Braster In-home Breast Examination System Instrukcja obsługi
- Typ
- Instrukcja obsługi
EN
USER MANUAL
Braster System – in-home breast examination system
PL
INSTRUKCJA OBSŁUGI
System Braster – system domowej profilaktyki
raka piersi
ES
MANUAL DE INSTRUCCIONES
Sistema de exploración de mamas para uso
doméstico –Sistema Braster
HU
FELHASZNÁLÓI KÉZIKÖNYV
Otthoni emlővizsgáló rendszer – Braster Rendszer
Braster Care App
11001001
BRASTER –
AR
Braster S.A.
Rev. 6,2018.06.19_EN_PL_HU_ES_AR
CONTACT THE MANUFACTURER
KONTAKT DO PRODUCENTA
PÓNGASE EN CONTACTO CON EL FABRICANTE
VEGYE FEL A KAPCSOLATOT A GYÁRTÓVAL
OFFICE / BIURO / OFICINA / IRODA /
Poland / Polska / Polonia / Lengyelország /
Poland / Polska / Polonia / Lengyelország /
EN
USER MANUAL 5
PL
INSTRUKCJA OBSŁUGI 31
ES
MANUAL DE INSTRUCCIONES 57
HU
FELHASZNÁLÓI KÉZIKÖNYV 83
109
Caution
Uwaga
Precaución
Vigyázat
Warning
Ostrzeżenie
Advertencia
Figyelem
Operating instructions (read the user manual)
Instrukcja postępowania (zapoznaj się z instrukcją obsługi)
Instrucciones de uso (lea el manual de instrucciones)
Üzemeltetési útmutató (olvassa el a felhasználói kézikönyvet)
( )
Serial number
Numer seryjny urządzenia
Número de serie
Sorozatszám
The device contains an applied part
Urządzenie zawiera część aplikacyjną
El dispositivo contiene una parte aplicada
Az eszköz egy gyakorlatban használt részt is tartalmaz
EXPLANATION OF SYMBOLS USED IN THE USER MANUAL, ON THE LABEL AND ON THE PACKAGING
WYJAŚNIENIE SYMBOLI STOSOWANYCH W INSTRUKCJI, NA ETYKIECIE I OPAKOWANIU
EXPLICACIÓN DE LOS SÍMBOLOS UTILIZADOS EN EL MANUAL DE INSTRUCCIONES, EN LA ETIQUETA Y EL EMBALAJE
A FELHASZNÁLÓI KÉZIKÖNYVBEN, A CÍMKÉN ÉS A CSOMAGOLÁSON HASZNÁLT SZIMBÓLUMOK MAGYARÁZATA
Date of manufacture
Data wyprodukowania
Fecha de fabricación
Gyártás dátuma
Manufacturer’s name and address
Producent
Nombre y dirección del fabricante
A gyártó neve és címe
Power supply information
Informacja o zasilaniu
Información sobre la tensión de funcionamiento
Tápegység adatai
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°
Urządzenie z założoną matrycą posiada ochronę przed ciałami stałymi (o średnicy 12,5 mm
i większej) oraz pionowo padającymi kroplami wody przy obudowie nachylonej do 15°
El dispositivo con matriz encendida está equipado con protección contra partículas sólidas
(diámetro ≥12,5 mm) y goteos cuando se inclina hasta 15°
Az érzékelővel rendelkező eszköz szilárd részecskékkel (átmérő ≥ 12,5 mm) és csepegő vízzel
szembeni védelemmel van felszerelve, ha max. 15°-ig dönti
15 ( 12.5 ≤ )
Operating conditions (ambient temperature and humidity)
Ograniczenie dopuszczalnych temperatur oraz wilgotności powietrza podczas pracy urządzenia
Condiciones de funcionamiento (temperatura y humedad ambiente)
Működési feltételek (környezeti hőmérséklet és páratartalom)
( )
Storage and transport conditions (ambient temperature and humidity)
Ograniczenie dopuszczalnych temperatur oraz wilgotności powietrza podczas transportu
i przechowywania urządzenia
Condiciones de almacenamiento y transporte (temperatura y humedad ambiente)
Tárolási és szállítási feltételek (környezeti hőmérséklet és páratartalom)
( )
4
This symbol means that the medical device satisfies the requirements of the Directive 93/42/EEC
Symbol wskazujący, że wyrób medyczny jest zgodny z wymaganiami dyrektywy 93/42/EWG
Este símbolo indica que el dispositivo sanitario cumple los requisitos de la directiva 93/42/CEE
Ez a szimbólum azt jelenti, hogy az orvostechnikai eszköz megfelel a 93/42/EGK irányelv
követelményeinek
EEC/93/42
The device communicates wirelessly via WiFi
Urządzenie komunikuje się bezprzewodowo przez sieć Wi-Fi
El dispositivo se comunica de forma inalámbrica mediante Wi-Fi
Az eszköz vezeték nélkül, WiFi segítségével kommunikál
WiFi
The device needs to be protected from moisture
Należy chronić urządzenie przed wilgocią
El dispositivo debe ser protegido contra la humedad
