Beckman Coulter StatSpin Express 2 M501-22 User manual

Instructions for Use
StatSpin Express 2 Centrifuge Model Number M501-22
This manual is intended for
SSX2 - Express 2 for 100 to 240 VAC, 50/60 Hz
55-003910-001FD
September 2018
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821 U.S.A.

Instructions for Use
StatSpin Express 2 Centrifuge Model Number M501-22
PN 55-003910-001FD (September 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
Original Instructions

Revision History
55-003910-001 FD, 09/2018
• Moved: Symbol/Regulatory Mark and a link to the website in the California
Proposition 65 statement
55-003910-001 FC, 3/2018
• Added: Symbols and Definitions table
• Updated: Manufacturer address, Warning and Cautions, Limited Warranty statement
• Deleted: CE, and EC Rep
55-003910-001 FB, 9/2016
• Converted the Express 2 Operator's Manual to a Beckman Coulter Instructions for Use
(IFU)
• Made general clarifications to the IFU
• Updated Logo
• Added CE, and EC Rep
• Deleted "In Vitro Diagnostics", and IVD symbol
• Added warning and caution statements, and updated existing warning and caution
statements
• Added the Recycling Label information
• Updated information in specification, symbol table, and troubleshooting sections
• Updated specifications, symbol tables, error codes, troubleshooting and maintenance
sections
• Updated the limited warranty statement
55-003910-001FD iii

Revision History
iv 55-003910-001FD

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 manufacturer’s recommendations. If
you have any questions:
• Visit http://www.beckmancoulter.com.
• US customers: Contact Beckman Coulter Customer Support at 1-800-854-3633.
• International customers: Contact your local distributor.
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.
Warnings and Cautions
Pay close attention to the instructions that accompany the notes and symbols and the
standard laboratory procedures outlined by your facility and local regulatory agencies.
55-003910-001FD v

Warning
Always operate the system with all shields in place and covers closed to avoid injury.
Perform system operations with caution.
Wear Personal Protective Equipment (PPE) such as gloves, eye shields, and lab coats.
Wash hands thoroughly after contact with sample media and all maintenance
activities.
Observe all laboratory policies and procedures related to the handling of
biohazardous materials.
Refer to the applicable sources (such as Material Safety Data Sheets) for specific
hazard information.
Warning
Do not expose the rotor to strong or concentrated acids, bases, esters, aromatic or
halogenated hydrocarbons, ketones, or strong oxidizing agents, or environmental
influences, including natural ultra-violet radiation.
Warning
Do not operate the centrifuge below the minimum operating temperature. Do not
store the rotor below the minimum storage temperature. Doing so will subject the
rotor materials to damage. See Specifications.
Warning
Handle and dispose of sharp fragments according to the World Health Organization's
Laboratory Biosafety Manual and relevant local and national regulations.
Warning
If the equipment is used in a manner not specified by Beckman Coulter, the
protection provided by the equipment may be impaired.
Warning
Inspect the instrument for cracks or any physical damage to housing, cover, and rotor
upon the receipt of the unit. Damage can cause unsafe operation; if damage or cracks
are found, discontinue use until repairs have been performed.
Safety Notice
Warnings and Cautions
vi 55-003910-001FD

Warning
Only reset the cycle counter after conducting the recommended inspections and
service. Resetting the cycle counter without performing the recommended
inspections and service reduces the reliability and safety of the instrument.
Warning
Only use the external power supply (Beckman Coulter Part Number B95657) included
with the centrifuge. This power supply is only for use with centrifuges that have a
marked input current rating of 3A (shall not be used on units rated 1.7A). Use of any
other external power supply can cause damage to the centrifuge and will void the
warranty.
Warning
Outside of North America: do not use the power cord supplied. Use power cord for at
least 2.0 Amp with an IEC320/CEE22 female connector and male connector suitable
for the power outlet to be used.
Warning
Picking up or moving the centrifuge during operation can cause injury to the operator
and/or damage to the centrifuge.
Warning
Electromagnetic Wave and Noise
The system generates, uses, and can radiate radio frequency energy. If the system is
not installed and operated correctly, this energy can cause interference with other
equipment. In addition, other equipment can radiate radio frequency energy to
which the system is sensitive. If you suspect interference between the system and
other equipment, Beckman Coulter recommends the following actions to correct the
interference:
•This equipment complies with the emission and immunity requirements described in this
part of the EN/IEC 61326 -1.
•As to emission, this system has been designed and tested to CISPR 11 Class A, so in a
domestic environment, it may cause radio interference, in which case, you may need to
take measure to mitigate the interference.
•It is recommended to evaluate the electromagnetic environment prior to operations of
the system.
•Do not use this system in close proximity to sources of strong electromagnetic radiation
(for example, unshielded intentional RF sources), as they can interfere with the proper
operation.
Safety Notice
Warnings and Cautions
55-003910-001FD vii

