Precision valve failure.
• Mechanical or electrical failure.
Pump Stay • Precision pump motion error 1. Review the Event Log and troubleshoot according to the error
Awake routine • Precision valve motion error events with a similar date and time to this event.
failed to start 2. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
QC Result Not • Previous device motion error. 1. Review the Event Log and troubleshoot according to any
Obtained - No device motion error event with a date and time shortly before
Value Stored this event.
2. Repeat the test with a freshly prepared control. If you need
assistance or if the problem persists, contact Technical
Support.
Rake Homing • Obstruction interfering with rake 1. Check for fallen RVs or other obstructions between the rake
Error movement. and the wall of the incubator track (see Section 7.5).
• Mechanical failure. 2. Close the front panel.
3. From the Mechanics screen, home the RV Shuttle (see
Section 5.5).
4. Select Rake (Device) at RV Shuttle (Position). Select Home
Device F1, then Move Z to Position F3.
5. Be sure all covers are closed and initialize the system (see
Section 5.2).
6. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
Rake Motion • Fallen RVs in RV loader. 1. Check for fallen or missing RVs in the shuttle, and check for
Error • Missing or extra RVs in the RV fallen RVs or other obstructions between the rake and the wall
loader. of the incubator track (see Section 7.5).
• Obstruction interfering with rake • If RVs are fallen or missing, remove all the RVs in the
movement. shuttle and continue troubleshooting.
• Mechanical failure. 2. Close the front panel.
• RVs improperly loaded. 3. From the Mechanics screen, home the RV Shuttle (see
Section 5.5).
4. Select Rake (Device) at RV Shuttle (Position). Select Home
Device F1, then Move Z to Position F3.
• If RVs are still fallen or missing in the shuttle, repeat step 1
through step 4 until no RVs are missing.
5. Be sure all covers are closed and initialize the system (see
Section 5.2).
6. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
Reading Patient LIS test request did not include the 1. The Patient ID is required information in an LIS test request.
Record: Patient Patient ID. The test must be requested again with the Patient ID.
ID Missing 2. Share this information with the LIS vendor and if needed, refer
the vendor to Technical Support for clarification.
Reagent • Improperly loaded reagent pack 1. From the Mechanics screen, select Disable Motors F8 (see
Carousel interfering with movement. Section 5.5).
Motion Error • Defective sensor. 2. Slide the carousel door to the left and open the reagent
• Defective thermistor allowed ice carousel door.
to form in the carousel. 3. Manually rotate the reagent carousel in both directions,
• Defective bearings. checking the tops of the reagent packs for signs of damage.
• Mechanical or electrical failure. • If you cannot rotate the carousel, contact Technical Support.
4. Remove damaged reagent packs.
5. Select Enable Motors F8.
6. Select Reagent Carousel (Device) at Pipettor (Position).
Select Home Device F1, then Move X to Position F2, then
Start Cycling F6 for six cycles, then Stop Cycling F6 (see
Section 5.5).
• If homing or cycling fails, contact Technical Support.
7. Close the reagent carousel door and the carousel door.
8. Initialize the system (see Section 5.2).
• If you removed reagent packs, go to the Supplies screen and
unload and delete any reagent pack you removed (see
Chapter 2 in the Operator's Guide). Discard the reagent
packs.
9. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
Reagent pack • Pack was moved by an operator 1. From the Supplies screen, select a reagent pack button with
bar code • Pack was loaded out of sequence ???? in the Reagent Pack Name and Lot Number fields.
discrepancy 2. Unload the pack.
• Pack was loaded without using the
identified
Load Packs function 3. Reload the pack using the external bar code reader.
Reagent pack • Incorrect bar code 1. From the Supplies screen, select a reagent pack button with
bar code is • Damaged bar code label ???? in the Reagent Pack Name and Lot Number fields.
invalid 2. Unload the pack.
• Problem with bar code reader
3. Load the pack again using the external bar code reader.
• If the system correctly reads the bar code, the pack is now
loaded and can be used by the system to run tests. To
determine if the internal reagent bar code reader is broken,
skip to step 4 to troubleshoot the internal reagent bar code
reader.
• If the external bar code reader also failed to read the bar
code, the label may be unreadable. Enter the code manually
using the keyboard, and then skip to the last step in this
procedure.
4. If the pack was successfully read with the external bar code
reader in step 3, the pack is now correctly loaded on the
instrument. To troubleshoot the internal reagent bar code
reader, try loading a pack with a known good bar code label,
using the internal bar code reader. If the system fails to read
the bar code, contact Technical Support to troubleshoot the
internal bar code reader.
5. Review the Supplies screen for additional instances of reagent
pack buttons with ???? in the Reagent Pack Name and Lot
Number fields. Repeat this procedure for each instance.
Reagent pack • Pack was improperly removed 1. From the Supplies screen, select a reagent pack button with
bar code is from the instrument ???? in the Reagent Pack Name and Lot Number fields.
unreadable or • Bar code is no longer readable 2. Unload the pack.
the slot is
NOTE: If the slot is empty when you attempt to unload a pack,
empty
complete the unload operation to allow the system to properly
identify the empty slot. Then, skip to the last step in this
procedure.
3. Load the pack again using the external bar code reader.
• If the system correctly reads the bar code, the pack is now
loaded and can be used by the system to run tests. To
determine if the internal reagent bar code reader is broken,
skip to step 4 to troubleshoot the internal reagent bar code
reader.
• If the external bar code reader also failed to read the bar
code, the label may be unreadable. Enter the code manually
using the keyboard, and then skip to the last step in this
procedure.
4. If the pack was successfully read with the external bar code
reader in step 3, the pack is now correctly loaded on the
instrument. To troubleshoot the internal reagent bar code
reader, try loading a pack with a known good bar code label,
using the internal bar code reader. If the system fails to read
the bar code, contact Technical Support to troubleshoot the
internal bar code reader.
5. Review the Supplies screen for additional instances of reagent
pack buttons with ???? in the Reagent Pack Name and Lot
Number fields. Repeat this procedure for each instance.
Reagent pack • Incorrect bar code 1. From the Supplies screen, select a reagent pack button with
bar code length • Damaged bar code label ???? in the Reagent Pack Name and Lot Number fields.
is incorrect 2. Unload the pack.
• Problem with bar code reader
3. Load the pack again using the external bar code reader.
• If the system correctly reads the bar code, the pack is now
loaded and can be used by the system to run tests. To
determine if the internal reagent bar code reader is broken,
skip to step 4 to troubleshoot the internal reagent bar code
reader.
• If the external bar code reader also failed to read the bar
code, the label may be unreadable. Enter the code manually
using the keyboard, and then skip to the last step in this
procedure.
4. If the pack was successfully read with the external bar code
reader in step 3, the pack is now correctly loaded on the
instrument. To troubleshoot the internal reagent bar code
reader, try loading a pack with a known good bar code label,
using the internal bar code reader. If the system fails to read
the bar code, contact Technical Support to troubleshoot the
internal bar code reader.
5. Review the Supplies screen for additional instances of reagent
pack buttons with ???? in the Reagent Pack Name and Lot
Number fields. Repeat this procedure for each instance.
Reagent pack • Packs were moved by an operator The system will automatically recover from this error by
found in • A pack was loaded out of remapping empty slots and packs that were automatically loaded.
slot XXX was sequence, without using the Load However, any packs that were manually entered will not be
not expected Packs function remapped. In this case, perform the following steps.
1. Review the reagent pack buttons on the Supplies screen, and
Reagent pack • Packs were moved by an operator take one of the following actions:
found in
• If no buttons are found with ???? in the Reagent Pack
unexpected
Name and Lot Number fields, skip the remaining steps of
slot. Expected
this procedure. No additional action is needed.
slot contains
another pack. • If buttons with ???? in the Reagent Pack Name and Lot
Number fields are found, select one of the buttons and
continue with the remaining steps of this procedure.
2. Unload the pack.
3. Load the pack again using the external bar code reader.
• If the system correctly reads the bar code, the pack is now
loaded and can be used by the system to run tests. To
determine if the internal reagent bar code reader is broken,
skip to step 4 to troubleshoot the internal reagent bar code
reader.
• If the external bar code reader also failed to read the bar
code, the label may be unreadable. Enter the code manually
using the keyboard, and then skip to the last step in this
procedure.
4. If the pack was successfully read with the external bar code
reader in step 3, the pack is now correctly loaded on the
instrument. To troubleshoot the internal reagent bar code
reader, try loading a pack with a known good bar code label,
using the internal bar code reader. If the system fails to read
the bar code, contact Technical Support to troubleshoot the
internal bar code reader.
5. Review the Supplies screen for additional instances of reagent
pack buttons with ???? in the Reagent Pack Name and Lot
Number fields. Repeat this procedure or each instance.
Reagent pack • Pack has been marked as deleted Unload the pack and discard it. If you can locate the pack on the
has been in the database, but was found on Reagent Inventory, unload it from that screen. If not, perform the
deleted the instrument following steps.
1. From the Mechanics screen, select Disable Motors F8 (see
Section 5.5).
2. Slide the carousel door to the left and open the reagent
carousel door.
3. Manually rotate the reagent carousel clockwise until the pack
is in the loading position.
4. Remove the pack and discard it.
5. Select Enable Motors F8.
6. Select Reagent Carousel in the Device list. Select Home
Device F1.
7. Close the reagent carousel door and the carousel door.
8. Remap the reagent packs (from the Reagent Inventory or
Supplies screen, select Remap F3).
Reagent pack • Expired reagent pack was loaded Unload the expired pack and discard it.
has expired
Reagent pack is • Duplicate bar code 1. From the Supplies screen, select a reagent pack button with
already loaded • Pack was improperly moved from ???? in the Reagent Pack Name and Lot Number fields.
one instrument to another in a 2. Unload the pack.
workgroup 3. Repeat step 1 and step 2 for all instances of reagent pack
buttons with ???? in the Reagent Pack Name and Lot
Number fields.
4. Visually inspect the bar code on each unloaded pack.
• For packs with duplicate bar codes, contact Technical
Support. Do not use packs that have the same bar code as
another pack.
• For unloaded packs with bar codes that are not duplicates,
continue with the remaining steps of this procedure.
5. Load the pack again using the external bar code reader.
• If the system correctly reads the bar code, the pack is now
loaded and can be used by the system to run tests. To
determine if the internal reagent bar code reader is broken,
skip to step 6 to troubleshoot the internal reagent bar code
reader.
• If the external bar code reader also failed to read the bar
code, the label may be unreadable. Enter the code manually
using the keyboard.
6. If the pack was successfully read with the external bar code
reader in step 5, the pack is now correctly loaded on the
instrument. To troubleshoot the internal reagent bar code
reader, try loading a pack with a known good bar code label,
using the internal bar code reader. If the system fails to read
the bar code, contact Technical Support to troubleshoot the
internal bar code reader.
Reagent pack is • Pack is empty Unload the pack and discard it. If you can locate the pack on the
empty • Reagent pack monitoring detected Reagent Inventory screen, unload it from that screen. If not,
an issue perform the following steps.
1. From the Mechanics screen, select Disable Motors F8 (see
Section 5.5).
2. Slide the carousel door to the left and open the reagent
carousel door.
3. Manually rotate the reagent carousel clockwise until the pack
is in the loading position.
4. Remove the pack and discard it.
5. Select Enable Motors F8.
6. Select Reagent Carousel in the Device list. Select Home
Device F1.
7. Close the reagent carousel door and the carousel door.
8. Remap the reagent packs (from the Reagent Inventory or
Supplies screen, select Remap F3).
Reagent Pack • Insufficient reagent pack volume. 1. Unload the reagent pack and load a new reagent pack (see
Monitoring • Misplaced pack. Section 2.7 in the Operator's Guide).
Detected • If the lot number of the new reagent pack is different than
Insufficient the removed pack, recalibrate the assay (see Section 3.3 in
Reagent the Operator's Guide).
• If the pack removed is not the correct pack, unload and
reload all reagent packs using the Retrieving Misplaced
Packs procedure (see Section 2.7 in the Operator's Guide).
2. Continue normal operation. Run canceled tests again.
• If the problem persists, contact Technical Support.
Reagent Pack • Missing or disconnected pressure 1. Print the event details (see Section 6.3).
Monitoring monitor. 2. Contact Technical Support.
Device Failure • Pressure monitor failure.
Reagent Pack • Pack shared among instruments 1. Unload the reagent pack, discard it, and load a new reagent
Rejected after that are not in a workgroup. pack (see Section 2.7 in the Operator's Guide).
Repeated • Insufficient reagent pack volume. • If the lot number of the new reagent pack is different than
Monitoring the removed pack, recalibrate the assay (see Section 3.3 in
• Misplaced or misaligned reagent
Failures the Operator's Guide).
pack.
• Precision pump failure. • If the pack discarded was not the correct pack, unload and
reload the remaining reagent packs using the Retrieving
• Air in the pipettor tubing.
Misplaced Packs procedure (see Section 2.7 in the
• Pressure monitor drift or failure. Operator's Guide).
• If the reagent pack you removed is the correct pack, but does
not seem low on reagent, contact Technical Support.
2. Continue normal operation. Run canceled tests again.
• If the problem persists, contact Technical Support.
Reagent pack • Pack was improperly removed Locate the pack in the carousel or in an external location. If the
was not found from the instrument pack is found in the carousel, reload it manually.
or the bar code • Bar code is no longer readable To locate the pack in the carousel, perform the following steps:
is not readable
• Database error 1. From the Mechanics screen, select Disable Motors F8 (see
Section 5.5).
2. Slide the carousel door to the left and open the reagent
carousel door.
3. Manually rotate the reagent carousel clockwise until the pack
is in the loading position.
4. Remove the pack.
5. Select Enable Motors F8.
6. Select Reagent Carousel in the Device list. Select Home
Device F1.
7. Reload the pack manually. For more information, see the
Loading a Reagent Pack and Manually Entering Bar Code
Information procedure in Section 2.7 of the Operator's Guide.
Remap • An error occurred during the Troubleshoot according to recent related events.
completed with remap operation. One or more
errors additional events will be displayed
Reagent pack • Packs were moved by an operator The system will automatically recover from this error by
found in • A pack was loaded out of remapping empty slots and packs that were automatically loaded.
slot XXX was sequence, without using the Load However, any packs that were manually entered will not be
not expected Packs function remapped. In this case, perform the following steps.
1. Review the reagent pack buttons on the Supplies screen, and
Reagent pack • Packs were moved by an operator take one of the following actions:
found in
• If no buttons are found with ???? in the Reagent Pack
unexpected
Name and Lot Number fields, skip the remaining steps of
slot. Expected
this procedure. No additional action is needed.
slot contains
another pack. • If buttons with ???? in the Reagent Pack Name and Lot
Number fields are found, select one of the buttons and
continue with the remaining steps of this procedure.
2. Unload the pack.
3. Load the pack again using the external bar code reader.
• If the system correctly reads the bar code, the pack is now
loaded and can be used by the system to run tests. To
determine if the internal reagent bar code reader is broken,
skip to step 4 to troubleshoot the internal reagent bar code
reader.
• If the external bar code reader also failed to read the bar
code, the label may be unreadable. Enter the code manually
using the keyboard, and then skip to the last step in this
procedure.
4. If the pack was successfully read with the external bar code
reader in step 3, the pack is now correctly loaded on the
instrument. To troubleshoot the internal reagent bar code
reader, try loading a pack with a known good bar code label,
using the internal bar code reader. If the system fails to read
the bar code, contact Technical Support to troubleshoot the
internal bar code reader.
5. Review the Supplies screen for additional instances of reagent
pack buttons with ???? in the Reagent Pack Name and Lot
Number fields. Repeat this procedure or each instance.
Remap • An error occurred during the Troubleshoot according to recent related events.
completed with remap operation. One or more
errors additional events will be displayed
RV Cleanout Failure to clean out RVs due to error 1. Open the front panel, then remove the supply cover and
Error detected in RV tracking scheme. incubator cover (see Section 7.2).
Codes: 2. Remove any RVs remaining in the shuttle (see Figure 7-18)
360101 and clear the shuttle path (see Section 7.5).
360201 3. From the Mechanics screen, home the RV Shuttle (see
Section 5.5).
360a01
4. Select Disable Motors F8 (see Section 5.5).
5. Manually rotate the incubator belt one complete turn, checking
the shuttle transfer position for remaining RVs.
• If there are remaining RVs, remove them from the shuttle
transfer position.
6. Select Enable Motors F8 and home the Incubator Belt (see
Section 5.5).
7. Clear the wash carousel (see Section 7.8).
8. Home the Incubator Belt, then the Wash Carousel.
9. Replace and close all covers, then initialize the instrument (see
Section 5.2).
10. Calibrate the incubator belt (see Section 5.8).
11. Continue normal operation. Contact Technical Support to
report the event.
RV Cleanout Failure to clean out RVs due to error 1. Open the front panel, then remove the supply cover and
Error detected in RV tracking scheme. incubator cover (see Section 7.2).
Codes: 2. Remove any RVs remaining in the shuttle (see Figure 7-14).
360301 3. Replace and close all covers, then reboot the instrument (see
360501 Section 7.3).
4. Continue normal operation. Contact Technical Support to
report the event.
RV Cleanout Failure to clean out RVs due to error 1. Review the Event Log and troubleshoot according to the error
Error detected in RV tracking scheme. events with a similar date and time to this event.
Code: 2. Continue normal operation. If you need assistance or if the
360b01 problem persists, contact Technical Support.
RV Cleanout Loss of NVRAM due to: 1. Print the event details (see Section 6.3).
Error • Battery backup loss while power 2. Contact Technical Support.
Code: was down.
360c01 • Changed or removed I/O board.
RV Cleanout Device is not on an index flag. 1. From the Mechanics screen, check if the Incubator Belt, RV
Error Note: Shuttle, and Wash Carousel (Device) are at the home or index
Codes: position (see Section 5.5).
This event usually occurs after a
360801 motion error. 2. Follow the steps for the appropriate situation below.
360901 If the incubator belt and shuttle are at home or index and the wash
carousel is not:
1. Home the Wash Carousel (see Section 5.5).
• If homing fails, contact Technical Support.
2. Initialize the system (see Section 5.2).
3. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
If the incubator belt and wash carousel are at home or index and
the shuttle is not:
1. Home the RV Shuttle (see Section 5.5).
• If homing fails, review the Event Log and troubleshoot
according to the error events with a similar date and time to
this event.
2. Initialize the system (see Section 5.2).
3. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
RV Ejected With • No RV waste bag present. 1. Open the supplies door and locate the waste bag.
No Waste Bag • Improperly seated RV waste bag. • If no waste bag is present, install the waste bag currently in
Present use (if it is not full), or install a new waste bag, following the
• Undetectable plastic collar on
waste bag. Changing the RV Waste Bag procedure (see Section 2.6 in
the Operator's Guide). Continue normal operation.
• Improperly adjusted or defective
sensor. 2. Press firmly on the plastic collar on the waste bag to be sure it
is fully seated into the slot on the waste chute.
3. Test the waste bag sensor (see Section 7.4). If you need to
adjust the waste bag sensor, or if the problem persists after
adjustment, contact Technical Support.
RV Location RV to be read by luminometer does 1. Print the event details (see Section 6.3).
Conflict not match test ID requested by 2. Contact Technical Support.
system sequencer.
RV Location • Instrument was unable to find a 1. Print the event details (see Section 6.3).
Software Error specific RV. 2. Record instrument operations preceding the event; for
• Instrument was unable to find an example, waste bag was changed.
empty position on a device for an 3. Reboot the instrument (see Section 7.3).
RV.
• If rebooting fails, contact Technical Support.
4. Continue normal operation. Contact Technical Support to
report the event.
RV Waste Bag • RV waste bag does not have 1. Install a new waste bag, following the Changing the RV Waste
has Insufficient enough room left to complete the Bag procedure (see Section 2.6 in the Operator's Guide).
Capacity operation. Continue normal operation.
RV Waste Bag • No RV waste bag present. 1. Open the supplies door and locate the waste bag.
is Missing • Improperly seated RV waste bag. • If no waste bag is present, install the waste bag currently in
• Undetectable plastic collar on use (if it is not full), or install a new waste bag, following the
waste bag. Changing the RV Waste Bag procedure (see Section 2.6 in
the Operator's Guide). Continue normal operation.
• Improperly adjusted or defective
sensor. 2. Press firmly on the plastic collar on the waste bag to be sure it
is fully seated into the slot on the waste chute.
3. Test the waste bag sensor (see Section 7.4). If you need to
adjust the waste bag sensor, or if the problem persists after
adjustment, contact Technical Support.
Sample • Improperly positioned sample 1. Open the front panel and remove the supply cover, then close
Carousel rack, electrical wiring, or other the front panel (see Section 7.2).
Motion Error obstruction interfering with 2. From the Mechanics screen, select Disable Motors F8 (see
movement. Section 5.5).
• Mechanical or electrical failure. 3. Manually rotate the carousel in both directions, checking for
improperly positioned racks, electrical wiring, or other
obstructions.
• If you find an obstruction, try to reposition or remove it, then
rotate the carousel one full rotation.
• If you cannot rotate the carousel freely, contact Technical
Support.
4. Select Enable Motors F8.
5. Select Sample Carousel (Device) at Bar Code Reader
(Position). Select Home Device F1, then Move X to Position
F2, then Start Cycling F6 for six cycles, then Stop Cycling F6
(see Section 5.5).
• If homing or cycling fails, contact Technical Support.
6. Replace and close all covers and initialize the system (see
Section 5.2).
7. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
Sample • Insufficient sample volume. 1. Be sure you use an approved sample container, and pipette
Quantity Not • Overfilled sample container. sufficient sample for the requested tests into the sample
Sufficient (QNS) container (see Section A.2 in the Operator's Guide). Do NOT
• Incorrect sample container for
overfill.
rack ID.
2. Be sure the ID of the rack you are using is appropriate for the
• Incorrectly loaded sample
sample container (see Section A.2 in the Operator's Guide).
container or rack.
3. Properly place the sample container in the rack and load the
• Damaged primary probe tip.
rack on the instrument (see Section 3.1 in the Operator's
• Incorrectly torqued primary probe. Guide).
• Defective connections between 4. Rerun the test(s) (see Section 5.2 in the Operator's Guide). If
the main pipettor and pipettor the problem persists, continue troubleshooting at step 5.
interface board.
5. Remove the primary probe and check the tip. Replace the
probe if it is pitted (see Section 7.6).
