Instructions for Use

for In Vitro Diagnostic Use

EC REP
Beckman Coulter Eurocenter S.A.
22, rue Juste-Olivier
Case Postale 1044
CH - 1260 Nyon 1, Switzerland
Tel: +41 (0) 22 365 36 11

C02062-AA
May 2017

Printed in U.S.A.
© 2017 Beckman Coulter, Inc.
Beckman Coulter, Inc. • 250 S. Kraemer Blvd. • Brea, CA 92821 • U.S.A.
Publication Notes
This manual, C02062-AA, release date 2017-05, supports:
• Access 2 published system software version 3, including full versions 3.4.2, 3.4.3, and 3.5.0.
• Access 2i published system software version 6, including full versions 6.2.2 and 6.2.3.
Each page of this Access 2 Instructions for Use is identified with its revision. For pages other than the title and
publication pages, revision information is located at the bottom of the page.
All pages of this manual are issued as C02062-AA, release date 2017-05.

Changes to this Revision:

Revision AA of this manual includes the following changes:

Chapter Page Change Description

1 1-3 Added information about the status light bar to the System Modes topic
1 1-12 Updated the LED Safety Statement with information about the handheld bar code
reader operating in hands-free mode
1 1-13 to 1-15 Removed specifications for system peripherals and the external computer
2 2-4 Updated the PC Power Switch graphic
3 3-6 Updated the procedure for loading a reagent pack
3 3-9 Added a procedure for remapping packs
7 7-29 Expanded the description and corrective actions for the IND result flag
This manual is intended for use with the Access 2 Immunoassay System. This manual also can be used as
supplemental material for the UniCel DxC 600i system, which consists of an Access 2 system integrated with
UniCel DxC 600 system.
Beckman Coulter, Inc. grants a limited non-exclusive license to the Access 2 system owner or operator to make
a copy of all or a portion of this book solely for laboratory use.

Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are
trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries.
ProClin™ is a trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow.
Microsoft, Windows, and the Windows logo are either registered trademarks or trademarks of Microsoft
Corporation in the United States and/or other countries.
All other trademarks are the property of their respective owners.
Access 2 Instructions for Use Table of Contents

Table of Contents

1 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

• Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
• Scope of Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
• Reference Materials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
• Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
• System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
• System Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
• System Status Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
• System Command Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
• Main Menu Workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
• Precautions and Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
• System Specifications and Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
• Electrical Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
• Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
• Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16

2 Shut Down and Restart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

• Rebooting the PC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
• Rebooting the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
• Shutting Down the Instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
• Restarting the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

3 Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
• Changing the Wash Buffer Bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
• Changing the Liquid Waste Bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
• Changing the Substrate Bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
• Loading Reaction Vessels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
• Changing the Reaction Vessel Waste Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
• Loading a Reagent Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
• Unloading a Reagent Pack. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
• Retrieving Misplaced Reagent Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
• Remapping Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

4 Racks and Sample Containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

• Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
• Calculating Sufficient Sample Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
• Sample Containers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

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Access 2 Instructions for Use Table of Contents

5 Sample Manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

• Processing LIS Patient Test Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
• Entering Patient Test Requests Manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
• Entering Calibration Test Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
• Entering Quality Control Test Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
• Processing Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

6 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
• Maintenance Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
• Daily Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
• Weekly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
• System Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
• Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13

7 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
• Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
• Troubleshooting Events. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
• System Check Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
• Instrument Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
• Assay Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20

8 Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

• Reaction Vessel Transport. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
• Assay Calibration Theory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
• Obstruction Detection Theory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

A Temperature-Sensitive Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

B Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

• Assay-Specific Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-1
• System Supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-6

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Access 2 Instructions for Use 1: System Overview

1 System Overview
Intended Use
The Access 2 system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative
determination of various analyte concentrations found in human body fluids.

Scope of Manual
The Access 2 Instructions for Use is intended for use after you have become familiar with the Access 2 system.
The Instructions for Use contains short instructions for everyday use and routine maintenance. It also contains
general information about the Access 2 instrument, such as theory of operation, system specifications, safety
labeling, and troubleshooting.

NOTE
Regardless of the frequency with which you perform a procedure, regularly review the complete
procedures, including their cautions for protecting the instrument from damage, and their warnings for
ensuring your personal safety.

Reference Materials
Additional Access 2 system documentation is listed in Appendix B. For more information, contact your
Beckman Coulter representative.

Technical Support
For technical assistance with the Access 2 Immunoassay System:
• In the U.S.A. or Canada, contact Beckman Coulter Technical Support by phone at 1-800-854-3633, or
online at www.beckmancoulter.com. Before using online support the first time, you will need to
register online.
• Outside the U.S.A. and Canada, contact your technical support representative.

NOTE
Be prepared to provide your system ID.

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Access 2 Instructions for Use 1: System Overview

System Description

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
NOTE
Technological advances and
availability may determine the
Instrument Software
specific external computer
components of your
instrument.
Interface Functions For
Workgroup and Server
Peripherals Module
 Printer
 Touch Screen Monitor
 Mouse
 Keyboard
 Articulated Arm
 External Bar Code Reader
 External Computer (PC)

Optional Link to 1-3

LIS System Linked to User Interface
Client PCs in the
Workgroup Server PC Software Workgroup

0501E.wmf

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C02062-AA
Access 2 Instructions for Use 1: System Overview

System Modes
The Access 2 system has four system modes that indicate the operating state of the system. The current mode is
displayed in the upper left corner of each screen. When the system is in the Running mode, the estimated
completion time for the requested function is displayed as a text line above the three system command buttons.
Additional system messages are displayed at various times at this location.
Some instruments are equipped with a status light bar that changes color to indicate the operational status of the
instrument. The color of the light bar matches the color of the system mode area of the user interface.

Status Light
Mode Screen Description
Bar Color

Ready Blue The system is ready to begin processing

samples.

Running Green The system is performing a function, such

as processing samples, running a
maintenance routine, or performing a
diagnostic procedure.
Paused Yellow The system continues current test
processing, but no new tests are schedu.

Not Ready Red The system is not ready to process samples.

The system is checking the status of
subsystems, initializing motors, priming
fluid lines, homing movable parts, warming
necessary modules, or requires
initialization.

System Status Buttons

Most buttons are color-coded to alert you when a supply level requires your attention, a sample processing issue
exists, or the instrument has recorded a system event. Under normal operating conditions the color of the button
is neutral. The color of some buttons can change to yellow to indicate a caution condition or red to indicate a
warning condition. The Help button color is always neutral.

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Access 2 Instructions for Use 1: System Overview

Button Description Button Colors

Wash Buffer Red

Select to view the status of the wash The wash buffer reservoir is almost
buffer bottle. You can change the wash empty, and no new tests can be scheduled.
buffer bottle at any time during sample You must change the wash buffer bottle to
processing. continue processing tests.
Liquid Waste Red
Select to view the status of the liquid The liquid waste bottle is full, and no new
waste bottle. You can change the liquid tests can be scheduled. You must change
waste bottle at any time during sample the liquid waste bottle to continue
processing processing tests.
Substrate Yellow
Select to display the Supplies screen to The system can process 60 or fewer test
check the level of onboard substrate, or requests with the remaining substrate.
change the substrate bottle. You can only Change the bottle at your next
change the substrate bottle while the opportunity.
system is in the Ready mode. Red
The substrate bottle is empty, and no new
tests can be scheduled. You must change
the substrate bottle to continue processing
tests.
Reaction Vessels (RVs) Yellow
Select to display the Supplies screen to The system can process 60 or fewer test
check the RV supply, or load an RV requests with the remaining RVs. Load an
cartridge. You can load RVs at any time RV cartridge now, or at your next
during sample processing. opportunity.
Red
The system can process 28 or fewer test
requests with the remaining RVs, and no
new tests can be scheduled. You must
load an RV cartridge to continue
processing tests.

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Access 2 Instructions for Use 1: System Overview

Button Description Button Colors

RV Waste Bag Yellow

Select to display the Supplies screen to The system can process 60 or fewer test
check the RV waste bag capacity, or requests with the remaining capacity in
change the RV waste bag. the waste bag. Change the RV waste bag
at your next opportunity.
Red
The RV waste bag is full, and no new
tests can be scheduled. You must change
the waste bag to continue processing tests.
Quality Control Red
Select to display the Quality Control A QC result is not within the acceptable
screen to set up quality control samples, range of expected values. You should
or review quality control results. review this result as soon as possible.

Event Log Yellow

Select to display the Event Log screen for The system has generated a caution event
information about events generated by the that requires your attention.
Access 2 system. From the Event Log Red
screen you can also display
troubleshooting information about caution The system has generated a warning
or warning events. event, indicating a serious fault or error
condition has occurred.
Work Pending Yellow
Select to display the Work Pending screen A sample required condition has
for information about samples for which occurred. You should load the required
the system cannot schedule tests. The sample, or delete it from the work list.
Work Pending screen allows you to
navigate to the Sample Manager screen to
load samples or delete sample requests.
Supplies Required Yellow
Select to display the Supplies Required The system requires supplies or
screen for information about supply and calibration(s) to complete the requested
calibration conditions. You can correct tests.
most conditions from the Supplies
Required screen.

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Access 2 Instructions for Use 1: System Overview

Button Description Button Colors

Help The Help button color is always neutral.

Select to display specific information
about the screen you are on, or to navigate
to a picture with descriptions of the
screen, to a list of related topics, or to any
topic within the Help system.

System Command Buttons

You use the three system command buttons to run, pause, and stop the Access 2 instrument.

Button Description
Run

Select to process samples or run a maintenance routine.

Pause

Select to pause the instrument. The system stops pipetting after it finishes
pipetting the current sample. Processing continues on samples already in
progress.
Stop

Select to stop the instrument. The system stops processing and cancels any tests in
progress.

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Access 2 Instructions for Use 1: System Overview

Main Menu Workflow

The Main Menu is the first screen you see when the system is installed or initialized. To get to this menu from
any screen, press Main Menu [F9]. You can navigate everywhere through the Access 2 system using the eight
function buttons across the bottom of the Main Menu.

F1 Load Rack /
Get/Edit Rack
F2 Delete Sample
F3 Show/Hide
F1 Load a Rack
Test Menu
F2 Work Pending
F4 Test Results
F3 Test Request
Sample Manager F5 Request QC
F4 Maintenance Request
F1 F6 Request
F6 Get Selected Rack
Calibration
F7 Clear Selected Rack
F7 Clear All
F8 Change Rack ID
Samples
F8 More Options F1 Filter
F2 Review Data
Calibration
F5 Calibrator Setup
F5
F6 Delete
F7 Print
F1 Filter
F2 Find
F3 Rerun Test
F4 Sample Details
F5 Send to LIS
Test Results
F6 Copy to Disk
F2 F1 Report
F7 Print
F2 Completed Samples

F1 Refresh Screen
F2 Configure Screen F2 System Checks
F8 More Options
F3 Delete Data F5 Run Utility Assay
Maintenance Review
F6 Enable/Disable Utility
F6
Assay
F7 Print

F1 Load Reagent Pack

F2 Unload Reagent Pack
Supplies F4 Load RVs F1 Load F1 Mechanics
F1 Initialize System
F3 F5 Change Substrate Reagent Pack F2 Analog Devices
F2 Prime Fluidics
F6 Change RV Waste Bag F2 Unload F3 Digital Devices
F3 Volume Checks
F7 Reagent Inventory Reagent Pack F4 Luminometer
F4 Device Diagnostics
F5 Delete Pack F5 Ultrasonics
F7 Print F6 Exerciser
F8 Filter F7 Calibrate
Incubator Belt
Diagnostics
F7
F1 LIS Setup
F3 Loopback
Check
F5 LIS F4 Query for
F6 Save Data Test Requests
F7 Diagnostic Reports F6 Copy to Disk
F8 Clear Screen

F1 System Revisions
F1 Filter F2 Bar Code
F2 Review Chart Reader Setup
and Data F1 System Setup F3 Set Workgroup
Quality Control
F3 Compare Charts Date/Time
F4
F4 Delete Comparison F5 Password Setup
F5 QC Setup F7 Reports Setup
F7 Print
F1 Filter
F2 Edit Units
F3 Ranges
Configure F2 Tests F4 Gray Zone
F8 F5 Special
F7 Print
F8 Update APF
F3 Test Panels
F4 Derived Results
F1 Scheduled Backup
F5 Reflex Tests
F2 Immediate Backup
F6 LIS
F3 Eject Tape
F7 PC Admin
F4 Restore
F8 About Access 2
F5 Auto-Delete Setup
F8 Shut Down PC

0863E.

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Access 2 Instructions for Use 1: System Overview

Precautions and Hazards

Safety Features
The Access 2 system is designed to meet U.S. and international safety standards. Safety labels are affixed to the
instrument to alert you to safety considerations.

Interlock Switch

WARNING
Do not defeat the safety interlock switch on the cover.

The Access 2 system is equipped with an interlock switch to protect you from injury. If 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 you open the front panel while the system is processing
samples, the system may cancel tests.

Safety Statements
The following statements describe general safety concerns.

WARNINGS
• Reagents, calibrators, and controls used with the system may contain small quantities of sodium
azide preservative. Sodium azide preservative may form explosive compounds in metal drain
lines. Refer to National Institute for Occupational Safety and Health Bulletin: Explosive Azide
Hazards (8/18/76).
• 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.

CAUTION
Always plug the Access 2 system into a grounded three-conductor outlet. DO NOT bypass the
grounding prong on the plug.

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Access 2 Instructions for Use 1: System Overview

Safety Symbols

Symbol Description

A symbol with an exclamation point calls attention to important information to

read, or is accompanied by another symbol indicating a particular safety hazard.
The information is located either on the label with the symbol or in the Access 2
customer documentation. The text following the symbol provides additional
information regarding safety conditions.
The general electrical safety symbol indicates an electrical shock hazard. The
luminometer contains a high-voltage power supply that presents a shock hazard.
The power supply does not contain operator-serviceable parts.

The biohazard symbols indicate areas of the instrument and associated

fluid-handling equipment that can contain potentially infectious human serum or
blood products. Follow good laboratory practices in handling and disposing of
materials from these areas.

The sharp objects symbol indicates areas of the instrument in which the skin can
be punctured. Do not put your hands in areas marked with this symbol while
the instrument is running.

The moving parts symbol indicates areas of the instrument in which moving parts
can cause injuries. Do not operate the instrument with the covers open.

The electrostatic discharge (ESD) symbol indicates areas of the instrument which
can be damaged by static discharge.

The laser symbol indicates areas of the instrument where laser light is used. Do
not stare into the laser beam.

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Access 2 Instructions for Use 1: System Overview

Disposal and Recycling

Symbol Description

WEEE Directive It is important to understand and follow all laws regarding the safe and proper
disposal of electrical instrumentation. The symbol of a crossed-out wheeled bin on
the product is required in accordance with the Waste Electrical and Electronic
Equipment (WEEE) Directive of the European Union. The presence of this
marking on the product indicates that the device:
• was put on the European Market after August 13, 2005.
• is not to be disposed via the municipal waste collection system of any member
state of the European Union.
For products under the requirement of WEEE directive, please contact your dealer
or local Beckman Coulter office for the proper decontamination information and
take-back program, which will facilitate the proper collection, treatment, recovery,
recycling, and safe disposal of the device.
EU Battery Battery Safety and Disposal Instructions - Dispose of all batteries in accordance
Directive with local regulations.
If you have any questions, please contact your local Beckman Coulter
representative for information on the correct disposal or recycle programs for
batteries.
Beckman Coulter products can have two types of batteries.
• User-Replaceable - Consult the product operating manual for battery
replacement instructions.
• Non-User-Replaceable - Please contact your local Beckman Coulter
representative.

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Access 2 Instructions for Use 1: System Overview

Symbol Description

RoHS The following labels and declarations meet the People’s Republic of China
Electronic Industry Standard SJ/T11364-2006 marking requirement for control of
pollution caused by electronic information products.
This logo indicates that this electronic information product contains certain toxic or
hazardous substance or elements, and can be used safely during its environmental
protection use period. The number in the middle of the logo indicates the
environmental protection use period (in years) for the product. The outer circle
indicates that the product can be recycled. The logo also signifies that the product
should be recycled immediately after its environmental protection use period has
expired. The date on the label indicates the date of manufacture.
This logo indicates that the product does not contain any toxic or hazardous
substances or elements. The “e” stands for electrical, electronic and environmental
electronic information products. This logo indicates that this electronic information
product does not contain any toxic or hazardous substances or elements, and is
XXXXXX-XX green and is environmental. The outer circle indicates that the product can be
recycled. The logo also signifies that the product can be recycled after being
discarded, and should not be casually discarded.

Regulatory Symbols and Statements

The Access 2 instrument meets the requirements of a variety of domestic and international regulatory agencies,
standards, and directives. This compliance is indicated by symbols and marks on the instrument, and by related
statements in the system documentation.

Symbol Description

The CSA (Canadian Standards Association) symbol indicates that the Access 2
Immunoassay System meets all U.S. and Canadian requirements for electrical
safety.
C US

A label with the CE mark of conformity signifies that the Access 2 Immunoassay
System complies with applicable EU directives. The instrument Declaration of
Conformity lists the directives with which the Access 2 system complies.

A label with the C-tick mark indicates that the instrument complies with
applicable Australian Communications Authority requirements.

