Introduction; Description And Intended Use; Description; Intended Use - Braster In-home Breast Examination System User Manual

INTRODUCTION

This User Manual comes with the Braster System – in-home breast examination system intended for breast self-examination by
the user. Read the User Manual before using the device for the first time. The User Manual contains the necessary information
on all of the functions and features of the device, its safety and the breast examination process.
It is recommended that you retain this User Manual for future reference.
BRASTER S.A. is the owner of an innovative, proprietary technology for the manufacturing of liquid crystal mixtures and special-
purpose liquid crystal emulsions. This manufacturing process was developed based on Continuous Liquid Crystal Film (CLCF)
technology. The technology used by BRASTER S.A. is protected by international patents.
Improper operation of the device which is inconsistent with the User Manual may pose risk to the health and life of the
user or third persons. You must comply with the User Manual when using the product. Only use the Braster device if
you have become familiar with the product and have read the User Manual.
The device must only be used for the purpose intended by the manufacturer. Arbitrary use of the product which is
inconsistent with the User Manual may result in the loss of guarantee rights and claims in case of damage.
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1. DESCRIPTION AND INTENDED USE

1.1. DESCRIPTION

The Braster System – in-home breast examination system, hereinafter referred to as the "Braster System", is a medical device
intended for thermographic breast examination. The system consists of:
• the Braster device, which is composed of:
− the image acquisition device, and
− three thermographic matrices;
• the Braster Care mobile app;
• the Braster AI automatic interpretation software.
See Fig. 1: Components of the Braster System
1. The Braster Care app 2. The Braster device 3. The Braster AI software
During the examination apply the Braster device to the 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.
Should any potentially dangerous pathological changes be indicated, you will be instructed to consult your doctor.
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 (SUCH AS MAMMOGRAPHY AND ULTRASOUND). It is a useful complementary tool to the aforementioned
examinations.

1.2. INTENDED USE

1.2.1. INDICATIONS

The Braster System – in-home breast examination system is intended for domestic breast examination by women of legal age
as an adjunct to examinations such as ultrasound and mammography. The device detects thermal irregularities that require
confirmation by diagnostic methods or healthcare consultation.
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