[Federal Register Volume 62, Number 210 (Thursday, October 30, 1997)] [Rules and Regulations] [Pages 58656-58659] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-28761] ======================================================================= ----------------------------------------------------------------------- FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 15 [ET Docket No. 95-177; FCC 97-379] Biomedical Telemetry Transmitters AGENCY: Federal Communications Commission. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: By this Report and Order, the Commission amends its regulations regarding the unlicensed operation of biomedical telemetry transmitters in the 174-216 MHz (TV channels 7-13) and 470-668 MHz (TV channels 14-46) bands, as proposed in the Notice of Proposed Rule Making (``Notice'') in this proceeding, 61 FR 3367, January 31, 1996. These amendments will provide patients in health care facilities the ability to move about in a limited area while being continually monitored, speeding patient recovery times, shortening lengths of stay, and reducing health care costs. The standards being adopted for these devices should protect the licensed services operating in the TV bands. Further, a coordination procedure has been implemented to protect radio astronomy observatories from potential interference from biomedical telemetry systems operating on 608-614 MHz (TV channel 37). DATES: Effective December 1, 1997. ADDRESSES: Federal Communications Commission, 1919 M Street, N.W., Washington, D.C. 20554. FOR FURTHER INFORMATION CONTACT: John A. Reed, Office of Engineering and Technology, (202) 418-2455. SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Report and Order in ET Docket No. 95-177, FCC 97-379, adopted October 9, 1997, and released October 20, 1997. The complete text of this Report and Order is available for inspection and copying during normal business hours in the FCC Reference Center (Room 239), 1919 M Street, N.W., Washington, D.C., and also may be purchased from the Commission's copy contractor, International Transcription Services, Inc., (202) 857-3800, 1231 20th Street, NW, Washington, D.C. 20036. Summary of the Report and Order 1. In the Report and Order (``Order''), the Commission amended Part 15 of its regulations to permit unlicensed biomedical telemetry transmission [[Page 58657]] systems operating on TV channels 7-46 in the 174-216 MHz and 470-668 MHz frequency bands to be used in health care facilities. Biomedical telemetry transmitters are used in hospitals to transmit patient measurement data to a nearby receiver, permitting patient mobility and improved comfort. Typical devices include heart, blood pressure and respiration monitors. 2. While the Commission proposed in the Notice to permit the operation of biomedical telemetry devices over TV channels 7-69, it noted that it was now proposing to reallocate TV channels 52-69 to other services. Further, it is undecided at this time whether the Commission will reallocate TV channels 2-6 or 47-51. Thus, the Commission amended its rules to permit unlicensed biomedical telemetry devices only on TV channels 7-46. The Commission believes that these products can share the spectrum with licensed services. Biomedical telemetry devices are expensive, complex products that are generally installed by the manufacturer or by a third party working with the manufacturer. In most cases, individual systems must be specifically engineered for each location. Further, biomedical telemetry devices are sensitive to interference. Because interference to these products could endanger the health and safety of patients using this equipment, it is expected that health care facilities, in combination with the manufacturers and installers, would expend considerable effort to avoid operating on occupied broadcast channels. Operators of unlicensed biomedical telemetry devices are reminded that they must accept whatever level of interference is received from other radio operations and are responsible for resolving any interference problems caused by the operation of their equipment, even if resolving that interference requires that the biomedical telemetry device cease operations. 3. Protection from potential harmful interference from biomedical telemetry devices must be provided to all authorized operations within the TV bands, including TV broadcast stations operating under Part 73 of the rules, Low Power TV, TV Translator and TV Booster Stations operation under Subpart G of Part 74 of the rules, Low Power Auxiliary Stations operating under Subpart H of Part 74 of the rules, and Private Land Mobile Radio Services operating under Part 90 of the rules. The minimum separation distances employed to avoid inference need to be established based on the protection criteria for the individual radio services. The interference analysis should not generally rely on assumptions about the attenuation of intervening walls and other objects since biomedical telemetry devices are designed to be used on ambulatory patients who could be near windows or immediately outside of the hospital walls, such as on an attached patio. Also, the interference analyses should not rely on assumptions about body shielding as manufacturers often request that measurement of body-worn transmitters be made while the transmitter is worn on a person. Based on these criteria, the Commission recalculated minimum co-channel separation distances that must be observed by the operators and installers of biomedical telemetry transmitters, as shown in the attached regulations. Parties wishing to operate biomedical telemetry transmitters on TV channel 37 should note that they first must obtain written concurrence from the director of the affected radio astronomy observatory if they are located closer than the specified minimum distance. The Commission declined to establish separation distances for adjacent channel operations, noting that the limits on unwanted emissions should prevent this type of interference problem. 