Novocure MyLink OTU5000 Manuale utente

QSD-QR-026 CA(EN) Rev01 MyLink 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

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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. Overview of MyLink .................................................................................................................................. 4

4. Glossary of Symbols .................................................................................................................................. 5

5. General Information ................................................................................................................................. 7

6. Instructions ............................................................................................................................................... 7

7. Environmental Conditions....................................................................................................................... 11

Conditions for operation......................................................................................................................... 11

Data Integrity .......................................................................................................................................... 11

Storage .................................................................................................................................................... 11

Transportation ........................................................................................................................................ 11

Cleaning................................................................................................................................................... 11

8. Expected Product Life............................................................................................................................. 11

9. Disposal................................................................................................................................................... 11

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

This manual is intended for patients receiving Tumor Treating Fields therapy using the following electric

field generator:

-Optune device (TFH9100)

Please note: The color of the front face of your device may look different from 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 patient 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 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 is using 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

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

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.

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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.

3. Overview of MyLink

MyLink is comprised of an 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)

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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; Contact technical support to coordinate disposal

Protect from heat and radioactive sources

MyLink unit should be kept away from extreme heat and sources of radiation

IP22

Ingress Protection: Protects persons against access to hazardous parts with fingers.

Protects the equipment inside the enclosure against ingress of solid foreign objects of

12.5 mm in diameter or greater. Protects the equipment inside the enclosure against

ingress of vertical falling water drops when enclosure is tilted up to 15°.

Do not wet the device

For indoor use only

Class II electrical equipment

Do not expose to temperatures below -5°C or above 40°C

REF

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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

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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.

2. Locate the main power switch on the back of the MyLink unit. Press

the switch to “I” to power up MyLink.

Result: The indicator on the top of your MyLink unit will blink

green, indicating MyLink is performing a self-test. Wait until the light

stops blinking and “turns steady green”.

3. Stop TTFields treatment by pressing the TTFields button on your

electric field generator, and unplug the connection cable from your

electric field generator.

4. Open the lid of your MyLink . Release enough cable to connect to the

electric field generator.

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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

the electric field generator.

6. Make sure your electric field generator is on.

The “POWER” indicator on the front of the electric field generator is

illuminated in green.

If a battery is installed and the plug-in power supply is not in use, the

“BATTERY” indicator is also illuminated in green.

7. Download the usage data from your electric field generator.

Result: The indicator on the top of your MyLink unit will blink

green. This indicator means the MyLink unit is downloading your

usage data from your electric field generator.

Important: After a few minutes, the indicator stops blinking

and turns steady green, indicating that the download process is

complete. Your MyLink unit will beep to indicate completion of the

download process. The beeps will continue until you disconnect the

MyLink cable from your electric field generator (see next step).

Electric field generator

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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. For more information, see the MyLink

troubleshooting tips section of this manual.

8. Disconnect the MyLink unit cable from the electric field generator.

Result: The beeping notification signal from the MyLink unit will stop.

9. Turn the electric field generator to OFF by switching the power

switch to “O”. Wait a few seconds until the indicator “POWER” turns

off and switch the power back on to “I” on the electric field generator.

10. Plug the electric field generator connection cable into the device

and push the TTFields therapy ON/OFF button to resume TTFields

treatment.

Result: The blue indicators surrounding the TTFields ON/OFF button

will light up and remain on for as long as the treatment continues.

11. Automatic upload of the usage data from MyLink to the remote

secured server.

Once starts blinking green, the MyLink unit is uploading your

treatment data directly to the remote secured server.

Wait up to 15 minutes for the uploading process to be completed.

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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.

Note: The unit may take up to 10 seconds to turn off.

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