Академический Документы
Профессиональный Документы
Культура Документы
P/N 105331J
November 2011
Printed in U.S.A.
2011 Beckman Coulter, Inc.
BECKMAN COULTER, INC. 250 S. KRAEMER BLVD. BREA, CA 92821 U.S.A.
Publication Each page of the Access 2 Reference Manual is identified with its revision and release
Notes date. For pages other than the title page, revision information is located at the bottom
of the page.
All pages in this manual are issued as P/N 105331J, release date 11/11.
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 and the
SYNCHRON LXi 725 systems, which consist of an Access 2 system integrated with
another Beckman Coulter system.
From time to time, the documentation for the Access 2 Immunoassay System will
need to be updated. You may receive the update as an entire replacement of an
online or paper document, as replacement pages for portions of a paper
document, or as a supplemental information update, in paper or electronic form.
Beckman Coulter, the stylized logo, Access, UniCel, and SYNCHRON LX are
trademarks of Beckman Coulter, Inc. and are registered with the USPTO.
Access 2 Reference Manual Table of Contents
Table of Contents
List of Figures and Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
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. . . . . . . . . . . . . . . . . . . . . . . . . 5-57
5.7 Luminometer Device Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-68
5.8 Advanced Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-73
5.9 LIS Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-86
5.10 Diagnostic Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-91
A Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-1
A.1 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-3
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Glossary-1
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1
Preface
About This Manual ................................................................................. Preface-2
About This The Reference Manual provides background, theory, troubleshooting, and advanced
Manual maintenance information. The Reference Manual contains the following chapters:
NOTE
In Japan, the Assay Manual is not applicable. In Japan only, see alternative local
information.
The Material Safety Data Sheet manual, which contains safety information
about materials used in conjunction with all Access Immunoassay Systems.
The LIS Vendor Information document, which provides interface
information for your laboratory information system vendor.
The Operator's Guide and Reference Manual, which provide the same text
delivered in the Help system Operating Procedures and Reference
Information books. These manuals are available in the English language.
From time to time, the Access 2 system documentation may include charts,
graphs, or other supplementary materials.
Notes, The Access 2 system documentation uses notes, cautions, and warnings to draw your
Cautions, 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....................................................................................................... 1-5
1.1
System Technology Overview
The Access 2 Immunoassay System is an automated analyzer that performs a wide
variety of immunoassays on body fluid samples.
The system processes calibration, quality control, and patient samples in individual,
disposable plastic tubes called reaction vessels (RVs) with reagents from up to 24
on-board 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 Bar Code Reader Pipettor Gantry Incubator Belt
Cup/Tube Detector Ultrasonic Transducer Wash/Read Carousel
Reagent Carousel Primary Probe Luminometer
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
Instrument Software
0501D.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.
For more information about workgroup database capacities, see Section 2.3:
Performance Characteristics.
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.
1.2
Instrument Technology
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 on-board 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 bar code reader that reads the
rack and sample container bar code labels.
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 instruments control mechanisms to
direct the actions of the processing modules.
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 PCs hard drive. 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 on-board
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 racks 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 the handheld bar code reader.
For information on how to configure the internal 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 2.3: 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 1-5C. This
temperature range ensures that the air and on-board reagent pack temperatures will be
within 3-10C. 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 manually, or by using the handheld bar code reader.
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
on-board 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 on-board 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 The fluidic module acts in concert with the main pipettor module and the analytical
Module 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, 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
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.
Vacuum Reservoir
The vacuum reservoir temporarily stores liquid removed from the probe wash tower
during its wash cycle.
Fluids Tray
The fluids tray (see Figure 1-6) 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.
1
6
5
2
0225D.eps
Electronics The electronics module performs control functions that direct the operation of the
Module instruments 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
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 (see Figure 1-8) consists of the
instruments external devices. This includes the touch screen monitor, external
computer (PC), articulated arm, keyboard, handheld bar code reader, mouse, and
printer.
For information about the peripherals module device specifications, see Chapter 2:
System Specifications.
3
4
0059E.eps
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.
NOTE
Technological advances and availability may determine the specific external
computer components of your instrument. USB flash drive technology became
available with software version 3.0 and higher, and is not compatible with all
Access 2 systems.
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. You can use the 3.5-inch
disk or PC hard drive to copy LIS diagnostic data. The PC is also equipped with a tape
or USB flash drive for backing up the systems 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.
1.3
Assay Technology
An immunoassay is an analytical method that uses antigen-antibody reactions to
detect or measure a specific antigen or antibody (analyte) in a sample of body fluid,
such as serum or plasma.
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.
Paramag- Access Immunoassay Systems assays use micron-sized paramagnetic particles, either
netic 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
Competitive Competitive binding assays (see Figure 1-9) 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 1-9 Competitive Binding Assays
Sandwich Sandwich assays (see Figure 1-10) 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 1-10 Sandwich Assays
Antibody Antibody detection assays (see Figure 1-11) 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 1-11 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 3-10C. 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 shake packs or use a
vortex mixer. Do not invert a punctured pack.
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.
2
System Specifications
2.1 Components and Peripherals ..................................................................... 2-2
2.1
Components and Peripherals
The Access 2 system comes with an external system computer, along with a touch
screen monitor, mouse, keyboard, printer, and handheld bar code reader.
External The Access 2 system external computer meets the following specifications:
Computer
Central processing unit (CPU) Minimum 400 megahertz (MHz) processor
Random access memory Minimum 128 megabytes (MB)
(RAM)
Internal hard drive (HD) Minimum 6.5 gigabyte (GB)
Disk drive (not available on all 1.44 MB, 3.5-inch
systems)
Peripheral The following peripheral hardware devices are connected to the external computer:
Devices
Monitor Minimum 15-inch flat, LCD touch screen,
color monitor
Keyboard Standard 101 key, AT style
Printer Sourced in country of delivery, compatible
with external computer operating system and
supporting Kanji
Pointing device Standard mouse
Scanning device Handheld bar code reader
Peripheral The peripheral devices are connected to the system through ports located on either the
Connections external computer or the Access 2 instrument.
Instrument Ports
The instrument peripheral connection ports are located on the right side panel. The
Ethernet connection, which links the external computer to the instrument, is the only
port that is used.
2 RXD TXD
3 TXD RXD
5 Ground Ground
2.2
Space and Environmental
Requirements
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
printer, see the documentation provided by the local manufacturer.
Instrument The weight of the instrument and the peripheral devices are listed in the following
and table. Be sure that the surface where these components will reside can support the
Peripheral system. For information about the printer, see the documentation provided by the
Device local manufacturer.
Weights
Instrument (before supplies and 200 pounds (91 kg)
samples added)
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 feet (2,000 m)
Exposure: 40,000 feet (12,200 m)
Temperature Operational: 64F to 90F (18C to 32C)
Exposure: -22F to 122F (-30C to 50C)
Maximum ambient 3.6F per 30 minutes (2C)
temperature change
rate
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 feet of the
outlet.
Line protection device Circuit breaker rated:
15 amps (115-120 VAC line)
6 amps (220-240 VAC line)
Line voltage fluctuations Not to exceed 10 VAC per cycle
Electrical
Power
Component 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:
2.3
Performance Characteristics
The Access 2 instrument performance characteristics include instrument operating
characteristics and temperatures, luminometer performance, reaction vessel
characteristics, instrument capacities, and bar code hardware characteristics.
Continuous access You can enter new test requests while other samples are
in 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 single 0.2% CV
reaction vessel
Reaction The Access 2 system reaction vessels (RVs) have the following properties:
Vessel 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 1-4 instruments in the workgroup,
but is sometimes limited per instrument.
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 a handheld bar code reader and an internal bar code reader.
Hardware
Performance Handheld Bar Code Reader Properties
Properties
The handheld bar code reader has the following performance properties:
Bar Code A bar code label consists of vertical black bars (the bar code), the equivalent
Label characters printed underneath the bar code, and the quiet zones at either end of the bar
Specifications code. For a bar code label illustration, see Figure 2-19.
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 handheld bar code reader
are the same.
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
3.1
Sample Processing Theory
Samples are processed on the Access 2 system by assigning them a position on a
sample rack, entering test requests for those samples, and then loading the sample
racks onto the instrument for processing.
For sample processing, the system provides random, continuous, and STAT access.
Random access allows you to run any test on any sample, using the on-board
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 on-board 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 The chemical reaction between patient sample and assay-specific reagents occurs in
Vessel the reaction vessel (RV). During sample processing, the RV shuttle and incubator belt
Transport 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.
3.2
Luminometer Calibration
Theory
Luminometer calibration ensures accurate relative light unit (RLU) readings by
verifying that the luminometer is reading within an acceptable range.
The luminometer is part of the analytical module. To calibrate the luminometer, the
instrument uses a light emitting diode (LED) as an on-board 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.
3.3
Assay Calibration Theory
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.
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.
Assay The Access 2 system performs the following types of assay calibrations:
Calibration
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 and the instrument measures the RLU response. The Access 2 system derives a
Semi-Quan- mathematical relationship between the measured response and the analyte
titative 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
3
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 3.2: Patient Test
Requests in the Operator's Guide.
3.4
Quality Control Theory
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.
3.5
System Check Theory
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:
For information about running the System Check routine, see Section 8.4: System
Check in the Operator's Guide.
For information about running individual system checks, see Section 5.11: Individual
System Checks.
For information about troubleshooting your System Check routine results, see
Appendix A: Troubleshooting.
Washed The washed check evaluates the performance of the RV wash and mixing systems.
Check
During the washed check, the main pipettor:
Pipettes 150 L of undiluted System Check Solution into ten RVs.
Performs three wash cycles on each RV.
Pipettes 200 L 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 L of diluted System Check Solution into ten RVs. The RVs are
not washed.
Pipettes 200 L 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 0-1.25. 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 Wash efficiency is a calculation based upon the results from the washed, substrate,
Efficiency and unwashed checks. To obtain a wash efficiency result you must run the entire
System Check routine.
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.
3.6
Obstruction Detection Theory
An Access 2 instrument equipped with a pressure monitor can detect an obstruction in
the primary probe while aspirating sample by monitoring the pressure required to
draw a sample.
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 3-7.
For more information, see the Determining a Reference Curve for Obstruction
Detection procedure in Section 5.6: Analog and Digital Device Diagnostics.
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 3-7 Obstruction Detection Flowchart
4
System Configuration
4.1 System Configuration .................................................................................... 4-5
4.1
System Configuration
A Beckman Coulter technical support representative installs the Access 2 system in
your laboratory. During the installation, the technical support representative works
with your laboratory to determine certain system parameters that are unique to your
lab and rarely change. The parameters include configuring server and workgroup
settings, and establishing an LIS connection.
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 Panel 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
Configure Menu
You use the Configure menu to:
Select the screens you use to set up your system
Display configuration information about the system
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 Panel Setup.
Derived Results (Button) Select to display the Derived Results screen. You use this screen to enable,
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 Access 2 (Button) Select to display the About Access 2 window. You use this window to view
F8 license and Technical Support information about the Access 2 system.
4.2
System Setup
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
To get to this screen from the Main Menu, select Configure F8 to display the
Configure menu, then select System Setup F1.
0794B.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) Select the language that is appropriate for your laboratory. The information
on the screen, in the Help, and in reports is displayed and printed in this language.
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.
Date Format (Field) Select the date format that is appropriate for your laboratory. 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.
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
NOTE
This field is displayed on the server system only.
System Revisions (Button) Select to display the System Revisions window. The window displays the
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 configure the internal bar code reader to read the symbologies you use in your lab.
For more information about the bar code reader, see Section 4.3: Bar Code Reader
Setup.
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 Setup (Button) Select to display the Password Setup window. You use the window to
F5 change the system password, if you are authorized.
Reports Setup F7 (Button) Select to display the Reports Setup window. You use the window to define
information that prints on the reports, and which reports print automatically.
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. For more information, see the Applying a QC Filter and the
Editing a Test Result Filter procedures in the Operator's Guide.
Selecting the Use this procedure to select the language used on the screens, Help, and reports, only
Language 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 in this
section.
3 Select the Language list to display the language options. Select the language
that is appropriate for your laboratory.
NOTE
If you select an unrecognizable language, contact Technical Support to help you
select the appropriate language.
1 Go to the System Revisions window. To get to this window from the Main
Menu, select Configure F8 to display the Configure menu, then
Select System Setup F1 to display the System Setup screen, then
Select System Revisions 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 in this section.
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.
1 Be sure the system is in the Ready or Not Ready mode. 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 In the Date field, enter the current date in the format for your system.
4 In the Time field, enter the current time in the format for your system.
5 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 Formats NOTES
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.
Deleting a QC point (see Section 7.2: Reviewing Quality Control Charts and
Data in the Operator's Guide)
Deleting Quality Controls (see Section 7.4: Setting Up Quality Controls in
the Operator's Guide)
Performing PC backup functions (see Section 4.10: PC Administration
Setup)
Setting the Auto-Delete function (see Section 4.10: PC Administration
Setup)
If your laboratory has authorized you to do so, use this procedure to change the
system password.
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 Password Setup window. To get to this window from the Main Menu,
select Configure F8 to display the Configure menu, then
Select System Setup F1 to display the System Setup screen, then
Select Password Setup F5.
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 Confirm New Password field, enter the new password again.
5 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 type the information for
Information 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 Reports Setup window. To get to this window from the Main Menu,
select Configure F8 to display the Configure menu, then
Select System Setup F1 to display the System Setup screen, then
Select Reports Setup F7.
2 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.
3 Select OK F1 to save and apply the changes and exit the window.
2 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.
3 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 Printer Access 2 system. Use this procedure to select the printer from which to print reports
or to print what is displayed on the monitor (using the [Print Screen] key) for this
instrument only.
1 Go to the Reports Setup window. To get to this window from the Main Menu,
select Configure F8 to display the Configure menu, then
Select System Setup F1 to display the System Setup screen, then
Select Reports Setup F7.
3 Select OK F1 to save and apply the changes and exit the window.
4.3
Bar Code Reader Setup
The internal bar code reader reads 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 available bar code parameters. Parameters include check digits, 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.
Table 4-8 lists the choices that are available for the bar code symbologies. 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.
When you have identified your configuration choices, use the Bar Code Reader Setup
window to set up the internal bar code reader.
NOTE
The bar code parameters configured for the Access 2 system must match the
parameters of the printed bar code labels you use. If, after consulting your bar
code printer information, you cannot identify which bar code or bar code
parameters you need to configure, contact Technical Support.
Bar Code Table 4-8 lists the available parameters for supported internal bar code symbologies,
Symbology sorted by symbology. Definitions of the bar code parameters are included below the
Parameters table.
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 Set the parameters for three bar code symbologies
Window
Enable and disable the internal bar code reader
NOTE
You can disable the bar code reader for sample IDs only, not for racks.
To get to this window from the Main Menu, select Configure F8 to display the
Configure menu, then
Select System Setup F1 to display the System Setup screen, then
Select Bar Code Reader Setup F2.
0795B.bmp
Figure 4-9 Bar Code Reader Setup Window
Read Sample IDs (Box) Select to enable the internal bar code reader to read the bar codes on the
sample tubes. If you clear the box, the bar code reader only attempts to read the bar
codes on the racks.
Interleaved 2 of 5 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 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.
CODE 39 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 bar code reader for the individual
Bar Code instrument you are working on. You can configure the bar code reader for more than
Reader one symbology. Also, you can set up each instrument in a workgroup with a unique
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 Bar Code Symbology
Parameters in this section.
1 Be sure that the system is in the Ready mode, then go to the Bar Code Reader
Setup window. To get to this window from the Main Menu, select
Configure F8 to display the Configure menu, then
2 Select the Read Sample IDs box to configure the bar code reader to scan the
bar codes on the sample tubes.
NOTE
The default for this option is ON. You should leave the bar code reader enabled
unless it is malfunctioning. If it is malfunctioning, contact Technical Support
immediately.
3 Select or clear the boxes as appropriate to configure the 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.
4.4
Test Setup
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.
Tests Screen
You use the Tests screen to:
Enable and disable tests and assign unique test IDs
Change the default sample types and decimal precision
Edit the default units
Display the Ranges, Gray Zone, and Dilution Factor windows
Print the Ranges and Tests Setup Reports
To get to this screen from the Main Menu, select Configure F8 to display the
Configure menu, then select Tests F2.
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
Sample Types NOTE
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 decimal point when it displays a test result.
Precision of
1 Go to the Tests screen. To get to this screen from the Main Menu, select
Test 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 A tests filter is a set of parameters you apply to the Tests screen to reduce or expand
Filters and the number of tests displayed on the Tests screen, and to change the order in which the
Sort Orders for tests are displayed. Use this procedure to apply a different filter and sort order for the
Tests tests on the Tests screen.
1 Go to the Filter window. To get to this window from the Main Menu, select
Configure F8 to display the Configure menu, then
0828B.bmp
Figure 4-13 Filter (Test Setup) Window
Filter (List) Select a filter that limits the tests that display on the
Tests screen.
Values are: All Tests, Enabled, and Disabled.
Sort Order (Options) Select to change the default sort order of the tests.
Values are: Test Name and Test ID.
Ascending (Box) Select to change the order that the system displays the
tests on the Tests screen. Select the box to sort the tests in
ascending order and clear the box to sort in descending order.
2 Select a filter.
4 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.
5 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.
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.
Setting a The Dilution Factor window is only available for tests that are defined in the APF to
Dilution 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.
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.
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 Print window. To get to this window from the Main Menu, select
Configure F8 to display the Configure menu, then select Tests F2 to display
the Tests screen, then select Print F7.
The Print window is displayed.
Laboratories, Inc.
Laboratory A
Tests Setup Report 123 Lake Street
Access 2 Immunoassay System Townsville, ST 33333
S/N 501240 101-555-2323 ext. 109 Jane Smith
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.
4.5
Test Panel Setup
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.
To get to this screen from the Main Menu, select Configure F8 to display the
Configure menu, then select Test Panels F3.
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 Filter window. To get to this window from the Main Menu, select
Configure F8 to display the Configure menu, then
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.
Values are: All Panels, Enabled Panels, and Disabled
Panels.
