Braster Braster Pro Operation & User’s Manual

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 ............ ...

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 MAIN ...

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 ...

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 (o ...

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. ...

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) ...

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. ...

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 wil ...

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 ther ...

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 e ...

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 ...

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 d ...

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 ...

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. ...

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 ...

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 ...

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. ...

Do not remove the label. Write down the data which is on the label and keep it in a safe place. Device label ...

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 ...