§ 95.628 - MedRadio transmitters in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz and 2360-2400 MHz bands.

§ 95.628 MedRadio transmitters in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz and 2360-2400 MHz bands.

The following provisions apply to MedRadio transmitters operating in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands as part of a Medical Micropower Network (MMN) and in the 2360-2400 MHz band as part of a Medical Body Area Network (MBAN).

(a) Operating frequencies. A MedRadio station authorized under this part must have out-of-band emissions that are attenuated in accordance with § 95.635.

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

(2) Only MedRadio stations that are part of an MBAN may operate in the 2360-2400 MHz frequency band.

(b) Requirements for a Medical Micropower Network.

(1) Frequency monitoring. 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 antenna used by the programmer/control transmitter for a communications session.

(i) 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.

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

(iii) 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 frequency band.

(2) MedRadio transmitters. 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 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.

(3) MedRadio programmer/control transmitters. MedRadio programmer/control transmitters shall have the ability to operate in the presence of other primary and secondary users in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands.

(4) Authorized bandwidth. The 20 dB authorized bandwidth of the emission from a MedRadio station operating in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands shall not exceed 6 MHz.

(c) Requirements for Medical Body Area 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.

(d) Frequency stability. Each transmitter in the MedRadio service must maintain a frequency stability of ±100 ppm of the operating frequency over the range:

(1) 25 °C to 45 °C in the case of medical implant transmitters; and

(2) 0 °C to 55 °C in the case of MedRadio programmer/control transmitters and Medical body-worn transmitters.

(e) 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.

(f) Measurement procedures.

(1) MedRadio transmitters shall be tested for frequency stability, radiated emissions and EIRP limit compliance in accordance with paragraphs (f)(2) and (3) of this section.

(2) Frequency stability testing shall be performed over the temperature range set forth in (d) of this section.

(3) Radiated emissions and EIRP limit measurements may be determined by measuring the radiated field from the equipment under test at 3 meters and calculating the EIRP. The equivalent radiated field strength at 3 meters for 1 milliwatt, 25 microwatts, 250 nanowatts, and 100 nanowatts EIRP is 115.1, 18.2, 1.8, or 1.2 mV/meter, respectively, when measured on an open area test site; or 57.55, 9.1, 0.9, or 0.6 mV/meter, respectively, when measured on a test site equivalent to free space such as a fully anechoic test chamber. Compliance with the maximum transmitter power requirements set forth in § 95.639(f) shall be 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 Commission in accordance with § 2.947 of this chapter may be used to demonstrate compliance. For a transmitter intended to be implanted in a human body, radiated emissions and EIRP measurements for transmissions by stations authorized under this section may be made in accordance with a Commission-approved human body simulator and test technique. A formula for a suitable tissue substitute material is defined in OET Bulletin 65 Supplement C (01-01).

[77 FR 55732, Sept. 11, 2012, as amended at 79 FR 60099, Oct. 6, 2014]