Image Capture

TLM009-A
A Tool for Conjunctival Imaging

User Manual

1. General Information
            1.1 Overview
            1.2 Intended Use
            1.3 What is the activity ?
            1.4 Warnings and precautions
2. Preparing to complete a session
            2.1 Before starting, disconnect power to your device
            2.2 Check your screen
            2.3 Lighting
            2.4 Internet and network connection
            2.5 Activity Instructions
3. Additional Information
            3.1 Review the pre-activity screen
            3.2 Device position
            3.3 Submit or retake a photo
4. Activity Complete
            4.1 Review the timeline
            4.2 Session complete
            4.3 Session frequency
5. Additional Information
            5.1 Contact us
            5.2 Questions
            5.3 Your rights
            5.4 User manual information
            5.5 Symbols

1. General Information

1.1 Overview

The Image Capture tool (also called the “activity”, “test”, or “assessment”) is designed to capture data (also called an “image”, “group of images”, or “video”) by a companion (such as a friend, partner, caregiver, or family member) and then share that data with your eyecare professional. You will only be able to access the activity if you have been given a registration code by your eyecare professional.

For research purposes only:

Image data will be shared with your eyecare professional. Please contact your eyecare professional if you have any questions regarding how the images collected as part of this activity will and will not be used. If you experience changes in your vision; consult your eyecare professional immediately.

Do not perform the activity without prior assessment by your eyecare professional.

Your eyecare professional is the primary source of information regarding your eye condition. Be sure to consult your eyecare professional with any specific questions related to your vision or health.

Caution: If you experience changes in your vision; consult your eyecare professional immediately.

1.2 Intended Use

TLM009 (Conjunctival Imaging): Tool TLM009-A is intended to image the conjunctival surface of the eye. It is intended to aid health care professionals and companions in capturing and transferring images. The tool is not intended for the diagnosis or treatment of disease.

1.3 Activity Description

The activity will provide a silhouette of the eye and eyelid to assist with taking a picture of the surface of the eye using the rear-facing camera of a compatible mobile device. First, open the application, and then enter your pin as mentioned in the User Manual of the application in the “More Menu”. Next hand your device to your eyecare professional or companion who will take the picture. Your eyecare professional or companion will place the eye in the appropriate position to take a picture as indicated by the silhouette displayed on the screen. To take a picture, your eyecare professional or companion will press and hold the camera button that appears on the screen to take a burst of photos. Finally, the eyecare professional or your companion will inspect the image quality; if the image is blurry or misaligned it will need to be retaken. Ask your eyecare professional or companion to retake or submit accordingly. It takes on average two (2) to three (3) minutes to complete the activity.

1.4 Warnings and precautions

Contact your eyecare professional if you or your companion do not understand how to perform the activity.
Complete the activities using the application as often as recommended by your eyecare professional.
Performing the activity does not replace regular visits to your eyecare professional.
If the activity does not work properly, do not use it. Use the ‘Contact Us’ button in the ‘More’ menu to inform us of any comments or possible issues with the activity. You can also communicate any issues that affect your ability to complete the activity to your eyecare professional.
Your device must be connected to the internet while performing the image capture activity.
The activity is compatible with most Apple and select Android devices. Compatibility information can be found in the Apple App Store® and the Google Play Store.
Minimum operating system requirements necessary for this version of the activity can be found in the Apple App Store® and the Google Play Store.

2. Preparing to complete a session

2.1 Before starting, disconnect power to your device

We recommend that you disconnect (unplug) the power cable from your device before starting a session so that the cable does not interfere with your ability to complete the activity.

2.2 Check your screen

Check the device’s screen and camera lens for smudges and cracks. Smudges and cracks could interrupt the view of the eye and influence the activity. If smudges are present, wipe the screen with a soft cloth to remove before testing. The activity should not be completed on a device with a cracked screen or camera lens.

2.3 Lighting

Choose a quiet location to perform the activity. Ensure good lighting and sit in space that is well lit; sit to the side of a light source. This will help with clarity and quality of the photograph. Avoid facing the light source toward the mobile device as it can create glare. Check for glare on the screen before taking a picture.

