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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 Pro

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

  • Page 2: Table Of Contents

    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 ................
  • Page 3 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.

  • Page 4: Glossary

    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.
  • Page 5 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.
  • Page 6 – 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.

  • Page 7: Explanation Of Symbols Used In The User Manual, On The Label And On The Packaging

    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 8: Important Safety Information

    Storage 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...
  • Page 9 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 10 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...

  • Page 11: Introduction

    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...

  • Page 12: 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 the Braster device, which is composed of: •...

  • Page 13: Intended Use

    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.

  • Page 14: Operating Principles Of The Device

    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: •...
  • Page 15 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 characteristic morphological structure higher temperature than normal areas of the body. As a result, they are shown in the thermogram as areas of different colors.

  • Page 16: Package Contents

    Contact thermography is a complementary examination. It complements commonly performed examinations such 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 17: Overview Of The Braster Device Interface

    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.
  • Page 18 Examination Power Indicator Indicator Description Status Status No light No light The device is off No light Blinking green The device is on The device is connected with a No light Steady green mobile device Thermogram acquisition in Pulsing white Steady green progress No light...
  • Page 19 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 20: Matrix Replacement

    Name of the Wi-Fi Password to Wi-Fi signal broadcast by the signal broadcast by the 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.
  • Page 21 Step 2 Pull the matrix off the device. Fig. 5B Step 3 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. Fig.

  • Page 22: Device Preparation Prior To Examination

    11 and 12 of the User Manual). Charge the device for at least 30 minutes before the first examination. If you are a user of Braster Pro version Basic, to perform an examination, sign up at myaccount.braster.eu. For this purpose: Go to www.braster.eu...

  • Page 23: Preparation Of The Braster Device Before Subsequent Examinations

    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.

  • Page 24: Examination

    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 menstrual 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 25 be clean and dry; • did not have a sauna or a steam bath.

  • Page 26: How To Perform An Examination

    7.2.2. PATIENT SEARCH (ONLY FOR BRASTER PRO VERSION PREMIUM) If you are a user of Braster Pro version Premium, you must: select a patient before starting an examination if the patient • has already undergone such an examination in this clinic or...

  • Page 27: Turning The Device On/Off

    The device turns off automatically after ten minutes if it is not connected to the mobile app. 7.2.4. DEVICE CONNECTION To connect the Braster device follow the instructions displayed in the mobile app. DURING THE CONNECTION WITH THE BRASTER DEVICE, THERE WILL BE NO INTERNET ACCESS ON THE MOBILE DEVICE 7.2.5.

  • Page 28: Acclimatization

    To complete the acclimatization process, follow the instructions displayed on subsequent mobile app screens. For Braster Pro version Basic you must enter the examination ID (it can be, e.g. a unique number assigned to the patient) and the patient's date of birth.

  • Page 29: Examination

    When instructed apply the device centrally to the 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. Make sure, that the whole matrix adheres tightly to the body Do not move the device across the breast, hold it firmly in one place.
  • Page 30 examination: • apply the device perpendicular to the patient’s breast (see Fig. 7); • do not lift the patient’s breast; • do not move the device across the patient’s breast, instead hold it firmly in one place (see Fig. 8); •...
  • Page 31 Fig. 8: Improperly applied device Depending on the breast size which you indicated at the beginning of the examination, you will be required to make three or five applications to each breast. ALWAYS BEGIN WITH THE RIGHT BREAST Breast size 1, 2 or 3 If patient’s breast size is 1, 2 or 3 (see Fig.
  • Page 32 breast and the sternum. The applications may overlap, but do not worry if in some of your patients’ cases they do not overlap as shown in the illustrations. The crucial thing is to make sure that the entire breast is covered. Follow the instructions displayed on the screen of your mobile device.
  • Page 33 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 34 breast up. Divide the breast into four equal quadrants, as if there was a vertical 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 35: 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...

  • Page 36: Troubleshooting The Mobile App

    Wi-Fi network. For Braster Pro version Basic, if no manual interpretation is needed, the examination result will be sent to your account on myaccount.braster.eu...

  • Page 37: Charging

    Select “Cancel the Examination” to return to the start screen. 9. CHARGING Charge the Braster 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 off before charging.

  • Page 38: Safe Operation

    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 buton. 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).

  • Page 39: Disinfection

    • 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. • Do not place any items into the image acquisition device, this may cause damage to the internal framework of the device.

  • Page 40: Cleaning And Maintenace

    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 Pro or the manufacturer. Contact details of the manufacturer are available on www.braster.eu.

  • Page 41: Declaration Of Conformity

    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.

  • Page 42: Technical And Operational Specification Of The Device

    TECHNICAL OPERATIONAL SPECIFICATION OF THE DEVICE Weight of the image acquisition device 305 g (excluding matrix) Weight of one matrix 87 g Device size (excluding diameter 17.2 cm height 13 cm matrix) −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 condensation, conditions...

  • Page 43: Adverse Event And Medical Incidents

    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.

  • Page 44: Canadian Regulatory Statement

    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...

  • Page 45: Disposal

    DISPOSAL This symbol is used by the company Braster S.A. as part of the resource-efficient initiative and health and environment protection, in accordance with governmental instructions. The symbol means...

  • Page 46: Contact To The Manufacturer

    CONTACT TO THE MANUFACTURER BRASTER S.A. Szeligi, ul. Cichy Ogród 7 05-850 Ożarów Mazowiecki, Poland Phone no. +48 22 295 03 50 E-mail: contactcenter@braster.eu www.braster.eu...
  • Page 47 Ver.4.0_05.02.2020_EN...

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