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 P6QPa7PC2,W XP\  P6QXPb2J=.,/&J\  P6Q&P.c2N=.,&N4  pQ&dP,%,J,\  P6QJPeI(!,,(\  P6Q,Pf{,C8*,3C*f9 xQX0J=.,3V^&J*f9 xQ&Xd,XZZeers (W1) (Bold)Univ S- X   )y S- #&J\  P6Q/&P#Federal Communications Commission`j(#FCC 97379 ă  yx}dddy )O3 Before the Federal Communications Commission  S-& Washington, D.C. 20554 ă  S`-In the Matter ofR#&J\  P6Q/&P#) R) Amendment of Part 15 of the Commission'sR)  S-Rules to permit operation of biomedical R)hET Docket No. 95177 telemetry devices on VHF TV channels 713R) and on UHF TV channels 1446R)  S -! REPORT AND ORDER  S - (Proceeding Terminated) TP  S -X` hp x (#%'0*,.8135@8:that are installed by trained persons or fixedfrequency devices that are preset for use in a given area.  x[CCTG added that any interference potential is further reduced by limiting the use of these devices to the  xpremises of health care facilities. Even with the future introduction of DTV, CCTG asserted that useable  S - xspectrum would exist in any given area. On December 5, 1995, the Commission adopted a Notice of  S - xProposed Rule Making ("Notice") in this proceeding addressing the petition from CCTG. d. {O-ԍxSee Notice of Proposed Rule Making, ET Docket No. 95155, 11 FCC Rcd 1063 (1996). The parties  S\-filing comments in response to the Notice are shown in Appendix A.  S-( DISCUSSION ă  S- A. Permitted bands of operation  SF-  x5. In the Notice, the Commission noted that it generally has not permitted the operation of  xunlicensed Part 15 devices within the television bands. Furthermore, it is in the process of establishing  S- xprocedures and technical criteria for the introduction of DTV." d. yO$-  ԍxThe Commission has provided a 6 MHz transitional channel for each existing broadcast station to be used  xLto implement DTV operations and has established a transition period during which broadcasters will continue  {O%- xexisting TV operations while the new DTV operations are deployed. See Sixth Report and Order, MM Docket No. 87268, 62 FR 26684, May 14, 1997.  However, the Commission also recognized  x]the need for additional spectrum for biomedical telemetry devices and indicated that the spectrum"p,l(l(,,"  xallocated for television broadcast stations may be appropriate for use by biomedical telemetry devices.  xAccordingly, it proposed to allow biomedical telemetry devices to operate on VHF channels 713 (174216  xMHz) and on all UHF channels (470806 MHz) on a noninterference basis under Part 15 of the rules.  xyComments were requested on the feasibility of unlicensed biomedical telemetry devices sharing spectrum  S`- xwith TV operations and the Private Land Mobile Radio Services.`d. yO-  .ԍxThe land mobile services, under Part 90 of the rules, are authorized to operate in parts of the 470512 MHz  {O-band, dependent on location. See 47 CFR Part 90 Subpart L. Comments also were sought on the  xviability of biomedical telemetry devices sharing UHF channel 37 (608614 MHz), a band reserved  S- xexclusively for radio astronomy.Q "d. {O -ԍxSee 47 CFR  73.603(c).Q By allowing a broad range of operating frequencies, the Commission  xindicated that it should be easier for manufacturers and operators to identify and use unoccupied  xfrequencies and, therefore, help reduce any potential interference. Comments were sought on the total  xamount of spectrum that is needed to support biomedical telemetry devices and whether there may be a range of operating frequencies that may be more favorable than others.  S -  x6. Comments. CCTG states that there is a need for two to four TV channels (12 to 24 MHz of  xspectrum) in each major metropolitan area in order to provide approximately 200 to 500 channels of 50  S - xkHz bandwidth for biomedical telemetry devices at each hospital.R d. {O&-ԍxSee CCTG comments at pg. 4.R CCTG also states that TV channel  x[37, allocated exclusively for radio astronomy applications, is well suited for use by biomedical telemetry  S -on a secondary basis.Q Fd. {Oh-ԍxSee CCTG comments at pg. 7Q  S2-  nx7. However, commenters expressed considerable concern regarding the potential impact of  xbiomedical telemetry devices sharing spectrum with the TV broadcast frequencies, especially in light of  x the forthcoming introduction of DTV. Many of the commenters requested that dedicated spectrum,  S- xMoutside of the TV bands, be set aside for biomedical telemetry devices. d. {O2-  OԍxSee, for example, Capital Cities/ABC (CC/ABC) reply comments at pg. 6, Center for Devices and  xRadiological Health of the Food and Drug Administration under the Department of Health and Human Services  x,(CDRH) reply comments at pg. 1, KUED comments at pg. 2, Association of Maximum Service Television (MSTV)  xcomments at pg. 5, Public Broadcasting Service and the Association of America's Public Television Stations (PBS/APTS) reply comments at pg. 7, and Society of Broadcast Engineers (SBE) reply comments at pg. 2. For example, the Society of  xBroadcast Engineers (SBE) states that potentially lifecritical biomedical telemetry has no place as a  x"bottomofthefoodchain" Part 15 device; if CCTG needs more spectrum, it should explore bands where  x\such use can occur on a licensed, and therefore protected, basis. The Public Broadcasting Service and  xthe Association of America's Public Television Stations (PBS/APTS) add that it would be a mistake for  xthe Commission to establish a new system in the TV broadcasting spectrum where substantial changes  xare planned. The Community Broadcasters Association (CBA) states that TV spectrum is a poor  xenvironment into which to launch more intensive and higher powered use of critical medical devices on  Sz- xwhich health and lives will depend.Q z d. {O&-ԍxSee CBA comments at pg. 1.Q The Center for Devices and Radiological Health of the Food and  xDrug Administration under the Department of Health and Human Services (CDRH) expressed concern"R ,l(l(,,"  xMabout the potential for injury to patients that might occur if there is interference between the medical  xdevice and the primary licensees, recommending that the Commission grant exclusive licenses to  S- xbiomedical telemetry devices for the primary use of locally unused TV channels.Zd. {O-ԍxSee CDRH reply comments at pg. 12.Z Even CCTG states that  xthe Commission should consider dedicating spectrum to the exclusive use of medical telemetry after the  S`- x!DTV transition.R`Zd. {OZ-ԍxSee CCTG comments at pg. 6.R Other commenters, such as the Leesburg Regional Medical Centern`d. {O-ԍxSee Leesburg Regional Medical Center comments at pg. 1.n and Texas  S8- xChildren's Hospital,g8~d. {OV -ԍxSee Texas Children's Hospital comments at pg. 1.g are concerned that interference will be caused to biomedical devices from TV signals rather than interference from biomedical devices to TV signals.  S-  mx8. Decision. The Commission continues to believe that the TV broadcast spectrum, including  S- x=operation on TV channel 37, can support lowpowered biomedical telemetry systems. While the Notice  xyproposed to permit biomedical telemetry operation over the frequency ranges of 174216 MHz and 470 x806 MHz (TV channels 769), we no longer believe that this entire frequency range can be made  S$ - xavailable. In the DTV Sixth Report and Order in MM Docket No. 87268 the Commission indicated that  S - xit plans to reallocate TV channels 5269 (698 MHz to 806 MHz) to other services., d. {O-  NԍxSee the Sixth Report and Order in MM Docket No. 87268, supra at para. 83. See also the Notice of  {Ox- xProposed Rule Making in ET Docket No. 97157, 62 FR 41012, July 31, 1997, proposing to reallocate TV channels  {OB- x60 69 for public safety use and for other services. In addition, see Balanced Budget Act of 1997, Pub. L. 10533,  xK111 Stat. 251 (1997), requiring the Commission to reallocate TV channels 52 69 for other services. The final  x;reallocation will not be decided until the completion of these rule making proceedings. This final reallocation could impact the frequencies available for biomedical telemetry devices., Further, it is  x