ETSI TR 101 557 V1.1.1 (2012-02)

Electromagnetic compatibility and Radio spectrum Matters (ERM); System Reference document (SRdoc); Medical Body Area Network Systems (MBANSs) in the 1 785 MHz to 2 500 MHz range

DTR/ERM-TG30-100

General Information

• Status: Published
• Publication Date: 20-Feb-2012
• Technical Committee: ERM TG30 - ERM Wireless Medical Devices
• Current Stage: 12 - Completion
• Due Date: 22-Feb-2012
• Completion Date: 21-Feb-2012

Standards Content (Sample)

Technical Report
Electromagnetic compatibility
and Radio spectrum Matters (ERM);
System Reference document (SRdoc);
Medical Body Area Network Systems (MBANSs) in the
1 785 MHz to 2 500 MHz range
2 ETSI TR 101 557 V1.1.1 (2012-02)

Reference
DTR/ERM-TG30-100
Keywords
SRD, SRdoc, health
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3 ETSI TR 101 557 V1.1.1 (2012-02)
Contents
Intellectual Property Rights . 5
Foreword . 5
Executive summary . 5
Introduction . 6
1 Scope . 7
2 References . 7
2.1 Normative references . 7
2.2 Informative references . 7
3 Definitions, symbols and abbreviations . 10
3.1 Definitions . 10
3.2 Symbols . 11
3.3 Abbreviations . 11
4 Comments on the System Reference Document . 13
4.1 Statements by ETSI Members . 13
5 Presentation of the system or technology . 13
5.1 Definition and applications. 13
5.2 Societal benefits . 14
6 Market information. 15
6.1 Wireless patient monitoring - general trends . 15
6.2 Wireless patient monitoring in hospitals . 16
7 Technical information . 16
7.1 Detailed technical description . 17
7.2 Technical parameters and implications on spectrum . 17
7.2.1 Status of technical parameters . 18
7.2.1.1 Current ITU and European Common Allocations . 18
7.2.1.2 Sharing and compatibility studies (if any) already available . 20
7.2.1.3 Sharing and compatibility issues still to be considered . 20
7.2.2 Transmitter parameters . 22
7.2.2.1 Transmitter Output Power / Radiated Power. 22
7.2.2.1a Antenna Characteristics . 22
7.2.2.2 Operating Frequency . 23
7.2.2.3 Bandwidth . 23
7.2.2.4 Unwanted emissions. 23
7.2.3 Receiver parameters . 23
7.2.3.1 Receiver Sensitivity . 23
7.2.3.2 Receiver blocking . 24
7.2.3.3 Interference criteria . 24
7.2.4 Channel access parameters . 24
7.3 Information on relevant standard(s) . 24
8 Radio spectrum request and justification . 25
8.1 Preliminary frequency band evaluation . 25
8.1.1 1 785 MHz to 1 805 MHz . 25
8.1.2 2 360 MHz to 2 400 MHz . 26
8.1.3 2 400 MHz to 2 483,5 MHz (2,4 GHz generic SRD band) . 26
8.1.4 2 483,5 MHz to 2 500 MHz . 27
8.2 Summary of the preliminary assessment of the frequency bands . 27
9 Regulations . 28
9.1 Current regulations . 28
9.1.1 ITU-R Radio Regulations . 28
9.1.2 European Common Allocation Table . 29
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4 ETSI TR 101 557 V1.1.1 (2012-02)
9.2 Proposed regulation and justification . 32
Annex A: Detailed technical information . 34
A.1 Technical parameters and justifications for spectrum . 34
A.1.1 Maximum Radiated Power . 34
A.1.1.1 Proposed Maximum Radiated Power . 34
A.1.1.2 Link Budget Analysis . 34
A.1.1.2.1 MBANS Radio Parameters . 34
A.1.1.2.2 Link Budget Analysis for In-hospital MBANS Applications . 35
A.1.1.2.3 Link Budget Analysis for Home Healthcare MBANS Applications . 39
A.1.2 Emission Bandwidth. 41
A.1.2.1 Proposed Emission Bandwidth . 41
A.1.2.2 Technical Justification . 42
A.1.3 Total amount of Spectrum Designation . 45
A.2 RF safety considerations . 49
Annex B: Bibliography . 50
History . 51

ETSI
5 ETSI TR 101 557 V1.1.1 (2012-02)
Intellectual Property Rights
IPRs essential or potentially essential to the present document may have been declared to ETSI. The information
pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found
in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in
respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web
server (http://ipr.etsi.org).
Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee
can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web
server) which are, or may be, or may become, essential to the present document.
Foreword
This Technical Report (TR) has been produced by ETSI Technical Committee Electromagnetic compatibility and Radio
spectrum Matters (ERM).
ETSI ERM has in preparation a System Reference Document, TR 102 889-2 [i.29] for Technical characteristics for
SRD equipment for wireless industrial applications using technologies different from Ultra-WideBand (UWB). ETSI
has also identified two of the candidate frequency bands (2 360 MHz to 2 400 MHz and 2 483,5 MHz to 2 500 MHz)
proposed for MBANSs as candidate bands for these wireless industrial applications. Both applications are license
exempt SRD applications but can be both considered as critical within their environment and hence why the usual SRD
bands are not intended to be used by these systems.
A MBANS is intended to be used mainly in hospitals, or at a later stage of the treatment, at the patient's home. In any
case the environment for the application is far away from the application of e.g. wireless sensors used for machine
automation in a factory environment. This is why these two applications in such clearly defined but totally different
environments will not harmfully interfere with each other.
The CEPT is requested to give due consideration on both requests simultaneously. Obviously, the possible impact on
other services remains to be studied.
Executive summary
MBANSs are intended to provide wireless networking of multiple body sensors and actuators used for monitoring
patient physiological parameters, patient diagnosis and patient treatment, primarily in healthcare facilities as well as in
other healthcare monitoring situations such as ambulances and the patient's home. Use of MBANSs holds the promise
of improved quality and efficiency of patient care by reducing or eliminating a wide array of hardwired, patient-
attached cables used by present monitoring technologies.
Providing spectrum for MBANS operations would serve the public interest in the light of the significant healthcare
benefits provided by MBANSs. The present document provides an overview of MBANS technologies that can address
this opportunity.
The proponents (Philips, Zarlink, Texas Instruments and Dutch Ministry of Economic Affairs Agriculture and
Innovation) have an interest in addressing a growing market for MBANS services in the frequency range 1 785 MHz to
2 500 MHz but are concerned that no specific regulatory guidance from CEPT/ECC exists for administrations wishing
to implement the MBANSs.
The present document gives an overview of a MBANS, its technical parameters, possible implementation scenarios,
including co-existence scenarios with the incumbent services and economical and societal benefits.
A spectrum of 40 MHz between 1 785 MHz and 2 500 MHz is required for MBANS operation. A 40 MHz spectrum
designation plays a key role in enabling MBANS devices achieve harmonized coexistence with other services. It
enables MBANS equipment to use low-power and limited duty cycle, while providing sufficient space for MBANSs to
avoid interference to/from other services. It is also needed to support MBANS co-existence in high-density deployment
scenarios. The proposed 40 MHz designation affords meaningful frequency diversity that would allow MBANS devices
to use lower transmission power and therefore mitigate potential interference to other services.
ETSI
6 ETSI TR 101 557 V1.1.1 (2012-02)
Initially, only the band 2 360 MHz to 2 400 MHz has been proposed by the SRdoc to be considered for use by MBANS.
However, during the SRdoc development process, the 1 785 MHz to 1 805 MHz, 2 400 MHz to 2 483,5 MHz and
2 483,5 MHz to 2 500 MHz bands were suggested as other candidate bands to be considered for designation for
MBANS use. A preliminary assessment of these bands is given in clause 8.
It is proposed that the bigger portion (75 %) of the required operational band should be used only inside the healthcare
facilities such as hospitals, clinics, emergency rooms etc. (indoor use), and the smaller portion (25 %) should be used
both inside and outside the boundaries of healthcare facilities (indoor and outdoor).
Frequency aspects of MBANS are discussed in greater detail in clause 8 and annex A.
