2ACOO-670854RI Witness Sperm Prep Reader
RESEARCH INSTRUMENTS LTD (COOPERSURGICAL, INC)
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Application Details
- Equipment Class
- DXX - Part 15 Low Power Communication Device Transmitter
- Date of Grant
- Feb 17, 2015
- Application Purpose
- Original Equipment
- Date of Application
- Feb 16, 2015
- Equipment Note
- RI Witness Sperm Prep Reader
- Frequency Range
- 13.56000000 - 13.56000000
- Country
- United Kingdom
Documents & Files
Document Text
Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.
Users Manual
User Manual RI Witness ⢠Document 6-70-121UM, Issue 13, 26 th January 2015, MRF 1636 RESEARCH INSTRUMENTS LTD Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK t: +44 (0) 1326 372 753 | f: +44 (0) 1326 378 783 |e: [email protected] www.research-instruments.com CONTENTS SECTION 1 - PREFACE 1 SECTION 2 - INTRODUCTION TO RI WITNESS⢠2 Intended Use 2 Medical Device Component 2 Applicable Part Numbers 2 Compatibility3 Installation3 SECTION 3 - SAFETY WARNINGS 4 GuidanceandManufacturerâsDeclaration(Part15ofFCC) âElectromagneticEmissions5 GuidanceandManufacturerâsDeclaration(IEC60601-1-2) âElectromagneticEmissions5 GuidanceandManufacturerâsDeclaration âElectromagneticImmunity6 Safety/InformationSymbols8 Safety and Reliability 9 Temperature Safety 9 Mains Power Supply 10 RFID Reader Environment 10 Startup / Shutdown Procedure 10 SECTION 4 - PRODUCT OVERVIEW 11 Data Capture 12 Imaging 12 Traceability 13 Cryo 13 RI Witness⢠Work Area 13 RI Witness⢠Manager for Traceability, Data Capture and Imaging 14 RFID Overview 15 The Shared RI Witness⢠Database 15 Hardware Overview 16 Work Area Reader Types 16 Multiplexer17 Control Units 17 Unheated Control Unit 17 Heated Control Unit 18 Auto Tuning Readers 18 RFCalibration19 RIWitnessâ˘WorkAreaSpecificationTable20 SECTION 5 - RI WITNESS⢠BASIC OPERATION 21 Introduction21 RI Witness⢠RFID tags 22 TaggingPlasticware22 Dishes and Pots 22 Tubes 22 Handling RFID Tags 23 How to Switch On 24 SystemInformation24 ToOpentheSystemInformation25 How to Shut Down a Work Area 25 Logging In 25 Auto Logon 25 Logging Out 26 The WorkArea Interface 27 Performing A Procedure in RI Witness⢠28 Beginning a New Cycle in RI Witness⢠28 WitnessPointConfirmation30 Double Witness Points 30 QuestionWitnessPoints31 Record Witness Points 32 Unassigned Tags 32 Tag Mismatch 33 Unassigned Tag Removal 33 RecordLocationofTags34 Training Mode 35 ClearDemoTables(legacyworkareasforpresoftwareversion2.3only)35 Admin Assign 36 Discards 36 Cycle Summary 37 CONTENTS Daily Lists 37 Windowed Work Area 37 Language and Keyboard Layout 38 Foot Pedal Control 38 To Rename the Work Area 39 ToChangetheLocationofaWorkArea39 ToViewWorkAreaLocationsorDisableaWorkArea40 AlarmifTagsLeftinWorkArea40 SECTION 6 - RI WITNESS⢠MANAGER 42 Logging In 42 License Management 42 License Request Form 43 Database Management 45 InitialScreen-MainMenuButtons46 Home 46 HowtoConfiguretheHomeScreen47 Patients48 EnteringNewPatientDetailsintoRIWitnessâ˘Manager48 EditingExistingPatientDetails49 LookingUpPatientHistories49 Assigning Donor Status 50 Assigning Partners 50 Cycle Types 51 StartingaNewCycle51 Assign a Cycle Type 51 CollectionandTransferDates52 Cycle Status 52 Revert Status 52 RIPatientIdentityLabels53 PrintingPatientLabels54 Label Styles 55 Operator Management 55 Operator Details 56 Group Membership 56 Enabled Operators 56 Operator PIN 56 CONTENTS Clinic Details 56 Mismatch Comments In RI Witness⢠Manager 57 The Witness Point Diagram 58 Links 59 Reassigned Tags 59 Unassigned Tags 59 Witness Point Inputs 60 MultipleSourcesoftheSameTagType60 MultipleTagTypes60 Entry Witness Points 60 Double Witness Points 60 Donor Witness Points 61 TaggedDonations61 UntaggedDonations62 WitnessPointQuestions62 Witness Point Order 63 The Witness Point Log 63 Tag Types 63 ExploretheWitnessPointLog64 WitnessPointLogStatistics64 SECTION 7 - CRYO WITNESSING 65 AnIntroductiontoCryoWitnessing65 PrintingBarcodes65 Scanning Barcodes 67 SECTION 8 - RI WITNESS⢠MANAGER FOR TRACEABILITY 68 Managing Materials 68 Material Types 68 Material Type Details 69 Notes on GS1 Barcodes 70 Cycle Types 70 