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Access 2 Instructions for Use 1: System Overview

Radio Frequency Emissions Statement

This IVD equipment complies with the emission and immunity requirements described in IEC 61326-2-6.
The Access 2 system has been tested and shown to be compliant with the requirements of CISPR 11 and part 15
of FCC rules for a Class A digital device. These requirements are intended to provide reasonable protection
from interference when the instrument is operated in a commercial environment.

CAUTIONS
• This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it
could cause radio interference, in which case you may need to take measures to mitigate the
interference.
• Prior to operation of this device, the electromagnetic environment should be evaluated. Do not
use this device in close proximity to sources of strong electromagnetic radiation (for example,
unshielded intentional RF sources) as these could interfere with proper operation.

• If you suspect interference between the Access 2 system and other equipment, you must take
whatever action is required to correct the interference. Beckman Coulter suggests the following
actions:
- Move the equipment so there is a greater distance between the equipment and the
Access 2 system.
- Re-orient the equipment with respect to the Access 2 system.
- Be sure that the equipment is operating from a different power service connector than that of
the Access 2 system.

LED Safety Statement

The handheld bar code reader has been tested in accordance with EN60825-1 LED safety, and has been certified
to be under the limits of a Class 1 LED device.

The handheld bar reader that also operates in a hands-free mode is exempt from an LED safety class, according
to IEC 62471.

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Access 2 Instructions for Use 1: System Overview

System Specifications and Characteristics

Space Requirements
The dimensions of the instrument and the peripheral devices as of the date of this document are listed in the
following table. The Access 2 system operates from a bench top. Be sure that the surface and surrounding area
designated for these components is large enough to accommodate the system. For information about the
external computer, monitor, and printer, see the documentation provided by the manufacturer.

Instrument Width = 99 cm (39 in)

Height = 47 cm (18.5 in) (Instrument Serial Numbers < 570,000)
Height = 49.54 cm (19.5 in) (Instrument Serial Numbers ≥ 570,000)
Depth = 61 cm (24 in)
Instrument clearance required Rear = 5 cm (2 in)
• Left clearance is for the fluids Left = 30 cm (12 in)
tray
Right = 76 cm (30 in)
• Right clearance is for the
monitor and keyboard on the Top = 76 cm (30 in)
articulated arm
• Top clearance is measured from
the bench top

Instrument and Peripheral Device Weights

The weight of the instrument is listed in the following table. Be sure that the surface where the instrument,
external computer, monitor, and printer will reside can support the system.

Instrument (before supplies and samples 91 kg (200 lb)

added)
External computer See the documentation provided by the manufacturer
Monitor
Printer

Operating Environment Requirements

The Access 2 system is for indoor use only and requires the following environmental conditions to operate
properly:

Humidity Operational: 20% to 80%

Exposure: 10% to 80%
Maximum altitude Operational: 2 km (6,500 ft)
Exposure: 12.2 km (40,000 ft)

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Access 2 Instructions for Use 1: System Overview

Temperature Operational*,†: 18 °C to 28 °C (64 °F to 82 °F)

Exposure: -30 °C to 50 °C (-22 °F to 122 °F)
Maximum ambient temperature change 2°C per 30 min (3.6°F)
rate
Ambient light Results not affected by ambient light levels 0–2,152 lx (0–
200 foot-candles)
Pollution degrees According to IEC 664 definitions, the Access 2 system has
been tested and shown to be operational at pollution
degree 2
* Some assays require additional temperature restrictions. See Appendix A of this manual for information on these
restrictions.
† The operating environment temperature is influenced by factors such as room temperature, air circulation, heat
sources near the system, and direct sunlight.

Electrical Requirements
The electrical line and any surge suppressors, backup power supplies (UPS units), and 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:

Line power supply 115–120 volts alternating current (V AC) at 15 A, or

220–240 V AC at 6 A, at either 50 or 60 Hz, single
phase power
Line dedication Dedicated (Access 2 instrument is the only
equipment connected to the electrical line)
Line outlet Located within 1.5 m (5 ft) of the Access 2 system

NOTE
The Access 2 system may be connected to a line
conditioner. In this case, locate the line
conditioner within 5 ft (1.5 m) of the outlet.
Line protection device Circuit breaker rated:
• 15 A (115–120 V AC line)
• 6 A (220–240 V AC line)
Line voltage fluctuations Not to exceed ±10 V AC per cycle

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Access 2 Instructions for Use 1: System Overview

Line voltage sags Not to fall below:

• 90 V AC at 15 A
• 180 V AC at 6 A
Line voltage surges Not to exceed:
• 135 V AC at 15 A
• 250 V AC at 6 A
Line voltage supplied to printer See documentation provided by the manufacturer
Maximum voltage between neutral Not to exceed 2 V AC root mean squared (RMS)
conductor and safety ground conductor
Maximum resistance between the safety Not to exceed 0.1 ohm
ground conductor and an accessible
building safety ground
Transient overvoltages According to UL3101 Installation Category II

Electrical Current Consumption, Power Consumption, and Heat Production

The Access 2 instrument consumes current and power, and produce heat at the following levels. For
information about the external computer, monitor, and printer, see the documentation provided by their
manufacturers.

Electrical Current
Power Consumption Heat Production
Consumption

<1.5 kV·A 800 W 2 880 kJ/h (2,730 Btu/h)

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.

Instrument Line Conditioning Transformers

If you suspect you have alternating current (AC) power line problems, Beckman Coulter recommends that you
connect the Access 2 instrument to a line conditioning transformer with local ground and high frequency
isolation. If you use a line conditioning transformer, it should meet the following requirements:

Minimum output capacity 1.3 kV·A

Output voltage 120 or 240 V AC
Output frequency 50 or 60 Hz, single phase
Output wave form True sine wave (<5% distortion)

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Access 2 Instructions for Use 1: System Overview

Output safety ground Isolated local ground

Approvals UL 1012, CSA C22.2 107.1 (UL 544, optional)

Instrument Backup Power Supplies (UPS Units)

If you want to use an uninterruptable power supply (UPS) unit as a backup power supply, Beckman Coulter
recommends a UPS unit with local ground isolation. UPS units are designed to provide continuous AC power to
equipment when the main AC power line is lost. These units use a standby battery with an AC inverter circuit to
provide the required electrical output. Some units also provide various combinations of the protection features
found in surge suppressors and line conditioning transformers. If your system is in a workgroup, the external
computer acting as the server for your workgroup should be connected to a UPS unit. Your UPS unit should
meet the following requirements:

Minimum output capacity 1.3 kV·A

Output voltage 120 or 240 V AC
Output frequency 50 or 60 Hz, single phase
Output wave form True sine wave (<5% distortion)
Standby runtime Minimum 15 min at 1 kW output (low battery indicator and/or
shutdown recommended)
Approvals UL 1778, CSA C22.2 107.1 (UL 544, optional)

Installation
The Access 2 instrument must be installed by a qualified Beckman Coulter technical support representative. Do
not remove the instrument from the shipping crate until a technical support representative is present.

Warranty
The Access 2 Immunoassay System is covered by and subject to the provisions of the warranty included in your
contractual agreement for the system or its reagents.

The customer is responsible for routine preventive maintenance procedures. Repairs arising from the failure to
perform these maintenance procedures at the indicated time intervals will be made at the discretion of
Beckman Coulter, and at the customer’s expense.

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Access 2 Instructions for Use 2: Shut Down and Restart

2 Shut Down and Restart

You can reboot the PC, the instrument, or both. Rebooting either one does not affect the other. You may use a
reboot procedure in the following situations:
• The user interface (UI) is not responding correctly (PC reboot).
• You are directed to do so by a technical support representative or if you are following instructions in
Help system or in an Access 2 manual (PC and/or instrument reboot).

During the instrument rebooting process, the instrument system software is reset and a routine brings all devices
to their home, or known, states. This routine is called initialization, and it prepares the system for further
processing.

NOTES
• If you are rebooting both the PC and the instrument, you can reboot them in any order. For simplicity,
the procedures instruct you to reboot the PC first, then the instrument.
• If you are rebooting an Access 2 PC that is a workgroup server, first you must shut down the other PCs
(clients) in the workgroup. Next, restart the server PC. Finally, restart the client PCs.
• If you reboot only the PC, the instrument continues sample processing if it is in the Running mode.
When the PC reestablishes communication with the instrument, the test data is automatically sent to the
PC.

The instrument does not require periodic shutdowns. However, you should shut down the instrument before
moving it or whenever the power will be turned off for an extended period of time (more than 5 days). Before
shutting down the instrument, contact Technical Support to confirm your decision.

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Access 2 Instructions for Use 2: Shut Down and Restart

Rebooting the PC
To reboot the PC, you shut it down and then restart it. You do not need to reboot the instrument unless you are
directed to do so. Use this procedure to reboot the PC.

Shutting Down the PC Under Normal Conditions

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.

2. Select Shut Down PC F8. A confirmation message is displayed.

3. Select Yes F1 to shut down the PC.

If you are preparing to shut down the server, repeat step 1 through step 3 for each of the client PCs first.
Then repeat step 1 through step 3 for the server.

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.

Shutting Down the PC When the UI is not Accessible

NOTES
• If the server UI is the only UI that is not accessible, shut down each of the client PCs. Then use this
procedure to shut down the server.
• If a client UI is not accessible, use this procedure to shut down that client PC.
• If the keyboard does not respond during the performance of this procedure, press the PC power switch
on the front of the PC to turn the power off. The power switch is identified by the power switch
symbol.

1. Take one of the following actions:

• If you know the software operating system on your Access 2 system PC, proceed to the appropriate
instructions in the table below.
• To determine the software operating system on your Access 2 system PC, press the Windows® key
[®] on the computer keyboard, or press [Ctrl] + [Esc].
For PCs operating with Windows® 8e, the Windows® 8e Start screen is displayed. The image below is
visible in the upper left portion of the screen. If the Windows® 8e Start screen is not displayed, your system
is operating with Windows® XPe.

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Access 2 Instructions for Use 2: Shut Down and Restart

2379A.bmp
Windows® 8e Start Screen

Windows® XPe Windows® 8e

1. Simultaneously press the [Ctrl], [Alt], and 1. If necessary, press the Windows® key [®] on
[Delete] keys, then select Shutdown. the keyboard to display the Start screen.
The Shut Down Windows window is displayed. 2. Move the mouse cursor to the lower-right corner
of the Start screen.
2. Select Restart or Shut down from the list,
depending upon whether you want to A narrow vertical panel of icons is displayed
immediately restart the PC software. along the right side of the screen.

3. Select OK. 3. Select the Settings icon.

4. Wait about 20 seconds, then perform the

restarting procedure.
2380A.bmp
The Settings panel is displayed.
4. Select the Power icon.
5. Select Shut down or Restart, depending upon
whether you want to immediately restart the PC
software.
6. If a screen displays with a button named Shut
down anyway or Restart anyway near the
bottom of the screen, select the button.
7. If you selected to shut down the PC, wait 20
seconds, then perform the restarting procedure.

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Access 2 Instructions for Use 2: Shut Down and Restart

Restarting a PC that Is Shut Down

NOTE
If you are restarting multiple Access 2 PCs in a workgroup, restart the workgroup server first, then restart
the client PCs.

1. Press the PC power switch on the front of the PC to turn the power on. The power switch is identified by the
power switch symbol.
I

1054B.eps
PC Power Switch Symbol

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. 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 Instrument

Use this procedure to reboot the Access 2 instrument. There are two different ways to 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.

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Access 2 Instructions for Use 2: Shut Down and Restart

Rebooting Using the Reset Button

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.

2. Locate the reset button, just to the right of the pipettor gantry.

3. Push and hold in the reset button for one second, then release.

4. Close the front panel of the instrument immediately.

0045Cc.eps

NOTE Reset Button

0045Cc
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.

Rebooting Using the Power Switch

1. Be sure the front panel of the instrument is

closed.

2. Locate the power switch on the lower, right

side near the back of the instrument. Press
the lower part of the switch to turn the
power off (O position).

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 0042Dc.eps

mode area before you continue normal Instrument Power Switch

operation.

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Access 2 Instructions for Use 2: Shut Down and Restart

Shutting Down the Instrument

Use this procedure only if you plan to move the instrument or if the system power will be 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 explosive compounds in metal drain
lines. Refer to National Institute for Occupational Safety and Health Bulletin: Explosive Azide
Hazards (8/18/76).
Use this procedure to shut down the Access 2 system.

1. Run the Special Clean routine. For more information about performing the Special Clean routine, see the
Help system.

2. Empty the liquid waste bottle.

3. If necessary, shut down the PC.

4. Locate the power switch on the lower, right side near the back of the instrument. Press the lower part of the
switch to turn the power off (O position).

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Access 2 Instructions for Use 2: Shut Down and Restart

Restarting the Instrument

Use this procedure to restart the instrument from a shutdown state.

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.

NOTE
You must equilibrate the substrate used in this procedure to room temperature for the time specified in the
reagent instructions for use before you load it onto the instrument. For detailed information, see the
substrate reagent instructions for use.

Turning the Power On

1. If the PC was shut down, restart it.

2. Locate the power switch on the lower right side near the back of the instrument. 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.

 (Optional, except following an extended shutdown) Prime the system fluidics.

 (Optional, except following an extended shutdown) Perform the probe volume checks.

 (Optional) Replenish supplies.

 (Optional, except following an extended shutdown) Run the Special Clean routine.

 (Optional, except following an extended shutdown) Run the System Check routine.

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Access 2 Instructions for Use 3: Supplies

3 Supplies
Changing the Wash Buffer Bottle
You can change the wash buffer bottle at any time. Because of the internal reservoir, the system continues
processing samples even when you remove the wash buffer bottle. If you wait until the Wash Buffer button is
red, the system schedules no new tests because the internal reservoir is almost empty.

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.

CAUTION
To avoid contaminating the wash buffer, do not touch any part of the dispense cap assembly that
enters the reservoir. Handle the dispense cap assembly only by the screw cap, not the nozzle.

Wash Buffer
Gently invert new
wash buffer bottle
3 or 4 times

Remove cap and inner

seal from new bottle

Remove empty bottle

Remove dispense
cap assembly from
empty bottle

Attach dispense cap

assembly to new bottle

Turn new bottle upside

down and place into
reservoir receptacle

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Access 2 Instructions for Use 3: Supplies

Changing the Liquid Waste Bottle

The Liquid Waste button turns red when the waste bottle is full. The system will not schedule any new tests
until you change the liquid waste bottle. You can change the liquid waste bottle at any time, even during sample
processing, but preferably before the bottle is full. The Liquid Waste button does not turn yellow.

WARNING
You will come in contact with potentially infectious materials during this procedure. Handle and
dispose of biohazardous materials according to proper laboratory procedures. Proper hand, eye, and
facial protection is required.

Liquid Waste
Loosen cap of full
liquid waste bottle

Stopped
Remove bottle cap and
Processing No
insert in clean bottle
samples?

NOTE Yes
The liquid waste
drain kit may be used Release the quick
disconnects from full
in place of the waste bottle
bottle. The drain kit
directs liquid waste
to a floor drain. Connect quick
Because site disconnects to empty
liquid waste bottle
conditions vary,
Beckman Coulter
requires that you
Remove full liquid
consult with waste bottle and place
Technical Support to clean bottle in fluids tray
determine whether WARNING
your system can be
fitted with the kit. Decontaminate Thoroughly flush any decontaminant
contents of full liquid
waste bottle from the liquid waste bottle before you
store the liquid waste bottle. If you
reinstall the liquid waste bottle before
Dispose of liquid waste
and rinse bottle
you flush it, any remaining
thoroughly decontaminants may react with chemicals
pumped into the liquid waste bottle and
the resulting chemical reactions can
Store clean bottle for
future use create gases harmful to you or the
instrument.

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Access 2 Instructions for Use 3: Supplies

Changing the Substrate Bottle

When the system can process 60 or fewer tests with the current supply of substrate, the Substrate button turns
yellow. When the substrate bottle is empty, the button turns red, and the system cannot start processing samples
until you connect a new bottle of substrate. You can only change the substrate bottle while the system is in the
Ready mode.

Substrate any screen

CAUTION
Do not combine partial
bottles of substrate.

Supplies

Change Substrate
F5

Change Substrate

Scan the new,

equilibrated substrate
bottle

Move substrate supply

cap from bottle in use to
equilibrated bottle

Discard empty bottle and

equilibrate new bottle
prior to use

Done
F1

Yes
F1

System primes the

substrate fluidic lines

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Access 2 Instructions for Use 3: Supplies

Loading Reaction Vessels

During an Access 2 test, the chemical reaction occurs in a container called a reaction vessel (RV). Each test uses
one or two RVs.
• When there are 60 or fewer RVs available, the RVs button turns yellow.
• When there are 28 or fewer RVs available, the RVs button turns red.
• When no RVs are available, the system cannot process another sample until you load a new RV
cartridge onto the instrument.

NOTES
• You can load only full cartridges of RVs. If you try to load RVs when the instrument has room for only
a partial cartridge, the system displays a message.
• If the system is processing samples and has one row or fewer RVs left when you try to load more, the
system displays a message. You must wait until the instrument stops before you load the new cartridge.
• 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 screen or Supplies Required screen.
• To be sure that all 98 RVs are firmly seated in the cartridge spine, press down on the spine before you
load the cartridge.

RVs
any screen CAUTION
Remove the empty cartridge
spine to prevent damage to the
RV rake.