The required emission bandwidth is up to 5 MHz for proper operation of the MBANS. The emission bandwidth used
would depend on the data-rate requirement of the particular MBANS application. For high data-rate applications
(e.g. 250 kbps and beyond), the bandwidth would be 3 MHz to 5 MHz. For low data-rate applications, the bandwidth
would be 1 MHz to 3 MHz.
For MBANS transmitters operating within the healthcare facility sub-band (indoor), the maximum transmitted power
over the emission bandwidth is 1 mW e.i.r.p. For MBANS transmitters operating within the location independent
sub-band, the maximum transmitted power over the emission bandwidth is 20 mW e.i.r.p.
The proposed MBANSs will operate at limited duty cycle to reduce power consumption and avoid interference to other
services. It is expected that the duty cycle of a MBANS for in-hospital use will not be more than 25 %. For location
independent MBANS applications, such as in patient homes, a much lower duty cycle of usually less than 2 % is
expected.
Listen-Before-Talk (LBT), Adaptive Power Control (APC), Automatic Repeat Request (ARQ), channel coding,
spectrum spreading, frequency agility, and other mechanisms may be used by MBANSs for efficient operation and
compatibility with other services.
A detailed technical description of MBANS, including the required bandwidth, power and channel access mechanisms,
is provided in clause 7.
The proponents are of the opinion that designation of the required spectrum for the use of MBANSs based on the
proposed technical and operational characteristics will not be a source of interference to current users of the band.
MBANS is proposed to operate as license exempt SRD.
Introduction
The present document has been developed to support the co-operation between ETSI and the Electronic
Communications Committee (ECC) of the European Conference of Postal and Telecommunications Administrations
(CEPT).
The present document is intended to define the required frequency range by describing the system and providing an
estimation of the radio spectrum demand for Medical Body Area Network Systems (MBANSs). It thus intends to lay
the foundation for industry to quickly implement innovative systems within Europe while avoiding harmful interference
with other services and systems and providing spectrum identical with other parts of the world, thus allowing European
industry to be more competitive.
ETSI
7 ETSI TR 101 557 V1.1.1 (2012-02)
1 Scope
The present document describes Medical Body Area Network Systems (MBANSs), which will require a change of the
present frequency designation within CEPT.
The types of devices that can belong to MBANSs are on-body and off-body medical sensors, patient monitoring devices
and medical actuators covered by the Medical Device Directive (Directive 93/42/EEC [i.30]). Implantable devices do
not fall within the scope of MBANSs.
The present document includes in particular:
• Market information.
• Technical information including expected sharing and compatibility issues.
• Regulatory issues.
2 References
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the
reference document (including any amendments) applies.
Referenced documents which are not found to be publicly available in the expected location might be found at
http://docbox.etsi.org/Reference.
NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee
their long term validity.
2.1 Normative references
The following referenced documents are necessary for the application of the present document.
Not applicable.
2.2 Informative references
The following referenced documents are not necessary for the application of the present document but they assist the
user with regard to a particular subject area.
[i.1] GE Healthcare, Ex Parte Comments of GE Healthcare in Docket 06-135, December 2007.
NOTE: Available at http://fjallfoss.fcc.gov/ecfs/document/view.action?id=6519820996.
[i.2] Notice of Proposed Rulemaking in 08-59.
NOTE: Available at http://fjallfoss.fcc.gov/ecfs/document/view?id=7020036990.
[i.3] ERC Report 25: "The European table of frequency allocations and utilisations in the frequency
range 9 kHz to 3000 GHz".
[i.4] ITU-R Radio Regulations, Edition 2008; Article 5.
[i.5] ERC/REC 62-02 E (Tromsø 1997): "Harmonised frequency band for civil and military airborne
telemetry applications".
[i.6] Revised ERC/REC 25-10: "Frequency ranges for the use of temporary terrestrial audio and video
SAP/SAB links" (incl. ENG/OB).
ETSI
8 ETSI TR 101 557 V1.1.1 (2012-02)
[i.7] ETSI EN 301 783: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Land
Mobile Service; Commercially available amateur radio equipment".
[i.8] ETSI EN 302 064: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Wireless
Video Links (WVL) operating in the 1,3 GHz to 50 GHz frequency band".
