Instruction For Use (IFU)

Manufacturer Information

SCARLETRED Holding GmbH (EUROPE)
MQM 3.4, Maria Jacobi Gasse 1
1030 Vienna, Austria
www.scarletred.com
Contact Us: office@scarletred.com



Distributor (USA): SCARLETRED Inc.
1 Broadway, 14th floor, Cambridge
MA 02142, USA.

Company Contact Information

SCARLETRED Holding GmbH (EUROPE) MQM 3.4, Maria Jacobi Gasse 1
1030 Vienna, Austria
www.scarletred.com
Contact Us: office@scarletred.com

Device name: Scarletred®Vision

Basic UDI- DI: 912013510SCRVISIONCH

European Medical Device Nomenclature (EMDN) coding: V0399

MDR Code: MDA0204

Risk Classification according to EU MDR 2017/745: Class IIa

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

Exporting functions
Imaging, analysis, and audit trail data

Archiving functions
Data lock and living online archive.

Indications for Use

The Scarletred® Vision system is indicated for recording, displaying and transferring images, and for optional measurement of pigmentation changes of the skin (measurement of colour and intensity). Furthermore, the size of skin lesions can be assessed (measurement of 2D parameters). Primary applications are listed below:

INDICATIONS
Acne Like Skin Rash (ALSR) Cutaneous T-cell lymphoma Onychomycosis (ONY)
Acne vulgaris Epidermolysis bullosa (EB) Palmoplantar pustulosis (PPP)
Actinic Keratosis (AK) Generalized Pustular Psoriasis (GPP) Psoriasis vulgaris (PSO)
Atopic Dermatitis (AD) Hidradenitis suppurativa (HS) Rosacea (ROS)
Bacterial infection Hyper-Pigmentation Skin Patch testing
Blepharitis Hypo-Pigmentation Skin Prick testing
Burning wounds Lentigo Solaris Viral infection
Chronic wounds Mechanical stress Vitiligo (VIT)

Table 1: List of indications

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 assessmentsunder 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 accordance with hospital or clinic protocol.: Open the package and remove the Scarletred® Vision onto a clean surface in
2. Registration & Login : Login using the provided user credentials.
3. Affixing 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
Symbol Abbrevation Description
Regulation EU MDR 2017/745 CE marking
Use by Date Indication of the date of use of Scarletred®Vision system after which the medical device is not to be used.
Non-Sterile Device Indicates that Scarletred®Vision system has not been subjected to a sterilization process.
Protections from light source Indicates that Scarletred®Vision system needs protection from light sources.
Moisture Indicates that Scarletred®Vision system shall be kept dry.The Scarletred®Skin Patch must be protected against moisture.
Temperature Limit Scarletred®Vision package recommended storage temperature between 0’C to 40’C
Instructions Read the instructions before use

eIFU		 Electronic Instructions Read the instructions before use (electronic IFU)
Do not Re-Use
  • This device has been validated and warranted for single use only. Any re-use, could result in invalid image data
  • The Scarletred®Skin Patches (SCR001-301#2S/M) are a single-use product.
  • The Skin Patch must be disposed of as residual waste after the usage.
Package damage
  • To avoid potential threats, check that the packaging is intact, sealed, and free from damage that could compromise the products inside.
  • Do not use the Scarletred® Vision system package if it appears to be damaged.
Medical device Indicates that the Scarletred® Vision system is a medical device.
Warning
  • In case of observing an incorrect operation of the software, notify the manufacturer as soon as possible: office@ Scarletred.com or raise ticket via helpdesk. The manufacturer will proceed accordingly. Any serious incident should be reported to Scarletred Holding GmbH. as well as to the National Competent Authority of the country.
  • The medical device does NOT contain diagnostic features and is NOT a diagnostic product. It should thus NOT be used or applied for diagnostic purpose.
Unique device identifier Indicates a carrier that contains unique device identifier information