Beckman Coulter Allegra X-5 User manual

PN B29071AE
April 2017
Instructions For Use
Allegra X-5
Centrifuge
Rx Only in the U.S.A.
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821 U.S.A.

Allegra X-5 Centrifuge
Instructions for Use
PN B29071AE (April 2017)
©2017 Beckman Coulter, Inc.
All rights reserved
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, service marks, products, or services
are trademarks or registered trademarks of their
respective holders.
Contact Us
If you have any questions, contact our Customer Support
Center.
• Worldwide, find us via our website at
www.beckmancoulter.com/customersupport/support
• In the USA and Canada, call us at 1-800-369-0333.
• Outside of the USA and Canada, contact your local
Beckman Coulter Representative.
Beckman Coulter Eurocenter S.A.
22, rue Juste-Olivier
Case Postale 1044
CH - 1260 Nyon 1, Switzerland
Tel: [phone]
Printed in the U.S.A.

PN B29071AE iii
Revision Status
This document applies to the latest software listed and higher versions. When a subsequent software version affects
the information in this document, a new issue will be released to the Beckman Coulter website. For labeling updates,
go to www.beckmancoulter.com and download the latest version of the manual or system help for your instrument.
Initial Issue 29071AA, 7/2013
Issue AB, 12/2015
Changes were made to: CE Mark
Issue AC, 03/2016
Changes were made to: Australian EMC Compliance Label, Preparation and Loading.
Issue AD, 04/2016
Changes were made to: Symbols and Labels.
Issue AE, 04/2017
Changes were made to: APPENDIX B, Table of Hazardous Substance’s Name and Concentration.
Note: Changes or additions that are part of the most recent revision are indicated in text by a bar in the margin of the
amended page.

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Revision Status

PN B29071AE v
Safety Notice
Read all product manuals and consult with Beckman Coulter-trained personnel before attempting
to operate the instrument. Do not attempt to perform any procedure before carefully reading all
instructions. Always follow product labeling and manufacturer’s recommendations. If in doubt as to
how to proceed in any situation, contact us.
Alerts for Danger, Warning, Caution, Important, and Note
DANGER
DANGER indicates an imminently hazardous situation which, if not avoided,
will result in death or serious injury.
WARNING
WARNING indicates a potentially hazardous situation which, if not avoided,
could result in death or serious injury.
CAUTION
CAUTION indicates a potentially hazardous situation, which, if not avoided,
may result in minor or moderate injury. It may also be used to alert against unsafe
practices.
IMPORTANT
IMPORTANT is used for comments that add value to the step or procedure being performed.
Following the advice in the Important adds benefit to the performance of a piece of equipment or to a
process.
NOTE NOTE is used to call attention to notable information that should be followed during installation, use,
or servicing of this equipment.

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Safety Notice
Safety During Installation and/or Maintenance
Safety During Installation and/or Maintenance
WARNING
Risk of personal injury or equipment damage. The centrifuge weighs 77 kg/169 lb.
DO NOT attempt to lift or move it without assistance from a lifting device and/or
another person.
WARNING
Risk of personal injury. Any servicing of this equipment that requires removal of
any covers can expose parts which involve the risk of electric shock or personal
injury. Make sure that the power switch is turned off and the instrument is
disconnected from the main power source by removing the Main (power) plug
from the outlet receptacle, and refer such servicing to qualified personnel.
Do not replace any centrifuge components with parts not specified for use on this instrument.
Electrical Safety
To reduce the risk of electrical shock, this equipment uses a three-wire electrical cord and plug to
connect this equipment to earth-ground. To preserve this safety feature:
• Make sure that the matching wall outlet receptacle is properly wired and earth-grounded.
Check that the line voltage agrees with the voltage listed on the name-rating plate affixed to the
instrument.
• Never use a three-to-two wire plug adapter.
• Never use a two-wire extension cord or a two-wire non-grounding type of multiple-outlet
receptacle strip.
• Do not place containers holding liquid on or near the chamber door. If they spill, liquid may get
into the instrument and damage electrical or mechanical components.
• Work on the power supply system must be performed by certified electricians.
• Inspect the electrical equipment of the unit regularly. Defects such as loose or burnt cables must
be eliminated immediately.