Sort Order (Options) Select to change the default sort order of the test
panels.
Values are: Panel Name and Test ID.
Ascending (Box) Select to change the order that the system displays the
test panels on the Test Panels screen. Select the box to sort the
test panels in the ascending order and clear the box to sort in
descending order.
2 Select a filter.
4 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.
5 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.
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 Flowchart
Adding a Test Use this procedure to add a test panel to all instruments in the workgroup. Any tests
Panel 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 Add Panel window. To get to this window from the Main Menu,
select Configure F8 to display the Configure menu, then
Select Test Panels F3 to display the Test Panels screen, then
Select Add Panel F4.
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.
2 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.
4 From the Enabled Tests list, select a test to add to the panel, then select
Add F3.
(Optional) To add a replicate for the test, add the same test again.
5 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.
6 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.
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
Test Panels Setup Report 123 Lake Street
Access 2 Immunoassay System Townsville, ST 33333
S/N 501240 101-555-2323 ext. 109 Jane Smith
Page 1 of 1
Technologist ________________________________________ Printed 10-10-10 10:10
0880D.bmp
Figure 4-30 Test Panels Setup Report
4.6
Derived Result Setup
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.
Operators, specifying mathematical operations or functions (see the
Derived Result Operators and Order of Operations Rules topic in this
section).
Numeric constants, may be integers or decimal numbers; sometimes
interpreted within context as concentrations or patient ages.
NOTES
You may include spaces between the elements in the formula to improve
readability. Spaces have no effect on the expressions.
For system software versions lower than version 3.0, do not use a test in a
derived result formula more that once. For example, do not use TestA +
TestA.
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.
To get to this screen from the Main Menu, select Configure F8 to display the
Configure menu, then select Derived Results F4.
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 edit
Result F5 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 Result
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 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 decimal point when it displays a derived result.
Precision of a
1 Go to the Derived Results screen. To get to this screen from the Main Menu,
Derived Result
select Configure F8 to display the Configure menu, then select Derived
Results F4.
2 Locate the derived result that contains the decimal precision to change.
4 Type the 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 Result
NOTE
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 Add Derived Result window. To get to this window from the Main
Menu, select Configure F8 to display the Configure menu, then
Select Derived Results F4 to display the Derived Results screen, then
Select Add Derived Result F4.
0803b.bmp
Figure 4-35 Add Derived Result Window
Derived Result (Field) Type a unique name for the derived result.
Name
The derived result name can contain up to eight
characters.
NOTE
If you entered a derived result name that already
exists, when you select OK F1 a message appears
that prompts you to type a new name.
Units (Optional) (Field) Type the unit of measure for the derived result. A
unit of measure is optional.
The unit of measure can contain up to eight characters.
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.
2 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.
3 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.
4 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 Result
NOTES
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.
(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 Result can be deleted.
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 the 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 Print window. To get to this window from the Main Menu, select
Configure F8 to display the Configure menu, then
2 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)
Critical Range Report (Lists all critical ranges by derived result)
LIS Range Report (Lists all LIS ranges by derived result)
Laboratories, Inc.
Laboratory A
123 Lake Street
Derived Results Setup Report Townsville, ST 33333
101-555-2323 ext. 109
Access 2 Immunoassay System
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
4.7
Ranges Setup
The Access 2 system produces numeric results from quantitative tests,
semi-quantitative tests, and derived results. If a range is defined for the test or derived
result, the system compares the tests results to the range before reporting the results.
The system flags the results that are out of range.
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.
Ranges Windows
You use the ranges windows to:
View different reference ranges for a test or derived result by sample type
View different ranges defined for a test or derived result by range type
Set the Reference, Critical, and LIS ranges
Set the demographic conditions for a range
NOTE
Because of their similarity, only one of the three range windows is displayed in
this manual (see Figure 4-38).
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 range, and the
Low Units and corresponding age units. You use these fields to set the age demographic conditions
High Units for the corresponding range.
Units values are: Days, Weeks, Months, and Years.
Range Low and (Fields) Enter the lower and/or upper limits of the Reference, Critical, or LIS ranges.
Range High The default values for reference ranges may be defined in the APF.
Clear F3 (Button) Select to delete a selected range in the window.
(Optional) To add a range for a different sample type, select the sample type
from the list in the Sample Type field.
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 a range for a different sample type, select the sample type
from the list in the Sample Type field.
(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.
(Optional) To delete a range for a different sample type, select the sample type
from the list in the Sample Type field.
4 Select OK F1 to save and apply the changes and exit the window.
4.8
Reflex Test Setup
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 on board any
instrument in the workgroup. If the sample is located, the reflex test is scheduled. If
the system cannot find the sample on board 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.
Numeric constants: Integers or decimal numbers of any decimal precision,
which may represent concentration or patient ages, depending on the
situation.
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.
Assay, SEX, or AGE must Assay or AGE must precede other A number, integer, qualitative
precede equal sign (non =) relational operators interpretation, or flag must follow
(e.g. SEX = MALE) (e.g. AGE > 10) an assay.
(e.g. TestA = OVR)
SEX must precede MALE or Relational operator must precede Assay and equal sign must
FEMALE a number precede a qualitative assay
(e.g. SEX = MALE) (e.g. AGE >10) interpretation
(e.g. TestA = REACTIVE)
Equal sign must be between assay Assay or AGE must precede an Assay and equal sign must
and assay interpretation integer precede a flag
(e.g. TestA = REACTIVE) (e.g. AGE >10) (e.g. TestA = OVR)
By rearranging a condition, you can change the result by causing the system to
evaluate the operators in a different order.
() parentheses
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.
Repeated self-reflexing (an original test may reflex itself one time only)
Non-integer ages (an age must be a positive integer value [no decimal
point], such as 3, 15, or 46)
Incorrect syntax (condition must follow proper syntax rules, Table 4-41)
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-
siderations Precision of Results
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.
To get to this screen from the Main Menu, select Configure F8 to display the
Configure menu, then select Reflex Tests F5.
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 Test (Button) Select to display the Add Reflex Condition window. You use this window to
F4 define reflex tests.
Edit Reflex Test (Button) Select to display the Edit Reflex Condition window. You use the window to
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 a You suppress a reflex test to prevent it from running when that test is already ordered
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 Add Reflex Condition window. To get to this window from the Main
Menu, select Configure F8 to display the Configure menu, then select Reflex
Tests F5 to display the Reflex Tests screen, then select Add Reflex Test F4.
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 the 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
2 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.
3 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.
4 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
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 to display
the Reflex Tests screen, then select Print F7.
Laboratories, Inc.
Laboratory A
Reflex Tests Setup Report 123 Lake Street
Access 2 Immunoassay System Townsville, ST 33333
S/N 501240 101-555-2323 ext. 109 Jane Smith
Page 1 of 1
Technologist ________________________________________ Printed 10-10-2005 10:10
0882B.bmp
Figure 4-49 Reflex Tests Setup Report
4.9
LIS Setup
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.
To get to this window from the Main Menu, select Configure F8 to display the
Configure menu, then select LIS F6.
0806B.bmp
Figure 4-50 LIS Setup Window
Local LIS Interface (Field) Select a value from the list to switch the data 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.
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 in this section.
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 LIS the PC that you are working on and the 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 the Ranges Setup in 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 Host found in the LIS workpool, the Access 2 system can automatically query the LIS for
Query any unsent test requests.
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
Settings NOTE
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
Mode NOTE
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 in
this section.
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 the Sending Test Results to the LIS procedure
in 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.
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.
8 Select OK F1 to confirm the change and exit the LIS Setup window.
A message displays for you to confirm your choice.
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 in
this section.
4.10
PC Administration Setup
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.
NOTE
USB flash drive technology became available with software version 3.0 and
higher, and is not compatible with all Access 2 systems.
Either medium provides sufficient storage capacity for complete system backups.
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.
PC Admin Screen
You use the PC Admin screen to:
View the results of the last backup and the status of the next scheduled
backup
Schedule automatic system backups or perform immediate system backups
Eject a backup tape
Restore system data
Set up the Auto-Delete function to automatically delete patient test and QC
results from the database
Shut down the PC
To get to this screen from the Main Menu, select Configure F8 to display the
Configure menu, then select PC Admin F7.
0841B.bmp
Figure 4-52 PC Admin Screen
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.
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
Scheduling Use this procedure to schedule system data backups to a backup tape or USB flash
System drive.
Backups
NOTES
USB flash drive technology became available with software version 3.0 and
higher, and is not compatible with all Access 2 systems.
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.
2 Be sure the system is in the Ready or Not Ready mode, then 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.
5 Select OK F1.
The Scheduled Backup window is displayed.
2156A.bmp
Figure 4-55 Scheduled Backup Window
NOTE
When you select the Weekly Backup option, also
select a day of the week and the time of day for the
backup to run.
Start Time (Field) Select a time from the list. This is the time the
system backup will run.
6 Select the Enable Automatic Backup box to enable the scheduled backup.
7 Select the Daily Backup or Weekly Backup option to set the backup frequency.
8 If you selected the Weekly Backup box, select the day from the list that you
want the backup to run.
9 Select a backup start time from the list in the Start Time field.
10 Select OK F1 to save and apply the changes and exit the window.
The backup runs at the scheduled time and date.
11 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 in this section).
If the backup aborts or fails again, contact Technical Support.
Performing Use this procedure to perform a system data backup to a backup tape or USB flash
Immediate drive on demand.
System
Backups NOTES
USB flash drive technology became available with software version 3.0 and
higher, and is not compatible with all Access 2 systems.
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.
2 Be sure the system is in the Ready or Not Ready mode. 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.
5 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.
6 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.
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.
3 Remove the tape from the tape drive on the external PC.
4 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.
5 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
Function NOTE
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 in this section.
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...................................................................................................... 5-4
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.
Diagnostics Menu
You use the Diagnostics menu to:
View or print system parameters
Run diagnostic or maintenance procedures
Perform validation procedures after troubleshooting
Copy test result information
NOTES
Some diagnostic procedures should be used only as directed by a technical
support representative or when you are following instructions in Help 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.
0733C.bmp
Figure 5-1 Diagnostics Menu
Initialize System F1 (Button) Select to initialize the primary system devices. The Initialize System
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 Checks F3 (Button) Select to display the Volume Checks screen. You can check the
accuracy of 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 Diagnostics F4 (Button) Select to display the Device Diagnostics screen. You can perform
advanced 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.
Copy to Disk F6 (Button) Select to copy information onto 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.
NOTE
The system must be in the Ready or Not Ready mode to display this
window.
Diagnostic Reports F7 (Button) Select to print one of the following diagnostic reports:
Alignment Report
Level Sense Report
Incubator Belt Calibration Report
Temperature Report
5.2
Initialize System
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
1 Be sure the system is in the Ready or Not Ready mode, then go to the Initialize
System window. To get to this window from the Main Menu, select
Diagnostics F7 to display the Diagnostics menu, then select
Initialize System F1.
5.3
Prime Fluidics
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 Be sure the system is in the Ready mode, then 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
5.4
Volume Checks
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 L, 200 L, or 350 L
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.
To get to this screen from the Main Menu, select Diagnostics F7 to display the
Diagnostics menu, then select Volume Checks F3.
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 L F2 (Button) Select to check the aspirated and dispensed volume of the main pipettor.
The Pipettor 50 L window is displayed, from which you can load a rack and start
the volume test.
Pipettor 200 L F3 (Button) Select to check the aspirated and dispensed volume of the main pipettor.
The Pipettor 200 L window is displayed, from which you can load a rack and start
the volume test.
Pipettor 350 L F4 (Button) Select to check the aspirated and dispensed volume of the main pipettor.
The Pipettor 350 L window is displayed, from which you can load a rack and start
the volume test.
Dispense Probe 1 (Button) Select to check the dispensed volume of the dispense probe in position 1.
F5 The Dispense Probe 1 window is displayed, from which you can run the dispense
probe volume test.
Dispense Probe 2 (Button) Select to check the dispensed volume of the dispense probe in position 2.
F6 The Dispense Probe 2 window is displayed, from which you can run the dispense
probe volume test.
Dispense Probe 3 (Button) Select to check the dispensed volume of the dispense probe in position 3.
F7 The Dispense Probe 3 window is displayed, from which you can run the dispense
probe volume test.
Aspirate Probes F8 (Button) Select to check the aspirated volume of the three aspirate probes. The
Aspirate Probe window is displayed, from which you can run the aspirate probe
volume test.
Access to RVs When performing a volume check, you access the RVs in shuttle positions 1, 2, and 3.
for Volume
Checks 1
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 dispensed volumes. You visually evaluate dispensed volumes for all three checks the
Volume same way. Refer to the following guide when comparing dispensed volumes to the
Checks 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 illustration when evaluating dispense characteristics.
Dispense
Characteris- 1 2 3
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 the Opening and Closing the Front Panel procedure
in Section 7.2: Instrument Cover Procedures.
Main Menu
Diagnostics
F7
Volume 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 Flowchart
Performing Use this procedure to detect gross volume errors or irregular dispense characteristics
Visual of the substrate or dispense fluidic system. This procedure checks the substrate probe
Substrate or or one dispense probe. Repeat the procedure to check another probe, as needed.
Dispense
Probe Volume WARNINGS
Checks 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 ProClin 300* 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 L to 500 L
Wash Buffer
7
6
1
5 4 3 2
1
6
3 2
5
4
0195Hc.eps
3 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
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.
Main Menu
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 Flowchart
Performing Use this procedure to detect gross volume aspirate or dispense errors or irregular
Visual Main dispense characteristics of the main pipettor fluidic system. This procedure checks
Pipettor one volume. Repeat the procedure to check another volume, as needed.
Volume
Checks 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 ProClin 300 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 L to 1.5 mL fluid
Wash buffer
13 mm rack for 2 mL sample cups
Forceps
Empty reaction vessel (RV)
2 From the Volume Checks screen, select the pipettor volume to check from the
following buttons:
Pipettor 50 L F2
Pipettor 200 L F3
Pipettor 350 L F4
The appropriate pipettor volume check window is displayed.
0731b.bmp
Figure 5-13 Pipettor Volume Check Window
Load a Rack F1 (Button) Select Load a Rack F1 to load the rack prepared for
the pipettor volume check. When the rack is on board, the
or button changes to Unload Rack F1.
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 on board.
3 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 L
volumes, be sure to refill the sample cup before repeating the check.
8 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.
9 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.
2 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 results, see Table 5-8.
3 If you see a significant volume difference between the reference RV and any of
the test RVs, contact Technical Support.
4 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
chapter.
Main Menu
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 Flowchart
Performing Use this procedure to detect gross volume errors of the aspirate fluidic system. This
Visual procedure checks all three aspirate probes at the same time. A different probe
Aspirate aspirates from each of three dispensed RVs.
Probes
Volume WARNING
Check You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
Required Materials
Forceps
Marker to number the dispensed RVs
0877b.bmp
Figure 5-16 Aspirate Probes Volume Check Window
2 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 of this manual.
4 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.
5 Repeat step 3 and step 4 for the RVs in shuttle positions 2 and 3.
7 When prompted by the system message, open the front panel of the instrument.
8 With forceps, remove the aspirated RVs from shuttle positions 1, 2, and 3.
NOTE
To determine if a drop of fluid is within the guideline, turn the RV upside down.
An amount of 4 L or less will not run out of an RV when the RV is turned
upside down.
1 1 2
2 2 4
3 3 6
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:
Checks Wear gloves to prevent transferring oils onto the RVs.
Use forceps to remove the RVs from the instrument and balance.
Number the RVs before you weigh them to ensure correct sequences.
Weigh the RVs immediately after dispensing to minimize evaporation.
Take at least 10 replicates of the measurements to obtain a meaningful
representation of system precision and accuracy.
Main Menu
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 Flowchart
Performing Use this procedure to quantitatively determine the dispense precision and accuracy of
Analytical the substrate fluidic system.
Substrate
Probe Volume WARNING
Check You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
Required Materials
Forceps
Marker to number the dispensed RVs
Analytical balance
3 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 Repeat step 3 through step 6 for the RVs in shuttle positions 2 and 3.
8 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.
3 Weigh the RV using the analytical balance, and record the weight.
6 Select OK F1.
The Volume Checks screen is displayed.
2 Subtract the RV weight from the dispensed RV weight for each replicate, then
convert the remaining RV weights (in mg) to volumes (in L) using the
following conversion equation.
mg / (1.006 mg/L) = L
3 Calculate the mean, the standard deviation, and the %CV of the replicates.
4 Compare the substrate volume check results to the following expected results.
Main Menu
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/L) = L
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 Flowchart
Performing Use this procedure to quantitatively assess the precision and accuracy of the dispense
Analytical probes. This procedure checks one dispense probe. Repeat the procedure to check
Dispense another dispense probe, as needed.
Probe Volume
Check 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
3 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
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 dispense probe you selected in step 2 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.
3 Weigh the RV using the analytical balance, and record the weight.
6 Select OK F1.
The Volume Checks screen is displayed.
2 Subtract the RV weight from the dispensed RV weight for each replicate, then
convert the remaining RV weights (in mg) to volumes (in L) using the
following conversion equation.
f
mg / (1.007 mg/L) = L
4 Compare the dispense probe volume check results to the following expected
results.
Main Menu
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/L) = L
RV weights to volumes
Expected Results:
Target Volume 50 L Compare results with
Expected Volume Range 47.5 - 52.5 L expected results
Expected %CV <2%
Yes
Done
0917b.bmp
Figure 5-25 Performing Analytical Main Pipettor Volume Checks Flowchart
Performing Use this procedure to quantitatively assess the main pipettor dispense volume at
Analytical 50 L, 200 L, and 350 L. This procedure checks one volume. Repeat the procedure
Main Pipettor to check another volume, as needed.
Volume
Checks 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 ProClin 300 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 From the Volume Checks screen, select the pipettor volume to check from the
following buttons:
Pipettor 50 L F2
Pipettor 200 L F3
Pipettor 350 L F4.
For an illustrated pipettor volume check window, see Figure 5-13.
3 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 L
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.