undecided at this time whether the Commission will reallocate TV channels 26 (5488 MHz) or TV  S - x channels 4751 (668698 MHz). d. {O-ԍxSee Sixth Report and Order in MM Docket No. 87268, supra at para. 83. Thus, this spectrum no longer appears suitable for assignment to  xzunlicensed biomedical telemetry operation. Contrary to the arguments of SBE, PBS/APTS, CBA and  xyothers, we believe that the patient benefits provided from providing additional frequencies for biomedical  xtelemetry devices are of sufficient importance to justify the operation of these products on vacant channels  xwithin the TV broadcast bands. Further, biomedical telemetry devices are expensive, complex products  xthat are generally installed by the manufacturer or by a third party working with the manufacturer. In  x{most cases, individual systems must be specifically engineered for each location. We observe that  xbiomedical telemetry systems are very sensitive to interference and are more likely to receive interference  x.on any given channel before causing interference. Because interference to these products could endanger  xthe health and safety of the patients using this equipment, it is expected that health care facilities, in  xcombination with the manufacturers and installers, would expend considerable effort to avoid operating  S- xon occupied broadcast channels. d. yO%-  =ԍxFor this reason, the Commission is not as concerned that interference will be caused to biomedical telemetry devices, such as would occur should these devices be located too close to a licensed station. As already required under the rules, the operator of a Part 15 device,  S- xe.g., a health care facility operating a biomedical telemetry device, must accept whatever level of"x,l(l(,,"  xinterference is received from other radio operations and is responsible for resolving any harmful  x=interference problems caused by the operation of their device, even if resolving that interference requires  S- x!that the biomedical telemetry device cease operations. Ld. {O-ԍxSee 47 CFR  15.5.L Thus, health care facilities should avoid  S- xoperating on channels that could cause interference to the reception of TV or land mobile servicesZd. yO-  ԍxWithin certain cities, the Public Land Mobile Radio Service share operation over TV channels 1420 (470 {OJ-512 MHz). See 47 CFR  90.301317. or  xythat could cause the biomedical telemetry devices to receive interference since such interference problems  xcould result in the health care facilities having to change frequencies, an expensive process if it also  xrequires changes to the antenna design or replacement of the transmission system. Further, unlike other  x=Part 15 products that generally are designed for consumer applications, biomedical telemetry devices are  x"prescription" devices that would be employed by professional health care providers and primarily by  x<hospitals. Accordingly, the Commission believes that the manufacturers and users of these products would  x=take sufficient steps to ensure that proper operating frequencies are found and employed. However, for  xadditional assurance the Commission will note in the rule section pertaining to these devices the need to  xavoid interference to the authorized services and to accept interference received from other radio operations.  S -  x9. The Commission is not implementing dedicated channels for biomedical telemetry devices at  xthis time. The record in this proceeding is not sufficiently complete to determine which, if any, additional  xchannels should be employed. Dedicated channels can be investigated in future proceedings should the  x/equipment manufacturers and users later determine that additional frequencies, without the potential  xinterference problems associated with operation within the TV broadcast bands, are needed. Accordingly,  x.we are amending the rules to permit the operation of biomedical telemetry devices only in the frequency  xLbands of 174216 MHz (TV channels 713) and 470668 MHz (TV channels 1446). We recognize that  xsufficient TV channels may not be available for biomedical use in all major cities. With regard to the  xforthcoming introduction of DTV, for some period of time coordination may prove more challenging for  xbiomedical telemetry device users. However, we expect that this will become easier once DTV systems have been implemented and standard analog TV broadcasting is phased out.  S- B. Technical standards  SP-  lx 10. The Commission proposed to allow biomedical telemetry devices to operate, as suggested by  xCCTG, at transmitter power levels not to exceed 5 milliwatts. However, noting that the Part 15 rules  xgenerally are based on measurements of radiated emission field strengths and not on transmitter power,  xthat biomedical telemetry devices may not have a readily accessible antenna port to permit output power  x=measurements, and that transmitter power alone is not sufficient to predict the potential for interference  x.to other users, comments were requested on applying a field strength limit of 200mV/m, as measured at  S`- x3 meters.`d. yO$-  ԍxAn effective radiated power (ERP) of 5 mW is equivalent to a field strength of 165 mV/m at 3 meters. A field strength of 200 mV/m at 3 m is equivalent to an ERP of 7.3 mW, an increase of 1.64 dB. The Commission also proposed to permit an emission bandwidth of 200kHz with unwanted emissions appearing outside this bandwidth limited to 150 uV/m at 3 meters. "  ,l(l(,,!"Ԍ",l(l(,,"  S-  x 11. Comments. With one exception, the comments supported the application of a field strength  S- xllimit of 200 mV/m at 3 m, rather than the use of a transmitter output power limit.d. {OB-  MԍxSee comments of Association for the Advancement of Medical Instrumentation at pg. 2, CCTG at pg. 8, and Consumer Electronics Manufacturers Association (CEMA) at pg. 3. The National  xLAssociation of Broadcasters (NAB), while supporting a standard based on a field strength limit, believes  xythat an unspecified lower field strength limit is necessary to permit biomedical telemetry devices to share  Sb- xthe spectrum with VHF and UHF broadcast stations.Wb"d. {O$-ԍxSee NAB comments at pg. 6 and 8.W While the Association for the Advancement of  S:- xMedical Instrumentation (AAMI) states that 200 kHz bandwidth is sufficient,R:d. {O -ԍxSee AAMI comments at pg. 2.R CCTG states that a 6 MHz  xzemission bandwidth would give medical devices flexibility to operate and coexist with other users and  S- xwould permit manufacturers to incorporate additional channels in each unit.wFd. {O -ԍxSee CCTG comments at pg. 10 and Appendix A to comments at pg. 9.w With regard to the limit  x=on unwanted emissions, CCTG states that 150 uV/m limit is too restrictive and proposes 630 uV/m at 3  xm, arguing that a lesser level of attenuation is sufficient for TV broadcast stations under Part 73 of the  Sr- xzrules and for LPTV and Low Power Auxiliary Stations (LPAS) operating under Part 74 of the rules.rd. {O-ԍxSee CCTG comments at pg. 10, Appendix A to comments at pg. 78, and reply comments at pg. 7.  SJ -AAMI recommends a level of 1/10th of the fundamental output.RJ j d. {OT-ԍxSee AAMI comments at pg. 2.R  S -  mx 12. Decision. The Commission agrees that the designation of a field strength limit is the more  xdesirable method of specifying an output level of a transmitter operating under Part 15. This is so because  xa limit based on field strength takes into account the gain provided by the antenna, and therefore provides  x\better control of interference potential. The Commission also notes that field strength measurements  S\- xMalready must be made on the transmitter to demonstrate compliance with the restricted band limits.N\ d. {O-ԍxSee 47 CFR  15.205.N  xThus, no additional burden would be imposed on the manufacturers of biomedical telemetry devices by  S -specifying the fundamental emission in terms of its field strength.u\  d. yO:-  ԍxWhile PBS/APTS state that strict rules must be imposed to prevent installation of alternative antenna  {O- xsystems to improve performance, such rules are already in place in Part 15. See PBS/APTS reply comments at pg.  {O-5. See, also, 47 CFR  15.203.u  S-  x 13. As CCTG has made persuasive arguments that increased power is needed for biomedical  xtelemetry devices. The Commission proposed a limit of 200 mV/m as appropriate based on the 5 mW  Sl- x.requested by CCTG and given variations in antennas and equipment design.J ld. {O$-ԍxNotice at para. 10.J While NAB expresses its  xconcern that a lower field strength level should be applied to prevent interference to television broadcasts,  x]NAB does not suggest a lower limit. However, the Commission believes that the 200 mV/m limit  S- xproposed in the Notice can be employed without causing interference to licensed stations provided"D ,l(l(,,a"  S- xsufficient cochannel separation distances are maintained.!d. yOh-ԍxThe protection of licensed radio services from interference is discussed later in this Report and Order. It also appears that this field strength level  xis sufficient to permit a workable biomedical telemetry system within the high background radio frequency  xnoise levels associated with a hospital environment. Accordingly, the Commission is adopting the proposed fundamental limit of 200 mV/m, as measured at 3 meters.  S8-  ^x 14. The Commission also agrees with CCTG that a 6 MHz bandwidth would give biomedical  xLtelemetry devices more operating flexibility, permitting manufacturers to incorporate additional channels  xin each unit without an increase in interference potential. The limit being adopted for the fundamental  xemission is based on a quasipeak field strength measured with a defined bandwidth, resulting in what is  xequivalent to a spectral power density or field strength per unit bandwidth. Thus, as long as the emission  xfrom the biomedical telemetry system meets the field strength limit and is contained within a single TV  x[broadcast channel, its interference potential to the authorized services should be unchanged. We observe  xthat permitting wider bandwidth will provide the flexibility to design systems that make the most efficient  xuse of the spectrum. Accordingly, we are requiring only that the signal may not be wider than the 6 MHz bandwidth of a single TV channel, and that the signal must be contained within a single TV channel.  S -  0x15. The Commission agrees with AAMI and CCTG that some relaxation can be provided on the  x/limits for unwanted emissions, but it does not agree that the limits on unwanted emissions should be  xrelaxed to correspond to those applied to licensed stations. Unlike Part 15 devices, TV broadcast stations,  xLPTV and LPAS are licensed by the Commission, are coordinated in frequency and location to prevent  xinterference to cochannel and adjacent channel operations, and are operated at locations known by the  S- xCommission.l"XXd. yO-  lԍxAs discussed later, the Commission believes that the attenuation provided by the building in which the  x<biomedical telemetry equipment is located varies and can not be ensured. Thus, no additional attenuation due to installation was incorporated into the interference considerations.l The general emission limits contained in 47 CFR  15.209 are applied to the unwanted  x>emissions produced by most other Part 15 devices. They were developed with the specific intent of  Sh- xjpreventing interference to television reception and have proved to be effective in this regard. #hxd. yO-  ԍxThe Commission also continues to believe that unwanted emissions should be reduced to the greatest extent that is economically feasible in order to minimize background noise levels within the radio spectrum.  However,  x/biomedical telemetry devices would be operated within vacant TV channels and there is no reason to  x[require unwanted emissions appearing within those vacant channels to be attenuated to the general limits  S- xin Part 15. Any interference would be only to other biomedical telemetry systems.$d. yO`-  ԍxThus, it is in the best interest of the operators that the manufacturer attenuate withinchannel emissions to the maximum extent possible. As discussed above,  xthe Commission expects each system to be specifically engineered for the individual health care facility  xin order to avoid interference not only to authorized services but also to other biomedical telemetry  xequipment. Thus, the Commission believes that it is necessary to establish a limit on unwanted emissions  x!only outside of the TV channel within which the biomedical telemetry device is operated. These unwanted emissions shall be attenuated to the limits in 47 CFR  15.209. "( $,l(l(,,"  S- C. Protection of authorized services  S-  ?x16. In order to protect the television broadcast service from interference from Part 15 biomedical  xLtelemetry devices, the Commission proposed to adopt the cochannel separation requirements suggested  xby CCTG. Biomedical telemetry devices would be required to be removed from cochannel television  xbroadcast station transmitters by minimum separation distances, as follows: not less than 107.1 km in  x=Zone I and 131.8 km in Zones II and III for devices using VHF channels 713 in the 174216 MHz band  x=and 113.2 km for devices using UHF channels 1436 and 3869 in the bands 480608 MHz and 614806  S- xMHz in all Zones.x%d. {O( -ԍxSee 47 CFR  73.609 for the definition of Zones I, II and III.x The Commission noted that the proposed separation requirements are very close to  S- x those specified for LPAS associated with broadcast stations.&Zd. {O -  ԍxSee 47 CFR  74.802. Examples of low power auxiliary station uses include wireless microphones, cue and control communications and synchronization of TV camera signals. Additionally, it noted that LPAS are  xintended to transmit over distances of approximately 100 meters and are authorized to operate at higher  SH - xMpower levels than what was proposed for biomedical telemetry devices.'H d. yO-  ԍxUnder 47 CFR  74.861(e)(1)(i) and (ii) LPAS are authorized powers up to 50 mW on the VHF TV channels and 250 mW on UHF channels. Given the lower operating  xypower of biomedical telemetry devices and shorter transmission distances compared to LPAS, comments  xwere sought on whether the proposed cochannel separation distances are overly restrictive. Additionally,  x.the Commission questioned who would be responsible for ensuring adherence to the separation distance  xrequirement. Since there is no licensee that would be responsible for the installation of the equipment,  xthe Commission proposed, as suggested by CCTG, that the equipment be installed by trained field  xpersonnel that would select the appropriate operating frequency for a given location. This would result  xin the installer and end user being responsible for ensuring that devices are properly deployed according  x=to the separation requirements. In addition, the user would be responsible for resolving any interference  x\that occurs subsequent to installation. Comments also were sought on whether any restrictions were needed to protect adjacent TV channels.  Sh-  x17. The Commission also expressed concern about the interaction of biomedical telemetry devices  xwith LPTV stations. As spectrum is needed for new DTV stations, displaced LPTV stations would be  S- xMpermitted to relocate to other available television channels.( d. {O-  ԍxSee Second Further Notice of Proposed Rule Making in MM Docket No. 87268, at para. 41 and footnote 48. This relocation of LPTV stations could  xdirectly impact the ability of biomedical telemetry devices to find usable spectrum. Thus, comments were sought on the ability of biomedical telemetry devices to share spectrum with the LPTV service.  