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Electronic Code of Federal Regulations

e-CFR data is current as of October 17, 2019

Title 47Chapter ISubchapter DPart 95 → Subpart I


Title 47: Telecommunication
PART 95—PERSONAL RADIO SERVICES


Subpart I—Medical Device Radio Communications Service


Contents
§95.2501   Scope.
§95.2503   Definitions, MedRadio.
§95.2505   MedRadio operator eligibility.
§95.2507   MBAN devices restricted to indoor operation within a health care facility.
§95.2509   MBAN registration and frequency coordination.
§§95.2511-95.2521   [Reserved]
§95.2523   MedRadio transmitter inspection.
§95.2525   MedRadio interference.
§§95.2527-95.2529   [Reserved]
§95.2531   Permissible MedRadio uses.
§95.2533   Prohibited MedRadio uses.
§95.2535   MedRadio equipment certification exception.
§§95.2537-95.2539   [Reserved]
§95.2541   MedRadio outdoor antenna restrictions.
§§95.2543-95.2545   [Reserved]
§95.2547   MedRadio automatic control.
§95.2549   MedRadio network connection.
§§95.2551-95.2555   [Reserved]
§95.2557   MedRadio duration of transmissions.
§95.2559   MedRadio channel access requirements.
§95.2561   MedRadio transmitter certification.
§95.2563   MedRadio frequency bands.
§95.2565   MedRadio frequency accuracy.
§95.2567   MedRadio radiated power limits.
§95.2569   MedRadio field strength measurements.
§95.2571   MedRadio emission types.
§95.2573   MedRadio authorized bandwidths.
§§95.2575-95.2577   [Reserved]
§95.2579   MedRadio unwanted emissions limits.
§§95.2581-95.22583   [Reserved]
§95.2585   MedRadio RF exposure evaluation.
§95.2587   MedRadio additional requirements.
§95.2589   [Reserved]
§95.2591   MedRadio marketing limitations.
§95.2593   MedRadio labeling requirements.
§95.2595   MedRadio disclosures.
§§95.2597-95.2699   [Reserved]

§95.2501   Scope.

This subpart contains rules that apply only to the Medical Device Radio Communications (MedRadio) 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.

§95.2505   MedRadio operator eligibility.

Only the following persons are eligible to operate transmitters in the MedRadio Service:

(a) Duly authorized health care professionals are permitted to operate MedRadio transmitters.

(b) Individuals may also operate MedRadio transmitters that they use at the direction of a duly authorized health care professional. This includes medical devices that have been implanted in or placed on the body of the individual by, or under the direction of, a duly authorized health care professional.

(c) Manufacturers of medical devices that include MedRadio transmitters, and their representatives, are eligible to operate MedRadio transmitters for the purpose of demonstrating such equipment to duly authorized health care professionals.

§95.2507   MBAN devices restricted to indoor operation within a health care facility.

Use of Medical Body Area Network (MBAN) devices in the 2360-2390 MHz band is restricted to indoor operation within a health care facility registered with the MBAN frequency coordinator under §95.2509. For the purposes of this subpart, health care facilities are limited to hospitals and other establishments, both Federal and non-Federal, that offer services, facilities and beds for use beyond a 24 hour period in rendering medical treatment.

§95.2509   MBAN registration and frequency coordination.

Operation of Medical Body Area Network (MBAN) devices is subject to the frequency coordination procedures in this section.

(a) The FCC will designate a frequency coordinator(s) to manage the operation of medical body area networks by eligible health care facilities.

(b) The frequency coordinator shall perform the following functions:

(1) Register health care facilities that operate MBAN transmitters, maintain a database of these MBAN transmitter locations and operational parameters, and provide the FCC with information contained in the database upon request;

(2) Determine if an MBAN is within line-of-sight of an Aeronautical Mobile Telemetry (AMT) receive facility in the 2360-2390 MHz band and coordinate MBAN operations with the designated AMT frequency coordinator, as specified in §87.305 of this chapter;

(3) Notify a registered health care facility when an MBAN has to change frequency within the 2360-2390 MHz band or to cease operating in the band, consistent with a coordination agreement between the MBAN and AMT frequency coordinators;

(4) Develop procedures to ensure that registered health care facilities operate an MBAN consistent with the coordination requirements under this section; and,

(5) Identify the MBAN that is the source of interference in response to a complaint from the AMT coordinator and notify the health care facility of alternative frequencies available for MBAN use or to cease operation consistent with the rules.