3 Weigh the RV using the analytical balance, and record the weight.
2 Subtract the RV weight from the dispensed RV weight for each replicate, then
convert the remaining RV weights (in mg) to volumes (in L) using the
following conversion equation.
mg / (1.007 mg/L) = L
4 Compare the main pipettor volume check results to the following expected
results.
Target Volume 50 L
Main Menu
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/L) = L
RV weights to volumes
Yes
Done
0919b.wmf
Figure 5-28 Performing Analytical Aspirate Probe Volume Check Flowchart
Performing Use this procedure to quantitatively assess the precision and accuracy of the aspirate
Analytical fluidic system. This procedure checks all three aspirate probes at the same time. A
Aspirate different probe aspirates from each of the three dispensed RVs.
Probes
Volume WARNING
Check You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
Required Materials
Forceps
Marker to number the dispensed RVs
Analytical balance
3 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.
8 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 L 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.
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.
6 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 L).
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.
5.5
Mechanics and Device
Diagnostics
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 or in an Access 2 manual.
To get to this screen from the Main Menu, select Diagnostics F7 to display the
Diagnostics menu, then select Device Diagnostics F4.
0911B.bmp
Figure 5-30 Device Diagnostics Screen
Mechanics F1 (Button) Select to display the Mechanics screen (see Figure 5-32 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 5-32 in this section.
Calibrate Incubator (Button) Select to display the Calibrate Incubator Belt window. You can use the
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.
Mechanics Screen
You 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
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, then
Select Mechanics F1.
0737C.bmp
Figure 5-32 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 or in an
Access 2 manual.
Position/Status (Indicator) Displays the status of one or more of the following device sensors for
Indicators the 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 Position F2 (Button) Select to move the device to an alignment position. If the device is not
homed, the system first homes the device and then moves the device to the
or alignment position.
Move Z to Position F3 Both a device and a position must be selected for the button to be available. The
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 between home position and the alignment position. Cycling continues until
or you select Stop Cycling F6, and the device reaches a known state at which to
stop. Available for all devices except the rake and RV shuttle.
Stop Cycling F6
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 Motors F8 (Button) Select Disable Motors F8 to disable all of the mechanical device
motors. The motors remain disabled until you select Enable Motors F8.
or
The button name switches between Disable Motors and Enable Motors each time
Enable Motors F8 you select it.
1 Be sure the system is in the Ready or Not Ready mode, then go to the
Mechanics screen. To get to this screen from the Main Menu, select
Diagnostics F7 to display the Diagnostics menu, then
2
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.
3 When you are done viewing an alignment for a device, select another device or
select an appropriate button or tab to exit this screen.
1 Be sure the system is in the Ready or Not Ready mode, then go to the
Mechanics screen. To get to this screen from the Main Menu, select
Diagnostics F7 to display the Diagnostics menu, then
2 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.
1 Be sure the system is in the Ready or Not Ready mode, then go to the
Mechanics screen. To get to this screen from the Main Menu, select
Diagnostics F7 to display the Diagnostics menu, then
2 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.
3 If positions are available, select the end position for cycling from the Position
list.
6 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.
7 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 or in an Access 2 manual.
1 Be sure the system is in the Ready or Not Ready mode, then go to the
Mechanics screen. To get to this screen from the Main Menu, select
Diagnostics F7 to display the Diagnostics menu, then
2 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
5.6
Analog and Digital Device
Diagnostics
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 or in an Access 2 manual.
Viewing Use this procedure to review the temperatures of various system zones and the voltage
Analog of the related power supply.
Device
1 Be sure the system is in the Ready mode, then go to the Analog Devices
Temperatures
window. To get to this window from the Main Menu, select Diagnostics F7 to
and Voltage
display the Diagnostics menu, then
Select Device Diagnostics F4 to display the Device Diagnostics screen, then
Select Analog Devices F2, to display the Analog Devices menu, then
Select Analog Data F1.
0738b.bmp
Figure 5-34 Analog Devices Window
Temperature (Column) Displays the names of the temperature sensors for analog devices.
Sensor
Temp. (deg. C) (Column) Displays the temperature reading in degrees Celsius for the temperature
sensor named to the left.
Duty Cycle (Column) Displays the percent of time (expressed in hundredths) that the
temperature control device operates in order to maintain temperature for the device
to the left. For example, a reading of .23 for the incubator means that in order to
maintain temperature, the incubator heater runs 23 percent of the time that the
instrument is on.
Status (2 Columns) Displays the status of the sensor temperatures or power supply
voltages. A status of 0 means normal. For status readings other than 0, a warning or
caution event is displayed in the Event Log.
Power Supply (Column) Lists the expected power supply voltages for the power driver, and the
PMT High Voltage category for the luminometer.
Voltage (Column) Displays the voltage readings for the power supply categories listed to
the left.
Raw Voltage Data (Button) Select to display the Raw Voltage Data window, in which you can view
F2 scaled volts and raw volts for power driver channels, in a two column format.
0739b.bmp
Figure 5-36 Raw Voltage Data Window
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, then
Select Analog Devices F2 to display the Analog Devices menu, then
Select Pressure Monitor F2.
1029A.bmp
Figure 5-38 Pressure Monitor Screen
The button name switches between Enable and Disable each time you select it.
Determining a Use this procedure to determine a reference curve for obstruction detection.
Reference
Curve for CAUTION
Obstruction Use this procedure only as directed by a technical support representative
Detection or if you are following instructions in Help or in an Access 2 manual.
1 Be sure the system is in the Ready mode, then go to the Determine Curve
window. To get to this window from the Main Menu, select Diagnostics F7 to
display the Diagnostics menu, then
Select Device Diagnostics F4 to display the Device Diagnostics screen, then
Select Analog Devices F2 to display the Analog Devices menu, then
Select Pressure Monitor F2 to display the Pressure Monitor screen, then
Select Determine Curve F1.
3 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 Digital Use this procedure to turn various digital devices (pumps, valves, and motors) off or
Devices Off on.
and On
CAUTION
Use this procedure only as directed by a technical support representative
or if you are following instructions in Help or in an Access 2 manual.
1 Be sure the system is in the Ready or Not Ready mode, then go to the Digital
Devices window. To get to this window from the Main Menu, select
Diagnostics F7 to display the Diagnostics menu, then
0740b.bmp
Figure 5-40 Digital Devices Window
Vacuum Pump On
(Box) Select to turn the vacuum pump on or off,
depending on the current status.
Probe Wash Valve On
(Box) Select to turn the probe wash vacuum valve on or
off, depending on the current status.
mm Hg
(Field) Displays the current vacuum pressure in mm Hg.
Default value of Pump On and Probe Wash Valve On
boxes: Not checked
Mixer Motor On
(Box) Select to turn the mixer motor on or off, depending
on the current status.
Motor
(Indicators) Display the running direction (clockwise or
counterclockwise) of the mixer motor.
RPM
(Field) Displays the current mixer rotations per minute
(RPMs).
Default values of Motor On, CW, and CCW Motor
options: Not checked
Peristaltic Pump Peristaltic Pump On
(Box) Select to turn the peristaltic pump on or off,
depending on the current status.
Peristaltic Pump
(Field) Displays whether or not the peristaltic pump is
running.
Default value of Peristaltic Pump On box: Not checked
Digital Sensors (Fields) Displays the status of items from several digital
sensor devices in the Access 2 instrument.
Status of items included are:
Wash buffer or waste bottle level: OK or Not OK
Waste bag present: Yes or No
RV load door or front panel: Open or Closed
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.
2 Select or clear the boxes for the following devices to turn them on or off:
Vacuum Pump On
Probe Wash Valve On
Mixer Motor On (you can also select clockwise or counterclockwise
direction)
Peristaltic Pump On
Stepper Motor Driver PCB On
Viewing Use this procedure to view the information provided by various digital sensors,
Digital Device including measured supply levels and open access doors.
Sensor
1 Be sure the system is in the Ready or Not Ready mode, then go to the Digital
Information
Devices window. To get to this window from the Main Menu, select
Diagnostics F7 to display the Diagnostics menu, then
2 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 vacuum test. This test is used to help determine if there
Vacuum Test is a leak in the vacuum system.
CAUTION
Use this procedure only as directed by a technical support representative
or if you are following instructions in Help or in an Access 2 manual.
1 Be sure the system is in the Ready or Not Ready mode, then go to the Digital
Devices window. To get to this window from the Main Menu, select
Diagnostics F7 to display the Diagnostics menu, then
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.
5.7
Luminometer Device
Diagnostics
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 or in an Access 2 manual.
For more information about the function of the luminometer, see Section 1.2:
Instrument Technology in Chapter 1: Technology Overview.
For more information about luminometer calibration, see Section 3.2: Luminometer
Calibration Theory.
Luminometer Screen
You use the Luminometer screen to:
Turn the LED on and off
Take an RLU reading with or without a vessel
Save the light emitting diode (LED) calibration value
Set the high voltage control value
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, then
Select Luminometer F4.
0741B.bmp
Figure 5-42 Luminometer Screen
Enable LED (Box) Select to turn on the light emitting diode (LED).
Default value: Not Selected
High Voltage Control (Field) Select to adjust the high voltage reading for the luminometer power
supply. 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 or in an Access 2 manual.
High Voltage Reading (Field) Displays the power supply output of the luminometer.
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 Vessel F2 (Button) Select to transport the vessel in RV shuttle position 1 to the
luminometer. 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 Reading F3 (Button) Select to save the LED reading as the LED target value. An
informational 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 Use this procedure to view information about the luminometer calibration.
Luminometer
Information CAUTION
Perform luminometer readings and save values only as directed by a
technical support representative or if you are following instructions in Help
or in an Access 2 manual.
1 Be sure the system is in the Ready or Not Ready mode, then go to the
Luminometer screen. To get to this screen from the Main Menu, select
Diagnostics F7 to display the Diagnostics menu, then
2 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 or in an Access 2 manual.
1 Be sure the system is in the Ready mode, then go to the Luminometer screen.
To get to this screen from the Main Menu, select Diagnostics F7 to display the
5.8
Advanced Diagnostics
The following procedures are categorized as advanced diagnostic procedures:
Viewing ultrasonics or performing the level sense test
Exercising devices
Calibrating the incubator belt
Copying database information to a disk or USB flash drive
CAUTION
Use these procedures only as directed by a technical support representative
or if you are following instructions in Help or in an Access 2 manual.
For more information about the Event Log troubleshooting, see Section 6.3:
Troubleshooting Events, and see Section A.1: Troubleshooting.
Viewing Use this procedure to view the information about the ultrasonic transducer and level
Ultrasonics 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 or in an Access 2 manual.
1 Be sure the system is in the Ready or Not Ready mode, then go to the
Ultrasonics window. To get to this window from the Main Menu, select
0742b.bmp
Figure 5-44 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).
Level Sense Ready (Box) Displays the readiness of the ultrasonics transducer to detect a surface.
You can only select this box when the system is in the Ready mode.
Sonicator Power (Field) Displays the sonicator power setting, which is Low when ultrasonic
testing is not being performed.
Values are: Low, Med-Low, Med-High, High
Burst Frequency (Hz) (Field) Displays the frequency of electrical vibrations per second (hertz or Hz)
for the sonicator burst mode, which is 1 when ultrasonic testing is not being
performed.
Value range: 1 - 100
Duty Cycle (%) (Field) Displays the current duty cycle percentage for the transducer, which is
100 when ultrasonic testing is not being performed.
If you have not performed a fluid surface check, the field displays Not
Detected.
Phase Lock Loop (Field) Displays the status of the phase lock loop (PLL), which is Unlocked
Status when ultrasonic testing is not being performed.
Level Sense Test F2 (Button) Select to display the Ultrasonics Level Sense Test window and begin
the level sense test.
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 ProClin 300 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 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 L of fluid
Steps
1 Be sure the system is in the Ready mode, then go to the Ultrasonics window. To
get to this window from the Main Menu, select Diagnostics F7 to display the
Diagnostics menu, then
Select Device Diagnostics F4 to display the Device Diagnostics screen, then
Select Ultrasonics F5.
2 Be sure that Low is selected for the Sonicator Power field, then select
Level Sense Test F2.
0743A.bmp
Figure 5-46 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 Count (Field) Displays the number of repetitions in which 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 Repetition (Field) Displays the number of steps for the current repetition.
Wet Failure Count (Field) Displays the number of repetitions in which the ultrasonics did not sense
fluid when fluid was present.
Wet Z Step Range (Field) Displays the minimum and maximum steps that the 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 end of (Box) Select to print the Level Sense Report automatically when the level sense
Test test is complete.
Load a Rack F1 (Button) Select to load a rack. The button text changes from Load a Rack F1 to
or Unload Rack F1 when you select the button.
Unload Rack F1
Start Test F2 (Button) Select to start or stop the level sense test. The button text changes from
or Start Test F2 to Stop Test F2 when you select the button.
Stop Test F2
3 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.
Dry and Wet
4 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.
For the wet test, pipette a minimum of 200 L wash buffer in a 2 mL sample
cup, then place it in position 2.
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.
7 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.
10 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 pre-programmed 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 or in an Access 2
manual.
1 Be sure the system is in the Ready mode, then go to the Exerciser window. To
get to this window from the Main Menu, select Diagnostics F7 to display the
Diagnostics menu, then
Select Device Diagnostics F4 to display the Device Diagnostics screen, then
Select Exerciser F6.
0744A.bmp
Figure 5-48 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
Current Test Status (Field) Displays the current test status. Nothing is
displayed if no tests have been started.
Statuses:
In process - Displays when devices are cycling.
Canceling - Displays when you select
Stop Cycling F2, and a cycle is ending.
Cycles Completed (Field) Displays the number of cycles the system has
completed.
Start Cycling F2 (Button) Select to begin cycling. As soon as you select
or this button, the text changes to Stop Cycling F2. When
Stop Cycling F2 you select to stop cycling, the system continues until it
has finished the cycle in progress.
NOTE
Selecting Stop Cycling F2 does not immediately stop the exercise routine. The
test stops after the present cycle is complete.
1 Be sure the system is in the Ready mode, then go to the Calibrate Incubator Belt
window. To get to this window from the Main Menu, select Diagnostics F7 to
display the Diagnostics menu, then
Select Device Diagnostics F4 to display the Device Diagnostics screen, then
Select Calibrate Incubator Belt F7.
(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 in the
Reference Manual.
Copying Use this procedure to copy test result data, QC data, event log information, system
Diagnostic configuration information, and other diagnostic information to a 3.5-inch high density
Data to a Disk disk or a USB flash drive.
or USB Flash
Drive NOTES
USB flash drive technology became available with software version 3.0 and
higher, and is not compatible with all Access 2 systems.
Copying data does not remove it from the database.
1 Be sure the system is in the Ready or Not Ready mode, and go to the Copy to
Disk window. To get to this window from the Main Menu, select Diagnostics
F7 to display the Diagnostics menu, then select Copy to Disk F6.
NOTE
If your instrument has USB flash drive technology, a Drive field is displayed
beneath the File name field.
0898b.bmp
Figure 5-51 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 seven days ago.
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.
3 Type a start date into the Start Date field. A default date (seven 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.
5 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.
6 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.
- Insert a new disk and select OK F1.
- The system automatically names the file on the new disk the same as the
file on the first disk, only with the disk number at the end. For example,
mydata.csv = disk 1 and mydata(2).csv = disk 2.
For a USB flash drive, clear sufficient space on the drive, or copy the files to
a different flash drive.
7 Remove the disk or flash drive from the PC when copying is complete. Label it
with its data file name.
5.9
LIS Diagnostics
The Access 2 system monitors the data transmissions to and from the LIS and
displays this coded information on the LIS Diagnostics screen. 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 and print the information displayed on
the screen.
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.
To get to this screen from the Main Menu, select Diagnostics F7 to display the
Diagnostics menu, then select LIS F5.
0865D.bmp
Figure 5-53 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
Monitor the 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 Check F3 (Button) Select to run a loopback check, which verifies that the communication
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
Requests F4 sample ID.
Copy to Disk F6 (Button) Select to copy all of the information from the LIS Diagnostics screen to a
disk or hard drive. This button is unavailable when there are no transmissions.
For more information about how to use this option, see the Copying Data
Transmissions to Disk or Hard Drive 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 to query the LIS for test request information for a specific sample.
Query for Test
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.
Copying Data Use this procedure to copy the data transmissions displayed on the LIS Diagnostics
Transmissions screen to a 3.5-inch high-density, DOS-formatted disk or to the C:\ directory of the
to Disk or PC.
Hard Drive
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.
3 The window indicates the drive or directory to which the data transmissions will
be copied.
For system software versions lower that 3.0, the data will be copied to a
3.5-inch high-density, DOS-formatted disk. Insert a disk into the 3.5-inch
disk drive of the PC.
NOTE
Be sure you insert the disk into the 3.5-inch disk drive of the PC, not the
Access 2 instrument.
For system software version 3.0 or higher, the data will be copied to the C:\
directory of the PC. If you need assistance in retrieving it, contact Technical
Support.
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.
For a 3.5-inch disk, remove the disk from the drive and label it.
Clearing the Use this procedure to clear the LIS Diagnostics screen of all data transmissions to and
Data from the LIS.
Transmissions
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.
5.10
Diagnostic Reports
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.
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
Tube Detector 0
Bar Code Reader 2
Pipettor -6
Pipettor 5
Shuttle Transfer -6
Wash In 5
Wash Out 8
Device: Rake
RV Shuttle -10
CCW Align 0
Page 1 of 2
Technologist ______________________________________________ Printed 09-09-01 12:43 PM
0901C.bmp
Figure 5-56 Alignment Report, Page 1 of 2
Laboratories, Inc.
S/N 500135 Laboratory A
Hardware Versions:
Model Number
Instrument Serial Number 500135
SMC Firmware 103
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 12:43 PM
0902D.bmp
Figure 5-57 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 5-58 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 5-59 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 10-10-10 02:43 PM
0905B.bmp
Figure 5-60 Temperature Report
5.11
Individual System Checks
The System Check routine consists of three individual system checks:
Washed Check
Substrate Check
Unwashed Check
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 ProClin 300 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 loaded, take the rack off board,
clear it, and load it 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 Check Report automatically prints, and the
system runs the Utility Assay.