[i.9] ERC/REC 70-03: "Relating to the use of short range devices (SRD)".
[i.10] ERC Report 038: "Handbook on radio equipment and systems video links for ENG/OB use".
[i.11] ECC Report 149: "Analysis on compatibility of Low Power-Active Medical Implant (LP-AMI)
applications within the frequency range 2360-3400 begin-of-the-skype-highlightingend-of-the-
skype-highlighting MHz, in particular for the band 2483.5-2500 MHz, with incumbent services".
[i.12] ERC/REC 74-01: "Unwanted emissions in the spurious domain".
[i.13] ITU-R Recommendation M.1459 for interference protection.
[i.14] White paper: "Together for Health: A Strategic Approach for the EU 2008-2013".
NOTE: Available at http://ec.europa.eu/health-eu/doc/whitepaper_en.pdf.
[i.15] MedWiN Physical Layer Proposal, IEEE P802.15-09-0329-00-0006, May 2009.
NOTE: Available at https://mentor.ieee.org/802.15/dcn/09/15-09-0329-00-0006-medwin-physical-layer-proposal-
documentation.pdf.
[i.16] K.Y.Yazdandoost, et al: "Channel Model for Body Area Network (BAN)",
IEEE P802.15-08-0780-09-0006.
NOTE: Available at https://mentor.ieee.org/802.15/dcn/08/15-08-0780-09-0006-tg6-channel-model.pdf.
[i.17] Akram Alomainy, et al: "Statistical Analysis and Performance Evaluation for On-Body Radio
Propagation with Microstrip Patch Antennas", IEEE Transactions on antennas and propagation,
Vol. 55, No. 1, pp 245-248, January 2007.
[i.18] http://www.airlink101.com/download/download_links/7ma-manual.pdf.
[i.19] M.Singh, Z. Lei, F. Chin, and Y.S. Kwok: "A cyclic odd bit inversion code mapping and
modulation scheme for the IEEE 802.15.4b 868 MHz band", IEEE Wireless Communications and
Networking Conference (WCNC) vol. 4, pp. 1806-1810, 2006.
[i.20] John Pinkney, and Abu Sesay: "Characterization of the On-Body Wireless Channel at 2.4 and 5.8
GHz", IEEE VTC-2005-Fall.
[i.21] X. Liang, and I. Balasingham: "Performance analysis of the IEEE 802.15.4 based ECG monitoring
network", Proceedings of the seventh IASTED international conferences Wireless and Optical
Communications, 2007.
[i.22] "Eurostat population projections", published on the International Day of Older Persons,
29 September 2006.
[i.23] Standard IEEE 802.15.4: "Wireless medium access control (MAC) and physical layer (PHY)
specifications for low-rate wireless personal area networks (WPANs)", September 2006.
[i.24] Philips, GE, AFTRCC Joint FCC Ex Parte 01-14-2011.
NOTE: Available at http://fjallfoss.fcc.gov/ecfs/document/view?id=7021025926.
[i.25] Council Recommendation 1999/519/EC of 12 July 1999 on the limitation of exposure of the
general public to electromagnetic fields (0 Hz to 300 GHz).
[i.26] Chipcon Products from Texas Instruments, CC2400 datasheet.
NOTE: Available at: http://focus.ti.com/lit/ds/symlink/cc2400.pdf.
ETSI
9 ETSI TR 101 557 V1.1.1 (2012-02)
[i.27] Chipcon Products from Texas Instruments, CC2420 datasheet.
NOTE: Available at: http://focus.ti.com/lit/ds/symlink/cc2420.pdf.
[i.28] Andrew Fort: "Body area communications: Channel characterization and ultra-wideband system-
level approach for low power", Nov. 2007.
NOTE: Available at: http://wwwir.vub.ac.be/elec/PhDpdf/mainAndrew.pdf.
[i.29] ETSI TR 102 889-2: "Electromagnetic compatibility and Radio spectrum Matters (ERM); System
Reference Document; Short Range Devices (SRD); Part 2: Technical characteristics for SRD
equipment for wireless industrial applications using technologies different from Ultra-Wide Band
(UWB)".
