Technical Manual

Guidelines
Telemetry Data for Europe
20
8 Guidelines
Telemetry Data for Europe
Your device transmits diagnostic data to the CardioMessenger via a radio frequency (RF) assigned by
the European Conference of Postal and Telecommunications Administration for the operation of Ultra
Low Power Active Medical Implants (CEPT/ERC REC 70-03).
BIOTRONIK is legally obligated to inform you that the radio service does not have exclusive use of the
assigned frequencies and that the transmission of device data is not permitted to interfere with other
radio services. The frequency and technical parameters of the built-in transmitter have been carefully
selected to ensure that electromagnetic interference between other services and the data transmission
of the device is unlikely.
Furthermore, BIOTRONIK is obligated to inform you that the regulatory agency can withdraw the
frequency allocation and prohibit the radio service between the device and CardioMessenger. Since this
service is currently established throughout Europe and North America, withdrawal of the frequency
allocation is not expected in the foreseeable future.
The CardioMessenger, like the implantable device itself, has been evaluated by an independent testing
authority for its compliance with statutory regulations. The CardioMessenger carries the following
approval mark:
0123
In addition, the CardioMessenger contains a radio modem that connects to the cellular network at the
frequencies of 850/900/1800/1900/1900MHz. BIOTRONIK uses the radio modem in accordance with the
manufacturer’s specifications and in compliance with the approval requirements.
The radio modem has been evaluated by an independent authority for its compliance with the statutory
regulations. As an indication of this, it carries the following approval mark: