2ACOO-670854V5RI WITNESS SPERM PREP READER

+45 46 79 02 02 | [email protected] | fertility.coopersurgical.com Research Instruments Ltd Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK Document 6-70-854UM(5) | DRF 5438 | 9th June 2020 RI Witness ™ Sperm Preparation Reader CONTENTS SECTION 1 - PREFACE 1 SECTION 2 - INTRODUCTION TO RI WITNESS 2 Indication for Use for RI Witness System 2 Contraindication: 2 Applicable Part Numbers 2 Related Documents 2 Compatibility 2 Installation 2 SECTION 3 - SAFETY WARNINGS 3 Glossary of Safety/Information Symbols 4 Safety and Reliability 5 RFID Reader Environment 5 Guidance and Manufacturer’s Declaration (Part 15 of FCC) — Electromagnetic Emissions 5 SECTION 4 - PRODUCT OVERVIEW 6 Sperm Preparation Reader 6 Sperm Preparation Reader Specification Table 6 Electrical Connections 7 Connection to the Software 7 Operation 8 Cleaning 8 SECTION 6 - TROUBLESHOOTING 9 RFID System 9 SECTION 7 - WARRANTY INFORMATION AND LIMITS ON LIABILITY 10 SECTION 8 - RETURNING PRODUCT TO RI FOR REPAIR 11 Customer Service Contact details 12 US only customers contact details 12 Serious Incident Event 12 Feedback 12 Research Instruments LtdContents Section 1 1 1 Research Instruments LtdPreface SECTION 1 - PREFACE Thank you for choosing RI Witness. This manual provides all the necessary information to use RI Witness Sperm Preparation Reader and should be read in conjunction with any manuals provided with other RI Witness hardware or software components that you are using. The system should be operated by trained personnel only. All sections of this manual should be read and understood fully before any operation of the system. Please see the Intended Use section for more information. If you are unsure of any of the information contained in this manual then you should contact Research Instruments or an appointed representative before attempting to use this equipment. In no event does Research Instruments Ltd (RI) assume the liability for any technical or editorial errors of commission, or omission; nor is RI liable for direct, indirect, incidental, or consequential damages arising out of the use or inability to use this manual. The information in this manual is current at the time of publication. Our commitment to product improvement requires that we reserve the right to change equipment, procedures and specifications at any time. The latest version of the User Manual can be downloaded from software.research-instruments.com. The RI Witness manual belongs with the RI Witness system and should be passed on with the system if relocated to another clinic. The use of ™ in this manual indicates a trademark of Research Instruments Ltd. Any other brand names, referred to in this manual, are trademarks of their respective owners. © This manual is protected by copyright, all rights reserved, and no part may be photocopied or reproduced in any form without the prior written consent of RI. Patents - please go to this web page to see the patents that protect this product: www.csipatents.com A hard copy of this user manual is available on request. This indicates cautionary text which should be followed to avoid injury to users or damage to samples. The system should be operated by qualified and trained personnel only. Research Instruments Ltd Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK Section 2 Introduction 2 Research Instruments Ltd 2 SECTION 2 - INTRODUCTION TO RI WITNESS Indication for Use for RI Witness System To identify and track human samples, using RFID technology, through the assisted reproduction (AR) cycle, including cryopreservation. Contraindication: This device is not intended to be exposed to known sources of electromagnetic interference (EMI) with medical devices such as diathermy, CT, MRI, RFID (except other RI Witness RFID components) and electromagnetic security systems, e.g. metal detectors and electronic article surveillance systems. Applicable indications for use are 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. Applicable Part Numbers Related Documents 6-70-121UM RI Witness WorkArea Software Manual 6-70-122UM RI Witness Manager Software Manual Compatibility RI Witness is used in conjunction with the following: • Essential medical devices, e.g. dishes and tubes, maybe AR or non-AR specific. • Non-essential medical devices, e.g. safety cabinets, incubators, micromanipulators, lasers. • Non medical devices (general laboratory equipment), e.g. work benches, microscopes, PCs. This device has RFID reader capability. If it is the intention that it be employed in a clinical lab, we recommend its use alongside other medical devices and that the performance of these medical devices be monitored for potential effects of EMI disturbances, and reported when appropriate. Installation Installations of the RI Witness Sperm Preparation Reader should be carried out by a RI technician or other RI authorised personnel. Incorrect installation could result in overall poor performance. Part NumberDescription 6-70-854 RI Witness Sperm Preparation Reader Section 3 3 Safety WarningsResearch Instruments Ltd 3 SECTION 3 - SAFETY WARNINGS DO NOT disassemble or modify any part of the RI Witness Sperm Preparation Reader, or substitute any component for any other. Doing so may result in damage to samples. This voids the warranty and/or service contract. WARNING To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. ONLY use the power cable and power supply adaptor supplied with the system.The cable to the power supply is the ‘disconnect device’ for this equipment. To remove all electrical power from this product, disconnect the power cable from the electrical outlet. Equipment should be positioned so as to allow easy access to the power cable. The appliance coupler or mai…

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SPERM PREP READER EXTERNAL PHOTOS

DRAWN BY: MS | DRAWING NUMBER: 5-70-180L1 SPERM PREP READER BACK PANEL LABEL | DATE: 10/06/2020 DRF: 5438| REVISION: 7 LABEL: 1-10-L6012, AVERY 20 LABEL S PER SHEET, 96MM X 50.8MM UL 61010-1 CSA C22.2 No. 61010-1 E113973 FCC ID: 2ACOO-670854V5 ISED/IC ID: 12146A-670854V5 HVIN: 670854V5 This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. 12V 2.5A 6-70-854 5-70-180L1( 7 ) Consult User Manual for Symbols Glossary RI Witness ™ Sperm Prep Reader Research Instruments Ltd, Bickland Industrial Park, Falmouth, Cornwall, TR11 4TA, UK fertility.coopersurgical.com | MADE IN UK coopersurgical.com XXXXX YYYY-MM-DD

