16� Adverse Event And Medical Incidents; 17� Fcc Regulatory Statement - Braster Pro User Manual

Breast examination system
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The device can be
paired with
Charger
16. ADVERSE EVENT AND MEDICAL INCIDENTS
Any adverse event or serious incidents that occur in relation to
the Braster device should be reported to the manufacturer on the
address given in Section "Contact to the Manufacturer" and to the
competent authority of the country in which the user is established�
17. FCC REGULATORY STATEMENT
This Braster device complies with part 15 of the FCC rules� Oper-
ation 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 interfer-
ence to radio communications� However, there is no guarantee
that interference will not occur in a particular installation� If the de-
vice does cause harmful interference to radio or television recep-
tion, 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�
l
Increase the separation between the device and receiver�
l
A smartphone or tablet with a Wi-Fi mod-
ule and a RAM of at least 100 MB�
For system requirements, go to:
https://www.braster.eu/system
DC 5V 1A with a USB slot and meeting
the IEC 60950-1 or IEC 60601-1 standards
38

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