4. In the Order, the Commission established a maximum field strength limit of 200 mV/m, as measured at a distance of three meters. Further, the fundamental signal may not be wider than the 6 MHz bandwidth of a single TV channel, and the signal must be contained within a single TV channel. Emissions outside of the TV channel within which the fundamental emission from the biomedical telemetry transmitter is located must be attenuated to the general emission limits in 47 CFR Sec. 15.209. 5. Accordingly, It is ordered that Part 15 of the Commission's Rules and Regulations is amended. This action is taken pursuant to Sections 4(i), 301, 302, 303(e), 303(f), 303(r), 304, and 307 of the Communications Act of 1934, as amended, 47 U.S.C. Sections 154(i), 301, 302, 303(e), 303(f), 303(r), 304 and 307. Final Regulatory Flexibility Analysis 6. As required by Section 603 of the Regulatory Flexibility Act, 5 U.S.C. Sec. 603 (RFA), Initial Regulatory Flexibility Analysis (IRFA) was incorporated into the Notice of Proposed Rule Making (``Notice'') in ET Docket No. 95-177.1 The Commission sought written public comments on the proposals in the Notice including the IRFA. The Commission's Regulatory Flexibility Analysis (FRFA) in this Report and Order conforms to the RFA, as amended by the Contract with America Advancement Act of 1996 (CWAAA), Public Law 104-121, 110 Stat. 847 (1996). --------------------------------------------------------------------------- \1\ Amendment of Part 15 of the Commission's Rules to permit operation of biomedical telemetry devices on VHF TV channels 7-13 and on UHF TV channels, 11 FCC Rcd 1063 (1996). --------------------------------------------------------------------------- 7. Need for and Objective of the Rule. In this Order, the Commission amends Part 15 of its rules to expand the availability of frequencies and to increase the permitted power for unlicensed biomedical telemetry devices operating on VHF and UHF television channels 7-46 within health care facilities. These devices will provide patients the freedom to move about in a limited area while being continually monitored, speeding patient recovery times, shortening lengths of stay, and reducing health care costs. The changes to the regulations support spectrum efficiency by facilitating the sharing of scarce radio spectrum between two services and providing cost-efficient and needed medical technologies to health care communities. 8. Summary of Significant Issues Raised by the Public Comments in Response to the Initial Regulatory Flexibility Analysis. No comments were received in direct response to the Initial Regulatory Flexibility Analysis. However, commenters expressed considerable concern regarding the potential impact of biomedical telemetry devices sharing spectrum with the TV broadcast frequencies, especially in light of the forthcoming introduction of DTV. Many of the commenters requested that dedicated spectrum, outside of the TV bands, should be set aside for biomedical telemetry devices. For example, the Society of Broadcast Engineers (SBE) states that potentially life-critical biomedical telemetry has no place as a ``bottom-of-the-food-chain'' Part 15 device; if CCTG needs more spectrum, it should explore bands where such use can occur on a licensed, and therefore protected, basis. The Public Broadcasting Service and the Association of America's Public Television Stations (PBS/APTS) add that it would be a mistake for the Commission to establish a new system in the TV broadcasting spectrum where substantial changes are planned. The Community Broadcasters Association (CBA) states that TV spectrum is a poor environment into which to launch more intensive and higher powered use of critical medical devices on which health and lives will depend. Even CCTG states that the Commission should consider dedicating spectrum to the exclusive use of medical telemetry after the DTV [[Page 58658]] transition. Other commenters, such as the Leesburg Regional Medical Center and Texas Children's Hospital, are concerned that interference will be caused to biomedical devices from TV signals rather than interference from biomedical devices to TV signals. 