Supplies

Load RVs
F4

Load RVs

Remove cartridge
cover, load cartridge,
remove empty spine

Done
F1

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Access 2 Instructions for Use 3: Supplies

Changing the Reaction Vessel Waste Bag

When the waste bag has room for 60 or fewer RVs, the RV Waste Bag button turns yellow. When the RV waste
bag is full, the button turns red and the system will not start processing samples. You must change the RV waste
bag.

CAUTIONS
• If the system is in the Running mode when you change the RV waste bag, the system may try to
eject an RV when the plastic collar on the waste bag is blocking the ejection chute. This will cause
a jam.
• To prevent damaging the system, DO NOT push an RV that is sticking out from the ejection
chute all the way back into the chute.

RV Waste Bag any screen

WARNING
You will come in contact
with potentially infectious
materials during this
procedure. Handle and
dispose of biohazard
Supplies materials according to
proper laboratory
procedures. Proper hand,
eye, and facial protection is
Change RV Waste Bag required.
F6

Change RV Waste Bag

Open supplies door,

unfold and expand
new bag

Remove and seal old

bag, insert new bag,
and close the
supplies door

Done
F1

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Access 2 Instructions for Use 3: Supplies

Loading a Reagent Pack

When an onboard reagent pack does not contain enough reagent to process requested tests, the system assigns
those tests the Supplies Required status and the Supplies Required button turns yellow.

WARNING
If you are reloading a partially used reagent pack, it must be returned to the same stand-alone system
or Access 2 workgroup from which it was removed. If a partially used reagent pack is loaded on a
different system or workgroup, it will be inventoried as a full pack and inaccurate results may occur.

CAUTION
To prevent damaging the reagent pack, be sure it is properly seated in the reagent carousel.

Supplies You can load a reagent pack from

the Supplies Required screen Or from the Main Menu
Required
any screen Main Menu

Supplies
F3
You can also load a
Supplies Required Supplies reagent pack from the
Reagent Inventory screen

Load Reagent Pack Load Reagent Pack Reagent Inventory

F1 F1 F7

Load Reagent Pack Reagent Inventory

WARNING
You will come in contact
with potentially infectious Load Reagent Pack
F1

materials during this Invert unpunctured pack

several times*
procedure. Handle and * For the Access 25(OH)
Vitamin D Total assay, see

dispose of biohazard the reagent IFU for reagent

pack mixing instructions.

materials according to Insert reagent pack

proper laboratory
procedures. Proper hand, IRBR**
** Internal Reagent
eye, and facial protection is Bar Code Reader
present and
enabled?
No

required.
Yes

Manually scan
reagent pack

Load another
pack?

No
Yes

Next Done
F2 F1

Insert reagent pack

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Access 2 Instructions for Use 3: Supplies

Unloading a Reagent Pack

Use this procedure to unload a reagent pack from the instrument.

NOTES
• If the system is using a reagent pack to process tests, you cannot unload it (identified by the in-use
[padlock] icon on the Supplies screen).
• When you unload a partially full reagent pack, the system keeps track of the number of tests left in the
pack until you reload it or manually delete it from inventory.
• Immediately unload any reagent packs that are empty or are rejected as a result of reagent pack
monitoring.

Main Menu WARNING

You will come in contact with
potentially infectious materials
during this procedure. Handle and
Supplies
F3
dispose of biohazard materials
according to proper laboratory
Supplies You can also unload a procedures. Proper hand, eye, and
reagent pack from the
Reagent Inventory screen
facial protection is required.

Unload Reagent Pack Reagent Inventory

F2 F7

Unload Reagent Pack Reagent Inventory

Unload Reagent Pack

F2

Remove reagent pack

from reagent carousel Unload Reagent Pack

Done
F1

Remove reagent pack

from reagent carousel

Done
F1

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Access 2 Instructions for Use 3: Supplies

Retrieving Misplaced Reagent Packs

For the Access 2 system to accurately track the proper locations of reagent packs on the reagent carousel, the
packs must be loaded and unloaded using the appropriate system windows. If you load a pack and do not use the
Load Reagent Pack window, or if you use the Unload Reagent Pack window, but do not remove the pack, you
will have a misplaced pack on your system.

Use this procedure to retrieve a misplaced reagent pack.

NOTE
If your system is equipped with an internal reagent bar code reader, you can use the Remap feature to
automatically identify misplaced packs and add them to the reagent inventory.

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 mode or Not Ready mode, and then unload all reagent packs from the
reagent carousel.

2. Go to the Mechanics screen. To get to this screen from the Main Menu, select Diagnostics F7 to display
the Diagnostics menu, then
Select Device Diagnostics F4 to display the Device Diagnostics screen, then
Select Mechanics F1.

3. Select Disable Motors F8.

4. Slide the carousel door to the left to open it, and then open the reagent carousel door.

5. Gently turn the reagent carousel one rotation. If you find any reagent packs remaining on the carousel,
remove them as they come into position at the reagent carousel door.

6. After verifying that all packs are removed, close the reagent carousel door and then slide the carousel door
to the right to close it.

7. Select Enable Motors F8.

8. Home the reagent carousel.

9. When homing is complete, initialize the system.

10. When system initialization is complete, reload all of the packs you removed from the reagent carousel.

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Access 2 Instructions for Use 3: Supplies

Remapping Packs
On systems equipped with an internal reagent bar code reader (instruments with serial numbers ≥570000), you
can perform a Remap operation to scan for bar codes in all slots of the reagent carousel to identify loaded packs.

Packs that were originally manually loaded due to an unreadable bar code may not be identified by this remap
and will be assumed to still be loaded.

1. Confirm that the system is in the Ready mode.

2. Go to the Supplies screen. To get to this screen from the Main Menu, select Supplies F3.

3. Select Remap F3.

The system scans all of the onboard reagent packs and updates the inventory.

NOTE
If the Remap F3 button is unavailable, check the bar code reader configuration to ensure that the internal
reagent bar code reader is enabled. For more information, refer to the Access 2 Reference Manual.

© 2017 Beckman Coulter, Inc. 3-9

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Access 2 Instructions for Use 4: Racks and Sample Containers

4 Racks and Sample Containers

Racks
To accommodate sample containers of different sizes, the instrument uses three types of racks:
• 13 mm (for 12 mm and 13 mm sample tubes)
• 16 mm elevated (for 16x75 mm sample tubes)
• 16 mm (for 16x100 mm sample tubes)

Racks are identified by a bar code label. When the instrument scans the rack bar code label, it identifies the type
of sample containers in the rack and determines the appropriate pipetting depth for aspirating sample.

CAUTION
Only load sample containers on a rack with the appropriate ID.

Calculating Sufficient Sample Volume

To be sure the sample volume is sufficient for the tests to be run, calculate the total volume of sample needed
for the sample container by using this equation:

Sample volume
Number of Total sample
required per x replicates + Dead volume = volume required
replicate

0616A.wmf

NOTES
• To find the sample volume required per replicate, see the reagent instructions for use.
• Dead volume is the amount of sample in the bottom of a sample container that is required to be sure
that enough sample is available for the instrument to complete an assay.

WARNING
If you use tubes with separator gel, be sure that the tube contains sufficient sample volume.
Insufficient sample volume may cause the instrument to attempt to aspirate the separator gel, which
can damage the instrument and compromise the integrity of the test results.

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Access 2 Instructions for Use 4: Racks and Sample Containers

Sample Containers
Place all samples to be tested on the Access 2 system in racks before loading them onto the instrument. The
rack ID on each rack identifies what type of sample containers you may use in that rack. Each rack holds up to
ten sample containers. Place all sample containers except insert cups directly in the rack. Place insert cups into
another sample container appropriate for the rack you are using.

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.
• Air bubbles in samples can affect level sensing by the Access 2 system and compromise the
integrity of the test results. Avoid creating bubbles when transferring samples to a secondary
container. Always inspect samples before loading on the analyzer, and remove or break any
bubbles.
• Use only recommended sample containers and place them in a rack with a rack ID defined for
that type of sample container. Using containers other than those specified for use with a
particular rack ID may damage the system and compromise the integrity of test results.

The following table lists all of the sample containers you can currently use on the Access 2 instrument, the
corresponding rack ID range and the dead volume for each container.

WARNINGS
• You must have a sufficient volume of sample to process the tests you requested. To be sure you
have enough sample, calculate the total volume needed for the sample container using the
Calculating Sufficient Sample Volume procedure in this section. If you do not follow the
provided procedure, sample processing problems may occur without warning.
• Remove caps from all sample containers before loading on the Access 2 system.

Bar Code Bar Code

Sample Container Information Sample Container Information
Label Icon Label Icon
13x75 mm Tube with or without 13x100 mm Tube with or without
separator gel separator gel
13x100 GEL
13x75 GEL

• Border: Lime green • Border: Forest green

13x100
13x75

• Rack IDs: 1300–1399 • Rack IDs: 1400–1499

• Dead Volume: 500 µL • Dead Volume: 3.0 mL
• Sample rack: 13 mm • Sample rack: 13 mm
NOTE: 13x75 mm tubes may also be used NOTE: 13x100 mm tubes may also be used
with Rack IDs 1–99 or 800–899, at a Dead with Rack IDs 1–99 or 100–199, at a Dead
Volume of 3.4 mL. Volume of 4.9 mL.

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Access 2 Instructions for Use 4: Racks and Sample Containers

Bar Code Bar Code

Sample Container Information Sample Container Information
Label Icon Label Icon
12x75 mm Tube with or without 16x100 mm Tube with or without
separator gel separator gel

12x75

16x100 GEL
• Border: Lime green • Border: Midnight blue

16x100
• Rack IDs: 1300–1399 • Rack IDs: 1500–1599
• Dead Volume: 500 µL • Dead Volume: 4.5 mL
• Sample rack: 13 mm • Sample rack: 16 mm
NOTE: 12x75 mm tubes may also be used NOTE: 16x100 mm tubes may also be used
with Rack IDs 1–99, at a Dead Volume of with Rack IDs 900–999, at a Dead Volume
3.4 mL. of 7.6 mL.
16x75 mm Elevated Tube Beckman Coulter Access 3.0 mL
• Border: Purple 16x75 Sample Container

• Rack IDs: 1000–1099 • Border: Red

• Dead Volume: 700 µL • Rack IDs: 500–599
• Sample rack: 16x75 mm ELEV • Dead Volume: 150 µL
• Sample rack: 13 mm or 16 mm

Beckman Coulter Access Beckman Coulter Access

2.0 mL/13 mm Sample Cup 1.0 mL/13 mm Insert Cup in
• Border: Dark green 13x100 mm Tube

13x100
• Rack IDs: 1–99 or 400–499 (only 2.0 mL • Border: Blue
400–499 have the icon) • Rack IDs: 600–699
• Dead Volume: 150 µL • Dead Volume: 400 µL
• Sample rack: 13 mm • Sample rack: 13 mm
Beckman Coulter Access Beckman Coulter 0.5 mL Sample
1.0 mL/13 mm Insert Cup in Cup
13x75 mm Tube • Border: Light pink
13x75

• Border: Light green • Rack IDs: 2500–2599 0.5 mL

• Rack IDs: 700–799 • Dead Volume: 80 µL
• Dead Volume: 300 µL • Sample rack: 13 mm
• Sample rack: 13 mm
Beckman Coulter Auto Aliquot Tube Beckman Coulter Access
Autoaliquot

(use only Beckman Coulter P/N 2.0 mL/16 mm Insert Cup in

2910034) 16x100 mm Tube
• Border: Purple • Border: Orange
16 mm

• Rack IDs: 1600–1699 • Rack IDs: 200–299

• Dead Volume: 400 µL • Dead Volume: 400 µL
• Sample rack: 13 mm • Sample rack: 16 mm

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Access 2 Instructions for Use 4: Racks and Sample Containers

Bar Code Bar Code

Sample Container Information Sample Container Information
Label Icon Label Icon
Beckman Coulter Pediatric Insert Sarstedt S-Monovette* Tube
Cup in a Beckman Coulter Pediatric 90x13 mm 4.9 mL

Sarstedt
Tube Adapter • Border: Dark brown

Pediatric
• Border: Pink • Rack IDs: 2100–2199
• Rack IDs: 1800–1899 • Dead Volume: 3 mL
4.9 mL
• Dead Volume: 100 µL • Sample rack: 13 mm
• Sample rack: 13 mm
Sarstedt S-Monovette Tube Sarstedt S-Monovette Tube
75x15 mm 5.5 mL 92x15 mm 7.5 mL
Sarstedt

Sarstedt
• Border: Red-brown • Border: Light brown
• Rack IDs: 2200–2299 • Rack IDs: 2300–2399
• Dead Volume: 3.6 mL • Dead Volume: 5 mL
5.5 mL
• Sample rack: 16x75 mm ELEV • Sample rack: 16x100 mm 7.5 mL

Sarstedt S-Monovette Tube

92x16 mm 9 mL
Sarstedt

• Border: Gray-brown
• Rack IDs: 2400–2499
• Dead Volume: 6 mL
• Sample rack: 16x100 mm
9.0 mL

* Monovette is a trademark of Sarstedt A.G. & Co.

© 2017 Beckman Coulter, Inc. 4-4

C02062-AA
Access 2 Instructions for Use 5: Sample Manager

5 Sample Manager
Sample management is the process of placing patient, maintenance, quality control, or calibration samples in
racks, entering test requests, and loading the racks onto the Access 2 instrument for processing.

Place samples
on racks
WARNING
To minimize sample evaporation, be sure
Main Menu the sample is pipetted into the RVs within
one hour of loading it onto the instrument.
Be sure sample from 3-mL sample
Sample Manager
containers is pipetted into the RVs within
F1
two hours of loading.
Sample Manager

Are
sample IDs
read by internal Test Request
No Enter a rack ID
F3
bar code
reader?
Test Requests
Yes

Load a Rack Enter sample IDs

F1

Load Rack [X]

F1
Load rack and select
Done F1

Load rack and select

Done F1

Test Request
Using LIS? No F3

Test Requests No Using LIS?

Yes

Enter test requests

Yes

All racks
No loaded? All racks
loaded?
No

Yes
Yes
Run
Run

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Access 2 Instructions for Use 5: Sample Manager

Processing LIS Patient Test Requests

If you are using bar-coded sample containers and are downloading test requests from an LIS, use this procedure
to load racks and run the tests for LIS patient test requests. You can load up to six racks at one time.

Main Menu

Sample Manager
F1

Sample Manager

Place sample(s) in the rack

Load a Rack
F1

Load rack and select

Done F1

All racks
No
loaded?

Yes

System downloads
test requests from LIS

Verify downloaded
sample and test
information and make
any necessary changes

Run

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Access 2 Instructions for Use 5: Sample Manager

Entering Patient Test Requests Manually

If you have disabled sample bar code scanning, or need to enter test requests and sample information manually,
use this procedure to manually enter test requests.

Main Menu

Sample Manager
F1

Sample Manager

Enter rack ID
or select rack button
from Off Board list
Test Request
F3

Test Requests

Enter sample ID, test

requests, and sample
information

Place samples
in racks

Load Rack X
F1

Load rack and select

Done F1

All racks
loaded? No Back

Yes

Run

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Access 2 Instructions for Use 5: Sample Manager

Entering Calibration Test Requests

You run a calibration by setting up a set of calibrators specific for an assay or group of assays. Each calibration
is associated with a specific reagent pack lot number.

Main Menu NOTE

You must configure each new lot
of calibrators before you can use
Sample Manager
them for calibration.
F1

Sample Manager

Select off-board rack or

enter rack ID and
press [Enter]
Test Request
F3

Test Requests

Request Calibration
F6

Request Calibration

Select calibration set

OK
F1

System enters calibration

set lot number, calibrator
levels, and reagent pack
lot number

Test Requests

System enters each

calibrator level in
subsequent sample positions
Load Rack X
F1

Add samples to rack and

load rack

Run

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Access 2 Instructions for Use 5: Sample Manager

Entering Quality Control Test Requests

You run quality control by entering a quality control test request for a quality control sample or set of samples.
When you enter a quality control test request, you select a specific quality control lot number from the
Request QC window.

Main Menu
NOTE
You must set up each new
quality control lot in the
Sample Manager Access 2 system before you
F1 can select it during test
request entry.
Sample Manager

Enter rack ID and press

[Enter]

Test Request
F3

Test Requests

Request QC
F5

Request QC

Select a single or multi-

level quality control
OK
F1

Test Requests

Load Rack X
F1

Add samples to rack

and load rack

Run

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Access 2 Instructions for Use 5: Sample Manager

Processing Samples
Sample processing begins after you verify supplies, load samples, and enter or verify test request information.
Select Run.

Select Run if system is

not in Running mode
Run

(optional) (optional)
Monitor progress Supplies or
Samples Monitor progress
View results No calibration No
required? View results
Print results required?
Print results

Yes Yes

any screen any screen

Supplies Required Work Pending

Override
F8

Yes

(optional)
Override Apply filter
Correct the Load samples
No expired supply/ No condition now?
calibration? Delete samples
Print report

Yes

Load supply,
change waste
container, or
request calibration

0518B.wmf

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Access 2 Instructions for Use 6: Maintenance

6 Maintenance
Maintenance Overview
For optimal performance, the Access 2 system requires routine maintenance, including Daily Maintenance and
Weekly Maintenance.