6. Be sure the primary probe is installed and torqued correctly
(see Section 7.6).
7. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
Shuttle Motion • Overfilled RV waste bag. 1. From the Supplies screen, note the RV Waste number (see
Error • Improperly seated RV waste bag. Section 2.1 in the Operator's Guide).
• Mechanical or electrical failure. 2. Open the supplies door to view the waste bag. If the waste bag
is bulging, it may be overfilled.
• Obstruction in the path of the
shuttle. 3. Follow the steps for the appropriate situation below.
Snugging RVs • Missing RV from RV cartridge. 1. Check for fallen or missing RVs in the shuttle and shuttle
Into Shuttle • Fallen RV. transfer position (see Section 7.5).
Failed • If no RVs are fallen or missing, test the RV sensors and
• Dirty or defective RV sensor.
clean them if necessary (see Section 7.5).
• If RVs are fallen or missing, remove all the RVs in the
shuttle and continue troubleshooting.
2. Close the front panel.
3. From the Mechanics screen, home the RV Shuttle (see
Section 5.5).
4. Select Rake (Device) at RV Shuttle (Position). Select Home
Device F1, then Move Z to Position F3.
• If RVs are still fallen or missing in the shuttle, repeat step 1
through step 4 (omit the first bullet under step 1) until no
RVs are missing.
5. Be sure all covers are closed and initialize the system (see
Section 5.2).
6. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
Software Data Corrupted hard drive. 1. Print the event details (see Section 6.3).
Formatting 2. Record instrument operations preceding the event; for
Error example, waste bag was changed.
3. Reboot the instrument (see Section 7.3).
• If rebooting fails, contact Technical Support.
4. Continue normal operation. Contact Technical Support to
report the event.
Software Failure detected during a database 1. Print the event details (see Section 6.3).
Database update operation. 2. Record instrument operations preceding the event; for
Update Failure example, waste bag was changed.
3. Reboot the instrument (see Section 7.3).
• If rebooting fails, contact Technical Support.
4. Continue normal operation. Contact Technical Support to
report the event.
Software File Corrupted hard drive. 1. Print the event details (see Section 6.3).
Accessing Error 2. Record instrument operations preceding the event; for
example, waste bag was changed.
3. Reboot the instrument (see Section 7.3).
• If rebooting fails, contact Technical Support.
4. Continue normal operation. Contact Technical Support to
report the event.
Software Device did not complete a command 1. Print the event details (see Section 6.3).
Timeout Error from the software within the allotted 2. Reboot the instrument (see Section 7.3).
time.
3. Contact Technical Support to report the event.
Status Error detected while status 1. Print the event details (see Section 6.3).
Controller controller was initializing 2. Record instrument operations preceding the event; for
Initialization instrument parameters. example, waste bag was changed.
Error
3. Reboot the instrument (see Section 7.3).
• If rebooting fails, contact Technical Support.
4. Continue normal operation. Contact Technical Support to
report the event.
Supplies Insufficient supplies for the number 1. Check the Supplies Required screen to determine the supplies
Insufficient For of tests requested. needed (see Section 4.2 in the Operator's Guide).
Requested 2. Load the necessary supplies (see Chapter 2 in the Operator's
Tests Guide) and verify that supplies are sufficient on the Supplies
Required screen.
3. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
Supply • Insufficient wash buffer volume. 1. Check the wash buffer reservoir (see Figure 1-6).
Condition - • Defective buffer valve assembly. • If the buffer volume is low, change the wash buffer bottle
Scheduler (see Section 2.2 in the Operator's Guide). Continue normal
• Broken float level sensor wire.
Paused operation.
Code: • If the buffer volume is not low, continue troubleshooting.
521c03 2. Check the wire to the float level sensor.
• If the wire is broken, contact Technical Support.
• If the wire is intact, order a new wash buffer valve assembly
and replace the current one (see Figure 2-4 in the Operator's
Guide).
Supply • Liquid waste bottle full. 1. Check the liquid waste bottle (see Figure 1-6).
Condition - • Defective waste bottle scale. • If the bottle is full, change it (see Section 2.3 in the
Scheduler Operator's Guide). Continue normal operation.
Paused
• If the bottle is not full, continue to step 2 to obtain
Code: information for Technical Support.
521d03 2. Remove the liquid waste bottle from the scale.
3. Press down on the center of the scale and observe if it springs
back.
4. Contact Technical Support.
System Check • Hardware failure 1. Be sure all maintenance routines have been performed (see
result out of • Reagent failure Section 8.1 in the Operator's Guide).
range 2. Repeat the System Check routine. Be sure to follow the
instructions as written in the Running the System Check
Routine procedure in Section 8.4: System Check in the
Operator's Guide.
3. If System Check results are still out of range, display, print,
and review System Check result data (see Section 8.4 in the
Operator's Guide).
4. Contact Technical Support for assistance.
System Non-fatal error detected in the 1. Print the event details (see Section 6.3).
Software Error system software. 2. Record instrument operations preceding the event; for
example, waste bag was changed.
3. Continue normal operation. Contact Technical Support to
report the event.
Timeline Instrument scheduler was unable to 1. Print the event details (see Section 6.3).
Scheduler Error schedule all requested tests into the 2. Record instrument operations preceding the event; for
instrument timeline. example, waste bag was changed.
3. Reboot the instrument (see Section 7.3).
• If rebooting fails, contact Technical Support.
4. Continue normal operation. Contact Technical Support to
report the event.
Ultrasonic Ultrasonic board revision is invalid 1. Print the event details (see Section 6.3).
Board Revision for the software revision. 2. Contact Technical Support. The ultrasonic board may need
Invalid replacement.
Ultrasonic Ultrasonic control process failure. 1. Print the event details (see Section 6.3).
Board Status 2. Contact Technical Support.
Reading Failed
Ultrasonic • Damaged primary probe tip. 1. Remove and check the primary probe tip. Replace the probe if
Phased Lock • Incorrectly torqued primary probe. it is pitted (see Section 7.6).
Loop Failed... 2. Be sure the primary probe is installed and torqued correctly
• Defective connections between
the main pipettor and pipettor (see Section 7.6).
interface board. 3. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
Ultrasonic Defective ultrasonic board. 1. Print the event details (see Section 6.3).
Surface 2. Contact Technical Support. The ultrasonic board may need
Detection Failed replacement.
Before
Lowering Probe
Ultrasonic Ultrasonic probe failed to detect 1. Be sure you use an approved sample container, and pipette
Surface surface of sample due to: sufficient sample for the requested tests into the sample
Detection Failed • Insufficient sample volume. container (see Section A.2 in the Operator's Guide). Do NOT
While Lowering overfill.
• Overfilled sample container.
Probe 2. Be sure the ID of the rack you are using is appropriate for the
• Incorrect sample container for
sample container (see Section A.2 in the Operator's Guide).
rack ID.
3. Properly place the sample container in the rack and load the
• Incorrectly loaded sample
rack on the instrument (see Section 3.1 in the Operator's
container or rack.
Guide).
• Ultrasonic hardware or interface
4. Repeat the test(s). If you need assistance or if the problem
circuitry failure.
persists, contact Technical Support.
Ultrasonic XXX Ultrasonic hardware or interface 1. Print the event details (see Section 6.3).
Failed... circuitry failure. 2. Contact Technical Support.
Unable to • Attempt to initialize system before 1. If reagent packs might have been removed from the reagent
Initialize successfully completing carousel without using the user interface, look for packs using
System Due to troubleshooting instructions when the Retrieving Misplaced Packs procedure (see Section 2.7 in
Disabled Main main pipettor disabled. the Operator's Guide).
Pipettor • If there are missing or misplaced packs, unload and reload
all reagent packs according to the Retrieving Misplaced
Packs procedure. Then, continue troubleshooting with step
2.
• If the carousel contains the correct reagent packs in the
correct slots, contact Technical Support before continuing
troubleshooting.
2. Reset the pipettor and initialize the system (see Section 5.5).
• If initialization fails, contact Technical Support.
3. Continue normal operation. Run canceled tests again.
Unexpected RV • Fallen RV. 1. Check for fallen or missing RVs in the shuttle and shuttle
In Front Of Rake • Dirty or defective RV sensor. transfer position (see Section 7.5).
2. Test the RV sensors and clean them if necessary (see
Section 7.5).
3. Be sure all covers are closed and initialize the system (see
Section 5.2).
4. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
Vacuum Offset Defective vacuum pressure sensor. 1. Print the event details (see Section 6.3).
Over Limit 2. Contact Technical Support.
Vacuum Over • Constricted waste tubing. 1. Check the tubing from the liquid waste bottle (see
Limit Error • Failing vacuum valve. Figure 7-11).
• Obstructed vacuum system tubing • If the tubing is constricted, clear it. Continue normal
or waste filter. operation.
2. From the Maintenance Review screen, select Disable Utility
Assay F6 (see Section 8.1 in the Operator's Guide).
3. From the Digital Devices window, select Vacuum Test F2 to
run the automated vacuum test (see Section 5.6).
• If the vacuum test fails, contact Technical Support.
4. Enable the Utility Assay.
5. Remove the tubing from the waste filter at the quick
disconnect and place the end of the tubing in one of the
adjacent holes (see Figure 7-11). This may temporarily resolve
the error until you can install a new waste filter assembly.
6. Continue normal operation.
• If the event does not recur, order a new waste filter assembly
and replace the current one.
• If the problem persists, contact Technical Support.
Vacuum Under • Leak in vacuum system. 1. From the Maintenance Review screen, select Disable Utility
Limit Error • Missing or failing splash guard in Assay F6 (see Section 8.1 in the Operator's Guide).
vacuum reservoir bottle. Fluid in 2. Open the top cover (see Section 7.2).
the waste filter bottle 3. Inspect the vacuum reservoir bottle (see Section 7.7).
• Failing vacuum pump or valve. • If the tubing is constricted, clear it.
• Damaged or leaking peristaltic • If the tubing is damaged or leaking, or if it contains debris,
waste pump or waste pump tubing. contact Technical Support.
• If the splash guard is missing, is not in position, or is
cracked, contact Technical Support.
• If there is fluid in the bottle, contact Technical Support.
4. Check the waste filter bottle for fluid.
• If there is fluid in the bottle, replace it (see Section 7.4).
5. Open the front panel (see Section 7.2).
6. Inspect the peristaltic waste pump (see Figure 1-5) and tubing
for damage or leaking.
• If the pump is damaged or leaking, contact Technical
Support.
• If the tubing is damaged or leaking, replace the tubing (see
Section 7.7).
7. Run the manual vacuum test (see Section 5.6).
• If the mm Hg level for any of the steps is not within the
given parameters, contact Technical Support.
8. Close the top cover and front panel.
9. Enable the Utility Assay.
10. Continue normal operation. If you need assistance or if the
problem persists, contact Technical Support.
Wash Arm • Obstruction in the area of the Check for wash arm obstructions (see Section 7.8). If you need
Motion Error sensor. assistance or if the problem persists, contact Technical Support.
• Bent probe in wash arm.
• Defective home sensor.
• Mechanical or electrical failure.
Wash Carousel Wash carousel exceeded the 1. Print the event details (see Section 6.3).
Alignment Error cautionary limit of steps allowed 2. Contact Technical Support.
- May Need during a diagnostic procedure.
Service
Wash Carousel Wash carousel exceeded the limit of 1. Print the event details (see Section 6.3).
Alignment Error steps allowed during a diagnostic 2. Do not continue operating the instrument.
- Needs Service procedure.
3. Contact Technical Support.
Wash Carousel Mechanical or electrical failure. 1. Print the event details (see Section 6.3).
Motion Error 2. From the Mechanics screen, check if the RV Shuttle and
Incubator Belt (Devices) are at the home or index position
(see Section 5.5).
• If the shuttle is not at home:
a. Clear the shuttle path (see Section 7.5).
b. Home the RV Shuttle. If homing fails, review the Event
Log and troubleshoot according to the error events with
a similar Date/Time to this event.
• If the incubator belt is not at home or index:
a. Select Disable Motors F8, then manually rotate the
incubator belt until the index sensor is lit, then select
Enable Motors F8.
2. Clear the wash carousel (see Section 7.8).
3. Cycle the Wash Carousel for 4 cycles (see Section 5.5).
• If cycling fails, contact Technical Support.
4. Home the Incubator Belt (see Section 5.5).
5. Be sure all covers are closed and reboot the instrument (see
Section 7.3).
6. Calibrate the incubator belt (see Section 5.8).
7. Continue normal operation. Contact Technical Support to
report the event.
Wash • Utility Assay disabled and 1. Clean the wash valve (see Section 7.7).
Valve/Pump instrument idle for extended time. 2. Continue normal operation. If you need assistance or if the
Motion Error • Debris buildup on valve. problem persists, contact Technical Support.
• Wash valve failure.
• Mechanical or electrical failure.
XXX Hardware Open or shorted circuit. 1. Print the event details (see Section 6.3).
Error 2. Contact Technical Support.
XXX Outside • System recently restarted. 1. Review the event details (see Section 6.3).
Limits • Recently opened instrument • If the Details field indicates a device temperature is outside
covers. limits, check the device temperature on the Maintenance
• Analog reference outside limits. Review screen. If the temperature is outside the acceptable
limits, periodically monitor the temperature until it is within
• Power supply voltage outside
the acceptable limits.
limits.
a. If the system was rebooted or instrument covers were
• Vacuum pressure outside limits.
recently opened, wait up to 30 minutes for the
• Defective device. temperature to normalize.
b. If the system was recently restarted, wait up to 1 hour for
the temperature to normalize.
c. Continue normal operation. If the problem persists,
contact Technical Support.
• If the Details field indicates a condition other than a device
temperature outside limits:
a. Print the event details (see Section 6.3).
b. Contact Technical Support.
When you experience a system problem, you can sometimes perform procedures on
the Access 2 instrument to isolate or correct the problem. In most cases, you should
only perform these system support procedures when you are instructed by an Access 2
troubleshooting procedure or a technical support representative. For these restricted
procedures, a cautionary statement is included in the introductory section of the
procedure.
Be sure you understand all of the instructions in a support procedure before you begin
working on the instrument. If you have any questions about a support procedure,
contact Technical Support.
You must open instrument covers to reach various components in the instrument.
Open a cover only when you are directed to do so by a technical support
representative or if you are following instructions in Help or in an Access 2 manual.
WARNING
The Access 2 instrument has moving parts and uses high voltage in the ultrasonic
transducer. Both present an injury hazard. You should not operate the Access 2
instrument with the covers open.
Opening and Use this procedure to open or close the front panel of the instrument.
Closing the
Front Panel 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.
2. Grasp the lower portion of the left and right sides of the front panel (see
Figure 7-1).
3. Pull the bottom of the panel toward you, then lift the panel upward.
0073Fc.eps
1 Front Panel
2 Captive Screw
3 Status Light Bar (not available on all systems)
2. Be sure the lower corners are secure so the flag is fully engaged in the interlock
switch (see Figure 7-2).
0887Ac.eps
1 Flag
2 Front Panel Hinge
3 Interlock Switch
Opening and Use this procedure to open or close the top cover of the instrument.
Closing the
Top Cover 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.
2. Open the front panel (see the Opening and Closing the Front Panel procedure).
3. To release the top cover, loosen the captive screw located at the top of the pipettor
gantry (see Figure 7-1). You can loosen or tighten the captive screw, but you
cannot remove it.
5. Retract the top cover by sliding both sides back toward the rear of the instrument
approximately 1/4-in (6 mm) (see Figure 7-3).
0074Ec.eps
1 Top Cover
CAUTION
Do not try to lift the top cover before the cover is retracted.
2. Press down firmly on both rear corners of the top cover to be sure that the cover is
in the correct position.
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.
Removing Use this procedure to remove or replace the supply cover and incubator cover.
and Replacing
Required Materials
the Supply
and Incubator • 9/64-in hex wrench
Covers • Small screwdriver
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.
2. Open the front panel (see the Opening and Closing the Front Panel procedure).
3. Remove the 9/64-in hex screw from each end of the supply cover. The screws are
located where the supply cover meets the instrument frame (see Figure 7-4).
NOTE
The 9/64-in hex screws may not be present if they were not replaced during a
previous procedure.
4
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0241Bc.eps
1 Front Panel
2 Carousel Door
3 Hex Screws (under Front Panel)
4 Base Panel
5 Supply Cover
6 Supplies Door
4. Open the supplies door and remove the reaction vessel (RV) waste bag.
NOTE
Do not go to the Supplies screen and select Change RV Waste Bag F6 unless the
RV waste bag is full and you need to change it.
5. Remove the 9/64-in hex screw in the bottom of the RV waste bag well.
NOTE
The 9/64-in hex screw may not be present if it was not replaced during a previous
procedure.
6. While facing the instrument, grasp the back edge of the supply cover (see
Figure 7-4) with one hand and the front edge with the other hand. Pull the supply
cover up and toward you to remove it. Set the cover aside.
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.
1. Remove the supply cover (see the Removing the Supply Cover procedure).
2. Release the RV load door latch by pulling it toward you with a small screwdriver,
then raise the RV load door (see Figure 7-5).
The system sounds a warning alarm when you raise the RV load door. The alarm turns
off when you lower the door.
3. To remove the incubator cover, pull lightly outward on the incubator cover
release tabs and lift the cover up and toward you (see Figure 7-5). Set the cover
aside and lower the RV load door.
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0341Cc.eps
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.
2. Move the RV load door through the large opening in the incubator cover, and
slide the cover retaining slots under the RV load door frame retainers (see
Figure 7-5). Lower the RV load door.
3. Hook both cover release tabs over the front corners of the incubator housing (see
Figure 7-5).
4. Replace the supply cover (see the Replacing the Supply Cover procedure).
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.
1. Grasp the back edge of the supply cover with one hand and the front edge with
the other hand. Be sure the carousel door is closed (see Figure 7-4).
2. Raise the back edge of the supply cover slightly and guide the RV waste bag well
into place behind the base panel. Lower the back edge of the supply cover into
place and be sure all edges of the supply cover are seated snugly.
3. Reinstall the 9/64-in hex screws in the bottom of the waste bag well and at each
end of the supply cover.
You can reboot the PC, the instrument, or both. Rebooting either one does not affect
the other. You may use a reboot procedure in the following situations:
• The user interface (UI) is not responding correctly (PC reboot).
• You are directed to do so by a technical support representative or if you are
following instructions in Help system or in an Access 2 manual (PC and/or
instrument reboot).
During the instrument rebooting process, the instrument system software is reset and a
routine brings all devices to their home, or known, states. This routine is called
initialization, and it prepares the system for further processing.
NOTES
• If you are rebooting both the PC and the instrument, you can reboot them in
any order. For simplicity, the procedures instruct you to reboot the PC first,
then the instrument.
• If you are rebooting an Access 2 PC that is a workgroup server, first you
must shut down the other PCs (clients) in the workgroup. Next, restart the
server PC. Finally, restart the client PCs.
• If you reboot only the PC, the instrument continues sample processing if it is
in the Running mode. When the PC reestablishes communication with the
instrument, the test data is automatically sent to the PC.
The instrument does not require periodic shutdowns. However, you should shut down
the instrument before moving it or whenever the power will be turned off for an
extended period of time (more than 5 days). Before shutting down the instrument,
contact Technical Support to confirm your decision.
Rebooting the To reboot the PC, you shut it down and then restart it. You do not need to reboot the
PC instrument unless you are directed to do so. Use this procedure to reboot the PC.
NOTES
• Depending on the version of your PC, you may need the system password to
restart the PC. If you do not know the password, contact the lab supervisor.
• If you are shutting down a workgroup server PC, you must shut down each of
the client PCs in the workgroup first.
1. Go to the PC Admin screen. To get to this screen from the Main Menu, select
Configure F8 to display the Configure menu, then select PC Admin F7.
NOTES
• Depending on the version of your PC, you may need the system password to
restart the PC. If you do not know the password, contact the lab supervisor.
• If the server UI is the only UI that is not accessible, shut down each of the
client PCs (see step 1 through step 3 of the Shutting Down the PC Under
Normal Conditions procedure in this section). Then use this procedure to shut
down the server.
• If a client UI is not accessible, use this procedure to shut down that client PC.
• If the keyboard does not respond during the performance of this procedure,
press the PC power switch on the front of the PC to turn the power off. The
power switch is identified by the power switch symbol (see Figure 7-7).
2379A.bmp
Figure 7-6 Windows® 8e Start Screen
1. Simultaneously press the [Ctrl], [Alt], and 1. If necessary, press the Windows® key [ÿ®] on
[Delete] keys, then select Shutdown. the keyboard to display the Start screen.
The Shut Down Windows window is displayed. 2. Move the mouse cursor to the lower-right corner
2. Select Restart or Shut down from the list, of the Start screen.
depending upon whether you want to A narrow vertical panel of icons is displayed along
immediately restart the PC software. the right side of the screen.
3. Select OK. 3. Select the Settings icon.
4. Wait about 20 seconds, then perform the
restarting procedure.
2380A.bmp
NOTE
If you are restarting multiple Access 2 PCs in a workgroup, restart the workgroup
server first, then restart the client PCs.
1. Press the PC power switch on the front of the PC to turn the power on. The power
switch is identified by the power switch symbol (see Figure 7-7).
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Figure 7-7 PC Power Switch Symbol
Depending on the version of your PC, you may need the system password to
restart the PC. If you do not know the password, contact the lab supervisor.
2. Wait until the Main Menu screen appears before you continue normal operation.
If rebooting fails, contact Technical Support.
NOTE
If communication between the PC and the instrument is interrupted for an
extended time (more than 30 minutes) while the instrument is processing tests, it
may take a few minutes for test results to be sent to the PC after communication is
reestablished. Do not use the system until the PC receives all the test results.
Go directly to the Test Results screen and filter the results by completion time (see
Section 5.2: Reviewing Test Results in the Operator's Guide). Watch the Result and
Comp. Time columns. When it appears that the test results that were obtained while
communication was interrupted have been transferred to the PC, you can continue
normal operation.
If you have any questions, contact Technical Support.
Rebooting the Use this procedure to reboot the Access 2 instrument. There are two different ways to
Instrument reboot the instrument:
• You can reboot using the reset button. This is also called a warm boot.
• You can reboot using the power switch. This is also called a cold boot.
NOTES
• Do not select any buttons or press any keys until rebooting is complete. After
you initiate a reboot, there is a pause of approximately 2 minutes as the
software resets. Then the system enters the Not Ready mode and system
initialization begins.
