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USER MANUAL

Braster Pro

– breast examination system

Содержание Braster Pro

Страница 1: ...USER MANUAL Braster Pro breast examination system...

Страница 2: ...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 PREPARA...

Страница 3: ...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...

Страница 4: ...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 p...

Страница 5: ...wards 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 n...

Страница 6: ...phic 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...

Страница 7: ...e 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 again...

Страница 8: ...ice 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 SAF...

Страница 9: ...e 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...

Страница 10: ...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...

Страница 11: ...acturing 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...

Страница 12: ...mination 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...

Страница 13: ...tal 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...

Страница 14: ...nt 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 Ma...

Страница 15: ...mong other things through the formation of a dense pathological capillary network Pathological lesions with suspected malignancy have a characteristic morphological structure and higher temperature th...

Страница 16: ...graphy 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...

Страница 17: ...ff 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...

Страница 18: ...ry 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 und...

Страница 19: ...18 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...

Страница 20: ...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 fi...

Страница 21: ...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...

Страница 22: ...s specified in chapters 11 and 12 of the User Manual c Charge the device for at least 30 minutes before the first examination d If you are a user of Braster Pro version Basic to perform an examination...

Страница 23: ...at charging of the device is complete start the Braster Care app and follow the instructions described in chapter 7 6 2 PREPARATION OF THE BRASTER DEVICE BEFORE SUBSEQUENT EXAMINATIONS a When preparin...

Страница 24: ...the breast area physiotherapy massages etc 2 On the day of the examination is 18 years of age or older avoided procedures which may have increased blood circulation in the breast area physiotherapy ma...

Страница 25: ...24 be clean and dry did not have a sauna or a steam bath...

Страница 26: ...er the device with which you will use for examination by clicking on the icon on the start screen and then press the Register button The mobile app will ask you to enter the network name and password...

Страница 27: ...e turns off automatically once the examination is completed To turn the device off in the emergency mode press the ON OFF button and hold it for five seconds The device turns off automatically after t...

Страница 28: ...must answer several questions Remember to make sure that the patient answers truthfully because her answers affect the reliability of the result 7 2 7 MATRIX SELECTION At this stage you need to select...

Страница 29: ...tructed release the grip and move the device away from the breast see Fig 6 Fig 6 Device application to the breast REPEAT THESE STEPS FOR THE LEFT BREAST If matrix no 2 is suitable for the patient you...

Страница 30: ...vice across the patient s breast instead hold it firmly in one place see Fig 8 do not move the device away until instructed to do so keep the grip pressed as long as the examination is in progress do...

Страница 31: ...ation you will need 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 the breast not to the abdomen...

Страница 32: ...breast is covered Follow the instructions displayed on the screen of your mobile device Each application takes about 15 seconds depending on the Wi Fi conditions e g other transmitters or radio noise...

Страница 33: ...ze 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 One central application to the breast making sure that the lower edge of the matrix i e the...

Страница 34: ...does not extend to the other breast but runs along the centerline of the sternum 5 One application to the lower inner quadrant of the breast The lower edge of the matrix should adhere to the breast n...

Страница 35: ...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...

Страница 36: ...oment of submitting the required data Select Finish after having sent the examination After clicking on the icon you can check the status of the examination Sent for analysis When the results of the e...

Страница 37: ...t is too low i e is charged in less than 30 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...

Страница 38: ...f 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 mai...

Страница 39: ...ly 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 t...

Страница 40: ...0 C Do not expose the device to UV radiation e g from UV lamps used for air disinfection or from the sun Keep the device and matrices in an original packaging to protect them from dust which may impac...

Страница 41: ...he warranty 14 DECLARATION OF CONFORMITY BRASTER S A hereby declares that the Braster Pro conforms with the essential requirements and other relevant provisions of the Directive 93 42 EEC and the Dire...

Страница 42: ...5 C to 60 C 23 F to 140 F humidity between 10 and 90 without condensation Limits of operating conditions 5 C to 40 C 41 F to 104 F humidity between 15 and 90 without condensation Recommended operatin...

Страница 43: ...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...

Страница 44: ...h 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...

Страница 45: ...e antenne interne int gr e 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...

Страница 46: ...45 CONTACT TO THE MANUFACTURER BRASTER S A Szeligi ul Cichy Ogr d 7 05 850 O ar w Mazowiecki Poland Phone no 48 22 295 03 50 E mail contactcenter braster eu www braster eu...

Страница 47: ...Ver 4 0_05 02 2020_EN...

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