NOTE
To print the System Check Report at another time, 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
Table 5-61.
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 loaded, take the rack off board,
clear it, and load it 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 Check Report automatically prints, and the
system runs the Utility Assay.
NOTE
To print the System Check Report at another time, 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
Table 5-62.
If you need assistance, contact Technical Support.
Expected %CV 5%
Required Materials
WARNING
System Check Solution and wash buffer contain ProClin 300 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 L 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 loaded, take the rack off board,
clear it, and load it 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.
10 Select Run.
The system displays the test results as the samples are processed. When
processing is complete, the System Check Report automatically prints, and the
system runs the Utility Assay.
NOTE
To print the System Check Report at another time, 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 Table 5-63.
If you need assistance, contact Technical Support.
Expected %CV 2%
Expected RLU Mean 4-10 million*
Table 5-63 Unwashed Check Expected Results
* Although not a system specification, the RLU mean result for the Unwashed
Check can be used as a reference guideline. If results are not in the range of
410 million, try preparing the 1/501 dilution of System Check Solution again
and repeating the Unwashed Check procedure.
6
Event Log
6.1 Event Log ......................................................................................................... 6-2
6.1
Event Log
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.
To get to this screen from any screen, select the Event Log button or press
[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.
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 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.
6.2
Reviewing Events
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 number of events displayed on the Event Log screen.
Filter
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
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 Events F2 (Button) Select to turn the filter off and include all events
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 Events Use this procedure to sort the Event Log into ascending order (most recent events at
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 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.
Table 6-9 Print (Event Log) Window Descriptions
(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
6.3
Troubleshooting Events
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, see the
Viewing Troubleshooting Help procedure in this section.
For more information about the Help 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
2 Select the caution or warning event you want to get troubleshooting information
for.
NOTE
Troubleshooting Help 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.
Process (Field) Displays a software process identifier, intended
for interpretation by a technical support representative.
Table 6-14 Details (Event Log) Window Descriptions
Run Hours (Field) Indicates the number of hours the instrument had
been operating when the event occurred.
Instrument (Field) Displays the user-defined System ID.
Details (List box) Displays technical information that further
explains the event and may include an abbreviated device
or parameter name. The details information is usually
intended for interpretation by a technical support
representative.
The box may have a scroll bar.
Troubleshoot F2 (Button) Select to view troubleshooting Help information
for the selected event.
This function is not available for information events.
Print F7 (Button) Select to print the Event Log Report for the
event displayed in the Details window.
Table 6-14 Details (Event Log) Window Descriptions (continued)
(Optional) To view troubleshooting Help for the event, select Troubleshoot F2.
A troubleshooting Help topic is displayed. You can display the same topic for
this event from the Event Log screen.
6.4
List of Events
The List of Events provides a listing of caution and warning events (also referred to as
error events) that can appear in the Event Log.
NOTE
Disregard the first two digits of the code, which are always zeros.
The List of Events includes the following information for caution and warning events.
Code Lists the 6-digit code or codes that identify each event. The
first number of the code indicates the system module that the
event affects:
1 = Carousel Module 5 = Instrument Base Module
2 = Main Pipettor Module 7 = Software Module
3 = Analytical Module 8 = NT Module
4 = Fluidic Module
The third and fourth digit of the code are usually variable,
indicated as xx. These digits can be any number or letter.
Event Provides a brief description of each event.
Portions of some descriptions are variable, indicated as XXX.
The XXX may be replaced by text in the event description
displayed in the Event Log.
Possible Causes Lists the possible causes for each event. The most common
and/or most easily remedied causes are listed first.
Carousel Module
Codes Event Possible Causes Troubleshooting Instructions
11xx01 Software Timeout Device did not complete a 1. Print the event details (see Section 6.3).
12xx01 Error command from the software 2. Reboot the instrument (see Section 7.3).
within the allotted time.
3. Contact Technical Support to report the event.
11xx05 Reagent Carousel Improperly loaded reagent pack 1. From the Mechanics screen, select Disable
11xx06 Motion Error interfering with movement. Motors F8 (see Section 5.5).
11xx08 Defective sensor. 2. Slide the carousel door to the left and open the
11xx09
11xx0a
Defective thermistor allowed reagent carousel door.
ice to form in the carousel. 3. Manually rotate the reagent carousel in both
11xx0b
11xx11 Defective bearings. directions, 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 5.5).
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.
12xx05 Sample Carousel Improperly positioned sample 1. Open the front panel and remove the supply
12xx06 Motion Error rack, electrical wiring, or other cover, then close the front panel (see
12xx08 obstruction interfering with Section 7.2).
12xx09 movement. 2. From the Mechanics screen, select Disable
12xx0a Mechanical or electrical failure. Motors F8 (see Section 5.5).
12xx0b
3. Manually rotate the carousel in both directions,
12xx11
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.
12xx10 Bar Code Defective CPU board. 1. Print the event details (see Section 6.3).
Initialization Error 2. Reboot the instrument (see Section 7.3).
3. Contact Technical Support to report the event.
21xx01 Software Timeout Device did not complete a 1. Print the event details (see Section 6.3).
23xx01 Error command from the software 2. Reboot the instrument (see Section 7.3).
within the allotted time.
3. Contact Technical Support to report the event.
21xx05 Pipettor Motion Obstruction in vertical path of 1. Open the front panel (see Section 7.2).
21xx06 Error the main pipettor. 2. Check for obstructions in the main pipettor
21xx08 Obstruction in horizontal path pathway:
21xx09 of the main pipettor. In the vertical path, such as caps left on sample
21xx0a
21xx0b
Debris buildup on lower containers.
pipettor gantry shaft. In the horizontal path.
Mechanical or electrical failure. If you find an obstruction, remove it.
3. 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).
4. Close the front panel and initialize the system
(see Section 5.2).
5. Continue normal operation. If you need
assistance or if the problem persists, contact
Technical Support.
21xx10 Pipettor Motion Front panel not completely 1. Be sure the front panel is completely closed (see
Error - Front Panel closed. Section 7.2).
Open Defective interlock switch. 2. Initialize the system (see Section 5.2).
3. Continue normal operation. If you need
assistance or if the problem persists, contact
Technical Support.
21xx11 Pipettor X-Axis Defective main pipettor Z-axis 1. Test the pipettor Z-axis home sensor (see
Motion Error - home sensor. Section 7.6).
Pipettor Z-Axis Not 2. From the Mechanics screen, home the Pipettor
Home (see Section 5.5).
If homing fails, review the Event Log and
troubleshoot 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.
22xx01 Ultrasonic XXX Ultrasonic hardware or interface 1. Print the event details (see Section 6.3).
22xx02 Failed... circuitry failure. 2. Contact Technical Support.
22xx05
22xx07
22xx09
22xx0b
22xx0c
22xx0d
22xx0e
22xx0f
22xx10
22xx11
22xx03 Ultrasonic Board Ultrasonic control process failure. 1. Print the event details (see Section 6.3).
Status Reading 2. Contact Technical Support.
Failed
22xx04 Ultrasonic Phased Damaged primary probe tip. 1. Remove and check the primary probe tip.
22xx06 Lock Loop Failed... Incorrectly torqued primary Replace the probe if it is pitted (see Section 7.6).
probe. 2. Be sure the primary probe is installed and
Defective connections between torqued correctly (see Section 7.6).
the main pipettor and pipettor 3. Continue normal operation. If you need
interface board. assistance or if the problem persists, contact
Technical Support.
22xx08 Ultrasonic Surface Defective ultrasonic board. 1. Print the event details (see Section 6.3).
Detection Failed 2. Contact Technical Support. The ultrasonic board
Before Lowering may need replacement.
Probe
22xx0a Ultrasonic Surface Ultrasonic probe failed to detect 1. Be sure you use an approved sample container,
Detection Failed surface of sample due to: and pipette sufficient sample for the requested
While Lowering Insufficient sample volume. tests into the sample container (see Section A.2
Probe in the Operator's Guide). Do NOT overfill.
Overfilled sample container.
2. Be sure the ID of the rack you are using is
Incorrect sample container for appropriate for the sample container (see
rack ID.
Section A.2 in the Operator's Guide).
Incorrectly loaded sample 3. Properly place the sample container in the rack
container or rack.
and load the rack on the instrument (see
Ultrasonic hardware or interface Section 3.1 in the Operator's Guide).
circuitry failure.
4. Repeat the test(s). If you need assistance or if the
problem persists, contact Technical Support.
22xx13 Ultrasonic Board Ultrasonic board revision is 1. Print the event details (see Section 6.3).
Revision Invalid invalid for the software revision. 2. Contact Technical Support. The ultrasonic board
may need replacement.
22xx14 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 2. Be sure the ID of the rack you are using is
Obstruction While highly viscous sample. appropriate for the sample container (see
Aspirating Sample
Incorrect sample container for Section A.2 in the Operator's Guide).
rack ID. 3. Review the Event Log and troubleshoot any
Plugged primary probe. other events with a similar date and time to this
event.
4. Repeat the test. If you need assistance or if the
problem persists, contact Technical Support.
22xx15 Main Pipettor Fluid leak. 1. Visually inspect the tubing leading from the
Detected an Sensor failure. precision pump valve to the pressure monitor,
Abnormal Pressure and from the pressure monitor to the main
pipettor (see Figure 1-3). If you see leaks,
bubbles, or 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.
22xx16 Main Pipettor Pressure monitor detected five or 1. Prime the pipettor twice (see Section 5.3),
Detected Too Many more obstructions in multiple determine a new reference curve for obstruction
Consecutive samples due to: detection (see Section 5.6), be sure the sample is
Obstructions Plugged primary probe. free of clots or other solids, and repeat the test.
Damaged primary probe. 2. If the failure recurs, run the Special Clean
routine (see Section 8.5 in the Operator's Guide),
Mechanical problem or run the System Check routine, and determine a
alignment.
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.
23xx05 Precision Debris buildup on valve. 1. Clean the precision valve (see Section 7.7).
23xx06 Valve/Pump Motion Utility Assay disabled and 2. Continue normal operation. If you need
23xx08 Error instrument idle for extended assistance or if the problem persists, contact
23xx09 time. Technical Support.
23xx0a
23xx0b
Precision valve failure.
Mechanical or electrical failure.
Analytical Module
Codes Event Possible Causes Troubleshooting Instructions
31xx01 Software Timeout Device did not complete a 1. Print the event details (see Section 6.3).
32xx01 Error command from the software 2. Reboot the instrument (see Section 7.3).
33xx01 within the allotted time.
3. Contact Technical Support to report the event.
34xx01
37xx01
31xx05 Incubator Belt Mechanical or electrical failure. 1. Print the event details (see Section 6.3).
31xx06 Motion Error 2. Review the Event Log and troubleshoot
31xx08 according to any error event with a date and time
31xx09 shortly before this event.
31xx0a
3. From the Maintenance Review screen, select
31xx0b
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).
5. Check for fallen RVs in the shuttle transfer
position and in the front corners of the analytical
module (see Section 7.5).
6. Replace missing or damaged vessel holders (see
Section 7.5).
7. Home the Incubator Belt (see Section 5.5).
(Cont.)
31xx05 Incubator Belt Mechanical or electrical failure. 8. Be sure all covers are closed and reboot the
31xx06 Motion Error instrument (see Section 7.3).
31xx08 If you replaced any vessel holders, calibrate
31xx09 the incubator belt (see Section 5.8), cycle the
31xx0a belt for 1 minute (see Section 5.5), and
31xx0b exercise the belt for 2 cycles (see Section 5.8).
9. Enable the Utility Assay and continue normal
operation. Contact Technical Support to report
the event.
31xx10 Cannot Move - Software timing error. 1. Print the event details (see Section 6.3).
32xx10 Intersecting Device 2. From the Mechanics screen, check if the
34xx11 Moving Incubator Belt, RV 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.
31xx12 Incubator Belt Minor deviation detected during 1. Calibrate the incubator belt (see Section 5.8).
31xx14 Calibration Error - incubator belt calibration. If calibration fails or if the error recurs,
Belt May Need Note: continue troubleshooting.
Service The system is operable, but the 2. Switch the vessel holder positions (see
incubator belt may need service Section 7.5).
soon. Try to improve the incubator
3. Be sure all covers are closed and initialize the
belt calibration results by
system (see Section 5.2). If you need assistance
troubleshooting.
or if the problem persists, contact Technical
Support.
31xx13 Incubator Belt Defective incubator belt. 1. Print the event details (see Section 6.3).
31xx15 Calibration Error - 2. Contact Technical Support.
Belt Needs Service
31xx16 Incubator Belt Missing or damaged vessel 1. From the Maintenance Review screen, select
Calibration Error - holder or sensor flag. Disable Utility Assay F6 (see Section 8.1 in the
Check Belt Incubator jam. Operator's Guide).
2. Replace any missing or damaged vessel holders
(see 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.
31xx19 Incubator Belt Not Incubator belt has not been Calibrate the incubator belt (see Section 5.8). If you
Calibrated calibrated since software was need assistance or if the problem persists, contact
loaded. Technical Support.
32xx05 Wash Carousel Mechanical or electrical failure. 1. Print the event details (see Section 6.3).
32xx06 Motion Error 2. From the Mechanics screen, check if the RV
32xx08 Shuttle and Incubator Belt (Devices) are at the
32xx09 home or index position (see Section 5.5).
32xx0a
If the shuttle is not at home:
32xx0b
32xx11 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.
3. Clear the wash carousel (see Section 7.8).
4. Cycle the Wash Carousel for 4 cycles (see
Section 5.5).
If cycling fails, contact Technical Support.
5. Home the Incubator Belt (see Section 5.5).
6. Be sure all covers are closed and reboot the
instrument (see Section 7.3).
7. Calibrate the incubator belt (see Section 5.8).
8. Continue normal operation. Contact Technical
Support to report the event.
32xx12 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 Service during a diagnostic procedure.
32xx13 Wash Carousel Wash carousel exceeded the limit 1. Print the event details (see Section 6.3).
Alignment Error - of steps allowed during a 2. Do not continue operating the instrument.
Needs Service diagnostic procedure.
3. Contact Technical Support.
33xx05 Wash Arm Motion Obstruction in the area of the Check for wash arm obstructions (see Section 7.8).
33xx06 Error sensor. If you need assistance or if the problem persists,
33xx08 Bent probe in wash arm. contact Technical Support.
33xx09
33xx0a
Defective home sensor.
33xx0b Mechanical or electrical failure.
34xx05 Shuttle Motion Overfilled RV waste bag. 1. From the Supplies screen, note the RV Waste
34xx06 Error Improperly seated RV waste number (see Section 2.1 in the Operator's
34xx08 bag. Guide).
34xx09
34xx0a
Mechanical or electrical failure. 2. Open the supplies door to view the waste bag. If
the waste bag is bulging, it may be overfilled.
34xx0b Obstruction in the path of the
shuttle. 3. Follow the steps for the appropriate situation
below.
34xx10 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 If no waste bag is present, install the waste bag
Present bag. currently in use (if it is not full), or install a
Undetectable plastic collar on new waste bag, following the Changing the
waste bag. RV Waste Bag procedure (see Section 2.6 in
the Operator's Guide). Continue normal
Improperly adjusted or operation.
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.
35xx01 Cannot XXX Device driver failed to configure 1. Print the event details (see Section 6.3).
35xx02 Luminometer or disable the luminometer 2. Contact Technical Support.
Counter counter.
35xx03 Luminometer Read Device driver did not receive 1. Print the event details (see Section 6.3).
Failed acknowledgement from the 2. Contact Technical Support.
luminometer.
35xx04 Dark Counts Improperly closed covers 1. From the Digital Devices window, turn on the
Outside Limits Bright lighting near instrument. vacuum pump and probe wash valve (see
Section 5.6).
Electrical noise.
2. From the Luminometer screen, select Load/Read
Fluid spill in wash carousel.
Vessel F2 (see Section 5.7).
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.
a. 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.
a. If bright lighting is present, shield the
instrument or remove the light source and
repeat step 1 through step 4.
b. If RLU values decrease, remove the light
source permanently if possible, or contact
Technical Support for assistance with
relocating the instrument.
(Cont.)
35xx04 Dark Counts Improperly closed covers If all covers were closed tightly and there is no
Outside Limits Bright lighting near instrument. bright lighting present, repeat step 1 through
step 3.
Electrical noise.
a. Continue to observe the Current RLU field
Fluid spill in wash carousel.
for 5 - 10 minutes, and record atypical RLU
values. Turn off the vacuum pump and
probe wash valve.
b. 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.
35xx07 Sample Counts Empty substrate bottle. 1. Check the substrate bottle.
Outside Limits Constricted or loose tubing. If the bottle is empty, change it and prime the
Mechanical failure. substrate (see Section 2.4 in the Operator's
Guide). Continue normal operation.
Poor aspiration by aspirate
probe 3. If the bottle is not empty, continue
troubleshooting.
2. Open the front panel (see Section 7.2).
3. Check the white fittings on the substrate cap and
the substrate tubing along the visible path from
the substrate bottle to the substrate pump (see
Figure 1-5) and substrate probe (see Figure
5-11).
If a fitting is loose, tighten it (finger-tight). If
the tubing is loose or constricted, correct it.
Continue normal operation.
If the fittings and tubing are not loose or
constricted, continue troubleshooting.
4. Review the result report for a SYS flag.
If you find a SYS flag, contact Technical
Support.
5. Perform the visual dispense probe volume check
(see Section 5.4).
6. Review the Event Log and troubleshoot
according to any mechanical error event with a
similar date and time to this event.
If the problem persists, perform the visual
aspirate probe volume check (see Section 5.4).
7. Be sure all covers are closed and continue
normal operation. If you need assistance or if the
problem persists, contact Technical Support.
35xx08 Crosstalk Counts Leakage light from one RV to an 1. Review the event details for the date and time of
Outside Limits adjacent RV exceeded 10,000 the event and the crosstalk counts (see
RLUs. Section 6.3).
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.
35xx09 Drift Correction Significant change occurred 1. Print the event details (see Section 6.3).
Factor Outside within the luminometer circuit. 2. Contact Technical Support.