• During system initialization, the system homes mechanical devices and
displays a flashing message in the system mode area. When most system
devices complete initialization, the system changes to the Ready mode.
• The system continues to initialize the remaining devices and displays a
flashing message in the system mode area. When the message disappears,
system initialization is complete.
• If the system does not successfully initialize, contact Technical Support.
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.
1. Open the front panel of the instrument (see the Opening and Closing the Front
Panel procedure in this chapter).
2. Locate the reset button, just to the right of the pipettor gantry (see Figure 7-8).
3. Push and hold in the reset button for one second, then release.
0045Cc.eps
Figure 7-8 Reset Button
NOTE
If the front panel remains open too long, the system cannot home the mechanical
devices. If this occurs, press the reset button a second time, then close the front
panel immediately.
5. Wait until the system is in the Ready mode and no message appears in the blue
system mode area before you continue normal operation.
0042Dc.eps
Figure 7-9 Instrument Power Switch
3. Wait about 20 seconds, then press the top part of the switch to turn the power on
( | position).
4. Wait until the system is in the Ready mode and no message appears in the blue
system mode area before you continue normal operation.
Shutting Use this procedure only if you plan to move the instrument or if the system power will
Down the be turned off for an extended period of time (more than 5 days). Before you shut down
Instrument the instrument, contact Technical Support to confirm your decision.
WARNINGS
• 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.
• If you are moving the instrument, make sure that the new location is
properly plumbed. Reagents, calibrators, and controls used with the system
may contain small quantities of sodium azide preservative. Sodium azide
preservative may form explosive compounds in metal drain lines. Refer to
National Institute for Occupational Safety and Health Bulletin: Explosive
Azide Hazards (8/18/76).
1. Run the Special Clean routine (see Section 8.5: Special Clean in the Operator's
Guide).
2. Empty the liquid waste bottle (see Section 2.3: Liquid Waste in the Operator's
Guide).
4. Locate the power switch on the lower, right side near the back of the instrument
(see Figure 7-9). Press the lower part of the switch to turn the power off (O
position).
Restarting the Use this procedure to restart the instrument following an extended shutdown.
Instrument
NOTE
You must let the substrate equilibrate to room temperature for the time specified
in the reagent instructions for use before you load it on the instrument. See the
substrate reagent instructions for use for detailed information.
2. Locate the power switch on the lower, right side near the back of the instrument
(see Figure 7-9). Press the upper part of the switch to turn the power on
( | position).
3. Wait until the system is in the Ready mode and no message appears in the blue
system mode area before you continue the procedure.
If initialization fails, review the Event Log and troubleshoot according to any error
event with a similar date and time to the attempted initialization.
WARNING
Wash buffer contains a preservative, which may cause sensitization by skin
contact. After contact with skin, wash immediately with soap and water. Wear
suitable gloves.
1. Be sure that the wash buffer supply is adequate, and change the wash buffer bottle
if necessary (see Section 2.2: Wash Buffer in the Operator's Guide).
2. Go to the Prime Fluidics window. To get to this window from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Prime
Fluidics F2.
3. Select the Pipettor and Dispense Probes boxes. Use the default number (4) of
cycles. For more information about priming fluidics, see Section 5.3: Prime
Fluidics.
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.
3. If you cleaned and/or replaced an aspirate probe in the previous step, perform the
Visual Aspirate Probe Volume Check procedure again.
If the results fail, contact Technical Support. Your technical support representative
may instruct you to replace the tubing on the peristaltic waste pump (see
Section 7.7: Pump, Valve, and Vacuum Procedures).
4. If you replaced the waste pump tubing in the previous step, perform the Visual
Aspirate Probe Volume Check procedure again. If the results fail, do not
continue. Contact Technical Support.
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.
1. Change the current bottle of substrate with a fresh bottle and prime the substrate
(see Section 2.4: Substrate in the Operator's Guide).
2. Be sure that the RV supply is adequate, and load more RVs if necessary (see
Section 2.5: Reaction Vessels (RVs) in the Operator's Guide).
3. Be sure that the liquid waste container and the RV waste bag are not full. Change
the liquid waste container and change the RV waste bag if necessary (see
Section 2.3: Liquid Waste and see Section 2.6: Reaction Vessel Waste Bag, both
in the Operator's Guide).
4. Run the Special Clean routine (see Section 8.5: Special Clean in the Operator's
Guide).
5. Run the System Check routine (see Section 8.4: System Check in the Operator's
Guide).
If the results are outside the expected limits, repeat the System Check routine with a
fresh dilution of System Check Solution. If the out-of-range results persist,
troubleshoot according to Section A-2: System Check Troubleshooting.
The fluids tray and instrument base procedures involve the components in the fluids
tray and the molded base of the instrument.
Decontami- If the substrate gets contaminated, all system components that come into direct
nating the contact with the substrate must be decontaminated.
Substrate CAUTION
System
Perform this procedure only when you are instructed by a technical support
representative.
Possible substrate system contaminants include bacteria, oils from fingers, talc from
gloves, alkaline phosphatase from a test reagent pack, wash buffer, metal ions, dust,
and residual Citranox cleaning solution from an unsuccessful decontamination.
NOTE
You must let the substrate equilibrate to room temperature for the time specified
in the reagent instructions for use before you load it on the instrument. See the
substrate reagent instructions for use for detailed information.
WARNING
Citranox cleaning solution is acidic and may cause eye or skin irritation. See the
manufacturer’s label for details.
NOTE
To avoid contaminating the substrate again, only touch the tubing or inside of the
substrate cap with a clean, lint-free tissue. Do not allow the substrate tubing to
come in contact with any surface.
4. Place the substrate tubing into the container of diluted Citranox cleaning solution,
where the tubing can draw cleaning solution for the next priming cycle.
5. Go to the Prime Fluidics window. To get to this window from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Prime
Fluidics F2.
6. Select the Substrate box, and enter the number 10 for the number of substrate
priming cycles (see Section : Priming the Fluidics).
7. Select Start Priming F2.
8. While waiting for the cycles to complete, remove the contaminated bottle of
substrate from the fluids tray and discard the bottle.
9. Once priming is complete, remove the substrate tubing from the container of
diluted Citranox cleaning solution. Thoroughly wipe down the surfaces of the cap
and the substrate tubing exterior with a clean lint-free tissue.
10. Place the substrate tubing on a clean lint-free tissue and change the number of
substrate priming cycles to 2.
11. Select Start Priming F2, then wait for the cycles to complete.This creates an air
gap in the substrate tubing.
12. When priming is complete, select Done F8.
4. Select the Substrate box, then change the number of substrate priming cycles to
20 (the maximum), then select Start Priming F2.
5. When priming is complete, change the number of substrate priming cycles to 10
and select Start Priming F2.
6. When priming is complete, select Done F8.
Testing the The RV waste bag sensor notifies the system that the waste bag is present. Test the
RV Waste Bag waste bag sensor only when you are directed to do so by a technical support
Sensor representative or if you are following instructions in Help or in an Access 2 manual.
Use this procedure to test the RV waste bag sensor.
Required Materials
• Up to three unused RV waste bags from different lots (if testing more than
one bag is necessary)
• Fiber-free swab applicator (if cleaning the sensor is necessary)
• Deionized water (if cleaning the sensor is necessary)
Steps
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.
3. Go to the Device Diagnostics screen. To get to this window from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4.
5. Observe the status of the Waste Bag Present field while you remove and
reinstall the waste bag.
• If the status changes appropriately, be sure the waste bag is fully seated into the
slot on the waste chute, close the supplies door, and continue normal operation.
You do not need to continue.
• If the status does not change, continue to the next step.
6. Remove the waste bag and install another waste bag (from a different lot if
possible), while observing the status of the Waste Bag Present field. The
original waste bag may have a defective plastic collar.
• If the status changes, select the RV Waste Bag button and follow the standard
Changing the RV Waste Bag procedure (see Section 2.6: Reaction Vessel Waste
Bag in the Operator's Guide). Be sure the new waste bag is fully seated into the
slot on the waste chute, close the supplies door, and continue normal operation.
You do not need to continue.
• If the status does not change, repeat this step up to 2 more times with waste bags
from different lots. If the status still does not change, continue to the next step.
7. Remove the waste bag and observe the status of the Waste Bag Present field
when you place your finger in front of the sensor (see Figure 7-10).
• If the status changes, adjust the sensor (see the Adjusting the RV Waste Bag
Sensor procedure).
CAUTION
Adjusting the waste bag sensor is an advanced troubleshooting procedure.
Perform this procedure only when you are directed to do so by a technical
support representative.
• If the status still does not change, continue to the next step.
8. Slightly moisten a fiber-free swab applicator with deionized water and gently
wipe the sensor.
9. Place your finger in front of the RV waste bag sensor and observe the status of the
Waste Bag Present field.
• If the status changes, select the RV Waste Bag button and follow the standard
Changing the RV Waste Bag procedure to install a new waste bag (see
Section 2.6: Reaction Vessel Waste Bag in the Operator's Guide). Confirm that
the status changes appropriately, then close the supplies door and continue
normal operation.
• If the status still does not change, contact Technical Support. The sensor may be
defective.
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Adjusting the
RV Waste Bag CAUTION
Sensor Perform this procedure only when you are directed to do so by a technical
support representative.
Use this procedure to adjust the RV waste bag sensor. Ordinarily, you will have just
performed the Testing the RV Waste Bag Sensor procedure.
Required Materials
• 1/16-in Allen wrench
Steps
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.
2. Open the front panel and remove the supply cover (see Section 7.2: Instrument
Cover Procedures).
3. Locate the waste bag sensor mounting screws underneath the waste bag sensor
(see Figure 7-10).
You cannot see the screws, but you can feel them under the sensor.
4. With the short end of the Allen wrench, loosen the mounting screws. Slide the
sensor toward the front of the instrument and tighten the mounting screws.
5. Go to the Device Diagnostics screen. To get to this window from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4.
7. Observe the status of the Waste Bag Present field while you remove and
reinstall the waste bag (see Section 5.6: Analog and Digital Device Diagnostics).
• If the status changes appropriately, be sure the waste bag is fully seated into the
slot on the waste chute, close the supplies door, and continue normal operation.
• If the status still does not change, contact Technical Support.
NOTE
The entire waste bottle/filter assembly should be replaced once each year. For
more information about replacing the assembly, contact Technical Support.
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.
Required Materials
• Clean waste filter bottle.
For convenience, the system includes two waste filter bottles. You can install one
bottle on the system while you remove, decontaminate, and empty the other.
WARNING
The filter has sharp edges and it is a biohazard. Do not touch or remove the
filter, or lay it down on any surface. Immediately place the filter in a clean waste
filter bottle.
2. Place the top of the waste filter/bottle assembly in a clean waste filter bottle and
screw on the top.
1064A.eps
3. Rinse the bottle thoroughly by filling it with tap water and discarding the
contents.
5. Retain the clean bottle for the next time you need to replace the waste filter bottle.
Rinsing the
Wash Buffer CAUTION
Reservoir Use this procedure only as directed by a technical support representative or
when you are following instructions in Help system or in an Access 2 manual.
Use this procedure to rinse the wash buffer reservoir in the fluids tray.
WARNING
Wash buffer contains a preservative, which may cause sensitization by skin
contact. After contact with skin, wash immediately with soap and water. Wear
suitable gloves.
Required Materials
• Distilled or deionized water
3
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0224H.eps
2. Lift and remove the wash buffer bottle from the reservoir in the fluids tray on the
left side of the instrument.
3. Rotate the wash buffer reservoir receptacle 1/4 turn counterclockwise and lift it
out of the reservoir. Set the reservoir receptacle aside on a clean surface.
CAUTION
Be sure that the actuator rod inside the wash buffer reservoir receptacle
stays in place.
4. Slide the front of the fluids tray away from the instrument to allow you access to
the connections.
5. From the access hole in the tray tower, disconnect the black connector on the wire
that goes to the float level sensor.
6. Push the connector on the wire out through the black strain relief.
7. From the access hole in the tray tower, grip the tubing and luer fitting (located
below the black strain relief) and rotate them 3/4 turn counterclockwise. Pull the
tubing and luer fitting away from the wash buffer reservoir.
8. Press the quick release tab on the reservoir output tubing and pull the fitting and
tubing away from the reservoir.
CAUTION
Remove the reservoir as gently as possible. Agitating the reservoir
excessively may cause some wash buffer to splash out of the reservoir
receptacle opening.
2. Carry the reservoir to a sink and pour the contents out through the receptacle
opening.
3. Fill the reservoir through the receptacle opening with distilled or deionized water
until it is approximately 3/4 full. Gently swirl the reservoir for a few seconds to
rinse and then pour out the contents into the sink.
4. Repeat step 3 four more times. Be sure to thoroughly drain the reservoir after the
final rinse.
NOTE
If you suspect that the wash buffer supply was contaminated, you should also
rinse the wash buffer reservoir receptacle with distilled or deionized water.
2. Press the quick release tab on the reservoir output tubing and insert the tubing and
fitting onto the reservoir.
3. From the access hole in the tray tower, connect the luer fitting. Rotate the tubing
and fitting 3/4 turn clockwise.
CAUTION
After connecting the luer fitting and tubing, route the tubing upward into
the harness clamp in the access hole to prevent a siphon effect if the reservoir
is overfilled.
4. Push the black connector on the wire back through the black strain relief.
5. From the access hole in the tray tower, reconnect the wire.
6. Reinsert the wash buffer reservoir receptacle into the reservoir opening. Rotate
the receptacle 1/4 turn clockwise.
7. Slide the fluids tray back to its original position next to the instrument and then
insert a new wash buffer bottle into the wash buffer reservoir receptacle.
8. Prime the pipettor for 12 cycles and the dispense probes for 8 cycles.
For more information about priming the pipettor and dispense probes, see Section 5.3:
Prime Fluidics.
The incubator belt and shuttle procedures involve the incubator belt and shuttle areas
of the analytical module.
Clearing the Clear the RV shuttle path only when you are directed to do so by a technical support
RV Shuttle representative or if you are following instructions in Help or in an Access 2 manual.
Path Use this procedure to clear the RV shuttle path.
NOTE
If the Event Log button turns yellow or red at any time during this procedure,
check the Event Log before proceeding.
Required Materials
• Hemostat
Steps
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.
2. Open the front panel and remove the supply cover and incubator cover (see
Section 7.2: Instrument Cover Procedures).
3. With the hemostat, remove all RVs from the shuttle area (see Figure 7-13).
Discard the RVs.
1
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1 Shuttle Position 1
2 Shuttle Position 2
3 Shuttle Position 3
4 Shuttle Area
5 RV Load Door
6 3 Vessel Holders at Shuttle Transfer Position
4. Remove the 3 vessel holders, and any RVs in them, at the shuttle transfer position
(see Figure 7-13). To remove vessel holders, pull up on the tab at the top. Save all
of the vessel holders you remove.
NOTE
You remove the RVs in the shuttle and 3 vessel holders to create openings so the
shuttle can move freely regardless of the belt position. This prevents jams and
breakage.
CAUTION
If you do not immediately proceed to the next steps, leave the front panel
open or disable the Utility Assay until you are ready to continue. This will
prevent the Utility Assay from running automatically (see Section 8.1:
Routine Maintenance in the Operator's Guide).
6. Go to the Device Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4 to display the Device Diagnostics screen.
WARNING
Do not get close to the shuttle while it is moving.
10. Open the front panel and replace the vessel holders. To replace vessel holders,
push them down onto the incubator belt. They gently snap into place when they
are fully seated.
Checking for Check for fallen or missing RVs only when you are directed to do so by a technical
Fallen or support representative or if you are following instructions in Help or in an Access 2
Missing RVs manual.
NOTE
RVs can fall between the rake and the wall of the incubator if you do not load the
RVs properly by selecting Load RVs F4 from the Supplies or Supplies Required
screen.
Use this procedure to check for fallen or missing RVs in the incubator area.
Required Materials
• Hemostat
Steps
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.
2. Open the front panel and remove the supply cover and incubator cover (see
Section 7.2: Instrument Cover Procedures).
3. If you are instructed to check for missing, fallen, or tilted RVs or other
obstructions in the shuttle or other visible areas of the incubator, inspect the areas
identified (see Figure 7-14).
With the hemostat, remove any fallen/tilted RVs or other obstructions.
• If an RV is missing or fallen/tilted in a position on the right side of the shuttle
(closest to the shuttle transfer area), remove all the RVs in the shuttle.
• If an RV is missing or fallen/tilted in one of the rows in front of the shuttle,
remove all the RVs across in the row. Approximately three rows of RVs are
visible in front of the shuttle.
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4. If you are instructed to look for fallen RVs or other obstructions between the rake
and the wall of the incubator, open the RV load door. To open the door, pull the
latch toward you with the hemostat, and raise the RV load door (see Figure 7-5).
The system sounds a warning alarm when you raise the door. The alarm turns off
when you lower the door.
• Remove any fallen RVs in the area toward the front of the incubator.
• Close the RV load door.
5. Be sure all of the visible vessel holders are pushed firmly down onto the
incubator belt.
6. Continue troubleshooting as you are directed by a technical support
representative or by instructions in Help system or in an Access 2 manual.
Instructions should include the following steps if you removed RVs:
• Replace the incubator cover and supply cover, then close the front panel.
• Initialize the system (see Section 5.2: Initialize System).
Replacing The legs of the vessel holders (also called incubator belt clips) sometimes bend or
Missing or break, or an entire vessel holder may come off the incubator belt. This can cause a jam
Damaged in the incubator.
Vessel Hold- Replace vessel holders only when you are directed to do so by a technical support
ers representative or if you are following instructions in Help or in an Access 2 manual.
Use this procedure to find and replace any damaged or ejected vessel holders.
NOTE
If the Event Log button turns yellow or red at any time during this procedure,
check the Event Log before proceeding.
Required Materials
• Hemostat
• Vessel holders
• Home vessel holder (if needed for replacement)
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.
2. Open the front panel and remove the supply cover and incubator cover (see
Section 7.2: Instrument Cover Procedures).
5. Go to the Device Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4.
7. Select RV Shuttle from the list in the Device field, and check if it is at the Home
position (see Section 5.5: Mechanics and Device Diagnostics).
• If the shuttle is not at the Home position, home the shuttle.
• If homing fails, clear the RV shuttle path (see the Clearing the RV Shuttle Path
procedure).
8. Remove any loose RVs and any broken, bent, or ejected vessel holders or legs
(see Figure 7-15) from the visible area of the incubator belt.
• Use the hemostat to remove RVs. Discard the RVs.
• Use the hemostat to remove vessel holder legs and vessel holders that are not
attached to the incubator belt. Save these loose parts.
• Remove vessel holders with broken or bent legs by pulling up on the tab at the
top of the vessel holder (see Figure 7-15). Save these vessel holders.
0235Bc.eps
9. Select Disable Motors F8 (see Section 5.5: Mechanics and Device Diagnostics).
To manually rotate the belt, turn the incubator belt pulleys (see Figure 7-16) or pull
horizontally on the dovetails or vessel holders (see Figure 7-15).
CAUTION
If the incubator belt resists movement, stop rotating it and remove any
visible vessel holders that may be damaged. Contact Technical Support.
11. Repeat step 8 as you rotate the incubator belt one full turn.
2
0236Bc.eps
12. To be sure there are no vessel holder pieces left in the instrument, matchthe
number of broken vessel holders you removed to the number of broken legs you
retrieved from the instrument.
CAUTION
If there are still vessel holder legs or pieces missing, contact Technical
Support. If they are left in the instrument they may cause damage.
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.
3. Manually rotate the incubator belt one full turn clockwise and counterclockwise,
and Enable Motors F8.
If the belt resists moving, contact Technical Support.
5. If necessary, reorder any CARE kit parts that you used. For ordering information,
see the Instructions for Use.
Testing and Test and clean the RV sensors only when you are directed to do so by a technical
Cleaning the support representative or if you are following instructions in Help or in an Access 2
RV Sensors manual.
Required Materials
• Hemostat
• Fiber-free swab applicator (if cleaning the sensors is necessary)
• Deionized water (if cleaning the sensors is necessary)
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.
2. Open the front panel (see Section 7.2: Instrument Cover Procedures).
3. Go to the Device Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4 to display the Device Diagnostics screen.
5. Select RV Shuttle from the list in the Device field (see Section 5.5: Mechanics
and Device Diagnostics).
6. With the hemostat, individually lift and replace the RVs from shuttle positions 1
and 2 (see Figure 7-13). Observe whether the RV Sensor 1 and RV Sensor 2
position indicators on the Mechanics screen display the correct status.
• If the status displays correctly for both RVs, close the front panel. The sensors
pass the test.
• If the status does not display correctly for either RV, clean the sensors.
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.
1. Remove the supply cover and incubator cover (see Section 7.2: Instrument Cover
Procedures).
2. With the hemostat, remove the RVs from the first 3 positions in the shuttle and
the RVs from the first 3 positions in the row in front of the shuttle (see
Figure 7-13).
3. Slightly moisten a fiber-free swab applicator with deionized water.
4. Angle the applicator tip toward the bottom of the shuttle and gently wipe the
round black RV sensors (see Figure 7-18).
0910Ac.eps
1 RV Sensors
5. Replace the RVs in the first 2 positions of the RV shuttle (see Figure 7-13).
6. Retest the sensors.
With the hemostat, individually lift and replace the RVs from shuttle positions 1 and 2
(see Figure 7-13). Observe whether the RV Sensor 1 and RV Sensor 2 position
indicators on the Mechanics screen display the correct status (see Table 7-17).
• If the status displays correctly for both RVs, continue to step 7.
• If status does not display correctly for either RV, contact Technical Support.
Switching To try to improve incubator belt calibration for a belt that may soon require servicing,
Vessel Holder you can switch vessel holder positions.
Positions Switch the vessel holder positions only when you are directed to do so by a technical
support representative or if you are following instructions in Help or in an Access 2
manual.
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.
2. Open the front panel, then remove the supply cover and incubator cover (see
Section 7.2: Instrument Cover Procedures).
3. Switch the home vessel holder with another vessel holder 5 positions away (see
Figure 7-19).
To remove vessel holders, pull up on the tab at the top. To replace vessel holders,
push them down onto the incubator belt. They gently snap into place when they are
fully seated.
0889Ac.eps
4. Close the front panel and calibrate the incubator belt (see Section 5.8: Advanced
Diagnostics).