LABEL LOCATION

SPERM PREP READER INTERNAL PHOTOS

Eurofins Hursley Trafalgar House Trafalgar Close Chandlers Ford, Eastleigh Hampshire. UK. SO53 4BW EMC TEST REPORT No. 18C469 FR Issue#4: 18 th June 2020 UKAS Accredited EU Notified Body FCC & ISED Registered KC Lab ID: EU0184 Tel. +44 (0) 23 8027 1111 e mail. [email protected] www.hursley-emc.co.uk FCC Part 15C & Industry Canada Certification Report for the Research Instruments Ltd Sperm Prep Reader, USB and Powered via AC/DC Adapter FCC ID: 2ACOO-670854V5 IC ID: 12146A-670854V5 Project Engineer: R. Pennell Approval Signatory Approved signatories: J. A. Jones  A. V. Jones  D. Tiroke  A. Coombes  The above named are authorised Eurofins Hursley signatories. EMC TEST REPORT 18C469 FR FCC Part 15C Certification Report Issue#4: 18 th June 2020 Page 2 of 19 Contents 1.0 DECLARATION ................................................................................................................................................ 3 1.1 FCC PART 15C AND INDUSTRY CANADA STATEMENT .......................................................................................... 3 1.2 RELATED SUBMITTAL(S) GRANTS ......................................................................................................................... 3 1.3 EUT MANUFACTURER .......................................................................................................................................... 3 2.0 EUT DESCRIPTION ......................................................................................................................................... 4 2.1 IDENTITY ............................................................................................................................................................... 4 2.2 PRODUCT OPERATION ........................................................................................................................................... 4 2.3 SUPPORT EQUIPMENT ............................................................................................................................................ 4 2.4 EXERCISER PROGRAM ........................................................................................................................................... 4 3.0 MEASUREMENT PROCEDURE AND INSTRUMENTATION ................................................................. 5 3.1 EMI SITE ADDRESS & TEST DATE ........................................................................................................................ 5 3.2 GENERAL OPERATING CONDITIONS ...................................................................................................................... 5 3.3 ENVIRONMENTAL AMBIENT .................................................................................................................................. 5 3.4 RADIATED EMISSIONS ........................................................................................................................................... 6 3.5 TEST EQUIPMENT .................................................................................................................................................. 6 3.6 CONDUCTED EMISSIONS ........................................................................................................................................ 7 4.0 TEST DATA ....................................................................................................................................................... 8 4.1 POWER LINE CONDUCTED EMISSIONS ................................................................................................................... 8 4.1.1 Data ............................................................................................................................................................ 8 4.2 FCC – RADIATED EMISSIONS (TRANSMITTING) .................................................................................................. 10 4.3 TRANSMITTER MASK........................................................................................................................................... 12 4.3.1 Full mask plot ........................................................................................................................................... 12 4.3.2 Zoomed mask plot ..................................................................................................................................... 13 4.4 EMISSIONS PLOTS ................................................................................................................................................ 14 4.5 FREQUENCY ERROR ............................................................................................................................................. 17 4.6 OCCUPIED BANDWIDTH ....................................................................................................................................... 18 4.7 BANDWIDTH PLOT ............................................................................................................................................... 18 End of document ................................................................................................................................................................... 19 Document History: Issue#1: 29 th August 2018 was withdrawn and replaced by Issue#2: 5 th May 2020 updated with editorial correction. Issue#2: 5 th May 2020 was withdrawn and replaced by Issue #3: 9 th June 2020 updated with editorial corrections Issue#3: 9 th June 2020 was withdrawn and replaced by Issue #4: 18 th June 2020 updated with editorial corrections EMC TEST REPORT 18C469 FR FCC Part 15C Certification Report Issue#4: 18 th June 2020 Page 3 of 19 1.0 DECLARATION 1.1 FCC Part 15C and Industry Canada Statement The Equipment Under Test (EUT) operates at a transmit frequency of 13.56 MHz and complies with CFR 47 part 15.225 emission requirements. The EUT also complies with Industry Canada RSS-210 Issue 10 and…

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EMC TEST REPORT 18C469 FRA FCC Part 15C Certification Report 5 th May 2020 Page 1 of 4 Photo Log for the Research Instruments Ltd Sperm Prep Reader, USB and Powered via AC/DC Adapter FCC ID: 2ACOO-670854V5 IC ID: 12146A-670854V5 Document History: Issue#1: 29 th August 2018 was withdrawn and replaced by Issue#2: 5 th May 2020 updated with editorial correction. EMC TEST REPORT 18C469 FRA FCC Part 15C Certification Report 5 th May 2020 Page 2 of 4 1.0 PHOTO LOG Emissions: Radiated emissions, 9 kHz to 30 MHz OATS 10m Radiated emissions, Pre-scan, 30 MHz to 1000 MHz EMC TEST REPORT 18C469 FRA FCC Part 15C Certification Report 5 th May 2020 Page 3 of 4 Photo Log (continued) Radiated emissions, Pre-scan, > 1000 MHz Conducted emissions EMC TEST REPORT 18C469 FRA FCC Part 15C Certification Report 5 th May 2020 Page 4 of 4 Photo Log (continued) Modulation bandwidth Extremes Testing