Use Specification - Barco Demetra User Manual

Welcome!

1.1 Use specification

Indications for Use
The Barco Digital Dermatoscope is a non-invasive skin analysis system, which acquires multispectral and
white light dermoscopic images and clinical photographs of the skin. These can be stored, retrieved, displayed
and reviewed by trained medical practitioners.
Intended usage environment
The device is intended to be used in a normal working environment of medical practitioners examining skin
conditions. A number of considerations should be taken into account:
• It should be avoided to operate the device with wet hands, in order to prevent dropping the device.
• The touch display of the device can be operated wearing gloves. The following types of gloves were tested
to work with the touch display and scroll touchpad:
- Hartmann Peha-Soft Nitrile Powderfree
- Hartmann Peha-Soft Vinyl Powderfree
- Hartmann Peha-Soft Latex Powderfree
• The Demetra solution requires a wifi connection.
Intended patient population
The device is intended to be used on all patients who consult with a physician or other healthcare professional
regarding a certain skin condition, including, but not limited to, melanoma and non-melanoma skin cancers or
lesions suspicious for skin cancer, inflammatory skin conditions, skin infections, etc.
Medical conditions to be diagnosed, treated and/or monitored
Skin conditions, including, but not limited to, melanoma and non-melanoma skin cancers or lesions suspicious
for skin cancer, inflammatory skin conditions, skin infections, etc.
Intended part of the body or type of tissue applied to or interacted with
The device can be used on the following body parts:
• Skin
• Nails
• Hair
The device should not be used:
• For lesions in the eyes. The device should not be pointed towards the eyes. It is recommended that
patients close their eyes during examination near their eyes.
• In contact with breached or compromised skin surfaces. In case of small breached or compromised
lesions, it is recommended to install the non-contact cone on the Demetra Scope to perform non-contact
dermoscopy. In case of large breached or compromised lesions, the non-contact cone should not be used.
Contra-Indications
The device is not a Computer Aided Diagnosis (CAD) device. The additional information that the device
provides is intended as an aid for the trained medical practitioner when reviewing, analyzing and diagnosing
skin images. The final clinical decision is with the trained medical practitioner.
Intended users
The intended users for the Demetra solution are trained medical practitioners, whether they are active in a
private practice, hospital or clinic.
Operating principle
The Demetra solution consists of a hardware device and a stand-alone software application.
The hardware device is a portable, battery powered medical device for acquiring, processing and visualizing
images of the skin. The device acquires multispectral optical dermoscopic images in a contact mode (device in
contact with the skin). In addition the device can also acquire a clinical close-up image, when it is held at up to
10 to 15 cm from the skin, and a clinical overview image when it is held at approximately 35 to 55 cm from the
skin.
6 K5902200 /02AC Barco Demetra