Instruction For Use (IFU)

Description of the Device
‍Scarletred®Vision provides contact less skin documentation, that in opposite to spectrophotometer, obviates the risk of cutaneous damage, transmission of bacterial infection and in case of irritated skin, avoids painful procedure. Our tool serves as a noninvasive method enabling precise assessment of every skin condition, which cannot be achieved with others up-to-date technologies in dermatologic field, which is not for diagnostics purpose.

‍Intended Use
‍Scarletred^®Vision is a modern state-of-the-art Electronic Data Capture (EDC) solution comprising the following core and extended artificial intelligence (AI) functionalities which can be configured as per customer and digital service demand.

‍Main Functionalities
Imaging functions
‍Generation and management of standardized dermatological images and recording of clinical data
Objective monitoring of 2D/3D and color related skin changes in a local area or/and full body setup
Automated image data calibration reducing the influence of changing ambient light conditions

‍Analytics functions
‍Precise digital measurement of erythema, pigmentation, texture, and other visual skin changes based on the CIE-LAB colorspace.
Clinimetrics and planimetric assessments and visual scoring of skin diseases
Artificial Intelligence powered decision support and CNN based training
Biostatistics data analysis, data plotting and data unblinding

‍Monitoring functions
‍Evaluationof subject eligibility and home-based monitoring of study volunteers
Realtime sharing of imaging data among professionals
Online and remote study performance monitoring

‍Reading functions
‍Implementation of central reading procedures
Generation of real-world evidence data

Contra-Indications:
No Contra-indications observed for the Scarletred® Vision system
Scarletred® Vision system does not pose any threats or risk for the human beings and surroundingenvironment
No major risks or adverse events identified or reported for the product Scarletred® Vision
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‍Further Information
‍If further information is required, please contact SCARLETRED technical support and help desk via https://https://support.scarletred.com/desk
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‍Clinical benefits:
Clinical studies demonstrated that the system provides consistent digital skin assessments under standardized conditions. For publications visit https://www.scarletred.com/news
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‍Inspection of Package Contents
‍Examine the package carefully before opening to confirm its integrity and that the use by date has not passed. The device is provided in a sterile package. Do not use the Scarletred® Vision if the package is damaged oropened or if the use by date has passed.
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‍Instructions for Use
‍1. Unpacking: Open the package and remove the Scarletred Vision onto a clean surface in accordance with hospital or clinic protocol.
2. Registration & Login: Login using the provided user credentials.
3. Placing Skin patch: Place the skin patch on the healthy skin next to the region of interest.
4. Scan the QR code: Scan the provided QR code using the Scarletred mobile App.
5. Image Generation: Take an image of the region of interest.
6. Review Image: Ensure that captured image is clearly showing the region(s) of interest.
7. Image Upload: Ensure having an active internet connection to automatically upload the images.
8. Removing Skin patch: Do not reuse the skin patch once removed from the skin.
9. Disposal: Dispose of the skin patch in accordance with hospital or clinic protocol.
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Symbols and Abbrevations