Braster Braster Pro User manual

USER MANUAL

Braster Pro

– breast examination system

TABLE OF CONTENTS

GLOSSARY ............................................................................................ 3

EXPLANATION OF SYMBOLS USED IN THE USER MANUAL,

ON THE LABEL AND ON THE PACKAGING ................................................ 6

IMPORTANT SAFETY INFORMATION ....................................................... 7

INTRODUCTION ...................................................................................10

1. DESCRIPTION AND INTENDED USE....................................................11

1.1. DESCRIPTION.............................................................................11

1.2. INTENDED USE...........................................................................12

1.2.1. INDICATIONS .......................................................................12

1.2.2. CONTRAINDICATIONS...........................................................12

2. OPERATING PRINCIPLES OF THE DEVICE ...........................................13

3. PACKAGE CONTENTS ........................................................................15

4. OVERVIEW OF THE BRASTER DEVICE INTERFACE...............................16

5. MATRIX REPLACEMENT .....................................................................19

6. DEVICE PREPARATION PRIOR TO EXAMINATION ................................21

6.1. PREPARATION OF THE BRASTER DEVICE BEFORE THE FIRST

EXAMINATION.............................................................................21

6.2. PREPARATION OF THE BRASTER DEVICE BEFORE

SUBSEQUENT EXAMINATIONS......................................................22

7. EXAMINATION ..................................................................................23

7.1.IMPORTANT INFORMATION .........................................................23

7.2.HOW TO PERFORM AN EXAMINATION ..........................................25

7.2.1. PREPARATION ......................................................................25

7.2.2. PATIENT SEARCH (ONLY FOR BRASTER PRO VERSION

PREMIUM) ............................................................................25

7.2.3.TURNING THE DEVICE ON/OFF ..............................................26

7.2.4.DEVICE CONNECTION ...........................................................26

7.2.5.CONTRAINDICATIONS ...........................................................26

7.2.6.ACCLIMATIZATION................................................................27

7.2.7.MATRIX SELECTION ..............................................................27

7.2.8.EXAMINATION ......................................................................28

7.2.9.SENDING THE RESULTS TO THE TELEMEDICAL CENTER ..........34

8. TROUBLESHOOTING THE MOBILE APP ...............................................35

9. CHARGING .......................................................................................36

10. SAFE OPERATION............................................................................37

11. DISINFECTION................................................................................38

12. CLEANING AND MAINTENACE ..........................................................39

13. SERVICING AND TECHNICAL SUPPORT.............................................39

14. DECLARATION OF CONFORMITY ......................................................40

15. TECHNICAL AND OPERATIONAL SPECIFICATION OF THE DEVICE.......41

16. ADVERSE EVENT AND MEDICAL INCIDENTS......................................42

17. FCC REGULATORY STATEMENT........................................................42

18. CANADIAN REGULATORY STATEMENT..............................................43

19. DISPOSAL.......................................................................................44

CONTACT TO THE MANUFACTURER.......................................................45

GLOSSARY

Braster automatic interpretation (Braster AI) – software

responsible for analyzing the thermal images, along with the medical

information provided by the user via the Braster Care mobile

application.

Braster device or device – a device composed of an image

acquisition 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.

The Braster Pro system is available in two versions: Basic and

Premium.

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,

examination 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 purchased

only from a local distributor.

Clinic administrator – a person authorized by the clinic owner to

manage users and examination packages in the clinic in HCP Portal.

Examination package – a package containing a certain number

of interpretations of thermographic images. Without the purchased

examination package it is not possible to perform the examination

with Braster Pro.

HCP Portal – hcpportal.braster.eu portal, where the user of Braster

Pro version Premium must register in order to conduct examinations.

In HCP Portal the user of Braster Pro version Premium can, for

example, check the results of patient’s thermographic examination.

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

thermographic 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 device.

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 – myaccount.braster.eu portal, where the user of

Braster Pro version Basic must register in order to conduct

examinations. In My Account the user of Braster Pro version Basic

can, for example, check the results of a thermographic examination.

Patient – a woman 18 years of age or older, whose breasts are

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

examinations’ results offered by BRASTER S.A.

Thermogram (or thermographic image) – a graphic

representation of the thermal image created on the surface of the

liquid crystal 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 principles for disposal of this type of

waste

IMPORTANT SAFETY INFORMATION

This section is provided to familiarize the user with critical

information 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

reduce risk of fire or burns, do not disassemble, crush,

puncture, 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 being

charged.

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

damaged, 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 off 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 differ from the actual

appearance of the device and mobile app.

! According to Braster’s most recent studies thermographic

matrices lose their properties after 36 months from their first

use. 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

operator’s tariff.

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

and connect the Braster device to devices that are

mentioned in the User Manual. Do not modify the Braster

device. 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.

Other manuals for Braster Pro

Table of contents

Other Braster Medical Equipment manuals

Braster

Braster In-home Breast Examination System User manual

Popular Medical Equipment manuals by other brands

TekTone

TekTone Tek-CARE160 Installation and operation manual

NeuroMetrix

NeuroMetrix Quell 2.0 user manual

AMT

AMT XLR8 Quick reference guide

Medipost-Nutristoma

Medipost-Nutristoma MD300K2 instruction manual

EDAN

EDAN SONOTRAX Pro user manual

Restorative Therapies

Restorative Therapies RT300 Service guide

Gendex

Gendex Expert DC installation manual

Dexcowin

Dexcowin ADX4000W user manual

Libelium

Libelium MySignals user manual

Acelity

Acelity V.A.C.ULTA 4 user manual

Caputron

Caputron ActivaDose II tDCS quick start guide

FujiFilm

FujiFilm Sonart Features

Plinth 2000

Plinth 2000 93CDT Service manual

GE SENOGRAPHE 800T Operator's manual

GE Definium 5000 Operator's manual

Kanmed

Kanmed GE-1380 user manual

Huntleigh

Huntleigh FD1 Instructions for use

Stryker

Stryker SPR Plus Operation manual