User Guide – App

v1.0/2021-09-08
Tilak Healthcare SAS

74 rue du Faubourg Saint-Antoine
75012, PARIS, France
Tel : +33 (0)1 85 73 27 02
Fax : +33 (0)1 49 23 01 16
http://www.tilakhealthcare.com/
OdySight is a medical device according to European Directive 93/42/EEC.

1. OdySight presentation

1.1 Intended use
OdySight® is a medical software intended for self-evaluation of the following visual parameters: near visual acuity and symptoms such as metamorphopsia and scotoma. The test results are transmitted to physician.


OdySight® doesn’t interpret the test results and it is not intended to diagnose but rather to help patients determine if they need to consult a physician for diagnosis and treatment.
Indications: OdySight® is indicated for adult patients aged 18 and over.
1.2 Product presentation
OdySight is a remote based medical monitoring system, which is used by the patient remotely and reports results to a dashboard at the clinical center, allowing the healthcare professional to identify those patients who need to come in for a visit and examination.

The app is prescribed to the patient by a healthcare professional.

It is intended for patients with eye diseases that, from the point of view of the healthcare professional, would benefit from remote monitoring of visual parameters: near visual acuity or presence or progression of metamorphopsia and scotoma. The point is to assist with the planning of follow up care between scheduled clinic visits.

OdySight is recommended for patients affected by eye disease requiring regular, close monitoring of vision, such as wet or dry forms of AMD at risk of neovascularization, diabetic retinopathy with or without macular edema, high myopia with risk of neovascularization and other similar, treatable causes of blindness.

OdySight doesn't interpret the test results and is not intended to diagnose. The diagnosis and patient treatment remain the responsibility of the physician.

OdySight does not replace regularly scheduled clinic visits to monitor eye diseases.

OdySight shall be prescribed to adult users who have:

a) Binocular vision equal to or better than 3/10 (0,5 logMAR; (20/63))

b) Access to a compatible smartphone and/or tablet

c) A valid email address and phone number to create an account

The competence to use the app and complete the test modules remotely, without the guidance of a healthcare professional
1.3 Contre-indications
The OdySight app is contra-indicated for:

  • epileptic users
  • users with a binocular visual acuity of less than 3/10 (0.5 logMAR; 20/63)
  • users with both eyes with monocular visual acuity lower than 1/10
1.4 Product description
OdySight is a digital technology system composed of two different components: the OdySight app for users and OdySight dashboard for healthcare professional.

The OdySight app is divided into the following modules:

  • the Near Visual Acuity (NVA) module allows the user to test their visual acuity; based on the ETDRS (Early Treatment for Diabetic Retinopathy Study);
  • the Amsler Grid (AG) module evaluates metamorphopsia and scotomas; based on the paper Amsler grid;
  • the authentication module allows users to securely connect to the OdySight application;
  • the menu module allows for navigation within the OdySight app;
  • the game and DLC modules: connected to the puzzles which are designed for user retention.

The OdySight online dashboard

Intended for the healthcare professional who prescribes the OdySight app to users. The healthcare professional can then view the results from the medical tests performed by users.

NB: The game module is not considered as a part of OdySight as medical device.

OdySight app

The application consists two parts: visual tests (visual acuity, Amsler grid), and a game (puzzles). The visual tests are intended to collect test results similar to those usually obtained in a medical center using standard methods.

The visual acuity test assesses near vision, while the Amsler grid test assesses the evolution of scotomas (black spots) and / or metamorphosis (deformation).
Near visual acuity and Amsler Grid tests in the OdySight app
OdySight Dashboard

The dashboard, intended for use by healthcare professionals, is a secure website for viewing the results of visual tests taken by their patients.
1.5 Product performance
OdySight allows for remote monitoring of visual parameters.

OdySight is a tool intended to complement your standard medical monitoring. It does not replace visits and examinations prescribed by your physician, which you should continue to go to.

If the results of your tests seem to indicate the need, OdySight will advise you to contact your referring healthcare professional. Their contact details are recorded and can be accessed from the application.

This clinical investigational plan was designed to evaluate visual acuity, an important component of any eye examination and used to establish and monitor a patient's ocular status. Visual acuity is the most used visual parameter to characterize and follow up chronic optical diseases.

The visual tests have been compared and evaluated during a clinical study to standard tests performed in medical centers. The clinical study demonstrated that the visual acuity tests and the Amsler grid of OdySight have a significant accordance to the tests carried out in medical centers (gold standards used - the EDTRS Sloan near visual and distance ETDRS charts and paper Amsler Grid).

NB: Visual acuity alerts will be validated as part of clinical trials.

The color of paint splatters appearing in vision tests (visual acuity) is of purely artistic interest and does not indicate a right or wrong answer.

Every day, OdySight tells you which test has to be done and on which eye. On average, a test takes 5 minutes to complete.

This test allows you to unlock the fun part of the application. These game sessions are designed to be relatively short and not tire your eyes.

Visual acuity test

Visual acuity is the ability to discern the thinnest possible character with maximum contrast. In the monitoring and diagnosis of ocular diseases, we carry out this measure eye by eye using optimal optical correction (corrective lenses).