Sx-  x18. The Commission noted that any effort to accommodate biomedical telemetry devices in TV  xspectrum during the DTV transition period would require flexibility that could include the ability to  xlchange frequency to avoid interfering with DTV channels. Therefore, it proposed that biomedical  xtelemetry devices be designed to be frequency selective to operate over a given range of television channel" f (,l(l(,,\"  S- xjfrequencies.A)Xd. yOh-  ԍxThis proposal was intended to help avoid interference and minimize the economic impact of requiring  xZbiomedical telemetry device users to purchase new equipment due to changes in television frequency usage during the DTV transition period. A Comments were also requested on whether devices should be required to have a minimum number of channels that could be selected.  S-  x19. Comments. There were a considerable number of comments regarding potential interference  xbetween licensed services using the TV broadcast frequencies and biomedical telemetry devices. CCTG  x]states that the separation distances are highly conservative and are more than adequate to prevent  S- xinterference.X*d. {O -ԍxSee CCTG reply comments at pg. 2.X It adds that telemetry receivers are very sensitive and, in most areas, telemetry devices  xwould experience interference at closer distances, thus preventing use of that channel by the telemetry  S- x?devices.X+zd. {O -ԍxSee CCTG reply comments at pg. 5.X CCTG also states that telemetry signals transmitted inside health care facilities will be  xsufficiently attenuated by the walls of the buildings so as to assure that there will not be objectionable  Sr- xjinterference to TV reception outside of the facilities.,r d. {O-  ԍxCCTG claims that signals from the biomedical telemetry transmitters are attenuated by at least 20 dB. See CCTG reply comments at pg. 2 and Engineering Statement attached to the reply comments at pg. 14. CCTG adds that manufacturers will work closely  xLwith health care institutions to locate suitable frequencies and that health care personnel will have access  S" - x.to lists of available frequencies.X-" f d. {O(-ԍxSee CCTG reply comments at pg. 5.X Capital Cities/ABC (CC/ABC) indicates that there is a possibility for  xLsharing the VHF band and some sharing of the UHF band at greater cochannel distance separations than  S - xMthose proposed.Z. d. {Oj-ԍxSee CC/ABC reply comments at pg. 7.Z However, it also adds that this would require prior frequency coordination by the  S - xmedical telemetry user through the existing broadcast auxiliary frequency coordinator network.s/X d. yO-  >ԍxThe broadcast auxiliary frequency coordinator network reference by CC/ABC is a voluntary group of the  xSBE. A list of frequency coordinators for different areas is published once a month. The Commission has not received any acknowledgement from SBE that it agrees to perform this function.s NAB  x=adds that sharing of the VHF, and some sharing of the UHF spectrum, with higher power than currently  xpermitted under the rules, though not as high as that proposed, may be possible and practical, provided  xthere are adequate controls to insure cochannel distance separations and frequency coordination with other  S - xsecondary users.Q0 d. {OT!-ԍxSee NAB comments at pg. 6.Q However, controls and accountability must be established for the resolution of interference problems.  S-  x20. Texas Children's Hospital states that the deployment of telemetry systems should be restricted  Sj- xLin markets where cochannel and adjacent channel TV stations exist.g1j<d. {OF&-ԍxSee Texas Children's Hospital comments at pg. 2.g PBS/APTS state that interference"j 1,l(l(,,"  S- xjto adjacent TV channels and UHF taboo2Xd. yOh-  ԍxIn addition to cochannel and adjacent channel interference concerns, it is possible for television broadcast  xistations operating on certain other combinations of channels, principally in the UHF band, to interfere with one another. The frequency allotment constraints on these combinations are known as UHF taboos. problems are not addressed.\3d. {O-ԍxSee PBS/APTS reply comments at pg. 3.\ The  xiConsumer Electronics Manufacturers Association (CEMA) also states that the issue of interference to UHF  S-taboo channels is not addressed.R4zd. {O-ԍxSee CEMA comments at pg. 1.R  S`-  #x21. CCTG indicates that medical devices and LPAS can coexist using realtime frequency  S8- x!coordination, even in instances when a film crew is operating near a hospital.R58 d. {O -ԍxSee CCTG comments at pg. 9.R This drew strong  xopposition from CC/ABC, PBS/APTS and SBE. CC/ABC states that it fails to see why licensed, fee x=paying Part 74 operators should be required to take on the responsibility and added cost of coordinating  S- x>with unlicensed Part 15 operators.Z6d. {O-ԍxSee CC/ABC reply comments at pg. 5.Z PBS/APTS point out that coordination, especially the real time  xcoordination suggested by CCTG, would be difficult given that there will be no database of biomedical  Sp- xjtelemetry devices that an LPAS licensee could consult to identify occupied frequencies.\7p0 d. {O@-ԍxSee PBS/APTS reply comments at pg. 5.\ SBE proposes  xza minimum separation distance of 80 km to LPAS, TV translator, TV booster or LPTV stations using  S - x=coordinates from FCC Form 313.8\ d. {O-  ԍxSee SBE comments at pg. 4. SBE believes it would be realistic to expect conformance of separation  xdistances by licensed Part 90 users and recommends that CCTG file a petition for rule making to permit the  {O-operation of biomedical telemetry devices under Part 90. See SBE comments at pg. 5. It adds that the suggestion of CCTG that licensed Part 74 broadcast  xauxiliary stations should protect and be required to provide prior coordination to unlicensed Part 15  S - xdevices is ludicrous.W9 d. {OV-ԍxSee SBE reply comments at pg. 1.W SBE also points out that no separation distances were proposed to protect Part 74  S - xlicensed services of LPTV, LPAS, TV translators and TV boosters.Q: xd. {O-ԍxSee SBE comments at pg. 3.Q CBA states that the LPTV industry  S - xwill be more seriously affected than the full power TV industry if higher powered devices are permitted.S; d. {O*!-ԍxSee CBA comments at pg. 23.S  xIt adds that the risk of future difficulty is compounded by the fact that biomedical devices would be  xunlicensed, so there would be no database to help locate sources of interference, and there would be no  xway to contact all users to warn them of the risk of interference received when DTV operations start or LPTV stations change channels. " ;,l(l(,,"  S-  @x22. With regard to installation by trained personnel, CC/ABC is skeptical of the reliability of  S- x"trained personnel."Z<d. {O@-ԍxSee CC/ABC reply comments at pg. 6.Z SBE seriously questions whether trained field personnel would have the necessary  S- xknowledge to ensure proper spacing requirements.Q=Zd. {O-ԍxSee SBE comments at pg. 4.Q PBS/APTS state that the rule language in the item  S-does not propose any specific requirements for installers.\>d. {O-ԍxSee PBS/APTS reply comments at pg. 4.\  S8-  x23. With regard to equipment frequency selection capability, CCTG opposes requiring frequency  xselection; adding that since the market will demand frequency selection, a rule mandating a specific level  S- xof selection capability is unnecessary.R?~d. {O -ԍxSee CCTG comments at pg. 6.R CCTG states that if this requirement is retained, then the  xCommission should only require a range of 12 MHz since the TV adjacent channel rules would ensure the availability of spectrum. " SH -  "x24. Finally, CCTG indicates that TV Channel 37 is well suited for use by medical telemetry on  xa secondary basis, and that telemetry devices can be located approximately 13 km from a radio astronomy  S - x=facility and provide adequate interference protection to that facility.@ a. {O-  ԍxSee CCTG comments at pg. 7 and Appendix A of comments at pg. 910. CCTG based its calculated distance on the protection criteria proposed to be applied on TV broadcast stations to radio astronomy sites. While formal comments were not  xreceived on this issue, the Commission staff contacted Dr. Thomas Gergely, Electromagnetic Spectrum  S| - xManager, National Science Foundation, for additional information.A| j a. yO-ԍxA copy of Mr. Gergely's comments have been placed in the docket file for this proceeding. Dr. Gergely recommended that  xprotection be provided to the radio astronomy observatories shown in 47 CFR  2.106, footnote US 311.  