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Braster Pro User Manual

Breast examination system
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USER MANUAL
Braster Pro
– breast examination system

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Summary of Contents for Braster Braster Pro

  • Page 1 USER MANUAL Braster Pro – breast examination system...

  • Page 2: Table Of Contents

    1�2�2� CONTRAINDICATIONS ������������������������������������������������������������������������������������������������������ 2� OPERATING PRINCIPLES OF THE DEVICE ������������������������������������������������������������������������������������ 3� PACKAGE CONTENTS ��������������������������������������������������������������������������������������������������������������������������������� 4� OVERVIEW OF THE BRASTER DEVICE INTERFACE �������������������������������������������������������������� 5� MATRIX REPLACEMENT ����������������������������������������������������������������������������������������������������������������������������� 6� DEVICE PREPARATION PRIOR TO EXAMINATION ������������������������������������������������������������������ 6�1� PREPARATION OF THE BRASTER DEVICE PRIOR TO THE FIRST EXAMINATION ������������������������������������������������������������������������������������������������������...
  • Page 3 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�...
  • Page 4 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�...
  • Page 5 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 ≥...

  • Page 6: Important Safety Information

    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...
  • Page 7 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�...
  • Page 8 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...
  • Page 9 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�...

  • Page 10: Description And Intended Use

    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: the Braster device, which is composed of: –...

  • Page 11: Intended Use

    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�...

  • Page 12: Operating Principles Of The Device

    – 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-...

  • Page 13: Package Contents

    Contact thermography is a complementary examination� It com- plements 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�...

  • Page 14: Overview Of The Braster Device Interface

    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 sec- onds�...
  • Page 15 Examination Indicator Power Indicator Description Status Status No light No light The device is off 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...
  • Page 16 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�...

  • Page 17: Matrix Replacement

    Name of the Wi-Fi signal Password to Wi-Fi signal broadcast by the device 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�...
  • Page 18 Step 2 Pull the matrix off 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�...

  • Page 19: Device Preparation Prior To 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;...
  • Page 20 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�...

  • Page 21: Important Information

    7. EXAMINATION 7.1. IMPORTANT INFORMATION Do not use the device while it is being charged. 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 men- strual cycle, if you wish to compare the subsequent results of the same patient, select the examinations performed on a similar day of the menstrual cycle�...

  • Page 22: 7�2� How To Perform An Examination

    7.2. HOW TO PERFORM AN EXAMINATION 7.2.1.PREPARATION Place the Braster device in front of you� Make sure it is switched off� 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�...

  • Page 23: 7�2�3� Device Connection

    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 Wi-Fi signal and password� The label is inside the device and is visible only when the matrix has been removed (Fig�...

  • Page 24: Questions

    At the end enter the examination ID (e�g� it may be a unique number assigned to the patient), date of birth of patient, and her breast size according to the Braster scale� 7.2.5. ACCLIMATIZATION The next stage of the examination is a six-minute acclimatization, i�e�...

  • Page 25: 7�2�6� Matrix Selection

    To select a matrix, make one application of the Braster device to the central area of each breast� The mobile app will guide you step by step through this process�...

  • Page 26: Examination

    Fig� 6: Device application to the breast ! REPEAT THESE STEPS FOR THE LEFT BREAST. If matrix no� 2 is suitable for the patient, you can start the exami- nation� If it does not suit the patient, you will be asked to remove matrix no�...
  • Page 27 Fig� 7: Correctly applied device Fig� 8: Improperly applied device Depending on the breast size which you indicated at the begin- ning of the examination, you will be required to make three or five applications to each breast� ALWAYS BEGIN WITH THE RIGHT BREAST...
  • Page 28 Breast size 1, 2 or 3 If patient’s 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 need to per- form: 1. One central application to the breast, making sure that the lower edge of the matrix, i�e�...
  • Page 29 Fig� 9A Breast size 1 and 2 Fig� 9B Breast size 3 Breast size 4 or 5 If patient’s breast size is 4 or 5 (see Fig. 10A for size 4 and Fig. 10B for size 5), during the examination you will need to perform: 1.
  • Page 30 Divide the breast into four equal quadrants, as if there was a ver- tical and a horizontal line crossing the center of the breast� Now perform: 2. One application to the lower-outer quadrant of the breast, making sure that the lower edge of the matrix adheres to the breast (not the abdomen)�...

  • Page 31: 7�2�8� Sending The Results To The Telemedical Center

    Once you have made all the 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 Braster telemedical center for analysis� Before you send the data, please make sure that your mobile device reconnects to your local Wi-Fi network�...

  • Page 32: 8� Troubleshooting The Mobile App

    Below you may find tips on how to troubleshoot certain problems� 1. The Braster device uses Wi-Fi technology to transmit data to the mobile device� Wi-Fi technology, by design, relies on shar- ing radio bandwidth with other users� If the Wi-Fi environment...

  • Page 33: Charging

    Select “Cancel the Examination” to return to the start screen� 5. If after entering your login and password to the Braster Care mobile 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�...

  • Page 34: 10� Safe Operation

    To charge the battery, pull the rubber cap with the USB sign situ- ated 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)� Con- nect the charger to a power source (see Fig.
  • Page 35 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 device� Keep the device in the original box�...

  • Page 36: 13� Servicing And Technical Support

    If you require technical support or if you want to report a malfunc- tion of the device or any other unexpected circumstances, contact your local distributor of the Braster Pro or the manufacturer� Con- www.braster.eu. tact details of the manufacturer are available on...

  • Page 37: 14� Declaration Of Conformity

    User Manual and according to the intended use� Any repairs of the Braster device must be made by the manufac- turer’s servicing team� Any repairs performed by unauthorized persons will result in voiding of the warranty�...

  • Page 38: 15� Technical And Operational Specification Of The Device

    15. TECHNICAL AND OPERATIONAL SPECIFICATION OF THE DEVICE Weight of the image acquisition device 305 g (excluding matrix) Weight of one matrix 87 g Device size (exclud- diameter 17�2 cm ing matrix) height 13 cm −25°C to +5°C (-13°F to +41°F), and +5°C to +35°C (+41°F to +95°F) in ambient Limits of storage humidity of up to 90%, without condensa-...

  • Page 39: 16� Adverse Event And Medical Incidents

    17. FCC REGULATORY STATEMENT This Braster device complies with part 15 of the FCC rules� Oper- ation 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�...

  • Page 40: 18� Canadian Regulatory Statement

    The Braster device contains an internal, integrated antenna and it cannot operate in conjunction with any other antenna or transmitter� L’appareil Braster est conforme aux RSS exclus de la licence ISED Canada� L’exploitation est autorisée aux deux conditions suiv- antes: (1) l’appareil ne doit pas produire de brouillage, et (2) l’utili- sateur de l’appareil doit accepter tout brouillage radioélectrique...

  • Page 41: Contact To The Manufacturer

    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 Braster S�A� as part of the resource-efficient initiative and health and environment protection, in accord- ance with governmental instructions�...
  • Page 42 Rev� 2, 2018�10�10_ENG 12001001...

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