• If incubator belt calibration fails, repeat step 3 and step 4 up to 11 times. Move
the home vessel holder in the same clockwise or counterclockwise direction each
time.
• If incubator belt calibration still fails, contact Technical Support.
The procedures in this section support the operation of the main pipettor module.
Inspecting Inspect and clean the pipettor gantry only when you are directed to do so by a
and Cleaning technical support representative or if you are following instructions in Help or in an
the Pipettor Access 2 manual.
Gantry
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.
CAUTIONS
• Wipe ONLY the lower pipettor gantry shaft to remove debris. The lower
shaft is not lubricated.
• The upper pipettor gantry shaft is coated with a special lubricant to
protect it from corrosion. DO NOT wipe, touch, or remove the lubricant
from the upper shaft.
• A thin film of lubricant on the upper shaft is normal. It is not harmful if
a small amount of surface dust accumulates on the upper shaft.
Required Materials
• Lint-free tissue
Steps
1. Confirm that the system is in the Ready or Not Ready mode.
2. Open the front panel (see Section 7.2: Instrument Cover Procedures).
3. Inspect the upper pipettor gantry shaft for corrosion (see Figure 7-20).
If you notice significant corrosion or suspect that fluid or some other material came in
contact with the pipettor gantry, contact Technical Support.
4. Wipe the lower pipettor gantry shaft to either side of the main pipettor carriage
with a clean, lint-free tissue to remove debris (see Figure 7-20).
The lower pipettor gantry shaft is not lubricated, so there is no risk of inadvertently
removing the lubricant.
1 2
3
5
0036H.eps
5. 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.
6. Wipe the remaining section of the lower pipettor gantry shaft with the tissue.
7. Close the front panel.
8. Go to the Device Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4 to display the Device Diagnostics screen.
10. Select Pipettor from the list in the Device field, then select Home Device F1 (see
Section 5.5: Mechanics and Device Diagnostics).
Testing the A sensor recognizes when the main pipettor is in the correct position. Test the sensor
Pipettor only when you are directed to do so by a technical support representative or if you are
Z-Axis Home following instructions in Help or in an Access 2 manual.
Sensor
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.
2. Open the front panel (see Section 7.2: Instrument Cover Procedures).
3. Go to the Device Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4 to display the Device Diagnostics screen.
5. Select Pipettor from the list in the Device field (see Section 5.5: Mechanics and
Device Diagnostics).
6. To move the pipettor down, rotate the pulley downward (see Figure 7-20).
Verify that the Home-Z sensor on the Mechanics screen is not lit.
7. To move the pipettor up, rotate the pulley upward until it stops (see Figure 7-20).
Verify that the Home-Z sensor on the Mechanics screen is lit.
8. If the Home-Z sensor does not light correctly, contact Technical Support.
Required Materials
• Biohazard eye, hand, and facial protection
• 5/16-in open end wrench
• 1/4-in open end or box end wrench
• Pipettor torque tool
• Replacement primary probe
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.
CAUTION
Do not use the pipettor torque tool to remove the primary probe. You can
damage the tool if you use it in a manner other than as described for
installing the primary probe.
2. Open the front panel (see Section 7.2: Instrument Cover Procedures).
3. Move the main pipettor slightly to the left of the probe wash tower (see
Figure 7-21).
4
7
6
5
0304D.eps
4. Position the 5/16-in wrench on the flat sides of the lower end of the ultrasonic
transducer above the probe nut (see Figure 7-21).
You use this wrench to reduce stress on the ultrasonic transducer when you loosen the
probe nut.
CAUTION
Do not exert pressure with the 5/16-in wrench, or you may damage the
pipettor.
5. Position the 1/4-in wrench on the probe nut with the handle to the right of the
probe nut (see Figure 7-21).
6. To loosen the probe nut, hold the 5/16-in wrench in place and move the 1/4-in
wrench to the left (counterclockwise).
7. Remove both wrenches.
8. Continue to turn the nut by hand until it detaches (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 safety procedures.
10. Retain the probe nut for use with the new primary probe.
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.
1. Inspect the new primary probe to be sure it is straight and there is no blockage
inside.
2. Insert the new primary probe into the probe nut (see Figure 7-22).
3. Screw the probe and nut (finger-tight) onto the lower end of the ultrasonic
transducer (see Figure 7-21).
1
0293Bc.eps
1 Primary Probe
2 Probe Nut
4. Position the 5/16-in wrench on the flat sides of the lower end of the ultrasonic
transducer above the probe nut (see Figure 7-21).
You use this wrench to reduce stress on the ultrasonic transducer when you torque the
probe nut.
CAUTION
Do not exert pressure with the 5/16-in wrench, or you may damage the
pipettor.
5. With the stationary bar toward the left side of the instrument, fit the 1/4-in hex
opening of the pipettor torque tool (see Figure 7-23) over the probe nut.
1 2
4 3
0296Bc.eps
6. While holding the 5/16-in wrench in place, place your finger or thumb in the
notch on the pipettor torque tool (see Figure 7-23) and press the stationary bar to
the right (toward the reagent/sample carousel) until the stationary bar touches the
tension bar.
CAUTION
Do not touch the tension bar while rotating the pipettor torque tool.
9. If necessary, reorder any CARE kit part that you used. For ordering information,
see the Instructions for Use.
2. Prime the Pipettor, using the default number (4) of cycles (see Section 5.3: Prime
Fluidics).
4. Run the System Check routine (see Section 8.4: System Check in the Operator's
Guide).
If the System Check results fail, contact Technical Support.
5. Calibrate and run quality controls for all tests (see Chapter 3: Sample
Management in the Operator's Guide).
If the QC results are not within the acceptable ranges, recalibrate the tests and rerun
the quality controls.
Pump, valve, and vacuum procedures support the proper operation of the wash and
waste pumping functions of the fluidic module.
Cleaning the Clean the precision valve only when you are directed to do so by a technical support
Precision representative or if you are following instructions in Help or in an Access 2 manual.
Valve Use this procedure to clean the precision valve.
WARNING
You must shut the instrument off before opening the top cover.
Required Materials
• Biohazard eye, hand, and facial protection
• Alcohol wipes
• Deionized water
• Lint-free tissue
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.
2. Go to the Device Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4 to display the Device Diagnostics screen.
4. Select Precision Valve from the list in the Device field, then select
Home Device F1 (see Section 5.5: Mechanics and Device Diagnostics).
5. When homing is complete, select Pipettor from the list in the Device field, then
select Home Device F1 (see Section 5.5: Mechanics and Device Diagnostics).
6. When homing is complete, turn the instrument off by pressing the lower part of
the power switch to off (O position). See Figure 7-8.
7. Open the top cover (see Section 7.2: Instrument Cover Procedures).
0055Dc.eps
1 Precision Pump
2 Precision Valve
3 Wash Valve
4 Wash Pump
9. Turn the precision valve cap counterclockwise and remove it (see Figure 7-25).
The gasket may be stuck to the cap when you remove it.
2
3
12
5
11
1
10
9 5
7
3
0890B.eps
10. If the gasket was not removed with the precision valve cap, remove the gasket,
then the precision valve cap spacer.
11. Pull upward on the short end of the rotor shaft to remove the rotor.
The stator may be stuck to the rotor when you remove it.
12. If the stator does not come out with the rotor, remove the stator from the
manifold. To remove the stator, insert the short end of the rotor shaft into the
center hole of the stator, tilt the rotor gently toward the keying pin, and lift out the
stator.
CAUTION
To prevent damage to the stator and manifold, do not use a pointed tool to
pry out the stator.
13. If the precision valve seal is stuck to the stator, remove it and reseat it in the
manifold. Be sure that the keying notch on the precision valve seal is aligned with
the keying pin in the manifold.
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.
2. Rinse the cleaned components with deionized water and dry them with lint-free
tissue.
3. Examine the coupling surfaces of the rotor and stator to be sure there are no nicks
or scratches.
If the surfaces have nicks or scratches, contact Technical Support.
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.
4. Replace the precision valve cap. Turn the cap clockwise to hand tighten it.
5. Turn the instrument back on by pressing the top part of the power switch to on
( | position). See see Figure 7-9.
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.
2. From the Mechanics screen, with the Precision Valve still in the Device field,
select Home Device F1.
3. Through the glass in the valve cap, check the rotor indicator line. Be sure the line
points to the black dot on the manifold.
4. If the indicator line is not in the correct position, turn the instrument off and
disassemble and reassemble the components again. Repeat the verification.
If the indicator line is still not in the correct position, contact Technical Support.
5. With the Precision Valve still in the Device field, select Main Pipettor from the
Position list.
6. Select Start Cycling F6. Let the precision valve cycle for approximately 40
cycles, then select Stop Cycling F6.
If cycling fails, contact Technical Support.
7. Go to the Prime Fluidics window. To get to this window from the Main menu,
select Diagnostics F7 to display the Diagnostics menu, then select
Prime Fluidics F2.
8. Select the Pipettor box, then enter a minimum of 4 cycles, then select
Start Priming F2 (see Section 5.3: Prime Fluidics).
9. Be sure there are no air bubbles in the main pipettor line when priming is
complete. For the location of the main pipettor line, see Figure 7-20.
If there are air bubbles in the line, prime the main pipettor again. If the problem
persists, contact Technical Support.
Cleaning the Clean the wash valve only when you are directed to do so by a technical support
Wash Valve representative or if you are following instructions in Help or in an Access 2 manual.
WARNING
You must shut the instrument off before opening the top cover.
Required Materials
• Biohazard eye, hand, and facial protection
• Paper towels
• Alcohol wipes
• Deionized water
• Lint-free tissue
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.
2. Go to the Device Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4 to display the Device Diagnostics screen.
4. Select the Wash Valve from the list in the Device field, then select
Home Device F1 (see Section 5.5: Mechanics and Device Diagnostics).
5. When homing is complete, turn the instrument off by pressing the lower part of
the power switch to off (O position). See Figure 7-8.
6. Open the front panel and the top cover (see Section 7.2: Instrument Cover
Procedures).
7. Place paper towels under the dispense probes identified with the numbers 1, 3,
and 5 (see Figure 7-26).
The towels will absorb the wash buffer that drips from the dispense probes during this
procedure.
7
6
1
5 4 3 2
1
6
3 2
5
4
0195Hc.eps
10. Turn the wash valve cap counterclockwise and remove it (see Figure 7-27).
The gasket may be stuck to the cap when you remove it.
1
2
3
4
11
5
10 1
9
1
5
3 6
7
8
0891Ac.eps
11. If the gasket was not removed with the wash valve cap, remove the gasket.
12. Pull upward on the short end of the rotor shaft to remove the rotor.
The stator and the ten-hole rubber gasket may be stuck to the rotor when you remove
it.
13. If the stator does not come out with the rotor, remove the stator from the
manifold. To remove the stator, insert the short end of the rotor shaft into the
center hole of the stator, tilt the rotor gently toward the keying pin, and lift out the
stator.
CAUTION
To prevent damage to the stator and manifold, do not use a sharp or pointed
tool to pry out the stator.
The ten-hole rubber gasket may be stuck to the stator when you remove it.
14. If necessary, place the ten-hole rubber gasket back in the manifold.
Be sure that the keying notch on the rubber gasket is aligned with the keying pin in the
manifold and that the holes in the rubber gasket are aligned with the holes in the
manifold.
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.
2. Rinse the cleaned components with deionized water and dry them with lint-free
tissue.
3. Examine the coupling surfaces of the rotor and stator to be sure there are no nicks
or scratches.
If the surfaces have nicks or scratches, contact Technical Support.
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.
3. Replace the wash valve cap. Turn the cap clockwise to hand tighten it.
4. Remove and dispose of the paper towels from under the dispense probes.
5. Turn the instrument back on by pressing the top part of the power switch to on
( | position). See Figure 7-8.
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.
2. From the Mechanics screen, with Wash Valve still in the Device field, select
Home Device F1.
3. Through the glass in the wash valve cap, check the rotor indicator line. Be sure
the line points to the black dot on the manifold.
4. If the indicator line is not in the correct position, turn the instrument off and
disassemble and reassemble the components again. Repeat the verification.
If the indicator line is still not in the correct position, contact Technical Support.
5. With the Wash Valve still in the Device field, select Probe Wash from the
Position list.
6. Select Start Cycling F6. Let the wash valve cycle for approximately 40 cycles,
then select Stop Cycling F6.
If cycling fails, contact Technical Support.
7. Go to the Prime Fluidics window. To get to this window from the Main menu,
select Diagnostics F7 to display the Diagnostics menu, then select
Prime Fluidics F2.
8. Select the Pipettor box, then enter a minimum of 4 in the Cycles field.
9. Select the Dispense Probes box, then enter a minimum of 10 in the Cycles field,
then select Start Priming F2 (see Section 5.3: Prime Fluidics).
10. Be sure there are no air bubbles in the main pipettor and dispense probe lines
when priming is complete. For the location of the main pipettor line, see
Figure 7-20. For the location of the dispense probes, see Figure 7-26.
If there are air bubbles in the line, prime the main pipettor and dispense probes again.
If the problem persists, contact Technical Support.
Replacing the The peristaltic waste pump draws waste fluids from either the vacuum reservoir bottle
Peristaltic or the aspirate probes. The pump uses tubing that occasionally needs replacement.
Waste Pump Replace the waste pump tubing only when you are directed to do so by a technical
support representative or if you are following instructions in Help or in an Access 2
Tubing
manual.
You can replace pieces of the tubing or all of the tubing. A technical support
representative will help you determine which tubing you need to replace.
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.
2. Open the front panel of the instrument to expose the peristaltic waste pump
located in the front, on the left side of the instrument.
3. Determine if your system has the original or new waste pump assembly (see
Figure 7-28).
1 2
0285A.eps
Figure 7-28 Comparing the Original and New Waste Pump Assemblies
An original waste pump assembly contains a lever guard. The new pump assembly
does not contain the lever guard.
Required Materials
• Biohazard eye, hand, and facial protection
• Small cup for aspirate probes
• Scissors for cutting tubing to length
• Tubing, peristaltic pump vacuum, as needed
• Tubing, peristaltic pump aspirate, as needed
For catalog information about replacement tubing, see the Instructions for Use.
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.
2. Open the front panel of the instrument to expose the peristaltic waste pump
located in the front, on the left side of the instrument.
3. Determine which tubing you need to replace (see Figure 7-29). If you need
assistance, contact Technical Support.
3
7
6 4
0287A.eps
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
Beckman Coulter recommends that you replace the tubing for one cassette at a
time.
1. Pull the end of the vacuum tubing off the waste pump base on the left side of the
pump.
NOTE
If a metal connector on the base of the pump pulls out of its plastic fitting while
you are disconnecting the tubing:
3. To release the cassette from the pump, use your thumb and index finger to
simultaneously grasp the right side of the cassette and press the black tab on the
left side of the cassette (see Figure 7-30).
4. Pull the cassette toward you and slide it free of the waste pump.
0288A.eps
1 Black Tabs - When cassettes are installed properly, black tabs are
on the left side of the pump. The ridged black tab on the cassette
is a release lever.
2 Tubing Retainer Clips
3 Cassette
6. Use the tubing you removed as a measuring guide. Align the retainer clips and cut
the new vacuum tubing to the correct length with scissors.
7. Push the new tubing into the cassette, keeping the retainer clips positioned
outside of the cassette (see Figure 7-30).
8. Return the cassette to the waste pump by following the instructions below:
a. Grasp the cassette with your forefinger on the ridged portion of the right side
of the cassette and your thumb in front of the ridged black tab on the left side
of the cassette (see Figure 7-31).
b. Slide the right side (spring side) of the cassette into position on the pump
head, and then push on the left side until you hear or feel it click into place.
Release the cassette.
c. Press on the middle of the cassette (see Figure 7-31) to be sure it is
properly seated.
0286A.eps
9. Push the left end of the new tubing onto the metal connector on the left side of the
pump.
10. Push the right end of the tubing onto the connector on the right side of the pump.
11. Repeat step 1 through step 10 to replace the remaining vacuum tubing.
12. Confirm that all cassettes are properly seated by pushing on the middle (see
Figure 7-31) of each cassette.
WARNINGS
• 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.
• You must shut the instrument off while replacing the aspirate tubing.
NOTE
Beckman Coulter recommends that you replace the tubing for one cassette at a
time.
1. Turn the instrument off by pressing the lower part of the power switch to off
(O position)(see Figure 7-9).
2. Pull the end of the aspirate tubing off the waste pump base on the left side of the
pump.
NOTE
If a metal connector on the base of the pump pulls out of its plastic fitting while
you are disconnecting the tubing:
4. Disconnect the tubing from the aspirate probe at the square fitting. The fitting
remains with the aspirate probe.
5. To release the cassette from the pump, use your thumb and index finger to
simultaneously grasp the right side of the cassette and press the black tab on the
left side of the cassette (see Figure 7-30).
6. Pull the cassette toward you and slide it free of the waste pump.
8. Use the tubing you removed as a measuring guide. Align the retainer clips and cut
the new vacuum tubing to the correct length with scissors.
9. Push the new tubing into the cassette, keeping the retainer clips positioned
outside of the cassette (see Figure 7-30).
10. Return the cassette to the waste pump by following the instructions below:
a. Grasp the cassette with your forefinger on the ridged portion of the right side
of the cassette and your thumb in front of the ridged black tab on the left side
of the cassette (see Figure 7-31).
b. Slide the right side (spring side) of the cassette into position on the pump
head, and then push on the left side until you hear or feel it click into place.
Release the cassette.
c. Press on the middle of the cassette (see Figure 7-31) to be sure it is
properly seated.
11. Push the left end of the new tubing onto the metal connector on the left side of the
pump.
12. Push the right end of the tubing onto the square fitting that remained with the
aspirate probe in step 4.
13. Reinstall the aspirate probe in the wash arm. For information about how to install
an aspirate probe, see the Replacing the Aspirate Probes procedure in
Section 8.3: Weekly Maintenance of the Operator's Guide.
14. Repeat step 1 through step 13 to replace the remaining aspirate tubing.
15. Inspect the aspirate probes on the wash arm to be sure they are seated correctly
(see the Replacing Aspirate Probes procedure in the Operator's Guide). Gently
pull up on each aspirate probe. They should spring back into place.
Adjust probes if necessary.
16. Confirm that all cassettes are properly seated by pushing on the middle (see
Figure 7-31) of each cassette.
Be sure that the tubing on the left side of the pump does not get caught in the front
panel hinge.
18. Turn the instrument on by pressing the upper part of the power switch to on
(| position)(see Figure 7-9).
Required Materials
• Biohazard eye, hand, and facial protection
• Small cup for aspirate probes
• 3/32-in hex wrench
• Tubing, peristaltic pump vacuum, as needed
• Tubing, peristaltic pump aspirate, as needed
For catalog information about replacement tubing, see the Instructions for Use.
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.
2. Open the front panel (see Section 7.2: Instrument Cover Procedures in this
chapter).
The peristaltic waste pump is in the front, on the left side of the instrument (see
Figure 1-5 in Chapter 1: Technology Overview).
3. Determine which tubing you need to replace (see Figure 7-32). If you need
assistance, contact Technical Support.
2
1
12
11
10 5
9
8 6
7
0282Dc.eps
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.
1. Use a 3/32-in hex wrench to loosen the hex screws that secure the lever guard,
and remove the guard.
2. Pull the end of vacuum tubing #1 off the waste pump base on the left side of the
pump.
NOTE
If a metal connector on the base of the pump pulls out of its plastic fitting while
you are disconnecting the tubing:
4. On the cassette you are removing the tubing from, push the lever as far to the
right as possible to release the cassette from the pump (see Figure 7-33).
5. Pull the cassette toward you and slide it free of the waste pump.
2
3
0284Bc.eps
1 Cassette
2 Lever
3 Tubing Retainer Clips
7. Using the tubing you removed for measuring, match the retainer clips and cut the
new vacuum tubing to the correct length.
8. Push the new tubing into the cassette, keeping the retainer clips positioned
outside of the cassette (see Figure 7-33).
9. Slide the cassette back into position in the waste pump and push the lever about
90° to the left.
10. Push the left end of the new tubing onto the metal connector on the left side of the
pump.
11. Push the right end of the tubing onto the connector on the right side of the pump.
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.
1. Use a 3/32-in hex wrench to loosen the hex screws that secure the lever guard,
and remove the guard (see Figure 7-32).
2. Pull the end of aspirate tubing #3 off the waste pump base on the left side of the
pump.
NOTE
If a metal connector on the base of the pump pulls out of its plastic fitting while
you are disconnecting the tubing:
4. Disconnect the tubing from the aspirate probe at the square fitting. The fitting
remains with the aspirate probe.
5. On the cassette you are removing the tubing from, push the lever as far to the
right as possible to release the cassette from the pump (see Figure 7-33).
6. Pull the cassette toward you and slide it free of the waste pump.
8. Using the tubing you removed for measuring, match the retainer clips and cut the
new aspirate tubing to the correct length.
9. Push the new tubing into the cassette, keeping the retainer clips positioned
outside of the cassette (see Figure 7-33).
10. Slide the cassette back into position in the waste pump and push the lever about
90° to the left.
11. Push the left end of the new tubing onto the metal connector on the left side of the
pump.
12. Push the right end of the tubing onto the square fitting that remained with the
aspirate probe in step 4.
13. Reinstall the aspirate probe in the wash arm. For information about how to install
an aspirate probe, see Section 8.3: Weekly Maintenance of the Operator's Guide.
14. Repeat step 2 through step 13 for aspirate tubing #4 and #5.
16. Inspect all the probes on the wash arm to be sure they are seated correctly (see
Figure 7-26). Gently pull up on each aspirate and dispense probe (probes #1
through #6). They should spring back into place.
Adjust probes if necessary.
Be sure that the tubing on the left side of the pump does not get caught in the front
panel hinge.
Inspecting the Use this procedure to inspect the vacuum reservoir bottle tubing and splash guard.
Vacuum Res-
ervoir Bottle 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.
2 3
5
6
1056B.eps
6. Lift the bottle from the vacuum reservoir bottle holder only as high as needed for
you to inspect the splash guard (see Figure 7-34).
7. Verify that the splash guard is present in the bottle, is securely attached to the
tubing leading to the W TOWER fitting, and is not cracked.
• If the splash guard is missing, is not in position, or is cracked, contact Technical
Support.
• If there is fluid in the bottle, contact Technical Support.
8. Return the bottle to its position in the vacuum reservoir bottle holder. Be sure the
bottle is seated vertically in the holder, and is not at an angle.
