Instructions for use

2. Introduction

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

The SkinScreener mobile app allows you to perform a skin lesion risk assessment for visual signs of premalignancy and malignancy quickly and easily. Our artificial intelligence has been trained using appropriate images and compares the lesion you have captured with an existing dataset of images to perform a risk assessment of your lesion. It does not provide a medical diagnosis!

The app is available on the App Store® and Google Play Story. These Instructions for Use are applicable for the product version v3.0. The instructions for use can be accessed from the SkinScreener app’s “Your Account” screen. Please ensure that you always update the app to the newest compatible version.

If you have any additional questions about using SkinScreener, please contact us at support@medaia.atlassian.net. The instructions for use are available in electronic form. The printable PDF version of the instructions for use can be found at the following URL free of charge: https://skinscreener.com/en/instructions-for-use/. By user request, the instructions for use can be provided in paper form, and will be sent to the user within 3 working days. Please contact our support team at support@medaia.atlassian.net to order a printed version of the instructions for use free of charge.

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

3. Intended Use

SkinScreener is a mobile application intended to perform skin lesion risk assessment on iOS and Android mobile devices, using the device’s camera and flash. The app analyzes the images of skin lesions and returns the risk assessment calculated by an on device ML algorithm. Additionally, the user is reminded to have an annual dermatological examination performed. The scan must be carried out 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 is recommended 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 a dermatologist soon and not wait 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 examination or sooner if a closer control has been determined by the dermatologist.

The SkinScreener is intended to be used by adult users with Fitzpatrick skin type I (pale white skin) to IV (moderate brown skin). The SkinScreener application may not be used on children. The SkinScreener cannot replace a 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) solely through the use of artificial intelligence.

4. Vorgesehene Benutzergruppe

• 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.
• The SkinScreener is intended to be used by adults (+18 years of age) of all genders with skin type I (pale white skin) to IV (moderate brown skin), classified by the Fitzpatrick scale.
• Special language skills are not required as the SkinScreener application is localized in the language of the target country/market.
• A scan can be performed on all body parts, except on excluded body parts described in chapter 4.2 (Contraindications/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.

Fitzpatrick Skin Type:

See https://skinscreener.com/1wp/content/ uploads/2024/02/FitzpatrickSkinType-de-2.pdf  if you need help identifying your skin type.

5. Indications

• The user is over 18 years old.
• The user is capable of processing and understanding simple visual instructions/information displayed on the mobile device screen.
• The user has Fitzpatrick skin type I to IV.
• The user has a skin lesion on the skin (except lesions described in contraindications Nr. 3 – 11).

6. Contraindications

1. The user is under 18 years of age.
2. The user has a Fitzpatrick skin type of V or VI.
3. The skin is sunburned.
4. The lesion has been previously traumatized (excised/biopsied).
5. The skin surrounding the lesion is not intact (open sores, ulcers, bleeding).
6. The lesion is located on or next to anatomical structures (i.e. ears, eyes, hair, mouth, nipples, genitals, fingers, toes, umbilicus).
7. The lesion is very close to visible scars or tattoos, or areas partly or fully covered with opaque or glittering substances like makeup, skin cream, or sun cream.
8. The lesion is surrounded by or covered with hair.
9. The lesion is on mucosal surfaces like lips, in the mouth, or on the penis/vagina.
10. The lesion is not on human skin.
11. The lesion is in or on a skinfold.
12. Scanning lesions close to the eyes may cause temporary flash blindness caused by the camera light and should therefore be considered carefully.
13. Individuals must not scan or be scanned when performing actions where this could cause harm (e.g. driving a car).
14. The SkinScreener application should not be used by people who may have difficulty identifying a lesion to be assessed due to a lack of mental capacity for understanding the texts or medical matters, or due to a lack of technical
15. understanding for the operation of a mobile device.
16. The SkinScreener application does not replace a consultation with a dermatologist, which should be carried out at least every 2 years. However, we recommend an annual skin check-up by a dermatologist.

7. System & Hardware Requirements

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

iOS:

• Operating System: Version 16.0 or later
• Hardware: iPhone 8

Android:

• Operating system – Android 12 or later
• Hardware: 2.8 GB of RAM

We do further reserve the right to exclude certain devices from downloading the application from the Google Play Store.

8. Using SkinScreener

1) First-time use:

Install the App:

1. Go to the App Store and search for the app.
2. In the search result, tap on the SkinScreener app.
3. Tap “GET” and then “INSTALL”.
4.  If prompted, sign in to the App Store to complete the installation.
5.  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.

