Adverse Event And Medical Incidents; Fcc Regulatory Statement; Canadian Regulatory Statement - Braster In-home Breast Examination System User Manual

Limits of operating +5°C to +40°C (+41°F to +104°F)
conditions humidity between 15% and 90% (without condensation)
+20°C to +25°C (+68°F to +77°F)
Recommended operating
humidity between 30% and 85%
conditions
protected against UV radiation
The limits of the operating conditions guarantee the electrical safety of the device. To protect the thermographic matrices
against excess wear and damage, keep them in the recommended operating and storage conditions.
Maximum approved opera-
3500 m above sea level
tion altitude
Approved atmospheric
pressure 700–1060 hPa
(for the device to be used)
The device can be paired A smartphone or tablet with a WiFi module and a RAM of at least 100 MB.
with For system requirements, go to: https://www.braster.eu/system
Charger DC 5V 1A with a USB slot and meeting the IEC 60950-1 or IEC 60601-1 standards

16. ADVERSE EVENT AND MEDICAL INCIDENTS

Any adverse event or serious incidents that occur in relation to the device should be reported to the manufacturer on the address
given in Section "Contact the Manufacturer" and to the competent authority of the country in which the user is established.
28

17. FCC REGULATORY STATEMENT

This device complies with part 15 of the FCC rules. Operation 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.
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. The Braster device generates, uses,
and may radiate radio frequency energy and, if not installed and used in accordance with the User Manual, may cause harmful
interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.
If the device does cause harmful interference to radio or television reception, which can be determined by turning the device off
and on, the user is encouraged to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the device and receiver.
• Connect the device to an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
Any changes or modifications not approved by the party responsible for compliance will void the user's authority to
operate this equipment. This transmitter must not be co-located or operating in conjunction with any other antenna or
transmitter. The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications
to this device.
This equipment complies with FCC radiation exposure limits set forth 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 subject to the following two conditions: (1)
this device may not cause interference, and (2) this device must accept any interference, including interference that may cause
undesired operation of the device.
This device complies with the safety requirements for RF exposure in accordance with RSS-102 Issue 5 for portable conditions.
The Braster device contains an internal, integrated antenna and it cannot operate in conjunction with any other antenna or
transmitter.
29