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ETSI TR 101 981

M00001184

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ETSI TR 101 981 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); System Reference Document for inductive Loop - Ultra Low Power Active Medical Implants (ULP- AMI) - systems operating in the frequency bands 9 kHz to 315 kHz

standard by European Telecommunications Standards Institute, 04/01/2002

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Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); System Reference Document for inductive Loop - Ultra Low Power Active Medical Implants (ULP- AMI) - systems operating in the frequency bands 9 kHz to 315 kHzThe present document applies to the radio sections of inductive loop Ultra Low Power Active Medical Implants in thefield of Short Range Devices (SRDs) transmitters and receiver systems operating on various frequencies within therange of 9 kHz to 315 kHz.

The present document gives guidance on the definition of a transmitter mask for the operating frequencies, analyses andthe spectrum requirements for transmission of power and data from/to stationary programmers or mobileneurostimulation systems (pain control) to/from active medical implants.

The present document considers the ERC Report 44, [1] and contains the technical characteristics for radio equipmentas given in CEPT/ERC Recommendation 70-03 [2]. Therefore, the frequency range 9 kHz to 135 kHz is alreadysufficiently regulated for inductive systems in CEPT/ERC Recommendation 70-03 [2]. The necessary operation for thefrequency range 135 kHz to 315 kHz is not addressed in CEPT/ERC Recommendation 70-03 [2] and is addressed in thepresent document.

The spectrum parameters for inductive loop ULP-AMI devices that are the subject of this document are intended to beincluded as a normative annex in the EN 300 330-2 [3] or in a new European Harmonized Standard. They are submittedfor consideration to CEPT/ERC WGSE for compliance studies and in WGFM/SRD MG for inclusion in the CEPT/ERCRecommendation 70-03 [2], annex 12.