Beckman Coulter AutoMate 2500 series User manual

Instructions for Use
AutoMate 2500 Family Sample Processing System
B67471B
July 2018
Manufactured by
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821 U.S.A.

Instructions for Use
AutoMate 2500 Family Sample Processing System
PN B67471B (July 2018)
© 2018 Beckman Coulter, Inc.
All Rights Reserved.
Trademarks
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.
All other trademarks are the property of their respective owners.
Find us on the World Wide Web at:
www.beckmancoulter.com
EC REP
Beckman Coulter Eurocenter S.A.
22, rue Juste-Olivier
Case Postale 1044
CH -1260 Nyon 1, Switzerland
Tel: [phone]
Original Instructions

Revision History
This document applies to the latest software listed and higher versions. When a subsequent
software version changes the information in this document, a new issue will be released.
Following are the release dates for the original language English Instructions for Use.
Localized versions have followed at different times but always correspond to the latest
released version of the English manual.
Release date Revisions
May 2007 • AutoMate software version 3.0
May 2010 • AutoMate software version 4.0
June 2011 • AutoMate software version 4.1
February 2013 • AutoMate software version 4.1.1
February 2014 • AutoMate software version 4.1.3
June 2014 • New EZ Pipettor hardware: cleaning procedure and troubleshooting.
December 2015 • AutoMate software version 4.1.5. No changes in Graphical User Interface.
•Consumables and Spare Parts: B59017 Safe Sampling Closer (500 µl),
B59018 Safe Sampling Closer (1000 µl).
•Secondary Screw Cap Tubes refit for aliquoter module available.
•Filter tips that come in a gray rack available for the aliquoter.
• Non-essential operational information removed to The AutoMate 2500
Family Reference Manual.
March 2016 • AutoMate software version 4.1.5. Minor editorial changes.
•Aliquot Module Maintenance: Changed part number of syringe kit from
ODL08201 to ODL08211.
•Consumables and Spare Parts: Removed B59017 Safe Sampling Closer
(500 µl) and B59018 Safe Sampling Closer (1000 µl). They are not
available.
B67471B iii

Release date Revisions
May 2016 Changed maintenance schedule in order to reflect cleaning requirements for EZ
Pipettor. Daily cleaning is no longer required. Daily visual inspection instead
and cleaning only as required. Changes were made to the following sections:
•Maintenance Schedule
•Clean the Tip Carrier of EZ Pipettor (GEN 2)
February 2017 Changes were made to the following sections:
•Exchange the Film Cassette: Added pathway to instructional video stored
on AutoMate PC.
•Remove Parafilm Jam: Added pathway to instructional video stored on
AutoMate PC.
•Start the System: Corrected information on computer position
•Replace Gripper Jaws Of The Tube Gripper: Updated image to represent
current system parts
New sections added:
•System Freeze: Added instructions on recovering from a system freeze.
•Camera Inspection Window: Added description of the camera inspection
window.
•Tubes: Added topic describing the useable range of tube dimensions for
the AutoMate 2500 Family systems
•Glossary Of Standard Symbols Used In AutoMate 2500 Family System
Labels: Added list of standard symbols in use in current labels.
•Glossary Of Custom Labels Used In AutoMate 2500 Family Systems:
Added list of custom labels.
•Position Of Labels On AutoMate 2500 Family Systems: Added figure
displaying position of labels referred to in label glossary topics.
•Compliance Information: Added topic describing new compliance label
Removed topics:
• Removed topics describing position of old labels on the AutoMate 2500
Family Systems.
• Removed topic describing Recycling Label.
Revision History
iv B67471B

Release date Revisions
July 2018 As part of AutoMate Software Version 4.1.9, changes were made to the
following sections
•Maintenance Schedule: Added new compressor maintenance step and
clarified impacted compressors.
•Add Oil: specified impacted compressor.
•Compressor Types: listed new compressor.
•Check Oil Level: specified impacted compressor.
•Empty the drain bottle: specified impacted compressor.
•Safety instructions: added note about California Proposition 65.
•Depressurize compressor (with and without shut off valve): added
instructions for new compressor.
•EC Declaration by the Manufacturer: added RoHS compliance
information.
As part of the update, the following new sections were added:
•No Order Buffer Rack: described new feature.
•Clean air intake filter: created new compressor maintenance step.
•No Order Buffer Rack Frequently Full: added troubleshooting for new
feature.
•Troubleshooting the No Order buffer rack: added troubleshooting for new
feature.
•No Order buffer rack full: added troubleshooting for new feature.
•No Order buffer rack cannot be found: added troubleshooting for new
feature.
Revision History
B67471B v