Az eszközt óvni kell a nedvességtől
The device needs protection from light sources
Należy chronić urządzenie przed promieniami słonecznymi
El dispositivo necesita protección contra las fuentes de luz
Az eszközt óvni kell a fényforrásoktól
This symbol means that you must follow all applicable principles for disposal of this type of waste
Symbol wskazujący, że należy postępować zgodnie z wszystkimi mającymi zastosowanie
zasadami utylizacji odpadów tego rodzaju
Este símbolo indica que debe respetar todos los principios aplicables para la eliminación de
este tipo de desechos
Ez a szimbólum azt jelenti, hogy az összes, ilyen típusú hulladék ártalmatlanítására vonatkozó
elvet követnie kell
5
ENGLISH
USER MANUAL
7
ENGLISH
TABLE OF CONTENTS
GLOSSARY 8
IMPORTANT SAFETY INFORMATION 9
INTRODUCTION 10
1. DESCRIPTION AND INTENDED USE 11
1.1. DESCRIPTION 11
1.2. INTENDED USE 11
1.2.1. INDICATIONS 11
1.2.2. CONTRAINDICATIONS 12
2. OPERATING PRINCIPLES OF THE DEVICE 12
3. PACKAGE CONTENTS 13
4. OVERVIEW OF THE BRASTER DEVICE INTERFACE 13
5. MATRIX REPLACEMENT 15
6. DEVICE PREPARATION PRIOR TO EXAMINATION 15
6.1. PREPARATION OF THE BRASTER DEVICE BEFORE THE FIRST EXAMINATION 15
6.2. PREPARATION OF THE BRASTER DEVICE BEFORE SUBSEQUENT EXAMINATIONS 16
7. EXAMINATION 16
7.1. IMPORTANT INFORMATION 16
7.2. HOW TO PERFORM AN EXAMINATION 17
7.2.1. PREPARATION 17
7.2.2. QUESTIONS 18
7.2.3. TURNING THE DEVICE ON/OFF 18
7.2.4. DEVICE CONNECTION 19
7.2.4.1. CONNECTING TO AN iOS DEVICE 19
7.2.4.2. CONNECTING TO AN ANDROID DEVICE 19
7.2.5. ACCLIMATIZATION 20
7.2.6. MATRIX SELECTION 20
7.2.7. EXAMINATION 21
7.2.8. SENDING THE RESULTS TO THE TELEMEDICAL CENTER 23
8. TROUBLESHOOTING THE MOBILE APP 23
9. CHARGING 24
10. SAFE OPERATION 25
11. DISINFECTION 25
12. CLEANING AND MAINTENANCE 26
13. SERVICING AND TECHNICAL SUPPORT 26
14. DECLARATION OF CONFORMITY 27
15. TECHNICAL AND OPERATIONAL SPECIFICATION OF THE DEVICE 27
16. ADVERSE EVENT AND MEDICAL INCIDENTS 28
17. FCC REGULATORY STATEMENT 29
18. CANADIAN REGULATORY STATEMENT 29
19. DISPOSAL 30
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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 System does not replace existing diagnostic methods currently used in clinical practice (such
as mammography, ultrasound, MRI). Be sure to undergo routine mammography or ultrasound screening as recommended by your physician.
! 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 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 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 dier 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. 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 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 lifetime and the lifespan can 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 tari.
! 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.
! Charge the device for at least 30 minutes before the first examination.
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 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.
Examination package – a pre-paid package of automatic thermogram interpretations, encompassing a specific number of
interpretations.
Image acquisition device – the device used in the examination. On the image acquisition device, there is an ON/OFF button,
a USB slot and an 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 a 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.
Mammography – a radiological examination of the breast, performed on women, in which a series of pictures of the mammary
gland is taken using x-rays. With its ability to visualize a number of characteristic changes and lesions, mammography is used
for detection of breast cancer and other nipple pathologies before they manifest clinically. The ecacy of the examination is
strictly connected with the structure of the breast, for that reason it is recommended for women older than 50 years of age.
