The FCC recently dedicated spectrum for Medical Body Area Networks (MBANs) to allow multiple wireless sensors to monitor patients. An MBAN consists of a central hub that collects data from body-worn sensors and transmits it over a healthcare facility's network to monitoring stations. The FCC will permit MBANs to operate in the 2360-2400 MHz band either indoors with coordination or anywhere without coordination. This will enhance patient safety and mobility by reducing wired connections while supporting new medical applications and wireless devices.
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Medical Body Area Networks - MBAN
1. Medical Body Area Network’s
Man to Machine to Machine
JACK BROWN
June 23, 2012
Authored by: JEB
2. Medical Body Area Network’s
Man to Machine to Machine
Medical Body Area Network ’s
Medical Body Area Network (MBAN) technology will provide a flexible platform for the
wireless networking of multiple body transmitters 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. This platform will enhance patient
safety, care and comfort by reducing the need to physically connect sensors to essential
monitoring equipment by cables and wires. As the numbers and types of medical radio devices
continue to expand, these technologies offer tremendous power to improve the state of health
care in the United States.
An MBAN is a little like a cellular wireless system in miniature, worn on a patient’s
body. Sensors around the body monitor various functions, depending on the patient’s needs, and
communicate their data to a central hub, worn by the patient or located close by. The hub
aggregates data from the various sensors, and transmits those data using the health care facility’s
network (possibly over Wi-Fi or Ethernet) to a central control point, from where the data are
made available to the professional staff for interpretation and appropriate response.
Medical applications of BAN cover continuous waveform sampling of biomedical signals,
monitoring of vital signal information, and low rate remote control of medical devices. They can
be broadly classified into two categories depending on their operating environments. One is the
wearable BAN, which is mainly operated on the surface or in the vicinity of the body, such as
medical monitoring. Another is the implantable BAN, which is operated inside the human body,
e.g. capsule endoscope and pacemaker.
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3. Wired Technologies
Wired technologies inevitably result in reduced patient mobility and increased difficulty and
delay in transporting patients. Caregivers, in turn, can spend inordinate amounts of time
managing and arranging monitor cables, as well as gathering patient data.
The introduction of MBAN represents an improvement over traditional medical monitoring
devices (both wired and wireless) in several ways, and will reduce the cost, risk and complexity
associated with health care. For example, a health care facility could monitor more patients,
particularly in patient care areas where Wireless Medical Telemetry Service (WMTS) is not
currently installed; an MBAN could be used outside the health care facility, e.g., within patients’
homes; and an MBAN could be used for both monitoring and therapeutic applications.
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4. Wireless Technologies
Wireless Medical Telemetry Service (WMTS) in health care facilities has overcome some of the
obstacles presented by wired sensor networks. Nonetheless, WMTS is an in-building network
that is often used primarily for monitoring critical care patients in only certain patient care areas.
The MBAN concept would allow medical professionals to place multiple inexpensive wireless
sensors at different locations on or around a patient’s body and to aggregate data from the
sensors for backhaul to a monitoring station using a variety of communications media.
Currently, there are multiple frequency bands available for different types of wireless medical
device applications. The MedRadio service provides an umbrella framework to regulate the
operation of both implanted and body-worn wireless medical devices used for diagnostic and
therapeutic purposes in humans. MedRadio uses spectrum in the 401-406 MHz, 413-419 MHz,
426-432 MHz, 438-444 MHz, and 451-457 MHz bands, all on a secondary basis.
The Wireless Medical Telemetry Service (WMTS) allows for the transmission of patient-related
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telemetric medical information to a central monitoring location within a hospital or other medical
facility. WMTS operates in the 608-614 MHz, 1395-1400 MHz, and 1427-1432 MHz bands on
a primary basis. In addition, medical radio device manufacturers have for many years been
allowed to market products which operate on a variety of frequencies on an unlicensed basis.