CreatingaNewBatch70 DeletingaBatch72 Batch Status 72 ExpiredBatches73 View All Batches 74 CONTENTS Patients-ManagingTreatmentCycles74 ExcludingandIncludingBatchesforaCycle74 SECTION 9 - DATA CAPTURE 75 AnIntroductiontoDataCaptureforDataCollection75 Collected Data Setup 75 ParameterConfiguration76 Numerical Parameters 76 TextParameters76 List Parameters 77 Check Parameters 77 Date, Time and Date Time Parameters 78 CalculationParameters78 Built In Parameters 78 Sheet Contents 78 Shared Between Sheets 79 Treatment Cycle Sheets 80 ViewingandEditingSheets80 EditingSheetsattheWorkAreaTouchScreen80 ViewingandEditingSheetswithRIWitnessâ˘Manager82 Egg Parameters 82 The Number of Eggs 84 Egg Count Parameter 84 EggCountConflict84 Sheets and Witness Points 86 Cycle Summary Sheets 86 ParameterAttributes87 InitialValue87 Editable 88 Required 88 SECTION 10 - IMAGING 89 How to View Live Images 89 MultipleScreenConfiguration89 How to Take a Picture 90 How to Record Video 91 How to Zoom & Pan the Image 91 CONTENTS How to Perform Measurements 91 How to Select Cameras 92 Camera Flipping 92 How to Set the Preset Zoom 92 HowtoConfiguretheFootPedal/Keyboard92 HowtoSelectObjectives92 HowtoAddObjectives93 HowtoRemoveObjectives93 HowtoCheckObjectiveCalibration93 PatientDisplay93 Use of Saturn⢠Laser Systems with RI Witness⢠94 HowtoAccessSaturnLaserSystemInformationfromaWorkArea94 SECTION 11 - TROUBLE SHOOTING 95 SECTION 12 - TEMPERATURE CALIBRATION 97 TemperatureProfile97 TemperatureProfileChecklist97 TemperatureCalibration97 TemperatureCalibrationService98 TouchScreenCalibrationChecklist99 SECTION 13- CARE AND MAINTENANCE 100 Cleaning 100 SECTION 14 - REPAIRS AND RETURNS 101 Reuse Statement 101 RI Repairs System 101 Product Disposal (European Union) 101 RI Returns System 101 Contact Details 101 ObligationtoInform101 Feedback 102 CONTENTS Section 1 RI Witness⢠RFID Tags 1 1 Research Instruments Ltd SECTION 1 - PREFACE Thank you for choosing RI Witnessâ˘. The RI Witness⢠family of products is made up of RI Witnessâ˘, Data Capture, Traceability, Imaging and Cryo. This manual provides âŚ
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Cover Letter(s)
RESEARCH INSTRUMENTS LIMITEtr Bickland Industrial Park, Falmouth, Cornwall, TR11 4TA, UK Tel: 01326 372753 [lnternational +44 L326372753] Fax:0t326378783 [lnternational +44 L326 378 783] e-mail: [email protected] www.resea rch-instruments.com Request for Confi dentialitv Date: 13 February 2015 Subject: Confidentiality Request for: FCC lD 2AC00-670854 Pursuant to FCC 47 CRF 0.457(d) and 0.459, Research Instruments LTD requests that a part of the subject FCC application be held confidential. Type of Confidentiality Requested ! shortterm I Permanent I Short Term I Permanent I Short Term I Permanent I Short term I Permanent I Short Term I Permanent Exhibit Block Diagrams Operation Description/Theory of Operation Parts List & Placement/BOM Tune-Up Procedure Schematics Research Instruments LTD requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. The Rl Witness system is very unique and gives us a huge advantage against our competitors, not keeping the above documents confidential will put our position under risk. Sincerely, By:WILL THALLIENS (Print name) CompanyRegisteredinEnglandNumber:34I9143 RegisteredAddress: Bicklandlndustrial Park,Falmouth,Cornwall TR11 4TA VAT Number; 75O 4247 49 (Signatu relTitle)
ID Label/Location Info
LABEL LOCATION
Test Report
Hursley EMC Services Ltd. Trafalgar House Trafalgar Close Chandlers Ford, Eastleigh Hampshire. UK. SO53 4BW EMC TEST REPORT No. 14R243 FR Issue#1: 11 th July 2014 UKAS Accredited EU Notified Body FCC & VCCI Registered BSMI Lab ID: SL2-IN-E-3008 KC Lab ID: EU0184 Tel. +44 (0) 23 8027 1111 Fax. +44 (0) 23 8027 1144 e mail. [email protected] www.hursley-emc.co.uk FCC Part 15C & Industry Canada Certification Report for the Research Instruments Ltd Sperm Prep Reader Project Engineer: R. P. St John James Approval Signatory Approved signatories: S. M. Connolly ď J. A. Jones ďŁ The above named are authorised Hursley EMC Services engineers. EMC TEST REPORT 14R243 FR FCC Part 15C Certification Report Issue#1: 11 th July 2014 Page 2 of 18 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 CONDUCTED EMISSIONS ........................................................................................................................................ 