Electromagnetic Compatibility and Radio Spectrum Matters (ERM); Radio Equipment in the Frequency Range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories; Part 1: Technical Characteristics@ Including Electromagnetic Compatibili
The present document covers@ for Ultra Low Power-Active Medical Implants (ULP-AMI) and accessories used in a Medical Implant Communications Service (MICS)@ the required characteristics considered necessary to efficiently use the available spectrum and protect the public. ULP-AMI equipment and accessories in the MICS service is a unique new technology@ available world wide in the medical field@ that will provide high speed communications capability between individuals with implanted devices and medical practitioners engaged in utilizing these implants for the purposes of diagnosing and delivering therapy to individuals with various illnesses. The specifications contained in the present document were developed to insure that the health and safety of the patients that are using this equipment under the direction of medical practitioners is protected. Of particular importance is the inclusion of spectrum monitoring and access requirements (listen before talk protocol) designed to significantly reduce any interference potential between MICS systems operating in the band or between a MICS system and the primary users of the band. Equipment in the MICS service consists of active medical implants that communicate only to other active medical implants or to external programmer/control transmitters. The present document is a specific product standard applicable to active medical implants operating in the frequency band@ 402 MHz to 405 MHz@ and other radio devices that are considered to be accessories to active medical implants as described in Directive 90/385/EEC [6]. It is intended that the present document applies to operation in the band 402 MHz to 405 MHz only and that devices that can also operate in spectrum outside this band also meet any applicable requirements for operation in such bands. The present document contains the technical characteristics for ULP-AMI radio equipment and is referencing CEPT/ERC/REC 70-03 [3] and annex 12 to that document. It does not necessarily include all the characteristics@ which may be required by a user@ nor does it necessarily represent the optimum performance achievable. It applies to ULP-AMI devices and accessories operating in the band 402 MHz to 405 MHz: - for telecommand and telemetry to/from an implant in a patient's body to an external programmer/controller unit; or - for telecommand and telemetry to/from an implant to another implant within the human body; - with or without an integral antenna; and/or - with an antenna connection provided only for the purpose of connecting an external dedicated antenna. Compliance with the radiated emissions provisions of the present document is determined using a substitution technique. However@ if calibrated half wave dipole antennas are used to measure the radiated field strength of the emissions from the EUT@ it is permissible to calculate the erp levels of those emissions to show compliance. NOTE: If this technique is used@ the ground reflected component of the measured field strength needs to be accounted for. For purposes of computing erp levels@ the contribution to the measured level that is due to the ground reflected ray is considered to be 5 dB if measurements are performed on an open area test site or equivalent. For non-Harmonized parameters@ national regulatory conditions can apply regarding the type of modulation@ equipment marking and the inclusion of an automatic transmitter shut-off facility as a condition of the issue of an individual or general licence@ or@ as a condition of use under licence exemption. The extreme temperature and voltage ranges are fixed and are given in clauses 5.4.1 and 5.4.2 respectively. The present document covers requirements for radiated emissions above 25 MHz. Additional standards or specifications may be required for equipment such as that intended for connection to the Public Switched Telephone Network (PSTN).