Mobile app – the Braster Care app, software which is needed to perform the breast examination with the Braster device. It
needs to be downloaded onto the user’s mobile device (smartphone or tablet) before the first examination. The 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 the examinations. In My
Account the user can, for example, check the results of a thermographic examination.
Telemedical center – BRASTER’S S.A. infrastructure in which the users’ data is stored and where the software needed for the
provision of the services, in particular the results of examinations, oered by BRASTER S.A. is kept.
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.
Ultrasound – a non-invasive method in which ultrasound is used to visualize tissue. Ultrasound imaging is a basic diagnostic
tool used for detecting pathological changes in breast, including breast cancer.
User – a woman who uses the Braster System – in-home breast examination system.
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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
confirmationby diagnostic methods or healthcare consultation.
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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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 user manual,
• a quick start guide.
4. OVERVIEW OF THE BRASTER DEVICE INTERFACE
See Fig. 3: The Braster device interface
1. Grip
2. Examination idicator
3. Power status
4. Mini-USB slot
5. ON/OFF button
ON/OFF Button – turns the device on/o
• to turn the device on press the button and hold it for 2 seconds.
• after the examination is finished or after 10 minutes of inactivity 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
• The grip is pressed – acquisition of thermographic images is active (activated Examination idicator).
• The grip is not pressed – acquisition of thermographic images is not active.
1.2.2. CONTRAINDICATIONS
The Braster System 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 System:
• 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);
• the second phase of the menstrual cycle – due to changes in breast physiology in the menstrual cycle, it is best to perform
the thermographic examination between day three and day twelve of the cycle;
• i nadequate 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 eect”, 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
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 dierent
colors.
Contact thermography is a complementary examination. It complements commonly performed examinations such as ultrasound
and mammography.
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5. MATRIX REPLACEMENT
Step 1 (Fig. 5A ) 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.
Step 2 (Fig. 5B ) Pull the matrix o the device.
Step 3 (Fig. 5C ) Attach the matrix, pushing it parallel to the housing. Preferably hold the notch on the matrix with your thumb
and support the matrix from below with your other fingers.
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 user manual, 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 using, clean
and disinfect the inner and outer surfaces of all matrices (as per the description and by using the measures specified 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. You can do this while the battery is being charged. The instruction on how to download
the mobile app include:
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 mobile 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 and read the INTRO;
4. Click the SIGN UP link at the bottom of the screen.
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 in the shadowed chamber of the device, visible when the matrix is removed. The label contains the serial
number of the device, which is also the name of the WiFi signal broadcast by the device, and password (see Fig. 4A : Position
of the label, and 4B : Sample label with name of the WiFi signal and the password: 1. Name of the WiFi signal broadcast by the
device, 2: Password to WiFi signal broadcast by the device).
Do not remove the label. Write down the data which is on the label and keep it in a safe place.
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 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 performed.
The battery level is too low.
Steady white No light/orange Firmware upgrade mode
Blinking white No light/orange
Firmware upgrade
in progress
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• make sure that you have bought the examination package – if you have not, you may purchase it in the Braster e-store or,
depending on the country, the e-store or other outlets of the local distributor.
REMEMBER
Do not perform an examination in a room where the temperature is lower than 20˚C or higher than 25˚C.
Due to changes in breast physiology during the menstrual cycle, it is best to perform the thermographic examinations
between day three and day twelve of the cycle.
If you no longer menstruate, or your menstrual cycles are irregular (fluctuations of more than 10 days), we recommend
performing the examination at equal intervals once a month; e.g., between the 1st and 5th day of the month or on the
1st weekend of the month.
1. On the day before the examination:
• avoid procedures which may increase blood circulation in the breast area (physiotherapy, massages, etc.).
2. On the day of the examination:
• avoid procedures which may increase blood circulation in the breast area (physiotherapy, massages, etc.);
• make sure that you are between days three and twelve of your menstrual cycle or, if you do not menstruate, that about 30
days have passed from your previous exam;
• do not take a bath or a shower within approximately two hours before the examination;
• do not consume any alcoholic beverages;
• do not use peelings on your breasts and/or neckline and do not perform armpit depilation, as this may irritate your skin;
• refrain from sources of heat or cold, such as heaters or air conditioners, for at least thirty minutes before and during the
examination;
• avoid intense physical eort for approximately two hours prior to the examination;
• do not use cosmetics and do not wet the skin on your breasts within two hours prior to the examination – your skin should
be clean and dry;
• do not have a sauna or a steam bath.
