Research Instruments WITNESS User Manual

Embryology heated plate
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User Manual
R I W I T N E S S
Embryology Heated Plate
+44 (0) 1737 243869 | customerservice@origio.com | origio.com
Research Instruments Ltd, Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK
Document 6-70-807UM | DRF 3728 | Issue 5 | 1 December 2017
0120
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  • Page 1 R I W I T N E S S ™ Embryology Heated Plate +44 (0) 1737 243869 | customerservice@origio.com | origio.com only Research Instruments Ltd, Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK 0120 Document 6-70-807UM | DRF 3728 | Issue 5 | 1 December 2017...
  • Page 2: Table Of Contents

    Contents Research Instruments Ltd CONTENTS SECTION 1 - PREFACE SECTION 2 - INTRODUCTION TO RI WITNESS Indications for Use for RI Witness Embryology Heated Plate Contraindications: Applicable Part Numbers Related Documents Compatibility Installation SECTION 3 - SAFETY WARNINGS Safety/Information Symbols...
  • Page 3 CONTENTS Achieving the Correct Sample Temperature Changing the Temperature Setpoint Using the Device Changing the Temperature Setpoint Using a PC and RI Witness WorkArea Software Temperature Calibration ITO Glass Window Calibration Using Built-In User Interface Full 5-channel Calibration Using PC and RI Witness Work Area Software...
  • Page 4: Section 1 - Preface

    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.
  • Page 5: Section 2 - Introduction To Ri Witness

    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.
  • Page 6: Section 3 - Safety Warnings

    The system should be operated by qualified and trained personnel only. DO NOT disassemble or modify any part of the RI Witness Embryology Heated plate, or substitute any component for any other. Doing so may result in damage to samples. This voids the warranty and/or service contract.
  • Page 7: Safety/Information Symbols

    Section 3 Research Instruments Ltd Safety Warnings Safety/Information Symbols Symbol Meaning Do not dispose of product with normal waste. In accordance with Annex II of the European Medical Device Directive 93/42/EEC, as amended by Directive 2007/47/EC under the supervision of notified body No.0120, SGS, UK Ltd.
  • Page 8: 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 proximity of metal objects or electrical equipment Do not place metal objects near reader.
  • Page 9: Guidance And Manufacturer's Declaration (Part 15 Of Fcc) - Electromagnetic Emissions

    Guidance and Manufacturer’s Declaration (IEC 60601-1-2) — Electromagnetic Emissions RI Witness is intended for use in the electromagnetic environment specified below. The customer or the user of RI Witness should ensure that it is used in such an environment. Emissions test...
  • Page 10: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    40 % UT 40 % UT hospital environment. (60 % dip in UT) for 5 (60 % dip in UT) for 5 If the user of RI Witness IEC 61000-4-11 cycles cycles requires continued 70 % UT...
  • Page 11: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    Section 3 Research Instruments Ltd Safety Warnings Guidance and Manufacturer’s Declaration — Electromagnetic Immunity IMMUNITY Test IEC 60601 Compliance Electromagnetic environment - Test level level guidance Portable RF communications equipment Conducted RF IEC 3 Vrms 3 Vrms (including peripherals such as antenna...
  • Page 12: Section 4 - Product Overview

    Research Instruments Ltd SECTION 4 - PRODUCT OVERVIEW 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 13: Ri Witness Embryology Heated Plate Specification Table

    Section 4 Research Instruments Ltd Product Overview RI Witness Embryology Heated Plate Specification Table Part Description Temperature Sensor 5 x PT1000 (1 per Channel) Electrical heating is controlled by a built-in 5-channel PWM temperature controller: • Channel 1-4: Work surface surrounding the ITO glass window is divided into quarters •...
  • Page 14: Section 5 - Ri Witness Basic Operation

    Once the Windows operating system has recognised the devices within the Embryology Heated Plate, open the RI Witness WorkArea software. To verify that the RI Witness Work Area software can communicate successfully, navigate to the Work Area Status window (click the yellow triangle or press the (i) icon).
  • Page 15: Operator Position

