Invisalign Virtual Care 3.0: Automated Notifications User Guide

Read These Instructions Before Use

Before using the Automated Notifications available with Invisalign Virtual Care AI-based Automatic Assessment Version 3.0 (Virtual Care 3.0), patients and their parents or legal guardians should carefully read these instructions for important information, including warnings and precautions. It is recommended to save these instructions for future reference. Refer to Part III for compatible software and hardware systems needed to participate in Virtual Care 3.0. For questions or concerns, contact your Doctor or provide feedback through the My Invisalign Application.

© 2022-2024 Align Technology, Inc. English language version.

No part of this manual may be reproduced, photocopied, stored in a retrieval system, or transmitted in any manner (electronic or mechanical) for any purpose other than the customer's normal usage, without the prior written permission of Align Technology, Inc.

Patents: www.aligntech.com/patents

Align, Invisalign, and Virtual Care are trademarks of Align Technology, Inc.

Virtual Care 3.0 is a non-medical device Clinical Decision Support (CDS) software function per US Federal Regulations. These software tools do not diagnose or treat any condition, but only provide information for health care professionals. While Virtual Care identifies and describes dental attributes, it is not intended to substitute for the advice of a dentist, orthodontist, or other health care professional.

*The IFU is inclusive of Version 3.0 including minor updates and patch fixes within the series.

Manufacturer Information

Manufacturer: Align Technology, Inc.

Address: 2820 Orchard Parkway, San Jose, California 95134, USA

Authorized Representatives:

• Align Technology, B.V., Herikerbergweg 312, 1101CT Amsterdam, The Netherlands (EC REP)
• Align Technology Switzerland GmbH., Suurstoffi 22, 6343 Risch-Rotkreuz, Switzerland (CH REP)
• Align Technology UK Ltd., 2800 The Crescent, Solihull Parkway, Birmingham Business Park, Solihull B37 7YL, England, United Kingdom
• Align Technology GmbH, Dürerner Straße 405, 50858 Köln, Germany

Sponsor: Invisalign Australia Pty Ltd, Level 6, 154 Pacific Highway, St Leonards NSW, 2065 Australia

Customer Support

If you have questions or concerns about Virtual Care 3.0, please provide your feedback through the "Contact us for help" form in the My Invisalign App. Any serious incidents related to the device should be reported to your Doctor, who will inform Align Technology Inc. and the competent authority of the Member State in which the user and patient are established. Product availability and regulatory status may differ across countries depending on local regulations.

What is Virtual Care 3.0 Software Application?

The Automated Notifications available with Invisalign Virtual Care AI-based Automatic Assessment Version 3.0 (Virtual Care 3.0) is a system that helps your Doctor monitor your treatment progress. Virtual Care 3.0 uses artificial intelligence (AI)-based calculations and your Doctor's pre-set aligner space thresholds for automatic assessments, confirmed by trained personnel. It delivers your Doctor's communications regarding your Invisalign treatment progress. The system includes: Virtual Care Web UI, Aligner Fit Framework for Mobile, Invisalign Support Web, Aligner Fit Machine Learning engine, and Virtual Care 3.0 Aligner Fit Library. It also relies on other applications like the My Invisalign Application for communication with your Doctor.

Indications for Use

Virtual Care 3.0 system is intended to aid the Health Care Professional (HCP) in remotely monitoring and communicating intra-oral situations and malocclusion treatments using the Invisalign System. For this product, the Health Care Professional is your Doctor (dentist or other qualified dental health professional). Patients must have an established relationship with a Doctor during Invisalign treatment to upload photos and receive communication.

When Virtual Care 3.0 Software Application Should Not Be Used

Virtual Care 3.0 is contraindicated for use in the following circumstances:

• Doctors who are color blind or who have any visual impairment that may impact the Doctor's ability to use this device as directed.

