Intended Use; Indications; Contraindications - Braster Pro User Manual

During the examination apply the Braster device to the patient's
breast area. The device is fitted with a liquid crystal foil which
creates color images when it comes in contact with the surface of
the Breasts. At the end of the examination the acquired
thermographic images are stored in the mobile app and sent to the
telemedical center, where they are automatically analyzed by
Braster AI. After analysis the result is available:
• for the user of Braster Pro version Basic in My Account
portal,
• for the user of Braster Pro version Premium in HCP Portal.
The Braster medical device does not perform measurements, but
instead records temperature distribution across the breast, based
on which the thermographic images are analyzed.
The Braster examination DOES NOT REPLACE EXISTING
DIAGNOSTIC METHODS CURRENTLY USED IN CLINICAL
PRACTICE
ULTRASOUND). It is a useful complementary tool to the
aforementioned examinations.

1.2. INTENDED USE

1.2.1.

INDICATIONS

Braster Pro is intended for breast examination as an adjunct to
ultrasound and mammography examinations. The device detects
thermal irregularities that require confirmation by diagnostic
methods or healthcare consultation. The device should be used by
qualified healthcare professionals trained in its use.
1.2.2.

CONTRAINDICATIONS

(SUCH AS
12
MAMMOGRAPHY AND