7.2. HOW TO PERFORM AN EXAMINATION
7.2.1. PREPARATION
• Place the Braster device in front of you. Make sure it is turned o. Have at hand your mobile device with the Braster Care
app installed (as stated in chapter 6 of the User Manual). Check that your mobile device is connected to the Internet.
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 www.braster.eu and click the MY ACCOUNT button;
2. Fill in the data. In the
type of account
field select “Braster – for home use” and click the SIGN UP button;
3. Go to your e-mail account and find the e-mail from us with the activation link. If you cannot find it in the main folder, check
the “Spam” folder;
4. After you have activated the account by clicking the activation link, type your login (the e-mail address which you used
during registration) and password (the one which you used during registration) on the login page, and click LOG IN;
5. Fill in all medical and personal data in the survey.
If you do not complete this survey the first time you log in, you will not be able to perform the examination;
6. Activate your examination package by going to the tab “Activation codes” and clicking the button “Activate the
package”;
7. Log out from My Account after completing the registration.
f. When charging is complete, start the app and follow the instructions described in chapter 7.
6.2. PREPARATION OF THE BRASTER DEVICE BEFORE SUBSEQUENT EXAMINATIONS
a. When preparing for an examination, first clean the surface of the liquid crystal matrices. You should clean all of the matrices,
with 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, etc. as it
can alter the interpretation of the thermographic examination (for more information see chapter 11 titled “Disinfection” and 12
titled “Cleaning and Maintenance”).
b. When the matrices have been cleaned, start the app and follow the instructions provided in chapter 7.
7. EXAMINATION
7.1. IMPORTANT INFORMATION
Do not use the device while it is being charged.
Before the first examination:
• download the free Braster Care app from Google Play or the App Store onto your mobile device;
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7.2.4. DEVICE CONNECTION
Establishing a connection between the Braster device and a mobile device diers slightly for Android and iOS.
To connect the Braster device follow the instructions displayed on subsequent screens on your mobile device.
Position the device to see the label with the name of the Braster WiFi signal and password. The label is inside the device and is
visible only when the matrix has been removed (Fig. 4A & 4B ).
7.2.4.1. CONNECTING TO AN iOS DEVICE
Click “Settings” on the connection screen. Go to the WiFi settings. From the list of WiFi signals select the Braster signal
specified on the label and enter the password. Return to the app. A message will display information whether a connection has
been established successfully.
Do not worry if you went back to the main screen of your mobile device and not to the app directly, you may go back to the
application again. At this point you should already be connected to the device.
If, for some reason, you are unable to go to the WiFi settings on the connection screen in the app, leave the app, go to “Settings”
in your mobile device, select the “WiFi” tab and select the signal of your Braster device and enter the password. Afterwards,
you may return to the app.
7.2.4.2. CONNECTING TO AN ANDROID DEVICE
Select the signal of your Braster device on the connection screen and enter the password (the signal’s name and password
are given on the device label located inside the device). A message will display information whether a connection has been
established successfully.
The app will remember your login and password, so there will be no need for you to re-enter them when performing an
examination in the future.
YOUR MOBILE DEVICE WILL NOT HAVE ACCESS TO THE INTERNET WHEN IT IS CONNECTED TO THE BRASTER DEVICE
• Start the Braster Care mobile app on your smartphone or tablet.
• Log into the app by entering your login and password (which are the same as for your individual account on myaccount.
braster.eu).
• Click START to begin the examination. You do not need to undress at this stage yet.
During the examination the mobile device will display a navigation screen with all of the stages. The stage you are currently
going through will be highlighted in the app. Click the name of the stage to begin. The navigation screen will be displayed after
each stage. Note that you must go through all of the stages of the examination one by one. The app will not let you skip any
stage. Once you have finished a step, you will not be able to return to it.
7.2.2. QUESTIONS
In this part of the examination you will answer questions which will check whether you are eligible to perform the examination
on that particular day. These questions will also be useful for interpretation of the results. Some of them will be YES or NO
questions. If your answer enables you to perform the examination, you will be redirected to the next screen. However, if you
are unable to perform the examination, an explanatory note will be displayed. You can always return to the previous question
by clicking BACK.
In some of the questions you will select your answer from a number of options. Always remember to answer truthfully, as your
answers aect the reliability of the results.
7.2.3. TURNING THE DEVICE ON/OFF
Turn the device on by pressing the ON/OFF button for two seconds. When the device is on, the battery icon will flash green.
When the device is connected to your mobile device, the battery icon will be steady green.