xBased on the 200 mV/m limit being adopted, he stated that protection should include an exclusion zone  xof 50 miles radius around the Arecibo and Green Bank observatories and around the VLA near Socorro,  xNew Mexico along with an exclusion zone of 20 miles radius around the 10 Very Long Baseline Array (VLBA) stations.  S-  x25. Decision. Upon further reflection, we no longer believe that the separation distances  S- xproposed in the Notice are accurate for preventing interference problems between biomedical telemetry  xydevices and TV broadcast operations. Indeed, these proposed separation distances were designed for the  xkpurpose of allocating TV broadcast channels. The Commission even recognizes in its rules that these  SM- xdistances will not always prevent interference.QBM a. {O!-ԍxSee 47 CFR  73.612(a).Q The actual minimum separation distances for the purpose  xof avoiding interference should be based on antenna height, power, frequency and terrain roughness  xfactors of the individual broadcast stations. Further, the proposed separation distances addressed only  x>interference protection to television broadcast stations. However, protection from potential harmful  xinterference from biomedical telemetry devices must be provided to all authorized operations within the  x/TV bands, including TV broadcast stations operating under Part 73 of the rules, Low Power TV, TV  xTranslator and TV Booster Stations operating under Subpart G of Part 74 of the rules, Low Power  xAuxiliary Stations (LPAS) operating under Subpart H of Part 74 of the rules, and Private Land Mobile" B,l(l(,,j" Radio Services operating under Part 90 of the rules.  S-  x26. The minimum separation distances employed for the purpose of avoiding interference need  xto be established based on the protection criteria for the individual services. The protection criteria for  xtelevision reception requires that the field strength of an undesired signal be at least 45 dB less than the  xbroadcast signal. For the purpose of accepting LPTV applications, TV broadcast signals and associated  S- xzTV booster stations are protected to the broadcast stations' Grade B field strength contours.Ca. {O6-  ԍxSee 47 CFR  74.705(a). These contours are 56 dBuV/m for TV channels 713 and 64 dBuV/m for TV  {O-channels 1446. See 47 CFR  73.683(a). LPTV  S- xstations and TV translator stations are protected at a different field strength contour.D$a. yO_ -  jԍxThe protected field strength contours for LPTV and TV translator stations are 68 dBuV/m for channels 713  {O' -and 74 dBuV/m for channels 1446. See 47 CFR  74.707. Similar protection  xcontours are not provided for LPAS or land mobile stations. However, most LPAS and land mobile  xstations employ frequency modulation and operate at higher power than biomedical telemetry devices,  xreducing the distance necessary to protect against interference from biomedical telemetry devices. We  xbelieve that it is more likely that LPAS and land mobile stations would cause interference to biomedical  xtelemetry devices than it is that biomedical telemetry devices would cause interference to these operations.  xKWe also point out that interference analyses should not generally rely on assumptions about the attenuation  xof intervening walls and other objects. Biomedical telemetry transmitters are intended to be used on  xambulatory patients who could be near windows that offer little or no shielding. Patients could also be  S - xyimmediately outside of the hospital walls, such as on an attached patio.E ~a. yO-  zԍxOnly in cases where the biomedical telemetry device would only be located in the interior area of a health care facility could building shielding effects be considered. Also, the interference analyses  xshould not rely on assumptions about attenuation due to body shielding. The Commission notes that  xymanufacturers often request that measurements of bodyworn transmitters be made while the transmitter  xis on a person so that any absorption or attenuation of the transmission signal due to the proximity of the person is taken into account.  S-  x27. Based on the above, the Commission has recalculated the minimum separation distances  xnecessary to prevent interference to the licensed radio services using TV channels 746. Biomedical  xtelemetry devices must be located outside the Grade B field strength contours of cochannel TV broadcast  x[stations and associated TV booster stations by at least 10.3 km for TV channels 713 and 5.5 km for TV  S- x>channels 1446.Fza. {OH-  ԍxBiomedical telemetry transmitters are being authorized to radiate at a level of 200 uV/m, i.e., 106 dBuV/m,  xas measured at a distance of 3 meters. In order to maintain a signaltointerference ratio of at least 45 dB, the  xfundamental emissions from the biomedical telemetry transmitters must be reduced to no greater than 11 dBuV/m  xfor TV channels 713 and 19 dBuV/m for TV channels 1446. The calculated distances in the text are based on the  xKF(50,10) field strength charts, figures 10a and 10c, contained in 47 CFR  73.699 with the biomedical telemetry  xYtransmitter located at a height of 30 meters. The F(50,10) charts are used to predict interference potential whereas the F(50,50) charts are used to predict station coverage. Similarly, biomedical telemetry transmitters must be located outside the protected  xLcontours of cochannel LPTV and TV translator stations by at least 5.1 km on channels 713 and 3.1 km  Sl- xon channels 1446. Gla. yO$&-  >ԍxThese calculated distances are based on the F(50,10) field strength charts, figures 10a and 10c, contained in 47 CFR  73.699 with the biomedical telemetry transmitter located at a height of 30 meters.  The Commission is adopting these minimum separation distances. Minimum"l pG,l(l(,,"  xzseparation distances are not being specified for LPAS and land mobile stations, but we are referencing  xLin the rules that biomedical telemetry devices must be sufficiently removed from these stations so as not  xto cause harmful interference. We believe that these separation criteria are more representative of what  xLis necessary to prevent biomedical telemetry devices from causing harmful interference to the authorized  xradio services operating within the TV broadcast bands. We also believe that these separation distances  S-may, in many instances, be less than the separation distances originally proposed in the Notice.  S-  x28. The Commission does not agree with the comments that separation distances are necessary  xfor adjacent channel systems since the emissions from biomedical telemetry devices falling within adjacent  xchannels must comply with the general emission limits in 47 CFR  15.209, levels that have already  xproven to be effective in preventing interference. Further, the Commission does not believe that  xinterference problems would occur to UHF taboo channels due to the low signal levels emitted from the biomedical telemetry transmitters.  S7 -  nx29. We also do not believe that it is necessary to establish rules mandating that biomedical  xtelemetry devices be frequency selective and be installed by "trained field personnel." Due to the high  xcost of the equipment, the need for engineering studies to determine appropriate operating frequencies for  xeach location, and the potentially disastrous impact on patient health should the biomedical telemetry  xsystems be installed without properly addressing all interference concerns, the Commission can not  x=conceive that any reputable health care facility would install this equipment without using highly skilled  xinstallation personnel. Further, due to the upcoming changes in the operating frequencies of broadcast  xand LPTV stations, it is likely that manufacturers would incorporate some method to change the operating frequency of their equipment.  