Warnings

1. Virtual Care 3.0 does not provide diagnostic advice or recommendations on dental or orthodontic conditions or treatment. Any orthodontic treatment decisions supported by data generated by Virtual Care 3.0 service are the Doctor's responsibility. Overreliance on or substitution of this tool for the Doctor's professional judgment could lead to incorrect patient assessments and/or delays in treatment.
2. Simulations and measurements generated using AI-based systems may differ from final clinical results.
3. Several factors may prevent or delay the delivery of AI-based treatment guidance or guidance from your Doctor:
   • Low bandwidth, poor connectivity, lack of compatibility, or hardware failure.
   • Downtime or other technical issues with Virtual Care 3.0 or the My Invisalign Application.
   • Failure to receive your Doctor's notifications because My Invisalign Application notifications or alerts have been disabled in your smartphone.
   In case of any concerns, including serious incidents, please contact your Doctor immediately.
4. Virtual Care 3.0 is meant for Doctor use only and is solely intended for monitoring and communicating the progress of Invisalign treatments. Any other use may lead to incorrect patient assessments and/or delays in treatment.

Precautions

The following factors may impact AI assessment and/or lead to inaccurate guidance to the patient:

• (i) Poor photo quality; (ii) Photo not assessed by AI properly; (iii) Notifications or instructions set by your Doctor are vague or confusing. Delayed or inaccurate treatment guidance due to these issues could result in discomfort and tooth and/or periodontal tissue injury.

Virtual Care 3.0 is dependent upon:

• Maintaining regular contact with your Doctor and following their instructions and the steps outlined in Part I on how to take photos properly.
• Using proper photo-taking technique with a cheek retractor or other retracting device, especially when taking lateral photos (ensure premolars and 1st molars are visible). Refer to Part 1 (How to Take Photos).
• Following "aligners on" and "aligners off" prompts when taking "bite open" and "bite closed" photos.

If Virtual Care 3.0 does not perform as expected, contact your Doctor.

Doctors should not advise the use of Virtual Care 3.0 if patients (or their parents/guardians) lack regular access to a smartphone, cannot access/use the My Invisalign Application, or do not have sufficient bandwidth or resources necessary to regularly take and upload pictures. Product availability and regulatory status may differ across countries depending on local regulations. Talk to your Doctor or contact Align through the feedback form in the My Invisalign App.

How to Participate and Set Up Virtual Care 3.0

If you are reading these instructions, you have accepted your Doctor's invitation to participate in Virtual Care 3.0, as well as the terms and conditions associated with the program. For more information about the My Invisalign App, please refer to the FAQ in profile settings.

Part I. How to Take Photos

Refer to Part III for compatible software and hardware systems needed to participate in Virtual Care 3.0. My Invisalign App notifications must be enabled to proceed.

Steps for Photo Taking:

1. Press the "My Care" icon to start the process of photo taking. (Visual description: The app screen shows a "My Care" icon, a gallery of past photos, and options to "Take Photos" and view "Feedback history".)
2. Take 3 photos (straight on, facing right, facing left) in the following scenarios:
   • Aligners on and bite open
   • Aligners off and bite open
   • Aligners off and bite closed
3. Take occlusal photos (upper jaw and lower jaw). **Note:** Taking occlusal photos is only available with Invisalign Lens.
4. Before taking each photo, review the short video in the My Invisalign App on how to take photos.
5. Place the Invisalign cheek retractor or Invisalign Lens into your mouth. If you do not have a cheek retractor or similar device, choose the "I don't have retractors" option. (*Note: See the Invisalign Lens IFU for assembly and instructions for use. Invisalign Lens device may not be available in your country. Contact your Doctor if you have questions or concerns.)
6. For "Aligners on and bite open" photos, wear your aligners.
7. For "Aligners off and bite open" and "Aligners off and bite closed" photos, remove your aligners.
8. To take photos, align your mouth with the rectangular box on your phone screen. The photo will be taken automatically.
9. When taking lateral photos (head facing right/left), ensure your posterior (back) teeth (including premolars and 1st molars) are visible.
10. When taking occlusal photos (chewing surfaces of the upper and lower jaw), ensure the occlusal surface of posterior teeth is visible.
11. Once photos are submitted, they will be assessed by AI based on your Doctor's treatment settings. Your Doctor will also receive the photos and can review them. AI assessments are then routed to trained personnel to review and either accept or reject the assessment.