In normal conditions the device turns itself o automatically once the examination is completed. To switch the device o in the
emergency mode, press the ON/OFF button and hold it for five seconds.
The device turns o automatically after ten minutes of inactivity. Therefore, if you find it necessary to interrupt the examination
for more than ten minutes, you will be required to turn the Braster device on and connect it to the mobile device once again to
continue.
20 21
ENGLISH
7.2.7. EXAMINATION
Before you start the examination, read the instructions displayed when you select “Examination” on the navigation screen.
From those instructions, you will learn exactly what to do during the examination and how to apply the device to your breasts.
To ensure top quality thermographic images during the examination:
• apply the device perpendicular to your breast (see Fig. 7: correctly applied device);
• do not lift your breast;
• do not move the device across your breast, instead hold it firmly in one place (see Fig. 8: improperly applied device);
• do not move the device away until instructed;
• keep the grip pressed as long as the examination is in progress;
• do not touch your breast with your hands during the examination.
Depending on the breast size which you entered in “My data” tab in your individual account on myaccount.braster.eu, you will
be required to make three or five applications to each breast.
ALWAYS BEGIN WITH YOUR RIGHT BREAST
This is very important, as the thermographic images of your breasts produced in individual examinations are compared to
one another. We compare the image(s) from current examination with images produced during your last five examinations.
By comparing images produced during the past examinations we can observe if there have been any changes in structural or
thermal asymmetry over time.
Breast size 1, 2 or 3
If your breast size is 1, 2 or 3, see Fig. 9A for size 1 or 2 and Fig. 9B for size 3. During the examination you will have to perform:
1) One central application to the breast, making sure that the lower edge of the matrix, i.e. the black part (the thermographic
foil), adheres to your breast (not your abdomen). Do not push your breast up.
7.2.5. ACCLIMATIZATION
The next stage of the examination is a six-minute acclimatization, i.e. regulation and stabilization of breast skin temperature. To
do this, you will be required to undress from the waist up. Acclimatization is key if you want to obtain good quality thermographic
images during the examination. Only with a properly conducted acclimatization can you be sure that the results will be reliable.
To complete the acclimatization process, follow the instructions displayed on subsequent app screens.
7.2.6. MATRIX SELECTION
At this stage, you need to select the matrix for the examination. Your Braster device was provided with a set of three matrices.
Each of them works in a dierent range of temperatures. Remember that your body temperature depends on, among other
factors, the day of your menstrual cycle, your age and metabolism. In order to produce a high-resolution thermographic image
that will show the distribution of temperatures across your breasts, you will have to select a matrix before each examination.
To select a matrix, make one application of the Braster device to the central area of each breast. Make sure, that the whole
matrix adheres tightly to the body. The app will guide you step by step through this process.
First place matrix No. 2 on the device (the number of the matrix is stated on the plastic frame). Follow the instructions displayed
on subsequent screens.
! START THE MATRIX SELECTION WITH YOUR RIGHT BREAST.
When instructed apply the device centrally to your breast and press the grip (see. Fig. 3: to see the location of the grip). The
clicking sound means that the grip has been pressed correctly.
Remember to hold the grip down as long as the examination is in progress. Do not move the device across your breast, hold
it firmly in one place. When instructed, release the button and move the device away from your breast (see Fig. 6: device
application to the breast).
! REPEAT THESE STEPS FOR YOUR LEFT BREAST.
If matrix No. 2 is suitable for you, you can start the examination. If it does not suit you, you will be asked to remove matrix No. 2
and repeat the applications with matrix No. 1 or 3. You may be asked to return to matrix no. 2 if it is more suitable for the patient’s
body temperature. Once the appropriate matrix has been selected, you can start the examination.
22 23
ENGLISH
The applications may overlap, but do not worry if in your case they do not overlap as shown in the illustrations. The crucial thing
is to make sure that your entire breast is covered.
Follow the instructions displayed on the screen of your mobile device. Each application takes about 15 seconds which may
be extended for transfer if the WiFi conditions are poor (a lot of other transmitters or radio noise). The time interval between
applications lasts approximately 10-15 seconds (depending on your breast temperature and the ambient temperature). The
matrix should not be in contact with your body during this time.
7.2.8. SENDING THE RESULTS TO THE TELEMEDICAL CENTER
Once you have made all applications, you will be informed that the examination has come to an end and that you are able to
send your collected data to the manufacturer’s telemedical center for analysis. Please note that before you send the data,
you should first disconnect your mobile device from the Braster device and connect to a WiFi network. Due to the size of the
thermographic images produced during the examination, it is not recommended to send them via mobile data but by a WiFi
network. The examination results will be sent to your account on myaccount.braster.eu within two business days.