(c) Registration. Prior to operating MBAN devices that are capable of operation in the 2360-2390 MHz band, a health care facility must register with a frequency coordinator designated under §95.2509. Operation of MBAN devices in the 2360-2390 MHz band is prohibited prior to the MBAN coordinator notifying the health care facility that registration and coordination (to the extent coordination is required under paragraph (e) of this section) is complete. The registration must include the following information:

(1) Specific frequencies or frequency range(s) within the 2360-2390 MHz band to be used, and the capabilities of the MBAN equipment to use the 2390-2400 MHz band;

(2) Equivalent isotropically radiated power;

(3) Number of MedRadio programmer/control transmitters in use at the health care facility as of the date of registration, including manufacturer name(s) and model number(s) and FCC identification number(s);

(4) Legal name of the health care facility;

(5) Location of MedRadio programmer/control transmitters (e.g., geographic coordinates, street address, building);

(6) Point of contact for the health care facility (e.g., name, title, office address, phone number, fax number, email address); and,

(7) In the event that an MBAN has to cease operating in all or a portion of the 2360-2390 MHz band due to interference under §95.2525 or changes in coordination under paragraph (e) of this section, a point of contact (including contractors) for the health care facility that is responsible for ensuring that this change is effected whenever it is required (e.g., name, title, office address, phone number, fax number, email address). The health care facility also must state whether, in such cases, its MBAN operation is capable of defaulting to the 2390-2400 MHz band and that it is responsible for ceasing MBAN operations in the 2360-2390 MHz band or defaulting traffic to other hospital systems.

(d) Notification. A health care facility shall notify the MBAN frequency coordinator whenever an MBAN programmer/control transmitter in the 2360-2390 MHz band is permanently taken out of service, unless it is replaced with transmitter(s) using the same technical characteristics as those reported on the health care facility's registration, which will cover the replacement transmitter(s). A health care facility shall keep the information contained in each registration current and shall notify the MBAN frequency coordinator of any material change to the MBAN's location or operating parameters. In the event that the health care facility proposes to change the MBAN's location or operating parameters, the MBAN coordinator must first evaluate the proposed changes and comply with paragraph (e) of this section as appropriate before the health care facility may operate the MBAN in the 2360-2390 MHz band under changed operating parameters.

(e) Coordination procedures. The MBAN coordinator will determine if an MBAN is within the line-of-sight of an AMT receive facility in the 2360-2390 MHz band and notify the health care facility when it may begin MBAN operations under the applicable procedures below.

(1) If the MBAN is beyond the line-of-sight of an AMT receive facility, it may operate without prior coordination with the AMT coordinator, provided that the MBAN coordinator provides the AMT coordinator with the MBAN registration information and the AMT frequency coordinator concurs that the MBAN is beyond the line-of-sight prior to the MBAN beginning operations in the band.

(2) If the MBAN is within line-of-sight of an AMT receive facility, the MBAN coordinator shall achieve a mutually satisfactory coordination agreement with the AMT coordinator prior to the MBAN beginning operations in the band. Such coordination agreement shall provide protection to AMT receive stations consistent with International Telecommunication Union (ITU) Recommendation ITU-R M.1459, “Protection criteria for telemetry systems in the aeronautical mobile service and mitigation techniques to facilitate sharing with geostationary broadcasting-satellite and mobile-satellite services in the bands 1 452-1 525 and 2 310-2 360 MHz,” May 2000, as adjusted using generally accepted engineering practices and standards that are mutually agreeable to both coordinators to take into account the local conditions and operating characteristics of the applicable AMT and MBAN facilities, and shall specify when the device shall limit its transmissions to segments of the 2360-2390 MHz band or must cease operation in the band. This ITU document is incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 5 1. To enforce any edition other than that specified in this section, the Federal Communications Commission must publish a document in the Federal Register and the material must be available to the public. Copies of the recommendation may be obtained from ITU, Place des Nations, 1211 Geneva 20, Switzerland, or online at http://www.itu.int/en/publications/Pages/default.aspx. You may inspect a copy at the Federal Communications Commission, 445 12th Street SW., Washington, DC 20554, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA call 202-741-6030 or go to http://www.archives.gov/federal__register/code__of__federal__regulations/ibr__locations.html. “Generally accepted engineering practices and standards” include, but are not limited to, engineering analyses and measurement data as well as limiting MBAN operations in the band by time or frequency.

(3) If an AMT operator plans to operate a receive site not previously analyzed by the MBAN coordinator to determine line-of-sight to an MBAN facility, the AMT operator shall consider using locations that are beyond the line-of-sight of a registered health care facility. If the AMT operator determines that non-line-of-sight locations are not practical for its purposes, the AMT coordinator shall notify the MBAN coordinator upon no less than 7 days notice that the registered health care facility must cease MBAN operations in the 2360-2390 MHz band, unless the parties can achieve a mutually satisfactory coordination agreement under paragraph (e)(2) of this section.

(f) Coordinator functions. The MBAN frequency coordinator shall:

(1) Provide registration and coordination of MBAN operations to all eligible health care facilities on a non-discriminatory basis;

(2) Provide MBAN registration and coordination services on a not-for-profit basis;

(3) Notify the FCC of its intent to no longer serve as frequency coordinator at least six months prior to ceasing to perform these functions; and

(4) Transfer the MBAN registration data in usable form to a frequency coordinator designated by the FCC if it ceases to be the coordinator.