S9-  x30. The Commission wishes to emphasize that Part 15 devices, including biomedical telemetry  x[devices, operate on a sufferance basis. Regardless of the purpose for which the Part 15 devices are used,  x{they are not protected from interference and any interference problems caused to authorized radio  S- xoperations must be corrected. It is the operator of the product, i.e.., the health care facility, that is  xultimately responsible for correcting any interference problems, even if correcting the interference requires  S;- xthat the operator cease operation.gH;a. {O-ԍxSee 47 CFR  15.5, particularly  15.5(c).g Specifically, biomedical telemetry devices operating under Part 15  xmust not cause interference to any of the authorized operations within the TV bands, including TV  xbroadcast stations operating under Part 73 of the rules, Low Power TV, TV Translator and TV Booster  xStations operating under Subpart G of Part 74 of the rules, Low Power Auxiliary Stations operating under Subpart H of Part 74 of the rules, and land mobile stations operating under Part 90 of the rules.  S -  x31. With regard to operation on TV channel 37, the Commission recognizes that most radio  xLastronomy operations generally are located in rural areas where demand for biomedical telemetry devices  x{is least. However, there may also be circumstances where there is a need for biomedical telemetry  x.devices to be operated on TV channel 37 near such observatories. The Commission also recognizes that  xit may be possible to locate channel 37 biomedical telemetry devices relatively close to radio astronomy  xobservatories due to specific operating conditions, such as terrain shielding. This is a matter that must  x.be addressed on a casebycase basis. Accordingly, the Commission is amending its rules to require that  xthe user and installer of a biomedical telemetry device operating on TV channel 37 (608614 MHz) that  xis located within 32 km of any of the VLBA radio astronomy sites or within 80 km of any of the other  x\radio astronomy observatories noted in 47 CFR  2.106, footnote US 311, must coordinate with, and  xzobtain the written concurrence of, the director of the affected radio astronomy observatory before the  x^equipment can be installed or operated. The National Science Foundation point of contact for"$ZH,l(l(,,}("  x\coordination is: Spectrum Manager, Division of Astronomical Sciences, NSF Rm 1045, 4201 Wilson Blvd., Arlington, VA 22230; tel: (703) 3061823.  S4- D. Location of operation  S-  x32. When the Commission authorized the operation of biomedical telemetry devices in the 512 S- x=566 MHz band (TV channels 2129), it restricted the use of these devices to hospital buildings.TIa. {O-ԍxSee 47 CFR  15.209(g)(2).T In the  Sh- xNotice, the Commission proposed to permit the operation of biomedical telemetry devices in hospitals and  xMother health care facilities. The Commission also noted that health care facilities may include nursing  xlhomes and assisted living facilities that may be located in residential neighborhoods and expressed  xzconcern about interference that could occur in these residential neighborhoods. Thus, comments were sought on the impact of extending the operation of biomedical telemetry devices to health care facilities.  S7 -  0x 33. Comments. NAB states that the record does not support the operation of telemetry devices  S - xoutside of hospitals.RJ Za. {O-ԍxSee NAB comments at pg. 14.R SBE opposes allowing devices to operate outside of hospitals or ambulances.QK a. {O-ԍxSee SBE comments at pg. 6.Q  xCCTG states that devices should be permitted in "critical care facilities" whether or not they are  S - xhospitals.XL ~a. {O-ԍxSee CCTG reply comments at pg. 6.X CCTG adds that the definition of a health care facility must be broad enough to ensure the  xavailability of telemetry devices to a wide range of health care providers and points out that the devices  S9-are "prescription" devices and are not available to the public.SM9a. {O-ԍxSee CCTG comments at pg. 12.S  S-  x!34. Decision. The Commission agrees that the operation of these biomedical telemetry devices  xshould be expanded to include operation within any health care facilities. The definition of a health care  xfacility includes: hospitals and other establishments that offer services, facilities, and beds for use beyond  xL24 hours in rendering medical treatment and institutions and organizations regularly engaged in providing  xmedical services through clinics, public health facilities, and similar establishments, including  S- xgovernmental entities and agencies for their own medical activities.4Na. yO-   ԍxThis definition is based on the eligibility requirements for obtaining a license in the Private Land Mobile  {O-Radio Services as a Medical Service under Part 90 of the rules. See 47 CFR  90.35(a)(1), (a)(2), and (a)(7).4 As long as the frequencies of the  xbiomedical telemetry devices are chosen with sufficient care to avoid interference problems to television  xreception and with limits that are being established herein for unwanted emissions, there should not be  xany increased interference potential even if the equipment is located near a residential environment.  xHowever, the Commission sees no need to permit these products to be located within an ambulance or  xother moving vehicle. In an ambulance, there would be no method to ensure that a sufficient separation  xdistance from cochannel broadcast operations is maintained. Further, there does not appear to be any  xneed to use a wireless biomedical telemetry system, designed to allow a patient mobility, within an ambulance. "  N,l(l(,,"Ԍ S-ԙ E. Miscellaneous issues  S-  |x"35. The CDRH stated that the increase in power for telemetry devices may cause interference  xto other older medical devices that do not meet the voluntary electromagnetic compatibility immunity  S4- xstandards.XO4a. {O-ԍxSee CDRH reply comments at pg. 2.X Thus, it recommends that the biomedical telemetry devices include a warning that there is  xlan increased possibility of interference to other nearby medical devices. While the Commission is  x>sympathetic to the concerns expressed by the CDRH, it notes that this is not a new problem. Older  xmedical devices already are experiencing electromagnetic compatibility problems from cellular telephones  xMand other nearby radio frequency devices. The Commission believes that the health care facilities are  xalready familiar with this type of problem and will consider it when the individual biomedical telemetry systems are engineered for use at their locations.  S -  x#36. In addition to the new rules being adopted in this Report and Order, the Commission is  xretaining the existing standards for the operation of biomedical telemetry devices within the 174216 MHz  S6 - xband (TV channels 713).NP6 Za. {O0-ԍxSee 47 CFR  15.241.N At the lower signal level currently permitted, operation is not restricted to  x=health care facilities and coordination requirements with the authorized radio services using this band are  x=minimal. Further, this lower signal level may eliminate the need to change operating frequencies as DTV  xand LPTV stations change frequencies. Thus, the Commission sees no reason to delete this existing  xstandard. The Commission is, however, deleting the standard in 47 CFR  15.209(g)(2) that permitted  xbiomedical telemetry devices to operate under the general limits on TV channels 2129. It appears that  xno one has manufactured equipment for this application and that this rule is no longer necessary due to the expanded applications being adopted herein.  S8- PROCEDURAL MATTERS ă  S- Final Regulatory Flexibility Analysis  Sl-  x$37. As required by Section 603 of the Regulatory Flexibility Act, 5 U.S.C.  603 (RFA), Initial  S9- xRegulatory Flexibility Analysis (IRFA) was incorporated into the Notice of Proposed Rule Making  S- x("Notice") in ET Docket No. 95177.Qa. yO-  ԍxAmendment of Part 15 of the Commission's Rules to permit operation of biomedical telemetry devices on VHF TV channels 713 and on UHF TV channels, 11 FCC Rcd 1063 (1996). The Commission sought written public comments on the proposals  S- x>in the Notice including the IRFA. The Commission's Regulatory Flexibility Analysis (FRFA) in this  xjReport and Order conforms to the RFA, as amended by the Contract with America Advancement Act of  Sp-1996 (CWAAA), Public Law No. 104121, 110 Stat. 847 (1996).RpDa. yOT"-  OԍxSubtitle II of the CWAAA is "The Small Business Regulatory Enforcement Fairness Act of 1996"  {O#-(SBREFA), codified at 5 U.S.C.  601 et seq.  