Beckman Coulter AutoMate 2500 series User manual

Reference Manual
AutoMate 2500 Family Reference Manual
B85841D
May 2017
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821 U.S.A.

Reference Manual
AutoMate 2500 Family Reference Manual
PN B85841D (May 2017)
© 2017 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

Contents
Revision History, v
Safety Notice, vii
Introduction, xix
CHAPTER 1: System Overview, 1-1
System Features, 1-1
Input and Output Area, 1-1
Base Frame and Rack Types, 1-2
Base Frame Coding, 1-4
Sample Processing, 1-5
Sample ID Processing, 1-5
Overview of Sample Processing, 1-5
Tube Processing, 1-6
Processing Aliquots, 1-6
Overview of Sample Processing Steps, 1-9
Technical Specifications, 1-10
Technical Specifications: AutoMate 1200/2500, 1-10
Technical Specifications: AutoMate 1250/2550, 1-12
Throughput and Configuration Specifications, 1-14
Bar Code Label Format for Primary and Secondary Tubes, 1-15
Bar Code Label Design, 1-16
CHAPTER 2: Run the System, 2-1
Workplace Types, 2-1
Microtiter Plates (MTPs), 2-1
Microtiter Plates Dimensions, 2-1
CHAPTER 3: Troubleshooting, 3-1
Recapper: Remove a Parafilm Jam, Replace the Parafilm Roll, 3-1
APPENDIX A: AutoMate 2500 Family Documents, A-1
Related Documents, A-1
Glossary
Index
B85841D iii

Contents
iv B85841D

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.
Release date Revision Description
December 2015 A AutoMate software version 4.1.5. Additional
operational information moved to the AutoMate 2500
Family Reference Manual from the AutoMate 2500
Family IFU.
May 2016 B List of related documents updated.
October 2016 C Troubleshooting topic added on Recapper videos to
remove a Parafilm jam and exchange the Parafilm roll
April 2017 D Moved Tubes topic to IFU.
Updated voltage requirements in Electrical
Requirements for AutoMate 1200/2500 and Electrical
Requirements for AutoMate 1250/2550.
Added topic Compliance Information
Added topic Glossary of Symbols Used in AutoMate
2500 Family System Labels
Added topic Glossary of Labels Used in AutoMate 2500
Family Systems
Added topic Position of Labels on AutoMate Systems
B85841D v

Revision History
vi B85841D

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.
Symbol Meaning
Biological risk
This symbol warns of biohazardous material or risk of being
contaminated.
B85841D vii

Symbol Meaning
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:
Inspect the working environment
To avoid injury, inspect your working environment for edges, corners, or protruding parts
before working on the system.
Safety Notice
Safety Instructions
viii B85841D

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).
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.
Safety Notice
Safety Instructions
B85841D ix

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 the AutoMate 2500 Family PC. Do not install other software
on the AutoMate 2500 Family PC.
Do not enable remote access to the AutoMate 2500 Family PC or install any other software!
Doing so can disrupt correct operation of the PC and may lead to incorrect patient results.
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.
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.
Safety Notice
Safety Recommendations
xB85841D

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
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.
Safety Notice
Compliance Information
B85841D xi

Figure 1
C07698-A
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 the AutoMate 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 the
AutoMate beyond its 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
• Access to the system by untrained staff
• Manipulation of safety devices
Safety Notice
Intended use
xii B85841D

• 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 the AutoMate 2500 Family PC or install any other
software! Doing so can disrupt correct operation of the PC and may lead to incorrect
patient results.
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
B85841D 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 B85841D

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
www.beckmancoulter.com/ifu
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
AutoMate Name Rating Plate. Conveys
information regarding the specific
AutoMate 2500 Family System.
(8)
Safety Notice
Machine Safety Labels
B85841D xv

Label Meaning Of Label Figure Callout1
Warning; Biological Hazard. Caution -
risk of injury from moving parts. Consult
the Instructions For Use.
(2,10-12,17,23)
psi
6 bar
87
C07707-A
www.beckmancoulter.com/ifu
Normal working pressure of compressor
is 6 bar / 87 psi.
(3)3
C07347-A
Do not rotate manually. (7) 2
C07344-A
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)
C07344-A
Fully extend drawers before accessing
trays to prevent contact with moving
parts.
(18)
C07342-A
Tube direction. (21) 3
B67550-B
Screw cap secondary tubes only! (22) 4
CAUTION!
LASER RADIATION. CLASS 2 LASER PRODUCT.
DO NOT STARE INTO BEAM.
C07007-A
Max. output radiation: 1.5 mW Peak < 1.0 mW Average
Emitted wavelength: 655 nm
Pulse duration: < 300 µs
IEC60825-1:2007
Complies with 21CFR 1040.10 and 1040.11 except for deviations
pursuant to Laser Notice No. 50, dated June 24, 2007
Laser Radiation, Class 2 Laser Product.
Do not stare into beam.
(15,16,20)
B4 5 3 2 0 - AB
®
C US
1 6 9 5 0 2
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.
Safety Notice
Machine Safety Labels
xvi B85841D

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
B85841D xvii

Figure 2
1
2
8
10
8
11
8
12
8
13
6
5
479
3
14 21 22 18 19 23 15 16 20 17
Safety Notice
Machine Safety Labels
xviii B85841D

Introduction
About this Manual
This manual provides additional information on the AutoMate 2500 Family system
hardware and software, as well as its safe operation.
The recent version of the AutoMate 2500 Family Reference Manual is available for
download on www.beckmancoulter.com. If you open the page for the first time, you need to
select your region and your country (only necessary when accessing the website for the
first time).
Click Support>Technical Documents.
Select Market Segment Diagnostics, Product Line Automation, Product Series AutoMate,
Product AutoMate 2500 Family Systems. Download the AutoMate 2500 Family Reference
Manual.
Purpose and Target Group
This manual is addressed to operating staff. Operating staff roles include:
• Physicians
• Chemists and biologists
• Trained laboratory staff
All operating staff must be trained to use Beckman Coulter products on behalf of the owner.
These persons must be authorized by the owner for the fulfillment of their tasks.
The operator is responsible for the user maintenance procedures.
Information and Documentation Obligations
Comply with these documentation obligations:
• This manual must always be accessible to all operators of the system.
• Before operating the AutoMate system, all operators must read and understand this
manual.
• All operators must observe the safety precautions in this manual.
• All operators must be adequately informed about the modules of the AutoMate and
their principle of operation.
Definitions of Terms and Abbreviations Used in this Documentation
AU Analyzer Unit
BTU British Thermal Unit, energy unit, 1 BTU = 1,055 Joule
B85841D xix

LIS Laboratory Information System
MSDS Material Safety Data Sheets
MTP Microtiter Plates
Rack ID The bar code identifying the rack, typically a four-digit number Bar code type:
"NW-7 with checksum" (also referred to as "Codabar with checksum")
Sample Tube containing a specific material like serum, urine or others to perform the
tests on
TTP Thermal Transfer Printing
TTU Tube Transfer Unit
UPS Uninterruptible Power Supply
EC Declaration by the Manufacturer
The AutoMate conforms to the following EU product directives:
• 2006/42/EC concerning Machinery
• 2006/95/EC concerning Low Voltage Equipment
• 2004/108/EC concerning Electromagnetic Compatibility
Introduction
EC Declaration by the Manufacturer
xx B85841D