§§95.2511-95.2521   [Reserved]

§95.2523   MedRadio transmitter inspection.

Any non-implanted MedRadio transmitter must be made available for inspection upon request by an authorized FCC representative. Persons operating implanted or body-worn MedRadio transmitters shall cooperate reasonably with duly authorized FCC representatives in the resolution of interference.

§95.2525   MedRadio interference.

(a) To reduce interference and make the most efficient use of the authorized facilities, MedRadio transmitters must share the spectrum in accordance with §95.2559.

(b) MedRadio operations must not cause harmful interference to, and must accept any interference from, stations operating in the 400.150-406.000 MHz band in the Meteorological Aids, Meteorological Satellite or Earth Exploration Satellite Services, and other authorized stations operating in the 413-419 MHz, 426-432 MHz, 438-444 MHz, 451-457 MHz, and 2360-2400 MHz bands. MedRadio programmer/control transmitters must have the ability to operate in the presence of primary and secondary users in the 413-419 MHz, 426-432 MHz, 438-444 MHz, 451-457 MHz, and 2360-2400 MHz bands.

§§95.2527-95.2529   [Reserved]

§95.2531   Permissible MedRadio uses.

MedRadio programmer/control transmitters may be operated only for the uses set forth in this section.

(a) MedRadio programmer/control transmitters may transmit only non-voice data containing operational, diagnostic and therapeutic information associated with a medical implant device or medical body-worn device that has been implanted or placed on the person by or under the direction of a duly authorized health care professional.

(b) MedRadio programmer/control transmitters may be operated for the purposes of testing and demonstrating MedRadio operation to health care professionals.

§95.2533   Prohibited MedRadio uses.

MedRadio Service transmitters must not be operated for uses other than those set forth in §95.2531.

(a) Voice communications are prohibited in the MedRadio Service.

(b) MedRadio programmer/control transmitters may not be used to relay information in the 401-406 MHz band to a receiver that is not included with a medical implant or medical body-worn device. Wireless retransmission of information intended to be transmitted by a MedRadio programmer/control transmitter or information received from a medical implant or medical body-worn transmitter shall be performed using other radio services that operate in spectrum outside of the 401-406 MHz band.

(c) MedRadio programmer/control transmitters and medical implant transmitters may not be used to relay information in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands to a receiver that is not a part of the same Medical Micropower Network (MMN). Wireless retransmission of information to a receiver that is not part of the same MMN must be performed using other radio services that operate in spectrum outside of the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands. Notwithstanding the above restrictions, a MedRadio programmer/control transmitter of an MMN may communicate with a MedRadio programmer/control transmitter of another MMN to coordinate transmissions, so as to avoid interference between the two MMNs.

(d) Medical body-worn transmitters may relay only information in the 2360-2400 MHz band to a MedRadio programmer/control transmitter or another medical body-worn transmitter device that is part of the same Medical Body Area Network (MBAN). A MedRadio programmer/control transmitter must not be used to relay information in the 2360-2400 MHz band to other MedRadio programmer/control transmitters. Wireless retransmission of all other information from an MBAN transmitter to a receiver that is not a part of the same MBAN shall be performed using other radio services that operate in spectrum outside of the 2360-2400 MHz band. Notwithstanding the above restriction, a MedRadio programmer/control transmitter in the 2360-2400 MHz band may communicate with another MedRadio programmer/control transmitter in the 2360-2400 MHz band to coordinate transmissions so as to avoid interference between the two MBANs.

(e) Except as provided in §95.2559(b), no MedRadio implant or body-worn transmitter shall transmit except in response to—

(1) A transmission from a MedRadio programmer/control transmitter; or

(2) A non-radio frequency actuation signal generated by a device external to the body with respect to which device the MedRadio implant or body-worn transmitter is used.

§95.2535   MedRadio equipment certification exception.

Non-certified medical implant or medical body-worn transmitters that are not marketed for use in the United States, but which otherwise comply with the technical requirements in this subpart, may be used by individuals who travel to the United States.

§§95.2537-95.2539   [Reserved]

§95.2541   MedRadio outdoor antenna restrictions.

The antenna for a MedRadio transmitter, other than a MedRadio transmitter operating in the 2390-2400 MHz band, must not be configured for permanent outdoor use. Furthermore, except for MedRadio operations in the 2390-2400 MHz band, any MedRadio antenna used outdoors must not be affixed to any structure for which the height to the tip of the antenna would exceed three meters (9.8 feet) above ground level.

§§95.2543-95.2545   [Reserved]

§95.2547   MedRadio automatic control.

Notwithstanding the provisions of §95.347, MedRadio transmitters may be operated under automatic control or manual control.

§95.2549   MedRadio network connection.

MedRadio programmer/control transmitters may be interconnected with other telecommunications systems including the public switched network.

§§95.2551-95.2555   [Reserved]

§95.2557   MedRadio duration of transmissions.

For the purpose of facilitating MedRadio system operation during a MedRadio communications session, the duration of transmissions is to be limited in accordance with this section.