PN B29071AE vii
Safety Notice
Safety Against Risk of Fire
Safety Against Risk of Fire
WARNING
Risk of personal injury or equipment damage. This centrifuge is not designed for
use with materials capable of developing flammable or explosive vapors. Do not
centrifuge such materials (such as chloroform or ethyl alcohol) or materials which
could react chemically with sufficient vigor to cause a HAZARD, nor handle or
store them within the 30 cm (1ft) clearance envelope surrounding the centrifuge.
Do not use the centrifuge in hazardous locations.
Mechanical Safety
For safe operation of the equipment, observe the following:
• Use only the rotor and accessories designed for use in this centrifuge.
• Before starting the centrifuge, make sure that the rotor tie-down screw is securely fastened.
• Do not exceed the maximum rated speed of the rotor in use.
• NEVER attempt to slow or stop the rotor by hand.
• Do not lift or move the centrifuge while the rotor is spinning.
• If a glass tube breaks inside the chamber bowl, be careful when examining or cleaning the
gasket or chamber, as sharp glass fragments may be embedded in their surfaces.
• NEVER attempt to override the door interlock system while the rotor is spinning.
• Maintain a 30 cm (12 in.) clearance envelope around the centrifuge while it is running. During
operation you should come within the envelope only to adjust instrument controls, if necessary.
Never bring any flammable substances within the 30 cm (12 in.) area surrounding the
centrifuge. Never lean on the centrifuge or place items on the centrifuge while it is operating.
• Never operate the instrument without a rotor installed.
Chemical and Biological Safety
Normal operation may involve the use of solutions and test samples that are pathogenic, toxic, or
radioactive. Such materials should not be used in this instrument unless all necessary safety
precautions are taken.
• Observe all cautionary information printed on the original solution containers prior to
their use.
• Handle body fluids with care because they can transmit disease. No known test offers complete
assurance that they are free of micro-organisms. Some of the most virulent— Hepatitis (B and
C) and HIV (I–V) viruses, atypical mycobacteria, and certain systemic fungi—further emphasize
the need for aerosol protection. Handle other infectious samples according to good laboratory
procedures and methods to prevent spread of disease. Because spills may generate aerosols,

PN B29071AE
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Safety Notice
Chemical and Biological Safety
observe proper safety precautions for aerosol containment. Do not run toxic, pathogenic, or
radioactive materials in this centrifuge without taking appropriate safety precautions. Biosafe
containment should be used when Risk Group II materials (as identified in the World Health
Organization Laboratory Biosafety Manual) are handled; materials of a higher group require
more than one level of protection.
• Dispose of all waste solutions according to appropriate environmental health and safety
guidelines.
• Do not centrifuge materials that could result in a hazardous chemical reaction.
It is your responsibility to decontaminate the centrifuge and accessories before requesting service
by Beckman Coulter.

ix
Contents
Revision Status,iii
Safety Notice,v
Alerts for Danger, Warning, Caution, Important, and Note,v
Safety During Installation and/or Maintenance,vi
Electrical Safety,vi
Safety Against Risk of Fire,vii
Mechanical Safety,vii
Chemical and Biological Safety,vii
Introduction,xv
Intended Use,xv
Certification,xv
Scope of Manual,xv
Conventions,xvi
Typographic Conventions,xvi
CFC-Free Centrifugation,xvi
Symbols and Labels,xvi
Biohazard,xvi
Caution Symbol,xvii
High Voltage Danger,xvii
Protective Ground,xvii
Recycling Label,xvii
Risk of Fire Warning,xviii
Electric Shock Warning, xviii
Rotor Rotation,xviii
China RoHS Caution Label,xix
Australian EMC Compliance Label,xix
CE Mark,xix
Consult IFU Label,xx
IVD Label,xx
TUV-NRTL Label,xx
CHAPTER 1: Description,1-1
Introduction,1-1
Centrifuge Function and Safety Features,1-1

