myVisionTrack® Home Vision Monitor User Manual

1. General Information

1.1 Overview

Thank you for becoming a user of the myVisionTrack® Home Vision Monitor. Picking up changes in vision related to the eye disease you have is really important in making sure that your treatment plan is as effective as possible. It is important your doctor knows if your eyesight is changing, as this might mean you need a change to your treatment plan.

1.2 Indication for Use

The myVisionTrack® vision monitor is intended for the detection and characterization of the central 3 degrees metamorphopsia (visual distortion) in patients with maculopathy, including age-related macular degeneration and diabetic retinopathy, and as an aid in monitoring the progression of disease factors causing metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home. The myVisionTrack® vision monitor is not intended to diagnose; diagnosis is the responsibility of the prescribing eye care professional.

1.3 What is myVisionTrack® Home Vision Monitor?

The myVisionTrack® Home Vision Monitor uses an advanced “shape discrimination” vision test which has been proven accurate and effective for you to self-test your vision at home. Shape discrimination vision testing involves showing you multiple shapes on the screen, with one shape being different from the others. The application (“app”) allows you to quickly and accurately test your own vision to help monitor whether your vision is changing due to age- related macular disease or diabetes. During the test, you will be asked to select the shape that looks different to the others. Results of the test are stored, and automatically compared with your previous test results.

myVisionTrack® Home Vision Monitor is a personal monitor that should be used only by the individual to whom the application was prescribed. If someone else takes the test in your place, it could make your results inaccurate and mean that an important change in your vision is missed. To try the test without sending your test results, select “Demo” in the More Menu.

1.4 Risks and Benefits

Eye conditions like age-related macular degeneration and diabetic retinopathy can get worse and impact your ability to see clearly, in even a short period of time. Thus, early detection is very important so that your eye care professional can make any changes to your treatment plan as early as possible. The myVisionTrack® Home Vision Monitor can be used as an aid in monitoring changes in your disease that can cause distortion of your vision (also known as metamorphopsia).

1.5 Warnings and Precautions

Diagnosis and monitoring of retinal disease should not rely solely on the results obtained from the myVisionTrack® Home Vision Monitor. Diagnosis and monitoring should be based on any new symptoms you are noticing in your everyday life, alongside other tests and evaluations performed by a qualified medical professional.

The myVisionTrack® Home Vision Monitor is designed to be used after a visit to an eye care professional. If you have not had this assessment or you don’t know how to perform the test, do not use the device and contact your eye care professional.

Do the test as often as recommended by your eye care professional. Please note that self- testing at home does not replace your regular visits.

The myVisionTrack® Home Vision Monitor is for your use only. To avoid any confusion or misinterpretation of your test results, do not allow others to take the test.

If the application does not work properly, do not use it, and use the Contact Us button in the More Menu.

Should you be in a location without a WiFi connection or mobile data signal at the time of testing(s), you should continue testing at the recommended frequency without concern. Although this will prevent real time communication of results to your eye care professional, the results will be saved and automatically sent the next time you test with a WiFi connection or data signal.

The myVisionTrack® Home Vision Monitor is compatible with most Apple and selected Android devices. Look for compatibility information on the myVisionTrack® Home Vision Monitor product page in the Apple App Store or Google Play Store.

2. Using myVisionTrack® Home Vision Monitor

2.1 Getting started

a. Download the myVisionTrack® Home Vision Monitor application

Search for Home Vision Monitor in the Apple App Store or Google Play Store and download the application to your device. Please note that you can only use your prescription code on one device.

b. Register your device by entering your prescription code

Open the myVisionTrack® Home Vision Monitor application. The welcome screen will appear. Click “register,” then “OK”, followed by entering the valid 10-digit prescription code provided to you by your eye care professional.

c. Set up your 4-Digit PIN number

This step will set up your 4-digit PIN number. You will need to enter your 4-digit PIN number twice, to confirm the number you have selected. Try to use a code that you can easily remember or make a note of it, as you will need to enter the PIN number each time you take the vision test.

d. Review our Privacy Policy

We value your trust in the Home Vision Monitor application. Our Privacy Policy helps you understand what data we collect, why we collect it, and what we do with it. It’s important to read it carefully, in case you have any questions.

e. Review our Terms of Use

The terms of use describe the agreement between the provider of the application and the user. Please read them carefully in case you have any questions.

f. Push notifications

In order to be able to receive messages from your prescriber and other vital information, we need permission to send you push notifications. If you would like to accept Push Notifications, select “OK” and “Allow”. If you do not want to receive push notifications, click “Later".

g. Continue to use myVisionTrack® Home Vision Monitor

Great job! You are now ready to use myVisionTrack® Home Vision Monitor.

2.2 Preparing to test

Before using the myVisionTrack® Home Vision Monitor application, please follow these instructions:

• Choose a quiet location with moderate lighting conditions away from a window or overhead lighting glare.
  
  
• Find a place to sit down in a comfortable position.
  