Limits
35xx0a RV Location RV to be read by luminometer 1. Print the event details (see Section 6.3).
Conflict does not match test ID requested 2. Contact Technical Support.
by system sequencer.
35xx0b PMT H.V. Supply - Failure to write in DAC setup 1. Print the event details (see Section 6.3).
35xx0c DAC XXX values. 2. Contact Technical Support.
Corrupted data within NVRAM.
360101 RV Cleanout Error Failure to clean out RVs due to 1. Open the front panel, then remove the supply
360201 error detected in RV tracking cover and incubator cover (see Section 7.2).
360a01 scheme. 2. Remove any RVs remaining in the shuttle (see
Figure 7-13) and clear the shuttle path (see
Section 7.5).
3. From the Mechanics screen, select Disable
Motors F8 (see Section 5.5).
4. 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.
5. Select Enable Motors F8 and home the
Incubator Belt (see Section 5.5).
6. Clear the wash carousel (see Section 7.8).
7. Home the Incubator Belt, then the Wash
Carousel.
8. Replace and close all covers, then reboot the
instrument (see Section 7.3).
9. Calibrate the incubator belt (see Section 5.8).
10. Continue normal operation. Contact Technical
Support to report the event.
360301 RV Cleanout Error Failure to clean out RVs due to 1. Open the front panel, then remove the supply
360501 error detected in RV tracking cover and incubator cover (see Section 7.2).
scheme. 2. Remove any RVs remaining in the shuttle (see
Figure 7-13).
3. Replace and close all covers, then reboot the
instrument (see Section 7.3).
4. Continue normal operation. Contact Technical
Support to report the event.
360801 RV Cleanout Error Device is not on an index flag. 1. From the Mechanics screen, check if the
360901 Note: Incubator Belt, RV Shuttle, and Wash Carousel
This event usually occurs after a (Device) are at the home or index position (see
motion error. Section 5.5).
2. Follow the steps for the appropriate situation
below.
360b01 RV Cleanout Error Failure to clean out RVs due to 1. Review the Event Log and troubleshoot
error detected in RV tracking according to the error events with a similar date
scheme. and time to this event.
2. Continue normal operation. If you need
assistance or if the problem persists, contact
Technical Support.
360c01 RV Cleanout Error Loss of NVRAM due to: 1. Print the event details (see Section 6.3).
Battery backup loss while 2. Contact Technical Support.
power was down.
Changed or removed I/O board.
37xx05 Rake Motion Error Fallen RVs in RV loader. 1. Check for fallen or missing RVs in the shuttle,
37xx08 Missing or extra RVs in the RV and check for fallen RVs or other obstructions
37xx09 loader. between the rake and the wall of the incubator
37xx0a track (see Section 7.5).
37xx0b
Obstruction interfering with
rake movement. If RVs are fallen or missing, remove all the
RVs in the shuttle and continue
Mechanical failure. 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.
37xx06 Rake Homing Error Obstruction interfering with 1. Check for fallen RVs or other obstructions
rake movement. between the rake and the wall of the incubator
Mechanical failure. track (see Section 7.5).
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.
37xx0c Possible Rake Fallen RVs in RV loader. 1. Check for fallen or missing RVs in the shuttle
Motion Error Missing or extra RVs in the RV (see Section 7.5).
During Row loader. If RVs are fallen or missing, remove all the
Advance
RVs improperly loaded. 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 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.
Fluidic Module
Codes Event Possible Causes Troubleshooting Instructions
41xx01 Software Timeout Device did not complete a 1. Print the event details (see Section 6.3).
46xx01 Error command from the software 2. Reboot the instrument (see Section 7.3).
47xx01 within the allotted time.
3. Contact Technical Support to report the event.
48xx01
4axx01
41xx05 Wash Valve/Pump Utility Assay disabled and 1. Clean the wash valve (see Section 7.7).
41xx06 Motion Error instrument idle for extended 2. Continue normal operation. If you need
41xx08 time. assistance or if the problem persists, contact
41xx09 Debris buildup on valve. Technical Support.
41xx0a
41xx0b
Wash valve failure.
Mechanical or electrical failure.
46xx10 Vacuum Over Limit Constricted waste tubing. 1. Check the tubing from the liquid waste bottle
Error Failing vacuum valve. (see Figure 7-10).
Obstructed vacuum system If the tubing is constricted, correct it. Continue
tubing or waste filter. normal operation.
2. From the Digital Devices window, select
Vacuum Test F2 to run the vacuum test (see
Section 5.6).
If the vacuum test fails, contact Technical
Support.
3. 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 7-10).
This may temporarily resolve the error until you
can install a new waste filter assembly.
4. 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.
46xx11 Vacuum Under Leak in vacuum system. 1. Open the top cover (see Section 7.2).
Limit Error Failing vacuum pump or valve. 2. Check the tubing leading to and from the vacuum
Missing or failing splash guard reservoir (see Figure 1-5).
in vacuum reservoir. If the tubing is constricted, correct it.
Damaged or leaking peristaltic If the tubing is damaged or leaking, contact
waste pump or waste pump Technical Support.
tubing. 3. Check the waste filter bottle for fluid.
If there is fluid in the bottle, replace it (see
Section 7.4).
4. Open the front panel (see Section 7.2).
5. 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).
6. From the Digital Devices window, select
Vacuum Test F2 to run the vacuum test (see
Section 5.6).
If the vacuum test fails, contact Technical
Support.
7. Close the top cover and front panel. Continue
normal operation. If you need assistance or if the
problem persists, contact Technical Support.
46xx12 Vacuum Offset Defective vacuum pressure sensor. 1. Print the event details (see Section 6.3).
Over Limit 2. Contact Technical Support.
47xx0c Mixer Belt Speed Broken mixer belt. 1. Open the front panel (see Section 7.2).
47xx0d Error - Outside Defective sensor. 2. Check the mixer belt to verify that it is intact (see
Limits
Defective motor. Figure 7-29).
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.
47xx0e Mixer Belt Break Mixer speed measurement not 1. Print the event details (see Section 6.3).
Detection Not supported by I/O board. 2. Contact Technical Support. The I/O board may
Supported need replacement.
4axx0c Peristaltic Pump No movement of peristaltic pump 1. Open the front panel (see Section 7.2).
Stopped Error detected when the pump should be 2. From the Digital Devices window, turn on the
running. peristaltic pump (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.
4axx0d Peristaltic Pump Movement of peristaltic pump 1. Open the front panel (see Section 7.2).
Running Error detected when the pump should be 2. From the Digital Devices window, turn on the
stopped. peristaltic pump (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.
51xx01 NVRAM Test NVRAM test failure during 1. Print the event details (see Section 6.3).
Failed During software installation. 2. Contact Technical Support. The I/O board may
Installation need replacement.
52xx01 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
covers. temperature is outside limits, check the device
Analog reference outside limits. temperature on the Maintenance Review
screen. If the temperature is outside the
Power supply voltage outside acceptable limits, periodically monitor the
limits.
temperature until it is within the acceptable
Vacuum pressure outside limits. limits.
Defective device. a. If the system was rebooted or instrument
covers were recently opened, wait up to 30
minutes for the 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.
52xx02 XXX Hardware Open or shorted circuit. 1. Print the event details (see Section 6.3).
Error 2. Contact Technical Support.
521c03 Supply Condition - Insufficient wash buffer 1. Check the wash buffer reservoir (see Figure 1-6).
Scheduler Paused volume. If the buffer volume is low, change the wash
Defective buffer valve buffer bottle (see Section 2.2 in the Operator's
assembly. Guide). Continue normal operation.
Broken float level sensor wire. If the buffer volume is not low, continue
troubleshooting.
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).
521d03 Supply Condition - Liquid waste bottle full. 1. Check the liquid waste bottle (see Figure 1-6).
Scheduler Paused Defective waste bottle scale. If the bottle is full, change it (see Section 2.3
in the Operator's Guide). Continue normal
operation.
If the bottle is not full, continue to step 2 to
obtain information for Technical Support.
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.
53xx01 Invalid Firmware Invalid firmware revision for a 1. Print the event details (see Section 6.3).
On SMC Board device axis detected on the SMC 2. Contact Technical Support. The SMC board may
board. need replacement.
53xx02 Invalid Sensor Input Invalid sensor input detected on 1. Print the event details (see Section 6.3).
On SMC Board the SMC board. 2. Contact Technical Support. The SMC board may
need replacement.
Software Module
Code Event Possible Causes Troubleshooting Instructions
71xx01 FATAL System Fatal error detected within the 1. Print the event details (see Section 6.3).
71xx02 Software Error system software. 2. Record instrument operations preceding the
71xx03 event; for example, waste bag was changed.
71xx04
3. Reboot the instrument (see Section 7.3).
71xx05
71xx06 If rebooting fails, contact Technical Support.
71xx07 4. Continue normal operation. Contact Technical
71xx08 Support to report the event.
71xx09
71xx0a
71xx0c
72xx01 Software File Corrupted hard drive. 1. Print the event details (see Section 6.3).
72xx02 Accessing Error 2. Record instrument operations preceding the
72xx03 event; for example, waste bag was changed.
72xx05
3. Reboot the instrument (see Section 7.3).
72xx06
72xx07 If rebooting fails, contact Technical Support.
72xx08 4. Continue normal operation. Contact Technical
72xx09 Support to report the event.
72xx0b
72xx0c
73xx01 Software Data Corrupted hard drive. 1. Print the event details (see Section 6.3).
73xx02 Formatting Error 2. Record instrument operations preceding the
73xx03 event; for example, waste bag was changed.
73xx04
3. Reboot the instrument (see Section 7.3).
73xx05
73xx06 If rebooting fails, contact Technical Support.
73xx07 4. Continue normal operation. Contact Technical
73xx08 Support to report the event.
73xx09
73xx0a
73xx0b
73xx0c
73xx0d
73xx0e
73xx10
73xx11 System Software Non-fatal error detected in the 1. Print the event details (see Section 6.3).
74xx27 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.
74xx1a Supplies Insufficient supplies for the 1. Check the Supplies Required screen to determine
Insufficient For number of tests requested. the supplies needed (see Section 4.2 in the
Requested Tests Operator's Guide).
2. Load the necessary supplies (see Chapter 2 in the
Operator's 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.
75xx01 Calibration Failed Insufficient calibrator volume. 1. Review the Event Log and troubleshoot
For Assay XXX Insufficient substrate. according to any device error event with a date
and time shortly before this event.
Expired calibrator or reagent
pack. 2. If there are no device error events shortly before
this event, follow the assay calibration
Calibrators not in correct order troubleshooting instructions in Section A.4:
on sample rack.
Assay Troubleshooting.
Reagent pack in wrong slot. 3. Repeat the calibration. If you need assistance or
Unstable or contaminated if the problem persists, contact Technical
calibrator or reagent. Support.
Level sense failure.
Inadequate particle washing.
75xx04 QC Result Not Previous device motion error. 1. Review the Event Log and troubleshoot
Obtained - No according to any device motion error event with
Value Stored a date and time shortly before this event.
2. Repeat the test with a freshly prepared control. If
you need assistance or if the problem persists,
contact Technical Support.
76xx03 Software Database Failure detected during a database 1. Print the event details (see Section 6.3).
Update Failure update operation. 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.
76xx04 Sample Quantity Insufficient sample volume. 1. Be sure you use an approved sample container,
Not Sufficient Overfilled sample container. and pipette sufficient sample for the requested
(QNS) tests into the sample container (see Section A.2
Incorrect sample container for in the Operator's Guide). Do NOT overfill.
rack ID.
2. Be sure the ID of the rack you are using is
Incorrectly loaded sample appropriate for the sample container (see
container or rack.
Section A.2 in the Operator's Guide).
Damaged primary probe tip. 3. Properly place the sample container in the rack
Incorrectly torqued primary and load the rack on the instrument (see
probe. Section 3.1 in the Operator's Guide).
Defective connections between 4. Rerun the test(s) (see Section 5.2 in the
the main pipettor and pipettor Operator's Guide). If the problem persists,
interface board. continue troubleshooting at step 5.
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.
77xx01 Cannot Fork Error detected in the system 1. Print the event details (see Section 6.3).
Database Update software. 2. Record instrument operations preceding the
Process 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.
77xx02 No RV In Pipetting Missing RV from RV cartridge. 1. Check for fallen or missing RVs in the shuttle
7cxx09 Position 1 Or 2 Dirty or defective RV sensor. and shuttle transfer position (see Section 7.5).
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.
77xx03 Device Failed Error received from device 1. Review the Event Log and troubleshoot
During Timing controller or from another process. according to the error events with a similar date
Pitch and time to this event.
2. Continue normal operation. If you need
assistance or if the problem persists, contact
Technical Support.
77xx07 FATAL Device Fatal instrument error. 1. Review the Event Log and troubleshoot
Error - Tests In according to the error events with a similar date
Progress Cancelled and time to this event.
2. Run QC (see Section 3.4 in the Operator's
Guide) for all 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.
77xx0a Unexpected RV In Fallen RV. 1. Check for fallen or missing RVs in the shuttle
Front Of Rake Dirty or defective RV sensor. and shuttle 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.
77xx0b Error Recovery Exceeded maximum attempts 1. Review the Event Log and troubleshoot
Failed - No New allowed for device error recovery. according to the error events with a similar date
Tests Started and time to this event.
2. Continue normal operation. If you need
assistance or if the problem persists, contact
Technical Support.
77xx0c No Empty Position Instrument sequencer was unable 1. Print the event details (see Section 6.3).
Found On Incubator to find an empty position for an 2. Record instrument operations preceding the
Belt RV on the incubator belt. 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.
78xx01 Analog Device Error detected in the control of 1. Print the event details (see Section 6.3).
78xx02 Error analog devices. 2. Record instrument operations preceding the
78xx04 event; for example, waste bag was changed.
78xx05
3. Reboot the instrument (see Section 7.3).
78xx06
78xx08 If rebooting fails, contact Technical Support.
78xx0d 4. Continue normal operation. Contact Technical
78xx12 Support to report the event.
78xx13
78xx14
78xx15
78xx16
78xx18
78xx19 CPU Timeout Error CPU cannot process the 1. Print the event details (see Section 6.3).
transmitted information within the 2. Record instrument operations preceding the
allotted time. 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.
79xx02 Status Controller Error detected while status 1. Print the event details (see Section 6.3).
79xx03 Initialization Error controller was initializing 2. Record instrument operations preceding the
79xx04 instrument parameters. event; for example, waste bag was changed.
79xx05
3. Reboot the instrument (see Section 7.3).
79xx06
79xx07 If rebooting fails, contact Technical Support.
79xx08 4. Continue normal operation. Contact Technical
Support to report the event.
7axx01 A/D Converter Failure detected in reading 1. Print the event details (see Section 6.3).
7axx02 Reading Failure ADC data. 2. Reboot the instrument (see Section 7.3).
7axx03 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.
7bxx02 Timeline Scheduler Instrument scheduler was unable 1. Print the event details (see Section 6.3).
7bxx03 Error to schedule all requested tests into 2. Record instrument operations preceding the
the instrument timeline. 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.
7cxx01 RV Location Instrument was unable to find a 1. Print the event details (see Section 6.3).
7cxx02 Software Error specific RV. 2. Record instrument operations preceding the
Instrument was unable to find event; for example, waste bag was changed.
an empty position on a device 3. Reboot the instrument (see Section 7.3).
for an RV.
If rebooting fails, contact Technical Support.
4. Continue normal operation. Contact Technical
Support to report the event.
7cxx07 Snugging RVs Into Missing RV from RV cartridge. 1. Check for fallen or missing RVs in the shuttle
Shuttle Failed Fallen RV. and shuttle transfer position (see Section 7.5).
Dirty or defective RV sensor. 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.
7cxx0c Device Failed Device motion sequence failure. 1. Review the Event Log and troubleshoot
During Motion according to the error events with a similar date
Sequence and time to this event.
2. Continue normal operation. If you need
assistance or if the problem persists, contact
Technical Support.
NT Module
Code Event Possible Causes Troubleshooting Instructions
85xx07 Communication Error in communication between 1. Go to the screen that was displayed when the
Error the instrument and the PC. error occurred. 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.
7
System Support Procedures
7.1 System Support Procedures .........................................................................7-3
Removing and Replacing the Supply and Incubator Covers ............................ 7-8
7.1
System Support Procedures
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.
7.2
Instrument Cover Procedures
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.
0073Ec.eps
1 Front Panel
2 Captive Screw
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 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.
4 Retract the top cover by sliding both sides back toward the rear of the
instrument approximately 1/4, or 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 the Required Materials
Supply and
9/64 hex wrench
Incubator
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.
1 Be sure the instrument is in the Ready or Not Ready mode, then open the front
panel (see the Opening and Closing the Front Panel procedure in this section).
2 Remove the 9/64 hex screw from each end of the supply cover. The screws are
located where the supply cover meets the instrument frame (see Figure 7-4).
NOTE
The 9/64 hex screws may not be present if they were not replaced during a
previous procedure.
4
3
2
0241Bc.eps
1 Front Panel
2 Carousel Door
3 Hex Screws (under Front Panel)
4 Base Panel
5 Supply Cover
6 Supplies Door
3 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.
4 Remove the 9/64 hex screw in the bottom of the RV waste bag well.
NOTE
The 9/64 hex screw may not be present if it was not replaced during a previous
procedure.
5 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 in this
section).
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.
5
2
4
3
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 in this
section).
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 hex screws in the bottom of the waste bag well and at each
end of the supply cover.
7.3
Rebooting, Shutting Down, and
Restarting Procedures
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 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.
NOTE
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.
4 Press and hold the PC power switch for at least 15 seconds to turn off the power
to the PC.
5 Wait about 20 seconds, then perform the restarting procedure (see the
Restarting the PC procedure in this section).
NOTES
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.
1 Simultaneously press the [Ctrl], [Alt], and [Delete] keys, then select Shutdown.
If the keyboard does not respond, press the PC power switch to turn the
power off (see Figure 7-6).
Restarting the PC
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 to turn the power on (see Figure 7-6).
1054A.eps
Figure 7-6 PC Power Switch
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 7-7).