x
Contents
Centrifuge Function,1-2
Safety Features,1-2
Chassis,1-3
Housing,1-3
Door,1-3
Rotor Chamber,1-3
Drive,1-4
Controls and Indicators,1-4
Power Switch,1-4
Control Panel,1-5
System Keys,1-5
Program Keys,1-6
Digital Displays,1-7
Name Rating Plate,1-8
Specifications,1-8
Rotor,1-9
CHAPTER 2: Operation,2-1
Introduction,2-1
Run Procedure,2-1
Preparation and Loading,2-2
Entering Run Parameters,2-5
Setting Run Speed,2-5
Setting RPM,2-5
Setting RCF,2-6
Setting Run Time,2-6
Setting Acceleration Rate,2-7
Setting Deceleration Rate,2-7
Starting a Run,2-8
Pulse Function,2-9
Changing Parameters During a Run,2-9
Stopping a Run,2-10
Unloading,2-10
Enabling or Disabling the Audible Tones,2-11
Summary of Run Procedures,2-11
CHAPTER 3: Troubleshooting,3-1
Introduction,3-1
User Messages,3-1
Other Possible Problems,3-3
Emergency Door Release,3-3

xi
Contents
CHAPTER 4: Care and Maintenance,4-1
Introduction,4-1
Maintenance,4-1
Preventive Maintenance,4-1
Cleaning,4-2
Tube Breakage,4-3
Decontamination,4-3
Sterilization and Disinfection,4-3
Storage and Transport,4-4
Storage,4-4
Notes on Transport,4-4
Transport Safety Device,4-4
Returning a Centrifuge,4-5
Supply List,4-6
Replacement Parts,4-6
APPENDIX A: Installation,A-1
Introduction,A-1
Installing the Instrument,A-1
Transportation Safety Devices,A-2
Transport Safety Device,A-2
Electrical Requirements,A-3
Test Run,A-5
APPENDIX B: Table of Hazardous Substance’s
Name and Concentration,B-1
,B-1
Beckman Coulter, Inc.
Allegra X-5 Centrifuge Warranty

xii
Illustrations
Illustrations
1.1 Front View,1-1
1.2 Back View,1-2
1.3 Interior View of the Rotor Chamber,1-4
1.4 The Power Switch,1-5
1.5 The Control Panel,1-5
1.6 Digital Displays,1-7
2.1 Tapered Sleeve Position,2-2
2.2 Examples of Correctly and Incorrectly Loaded Buckets and
Carriers,2-4
2.3 Default Parameters,2-5
3.1 Location of the emergency door release. opening.,3-4
3.2 Insertion of Allen wrench.,3-5
4.1 Locking Screws (Transport Safety Device),4-5
A.1 Locking Screws (Transport Safety Device),A-3
A.2 Dimensions of the Centrifuge,A-4

xiii
Tables
Tables
2.1 Acceleration/Deceleration Times (in minutes:seconds),2-7
3.1 Error Message Chart,3-2
3.2 Troubleshooting Chart,3-3

xiv
Tables

PN B29071AE xv
Introduction
Intended Use
For In Vitro Diagnostic Use.
This Allegra X-5 centrifuge is intended for the separation of components through the use of relative
centrifugal force.
It is designed to separate human samples, including blood and other body fluids, for processing,
analysis, and in vitro diagnostic testing, as well as non-human body samples and chemicals,
including industrial and environmental samples.
This centrifuge should be operated by qualified personnel only.
Certification
The Beckman Coulter Allegra X-5 Centrifuge is manufactured in a facility that maintains
certifications to ISO 9001:2008 or ISO 13485:2003. It has been designed and tested to be compliant
(when used with Beckman Coulter rotors) with the laboratory equipment requirements of
applicable regulatory agencies. Declarations of conformity and certificates of compliance are
available at www.beckmancoulter.com.
Scope of Manual
This manual is designed to familiarize you with the Beckman Coulter Allegra X-5 Centrifuge, its
functions, specifications, operation, and routine operator care and maintenance. Beckman Coulter
recommends that you read this entire manual, especially the Safety Notice section and all safety
related information, before operating the centrifuge or performing instrument maintenance.
The following introductory pages contain the instrument specifications, as well as space,
electrical, and temperature conditions required for optimal centrifuge performance. A list of
available rotors is also included.
• CHAPTER 1, Description provides a brief physical and functional description of the centrifuge
and the operating controls and indicators.
• CHAPTER 2, Operation contains centrifuge operating procedures.
• CHAPTER 3, Troubleshooting lists diagnostic messages and other possible malfunctions,
together with probable causes and suggested corrective actions.
• CHAPTER 4, Care and Maintenance contains procedures for routine operator care and
maintenance, as well as a brief list of supplies and replacement parts.

