Goto Section: 95.626 | 95.628 | Table of Contents
FCC 95.627
Revised as of October 2, 2015
Goto Year:2014 |
2016
§ 95.627 MedRadio transmitters in the 401-406 MHz band.
The following provisions apply only to MedRadio transmitters operating in
the 401-406 MHz band.
(a) Frequency monitoring. Except as provided in (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 communications
session. Before the monitoring system of a MedRadio 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 emission bandwidth of the intended
transmission.
(2) Within 5 seconds prior to initiating a 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) Based on use of an isotropic monitoring system antenna, the monitoring
threshold power level must not be more than 10logB(Hz) −150 (dBm/Hz) +
G(dBi), where B is the emission bandwidth of the MedRadio communications
session transmitter having the widest emission and G is the MedRadio
programmer/control transmitter monitoring system antenna gain relative to an
isotropic antenna. For purposes of showing compliance with the above
provision, 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.
(4) If no signal in a MedRadio channel above the monitoring threshold power
level is detected, the MedRadio programmer/control transmitter may initiate
a MedRadio-communications session involving transmissions to and from a
medical implant or medical body-worn device on that channel. The MedRadio
communications session may continue as long as any silent period between
consecutive data transmission bursts does not exceed 5 seconds. If a channel
meeting the criteria in paragraph (a)(3) of this section is unavailable,
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. 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.
(5) When a channel is selected prior to a MedRadio communications session,
it is permissible to select an alternate 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 6dB 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)(5)(i) and (ii) are not
met, a channel must be selected using the access criteria specified in
paragraphs (a)(1) through (a)(4) of this section.
(6) As used in this section, the following definitions apply:
(i) Emission bandwidth— Measured as the width of the signal between the
points on either side of carrier center frequency that are 20 dB down
relative to the maximum level of the modulated carrier. Compliance will be
determined using instrumentation employing a peak detector function and a
resolution bandwidth approximately equal to 1% of the emission bandwidth of
the device under test.
(ii) MedRadio channel—Any continuous segment of spectrum in the MedRadio
band that is equal to the emission bandwidth of the device with the largest
bandwidth that is to participate in a MedRadio communications session.
Note to paragraph (a)(6)(ii): The rules do not specify a channeling scheme
for use by MedRadio systems.
(iii) MedRadio communications session—A collection of transmissions, that
may or may not be continuous, between MedRadio system devices.
(b) Exceptions to frequency monitoring criteria. MedRadio devices or
communications sessions that meet any one of the following criteria are not
required to use the access criteria set forth in paragraph (a) of this
section:
(1) MedRadio communications sessions 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) Operating frequency. MedRadio stations authorized under this part may
operate on frequencies in the 401-406 MHz band as follows provided that the
out-of-band emissions are attenuated in accordance with § 95.635:
(1) MedRadio stations associated with medical implant devices, which
incorporate a frequency monitoring system as set forth in paragraph (a) of
this section, may operate on any of the frequencies in the 401-406 MHz band.
(2) MedRadio stations associated with medical implant devices, which do not
incorporate a frequency monitoring system as set forth in paragraph (a) of
this section, may operate on any frequency in 401-402 MHz or 405-406 MHz
bands, or at 403.65 MHz in the 402-405 MHz band.
(3) MedRadio stations associated with medical body-worn devices, regardless
of whether a frequency monitoring system as set forth in paragraph (a) of
this section is employed, may operate on any of the frequencies in the
401-402 MHz or 405-406 MHz bands.
(4) MedRadio stations 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 paragraph (a) of this section is employed,
may operate on any of the frequencies in the 402-405 MHz band, provided
that:
(i) 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;
(ii) 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;
(iii) The maximum output power of the temporary body-worn device shall not
exceed 200 nW EIRP; and
(iv) 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.
(d) Authorized bandwidth. The authorized bandwidth of the emission from a
MedRadio station operating between 402-405 MHz shall not exceed 300 kHz, and
no communications session involving MedRadio stations shall use more than a
total of 300 kHz of bandwidth during such a session. The authorized
bandwidth of the emission from a MedRadio station operating between
401-401.85 MHz or 405-406 MHz shall not exceed 100 kHz, and no
communications session involving MedRadio stations shall use more than a
total of 100 kHz of bandwidth during such a session. The authorized
bandwidth of the emission from a MedRadio station operating between
401.85-402 MHz shall not exceed 150 kHz, and no communications session
involving MedRadio stations shall use more than a total of 150 kHz of
bandwidth during such a session.
Note to paragraph (d): This provision does not preclude full duplex or half
duplex communications provided that the total amount of bandwidth utilized
by all of the MedRadio channels employed in such a MedRadio communications
session does not exceed 300 kHz in the 402-405 MHz band, or 100 kHz in the
401-402 MHz and 405-406 MHz bands.
(e) 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 MedRadio body-worn transmitters.
(f) 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.
(g) Measurement procedures. (1) MedRadio transmitters shall be tested for
frequency stability, radiated emissions and EIRP limit compliance in
accordance with paragraphs (g)(2) and (g)(3) of this section.
(3) Radiated emissions and EIRP 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 25
microwatts, 250 nanowatts, and 100 nanowatts EIRP is 18.2, 1.8, or 1.2
mV/meter, respectively, when measured on an open area test site; or 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.
(2) Frequency stability testing shall be performed over the temperature
range set forth in (e) of this section.
(3) Radiated emissions and EIRP 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 25
microwatts, 250 nanowatts, and 100 nanowatts EIRP is 18.2, 1.8, or 1.2
mV/meter, respectively, when measured on an open area test site; or 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.
(i) 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).
[ 74 FR 22705 , May 14, 2009, as amended at 75 FR 52477 , Aug. 26, 2010.
Redesignated and amended at 77 FR 4268 , Jan. 27, 2012]
return arrow Back to Top
Goto Section: 95.626 | 95.628
Goto Year: 2014 |
2016
CiteFind - See documents on FCC website that
cite this rule
Want to support this service?
Thanks!
Report errors in
this rule. Since these rules are converted to HTML by machine, it's possible errors have been made. Please
help us improve these rules by clicking the Report FCC Rule Errors link to report an error.
hallikainen.com
Helping make public information public