Dedicated Medical Body Area Networks (MBANs ) Wireless Spectrum
The FCC recently took regulatory action (MBAN Joint Proposal) to dedicate spectrum for
wireless monitoring sensors, or Medical Body Area Networks (MBANs), making the U.S. the
first country in the world to dedicate spectrum specifically for wireless health devices. The FCC
concluded that the only cost resulting from these new regulations is the risk of increased
interference, and have minimized that risk by adopting rules that permit an MBAN device to
operate only over relatively short distances and as part of a low power networked system.
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5. Initially Aeronautical Mobile Telemetry (AMT) licensees and the MBAN proponents – parties
strongly disagreed as to whether MBAN and AMT operations could successfully coexist in the
same frequency band. The approach taken will permit providing frequencies where an MBAN
can co-exist with existing spectrum users and engage in robust frequency re-use, which will
result in greater spectral efficiency.
FCC MBAN Joint Proposal
This FCC Joint Proposal is a comprehensive plan that draws from both the existing MedRadio
and WMTS rules to specify MBAN operational requirements for body-worn sensors and hubs. It
includes a detailed set of requirements for MBAN management within a health care facility. It also
proposes that MBAN use in the 2360-2390 MHz band be limited mostly to indoor use and subject to
specific coordination procedures and processes to protect AMT users in that band, whereas MBAN use in
the 2390-2400 MHz band could occur at any location and without coordination.
The Joint Proposal describes an MBAN as consisting of a master transmitter (hereinafter referred to as a
―hub‖), which is included in a device close to the patient, and one or more client transmitters (hereinafter
referred to as body-worn sensors or sensors), which are worn on the body and only transmit while
maintaining communication with the hub that controls its transmissions. The hub would convey data
messages to the body-worn sensors to specify, for example, the transmit frequency that should be used.
The hub and sensor devices would transmit in the 2360-2400 MHz band. The hub would aggregate
patient data from the body-worn sensors under its control and, using the health care facility’s local area
network (LAN) (which could be, for example, Ethernet, WMTS or Wi-Fi links), transmit that information
to locations where health care professionals monitor patient data. The hub also would be connected via
the facility’s LAN to a central control point that would be used to manage all MBAN operations within
the health care facility.
To protect AMT operations from harmful interference, the Joint Proposal would have the Commission
designate an MBAN frequency coordinator who would coordinate MBAN operations in the 2360-2390
MHz band with the AMT frequency coordinator. The control point would serve as the interface between
the MBAN coordinator and the MBAN master transmitters to control MBAN operation in the 2360-2390
MHz band. The control point would receive an electronic key, which is a data message that specifies and
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enables use of specific frequencies by the MBAN devices. The control point, in turn, would generate a
beacon or control message to convey a data message to the hub via the facility’s LAN that specifies the
authorized frequencies and other operational conditions for that MBAN.
MBAN - Licensed by Rule
To help encourage the development of MBAN devices and applications, the FCC decided not to
require users to apply for and receive individual licenses from the FCC. Instead, all MBANs will
be ―licensed by rule,‖ which means that users will be deemed licensed as long as they abide by
all technical and operational limitations.
However, MBAN operations will be permitted only on a secondary basis — users must not cause
harmful interference to and must accept interference from the primary licensees in the band.
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6. MBAN Power and Frequency Summary
The permitted MBAN operations depend on which portion of the band will be used:
MBANs using the 30 MHz in the 2360-2390 MHz band. MBAN operations in this band
are restricted to indoor uses in health care facilities. Users of this portion of the band will
be required to register with an MBAN coordinator (discussed below, will be selected at a
later date) and coordinate with primary licensees, if necessary.
MBANs using the 10 MHz in the 2390-2400 MHz band. In this band, MBAN operations
can be used in any location, such as in a health care facility, in a patient’s home, or
outdoors while the patient is in transit (e.g. ambulances). Users of this portion of the band
will not be subject to registration and coordination requirements.
Power limits are relatively generous: 1 milliwatt at 2360-2390 MHz, with a higher limit
of 20 milliwatts at 2390-2400 MHz, in part to give patients greater mobility within their
homes.