7 4.0 TEST DATA ....................................................................................................................................................... 8 4.1 POWER LINE CONDUCTED EMISSIONS ................................................................................................................... 8 4.1.1 Data ............................................................................................................................................................ 8 4.2 FCC â RADIATED EMISSIONS (TRANSMITTING) .................................................................................................... 9 4.3 TRANSMITTER MASK........................................................................................................................................... 10 4.4 EMISSIONS PLOTS ................................................................................................................................................ 11 4.5 FREQUENCY ERROR ............................................................................................................................................. 14 4.1 OCCUPIED BANDWIDTH ....................................................................................................................................... 15 4.2 BANDWIDTH PLOT ............................................................................................................................................... 16 5.0 FCC DETAILS ................................................................................................................................................. 17 6.0 INDUSTRY CANADA LETTER .................................................................................................................... 18 EMC TEST REPORT 14R243 FR FCC Part 15C Certification Report Issue#1: 11 th July 2014 Page 3 of 18 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 8 requirements. For emissions outside the 13.110-13.410 MHz band the EUT, as described and reported within this document, complies with the parts 15.207 and 15.209 of the CFR 47 FCC rules in accordance with ANSI C63.4:2003. The EUT uses passive tags without their own power source and will only work when collocated with the EUT. 1.2 Related Submittal(s) Grants None 1.3 EUT Manufacturer Trade name: Research Instruments Ltd Company name: Research Instruments Ltd Company address: Brickland Industrial Park Falmouth Cornwall TR11 4TA United Kingdom Manufacturing address: As above. Company representative: Mr Will Thalliens Tel: +44 (0) 1326 372753 EMC TEST REPORT 14R243 FR FCC Part 15C Certification Report Issue#1: 11 th July 2014 Page 4 of 18 2.0 EUT DESCâŚ
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Test Setup Photos
Hursley EMC Services Ltd. Trafalgar House Trafalgar Close Chandlers Ford, Eastleigh Hampshire. UK. SO53 4BW EMC TEST REPORT No. 14R243 FRA UKAS Accredited EU Notified Body FCC & VCCI Registered BSMI Lab ID: SL2-IN-E-3008 KC Lab ID: EU0184 Tel. +44 (0) 23 8027 1111 Fax. +44 (0) 23 8027 1144 e mail. [email protected] www.hursley-emc.co.uk Photo Log for the Research Instruments Ltd Sperm Prep Reader EMC TEST REPORT 14R243 FRA FCC Part 15C Certification Report Page 2 of 4 1.0 PHOTO LOG Emissions: Radiated emissions, 9 kHz to 30 MHz OATS 10m Chamber Scan 3m EMC TEST REPORT 14R243 FRA FCC Part 15C Certification Report Page 3 of 4 Photo Log (continued) Radiated emissions, 30 MHz to 1000 MHz EMC TEST REPORT 14R243 FRA FCC Part 15C Certification Report Page 4 of 4 Photo Log (continued) Conducted emissions
Contact Information
Applicant
Wendy Hassan(Mrs)
Test Firm
Eurofins Hursley LtdAndrew Coombes
Technical Specifications
| # | Rule Parts | Frequency Range | Power Output |
|---|---|---|---|
| 1 | 15C | 13.56 MHz - 13.56 MHz | - |
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Equipment Class
DXX - Part 15 Low Power Communication Device Transmitter