Braster Braster Pro Bedienungsanleitung

Braster Pro

– breast examination system

USER MANUAL

TABLE OF CONTENTS

GLOSSARY��2

IMPORTANT SAFETY INFORMATION��5

INTRODUCTION ��8

1� DESCRIPTION AND INTENDED USE��9

1�1� DESCRIPTION��8

1�2� INTENDED USE ��10

1�2�1� INDICATIONS ��10

1�2�2� CONTRAINDICATIONS��10

2� OPERATING PRINCIPLES OF THE DEVICE�� 11

3� PACKAGE CONTENTS ��12

4� OVERVIEW OF THE BRASTER DEVICE INTERFACE ��13

5� MATRIX REPLACEMENT��16

6� DEVICE PREPARATION PRIOR TO EXAMINATION��18

6�1� PREPARATION OF THE BRASTER DEVICE PRIOR

TO THE FIRST EXAMINATION ��18

6�2�PREPARATION OF THE BRASTER DEVICE PRIOR

TO SUBSEQUENT EXAMINATIONS��19

7� EXAMINATION ��20

7�1� IMPORTANT INFORMATION �� 20

7�2� HOW TO PERFORM AN EXAMINATION ��21

7�2�1� PREPARATION��21

7�2�2� TURNING THE DEVICE ON/OFF �� 22

7�2�3� DEVICE CONNECTION �� 22

7�2�3�1� CONNECTING TO A DEVICE WITH iOS LOWER THAN 11�� 22

7�2�3�2� CONNECTING TO AN ANDROID DEVICE AND iOS 11 AND HIGHER ��23

7�2�4� QUESTIONS��23

7�2�5� ACCLIMATIZATION��23

7�2�6� MATRIX SELECTION��24

7�2�7� EXAMINATION�� 25

7�2�8� SENDING THE RESULTS TO THE TELEMEDICAL CENTER 30

8� TROUBLESHOOTING THE MOBILE APP��31

9� CHARGING��32

10� SAFE OPERATION��33

11� DISINFECTION ��34

12� CLEANING AND MAINTENANCE��35

13� SERVICING AND TECHNICAL SUPPORT��35

14� DECLARATION OF CONFORMITY ��36

15� TECHNICAL AND OPERATIONAL SPECIFICATION OF THE DEVICE�� 37

16� ADVERSE EVENT AND MEDICAL INCIDENTS��38

17� FCC REGULATORY STATEMENT��38

18� CANADIAN REGULATORY STATEMENT��39

19� DISPOSAL�� 40

CONTACT TO THE MANUFACTURER�� 40

GLOSSARY

Braster automatic interpretation (Braster AI) – software responsi-

ble for analyzing the thermal images, along with the medical informa-

tion provided by the user via the Braster Care mobile application�

Braster device or device – a device composed of an image acqui-

sition device and a thermographic matrix manufactured by Braster

S�A�

Braster Pro – a system for thermographic breast examination

manufactured by Braster S�A� The system includes: the Braster

device, Braster Care mobile app and AI algorithms for automatic

interpretation of thermograms produced during the examination�

Braster scale – a scale of breast sizes developed by BRASTER S�A�

It helps to determine how many applications should be made in

order to cover the whole breast area within an examination�

Braster e-store – www.braster.eu where the Braster device, ex-

amination packages and the set of thermographic matrices can be

purchased� Please note that in some markets the Braster device

as well as examination packages and other services can be pur-

chased only from a local distributor�

Examination package – a pre-paid package of automatic thermo-

gram interpretations, encompassing a speciﬁc number of auto-

matic interpretations� Without the examination package it is not

possible to perform the examination with Braster Pro�

Image acquisition device – the device used in the examination�

On the image acquisition device, there is an ON/OFF button, a

USB slot and a grip� The device is also ﬁtted with electronics and

image acquisition system� The inner part of the device consists

of a blackened chamber which ensures the appropriate quality

of the thermographic images� The image acquisition device is an

electronic device and is controlled by the mobile app�

Liquid crystal foil – an element of the liquid crystal matrix� The

foil contains liquid crystals, which map thermal variations in the

breast, creating color images (thermograms)�

Liquid crystal thermographic matrix (or liquid crystal matrix

or thermographic matrix) – an element of the Braster device

composed of a liquid crystal foil and a plastic clamp� The thermo-

graphic image is generated on the inner side of the foil surface,

i�e� on the side facing inwards (towards the inside of the device)�

The matrix is an applied part of the device, which means that it

comes into contact with the skin of the breast�

Mobile app or app – the Braster Care app, software which is

needed to perform the breast examination with the Braster de-

vice� It needs to be downloaded onto mobile device (smartphone

or tablet) before the ﬁrst examination� The mobile app is free of

charge and available via Google Play (for Android) or via the App

Store (for iOS)�

Mobile device – a smartphone or tablet (for system requirements,

go to: https://www.braster.eu/system)�

My Account – an account on myaccount.braster.eu, where the

user must register in order to conduct examinations� In My Ac-

count the user can, for example, check the results of a thermo-

graphic examination�

Patient – woman whose breast is examined with Braster Pro by

healthcare professional�

Telemedical center – BRASTER’S S�A� infrastructure used for the

provision of the services, in particular the analysis of the examina-

tions’ results oered by BRASTER S�A�

Thermogram (or thermographic image) – a graphic representa-

tion of the thermal image created on the surface of the liquid crys-

tal foil which maps temperature distribution across the breast�

User – a healthcare professional who uses Braster Pro for breast

examination in a clinical setting�

EXPLANATION OF SYMBOLS USED IN THE USER

MANUAL, ON THE LABEL AND ON THE PACKAGING

Caution

Warning

Operating instructions (read the user manual)

