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

Breast examination system
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The device can be
paired with
Charger
16.
ADVERSE
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.
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.
A smartphone or tablet with a Wi-Fi module 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
EVENT
42
AND
MEDICAL

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