[i.30] Council Directive 93/42/ECC of 14 June 1993 concerning medical devices.
[i.31] ETSI EN 301 908-19: "IMT cellular networks; Harmonized EN covering the essential
requirements of article 3.2 of the R&TTE Directive; Part 19: OFDMA TDD WMAN (Mobile
WiMAX) TDD User Equipment (UE)".
[i.32] ETSI EN 301 908-20: "IMT cellular networks; Harmonized EN covering the essential
requirements of article 3.2 of the R&TTE Directive; Part 20: OFDMA TDD WMAN (Mobile
WiMAX) TDD Base Stations (BS)".
[i.33] ETSI EN 301 473: "Satellite Earth Stations and Systems (SES); Aircraft Earth Stations (AES)
operating under the Aeronautical Mobile Satellite Service (AMSS)/Mobile Satellite Service (MSS)
and/or the Aeronautical Mobile Satellite on Route Service (AMS(R)S)/Mobile Satellite Service
(MSS)".
[i.34] ETSI EN 301 441: "Satellite Earth Stations and Systems (SES); Harmonized EN for Mobile Earth
Stations (MESs), including handheld earth stations, for Satellite Personal Communications
Networks (S-PCN) in the 1,6/2,4 GHz bands under the Mobile Satellite Service (MSS) covering
essential requirements under Article 3.2 of the R&TTE directive".
[i.35] ETSI EN 300 440: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Short
range devices; Radio equipment to be used in the 1 GHz to 40 GHz frequency range; Part 1:
Technical characteristics and test methods".
[i.36] ETSI EN 300 328: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband
transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using
wide band modulation techniques; Harmonized EN covering essential requirements under
article 3.2 of the R&TTE Directive".
[i.37] ETSI EN 300 761: "Electromagnetic Compatibility and Radio Spectrum Matters (ERM); Short
Range Devices (SRD); Automatic Vehicle Identification (AVI) for railways operating in the
2,45 GHz frequency range".
[i.38] ETSI EN 300 422: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Wireless
microphones in the 25 MHz to 3 GHz frequency range".
[i.39] ETSI EN 301 840: "Electromagnetic compatibility and Radio Spectrum Matters (ERM); Digital
radio microphones operating in the CEPT Harmonized band 1 785 MHz to 1 800 MHz".
[i.40] ETSI EN 301 357: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Cordless
audio devices in the range 25 MHz to 2 000 MHz".
[i.41] ETSI EN 300 454: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Wide
band audio links".
[i.42] ECC/DEC/(07)04 of 21 December 2007 on free circulation and use of mobile satellite terminals
operating in the Mobile-Satellite Service allocations in the frequency range 1-3 GHz.
[i.43] ECC/DEC/(07)05 of 21 December 2007 on exemption from individual licensing of land mobile
satellite terminals operating in the Mobile-Satellite Service allocations in the frequency range
1-3 GHz.
ETSI
10 ETSI TR 101 557 V1.1.1 (2012-02)
[i.44] ERC/DEC/(97)03 of 30 June 1997 on the Harmonised Use of Spectrum for Satellite Personal
Communication Services (S-PCS) operating within the bands 1610-1626.5 MHz,
2483.5-2500 MHz,1980-2010 MHz and 2170-2200 MHz.
[i.45] ERC/DEC/(97)05 of 30 June 1997 on Free Circulation, Use and Licensing of Mobile Earth
Stations of Satellite Personal Communications Services (S-PCS) Operating within the Bands
1610-1626.5 MHz, 2483.5-2500 MHz, 1980-2010 MHz and 2170-2200 MHz within the CEPT.
[i.46] IEEE 802.15.6: "IEEE Standard for Information technology—Telecommunications and
information exchange between systems—Local and metropolitan area networks—Specific
requirements; Part 15.6".
[i.47] Frost & Sullivan 2009: "The European Market for Wireless patient Monitoring devices".
[i.48] ECC/DEC/(02)06 of 15 November 2002 on the designation of frequency band 2500 - 2690 MHz
for UMTS/IMT-2000.
