Barco BDEM-01, Руководство пользователя

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K5902200 /07 Barco Demetra 6
1.1 Use specification
Indications for Use
The Barco Digital Dermatoscope is a non-invasive skin imaging 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.
Caution (USA): Federal law (United States of America) restricts this device to sale by or on the order of a
licensed healthcare practitioner (Details & exemptions are in the Code of Federal Regulations Title 21, 801
Part D).
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.
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.
Expected clinical benefits
Demetra BDEM-01 allows an easy, fast and accurate skin lesion follow-up.
Contra-Indications
Not for lesions in the eyes.
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 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.
The device uploads all images to cloud storage.
The stand-alone software application is cloud software with a related web application. This cloud software can
visualize images and related data and can generate consultation reports.
Welcome!