If you select “Finish” after having sent the examination, you will be redirected to the start screen, where you can check the
status of the examination (“Sent for analysis”). When the results of the examination have been sent to your account from the
telemedical center, the status will change to “Result available”.
You do not need to send the collected data for analysis immediately after completing the examination. You can send them
whenever it is convenient for you, when you have access to Internet (preferably via WiFi). When you are ready, go to the app
and select “List of examinations”, click on the last exam and choose whether to send it or delete it. Please note that you must
either delete the results or send them for analysis before you carry out a new examination, otherwise the system will not let
you perform your next exam.
The app will let you know when the result of your examination is available. To read it, go to your individual account on myaccount.
braster.eu.
8. TROUBLESHOOTING THE MOBILE APP
In certain circumstances, carrying out an examination will not be possible. Below you may find tips on how to troubleshoot
certain problems.
8.1. The Braster device uses WiFi technology to transmit data to the mobile device. WiFi technology, by design, relies on
sharing radio bandwidth with other users. If the WiFi environment in your location is overcrowded and/or many other WiFi
2) One upper application to the outer part of your breast, on the border with your axilla, making sure that the edge of the matrix,
i.e. the black part (the thermographic foil), touches upon the lateral edge of your breast and does not extend beyond it.
3) One upper application to the inner part of your breast, making sure that the edge of the matrix, i.e. the black part (the
thermographic foil), does not extend to your other breast and your sternum.
The applications may overlap, but do not worry if in your case they do not overlap as shown in the illustrations. The crucial thing
is to make sure that your entire breast is covered.
Follow the instructions displayed on the screen of your mobile device. Each application takes about 15 seconds which may
be extended for transfer if the WiFi conditions are poor (a lot of other transmitters or radio noise). The time interval between
applications lasts approximately 10-15 seconds (depending on your breast temperature and the ambient temperature). The
matrix should not be in contact with your body during this time.
Breast size 4 or 5
If your breast size is 4 or 5 see Fig. 10A for size 4 and Fig. 10B for size 5, during the examination you will have to perform:
1) One central application to your breast, making sure that the lower edge of the matrix, i.e. the black part (the thermographic
foil), adheres to your breast (not your abdomen). Do not push your breast up.
Divide the breast into four equal quadrants, as if there was a vertical and a horizontal line crossing the center of your breast.
Now perform:
2) One application to the lower-outer quadrant of your breast, making sure that the lower edge of the matrix, i.e. the black part
(the thermographic foil), adheres to your breast (not your abdomen). Do not push your breast up.
3) One application to the upper-outer quadrant of your breast, on the border with the axilla, making sure that the edge of the
matrix, i.e. the black part (the thermographic foil), touches upon the lateral edge of the breast and does not extend beyond it.
4) One application to the upper-inner quadrant of your breast, making sure that the edge of the matrix, i.e. the black part (the
thermographic foil), does not extend to your other breast but runs across the centerline of your sternum.
5) One application to the lower-inner quadrant of your breast. The lower edge of the matrix, i.e. the black part (the thermographic
foil), should adhere to your breast (not your abdomen). Do not push the breast up.
24 25
ENGLISH
When the device is connected to the charger, the Power status indicator will be lit as steady orange. The indicator turns itself
o when the battery is fully charged. Full charging takes approximately three hours. The device must be disconnected from
the power source via the USB cable, which must be safely disconnected from the mains supply when charging is complete.
10. SAFE OPERATION
Follow the recommendations below to ensure the safe operation of the Braster device:
• Before you use the device for the first time, charge the battery using the USB cable provided.
• Only use accessories and materials supplied or recommended by the manufacturer.
• Never let the Braster device or the matrices come into contact with water.
• After the examination, store the device with a matrix on. Place the device with the matrix facing downwards, making sure
that dust does not get into the matrix. Keep the device in the original box.
• Do not place any items into the image acquisition device, this may cause damage to the internal framework of the device.
For any damage caused by the user, the manufacturer will not be held responsible.
• Do not allow the foil on the matrix to come into contact with any sharp objects.
• During the examination, do not place any objects between the image acquisition device and the mobile device. If objects
are placed between, the connection between the image acquisition device and the mobile device may be lost.
• The device can only be repaired by the manufacturer’s servicing team. Any other attempt to repair the device will void the
warranty.