(a) MedRadio transmitters may transmit in the 401-406 MHz band in accordance with the provisions of §95.2559(a) for no more than 5 seconds without the communications of data.

(b) MedRadio transmitters may transmit in the 401-406 MHz band in accordance with the provisions of §95.2559(b)(2) and (3) for no more than 3.6 seconds in total within a one hour time period without the communications of data.

(c) MedRadio transmitters may transmit in the 401-406 MHz band in accordance with the provisions of §95.2559(b)(4) for no more than 360 milliseconds in total within a one hour time period without the communications of data.

(d) MedRadio programmer/control transmitters operating in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands shall not transmit with a duty cycle greater than 3 percent.

§95.2559   MedRadio channel access requirements.

To reduce interference and make the most effective use of the MedRadio frequency bands, MedRadio transmitter types must be designed to operate in accordance with the rules in this section.

(a) Frequency monitoring in the 401-406 MHz band. Except as provided in paragraph (b) of this section, all MedRadio programmer/control transmitters operating in the 401-406 MHz band must operate under the control of a monitoring system that incorporates a mechanism for monitoring the channel or channels that the MedRadio system devices intend to occupy. The monitoring system antenna shall be the antenna normally used by the programmer/control transmitter for a MedRadio communications session. Before the monitoring system of a programmer/control transmitter initiates a MedRadio communications session, the following access criteria must be met:

(1) The monitoring system bandwidth, measured at its 20 dB down points, must be equal to or greater than the MedRadio emission bandwidth of the intended transmission.

(2) Within 5 seconds prior to initiating a MedRadio communications session, circuitry associated with a MedRadio programmer/control transmitter must monitor the channel or channels the system devices intend to occupy for a minimum of 10 milliseconds per channel.

(3) The monitoring threshold power level, PMT, in dBm, is calculated using the following formula.

PMT = 10 log B−150 (dBm/Hz) + G

Where:

(i) B is the MedRadio emission bandwidth in Hertz of the MedRadio communications session transmitter having the widest emission; and,

(ii) G is the MedRadio programmer/control transmitter monitoring system antenna gain, in decibels, relative to the gain of an isotropic antenna (dBi).

(4) For the purposes of showing compliance with the above provisions, the above calculated threshold power level must be increased or decreased by an amount equal to the monitoring system antenna gain above or below the gain of an isotropic antenna, respectively.

(5) If no signal above the monitoring threshold power level is detected in a MedRadio channel, the MedRadio programmer/control transmitter may initiate on that channel a MedRadio communications session involving transmissions to and from a medical implant or medical body-worn device. The MedRadio communications session may continue as long as any silent period between consecutive data transmission bursts does not exceed 5 seconds. If no channel meeting the requirements in paragraphs (a)(3) and (4) of this section is available, MedRadio transmitters that are capable of operating on multiple channels may transmit on the alternate channel accessible by the device with the lowest monitored ambient power level.

(6) When a channel is selected prior to a MedRadio communications session, it is permissible to select an alternate authorized channel for use if communications are interrupted, provided that the alternate channel selected is the next best choice using the above criteria. The alternate channel may be accessed in the event a communications session is interrupted by interference. The following criteria must be met:

(i) Before transmitting on the alternate channel, the channel must be monitored for a period of at least 10 milliseconds.

(ii) The detected power level during this 10 millisecond or greater monitoring period must be no higher than 6 dB above the power level detected when the channel was chosen as the alternate channel.

(iii) In the event that this alternate channel provision is not used by the MedRadio system, or if the criteria in paragraphs (a)(6)(i) and (ii) of this section are not met, any alternate authorized channel must be selected using the access criteria specified in paragraphs (a)(1) through (5) of this section.

(7) Except as provided in paragraph (b) of this section, MedRadio transmitters that operate on a single channel and thus do not have the capability of operating on alternate channels may not transmit unless no signal on the single channel of operation exceeds the monitoring threshold power level.

(b) Exceptions to frequency monitoring in the 401-406 MHz band. MedRadio devices or communications sessions that meet any one of the following criteria are not required to be operated in accordance with the access rules set forth in paragraph (a) of this section:

(1) MedRadio communications sessions that are initiated by a medical implant event.

(2) MedRadio devices operating in either the 401-401.85 MHz or 405-406 MHz bands, provided that the transmit power is not greater than 250 nanowatts EIRP and the duty cycle for such transmissions does not exceed 0.1%, based on the total transmission time during a one-hour interval, and a maximum of 100 transmissions per hour.

(3) MedRadio devices operating in the 401.85-402 MHz band, provided that the transmit power is not greater than 25 microwatts EIRP and the duty cycle for such transmissions does not exceed 0.1%, based on the total transmission time during a one-hour interval, and a maximum of 100 transmissions per hour.

(4) MedRadio devices operating with a total emission bandwidth not exceeding 300 kHz, centered at 403.65 MHz, provided that the transmit power is not greater than 100 nanowatts EIRP and the duty cycle for such transmissions does not exceed 0.01%, based on the total transmission time during a one-hour interval and a maximum of 10 transmissions per hour.

