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US Regulatory Requirements
US Regulatory Requirements
Your implant is equipped with a radio frequency (RF)
transmitter for wireless communications to the
patient device. These messages are transmitted via an
RF assigned by the Federal Communications Com-
mission's (FCC) Medical Implant Communications
Service (MICS).
The transmitter is authorized by rule under the Medi-
cal Implant Communications service (47 CFR Part 95)
and must not cause harmful interference to stations
operating in the 400.150 - 406.000 MHz band in the
Meteorological Aids (i.e., transmitters and receivers
used to communicate weather data), the Meteorologi-
cal Satellite, or the Earth Exploration Satellite Ser-
vices and must accept interference that may be
caused by such aids, including interference that may
cause undesired operation. This transmitter shall be
used only in accordance with the FCC rules governing
the Medical Implant Communications Service.
Analog and digital voice communications are prohib-
ited. Although this transmitter has been approved by
the Federal Communications Commission, there is no
guarantee that it will not receive interference or that
any particular transmission from this receiver will be
free from interference.
The FCC ID number for this device is QRICM02-1.
The patient device, as well as the implant itself, must
conform with appropriate government standards and
regulations.
The patient device uses a GSM-Modem that connects
to the mobile cellular telephone service at (1900 MHz).
BIOTRONIK uses the modem according to the specifi-
cations of the manufacturer in compliance with FCC
approval requirements.