Onboarding and Account Creation:

1. When starting the app for the first time, onboarding screens with information about the app will open.
2.  Scroll through the screens, read the information provided, and once finished, click “Continue”.
3. Next, please follow the link to our instructions for use, terms and conditions, and privacy policy, and read them carefully.
4.  After reading these files, if you choose to accept, please confirm by checking the corresponding checkbox and pressing “Get Started”.
5. When asked, please allow access to your camera. This is needed to perform a scan.
6. After pressing “Start Scanning”, an interactive tutorial will guide you through the scanning process.
7.  After completing the tutorial, create an account by entering a valid email address and password or alternatively signing in with Apple or Google.
8. Next, to complete your account, please fill in your first and last name, year of birth, and sex assigned at birth.
9. Finally, if you wish to, set intervals to be reminded to perform a scan, and visit a doctor.

 2) Scanning a lesion:

1. To scan a lesion, press the “Scan” button on the menu bar.
2. Facing the lesion with your camera, hold your device steady and about 15cm (6 in) away from the lesion.
3.  If the scan was successful, the detected lesion appears with a border around it.
4. The associated risk assessment is shown by the app. Please read the entire assessment carefully.
5. SkinScreener classifies skin lesions into three different risk categories: LOW-RISK (green), MEDIUM-RISK (yellow), or HIGH-RISK (red).
6. If multiple lesions are detected in the image, you can switch between them by tapping them.

3) Archive:

1. To open the archive, click on the “Archive” button in your menu bar.
2. In the archive, you have the possibility to filter lesions by risk assessment and body region.
3. Press any lesion displayed on the archive screen to revisit that specific lesion’s risk assessment screen.

4) Change Settings and Additional Functionality:

Clicking on the “Your Account” icon on the top right corner of your home screen brings up your account menu with multiple setting options:

• To change your account and personal data or to delete your account entirely, please click “Account”.
• To change your reminder settings, please click “Reminders”.
• To subscribe to SkinScreener or change your subscription, please click “Subscription”.
• If you wish to give us feedback, please click “Give Feedback” and follow the instructions provided.
• If you have any further questions or need assistance, don’t hesitate to click “Help & Contact”.

9. Interpretation of the results

Assessment	What does this mean?	What to do next?
LOW RISK (green)	Text inside our app: “Our clinically proven algorithm did not detect any conspicuous skin lesion in the examined region.”   Our clinically proven algorithm did not detect any conspicuous skin lesion in the examined region. The assessment was not made by a doctor and does not replace a medical examination. It is a risk assessment based solely on artificial intelligence and is not a diagnosis. Our artificial intelligence is constantly being improved. Nevertheless, there is a possibility that due to various circumstances the risk assessment of the skin lesion is not correct. SkinScreener can make a significant contribution to supporting preventive care, but it cannot replace a regular check-up by your doctor, it can only supplement it in a meaningful way.	Text inside our app: “In case of doubts, contact your medical doctor immediately. It is important that you see your medical doctor regularly for a professional examination. Keep an eye on your entire skin.”   Check this lesion and your entire skin from time to time; it is important that you see your dermatologist regularly for a medical check-up. Ask your dermatologist at what intervals you should come for a check-up. If you are not sure about this risk assessment or if the skin lesion changes, contact your dermatologist immediately.
MEDIUM RISK (yellow)	Text inside our app: “Our clinically proven artificial intelligence has identified conspicuous characteristics in this skin lesion.”   Our clinically proven algorithm has assessed this skin lesion as conspicuous. Irregular patterns, different colouring, asymmetry, diffuse borders, increased diameter and increased keratinisation can be features of conspicuous skin lesions. The assessment was not made by a doctor and does not replace a medical examination. It is a risk assessment based solely on artificial intelligence and is not a diagnosis. Our artificial intelligence is constantly being improved. Nevertheless, there is a possibility that due to various circumstances the risk assessment of the skin lesion is not correct. SkinScreener can make a significant contribution to supporting preventive care, but it cannot replace a regular check-up by your doctor, it can only supplement it in a meaningful way.	Text inside our app: “This skin lesion should be examined more closely by a medical doctor. The further treatment as well as the check-up periods of the skin areas must be determined by the medical doctor. Keep an eye on your entire skin.”   Check this lesion and your entire skin from time to time; the skin lesion must be examined more closely by a dermatologist. Your dermatologist has to determine the check-up periods as well as the skin areas concerned.
HIGH RISK (red)	Text inside our app: “Our clinically proven artificial intelligence has assessed this skin lesion as very noticeable and detected possible different visual signs of skin cancer.”   Our clinically proven algorithm has assessed this skin lesion as very conspicuous and has identified possible different visual signs of skin cancer. For example, irregular patterns, different colouring, asymmetry, diffuse borders, increased diameter and keratinisation may indicate malignant skin lesions. The assessment was not made by a doctor and does not replace a medical examination. It is a risk assessment based solely on artificial intelligence and is not a diagnosis. Our artificial intelligence is constantly being improved. Nevertheless, there is a possibility that due to various circumstances the risk assessment of the skin change is not correct. SkinScreener can make a significant contribution to supporting preventive care, but it cannot replace a regular check-up by your doctor, it can only supplement it in a meaningful way.	Text inside our app: “The skin lesion must be examined immediately by a medical doctor. Further treatment, review periods, and skin areas must also be determined. Keep an eye on your entire skin.” Check this lesion and your entire skin from time to time; the skin lesion must be examined immediately by a dermatologist. He or she must also determine the further treatment, the check-up periods and the skin areas concerned.
No Risk Assessment Possible	Text inside our app: “Unfortunately, our AI wasn’t able to provide a risk assessment. This can happen if there is no visible vision detected, the lesion is too close to an anatomical structure or if the image is too blurry.”   Lesions next to anatomical structures are sometimes hard to detect. Also if an image is blurred, or if no lesion can be detected, no assessment is possible. In order to guarantee the quality and validity of our assessments, we have excluded some anatomical regions or blurred images for risk assessment.	Text inside our app: “Please try again. Make sure the lesion is clearly visible and focused. Avoid scanning your eyes, nails, and genitalia. ”   Due to skin structure differences in anatomical areas, this will lead to inaccurate results. Ask your dermatologist for an assessment of this lesion.