A technical support representative will schedule periodic preventive maintenance procedures on your Access 2
instrument in accordance with the terms of your service agreement, if applicable. For more information about
preventive maintenance, contact technical support.

Daily Maintenance
In order to keep the Access 2 system running properly, perform daily maintenance once every 24 hours.

NOTES
• If you use the Access 2 system to process the Vitamin B12 assay, you should also run the Special Clean
routine at the end of every day or whenever you will not use the instrument to process samples for
8 hours or more. For more information about performing the Special Clean routine, see the Help
system.
• Even if you do not use the system every day to run assays, it is still important to perform daily
maintenance on schedule to ensure that the system is ready when needed.

WARNINGS
• You will come in contact with potentially infectious materials during these procedures. Handle
and dispose of biohazard materials according to proper laboratory procedures. Proper hand,
eye, and facial protection is required.
• Citranox* cleaning solution is acidic and may cause eye or skin irritation. See the manufacturer’s
label for details.
• Contrad† 70 cleaning solution is alkaline and may cause severe eye irritation or mild skin
irritation. See the manufacturer’s label for details.
• 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.

* Citranox is a trademark of Alconox, Inc.

† Contrad is a trademark of Decon Laboratories, Inc.

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Access 2 Instructions for Use 6: Maintenance

Required Materials
• Fiber-free polyester swabs (or equivalent fiber-free applicators)
• Maintenance Log (see the Maintenance Log in this section)
• 13-mm rack for 2-mL sample cups; the rack must have a rack ID between 1 and 57 or 400 and 456
• Wash buffer (or deionized water)
• Citranox cleaning solution
• Contrad 70 cleaning solution
• 2.0-mL sample cups (three cups)

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.

CAUTIONS
• Be sure not to bend or damage the fragile probe tips.
• To avoid contamination, use a new applicator on each type of probe.
• Do not wipe the tip of the probe. Fibers on or inside the probes can clog the probes or valves in
the fluidic module.

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Access 2 Instructions for Use 6: Maintenance

Daily Maintenance Steps

Main Menu Sample Manager

Inspect the
Fluidic Module*

Maintenance Review Clean the Maintenance Requests

F6
Wash Carousel F4
Probe Exteriors*
Maintenance Review
Request Maintenance

Main Menu
Check the
Run the Daily
Zone Temperatures*
Clean System*
OK
F1
Check Diagnostics
System Check the Supplies F7 Maintenance Request
Status and Waste Prime Fluidics
Containers* F2

Prime Fluidics
Main Menu

Prime the Substrate*

Place cups in rack

Configure
F8 Main Menu
PC Admin
F7

PC Admin Load the rack

Sample Manager
F1
Check the
Backup* Run

* Initial the Maintenance Log

0787C.wmf
1. Check the System Status

2. Inspect the Fluidic Module

3. Clean the Wash Carousel Probe Exteriors

4. Prime the Substrate

5. Run the Daily Clean System Routine

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Access 2 Instructions for Use 6: Maintenance

Daily Clean System Routine

WARNINGS
• You will come in contact with potentially infectious materials during these procedures. Handle
and dispose of biohazard materials according to proper laboratory procedures. Proper hand,
eye, and facial protection is required.
• Unless there is an emergency, let the maintenance routine run to completion. Canceling the
routine may damage the instrument and compromise the integrity of subsequent test results.
• If you cancel the routine, do not initialize the system. Contact Technical Support for assistance.

Main Menu Maintenance Requests

Sample Manager
Load Rack
F1
F1

Sample Manager

Load rack
Enter the Maintenance Rack
Number in the Rack ID field

Maintenance Request
F4 Run

Request Maintenance
The system cleans
probe interiors
Select Daily Clean (15 minutes)
System

OK
F1
Wait until the status bar
indicates the cleaning
is complete
Place 2.0 mL sample
cups in rack positions
1, 2, and 3

Unload rack

Pipette 2.0 mL
Contrad 70 into cup 1

Initial the
Maintenance Log
Pipette 2.0 mL
1/5 Citranox/deionized
water dilution into cup 2
Complete the remaining
Daily Maintenance
Pipette 2.0 mL routines
deionized water
or wash buffer
into cup 3

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Access 2 Instructions for Use 6: Maintenance

Weekly Maintenance
In order to keep the Access 2 system running properly, perform weekly maintenance once every seven days.

NOTE
If the system is not used to run assays every day, it is still important to perform weekly maintenance on
schedule to ensure that the system is ready when needed.

WARNINGS
• Methanol is extremely flammable. Do not use near heat or flame. Do not ingest. Avoid contact
with eyes, skin, and clothing. Use with adequate ventilation.
• Contrad 70 cleaning solution is alkaline and may cause severe eye irritation or mild skin
irritation. See the manufacturer’s label for details.
• 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
• Lint-free cloth
• Deionized or distilled water
• Maintenance Log (see the Maintenance Log in this section)
• Spare liquid waste bottle (as needed)
• Spare waste filter bottle (as needed)
• Alcohol or alcohol swabs or wipes (methanol can be substituted for cleaning the exterior of the aspirate
probes)
• Proper hand, eye, and facial protection for handling biohazardous materials
• Clean aspirate probes (three)
• Contrad 70 cleaning solution
• Beakers (two)
• Aspirate Probe Cleaning Kit (3.0-mL syringe, disposable aspirate probe brush, aspirate probe syringe
fitting assembly consisting of a fitting and tubing)
• Disposable aspirate probe brushes (as needed)
• Absorbent paper
• Wash buffer

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Access 2 Instructions for Use 6: Maintenance

Weekly Maintenance 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.

Clean the
Instrument Exterior*

Discoloration
Inspect the Liquid
Cracking or Crazing
Waste Bottle for Wear*
Bulging

Check for Fluid in the

Waste Filter Bottle* CAUTION
Do not wipe the tip of the probe. Fibers
on or inside the probes can clog the
Inspect and Clean the probes or valves in the fluidic module.
Primary Probe*

Remove the Aspirate Probes

Replace and Clean the
Install Clean Probes
Aspirate Probes*
Clean the Removed Probes

Run Daily
Maintenance*

Run System
Check*

* Initial Maintenance Log

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Access 2 Instructions for Use 6: Maintenance

Replacing the Aspirate Probes

Turn the WARNING

instrument off
You will come in contact with
potentially infectious materials
during this procedure. Handle and
Open the front panel dispose of biohazard materials
and top cover
according to proper laboratory
procedures. Proper hand, eye, and
facial protection is required.
Remove the aspirate
probe from the
wash arm CAUTION
Handle the aspirate probes with
extreme care. The probes are
Disconnect the probe
tubing from the fragile, and will not function
barbed fitting
properly if bent.

Install a clean
aspirate probe

Repeat for the

other two probes

Close the front panel

and top cover

Turn the
instrument on

Clean the Soak the probes in

probes within distilled water
one hour? No

Yes

Clean the removed

aspirate probes

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Access 2 Instructions for Use 6: Maintenance

Precleaning the Aspirate Probes

WARNINGS
• You will come in contact with potentially infectious materials during these procedures. Handle
and dispose of biohazard materials according to proper laboratory procedures. Proper hand,
eye, and facial protection is required.
• Contrad 70 cleaning solution is alkaline and may cause severe eye irritation or mild skin
irritation. See the manufacturer’s label for details.
• Once a disposable aspirate probe brush has been used to clean 1 to 3 aspirate probes, it is
considered a biohazard. Handle and dispose of the brush according to appropriate laboratory
safety procedures. Do not save a used brush for future use.
• Take the necessary precautions when removing and reinserting the probe brush to avoid
scattering droplets of biohazardous material into the air.

CAUTIONS
• Handle the aspirate probes with extreme care. The probes are fragile, and will not function
properly if bent.
• The disposable aspirate probe brush handle bends easily.

FIll a beaker with 20 mL

of Contrad 70

Fill a beaker with 50 mL

of deionized water

Dip a new aspirate

probe brush into the
Contrad 70

Insert and remove the

probe brush in the
probe until all of the
residue is removed

Repeat for the other

two aspirate probes

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Access 2 Instructions for Use 6: Maintenance

Cleaning the Aspirate Probes with Contrad 70 Cleaning Solution

WARNINGS
• You will come in contact with potentially infectious materials during these procedures. Handle
and dispose of biohazard materials according to proper laboratory procedures. Proper hand,
eye, and facial protection is required.
• Contrad 70 cleaning solution is alkaline and may cause severe eye irritation or mild skin
irritation. See the manufacturer’s label for details.

CAUTIONS
• Do not wipe the tip of the probe. Fibers on or inside the probes can clog the probes or valves in
the fluidic module.
• Handle the aspirate probes with extreme care. The probes are fragile, and will not function
properly if bent.

Assemble the syringe

Draw the Contrad 70

into the syringe

Attach the probe to the

syringe

Empty the syringe into

the beaker

Rinse the probe by

drawing Contrad 70 into
the syringe; empty it
into the beaker

Remove the probe from

the syringe

Repeat for the other

two aspirate probes

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Access 2 Instructions for Use 6: Maintenance

Cleaning the Aspirate Probes with Distilled Water

WARNING
You will come in contact with potentially infectious materials during these procedures. Handle and
dispose of biohazard materials according to proper laboratory procedures. Proper hand, eye, and
facial protection is required.

CAUTIONS
Draw the distilled water
into the syringe • Do not wipe the tip of the
probe. Fibers on or inside
the probes can clog the
Attach the probe to the probes or valves in the
syringe fluidic module.
• Handle the aspirate probes
with extreme care. The
Empty the syringe
into a sink
probes are fragile, and will
not function properly if
bent.
Rinse the probe twice
by drawing water into
the syringe; empty it
into a sink

Remove the probe from

the syringe

Clean the exterior

of the probe
with alcohol

Position the probe on

absorbent paper for
10 minutes to drain

Repeat for the other

two probes

Initial the
Maintenance Log

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Access 2 Instructions for Use 6: Maintenance

System Check
You perform the System Check routine as part of weekly maintenance to verify system performance. During
weekly maintenance, the three System Checks (washed, unwashed, and substrate) are run together. You can
also run the System Check routine more often, or perform individual checks.

WARNINGS
• Unless there is an emergency, let the System Check routine run to completion. Cancelling the
routine may damage the instrument and compromise the integrity of subsequent test results.
• If you cancel the routine, do not initialize the system. Contact Technical Support for assistance.
• System Check Solution and wash buffer contain ProClin™ 300 preservative, which may cause
sensitization by skin contact. After contact with skin, wash immediately with plenty of soap and
water. Wear suitable gloves.

Required Materials
• 13-mm rack for 2-mL sample cups; the rack must have a rack ID between 1 and 57 or 400 and 456
• 2.0-mL sample cups (four cups)

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.

• Undiluted System Check Solution

• Wash buffer
• 1/501 dilution of System Check Solution (mix 20 µL of System Check Solution with 10.0 mL of Wash
Buffer)
• Maintenance Log

System Check Expected Results

Compare the obtained results with the expected results. Expected results are listed in the Maintenance Log,
included in this section.

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Access 2 Instructions for Use 6: Maintenance

Running the System Check Routine

Main Menu Maintenance Requests

WARNING
You will come in
contact with
potentially infectious
Sample Manager Load Rack
F1 F1 materials during these
procedures. Handle
Sample Manager and dispose of
Load rack biohazard materials
Type Rack ID according to proper
laboratory
Maintenance Requests
F4
Run procedures. Proper
hand, eye, and facial
Request Maintenance System performs protection is required.
system checks
Select System Check (40 minutes)
(and Daily Clean
System, if running
weekly maintenance)

Unload rack
OK
F1

Place 2.0 mL sample

cups in rack positions Compare results with
7, 8, 9, and 10 expected values

Pipette 2.0 mL
undiluted System
Check Solution Results Repeat the
into cup 7 acceptable? No System Check

Pipette at least 1.0 mL Yes

wash buffer into cup 8

Enter values
Results
and initial Yes acceptable?
Maintenance Log, as
applicable
Leave cup 9 empty
No

Troubleshoot System
Pipette 1.0 mL Check results, or
1/501 System Check contact Technical
Solution into cup 10 Support

0601B.wmf

© 2017 Beckman Coulter, Inc. 6-12

C02062-AA
 Access 2 system Serial # ____________ System ID ____________ Month ____________ Year ________Beckman Coulter, Inc.
Perform the tasks listed at the left and draw a check () in the accompanying box on the right. Initial the Tech Initials box.

DAILY MAINTENANCE 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Check Zone
Temperatures

C02062-AA
Check System Supplies
Empty Liquid Waste
Bottle
System Backup
Successful?
Maintenance Log

Inspect Fluidic Module

Access 2 Instructions for Use

© 2017 Beckman Coulter, Inc.

Clean Probe Exteriors
Prime Substrate
Run Daily Clean System
(If Necessary)
Perform Special Clean
Tech Initials
Perform the tasks listed at the left and draw a check () in the accompanying box on the right. Initial the Tech Initials box.
.

WEEKLY MAINTENANCE Week 1 Week 2 Week 3 Week 4 Week 5

Today’s Date
Clean Instrument Exterior
Inspect Liquid Waste Bottle
Check Waste Filter Bottle
Inspect/Clean Primary Probe
Replace/Clean Aspirate Probes
Run Daily Maintenance (Initial above) (Initial above) (Initial above) (Initial above) (Initial above)
Run System Check
Tech Initials
Enter the System Check Results in the boxes. Initial the Tech Initials box

SYSTEM CHECK RESULTS Week 1 Week 2 Week 3 Week 4 Week 5 Expected Results
Today’s Date *The Substrate :
Washed RLU/%CV 5,000 to 20,000 / ≤12.00 Washed Ratio and the
Unwashed Check RLU
Substrate RLU/%CV 5,000 to 9,000 / ≤5.00
mean result are not
Unwashed RLU/%CV 4 to 10 million* / ≤2.00 system specifications.
Wash Efficiency PPM -1.0 to +1.0 They are only
6: Maintenance

6-13
Substrate Ratio 0 to 1.40 reference guidelines.

Substrate : Washed Ratio 0 to 1.25*

Tech Initials
This page may be reproduced for laboratory use.
Access 2 Instructions for Use 7: Troubleshooting

7 Troubleshooting
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.

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.

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.

NOTE
Event troubleshooting information is available online within the Access 2 Help system.

© 2017 Beckman Coulter, Inc. 7-1

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Access 2 Instructions for Use 7: Troubleshooting

Troubleshooting Events

Any Screen Event Log

Event Log button turns

yellow or red

Event Log

Review events

Need help? No Take appropriate action

Yes

Event Log

Select the event you

need help for

Troubleshoot
F2

Access 2 Help

Call Technical Support

Follow troubleshooting
instructions

Yes

Need to view Need Close Help and

or print event No additional No continue normal
details? assistance? operation

Yes

Details
F4

Details

Print
F7

0840B.wmf

© 2017 Beckman Coulter, Inc. 7-2

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Access 2 Instructions for Use 7: Troubleshooting

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.

NOTE
The corrective actions in the troubleshooting tables contain abbreviated procedures. Regardless of the
frequency with which you perform a procedure, regularly review the complete procedures, including their
cautions for protecting the instrument from damage, and their warnings for ensuring your personal safety.
Links to the procedures are available for the tables in the Help system.

Substrate Check Problems

If the System Check results are not within the expected ranges, troubleshoot the substrate check first. You
should start here because problems with the substrate 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.

Substrate Check Troubleshooting

Symptoms Possible Causes Corrective Action

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.
3. Repeat the System Check routine.

Air in the substrate lines 1. Open the front panel.

2. Visually inspect the tubing at the substrate pump and heater for
air bubbles.
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.
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.

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Access 2 Instructions for Use 7: Troubleshooting

Substrate Check Troubleshooting (continued)

Symptoms Possible Causes Corrective Action

High %CV Leak in the substrate system 1. With the front panel open, open the top cover.
throughout the run tubing 2. Visually inspect the tubing leading to and away from the
(continued) substrate pump/valve/heater assembly for leaks and/or
crystalline deposits.
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, visually inspect the
tubing leading to and away from the substrate pump/valve/heater
assembly for kinks.
• 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.
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.
• Repeat the System Check routine.

Bent substrate probe tip 1. With the front panel open, inspect the substrate probe tip.
• 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.

Substrate pump or valve failure Contact Technical Support.

Luminometer problem Contact Technical Support.

High %CV from System Check solution diluted 1. Prepare a new 1/501 dilution using a new vial of System Check
high values in the incorrectly solution.
last one or two 2. Repeat the System Check routine.
replicates
Sample containers out of order in 1. Place the sample containers in the correct order.
the maintenance rack 2. Repeat the System Check routine.

High RLU mean Wash/read carousel or substrate 1. Check the wash carousel and substrate temperatures on the
temperatures too high (results Maintenance Review screen.
may be flagged TRS or TRW) 2. If the temperatures for either device is displayed in red (out of
range), contact Technical Support.

System Check solution diluted 1. Prepare a new 1/501 dilution using a new vial of System Check
incorrectly solution.
2. Repeat the System Check routine.

Sample containers out of order in 1. Place the sample containers in the correct order.
the maintenance rack 2. Repeat the System Check routine.