9. Close the top cover.
10. Enable the Utility Assay.
The procedures in this section involve the wash/read carousel and wash arm.
Clearing the Clear the wash/read carousel only when you are directed to do so by a technical
Wash/Read support representative or if you are following instructions in Help or in an Access 2
Carousel manual.
Required Materials
• Thin forceps
Steps
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.
2. Go to the Device Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4 to display the Device Diagnostics screen.
4. Select the Incubator Belt from the list in the Device field, and check if the
incubator belt is at the home or index position.
If the incubator belt is not at the home or index position, select Disable Motors F8.
Manually rotate the incubator belt until the index sensor is lit, then select Enable
Motors F8.
5. Select the Wash Carousel from the list in the Device field, then select
Home Device F1 (see Section 5.5: Mechanics and Device Diagnostics). While
the wash/read carousel homes, watch for RVs in the access hole (see
Figure 7-35).
1 2
7
6
1
5 4 3 2
6 5 4 3
0195Ic.eps
1 Sensor
2 Wash Arm (in Raised Position)
3 Wash/Read Carousel Housing
4 Access Hole
5 Nut/Nut Sleeve
6 Mixer Belt
6. From the Mechanics screen, with Wash Carousel still in the Device field, select
Advance CW F4 or Advance CCW F5.
Checking for Check for wash arm obstructions only when you are directed to do so by a technical
Wash Arm support representative or if you are following instructions in Help or in an Access 2
Obstructions manual.
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.
Use this procedure to check for obstructions that may prevent wash arm movement.
2. Go to the Device Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4 to display the Device Diagnostics screen.
4. Select the Wash Arm from the list in the Device field, then select
Disable Motors F8 (see Section 5.5: Mechanics and Device Diagnostics).
5. Open the front panel (see Section 7.2: Instrument Cover Procedures).
6. Locate the wash arm and inspect the tubing (see Figure 7-35).
• If the wash arm is raised, lower it by pushing down on the nut/nut sleeve. Be sure
to keep at least a 3/4” (2 cm) space between the wash arm and the wash/read
carousel housing.
• Check for and reposition any tubing or wiring in the area of the sensor.
• If the wash arm is lowered, check for and reposition any tubing or wiring in the
area of the sensor.
7. Raise the wash arm as far as it will go by pushing up on the nut/nut sleeve, then
check the Home indicator light on the Mechanics screen.
If the indicator is not lit, contact Technical Support.
8. Select Enable Motors F8.
9. Select Home Device F1 (see Section 5.5: Mechanics and Device Diagnostics).
If homing fails, contact Technical Support.
10. Check if any of the probes are bent.
CAUTION
Use this procedure only as directed by a technical support representative or
when you are following instructions in Help system or in an Access 2 manual.
Required Materials
• Replacement substrate probe
2. Open the front panel and top cover (see Section 7.2: Instrument Cover
Procedures).
4
5
7
6
1
5 4 3 2
0924B.eps
NOTE
The probe positions are numbered sequentially from right to left on the wash arm.
If you cannot identify the substrate probe (probe #7), contact Technical Support.
4. Gently grasp the locking nut above the wash arm. Gently push down on the
locking nut, then rotate it 1/4 turn counterclockwise.
5. While holding the probe by the locking nut, lift up to remove the substrate probe
from the wash arm.
6. Unscrew the fitting nut from the substrate heater assembly and remove the nut.
Be sure that the o-ring is removed with the fitting nut.
CAUTION
Handle the substrate probe with extreme care. The probe is fragile, and it
will not function properly if bent.
1. Gently grasp the locking nut on the new substrate probe and route the probe body
through the opening in the wash arm.
2. Gently push down on the locking nut and rotate it 1/4 turn clockwise.
3. Install the fitting nut with o-ring into the substrate heater assembly. Screw in the
fitting nut until finger-tight.
A Troubleshooting
A.1 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-3
A.1 Troubleshooting
Three additional types of troubleshooting procedures are available for identifying and
correcting problems that may occur during processing.
• System Check troubleshooting
• Instrument troubleshooting
• Assay troubleshooting
Diagnostics Menu
Identify the problem
using diagnostic
resources System Check
Result Flags
Troubleshooting
Records
Find troubleshooting
information using
Event Log Help
troubleshooting
resources
Troubleshooting tables
in Help or in manual
chapters
Technical Support, if
needed after you try
other resources
Follow corrective
actions from
troubleshooting
information
Yes
Begin processing
Identifying the You should always identify a problem before attempting any corrective action. Some
Problem problems, such as power failure, are easy to identify. You will need to investigate
other problems thoroughly before you can determine the cause and select a corrective
action. The Access 2 system provides several resources to assist you in this process.
Event Log The Event Log contains codes and messages related to
system processing. If the Event Log button is red or yellow,
review the message immediately to identify the problem.
From the Event Log, select Troubleshoot F2 to find more
information about the message and the corrective actions
you can take.
You can print the Event Log to use as a record of
troubleshooting related messages.
For more information about the events and Event Log
troubleshooting, see Chapter 6: Event Log.
Diagnostics From the Main Menu, select Diagnostics F7 to display a
Menu menu of diagnostic screens and windows from which you
can view instrument parameters that the system monitors,
or perform diagnostic tests.
For more information about Diagnostics, see
Chapter 5: Diagnostics.
System Check The System Check routine verifies that the system is
operating properly, and can detect some system
performance problems. The System Check routine is
performed each week as a part of regular maintenance. The
System Check routine, or the individual checks, can assist
you in identifying and troubleshooting a performance issue.
When you complete a corrective action for a failed result,
run the System Check routine again to determine if the
instrument is functioning properly, or if further
troubleshooting is required.
For information about performing the System Check
routine, see Section 8.4: System Check in the Operator's
Guide.
Finding the After you identify the problem, locate the appropriate troubleshooting information in
Information Help system or in the Access 2 manuals. If the problem generates an Event Log
message or a test result flag, the system provides suggested troubleshooting
procedures you can follow.
For more information about test result flags, see Section A.4: Assay Troubleshooting.
If the problem does not generate an Event Log message or test result flag, consult one
of the three sections in this appendix. Each section is separated into specific problem
areas.
The troubleshooting tables are organized with symptoms in the left column, possible
causes for the symptoms in the middle column, and corrective actions in the right
column. Read across a row to match the symptom that best describes your problem to
the possible causes and corrective actions you can take.
NOTES
• If no troubleshooting information in Help system or in an Access 2 manual
fits the problem, contact Technical Support.
• Contact Technical Support as instructed in troubleshooting information, or
before taking any corrective action that you are not sure of.
Correcting the Perform the corrective action suggested in the troubleshooting information. If the
Problem corrective action is successful, you can begin processing. If the corrective action is
not successful, you will need to troubleshoot the problem further to identify another
possible cause and corrective action.
Recording Beckman Coulter recommends that you keep a record of performance or component
Troubleshoot- problems for each instrument. The record can consist of printed Event Log pages,
ing Activity System Check results, screen printouts, test result reports, or notes from Technical
Support consultations. When a problem occurs, add new information to the record and
review the existing record to determine if the problem has occurred before. Keep the
information available for review with a technical support representative.
The System Check routine is typically run as part of weekly maintenance to verify
that the Access 2 system is operating properly. It may also be run to troubleshoot
another problem with the system, or to verify proper operation after unscheduled
maintenance is performed.
The System Check routine includes the substrate, unwashed, and washed checks.
These three checks verify that the substrate, pipetting, and washing systems are in
good working order. Each of these checks can be performed individually. When they
are run together during the System Check routine, additional results based on
individual check components are obtained.
When you troubleshoot failed results from the System Check routine, troubleshoot in
the following order to determine which instrument system is causing the problem:
• Substrate check problems
• Unwashed check problems
• Washed check problems
• Washed efficiency problems
For example, if the results for the substrate check are acceptable, you can eliminate
the substrate system from any further troubleshooting. Next, look at the unwashed
check results.
NOTES
• Always repeat the System Check routine after the first set of failed results to
rule out a procedural error. When you repeat the routine, use a new aliquot of
undiluted System Check solution and a freshly prepared 1/501 dilution.
• When you have completed the troubleshooting process for an individual
check, repeat the System Check routine to verify that the system is working
If you are unable to identify the cause of a problem, or if the problem persists after
performing the corrective actions, contact Technical Support for assistance.
To review the expected values for the System Check routine, see Section 8.4: System
Check of the Operator's Guide.
High %CV Insufficient supply of substrate 1. Check the level of substrate in the bottle.
throughout the 2. If necessary, change the substrate bottle from the
run Supplies screen (see Section 2.4 in the Operator's Guide).
3. Repeat the System Check routine.
Air in the substrate lines 1. Open the front panel (see Section 7.2).
2. Visually inspect the tubing at the substrate pump and
heater for air bubbles (see Figure 1-5).
3. If air bubbles are present:
• Check the substrate pump and heater fittings, and the
fitting on top of the substrate bottle. Finger-tighten any
loose connections. Be careful not to overtighten any of
the fitting connections.
• Close the front panel and prime the substrate system for
4 cycles (see Section 5.3).
4. Open the front panel and inspect the tubing again.
• If the bubbles are gone, close the front panel and repeat
the System Check routine.
• If you still see bubbles, contact Technical Support for
further instructions.
Leak in the substrate system tubing 1. With the front panel open, open the top cover (see
Section 7.2).
2. Visually inspect the tubing leading to, and away from the
substrate pump/valve/heater assembly for leaks and/or
crystalline deposits (see Figure 1-5).
3. Deposits may indicate the tubing is damaged and should
be replaced.
• If you find deposits, contact Technical Support for
further instructions.
• If you find no deposits, continue troubleshooting other
possible causes.
High %CV Kinked substrate system tubing 1. With the front panel and top cover open (see Section 7.2),
throughout the visually inspect the tubing leading to, and away from the
run substrate pump/valve/heater assembly for kinks (see
(continued) Figure 1-5).
• If no kinks are found, continue troubleshooting other
possible causes.
2. Straighten any kinks. Close the top cover and front panel.
• If the kinked tubing is part of the substrate probe,
remove and replace the substrate probe (see
Section 7.8).
3. Close the top cover and front panel.
4. If you straightened kinks, but did not need to replace the
substrate probe:
• Prime the substrate system for 4 cycles (see
Section 5.3).
• Repeat the System Check routine.
Bent substrate probe tip 1. With the front panel open (see Section 7.2), inspect the
substrate probe tip (see Figure 8-11 in the Operator's
Guide).
• If the substrate probe tip is not bent, continue
troubleshooting other possible causes.
2. If the substrate probe tip is bent, remove and replace the
substrate probe (see Section 7.8).
High %CV from System Check solution diluted 1. Prepare a new 1/501 dilution using a new vial of System
high values in the incorrectly Check solution.
last one or two 2. Repeat the System Check routine.
replicates
Sample containers out of order in the 1. Place the sample containers in the correct order.
maintenance rack 2. Repeat the System Check routine.
High RLU mean Wash/read carousel or substrate 1. Check the wash carousel and substrate temperatures on
temperatures too high (results may the Maintenance Review screen (see Section 8.1 in the
be flagged TRS or TRW) Operator's Guide).
2. If the temperatures for either device are displayed in red
(out of range), contact Technical Support.
System Check solution diluted 1. Prepare a new 1/501 dilution using a new vial of System
incorrectly Check solution.
2. Repeat the System Check routine.
Sample containers out of order in the 1. Place the sample containers in the correct order.
maintenance rack 2. Repeat the System Check routine.
Substrate pump delivering too much Run the Visual Substrate Volume Check procedure (see
substrate Section 5.4).
• If the results do not fail, continue troubleshooting other
possible causes.
• If the results fail, contact Technical Support.
Low RLU mean Expired substrate 1. Review the expiration date on the Supplies screen (see
Section 2.1 in the Operator's Guide).
2. If necessary, change the substrate bottle from the
Supplies screen (see Section 2.4 in the Operator's Guide).
3. Repeat the System Check routine.
Improperly stored substrate (bottle 1. Check the date the bottle was placed at room temperature.
stored at room temperature for too 2. If necessary, change the substrate bottle from the
long) Supplies screen (see Section 2.4 in the Operator's Guide).
3. Repeat the System Check routine.
Wash/read carousel or substrate 1. Check the wash carousel and substrate temperatures on
temperatures too low (results may be the Maintenance Review screen (see Section 8.1 in the
flagged TRS or TRW) Operator's Guide).
2. If the temperatures for either device are displayed in red
(out of range), contact Technical Support.
Low RLU mean Incomplete priming of the substrate 1. Prime the substrate system for 20 cycles again (see
(continued) after substrate system Section 5.3).
decontamination 2. Repeat the System Check routine.
Substrate bottle contaminated with 1. Change the substrate bottle from the Supplies screen (see
Citranox cleaning solution during Section 2.4 in the Operator's Guide). Do not prime the
substrate system decontamination substrate system when prompted as you change the bottle.
2. Prime the substrate system from the Prime Fluidics
window for 20 cycles (see Section 5.3).
3. Repeat the System Check routine.
Substrate dispense volume too low Run the Visual Substrate Volume Check procedure (see
Section 5.4).
• If the results do not fail, continue troubleshooting other
possible causes.
• If the results fail, contact Technical Support.
No RLU values Substrate bottle contaminated with 1. Change the substrate bottle from the Supplies screen (see
Citranox cleaning solution during Section 2.4 in the Operator's Guide). Do not prime the
substrate system decontamination substrate system when prompted as you change the bottle.
2. Prime the substrate system from the Prime Fluidics
window for 20 cycles (see Section 5.3).
3. Repeat the System Check routine.
RLUs trending up Substrate delivery inconsistent Troubleshoot according to the High %CV symptoms for
or down over time substrate check.
Substrate bottle contaminated with 1. Change the substrate bottle from the Supplies screen (see
Citranox cleaning solution during Section 2.4 in the Operator's Guide). Do not prime the
substrate system decontamination substrate system when prompted as you change the bottle.
2. Prime the substrate system from the Prime Fluidics
window for 20 cycles (see Section 5.3).
3. Repeat the System Check routine.
High substrate Dirty or plugged aspirate probes 1. Clean the aspirate probes (see Section 8.3 in the
ratio Operator's Guide).
2. Repeat the System Check routine.
Fluid dripping from aspirate probes 1. Open the front panel (see Section 7.2).
2. Visually inspect the tubing, and the area under the tubing,
from the peristaltic waste pump to the aspirate probes for
leaks and/or crystalline deposits (see Figure 1-5).
3. Deposits may indicate that the tubing is damaged and
should be replaced.
• If you find deposits, contact Technical Support for
further assistance.
• If you find no leaks/deposits, continue troubleshooting
other possible causes.
Plugged waste air filter 1. Check the tubing from the liquid waste bottle for
constrictions (see Figure 7-11).
• If the tubing is constricted, clear it and repeat the
System Check routine.
2. If the results fail, remove the tubing from the waste filter
at the quick disconnect and place the end of the tubing in
one of the adjacent holes (see Figure 7-11). This may
temporarily resolve the error until you can install a new
waste filter assembly.
3. Repeat the System Check routine.
• If the results are acceptable, contact Technical Support
for assistance in ordering and replacing the waste filter
assembly.
• If the results fail, contact Technical Support.
High %CV Air in the main pipettor fluid lines 1. Open the front panel (see Section 7.2).
2. Visually inspect the main pipettor line for air bubbles. Be
sure to check the tubing leading out of the precision pump
and entering the main pipettor (see Figure 1-3).
3. If bubbles are present, prime the pipettor (see
Section 5.3).
4. Inspect the tubing again.
• If the bubbles are gone, run the System Check routine.
• If you still see bubbles, contact Technical Support for
further instructions.
Wash buffer supply lines kinked 1. Open the front panel (see Section 7.2).
2. Visually inspect the tubing from the wash buffer supply
to the main pipettor for kinks (see Figure 1-3 and see
Figure 1-6).
• If no kinks are found, continue troubleshooting other
possible causes.
3. Straighten any kinks and close the front panel.
4. Prime the pipettor (see Section 5.3).
5. Repeat the System Check routine.
No wash buffer 1. Check the wash buffer supply in the fluids tray.
• If the wash buffer reservoir is empty, but the Wash
Buffer status button is not red, contact Technical
Support.
2. If necessary, change the wash buffer bottle (see
Section 2.2 in the Operator's Guide).
3. Repeat the System Check routine.
High %CV Precision pump, valve, fittings, or 1. Open the front panel and the top cover (see Section 7.2).
(continued) tubing damaged and leaking 2. Visually inspect the tubing leading from the precision
pump valve, to the pressure monitor if applicable, and
then to the main pipettor for leaks and/or crystalline
deposits (see Figure 1-3).
3. Examine the precision pump and valve for leaks and/or
crystalline deposits.
4. Deposits may indicate that the pipetting system is
damaged and should be replaced.
• If you see deposits, contact Technical Support for
further assistance.
• If you do not see deposits, continue troubleshooting
other possible causes.
Problems with the substrate system: 1. If the substrate check %CV result is within the expected
• Insufficient supply of substrate range, the substrate system is not the cause of the high
%CV for the unwashed check. Continue troubleshooting
• Air in the substrate lines
other possible causes.
• Leak in the substrate system
2. If the substrate check result is not within the expected
tubing
range, troubleshoot the substrate check result (see Table
• Kinked substrate system tubing A-4).
• Bent substrate probe
• Substrate pump or valve failure
Primary probe partially plugged 1. Look at the Pressure Monitor screen (see Section 5.6) to
determine if a pressure sensor is present, and that
obstruction detection is enabled.
• If the pressure sensor is not present, or if it is present
but obstruction detection is disabled, continue with
step 2.
• If obstruction detection is enabled, review the Event
Log, and troubleshoot according to the events related to
main pipettor obstructions or abnormal pressures (see
Section 6.3).
2. Run the Special Clean routine (see Section 8.5 in the
Operator's Guide).
3. Run the System Check routine.
4. If the results fail, contact Technical Support to verify the
need to replace the primary probe.
5. When needed, remove and replace the primary probe (see
Section 7.6).
High RLU mean System Check solution diluted 1. Prepare a new 1/501 dilution using a new vial of System
incorrectly Check solution.
2. Repeat the System Check routine.
Sample containers out of order in the 1. Place the sample containers in the correct order.
maintenance rack 2. Repeat the System Check routine.
Problems with the substrate system: 1. If the substrate check mean RLU result is within the
• Wash/read carousel or substrate expected range, the substrate system is not the cause of
temperatures too high the high mean RLU result for the unwashed check.
Continue troubleshooting other possible causes.
• Contaminated substrate supply
2. If the substrate check result is not within the expected
• Substrate pump delivering too
range, troubleshoot the substrate check result (see Table
much substrate
A-4).
Low RLU mean System Check solution diluted 1. Prepare a new 1/501 dilution using a new vial of System
incorrectly Check solution.
2. Repeat the System Check routine.
Sample containers out of order in the 1. Place the sample containers in the correct order.
maintenance rack 2. Repeat the System Check routine.
System Check expired or stored 1. Prepare a new 1/501 dilution using a new vial of
incorrectly unexpired System Check solution.
2. Repeat the System Check routine.
Problems with the substrate system: 1. If the substrate check RLU mean result is within the
• Expired substrate expected range, the substrate system is not the cause of
the low RLU mean result for the unwashed check.
• Insufficient supply of substrate
Continue troubleshooting other possible causes.
• Wash/read carousel or substrate
2. If the substrate check result is not within the expected
temperatures too low
range, troubleshoot the substrate check result (see Table
• Incomplete priming after substrate A-4).
system decontamination
• Substrate supply contaminated
with Citranox cleaning solution
during substrate system
decontamination
• Substrate dispense volume too low
High %CV Dirty or plugged aspirate probes 1. Clean the aspirate probes (see Section 8.3 in the
Operator's Guide).
2. Repeat the System Check routine.
Damaged aspirate probes 1. Open the front panel (see Section 7.2).
2. Visually inspect the aspirate probes on the wash arm (see
Figure 8-19 in the Operator's Guide).
3. Replace any probes that are damaged (see Section 8.3 in
the Operator's Guide).
4. With the front panel closed, repeat the System Check
routine.
5. If the problem persists, contact Technical Support.
Plugged waste air filter 1. Check the tubing from the liquid waste bottle for
constrictions (see Figure 7-11).
• If the tubing is constricted, clear it and repeat the
System Check routine.
2. If the results fail, remove the tubing from the waste filter
at the quick disconnect and place the end of the tubing in
one of the adjacent holes (see Figure 7-11). This may
temporarily resolve the error until you can install a new
waste filter assembly.
3. Repeat the System Check routine.
• If the results are acceptable, order a new waste filter
assembly and replace the current one.
• If the results fail, contact Technical Support.
Damaged peristaltic waste pump 1. Open the front panel and top cover (see Section 7.2).
tubing 2. Visually inspect the tubing, and the area under the tubing,
from the peristaltic waste pump to the aspirate probes for
leaks and/or crystalline deposits (see Figure 1-5).
3. Deposits may indicate that the tubing is damaged and
should be replaced.
• If you see deposits, contact Technical Support for
further assistance.
• If you do not see deposits, continue troubleshooting
other possible causes.
High %CV One or more aspirate probes stuck in 1. With the front panel open (see Section 7.2), verify that
(continued) the “up” position the aspirate probes can move up and down (see Figure
8-19 in the Operator's Guide).
• Grasp each probe gently just below the wash arm.
• The probe should move up and down slightly.
2. Replace any probe that does not move freely (see
Section 8.3 in the Operator's Guide).
3. With the front panel closed, repeat the System Check
routine.
4. If the problem persists, contact Technical Support.
Air in the wash pump system tubing 1. With the front panel open (see Section 7.2), visually
inspect the tubing from the wash buffer supply to the
dispense probes for air bubbles (see Figure 8-11 in the
Operator's Guide).
2. If you see bubbles, close the front panel and prime the
dispense probes for 4 cycles (see Section 5.3).
3. Open the front panel and inspect the tubing again.
• If the bubbles are gone, close the front panel and repeat
the System Check routine.
• If you still see bubbles, contact Technical Support for
further instructions.
Kinked wash pump system tubing 1. With the front panel open (see Section 7.2), visually
inspect the tubing from the wash buffer supply to the
dispense probes for kinks (see Figure 8-11 in the
Operator's Guide).
• If no kinks are found, continue troubleshooting other
possible causes.
2. Straighten any kinks.
3. Close the front panel and prime the dispense probes for 4
cycles (see Section 5.3).
