Instructions for use

Introduction

This booklet guides you on how to use the SkinScreener mobile app. Please read the booklet carefully, including the warnings section. This will help you get the full benefit of the app.

The SkinScreener mobile app for Apple® iOS and AndroidTM devices allows you to perform a skin lesion risk assessment for visual signs of premalignancy and malignancy quickly and easily.
The app is available on App Store® and Google PlayTM. These Instructions for Use are applicable for the product version v1.1.
Please ensure that you always update the app to the newest compatible version.

In case of any additional questions about the use of SkinScreener, please contact us at support@medaia.atlassian.net.
The printable PDF version of Instructions for Use can be found at the following URL free of charge:

https://skinscreener.at/gebrauchsanweisung/

The SkinScreener app is not intended to replace conventional methods of screening and assessing skin cancer risk, is not giving a diagnosis, and does not replace a medical professional’s visit.

Intended Use

The SkinScreener is a mobile app intended to provide the risk assessment of skin lesions using the mobile device’s camera and a flashlight. Additionally, the user is remembered to perform an annual dermatological examination. Before the scan, the user must perform a camera test, which will ensure a working camera and a good photo quality. The scan is performed according to the Instructions for Use. The algorithm calculates a risk assessment. The risk assessment can return: LOW RISK, MEDIUM RISK, or HIGH RISK. Based on the risk assessment, the user will receive a recommendation to see a dermatologist for further examination to obtain an accurate medical diagnosis. Users with MEDIUM RISK or HIGH RISK assessments should see the dermatologist sooner than the recommended preventive dermatological check-ups to verify the result by further specialist examination. In the case of LOW RISK assessment, the skin lesion should be observed regularly and scanned again, at least once a month. Nevertheless, the user should visit the dermatologist for a regular annual dermatological examination.

The SkinScreener is intended to be used by adult users with Fitzpatrick skin type I (ivory) to IV (light brown). The SkinScreener application must not be used on children.

The SkinScreener cannot replace the dermatological examination, it is not giving a diagnosis and cannot be a substitute for visiting a healthcare professional.

Indication: To assess a lesion on human skin for possible visual signs of premalignancy or malignancy, using a three-level classification (LOW RISK, MEDIUM RISK, or HIGH RISK).

Intended User Group

The SkinScreener is intended to be used by adults with skin type I (ivory) to IV (light brown) (classified by Fitzpatrick scale), both males and females.

Special language skills are not required as the SkinScreener application is localized in the target country’s language/market.

There is no specific education or training required for using the SkinScreener application. No previous experience with a similar product is required. Basic knowledge of handling an Android or iOS mobile device is desirable.
A scan can be performed at all body parts, except on excluded body parts, described in chapter Warnings/Exclusions.

Users with severe visual impairment are not supposed to use the SkinScreener application. Sex, age, or physical properties like weight or height do not influence the analysis.

Limited Use

The SkinScreener app should not be used by persons who might face difficulties, due to lack of mental capacity to understand the recommendation text, lack of technical understanding to operate a mobile device, or lack of medical understanding to identify a lesion to be assessed.

Disclaimer

medaia GmbH is not responsible for the consequences of using this app outside Intended use or Warnings. User will be solely responsible for all actions, causes of action, damages, losses, injury, costs, expenses and liabilities whatsoever arising out of or by virtue of any claim in respect of any misuse, abuse, negligence or failure to maintain the products as specified by medaia GmbH. Interpretations made by this device are potential findings are not a diagnosis of disease. All interpretations should be reviewed by healthcare professionals for clinical decision making.

System & Hardware Requirements

To be able to use the app, you need the following:

• Apple devices: iOS operating system – version 13.0 or later, iPhone 6 or newer.
• Android devices: Android operating system – version 9.0 or later, 3GB of RAM 3GB of RAM

Using SkinScreener

First-time use

1. The app SkinScreener can be used on compatible mobile devices with the operating system iOS 13.0 and Android 9.0 or higher. After installing the SkinScreener app and using it for the first time, the user must first read and accept the intended use, including the warnings, privacy policy, and terms and conditions in order to use the application.

Terms and Conditions:

https://skinscreener.at/agb

Privacy Policy:

https://skinscreener.at/datenschutzerklaerung

1. Install the App

On iOS (Apple devices)

1. Go to App Store and search for the app.
2. In the search result, tap the SkinScreener app.
3. Tap “GET” and then “INSTALL”.
4. If prompted, sign in to the App Store to complete the installation.

On Android

1. Go to Google Play Store and search for the app.
2. In the search result, tap the SkinScreener app.
3. Tap “INSTALL”.

When the installation is complete, you will see the app’s icon on the home screen of your mobile device and the app is ready to be used.