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Access 2 Instructions for Use 7: Troubleshooting

Substrate Check Troubleshooting (continued)

Symptoms Possible Causes Corrective Action

High RLU mean Substrate pump delivering too Run the Visual Substrate Volume Check procedure.
(continued) much substrate • If the results do not fail, continue troubleshooting other possible
causes.
• If the results fail, contact Technical Support.

Contaminated substrate supply 1. Contact Technical Support to verify the need to decontaminate
the substrate system.
2. If Technical Support agrees, decontaminate the substrate system
and then verify system performance.

Luminometer problem Contact Technical Support.

Low RLU mean Expired substrate 1. Review the expiration date on the Supplies screen.
2. If necessary, change the substrate bottle from the Supplies
screen.
3. Repeat the System Check routine.

Improperly stored substrate 1. Check the date the bottle was placed at room temperature.
(bottle stored at room 2. If necessary, change the substrate bottle from the Supplies
temperature for too long) screen.
3. Repeat the System Check routine.

Insufficient supply of substrate 1. Check the level of substrate in the bottle.

2. If necessary, change the substrate bottle from the Supplies
screen.
3. Repeat the System Check routine.

Wash/read carousel or substrate 1. Check the wash carousel and substrate temperatures on the
temperatures too low (results Maintenance Review screen.
may be flagged TRS or TRW) 2. If the temperatures for either device are displayed in red (out of
range), contact Technical Support.

Incomplete priming of the 1. Prime the substrate system for 20 cycles again.
substrate after substrate system 2. Repeat the System Check routine.
decontamination

Substrate bottle contaminated 1. Change the substrate bottle from the Supplies screen. Do not
with Citranox cleaning solution prime the substrate system when prompted as you change the
during substrate system bottle.
decontamination 2. Prime the substrate system from the Prime Fluidics window for
20 cycles.
3. Repeat the System Check routine.

Substrate dispense volume too Run the Visual Substrate Volume Check procedure.
low • If the results do not fail, continue troubleshooting other possible
causes.
• If the results fail, contact Technical Support.

Luminometer problem Contact Technical Support.

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Access 2 Instructions for Use 7: Troubleshooting

Substrate Check Troubleshooting (continued)

Symptoms Possible Causes Corrective Action

No RLU values Substrate bottle contaminated 1. Change the substrate bottle from the Supplies screen. Do not
with Citranox cleaning solution prime the substrate system when prompted as you change the
during substrate system bottle.
decontamination 2. Prime the substrate system from the Prime Fluidics window for
20 cycles.
3. Repeat the System Check routine.

Luminometer problem Contact Technical Support.

RLUs trending up Substrate delivery inconsistent Troubleshoot according to the High %CV symptoms for substrate
or down over time check.

Substrate bottle contaminated 1. Change the substrate bottle from the Supplies screen. Do not
with Citranox cleaning solution prime the substrate system when prompted as you change the
during substrate system bottle.
decontamination 2. Prime the substrate system from the Prime Fluidics window for
20 cycles.
3. Repeat the System Check routine.

High substrate Dirty or plugged aspirate probes 1. Clean the aspirate probes.
ratio 2. Repeat the System Check routine.

Fluid dripping from aspirate 1. Open the front panel.

probes 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.
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.
• 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. 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.

© 2017 Beckman Coulter, Inc. 7-6

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Access 2 Instructions for Use 7: Troubleshooting

Unwashed Check Problems

Begin troubleshooting the unwashed check once you have determined that the substrate check results are within
the expected ranges. The unwashed check troubleshooting table provides information about the pipetting
system, and does not provide detail on problems related to the substrate or washing systems.

Unwashed Check Troubleshooting

Symptoms Possible Causes Corrective Action

High %CV Air in the main pipettor fluid 1. Open the front panel.
lines 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.
3. If bubbles are present, prime the pipettor.
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.

2. Visually inspect the tubing from the wash buffer supply to the
main pipettor for kinks.
• If no kinks are found, continue troubleshooting other possible
causes.
3. Straighten any kinks and close the front panel.
4. Prime the pipettor.
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.
3. Repeat the System Check routine.

Precision pump, valve, fittings, 1. Open the front panel and the top cover.
or tubing damaged and leaking 2. Visually inspect the tubing leading from the precision pump
valve, to the pressure monitor if applicable, to the main pipettor
for leaks and/or crystalline deposits.
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.

Worn or damaged precision Contact Technical Support.

pump seals

© 2017 Beckman Coulter, Inc. 7-7

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Access 2 Instructions for Use 7: Troubleshooting

Unwashed Check Troubleshooting (continued)

Symptoms Possible Causes Corrective Action

High %CV Problems with the substrate 1. If the substrate check %CV result is within the expected range,
(continued) system: the substrate system is not the cause of the high %CV for the
• Insufficient supply of substrate unwashed check. Continue troubleshooting other possible
causes.
• Air in the substrate lines
2. If the substrate check result is not within the expected range,
• Leak in the substrate system
troubleshoot the substrate check result.
tubing
• Kinked substrate system
tubing
• Bent substrate probe
• Substrate pump or valve
failure

Primary probe partially plugged 1. Look at the Pressure Monitor screen 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.
2. Run the Special Clean routine.
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.

Splashing in the RVs Contact Technical Support.

Luminometer problem Contact Technical Support.

High RLU mean System Check solution diluted 1. Prepare a new 1/501 dilution using a new vial of System Check
incorrectly solution.
2. Repeat the System Check routine.

Sample containers out of order in 1. Place the sample containers in the correct order.
the maintenance rack 2. Repeat the System Check routine.

Problems with the substrate 1. If the substrate check mean RLU result is within the expected
system: range, the substrate system is not the cause of the high mean
• Wash/read carousel or RLU result for the unwashed check. Continue troubleshooting
substrate temperatures too other possible causes.
high 2. If the substrate check result is not within the expected range,
• Contaminated substrate supply troubleshoot the substrate check result.
• Substrate pump delivering too
much substrate

Luminometer problem Contact Technical Support.

© 2017 Beckman Coulter, Inc. 7-8

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Access 2 Instructions for Use 7: Troubleshooting

Unwashed Check Troubleshooting (continued)

Symptoms Possible Causes Corrective Action

Low RLU mean System Check solution diluted 1. Prepare a new 1/501 dilution using a new vial of System Check
incorrectly solution.
2. Repeat the System Check routine.

Sample containers out of order in 1. Place the sample containers in the correct order.
the 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 unexpired
incorrectly System Check solution.
2. Repeat the System Check routine.

Problems with the substrate 1. If the substrate check RLU mean result is within the expected
system: range, the substrate system is not the cause of the low RLU mean
• Expired substrate result for the unwashed check. Continue troubleshooting other
possible causes.
• Insufficient supply of substrate
2. If the substrate check result is not within the expected range,
• Wash/read carousel or
troubleshoot the substrate check result.
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.

Low RLU outliers Ultrasonic transducer problem Contact Technical Support.

Washed Check Problems

Begin troubleshooting the washed check once you have determined that the substrate check and unwashed
check results are within the expected ranges. The washed check troubleshooting table provides information
about the RV wash system, and does not provide detail on problems related to the substrate or the pipetting
systems.

Washed Check Troubleshooting

Symptoms Possible Causes Corrective Action

High %CV Dirty or plugged aspirate probes 1. Clean the aspirate probes.
2. Repeat the System Check routine.

Damaged aspirate probes 1. Open the front panel.

2. Visually inspect the aspirate probes on the wash arm.
3. Replace any probes that are damaged.
4. With the front panel closed, repeat the System Check routine.
5. If the problem persists, contact Technical Support.

© 2017 Beckman Coulter, Inc. 7-9

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Access 2 Instructions for Use 7: Troubleshooting

Washed Check Troubleshooting (continued)

Symptoms Possible Causes Corrective Action

High % CV Plugged waste air filter 1. Check the tubing from the liquid waste bottle for constrictions.
(continued) • 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. This may temporarily resolve the error until you
can install a new waste filter assembly.
3. Repeat the System Check routine.
• If the results are acceptable, order a new waste filter assembly
and replace the current one.
• If the results fail, contact Technical Support.

Damaged peristaltic waste pump 1. Open the front panel and top cover.
tubing 2. Visually inspect the tubing and area under the tubing, from the
peristaltic waste pump to the aspirate probes for leaks and/or
crystalline deposits.
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.

One or more aspirate probes 1. With the front panel open, verify that the aspirate probes can move
stuck in the “up” position up and down.
• 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.
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 1. With the front panel open, visually inspect the tubing from the
tubing wash buffer supply to the dispense probes for air bubbles.
2. If you see bubbles, close the front panel and prime the dispense
probes for 4 cycles.
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 1. With the front panel open, visually inspect the tubing from the
tubing wash buffer supply to the dispense probes for kinks.
• 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.
4. Repeat the System check routine.

© 2017 Beckman Coulter, Inc. 7-10

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Access 2 Instructions for Use 7: Troubleshooting

Washed Check Troubleshooting (continued)

Symptoms Possible Causes Corrective Action

High % CV Problems with the substrate 1. If the substrate check %CV result is within the expected range, the
(continued) system: substrate system is not the cause of the high %CV for the washed
• Insufficient supply of substrate check. Continue troubleshooting other symptoms.
• Air in substrate lines 2. If the substrate check result is not within the expected range,
troubleshoot the substrate check result.
• Leak in the substrate system
tubing
• Kinked substrate system
tubing
• Bent substrate probe
• Substrate pump or valve
failure

Problems with the pipetting 1. If the unwashed check %CV result is within the expected range,
system: the pipetting system is not the cause of the high %CV for the
• No wash buffer washed check. Continue troubleshooting other possible causes.
• Worn or damaged precision 2. If the unwashed check result is not within the expected range,
pump seals troubleshoot the unwashed check result.
• Partially plugged primary
probe
• Precision pump, valve,
fittings, or tubing damaged
and leaking

Incorrect aspirate probe height Contact Technical Support.

Defective peristaltic waste pump Contact Technical Support.

RV mixing problem Contact Technical Support.

Splashing in the RVs Contact Technical Support.

High RLU mean Dirty or plugged aspirate probes 1. Clean the aspirate probes.
2. Repeat the System Check routine.

Damaged aspirate probes 1. Open the front panel.

2. Visually inspect the aspirate probes on the wash arm.
3. Replace any probes that are damaged.
4. With the front panel closed, repeat the System Check routine.
5. If the problem persists, contact Technical Support.

One or more aspirate probes 1. With the front panel open, verify that the aspirate probes can move
stuck in the “up” position up and down.
• 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.
3. With the front panel closed, repeat the System Check routine.
4. If the problem persists, contact Technical Support.

© 2017 Beckman Coulter, Inc. 7-11

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Access 2 Instructions for Use 7: Troubleshooting

Washed Check Troubleshooting (continued)

Symptoms Possible Causes Corrective Action

High RLU mean Problems with the substrate 1. If the substrate check RLU mean result is within the expected
(continued) system: range, the substrate system is not the cause of the high RLU mean.
• Wash/read carousel or Continue troubleshooting other possible causes.
substrate temperatures too 2. If the substrate check result is not within the expected range,
high troubleshoot the substrate check result.
• Contaminated substrate supply
• Substrate pump delivering too
much substrate

Incorrect aspirate probe height Contact Technical Support.

Luminometer problem Contact Technical Support.

Low RLU mean Diluted System Check solution 1. Be sure that sample container 1 contains undiluted System Check
used instead of undiluted solution.
2. Repeat the System Check routine.

Containers 1 and 4 switched in 1. Be sure that sample container 1 contains undiluted System Check
the maintenance rack solution and sample container 4 contains 1/501 diluted System
Check.
2. Repeat the System Check routine.

Problems with the pipetting 1. If the unwashed check %CV result is within the expected range,
system 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.

Problems with the substrate 1. If the substrate check %CV and RLU mean results are within
system: expected ranges, the substrate system is not the cause of the low
• Air in the substrate lines RLU mean result for the washed check. Continue troubleshooting
other possible causes.
• Leak in the substrate system
tubing 2. If the substrate check results are not within the expected ranges,
troubleshoot the substrate check result.
• Kinked substrate system
tubing
• Bent substrate probe
• Substrate pump or valve
failure
• Expired substrate
• Insufficient supply of substrate
• Wash/read carousel or
substrate temperatures too low
• Incomplete priming after
substrate system
decontamination
• Substrate supply contaminated
with Citranox cleaning
solution during substrate
system decontamination
• Substrate dispense volume too
low

Luminometer problem Contact Technical Support.

© 2017 Beckman Coulter, Inc. 7-12

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Access 2 Instructions for Use 7: Troubleshooting

Wash Efficiency Problems

The wash efficiency is a calculation based upon the results from the substrate, washed, and unwashed checks of
the System Check routine. The wash efficiency value provides information about the washing system.

Wash Efficiency Troubleshooting

Symptoms Possible Causes Corrective Action

Wash Efficiency Problems with the RV wash system (washed Troubleshoot the washed check result.
PPM fails to meet check mean RLUs or %CVs too high)
criteria
Problems with the pipetting system (unwashed Troubleshoot the unwashed check result.
check mean RLUs too low)

Problems with the substrate system Troubleshoot the substrate check result.
(contaminated substrate bottle)

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.

NOTE
The corrective actions in the troubleshooting tables contain abbreviated procedures. Regardless of the
frequency with which you perform a procedure, regularly review the complete procedures, including their
cautions for protecting the instrument from damage, and their warnings for ensuring your personal safety.
Links to these procedures are available for these tables in the Help system.

General Instrument Problems

General Instrument Troubleshooting

Symptoms Possible Causes Corrective Action

System mode is Not System rebooting or initializing Wait for the instrument to finish rebooting or initializing.
Ready When this occurs, the system mode will change to the
Ready mode and any text message in the system mode area
will disappear.

Many circumstances other than Warning:

rebooting or initializing can place the If the system is in the Not Ready mode because Stop was
instrument in the Not Ready mode, selected during a maintenance routine, do not initialize
some examples are: the system. Contact Technical Support for assistance.
• Front panel of the instrument is open The system must be initialized to return to the Ready mode.
• Pipettor gantry was just cleaned • If you are experienced at initializing the system, and are
• System detected a device motion error following instructions in the Help system or in an
• Stop was selected during a Access 2 manual, initialize the system.
maintenance routine • If you are not experienced at initializing the system or
you are not following instructions in Help system or in an
Access 2 manual, contact Technical Support.

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Access 2 Instructions for Use 7: Troubleshooting

General Instrument Troubleshooting (continued)

Symptoms Possible Causes Corrective Action

The Event Log System event occurred Review the event log message and its troubleshooting
button is yellow or information. Take the recommended corrective action.
red

System Database contains too many test and QC 1. Set up the system to automatically delete test and QC
performance is slow results results from the database.
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 Start-Up Problems

Use the following table to troubleshoot the instrument if you are having problems rebooting or initializing the
Access 2 system and no events report in the Event Log. If an event is generated, follow the Event Log
troubleshooting procedures.

Instrument Start-Up Troubleshooting

Symptoms Possible Causes Corrective Action

System fails during No power to instrument Refer to the power supply troubleshooting table.
reboot
CD in CD-ROM or DVD drive, or Remove the CD from the CD-ROM or DVD drive, or remove
data disk in 3.5-inch disk drive. the disk from 3.5-inch disk drive and reboot the instrument.

Instrument hardware (power supply, Reboot the instrument.

internal hard drive, CPU, printed
circuit board) or software failure.

System fails during Interlock switch detects front panel of Close the front panel of the instrument and initialize the
initialization instrument is open system.

Power Supply Problems

Use the following table to troubleshoot when the instrument or the peripheral devices do not have power. The
peripheral devices that require a power supply include the external computer (PC), touch screen monitor, and
printer.

Power Supply Troubleshooting

Symptoms Possible Causes Corrective Action

No power to the Faulty power outlet or power 1. Plug the instrument and the peripherals into a different power
instrument or strip 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.

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Power Supply Troubleshooting (continued)

Symptoms Possible Causes Corrective Action

No power to the Instrument power switch not on Turn on the power switch located on the right side of the instrument.
instrument
Power cord connector loose at Be sure that the power cord connections to the outlet and instrument
either end are plugged in tightly.

Faulty power supply or circuit Contact Technical Support.

breaker

No power to Peripheral device power switch 1. Turn on the peripheral device power switch.
peripheral(s) not on 2. If you cannot locate the power switch, see the documentation
provided by the manufacturer.

Peripheral device power cord Be sure that the power cord connections to the outlet and peripheral
connector loose at either end device are plugged in tightly.

Defective peripheral device Contact Technical Support.

Keyboard Problems
Use the following table to troubleshoot situations when the computer keyboard is not responding to your key
strokes.

Keyboard Troubleshooting

Symptoms Possible Causes Corrective Action

No response from Loose connector Be sure that the cable connections (located on the back side of the
the keyboard external computer) between the keyboard, the external bar code
reader, and the computer are plugged in tightly.

Invalid key selected Look at the status line above the function buttons near the bottom of
the screen to verify that the key selected is an acceptable keyboard
response.

System software not responding Reboot the PC.

Hardware problem Contact Technical Support.

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Printer Problems
Use the following table to troubleshoot problems with the printer.

Printer Troubleshooting

Symptoms Possible Causes Corrective Action

Print job was not Communication interrupted 1. Check the printer paper tray.
printed, or is between 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.
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 Reading Problems

Use the following table to troubleshoot when the bar code reader does not scan bar code information.