4. Repeat the System check routine.
Problems with the substrate system: 1. If the substrate check %CV result is within the expected
• Insufficient supply of substrate range, the substrate system is not the cause of the high
%CVs for the washed check. Continue troubleshooting
• Air in substrate lines
other symptoms.
• Leak in the substrate system
2. If the substrate check result is not within the expected
tubing
range, troubleshoot the substrate check result (see Table
• Kinked substrate system tubing A-4).
• Bent substrate probe
• Substrate pump or valve failure
High %CV Problems with the pipetting system: 1. If the unwashed check %CV result is within the expected
(continued) • No wash buffer range, the pipetting system is not the cause of the high
%CV for the washed check. Continue troubleshooting
• Worn or damaged precision pump
other possible causes.
seals
2. If the unwashed check result is not within the expected
• Partially plugged primary probe
range, troubleshoot the unwashed check result (see Table
• Precision pump, valve, fittings, or A-5).
tubing damaged and leaking
High RLU mean Dirty or plugged aspirate probes 1. Clean the aspirate probes (see Section 8.3 in the
Operator's Guide).
2. Repeat the System Check routine.
Damaged aspirate probes 1. Open the front panel (see Section 7.2).
2. Visually inspect the aspirate probes on the wash arm (see
Figure 8-19 in the Operator's Guide).
3. Replace any probes that are damaged (see Section 8.3 in
the Operator's Guide).
4. With the front panel closed, repeat the System Check
routine.
5. If the problem persists, contact Technical Support.
One or more aspirate probes stuck in 1. With the front panel open (see Section 7.2), verify that
the “up” position the aspirate probes can move up and down (see Figure
8-19 in the Operator's Guide).
• Grasp each probe gently just below the wash arm.
• The probe should move up and down slightly.
2. Replace any probe that does not move freely (see
Section 8.3 in the Operator's Guide).
3. With the front panel closed, repeat the System Check
routine.
4. If the problem persists, contact Technical Support.
Problems with the substrate system: 1. If the substrate check RLU mean result is within the
• Wash/read carousel or substrate expected range, the substrate system is not the cause of
temperatures too high the high RLU mean. Continue troubleshooting other
possible causes.
• Contaminated substrate supply
2. If the substrate check result is not within the expected
• Substrate pump delivering too
range, troubleshoot the substrate check result (see Table
much substrate
A-4).
Low RLU mean Diluted System Check solution used 1. Be sure that sample container number one contains
instead of undiluted undiluted System Check solution.
2. Repeat the System Check routine.
Containers 1 and 4 switched in the 1. Be sure that sample container number one contains
maintenance rack undiluted System Check solution and number four
contains 1/501 diluted System Check.
2. Repeat the System Check routine.
Problems with the pipetting system 1. If the unwashed check %CV result is within the expected
range, the main pipettor is not the cause of the low RLU
mean result for the washed check. Continue
troubleshooting other possible causes.
2. If the unwashed check result is not within the expected
range, troubleshoot the unwashed check result (see Table
A-5).
Problems with the substrate system: 1. If the substrate check %CV and RLU mean results are
• Air in the substrate lines within expected ranges, the substrate system is not the
cause of the low RLU mean result for the washed check.
• Leak in the substrate system
Continue troubleshooting other possible causes.
tubing
2. If the substrate check results are not within the expected
• Kinked substrate system tubing
ranges, troubleshoot the substrate check result (see Table
• Bent substrate probe A-4).
• Substrate pump or valve failure
• Expired substrate
• Insufficient supply of substrate
• Wash/read carousel or substrate
temperatures too low
• Incomplete priming after substrate
system decontamination
• Substrate supply contaminated
with Citranox cleaning solution
during substrate system
decontamination
• Substrate dispense volume too low
Wash Efficiency Problems with the RV wash system Troubleshoot the washed check result (see Table A-6).
PPM fails to meet (washed check mean RLUs or %CVs too
criteria high)
Problems with the pipetting system Troubleshoot the unwashed check result (see Table
(unwashed check mean RLUs too low) A-4).
Problems with the substrate system Troubleshoot the substrate check result (see Table
(contaminated substrate bottle) A-4).
Instrument troubleshooting information can help you identify and correct instrument
problems that are not resolved during System Check troubleshooting. Most
instrument troubleshooting is available through the Event Log. The information in
this section addresses problems you notice during operation or inspection that do not
generate a caution or warning event. The information is sorted into the following
categories:
• General instrument troubleshooting
• Start-up problems
• Power supply problems
• Keyboard problems
• Printer problems
• Bar code reading problems
• Air in the system
• Main pipettor problems
• Communication problems
If you are unable to identify the cause of a problem, or if the problem persists after
performing the corrective actions, contact Technical Support for assistance.
NOTE
Some corrective actions listed in this section ask you to run the System Check
routine. For procedural information about this routine, see Section 8.4: System
Check in the Operator's Guide.
System mode is System rebooting or initializing Wait for the instrument to finish rebooting (see Section 7.3)
Not Ready or initializing (see Section 5.2). When this occurs the system
mode will change to the Ready mode and any text message in
the system mode area will disappear.
The Event Log System event occurred Review the event log message and its troubleshooting
button is yellow information (see Chapter 6: Event Log). Take the
or red recommended corrective action.
System Database contains too many test and 1. Set up the system to automatically delete test and QC
performance is QC results results from the database (see Section 4.10).
slow 2. If the Auto-Delete function is already set up, consider
reducing the number of days that must elapse before the
test results are deleted.
System fails No power to instrument Refer to the power supply troubleshooting table (see Table
during reboot A-10).
CD in CD-ROM or DVD drive, or Remove the CD from the CD-ROM or DVD drive, or remove
data disk in 3.5-inch disk drive the disk from 3.5-inch disk drive and reboot the instrument
(see Section 7.3).
Instrument hardware (power supply, Reboot the instrument (see Section 7.3).
internal hard drive, CPU, printed
circuit board) or software failure
System fails Interlock switch detects front panel Close the front panel of the instrument (see Section 7.3) and
during of instrument is open initialize the system (see Section 5.2).
initialization
No power to the Faulty power outlet or power strip 1. Plug the instrument and the peripherals into a different
instrument or power outlet or strip.
peripherals 2. If the problem persists, troubleshoot the power system for
the instrument and each peripheral device individually.
3. When the source of the problem has been identified,
contact Technical Support if necessary.
No power to the Instrument power switch not on Turn on the power switch located on the right side of the
instrument instrument (see Figure 7-9).
Power cord connector loose at either Be sure that the power cord connections to the outlet and
end instrument are plugged in tightly.
No power to Peripheral device power switch not 1. Turn on the peripheral device power switch.
peripheral(s) on 2. If you cannot locate the power switch, see the
documentation provided by the manufacturer.
Peripheral device power cord Be sure that the power cord connections to the outlet and
connector loose at either end peripheral device are plugged in tightly.
Keyboard Problems
Use the following table to troubleshoot situations when the computer keyboard is not
responding to your key strokes.
No response from Loose connector Be sure that the cable connections (located on the back side of
the keyboard the external computer) between the keyboard, the external bar
code reader, and the computer are plugged in tightly.
Invalid key selected Look at the status line above the function buttons near the
bottom of the screen to verify that the key selected is an
acceptable keyboard response (see Figure 1-18 in the
Operator's Guide).
Printer Problems
Use the following table to troubleshoot problems with the printer.
Print job was not Communication interrupted between 1. Check the printer paper tray.
printed, or is system and printer • If empty, load paper into the printer paper tray.
incomplete
2. Try to print the missing or incomplete report once.
• If print service is restored, continue normal operation.
3. If print service is not restored, reboot the PC (see
Section 7.3).
4. If print service is not restored, locate missing report and
print from the appropriate screen. For example, print a
missing Calibration report from the Calibration screen.
5. If the report does not print, be sure the cable connections
between the printer and the computer are plugged in
tightly.
6. Reload paper into the printer paper tray.
7. Try to print the report again.
8. If report still does not print, contact Technical Support.
Sample rack bar Bar code label attached incorrectly Attach the bar code label correctly (see Section A.1 in the
code label was to the rack Operator's Guide).
not read by the
internal bar code Incorrect system bar code label on If the sample rack is labeled with an Access (not an Access 2)
reader rack system label, the rack cannot be used.
Either replace the bar code label with an Access 2 rack label
(see Section A.1 in the Operator's Guide) or move the
samples to an Access 2 labeled rack.
Sample bar code Sample bar code reading not enabled Set up the bar code reader to read sample IDs (see
label was not read Section 4.3).
by the internal bar
code reader Sample container placed incorrectly Turn the sample container until its bar code label faces the
in the rack same direction as the rack bar code label, and is visible
through the slot in the sample rack (see Figure A-4 in the
Operator's Guide).
Bar code label applied incorrectly on Apply the bar code label correctly on the sample container
the sample container (see Section A.2 in the Operator's Guide).
Bar code reader not set up to read Set up the bar code reader parameters to match the symbology
the sample bar code symbology you are using (see Section 4.3).
Bar code symbology or parameters 1. Verify that the bar code symbology and parameters used
not supported on the sample label are supported (see Section 4.3).
2. If the symbology or parameters are not supported, contact
Technical Support.
Number of bar code characters on 1. Check the number of characters entered for the
label does not agree with the number Interleaved 2 of 5 symbology in the Bar Code Reader
of characters specified in the Bar Setup window (see Section 4.3).
Code Reader Setup window (for 2. If necessary, change the number of characters to match
Interleaved 2 of 5 only) the number of characters on the label.
3. If the number of characters match, contact Technical
Support.
Loose connector Be sure that the cable connections (located on the back side of
the external computer) between the keyboard, the external bar
code reader, and the computer are plugged in tightly.
Air in the fluid Insufficient priming 1. Prime all fluidic components (see Section 5.3).
lines 2. Run the System Check routine.
3. If the problem persists, contact Technical Support.
System prime lost due to a leak in 1. Be sure the connections between the fittings (located on
the fluidic system the left side of the instrument) and the fluids tray (see
Figure 1-6) fit together tightly. Visually inspect the
tubing and fittings for leaks and deposits.
2. Visually inspect the fluidic module tubing and fittings for
leaks and deposits (see Figure 1-5).
3. Inspect the precision pump valve and valve fittings for
leaks and deposits (see Figure 1-3).
4. Leaks and deposits may indicate that the fluidics system
is damaged.
• If you find leaks and deposits, contact Technical
Support for further assistance.
• If you find no leaks or deposits, continue
troubleshooting other possible causes.
Kinked tubing in the fluids tray 1. Visually inspect all tubing leading away from the fluids
tray components for kinks (see Figure 1-6). Pay close
attention to the tubing leading away from the substrate
bottle.
• If no kinks are found, continue troubleshooting other
possible causes.
2. Straighten any kinks.
3. Prime all fluidic components (see Section 5.3).
4. Run the System Check routine.
Plugged waste air filter 1. Check the tubing from the liquid waste bottle for
constrictions (see Figure 7-11).
• If the tubing is constricted, clear it and repeat the
System Check routine.
2. If the results fail, remove the tubing from the waste filter
at the quick disconnect and place the end of the tubing in
one of the adjacent holes (see Figure 7-11). This may
temporarily resolve the error until you can install a new
waste filter assembly.
3. Repeat the System Check routine.
• If the results are acceptable, order a new waste filter
assembly and replace the current one.
• If the results fail, contact Technical Support.
Main pipettor Primary probe partially plugged 1. Look at the Pressure Monitor screen (see Section 5.6) to
leaking determine if a pressure sensor is present, and that
obstruction detection is enabled.
• If the pressure sensor is not present, or if it is present
but obstruction detection is disabled, continue with
step 2.
• If obstruction detection is enabled, review the Event
Log, and troubleshoot according to the events related to
main pipettor obstructions or abnormal pressures (see
Section 6.3).
2. Run the Special Clean routine (see Section 8.5 in the
Operator's Guide).
3. Run the System Check routine.
4. If the results fail, contact Technical Support to verify the
need to replace the primary probe.
5. When needed, remove and replace the primary probe (see
Section 7.6).
Loose fitting between the main 1. Open the front panel and top cover (see Section 7.2).
pipettor and precision pump valve 2. Visually inspect the fittings between the primary probe
and precision pump valve for leaks and deposits (see
Figure 7-24).
3. Inspect all fluid fittings to the manifold for leaks and
deposits.
4. Leaks or deposits may indicate that the tubing or fittings
are damaged.
• If you find leaks or deposits, contact Technical Support
for further assistance.
• If you find no leaks or deposits, continue
troubleshooting other possible causes.
Main pipettor Primary probe partially plugged, 1. Look at the Pressure Monitor screen (see Section 5.6) to
dispensing fluid causing the main pipettor to determine if a pressure sensor is present, and that
with excess dispense fluid with too much obstruction detection is enabled.
pressure pressure • If the pressure sensor is not present, or if it is present
but obstruction detection is disabled, continue with
step 2.
• If obstruction detection is enabled, review the Event
Log, and troubleshoot according to the events related to
main pipettor obstructions or abnormal pressures (see
Section 6.3).
2. Check RV locations 1 and 2 of the RV Shuttle for
crystalline deposits (see Figure 7-13).
• If you find no deposits, continue troubleshooting other
possible causes.
3. Run the Special Clean routine (see Section 8.5 in the
Operator's Guide).
4. Run the System Check routine.
5. If the results fail, contact Technical Support to verify the
need to replace the primary probe.
6. When needed, remove and replace the primary probe (see
Section 7.6).
Communication Problems
Use the following table to troubleshoot communication problems between the
external computer (PC) and the instrument, or other systems in your workgroup.
Workgroup Loose connection between PC and 1. Be sure that the Access 2 instrument power switch is on.
communication other systems in the workgroup • If the power switch is off, restart the instrument (see
error occurs Section 7.3).
during rebooting
• If the power switch is on, but there is no power to the
process
instrument, refer to the power supply troubleshooting
table (see Table A-10).
2. Check both ends of the cable connecting the PC to the
other systems in your workgroup:
• If the cable connection is loose at either end, connect it
securely.
• If the cable is not loose, contact Technical Support.
3. Reboot the PC (see Section 7.3).
Before using assay troubleshooting information to troubleshoot assay issues, run the
System Check routine and troubleshoot unexpected results. Running the System
Check routine will help you to identify and correct, or rule out, some system issues as
the cause of your problem. Some examples are:
• Inadequate washing
• Expired or contaminated substrate
• Inaccurate delivery of substrate
• Inaccurate delivery of sample or reagents
For procedural information about the System Check routine, see Section 8.4: System
Check in the Operator's Guide.
If you are unable to identify the cause of an assay-related problem, or if the problem
persists after performing the specified troubleshooting procedure(s), contact
Technical Support for assistance.
Although Multi-level calibrators pipetted out 1. Be sure that the calibrators are placed in the rack in the
precision is good, of order: proper order.
the calibration • Calibration curve does not ascend 2. Repeat the calibration.
fails for any or descend smoothly.
reason other than
• Calibration cutoff is opposite of
Insuff Data
the expected result.
Expired calibrator 1. Check the expiration date on the calibrator vial(s) or the
Calibrator Setup screen.
2. If the calibrator is expired, add a new, unexpired
calibrator on the Calibrator Setup screen (see Section 6.4
in the Operator's Guide).
3. Repeat the calibration.
Calibrator unstable or contaminated Repeat the calibration. If possible, repeat with a new set of the
due to improper handling same calibrator lot.
Reagent pack unstable or 1. Unload the reagent pack and load a new reagent pack (see
contaminated due to improper Section 2.7 in the Operator's Guide).
handling • If the lot number of the new reagent pack is different
than the removed pack, recalibrate the assay.
2. For calibration problems, repeat the calibration.
Although Incorrect calibration information 1. Verify the calibration information on the Calibrator Setup
precision is good, entered during calibrator setup screen.
the calibration 2. If necessary, edit the information on the Calibrator Setup
fails for any screen (see Section 6.4 in the Operator's Guide).
reason other than
3. Repeat the calibration.
Insuff Data
(continued)
Although Wrong calibrator placed in rack 1. Be sure that the correct calibrator is loaded on the rack.
precision is good, 2. Repeat the calibration.
the quantitative
curve is flat or the Wrong reagent pack loaded, or 1. Verify that the reagent pack was loaded by checking the
qualitative result placed in an incorrect position on the Supplies screen. If it is missing, load a reagent pack (see
is No Value; reagent carousel Section 2.7 in the Operator's Guide).
calibration fails 2. If the reagent pack is listed on the screen, verify its
for any reason location by unloading it from the carousel (see
other than Insuff Section 2.7 in the Operator's Guide).
Data
• If the reagent pack is on-board, but is not presented
during this process, contact Technical Support for
assistance.
• If Technical Support confirms a misplaced reagent
pack, retrieve the pack (see Section 2.7 in the
Operator's Guide).
3. Reload the reagent pack after you have verified its
location.
4. Repeat the calibration.
Poor precision, Daily or weekly maintenance not 1. Perform daily (see Section 8.2 in the Operator's Guide)
and calibration performed or weekly (see Section 8.3 in the Operator's Guide)
fails for any maintenance.
reason other than 2. Repeat the calibration.
Insuff Data
Problems with the pipetting system: 1. If the System Check routine results are within the
• Air in the main pipettor fluid lines. expected ranges, the pipetting system is not the cause of
the calibration failure. Continue troubleshooting other
• Wash buffer supply lines kinked.
possible causes.
• Precision pump, valve, fittings, or
2. If the unwashed check result is not within the expected
tubing damaged and leaking.
range, troubleshoot the unwashed check result (see Table
A-5).
Problems with the substrate system: 1. If the System Check routine results are within the
• Insufficient supply of substrate. expected ranges, the substrate system is not the cause of
the calibration failure. Continue troubleshooting other
• Air in the substrate lines.
possible causes.
• Kinked substrate system tubing.
2. If the substrate check result is not within the expected
• Leak in the substrate system range, troubleshoot the substrate check result (see Table
tubing. A-4).
Reagent gone because it leaked out 1. Load a new reagent pack (see Section 2.7 in the
of the pack during off-board storage Operator's Guide).
2. Repeat the calibration.
RLUs are too low Reagent pack switch occurred, and 1. Verify that the second reagent pack was loaded by
at one end of the the second reagent pack is missing checking the Supplies screen. If the pack is missing, load
calibration curve, or loaded incorrectly (RLUs drop off a new reagent pack.
and calibration suddenly at the end of the calibration 2. If the second reagent pack is listed on the screen, verify
fails for any curve) its location by unloading it from the carousel (see
reason other than Section 2.7 in the Operator's Guide).
Insuff Data
• If the reagent pack is on-board, but is not presented
during this process, contact Technical Support for
assistance.
• If Technical Support confirms a misplaced reagent
pack, retrieve the pack (see Section 2.7 in the
Operator's Guide).
3. Reload the second pack after you have verified its
location.
4. Repeat the calibration.
Calibration fails Quantity of calibrator not sufficient 1. Calculate the correct volume of calibrator needed for the
for the reason for testing (QNS result flag and number of replicates and type of sample container used
Insuff Data event) (see Section A.2 in the Operator's Guide for equation).
2. Pipette the amount of calibrator calculated in step 1 into
the appropriate sample container.
3. Be sure the rack and rack ID are correct (see Section A.2
in the Operator's Guide).
4. Repeat the calibration.
5. If the calibration fails again, contact Technical Support
for assistance.
Two or more replicates not 1. Review the Event Log messages (see Section 6.2) for
calculated due to instrument error device errors prior to the calibration failure.
2. Review the Test Results screen for any error messages
(see Section 5.2 in the Operator's Guide).
3. Troubleshoot the device errors (see Section 6.4). If
necessary, contact Technical Support for assistance.
4. After resolving the device errors, repeat the calibration.
Sample container missing or placed 1. Be sure that the sample containers are in the proper order
in incorrect position in the rack in the rack.
2. Repeat the calibration.
Controls violate Daily or weekly maintenance not 1. Perform daily (see Section 8.2 in the Operator's Guide)
applied QC rule performed or weekly (see Section 8.3 in the Operator's Guide)
maintenance.
2. Repeat the test(s).
Wrong quality control loaded onto 1. Load the correct quality control.
the sample rack 2. Repeat the test(s).
Wrong quality control lot number Repeat the test(s) using the correct lot number.
selected for the test
Wrong mean and/or standard 1. Review the QC information using Edit Control F2 from
deviation information entered when the QC Setup screen.
setting up the quality controls 2. If necessary, edit the information (see Section 7.4 in the
Operator's Guide).
3. Repeat the test(s).
Quality control sample type does not 1. Verify that the sample type used matches what is listed on
match QC setup the Test Requests screen (see Section 3.2 in the
Operator's Guide).
2. Verify that the sample type used matches the sample type
set up for the quality control (see Section 7.4 in the
Operator's Guide).
3. If the quality control sample type entered during setup is
incorrect, you must delete the control and set up the
control again using the correct sample type (see
Section 7.4 in the Operator's Guide).
Expired quality control Load new, unexpired quality control, and repeat the test(s).
Quality controls unstable or 1. Prepare new quality controls according to the procedure
contaminated due to incorrect provided by the manufacturer.
handling 2. Load the freshly prepared quality controls and repeat the
test(s).
Controls violate Quantity of quality control not 1. Calculate the correct volume of quality control needed for
applied QC rule sufficient for testing (QNS result the number of replicates and type of sample container
(continued) flag and event) used (see Section A.2 in the Operator's Guide for
equation).
2. Pipette the amount of quality control calculated in step 1
into the appropriate sample container.
3. Be sure the rack and rack ID are correct (see Section A.2
in the Operator's Guide).
4. Repeat the test(s).
5. If the test(s) fail again, contact Technical Support for
assistance.
Quality controls evaporating from 1. Load a fresh aliquot of each quality control.
being on the instrument too long 2. Repeat the test(s). Be sure the controls are pipetted into
the RVs within one hour of loading onto the instrument.
Be sure controls from 3 mL sample containers are
pipetted into the RVs within two hours of loading.
Reagent pack unstable or 1. Unload the reagent pack and load a new reagent pack (see
contaminated due to improper Section 2.7 in the Operator's Guide).
handling • If the lot number of the new reagent pack is different
than the removed pack, recalibrate the assay.
