FAQ & Spec.

Frequently Asked Questions

WHAT IS WOUNDVIEWER?

WoundViewer is a class 1 medical device able to acquire and process automatically in two minutes the images of cutaneous ulcers by an algorithm of artificial intelligence (AI) that gives the physician the basic parameters of the lesions and organizes the information in digital health records. Thanks to its 4 G and WiFi connectivity, WoundViewer can be used for telemedicine services.

How long does it take to measure the parameters of the lesion with woundviewer?

WoundViewer allows to calculate in 2 minutes the basic parameters of a skin lesions.

What are the parameters monitored?

WoundViewer allows the user to measure, in a matter of minutes and automatically, all the main parameters that characterize skin lesions:

Perimeter of the wound

Area of the wound

Depth of the wound

Granulation tissue

Ulcer classification according to international protocols

Exudate and degree of infection (under development)

what languages are available?

WoundViewer is currently available in Italian and English. Other languages will be supported in the coming months.

is data protection guaranteed?

Security is one of our priorities. All data is transferred according to the SSL/TLS security protocol to avoid malicious actions. The access to WoundViewer account is safe on the Web as on your phone to prevent patient data to fall into the wrong hands.

do you have a privacy policy?

All personal and patients’ information will be kept confidential and will not be sold to third parties, nor will be added to the mailing list. WoundViewer respects the GDPR, the European regulation on data protection and privacy.

Technical Specifications

DISPLAY

LCD interface capacitive
Touch Screen
2 USB Plugs

CAMERA

1 x CMOS Camera
16 x IR Sensors
4 x White LEDs
Microphone
Geo-localization
microSD

COMMUNICATION

WiFi interface
4G interface
Bluetooth
Micro – nano SIM

REGULATORY STANDARDS REQUIRED

Regulatory standards to achieve CE certification are those contained in the family CE93/42

(47/2007). In order to protect the future marketing of the device, WoundViewer was designed and built in

compliance with the following standards:

[S1] EN ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes.

[S2] EN 60601-1 Medical electric equipment Part 1: General requirements for safety.

[S3] EN 60601-1-11 Medical electrical equipment General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

[S4] EN 60601-1-2 Medical electric equipment Part 1: General requirements for safety 2- Collateral Standard: Electromagnetic compatibility- Requirements and tests.

[S5] EN 62304 Medical device software – Software life-cycle processes.

[S6] EN ISO 14971 Medical devices – Application of risk management to medical devices.

[S7] 1907/2006 Regulation (EC) of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACh), establishing a European Chemicals Agency

[S8] 2011/65/EU Directive of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances (RoHS) in electrical and electronic equipment (recast).

[S9] EN ISO 14971 Medical devices – Application of risk management to medical device

[S10] EN 62366-1 Medical devices. Application of usability engineering to medical devices