Bar Code Reader Troubleshooting

Symptoms Possible Causes Corrective Action

Sample rack bar Bar code label attached Attach the bar code label correctly.
code label was not incorrectly to the rack
read by the internal
bar code reader Incorrect system bar code label If the sample rack is labeled with an Access (not an Access 2)
on rack system label, the rack cannot be used.
Either replace the bar code label with an Access 2 rack label or
move the samples to an Access 2 labeled rack.

Bar code reader not operating Contact Technical Support.

properly

Sample bar code Sample bar code reading not Set up the bar code reader to read sample IDs.
label was not read enabled
by the internal bar
code reader Sample container placed Turn the sample container until its bar code label faces the same
incorrectly in the rack direction as the rack bar code label, and is visible through the slot in
the sample rack.

Bar code label applied Apply the bar code label correctly on the sample container.
incorrectly on the sample
container

Bar code reader not set up to read Setup the bar code reader parameters to match the symbology you
the sample bar code symbology are using.

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Bar Code Reader Troubleshooting (continued)

Symptoms Possible Causes Corrective Action

Sample bar code Bar code symbology or 1. Verify that the bar code symbology and parameters used on the
label was not read parameters not supported sample label are supported.
by the internal bar 2. If the symbology or parameters are not supported, contact
code reader Technical Support.
(continued)
Number of bar code characters 1. Check the number of characters entered for the Interleaved 2 of 5
on label does not agree with the symbology in the Bar Code Reader Setup window.
number of characters specified in 2. If necessary, change the number of characters to match the
the Bar Code Reader Setup number of characters on the label.
window (for Interleaved 2 of 5
3. If the number of characters match, contact Technical Support.
only)

No response from Incorrect scanning technique 1. Verify the following:

the external bar • The correct screen or window is displayed for the item you are
code reader scanning.
• The correct field is selected.
2. Scan the label a second time.

Loose connector Be sure that the cable connections (located on the back side of the
external computer) between the keyboard, the external bar code
reader, and the computer are plugged in tightly.

System software not responding Reboot the PC.

External bar code reader not Contact Technical Support.

configured properly

Hardware problem Contact Technical Support.

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Air in the System

Air bubbles in the fluid lines can lead to poor precision. If you notice air in the lines, use the following table to
troubleshoot the problem.

Troubleshooting Air in the System

Symptoms Possible Causes Corrective Action

Air in the fluid lines Insufficient priming 1. Prime all fluidic components.
2. Run the System Check routine.
3. If the problem persists, contact Technical Support.

System prime lost due to a leak 1. Be sure the connections between the fittings (located on the left
in the fluidic system side of the instrument) and the fluids tray 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.
3. Inspect the precision pump valve and valve fittings for leaks and
deposits.
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. 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.
4. Run the System Check routine.

Plugged waste air filter 1. Check the tubing from the liquid waste bottle for constrictions.
• 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. 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.

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Main Pipettor Problems

Problems with the main pipettor can lead to poor precision. If you notice any leaking or deposits, use the
following table to troubleshoot the problem.

Main Pipettor Troubleshooting

Symptoms Possible Causes Corrective Action

Main pipettor Primary probe partially plugged 1. Look at the Pressure Monitor screen to determine if a pressure
leaking 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.
2. Run the Special Clean routine.
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.

Loose fitting between the main 1. Open the front panel and top cover.
pipettor and precision pump 2. Visually inspect the fittings between the primary probe and
valve precision pump valve for leaks and deposits.
3. Inspect all fluid fittings to the manifold for leaks and deposits.
4. Leaks or deposits may indicate that the tubing or fittings are
damaged.
• If you find leaks or deposits, contact Technical Support for
further assistance.
• If you find no leaks or deposits, continue troubleshooting
other possible causes.

Main pipettor Primary probe partially plugged, 1. Look at the Pressure Monitor screen to determine if a pressure
dispensing fluid causing the main pipettor to sensor is present, and that obstruction detection is enabled.
with excess dispense fluid with too much • If the pressure sensor is not present, or if it is present but
pressure pressure 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.
2. Check RV locations 1 and 2 of the RV Shuttle for crystalline
deposits.
• If you find no deposits, continue troubleshooting other
possible causes.
3. Run the Special Clean routine.
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.

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Communication Problems
Use the following table to troubleshoot communication problems between the external computer (PC) and the
instrument, or other systems in your workgroup.

Communications Troubleshooting

Symptoms Possible Causes Corrective Action

Communication Function that requires Contact Technical Support.

between PC and communication between the PC
instrument and the instrument, such as
interrupted for getting a rack or loading
more than supplies, was attempted while
30 minutes during the PC was updating the Test
a run, PC locks up Results screen
after
communication is
reestablished

Workgroup Loose connection between PC 1. Be sure that the Access 2 instrument power switch is on.
communication and other systems in the • If the power switch is off, restart the instrument.
error occurs during workgroup
• If the power switch is on, but there is no power to the
rebooting process
instrument, refer to the power supply troubleshooting table.
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.

Assay Troubleshooting
Assay troubleshooting information provides troubleshooting tables to help you identify and correct
assay-related problems. 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.

NOTE
The corrective actions in the troubleshooting tables contain abbreviated procedures. Regardless of the
frequency with which you perform a procedure, regularly review the complete procedures, including their
cautions for protecting the instrument from damage, and their warnings for ensuring your personal safety.
Links to these procedures are available for these tables in the Help system.

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Assay Calibration Problems

When a calibration fails, the system displays a failure code in the Reason field on the Calibration Data screen.
Use the following table to help you troubleshoot the calibration problem.

Assay Calibration Troubleshooting

Symptoms Possible Causes Corrective Action

Although precision Multi-level calibrators pipetted 1. Be sure that the calibrators are placed in the rack in the proper
is good, the out of order: order.
calibration fails for • Calibration curve does not 2. Repeat the calibration.
any reason other ascend or descend smoothly.
than Insuff Data
• Calibration cutoff is opposite
of the expected result.

Expired calibrator 1. Check the expiration date on the calibrator vial(s) or the
Calibrator Setup screen.
2. If the calibrator is expired, add a new, unexpired calibrator on
the Calibrator Setup screen.
3. Repeat the calibration.

Calibrator unstable or Repeat the calibration. If possible, repeat with a new set of the same
contaminated due to improper calibrator lot.
handling

Reagent pack unstable or 1. Unload the reagent pack and load a new reagent pack.
contaminated due to improper • If the lot number of the new reagent pack is different than the
handling removed pack, recalibrate the assay.
2. For calibration problems, repeat the calibration.

Contaminated substrate supply 1. Contact Technical Support to verify the need to decontaminate
the substrate system.
2. If Technical Support agrees, decontaminate the substrate system
and then verify system performance.

Incorrect calibration information 1. Verify the calibration information on the Calibrator Setup
entered during calibrator setup screen.
2. If necessary, edit the information on the Calibrator Setup screen.
3. Repeat the calibration.

Although precision Wrong calibrator placed in rack 1. Be sure that the correct calibrator is loaded on the rack.
is good, the 2. Repeat the calibration.
quantitative curve
is flat or the Wrong reagent pack loaded, or 1. Verify that the reagent pack was loaded by checking the Supplies
qualitative result is placed in an incorrect position on screen. If it is missing, load a reagent pack.
No Value; the reagent carousel 2. If the reagent pack is listed on the screen, verify its location by
calibration fails for unloading it from the carousel.
any reason other
• If the reagent pack is onboard, but is not presented during this
than Insuff Data
process, contact Technical Support for assistance.
• If Technical Support confirms a misplaced reagent pack,
retrieve the pack.
3. Reload the reagent pack after you have verified its location.
4. Repeat the calibration.

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Assay Calibration Troubleshooting (continued)

Symptoms Possible Causes Corrective Action

Poor precision, and Daily or weekly maintenance not 1. Perform daily or weekly maintenance.
calibration fails for performed 2. Repeat the calibration.
any reason other
than Insuff Data Problems with the pipetting 1. If the System Check routine results are within the expected
system: ranges, the pipetting system is not the cause of the calibration
• Air in the main pipettor fluid failure. Continue troubleshooting other possible causes.
lines. 2. If the unwashed check result is not within the expected range,
• Wash buffer supply lines troubleshoot the unwashed check result.
kinked.
• Precision pump, valve,
fittings, or tubing damaged
and leaking.

Problems with the substrate 1. If the System Check routine results are within the expected
system: ranges, the substrate system is not the cause of the calibration
• Insufficient supply of failure. Continue troubleshooting other possible causes.
substrate. 2. If the substrate check result is not within the expected range,
• Air in the substrate lines. troubleshoot the substrate check result.
• Kinked substrate system
tubing.
• Leak in the substrate system
tubing.

Reagent gone because it leaked 1. Load a new reagent pack.

out of the pack during off-board 2. Repeat the calibration.
storage

RLUs are too low at Reagent pack switch occurred, 1. Verify that the second reagent pack was loaded by checking the
one end of the and the second reagent pack is Supplies screen. If the pack is missing, load a new reagent pack.
calibration curve, missing or loaded incorrectly 2. If the second reagent pack is listed on the screen, verify its
and calibration fails (RLUs drop off suddenly at the location by unloading it from the carousel.
for any reason end of the calibration curve)
• If the reagent pack is onboard, but is not presented during this
other than Insuff
process, contact Technical Support for assistance.
Data
• If Technical Support confirms a misplaced reagent pack,
retrieve the pack.
3. Reload the second pack after you have verified its location.
4. Repeat the calibration.

Calibration fails for Quantity of calibrator not 1. Calculate the correct volume of calibrator needed for the number
the reason Insuff sufficient for testing (QNS result of replicates and type of sample container used.
Data flag and event) 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.
4. Repeat the calibration.
5. If the calibration fails again, contact Technical Support for
assistance.

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Assay Calibration Troubleshooting (continued)

Symptoms Possible Causes Corrective Action

Calibration fails for Two or more replicates not 1. Review the Event Log messages for device errors prior to the
the reason Insuff calculated due to instrument calibration failure.
Data error 2. Review the Test Results screen for any error messages.
(continued) 3. Troubleshoot the device errors. If necessary, contact Technical
Support for assistance.
4. After resolving the device errors, repeat the calibration.

Sample container missing or 1. Be sure that the sample containers are in the proper order in the
placed in incorrect position in the rack.
rack 2. Repeat the calibration.

Quality Control Problems

When a QC result violates an applied QC rule, the Quality Control button turns red. The button remains red
until you review the QC Data screen. Use the following table to help you troubleshoot problems with your QC
results.

Quality Control Troubleshooting

Symptoms Possible Causes Corrective Action

Controls violate Daily or weekly maintenance not 1. Perform daily or weekly maintenance.
applied QC rule performed 2. Repeat the test(s).

Wrong QC control loaded onto 1. Load the correct QC control.

the sample rack 2. Repeat the test(s).

Wrong QC control lot number Repeat the test(s) using the correct lot number.
selected for the test

Wrong mean and/or standard 1. Review the QC information using Edit Control F2 from the QC
deviation information entered Setup screen.
when setting up the QC controls 2. If necessary, edit the information.
3. Repeat the test(s).

QC control sample type does not 1. Verify that the sample type used matches what is listed on the
match QC setup Test Request screen.
2. Verify that the sample type used matches the sample type set up
for the QC control.
3. If the QC control sample type entered during setup is incorrect,
you must delete the control and set up the control again using the
correct sample type.

Expired QC control Load new, unexpired QC control, and repeat the test(s).

QC controls unstable or 1. Prepare new QC controls according to the procedure provided by

contaminated due to incorrect the manufacturer.
handling 2. Load the freshly prepared QC controls and repeat the test(s).

QC controls reconstituted 1. Reconstitute new QC controls according to the procedure

incorrectly provided by the manufacturer.
2. Load the freshly reconstituted QC controls and repeat the test(s).

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Quality Control Troubleshooting (continued)

Symptoms Possible Causes Corrective Action

Controls violate Quantity of QC control not 1. Calculate the correct volume of QC control needed for the
applied QC rule sufficient for testing (QNS result number of replicates and type of sample container used.
(continued) flag and event) 2. Pipette the amount of QC control calculated in step 1 into the
appropriate sample container.
3. Be sure the rack and rack ID are correct.
4. Repeat the test(s).
5. If the test(s) fail again, contact Technical Support for assistance.

QC controls evaporating from 1. Load a fresh aliquot of each QC control.

being on the instrument too long 2. Repeat the test(s). Be sure the controls are pipetted into the RVs
within 1 hour of loading onto the instrument. Be sure controls
from 3-mL sample containers are pipetted into the RVs within
two hours of loading.

Reagent pack unstable or 1. Unload the reagent pack and load a new reagent pack.
contaminated due to improper • If the lot number of the new reagent pack is different than the
handling removed pack, recalibrate the assay.
2. Repeat the test(s).

Wrong reagent pack loaded, or 1. Verify that the reagent pack was loaded by checking the Supplies
placed in an incorrect position on screen. If it is missing, load a reagent pack.
the reagent carousel 2. If the reagent pack is listed on the screen, verify its location by
unloading it from the carousel.
• If the reagent pack is onboard, but is not presented during this
process, contact Technical Support for assistance.
• If Technical Support confirms a misplaced reagent pack,
retrieve the pack.
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.
2. Unload the expired reagent pack and load a new one.
• 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 Load the samples using appropriate sample containers and racks. Be
rack sure that the sample containers are in a rack with the correct rack ID.

Sample container missing or 1. Be sure that the sample containers are in the proper order in the
placed in incorrect position in the rack.
rack 2. Repeat the test(s).

Expired assay calibration 1. Check the Reagent Pack button on the Supplies screen. If the lot
number is red, the calibration has expired.
2. View the test results. Any test results calculated with an expired
calibration will be flagged.
3. Recalibrate the assay.
4. Repeat the test(s).

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Quality Control Troubleshooting (continued)

Symptoms Possible Causes Corrective Action

Controls violate QC controls not run after 1. Run QC.

applied QC rule preventive maintenance or repair 2. Evaluate any out-of-range QC results according to your
(continued) established laboratory procedures.
3. Troubleshoot any test result flags, and recalibrate the assay if
necessary.
4. Repeat the test.

Substrate not equilibrated to The substrate must be at room temperature for specified period of
room temperature when loaded time before it is loaded.
on the system For more information about the substrate, refer to the reagent
instructions for use.

Increasing values QC controls evaporating from 1. Load a fresh aliquot of each QC control.
across the run being on the instrument too long 2. Repeat the test(s). Be sure the controls are pipetted into the RVs
within 1 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 Sample Problems

Use the following table to troubleshoot problems with your patient sample test results. If a special circumstance
exists for a test result, the Access 2 system will code the 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.

Patient Sample Troubleshooting

Symptoms Possible Causes Corrective Action

Unexpected Incorrect patient sample type Refer to the reagent instructions for use for the appropriate sample
sample results types for each assay.

Patient sample handled Be sure that sample is stored and handled according to proper
incorrectly laboratory procedures. Refer to individual assay reagent instructions
for use for proper sample handling instructions.

Microclots present in the serum 1. Spin the sample again or use a serum filter to separate the serum
sample from any microclots.
2. Repeat the test(s).

Quantity of patient sample not 1. Calculate the correct volume of patient sample needed for the
sufficient for testing (QNS result number of replicates and type of sample container used.
flag and event) 2. Pipette the amount of QC control calculated in step 1 into the
appropriate sample container.
3. Be sure the rack and rack ID are correct.
4. Repeat the test(s).
5. If the test(s) fail again, contact Technical Support for assistance.

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Patient Sample Troubleshooting (continued)

Symptoms Possible Causes Corrective Action

Unexpected Patient samples evaporating from 1. Load a fresh aliquot of each patient sample.
sample results being on the instrument too long 2. Repeat the test(s). Be sure the sample is pipetted into the RVs
(continued) within 1 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.

Wrong reagent pack loaded, or 1. Verify that the reagent pack was loaded by checking the Supplies
placed in an incorrect position on screen. If it is missing, load a reagent pack.
the reagent carousel 2. If the reagent pack is listed on the screen, verify its location by
unloading it from the carousel.
• If the reagent pack is onboard, but is not presented during this
process, contact Technical Support for assistance.
• If Technical Support confirms a misplaced reagent pack,
retrieve the pack.
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.
2. Unload the expired reagent pack and load a new one.
• If the lot number of the new reagent pack is different than the
expired pack, recalibrate the assay.
3. Repeat the test(s).

Reagent pack unstable or 1. Unload the reagent pack and load a new reagent pack.
contaminated due to improper • If the lot number of the new reagent pack is different than the
handling removed pack, recalibrate the assay.
2. Repeat the test(s).

Expired assay calibration 1. Check the Reagent Pack button on the Supplies screen. If the lot
number is red, the calibration has expired.
2. View the test results. Any test results calculated with an expired
calibration will be flagged.
3. Recalibrate the assay.
4. Repeat the test(s).

QC controls not run after 1. Run QC.

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 if
necessary.
4. Repeat the test.

Partial bottles of substrate 1. Change the substrate bottle and prime the substrate.
combined 2. Repeat the test(s).

Daily or weekly maintenance not 1. Perform daily or weekly maintenance.

performed 2. Repeat the test(s).

Wrong sample container and/or Load the samples using appropriate sample containers and racks. Be
rack sure that the sample containers are in a rack with the correct rack ID.