•Do not use mobile or cordless telephones and transceivers in the same room as the
system.
•Do not use medical equipment that can be susceptible to malfunctions caused by Electric
Magnetic Field (EMF) near the system.
Caution
Disconnect the power cord of the external power supply from the electrical outlet
before performing maintenance or inspection.
Caution
Do not spray cleaning solutions directly onto the centrifuge bowl or housing.
Overspray can reach the motor bearings or internal circuitry, causing harm to the
electronics. Before using any cleaning or decontamination methods other than those
recommended by the manufacturer, users should check with the manufacturer that
the proposed method will not damage the equipment.
Caution
During operation maintain a 30 cm (12 inch) clearance around the centrifuge. The
clearance must be free from obstruction and away from the edge of the surface that
the centrifuge is on.
Caution
Follow Universal Precautions with all biological specimens, regardless of whether the
specimen is known to contain an infectious agent. (See References)
Caution
Use the same size and style tubes in opposite positions. Balance liquid in tubes to
within 0.5mL. If glass tubes are used to balance rotor load, replace the glass balance
tube every ten cycles to prevent possible breakage caused by the repeated stress of
centrifugation. Replace the tube inserts immediately if a tube breaks during
centrifugation.
Caution
Inspect rotor on a routine basis. Rotor lifespan depends on usage. Inspect rotors for
cracks and replace the rotors immediately when any crack or visible wear occurs.
Caution
Never operate the centrifuge without the rotor properly mounted and the locking nut
tightened. Failure to install and secure the rotor correctly can damage the centrifuge.
Safety Notice
Warnings and Cautions
viii 55-003910-001FD

Caution
Replace Tube Insert immediately if a tube breaks during centrifugation. Wear
Personal Protective Equipment (PPE) such as gloves, eye shields, and lab coats.
Caution
Running the centrifuge repeatedly with an unbalanced load condition can cause
excessive vibrations and premature equipment failure.
Caution
The cover interlock bypass is for emergency use only. Disconnect the power cord of
the external power supply from the electrical outlet and ensure the rotor has come to
a complete stop before using the interlock bypass. If the equipment is not used
correctly, safety can be impaired.
Caution
The instructions prohibit use of the specified materials within the centrifuge
•flammable or explosive materials.
•materials which could react chemically with sufficient vigor to cause a hazard.
Caution
Ensure to replace the fuse with the correct type and rating for continued protection
against risk of fire and/or improper instrument operation.
Caution
If the fuse continues to blow after being replaced, contact service for additional
assistance.
Please use the instrument as intended. Improper use may cause damage to the instrument,
inaccurate results, or potentially nullify warranties.
Safety Notice
Warnings and Cautions
55-003910-001FD ix

Symbols and Definitions
Express 2 Symbols GlossaryTable 1
Symbol Description
Warning; Biological hazard
To warn of a biological hazard.
IEC 60878. Graphical Symbols for electrical equipment in medical practices.
#7010-W009
Supplemental Product-Specific Manufacturer Information
This label indicates a caution to operate only with all covers in position to
decrease risk of personal injury or biohazard.
This label indicates the use of biohazardous materials in the area. Use
caution when working with possible infectious samples.
Wear Personal Protective Equipment (PPE) such as gloves, eye shields, and
lab coats. Handle and dispose of biohazardous materials according to your
laboratory procedures.
Consult instructions for use
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. #5.4.3
Caution
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, be presented on the medical device itself.
ISO 15223-1. Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1: General
Requirements. #5.4.4
Moving Parts Symbol
The moving parts symbol indicates that there are moving parts in the area.
Only operate the system when all covers are in position and use caution to
reduce the risk of personal injury. While the system is operating, do not
touch the moving parts of the system. Do not insert fingers or hands into
any system opening.
Safety Notice
Symbols and Definitions
x55-003910-001FD