2. Repeat the test(s).
Wrong reagent pack loaded, or 1. Verify that the reagent pack was loaded by checking the
placed in an incorrect position on the Supplies screen. If it is missing, load a reagent pack.
reagent carousel 2. If the reagent pack is listed on the screen, verify its
location by unloading it from the carousel (see
Section 2.7 in the Operator's Guide).
• If the reagent pack is on-board, but is not presented
during this process, contact Technical Support for
assistance.
• If Technical Support confirms a misplaced reagent
pack, retrieve the pack (see Section 2.7 in the
Operator's Guide).
3. Reload the reagent pack after you have verified its
location.
4. Repeat the test(s).
Expired reagent pack 1. Check the reagent pack expiration date on the Reagent
Inventory screen (see Section 2.8 in the Operator's
Guide).
2. Unload the expired reagent pack and load a new one (see
Section 2.7 in the Operator's Guide).
• If the lot number of the new reagent pack is different
than the expired pack, recalibrate the assay.
3. Repeat the test(s).
Controls violate Wrong sample container and/or rack Load the samples using appropriate sample containers and
applied QC rule racks. Be sure that the sample containers are in a rack with the
(continued) correct rack ID (see Section A.1 and see Section A.2 in the
Operator's Guide).
Sample container missing or placed 1. Be sure that the sample containers are in the proper order
in incorrect position in the rack in the rack.
2. Repeat the test(s).
Expired assay calibration 1. Check the Reagent Pack button on the Supplies screen
(see Section 2.1 in the Operator's Guide). If the lot
number is red, the calibration has expired.
2. View the test results (see Section 5.2 in the Operator's
Guide). Any test results calculated with an expired
calibration will be flagged.
3. Recalibrate the assay.
4. Repeat the test(s).
Quality controls (QC) not run after 1. Run QC (see Section 3.4 in the Operator's Guide).
preventive maintenance or repair 2. Evaluate any out-of-range QC results according to your
established laboratory procedures.
3. Troubleshoot any test result flags, and recalibrate the
assay (see Section 3.3 in the Operator's Guide) if
necessary.
4. Repeat the test.
Substrate not equilibrated to room The substrate must be at room temperature for specified
temperature when loaded on the period of time before it is loaded.
system For more information about the substrate, refer to the reagent
instructions for use.
Increasing values Quality controls evaporating from 1. Load a fresh aliquot of each quality control.
across the run being on the instrument too long 2. Repeat the test(s). Be sure the controls are pipetted into
the RVs within one hour of loading onto the instrument.
Be sure controls from 3 mL sample containers are
pipetted into the RVs within two hours of loading.
Unexpected Incorrect patient sample type Refer to the reagent instructions for usefor the appropriate
sample results sample types for each assay.
Patient sample handled incorrectly Be sure that sample is stored and handled according to proper
laboratory procedures. Refer to individual assay reagent
instructions for use for proper sample handling instructions.
Microclots present in the serum 1. Spin the sample again or use a serum filter to separate the
sample serum from any microclots.
2. Repeat the test(s).
Quantity of patient sample not 1. Calculate the correct volume of patient sample needed for
sufficient for testing (QNS result the number of replicates and type of sample container
flag and event) used (see Section A.2 in the Operator's Guide for
equation).
2. Pipette the amount of quality control calculated in step 1
into the appropriate sample container.
3. Be sure the rack and rack ID are correct (see Section A.2
in the Operator's Guide).
4. Repeat the test(s).
5. If the test(s) fail again, contact Technical Support for
assistance.
Patient samples evaporating from 1. Load a fresh aliquot of each patient sample.
being on the instrument too long 2. Repeat the test(s). Be sure the sample is pipetted into the
RVs within one hour of loading it onto the instrument. Be
sure sample from 3 mL sample containers is pipetted into
the RVs within two hours of loading.
Unexpected Wrong reagent pack loaded, or 1. Verify that the reagent pack was loaded by checking the
sample results placed in an incorrect position on the Supplies screen. If it is missing, load a reagent pack.
(continued) reagent carousel 2. If the reagent pack is listed on the screen, verify its
location by unloading it from the carousel (see
Section 2.7 in the Operator's Guide).
• If the reagent pack is on-board, but is not presented
during this process, contact Technical Support for
assistance.
• If Technical Support confirms a misplaced reagent
pack, retrieve the pack (see Section 2.7 in the
Operator's Guide).
3. Reload the reagent pack after you have verified its
location.
4. Repeat the test(s).
Expired reagent pack 1. Check the reagent pack expiration date on the Reagent
Inventory screen (see Section 2.8 in the Operator's
Guide).
2. Unload the expired reagent pack and load a new one (see
Section 2.7 in the Operator's Guide).
• If the lot number of the new reagent pack is different
than the expired pack, recalibrate the assay.
3. Repeat the test(s).
Reagent pack unstable or 1. Unload the reagent pack and load a new reagent pack (see
contaminated due to improper Section 2.7 in the Operator's Guide).
handling • If the lot number of the new reagent pack is different
than the removed pack, recalibrate the assay.
2. Repeat the test(s).
Expired assay calibration 1. Check the Reagent Pack button on the Supplies screen
(see Section 2.1 in the Operator's Guide). If the lot
number is red, the calibration has expired.
2. View the test results (see Section 5.2 in the Operator's
Guide). Any test results calculated with an expired
calibration will be flagged.
3. Recalibrate the assay.
4. Repeat the test(s).
Quality controls (QC) not run after 1. Run QC (see Section 3.4 in the Operator's Guide).
preventive maintenance or repair 2. Evaluate any out-of-range QC results according to your
established laboratory procedures.
3. Troubleshoot any test result flags, and recalibrate the
assay (see Section 3.3 in the Operator's Guide) if
necessary.
4. Repeat the test.
Unexpected Partial bottles of substrate combined 1. Change the substrate bottle and prime the substrate (see
sample results Section 2.4 in the Operator's Guide).
(continued) 2. Repeat the test(s).
Daily or weekly maintenance not 1. Perform daily (see Section 8.2 in the Operator's Guide)
performed or weekly (see Section 8.3 in the Operator's Guide)
maintenance.
2. Repeat the test(s).
Wrong sample container and/or rack Load the samples using appropriate sample containers and
racks. Be sure that the sample containers are in a rack with the
correct rack ID (see Section A.1 and see Section A.2 in the
Operator's Guide).
Sample container missing or placed 1. Be sure that the sample containers are in the proper order
in incorrect position in the rack in the rack.
2. Repeat the test(s).
Sample values are Patient samples evaporating from 1. Load a fresh aliquot of each patient sample.
too high being on the instrument too long 2. Repeat the test(s). Be sure the sample is pipetted into the
RVs within one hour of loading it onto the instrument. Be
sure sample from 3 mL sample containers is pipetted into
the RVs within two hours of loading.
Low sample value Incorrect dilution factor 1. If the sample result was generated with an automated
flag dilution (for example, the Diluted βhCG assay), repeat
the sample in the standard assay format (Total βhCG
assay).
2. If the results are still too high, contact Technical Support.
Patient sample handled incorrectly Be sure that sample is stored and handled according to proper
laboratory procedures. Refer to individual assay reagent
instructions for use for proper sample handling instructions.
Increased assay Wrong reagent pack loaded, or 1. Verify that the reagent pack was loaded by checking the
variability/poor placed in an incorrect position on the Supplies screen. If it is missing, load a reagent pack.
precision reagent carousel 2. If the reagent pack is listed on the screen, verify its
location by unloading it from the carousel (see
Section 2.7 in the Operator's Guide).
• If the reagent pack is on-board, but is not presented
during this process, contact Technical Support for
assistance.
• If Technical Support confirms a misplaced reagent
pack, retrieve the pack (see Section 2.7 in the
Operator's Guide).
3. Reload the reagent pack after you have verified its
location.
4. Repeat the test(s).
Unexpected shift Expired reagent pack 1. Check the reagent pack expiration date on the Reagent
in assay results Inventory screen (see Section 2.8 in the Operator's
Guide).
2. Unload the expired reagent pack and load a new one (see
Section 2.7 in the Operator's Guide).
• If the lot number of the new reagent pack is different
than the expired pack, recalibrate the assay.
3. Repeat the test(s).
Expired assay calibration 1. Check the Reagent Pack button on the Supplies screen
(see Section 2.1 in the Operator's Guide). If the lot
number is red, the calibration has expired.
2. View the test results (see Section 5.2 in the Operator's
Guide). Any test results calculated with an expired
calibration will be flagged.
3. Recalibrate the assay.
4. Repeat the test(s).
Quality controls (QC) not run after 1. Run QC (see Section 3.4 in the Operator's Guide).
preventive maintenance or repair 2. Evaluate any out-of-range QC results according to your
established laboratory procedures.
3. Troubleshoot any test result flags, and recalibrate the
assay (see Section 3.3 in the Operator's Guide) if
necessary.
4. Repeat the test.
Wash buffer contaminated 1. Contact Technical Support to verify the need to rinse the
wash buffer reservoir.
2. If Technical Support confirms, rinse the wash buffer
reservoir (see Section 7.4).
3. If the System Check results are acceptable:
• Recalibrate the assay.
• Run controls and repeat the test(s).
4. If the System Check results are not acceptable, contact
Technical Support.
Increasing values Patient samples evaporating from 1. Load a fresh aliquot of each patient sample.
across the run being on the instrument too long 2. Repeat the test(s). Be sure the sample is pipetted into the
RVs within one hour of loading it onto the instrument. Be
sure sample from 3 mL sample containers is pipetted into
the RVs within two hours of loading.
NOTE
The system may print the same test result flag twice on a sample report. Ignore
the duplicate flag. For example, if the flag NCRNCR appears on the sample
report, review the Reference Manual or Help system system for information
about the NCR flag.
Fatal Flags
CCR A result could not be calculated because: 1. Take one of the following actions:
• One of the tests included in a derived • For results other than derived results, skip to step 2.
result formula (see Section 4.6) did not • For derived results, review each test result used in the
produce a result. derived result formula. If a result failed, troubleshoot
• A confirmatory test result could not be according to the flag for that result.
calculated. Usually this occurs because 2. Review the Event Log and troubleshoot according to the
the samples for the qualitative and error events with a similar date and time to this event (see
confirmatory tests were not aspirated at Section 6.3).
the same time (see Section 3.3).
3. Repeat the test.
• Another error prevented the system
• For a derived result, repeat all tests included in the
from calculating a result.
derived result formula.
• For a confirmatory result, repeat the confirmatory and
qualitative tests.
4. If the problem persists, contact Technical Support.
CLT An obstruction was detected. 1. Review the Event Log and troubleshoot according to the
error events with a similar date and time to this event (see
Section 6.3).
2. Repeat the test.
3. If the problem persists, contact Technical Support.
IND • For sandwich assays, which use 1. For IND flagged results which meet the following
positive slope calibration curves, the criteria, dilute and rerun the sample:
result is at the low end of the • The result is on a competitive assay, and
concentration curve and cannot be
• Sample dilution is allowed for the assay, and
distinguished from a system failure
because the RLU reading is too low. • The sample RLU is low.
• For competitive assays, which use See the reagent instructions for use to determine the assay
negative slope calibration curves, the type and whether sample dilution is allowed.
result is at either: 2. Rule out a system problem by reviewing the Event Log
• The high end of the concentration for error events with a date and time shortly before this
curve and cannot be distinguished event. Troubleshoot accordingly.
from a system failure because the 3. If you have ruled out a system problem and the IND flag
RLU reading is too low, or event is the only issue, recalibrating the affected assay
• The low end of the concentration may resolve the problem.
curve and cannot be distinguished • Recalibrate the assay using a new reagent pack and a
from a system failure because the new set of calibrators.
RLU reading is too high. • Run QC.
• Repeat the test on the affected sample.
If IND flags persist, contact Technical Support.
NCR No calibration data existed for the reagent 1. Calibrate the assay (see Section 3.3 in the Operator's
lot when the result was processed. Guide).
2. Repeat the test(s).
QSD Insufficient reagent volume was 1. Review the Event Log and troubleshoot according to the
dispensed into an RV. error events with a similar date and time to this event (see
Section 6.3).
2. Run cancelled tests again.
3. If the problem persists, contact Technical Support.
QNS The sample volume is insufficient. 1. Follow the troubleshooting instructions for the QNS
Additional tests will not be scheduled for event in the Event Log (see Section 6.4).
this sample. Tests already scheduled will 2. Repeat the test(s).
be completed.
3. If the problem persists, contact Technical Support.
RLU The relative light units (RLUs) are 1. Review the Event Log and troubleshoot according to the
outside the acceptable luminometer error events with a similar date and time to this event (see
measuring range. Section 6.3).
2. Repeat the test(s).
3. If the problem persists, contact Technical Support.
SYS A device error occurred during 1. Review the Event Log and troubleshoot according to the
processing. error events with a similar date and time to this event (see
Section 6.3).
2. Repeat the test(s).
3. If the problem persists, contact Technical Support.
TRI The temperature of the incubator was 1. Check the incubator temperature on the Maintenance
outside the acceptable limits. All tests Review screen. If the temperature is outside the
being incubated when the temperature acceptable limits, periodically monitor the incubator
was outside limits are flagged. temperature on this screen until it is within the acceptable
limits.
• If the system was rebooted or instrument covers were
recently opened, you may need to wait up to 30 minutes
for the temperature to normalize.
• If the system was recently restarted, you may need to
wait up to 1 hour for the temperature to normalize.
2. When the incubator temperature is within the acceptable
limits, repeat the test(s).
3. If the temperature does not normalize, or if the problem
persists, contact Technical Support.
TRS The temperature of the substrate was 1. Check the substrate temperature on the Maintenance
outside the acceptable limits when it was Review screen. If the temperature is outside the
dispensed. acceptable limits, periodically monitor the substrate
temperature on this screen until it is within the acceptable
limits.
• If the system was rebooted or instrument covers were
recently opened, you may need to wait up to 30 minutes
for the temperature to normalize.
• If the system was recently restarted, you may need to
wait up to 1 hour for the temperature to normalize.
2. When the substrate temperature is within the acceptable
limits, repeat the test(s).
3. If the temperature does not normalize, or if the problem
persists, contact Technical Support.
TRW The temperature of the wash/read 1. Check the wash/read carousel temperature on the
carousel was outside the acceptable Maintenance Review screen. If the temperature is outside
limits. All tests with RVs in the the acceptable limits, periodically monitor the wash/read
wash/read carousel when the temperature carousel temperature on this screen until it is within the
was outside limits are flagged. acceptable limits.
• If the system was rebooted or instrument covers were
recently opened, you may need to wait up to 30 minutes
for the temperature to normalize.
• If the system was recently restarted, you may need to
wait up to 1 hour for the temperature to normalize.
2. When the wash/read carousel temperature is within the
acceptable limits, repeat the test(s).
3. If the temperature does not normalize, or if the problem
persists, contact Technical Support.
Non-Fatal Flags
Non-Fatal
Description Corrective Action
Flag
CEX The calibration curve or cut-off value is 1. Recalibrate the assay (see Section 3.3 in the Operator's
expired. Guide).
2. Repeat the test(s).
CRH The result is above the upper limit of the This is a valid test result. No corrective action is necessary.
critical range.
Not applicable for QC or calibrations.
CRL The result is below the lower limit of the This is a valid test result. No corrective action is necessary.
critical range.
Not applicable for QC or calibrations.
EXS The substrate is expired. 1. Change the substrate bottle from the Supplies screen (see
Section 2.4 in the Operator's Guide).
2. Repeat the test(s).
GRY For qualitative assays, the result is within This is a valid test result. No corrective action is necessary.
the specified gray zone.
LEX The reagent pack lot is expired. 1. Unload the expired reagent pack and load a new one (see
Section 2.7 in the Operator's Guide).
• If the lot number of the new reagent pack is different
than the expired pack, recalibrate the assay.
2. Repeat the test(s).
LRH The result is above the upper limit of the 1. Review the result.
LIS range. The system does not send 2. Take one of the following actions:
results with this flag to the LIS.
• Send the result to the LIS manually (see Section 5.3 in
Notes: the Operator's Guide).
• This flag is displayed only when the • Delete the result (see Section 5.3 in the Operator's
Auto-Send to LIS option is set to Guide) and repeat the test(s).
Verify.
• This flag is for quantitative assays,
semi-quantitative assays, and derived
results only.
LRL The result is below the lower limit of the 1. Review the result.
LIS range. The system does not send 2. Take one of the following actions:
results with this flag to the LIS.
• Send the result to the LIS manually (see Section 5.3 in
Notes: the Operator's Guide).
• This flag is displayed only when the • Delete the result (see Section 5.3 in the Operator's
Auto-Send to LIS option is set to Guide) and repeat the test(s).
Verify.
• This flag is for quantitative assays,
semi-quantitative assays, and derived
results only.
LOW The result is lower than the minimum No corrective action is necessary.
reportable result value defined in the
APF.
Non-Fatal
Description Corrective Action
Flag
ORH The result is above the upper limit of the No corrective action is necessary.
reference range.
Not applicable for QC or calibrations.
ORL The result is below the lower limit of the No corrective action is necessary.
reference range.
Not applicable for QC or calibrations.
OVR The calculated concentration is above the 1. Review the Event Log for error events with a similar date
highest or most concentrated calibrator. and time to this event (see Section 6.2).
This flag is only used for quantitative and • If events occurred, troubleshoot (see Section 6.3).
semi-quantitative assays.
2. Take one of the following actions:
• If events occurred, and you performed troubleshooting
procedures, run controls and then repeat the test.
- If the controls are in range, and the test result is
reported as greater than the value of the highest
calibrator (>X), you may be able to dilute the
sample. To identify whether the assay allows
dilutions, see the reagent instructions for use.
- If the controls are not in range, follow the QC
troubleshooting instructions.
• If no events occurred, take one of the following actions:
- If the test result is reported as >X, you may be able
to dilute the sample. To identify whether the assay
allows dilutions, see the reagent instructions for use.
If dilutions are allowed, dilute and repeat the test.
- If dilutions are not allowed, no further action is
necessary.
3. If you have questions about the result, or if the problem
persists, contact Technical Support.
PEX The open pack stability time has elapsed 1. Unload the expired reagent pack and load a new one (see
for the reagent pack. The system Section 2.7 in the Operator's Guide).
measures this from the time it first • If the lot number of the new reagent pack is different
punctures the pack. than the expired pack, recalibrate the assay.
2. Repeat the test(s).
QCF A quality control violates one or more 1. Display the QC Chart and Data screen to review which
QC rules. criteria is not met.
2. Follow the QC troubleshooting instructions in
Section A.4: Assay Troubleshooting.
QEX The quality control lot is expired. 1. Add a new, unexpired quality control (see Section 7.4 in
the Operator's Guide).
2. Repeat the test(s).
RFX The result is from a reflex test. This is a valid test result. No corrective action is necessary.
Glossary
%CV
See coefficient of variation (CV).
A
acceptance limits
For qualitative assays, the APF defines acceptance limits for the RLUs obtained for means and replicates
of each calibrator. If the RLUs obtained are outside these limits, the assay calibration fails.
The APF defines acceptance limits for the %CV of the RLUs obtained for replicates of the S0 (zero)
calibrator for some quantitative assays. If the %CV obtained is outside these limits, the calibration fails.
active calibration
The assay calibration currently being used for reporting assay results.
ADC
See A/D converter (ADC).
A/D converter (ADC)
A device that converts the analog signals from the instrument into a binary coded form for the computer.
alkaline phosphatase
An enzyme that acts on a wide variety of organic compounds by removing a phosphate group
(dephosphorylation). The enzyme label used in Access 2 system assays to produce chemiluminescence
when substrate is added.
analyte
The specific substance in the sample (blood, urine, or other body fluid) that is being measured or
otherwise evaluated.
analytical module
The part of the instrument that includes the RV loader, incubator belt, wash/read carousel, and
luminometer.
antibody
A protein in body fluid that is formed in response to, and is capable of binding with, an antigen.
B
bar code
A computer-readable array of varying width parallel rectangular bars and spaces. Used on reagent packs,
substrate bottles, calibrator cards, rack labels, and sample labels to permit the scanning of data into the
system using the internal bar code reader or the external bar code reader.
bar code reader
See internal sample bar code reader or external bar code reader.
batch request
A system function used to simplify manual test request entry. When activated, the system automatically
selects the same test IDs to run on each additional sample ID you enter.
baud rate
The unit of measure of data transmission speed.
board
See printed circuit board (PCB).
bound analyte
The components of an assay that are bound to a paramagnetic particle to form an immune complex.
broadcast
A download of information that is initiated by the laboratory information system (LIS).
C
calculated concentration
The concentration of analyte in calibration material, as measured and calculated by the system. For
contrast, see assigned concentration.
calibrators
A set of solutions containing precisely measured amounts of analyte spanning a range of concentrations.
You run calibrators on the system to establish a calibration curve or cutoff. The system uses the curve or
cutoff to determine patient and quality control test results for quantitative, semi-quantitative assays, or
qualitative assays.
CARE kit
A parts and repair kit that contains spare instrument parts.
carousel module
The part of the instrument that includes the sample carousel, reagent carousel, cup/tube detector, and
internal bar code reader.
central processing unit (CPU)
The part of a computer or instrument that processes the data stored in memory. Both the external
computer (PC) and the instrument computer have CPUs.
chemiluminescence
The emission of light resulting from a chemical reaction.
Citranox cleaning solution
An industrial solvent used to clean appropriate parts of the instrument according to documented Access 2
procedures.
clean check
A part of the System Check routine that evaluates how effectively the instrument washes the aspirate
probes. The clean check cannot be requested as an individual check.
client
A PC in an Access 2 workgroup of multiple instruments that is not the server. A workgroup can have up
to three clients and one server. See also server.
coefficient of variation (CV)
A measure of the relative precision of a group of data points. The CV is calculated by dividing the
standard deviation by the mean. Calculating the CV allows you to measure the precision of different sets
of data that have different means. The CV is often calculated as the %CV, which is the CV * 100.
cold boot
To reboot the instrument using the power switch. See also reboot and warm boot.
D
D/A converter (DAC)
A device that converts digital pulses into analog signals.
DAC
See D/A converter (DAC).
daily maintenance
The inspection, cleaning, and priming procedures you perform every day on the Access 2 system.
dark counts
The background light that is present in the instrument when there is no RV in front of the luminometer.