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Patient Sample Troubleshooting (continued)

Symptoms Possible Causes Corrective Action

Unexpected Sample container missing or 1. Be sure that the sample containers are in the proper order in the
sample results placed in incorrect position in the rack.
(continued) rack 2. Repeat the test(s).

Sample values are Patient samples evaporating from 1. Load a fresh aliquot of each patient sample.
too high being on the instrument too long 2. Repeat the test(s). Be sure the sample is pipetted into the RVs
within 1 hour of loading it onto the instrument. Be sure sample
from 3-mL sample containers is pipetted into the RVs within two
hours of loading.

Low sample value Incorrect dilution factor 1. If the sample result was generated with an automated dilution
flag (for example, the Diluted ßhCG assay), repeat the sample in the
standard assay format (Total ßhCG assay).
2. If the results are still too high, contact Technical Support.

Patient sample handled Be sure that sample is stored and handled according to proper
incorrectly laboratory procedures. Refer to individual assay reagent instructions
for use for proper sample handling instructions.

Increased assay Wrong reagent pack loaded, or 1. Verify that the reagent pack was loaded by checking the Supplies
variability/poor placed in an incorrect position on screen. If it is missing, load a reagent pack.
precision the reagent carousel 2. If the reagent pack is listed on the screen, verify its location by
unloading it from the carousel.
• If the reagent pack is onboard, but is not presented during this
process, contact Technical Support for assistance.
• If Technical Support confirms a misplaced reagent pack,
retrieve the pack.
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 Reagent Inventory
assay results screen.
2. Unload the expired reagent pack and load a new one.
• 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. If the lot
number is red, the calibration has expired.
2. View the test results. Any test results calculated with an expired
calibration will be flagged.
3. Recalibrate the assay.
4. Repeat the test(s).

QC controls not run after 1. Run QC.

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 if
necessary.
4. Repeat the test.

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Patient Sample Troubleshooting (continued)

Symptoms Possible Causes Corrective Action

Unexpected shift in Wash buffer contaminated 1. Contact Technical Support to verify the need to rinse the wash
assay results buffer reservoir.
(continued) 2. If Technical Support confirms, rinse the wash buffer reservoir.
3. If the System Check results are acceptable:
• Recalibrate the assay.
• Run controls and repeat the test(s).
4. If the System Check results are not acceptable, contact Technical
Support.

Increasing values Patient samples evaporating from 1. Load a fresh aliquot of each patient sample.
across the run being on the instrument too long 2. Repeat the test(s). Be sure the sample is pipetted into the RVs
within 1 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 Flags

Use the following tables to troubleshoot fatal (no calculated result) or non-fatal (the 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.

Fatal Flags

Fatal Flag Description Corrective Action

CCR A result could not be calculated 1. Take one of the following actions:
because: • For results other than derived results, skip to step 2.
• One of the tests included in a • For derived results, review each test result used in the derived
derived result formula did not result formula. If a result failed, troubleshoot according to the
produce a result. flag for that result.
• A confirmatory test result could not 2. Review the Event Log and troubleshoot according to the error
be calculated. Usually this occurs events with a similar date and time to this event.
because the samples for the
3. Repeat the test.
qualitative and confirmatory tests
were not aspirated at the same time. • For a derived result, repeat all tests included in the derived
result formula.
• Another error prevented the system
from calculating a result. • 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.
2. Repeat the test.
3. If the problem persists, contact Technical Support.

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Access 2 Instructions for Use 7: Troubleshooting

Fatal Flags (continued)

Fatal Flag Description Corrective Action

IND • For sandwich assays, which use 1. For IND flagged results which meet the following criteria, dilute
positive slope calibration curves, and rerun the sample:
the result is at the low end of the • The result is on a competitive assay, and
concentration curve and cannot be
• Sample dilution is allowed for the assay, and
distinguished from a system failure
because the RLU reading is too • The sample RLU is low.
low. See the reagent instructions for use to determine the assay type
• For competitive assays, which and whether sample dilution is allowed.
use negative slope calibration 2. Rule out a system problem by reviewing the Event Log for error
curves, the result is at either: events with a date and time shortly before this event.
• The high end of the Troubleshoot accordingly.
concentration curve and cannot 3. If you have ruled out a system problem and the IND flag event is
be distinguished from a system the only issue, recalibrating the affected assay may resolve the
failure because the RLU reading problem.
is too low, or • Recalibrate the assay using a new reagent pack and a new set
• The low end of the of calibrators.
concentration curve and cannot • Run QC.
be distinguished from a system
failure because the RLU reading • Repeat the test on the affected sample.
is too high. • If IND flags persist, contact Technical Support.

NCR No calibration data existed for the 1. Calibrate the assay.

reagent lot when the result was 2. Repeat the test(s).
processed.

QNS The sample volume is insufficient. 1. Follow the troubleshooting instructions for the QNS event in the
Additional tests will not be scheduled Event Log.
for this sample. Tests already 2. Repeat the test(s).
scheduled will be completed.
3. If the problem persists, contact Technical Support.

QSD Insufficient reagent volume was 1. Review the Event Log and troubleshoot according to the error
dispensed into an RV. events with a similar date and time to this event.
2. Run canceled tests again.
3. If the problem persists, contact Technical Support.

RLU The relative light units (RLUs) are 1. Review the Event Log and troubleshoot according to the error
outside the acceptable luminometer events with a similar date and time to this event.
measuring range. 2. Repeat the test(s).
3. If the problem persists, contact Technical Support.

SYS A device error occurred during 1. Review the Event Log and troubleshoot according to the error
processing. events with a similar date and time to this event.
2. Repeat the test(s).
3. If the problem persists, contact Technical Support.

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Access 2 Instructions for Use 7: Troubleshooting

Fatal Flags (continued)

Fatal Flag Description Corrective Action

TRI The temperature of the incubator was 1. Check the incubator temperature on the Maintenance Review
outside the acceptable limits. All tests screen. If the temperature is outside the acceptable limits,
being incubated when the temperature periodically monitor the incubator temperature on this screen
was outside limits are 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 incubator temperature is within the acceptable limits,
repeat the test(s).
3. If the temperature does not normalize, or if the problem persists,
contact Technical Support.

TRS The temperature of the substrate was 1. Check the substrate temperature on the Maintenance Review
outside the acceptable limits when it screen. If the temperature is outside the acceptable limits,
was dispensed. periodically monitor the substrate temperature on this screen
until it is within the acceptable limits.
• If the system was rebooted or instrument covers were recently
opened, you may need to wait up to 30 minutes for the
temperature to normalize.
• If the system was recently restarted, you may need to wait up
to 1 hour for the temperature to normalize.
2. When the substrate temperature is within the acceptable limits,
repeat the test(s).
3. If the temperature does not normalize, or if the problem persists,
contact Technical Support.

TRW The temperature of the wash/read 1. Check the wash/read carousel temperature on the Maintenance
carousel was outside the acceptable Review screen. If the temperature is outside the acceptable
limits. All tests with RVs in the limits, periodically monitor the wash/read carousel temperature
wash/read carousel when the on this screen until it is within the acceptable limits.
temperature was outside limits are • If the system was rebooted or instrument covers were recently
flagged. opened, you may need to wait up to 30 minutes for the
temperature to normalize.
• If the system was recently restarted, you may need to wait up
to 1 hour for the temperature to normalize.
2. When the wash/read carousel temperature is within the
acceptable limits, repeat the test(s).
3. If the temperature does not normalize, or if the problem persists,
contact Technical Support.

Non-Fatal Flags

Non-Fatal Flag Description Corrective Action

CEX The calibration curve or cut-off value 1. Recalibrate the assay.

is expired. 2. Repeat the test(s).

CRH The result is above the upper limit of This is a valid test result. No corrective action is necessary.
the critical range.
Not applicable for QC or Calibrations.

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Access 2 Instructions for Use 7: Troubleshooting

Non-Fatal Flags (continued)

Non-Fatal Flag Description Corrective Action

CRL The result is below the lower limit of This is a valid test result. No corrective action is necessary.
the critical range.
Not applicable for QC or Calibrations.

EXS The substrate is expired. 1. Change the substrate bottle from the Supplies screen.
2. Repeat the test(s).

GRY For qualitative assays, the result is This is a valid test result. No corrective action is necessary.
within the specified gray zone.

LEX The reagent pack lot is expired. 1. Unload the expired reagent pack and load a new one.
• 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 1. Review the result.
the LIS range. The system does not 2. Take one of the following actions:
send results with this flag to the LIS.
• Send the result to the LIS manually.
Notes:
• Delete the result and repeat the test(s).
• This flag is displayed only when the
Auto-Send to LIS option is set to
Verify.
• This flag is for quantitative assays,
semi-quantitative assays, and
derived results only.

LRL The result is below the lower limit of 1. Review the result.
the LIS range. The system does not 2. Take one of the following actions:
send results with this flag to the LIS.
• Send the result to the LIS manually.
Notes:
• Delete the result and repeat the test(s).
• This flag is displayed only when the
Auto-Send to LIS option is set to
Verify.
• This flag is for quantitative assays,
semi-quantitative assays, and
derived results only.

LOW The result is lower than the minimum No corrective action is necessary.
reportable result value defined in the
APF.

ORH The result is above the upper limit of No corrective action is necessary.
the reference range.
Not applicable for QC or calibrations.

ORL The result is below the lower limit of No corrective action is necessary.
the reference range.
Not applicable for QC or calibrations.

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Access 2 Instructions for Use 7: Troubleshooting

Non-Fatal Flags (continued)

Non-Fatal Flag Description Corrective Action

OVR The calculated concentration is above 1. Review the Event Log for error events with a similar date and
the highest or most concentrated time to this event.
calibrator. This flag is only used for • If events occurred, troubleshoot.
quantitative and semi-quantitative
2. Take one of the following actions:
assays.
• 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 1. Unload the expired reagent pack and load a new one.
elapsed for the reagent pack. The • If the lot number of the new reagent pack is different than the
system measures this from the time it expired pack, recalibrate the assay.
first punctures the pack.
2. Repeat the test(s).

QCF A QC control violates one or more QC 1. Display the QC Chart and Data screen to review which criteria is
rules. not met.
2. Follow the QC troubleshooting instructions in Assay
Troubleshooting on page 7-21.

QEX The QC control lot is expired. 1. Add a new, unexpired QC control.

2. Repeat the test(s).

RFX The result is from a reflex test. This is a valid test result. No corrective action is necessary.

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Access 2 Instructions for Use 8: Theory of Operation

8 Theory of Operation
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.

Reaction Vessel Transport

The instrument moves the RV through the following stages:

Pipetting
RV moves from RV
supply to pipetting
position

Some 2-step assays Incubation

return RV to pipetting RV moves from
position for additional pipetting position to
sample or reagent incubator belt

Washing Some 2-step assays

RV moves from inc. belt return RV to pipetting
to wash position on position for additional
wash/read carousel sample or reagent

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

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Access 2 Instructions for Use 8: Theory of Operation

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.

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.

The Access 2 system performs the following types of assay calibrations:

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.

Calculating Predicted Precision

After an acceptable calibration curve is obtained, the system calculates an error band around the curve. This
calculation is based on the distance of the calibration data points from the curve. The system uses the calibration
data and the shape of the math model to predict the precision at the predefined analyte concentrations.

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Access 2 Instructions for Use 8: Theory of Operation

Comparing Predicted Precision to Defined Limits

The system compares the calculated predicted precision to the limits defined in the APF. If the result for any
analyte concentration is outside the acceptable limits defined by the error band, the calibration fails.

2
1

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

Calculating Test Results

To determine the analyte concentration in a sample, the system must have a current (accepted) calibration
curve. When the patient or quality control sample is tested, the system measures the RLUs and then uses the
calibration curve to convert the result to an analyte concentration.

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.

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Access 2 Instructions for Use 8: Theory of Operation

Pressure Monitor Reference Curve Determination

The system determines a reference curve for the pressure monitor by measuring the pressure profiles for two
different sample volumes. The reference curve is used to identify the expected pressure profile for any given
sample volume.

A reference curve is determined when the obstruction detection hardware is installed. Determine a new curve
after the main pipettor is cleared of an obstruction; after the main pipettor, pressure sensor, or associated tubing
is replaced; when following troubleshooting instructions; or as instructed by a technical support representative.

NOTE
The reference curve has no impact on reagent pack monitoring, which is also a function of the pressure
monitor.

Obstruction Detection Flowchart

Aspirate the sample.

Was an
obstruction No Process the sample.
detected?

Yes

Cancel the test, wash the probe, log a

warning event, and apply the CLT flag
to test.

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.

Continue processing with the next

sample.

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Access 2 Instructions for Use A: Temperature-Sensitive Assays

A Temperature-Sensitive Assays
The Access assays listed in the table below are affected by changes in the room temperature of the Access 2
system. The result for a given sample test may shift if the room temperature changes significantly from the
temperature at which the assay was calibrated. Depending on the assay, an increase or decrease in room
temperature causes test results to increase or decrease. The magnitude and direction of the result shift for each
assay is shown in the table.

If the change in room temperature exceeds the restricted calibration temperature range, the assay must be
recalibrated at the new temperature before samples are tested. Recalibrating these assays at the new room
temperature limits the magnitude of the shift on sample results.

For each of the affected assays, Beckman Coulter has established a restricted calibration temperature range in
which the assay should be calibrated and run. Within this range, the change in assay results due to temperature
is expected to be within the allowable performance characteristics of the assay.

Restricted
Allowable If the temperature
* * calibration
Part # Product % Change increases, the
temperature
in result assay result…
range

33600 Access Cortisol ±4 °C (±7.2 °F) ±12% Increases

98200 Triage BNP Test for Beckman ±4 °C (±7.2 °F) ±9% Decreases
Coulter Immunoassay Systems†
A49752 Access Hybritech p2PSA ±6 °C (±10.8 °F) ±16.9% Decreases
B03704
* The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
Contact your Beckman Coulter representative if you have questions about the availability of particular assays.
† Available exclusively from Alere or its authorized distributors for use in Beckman Coulter Immunoassay Systems.
Alere and Triage are trademarks of the Alere group of companies.

The Access 2 system does not monitor the room temperature or alert the operator if room temperature changes
from the original calibration temperature for assays identified in the table. You should ensure that your
laboratory has established a procedure to monitor and review temperature during system operation. Quality
control may not detect temperature related change in assay results and cannot be used as a substitute for
temperature monitoring.

If your laboratory is unable to maintain the required temperature ranges, do not report results out of the
laboratory. Please contact Beckman Coulter for additional suggestions regarding temperature monitoring and
control.

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Access 2 Instructions for Use B: Ordering Information

B Ordering Information
Assay-Specific Reagents
The availability of these assays in your country depends on the status of submissions to local regulatory
agencies. In addition, an assay may not be available for use on all systems. Contact your Beckman Coulter
representative if you have questions about the availability of particular assays.

To obtain assay-specific reagents:

• In the U.S.A. or Canada, contact Beckman Coulter Customer Service at 1-800-526-3821.
• Outside the U.S.A. and Canada, contact your local Beckman Coulter representative.