[i.49] ERC/DEC/(01)07 of 12 March 2001 on harmonised frequencies, technical characteristics and
exemption from individual licensing of Short Range Devices used for Radio Local Area Networks
(RLANs) operating in the frequency band 2400 - 2483.5 MHz.
[i.50] ERC/DEC/(01)08 of 12 March 2001 on harmonised frequencies, technical characteristics and
exemption from individual licensing of Short Range Devices used for Movement Detection and
Alert operating in the frequency band 2400 - 2483.5 MHz.
3 Definitions, symbols and abbreviations
3.1 Definitions
For the purposes of the present document, the following terms and definitions apply:
acuity: characteristic of a medical condition that expresses the degree to which the condition has either or both of a
rapid onset and a short course
NOTE: Emergency rooms, operating rooms and intensive care units are typical high acuity settings, whereas
general wards and the patient's home are low acuity settings.
contention-based protocol: protocol that allows multiple devices to share the same spectrum by defining the events
that occurs when two or more transmitters attempt to simultaneously access the same channel and establishing rules by
which a transmitter provides reasonable opportunities for other transmitters to operate on the same channel
NOTE: Such a protocol may consist of procedures for initiating new transmissions, procedures for determining
the state of the channel (available or unavailable), and procedures for managing retransmissions in the
event of an occupied channel.
duly authorized healthcare professional: physician or other individual authorized by law to provide healthcare
services using prescription medical devices
healthcare facility: hospital or other establishment where medical care is provided by authorized healthcare
professionals
hub: MBANS device functioning as a patient monitor that selects frequency of operation, gives instructions to
participating devices of the MBANS, collects data and controls system operation
Medical Body Area Network System (MBANS): low power radio system used for the transmission of non-voice data
to and from medical devices for the purposes of monitoring, diagnosing and treating patients as prescribed by duly
authorized healthcare professionals
ETSI
11 ETSI TR 101 557 V1.1.1 (2012-02)
patient monitor: medical device used to display, analyze, and process the vital signs of a patient
NOTE: It may also be used to control medical actuators such as respirator devices or infusion pumps. Two types
of patient monitor can be identified: (1) bedside patient monitors, non-portable and designed to be placed
next to the patient's bed (2) portable patient monitors, designed to be worn (e.g. attached to the belt) or
carried by the patient.
telecare: delivery of health and social care to individuals within the home or wider community, with the support of
systems enabled by ICT
telehealth: synonym of remote healthcare, e.g. remote patient monitoring
3.2 Symbols
For the purposes of the present document, the following symbols apply:
dB deciBel
dBi deciBel relative to an isotropic radiator
dBm deciBel relative to 1 mW
ppm parts per million
3.3 Abbreviations
For the purposes of the present document, the following abbreviations apply:
3GPP 3rd Generation Partnership Project
ACK Acknowledgement
AFTRCC Aerospace and Flight Test Radio Coordinating Council
APC Adaptive Power Control
ARQ Automatic Repeat reQuest
ATS Aeronautical Telemetry System
AVI Automatic Vehicle Identification
AWGN Additive White Gaussian Noise
BAN Body Area Network
BER Bit Error Rate
BP Blood Pressure
BW Bandwidth
BWS Broadband Wireless Systems
CEPT Conference of European Postal and Telecommunications Administration
CGC Complementary Ground Component
CSMA Carrier Sense Multiple Access
CSMA/CA Collision Sensing Multiple Access / Collision Avoidance
DARC Deutscher Amateur Radio Club
DSSS Direct Sequence Spread Spectrum
e.i.r.p. effective isotropically radiated power
e.r.p. effective radiated power
EC European Commission
ECA European Common Allocation
ECC Electronics Communications Committee
ECG Electrocardiogram
EMG Electromyogram
ER Emergency Room
ETSI European Telecommunications Standards Institute
EU European Union
E-UTRA Evolved Universal Terrestrial Radio Access
FCC Federal Communications Commission
FM Frequency Management
FSK Frequency Shift Keying
FWA Fixed Wireless Access
GDP Gross Domestic Product
GFSK Gaussian Frequency Shift Keying