Dark counts are measured in RLUs. High dark counts affect results.
dead volume
The amount of sample in a sample container that is not available for processing and must be included in
the sufficient sample volume calculation.
deionized water (DI water)
The purified water created by removing ions through ion exchange. It is used to clean appropriate parts of
the instrument according to documented Access 2 procedures.
demographics
The characteristics of patients, especially their age, sex, weight, height, and other physical attributes.
derived result
A calculated result that is generated when a test result is operated on by a derived result formula. Derived
result formulas are either predefined in the APF or are set up according to laboratory preference. Derived
results are included on the test result reports and they can be sent to the LIS.
detection phase
The part of an assay that occurs when the immune complexes that are bound to paramagnetic particles
(the solid phase) are detected by adding substrate and measuring the resulting chemiluminescence.
dioxetane
A chemiluminescent compound that is activated by alkaline phosphatase.
dispense probe
A probe that dispenses wash buffer into RVs to wash the paramagnetic particles.
distilled water
The purified water created by successive evaporation and condensation. It is used to clean appropriate
parts of the instrument according to documented Access 2 procedures.
download
The process of transmitting data to the Access 2 system from a host computer, usually a laboratory
information system (LIS).
E
e format
A method of expressing numbers with many digits by placing the decimal to the right of the first single
digit, by rounding the last digit to the right of the decimal, and by indicating the number of places right (-)
or left (+) that the decimal shifted from the original number. For example, the 11-character number
12345678.99 is expressed as the 10-character number 1.235e+007 in e format. The Access 2 system uses
e format in some calculated fields.
electronics module
The part of the instrument that includes the power supply, reset button, interlock switch, reaction vessel
load door alarm, internal hard drive, 3.5-inch disk drive, and printed circuit boards.
error band
The calculated acceptable limits of variability around a calibration curve.
event details
The technical information you can display for an event. Technical Support may use the event details to
troubleshoot the instrument if you contact them for assistance.
Event Log
A list of events the Access 2 system generates as it monitors the status of various system parameters. An
event can be one of three types: Information, Caution, or Warning.
external bar code reader
The Access 2 peripheral device that reads printed bar codes on calibrator cards, substrate labels, and
reagent packs. You can also use the external bar code reader as a backup to the internal bar code reader for
reading sample IDs and rack IDs. The instrument is equipped with an external handheld bar code reader
or an external bar code wand. For some Access 2 systems the handheld bar code reader also operates in a
hands-free mode.
F
fatal event
A condition that stops the Access 2 system, or a portion of the system, and must be corrected before the
system can continue processing samples.
fatal flag
A flag applied to a test result when the system encounters a condition that may cause the result to be
invalid. The system suppresses these test results.
filter
A system function used to find the data stored in the Access 2 system database that fits a selected set of
parameters. You can apply a different filter or change the set of parameters to reduce or expand the
number of items the system displays.
firmware
A software program that is contained permanently on a hardware device. For example, the SMC board
contains firmware for the Access 2 stepper motor controller.
flags
The codes the Access 2 system attaches to test results when a special circumstance requires your
attention. Also, a mechanism that indicates to a sensor that a device is in a specified position.
fluidic module
The part of the instrument that includes the vacuum pump, wash pump, vacuum reservoir bottle, wash
valve, substrate pump/valve/heater, probe wash tower, probe wash valve, peristaltic waste pump, and
fluids tray.
G
gray zone
A range of values (up to 20%) above and/or below the cutoff value. The system can be configured so that
it flags (GRY) results in the gray zone. The GRY flag indicates that the result is near the cutoff.
H
heterogeneous assay
An assay that requires the separation of bound labeled material from unbound labeled material.
home position
A set starting position for any instrument device.
host query
An information request from the Access 2 system to the laboratory information system (LIS) for new test
requests. When a rack is loaded without test requests, and host query is enabled, the Access 2 system
sends a host query instead of waiting for a download.
I
immune complex
An antigen and antibody that are physically bound together.
immunoassay
An analytical method that depends on the antigen-antibody reaction to detect the substance being
measured.
initialization
A routine that resets the Access 2 system software, and brings all devices to a known safe state.
Initialization prepares the system for further processing.
input/output (I/O)
A transfer of data between the central processing unit and a peripheral device.
instrument software
A software program that controls the motion of devices in the instrument’s processing modules.
interlock switch
A safety feature designed to protect you from injury. When you open the front panel, the interlock switch
disengages, which cuts off power to the main pipettor.
internal reagent bar code reader
A device in the Access 2 instrument carousel module that reads the printed bar codes on reagent packs
(available on instruments with serial numbers ≥570000).
internal sample bar code reader
A device in the Access 2 instrument carousel module that reads the printed bar codes on sample
containers and racks.
L
laboratory information system (LIS)
A computer system that manages the entire workflow in a clinical laboratory from the point of specimen
collection to the creation of final patient reports. The LIS can interface with the Access 2 system to
provide test request information and receive results.
last run calibration
The results of the most recent calibration test request that either passed or failed.
LED
An abbreviation for light emitting diode. See light emitting diode (LED).
Levey-Jennings chart
A graphical representation of quality control test results that shows each result as a point on, above, or
below the expected mean result in distances measured in units of standard deviation (SD) between -3SD
and +3SD. Also called a Shewhart chart.
M
main pipettor
A device in the main pipettor module that transfers measured volumes of samples and reagents to reaction
vessels and prepares on-board sample dilutions (if necessary). See also primary probe.
main pipettor module
The part of the instrument that includes the precision pump, precision valve, pipettor gantry, pressure
monitor, and main pipettor (ultrasonic transducer and primary probe).
maintenance log
A record you use to document the completion of daily and weekly maintenance procedures.
math model
The statistical formula the Access 2 system uses to fit an assay’s calibration data to a curve.
methanol
A light, volatile, and flammable poisonous liquid alcohol (CH3OH). It is used to clean appropriate parts
of the instrument according to documented Access 2 procedures.
N
non-fatal event
A condition that does not stop the Access 2 system, but is posted to the event log, and should be examined
before the system continues processing samples.
non-fatal flag
A flag applied to a test result when the system encounters a notable condition. The system does not
suppress these test results.
non-volatile random access memory (NVRAM)
A data storage area that maintains critical system information. The NVRAM is backed up by a battery, so
the information is maintained when the power is off.
NVRAM
See non-volatile random access memory (NVRAM).
O
obstruction detection
A process performed by the pressure monitor in the main pipettor module to detect whether sufficient
sample is being aspirated, or whether there is an obstruction in the sample, such as a clot. A test requested
on a sample with an obstruction will be canceled and marked with the fatal flag CLT. If two consecutive
obstructions are detected for the same sample, all tests for that sample will be canceled.
onboard
The location of the rack or sample when it is in the instrument.
override
A feature that allows the system to start sample processing using expired supplies or calibrations listed on
the Supplies Required screen. The system flags tests results obtained using expired supplies or
calibrations.
P
paramagnetic
The ability to react to magnetism without holding residual magnetism.
paramagnetic particles
The particles used as the solid phase in assays to capture and then separate bound from unbound analyte.
Commonly made from ferrous oxide surrounded by cellulose or polystyrene and milled to a particle size
of 1-3µm.
PC
An abbreviation for personal computer. See personal computer (PC).
PCB
An abbreviation for printed circuit board. See printed circuit board (PCB).
peripheral module
The part of the instrument that includes the external computer, keyboard, mouse, monitor, printer, and
external bar code reader.
personal computer (PC)
The external computer that is connected to an Access 2 system. The PC has its own 3.5-inch disk drive
(on some instruments), CD-ROM or DVD drive, modem, and tape drive or USB flash drive. The
following peripheral devices are connected to the PC: touch screen monitor, keyboard, printer, mouse,
and external bar code reader.
plot
The method of marking a point on a grid using coordinates.
precision profile
The method the Access 2 system uses to determine if a quantitative or semi-quantitative assay’s
calibration meets the determined acceptance criteria.
previous active calibration
The calibration that was previously the active calibration.
primary probe
The probe through which the main pipettor transfers sample, reagents, or wash buffer into RVs. See also
main pipettor.
primary test
The test name on a reagent pack. Some assays can provide a secondary test from the same reagent pack,
such as Folate (primary) and RBC Folate (secondary).
prime (priming)
To fill the fluidic lines with liquid and eliminate air in the lines, which ensures that the system dispenses
and aspirates accurate volumes.
prime fluidics
The process of filling the instrument’s fluidic lines with liquid.
printed circuit board (PCB)
A flat board that holds silicon chips and other electronic components.
Q
QC
See quality controls (QC).
QC Rules
See Westgard QC rules.
qualitative assay
An assay that uses a cutoff value to classify a test result as reactive or non-reactive for the analyte. See
also cutoff value.
quality control (QC) calculations
The comparison of results to the acceptable range of expected values you entered during QC setup. QC
calculations include the mean (average) test result value, the standard deviation (SD) from the mean, and
the percent coefficient of variation (%CV).
quality controls (QC)
Samples of known reactivity, composed of a material similar to patient samples, which are run along with
patient samples to monitor system performance.
quantitative assay
An assay that uses a calibration curve to convert the measured response in RLUs to analyte concentration,
and expresses the results in incremental units.
R
rack
A device used to load samples onto the instrument. Each rack holds up to ten samples, and the instrument
holds up to six racks. The rack ID identifies the type of sample containers in the rack.
reaction vessel (RV)
The container where the chemical reaction between patient sample and assay-specific reagents occurs.
reaction vessel load door alarm
An alarm that sounds when you attempt to open the reaction vessel load door when the instrument is not
prepared for loading RVs. The alarm does not sound when you follow the proper procedure for loading
RVs.
reagent
A substance used to perform an assay. Access 2 system reagents include conjugate, paramagnetic
particles, and other assay-specific reagents such as antigens or antibodies specific for the analyte being
detected, stripping agents, or buffered protein solutions.
reagent inventory
A system process that defines and tracks the reagent name, lot number, serial number, number of tests
left, expiration date, and reagent carousel slot number (if the pack is on-board the instrument) for each
reagent pack.
reagent pack
A package that holds up to five assay-specific reagents in separate compartments. Reagent packs are
loaded on the instrument in the reagent carousel.
reagent pack monitoring
A measuring process performed by the pressure monitor when the main pipettor transfers reagent from a
reagent pack to an RV. Reagent pack monitoring may cancel a test when reagent packs are identified as
supplying insufficient reagent to complete the test. The process is intended to prevent errors from reagent
packs that are missing, improperly loaded, or used on more than one instrument (when not in a
workgroup).
real-time
In the same time frame. Real-time responses or file updates occur immediately. For example, when
diagnosing an LIS transmission problem, you can view LIS messages on the LIS Diagnostics screen in
real-time (as they happen).
reboot
The process of restarting the system software and the instrument. See cold boot or warm boot.
receiver
The device that receives data from the sender, according to communications protocols. The receiver may
be an Access 2 system or the LIS.
reference range
The range or expected test result values for a normal demographic population, as configured by your lab.
The system flags results that are out of range. See also critical range and LIS range.
reflex test
A test that the system runs automatically in response to one or more test results that meet predefined
conditions. For example, if the total ßhCG test result is greater than 1000, then the system runs the diluted
ßhCG test without needing additional information being entered into the system.
relative light unit (RLU)
A unit of measure used to express the amount of light reaching the luminometer.
replicate
The multiplier for the number of times a test is run on the system. Tests are run in replicates of 1, 2, 3, and
so on.
RLU
See relative light unit (RLU).
RV
See reaction vessel (RV).
RV waste bag
The container that collects the used RVs. The RV waste bag contents are considered biohazardous waste.
S
sample
The material loaded onto the instrument for processing.
sample processing
The process of performing requested tests on samples. Sample processing begins after you verify
supplies, load samples, enter or verify test request information, and select Run.
sample type
The type of body fluid being analyzed, such as serum, urine, or plasma.
sandwich immunoassay
An assay in which unlabeled analyte (antigen in the test sample) is sandwiched between an antibody
bound to the paramagnetic particles and a labeled antibody (conjugate).
secondary test
An alternative format for a test that uses the same reagent pack as the primary test. For example, RBC
Folate is a secondary test for Folate.
semi-quantitative assay
An assay that uses a calibration curve to convert the measured response in RLUs to analyte concentration
and may express the results in interpretive units, such as reactive, non-reactive, or equivocal.
sender
The device that sends (transmits) data to the receiver, according to communication protocols. The sender
may be an Access 2 system or the LIS.
separator gel
The gel in a sample container that separates blood from serum when the sample is centrifuged.
server
The PC that allocates resources for a workgroup, such as storing files and managing workgroup
communication with the LIS. See also client.
SMC
See stepper motor controller (SMC).
solid phase
The part of an assay that occurs when the immune complexes bind to paramagnetic particles and are then
separated from unbound materials.
sort order
The order that items are displayed on a screen or on a report. For example, you can sort test results by
sample ID, then by completion time in ascending (or descending) sort order.
Special Clean
A maintenance routine that prevents the buildup of debris on the primary probe and aspirate probes. The
Special Clean routine is run when the instrument is shut down, restarted, or as instructed by a technical
support representative.
spooling
The acronym for simultaneous peripheral operations on-line. Spooling refers to loading a document to
print in a special area in memory where the printer can access the document at its own rate. You can then
perform other operations on the system while the printing takes place in the background. Spooling also
lets you make multiple print requests without waiting for each one to finish before requesting the next
one.
stepper motor controller (SMC)
A programmable device that translates motion commands from the central processing unit into signals
that are usable by the stepper motors to move devices within the instrument.
substrate
A substance acted upon by an enzyme. In an Access Immunoassay system assay, the substrate is a
dioxetane-based chemiluminescent compound that emits light in response to the amount of alkaline
phosphatase (enzyme) to which it is exposed.
substrate check
An individual system check that evaluates the performance of the instrument’s substrate dispense system
and luminometer.
substrate probe
A probe that dispenses substrate into the RVs to initiate a chemiluminescent reaction.
substrate ratio
A calculation based on results from the substrate check. A failed substrate ratio is indicative of a
compromised waste system.
substrate : washed ratio
A calculation based on results from the substrate and washed checks. A failed substrate : washed ratio
could be caused by an improperly performed System Check routine, or by contaminated substrate.
supplies
The consumables that can be depleted and the waste containers that must be emptied or replaced.
Consumables are wash buffer, substrate, RVs, and reagent packs. Waste containers are the liquid waste
bottle and the RV waste bag.
System Check
A maintenance routine that verifies the wash efficiency and pipetting precision of the Access 2 system.
The System Check routine is part of weekly maintenance but may be performed more frequently or as
part of a troubleshooting procedure.
system mode
The operational state of the Access 2 system displayed in the upper left corner of each screen. System
modes include Ready, Running, Paused, and Not Ready.
system status buttons
Round pictorial icon buttons that display at the top of every screen. They notify you of supply and waste
container conditions, QC failures, test requests, pending samples not on board, and events that require
your attention.
T
test request
The sample and test information you enter for each sample to be processed.
test result
The analyte concentration in a sample. The system calculates the test result by comparing the RLU
measurement to a calibration curve or cutoff value.
test result flags
See flags.
thermal zones
The areas of the instrument that are cooled or heated by temperature control devices.
troubleshooting Help
The online troubleshooting information from the Access 2 system Help system that you can display for a
test result flag or for a caution or warning event by selecting Troubleshoot F2.
U
ultrasonic transducer
The instrument device on the main pipettor that applies ultrasonic vibrations to the tip of the primary
probe that mixes reagents in the reagent pack before sampling, mixes the contents in the RV, cleans the
probe after each use, and senses the level of the sample fluid.
unbound analyte
The components of an assay that have not formed immune complexes.
unwashed check
An individual system check that evaluates the precision of the instrument’s main pipettor module.
upload
The process of moving data from the Access 2 system to a host computer, usually a laboratory
information system (LIS).
user interface (UI) software
The software you use to interface with, and direct, the instrument system software. The UI contains
database, sample calibration, quality control, and LIS information, as well as the assay protocol file
(APF). The UI software is stored on the hard drive of the external computer (PC).
utility assay
A maintenance assay that flushes the instrument's probes and fluidic lines. When the utility assay is
enabled, it runs automatically every four hours. The assay can also be run manually when additional
cleaning is requested by Technical Support or required for troubleshooting.
W
warm boot
To reboot the instrument using the reset button. See also cold boot and reboot.
wash buffer
The buffered solution used by the Access 2 system to remove unbound material during assay processing,
to clean the probes, and to dilute sample for some assays.
wash efficiency
A calculation based on the results from the washed, substrate, and unwashed checks. To obtain a wash
efficiency result you must run the System Check routine.
washed check
An individual system check that evaluates the performance of the instrument’s RV wash and mixing
systems.
weekly maintenance
The inspection, cleaning procedures, and system check routine you perform every seven days to keep the
system running at optimal efficiency.
Westgard QC rules
A set of interpretive rules the system uses to avoid excessive false rejection rates, improve quality
monitoring, and decrease subjectivity of data analysis. (Also called Westgard rules or QC rules.)
The application of a Westgard QC rule consists of screening quality control test results for an amount of
standard deviation above or below the mean, and the number of consecutive occurrences. For example,
the 41S rule checks for 4 consecutive results that exceed ±1 SD from the mean. Your laboratory
determines the QC rules to apply and the course of action you need to take when a result violates a rule.
The Access 2 system uses five Westgard QC rules (12S, 13S, 22S, 41S, 10X).
work pending
The tests the system cannot schedule because it cannot find an on-board sample. Work pending tests can
be created because the system requested a reflex test, the LIS requested a test, or an operator requested a
test to be rerun.
workpool
See LIS workpool.
workgroup
A complete Access 2 Immunoassay System installation, which consists of from one to four instruments.
Within a workgroup, one PC is configured as the server. Additional PCs are clients. See also client and
server.
Mouse
M Instrument Peripheral, 1-17
Main Pipettor
Analytical Volume Checks, 5-37 N
Analytical Volume Checks (Flowchart), NCR Fatal Flag, A-47
5-37
Non-Fatal Flags, A-49
Excess Pressure when Dispensing, A-33
Leaking, A-32
Module, 1-8 O
Primary Probe Replacement, 7-51 Obstruction Detection
Resetting, 5-50 CLT Flag, 3-19
Sensor Testing, Z-Axis, 7-50 Determining Curve, 5-64
Support Procedures, 7-47 Flowchart, 3-20
Troubleshooting Table, A-32 Pressure Monitor Screen, 5-62
Visual Volume Checks, 5-22 Theory, 3-19
Visual Volume Checks (Flowchart), 5-22
Online
Volume Check Window, 5-24 Support, USA and Canada, Preface-4
Main Pipettor Module Operator’s Guide, Preface-3
Pipettor Gantry, 1-9
Order of Operations
Precision Pump and Valve, 1-8
Derived Result Rules, 4-56
Pressure Monitor, 1-9
Reflex Test, 4-79
Primary Probe, 1-9
Reflex Test Rules, 4-78
Technical Overview, 1-8
Ultrasonic Transducer, 1-9
ORH Non-Fatal Flag, A-50
ORL Non-Fatal Flag, A-50
Manuals
Operator’s Guide, Preface-3 OVR Non-Fatal Flag, A-50
Mechanical Devices
Diagnostics, 5-46 P
Mechanics Screen, 5-51 Paramagnetic Particles, 1-20
Menus Password
Configure, 4-7 Changing, 4-16
Diagnostics, 5-5 Default, 4-16
Mixer Motor Setup, 4-16
Turning Off and On, 5-65 Patient Sample Problems
Modules Increased Assay Variability, A-44
Analytical Module, 1-10 Increasing Values Across Run, A-45
Carousel Module, 1-6 Low Sample Value Flag, A-44
Electronics Module, 1-15 Poor Precision, A-44
Fluidic Module, 1-12 Sample Values Too High, A-44
Main Pipettor Module, 1-8 Test Result Flags, A-42
Peripherals Module, 1-17 Troubleshooting Table, A-42
Monitor Unexpected Sample Results, A-42, A-43,
Touch Screen Technology, 1-17 A-44
Unexpected Shift in Assay Results, A-45
Motors
Disabling or Enabling, 5-57 PCBs
Mixer, 5-65 See Printed Circuit Boards
Procedure, 7-12
Replenishing Supplies, 7-20 S
Running Special Clean, 7-20 Safety
Running System Check, 7-20 Interlock Switch, 1-16
Volume Checks, 7-19 Warnings, Preface-4
Restore System Data, 4-100, 4-102, 4-108 Sample
Results Bar Code Reading Problems, A-29
Also See Derived Results Carousel, 1-6
Also See Test Results Instrument Capacities, 2-10
RFX Non-Fatal Flag, A-50 Sample Processing
RLU Fatal Flag, A-47 Adding Substrate, 3-6
RLUs Continuous Access, 3-2
Current Luminometer Readings, 5-75 Luminometer Reading, 3-6
Luminometer Reading, 5-72 On-Board Incubation, 3-5
Rules Pipetting Position, 3-5
Derived Result Formulas, 4-56 Processing Order, 3-2
Reflex Conditions Syntax, 4-78 Random Access, 3-2
Reflex Test Order of Operations, 4-78 RV Wash, 3-5
STAT Access, 3-2
RV Load Door
Test Requests, 3-2
Removing Incubator Cover, 7-10
Theory, 3-2
Sensor, 5-68
Sample Types, Changing Default, 4-32
RV Loader, 1-10
Sandwich Assays, 1-22
RV Shuttle
Aspirate Probe Positions, 5-29 Screens
Clearing the Path, 7-34 Also See Menus
RV Positions, 5-15 Derived Results, 4-59
Support Procedures, 7-33 Device Diagnostics, 5-47
Transfer Position, 7-35 Diagnostics (Menu), 5-5
Event Log, 6-3
RV Waste Bag Sensor
LIS Diagnostics, 5-90
Adjusting, 7-27
Luminometer, 5-72
Testing, 7-25
Mechanics Screen, 5-51
RVs
PC Admin, 4-101
Checking for Fallen or Missing, 7-37
Pressure Monitor, 5-62
Dispense Characteristics, 5-16
Reflex Tests, 4-84
Sensor Testing and Cleaning, 7-43
System Setup, 4-10
Sensors, Diagram, 7-44
Test Panels, 4-45
Vessel Holders, 7-39
Tests, 4-29
Vessel Transport, 3-4
Volume Checks, 5-14
Volume Checks, Access, 5-15
Semi-Quantitative Assays
Wash Stages, 3-5
Technical Overview, 1-19
Waste Ejection, 3-6
Semi-Quantitative Calibrations
Acceptance Criteria, 3-9
Assay Theory, 3-9
Calculating Predicted Precision, 3-10