3 Push and hold in the reset button for one second, then release.
0045Cc.eps
Figure 7-7 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.
2 Locate the power switch on the lower, right side near the back of the instrument
(see Figure 7-8). Press the lower part of the switch to turn the power off (O
position).
0042Dc.eps
Figure 7-8 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 Down Shut down the instrument only if you plan to move it or if the system power will be
the Instrument turned off for an extended period of time (more than 5 days). Before you shut down
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 highly 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).
3 If necessary, shut down the PC (see the Rebooting the PC procedure in this
section).
4 Locate the power switch on the lower, right side near the back of the instrument
(see Figure 7-8). 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 7-8). 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 ProClin 300 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 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.
1 Perform the Visual Dispense Probe Volume Check procedure (see Section 5.4:
Volume Checks).
If the results of this procedure fail, contact Technical Support.
2 Perform the Visual Aspirate Probe Volume Check procedure (see Section 5.4:
Volume Checks).
If the results of this procedure fail, clean and/or replace the appropriate aspirate
probe (see Section 8.3: Weekly Maintenance in the Operator's Guide).
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 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.
7.4
Fluids Tray and Instrument Base
Procedures
The fluids tray and instrument base procedures involve the components in the fluids
tray and the molded base of the instrument.
Decontam- If the substrate gets contaminated, all system components that come into direct
inating the contact with the substrate must be decontaminated.
Substrate
System CAUTION
Perform this procedure only when you are instructed by a technical
support representative.
Low substrate check values (< 3000 RLUs) from the System Check routine.
Increase in zero calibrator RLUs for sandwich assays
Shift up in the analyte concentration responses for sandwich assays
Shift down in the analyte concentration responses for competitive assays
Increased variability of results, especially low signal calibrators
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
manufacturers label for details.
2 Put on the rubber gloves (without talc) and saturate a clean, lint-free tissue with
diluted Citranox cleaning solution.
* Citranox is a trademark of Alconox, Inc.
3 Remove the cap and tubing from the substrate container. Use the saturated
tissue to thoroughly wipe down the inside surface of the cap and exterior
surface of the substrate tubing that was exposed to the substrate.
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 5.3: Prime Fluidics).
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.
2 Scan and load a new bottle of substrate without priming the substrate fluidic
lines. When the system prompts you to prime the substrate fluidic lines, select
No F2. For more information, see the Changing the Substrate Bottle procedure
in Section 2.4: Substrate of the Operator's Guide.
3 Return 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.
4 Select the Substrate box, then change the number of substrate priming cycles
to 20 (the maximum), then select Start Priming F2.
3 Prime the substrate for an additional 20 cycles, then repeat the substrate check.
5 Run the System Check routine. For more information, see Section 8.4: System
Check in the Operator's Guide.
6 Run QC for all assays you use to analyze patient samples. Evaluate out-of-range
QC results. For more information, see Chapter 7: Quality Controls in the
Operator's Guide.
Testing the RV The RV waste bag sensor notifies the system that the waste bag is present. Test the
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.
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.
1 Be sure the instrument is in the Ready or Not Ready mode, then open the
supplies door (see Figure 7-4).
2 Go to the Digital Devices window. To get to this window from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then
Select Device Diagnostics F4 to display the Device Diagnostics screen, then
Select Digital Devices F3.
3 Observe if the status of the Waste Bag Present field changes 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.
4 If the status does not change, repeat step 3 with another waste bag from a
different lot, if possible. 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.
If the status does not change, repeat this step with up to 2 more waste bags
from different lots.
5 If the status still does not change, remove the waste bag.
6 Place your finger in front of the sensor and observe if the status of the Waste
Bag Present field changes (see Figure 7-9).
If the status changes, adjust the sensor (see the Adjusting the RV Waste Bag
Sensor procedure in this section).
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.
7 If the status still does not change, slightly moisten a fiber-free swab applicator
with deionized water and gently wipe the sensor.
2
3
0888Ac.eps
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 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.
1 Be sure the instrument is in the Ready or Not Ready mode, then open the front
panel and remove the supply cover (see Section 7.2: Instrument Cover
Procedures).
2 Locate the waste bag sensor mounting screws (see Figure 7-9). They are located
underneath the waste bag sensor.
You cannot see the screws, but you can feel them under the sensor.
3 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.
4 Go to the Digital Devices window. To get to this window from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then
Select Device Diagnostics F4 to display the Device Diagnostics screen, then
Select Digital Devices F3.
5 Observe if the status of the Waste Bag Present field changes 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.
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.
1
4
0229Dc.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 it.
Use this procedure to rinse the wash buffer reservoir in the fluids tray.
WARNING
Wash buffer contains ProClin 300 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
4
1
5
6
7
8
9
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.
7.5
Incubator Belt and Shuttle
Procedures
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 7-12).
Discard the RVs.
1
2
3
4 6
0908Ac.eps
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 7-12). 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 Mechanics screen. To get to this screen from the Main Menu, select
Diagnostics F7 to display the Diagnostics menu, then
WARNING
Do not get close to the shuttle while it is moving.
9 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 7-13).
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.
2
1
3
5
0909Ac.eps
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.
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
Replace vessel holders only when you are directed to do so by a technical support
Holders
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 Mechanics screen. To get to this screen from the Main Menu, select
Diagnostics F7 to display the Diagnostics menu, then
6 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 in this section).
7 Remove any loose RVs and any broken, bent, or ejected vessel holders or legs
(see Figure 7-14) 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 7-14). Save these vessel holders.
0235Bc.eps
CAUTION
If the incubator belt resists movement, stop rotating it and remove any
visible vessel holders that may be damaged. Contact Technical Support.
10 Repeat step 7 as you rotate the incubator belt one full turn.
2
0236Bc.eps
11 To be sure there are no vessel holder pieces left in the instrument, match the
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.
1 Replace any broken or damaged vessel holders with new ones. Manually rotate
the incubator belt as needed to find the empty locations.
To replace vessel holders, push them down onto the incubator belt. They gently
snap into place when they are fully seated.
If the home (with magnet) vessel holder is broken, be sure to replace it with
another home vessel holder. Be sure there is only one home vessel holder on
the incubator belt.
If the belt resists moving, contact Technical Support.
2 Be sure all of the vessel holders are pushed firmly down onto the incubator belt.
Manually rotate the incubator belt as needed.
If the belt resists moving, contact Technical Support.
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 instrument 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 Mechanics screen. To get to this screen from the Main Menu, select
Diagnostics F7 to display the Diagnostics menu, then
4 Select RV Shuttle from the list in the Device field (see Section 5.5: Mechanics
and Device Diagnostics).
5 With the hemostat, individually lift and replace the RVs from shuttle positions 1
and 2 (see Figure 7-12). 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 7-12).
4 Angle the applicator tip toward the bottom of the shuttle and gently wipe the
round black RV sensors (see Figure 7-17).
0910Ac.eps
1 RV Sensors
5 Replace the RVs in the first 2 positions of the RV shuttle (see Figure 7-12).
8 Replace the incubator cover and supply cover, then close the front panel.
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 7-18).
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.
7.6
Main Pipettor Procedures
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 Be sure the instrument is in the Ready or Not Ready mode, then open the front
panel (see Section 7.2: Instrument Cover Procedures).
2 Inspect the upper pipettor gantry shaft for corrosion (see Figure 7-19).
If you notice significant corrosion or suspect that fluid or some other material
came in contact with the pipettor gantry, contact Technical Support.
3 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 7-19).
The lower pipettor gantry shaft is not lubricated, so there is no risk of
inadvertently removing the lubricant.
1 2
3
5
0036H.eps
4 Move the main pipettor carriage a few inches to the right or left to expose the
section of the lower pipettor gantry shaft that was covered by the carriage.
5 Wipe the remaining section of the lower pipettor gantry shaft with the tissue.
7 Go to the Mechanics screen. To get to this screen from the Main Menu, select
Diagnostics F7 to display the Diagnostics menu, then
8 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 Z-Axis only when you are directed to do so by a technical support representative or if you are
Home Sensor 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.
1 Be sure the instrument is in the Ready or Not Ready mode, then open the front
panel (see Section 7.2: Instrument Cover Procedures).
2 Go to the Mechanics screen. To get to this screen from the Main Menu, select
Diagnostics F7 to display the Diagnostics menu, then
3 Select Pipettor from the list in the Device field (see Section 5.5: Mechanics and
Device Diagnostics).
4 To move the pipettor down, rotate the pulley downward (see Figure 7-19).
Verify that the Home - Z sensor on the Mechanics screen is not lit.
5 To move the pipettor up, rotate the pulley upward until it stops (see
Figure 7-19).
Verify that the Home - Z sensor on the Mechanics screen is lit.
6 If the Home - Z sensor does not light correctly, contact Technical Support.
Required Materials
Biohazard eye, hand, and facial protection
5/16 open end wrench
1/4 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 7-20).
4
7
6
5
0304D.eps
4 Position the 5/16 wrench on the flat sides of the lower end of the ultrasonic
transducer above the probe nut (see Figure 7-20).
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 wrench, or you may damage the
pipettor.
5 Position the 1/4 wrench on the probe nut with the handle to the right of the
probe nut (see Figure 7-20).
6 To loosen the probe nut, hold the 5/16 wrench in place and move the 1/4
wrench to the left (counterclockwise).
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 7-21).
3 Screw the probe and nut (finger-tight) onto the lower end of the ultrasonic
transducer (see Figure 7-20).
1
0293Bc.eps
1 Primary Probe
2 Probe Nut
4 Position the 5/16 wrench on the flat sides of the lower end of the ultrasonic
transducer above the probe nut (see Figure 7-20).
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 wrench, or you may damage the
pipettor.
5 With the stationary bar toward the left side of the instrument, fit the 1/4 hex
opening of the pipettor torque tool (see Figure 7-22) over the probe nut.
1 2
4 3
0296Bc.eps
6 While holding the 5/16 wrench in place, place your finger or thumb in the
notch on the pipettor torque tool (see Figure 7-22) 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 instrument 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.
7.7
Pump/Valve Procedures
The procedures in this section 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.
1 Be sure the system is in the Ready or Not Ready mode, then go to the
Mechanics screen. To get to this screen from the Main Menu, select
Diagnostics F7 to display the Diagnostics menu, then
2 Select Precision Valve from the list in the Device field, then select
Home Device F1 (see Section 5.5: Mechanics and Device Diagnostics).
3 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).
4 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.
5 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
7 Turn the precision valve cap counterclockwise and remove it (see Figure 7-24).
The gasket may be stuck to the cap when you remove it.
2
3
12
5
11
1
10
9 5
7
3
8
0890B.eps
8 If the gasket was not removed with the precision valve cap, remove the gasket,
then the precision valve cap spacer.
9 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.
10 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.
11 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 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 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 7-19.
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.
1 Be sure the system is in either the Ready or Not Ready mode, then go to the
Mechanics screen. To get to this screen from the Main Menu, select
Diagnostics F7 to display the Diagnostics menu, then
2 Select the Wash Valve from the list in the Device field, then select
Home Device F1 (see Section 5.5: Mechanics and Device Diagnostics).
3 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.
4 Open the front panel and the top cover (see Section 7.2: Instrument Cover
Procedures).
5 Place paper towels under the dispense probes identified with the numbers 1, 3,
and 5 (see Figure 7-25).
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
8 Turn the wash valve cap counterclockwise and remove it (see Figure 7-26).
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
9 If the gasket was not removed with the wash valve cap, remove the gasket.
10 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.
11 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.
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 7-19. For the location of the dispense probes, see Figure 7-25.
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 or the
Peristaltic aspirate probes. The pump uses tubing that occasionally needs replacement. Replace
Waste Pump the waste pump tubing only when you are directed to do so by a technical support
Tubing representative or if you are following instructions in Help or in an Access 2 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.
Required Materials
Biohazard eye, hand, and facial protection
Small cup for aspirate probes
3/32 hex wrench
Tubing, peristaltic pump vacuum, as needed
Tubing, peristaltic pump aspirate, as needed
For catalog information about replacement tubing, see the instrument 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 7-27). 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 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:
3 Pull the other end of the tubing off the waste pump base on the right side of the
pump.
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 7-28).
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 7-28).
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 hex wrench to loosen the hex screws that secure the lever guard,
and remove the guard (see Figure 7-27).
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:
3 Trace aspirate tubing #3 on the right side of the pump to the aspirate probe it
connects to.
Remove the aspirate probe from the wash arm and place it in a cup to prevent
any fluid from dripping into the instrument. For information about how to
remove an aspirate probe, see the Replacing the Aspirate Probes procedure in
Section 8.3: Weekly Maintenance of the Operator's Guide.
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 7-28).
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 7-28).
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 the Replacing the Aspirate Probes procedure in
Section 8.3: Weekly Maintenance of the Operator's Guide.
16 Inspect all the probes on the wash arm to be sure they are seated correctly (see
Figure 7-25). Gently pull up on each aspirate and dispense probe (probes #1
through #6). They should spring back into place.
Adjust probes if necessary.
7.8
Wash/Read Carousel
Procedures
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 Open the front panel (see Section 7.2: Instrument Cover Procedures).
3 Go to the Mechanics screen. To get to this screen from the Main Menu, select
Diagnostics F7 to display the Diagnostics menu, then
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 7-29).
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.
The wash/read carousel advances one position.
8 Repeat step 6 and step 7, advancing the wash/read carousel in the same
direction each time.
There are 55 positions on the wash/read carousel.
9 Home the wash carousel again and watch for RVs in the access hole.
If you see any RVs in the access hole, repeat step 6 through step 9.
10 If you do not need the covers open for further troubleshooting, close the front
panel.
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 Mechanics screen. To get to this screen from the Main Menu, select
Diagnostics F7 to display the Diagnostics menu, then
3 Select the Wash Arm from the list in the Device field, then select
Disable Motors F8 (see Section 5.5: Mechanics and Device Diagnostics).
4 Open the front panel (see Section 7.2: Instrument Cover Procedures).
5 Locate the wash arm and inspect the tubing (see Figure 7-29).
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.
6 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 Home Device F1 (see Section 5.5: Mechanics and Device Diagnostics).
If homing fails, contact Technical Support.
CAUTION
Use this procedure only as directed by a technical support representative
or when you are following instructions in Help 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
2
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
System event troubleshooting is available by selecting the Troubleshoot F2 button
from the Event Log screen. For more information, see Chapter 6: Event Log.
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
Throughout this process, Beckman Coulter recommends that you keep a record of
your diagnostic and troubleshooting activities.
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 You should always identify a problem before attempting any corrective action. Some
the 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 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 Event Log troubleshooting, see Section 6.3:
Troubleshooting Events.
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 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 Perform the corrective action suggested in the troubleshooting information. If the
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
Trouble- problems for each instrument. The record can consist of printed Event Log pages,
shooting System Check results, screen printouts, test result reports, or notes from Technical
Activity 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.
A-9
A.2: System Check Troubleshooting Access 2 Reference Manual
A.2
System Check Troubleshooting
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
again. Performing an individual check would not provide complete
information.
For procedural information about the System Check routine, see Section 8.4:
System Check in the Operator's Guide.
For procedural information about running individual checks, which you
would only do when instructed by an Access 2 manual or by a technical
support representative, see Section 5.11: Individual System Checks.
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 Table 8-32 in
Section 8.4: System Check of the Operator's Guide.
Substrate If the System Check results are not within the expected ranges, troubleshoot the
Check substrate check first. You should start here because problems with the substrate
Problems system can directly affect the unwashed and washed checks, and because the substrate
check uses the fewest system components. When the substrate check results are
within the expected ranges, the substrate and substrate system can be ruled out as the
cause of the problem you are troubleshooting.
High %CV Insufficient supply of substrate 1. Check the level of substrate in the bottle.
throughout the run 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.
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.
High %CV Leak in the substrate system tubing 1. With the front panel open, open the top cover (see
throughout the run Section 7.2).
(continued) 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.
Kinked substrate system tubing 1. With the front panel and top cover open (see
Section 7.2), visually inspect the tubing leading to,
and away from the substrate pump/valve/heater
assembly for kinks (see 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 incorrectly 1. Prepare a new 1/501 dilution using a new vial of
high values in the System 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 too high (results may be temperatures on the Maintenance Review screen
flagged TRS or TRW) (see Section 8.1 in the Operator's Guide).
2. If the temperatures for either device are displayed
in red (out of range), contact Technical Support.
System Check solution diluted incorrectly 1. Prepare a new 1/501 dilution using a new vial of
System 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
substrate (see 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 stored 1. Check the date the bottle was placed at room
at room temperature for too long) temperature.
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.
Low RLU mean Wash/read carousel or substrate 1. Check the wash carousel and substrate
(continued) temperatures too low (results may be temperatures on the Maintenance Review screen
flagged TRS or TRW) (see Section 8.1 in the Operator's Guide).
2. If the temperatures for either device are displayed
in red (out of range), contact Technical Support.
Incomplete priming of the substrate after 1. Prime the substrate system for 20 cycles again (see
substrate system decontamination Section 5.3).
2. Repeat the System Check routine.
Substrate bottle contaminated with 1. Change the substrate bottle from the Supplies
Citranox cleaning solution during screen (see Section 2.4 in the Operator's Guide).
substrate system decontamination Do not prime the 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
Citranox cleaning solution during screen (see Section 2.4 in the Operator's Guide).
substrate system decontamination Do not prime the 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
or down over time for substrate check.
Substrate bottle contaminated with 1. Change the substrate bottle from the Supplies
Citranox cleaning solution during screen (see Section 2.4 in the Operator's Guide).
substrate system decontamination Do not prime the 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 7-10).
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 7-10). 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.
Unwashed Begin troubleshooting the unwashed check once you have determined that the
Check substrate check results are within the expected ranges. The unwashed check
Problems troubleshooting table provides information about the pipetting system, and does not
provide detail on problems related to the substrate or washing systems.
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 tubing 1. Open the front panel and the top cover (see
(continued) damaged and leaking Section 7.2).
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
Insufficient supply of substrate expected range, the substrate system is not the
cause of the high %CV for the unwashed check.
Air in the substrate lines
Continue troubleshooting other possible causes.
