Beckman Coulter StatSpin Express 2 M501-22 Instructions For Use Manual Download

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APPENDIX B

References

References

1. CLSI. “Protection of Laboratory Workers from Occupationally Acquired Infections;

Approved Guideline-Second Edition.” CLSI document M29-A4 [ISBN 1-56238-453-8].
CLSI, 940 West Valley Rd, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2001.

2. CDC. Recommendations for prevention of HIV transmission in health care settings.

MMWR (Suppl. No. 2S):2S-18S, 1987.

3. CDC. Updated: US Public Health Service Guidelines for the Management of Occupational

Exposures to HBV, HCV and HIV and Recommendations for Post Exposure Prophylaxis.
Appendix A and B. MMWR 50 (RR-11): 1-42, June 29, 2001.

55-003910-001FD

B-1

Summary of Contents for StatSpin Express 2 M501-22

Page 1: ...r 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 ...

Page 2: ...demarks 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 ...

Page 3: ...ress 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...

Page 4: ...Revision History iv 55 003910 001FD ...

Page 5: ...ich 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 ...

Page 6: ...mental 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...

Page 7: ...rning 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 recommend...

Page 8: ...rance 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 roto...

Page 9: ...ck 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...

Page 10: ...r 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 de...

Page 11: ...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 b...

Page 12: ...006 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 p...

Page 13: ...ces 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...

Page 14: ... 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 ...

Page 15: ...s 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 Specificati...

Page 16: ...Contents xvi 55 003910 001FD ...

Page 17: ... Driver Warranty Card Complete the warranty registration card as directed Installing the System 1 Place 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 2 Position the StatSpin ...

Page 18: ...r 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 t...

Page 19: ... three factory set timed cycles of 30 120 and 180 seconds Operator Controls Express 2 Operator Controls Table 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 bu...

Page 20: ...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 drive...

Page 21: ... collection tubes 4 inserts package SV02 Inserts compatible with 3mL 10 25 x 64 mm blood collection tubes 4 inserts package SV05 Inserts for 1 5 2 mL microtubes 10 25 x 47 mm and BD Microtainers DL01 Disposable chamber liners 10 pk RTX4A Express 2 Rotor Includes SV01 inserts System Overview Accessories 2 55 003910 001FD 2 3 ...

Page 22: ...System Overview Accessories 2 4 55 003910 001FD ...

Page 23: ...the rotor has come to a complete stop before using the interlock bypass If the equipment is not used correctly safety can be impaired To release the electronically operated cover interlock mechanism insert the straightened end of a large paper clip or similar object into the small hole in the center of the front membrane panel If you press the Stop or Open button and the cover does not release pus...

Page 24: ... Loading Note The Express 2 has no on off switch and therefore is normally left plugged in and on The operator should experiment with different settings to achieve optimum performance for specific applications The following are general guidelines Express 2 Cycle Settings Table 3 1 Setting Description Speed Time 30 s Intended to provide a short spin to immediately separate the red cells from the pl...

Page 25: ...be 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 4 To close the lid firmly apply pressure on the cover directly above the latch until the gasket compresses completely and the latch engages with the cover 5 Select the cycle by pressing the cycle selector until the desired LED ...

Page 26: ...Operating Instructions Spinning the Sample 3 4 55 003910 001FD ...

Page 27: ...a spill occurs Clean the outside surfaces and the control panel with a water dampened cloth and mild detergent Clean the inner surface or bowl with a mild detergent and if necessary a disinfectant wiping with an cloth dampened with 70 alcohol or 10 bleach solution Caution Do not spray cleaning solutions directly onto the centrifuge bowl or housing Overspray can reach the motor bearings or internal...

Page 28: ...mpt to clean an insert that has a broken tube Dispose of the insert immediately 7 Dry the rotor and inserts with a clean absorbent paper towel or allow to air dry 8 Inspect rotor for cracks or damage 9 Reinstall the rotor For more information refer to Reinstalling the Rotor 10 Plug the power cord of the external power supply into the electrical outlet Inspecting the Rotor Speed The rated speeds ca...

Page 29: ...rifuge Will Not Spin or Shuts Off Table 4 2 Centrifuge Will Not Spin Shuts Off Prematurely Is the cover completely closed and cannot be opened manually No Completely close the cover Yes Contact Beckman Coulter Customer Support Centrifuge Does not Open at the End of the Cycle Table 4 3 Centrifuge Does not Open at the End of the Cycle Follow Cover Interlock By pass in Chapter 3 to open the cover and...

Page 30: ...ERFORMANCE OF THE PRODUCTS OR SERVICES BECKMAN COULTER DISCLAIMS ALL OTHER WARRANTIES INCLUDING WITHOUT LIMITATION ANY WARRANTY ABOUT THE MERCHANTABILITY OF THE PRODUCTS INFRINGEMENT OR THEIR FITNESS FOR A PARTICULAR PURPOSE IF ANY IMPLIED WARRANTIES APPLY AS A MATTER OF LAW THEY ARE LIMITED IN DURATION TO THE LENGTH OF THE TERM OF THIS AGREEMENT Representations and warranties made by any represen...

Page 31: ...r supply for 100 to 240 VAC 50 60 Hz Dimensions Height 6 0 in 15 2 cm Diameter 6 6 in 16 8 cm Weight 5 lbs 2 3 kg Environmental Indoor use IP20 Altitude up to 2 000 m Operating temperature 15 C 32 C Storage temperature 0 C 60 C Maximum relative humidity 80 for temperatures up to 31 C decreasing linearly to 50 relative humidity at 40 C Main supply voltage fluctuations not to exceed 10 of the nomina...

Page 32: ...Specifications Specifications A 2 55 003910 001FD ...

Page 33: ...Valley Rd Suite 1400 Wayne Pennsylvania 19087 1898 USA 2001 2 CDC Recommendations for prevention of HIV transmission in health care settings MMWR Suppl No 2S 2S 18S 1987 3 CDC Updated US Public Health Service Guidelines for the Management of Occupational Exposures to HBV HCV and HIV and Recommendations for Post Exposure Prophylaxis Appendix A and B MMWR 50 RR 11 1 42 June 29 2001 55 003910 001FD B...

Page 34: ...References References B 2 55 003910 001FD ...

Page 35: ......

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