S -x1. Need for and Objective of the Rule.  S-  x%38. In this Report and Order, the Commission amends Part 15 of its rules to expand the  xavailability of frequencies and to increase the permitted power for unlicensed biomedical telemetry devices"qR,l(l(,,!"  xoperating on VHF and UHF television channels 746 within health care facilities. These devices will  xyprovide patients the freedom to move about in a limited area while being continually monitored, speeding  xkpatient recovery times, shortening lengths of stay, and reducing health care costs. The changes to the  x[regulations support spectrum efficiency by facilitating the sharing of scarce radio spectrum between two services and providing costefficient and needed medical technologies to health care communities.  S-  x2. Summary of Significant Issues Raised by the Public Comments in Response to the Initial  S-Regulatory Flexibility Analysis.  S5-  !x&39. No comments were received in direct response to the Initial Regulatory Flexibility Analysis.  xHowever, commenters expressed considerable concern regarding the potential impact of biomedical  xtelemetry devices sharing spectrum with the TV broadcast frequencies, especially in light of the  xLforthcoming introduction of DTV. Many of the commenters requested that dedicated spectrum, outside  xof the TV bands, should be set aside for biomedical telemetry devices. For example, the Society of  xBroadcast Engineers (SBE) states that potentially lifecritical biomedical telemetry has no place as a  x"bottomofthefoodchain" Part 15 device; if CCTG needs more spectrum, it should explore bands where  x\such use can occur on a licensed, and therefore protected, basis. The Public Broadcasting Service and  xthe Association of America's Public Television Stations (PBS/APTS) add that it would be a mistake for  xthe Commission to establish a new system in the TV broadcasting spectrum where substantial changes  xare planned. The Community Broadcasters Association (CBA) states that TV spectrum is a poor  xenvironment into which to launch more intensive and higher powered use of critical medical devices on  xwhich health and lives will depend. Even CCTG states that the Commission should consider dedicating  x[spectrum to the exclusive use of medical telemetry after the DTV transition. Other commenters, such as  xjthe Leesburg Regional Medical Center and Texas Children's Hospital, are concerned that interference will  xbe caused to biomedical devices from TV signals rather than interference from biomedical devices to TV signals.  S-  x'40. The Critical Care Telemetry Group that petitioned the Commission to implement these rule  x=changes and filed comments in this proceeding consists of HewlettPackard Company Medical Products  x{Group, Marquette Electronics, Inc., Pacific Communications, Siemens Medical Systems, Inc., and  S-SpaceLabs Medical, Inc.  S-x3. Description and Estimate of the Number of Small Entities Subject to Which the Rules Apply.  S:-  x(41. For purposes of the Report and Order, the RFA generally defines the term "small business"  xas having the same meaning as the term "small business concern" under the Small Business Act, 15  xU.S.C.  632, unless the Commission has developed one or more definitions that are appropriate to its  S- xMactivities.PSa. yO<-ԍxSee 5 U.S.C.  601(3).P Under the Small Business Act, a small business concern is one that: (1) is independently  xzowned and operated; (2) is not dominant in its field of operation; and (3) meets any additional criteria  xestablished by the Small Business Administration (SBA). Since the Regulatory Flexibility Act  xamendments were not in effect until the record in this proceeding was closed, the Commission was unable  xto request information regarding the number of small businesses that would be affected by this action.  xThe rules adopted in this Report and Order apply to the operation of unlicensed biomedical telemetry  xtransmitter devices for medical care facilities. These devices are used to transmit data, including heart, blood pressure and respiration monitors, to a nearby receiver.  S$-  @x)42. The Commission has not developed a definition of small entities applicable to biomedical  x=telemetry transmitter devices. Therefore, the applicable definition of small entity is the definition under"%S,l(l(,,^)"  xthe Small Business Administration (SBA) rules applicable to Communications Services "Not Elsewhere  x{Classified." This definition provides that a small entity is one with $11.0 million or less in annual  S- xreceipts.yTa. yO-ԍx13 CFR  121.201, Standard Industrial Classification (SIC) Code 4899.y According to Census Bureau data, there are 848 firms that fall under the category of  xCommunications Services, Not Elsewhere Classified. Of those approximately 775 reported annual receipts  S4- xof $11 million or less and qualify as small entities.HUX4Xa. yO,-  ԍxU.S. Bureau of the Census, U.S. Department of Commerce, 1992 Census of Transportation,  x,Communications, and Utilities, UC92S1, Subject Series, Establishment and Firm Size, Table 2D, Employment Size of Firms: 1992, SIC Code 4899 (issued May 1995).H This category is very broad, and we are unable to determine how many operators of unlicensed biomedical telemetry devices will qualify as small entities.  S-x4. Description of Projected Reporting, Recordkeeping and Other Compliance Requirements.  S5-  mx*43. The rule change will not alter current reporting, recordkeeeping or other requirements. To  xreceive equipment authorization to operate on the television channels, applicants would have to  xLdemonstrate that their biomedical telemetry devices comply with the equipment standards and obtain an authorization from the Commission.  S6 -  {x5. Significant Alternatives and Steps Taken by Agency to Minimize Significant Economic Impact  S -on a Substantial Number of Small Entities Consistent with Stated Objectives.  S -  x+44. While the Notice proposed to permit biomedical telemetry operation over the frequency  x/ranges of 174216 MHz and 470806 MHz (TV channels 769), we no longer believe that this entire  S8- xfrequency range can be made available. In the DTV Sixth Report and Order in MM Docket No. 87268  xthe Commission indicated that it plans to reallocate TV channels 5269 (698 MHz to 806 MHz) to other  S- x=services and will reallocate either TV channels 26 (5488 MHz) or 4751 (668698 MHz).2V&xa. {O-  /ԍxSee the Sixth Report and Order in MM Docket No.87268, supra. See also the Notice of Proposed Rule  {O- xMaking in ET Docket No. 97157, 62 FR 41012, July 31, 1997, proposing to reallocate TV channels 60 69 for  {O- xpublic safety use and for other services. In addition, see Balanced Budget Act of 1997, Pub. L. 10533, 111 Stat. 251 (1997), requiring the Commission to reallocate TV channels 52 69 for other services.2 Thus, this  x]spectrum no longer appears suitable for assignment to unlicensed biomedical telemetry operation.  xAccordingly, we are amending the rules to permit the operation of biomedical telemetry devices only over the frequency bands of 174216 MHz and 470668 MHz (TV channels 746).  S-x6. Report to Congress.  Sn-  x,45. The Commission shall send a copy of this Final Regulatory Flexibility Analysis, along with  xthis Report and Order, in a report to Congress pursuant to the Small Business Regulatory Enforcement  xFairness Act of 1996, 5 U.S.C.  801(a)(1)(A). A copy of this FRFA will also be published in the Federal Register.  S<-0 ORDERING CLAUSES ă  S-  x-46. Accordingly, IT IS ORDERED that Part 15 of the Commission's Rules and Regulations IS  xAMENDED as specified in Appendix B, effective 30 days after publication in the Federal Register. This"f V,l(l(,, "  x1action is taken pursuant to Sections 4(i), 301, 302, 303(e), 303(f), 303(r), 304, and 307 of the  xCommunications Act of 1934, as amended, 47 U.S.C. Sections 154(i), 301, 302, 303(e), 303(f), 303(r), 304 and 307.  