2. Welcome Screen

1. When starting the app for the first time, a pop-up reminder to visit a dermatologist once a year will appear. To proceed, click the “OK” button.
2. To open Instructions for use, click to “Info” button. Click the “NEXT” button to proceed.

3. Intended Use

1. Read the intended use and accept it by clicking the “ACCEPT” button.
2. After accepting the intended use, the Sign In screen will appear.

4. Sign In

1. Click on the “Accept Privacy Policy” checkbox.
2. Click on the “Accept Terms and Conditions” checkbox.
3. To sign in, click on “Sign in with Google” (for Android devices) or “Sign in with Apple” (for iOS devices), and choose the account to log in.

5. Personal Data

1. Enter your name, email, gender, and date of birth.
2. Optionally, enable push notifications. Click the “NEXT” button to proceed.
3. To enable linking the image data with the email address, agree by clicking on the checkbox. Click “NEXT” to go to the Home Screen.

6. Home Screen

1. To start scanning, press the “Scan” button.
2. To read instructions for use, click the “Info” button.
3. To open the subscription screen, click the top right button (number of scans left)
4. To go to the settings, click the “Settings” button.
5. To open the archive with scanned lesions, click the “Archive” button.

7. Camera Test

1. A new screen with the camera test video instructions will appear.
2. Click on “NEXT” to proceed to the camera test.
3. Allow SkinScreener to take pictures and record video.
4. Allow SkinScreener to access photos, media, and files on your device.
5. Place fingers in front of the camera.
6. If the camera test is successfully performed, a message “Camera test successful” will appear.
7. Click on the “OK” button to proceed.

8. Assessment

1. The video assessment instructions will appear.
2. After watching the instructions, click on the “NEXT” button.
3. Center the lesion you want within a distance of 15cm and make sure that the picture is fully focused.
4. Make sure the lesion is focused, wait for the circle to become green, then tap and hold the screen to take aphoto of the lesion until the blue growing circle is closed.
5. If the lesion is captured correctly, the Review Image screen will appear.
6. Review the image , if the image shows the lesion to be assessed and if the image quality is satisfying.
7. Click on “PROCEED” to see the risk assessment, or click on “RETAKE” to repeat the procedure.
8. Risk Assessment screen will appear, with one of the 3 risk assessment levels: LOW RISK (green), MEDIUMRISK (yellow), or HIGH RISK (red). Additionally, you get information about what to do next.
9. To scan another lesion, click the “SCAN ANOTHER LESION” button. To go back to the home screen, click toback arrow.

9. Settings Screen

1. Account Information
   1.1. To log in again click again the “Account” field and sign in with the Google/Apple account.
   1.2. To log in again click again the “Account” field and sign in with the Google/Apple account.
2. To open the subscriptions screen and see the activated plan, click the “Subscription” field.
3. To preview and change personal data, click the “Personal Data” field.
4. To enable/disable linking the image data with the email address, press the switch next to “Save emailaddress with image data.
5. Press the switch next to the “Push notifications” to enable or disable getting notifications.
6. Privacy Policy (click to open external link)
7. Terms and Conditions (click to open external link)
8. Contact email: support@medaia.atlassian.net
9. Manufacturer information and app version
10. Compliancy information and UDI number
11. Self-test information: This shows if the camera test and risk self-test are passed successfully.

10. Archive

1. To open the archive of the lesions classified with MEDIUM-RISK (yellow) or HIGH-RISK (red), from the Home screen, click on the “Archive” button.
2. The list of MEDIUM-RISK and HIGH-RISK lesions will appear.
3. To delete an image of a lesion, swipe left and press the “Delete” button.

11. In-App Purchase

1. Click to “Buy 10 Scans” to purchase 10 risk assessments.
2. To subscribe to unlimited usage of SkinScreener for 3 months or 1 year, chose the subscription plan andmake payment through Google Play / Apple App Store payment gateway.
3. To activate a promo code click the “REDEEM PROMO CODE” button.

Interpretation of the results

Table 1: Interpretation of the results

To avoid possible misunderstandings at the result screen, the algorithm plots a box around the risk-assessed lesions, colored according to the assigned risk. This indicates exactly for which lesion which risk assessment was calculated. If there are different lesions, it creates multiple boxes with the corresponding color. If the lesion is not detected by the algorithm, there is no box visible at the result screen, so the user knows that the lesion was not assessed. In case two or more boxes overlap, only the highest risk box will be displayed.

App Uninstallation

iOS devices
Tap and hold the icon until it starts to shake. Tap the small “x” that appears in the upper corner. A message will appear asking you to confirm (by pressing “Delete”) or cancel (by pressing “Cancel”). Uninstalling the app means to permanently delete all MEDIUM RISK and HIGH RISK lesions saved within the app, without a possibility to restore the deleted data.