9. The Critical Care Telemetry Group that petitioned the Commission to implement these rule changes and filed comments in this proceeding consists of Hewlett-Packard Company Medical Products Group, Marquette Electronics, Inc., Pacific Communications, Siemens Medical Systems, Inc., and SpaceLabs Medical, Inc. 10. Description and Estimate of the Number of Small Entities Subject to Which the Rules Apply. For purposes of the Report and Order, the RFA generally defines the term ``small business'' as having the same meaning as the term ``small business concern'' under the Small Business Act, 15 U.S.C. Sec. 632, unless the Commission has developed one or more definitions that are appropriate to its activities.2 Under the Small Business Act, a small business concern is one that: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) meets any additional criteria established by the Small Business Administration (SBA). Since the Regulatory Flexibility Act amendments were not in effect until the record in this proceeding was closed, the Commission was unable to request information regarding the number of small businesses that would be affected by this action. The rules adopted in this Report and Order apply to the operation of unlicensed biomedical telemetry transmitter devices for medical care facilities. These devices are used to transmit data, including heart, blood pressure and respiration monitors, to a nearby receiver. --------------------------------------------------------------------------- \2\ See 5 U.S.C. Sec. 601(3). --------------------------------------------------------------------------- 11. The Commission has not developed a definition of small entities applicable to biomedical telemetry transmitter devices. Therefore, the applicable definition of small entity is the definition under the Small Business Administration (SBA) rules applicable to Communications Services ``Not Elsewhere Classified.'' This definition provides that a small entity is one with $11.0 million or less in annual receipts.3 According to Census Bureau data, there are 848 firms that fall under the category of Communications Services, Not Elsewhere Classified. Of those approximately 775 reported annual receipts of $11 million or less and qualify as small entities.4 This category is very broad, and we are unable to determine how many operators of unlicensed biomedical telemetry devices will qualify as small entities. --------------------------------------------------------------------------- \3\ 13 CFR 121.201, Standard Industrial Classification (SIC) Code 4899. \4\ U.S. Bureau of the Census, U.S. Department of Commerce, 1992 Census of Transportation, Communications, and Utilities, UC92-S-1, Subject Series, Establishment and Firm Size, Table 2D, Employment Size of Firms: 1992, SIC Code 4899 (issued May 1995). --------------------------------------------------------------------------- 12. Description of Projected Reporting, Recordkeeping and Other Compliance Requirements. The rule change will not alter current reporting, recordkeeping or other requirements. To receive equipment authorization to operate on the television channels, applicants would have to demonstrate that their biomedical telemetry devices comply with the equipment standards and obtain an authorization from the Commission. 13. Significant Alternatives and Steps Taken by Agency to Minimize Significant Economic Impact on a Substantial Number of Small Entities Consistent with Stated Objectives. While the Notice proposed to permit biomedical telemetry operation over the frequency ranges of 174-216 MHz and 470-806 MHz (TV channels 7-69), we no longer believe that this entire frequency range can be made available. In the DTV Sixth Report and Order in MM Docket No. 87-268 the Commission indicated that it plans to reallocate TV channels 52-69 (698 MHz to 806 MHz) to other services and will reallocate either TV channels 2-6 (54-88 MHz) or 47- 51 (668-698 MHz).5 Thus, this spectrum no longer appears suitable for assignment to unlicensed biomedical telemetry operation. Accordingly, we are amending the rules to permit the operation of biomedical telemetry devices only over the frequency bands of 174-216 MHz and 470-668 MHz (TV channels 7-46). --------------------------------------------------------------------------- \5\ See the Sixth Report and Order in MM Docket No. 87-268, 62 FR 26684, May 14, 1997. See also the Notice of Proposed Rule Making in ET Docket No. 97-157, 62 FR 41012, July 31, 1997, proposing to reallocate TV channels 60-69 for public safety use and for other services. In addition, see Balanced Budget Act of 1997, Public Law 105-33, 111 Stat. 251 (1997), requiring the Commission to reallocate TV channels 52-69 for other services. --------------------------------------------------------------------------- 14. Report to Congress. The Commission shall send a copy of this Final Regulatory Flexibility Analysis, along with this Report and Order, in a report to Congress pursuant to the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. Sec. 801(a)(1)(A). List of Subjects 47 CFR Part 15 Communications equipment, Radio, Reporting and recordkeeping requirements. Federal Communications Commission. William F. Caton, Acting Secretary. Rule Changes Title 47 of the Code of Federal Regulations, Part 15, is amended as follows: PART 15--RADIO FREQUENCY DEVICES 1. The authority citation for part 15 continues to read as follows: Authority: Secs. 4, 302, 303, 304, 307 and 624A of the Communications Act of 1934, as amended, 47 U.S.C. 154, 302, 303, 304, 307 and 544A. 2. Section 15.205 is amended by adding a new paragraph (d)(5), to read as follows: Sec. 15.205 Restricted bands of operation. * * * * * (d) * * * (5) Biomedical telemetry devices operating under the provisions of Sec. 15.242 of this part are not subject to the restricted band 608-614 MHz but are subject to compliance within the other restricted bands. * * * * * 3. Section 15.209 is amended by revising paragraph (g) to read as follows: Sec. 15.209 Radiated emission limits; general requirements. * * * * * (g) Perimeter protection systems may operate in the 54-72 MHz and 76-88 MHz bands under the provisions of this section. The use of such perimeter protection systems is limited to industrial, business and commercial applications. 