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, no risk assessment is possible.

10. App Uninstall

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.

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”).

Android devices

Tap and hold the icon until the possibility to uninstall pops up. Tap the “Uninstall” or move the icon to the in the designated uninstall field, represented by a garbage can symbol. Then confirm to the uninstillation.

11. Privacy Policy

To use the SkinScreener mobile app, medaia GmbH needs to collect data from you. We very much value our customer’s privacy. To learn more about the data we collect, and how we process it, visit https://skinscreener.com/en/privacy-policy/.

12. Terms and Conditions

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

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.

13. 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 healthcare 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 IIa medical device and is used to support skin cancer risk assessment. SkinScreener is intended to be used additionally to the common skin ncancer prevention and the annual dermatological check-up, it does whether give a diagnosis nor replace regular 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.d.
	Do not use the app if the camera/flashlight is not working! If the camera or flash of your mobile device is 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:   You have 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 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;

Any serious incident should be reported to the manufacturer and the competent authority. An incident can be reported via email: support@medaia.atlassian.net or per post: medaia GmbH, Am Eisernen Tor
5, 8010 Graz Austria.

A list of competent authorities can be found at the following link: https://ec.europa.eu/health/document/ download/c28e965a-3b7c-4a5b-a6ee-d1724d06f20d_en?filename=md_contact_points_of_national_authorities.pdf

14. Troubleshooting

Problem	Solution
The app is crashing or not working properly.	Reinstall the app and try again. Report the issue to our customer support: support@medaia.atlassian.net
The camera is not focusing on the skin lesion properly.	Make sure the camera and flashlight are clean and in working condition. If the device’s camera is dirty, wipe it with a soft cloth. Place the mobile device camera at a distance of approximately 15cm (6in) and slightly move the device to focus the lesion.
Not able to take an image of a skin lesion	Make sure the lesion is focused, and the distance between the camera and the skin area is approximately 15 cm (6in). Make sure to keep your device straight while the scan process is ongoing.
The same skin change shows different risk assessments when evaluated several times.	Take a picture of the skin change from a distance of 10 to 15 cm, as specified in the intended use. Larger (>15 cm) or smaller (<10 cm) distances reduce the reliability of the risk assessment. If there are different risk assessments within the intended distance, the most serious one shall be considered valid.

15. 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 app stores and the app label. 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 actively released and started by you. Automatic updates are highly recommended to be enabled.

16. 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 Medical Device Regulation 2017/745.
	CE Mark The device complies with Medical Device Regulation 2017/745.
	Consult electronic instructions for use Indicates the need for the user to consult electronic instructions for use..

17. CE Mark and product availability

SkinScreener has received the CE marking as a class IIa medical device in accordance with the European Medical Devices Regulation 2017/745 on medical devices on the 28th of November 2022.

The instructions for use are available in the languages of the respective countries where the product is on the market. SkinScreener is available via App Stores in the following countries:

• Austria
• Germany
• Ireland
• United Kingdom
• Spain
• France
• Italy
• Portugal
• Switzerland

Related or previous products:

Product	Product Version	Available Plattform	Status
SkinScreener	3.0	Android	current
SkinScreener	3.0	iOS	current
SkinScreener	2.0	Android	expiring
SkinScreener	2.0	iOS	expiring
SkinScreener	1.1	Android	end of life
SkinScreener	1.0	iOS and Android	end of life

18. Product and Manufacturer Information

Product Name	Product Version	Software version	Basic UDI-DI	UDI-DI
SkinScreener	v3.0	v3.0	912011561SKSC354	iOS: 9120115610077   Android: 9120115610084

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

 

CMC Medical Devices GmbH
Rigistrasse 3, 6300 Zug, Switzerland