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Publication Number: 703967 Rule Parts:  Publication Date: 12/08/2017
Keyword: 15.241, 15.242, Part 95 Subpart H, Biomedical Telemetry and Wireless Medical Telemetry (WMTS) devices

First Category: Equipment Authorization Process *
Second Category: General [Equipment Authorization Process]

Question:   What are the rules for Biomedical Telemetry Devices using the same frequency bands as VHF or UHF TV broadcast services? 



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


 



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