Braster Braster pro User manual

Braster Pro

– breast examination system

USER MANUAL

1

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

2

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)�

3

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�

4

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)

5

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�

6

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�

7

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

8

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�

9

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

10

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:

lpregnancy or breastfeeding (up to three months after weaning);

lgeneral infection, with a body temperature of or in excess of

38˚C;

11

lbreast infection with pain, skin redness and bruises (when

the said symptoms are present);

linadequate 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;

lsurgical 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;

laesthetic 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 tech-

nique for detecting changes in tissue metabolism� In medicine,

thermography is based on a phenomenon known as the “der-

mo-thermal eect”, 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 patho-

logical capillary network� Pathological lesions with suspected ma-

lignancy 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 dierent colors�

12

Contact thermography is a complementary examination� It com-

plements commonly performed examinations such as ultrasound

and mammography�

3. PACKAGE CONTENTS

The package contains:

lan image acquisition device, model: BRA-1�0 (see Fig� 2A),

la set of three thermographic matrices numbered 1, 2 and 3,

model: TMS-1�0 (see Fig� 2B),

la mini USB cable,

la cleaning cloth,

la quick start guide�

Fig� 2A: Image Acquisition Device

Fig� 2B: Set of three thermographic matrices numbered 1, 2 and 3

13

4. OVERVIEW OF THE BRASTER DEVICE INTERFACE

Grip

Examination Indicator

Power status

Mini-USB slot

ON/OFF Button

Fig� 3: The Braster device interface

ON/OFF Button – turns the device on/o

lto turn the device on press the button and hold it for 2 sec-

onds�

lafter the examination is ﬁnished or after 10 minutes of inac-

tivity the device will turn o automatically� To turn the device

o in emergency mode press the button and hold it for 5

seconds�

Grip – activates acquisition of thermographic images during the

examination�

lThe grip is pressed during the examination – acquisition of

thermographic images is in progress (activated Examination

idicator)�

lThe grip is not pressed – acquisition of thermographic imag-

es is not in progress�

14

Examination Indicator

Status

Power Indicator

Status

Description

No light No light The device is o

No light Blinking green The device is on

No light Steady green The device is con-

nected with a mobile

device

Pulsing white Steady green Thermogram acquisi-

tion in progress

No light Steady orange Charging in progress

No light Blinking orange The examination can-

not be performed� The

battery level is too low�

Steady white No light/orange Firmware upgrade

mode

Blinking white No light/orange Firmware upgrade in

progress

Tab� 1� Indicator colors in user interface

Mini-USB slot – is located under the rubber cap� To access the

slot, you need to raise the cap� The mini-USB slot is intended for:

lupdating software for the image acquisition device,

lbattery charging�

Device label – placed inside the device, visible when the matrix

is removed� The label contains the serial number of the device,

which is also the name of the Wi-Fi signal broadcast by the de-

vice, and password (see Fig� 4A and 4B)�

15

Device label

Fig� 4A: Position of the label

Do not remove the label� Write down the data which is

on the label and keep it in a safe place�

16

Name of the Wi-Fi signal

broadcast by the device

Password to Wi-Fi signal

broadcast by the device

4B: Sample label with name of the Wi-Fi signal and the password

5. MATRIX REPLACEMENT

Step 1 Pull the edge of the matrix in the place where there is

a notch in the body of the device� Preferably hold the

notch on the matrix with your thumb and support the

matrix from below with your other ﬁngers�

Fig� 5A

17

Step 2 Pull the matrix o the device�

Fig� 5B

Step 3 Attach the matrix, pushing it parallel to the housing� Pref-

erably hold the notch on the matrix with your thumb and

support the matrix from below with your other ﬁngers�

Fig� 5C

18

6. DEVICE PREPARATION PRIOR TO EXAMINATION

6.1. PREPARATION OF THE BRASTER DEVICE BEFORE

THE FIRST EXAMINATION

a. After unpacking the device, check it for completeness� The

box should contain: the image acquisition device, three

matrices (numbered 1, 2 and 3), a mini USB cable, a quick

start guide and a cleaning cloth� If you ﬁnd that any of those

elements are missing, immediately ﬁll in the complaint form

available on the Braster website�

b. The matrix is a part of the device, which means that it comes

into direct contact with the skin� Therefore, before each use,

disinfect and clean the inner and outer surfaces of all matri-

ces (as per the description and by using the measures speci-

ﬁed in chapters 11 and 12 of the User Manual)�

c. Charge the device for at least 30 minutes before the ﬁrst

examination.

d. Download the free Braster Care mobile app onto

your smartphone or tablet and create your account on

myaccount.braster.eu in order to perform an examination�

The instruction on how to download the mobile app in-

cludes the following actions:

1. Download the Braster Care app from the App Store, if

your mobile device has the iOS operating system (i�e� is

an iPhone or an iPad), or from Google Play, if your mo-

bile device has the Android operating system;

2. Install the Braster Care app on your mobile device;

3. Start the Braster Care app on your mobile device;

4. Click the SIGN UP link at the bottom of the screen�

e. Register your individual account as instructed (please note,

that we recommend registering and using your individual

account on PC’s or laptops, since it has been designed for

large screens):

1. If after clicking the SIGN UP link you are not redirected

automatically, go to myaccount.braster.eu;

19

2. Fill in the data and in the

type of account

ﬁeld

select

“Braster Pro – for professional use”� Indicate the coun-

try, where you provide your services, and enter your

activation code� Please remember that the activation

code is assigned to the country�

3. Click the SIGN UP button;

4. Go to your e-mail account and ﬁnd the e-mail from

BRASTER S�A� with the activation link� If you cannot ﬁnd

it in the main folder, check the “Spam” folder�

5. After you have activated the account by clicking the

activation link, make sure that charging of the device is

complete, start the mobile app and follow the instruc-

tions described in chapter 7�

6.2. PREPARATION OF THE BRASTER DEVICE BEFORE

SUBSEQUENT EXAMINATIONS

a. When preparing for an examination, ﬁrst disinfect and clean

the surface of the liquid crystal matrices� You should pay

particular attention to the surface on the inner side of each

matrix� It is important to use the recommended cleaning

and disinfection agents and thoroughly clean the surface of

the foil so as to not leave any ﬁngerprints, smudges, dust

etc� as it can alter the interpretation of the thermogra-

phic examination (for more information see chapter 11 titled

“Disinfection” and chapter 12 titled “Cleaning and Mainte-

nance”)�

b. When the matrices have been cleaned, start the mobile app

and follow the instructions provided in chapter 7�

Braster Braster Pro User manual

Popular Diagnostic Equipment manuals by other brands