Beckman Coulter StatSpin Express 4 M510 User manual

Instructions for Use
StatSpin Express 4 Centrifuge Model Number M510
This manual is intended for
SSH4 – StatSpin Express 4 for 100-240 VAC, 50/60 Hz
55-006276-001CC
September 2018
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821 U.S.A.

Instructions for Use
StatSpin Express 4 Centrifuge Model Number M510
PN 55-006276-001CC (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
55-006276-001 CC, 09/2018
• Moved: Symbol/Regulatory Mark and a link to the website in the California
Proposition 65 statement
55-006276-001 CB, 3/2018
• Converted the StatSpin Express 4 Operations Manual to a Beckman Coulter
Instructions for Use (IFU) Manual, and made general clarifications to the IFU
• Added: Revision History, Safety Notice, Symbols and Definitions table, Alerts for
Warning, Caution, Important, Note, and Tip explanations, Warning and Cautions, and
How to Replace the Fuse
• Updated: Logo, Manufacturer address, Intended Use, and Limited Warranty statement
• Deleted: EC Rep
55-006276-001CC iii

Revision History
iv 55-006276-001CC

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.
55-006276-001CC v

Warning
Always operate the system with all shields and doors in position and secured 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 operate the centrifuge below the minimum operating temperature (2°C). Do
not store the rotor below the minimum storage temperature. Doing so will subject
the rotor materials to damage. See Specification.
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
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 55-006276-001CC

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
Outside of North America: do not use the power cord supplied. Use power cord for at
least 3.0 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.
•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 from the electrical outlet before performing maintenance
or inspection.
Safety Notice
Warnings and Cautions
55-006276-001CC vii

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 hex screw
tightened. Failure to install and secure the rotor correctly can damage the centrifuge.
Caution
Replace Tube Insert immediately if a tube breaks during centrifugation. Wear
Personal Protective Equipment (PPE) such as gloves, eye shields, and lab coats.
Safety Notice
Warnings and Cautions
viii 55-006276-001CC

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
from the wall 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
55-006276-001CC ix

Symbols and Definitions
Express 4 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
x55-006276-001CC

Express 4 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
55-006276-001CC xi

Express 4 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 55-006276-001CC

Express 4 Symbols Glossary (Continued)
Table 1
Symbol Description
Fuse
To identify fuse boxes or their location.
IEC 60417: Graphical symbols for use on equipment - Overview and
application, #5016
Supplemental Product-Specific Manufacturer Information
This symbol is used to identify a fuse location and rating.
Protective earth; protective ground
To identify any terminal which is intended for connection to an external
conductor for protection against electric shock in case of a fault, or the
terminal of a protective earth (ground) electrode.
IEC 60417: Graphical symbols for use on equipment - Overview and
application, #5019
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.
Safety Notice
Symbols and Definitions
55-006276-001CC xiii

Express 4 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.
Non-sterile
Indicates non-sterile product.
Temperature limitation
Indicates storage requirements limit.
Start button
The Start button initiates the selected cycle.
Stop or Open button
The Stop or Open button interrupts the cycle and stops the centrifugation.
This button releases the cover.
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.
Lock
Locked position for shield.
Unlock
Unlocked position for shield.
Safety Notice
Symbols and Definitions
xiv 55-006276-001CC

Contents
Revision History, iii
Safety Notice, v
CHAPTER 1: Installation, 1-1
Inspecting the Package, 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
Error Code Table, 2-2
Accessories, 2-4
CHAPTER 3: Operating Instructions, 3-1
Opening and Closing the Cover, 3-1
Cover Interlock By-pass, 3-1
Removing and Installing the Rotor, 3-1
Removing the Rotor, 3-1
Reinstalling the Rotor, 3-2
Spinning the Sample, 3-3
Loading, 3-3
Cycle Selection, 3-4
Unloading, 3-5
CHAPTER 4: Maintenance, 4-1
Overview, 4-1
Cleaning, 4-1
General Cleaning, 4-1
Disinfecting the Rotor, 4-2
Checking the Rotor Speed, 4-2
Inspecting the Rotor, 4-2
Periodic Maintenance Check, 4-3
Resetting the Cycle Counter, 4-3
Troubleshooting, 4-4
Replacing the Fuse, 4-5
Service, 4-6
APPENDIX A: Specifications, A-1
Specifications, A-1
55-006276-001CC xv