(c) Shared access. The provisions of this section shall not be used to extend the range of spectrum occupied over space or time for the purpose of denying fair access to spectrum for other MedRadio systems.

(d) Frequency monitoring in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands. MedRadio programmer/control transmitters must incorporate a mechanism for monitoring the authorized bandwidth of the frequency band that the MedRadio transmitters intend to occupy. The monitoring system antenna shall be the same antenna used by the programmer/control transmitter for a communications session.

(1) The MedRadio programmer/control transmitter shall be capable of monitoring any occupied frequency band at least once every second and monitoring alternate frequency bands within two seconds prior to executing a change to an alternate frequency band.

(2) The MedRadio programmer/control transmitter shall move to another authorized frequency band within one second of detecting a persistent (i.e., lasting more than 50 milliseconds) signal level greater than −60 dBm as received by a 0 dBi gain antenna in any 12.5 kHz bandwidth within the authorized bandwidth.

(3) The MedRadio programmer/control transmitter shall be capable of monitoring the authorized bandwidth of the occupied frequency band to determine whether either direction of the communications link is becoming degraded to the extent that communications is likely to be lost for more than 45 milliseconds. Upon making such a determination the MedRadio programmer/control transmitter shall move to another authorized frequency band.

(e) System shutdown. MedRadio transmitters shall incorporate a programmable means to implement a system shutdown process in the event of communication failure, on command from the MedRadio programmer/control transmitter, or when no authorized alternate frequency band is available. The shutdown process shall commence within 45 milliseconds after loss of the communication link or receipt of the shutdown command from the MedRadio programmer/control transmitter. This requirement does not apply to MedRadio operations in the 401-406 MHz band.

(f) Requirements for MBAN Networks. A MedRadio programmer/control transmitter and its associated medical body-worn transmitters shall not commence operating in, and shall automatically cease operating in, the 2360-2390 MHz band if the programmer/control transmitter does not receive, in accordance with the protocols specified by the manufacturer, a control message permitting such operation. Medical body-worn transmitters shall cease operating in 2360-2390 MHz if they lose communication with their associated programmer/control transmitter. Additionally, a MedRadio programmer/control transmitter and its associated medical body-worn transmitters operating in the 2360-2390 MHz band shall comply with a control message that notifies the devices to limit transmissions to segments of the 2360-2390 MHz band or to cease operation in the band.

§95.2561   MedRadio transmitter certification.

(a) Except as provided §95.2535, each MedRadio transmitter (a transmitter that operates or is intended to operate as a station in the MedRadio Service) must be certified in accordance with this subpart and part 2 of this chapter.

(b) A grant of equipment certification for the MedRadio Service will not be issued for any MedRadio transmitter type that fails to comply with all of the applicable rules in this subpart.

§95.2563   MedRadio frequency bands.

MedRadio transmitters operate in the 401-406 MHz, 413-419 MHz, 426-432 MHz, 438-444 MHz, 451-457 MHz, and 2360-2400 MHz bands. The FCC does not specify a channeling scheme for MedRadio systems.

(a) MedRadio transmitters associated with medical implant devices, which incorporate a frequency monitoring system as set forth in §95.2559(a), may transmit on any frequency in the 401-406 MHz band.

(b) MedRadio transmitters associated with medical implant devices, which do not incorporate a frequency monitoring system as set forth in §95.2559(a), may transmit on any frequency in the 401-402 MHz or 405-406 MHz bands, or on the frequency 403.65 MHz in the 402-405 MHz band.

(c) MedRadio transmitters associated with medical body-worn devices, regardless of whether a frequency monitoring system as set forth in §95.2559(a) is employed, may transmit on any frequency in the 401-402 MHz or 405-406 MHz bands.

(d) MedRadio transmitters that are used externally to evaluate the efficacy of a more permanent medical implant device, regardless of whether a frequency monitoring system as set forth in §95.2559(a) is employed, may operate on any frequency in the 402-405 MHz band, provided that:

(1) Such external body-worn operation is limited solely to evaluating with a patient the efficacy of a fully implanted permanent medical device that is intended to replace the temporary body-worn device;

(2) RF transmissions from the external device must cease following the patient evaluation period, which may not exceed 30 days, except where a health care practitioner determines that additional time is necessary due to unforeseen circumstances;

(3) The maximum output power of the temporary body-worn device must not exceed 200 nW EIRP; and

(4) The temporary body-worn device must comply fully with all other MedRadio rules applicable to medical implant device operation in the 402-405 MHz band.

(e) Only MedRadio transmitters that are part of a Medical Micropower Network (MMN) may operate in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands. Each MedRadio transmitter that is part of an MMN must be capable of operating in each of the following bands: 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz. All MedRadio transmitters that are part of a single MMN must operate in the same band.

