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Medical Body Area Networks

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Released: May 13, 2013
Federal Communications Commission
Washington, D.C. 20554
‘ May 13, 2013

DA 13-1081

Small Entity Compliance Guide

Medical Body Area Networks

Report and Order
FCC 12-54
ET Docket No. 08-59
Released: May 24, 2012

This Guide is prepared in accordance with the requirements of Section 212 of the
Small Business Regulatory Enforcement Fairness Act of 1996. It is intended to
help small entities—small businesses, small organizations (non-profits), and
small governmental jurisdictions—comply with the new rules adopted in the
above-referenced FCC rulemaking docket(s). This Guide is not intended to
replace the rules and, therefore, final authority rests solely with the rules.
Although we have attempted to cover all parts of the rules that might be
especially important to small entities, the coverage may not be exhaustive. This
Guide may, perhaps, not apply in a particular situation based upon the
circumstances, and the FCC retains the discretion to adopt approaches on a case-
by-case basis that may differ from this Guide, where appropriate. Any decisions
regarding a particular small entity will be based on the statute and regulations.

In any civil or administrative action against a small entity for a violation of
rules, the content of the Small Entity Compliance Guide may be considered as
evidence of the reasonableness or appropriateness of proposed fines, penalties or
damages. Interested parties are free to file comments regarding this Guide and
the appropriateness of its application to a particular situation; the FCC will
consider whether the recommendations or interpretations in the Guide are
appropriate in that situation. The FCC may decide to revise this Guide without
public notice to reflect changes in the FCC’s approach to implementing a rule,
or to clarify or update the text of the Guide. Direct your comments and
recommendations, or calls for further assistance, to the FCC’s Con sumer
Center:

1-888-CALL-FCC (1-888-225-5322)

TTY: 1-888-TELL-FCC (1-888-835-5322)

