Electromagnetic compatibility Radio spectrum Matters (ERM); Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants and Accessories; Part 1: Technical characteristics and test mehtods (V1.1.1)
The present document applies to Ultra Low Power Active Medical Implant (ULP-AMI) transmitters and receivers operating in the range from 9 kHz to 315 kHz and any associated radio apparatus transmitting in the frequency range of 9 kHz to 315 kHz including external programmers and patient related telecommunication devices using digital modulation techniques such as@ but not limited to@ FSK or pulse position modulation. Analog voice modulation is prohibited. The present document contains the technical characteristics for radio equipment and is referenced in CEPT/ERC Recommendation 70-03 [2] and ERC Decisions. The present document does not necessarily include all the characteristics which may be required by a user@ nor does it necessarily represent the optimum performance achievable. It is a product standard which may be completely or partially superseded by specific standards covering specific applications. The present document applies to ULP-AMI transceivers conforming to the following: - inductive loop systems; - with an antenna connection and/or with an integral antenna; - for use as telecommunications and telecommand transmission to/from active medical implants. ULP-AMI equipment has an inherent safety of human life implication@ manufacturers and users are cautioned to pay particular attention to the potential for interference from other systems operating in the same or adjacent bands. The present document covers physician operated programmer/controllers transmitters (typically fixed stations)@ patient operated external transmitters (fixed or mobile stations) and implanted radio transmitting devices (portable stations). All types of digital modulation for radio devices are covered by the present document. The radio equipment@ covered by the classification SRD is divided into several power classes based on maximum radiated field strength or output power (see table 1). The power class designation is based on CEPT/ERC Recommendation 70-03 [2] and ERC Decisions. The measuring method defined in the present document measures the radiated H-field