Beckman Coulter CSD2 Instructions For Use Manual Download Page 2

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Instructions for Use

StatSpin CritSpin Digital Reader Model Number S120

PN 55-003823-001CC (September 2018)

2018 Beckman Coulter, Inc.

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

Rx Only

Original Instructions

Summary of Contents for CSD2

Page 1: ...Number S120 For In Vitro Diagnostic Use This manual is intended for CSD2 Digital Reader with tube adapter for 75mm tubes and with a universal power supply Printed in U S A 55 003823 001CC September 2018 Beckman Coulter Inc 250 S Kraemer Blvd Brea CA 92821 U S A ...

Page 2: ...rks 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 Rx Only Original Instructions ...

Page 3: ...pin Digital Reader Operations Manual to a Beckman Coulter Instructions for Use IFU Manual and made general clarification to the IFU Added Revision History Safety Notice Symbols and Definitions table Alerts for Warning Caution Important Note and Tip explanations and Warning and Cautions Updated Logo Manufacturer address and Limited Warranty statement Deleted EC Rep 55 003823 001CC iii ...

Page 4: ...Revision History iv 55 003823 001CC ...

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: ... 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 wi...

Page 7: ...r 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 Direct current To indicate on the rating plate that the equipment is suitable for direct current only to...

Page 8: ...dentified 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 Re...

Page 9: ...l 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 California Proposition 65 This product can expose you to chemicals known to the State of...

Page 10: ...Safety Notice Symbols and Definitions x 55 003823 001CC ...

Page 11: ...APTER 2 Operating Instructions 2 1 Operation 2 1 Read Spun Hematocrit Tubes inside Rotor 2 1 Use 75 mm Adapter 2 3 Readout Setting 2 3 Cleaning 2 4 Troubleshooting and Maintenance 2 4 APPENDIX A Specifications A 1 Specifications A 1 Accessories List A 1 APPENDIX B References B 1 References B 1 55 003823 001CC xi ...

Page 12: ...Contents xii 55 003823 001CC ...

Page 13: ... centrifuges For in vitro diagnostic use Description The CritSpin Digital Reader operates from the switching power supply PN X01 003553 001 provided with the digital reader Plug the power supply into the digital reader Digital Reader PN CSD2 Important Use only the AC Power Adapter supplied with the digital reader Use of another power supply will damage the Reader and void the warranty Figure 1 1 R...

Page 14: ...System Overview Description 1 2 55 003823 001CC ...

Page 15: ...moved from the centrifuge and placed into the digital reader Read Spun Hematocrit Tubes inside Rotor The digital reader has a tilt bar on the underside Use the tilt bar to provide a tilted position from which to read tubes You can use either position for reading 1 Install the rotor in the digital reader a Move the pointer all the way to the right Tip To move the pointer gently press it down to all...

Page 16: ...Then press Set The system displays 100 in the digital display The digital display becomes active and numbers change as you move the pointer 6 Move the pointer slowly to the plasma and red cell interface and then press Press Note To avoid false readings do not press the membrane on either side of the gliding pointer arm 7 Read the digital display and record the number 8 Turn the rotor for the next ...

Page 17: ... Setting The digital display can be set to read either percent or decimal figures When the digital reader is shipped it is set in the percent mode The mode can be changed from a percent to a decimal figure 1 Remove the base plate on the underside of the digital reader by removing four Phillips screws Set the base plate and screws aside 2 Move the jumper small black piece from pins 1 2 to pins 2 3 ...

Page 18: ...e only user serviceable part of the digital reader To replace the light remove the bottom plate by releasing the four screws on the underside For more information refer to Readout Setting figure Gently dislodge the bulb by pulling out the bulb Remove bulb and snap in new bulb Replace the component to the original position The StatSpin CritSpin Digital Reader has no other user serviceable parts If ...

Page 19: ...tive 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 nominal voltage Transient overvoltages according to installation category II Pollution degree 2 Accessories List CritSpin Digital Reader Accessories Table A 2 PN Description X01 003553 001 Power Supply X01 003877 001 Light Bulb for Digital Reader...

Page 20: ...Specifications Accessories List A 2 55 003823 001CC ...

Page 21: ...ities and Units SI Committee Report CLSI Publication C11 CR CLSI Villanova PA 1983 5 Clinical Laboratory Standards Institute Procedure for Determining Packed Cell Volume by the Microhematocrit Method Approved Standard CLSI Publication H7 A NCCLS Villanova PA 1985 6 Miale JB Laboratory Medicine Hematology 5th Edition C V Mosby Co St Louis 1977 7 Clinical Laboratory Standards Institute Procedures fo...

Page 22: ...References References B 2 55 003823 001CC ...

Page 23: ......

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