Leak in the substrate system tubing
2. If the substrate check result is not within the
Kinked substrate system tubing expected range, troubleshoot the substrate check
Bent substrate probe result (see Table A-4).
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 incorrectly 1. Prepare a new 1/501 dilution using a new vial of
System 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
Wash/read carousel or substrate the expected range, the substrate system is not the
temperatures too high cause of the high mean RLU result for the
unwashed check. Continue troubleshooting other
Contaminated substrate supply possible causes.
Substrate pump delivering too much 2. If the substrate check result is not within the
substrate
expected range, troubleshoot the substrate check
result (see Table A-4).
Low RLU mean System Check solution diluted incorrectly 1. Prepare a new 1/501 dilution using a new vial of
System 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
Expired substrate the expected range, the substrate system is not the
cause of the low RLU mean result for the
Insufficient supply of substrate unwashed check. Continue troubleshooting other
Wash/read carousel or substrate possible causes.
temperatures too low
2. If the substrate check result is not within the
Incomplete priming after substrate expected range, troubleshoot the substrate check
system decontamination result (see Table A-4).
Substrate supply contaminated with
Citranox cleaning solution during
substrate system decontamination
Substrate dispense volume too low
Luminometer problem Contact Technical Support.
Washed Begin troubleshooting the washed check once you have determined that the substrate
Check check and unwashed check results are within the expected ranges. The washed check
Problems troubleshooting table provides information about the reaction vessel (RV) wash
system, and does not provide detail on problems related to the substrate or the
pipetting systems.
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 7-10).
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 7-10). 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 tubing 1. Open the front panel and top cover (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 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 the 1. With the front panel open (see Section 7.2), verify
(continued) up position that 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
Insufficient supply of substrate expected range, the substrate system is not the
cause of the high %CVs for the washed check.
Air in substrate lines
Continue troubleshooting other symptoms.
Leak in the substrate system tubing
2. If the substrate check result is not within the
Kinked substrate system tubing expected range, troubleshoot the substrate check
Bent substrate probe result (see Table A-4).
Substrate pump or valve failure
High %CV Problems with the pipetting system: 1. If the unwashed check %CV result is within the
(continued) No wash buffer expected range, the pipetting system is not the
cause of the high %CV for the washed check.
Worn or damaged precision pump seals
Continue troubleshooting other possible causes.
Partially plugged primary probe
2. If the unwashed check result is not within the
Precision pump, valve, fittings, or expected range, troubleshoot the unwashed check
tubing damaged and leaking result (see Table A-5).
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 the 1. With the front panel open (see Section 7.2), verify
up position that 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
Wash/read carousel or substrate the expected range, the substrate system is not the
temperatures too high cause of the high RLU mean result for the
unwashed check. Continue troubleshooting other
Contaminated substrate supply possible causes.
Substrate pump delivering too much 2. If the substrate check result is not within the
substrate
expected range, troubleshoot the substrate check
result (see Table A-4).
High RLU mean Incorrect aspirate probe height Contact Technical Support.
(continued)
Luminometer problem Contact Technical Support.
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
Air in the substrate lines are within expected ranges, the substrate system is
not the cause of the low RLU mean result for the
Leak in the substrate system tubing washed check. Continue troubleshooting other
Kinked substrate system tubing possible causes.
Bent substrate probe 2. If the substrate check results are not within the
expected ranges, troubleshoot the substrate check
Substrate pump or valve failure
result (see Table A-4).
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
Luminometer problem Contact Technical Support.
Wash The wash efficiency is a calculation based upon the results from the substrate,
Efficiency washed, and unwashed checks of the System Check routine. The wash efficiency
Problems value provides information about the washing system.
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
(unwashed check mean RLUs too low) Table A-5).
Problems with the substrate system Troubleshoot the substrate check result (see
(contaminated substrate bottle) Table A-4).
A.3
Instrument Troubleshooting
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.
General Use the following table to troubleshoot the instrument when the system is in the Not
Instrument Ready mode or a system event has occurred.
Problems
System mode is System rebooting or initializing Wait for the instrument to finish rebooting (see
Not Ready Section 7.3) 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 or information (see Chapter 6: Event Log). Take the
red recommended corrective action.
System Database contains too many test and QC 1. Set up the system to automatically delete test and
performance is results QC 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.
Instrument Use the following table to troubleshoot the instrument if you are having problems
Start-Up rebooting or initializing the Access 2 system and no events report in the Event Log. If
Problems an event is generated, follow the Event Log troubleshooting procedures (see
Section 6.3: Troubleshooting Events).
System fails during No power to instrument Refer to the power supply troubleshooting table (see
reboot Table A-10).
System fails during Data disk in 3.5-inch disk drive Remove the disk from 3.5-inch disk drive and reboot
reboot the instrument (see Section 7.3).
(continued)
Instrument hardware (power supply, hard Reboot the instrument (see Section 7.3).
disk drive, CPU, printed circuit board) or
software failure
System fails during Interlock switch detects front panel of Close the front panel of the instrument (see
initialization instrument is open Section 7.3) and initialize the system (see
Section 5.2).
Power Supply Use the following table to troubleshoot when the instrument or the peripheral devices
Problems do not have power. The peripheral devices that require a power supply include the
external computer (PC), touch screen monitor, and printer.
No power to the Faulty power outlet or power strip 1. Plug the instrument and the peripherals into a
instrument or different 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
instrument the instrument (see Figure 7-8).
Power cord connector loose at either end Be sure that the power cord connections to the outlet
and instrument are plugged in tightly.
No power to Peripheral device power switch not on 1. Turn on the peripheral device power switch.
peripheral(s) 2. If you cannot locate the power switch, see the
documentation provided by the manufacturer.
Peripheral device power cord connector Be sure that the power cord connections to the outlet
loose at either end and peripheral device are plugged in tightly.
Keyboard Use the following table to troubleshoot situations when the computer keyboard is not
Problems responding to your key strokes.
No response from Loose connector Be sure that the cable connections (located on the back
the keyboard side of the external computer) between the keyboard,
the handheld 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 Use the following table to troubleshoot problems with the printer.
Problems
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.
Bar Code Use the following table to troubleshoot when the bar code reader does not scan bar
Reading code information.
Problems
Sample rack bar Bar code label attached incorrectly to the Attach the bar code label correctly (see Section A.1 in
code label was not rack the Operator's Guide).
read by the internal
bar code reader Incorrect system bar code label on rack If the sample rack is labeled with an Access (not an
Access 2) 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 in the Turn the sample container until its bar code label faces
rack the 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 the Apply the bar code label correctly on the sample
sample container container (see Section A.2 in the Operator's Guide).
Bar code reader not set up to read the Set up the bar code reader parameters to match the
sample bar code symbology symbology you are using (see Section 4.3).
Bar code symbology or parameters not 1. Verify that the bar code symbology and
supported parameters used 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 label 1. Check the number of characters entered for the
does not agree with the number of Interleaved 2 of 5 symbology in the Bar Code
characters specified in the Bar Code Reader Setup window (see Section 4.3).
Reader Setup window (for Interleaved 2 of 2. If necessary, change the number of characters to
5 only) match 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 handheld bar code reader, and the computer are
plugged in tightly.
Air in the Air bubbles in the fluid lines can lead to poor precision. If you notice air in the lines,
System use the following table to troubleshoot the problem.
Air in the fluid lines Insufficient priming 1. Prime all fluidic components (see Section 5.3).
2. Run the System Check routine.
3. If the problem persists, contact Technical Support.
System prime lost due to a leak in the 1. Be sure the connections between the fittings
fluidic system (located on 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 7-10).
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 7-10). 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 Problems with the main pipettor can lead to poor precision. If you notice any leaking
Problems or deposits, use the following table to troubleshoot the problem.
Main pipettor Primary probe partially plugged 1. Look at the Pressure Monitor screen (see
leaking 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).
Loose fitting between the main pipettor 1. Open the front panel and top cover (see
and precision pump valve Section 7.2).
2. Visually inspect the fittings between the primary
probe and precision pump valve for leaks and
deposits (see Figure 7-23).
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, causing 1. Look at the Pressure Monitor screen (see
dispensing fluid the main pipettor to dispense fluid with too Section 5.6) to determine if a pressure sensor is
with excess much pressure present, and that obstruction detection is enabled.
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 7-12).
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).
Communica- Use the following table to troubleshoot communication problems between the
tion Problems external computer (PC) and the instrument, or other systems in your workgroup.
Workgroup Loose connection between PC and other 1. Be sure that the Access 2 instrument power switch
communication systems in the workgroup is on.
error occurs If the power switch is off, restart the instrument
during rebooting (see Section 7.3).
process
If the power switch is on, but there is no power
to the 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).
A.4
Assay Troubleshooting
Assay troubleshooting information provides troubleshooting tables to help you
identify and correct assay-related problems. The information is provided in the
following categories:
Assay calibration problems
Quality control (QC) problems
Patient sample problems
Test result flags
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.
Assay When a calibration fails, the system displays a failure code in the reason field on the
Calibration Calibration Data screens. Use the following table to help you troubleshoot the
Problems calibration problem.
For additional information about assay calibration and calibrators, see the following
references:
Although precision Multi-level calibrators pipetted out of 1. Be sure that the calibrators are placed in the rack in
is good, the order: the proper order.
calibration fails for Calibration curve does not ascend or 2. Repeat the calibration.
any reason other descend smoothly.
than Insuff Data
Calibration cutoff is opposite of the
expected result.
Calibrator unstable or contaminated due to Repeat the calibration. If possible, repeat with a new
improper handling set of the same calibrator lot.
Reagent pack unstable or contaminated 1. Unload the reagent pack and load a new reagent
due to improper handling pack (see Section 2.7 in the Operator's Guide).
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 precision Contaminated substrate supply 1. Contact Technical Support to verify the need to
is good, the decontaminate the substrate system.
calibration fails for 2. If Technical Support agrees, decontaminate the
any reason other substrate system and then verify system
than Insuff Data performance (see Section 7.4).
(continued)
Incorrect calibration information entered 1. Verify the calibration information on the
during calibrator setup Calibrator Setup screen.
2. If necessary, edit the information on the Calibrator
Setup screen (see Section 6.4 in the Operator's
Guide).
3. Repeat the calibration.
Although precision Wrong calibrator placed in rack 1. Be sure that the correct calibrator is loaded on the
is good, the rack.
quantitative curve 2. Repeat the calibration.
is flat or the
qualitative result is Wrong reagent pack loaded, or placed in 1. Verify that the reagent pack was loaded by
No Value; an incorrect position on the reagent checking the Supplies screen. If it is missing, load
calibration fails carousel a reagent pack (see Section 2.7 in the Operator's
for any reason Guide).
other than Insuff 2. If the reagent pack is listed on the screen, verify its
Data 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 calibration.
Poor precision, Daily or weekly maintenance not 1. Perform daily (see Section 8.2 in the Operator's
and calibration performed Guide) or weekly (see Section 8.3 in the
fails for any reason Operator's Guide) maintenance.
other than Insuff 2. Repeat the calibration.
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
Wash buffer supply lines kinked. troubleshooting other possible causes.
Precision pump, valve, fittings, or 2. If the unwashed check result is not within the
tubing damaged and leaking.
expected range, troubleshoot the unwashed check
result (see Table A-5).
Poor precision, Problems with the substrate system: 1. If the System Check routine results are within the
and calibration Insufficient supply of substrate. expected ranges, the substrate system is not the
fails for any reason cause of the calibration failure. Continue
other than Insuff
Air in the substrate lines.
troubleshooting other possible causes.
Data (continued) Kinked substrate system tubing.
2. If the substrate check result is not within the
Leak in the substrate system tubing. expected range, troubleshoot the substrate check
result (see Table A-4).
Reagent gone because it leaked out of the 1. Load a new reagent pack (see Section 2.7 in the
pack during off-board storage Operator's Guide).
2. Repeat the calibration.
RLUs are too low Reagent pack switch occurred, and the 1. Verify that the second reagent pack was loaded by
at one end of the second reagent pack is missing or loaded checking the Supplies screen. If the pack is
calibration curve, incorrectly (RLUs drop off suddenly at the missing, load a new reagent pack.
and calibration end of the calibration curve) 2. If the second reagent pack is listed on the screen,
fails for any reason verify its location by unloading it from the
other than Insuff carousel (see 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 second pack after you have verified its
location.
4. Repeat the calibration.
Calibration fails for Quantity of calibrator not sufficient for 1. Calculate the correct volume of calibrator needed
the reason Insuff testing (QNS result flag and event) for the number of replicates and type of sample
Data container used (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.
Calibration fails for Two or more replicates not calculated due 1. Review the Event Log messages (see Section 6.2)
the reason Insuff to instrument error for device errors prior to the calibration failure.
Data 2. Review the Test Results screen for any error
(continued) 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 in 1. Be sure that the sample containers are in the proper
incorrect position in the rack order in the rack.
2. Repeat the calibration.
Quality When a quality control result violates an applied QC rule, the Quality Control button
Control turns red. The button remains red until you review the QC Data screen. Use the
Problems following table to help you troubleshoot problems with your QC results.
For information about reviewing quality control results, see Section 7.2: Reviewing
Quality Control Charts and Data in the Operator's Guide.
Controls violate Daily or weekly maintenance not 1. Perform daily (see Section 8.2 in the Operator's
applied QC rule performed Guide) or weekly (see Section 8.3 in the
Operator's Guide) maintenance.
2. Repeat the test(s).
Wrong quality control loaded onto the 1. Load the correct quality control.
sample rack 2. Repeat the test(s).
Wrong quality control lot number selected Repeat the test(s) using the correct lot number.
for the test
Wrong mean and/or standard deviation 1. Review the QC information using Edit Control F2
information entered when setting up the from the QC Setup screen.
quality controls 2. If necessary, edit the information (see Section 7.4
in the Operator's Guide).
3. Repeat the test(s).
Controls violate Quality control sample type does not 1. Verify that the sample type used matches what is
applied QC rule match QC setup listed on the Test Requests screen (see Section 3.2
(continued) 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 contaminated 1. Prepare new quality controls according to the
due to incorrect handling procedure provided by the manufacturer.
2. Load the freshly prepared quality controls and
repeat the test(s).
Quality controls reconstituted incorrectly 1. Reconstitute new quality controls according to the
procedure provided by the manufacturer.
2. Load the freshly reconstituted quality controls and
repeat the test(s).
Quantity of quality control not sufficient 1. Calculate the correct volume of quality control
for testing (QNS result flag and event) needed for the number of replicates and type of
sample container 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 being 1. Load a fresh aliquot of each quality control.
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 contaminated 1. Unload the reagent pack and load a new reagent
due to improper handling pack (see Section 2.7 in the Operator's Guide).
If the lot number of the new reagent pack is
different than the removed pack, recalibrate the
assay.
2. Repeat the test(s).
Controls violate Wrong reagent pack loaded, or placed in 1. Verify that the reagent pack was loaded by
applied QC rule an incorrect position on the reagent checking the Supplies screen. If it is missing, load
(continued) carousel a reagent pack.
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).
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 in 1. Be sure that the sample containers are in the proper
incorrect position in the rack order 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.
Controls violate Substrate not equilibrated to room The substrate must be at room temperature for
applied QC rule temperature when loaded on the system specified period of time before it is loaded.
(continued)
For more information about the substrate, refer to the
reagent instructions for use.
Increasing values Quality controls evaporating from being 1. Load a fresh aliquot of each quality control.
across the run 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.
Patient Use the following table to troubleshoot problems with your patient sample test results.
Sample If a special circumstance exists for a test result, the Access 2 system will code the
Problems result with a flag. The flags are either fatal (no calculated result), or non-fatal (the
result was calculated, but a condition exists for that result). You can use these flags to
assist you in the troubleshooting process.
For more information about test result flags and their meaning, see the Test Result
Flags section in this chapter.
Unexpected Incorrect patient sample type Refer to the reagent instructions for usefor the
sample results appropriate 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 sample 1. Spin the sample again or use a serum filter to
separate the serum from any microclots.
2. Repeat the test(s).
Quantity of patient sample not sufficient 1. Calculate the correct volume of patient sample
for testing (QNS result flag and event) needed for the number of replicates and type of
sample container 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 being on 1. Load a fresh aliquot of each patient sample.
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 placed in 1. Verify that the reagent pack was loaded by
sample results an incorrect position on the reagent checking the Supplies screen. If it is missing, load
(continued) carousel a reagent pack.
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 contaminated 1. Unload the reagent pack and load a new reagent
due to improper handling pack (see Section 2.7 in the Operator's Guide).
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
sample results (see 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
performed Guide) 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 in 1. Be sure that the sample containers are in the proper
incorrect position in the rack order in the rack.
2. Repeat the test(s).
Sample values are Patient samples evaporating from being on 1. Load a fresh aliquot of each patient sample.
too high 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
flag automated dilution (for example, the Diluted
hCG assay), repeat the sample in the standard
assay format (Total hCG 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 placed in 1. Verify that the reagent pack was loaded by
variability/poor an incorrect position on the reagent checking the Supplies screen. If it is missing, load
precision carousel a reagent pack.
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 in Expired reagent pack 1. Check the reagent pack expiration date on the
assay results 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).
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.
Increasing values Patient samples evaporating from being on 1. Load a fresh aliquot of each patient sample.
across the run 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.
Test Result Use the following tables to troubleshoot fatal (no calculated result) or non-fatal (the
Flags result was calculated, but a condition exists for that result) test result flags.
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 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
result formula (see Section 4.6) did step 2.
not produce a result. For derived results, review each test result used
A confirmatory test result could not in the derived result formula. If a result failed,
be calculated. Usually this occurs troubleshoot according to the flag for that result.
because the samples for the 2. Review the Event Log and troubleshoot according
qualitative and confirmatory tests to the error events with a similar date and time to
were not aspirated at the same time this event (see Section 6.3).
(see Section 3.3).