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FDA Role in MBAN Functions
In the past, the Food and Drug Administration (―FDA‖) has expressed concern about the
potential for interference when health care providers rely on wireless medical devices. In a 2007
draft guidance document, Radio-Frequency Wireless Technology in Medical Devices, FDA
commented that a quality system for devices that incorporate wireless technology should address
potential concerns such as wireless quality of service, wireless coexistence, data integrity and
security, and applicable EMC and telecommunications standards and regulations. As a result,
there is likely to be increased collaboration between the FCC and the FDA as wireless medical
devices enter the market. In particular, the FCC suggested that the FDA could play an important
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7. role in specifying whether MBANs may be used to perform functions that are life-critical or
time-sensitive.
Wireless Coexistence
Although there is some overlap between electromagnetic compatibility (EMC) and wireless
coexistence, differences exist. Wireless coexistence is the ability of one wireless system to
perform a task in an environment where other systems that may or may not be using the same set
of rules can also perform their tasks.EMC is the ability of a device to function properly in its
intended electromagnetic environment without introducing excessive electromagnetic energy that
could interfere with other devices. Manufacturers of electrically powered medical devices
routinely test their equipment to applicable national and international consensus safety standards.
EMC test results are often used to support safety claims to regulatory agencies such as FDA.
Less well-known are the issues and concerns associated with wirelessly enabled medical devices,
although this is changing thanks to FDA’s guidance document on wireless medical devices.
At any given time, a typical home or hospital uses a number of wireless systems (e.g., IEEE
802.11a/b/g/n, or WiFi; Bluetooth; ZigBee; cordless phones) operating on the same industrial,
scientific, and medical (ISM) band. Given the increasing use of wireless, RF wireless medical
devices and other wireless systems operating nearby can interfere with each other. If a collision
between their respective transmissions occurs, data packets transmitted by medical devices could
be delayed or blocked, potentially interfering with timely transmissions of critical data.
Techniques such as retransmission and forward error correction might no longer be sufficient to
overcome interference and spectrum congestion. Hence, methods to design and test wirelessly
enabled medical devices for risks associated with coexistence of wireless technologies are
essential for innovative, safe, and effective RF wireless medical devices.
Summary
There is a need for ultra low power devices and operation on, in or around the human body to
serve a variety of applications including medical and personal entertainment. Examples of the
applications are: Electroencephalogram (EEG), Electrocardiogram (ECG), Electromyography
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(EMG), vital signals monitoring (temperature (wearable thermometer), respiratory, wearable
heart rate monitor, wearable pulse oximeter, wearable blood pressure monitor, oxygen, pH value,
wearable glucose sensor, implanted glucose sensor, cardiac arrhythmia), wireless capsule
endoscope (gastrointestinal), wireless capsule for drug delivery, deep brain stimulator, cortical
stimulator (visual neuro-stimulator, audio neuro stimulator, Parkinson’s disease, etc…), remote
control of medical devices such as pacemaker, actuators, insulin pump, hearing aid (wearable
and implanted), retina implants, disability assistance, such as muscle tension sensing and
stimulation, wearable weighing scale, fall detection, aiding sport training. This will include
body-centric solutions for future wearable computers.
In a similar vein, the same technology can provide effective solutions for personal entertainment
as well. The existence of medical body area networks will provide opportunities to expand these
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8. product features, better healthcare and well being for the users. It will therefore result in
economic opportunity for technology component suppliers and equipment manufacturers.
Medical applications are critical applications and may be life critical. The requirements for
medical Body Area Networks (BANs) include: robust links for bounded data loss and bounded
latency, capacity for high density of patients and sensors, coexistence with other radios, battery
life for days to months of continuous operation, and small form factors for body devices.
These requirements can be satisfied through the utilization of a number of techniques including
error control techniques and adaptive repeat requests, low duty cycle and power management,
and the development of more efficient, diverse antennas.
Existing standards have been designed for commercial applications with little or no consideration
for life saving emergency scenarios. In particular, there is a need to ensure reliable
communications by network devices such as sensors that are involved in emergency situations,
while ensuring low power consumption.
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