Revision History
vi B67471B

Safety Notice
Read all product manuals and consult with Beckman Coulter trained personnel before you
operate the system. Do not perform any procedure before you carefully read all
instructions. Always follow the product labels and the recommendation from the
manufacturer. For more information, contact Beckman Coulter.
Symbols and Warnings
Alerts for Warning, Caution, Important, Note, and Tip
Warning
Warning indicates a potentially hazardous situation which, if not avoided, could
cause death or serious injury. Warning can indicate the possibility of erroneous data
that could cause an incorrect diagnosis.
Caution
Caution indicates a potentially hazardous situation which, if not avoided, can cause
minor or moderate injury. Caution can also alert against unsafe practices, or indicate
the possibility of erroneous data that could cause an incorrect diagnosis.
Important
Important indicates important information to follow.
Note
Note indicates notable information to follow.
Tip
Tip indicates information to consider.
Symbols Used
The following symbols are used in our documentation.
B67471B vii

Symbol Meaning
Biological risk
This symbol warns of biohazardous material or risk of being
contaminated.
Caution
This symbol indicates a potential hazard which, if not avoided, could
result in minor or moderate injury.
Electrical hazard
This symbol denotes an area of the system that should under no
circumstances be accessed as an electric shock risk exists.
Laser radiation
This symbol warns that a laser is part of the device. To avoid eye
injuries do not look directly into the laser beam.
Hand injury
This symbol indicates areas where there is a risk of injury to fingers
or the hand due to instrument movement.
Wear Gloves
Wear Eye Protection
Disconnect Mains Plug
Safety Instructions
Caution
Observe the following safety instructions when working on the system:
Safety Notice
Safety Instructions
viii B67471B

Inspect the working environment
To avoid injury, inspect your working environment for edges, corners, or protruding parts
before working on the system.
Avoid moving parts
While the system is in operation, do not touch or go close to any moving parts. Close
protective guards and covers during operation. Failure to close covers correctly can cause
injury or incorrect results.
Disconnect system from the mains when working on electrical cabinet
The electrical cabinet contains live wires even when the main switch is turned off. These
wires have visible, yellow markings near all connection points.
Check locking of safety cover position
When lifting safety covers, lock the cover in the raised position before releasing it to avoid
injury.
Risk of injury caused by heavy load
During installation, you risk injuring your hands, fingers and back while handling heavy
loads. To avoid these risks, carry or transport the system or parts of the system following
the specified transportation instructions.
Avoid contact with sample fluid
Avoid direct contact with patient samples, disposable pipette tips, used caps, any machine
components that come in contact with sample fluids, and liquid waste. Always wear gloves
and other protective gear to protect yourself from infection. Before troubleshooting the
system with open doors and covers, remove patient samples. Handle all liquid waste as
potentially infectious. Some liquid waste can require special treatment before disposal.
Follow your laboratory procedure.
Take measures after contact with sample fluid
If you come into direct contact with sample fluid, thoroughly wash the affected area and
consult a physician. Immediately wipe off any contaminants from the system. Clean the
system using approved liquid disinfectant. After working on the system, clean your hands
thoroughly.
Use non bio-hazardous substitutes only when performing tests
Take protective measures if you have to test the system using patient samples. Use
protective equipment for your eyes, nose, and mouth, such as safety glasses or a visor or
mask.
Wear protective clothing
Wear protective clothing and follow universal precautions as dictated by local or national
regulations (CLSI GP17-A2, ISO15190 or 29CFR 1910.1030).
Safety Notice
Safety Instructions
B67471B ix