Express 2 Symbols Glossary (Continued)
Table 1
Symbol Description
cNRTLus Certification Mark
This symbol indicates recognition by a Nationally Recognized Testing
Laboratory (NRTL) that the system has met the relevant product safety
standards for the United States and Canada.
OSHA, CEC
RCM Symbol
This symbol indicates compliance with the Australian Communications
Media Authority (ACMA) requirements (safety and EMC) for Australia and
New Zealand.
Recycling Symbol
This label is required by 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 your local
Beckman Coulter Representative for more information on the take-back
program that facilitates the correct collection, treatment, recovery,
recycling, and safe disposal of these products.
EU Directive 2002-96-EC: waste electrical and electronic equipment (WEEE)
For the Japan market:
This system is considered an industrial waste, subject to special controls
for infectious waste. Before disposal of the system, refer to the Waste
Disposal and Public Cleaning Law for compliance procedures.
Safety Notice
Symbols and Definitions
55-003910-001FD xi

Express 2 Symbols Glossary (Continued)
Table 1
Symbol Description
RoHS Caution Symbol
This symbol 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 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.
These labels and materials declaration table (the Table of Hazardous
Substance's Name and Concentration) meet People's Republic of China
Electronic Industry Standard SJ/T11364-2006 Marking for Control of
Pollution Caused by Electronic Information Products requirements.
"OFF" (power)
To indicate disconnection from the mains, at least for mains switches or
their positions, and all those cases where safety is involved.
IEC 60417: Graphical symbols for use on equipment - Overview and
application, #5008
Supplemental Product-Specific Manufacturer Information
This symbol indicates the off position.
"ON" (power)
To indicate connection to the mains, at least for mains switches or their
positions, and all those cases where safety is involved.
IEC 60417: Graphical symbols for use on equipment - Overview and
application, #5007
Supplemental Product-Specific Manufacturer Information
This symbol indicates the on position.
Alternating current
To indicate on the rating plate that the equipment is suitable for
alternating current only; to identify relevant terminals.
IEC 60417: Graphical symbols for use on equipment - Overview and
application, #5032
Safety Notice
Symbols and Definitions
xii 55-003910-001FD

Express 2 Symbols Glossary (Continued)
Table 1
Symbol Description
Direct current
To indicate on the rating plate that the equipment is suitable for direct
current only; to identify relevant terminals.
IEC 60417: Graphical symbols for use on equipment - Overview and
application, #5031
Date of Manufacture
To indicate the date when the medical device was manufactured.
ISO 15223-1. Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1: General
Requirements. #5.1.3
Catalogue Number
Indicates the manufacturer's catalogue number so that the 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. #5.1.4
Serial number
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. #5.1.7
Country of Origin Symbol
This symbol indicates the country that the product was manufactured.
Polarity of d.c. power connector
To identify the positive and negative connections (the polarity) of a d.c.
power supply, or the positive and negative connections on a piece of
equipment to which a d.c. power supply may be connected.
IEC 60417: Graphical symbols for use on equipment - Overview and
application, #5926
Safety Notice
Symbols and Definitions
55-003910-001FD xiii

Express 2 Symbols Glossary (Continued)
Table 1
Symbol Description
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.
Temperature limitation
Indicates storage requirements limit.
Start button
The Start button initiates the pre-timed cycle at a fixed speed.
Note
The Express 2 has no on-off switch, and therefore is
normally left plugged in and on.
Stop or Open button
The Stop or Open button interrupts the cycle and stops the centrifugation.
This button can also be used to release the cover.
Cycle Selector
The Cycle Selector button allows for selection of the cycle.
Error or Service Indicator
The red indicator with an adjacent wrench symbol flashes to signal an
error condition or remains continuously illuminated when service is
needed.
Safety Notice
Symbols and Definitions
xiv 55-003910-001FD

Contents
Revision History, iii
Safety Notice, v
CHAPTER 1: Installation, 1-1
Inspecting the Packaging, 1-1
Confirming the Contents, 1-1
Installing the System, 1-1
Connecting the Power, 1-1
CHAPTER 2: System Overview, 2-1
Intended Use, 2-1
Operator Controls, 2-1
Error Indicators, 2-2
Accessories, 2-3
CHAPTER 3: Operating Instructions, 3-1
Opening and Closing the Cover, 3-1
Removing and Installing the Rotor, 3-1
Reinstalling the Rotor, 3-2
Spinning the Sample, 3-2
Unloading, 3-3
CHAPTER 4: Maintenance, 4-1
Overview, 4-1
Cleaning, 4-1
General Cleaning, 4-1
Disinfecting the Rotor, 4-2
Inspecting the Rotor Speed, 4-2
Troubleshooting, 4-3
Service, 4-3
APPENDIX A: Specifications, A-1
Specifications, A-1
APPENDIX B: References, B-1
References, B-1
55-003910-001FD xv