(f) Only MedRadio transmitters that are part of a Medical Body Area Network (MBAN) may operate in the 2360-2400 MHz band.

§95.2565   MedRadio frequency accuracy.

Each MedRadio transmitter type must be designed to maintain a frequency stability of ±100 ppm of the operating frequency over the applicable temperature range set forth in this section. Frequency stability testing shall be performed over the appropriate temperature range.

(a) 25 °C to 45 °C in the case of medical implant transmitters; and

(b) 0 °C to 55 °C in the case of MedRadio programmer/control transmitters and medical body-worn transmitters.

§95.2567   MedRadio radiated power limits.

Each MedRadio transmitter type must be designed such that the MedRadio equivalent isotropically radiated power (M-EIRP) does not exceed the limits in this section. Compliance with these limits must be determined as set forth in §95.2569.

(a) Transmitters subject to frequency monitoring—401-406 MHz. For MedRadio transmitters that are not excepted under §95.2559(b) from the frequency monitoring requirements of §95.2559(a):

(1) The M-EIRP within any 300 kHz bandwidth within the 402-405 MHz band must not exceed 25 microwatts.

(2) The M-EIRP within any 100 kHz bandwidth within the 401-402 MHz or 405-406 MHz bands must not exceed 25 microwatts.

(b) Transmitters excepted from frequency monitoring—401-402 MHz and 405-406 MHz. For MedRadio transmitters that are excepted under §95.2559(b)(2) or (3) from the frequency monitoring requirements of §95.2559(a):

(1) The M-EIRP of any transmitter operating in the 401-401.85 MHz or 405-406 MHz bands must not exceed 250 nanowatts in any 100 kHz bandwidth.

(2) The M-EIRP of any transmitter operating in the 401.85-402 MHz band must not exceed 25 microwatts in any 150 kHz bandwidth.

(c) Transmitters excepted from frequency monitoring—403.65 MHz. For MedRadio transmitters that are excepted under §95.2559(b)(4) from the frequency monitoring requirements of §95.2559(a), the M-EIRP must not exceed 100 nanowatts in the 300 kHz bandwidth centered at 403.65 MHz.

(d) Transmitters—other frequency bands. For MedRadio transmitters operating in the 413-419 MHz, 426-432 MHz, 438-444 MHz, or 451-457 MHz bands:

(1) The peak M-EIRP over the frequency bands of operation must not exceed the lesser of zero dBm (1 mW) or 10 log (B)−7.782 dBm, where B is the MedRadio 20 dB emission bandwidth in megahertz.

(2) The peak power spectral density must not exceed 800 microwatts per megahertz in any one megahertz band.

(e) Transmitters—2360-2390 MHz band. For MedRadio transmitters operating in the 2360-2390 MHz band, the M-EIRP over the bands of operation must not exceed the lesser of zero dBm (1 mW) or 10 log (B) dBm, where B is the MedRadio 20 dB emission bandwidth in megahertz.

(f) Transmitters—2390-2400 MHz band. For MedRadio transmitters operating in the 2390-2400 MHz band, the M-EIRP over the bands of operation must not exceed the lesser of 13 dBm (20 mW) or 16 + 10 log (B) dBm, where B is the MedRadio 20 dB emission bandwidth in megahertz.

§95.2569   MedRadio field strength measurements.

Compliance with MedRadio equivalent isotropic radiated power (M-EIRP) limits can be determined by measuring the radiated field strength from the transmitter type, in accordance with the rules in this section.

(a) Radiated field strength values corresponding to the M-EIRP limits in §95.2567 are given in the table in this paragraph, for an open area test site, and for a test site equivalent to free space, such as a fully anechoic test chamber. Field strength is measured at a distance of 3 meters from the equipment under test.

M-EIRP
limit
Open
area
(mV/m)
Free
space
(mV/m)
1 mW115.157.55
25 μW18.29.1
250 nW1.80.9
100 nW1.20.6

(b) Compliance with the maximum transmitter power requirements in §95.2567 is based on measurements using a peak detector function and measured over an interval of time when transmission is continuous and at its maximum power level. In lieu of using a peak detector function, measurement procedures that have been found to be acceptable to the FCC in accordance with §2.947 of this chapter may be used to demonstrate compliance.

(c) For a MedRadio transmitter intended to be implanted in a human body, radiated emissions and M-EIRP measurements for transmissions by stations authorized under this section may be made in accordance with an FCC-approved human body simulator and test technique. Guidance regarding SAR measurement techniques dielectric parameters for the tissue-equivalent material can be found in the Office of Engineering and Technology (OET) Laboratory Division Knowledge Database (KDB).

§95.2571   MedRadio emission types.

A MedRadio station may transmit any emission type appropriate for communications in this service. Voice communications, however, are prohibited.

§95.2573   MedRadio authorized bandwidths.

Each MedRadio transmitter type must be designed such that the MedRadio emission bandwidth does not exceed the applicable authorized bandwidth set forth in this section.