  
• If you wear glasses or contact lenses, you should always use the glasses or contact lenses that provide you the most up to date and best-corrected vision for near distance viewing (e.g. reading).
  
  
• Do not take this test in the dark or if you are tired or distracted.

2.3 Test Set-up

a. Before testing, disconnect power to your device

We recommend that you completely disconnect (unplug) the power cable from your device before taking the test so that the cable does not interfere with your ability to use your device during the test.

b. Check your screen is clean

Check the screen for smudges. Smudges could interrupt your view of the test shapes. If smudges are present, wipe with a soft cloth to remove before testing.

c. Distance

Place or hold the device at the same distance you would use to hold a book to read.

d. Device Stand

If you have trouble holding the device, please consider using a device stand during testing. Set up the stand on a table and place the device in a vertical orientation so that the “home” button is located at the bottom of the stand. When performing self-testing, we recommend you place the device so that you are looking at the center of the screen. The device screen should be placed fully in the line of sight without tilting it to the side or up and down.

e. Turning on the device

If it is not already on, turn on the device with the myVisionTrack® Home Vision Monitor application installed.

f. Internet and network connection

Check whether your device shows WiFi or a mobile data connection in the top left corner.

g. Unlock device and open the application

Unlock your device as you would usually do, then select the myVisionTrack® Home Vision Monitor application in order to open.

h. Start - main menu

With your finger, select the “Start” icon to begin the process of taking the vision test.

i. 4-Digit PIN

Select “OK” to enter your 4-digit PIN number using the numbers on the screen. The “back” key will allow you to go back and re-enter the last digit.

j. Wrong PIN

If you enter the wrong 4-digit PIN number you will be prompted to “try again.” Please make sure you have the correct 4-digit PIN number and try again. You will have chosen your PIN number when you first downloaded and registered the app. After 5 unsuccessful attempts, you may be locked out from taking the vision test. If you need assistance with resetting your PIN number, please contact your eye care professional.

3. Taking the Test

Please Note: Each eye will be tested at least two times, and three times if necessary.

a. Test your right eye first. Carefully cover your left eye with the palm of your hand.

b. Select “START” when you are ready to begin testing.

c. Touch the shape that is different from the other three. Continue to find and touch the different shape until more instructions are given.

d. When completed, you will get a message confirming that your first test is done. Well done! Please keep your eye completely covered and select “Start” when you are ready to repeat the test.

e. After the 2nd test, a third test may be required. The application will show a message if a third test is needed. Please keep your eye covered and select the “Start Test” button.

f. After the 2nd test (or the 3rd test if asked to do so) on your first eye, you will now be asked to test your other eye. Please cover your right eye with your hand and select the “Start Test” button.

g. After completing tests for both eyes, you will get a message confirming that you are done. Select “OK” to continue. After doing so, your test results will automatically be sent to your eye care professional for review. Your test results will not appear on your personal device screen.

h. Your testing frequency will be prescribed by your eye care professional. If you forget to take the test, the myVisionTrack® Home Vision Monitor will remind you when to take the next test. A reminder will pop up on your screen to alert you.

i. Should you run into an interruption or urgent situation during the test and are unable to finish the test in one sitting, exit the application and retake the test as soon as you are able to do so. When you are ready to take the test again, please start the vision test from the beginning (2.2. Preparing to test).

4. General Information

4.1 Demo

myVisionTrack® Home Vision Monitor should be used only by the individual to whom the application was prescribed. Remember that this is your personal test and the test results are used to inform your eye care professional. If you want to try out the test mode or demo the test to someone else without sending your test results, please select “Demo” in the More Menu.

4.2 Contact Us

We are here for you! Should you have any questions or concerns about myVisionTrack® Home Vision Monitor, please use the “Contact Us” button in the More Menu, where you will find our contact information.

4.3 Instructions

Your eye care professional should have given you detailed instructions about the myVisionTrack® Home Vision Monitor application. For more information, or if you have questions about these instructions, please use the "Contact Us" button in the More Menu. We are here to help you with any questions.

4.4 Your Rights

We value your trust in the myVisionTrack® Home Vision Monitor application. Our Privacy Policy menu helps you understand what data we collect, why we collect it, and what we do with it. It’s important to read it carefully, in case you have any questions. If you have any questions regarding privacy while using the application, or have questions about our practices, please contact us via email at global.privacy@roche.com. In all communications to us, please indicate that you are writing concerning the myVisionTrack® Home Vision Monitor application. We will do our best to respond to all reasonable inquiries in a timely manner.

Thank you for using the myVisionTrack® Home Vision Monitor application.

4.5 Labeling

4.6 Country Information 
 

In the UK, the myVisionTrack® Home Vision Monitor devices and associated technical support services are supported and funded by Roche Products Limited (and its group of companies).

4.7 User Manual Information

User manual version: 004. Date of Issue: 27th February 2023

© 2023 Genentech, Inc. All rights reserved. Reproduction or transmission in whole or in part, in any form or by any means, electronic, mechanical, or otherwise, is prohibited without the prior written consent of Genentech, Inc.