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Electronic Code of Federal Regulations

e-CFR data is current as of November 7, 2019

Title 47Chapter ISubchapter DPart 95Subpart I → §95.2503


Title 47: Telecommunication
PART 95—PERSONAL RADIO SERVICES
Subpart I—Medical Device Radio Communications Service


§95.2503   Definitions, MedRadio.

Duly authorized health care professional. A physician or other individual authorized under State or Federal law to provide health care services.

Medical Body Area Network (MBAN). An MBAN is a low power network consisting of a MedRadio programmer/control transmitter and one or more medical body-worn devices all of which transmit or receive non-voice data or related device control commands for the purpose of measuring and recording physiological parameters and other patient information or performing diagnostic or therapeutic functions via radiated bi-directional or uni-directional electromagnetic signals

Medical body-worn device. Apparatus that is placed on or in close proximity to the human body (e.g., within a few centimeters) for the purpose of performing diagnostic or therapeutic functions.

Medical body-worn transmitter. A MedRadio transmitter intended to be placed on or in close proximity to the human body (e.g., within a few centimeters) used to facilitate communications with other medical communications devices for purposes of delivering medical therapy to a patient or collecting medical diagnostic information from a patient.

Medical Device Radio Communications (MedRadio) Service. An ultra-low power radio service for the transmission of non-voice data for the purpose of facilitating diagnostic and/or therapeutic functions involving implanted and body-worn medical devices.

Medical implant device. Apparatus that is placed inside the human body for the purpose of performing diagnostic or therapeutic functions.

Medical implant event. An occurrence or the lack of an occurrence recognized by a medical implant device, or a duly authorized health care professional, that requires the transmission of data from a medical implant transmitter in order to protect the safety or well-being of the person in whom the medical implant transmitter has been implanted.

Medical implant transmitter. A MedRadio transmitter in which both the antenna and transmitter device are designed to operate within a human body for the purpose if facilitating communications from a medical implant device.

Medical Micropower Network (MMN). An ultra-low power wideband network consisting of a MedRadio programmer/control transmitter and medical implant transmitters, all of which transmit or receive non-voice data or related device control commands for the purpose of facilitating functional electric stimulation, a technique using electric currents to activate and monitor nerves and muscles.

MedRadio channel. Any continuous segment of spectrum that is equal to the MedRadio emission bandwidth of the device with the largest bandwidth that is to participate in a MedRadio communications session.

MedRadio communications session. A collection of transmissions, that may or may not be continuous, between MedRadio system devices.

MedRadio emission bandwidth. The difference in frequency between the nearest points on either side of the carrier center frequency where the emission power is at least 20 dB below the maximum level of the modulated carrier power, measured using instrumentation employing a peak detector function and a resolution bandwidth approximately equal to 1% of the emission bandwidth.

MedRadio equivalent isotropically radiated power (M-EIRP). Antenna input power times gain for free-space or in-tissue measurement configurations required for MedRadio equipment, expressed in Watts, where the gain is referenced to an isotropic radiator.

MedRadio programmer/control transmitter. A MedRadio transmitter that operates or is designed to operate outside of a human body for the purpose of communicating with a receiver, or for triggering a transmitter, connected to a medical implant device or to a medical body-worn device used in the MedRadio Service; and which also typically includes a frequency monitoring system that initiates a MedRadio communications session.

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