Caution:
Being close to a window or under a bright light may cause a glare and make it difficult to complete the activity. Check for glare on the screen before the activity begins and move to a different location in order to reduce the glare on the screen before testing.

2.4 Internet and network connection

The activity requires an internet connection to assist with the capture process. Before beginning the activity, ensure there is an internet connection.

2.5 Activity Instructions

Before beginning the activity, please review the instructions.

2.5.1 Ensure good lighting, start by seating in a well-lit area

2.5.2 Lift up the eyelid and position the eye. Lift the upper eyelid and without moving the head, look down and in toward the nose.

2.5.3 Assisting the patient, ask the patient to look down without moving their head. Then, only if needed, you can gently shift their upper eyelid.

2.5.4 Align the silhouette, fit the patient’s eye in the silhouette then press and hold the button to take a burst of photos.

2.5.5 Review and approve, retake the photo burst if the eye is misaligned or blurry.

3. Additional Information

3.1 Review pre-activity screen

3.2 Device position

The User Manual and Product Label can be accessed from the pre-activity screen. The name of the activity is listed at the top of the screen as a reminder of the activity that is about to be taken.

When ready, please click the “begin” button to start the activity. A screen will appear to take pictures of the eye.

Adjust the position of the device such that the eye is centered and is aligned with the silhouette displayed on the screen to help take the images.

3.3 Submit or retake a photo

Once the images have been collected, please review the representative image for the set of images. If it is acceptable, i.e., clear and aligned in the silhouette, click the “Submit” button. If you wish to retake the set of images, click “Retake”. Be aware that you may be asked to capture a second set of images and repeat the steps in section 2.5.

4. Activity Complete

4.1 Review the timeline

When the activity is complete, a purple circle with a check mark will appear on the session timeline screen. Please review the timeline for an overview of completed and future activities.

4.2 Session complete

Once all activities are complete for a session, a purple screen will appear letting you know your images have been submitted. This concludes the session. Great job!

4.3 Session frequency

The frequency of sessions will be defined by your eyecare professional. Please review how often you should complete the activity with your eyecare professional.

Should an interruption or urgent situation occur during the activity so that you are unable to finish the activity in one sitting, exit the activity and restart the session when it is safe for you to do so. When you are ready to begin the session again, please start the activity from the beginning.

5. Additional Information

5.1 Contact us

Should you have any questions or concerns about the activity, please contact your study team at your site.

5.2 Questions

Your eyecare professional should provide instructions about the activity. For more information, or if you have questions about these instructions, contact your study team at your site.

5.3 Your rights

We value your trust and the protection of your data is important to us. Please review the application’s privacy policy for information about how data is collected and used. If you have any questions regarding privacy, or about our practices, please contact us using the “Contact Us” button in the More Menu.

5.4 User manual information

Document Number: IFU005

Revision: A

Date of Issue: 2021-11-11

© F. Hoffmann-La Roche Ltd. 2021. All rights are 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 the copyright owner. Copyrights and all other proprietary rights in any software and related documentation ("Software") made available to you rest exclusively with Roche, its affiliates, or its licensors. No title or ownership in the Software is conferred to you. Use of the Software is subject to an end user license agreement. To the maximum extent permitted by law, you shall not decompile and/or reverse engineer the software For research purposes only. Please contact your eyecare professional if you have any questions regarding how the results of this activity will and will not be used. If you experience changes in your vision; consult your eyecare professional immediately. Do not perform the activity without prior assessment by your eyecare professional or any part thereof. Not for diagnostic, monitoring or therapeutic purposes or in any other manner for regular medical practice.

5.5 Symbols

Caution: To indicate that the current situation requires user awareness or action in order to avoid undesirable consequences.

Consult Operating Instructions: To identify information that relates to the operating instructions. To indicate that the operating instructions should be considered when using the product or control close to where the symbol is placed.

Manufacturer: To identify the legal manufacturer of the product.

Catalog Number: To indicate the manufacturer’s catalogue number so that the product can be identified.

Batch Code: Indicates the manufacturer’s batch code so that the batch or lot can be identified.