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Introduction
Conventions
• APPENDIX A, Installation contains instructions for installing and connecting the centrifuge.
NOTE
If the centrifuge is used in a manner other than specified in this manual, the safety and performance
of this equipment could be impaired. Further, the use of any equipment other than that recommended
by Beckman Coulter has not been evaluated for safety. Use of any equipment not specifically
recommended in this manual and/or the applicable rotor manual is the sole responsibility of the user.
Conventions
Certain symbols are used in the product labeling to call out safety-related and other important
information. These international symbols may also be displayed on the centrifuge and are
reproduced on the inside of the back cover of this manual.
Typographic Conventions
Certain typographic conventions are used throughout this manual to distinguish names of user
interface components, such as keys and displays.
• Key names (for example,
START or ENTER ) and display names (for example, TIME or SPEED )
appear in bold type.
• Cursor keys, used to increment values up or down when setting parameters, are shown as up and
down arrows (▲or ▼).
CFC-Free Centrifugation
To ensure minimal environmental impact, no CFCs are used in the manufacture or operation of
Allegra X-5 centrifuges.
Symbols and Labels
This section provides information for some labels and symbols appearing on the Allegra X-5
instrument housing. These labels and symbols may be associated with user-serviceable procedures.
Individual hazards associated with a specific procedure in this manual may use these labels and
symbols, and are included in Warnings or Cautions within the procedures for that task.
Biohazard
This caution symbol indicates biohazardous risk from possible patient specimen contamination.

PN B29071AE xvii
Introduction
Symbols and Labels
Caution Symbol
This symbol indicates a caution message and appears adjacent to an explanation or other symbols
that define the caution.
High Voltage Danger
This symbol indicates high voltage is present or that there is a risk of electric shock when working
in this area. Operation, replacement or servicing of any components where contact with bare, live
hazardous parts could occur, possibly resulting in electric shock, should only be performed by your
Beckman Coulter representative.
Protective Ground
This symbol is used to indicate a protective ground. This instrument must be properly grounded.
Do not under any circumstances operate the instrument unless it is properly grounded.
Recycling Label
This symbol 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:
• the device was put on the European Market after August 13, 2005 and
• the device is not to be disposed of via the municipal waste collection system of any member
state of the European Union.
A28219-AA

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Introduction
Symbols and Labels
It is very important that customers understand and follow all laws regarding the proper
decontamination and safe disposal of electrical equipment. For Beckman Coulter products bearing
this label, please contact your dealer or local Beckman Coulter office for details on the take-back
program that will facilitate the proper collection, treatment, recovery, recycling and safe disposal
of the device.
Risk of Fire Warning
Before replacing fuses, shut off power and disconnect the power cord. Failure to do so can cause
electric shock and/or equipment damage. Replace fuses only with approved type and rating
replacement fuse.
Electric Shock Warning
Operation, replacement or servicing of any components where contact with electronic components
could occur can result in electric shock, and should only be performed by your Beckman Coulter
representative.
Rotor Rotation
This label indicates the direction of the rotor rotation.

PN B29071AE xix
Introduction
Symbols and Labels
China RoHS Caution Label
This label and materials declaration table (APPENDIX B, Table of Hazardous Substance’s Name and
Concentration) are to meet People's Republic of China Electronic Industry Standard SJ/T11364-2006
“Marking for Control of Pollution Caused by Electronic Information Products” requirements.
This label indicates that this electronic information product contains certain toxic or hazardous
elements, and can be used safely during its environmental protection use period. The number in the
middle of the logo is the environmental protection use period 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.
Australian EMC Compliance Label
The C-Tick mark is intended for use on products that comply with Australian Communication
Authority (ACA) EMC Requirements.
CE Mark
A “CE” mark indicates that a product has been assessed before being placed on the market, and has
been found to meet European Union safety, health and/or environmental protection requirements.

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Introduction
Symbols and Labels
Consult IFU Label
This label indicates that the Instructions for Use should be referred to for more information.
IVD Label
This label indicates an In Vitro diagnostic medical device.
TUV-NRTL Label
This label indicates recognition by a Nationally Recognized Test Laboratory (NRTL) that the
instrument has met the relevant product safety standards.