CooperSurgical RI Witness User Manual

Sperm preparation reader
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RI Witness
Sperm Preparation Reader
User Manual
+45 46 79 02 02 | sales@coopersurgical.com | fertility.coopersurgical.com
CooperSurgical, Inc.
95 Corporate Drive, Trumbull, CT 06611, USA

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Summary of Contents for CooperSurgical RI Witness

  • Page 1 RI Witness ™ Sperm Preparation Reader User Manual +45 46 79 02 02 | sales@coopersurgical.com | fertility.coopersurgical.com CooperSurgical, Inc. 95 Corporate Drive, Trumbull, CT 06611, USA...
  • Page 2: Table Of Contents

    Contents CONTENTS SECTION 1 - PREFACE SECTION 2 - INTRODUCTION TO RI WITNESS SPERM PREPARATION READER 2 Intended Purpose Contraindication Applicable Part Numbers Related Documents Compatibility Installation SECTION 3 - SAFETY WARNINGS Warnings Cautions Safety/Information Symbols Safety and Reliability RFID Reader Environment Guidance and Manufacturer’s Declaration (Part 15 of FCC)
  • Page 3 Contents SECTION 7 - TROUBLESHOOTING RFID System SECTION 8 - WARRANTY INFORMATION AND LIMITS ON LIABILITY SECTION 9 - RETURNING PRODUCT FOR REPAIR Returned Goods Policy Customer Service Contact details Contact details for customers in the USA Serious Incident Event Reuse Statement...
  • Page 4: Section 1 - Preface

    The RI Witness manual belongs with the RI Witness system and should be passed on with the system if relocated to another clinic.
  • Page 5: Section 2 - Introduction To Ri Witness Sperm Preparation Reader

    Applicable intended purpose is subject to the regulations of the country into which the device is sold. Availability of RI Witness for clinical use is dependent on the regulatory approval status of RI Witness within the country the device is intended to be sold into.
  • Page 6: Section 3 - Safety Warnings

    30 cm (12 inches) to any part of the RI Witness Sperm Preparation Reader, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • Page 7: Safety/Information Symbols

    Meaning In accordance with Radio Radio Equipment Regulations Equipment Directive (RED) 2017 (2017 No. 1206) 2014/53/EU 0120 CooperSurgical.com Consult instructions for use Catalogue or Part number Authorized representative in This product complies with the European Community/ FCC rules and regulations...
  • Page 8 Section 3 Safety Warnings This electrical product is independently certified UL 61010-1 by MET to meet USA and Stacking limited to 3 units CSA C22.2 No. 61010-1 E113973 Canadian safety standards Fragile, handle with care This way up Keep dry Fragile, handle with care...
  • Page 9: Safety And Reliability

    RFID Reader Environment An RI Witness system uses Radio Frequency Identification (RFID) readers to monitor a work area. Readers detect RFID tagged containers that are placed in the work area. The performance of RFID tag detection may be compromised by the proximity of metal objects or electrical equipment that were not present during installation.
  • Page 10: Section 4 - Product Overview

    SECTION 4 - PRODUCT OVERVIEW RI Witness Sperm Preparation Reader RI Witness is a system which operates within an assisted reproduction (AR) clinic setting and provides a method of identifying human samples throughout an AR cycle (from egg and sperm collection to embryo transfer).
  • Page 11: Section 5 - Ri Witness Basic Operation

    WorkArea Status window, by clicking the yellow triangle or pressing the icon. This will bring up the WorkArea Status window in which the RI Witness Sperm Preparation Reader should be listed in the Connected Devices section with a green tick next to it.
  • Page 12: Operation

    The RI Witness Sperm Preparation Reader will detect the tags and the RI Witness system will record the step Cleaning The RI Witness Sperm Preparation Reader may be cleaned with a soft cloth and mild detergent solution.
  • Page 13: Section 6 - Ri Witness Rfid Tags

    “Admin Assign” on the new tag to bring cause inability to read the tag or may cause the dish into the system (see RI Witness Work the tag to detach from the container. Area 6-70-121UM).
  • Page 14 Section 6 RFID Tags Square Tag Time-Lapse Tag 12 mm 22 mm Slim Tag Chip Bridge 9 mm Peel 50 mm from here Rectangular Tag Circular Tag 36 mm 18 mm...
  • Page 15 Section 6 RFID Tags Peel line Chip and bridge line 4-well dish with Square Tag Square dish with Slim Tag positioned positioned on base on front tab Round dish with Circular Tag Rectangular dish with Time-Lapse tag positioned on base positioned on base Test Tube with Rectangular Tag positioned on side...
  • Page 16: Section 7 - Troubleshooting

    Tags Not Reading Check whether the tag is readable by a different Broken tag RI Witness device. If it is not, discard that tag Navigate to the Work Area Settings screen, then click Connected Devices, then Sperm Prep Reader, then RFID Tuning, check that all...
  • Page 17: Section 8 - Warranty Information And Limits On Liability

    No terms, conditions, understandings or agreements that purport to modify the above warranties or that make any additional warranties for any CooperSurgical product shall have any legal effect unless made in writing and signed by an authorized CooperSurgical corporate officer.
  • Page 18: Section 9 - Returning Product For Repair

    Section 9 Returning Products for Repair SECTION 9 - RETURNING PRODUCT FOR REPAIR Please refer to the ‘Troubleshooting’ section in this manual before returning product. If the problem continues with the device, please follow the instructions below. Returned Goods Policy Goods will be accepted for return for the following reasons: •...
  • Page 19: Customer Service Contact Details

    7 years continual use, after which time we recommend you consider its replacement. Should you notice impaired performance and/or any issues where safety is compromised, or have any other concerns during the use of RI Witness, seek the advice of CooperSurgical or their authorised representative promptly.

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