User's Manual

RegulatorRegulator

Regulator

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y aspects

Your implant is equipped with an RF transmitter for wire-

less communications to the patient device. These mes-

sages are transmitted via a radio frequency assigned by

the Federal Communications Commission for Medical

Implant Communications Service (MICS).

The transmitter is authorized by rule under the Medical

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 Meteorological Satellite, or the Earth

Exploration Satellite Services and must accept interfer-

ence that may be caused by such aids, including interfer-

ence that may cause undesired operation. This transmit-

ter shall be used only in accordance with the FCC rules

governing the Medical Implant Communications Service.

Analog and digital voice communications are prohibited.

Although this transmitter has been approved by the

Federal Communications Commission, there is no guaran-

tee that it will not receive interference or that any particular

transmission from this receiver will be free from interfer-

ence.

The FCC ID number for this device is PG6BA0T

The patient device, as well as the implant itself, are tested

by an independent regulatory authorities such as the FCC,

to comply with the appropriate 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 specifica-

tions of the manufacturer and in compliance with FCC

approval requirements.