Answer: Biomedical Telemetry Devices can
operate under the following rules:
Section 15.241 within the band
174-216 MHz (TV channels 7 to 13) and limited to Biomedical Telemetry
Devices confined to an emission bandwidth of 200 kHz within the 176-216 MHz
band.
Section 15.242 in TV channel bands 7
to 46 (174-216 MHz and 470-688 MHz) and limited to Biomedical Telemetry
Devices employed within health care facilities, and limited to operate within a
single 6 MHz bandwidth TV channel as defined in Part 73.
Part 95 Subpart H Channel 37 band (608-614
MHz). Part 95 Subpart H--Wireless Medical
Telemetry Service (WMTS) is a licensed service requiring a registration process
as stated in Section 95.2309 prior to operation. WMTS operation is also permitted in the 1395-1400
MHz band, and in portions of the 1427-1432 MHz band, where the frequencies
available vary by geographic location.
Notwithstanding the preceding Part
15 rule references and any legacy operations thereunder, since October 2002 new
equipment authorization grants under Sections 15.241 and 15.242 are not
permitted [per Section 15.37(b)].
In all cases, Biomedical Telemetry and
WMTS devices that are operated must have been certified under the equipment
authorization provisions of Part 2 Subpart J. Biomedical Telemetry
Devices must not cause harmful interference to licensed TV broadcast stations
or to other authorized radio services, and the operator of a device must accept
whatever interference is received. As a
result of the recent broadcast television spectrum incentive auction, TV
channels 38-51 are being repurposed for licensed wireless services, and some TV
stations that remain on the air will be required to change their channels of
operation. These changes may create
interference to existing medical telemetry devices or result in harmful
interference to authorized services, requiring alteration of the operating channel
for some devices. Channel 37 (608-614
MHz) is not assigned to any television broadcaster and is a coordinated, shared
channel for WMTS devices under Section 95.2309 generally and the National
Astronomy and Observatory Centers (NRAO) under Section 95.2309(f).
Subpart H of Part 95 describes the
requirements for transmitters operating in the Wireless Medical Telemetry
Service. WMTS devices in the 608-614 MHz
band must have the capability to operate in one or more of the 1.5 MHz
channel(s) specified in Section 95.2363(b). Spread spectrum devices that operate in the
WMTS bands under Part 95 Subpart H require the 1.5 MHz channel mode in the
event there are frequency coordination issues as specified in Section 95.2325.
Certification applications should have
specific test data for the 1.5 MHz channel mode at the Section 95.2363(b)
frequencies supported, along with test data for other operating modes if
supported by a device. In addition,
there should be multiple Form 731 line entries (one for each transmit mode) and
grant conditions stating that there is a 1.5 MHz channel mode, to support
frequency coordination if the spread spectrum mode causes frequency
coordination issues.
Other general information on medical
telemetry devices can be found on the FCC webpage at:
Sharing of Analog and
Digital Television Spectrum by Medical Telemetry Devices
https://www.fcc.gov/faq/sharing-analog-and-digital-television-spectrum-medical-telemetry-devices
A listing of the current DTV channel
assignments can be found at:
https://www.fcc.gov/media/television/tv-query
Other information on medical telemetry operations is
available from the US Food and Drug Administration (FDA):
Wireless Medical Telemetry Systems https://www.fda.gov/medicaldevices/digitalhealth/wirelessmedicaldevices/ucm364308.htm
Radio Frequency Wireless Technology
in Medical Devices - Guidance for Industry and Food and Drug Administration
Staff
https://www.fda.gov/MedicalDevices/ucm077210.htm |