4. A new Sec. 15.242 is added to read as follows: Sec. 15.242 Operation in the bands 174-216 MHz and 470-668 MHz. (a) The marketing and operation of intentional radiators under the provisions of this section is restricted to biomedical telemetry devices employed solely on the premises of health care facilities. (1) A health care facility includes hospitals and other establishments that offer services, facilities, and beds for use beyond 24 hours in rendering medical treatment and institutions and organizations regularly engaged in providing medical services through [[Page 58659]] clinics, public health facilities, and similar establishments, including governmental entities and agencies for their own medical activities. (2) This authority to operate does not extend to mobile vehicles, such as ambulances, even if those vehicles are associated with a health care facility. (b) The fundamental emissions from a biomedical telemetry device operating under the provisions of this section shall be contained within a single television broadcast channel, as defined in part 73 of this chapter, under all conditions of operation and shall lie wholly within the frequency ranges of 174-216 MHz and 470-668 MHz. (c) The field strength of the fundamental emissions shall not exceed 200 mV/m, as measured at a distance of 3 meters using a quasi- peak detector. Manufacturers should note that a quasi-peak detector function indicates field strength per 120 kHz of bandwidth20 kHz. Accordingly, the total signal level over the band of operation may be higher than 200 mV/m. The field strength of emissions radiated on any frequency outside of the television broadcast channel within which the fundamental is contained shall not exceed the general limits in Sec. 15.209. (d) The user and the installer of a biomedical telemetry device operating within the frequency range 174-216 MHz, 470-608 MHz or 614- 668 MHz shall ensure that the following minimum separation distances are maintained between the biomedical telemetry device and the authorized radio services operating on the same frequencies: (1) At least 10.3 km outside of the Grade B field strength contour (56 dBuV/m) of a TV broadcast station or an associated TV booster station operating within the band 174-216 MHz. (2) At least 5.5 km outside of the Grade B field strength contour (64 dBuV/m) of a TV broadcast station or an associated TV booster station operating within the bands 470-608 MHz or 614-668 MHz. (3) At least 5.1 km outside of the 68 dBuV/m field strength contour of a low power TV or a TV translator station operating within the band 174-216 MHz. (4) At least 3.1 km outside of the 74 dBuV/m field strength contour of a low power TV or a TV translator station operating within the bands 470-608 MHz or 614-668 MHz. (5) Whatever distance is necessary to protect other authorized users within these bands. (e) The user and the installer of a biomedical telemetry device operating within the frequency range 608-614 MHz and that will be located within 32 km of the very long baseline array (VLBA) stations or within 80 km of any of the other radio astronomy observatories noted in footnote US 311 of Section 2.106 of this chapter must coordinate with, and obtain the written concurrence of, the director of the affected radio astronomy observatory before the equipment can be installed or operated. The National Science Foundation point of contact for coordination is: Spectrum Manager, Division of Astronomical Sciences, NSF Rm 1045, 4201 Wilson Blvd., Arlington, VA 22230; tel: (703) 306- 1823. (f) Biomedical telemetry devices must not cause harmful interference to licensed TV broadcast stations or to other authorized radio services, such as operations on the broadcast frequencies under subparts G and H of part 74 of this chapter, land mobile stations operating under part 90 of this chapter in the 470-512 MHz band, and radio astronomy operation in the 608-614 MHz band. (See Sec. 15.5.) If harmful interference occurs, the interference must either be corrected or the device must immediately cease operation on the occupied frequency. Further, the operator of the biomedical telemetry device must accept whatever level of interference is received from other radio operations. The operator, i.e., the health care facility, is responsible for resolving any interference that occurs subsequent to the installation of these devices. (g) The manufacturers, installers, and users of biomedical telemetry devices are reminded that they must ensure that biomedical telemetry transmitters operating under the provisions of this section avoid operating in close proximity to authorized services using this spectrum. Sufficient separation distance, necessary to avoid causing or receiving harmful interference, must be maintained from co-channel operations. These parties are reminded that the frequencies of the authorized services are subject to change, especially during the implementation of the digital television services. The operating frequencies of the part 15 devices may need to be changed, as necessary and in accordance with the permissive change requirements of this chapter, to accommodate changes in the operating frequencies of the authorized services. (h) The manufacturers, installers and users of biomedical telemetry devices are cautioned that the operation of this equipment could result in harmful interference to other nearby medical devices. [FR Doc. 97-28761 Filed 10-29-97; 8:45 am] BILLING CODE 6712-01-P