[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]
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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.
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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).
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\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).
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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.
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\2\ See 5 U.S.C. Sec. 601(3).
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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.
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\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).
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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).
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\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.
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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 bandwidth
20 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