APPENDIX B: References, B-1
References, B-1
Contents
xvi 55-006276-001CC

CHAPTER 1
Installation
Inspecting the Package
The StatSpin Express 4 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 StatSpin Express 4 horizontal centrifuge (Product No. SSH4)
• One centrifuge rotor (Product No. RTH8)
• Eight rotor inserts for 13x100 mm tubes (Product No. SV09)
• Eight rotor inserts for 16x100 mm tubes (Product No. SV07)
• One line cord for use in North America only.
• One Instructions for Use Manual
• One manual latch release tool
• One 1/8 inch hex key
Installing the System
1Place the centrifuge on a solid level surface suitable for operation of 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 4 away from direct sunlight and sources of heat or cold.
3For the acceptable range of operating temperature and humidity, refer to Specifications.
4Remove the packaging around the rotor and in the lid before operating the centrifuge.
Connecting the Power
1Plug the centrifuge into a grounded outlet supplying 100-240 V @ 50-60 Hz.
55-006276-001CC 1-1

2Turn on the power switch (located on the rear panel, above the line cord connector).
3When the instrument is ready for use, it will give a two beep signal and illuminate the
two minute cycle light on the front keypad. Press the stop button to release the latch
and open the cover.
Warning
Outside of North America: do not use the power cord supplied. Use power cord
for at least 3.0 Amp with an IEC320/CEE22 female connector and male connector
suitable for the power outlet to be used.
Installation
Connecting the Power
1-2 55-006276-001CC

CHAPTER 2
System Overview
Intended Use
The StatSpin Express 4 is a high-speed horizontal bench top centrifuge used to rapidly
separate whole blood in the original sample collection tubes. Do Not centrifuge substances
with a density greater than 1.2 kg/dm3.
The horizontal rotor included with the centrifuge accepts up to 8 primary 16x100mm
primary blood tubes with a maximum volume of 10 mL per tube. The operator selects a
fixed spin time of 3, 5 or 10 minutes. The rotation speed is 5100 rpm for the 3 and 5 minute
cycles, producing a centrifugal force of 4000 xg at a rotor radius of 13.8 cm. The 10 minute
cycle generates 3100 xg at 4500 rpm. This setting provides lower g-forces for procedures
which require a traditional spin.
Operator Controls
Express 4 Operator ControlsTable 2.1
Symbol Description
Start button
The Start button initiates the selected cycle.
Stop or Open button
The Stop or Open button interrupts the cycle and stops the
centrifugation. This button releases the cover.
3 Minute Cycle
The 3 min button selects a cycle of three minutes at 5100
rpm.
5 Minute Cycle
The 5 min button selects a cycle of five minutes at 5100 rpm.
10 Minute Cycle
The 10 min button selects a cycle of ten minutes at 4500 rpm.
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.
Lock
Locked position for shield.
55-006276-001CC 2-1

Express 4 Operator Controls (Continued)
Table 2.1
Symbol Description
Unlock
Unlocked position for shield.
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
A flashing red Error or Service indicator on the control panel signals a StatSpin Express 4
error condition.
Use the combination of green cycle time indicators that are flashing to identify the cause of
the error condition. For more information, refer to Error Indicators.
To clear the error condition, correct the problem and press the Stop or Open button.
1. Error or Service light flashing
Error Code Table
Error Code TableTable 2.2
Cycle Time Indicator Combination Problem Solution
Failure to reach speed in 30
seconds. Confirm no obstruction in
bowl area, contact customer
service.
System Overview
Error Indicators
2-2 55-006276-001CC