Fax: 1-866-418-0232

fccinfo@fcc.gov

Medical Body Area Networks

1. Objectives of the Proceeding
In the First Report and Order adopted May 24, 2012 in ET Docket 08-59, the Commission amended the
Part 95 rules governing MedRadio devices to enable networks of body-worn medical devices called
medical body area networks. Medical body area networks, or MBANs for short, are networks of devices
worn on the human body that communicate with a programmer/controller device outside the body using a
wireless communication link. MBANs are used for the purpose of measuring and recording physiological
parameters and other patient information or for performing diagnostic or therapeutic functions, primarily
in health care facilities.
The existing MedRadio rules under Part 95 of the Commission’s rules allow implanted and body-worn
medical devices to operate in discrete bands within the 401-457 MHz spectrum. The First Report and
Order
amends the MedRadio rules to allow MBANs to operate in the 2360-2400 MHz frequency band on
a secondary basis. This frequency band is used for other purposes on a primary basis, such as Federal
government and private aeronautical mobile telemetry (AMT) transmissions, amateur radio, and radio
astronomy. Because MBANs will operate on a secondary basis, they may not cause interference to and
must accept interference from primary users of these frequency bands. MedRadio device use of this
frequency band is limited to MBANs.
A copy of this First Report and Order is available at:
http://hraunfoss.fcc.gov/edocs_public/attachmatch/FCC-12-54A1_Rcd.pdf
2. Definitions
MBANs are defined in the Part 95 rules as follows:
A low power network consisting of a MedRadio programmer/control transmitter and
multiple medical body-worn devices all of which transmit or receive non-voice data or
related device control commands for the purpose of measuring and recording
physiological parameters and other patient information or performing diagnostic or
therapeutic functions via radiated bi- or uni-directional electromagnetic signals.
3. Restrictions on MBAN Operation
Use of MBANs must comply with the following restrictions:
 MBANs can be used only for diagnostic and therapeutic purposes.
 MBANs must be provided to a patient only under the direction of a duly authorized health care
professional.
 MBANs may not cause harmful interference to other authorized stations operating in the 2360-
2400 MHz band.
 MBANs must accept interference from other authorized stations operating in the 2360-2400 MHz
band.
 MBAN devices may not be used to relay information to other devices that are not part of the
MBAN using the 2360-2400 MHz frequency band.
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 In order to protect AMT operations, there are additional restrictions placed on MBAN operation
in the 2360-2390 MHz band: operation within this band may only occur indoors at an authorized
healthcare facility (as defined in the Part 95 MedRadio Rules); and operation may only occur
upon completion of registration, and, if necessary, coordination with an authorized MBAN
frequency coordinator.
 MBAN body-worn devices may only communicate with the programmer/controller for their
MBAN. An MBAN body-worn device may not communicate directly with another MBAN body-
worn device.
 MBAN transmitters must be certificated by the FCC or a Telecommunications Certification Body
(TCB) designated by the FCC. To obtain certification, the manufacturer must submit a
certification application accompanied by a measurement report showing compliance with the
FCC technical requirements to the Commission or TCB. See 47 C.F.R. § 2.1033 for the
certification application requirements or http://www.fcc.gov/encyclopedia/equipment-
authorization-procedures for more information.
 MBAN devices are licensed by rule and, as such, individual licenses are not required for MBAN
use.
4. Technical Requirements
MBANs must comply with a number of technical requirements designed to allow them to share the 2360-
2400 MHz frequency band with primary users and other MBANs. Specifically, these requirements are
that:
 An MBAN programmer/control transmitter shall not commence operating and shall
automatically cease operating in the 2360-2390 MHz band if it does not receive, in accordance
with the protocols specified by the manufacturer, a control message permitting such operation
Additionally, an MBAN programmer/control transmitter operating in the 2360-2390 MHz band
shall comply with a control message that notifies the device to limit its transmissions to segments
of the 2360-2390 MHz band or to cease operation in the band.
 MBAN transmitters are allowed a maximum emission bandwidth of five megahertz.
 MBAN transmitters operating in the 2360-2390 MHz band are allowed a maximum EIRP over
the frequency bands of operation that shall not exceed the lesser of 1 mW or 10*log (B) dBm,
where B is the 20 dB emission bandwidth in MHz.
 MBAN transmitters operating in the 2390-2400 MHz band are allowed a maximum EIRP over
the frequency bands of operation that shall not exceed the lesser of 20 mW or 16+10*log (B)
dBm, where B is the 20 dB emission bandwidth in MHz.
 In the first 2.5 megahertz beyond the 2360-2400 MHz band, the EIRP level associated with any
unwanted emission must be attenuated within a 1 megahertz bandwidth by at least 20 dB relative
to the maximum EIRP level within any 1 megahertz of the fundamental emission. In addition,
emissions from an MBAN transmitter that are more than 2.5 megahertz beyond any of the
frequency bands authorized for MBAN operation must be less than field strength limits specified
in the Part 95 rules.
 Each MBAN transmitter must maintain a frequency stability of ±100 ppm of the operating
frequency over the range 0 °C to 55 °C.
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5. Labeling and Other Requirements
MBANs must comply with a number of other requirements designed to inform medical professionals
about the secondary status of MBANs and allow the Commission to enforce the Part 95 rules governing
MBAN operation:
 All MBAN devices must be made available for inspection upon request by an authorized FCC
representative.
 Persons operating body-worn MBAN transmitters are required to cooperate reasonably with duly
authorized FCC representatives in the resolution of interference.
 A disclosure statement as specified in the Part 95 rules must be included with each MBAN
transmitting device. This disclosure statement warns that the device must accept interference
from and not cause interference to primary users sharing the same frequency bands. The
statement also warns that there is no guarantee that the MBAN device will not receive
interference.
 MBAN programmer/control transmitters must be labeled with a statement as specified in the Part
95 rules. The statement warns that the device may not cause interference to and must accept
interference from devices that are operating on a primary basis in the same frequency bands as the
MBAN programmer/control transmitter. The statement may be placed in the instruction manual
for the transmitter where it is not feasible to place the statement on the device.
 MBAN programmer/controller transmitters must be identified by a serial number that is assigned
by the device manufacturer. This serial number may be placed either on the device or in the
instruction manual for the transmitter.
6. Weblink and Citations
The First Report and Order adopted May 24, 2012: Amendment of the Commission’s Rules to Provide
Spectrum for the Operation of Medical Body Area Networks, ET Docket No. 08-59, First Report and
Order and Further Notice of Proposed Rulemaking,
27 FCC Rcd 6422 (2012). Available at:
http://hraunfoss.fcc.gov/edocs_public/attachmatch/FCC-12-54A1_Rcd.pdf
The Notice of Proposed Rulemaking that preceded the May 24, 2012 First Report and Order:
Amendment of the Commission’s Rules to Provide Spectrum for the Operation of Medical Body Area
Networks, ET Docket No. 08-59, Notice of Proposed Rulemaking, 24 FCC Rcd 9589 (2009). Available
at: http://hraunfoss.fcc.gov/edocs_public/attachmatch/FCC-09-57A1_Rcd.pdf.
The Notice of Inquiry regarding medical devices which proceeded the Notice of Proposed Rulemaking:
Investigation of the Spectrum Requirements for Advanced Medical Technologies, ET Docket Nos. 06-
135, 05-213, 03-92, Notice of Proposed Rulemaking, Notice of Inquiry, and Order, 21 FCC Rcd 8164
(2006). Available at: http://hraunfoss.fcc.gov/edocs_public/attachmatch/FCC-06-103A1.pdf
A previous small business compliance guide addressing the previous amendment to the MedRadio rules is
available at: http://hraunfoss.fcc.gov/edocs_public/attachmatch/DA-11-912A1.doc
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