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Revision History

55-003823-001 CC, 09/2018

• Moved: Symbol/Regulatory Mark and a link to the website in the California

Proposition 65 statement

55-003823-001 CB, 03/2018

• Converted the CritSpin 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

Содержание CSD2

Страница 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 ...

Страница 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 ...

Страница 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 ...

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

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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 ...

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

Страница 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...

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

Страница 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...

Страница 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 ...

Страница 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 ...

Страница 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 ...

Страница 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...

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

Страница 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...

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

Страница 23: ......

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