§ 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 shall not commence operating and shall
   automatically cease operating in the 2360-2390 MHz band if it does not
   receive, in accordance with the protocols specified by the
   manufacturer, a control message permitting such operation Additionally,
   a MedRadio programmer/control transmitter operating in the 2360-2390
   MHz band shall comply with a control message that notifies the device
   to limit its 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 DEGC to 45 DEGC in the case of medical implant transmitters; and

   (2) 0 DEGC to 55 DEGC 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]

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