The international standard for vision tests is the ETDRS. The test used in OdySight is directly inspired by this reference.
For reasons of international compatibility, OdySight uses the version of the ETDRS with the "Tumbling E", which is already used in certain sight tests:
Near visual acuity, as calculated in OdySight, is tested at a set distance of 40 cm, one eye at a time, with glasses for near vision.

IMPORTANT: If the results of your tests seem to require it, OdySight will advise you to contact your doctor. Please follow this advice.

Amsler grid test

The Amsler grid was created by Marc Amsler, a Swiss ophthalmologist, in 1945. It is a self-monitoring tool for maculopathies such as AMD and macula edema.

By staring at the center of the grid with one eye open at a set distance (around 40 cm), a person may see metamorphopsia (wavy lines) or scotoma (white, colored, or black patches) appear, which are symptoms of a change to an optical condition. In this case, monitoring by an ophthalmologist is required.
Wavy lines
Dark patch
Light patch
If, when taking the Amsler grid test on OdySight, you notice the appearance or deterioration of one of these anomalies, contact your doctor immediately.
1.6 Security
Your personal health data can be consulted by your physician at any time via their dashboard, which only they have access to.

This data, which includes your medical test results, is stored on an approved health data host that complies with the legal and regulatory requirements current in force. The transmission of data by the server to the dashboard is secured and encrypted.

2. General set up and use

2.1 Installing OdySight
OdySight can be installed on a smartphone or a tablet.

To download OdySight, you will need a device with the minimum technical specification's requirements (cf. section 3.1) and an internet connection.

If you are using an Apple device:

  1. Go to the App Store
  2. Click the search bar
  3. Write OdySight and click search
  4. Click the download button beside the OdySight logo

If you are using an Android device:

  1. Go to the page
  2. Read the instructions to make sure that your device is compatible with OdySight
  3. Click the Download OdySight button
  4. Follow the instructions on the screen

The OdySight application will then be installed on your device.

Downloading OdySight can also be done by clicking on the link in the email or text message received when registering.
2.2 Connect to OdySight
Once the application is installed on your smartphone or tablet, you must log in using two separate codes:

  • A keycode. This keycode is sent to you by email from Tilak Healthcare when your healthcare professional signs you up for the application and has created your patient account on their Dashboard. This is a temporary code that is used the first time you log into OdySight.

  • A personal password. You must choose and use your personal password when you first log in to the application. This password will be asked each time you connect.

When you enter your personal password, you can check the remember me box if you don't want to type your password each time you open the app* then click Connection to access OdySight.

⚠️ The use of OdySight is strictly personal. We discourage you from using the remember me box on a device that is not your own.

If you have lost your keycode or yours is not accepted by the application, please consult this page.

If you have lost your password, please consult this page.
2.3 Menu and navigation
The Map

The map is the main menu in the application. It is from here that you can start a vision test, play the puzzle game, change your settings, or find information about OdySight.

To access it, click the Pause (II) button at the top of your screen. To return to the map, click on "Return to the map" at the bottom of the menu.

Menus

OdySight has three menus, accessible from the map:
The vision test menu. This menu lets you start a vision test.
The Help menu. This menu allows you to find information, such as: your clinic's phone number, the OdySight service email, frequently asked questions and their answers, information about the product, and legal information.
The Pause menu. This menu lets you change the sound settings for the application, the language, and to return to the map.
2.4 To start a test
You can start a test in two ways:

  • When you open the application for the first time each day, a window will appear letting you know you need to take your daily test. You can click accept, then follow the instructions shown on the screen.

  • When you click on the Visual test menu, a list of tests will appear. Click on a vision test and follow the instructions shown on the screen.
To take a test in the best possible conditions:

  1. Make sure your smartphone or tablet is connected to the internet.
  2. Ensure that there is plenty of ambient light, but that none of it is shining directly on your face.
  3. Place your device on a stable surface.
  4. Make sure your device is in portrait orientation, that is to say vertical, as shown in the picture below.
  5. Click on the Visual test menu and choose your visual test.
  6. If you wear glasses for nearsightedness, put them on.
  7. Make sure you are 40 cm from the screen (plus or minus 5 cm)
  8. Follow the instructions that are shown on the screen.
The visual acuity test is presented in the form of a short and interactive test in which the user must indicate the direction of the letter "E" by swiping their finger in the corresponding direction (top, bottom, right, or left).

The Amsler grid test is a digitalized version of the paper Amsler grid. By using their finger as a pencil, the user can draw any irregularities which they see appear.
2.5 Test results
The results are shown at the end of each vision test:

  • The results for the visual acuity test are shown out of 10 (Monoyer scale). The Monoyer scale is a unit of measurement for visual acuity currently used by ophthalmologists. The results shown are for information purposes only.

  • The results of the Amsler grid are presented in the form of an image.

⚠️ The color of paint splatters appearing in vision tests (visual acuity) is of purely artistic interest and does not indicate a right or wrong answer.