Biological risks and hand injury when removing samples
If it is necessary to remove a sample tube manually from the robot grippers, take care not
to come into contact with the sample.
Contamination by exceeded fill level
Exceeding the maximum fill level can contaminate the device and samples.
Use only input and output drawers for loading and unloading tubes
While the system is running, only use the input and output drawers to load racks and tubes.
Do not reach into the system to manually insert or remove tubes while the system is
running! If you need to remove tubes manually, for example in case of an error, stop the
system first.
Do not enable remote access to any AutoMate 2500 Family product PCs.
Do not enable remote access to any of the AutoMate 2500 Family PCs (including the
Sorting-Drive Plus, Sorting-Drive Professional or iPAW PC) or install any other software!
Doing so can disrupt correct operation of the PC.
California Proposition 65
Warning
California Proposition 65
This product can expose you to chemicals known to the State of California to cause
cancer and reproductive harm.
For more information go to https://www.P65Warnings.ca.gov.
Safety Recommendations
Avoid problems caused by power failure
To avoid the problems caused by a power failure and to protect sample data, we
recommend using a UPS (uninterruptible power supply).
Software restart mandatory after intended or unintended power interruptions
After any intended or unintended power interruption, be sure to restart the software and
to perform a complete system initialization.
Equipment damage due to failure to meet power requirements
Before connecting the system to the power line, check that the voltage and frequency
ratings of your power line match those indicated on the device label.
Safety Notice
Safety Recommendations
xB67471B

Disconnect mains plug
Always disconnect mains plug when working on electronic parts or on parts connected to
the power supply.
Read documentation
Read and understand the documentation before operating the system.
Compliance Information
Recycling
This label is required in accordance with the Waste Electrical and Electronic Equipment
(WEEE) Directive of the European Union. The presence of this label indicates that:
1. The device was put on the European Market after August 13, 2005
2. The device is not to be disposed of via the municipal waste collection system of any
member state of the European Union
Customers must understand and follow all laws regarding the correct decontamination and
safe disposal of electrical equipment. For Beckman Coulter products bearing this label,
contact your dealer or local Beckman Coulter office for details on the take-back program
that facilitates the correct collection, treatment, recovery, recycling and safe disposal of
these products.
For the Japan Market:
This system is considered an industrial waste, subject to special controls for infectious
waste. Prior to disposal of the system, refer to the "Waste Disposal and Public Cleaning
Law" for compliance procedures.
C-Tick Mark
The C-Tick mark is intended for use on products that comply with the applicable
Electromagnetic Compatibility (EMC) standards in the Australian or New Zealand market.
CE Mark
CE marking attests the conformity of the product with the applicable requirements of the
relevant European Community harmonization legislation.
CSA Mark
Safety Notice
Compliance Information
B67471B xi

Indicates that the product was tested and has met the certification requirements for
electrical, plumbing and/or mechanical products in Canada and the United States.
Figure 1
Intended use
The AutoMate 2500 Family is a series of semi-open pre and post-analytical sample
processing and sorting systems. The system automates the process of sorting, decapping,
and archiving samples. The tube and cap type and cap color of a sample is identified.
Optional features include:
• Aliquot module to create labeled secondary tubes and detect that the sample volume is
sufficient for the requested aliquots
• Recapper module to reseal decapped tubes for archiving
Misuse
Important
Only use AutoMate 2500 Family systems for the intended use!
Any use of AutoMate 2500 Family systems which is not explicitly defined in this manual as
compliant with the intended use is regarded as a violation of the intended use. Any use or
operation of 2500 Family systems beyond the intended use will render warranty and
liability claims null and void.
Violation of the intended use include:
• Modifications to the system installation or configuration (contact your local Beckman
Coulter representative)
• Use of accessories or consumables not approved by Beckman Coulter
• Operation of the system by untrained staff
Safety Notice
Intended use
xii B67471B

• Access to the system by untrained staff
• Manipulation of safety devices
• Disregard of the warnings and cautions in this manual
• Disregard of applicable standards, guidelines and other provisions
• Disregard of the service and cleaning instructions in this manual
• Do not enable remote access to any of the AutoMate 2500 Family PCs (including the
Sorting-Drive Plus, Sorting-Drive Professional or iPAW PC) or install any other
software! Doing so can disrupt correct operation of the PC.
Owner's responsibility
The owner is responsible for:
• Maintaining the equipment in optimum condition to prevent equipment failure and
possible health hazards. The equipment requires regular maintenance to guarantee
technical reliability.
• Providing adequate lighting and ventilation of the operating area.
• Giving equipment operators regular instruction for their responsibilities and ensuring
compliance.
Only authorized staff can service the system. Any attempt to repair equipment under
warranty will violate that warranty.
Note
Operating a system that is unfit for use is considered an infringement of the intended
use. The operator assumes liability for personal injury and damage to property
resulting from non-compliance with the instructions provided for the product.
Risk Management
The AutoMate System is designed and manufactured on the basis of a risk management
analysis in compliance with ISO 14971. The risk management checklist for the AutoMate
and the ANSI Z535.4 standard are the basis for all safety labels and instructions and defined
sources of danger.
Machine Safety Labels
The following sections give you an overview about the different safety relevant labels on
the system and their meaning.
Safety Notice
Owner's responsibility
B67471B xiii

