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- Page 1 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.
- Page 2 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.
- Page 3 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...
- Page 4 Revision History 55-006276-001CC...
- Page 5 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: •...
- Page 6 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.
- Page 7 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: •...
- Page 8 Safety Notice Warnings and Cautions 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.
- Page 9 Safety Notice Warnings and Cautions 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.
- Page 10 Safety Notice Symbols and Definitions Symbols and Definitions Table 1 Express 4 Symbols Glossary 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.
- Page 11 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.
- Page 12 Safety Notice Symbols and Definitions Table 1 Express 4 Symbols Glossary (Continued) 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.
- Page 13 Safety Notice Symbols and Definitions Table 1 Express 4 Symbols Glossary (Continued) 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;...
- Page 14 Safety Notice Symbols and Definitions Table 1 Express 4 Symbols Glossary (Continued) 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.
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Page 15: Table Of Contents
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... - Page 16 Contents APPENDIX B: References, B-1 References, B-1 55-006276-001CC...
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Page 17: Installation
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: •... - Page 18 Installation Connecting the Power Turn on the power switch (located on the rear panel, above the line cord connector). When 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.
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Page 19: System Overview
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/dm 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. -
Page 20: Error Indicators
System Overview Error Indicators Table 2.1 Express 4 Operator Controls (Continued) 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. - Page 21 System Overview Error Code Table Table 2.2 Error Code Table (Continued) Cycle Time Indicator Combination Problem Solution Latch is not locked. Confirm cover is fully seated in closed position. Rotor exceeded set speed. Remove and inspect rotor, reinstall. Cover is not closed. Confirm cover is fully seated in closed position.
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Page 22: Accessories
System Overview Accessories Accessories Table 2.3 Accessories Product No. Description SV02 Inserts for 3 mL tubes (10.25 x 64 mm) 4/pk. SV05 Inserts for 1.5 - 2.0 mL microtubes (10.25 x 47 mm or BD Microtainers) 4/pk. SV06 Inserts for 7 mL tubes (16 x 75 mm) 8/pk. SV07 Inserts for 10 mL tubes (16 x 100 mm) 8/pk. -
Page 23: Operating Instructions
CHAPTER 3 Operating Instructions Opening and Closing the Cover The electronically operated cover interlock mechanism prevents operation until the cover is completely closed and locked, and prevents the cover from being opened while the centrifuge is in operation. When the cover is completely closed and locked, an operating cycle can be initiated. -
Page 24: Reinstalling The Rotor
Operating Instructions Removing and Installing the Rotor Figure 3.1 Removing Shield 1. Remove the shield by lifting it straight up and out of the centrifuge. Figure 3.2 Locking Shield 1. Locked and Unlocked Positions Use an 1/8 inch hex key to remove the hex screw of the rotor hub. Remove the rotor by lifting it straight up and out of the centrifuge. -
Page 25: Spinning The Sample
Operating Instructions Spinning the Sample Spinning the Sample Loading 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. -
Page 26: Cycle Selection
Operating Instructions Spinning the Sample Warning Handle and dispose of sharp fragments according to the World Health Organization's Laboratory Biosafety Manual and relevant local and national regulations. 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 Use the same size and style tubes in opposite positions. -
Page 27: Unloading
Operating Instructions Spinning the Sample Unloading 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. - Page 28 Operating Instructions Spinning the Sample 55-006276-001CC...
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Page 29: Maintenance
Maintenance Overview Beckman Coulter recommends that instrument operators perform periodic inspections and preventative maintenance on all devices. Contact Beckman Coulter at any time if the instrument is not functioning correctly. Caution Disconnect the power cord from the electrical outlet before performing maintenance or inspection. -
Page 30: Disinfecting The Rotor
Do not defeat any safety interlocks while performing the test. If the StatSpin Express 4 fails to achieve an operating speed of 5,100 rpm ±5% in the 3 minute and 5 minute settings or 4,500 rpm ±5% in the 10 minute setting, contact Beckman Coulter. Inspecting the Rotor To inspect the rotor for cracks or damage monthly: Clean and dry the rotor. -
Page 31: Periodic Maintenance Check
Maintenance Periodic Maintenance Check Inspect the rotor for cracks or damage. Discontinue use of centrifuge if any are found and replace the rotor. Contact Beckman Coulter at any time if the instrument is not functioning correctly. Periodic Maintenance Check When the cycle counter in the instrument reaches 50,000 spins, the Error or Service indicator will continuously illuminates. -
Page 32: Troubleshooting
Follow the instructions on how to inspect the rotor. Remove rotor and inspect for cracks, warping, or loose hardware. If any are found, discontinue operation and contact Beckman Coulter Customer Service for rotor replacement. A crack in the top cover or housing. -
Page 33: Replacing The Fuse
Maintenance Replacing the Fuse Table 4.1 Troubleshooting (Continued) Symptom: Solution: Sample is not separating adequately. Be sure the tubes are correctly mixed immediately following collection. Refer to tube manufacturer for recommended procedure. Inspect rotor speed and cycle times. Allow serum tubes to clot before centrifugation. -
Page 34: Service
Representations and warranties made by any representatives, salespersons or agents of Beckman Coulter, which are inconsistent or in conflict with or in addition to the terms of this Agreement, will not be binding upon Beckman Coulter unless reduced to writing and approved by an expressly authorized officer of Beckman Coulter. - Page 35 INCIDENTAL, CONSEQUENTIAL, EXEMPLARY OR PENAL LOSS OR DAMAGE OF ANY NATURE WHATSOEVER (INCLUDING WITHOUT LIMITATION LOSS OF PROFITS OR LOSS OF USE), EVEN IF BECKMAN COULTER WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND WHETHER OR NOT SUCH DAMAGES WERE FORESEEABLE.
- Page 36 Maintenance Service 55-006276-001CC...
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Page 37: Appendix A: Specifications
APPENDIX A Specifications Specifications Product Number SSH4 Model Number M510 Spin Parameters 3 minutes: 180 seconds at 5100 rpm, 4000 xg 5 minutes: 300 seconds at 5100 rpm, 4000 xg 10 minutes: 600 seconds at 4500 rpm, 3100 xg Acceleration Time ≤30 seconds Deceleration Time ≤30 seconds... -
Page 38: Specifications
Specifications Specifications 55-006276-001CC... - Page 39 APPENDIX B References References 1. CLSI. Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline-Third Edition. "CLSI document M29-A3 [ISBN 1-56238-567-4]. CLSI, 940 West Valley Rd, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005. 2. CDC. Recommendations for Prevention of HIV Transmission in Health Care Settings. MMWR (Suppl.
- Page 40 References References 55-006276-001CC...
- Page 42 © 2018 Beckman Coulter, Inc. All Rights Reserved.
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