Related Manuals for novocure MyLink OTU5000
Summary of Contents for novocure MyLink OTU5000
- Page 1 MyLink™ User Guide MODEL OTU5000 Easier data collection from the Electric Field Generator with MyLink QSD-EUUM-300 EU(EN) Rev02 MyLink User Manual Page 1/19...
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Page 2: Table Of Contents
Contents About MyLink – Device Description ..................... 4 Intended Purpose ............................4 Intended Users and Use Environment ...................... 4 Contraindications, Warnings, Precautions and Notices ................4 WARNINGS ............................4 PRECAUTIONS ............................4 NOTICES ..............................4 Principles of Operation ......................... 4 Overview of MyLink .......................... - Page 3 This manual is intended for patients receiving Tumor Treating Fields therapy using one of the following electric field generators: Optune device (TFH9100) Optune Lua device (TFT9200) Please note: The color of the front face of your device may look different to the color shown in the diagram QSD-EUUM-300 EU(EN) Rev02 MyLink User Manual Page 3/19...
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Page 4: About Mylink - Device Description
MyLink is a standalone technical unit which enables the easy upload of data from the electric field generators 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 identifiable patient information. -
Page 5: Overview Of Mylink
3. Overview of MyLink MyLink is comprised of the enclosure incorporating a cellular modem and custom software, a cable that connects the unit to the electric field generator and a power cord. It is powered from AC mains and is equipped with an internal backup battery. -
Page 6: Glossary Of Symbols
4. Glossary of symbols Follow instructions for use Medical Device symbol Manufacturer information Novocure GmbH, Business Village D4, Park 6/Platz 10, 6039 Root, Switzerland Model number Catalogue number Serial number Unique Device Identifier symbol Indicates a device carries Unique Device Identifying information. - Page 7 Do not expose to humidity below 15% or above 93% Fragile – handle with care CE mark symbol Authorized representative in the European Community Importer details: Novocure Netherlands B.V., Prins Hendriklaan 26, 1075 BD, Amsterdam, The Netherlands Power ON / OFF switch On/off indicator Download indicator Upload indicator...
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Page 8: 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 side of the MyLink unit and connect the unit to a wall outlet. - Page 9 5. Plug the cable of your MyLink unit into electric field generator. 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 the electric field generator. Electric field MyLink generator...
- Page 10 Wait up to 15 minutes for the uploading process to be completed. 12. Once all 3 MyLink indicator lights stop blinking and turn steady green, the upload has been successful. The data are now available to your Novocure representative. QSD-EUUM-300 EU(EN) Rev02 MyLink User Manual Page 10/19...
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Page 11: Environmental Conditions
13. Turn off your MyLink unit using the main power switch on the back. Note: The unit may take up to 10 seconds to turn off. 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”... -
Page 12: Expected Service Life
8. Expected Service Life The MyLink device expected service life is 5 years. 9. Disposal Please contact your Device Support Specialist for proper disposal. Do not throw in the trash. 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... - Page 13 If the indicator is still OFF, please contact your Device Support Specialist for further support. The Download ( ) Indicator is RED This indicates that the transfer of data from your electric field generator to your MyLink unit was unsuccessful. PART A: Free up storage space on your MyLink unit for data transfer: Disconnect your MyLink unit cable from the electric field generator.
- Page 14 7. Wait a few seconds until the indicator turns to steady green. 8. Make sure the indicator is flashing in green, and wait a few minutes while your MyLink unit is downloading data. 9. You will know the data download to your MyLink unit is successful when: a.
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Page 15: Assistance And Information
If the indicator stays red in one of above steps, please contact your Device Support Specialist for further support. NOTE: MyLink will attempt to upload data for 15 minutes. You will know the upload of data has failed when the indicator becomes steady red. -
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 Importer details: Novocure Netherlands B.V., Prins Hendriklaan 26, 1075 BD, Amsterdam, The Netherlands MDSS GmbH, Schiffgraben 41 30175 Hannover, Germany ©2022 Novocure GmbH. All rights reserved. MyLink and Novocure are registered trademarks of Novocure GmbH. QSD-EUUM-300 EU(EN) Rev02 10 November 2022 manuals.novocure.eu...
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