Glossary of Symbols Used in AutoMate 2500 Family System Labels
Symbol Standard Number And Title Of
Standard
Title of Symbol And
Symbol Reference
Number
Meaning Of Symbol
IEC 60878. Graphical Symbols for
electrical equipment in medical
practices.
Warning; Biological
Hazard,
ISO 7010-W009
To warn of a
biological hazard.
ISO 15223-1. Medical devices -
Symbols to be used with medical
device labels, labelling and
information to be supplied - Part
1: General Requirements.
Caution,
5.4.4.
Indicates the need for
the user to consult
the instructions for
use for important
cautionary
information such as
warnings and
precautions that
cannot, for a variety
of reasons , the
presented on the
medical device itself.
IEC 60878. Graphical Symbols for
electrical equipment in medical
practices.
Warning; Hot surface,
ISO 7010-W017
To warn of a hot
surface.
IEC 60878. Graphical Symbols for
electrical equipment in medical
practices.
Warning; Sharp
elements,
ISO 7010-W022
To warn of a sharp
element.
IEC 60878. Graphical Symbols for
electrical equipment in medical
practices.
Warning; Laser Beam,
ISO 7010-W004
To warn of a laser
beam.
ISO 15223-1. Medical devices -
Symbols to be used with medical
device labels, labelling and
information to be supplied - Part
1: General Requirements.
Consult instructions
for use,
5.4.3
Indicates the need for
the user to consult
the instructions for
use.
ISO 15223-1. Medical devices -
Symbols to be used with medical
device labels, labelling and
information to be supplied - Part
1: General Requirements.
Serial Number,
5.1.7
Indicates the
manufacturer's serial
number so that a
specific medical
device can be
identified.
ISO 15223-1. Medical devices -
Symbols to be used with medical
device labels, labelling and
information to be supplied - Part
1: General Requirements.
Catalogue Number,
5.1.4
Indicates the
manufacturer's
catalogue number so
that the medical
device can be
identified.
Safety Notice
Machine Safety Labels
xiv B67471B

Symbol Standard Number And Title Of
Standard
Title of Symbol And
Symbol Reference
Number
Meaning Of Symbol
ISO 15223-1. Medical devices -
Symbols to be used with medical
device labels, labelling and
information to be supplied - Part
1: General Requirements.
Authorised
representative in the
European Community,
5.1.2
Indicates the
authorized
representative in the
European community.
ISO 15223-1. Medical devices -
Symbols to be used with medical
device labels, labelling and
information to be supplied - Part
1: General Requirements.
Manufacturer,
5.1.1
Indicates the medical
device manufacturer
as defined in EU
Directives 90/385/
EEC, 93/42/EEC and
98/79/EC.
ISO 15223-1. Medical devices -
Symbols to be used with medical
device labels, labelling and
information to be supplied - Part
1: General Requirements.
Date of Manufacture,
5.1.3
To indicate the date
when the medical
device was
manufactured.
Glossary of Labels Used On AutoMate 2500 Family Systems
Label Meaning Of Label Figure Callout1
Consult the Instructions For Use. The
instructions for use can be obtained by
contacting your local Beckman Coulter
representative or obtained
electronically at:
www.beckmancoulter.com/ifu
(19)
Caution - risk of injury from moving
parts.
(1,5)
Warning; Hot Surface. Consult the
instructions for use.
(13)
Warning; Sharp Element. (6) 2
Warning; Biological Hazard. (4) 2
Safety Notice
Machine Safety Labels
B67471B xv

Label Meaning Of Label Figure Callout1
AutoMate Name Rating Plate. Conveys
information regarding the specific
AutoMate 2500 Family System.
(8)
Warning; Biological Hazard. Caution -
risk of injury from moving parts. Consult
the Instructions For Use.
(2,10-12,17,23)
Normal working pressure of compressor
is 6 bar / 87 psi.
(3)3
Do not rotate manually. (7) 2
Stop the system before opening
protective covers. When lifting a
protective cover, make sure that it locks
in the raised position before releasing it.
(14)
Fully extend drawers before accessing
trays to prevent contact with moving
parts.
(18)
Tube direction. (21) 3
Screw cap secondary tubes only! (22) 4
Laser Radiation, Class 2 Laser Product.
Do not stare into beam.
(15,16,20)
Safety Notice
Machine Safety Labels
xvi B67471B