• Keep the device away from children.
11. DISINFECTION
Before each examination disinfect the inner and outer surfaces of all of the three matrices. Disinfection consists of spraying
Softasept or disinfectants based on isopropyl alcohol over entire matrix, on both sides, and cleaning it thoroughly with a
disposable cotton gauze or tissue. By disinfecting you make sure that the surface is free of pathogenic microorganisms such
as bacteria, viruses and fungi.
The device must not be washed or immersed in water. Do not clean the applied parts of the matrices, which come into
contact with your breast skin, with any mechanical agents that may cause damage to such surfaces (e.g. brushes) and
do not use agents that contain organic solvents (e.g. gasoline, acetone) as, once damaged, matrices will not be fit for
further use.
signals are available, performance of the Braster device may be decreased resulting in a longer registration time during
applications or even, in extreme WiFi conditions, inability to register a full set of images. In this situation, please go to a
place where the WiFi environment is not overcrowded or return to the examination later that day.
8.2. If you have not bought an examination package or have used up all purchased examinations, the app will display an
appropriate message and the examination will be impossible. You will have to buy an examination package to continue. To
do this, go to the Braster e-store or depending on the country, the e-store or other outlet of the local distributor. If you do
not want to purchase an examination package right now, select “Cancel the Examination”.
8.3. If the battery level of your smartphone or tablet is too low, the examination will be impossible to perform until the device has
been charged to a level indicated in the message. Select “Cancel the Examination” to return to the start screen.
8.4. If there is not enough disc space in your mobile device to save a complete examination, the examination will be impossible
to perform until the appropriate amount of disc space is made available. Select “Cancel the Examination” to return to the
start screen.
8.5. If after entering your login and password to the Braster Care app a “Server is unavailable” message is displayed, you should
install an additional certificate. Please contact our contact center by e-mail to find out more: contactcenter@braster.eu.
9. CHARGING
Charge the device with a USB-A charger consistent with IEC 60950-1 or IEC 60601-1, charger parameters: DC 5V 1A, USB slot
(specification of the feeding device). Switch the device o before charging. For safety purposes, while charging, place the
device in a position where you may easily remove the USB cable from the device.
The device must not be charging while an examination is in progress.
Do not turn the device on while it is being charged.
To charge the battery, pull the rubber cap with the USB sign situated on the side of the Braster device next to the ON/OFF
button. Connect one end of the USB cable to the Braster device and the other end to the charger (the plug is not included in the
set). Connect the charger to a power source (see Fig. 11: location of the USB slot: 1. mini-USB slot, 2. USB slot).
26 27
ENGLISH
14. DECLARATION OF CONFORMITY
BRASTER S.A. hereby declares that the Braster System conforms with the essential requirements and other relevant provisions
of the Directive 93/42/EEC and the Directive 2011/65/EU. If you would like to receive the declaration of conformity, contact the
manufacturer (contact details are given on the last page of this User Manual).
ELECTROMAGNETIC COMPATIBILITY
The Braster device is intended for use in an electromagnetic environment with controlled RF interference. The customer or
the user of the image acquisition device may help prevent electromagnetic interference by maintaining the minimum required
distance between the mobile device and cellular radio devices (transmitters). This equipment is not subject to the protection
from harmful interference and may not cause interference with duly authorized systems.
15. TECHNICAL AND OPERATIONAL SPECIFICATION OF THE DEVICE
Weight of the image
acquisition device (excluding
matrix)
305 g
Weight of one matrix 87 g
Device size (excluding
matrix)
diameter 17.2 cm
height 13 cm
Limits of storage conditions
−25°C to +5°C (-13°F to +41°F), and
+5°C to +35°C (+41°F to +95°F) in ambient humidity of up to 90%, without condensation, and
+35°C to +70°C (+95°F to +158°F) with vapor pressure of up to 50 hPa
Recommended storage
conditions
−5°C to +60°C (+23°F to +140°F)
humidity between 10% and 90% (without condensation)
12. CLEANING AND MAINTENANCE
Wipe thoroughly both surfaces of all of the three matrices with the cloth provided. It is important that the surface of the matrix
is clean, i.e. free of any visible contamination (e.g. fingerprints, dust). The inner side of the matrix is technologically matted. The
foil surface on the inner side of the matrix bears directional scratches, which have been made deliberately in a technological
procedure performed in order to achieve appropriate light diusion in the working space of the image acquisition device.
The image acquisition device and the matrices must be kept in the original packaging, at temperatures between −5°C and
+60°C. Do not expose the device to UV radiation (e.g. from UV lamps used for air disinfection or from the sun).
