novocure MyLink OTU5000 User manual

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MyLink™ User Guide
MODEL OTU5000
Easier data collection from the Electric Field Generator with MyLink

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Contents
1. 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
2. Principles of Operation ......................................................................................................................... 4
3. Overview of MyLink ............................................................................................................................. 5
4. Glossary of symbols.............................................................................................................................. 6
5. General Information............................................................................................................................. 8
6. Instructions............................................................................................................................................... 8
7. Environmental Conditions .....................................................................................................................11
Conditions for operation......................................................................................................................... 11
Data Integrity ..........................................................................................................................................11
Storage .................................................................................................................................................... 11
Transportation ........................................................................................................................................ 11
Cleaning...................................................................................................................................................11
8. Expected Service Life..............................................................................................................................12
9. Disposal...................................................................................................................................................12
10. MyLink troubleshooting tips................................................................................................................ 12
11. Assistance and Information .................................................................................................................15
12. Appendix A – Applicable Standards....................................................................................................15
13. Appendix B - Electrical specifications and cellular network specifications.......................................15
14. Appendix C - Emitted radiation and electromagnetic compatibility.................................................16

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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

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1. About MyLink – Device Description
Intended Purpose
MyLink enables the patient to upload the electric field generator’s log files to a remote secured
Novocure server from the comfort of his/her home.
Intended Users and Use Environment
The device is intended for use by the adult patients or their caregivers in the home health care
environment.
Contraindications, Warnings, Precautions and Notices
WARNINGS
Warning — All servicing procedures must be performed by qualified and trained personnel. Attempting
to open and service your MyLink unit may result in an electric shock by touching the inner parts of the
equipment. It could also cause damage to the unit.
Warning — No modification of this equipment is allowed.
PRECAUTIONS
Caution — MyLink is to be used with the electric field generators listed on page 2 only.
NOTICES
Notice — your MyLink unit uses a cellular network for its operation. If you are trying to use it in a non-
cellular reception environment, the unit will not work properly.
2. Principles of Operation
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.
MyLink connects to the electric field generator to download the data log files to an internal memory and
then uploads the downloaded data to the remote secured Novocure server using the cellular network.
Data integrity is maintained at all times even when the data transfer stops, loses signal or cannot be
completed.
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.

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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.
On/off indicator
Download indicator
Upload indicator
Electric field generator
MyLink (front)
MyLink (back)