    Operator Position The operator should be positioned in such a place to easily access the User Interface, work surface of the device and the connected touch screen (if used with the RI Witness WorkArea software). Achieving the Correct Sample Temperature The heated plate is divided into 5 areas for calibration purposes.
  • Page 16: Changing The Temperature Setpoint Using The Device

    WARNING: In the event of sensor failure the plate may become hot (up to 65°C). The temperature setpoint is applied to all heating channels and is set using the following procedure, or from within the RI Witness WorkArea software. Refer to the RI Witness Software Manual (6-70-121UM) for further information.
  • Page 17: Temperature Calibration

    Figure 5-5 Recommended Thermocouple Positions for Temperature Calibration ITO Glass Window Calibration Using Built-In User Interface During calibration using the built-in user interface close the RI Witness WorkArea software to prevent interference with the thermometer reading. 1. Position the thermocouple probe on the Window in the location shown above.
  • Page 18: Full 5-Channel Calibration Using Pc And Ri Witness Workarea Software

    Full calibration of the 5 heated areas requires that each of the areas is calibrated in turn. 1. Open the RI Witness WorkArea software and navigate to the WorkArea Status window. 2. Click on the yellow triangle or the (i) icon then click...
  • Page 19: Tube Reader Antenna Accessory

    Section 5 Research Instruments Ltd RI Witness™ Basic Operation Tube Reader Antenna Accessory The Tube Reader Antenna is an accessory for the Embryology Heated Plate that allows tags to be read in a vertical orientation. It is specifically designed to read tags placed on tubes in the RI Tube Holder. The Tube Reader Antenna is a passive device that only becomes powered when attached to the Embryology Heated Plate.
  • Page 20: Section 6 - Troubleshooting

    Area 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 Embryology Reader, then RFID Tuning, check that all 5...
  • Page 21: Alarms And System Status

    When multiple alarms are active, the highest priority alarm will be shown or the icon in the RI Witness WorkArea Software, and on the device the Status Indicator Light.
  • Page 22: Alarm System Testing

    Section 6 Troubleshooting Research Instruments Ltd Alarm System Testing In order to test functionality of the alarm system hold down the button for 3 seconds when there are no active alarms. This will trigger a medium priority alarm signal, (3 audible pulses and 3 yellow flashes of the status indicator light).
  • Page 23 Section 6 Research Instruments Ltd Troubleshooting Alarm Fault Priority Fault Description Alarm Solution Code Condition Actions ITO Window Low / Heating channel has Temperature Possible heater or Heating Medium exceeded the maximum controller controller fault. Channel Over allowable setpoint power is set...
  • Page 24 Section 6 Troubleshooting Research Instruments Ltd Alarm Fault Priority Fault Description Alarm Solution Code Condition Actions ITO Window Medium Heating channel has This may be caused Heating Channel deviated by more than temperature by placing either Temperature 2.5˚C from the setpoint...
  • Page 25 Section 6 Research Instruments Ltd Troubleshooting Alarm Fault Priority Fault Description Alarm Solution Code Condition Actions ITO Window Medium Heating controller Temperature If the device is Heating Channel did not achieve a controller operated in an Low Heating temperature within 2.5˚C...
  • Page 26: Section 7- Care And Maintenance

    SECTION 7- CARE AND MAINTENANCE Cleaning RI Witness Embryology Heated Plate and Tube Reader Antenna may be cleaned with a soft cloth and mild detergent. Do not disconnect the cables attached to the device. If the Tube Reader Antenna is removed for cleaning be mindful to allow the contact surfaces on both the Heated Plate and the Tube Reader Antenna to fully dry before reattaching to ensure cleaning products are not trapped in the interface.
  • Page 27: Section 8 - Repairs And Returns

    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 RI or their authorised representative promptly.

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