Braster Braster Pro User manual

USER MANUAL
Braster Pro
– breast examination system

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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

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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

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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.

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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.

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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.

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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)

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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.

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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.

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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.

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! Charge the device for at least 30 minutes before the first
examination.
INTRODUCTION
This User Manual comes with the Braster Pro – breast examination
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
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 Pro – breast examination system, hereinafter referred
to as the “Braster Pro”, is a medical device intended for
thermographic breast examination. The system is available in two
versions: Basic and Premium. The system in both versions 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.
Fig. 1: Components of the Braster Pro:
1. Th
e Braster Care app
2. The Braster device
3. The Braster AI software

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During the examination apply the Braster device to the patient’s
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. After analysis the result is available:
•for the user of Braster Pro version Basic in My Account
portal,
•for the user of Braster Pro version Premium in HCP Portal.
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
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
methods or healthcare consultation. The device should be used by
qualified healthcare professionals trained in its use.
1.2.2. CONTRAINDICATIONS

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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
radiation therapy.
Temporary contraindications against using the Braster Pro:
•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);
•inadequate 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

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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.

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Contact thermography is a complementary examination. It
complements commonly performed examinations such as
ultrasound and mammography.
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 quick start guide.
Fig. 2A: Image Acquisition Device
Fig. 2B: Set of three thermographic matrices numbered 1, 2 and 3

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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/off
•to turn the device on press the button and hold it for 2 seconds.
•the device will turn off automatically after the examination is
finished or after 10 minutes if it is not connected to the mobile
app. To turn the device off in emergency mode press the button
and hold it for 5 seconds.
Grip – activates acquisition of thermographic images during the
examination.
•The grip is pressed during the examination – acquisition of
thermographic images is in progress (activated Examination
indicator).
•The grip is not pressed – acquisition of thermographic images
is not in progress.

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Examination
Indicator
Status
Power Indicator
Status Description
No light No light The device is off
No light Blinking green The device is on
No light Steady green
The device is
connected with a
mobile device
Pulsing white Steady green
Thermogram
acquisition in
progress
No light Steady orange Charging in progress
No light Blinking orange
The examination
cannot be performer.
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:
•updating software for the image acquisition device,
•battery 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 device, and
password (see Fig. 4A and 4B).

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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.
Device label

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Fig. 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
Name of the Wi-Fi
signal broadcast by the
Password to Wi-Fi
signal broadcast by the