# Tests or #
Calibrations
Assay Panel Assay Part # Description Volume
(@ 500 µL/
Calibration)
Adrenal/ Cortisol 33600 Reagent 2 x 50 tests 100
Pituitary 33605 Calibrator 6 x 4.0 mL 8
33606 Diluent (S0) 1 x 4.0 mL
Allergy Total IgE 35000 Reagent 2 x 50 tests 100
35005 Calibrator 7 total; S0 @ 6.0 mL 8
S1–S6 @ 4.0 mL
35006 Diluent (S0) 1 x 6.0 mL
Anemia EPO A16364 Reagent 2 x 50 tests 100
A16365 Calibrator 6 total; S0 @ 10 mL 5
S1–S5 @ 2.5 mL
Ferritin/ 33020 Reagent 2 x 50 tests 100
Dil-Ferritin 33025 Calibrator 6 x 4.0 mL 8
Folate / RBC Folate A98032 Reagent 2 x 50 tests 100
A98033 Calibrator 6 x 4.0 mL 8
A99250 Diluent (S0) 1 x 4.0 mL
A14206 Lysing Agent 2 x 100 mL
Intrinsic Factor Ab 387992 Reagent 2 x 50 tests 100
387993 Calibrator 2 x 4.0 mL 16
387999 QC 2 levels; 3 x 4.0 mL each
sTfR A32493 Reagent 2 x 50 tests 100
Soluble Transferrin A32494 Calibrator 6 total; S0 @ 4 mL 5
Receptor S1–S5 @ 2.5 mL
B11056 QC1 1 level; 2 x 2.5 mL each
B11057 QC2 and QC3 2 levels; 2 x 2.5 mL each
Vitamin B12 33000 Reagent 2 x 50 tests 100
33005 Calibrator 6 x 4.0 mL 8
33006 Diluent (S0) 1 x 4.0 mL

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Access 2 Instructions for Use B: Ordering Information

# Tests or #
Calibrations
Assay Panel Assay Part # Description Volume
(@ 500 µL/
Calibration)
Blood Virus HAV Ab* 34200 Reagent 2 x 50 tests 100
34205 Calibrator 5 x 2.0 mL 4
34209 QC 2 levels; 3 x 3.5 mL each
HAV IgM* 34210 Reagent 2 x 50 tests 100
34215 Calibrator 2 x 1.0 mL 2
34219 QC 2 levels; 3 x 2.5 mL each
*
HBc Ab 34240 Reagent 2 x 50 tests 100
34245 Calibrator 2 x 1.0 mL 2
34249 QC 2 levels; 3 x 2.0 mL each
HBc IgM* 34250 Reagent 2 x 50 tests 100
34255 Calibrator 2 x 1.0 mL 2
34259 QC 2 levels; 3 x 2.5 mL each
*
HBs Ab A24296 Reagent 2 x 50 tests 100
A24297 Calibrator 6 x 2.5 mL 5
A24298 QC 2 levels; 3 x 3.5 mL each
HBs Ag* A24291 Reagent 2 x 50 tests 100
A24292 Calibrator 2 x 2.7 mL 5
A24294 QC 2 levels; 3 x 4.0 mL each
HBs Ag A24295 Confirmatory Reagent 2 x 50 tests 100 (50 patient
Confirmatory* samples)
HCV Ab PLUS *, † 34330 Reagent 2 x 50 tests 100
34335 Calibrator 2 x 1.0 mL 2
34339 QC 2 levels; 3 x 2.5 mL each
HCV Ab V3*, † B33458 Reagent 2 x 50 tests 100
B33459 Calibrator 2 levels; 1 x 1.0 mL each 4
B33460 QC 2 levels; 2 x 3.5 mL each
HIV Combo *, † A59428 Reagent 2 x 50 tests 100
A59429 Calibrator 2 x 1.7 mL 3
A59430 QC1, QC2, and QC3 3 levels; 2 x 4.4 mL each
B22822 QC4 and QC5 2 levels; 2 x 4.4 mL each
Bone Intact PTH A16972 Reagent 2 x 50 tests 100
Metabolism (routine and A16953 Calibrator 6 x 1.0 mL 2
intraoperative)
Ostase 37300 Reagent 2 x 50 tests 100
(bone alkaline B83876 Calibrator 6 x 2.5 mL 5
phosphatase)
B83877 QC 2 levels; 4.0 mL each
Ultrasensitive hGH 33580 Reagent 2 x 50 tests 100
33585 Calibrator 6 x 2.0 mL 4
25(OH) Vitamin D B24838 Reagent 2 x 50 tests 100
Total B24839 Calibrator 6 x 1.4 mL 2

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Access 2 Instructions for Use B: Ordering Information

# Tests or #
Calibrations
Assay Panel Assay Part # Description Volume
(@ 500 µL/
Calibration)
Cardiovascular AccuTnI+3 A98143 Reagent 2 x 50 tests 100
A98144 Calibrator 6 total; S0 & S1@ 1.5 mL 2
S2–S5 @ 1.0 mL
AccuTnI** A78803 †† Reagent 2 x 50 tests 100
33345 Calibrator 6 x 1.0 mL 2
CK-MB 386371 Reagent 2 x 50 tests 100
386372 Calibrator 6 x 2.0 mL 4
Digoxin 33710 Reagent 2 x 50 tests 100
33715 Calibrator 6 x 4.0 mL 8
33716 Diluent 1 x 4.0 mL
Myoglobin 973243 Reagent 2 x 50 tests 100
973244 Calibrator 6 x 1.0 mL 2
Diabetes Ultrasensitive Insulin 33410 Reagent 2 x 50 tests 100
33415 Calibrator 6 x 2.0 mL 4
Infectious CMV IgG* A40702 Reagent 2 x 50 tests 100
Disease A40703 Calibrator 6 x 1.0 mL 2
A40704 QC 2 levels; 3 x 2.5 mL each
CMV IgM* A40705 Reagent 2 x 50 tests 100
A40706 Calibrator 2 levels; 1.0 mL each 2
A40707 QC 2 levels; 3 x 2.5 mL each
Rubella IgG 34430 Reagent 2 x 50 tests 100
34435 Calibrator 6 x 1.0 mL 2
34439 QC 2 levels; 3 x 2.5 mL each
Rubella IgM* A32937 Reagent 2 x 50 tests 100
34445 Calibrator 4 x 1.0 mL 2
34449 QC 2 levels; 3 x 2.5 mL each
Toxo IgG A31588 Reagent 2 x 50 tests 100
A31589 Calibrator 6 x 1.0 mL 2
A31590 QC 2 levels; 3 x 2.5 mL each
Toxo IgM II 34470 Reagent 2 x 50 tests 100
34475 Calibrator 2 x 1.5 mL 3
34479 QC 2 levels; 3 x 3.5 mL each
Inflammation IL-6* A16369 Reagent 2 x 50 tests 100
A16370 Calibrator 6 total; S0 @ 4.0 mL 5
S1–S5 @ 2.5 mL
A16371 QC 3 levels; 2 x 2.5 mL each
Reproductive AFP / Dil-AFP 33211 300 test kit 6 x 50 tests 300
(Cals included) Cals: 7 x 2.5 mL 5
33210* 100 test kit 2 x 50 tests 100
(outside US only)
33215* Calibrator 7 x 2.5 mL 5
(for 100 test kit)
33216 Diluent 1 x 14.0 mL

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Access 2 Instructions for Use B: Ordering Information

# Tests or #
Calibrations
Assay Panel Assay Part # Description Volume
(@ 500 µL/
Calibration)
Reproductive, AMH* B13127 Reagent 2 x 50 tests 100
(continued) B13128 Calibrator 6 x 2.0 mL 4
B13129 QC 3 levels; 2 x 2 mL each
DHEA-S A10826 Reagent 2 x 50 tests 100
A10827 Calibrator 6 x 2.0 mL 4
Estradiol 33540 Reagent 2 x 50 tests 100
33545 Calibrator 6 total; S0 @ 4.0 mL 5
S1–S5 @ 2.5 mL
33546 Diluent (S0) 1 x 4.0 mL
Estriol, 33570 Reagent 2 x 50 tests 100
Unconjugated 33575 Calibrator 7 total; S0 @ 4.0 mL 5
S1–S6 @ 2.5 mL
hFSH 33520 Reagent 2 x 50 tests 100
33525 Calibrator 6 x 4.0 mL 8
hLH 33510 Reagent 2 x 50 tests 100
33515 Calibrator 6 x 4.0 mL 8
Inhibin A A36097 Reagent 2 x 50 tests 100
A36098 Calibrator 7 x 2.5 mL 5
A36100 QC 3 levels; 2 x 2.5 mL each
PAPP-A* A48571 Reagent 2 x 50 tests 100
A48572 Calibrator 6 x 1.0 mL 2
A48573 QC 3 levels; 2 x 2.5 mL each
Progesterone 33550 Reagent 2 x 50 tests 100
33555 Calibrator 6 total; S0 @ 4.0 mL 5
S1–S5 @ 2.5 mL
33556 Diluent (S0) 1 x 4.0 mL
Prolactin 33530 Reagent 2 x 50 tests 100
33535 Calibrator 6 total; S0 @ 4.0 mL 5
S1–S5 @ 2.5 mL
SHBG A48617 Reagent 2 x 50 tests 100
A48618 Calibrator 6 x 1.0 mL 2
A48619 QC 2 levels; 3 x 2 mL each
Testosterone 33560 Reagent 2 x 50 tests 100
33565 Calibrator 6 x 2.5 mL 5
Total ßhCG (5th IS) / A85264 Reagent 2 x 50 tests 100
Diluted Total ßhCG B11754 Calibrator 6 x 4.0 mL 8
(5th IS)
Total ßhCG*, ***/ 33500 Reagent 2 x 50 tests 100
Diluted Total ßhCG 33505 Calibrator 6 x 4.0 mL 8

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Access 2 Instructions for Use B: Ordering Information

# Tests or #
Calibrations
Assay Panel Assay Part # Description Volume
(@ 500 µL/
Calibration)
Thyroid Free T3 A13422 Reagent 2 x 50 tests 100
A13430 Calibrator 6 x 2.5 mL 5
Free T4 33880 Reagent 2 x 50 tests 100
33885 Calibrator 6 x 2.5 mL 5
hTSH, Fast / 33820 Reagent 2 x 50 tests 100
HYPERsensitive††† 33825 Calibrator 6 x 4.0 mL 8
Thyroglobulin 33860 Reagent 2 x 50 tests 100
33865 Calibrator 6 x 2.0 mL 4
33866 Diluent 1 x 14.0 mL
Thyroglobulin A32898 Reagent 2 x 50 tests 100
Antibody II A36920 Calibrator 6 total; S0 @ 4.0 mL 5
S1–S5 @ 2.5 mL
Total T3 33830 Reagent 2 x 50 tests 100
33835 Calibrator 6 x 4.0 mL 8
Total T4 33800 Reagent 2 x 50 tests 100
33805 Calibrator 6 x 4.0 mL 8
Thyroid Uptake 33810 Reagent 2 x 50 tests 100
33815 Calibrator 1 level; 6 x 1.0 mL 12
TPO Antibody A12985 Reagent 2 x 50 tests 100
A18227 Calibrator 6 x 2.0 mL 4
TSH (3rd IS)* / B63284 Reagent 2 x 100 tests 200
Diluted TSH (3rd IS) B63285 Calibrator 6 x 2.5 mL 5
Tumor Markers AFP / Dil-AFP 33211 300 test kit 6 x 50 tests 300
(Cals included) Cals: 7 x 2.5 mL 5
33210 * 100 test kit 2 x 50 tests 100
(outside US only)
33215 * Calibrator 7 x 2.5 mL 5
(for 100 test kit)
33216 Diluent 1 x 14.0 mL
BR Monitor 387620 Reagent 2 x 50 tests 100
(cancer antigen 15-3) 387647 Calibrator 6 x 1.5 mL 3
CEA 33200 Reagent 2 x 50 tests 100
33205 Calibrator 6 x 2.5 mL 5
33206 Diluent 1 x 4.0 mL
33209 QC 2 levels; 3 x 2.5 mL each
GI Monitor 387687 Reagent 2 x 50 tests 100
(cancer antigen 19-9) 387688 Calibrator 6 x 2.5 mL 5
Hybritech PSA 37200 Reagent 2 x 50 tests 100
37205 Calibrator 6 x 2.5 mL 5
37206 Diluent 1 x 14.0 mL
37209 QC 3 levels; 5.0 mL each

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# Tests or #
Calibrations
Assay Panel Assay Part # Description Volume
(@ 500 µL/
Calibration)
Tumor Hybritech free PSA 37210 Reagent 2 x 50 tests 100
Markers, 37215 Calibrator 6 total; S0 @ 5.0 mL 5
(continued) S1–S5 @ 2.5 mL
37219 QC 2 levels; 5.0 mL each
Hybritech p2PSA A49752 * Reagent 2 x 50 tests 100
A49753 * Calibrator 7 x 2.1 mL 4
B03704 Reagent 2 x 50 tests 100
B03705 Calibrator 7 x 2.1 mL 4
A56934 QC 3 levels; 5.0 mL each
OV Monitor 386357 Reagent 2 x 50 tests 100
(cancer antigen 125) 386358 Calibrator 6 x 2.5 mL 5
Research Use IL-6 (RUO) A30945 Reagent 2 x 50 tests 100
Only (RUO) A30944 Calibrator 6 total; S0 @ 4.0 mL 5
S1–S5 @ 2.5 mL
A30946 QC 3 levels; 2 x 2.5 mL each
AMH (RUO) B69047 Reagent 2 x 50 tests 100
B69048 Calibrator 6 x 2.0 mL 4
B69049 QC 3 levels; 2 x 2.0 mL each
* Not available in the U.S.
† Distributed by Beckman Coulter for Bio-Rad for use on Beckman Coulter immunoassay systems. Bio-Rad is a
trademark of Bio-Rad Laboratories, Inc.
** These products are being replaced world wide with AccuTnI+3 as registrations are obtained. AccuTnI will be
discontinued, please check with your local Beckman Coulter Representative for product availability.
†† The AccuTnI reagent available in your country depends on the status of registration with local regulatory agencies.
*** These products are being replaced world wide with Total ßhCG (5th IS) as registrations are obtained. Total ßhCG
will be discontinued, please check with your local Beckman Coulter Representative for product availability.
††† These products are being replaced worldwide with TSH (3rd IS) as registrations are obtained. HYPERsensitive and
Fast hTSH will be discontinued. Please check with your local Beckman Coulter Representative for product
availability.

System Supplies
System supplies are organized alphabetically in two tables. The first table contains supplies ordered through
Customer Service. The second table contains supplies ordered through Technical Support.

To obtain the following supplies:

• In the U.S.A. or Canada, contact Customer Service at 1-800-526-3821.
• Outside the U.S.A. and Canada, contact your local Beckman Coulter representative.

System Supply Description Part # Quantity

Aspirate probe supplies:
Aspirate probe, stainless steel universal 8409B* 1
Aspirate probe cleaning kit 80769 (Syringe, fitting assembly,
and 10 brushes)
Aspirate probe brushes, disposable 973001 10

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System Supply Description Part # Quantity

Citranox† acid cleaner and detergent 81912 1 gallon
Contrad † 70 cleaning solution 81911 1 liter
Data storage devices:**
Travan † 8 GB tape** 973087 1
Travan 20 GB tape** 386175 1 box of 3 tapes
**
USB 8 GB Flash Drive A81923 1
Printer supplies are no longer available from Beckman Coulter, Inc. Obtain printer supplies from your local office supplier or the
printer manufacturer.
Reaction vessel cartridges 81901 16 @ 98 vessels each
Sample Diluent A 81908 1 x 4 mL
Sample containers
0.5 mL sample cups, Beckman Coulter 651412 1000
1.0 mL/13 mm insert cups, Beckman Coulter 81915 1000
1.0 mL/13 mm insert cup caps 81920 1000
2.0 mL/13 mm sample cups, Beckman Coulter 81902 or 652730 1000
2.0 mL/16 mm insert cups, Beckman Coulter 81917 1000
3.0 mL sample containers, Beckman Coulter 81914 500
*
3.0 mL sample container caps 81922A 1000
Autoaliquot tubes (13x100 mm false bottom), Beckman Coulter 2910034 4000
Pediatric insert cups, 1.0 mL, Beckman Coulter 81916 1000
Pediatric tube adapters for 13 mm rack, Beckman Coulter 472987 100
Sample racks:
13 mm 81606 6
16 mm x 100 mm 81608 6
16 mm x 75 mm Elevated 81609 6
Sample rack bar code label kit 973099 57 bar code label
Substrate 81906 4 @ 130 mL each
Swab applicators, fiber-free polyester 104838 100
System Check Solution 81910 6 @ 4 mL each
Wash buffer II, Access A16792 4 @ 1950 mL each
Waste bags, reaction vessel 81904 20
* An item with a part number ending in a letter may be revised from time to time. If you have difficulty ordering this
item, ask your Beckman Coulter representative to check for a more recent revision.
† Citranox is a trademark of Alconox, Inc.
Contrad is a trademark of Decon Laboratories, Inc.
Travan is a trademark of Imation Corp.
** Be sure to order the appropriate data storage device for your Access 2 system. Storage devices are not
interchangeable. Contact Technical Support if you cannot determine which storage device to order for your system.

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To obtain the following supplies:

• In the U.S.A. or Canada, contact Technical Support by phone at 1-800-854-3633.
• Outside the U.S.A. and Canada, contact your technical support representative.

System Supply Description Part # Quantity

CARE Kit 973077 1
Keyboard templates:
English 973041 1
French 973254 1
German 973256 1
Italian 973257 1
Spanish 973255 1
Manuals / System Documentation:
Installation Implementation Guide; Paper, with binder 973265 1
LIS Vendor Information document CD-ROM; English 387848 1
Maintenance and Service Log; Paper, with binder 973266 1
Material Safety Data Sheet (MSDS) CD-ROM (Multilingual) A85935 1
Individual MSDSs are also available at http://www.beckmancoulter.com
Instructions for Use; Paper, with binder
English B14256 1
Chinese, Simplified B14193 1
Czech B14189 1
Danish B14207 1
Dutch C07758 1
French B14195 1
Italian B14199 1
German B14201 1
Greek B14191 1
Hungarian B14187 1
Japanese B14780 1
Lithuanian B14185 1
Norwegian B14211 1
Polish B14209 1
Portuguese B14203 1
Romanian B79295 1
Russian B14183 1
Spanish B14197 1
Swedish B14205 1
Turkish B14213 1
Operator’s Guide; Paper, with binder; English B14252 1
Reference Manual; Paper, with binder; English B14254 1
Nozzle/O-ring (for probe wash tower) 81051 1
Probes/pipettors and supplies:
Dispense probe 8299B* 1
Pipettor tip, 3-inch (Primary probe) 6071 1
Pipettor torque tool 7343A* 1
Substrate probe 7143C* 1

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System Supply Description Part # Quantity

Tubing:
Aspirate probe 79102 1 foot length
Peristaltic pump aspirate 77372 1
Peristaltic pump vacuum 77512 1
Vessel holders:
Chamfered (hole in top), no magnet 973005 65
Home position, chamfered, with magnet 973006 1
Wash buffer valve assembly (dispense cap assembly) A49183 1
Waste bottle with lid and fittings 6769C* 1
Waste drain kit 7154A* 1
Waste filter/bottle assembly 80171 1
* An item with a part number ending in a letter may be revised from time to time. If you have difficulty ordering this
item, ask your Beckman Coulter representative to check for a more recent revision.

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