DANSK DS/EN 301 839 V2.1.1 PDF

The present document applies to the following radio equipment types: • Ultra Low Power Active Medical Implants (ULP-AMI). • Ultra Low Power Active Medical Implant Peripherals (ULP-AMI-P). These radio equipment types are capable of operating in all or any part of the frequency bands in table 1. Table 1: Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating frequency bands Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating frequency bands Transmit Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) 402 MHz to 405 MHz Receive Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) 402 MHz to 405 MHz The present document contains the technical characteristics for ULP-AMI and ULP-AMI-P radio equipment which is also addressed by ERC/DEC (01)17 [i.1]. It applies to ULP-AMI devices and accessories ULP-AMP-P operating in the frequency band 402 MHz to 405 MHz: • for telecommand and telemetry to/from an AIMD in a patient's body to an ULP-AMI-P; or • for telecommand and telemetry to/from an AIMD to another AIMD within the human body. The present document contains requirements to demonstrate that Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) used in a Medical Implant Communications Service (MICS)" … shall be so constructed that it both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference" (article 3.2 of the Directive 2014/53/EU) [i.2]. It does not necessarily include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum performance achievable.