novocure MyLink OTU5000 User Manual
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MyLink™ User Guide
Model # OTU5000
Making data collection from the Electric Field Generator with MyLink
QSD-QR-026 CA(EN) Rev01 MyLink User Manual
Page 1/19

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Summary of Contents for novocure MyLink OTU5000

  • Page 1 MyLink™ User Guide Model # OTU5000 Making data collection from the Electric Field Generator with MyLink QSD-QR-026 CA(EN) Rev01 MyLink User Manual Page 1/19...
  • Page 2: Table Of Contents

    Contents 1. About MyLink – Device Description ......................3 Intended Purpose ............................3 Intended Users and Use Environment ...................... 3 Contraindications, Warnings, Precautions and Notices ................3 WARNINGS ............................3 PRECAUTIONS ............................3 NOTICES ..............................3 2. Principles of Operation ..........................3 3.
  • Page 3: About Mylink - Device Description

    MyLink is a standalone technical unit which enables the easy upload of data from the electric field generator to a remote secured Novocure server from the comfort of the patient’s home. The data uploaded contains only information about the usage of the device and any errors, it does not contain...
  • Page 4: Overview Of Mylink

    The download time should take 1-3 minutes while the upload time takes up to 15 minutes with a good connection. The data download mode must be finished before the upload mode can start. The separation between the two modes is done by disconnecting the data cable from the electric field generator.
  • Page 5: Glossary Of Symbols

    4. Glossary of Symbols Follow instructions for use Manufacturer information: Novocure GmbH Model number Catalogue number Serial Number Date of Manufacture Caution - Consult the instructions for use for important cautionary information WEEE; Waste Electrical and Electronic Equipment; Contact technical support to coordinate disposal;...
  • Page 6 Do not expose to humidity below 15% or above 93% Fragile – handle with care Industry Canada Power ON / OFF switch On/off indicator Download indicator Upload indicator MET mark for electrical safety released by an accredited lab QSD-QR-026 CA(EN) Rev01 MyLink User Manual Page 6/19...
  • Page 7: General Information

    5. General Information You should download your usage data from your electric field generator to the MyLink unit every month and when in need of technical assistance. 6. Instructions 1. Plug the power cord into the back of the MyLink unit and connect the unit to a wall outlet.
  • Page 8 5. Connect your MyLink unit to the electric field generator connection port. Note: To ensure proper connection, align the arrow on the cable of your MyLink unit with the arrow on the socket on the front panel of Electric field generator the electric field generator.
  • Page 9 Important: MyLink will beep for both successful and failed data collection. This beeping notification signal tells you to disconnect the MyLink unit and go back on treatment, even if data collection failed. In the case of download failure, the indicator of your MyLink unit will show red.
  • Page 10 12. Once all 3 MyLink indicator lights stop blinking and turn steady green, the upload has been successful. The data is now available for your Novocure representative. 13. Turn off your MyLink unit using the main power switch on the back.
  • Page 11: Environmental Conditions

    7. Environmental Conditions Conditions for operation Mainly for home use. For indoor use only. Data Integrity The integrity and availability of the usage data are assured: Usage data remain in the electric field generator until MyLink “confirms” all data have been •...
  • Page 12: Mylink™ Troubleshooting Tips

    10. MyLink™ troubleshooting tips Follow the instructions provided if your MyLink is experiencing the following: The On/Off ( ) Indicator is OFF Make sure your MyLink unit power cord is plugged into the AC port and a standard power source (wall outlet). Make sure your MyLink unit power switch is in the “I”...
  • Page 13 If it stays OFF, continue with “PART B.” Wait for the indicator to be steady green. Switch your MyLink unit to OFF (power switch in “O” position). It may take a few seconds for the indicators to turn OFF. Switch your MyLink unit to ON (power switch in “I” position). Wait for the indicator to turn steady green.
  • Page 14 2. Make sure your MyLink unit is disconnected from your electric field generator. 3. If the indicator stays OFF, please contact nCompass for further support. The Upload ( ) Indicator is RED This indicates that your data was unsuccessfully uploaded from your MyLink unit to the remote secured server.
  • Page 15: Assistance And Information

    11. Assistance and Information TECHNICAL SUPPORT For technical support, contact Novocure via phone 1.866.320-2006 or email support@novocure.com 12. Appendix A – Applicable Standards The MyLink unit complies with UL/CSA-C22.2 No.62368-1:2014 Audio/Video, Information and Communication Technology Equipment - Part 1: Safety Requirements;...
  • Page 16: Appendix C - Emitted Radiation And Electromagnetic Compatibility

    14. Appendix C - Emitted radiation and electromagnetic compatibility MyLink is intended for use in a home healthcare environment (such as domiciles [residences, homes, nursing homes], hotels, hostels and pensions). Warning - Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation.
  • Page 17 Table 2 – Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS Electromagnetic environment - Immunity test IEC 60601 level Compliance level guidance Floors should be wood, concrete or 8 kV contact 8 kV contact Electrostatic discharge ceramic tile.
  • Page 18 Table 3 – Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC IMMUNITY – for HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT and ME SYSTEMS Immunity test IEC 60601 level Compliance level IEC 61000-4-6 3 Vrms [V] = 3 Vrms 150 kHz to 80 MHz Conducted RF 6 Vrms in ISM bands (6.765 MHz to 6.795 MHz;...
  • Page 19 Novocure GmbH, Business Village D4, Park 6/Platz 10 6039 Root, Switzerland ©2022 Novocure. All rights reserved. nCompass, MyLink, and Novocure are trademarks of Novocure QSD-QR-026 CA(EN) Rev01 MyLink User Manual Page 19/19...

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