S4-  mx.47. For further information regarding this Report and Order, contact the Office of Engineering and Technology, John Reed at (202) 4182455. x FEDERAL COMMUNICATIONS COMMISSION William F. Caton Acting Secretary "6 V,l(l(,,N "  S-, APPENDIX A ă  S- COMMENTING PARTIES ă Comments were filed by: Abbott Northwestern Hospital American College of Cardiology American Hospital Association (AHA) Association for the Advancement of Medical Instrumentation (AAMI) Association of Maximum Service Television (MSTV) Cleveland Clinic Foundation Community Broadcasters Association (CBA) Consumer Electronics Manufacturers Association (CEMA) Critical Care Telemetry Group (CCTG) Health Industry Manufacturers Association (HIMA) Huntsville Hospital KUED, Salt Lake City Lee Memorial Health System Leesburg Regional Medical Center Medical College Hospitals (MCH) National Association of Broadcasters (NAB) National Electrical Manufacturers Association (NEMA) Rapid City Regional Hospital Saint Agnes Medical Center San Francisco General Hospital Scott & White Memorial Hospital Society of Broadcast Engineers (SBE) Texas Children's Hospital University of California, Davis University of California, San Francisco Reply Comments were filed by: Albany Medical Center American Association of CriticalCare Nurses (AACN) Capital Cities/ABC, Inc. (CC/ABC) Critical Care Telemetry Group (CCTG) Deaconess Hospital  xDepartment of Health and Human Services, Center for Devices and Radiological Health of the Food and xDrug Administration (CDRH) Harvard Medical School, Veterans Administration Medical Center Lakeland Regional Medical Center Mission St. Joseph's Health System New England Medical Center Public Broadcasting Service and the Association of America's Public Television Stations (PBS/APTS) Rapid City Regional Hospital St. Agnes Medical Center St. Margaret Mercy Healthcare Centers Society of Broadcast Engineers (SBE)"='V,l(l(,,+"ԌUniversity of California, Los Angeles University of California, San Francisco University of Cincinnati Medical Center University Hospitals of Cleveland Westchester County Medical Center"4V,l(l(,,"  S- APPENDIX B FINAL RULES ă xPart 15 of Title 47 of the Code of Federal Regulations is amended as follows:  S4-x Part 15 RADIO FREQUENCY DEVICES x1. The authority citation for Part 15 continues to read as follows:  Sh-   x AUTHORITY: Sec. 4, 302, 303, 304, 307 and 624A of the Communications Act of 1934, as  S5-amended, 47 U.S.C. 154, 302, 303, 304, 307 and 544A. x2. Section 15.205 is amended by adding a new paragraph (d)(5), to read as follows:  Si -  15.205 Restricted bands of operation. Z * * * * * TP  x(d)(5) Biomedical telemetry devices operating under the provisions of Section 15.242 of this part are not subject to the restricted band 608614 MHz but are subject to compliance within the other restricted bands. Z * * * * * TP   x3. Section 15.209 is amended by deleting paragraphs (g)(1) and (g)(2) and by revising paragraph (g) to read as follows:  S-  15.209 Radiated emission limits; general requirements. Z * * * * * TP  x(g) Perimeter protection systems may operate in the 5472 MHz and 7688 MHz bands under the  xprovisions of this section. The use of such perimeter protection systems is limited to industrial, business and commercial applications. x4. A new Section 15.242 is added to read as follows:  S-  15.242 Operation in the bands 174216 MHz and 470668 MHz.  x[(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.  x(1) A health care facility includes hospitals and other establishments that offer services, facilities, and  x=beds for use beyond 24 hours in rendering medical treatment and institutions and organizations regularly  xengaged in providing medical services through clinics, public health facilities, and similar establishments, including governmental entities and agencies for their own medical activities.  x(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.  x(b) The fundamental emissions from a biomedical telemetry device operating under the provisions of this  x{section shall be contained within a single television broadcast channel, as defined in Part 73 of this"='V,l(l(,,+"  xzchapter, under all conditions of operation and shall lie wholly within the frequency ranges of 174216 MHz and 470668 MHz.  x(c) The field strength of the fundamental emissions shall not exceed 200 mV/m, as measured at a distance  xof 3 meters using a quasipeak detector. Manufacturers should note that a quasipeak detector function  S- x=indicates field strength per 120 kHz of bandwidth + 20 kHz. Accordingly, the total signal level over the  xNband of operation may be higher than 200 mV/m. The field strength of emissions radiated on any  xfrequency outside of the television broadcast channel within which the fundamental is contained shall not exceed the general limits in Section 15.209.  xj(d) The user and the installer of a biomedical telemetry device operating within the frequency range 174 x216 MHz, 470608 MHz or 614668 MHz shall ensure that the following minimum separation distances  xare maintained between the biomedical telemetry device and the authorized radio services operating on the same frequencies:  x(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 174216 MHz.  xy(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 470608 MHz or 614668 MHz.  x(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 174216 MHz.  x(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 470608 MHz or 614668 MHz. (5) Whatever distance is necessary to protect other authorized users within these bands.  x[(e) The user and the installer of a biomedical telemetry device operating within the frequency range 608 x614 MHz and that will be located within 32 km of the very long baseline array (VLBA) stations or within  x80 km of any of the other radio astronomy observatories noted in footnote US 311 of Section 2.106 of  xthis chapter must coordinate with, and obtain the written concurrence of, the director of the affected radio  xastronomy observatory before the equipment can be installed or operated. The National Science  xLFoundation point of contact for coordination is: Spectrum Manager, Division of Astronomical Sciences, NSF Rm 1045, 4201 Wilson Blvd., Arlington, VA 22230; tel: (703) 3061823.  x(f) Biomedical telemetry devices must not cause harmful interference to licensed TV broadcast stations  xor to other authorized radio services, such as operations on the broadcast frequencies under Subparts G  x=and H of Part 74 of this chapter, land mobile stations operating under Part 90 of this chapter in the 470 x512 MHz band, and radio astronomy operation in the 608614 MHz band. (See Section 15.5.) If  x/harmful interference occurs, the interference must either be corrected or the device must immediately  xcease operation on the occupied frequency. Further, the operator of the biomedical telemetry device must  So"- xaccept whatever level of interference is received from other radio operations. The operator, i.e., the health  xcare facility, is responsible for resolving any interference that occurs subsequent to the installation of these devices.  x.(g) The manufacturers, installers, and users of biomedical telemetry devices are reminded that they must  x-ensure that biomedical telemetry transmitters operating under the provisions of this section avoid operating  xin close proximity to authorized services using this spectrum. Sufficient separation distance, necessary">'V,l(l(,,+"  xto avoid causing or receiving harmful interference, must be maintained from cochannel operations. These  xparties are reminded that the frequencies of the authorized services are subject to change, especially during  xzthe implementation of the digital television services. The operating frequencies of the Part 15 devices  x=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.  x](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.