Important Safety Information; Glossary - Braster In-home Breast Examination System User Manual

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 efficacy 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, offered 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.
8

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 off
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 differ 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 tariff.
! 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.
9