Serial number

The device contains an applied part

Date of manufacture

Manufacturer’s name and address

Power supply information

The device with a matrix on is ﬁtted with protection against

solid particles (diameter ≥ 12.5 mm) and dripping water when

tilted up to 15°

Operating conditions (ambient temperature and humidity)

Storage and transport conditions (ambient temperature and

humidity)

This symbol means that the medical device satisﬁes the

requirements of the Directive 93/42/EEC

The device communicates wirelessly via Wi-Fi

The device needs to be protected from moisture

The device needs protection from light sources

This symbol means that you must follow all applicable princi-

ples for disposal of this type of waste

IMPORTANT SAFETY INFORMATION

This section is provided to familiarize the user with critical infor-

mation needed before the device is used� Additional warnings

and precautions are also given in the other sections of the User

Manual�

WARNINGS

Warnings are statements that alert the user to the possibility of

injury, death, or other serious adverse reactions associated with

the use or misuse of the device.

! It is important to note that an examination with the use of

Braster Pro does not replace existing diagnostic methods

currently used in clinical practice (such as mammography,

ultrasound, MRI)� Any use, operation and servicing of the

device breeching this User Manual is prohibited and may

cause damage to the device or disrupt its operation� The

device must be used and operated as stipulated in the

User Manual and serviced in a place indicated by BRASTER

S�A� The manufacturer will not be held responsible for any

consequences of improper use of the device�

! The device contains a Lithium-ion polymer battery� To re-

duce risk of ﬁre or burns, do not disassemble, crush, punc-

ture, short external contacts or circuits, dispose of in ﬁre

or water, or expose a battery pack to temperatures higher

than 60°C�

! The device must not be charged while an examination is

in progress� Use of the device while charging may lead to

electrocution� Avoid contact with the device while it is be-

ing charged�

! Do not use the device if the housing of the device is dam-

aged, as that may cause electrocution�

! The device should be charged using a USB Power Adapter

(parameters: DC 5V 1A) which complies with IEC 60950-1 or

IEC 60601-1� Switch the device o before charging it�

CAUTIONS

Cautions are statements that alert the user to the possibility of

a problem with the device associated with its use or misuse, i.e.

device failure, device malfunction, damage to the device or data

loss.

! To ensure the safety and appropriate operation of the

device, read the information on precautionary measures

set out in the chapter of this User Manual titled “Important

Safety Information” and other information included herein

before using the device� The illustrations and screenshots

used in this User Manual may slightly dier from the actual

appearance of the device and mobile app�

! According to Braster’s most recent studies thermograph-

ic matrices lose their properties after 36 months from

their ﬁrst use� If you use the matrices after the lapse of 36

months from their ﬁrst use, a reliable interpretation of the

examination will not be possible� To ensure the proper

operation of the device, replace the set of matrices after

36 months since the ﬁrst use� However, please note that

Braster S�A� still conducts studies on the matrices’ service

life and it may be extended even further in the future�

! The device and matrices may be damaged if stored in a hot

and/or moist place and/or in direct sunlight� Store them in a

dry, cool and shaded place�

! You will pay for data transfer in accordance with your oper-

ator’s tari�

! You must only use the parts indicated in the User Manual

and connect the Braster device to devices that are men-

tioned in the User Manual� Do not modify the Braster de-

vice� If you use parts other than those indicated in the User

Manual or if you modify the Braster device or connect it to

devices that are not mentioned in the User Manual, you

may encounter problems with its operation and/or cause

damage that will be attributed to the user, for which the

manufacturer will not be held responsible�

! Charge the device for at least 30 minutes before the ﬁrst

examination�

INTRODUCTION

This User Manual comes with the Braster Pro – breast examina-

tion system intended for breast examination in a clinical setting�

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 ref-

erence�

BRASTER S�A� is the owner of an innovative, proprietary tech-

nology for the manufacturing of liquid crystal mixtures and spe-

cial-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�

1. DESCRIPTION AND INTENDED USE

1.1. DESCRIPTION

The Braster Pro – breast examination system, hereinafter referred

to as the “Braster Pro”, is a medical device intended for thermo-

graphic breast examination� The system consists of:

lthe Braster device, which is composed of:

– the image acquisition device, and

– three thermographic matrices;

lthe Braster Care mobile app;

lthe Braster AI automatic interpretation software�

Fig� 1: Components of the Braster Pro:

1. The Braster Care app

2. The Braster device

3. The Braster AI software

During the examination apply the Braster device to the patient’s

breast area� The device is ﬁtted with a liquid crystal foil which cre-

ates color images when it comes in contact with the surface of the

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