Visual Description of App Screens:

• Screen 1: Shows a user with aligners and a cheek retractor, with text "Put aligners on and use retractors" and a "Next step" button.
• Screen 2: Shows a user opening their bite with a retractor, with a "Hold still" prompt.
• Screen 3: Shows a "Processing" screen with text "Please wait while we analyze your smile".
• Screen 4: Shows a "Nice shot" confirmation, indicating "You have completed 2 of 9 photos. Don't give up!".
• Screen 5: Shows instructions for photo taking: "Wear your current aligners", "Face a mirror", "Make a 90-degree angle".
• Screen 6: Shows a "Great start" confirmation, indicating "You have completed 1 of 11 photos. Don't give up!".

Part II. How to Receive Feedback

Virtual Care 3.0 uses your Doctor's notification settings to provide one of two types of feedback after AI assesses your photo submission. Your doctor may also provide feedback directly.

• "On track" indicates that your new smile is progressing according to your custom treatment plan. Continue wearing your aligners as directed.
• "Instructions" indicates that your Doctor or Virtual Care 3.0 (based on your Doctor's settings) has provided additional guidance, for example, an instruction to wear your current aligners for an additional time, or to use 'chewies' to help seat your aligners properly.

Visual Description of App Screens:

• Screen 1: Shows a phone lock screen with a notification about "Your smile is on track!".
• Screen 2: Shows the My Invisalign app with "On Track" status for Aligner #10.
• Screen 3: Shows feedback from Dr. Smith: "You're making great progress. Keep up the good work."
• Screen 4: Shows feedback from Invisalign Virtual Care AI: "You're making great progress. Keep up the good work."
• Screen 5: Shows the My Invisalign app with "Instructions" status for Aligner #10.
• Screen 6: Shows feedback from Dr. Smith: "Please change to aligner #11 on Feb 8. You are making progress."
• Screen 7: Shows feedback from Invisalign Virtual Care AI: "Jane, please go back to previous aligner #10 for an additional week and don't forget to use your chewies."

If you have any questions about feedback notifications, please contact your Doctor's office. If you have questions or concerns about Virtual Care 3.0, please provide your feedback through the "Contact us for help" form in the My Invisalign App.

Always follow treatment instructions to keep your new smile on track.

Part III. What Software and Hardware Systems Will You Need?

This section presents system requirements and explains important information about data security.

How is Your Data Security Maintained?

Align takes great care in protecting the integrity and confidentiality of data from the moment it is collected. Patient data backed up to servers is transmitted over transport layer security (TLS 1.2 and above) encryption using trusted certificates, preventing attackers from capturing information in transit. PII information is encrypted at rest.

Device Protection Recommendations

It is your responsibility to protect access to your mobile device and install appropriate malware protections. Align recommends the following for protecting devices/data:

• Protect your mobile device with a passcode.
• Set a PIN code or biometric authentication (if your device supports it).
• Lock the screen during periods of inactivity.
• Use only on private, firewalled networks.
• Avoid using the My Invisalign App on rooted or jailbroken devices. (Rooting/jailbreaking grants complete administrator rights, allowing third-party programs to perform operations not originally possible).
• Keep operating system patches up-to-date to address vulnerabilities.
• Do not run proxies on the mobile device.
• Swipe away the application from your App Switcher to fully close it after use.

System Requirements

To take photos and get notifications from your Doctor or Virtual Care 3.0, you must have Internet access and your mobile device must meet the minimum specifications below. If software loses functionality (e.g., specific Aligner features are not displayed), contact Customer Support.

Minimum & Recommended OS Requirements:

Recommended Devices:

Software Update

Align recommends installing all recent My Invisalign App updates to keep it up to date. If you experience issues accessing Invisalign Virtual Care, please contact your Doctor.

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