⚠️ The visual acuity test results may be different from those obtained during an appointment. OdySight measures near vision, nor far, as may be done during an appointment. In addition, OdySight may not use the same system of measurement as your ophthalmologist.

If variations above the threshold determined by the app are detected, an alert is triggered. You are advised to contact your clinic to discuss the possibility of setting up an appointment.
2.6 Close the app
The way to close the application depends on your device. Here are several methods for closing the OdySight application.

If you have an Apple device

To close OdySight on an Apple device (iPhone or iPad), follow these instructions:

  1. Click twice on the home button (the round button below your screen) quickly. The list of opened apps will appear, with the OdySight window first.
  2. Slide the OdySight window from top to bottom until it disappears.
  3. When the window disappears, the app is closed.

If you have an Android device

When you open OdySight, the app is put in full screen. Follow these instructions to leave the full screen mode:

  • Put your finger at the bottom of the screen and swipe or slide it up. The triangle, round, and square buttons of your Android device will appear.
  • Click the square. The window of the app will reduce in size, and you will see your wallpaper as well as the other opened apps (if there are ones).

The method to close an app is not the same on all Android devices, but here is a list of possibilities to close OdySight:

  • Click the cross at the top right side of the OdySight window.
  • Click the cross at the top left side of the OdySight window.
  • Slide the OdySight window from left to right until it disappears.
  • Slide the OdySight window from top to bottom until it disappears.
  • When the window disappears, the app is closed.
2.7 Application updates
Major application updates happen automatically when your device is connected to the internet. When one of these updates is available, you will see a message appear in OdySight letting you know about the update.

You can install the smaller updates if you want. These slightly improve the application. To do so, follow these steps:

  1. Go to the App Store (Apple devices) or Play Store (Android™ devices).
  2. Type OdySight into the search bar, then select the OdySight application.
  3. Click the "Update" button which appears next to the application logo. This will start the update download.

If the "Update" button does not appear, your device is up to date.

3. Informations techniques

3.1 Minimal requirements and supported devices
Any device which meets the following criteria may download the app:

  • Minimal operating system:
    - Android™ 6.0
    - iOS® 10
  • Screen resolution equal to or higher than:- 280 ppi* for Android™ - 260 ppi* for iOS®
  • Screen diagonal larger than 4.7"
  • Presence of a front camera at the top of the device
  • Presence of a light sensor (for Android™ devices)

⚠️ If one of your eyes has a visual acuity greater than 6/10 (+0.2 logMAR or 20/32), the resolution of the screen must be at least 320 ppi.

You can find the list of supported devices here.

If you are unsure, feel free to send an email to the following email address: supportFR@odysight.app
3.2 Battery
To take the different tests, the screen of your device must admit sufficient light. This is why the phone should be properly charged to avoid it going into "low battery" mode.

If the batter has less than 30% remaining, the application will not let the user start the tests, and if the battery is below 15%, the application will stop entirely; the phone much be recharged to continue.
3.3 Screen cleanliness
For the best test performance, it is important that the device's screen is intact and free of any deep scratches or dents and is clean.

4. Warnings and precautions

OdySight does not replace your healthcare facilities visit and tests prescribed by your healthcare professional as part of monitoring your vision. Continue follow your visits calendar.

OdySight does not provide an interpretation of test results, diagnose or treatment recommendations. It is not intended to provide a diagnosis. Diagnosis remains the responsibility of the physician.

All medical decisions must be made by a healthcare professional.

If you notice a change in your vision and you think there is a need, contact the healthcare professional who prescribed you OdySight. Their contact information is available in the app.

The application should be used only by the patient whom the application has been prescribed to ensure that the data being sent to the healthcare professional.

The test results may differ from those obtained during your medical appointment. They should be considered as relative values.

The OdySight alert system is not intended to have a direct impact or change the clinical care flow for patients suffering from a chronic ocular disease, but it is only intended to help healthcare professionals to improve patient follow-up. The specificity and sensitivity of the alert system for the evaluation of new and/or adverse events in chronic ocular disease has not yet been confirmed.

During your tests, do not force your sight. During visual acuity tests, a "I don't know" button will appear after a few seconds without touching the screen. If you click it, the size of the "E" will increase. This will not distort your results, feel free to use it.

Do NOT use this product to self-diagnose vision problems. Do NOT leave your smartphone or tablet within reach of children while performing your tests.

Tilak Healthcare is not liable for data collected by mistake on the device due to misuse or malfunction resulting from abuse, accidents, modifications or negligence.

5. Contact us

If you have any problems with OdySight, please see our website where you can find a list of frequently asked questions: https://odysight.app/faq-fr.

If you don't find an answer to your question, contact us at: supportFR@odysight.app

Any serious incident occurring in connection with the device must be brought to the attention of the manufacturer and to the competent authority of the Member State in which the user is established.

6. Additional information

For a list of frequently asked questions about the application and their answers, go to: https://odysight.app/faq-fr

7. Symbols used on the device labelling and user guide

European CE marking of conformity. The device is in compliance with EU Medical device directive

Consult instruction for use/ User Guide

Manufacturer