Contraindications; Operating Principles Of The Device; Package Contents; Overview Of The Braster Device Interface - Braster In-home Breast Examination System User Manual

1.2.2. CONTRAINDICATIONS

The Braster System 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 radiation therapy.
Temporary contraindications against using the Braster System:
• pregnancy or breastfeeding (up to three months after weaning);
• general infection, with a body temperature of or in excess of 38˚C;
• breast infection with pain, skin redness and bruises (when the said symptoms are present);
• the second phase of the menstrual cycle – due to changes in breast physiology in the menstrual cycle, it is best to perform
the thermographic examination between day three and day twelve of the cycle;
• i nadequate temperature (too hot or too cold) in the room where the examination is to be performed – the ambient
temperature must be between 20˚C and 25˚C;
• surgical procedure in the breast area with benign lesion diagnosis:
– fine-needle biopsy (FNB) – up to four weeks after the procedure,
– core-needle biopsy (CNB) or Mammotome's breast biopsy – up to 6 months after the procedure,
– breast tumor resection – up to 12 months after the procedure;
• aesthetic implant placement, filler injections (e.g. hyaluronic acid) and lipotransfer – up to 12 months after the procedure.

2. OPERATING PRINCIPLES OF THE DEVICE

The Braster device uses a type of technology known as contact thermography. Contact thermography is a medical imaging
technique for detecting changes in tissue metabolism. In medicine, thermography is based on a phenomenon known as the
"dermo-thermal effect", in which the thermal processes that occur in the organ examined (inside the body) manifest on the
surface of the skin as temperature anomalies.
The neoplastic process is characterized by a higher metabolic rate among other things through the formation of a dense
pathological capillary network. Pathological lesions with suspected malignancy have a characteristic morphological structure
and higher temperature than normal areas of the body. As a result, they are shown in the thermogram as areas of different
colors.
Contact thermography is a complementary examination. It complements commonly performed examinations such as ultrasound
and mammography.
12

3. PACKAGE CONTENTS

The package contains:
• an image acquisition device, model: BRA-1.0 (see Fig. 2A ),
• a set of three thermographic matrices numbered 1, 2 and 3, model: TMS-1.0 (see Fig. 2B ),
• a mini USB cable,
• a cleaning cloth,
• a user manual,
• a quick start guide.

4. OVERVIEW OF THE BRASTER DEVICE INTERFACE

See Fig. 3: The Braster device interface
1. Grip
2. Examination idicator
3. Power status
4. Mini-USB slot
5. ON/OFF button
ON/OFF Button – turns the device on/off
• to turn the device on press the button and hold it for 2 seconds.
• after the examination is finished or after 10 minutes of inactivity the device will turn off automatically. To turn the device off
in emergency mode press the button and hold it for 5 seconds.
Grip – activates acquisition of thermographic images
• The grip is pressed – acquisition of thermographic images is active (activated Examination idicator).
• The grip is not pressed – acquisition of thermographic images is not active.
13