Research Instruments RI WITNESS User Manual

Embryology heated plate

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User Manual
R I W I T N E S S
Embryology Heated Plate
RESEARCH INSTRUMENTS LTD
Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK
t: +44 (0) 1326 372 753 | f: +44 (0) 1326 378 783 |e: sales@research-instruments.com
www.research-instruments.com
Document 6-70-807UM, Issue P1, 18 February 2016
0120
only

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  • Page 1 R I W I T N E S S ™ Embryology Heated Plate RESEARCH INSTRUMENTS LTD Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK only t: +44 (0) 1326 372 753 | f: +44 (0) 1326 378 783 |e: sales@research-instruments.com 0120 www.research-instruments.com...
  • Page 2: Table Of Contents

    SECTION 5 - RI WITNESS BASIC OPERATION Startup Procedure Shutdown Procedure Connecting to the Software User Interface Achieving the Correct Sample Temperature Changing the Temperature Setpoint Using the Device Changing the Temperature Setpoint using a PC and RI Witness Work Area software...
  • Page 3 Research Instruments Ltd Contents CONTENTS Temperature Calibration ITO Glass Window Calibration Using Built-In User Interface Full 5-channel Calibration Using PC and RI Witness Work Area Software Tube Reader Antenna Accessory SECTION 6 - TROUBLESHOOTING Alarms and System Status Audible Alarms...
  • 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: 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 8: 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 9: Electromagnetic Immunity

    If the measured field strength in the location in which RI Witness is used exceeds the applicable RF compliance level above, RI Witness should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating RI Witness.
  • Page 10: Safety/Information Symbols

    Section 3 Safety Warnings Research Instruments Ltd Safety/Information Symbols Symbol Meaning Indicates instruction for disposal of goods. 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 11: Safety And Reliability

    If the device is relocated ensure that the autotuning procedure documented in the RI Witness Software Manual (6-7-121UM) is followed to ensure optimum level of performance.
  • 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 Work Area 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: Achieving The Correct Sample Temperature

    Section 5 Research Instruments Ltd RI Witness™ Basic Operation Achieving the Correct Sample Temperature The heated plate is divided into 5 areas for calibration purposes. In order to achieve the correct sample temperature place the sample on top of the heated areas shown below. Do not place samples on top of the User Interface.
  • Page 16: Changing The Temperature Setpoint Using The Device

    Changing the Temperature Setpoint Using the Device The temperature setpoint is applied to all heating channels and is set using the following procedure, or from within the RI Witness Work Area 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 Work Area 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 Work Area Software

    Full calibration of the 5 heated areas requires that each of the areas is calibrated in turn. 1. Open the RI Witness Work Area software and navigate to the WorkArea Status window. 2. Click on the yellow triangle or the (i) icon then click Workarea Settings, then Connected Devices, then Temperature Controller, then Check Calibration.
  • 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

    Section 6 Troubleshooting Research Instruments Ltd SECTION 6 - TROUBLESHOOTING Problem Possible Cause Solution Check security of USB and power cable Loose connection connections. Navigate to the Workarea Settings screen, then Antenna not tuned Tags Reading click Connected Devices , then Embryology...
  • Page 21: Alarms And System Status

    3 seconds. A beep will be heard to confirm codes have been cleared. When multiple alarms are active, the icon on the RI Witness WorkArea Software on the device and Status Indicator Light for the highest priority alarm will be shown.
  • Page 22: Alarm Conditions Codes

    Section 6 Troubleshooting Research Instruments Ltd Alarm Conditions Codes Alarm Fault Priority Fault Description Alarm Solution Code Condition Actions ITO Window Heating system is not Heating Restart the device Heating Failure able to heat the specified controller by removing mains heating channel.
  • 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 Memory Fault Memory/controller System Recalibrate device. fault. During normal use continues to If the problem controller has failed to operate persists after re- save data. When power...
  • 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. The device may be lifted and returned to its original location. Do not disconnect the cables attached to the device.
  • 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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