(a) For MedRadio transmitters operating in the 402-405 MHz band, the maximum authorized bandwidth is 300 kHz. Such transmitters must not use more than 300 kHz of bandwidth (total) during a MedRadio communications session. This provision does not preclude full duplex or half duplex communications provided that the total bandwidth of all of the channels employed in a MedRadio communications session does not exceed 300 kHz.

(b) For MedRadio transmitters operating in the 401-401.85 MHz band or the 405-406 MHz band, the maximum authorized bandwidth is 100 kHz. Such transmitters must not use more than 100 kHz of bandwidth (total) during a MedRadio communications session. This provision does not preclude full duplex or half duplex communications provided that the total bandwidth of all of the channels employed in a MedRadio communications session does not exceed 100 kHz.

(c) For MedRadio transmitters operating in the 401.85-402 MHz band, the maximum authorized bandwidth is 150 kHz. Such transmitters must not use more than 150 kHz of bandwidth (total) during a MedRadio communications session. This provision does not preclude full duplex or half duplex communications, provided that the total bandwidth of all of the channels employed in a MedRadio communications session does not exceed 150 kHz.

(d) For MedRadio transmitters operating in the 413-419 MHz, 426-432 MHz, 438-444 MHz or 451-457 MHz bands, the maximum 20 dB authorized bandwidth is 6 MHz.

(e) For MedRadio transmitters operating in the 2360-2400 MHz band, the maximum authorized bandwidth is 5 MHz.

(f) Lesser emission bandwidths may be employed, provided that the unwanted emissions are attenuated as provided in §95.2579. See also §95.2567 regarding maximum radiated power limits, §95.2565 on frequency accuracy, §95.2569 on field strength measurements, and §95.2585 on RF exposure.

§§95.2575-95.2577   [Reserved]

§95.2579   MedRadio unwanted emissions limits.

Unwanted emission field strength limits and attenuation requirements apply to each MedRadio transmitter type, as set forth in this section and part 2.

(a) Field strength limits. The field strengths of unwanted emissions from each MedRadio transmitter type, measured at a distance of 3 meters, must not exceed the field strength limits shown in the table in this paragraph for the indicated frequency ranges, if the frequencies of these emissions are:

(1) More than 250 kHz outside of the 402-405 MHz band (for devices designed to operate in the 402-405 MHz band);

(2) More than 100 kHz outside of either the 401-402 MHz or 405-406 MHz bands (for devices designed to operate in the 401-402 MHz or 405-406 MHz bands);

(3) In the 406.000-406.100 MHz band (for devices designed to operate in the 401-402 MHz or 405-406 MHz bands); or

(4) More than 2.5 MHz outside of the 413-419 MHz, 426-432 MHz, 438-444 MHz or 451-457 MHz bands (for devices designed to operate in these four bands).

(5) More than 2.5 MHz outside of the 2360-2400 MHz band (for devices designed to operate in the 2360-2400 MHz band).

Frequency range
(MHz)
Field
strength (μV/m)
30-88100
88-216150
216-960200
960 and above500

Note to table in paragraph (a)(5): At the boundaries between frequency ranges, the tighter limit (lower field strength) applies. Below 1 GHz, field strength is measured using a CISPR quasi-peak detector. Above 1 GHz, field strength is measured using an average detector with a minimum reference bandwidth of 1 MHz. See also part 2, subpart J of this chapter.

(b) Harmonic emissions. Radiated unwanted emissions from a MedRadio transmitter type must be measured to at least the tenth harmonic of the highest fundamental frequency emitted.

(c) Attenuation requirements, 402-405 MHz. For MedRadio transmitter types designed to operate in the 402-405 MHz band, unwanted emissions must be attenuated below the maximum permitted transmitter output power by at least:

(1) 20 dB, on any frequency within the 402-405 MHz band that is more than 150 kHz away from the center frequency of the occupied bandwidth;

(2) 20 dB, on any frequency between 401.750 MHz and 402.000 MHz, and on any frequency between 405 MHz and 405.250 MHz.

(d) Attenuation requirements, 401-402 MHz, 405-406 MHz. For MedRadio transmitter types designed to operate in the 401-402 MHz band or 405-406 MHz band, the power of unwanted emissions must be attenuated below the transmitter output power by at least:

(1) 20 dB, on any frequency within the 401-401.85 MHz or 405-406 MHz bands that is:

(i) More than 75 kHz away from the center frequency of the occupied bandwidth if the MedRadio transmitter type is operating on a frequency between 401.85 and 402 MHz; or,

(ii) More than 50 kHz away from the center frequency of the occupied bandwidth and 100 kHz or less below 401 MHz or above 406 MHz.

(2) 20 dB, on any frequency between 400.900 MHz and 401.000 MHz, and on any frequency between 406.000 MHz and 406.100 MHz.

