Intended Use - Braster Pro User Manual

breasts� At the end of the examination the acquired thermogra-
phic images are stored in the mobile app and sent to the telemed-
ical center, where they are automatically analyzed by Braster AI�
You will receive the result to your individual account�
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 EXIST-
ING DIAGNOSTIC METHODS CURRENTLY USED IN
CLINICAL PRACTICE (SUCH AS MAMMOGRAPHY AND
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 meth-
ods or healthcare consultation� The device should be used by
qualified healthcare professionals trained in its use�
1.2.2. CONTRAINDICATIONS
The Braster Pro is not intended for women who are undergoing or
have undergone breast cancer treatment, i�e� breast-conserving
surgery, mastectomy (unilateral or bilateral), systematic treatment
(chemotherapy, hormonal therapy, biological therapy) and radia-
tion therapy�
Temporary contraindications against using the Braster Pro:
pregnancy or breastfeeding (up to three months after weaning);
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general infection, with a body temperature of or in excess of
l
38˚C;
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