1. OdySight presentation

1.1 Intended use

1.2 Product presentation

1.3 Contre-indications

1.4 Product description

1.5 Product performance

1.6 Security

2. General set up and use

2.1 Creating your Center account

2.2 Creating a healthcare professional account

2.3 User rights

2.4 Access your OdySight Account

2.5 Navigation

2.5.1 Home Page

2.5.2 Navigation Menu

2.5.3 Navigation bar

2.5.4 Patient List

2.5.5 Archived Patients

2.5.6 Results Page

2.6 How to prescribe OdySight

2.7 View Results

2.8 Alerts

2.8.1 Triggering Alerts

2.8.2 Dealing with an Alert

2.9 Log out of the Dashboard

2.10 Updating the Dashboard

3. Technical information

3.1 Hardware

3.2 Security

4. Warnings and precautions

5. Contact us

6. Additional information

7. Symbols used on the device labelling and user guide

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 the 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.

OdySight is a remote based medical monitoring system, which can be used by the patient remotely and can report results into a web 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 disease 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. It 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

d) The competence to use the app and complete the test modules remotely, without the guidance of a healthcare professional

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

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 metamorphosis 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: related to the puzzles which are designed for the retention of the user.

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 vision 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: vision tests (visual acuity, Amsler grid), and a game (puzzles). The vision 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).

OdySight Dashboard

The dashboard, intended for use by healthcare professionals, is a secure website for viewing the results of vision tests taken by their patients.

OdySight allows the 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 attend.

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 vision 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 physician. 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.

If, when taking the Amsler grid test on OdySight, you notice the appearance or deterioration of one of these anomalies, contact your physician immediately.

Personal health data are made available to the physician on a dashboard. Such data including the results of the vision tests are hosted by a certified health data server in the European Union. The transmission of data by the server to the dashboard is secured and encrypted.

The dashboard allows you to prescribe OdySight and to follow the evolution of your patients' visual parameters obtained during their vision tests performed with the application.

To create a Center account, you must fill out a center creation form and then click on the confirmation button.

Once the form is submitted, you will be redirected to an account creation form. Fill it in and click on the confirmation button.

Once the form is submitted you will receive an automatic email containing an activation link. Click on the activation link to confirm the creation of your account. Once this action is completed, your account will be created, and you will be able to access your dashboard.

To create a healthcare professional account, you must go to the Administration menu and select Add a Healthcare Professional. Then, you must fill out a user creation form and click on the confirmation button.

Once the form is submitted, the healthcare professional will receive an automatic email inviting them to join your OdySight Center and containing an inscription link. Clicking on the inscription link will lead them to an account creation form. They will then have to fill it in and click on the confirmation button to create their account.

⚠️ Healthcare professionals can't be created by non-administrator users

When you create a healthcare professional account, you must define their role. This role will have an impact on their use of the dashboard and will grant them specific rights. Parts of the dashboard and actions might not be available for users depending to their restricted rights. Details of user rights are available in the FAQ.

When you connect to the dashboard, you will be asked for two codes:
A personal password, which you set when creating the account

A temporary code automatically sent by email or SMS to confirm your identity. A new temporary code will be sent to you at each connection, usable for one hour.

To access your OdySight Dashboard:

1. Go to: https://dashboard-us.tilakhealthcare.com/dashboard/us/login
2. In the login fields, enter your email address and your personal password.
3. A temporary code is sent to you. Enter this code in the field provided and then click on the "Validate" button to access your dashboard.

You can check the "Make this device my trusted computer" box to avoid having to enter the temporary code the next time you log in.

⚠️ Attention, this dual authentication connection (i.e. with two codes) is used to protect medical data.

If you lose your password, follow the steps below:

1. 1. Go to the login page of the dashboard and click on "Forgot your password?
2. Fill in your email address in the dedicated field. A message will confirm that a password reset email will be sent to you.
3. Check your mailbox and click on the reset link.
4. Choose a new password (for more information, see section 3.2 "Computer Security") and type it twice.
5. Click "Save".

You will now be able to access your Dashboard.

2.5.1 Home Page

The home page is the first page that appears when you log in to the dashboard. From this page you can:

• Prescribe OdySight to a patient

• See your patients with alerts, check their test results, and remove alerts

• Access the Navigation menu (see section 2 of this document)

• Access the Navigation bar (see section 3 of this document)

• See patient statistics

2.5.2 Navigation Menu

The navigation menu is located on the left side of the dashboard. From this menu you can access:

• The Home page (Dashboard)

• The Prescription formula (Add a Patient)

• OdySight patient list (Patients)

• Archived Patient list (Archived Patients)

• Your account settings (Profile and Change Password)

• The Administration menu (Add and update Healthcare Professionals)

• OdySight customer service (Contact us)

2.5.3 Navigation bar

The navigation bar is located at the very top of your dashboard. It includes:

• A button to return to the home page (the house)

• The User Guide (the book)

• A link to a Questions and Answers page with answers to frequently asked questions about the dashboard (the "i")

• A button to display the notifications of your patients with alerts (the bell)

• A button to access your profile settings and to log out of the dashboard (the physician).