(e) Attenuation requirements, 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz. For MedRadio transmitter types designed to operate in the 413-419 MHz, 426-432 MHz, 438-444 MHz and 451-457 MHz bands: In the first 2.5 megahertz above or below any of the frequency bands authorized for Medical Micropower Network operation, the EIRP of any unwanted emission must be attenuated within a 1 megahertz bandwidth by at least 20 dB relative to the maximum EIRP within any 1 megahertz bandwidth of the fundamental emission.

(f) Attenuation requirements, 2360-2400 MHz. For MedRadio transmitter types designed to operate in the 2360-2400 MHz band: In the first 2.5 megahertz above or below any of the frequency bands authorized for MBAN operation, the EIRP of any unwanted emission must be attenuated within a 1 megahertz bandwidth by at least 20 dB relative to the maximum EIRP within any 1 megahertz bandwidth of the fundamental emission.

(g) Measurements. Compliance with the limits in paragraphs (c), (d), and (e) of this section is based on the use of measurement instrumentation using a peak detector function with an instrument reference bandwidth approximately equal to 1.0 percent of the emission bandwidth of the device under measurement.

§§95.2581-95.22583   [Reserved]

§95.2585   MedRadio RF exposure evaluation.

A MedRadio medical implant device or medical body-worn transmitter is subject to the radiofrequency radiation exposure requirements specified in §§1.1307(b) and 2.1093 of this chapter, as appropriate. Applications for equipment authorization of devices operating under this section must demonstrate compliance with these requirements using either finite difference time domain (FDTD) computational modeling or laboratory measurement techniques. Where a showing is based on computational modeling, the Commission retains the discretion to request that supporting documentation and/or specific absorption rate (SAR) measurement data be submitted.

§95.2587   MedRadio additional requirements.

(a) The antenna associated with any MedRadio transmitter must be supplied with the transmitter and is considered part of the transmitter subject to equipment authorization.

(b) MedRadio transmitters shall be tested for frequency stability, radiated emissions and EIRP limit compliance in accordance with applicable rules.

§95.2589   [Reserved]

§95.2591   MedRadio marketing limitations.

Transmitters intended for operation in the MedRadio Service may be marketed and sold only for the use in accordance with §95.2531.

§95.2593   MedRadio labeling requirements.

MedRadio transmitters must be labeled in accordance with the requirements in this section.

(a) MedRadio programmer/control transmitters operating in the 401-406 MHz band shall be labeled as provided in part 2 of this chapter and shall bear the following statement in a conspicuous location on the device:

This device may not interfere with stations operating in the 400.150-406.000 MHz band in the Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must accept any interference received, including interference that may cause undesired operation.

(b) MedRadio programmer/control transmitters operating in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands shall be labeled as provided in part 2 of this chapter and shall bear the following statement in a conspicuous location on the device:

This device may not interfere with stations authorized to operate on a primary basis in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands, and must accept any interference received, including interference that may cause undesired operation.

(c) MedRadio programmer/control transmitters operating in the 2360-2400 MHz band shall be labeled as provided in part 2 of this chapter and shall bear the following statement in a conspicuous location on the device:

This device may not interfere with stations authorized to operate on a primary basis in the 2360-2400 MHz band, and must accept any interference received, including interference that may cause undesired operation.

(d) If it is not feasible to place the statement specified by paragraph (a), (b), or (c) of this section on the device, it may be placed in the instruction manual for the transmitter instead.

(e) If a MedRadio programmer/control transmitter is constructed in two or more sections connected by wire and marketed together, the statement specified in this section is required to be affixed only to the main control unit.

(f) MedRadio transmitters shall be identified with a serial number on each device, except as noted in paragraphs (f)(1) and (2) of this section.

(1) For MedRadio transmitters that operate in the 2360-2400 MHz band, only the programmer/control transmitter shall be identified with a serial number.

(2) The FCC ID number associated with a medical implant transmitter and the information required by §2.925 of this chapter may be placed in the instruction manual for the transmitter and on the shipping container for the transmitter, in lieu of being placed directly on the transmitter.

§95.2595   MedRadio disclosures.

Manufacturers of MedRadio transmitters must include with each transmitting device the statement set forth in this section that applies to the frequency bands in use.

(a) For MedRadio transmitters operating in the 401-406 MHz band, the following statement applies:

This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150-406.000 MHz band in the Meteorological Aids (i.e., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference.

(b) For MedRadio transmitters operating in the 413-419 MHz, 426-432 MHz, 438-444 MHz and 451-457 MHz bands, the following statement applies:

This transmitter is authorized by rule under the MedRadio Service (47 CFR part 95). This transmitter must not cause harmful interference to stations authorized to operate on a primary basis in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands, and must accept interference that may be caused by such stations, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the MedRadio Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference.

(c) For MedRadio transmitters operating in the 2360-2400 MHz band, the following statement applies:

This transmitter is authorized by rule under the MedRadio Service (47 CFR part 95). This transmitter must not cause harmful interference to stations authorized to operate on a primary basis in the 2360-2400 MHz band, and must accept interference that may be caused by such stations, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the MedRadio Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference.

§§95.2597-95.2699   [Reserved]

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