3. Repeat the test.
Another error prevented the system
For a derived result, repeat all tests included in
from calculating a result.
the 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, the result is at the 1. Review the Event Log for error events with a
low end of the analyte concentration similar date and time to this event.
curve. The result cannot be If events occurred, troubleshoot (see Section
distinguished from a system failure 6.3).
because the RLU reading or 2. Run controls, then repeat the test.
concentration is too low. If the controls are not in range, troubleshoot (see
For competitive assays, the result is at Section A.4).
either the high or low end of the analyte If you have questions about the result, or if the
concentration curve. The result cannot problem persists, contact Technical Support.
be distinguished from a system failure
because the RLU reading or
concentration is either too high or too
low.
NCR No calibration data existed for the reagent 1. Calibrate the assay (see Section 3.3 in the
lot when the result was processed. Operator's Guide).
2. Repeat the test(s).
QNS The sample volume is insufficient. 1. Follow the troubleshooting instructions for the
Additional tests will not be scheduled for QNS 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 outside 1. Review the Event Log and troubleshoot according
the acceptable luminometer measuring to the error events with a similar date and time to
range. this event (see Section 6.3).
2. Repeat the test(s).
3. If the problem persists, contact Technical Support.
SYS A device error occurred during processing. 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(s).
3. If the problem persists, contact Technical Support.
TRI The temperature of the incubator was 1. Check the incubator temperature on the
outside the acceptable limits. All tests Maintenance Review screen. If the temperature is
being incubated when the temperature was outside the acceptable limits, periodically monitor
outside limits are flagged. the incubator 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
outside the acceptable limits when it was Maintenance Review screen. If the temperature is
dispensed. outside the 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 carousel 1. Check the wash/read carousel temperature on the
was outside the acceptable limits. All tests Maintenance Review screen. If the temperature is
with RVs in the wash/read carousel when outside the acceptable limits, periodically monitor
the temperature was outside limits are the wash/read carousel temperature on this screen
flagged. 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 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
CEX The calibration curve or cut-off value is 1. Recalibrate the assay (see Section 3.3 in the
expired. Operator's 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
critical range. necessary.
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
critical range. necessary.
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
the specified gray zone. necessary.
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
Notes: Section 5.3 in the Operator's Guide).
This flag is displayed only when the Delete the result (see Section 5.3 in the
Auto-Send to LIS option is set to Verify .
Operator's Guide) and repeat the test(s).
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
Notes: Section 5.3 in the Operator's Guide).
This flag is displayed only when the Delete the result (see Section 5.3 in the
Auto-Send to LIS option is set to Verify .
Operator's Guide) and repeat the test(s).
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.
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
highest or most concentrated calibrator. similar date and time to this event (see
This flag is only used for quantitative and Section 6.2).
semi-quantitative assays. If events occurred, troubleshoot (see
Section 6.3).
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
for the reagent pack. The system measures one (see Section 2.7 in the Operator's Guide).
this from the time it first punctures the If the lot number of the new reagent pack is
pack. different than the expired pack, recalibrate the
assay.
2. Repeat the test(s).
QCF A quality control violates one or more QC 1. Display the QC Chart and Data screen to review
rules. which 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.
B
System and Mode Availability
Tables
B.1 System and Mode Availability ..................................................................... B-2
B.1
System and Mode Availability
Some Access 2 Customer procedures only affect the individual instrument you are
working on, some affect all of the instruments in the workgroup, and others can be
performed on the server only but affect all of the workgroup instruments. Similarly,
some procedures can be performed in any operating mode, while other procedures can
be performed in limited operating modes. The following tables list procedures that
have special system or mode availabilities (organized as they appear in the Access 2
Operator's Guide and Reference Manual). Procedures that can be performed in any
mode and that apply only to the individual system you are working on are excluded
from these tables.
The Operator's Guide and Reference Manual Procedures tables contain the following
information.
Chapter: the name of the chapter where the procedure resides.
System Availability: the systems where you can perform the procedures, and
the systems that are affected. Values are:
Individual - Performed on, and affects, the individual system only.
Workgroup - Performed on any system in the workgroup, and affects all of
the workgroup instruments.
Server Only - Performed on the server system only, and affects all of the
workgroup instruments.
Mode Availability: the mode that the system must be in for the procedure to
be performed.Values are:
Any (mode is not a factor), Running, Ready, Not Ready, or Paused.
The following table lists the procedures in the Operator's Guide that apply to workgroups or servers or that cannot be performed in any mode.
System
Chapter Procedure Mode Availability
Availability
Chapter 2 Supplies Changing the Substrate Bottle on page 2-20 Individual Ready
Changing the RV Waste Bag on page 2-28 Individual Ready, Running, or Paused
Chapter 3 Sample Loading Racks on page 3-11 Individual Ready, Running, or Paused
Management
Unloading Racks on page 3-12 Individual Ready, Running, or Paused
Processing LIS Patient Test Requests on page 3-27 Individual Ready, Running, or Paused
Reusing Sample IDs on page 3-37 System and Mode availability vary according to
steps of the procedure
B-3
B-4
System
Chapter Procedure Mode Availability
Availability
Chapter 3 Sample Adding, Removing, and Rearranging On-Board Samples on Individual Ready, Running, or Paused
Management page 3-50
(Continued)
Editing Test Requests for On-Board Samples on page 3-53 Individual Ready, Running, or Paused
Deleting Test Requests for On-Board Samples on page 3-55 Individual Ready, Running, or Paused
Adding Test Requests to On-Board Samples Using the Pause Button Individual Running
on page 3-57
B.2: Operator's Guide Procedures
Deleting Test Requests from On-Board Samples Using the Pause Individual Running
Button on page 3-59
Chapter 4 Sample Starting Sample Processing on page 4-5 Individual Ready or Paused
Processing
Pausing Sample Processing on page 4-5 Individual Running
Chapter 6 Assay Deleting Calibrations on page 6-7 Individual Ready or Not Ready
Calibrations
Switching the Active with the Previous Active Calibration on Individual Ready or Not Ready
page 6-16
Chapter 8 Routine Running the Utility Assay on page 8-5 Individual Ready
Maintenance
Requesting Maintenance Routines on page 8-7 Individual Ready or Running
Inspecting the Fluidic Module on page 8-19 Individual Ready or Not Ready
Cleaning the Wash Carousel Probe Exteriors on page 8-20 Individual Ready or Not Ready
Running the Daily Clean System Routine on page 8-25 Individual Ready or Running
Inspecting and Cleaning the Primary Probe on page 8-33 Individual Ready or Not Ready
Replacing the Aspirate Probes on page 8-36 Individual Ready or Not Ready; System
will be turned off
B-5
B-6
System
Chapter Procedure Mode Availability
Availability
Chapter 8 Routine Running the System Check Routine on page 8-54 Individual Ready or Running
Maintenance
Running the Special Clean Routine on page 8-60 Individual Ready or Running
(Continued)
The following table lists the procedures in the Reference Manual that apply to workgroups or servers or that cannot be performed in any mode.
System
Chapter Procedure Mode Availability
Availability
Chapter 4 System Setting the Date and Time on page 4-14 Server Only Ready or Not Ready
Configuration
Changing the System Password on page 4-15 Workgroup Any
Setting Up Reports on page 4-17 Workgroup Any
Setting Up the Bar Code Reader on page 4-23 Individual Ready
Assigning Unique Test IDs to Test Panels on page 4-45 Workgroup Any
B.3: Reference Manual Procedures
B-7
Table B-2 Reference Manual Procedures
B-8
System
Chapter Procedure Mode Availability
Availability
Chapter 4 System Applying a Test Panels Filter on page 4-46 Workgroup Any
Configuration
(Continued) Adding a Test Panel on page 4-49 Workgroup Any
Editing a Test Panel on page 4-51 Workgroup Any
Deleting a Test Panel on page 4-51 Workgroup Any
Printing the Test Panels Setup Report on page 4-52 Workgroup Any
Changing the Decimal Precision of a Derived Result on page 4-60 Workgroup Any
B.3: Reference Manual Procedures
Chapter 4 System Configuring the LIS Send Mode on page 4-96 Server Only Ready or Not Ready for each
Configuration system in the workgroup
Restoring System Data on page 4-108 Contact Technical Support for more information
Setting the Auto-Delete Function on page 4-108 Server Only Any
Chapter 5 Initializing the System on page 5-8 Individual Ready or Not Ready
Diagnostics
Priming the Fluidics on page 5-10 Individual Ready
Performing Visual Aspirate Probes Volume Check on page 5-27 Individual Ready
Performing Analytical Substrate Probe Volume Check on page 5-31 Individual Ready
B-9
System
B-10
Chapter Procedure Mode Availability
Availability
Chapter 5 Performing Analytical Dispense Probe Volume Check on page 5-34 Individual Ready
Diagnostics
Performing Analytical Main Pipettor Volume Checks on page 5-38 Individual Ready
(Continued)
Performing Analytical Aspirate Probes Volume Check on page 5-43 Individual Ready
Aligning a Device on page 5-56 Contact Technical Support for more information
Viewing Analog Device Temperatures and Voltage on page 5-58 Individual Ready or Not Ready
Viewing Digital Device Sensor Information on page 5-66 Individual Ready or Not Ready
Running the Vacuum Test on page 5-67 Individual Ready or Not Ready
Chapter 5 Copying Diagnostic Data to a Disk or USB Flash Drive on page 5-82 Individual Ready or Not Ready
Diagnostics
Running Washed Check Individually on page 5-99 Individual Ready
Chapter 7 System Opening and Closing the Front Panel on page 7-5 Individual Ready or Not Ready
Support Procedures
Opening and Closing the Top Cover on page 7-6 Individual Ready or Not Ready
Removing and Replacing the Supply and Incubator Covers on Individual Ready or Not Ready
page 7-8
Rebooting the Instrument on page 7-15 Individual Ready or Not Ready
Testing the RV Waste Bag Sensor on page 7-25 Individual Ready or Not Ready
Adjusting the RV Waste Bag Sensor on page 7-27 Individual Ready or Not Ready
Rinsing the Wash Buffer Reservoir on page 7-28 Individual Ready or Not Ready
Clearing the RV Shuttle Path on page 7-34 Individual Ready or Not Ready
Checking for Fallen or Missing RVs on page 7-37 Individual Ready or Not Ready
Replacing Missing or Damaged Vessel Holders on page 7-39 Individual Ready or Not Ready
Testing and Cleaning the RV Sensors on page 7-44 Individual Ready or Not Ready
Switching Vessel Holder Positions on page 7-46 Individual Ready or Not Ready
B-11
System
B-12
Chapter Procedure Mode Availability
Availability
Chapter 7 System Inspecting and Cleaning the Pipettor Gantry on page 7-48 Individual Ready or Not Ready
Support Procedures
(Continued) Testing the Pipettor Z-Axis Home Sensor on page 7-50 Individual Ready or Not Ready
Removing and Replacing the Primary Probe on page 7-51 Individual Ready or Not Ready
Cleaning the Precision Valve on page 7-56 Individual Ready or Not Ready to home
device; then turn instrument off
Cleaning the Wash Valve on page 7-62 Individual Ready or Not Ready to home
B.3: Reference Manual Procedures
Clearing the Wash/Read Carousel on page 7-74 Individual Ready or Not Ready
Checking for Wash Arm Obstructions on page 7-76 Individual Ready or Not Ready
Removing and Replacing the Substrate Probe on page 7-77 Individual Ready or Not Ready
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.
antibody detection immunoassay
An assay that detects the presence of an antibody in a patient sample. The
antibody binds to the paramagnetic particles, and is detected by an
enzyme-labeled antibody that binds to the antibody captured on the particle. For
this assay, the measured RLUs are proportional to the amount of antibody in the
sample.
antigen
A protein or other molecule that initiates the production of antibodies by an
organism.
APF
See assay protocol file (APF).
aspirate probe
A probe that aspirates fluids from RVs after the instrument separates the
paramagnetic particles.
assay protocol file (APF)
A software file that provides processing instructions specific for each assay. An
updated APF may be supplied by Beckman Coulter, Inc. to introduce new
assays or change existing assay protocols.
assigned concentration
The stated concentration of analyte in calibration material, as provided by the
manufacturer. For contrast, see calculated concentration.
auto sample ID
A system function used to simplify manual test request entry. When activated,
the system automatically assigns sequential sample IDs to samples. After you
enter the initial sample ID, the system increments each subsequent sample ID
by 1.
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 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.
competitive binding assay
An assay in which a labeled analyte (the assay reagent) and an unlabeled
analyte (antigen in the test sample) compete for a limited number of binding
sites on the binding reagent.
compound expression
A reflex condition that is made up of two or more expressions connected by
AND or OR. See also reflex test.
concentration
The amount of analyte in a sample. See also assigned concentration or
calculated concentration.
confirmatory test
An assay that is run to confirm the results of a qualitative assay. You can
configure a confirmatory assay to run automatically as a reflex test.
conjugate
The antigen or antibody reagent that has an enzyme (alkaline phosphatase) label
attached to it. The substrate reacts with the conjugate present in bound immune
complexes, which results in chemiluminescence.
console
See personal computer (PC).
Contrad* 70 cleaning solution
A solution used to clean or decontaminate appropriate parts if the instrument
according to documented Access 2 procedures.
control
See quality controls (QC).
corrupted
An item that is altered from its correct or original form.
critical range
A range of results determined by your laboratory, which may depend on
demographics, lab policy, or other factors. You can configure critical ranges by
test. The system flags results that are out of range. See also reference range and
LIS range.
crosstalk count
A check to verify that light emitted by a sample on the wash/read carousel is not
influencing the test results of an adjacent sample. When crosstalk counts exceed
expected limits, an event is posted in the Event Log.
cutoff value
The level of response which distinguishes reactive from non-reactive (positive
from negative) qualitative assays.
CV
See coefficient of variation (CV).
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).
drift correction factor
A correction factor applied to the luminometer output, which accounts for small
changes to the photomultiplier tube as it ages.
To determine the appropriate drift correction factor, the luminometer reads the
amount of light produced by an LED (light emitting diode) on the wash/read
carousel. The reading is taken at pre-programmed intervals, after which the
system compares this observed value to the LED target value retained in
memory. The system then calculates the drift correction factor by dividing the
LED target value by the observed LED value.
duty cycle
The relationship between a devices operating and rest times. Also, the
repeatable operations under different loads. For example, the amount of time a
temperature control device operates in order to maintain temperature for a
device, compared to the overall operating time of the instrument. A duty cycle
of 23 for the incubator means that the incubator heater runs 23 percent of the
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 external bar code reader may be a wand or another kind if
handheld bar code reader.
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, 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 instruments
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 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.
light emitting diode (LED)
A semiconductor diode that emits light of a constant wavelength and intensity
throughout its life when a voltage is applied.
The Access 2 system uses an LED as an on-board reference standard to
maintain luminometer reading consistency. The LED is located on the
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, 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 assays 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.
minimum sample volume
The amount of sample required to minimize the effects of evaporation and to
allow for factors that can cause variations in sample height, such as clot or gel
height, in a sample container.
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
off board
The location of the rack or sample when it is not loaded on the system.
on board
The location of the rack or sample when it is loaded on the system.
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 1-3m.
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 handheld bar code reader.
personal computer (PC)
The external computer that is connected to an Access 2 system. The PC has its
own hard disk drive or flash drive, 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 assays 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 instruments 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.
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 hCG test result is
greater than 1000, then the system runs the diluted hCG 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 instruments
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
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 instruments
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 instruments
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.
Index
Main Pipettor 5-38
A Main Pipettor (Flowchart) 5-37
Acceptance Criteria Main Pipettor Expected Results 5-41
Qualitative Calibration 3-12 Substrate 5-31
Quantitative Calibration 3-10 Substrate (Flowchart) 5-30
Semi-Quantitative Calibration 3-10 Substrate Expected Results 5-32
Substrate Weight-to-Volume
Access 2 System Documentation Preface-3
Conversion 5-32
Air in the Lines, Troubleshooting A-30
Antibody Detection Assays 1-27
Alarm, RV Load Door 1-18
APF
Alignments Assay Technology 1-22
Performing 5-56 Revision Number 4-14
Report 5-91, 5-93, 5-94 Updating 4-42
Viewing 5-53
Articulated Arm
Analog Devices Instrument Peripheral 1-20
Diagnostics 5-57
Aspirate Probes
Viewing Temperatures 5-58
Analytical Volume Check 5-43
Viewing Voltages 5-58
Analytical Volume Checks
Viewing Voltages, Raw 5-60 (Flowchart) 5-42
Window 5-58 Locations 7-63
Analytical Module Shuttle Positions 5-29
Incubator Belt 1-13 Tubing Replacement 7-72
List of Events 6-24 Visual Volume Check 5-27
Luminometer 1-13 Visual Volume Check
RV Loader 1-12 (Flowcharts) 5-26
Technical Overview 1-12 Volume Check Window 5-27
Wash/Read Carousel 1-13 Assay Calibration Failures
Analytical Volume Checks Flat Quantitative Curve A-36
Aspirate Probe Expected Results 5-45 Insufficient Data A-37, A-38
Aspirate Probes 5-43 No Response for Qualitative Assay A-36
Aspirate Probes (Flowchart) 5-42 Precision Good A-35, A-36
Dispense Probe 5-34 Precision Poor A-36, A-37
Dispense Probe (Flowchart) 5-33 RLUs Too Low at One End of
Dispense Probe Expected Results 5-36 Curve A-37
Handling RVs 5-29 Troubleshooting Table A-35
M Monitor
Touch Screen Technology 1-20
Main Pipettor
Motors
Analytical Volume Checks 5-38
Disabling or Enabling 5-56
Analytical Volume Checks
Mixer 5-63
(Flowchart) 5-37
Excess Pressure when Dispensing A-32 Mouse
Leaking A-31 Instrument Peripheral 1-20
Module 1-10
Primary Probe Replacement 7-51 N
Sensor Testing, Z-Axis 7-50 NCR Fatal Flag A-47
Support Procedures 7-48
Non-Fatal Flags A-48
Troubleshooting Table A-31
NT Module Events 6-46
Visual Volume Checks 5-23
Visual Volume Checks (Flowchart) 5-22
Volume Check Window 5-24 O
Main Pipettor Module Obstruction Detection
List of Events 6-21 CLT Flag 3-21
Pipettor Gantry 1-11 Determining Curve 5-62
Precision Pump and Valve 1-11 Flowchart 3-22