Instructions for Use

Instructions for Use

Instructions for Use (IFU)

Version / Revision 1.1
Valid from 27.08.2020
Replaces Version/Revision 1.0
Product SkinScreener
Product version 1.0

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 Android™ devices allows you to perform a risk assessment of a skin lesion for visual signs of premalignancy and malignancy quickly and easily.

The app is available on App Store® and on Google Play™. These Instructions for Use are applicable for the product version v1.0.
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@skinscreener.at.

The printable PDF version of Instructions for Use can be found at the following URL free of charge:
https://skinscreener.at/en/instructions-for-use

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 the visit of a medical professional.

Intended Use

The SkinScreener is a mobile application 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 the risk assessment, which can be: LOW RISK, MEDIUM RISK or HIGH RISK. Based on the risk assessment, the user gets a recommendation to visit a dermatologist for a further check-up to get 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 the 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 language of the target country/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 for the App

medaia GmbH is not responsible for the consequences of using this app outside Intended use or Warnings. medaia GmbH does not warrant that the device may unintentionally collect, nor tolerate any misuse or claim to correctness due to malfunction caused by misuse, accident, alteration, neglect, or failure to maintain the products as specified. 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 Requirements

To be able to use the app, you need the following:
Apple devices: iOS operating system - version 13.0 or later.
Android devices: Android operating system - version 9.0 or later.

Using SkinScreener

First-time use

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/en/terms-and-conditions
Privacy Policy: https://skinscreener.at/en/privacy-policy

1. Install the App

On iOS (Apple devices)

  1. Go to App Store and search for the app.
  2. In the search result, tap to 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. Home Screen

  1. Allow SkinScreener to take pictures and record video.
  2. Allow SkinScreener to access photos, media, and files on your device.
  3. Read the message "Ensure that once a year you see a dermatologist for a skin checkup", and press OK.
  4. To read instructions for use click the "Instructions for Use" button.
  5. Press "Tap to continue" to proceed to the "Intended use" screen.

3. Intended Use

  1. Read the intended use and accept it by clicking to the "Accept" button.
  2. After accepting the intended use, the Sign In screen will appear.

4. Sign In

  1. 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.
  2. Click on the "Accept Privacy Policy" checkbox.
  3. Click on the "Accept Terms and Conditions" checkbox.
  4. Click on "Tap to continue" to proceed to the camera test instructions.

5. Camera Test Instructions

  1. A new screen with the camera test video instructions will appear.
  2. Click on "Tap to continue" to proceed to the camera test.

6. Camera Test

  1. Place fingers in front of the camera.
  2. If the camera test is successfully performed, a message "Camera test successful" will appear.
  3. Click on the "OK" button to proceed.

7. Assessment Instructions

  1. The video assessment instructions will appear.
  2. After watching the instructions, click on the "Tap to continue" button.

8. Assessment

  1. Centre the lesion you want within a distance of 15cm and make sure that the picture is fully focused.
  2. Make sure the lesion is focused, wait for the circle to become green, then tap and hold the screen to take a photo of the lesion until the blue growing circle is closed.
  3. If the lesion is captured correctly, the Review Image screen will appear.
  4. Review the image, if the image shows the lesion to be assessed and if the image quality is satisfying.
  5. Click on "Proceed" to see the risk assessment, or click on "Retake" to repeat the procedure.
  6. 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.
  7. To scan another lesion, click on "Scan another lesion" button. To go back to the home screen, click to back arrow.

9. Settings Screen

  1. Account Information
    1. To log out from the current account, click on the "Log out" button.
    2. Subscription information. (for iOS only: the user can restore the previously purchased subscription plan
      by clicking to the RESTORE button)
  2. Feedback: Click on "Give Feedback" to send your feedback to the customer support.
  3. Information
    1. Privacy Policy
    2. Terms and Conditions
    3. Contact email: support@skinscreener.at
    4. Manufacturer information
    5. Instructions for Use version
    6. App version
    7. Compliancy information
  4. Self Test: Shows if the camera test and risk self-test are passed successfully.

10. My Yellow and Red Lesions

  1. To open the archive of the lesions classified with MEDIUM-RISK (yellow) or HIGH-RISK (red), from the Home screen, click on the "My yellow and red lesions" 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.

 

Assessment What does this mean? What to do next?
LOW RISK
(green)
Our clinical proven algorithm did not detect visual signs of skin cancer or its precursors in the assessed region Check this lesion and your entire skin from time to time, nevertheless it is important to see your dermatologist once a year for a professional checkup, if you are not sure about this risk assessment or if the lesion is changing contact your dermatologist
MEDIUM RISK
(yellow)
Our clinical proven algorithm did detect possible visual signs of precursors of skin cancer. Irregular pattern, multiple colours, asymmetry, diffuse borders, increased diameter or cornification may be a sign of precursors of skin cancer Contact your dermatologist and show her or him this lesion as soon as possible
HIGH RISK
(red)
Our clinical proven algorithm did detect signs of skin cancer. Irregular pattern, multiple colours, asymmetry, diffuse borders, increased diameter or cornification may indicate malignant skin lesions. Immediate action is required! Show your dermatologist this region immediately.
No risk
assessment
possible
Lesions next to anatomical structures are sometimes hard to detect. In order to guarantee the quality and the validity of our assessments, we have excluded some anatomical regions for risk assessment. Naturally, we did not charge a credit for this assessment. Ask your dermatologist for an assessment of this lesion.

Table 1: Interpretation of the results

 

To avoid possible misunderstandings at the result screen, the algorithm plots a box around the risk-assessed lesions, coloured 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 colour. 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.

In-App Purchase

After all free scans are used, the pop-up screen will appear with the possibility to buy an additional amount of scans. The user can choose to buy a "Single Scan", "5 Scans" pack or "Limitless Plan". The "Limitless Plan" can be activated anytime from the Settings screen. Payment will be processed automatically through the Google Play Store / Apple Store payment gateway.

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. 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/en/privacy-policy

Terms and Conditions

Before using the app, the user must agree to the Terms and Conditions:
https://skinscreener.at/en/terms-and-conditions

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 are 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@skinscreener.at

Problem Solution
The app is crashing or not working properly
  1. Reinstall the app and try again.
  2. Report the issue to our customer support: support@skinscreener.at.
The camera is not focusing the skin lesion properly
  1. Make sure the camera and flashlight are clean and in working condition.
  2. If the device's camera is dirty, wipe it with a soft cloth.
  3. Place the mobile device camera at a distance of approximately 15cm and slightly move the device to focus the lesion.
Not able to take an image of a skin lesion
  1. Make sure the lesion is focused and the distance between the camera and the skin area is approximately 15cm.
  2. Zoom in or zoom out a skin lesion, tap and hold the screen to scan the skin area.

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

Warnings
Text marked with a warning symbol must be read before using the device.
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 3: Descriptions of symbols used in this booklet

 

Manufacturer Information

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

medaia GmbH
Neue Stiftingtalstraße 2,
8010 Graz Austria
Web: https://skinscreener.at
Mail: support@skinscreener.at

For questions about the product and its application, please contact our customer service: support@skinscreener.at