Label Meaning Of Label Figure Callout1
Compliance label. Refer to Compliance
Information for details.
(9)
1 The numbers detailed in Figure Callout correspond with the callout numbers displayed
in the figure within Position of Labels on AutoMate Systems.
2 These labels are only present on AutoMate 2500 Family Systems with the optional
Recapper module installed.
3 These labels are only present on Automate 1250 and AutoMate 2550 Systems.
4 This label is only present on Automate 1250 and AutoMate 2550 Systems which have
been refitted according to MOD 11564: AutoMate 2500 Family Screw Cap Secondary
Tubes.
Position of Labels on AutoMate 2500 Family Systems
The Figure shows the positions of labels on the rear (top image) and front (bottom image)
of the AutoMate 2500 Family Systems. The numbers in the figure correspond with each
label listed in the Glossary of Labels on AutoMate 2500 Family Systems.
Safety Notice
Machine Safety Labels
B67471B xvii

Figure 2
Safety Notice
Machine Safety Labels
xviii B67471B

Contents
Revision History, iii
Safety Notice, vii
Introduction, xxiii
CHAPTER 1: System Overview, 1-1
Introduction, 1-1
Placement of Rack on Base Frame, 1-2
Drawer Handling, 1-3
Upper Drawers, 1-3
Lower Consumable Drawers (Aliquot Module), 1-4
Sample Processing, 1-5
Tube Status Overview, 1-5
Handling Rejected Tubes, 1-7
Technical Specifications, 1-8
Pump System, 1-8
Pipette Tips, 1-9
Tubes, 1-9
CHAPTER 2: Run the System, 2-1
Graphical User Interface, 2-1
System Menus, 2-2
Operating Options, 2-5
Tube Type and Cap Color Selection, 2-6
Consumable Status, 2-6
Open Drawer, 2-6
System Communication Status, 2-7
Sample Tube Distribution Status, 2-7
Status Bar, 2-7
Camera Inspection Window, 2-8
Preconditions Before You Start, 2-8
Input Drawer, 2-9
Output Drawer, 2-9
Systems with MTP Rack Reader, 2-9
Start the System, 2-9
Start the System with Sorting-Drive Connected, 2-13
Startup Checklist, 2-14
Before You Start Distribution, 2-15
Status Bars of Consumables and Waste (Aliquot Module), 2-15
View Status Bar Information, 2-15
Fill Up Consumables or Empty Waste Container, 2-16
Fill Up Disposable Pipette Tips, 2-17
Verify Tube Type Setting, 2-17
B67471B xix

Run Distribution, 2-17
Distribution Information, 2-18
Detailed Workplace Information, 2-18
Base Frame Information, 2-20
Rack Information, 2-20
Detailed Information on Sample Tubes, 2-21
Rack and Tube Information Warning, 2-23
Actions During Distribution, 2-23
Input Drawer, 2-23
Output Drawer, 2-26
Remove Single Tube from Conveyor Belt 01, 2-28
Remove Sample Tube from Robot Grippers, 2-29
Replace Pippette Tip after Error, 2-30
Aliquot Module Operation, 2-30
Safety Precautions, 2-30
Reload Secondary Tubes, 2-30
Screw Cap Secondary Tubes, 2-34
Empty the Waste Container, 2-36
Reset the Label Counter, 2-37
Reload Pipette Tips, 2-38
Operate Label Printer, 2-39
Detailed Rack Information, 2-53
Error Racks, 2-53
Archive Racks, 2-53
Recapper Buffer Rack, 2-53
No Order Buffer Rack, 2-54
Microtiter Plates (MTPs), 2-56
CHAPTER 3: User Maintenance, 3-1
Introduction to Maintenance, 3-1
Safety Precautions During Maintenance, 3-1
Maintenance Operation Sequence, 3-2
Cleaning and Decontamination, 3-4
How to Clean the System, 3-4
Recommended Disinfectant for Decontamination, 3-4
Distributors of Virkon Disinfectant, 3-4
Order Numbers for Virkon Disinfectant, 3-5
How to Apply Virkon, 3-5
List of Prohibited Cleaning Agents, 3-6
Maintenance Schedule, 3-6
Sorter Module Maintenance, 3-9
Clean the Decapper Cap Slide (AutoMate 1200/1250), 3-9
Clean the Components of Waste Hopper (AutoMate 2500/2550), 3-10
Contents
xx B67471B