13. SERVICING AND TECHNICAL SUPPORT
If you require technical support or if you want to report a malfunction of the device or any other unexpected circumstances,
contact your local distributor of the Braster System or the manufacturer. Contact details are available on www.braster.eu.
USER RESPONSIBILITIES
The Braster device must be used in accordance with the recommendations given in this User Manual and labels. Do not use
the device if it has been damaged. Any parts that are missing, incomplete, damaged or worn out must be immediately replaced
at an authorized service point (details are available on www.braster.eu). Any actions connected with repairs or replacements
may only be performed by personnel of an authorized service point. The manufacturer is not liable for any damages caused by
non-compliance with the user manual.
Warranty
The Braster device is covered by the manufacturer’s warranty for 24 months. The warranty shall only be valid if accessories
and spare parts approved by BRASTER S.A. are used and the device is used as described in the user manual and according to
the intended use.
Any repairs of the Braster device must be made by personnel of an authorized service point. Any repairs performed by
unauthorized persons will result in voiding of the warranty.
28 29
ENGLISH
17. FCC REGULATORY STATEMENT
This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions: (1) this device may not
cause harmful interference, and (2) this device must accept any interference received, including interference that may cause
undesired operation.
The Braster device has been tested and found to comply with the limits for a Class B digital device. These limits are designed
to provide reasonable protection against harmful interference in a residential installation. The Braster device generates, uses,
and may radiate radio frequency energy and, if not installed and used in accordance with the User Manual, may cause harmful
interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.
If the device does cause harmful interference to radio or television reception, which can be determined by turning the device o
and on, the user is encouraged to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the device and receiver.
• Connect the device to an outlet on a circuit dierent from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
Any changes or modifications not approved by the party responsible for compliance will void the user’s authority to
operate this equipment. This transmitter must not be co-located or operating in conjunction with any other antenna or
transmitter. The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications
to this device.
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment in accordance with FCC
rule part 2.1093 and KDB 447498.
18. CANADIAN REGULATORY STATEMENT
The Braster device complies with ISED Canada License-exempt RSSs. Operation is subject to the following two conditions: (1)
this device may not cause interference, and (2) this device must accept any interference, including interference that may cause
undesired operation of the device.
This device complies with the safety requirements for RF exposure in accordance with RSS-102 Issue 5 for portable conditions.
The Braster device contains an internal, integrated antenna and it cannot operate in conjunction with any other antenna or
transmitter.
16. ADVERSE EVENT AND MEDICAL INCIDENTS
Any adverse event or serious incidents that occur in relation to the device should be reported to the manufacturer on the address
given in Section “Contact the Manufacturer” and to the competent authority of the country in which the user is established.
Limits of operating
conditions
+5°C to +40°C (+41°F to +104°F)
humidity between 15% and 90% (without condensation)
Recommended operating
conditions
+20°C to +25°C (+68°F to +77°F)
humidity between 30% and 85%
protected against UV radiation
The limits of the operating conditions guarantee the electrical safety of the device. To protect the thermographic matrices
against excess wear and damage, keep them in the recommended operating and storage conditions.
Maximum approved opera-
tion altitude
3500 m above sea level
Approved atmospheric
pressure
(for the device to be used)
700–1060 hPa
The device can be paired
with
A smartphone or tablet with a WiFi module and a RAM of at least 100 MB.
For system requirements, go to: https://www.braster.eu/system
Charger DC 5V 1A with a USB slot and meeting the IEC 60950-1 or IEC 60601-1 standards
30
L’appareil Braster est conforme aux RSS exclus de la licence ISED Canada. L’exploitation est autorisée aux deux conditions
suivantes: (1) l’appareil ne doit pas produire de brouillage, et (2) l’utilisateur de l’appareil doit accepter tout brouillage
radioélectrique subi, même si le brouillage est susceptible d’en compromettre le fonctionnement.
Cet appareil est conforme aux exigences de sécurité pour l’exposition aux radiofréquences conformément au RSS-102 Issue 5
pour les conditions portables.
Le dispositif Braster contient une antenne interne intégrée et il ne peut pas fonctionner avec d’autres antennes ou transmetteurs.
19. DISPOSAL
This symbol is used by the Company as part of the resource-ecient initiative and health and environment
protection, in accordance with governmental instructions. The symbol means that the electronic device
(including batteries) must not be thrown away together with conventional household waste. Should you need
more information on the dedicated waste collection points, please contact your local authorities.
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