2.5.4 Patient List

To access the list of patients, click on "Patients" in the navigation menu.

• Patients with alerts are shown in red and at the top of the list.
• Active patients are colored green and in second position on the list. A patient is considered active if they have done at least one vision test in the last 30 days.
• Inactive patients are in dark blue and appear last. A patient is considered inactive if they have never downloaded the application or have not done a vision test within the last 30 days.

From this list, you can:

• View a patient's results by clicking on "Results" (see "The Results Page" section for more details).
• Remove a patient's alert by clicking on their line to display an alert removal form. This will allow you to remove the alert.
• Modify patient information by clicking on "Profile".
• Archive a patient by clicking on "Archive". This function is only available if the patient has no current alerts.

2.5.5 Archived Patients

To access the list of archived patients, click on "Archived Patients" in the navigation menu. This list contains all patients that have been archived manually (from the patient profile) or automatically (after 90 days of inactivity).

From this list, you can:

• View a patient's results by clicking on "Results" (see "The Results Page" section for more details).

• Modify a patient's information by clicking on their profile

• Send a follow-up email to a patient by clicking on the "Restart" button. This function is only available if the patient has never taken a vision test.

• Delete a patient's profile by clicking on "Delete". This function is only available if the patient has never downloaded OdySight or has never used their encrypted key (activation code for the OdySight patient account).

The personal and medical data of an archived patient is automatically deleted after 365 days of inactivity.

2.5.6 Results Page

The results page is where you can see your patient's visual acuity curve for each eye, as well as your patient's drawings on the Amsler grids. To access it, click on "Patients" in the navigation menu, then click on the patient's profile of your choice, either by clicking on his line (if the patient doesn't have any alerts) or by clicking on "Results".

From this page, you can:

• Remove an alert

• Consult visual acuity test scores

• Consult Amsler grid drawings

• See previous Amsler grid drawings

The OdySight prescription form is available from two dashboard pages:

• From the home page: click on "prescribe OdySight"

• From the navigation menu (on the left): click on "Add a patient" to be taken to the page where you can fill out the patient's information to prescribe OdySight

To prescribe OdySight, fill out one of these two forms with the required information about your patient. Then click "Create". Your patient will automatically receive an e-mail and a text message containing all the information required to use OdySight. The prescription procedure is then complete.

Your patients' medical data can be consulted at any time on your online dashboard, with restricted access.

To see patient results:

1. In the navigation menu, click "Patients". The list of all patients to whom you have prescribed OdySight will be displayed (except for archived patients).
   
2. Go to the patient line of your choice. In the "Actions" column, click on "Results". You will then be redirected to your patient's results page.

2.8.1 Triggering Alerts

An OdySight alert is triggered when a change is observed in a patient's visual acuity results. The patient and the physician are informed as follows:

1. The patient receives an email and a text message asking them to contact their physician. A notification is also displayed in the application, asking them to confirm whether they have contacted their physician.
2. The physician receives a notification on their dashboard and a mention of the alert in the bi-weekly summary email. In addition, the patient's profile appears on the home page of the dashboard, in the list of patients with alerts (in red).

2.8.2 Dealing with an Alert

To deal with an alert:

1. 1. Go to the patient results page. Check the patient's most recent vision tests to see if the alert seems justified to you.
2. If necessary, speaking with your patient by phone. Make sure the alert is justified. Offer the patient an emergency appointment if necessary.
3. Once the alert has been processed, go to your dashboard and click on the patient's name. An Alert Qualification Form will be displayed.
4. Answer the Alert Qualification Form to specify the relevance of the alert as well as any possible treatments.
5. Finally click on the "Confirm" button to definitively lift the patient's alert.

Once the alert is lifted, your patient will revert to active status on your dashboard (their profile will no longer be displayed in red, but in green).

When you have finished using the dashboard, it is important that you log out to protect medical data. To do so:

1. In the bar at the very top of the dashboard, click on the icon representing a physician.
2. A menu will be displayed, including the "Logout" button. Click it to log out.

Updates to the Dashboard will happen automatically, there is nothing specific that you need to do.

The dashboard is used on a web browser and is therefore available on any device (computer, tablet, or smartphone) with a web browser. This device can be on any operating system (Windows, MacOS, Linux, iOS, Android, etc.). The use of the dashboard requires an internet connection.

Vision test results are stored on an approved health data host that complies with the requirements of the European Data Protection Regulation 2016/679.

Here are some precautions to take for safety reasons:

• Do not create your password with personal information (date of birth, name, nickname, etc.).

• Do not use obvious sequences (qwerty, 1234, etc.).

• Don't put special characters at the end; don't start with uppercase (Randomword0? => ran?Dom0word).

• Never give out your password.

• If you think your account has been compromised, change your password!

• Disconnect from the dashboard manually when you are not using it.

⚠️ You will automatically be logged out from your dashboard after 12 hours of inactivity.

⚠️ When you leave the room where you use your computer, be sure to lock or turn off your computer to protect it from unauthorized access.

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.

If you have any problems with OdySight, please see our website where you can find a list of frequently asked questions: https://faq.tilakhealthcare.com/en/support.

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

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