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Instructions for Use
StatSpin CritSpin Digital Reader Model 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.
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Summary of Contents for Beckman Coulter CSD2
- Page 1 Instructions for Use StatSpin CritSpin Digital Reader Model 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.
- 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 55-003823-001 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 •...
- Page 4 Revision History 55-003823-001CC...
- 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 Refer to the applicable sources (such as Material Safety Data Sheets) for specific hazard information. Warning If the equipment is used in a manner not specified by Beckman Coulter, the protection provided by the equipment may be impaired. Warning Outside of North America: do not use the power cord supplied. Use power cord for at least 1.0 Amp with an IEC320/CEE22 female connector and male connector suitable...
- Page 7 Safety Notice Symbols and Definitions • 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. Please use the instrument as intended.
- Page 8 Safety Notice Symbols and Definitions Table 1 CritSpin Symbols Glossary (Continued) Symbol Description 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.
- Page 9 Safety Notice Symbols and Definitions Table 1 CritSpin Symbols Glossary (Continued) 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 10 Safety Notice Symbols and Definitions 55-003823-001CC...
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Page 11: Table Of Contents
Contents Revision History , iii Safety Notice, v CHAPTER 1: System Overview, 1-1 Intended Use, 1-1 Description, 1-1 CHAPTER 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... - Page 12 Contents 55-003823-001CC...
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Page 13: System Overview
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. - Page 14 System Overview Description 55-003823-001CC...
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Page 15: Operating Instructions
CHAPTER 2 Operating Instructions Operation To use this digital reader, hematocrit tubes are filled with blood, sealed and centrifuged in the RH12 hematocrit rotor. The procedure and step-by-step drawings for filling hematocrit tubes can be found in your centrifuge Instructions for Use manual. Normal values are located in your Instructions for Use manual, read the manual before performing a hematocrit. - Page 16 Operating Instructions Read Spun Hematocrit Tubes inside Rotor 1. Press button 2. Set button Figure 2.2 LEDs that Flash 1. LED that flashes for step 3. 2. LED that flashes for step 4. Move the pointer to the bottom of the red blood cells (top of the clay). Then press Set. The system displays 0 in the digital display.
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Page 17: Use 75 Mm Adapter
Operating Instructions Use 75 mm Adapter Use 75 mm Adapter Move the pointer completely to the right. Place the tube adapter in the slot in the center of the digital reader. Place the spun 75 mm hematocrit tube in tube adapter (clay on the right). Slide the hematocrit tube completely to the right. -
Page 18: Cleaning
Replace the component to the original position. The StatSpin CritSpin Digital Reader has no other user-serviceable parts. If a problem occurs, the operator must contact Beckman Coulter Customer support 1-800-854-3633. Disassembly of the unit voids the warranty. -
Page 19: Appendix A: Specifications
Accessories List Table A.2 CritSpin Digital Reader Accessories Description X01-003553-001 Power Supply X01-003877-001 Light Bulb for Digital Reader X00-002227-001 RH12-1 12-position Hematocrit Rotor Plastic and glass tubes are available from your local dealer, or Contact Beckman Coulter Customer Support 1-800-854-3633. 55-003823-001CC... -
Page 20: Specifications Accessories List
Specifications Accessories List 55-003823-001CC... -
Page 21: Appendix B References
APPENDIX B References References Clinical Laboratory Standards Institute. Proposed Guideline, Protection of Laboratory Workers from Instrument Biohazards, Document I 17-P, Vol. 11, No. 15, Appendix A, Pg. CDC. Recommendations for prevention of HIV transmission in health care settings. MMWR (Suppl. No. 2S):2S-18S, 1987. CDC. - Page 22 References References 55-003823-001CC...
- Page 24 © 2018 Beckman Coulter, Inc. All Rights Reserved.
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