Android devices
In the Settings of your Android phone look for Apps, find SkinScreener in the list and tap “Uninstall”. Uninstalling the app means to permanently delete all MEDIUM RISK and HIGH RISK lesions saved within the app, without a possibility to restore the deleted data. without a possibility to restore the deleted data.
SkinScreener is stand-alone software that can be used in conjunction with a mobile device but is not a piece of medical electrical equipment in the sense of IEC 60601-1. The product is disposed of by uninstalling the app from the user’s mobile device. If you remove an app for which you have paid, you can reinstall it free of charge, without restoring the previously deleted data.

Privacy Policy

To use the SkinScreener mobile app, medaia GmbH needs to collect data from you. You will be prompted for your consent when you set up an account. (See the section “Sign In”). You can withdraw your consent at any time by uninstalling the app.

For further information visit https://skinscreener.at/datenschutzerklaerung/.

Terms and Conditions

Before using the app, the user must agree to the Terms and Conditions: https://skinscreener.at/agb/.

Warnings/Exclusions

To ensure personal safety and correct use, you should familiarize yourself fully with the following warnings and the entire contents of this booklet before using the app. Consult your health care, professional or dermatologist, if you experience unexpected operations or events with the app. Using the app can distract you in situations where full concentration is required. Be aware of your surroundings while using the app.

	The SkinScreener app does not replace a visit to your doctor! The SkinScreener app is a registered CE Class I medical device and is used to support skin cancer risk assessment. SkinScreener is intended to be used additionally to the common skin cancer prevention and the annual dermatological check-up, it does whether give a diagnosis nor replace regularly consultations of a dermatologist.
	Do not use SkinScreener while driving, during physical activity or at places where the usage of the mobile device is prohibited! The SkinScreener app can generally be used anywhere it is possible to use a mobile device. There’s a clear advantage in that you can perform a skin lesion scan and get a risk assessment almost anywhere and almost immediately. However, there are some exceptions. The SkinScreener app may not be used in places where the use of a mobile device is prohibited. These places may include, but are not limited to, for example, certain areas in hospitals, in an aircraft, in a car if you are driving and wherever else the use of a smartphone is prohibited or advised against.
	Do not use the app if the camera/flashlight is not working! If the camera or flash of your mobile device are not working properly (broken, scratched, etc.) or if the mobile device becomes noticeably too hot, stop using the app.
	Do not use the app in the following cases: The user has Fitzpatrick skin type V (dark brown) or VI (darkest brown); The lesion has low visual contrast to the surrounding skin area; The lesion is surrounded or covered by the hair; The skin is sunburnt; The lesion has been previously traumatized (excised/biopsied); The skin surrounding the lesion is not intact (open sores, ulcers, bleeding); The lesion is located in or next to the anatomical structures as ear, eye, genitals, hair, mouth, nails, nares, nipple; The lesion is very close to visible scars or tattoo, or areas partly or fully covered with opaque or glittering substances like makeup, skin cream or sun cream or similar; The lesion is on mucosal surfaces like on lips, in the mouth or in the genital region; The lesion is in a skinfold; The lesion is not on human skin; The scanned region is even partially covered by clothes If the skin changes are less than 4 weeks old.

Table 2: Warnings/Exclusions

Troubleshooting

If you need help with the camera test or assessment procedure, please watch the video tutorial. If you still have difficulties, please contact us at support@medaia.atlassian.net.

Table 3: Troubleshooting

Lifetime of the Product

The lifetime is defined as the time span until a new version of the app is released. This is indicated by an increase of at least the second digit of the version number. The version number information is given in the Apple App Store and Google Play Store. Information about updates is provided via the operating system. Depending on the respective user settings on the smartphone, the update is carried out automatically or must be active be actively released and started by you. Automatic updates are highly recommended to be enabled.

Description of Symbols

	Warning Text marked with a warning symbol must be read before using the device. be read
	Manufacturer The device is produced by the manufacturer whose name and address are stated next to the symbol. Indicates the medical device manufacturer, as defined in EU Directive 93/42/EEC.
	CE mark The device complies with Medical Device Directive 93/42/EEC
	Consult electronic instructions for use Indicates the need for the user to consult electronic instructions for use.

Table 4: Descriptions of symbols used in this booklet

Manufacturer Information

The app SkinScreener is a product of medaia GmbH.
Contact details

medaia GmbH Am Eisernen Tor 5, 8010 Graz, Austria Web: https://skinscreener.com Mail: support@medaia.atlassian.net

For questions about the product and its application, please contact our customer service: support@medaia.atlassian.net