Contents
xvi 55-003910-001FD

CHAPTER 1
Installation
Inspecting the Packaging
The StatSpin Express 2 and its accessories are delivered in one carton. If the centrifuge or
accessories have suffered any damage in transport, inform your carrier immediately.
Note
Save shipping carton and components to simplify return if service is required.
Confirming the Contents
The package contains:
• One Express 2 centrifuge (Model No. M501-22)
• One centrifuge rotor (Product No. RTX4A)
• Four rotor inserts for 13x75-mm tubes (Product No. SV01)
• One external power supply (Beckman Coulter Part No. B95657)
• One grounded power cord (for North American use only)
• One Instructions for Use
• One tool for removing rotor, 7/16" Nut Driver
• Warranty Card - Complete the warranty registration card as directed.
Installing the System
1Place the StatSpin Express 2 on a level surface suitable for laboratory instrumentation.
Caution
During operation maintain a 30 cm (12 inch) clearance around the centrifuge. The
clearance must be free from obstruction and away from the edge of the surface
that the centrifuge is on.
2Position the StatSpin Express 2 away from direct sunlight and sources of heat or cold.
For the acceptable range of operating temperature and humidity, refer to Specifications.
3Remove the foam packaging around the rotor and in the lid before operating the
centrifuge.
Connecting the Power
Plug the external power supply into a grounded outlet supplying the voltage and frequency
indicated on the power supply. When power is connected, the 30s LED illuminates, two
55-003910-001FD 1-1

beeps sound, and the cover lock releases. To turn the system off completely, disconnect the
power located at the rear of the unit.
Warning
Only use the external power supply (Beckman Coulter Part Number B95657) included
with the centrifuge. This power supply is only for use with centrifuges that have a
marked input current rating of 3A (shall not be used on units rated 1.7A). Use of any
other external power supply can cause damage to the centrifuge and will void the
warranty.
Warning
Outside of North America: do not use the power cord supplied. Use power cord for at
least 2.0 Amp with an IEC320/CEE22 female connector and male connector suitable
for the power outlet to be used.
Installation
Connecting the Power
1-2 55-003910-001FD

CHAPTER 2
System Overview
Intended Use
The StatSpin Express 2 is a microprocessor controlled, high-speed bench top centrifuge
designed to rapidly separate whole blood in the original evacuated or syringe type
collection tubes.
The four-place 30° angle rotor included with the centrifuge is designed to provide rapid
separation while minimizing potential re-suspension of cells. The speed is fixed at 8500
rpm (± 5%), producing a centrifugal force of 4440 xg at the maximum tube radius of 5.5 cm.
The operator may select three factory-set timed cycles of 30, 120, and 180 seconds.
Operator Controls
Express 2 Operator ControlsTable 2.1
Symbol Description
Start button
The Start button initiates the pre-timed cycle at a
fixed speed.
Note
The Express 2 has no on-off switch,
and therefore is normally left plugged
in and on.
Stop or Open button
The Stop or Open button interrupts the cycle and
stops the centrifugation. This button can also be
used to release the cover.
Cycle Selector
The Cycle Selector button allows for selection of
the cycle.
Error or Service Indicator
The red indicator with an adjacent wrench symbol
flashes to signal an error condition or remains
continuously illuminated when service is needed.
55-003910-001FD 2-1

Note
Buttons should be depressed with finger tips only. Never press buttons with a sharp
object such as a pen, screwdriver, centrifuge insert, fingernail, etc. The buttons are
membrane switches designed to be activated by finger actuation. Use with any hard or
sharp object can cause damage to the tactile layer of the button, rendering the button
unstable and prone to premature failure.
Error Indicators
The combination of the Error / Service indicator and the cycle LEDs on the front panel
specify the error code.
Error/Service =
Quick Spin = 30 seconds
Normal Spin = 120 seconds
Hard Spin = 180 seconds
1. Error/Service indicator.
2. When 180s cycle LED and Error/Service indicator flash, it indicates the centrifuge is
unable to reach or maintain target rotor speed.
3. When 120s cycle LED and Error/Service indicator flash, it indicates cover opened or
cycle changed during operation.
4. The system beeps continuously if one of the following conditions are present:
— Centrifuge is over operating temperature
— Short circuit of the motor drives, fan, or solenoid
— Reduction in the availability of electrical power
— Short-term power failures
To stop the beeps, press the Stop button.
Error/Service light will continuously illuminate when the centrifuge has achieved a total
run time of 150 hours, which is the useful life of the drive system. Drive mechanism needs
replacing. Contact Beckman Coulter Customer Support.
System Overview
Error Indicators
2-2 55-003910-001FD