ETSI
12 ETSI TR 101 557 V1.1.1 (2012-02)
GSM Global System for Mobile communications
IARU VHF International Amateur Radio Union - Very High Frequency
IARU International Amateur Radio Union
ICT Information and Communication Technologies
ICU Intensive Care Unit
IEEE Institute of Electrical and Electronics Engineers
IL Implementation Loss
IMEC Interuniversity Microelectronics Centre
IMT International Mobile Telecommunications
ISM Industrial, Scientific and Medical
ITU International Telecommunication Union
K Boltzmann constant
B
LBT Listen-Before-Talk
LP-AMI Low Power Active Medical Implant
MAC Medium Access Control
MBANS Medical Body Area Network System
MCU Micro Controller Unit
MFCN Mobile/Fixed Communication Networks
MSS Mobile Satellite Service
NF Noise Figure
NICT National Institute of Information and Communications Technology
NPRM Notice of Proposed Rulemaking
OJEU Official Journal of the European Union
O-QPSK Offset Quadrature Phase Shift Keying
OR Operating Room
PER Packet Error Rate
PHY Physical / Physical Layer
PT Project Team
QoS Quality of Service
QPSK Quadrature Phase Shift Keying
REP Report
RF Radio Frequency
RFID Radio Frequency Identification
RR Radio Regulations
RX Receiver (Reception)
SAP/SAB Services Ancillary to Programme making / Services Ancillary to Broadcasting
SAR Specific Absorption Rate
SNR Signal-to-Noise Ratio
SpO2 Saturation of Peripheral Oxygen
SRD Short Range Device
TDD Time Division Duplex
TFES Task Force for Harmonized Standards for IMT-2000
TX Transmitter (Transmission)
TX/RX Transmission/Reception
TX-RX Transmitter to Receiver
UHF Ultra High Frequency
UMTS Universal Mobile Telecommunications System
US United States
UTRA Universal Terrestrial Radio Access
UWB Ultra Wide Band
VHF Very High Frequency
WG Working Group
TM
WiMAX Worldwide interoperability for Microwave Access
ETSI
13 ETSI TR 101 557 V1.1.1 (2012-02)
4 Comments on the System Reference Document
4.1 Statements by ETSI Members
Siemens objects against the restriction to "non-voice" services in the present document: System Reference document
(SRdoc) on "Medical Body Area Network Systems (MBANSs) in the 1 785 MHz to 2 500 MHz range" for the
following reasons:
1) It is entirely feasible to fulfil all requirements for audio and voice transmission within the restrictions
described in the present document. Limited duty-cycle, enforcement of indoor operation for the lower sub-
band, contention-based protocol and power limitations could be implemented in the same way as for the
proposed data transmission. E.g. the requirements for ECG transmission are similar to the ones for transmitting
a stereo audio signal.
2) The missing ability to transmit audio and voice signals blocks relevant MBANS applications from the market.
Neither applications, that are related to monitoring audio signals (recording heart beatings) nor applications
related hearing impairments (e.g. hearing aids, cochlear implants) are feasible. Hence, a significant market is
lost in which synergies could have been leveraged to provide health care at reasonable cost.
3) Public address systems, that are recognized key in integrating people with hearing impairments into public life,
are forbidden in the context of the present document although they would technically fit into the described
MBANSs. This limitation would stop the progress within the Hearing Aid Industry to converge to a digital
public address system standard as requested by the EC.
5 Presentation of the system or technology
5.1 Definition and applications
Today, existing technologies allow for wired solutions for monitoring patient vital signs such as oxygen saturation
(SpO2), blood pressure, electrocardiogram (ECG) and blood glucose, as well as controlling actuators such as ventilators
and infusion pumps. On-body sensors—measuring vital signs of a patient—and actuators are wired up to, typically, a
bedside patient monitor. This bundle-of-wires situation limits the mobility of patients and reduces their comfort,
adversely affecting their recovery times. Workflow delays are also introduced due to care givers moving tethered
patients. The first wireless patient monitoring solutions operating in the generic SRD band from 2 400 MHz to
2 483,5 MHz have recently been introduced to overcome the disadvantages of wired solutions. However the ®
increasingly intensive use of this band by other applications (such as WiFi, Bluetooth and ISM equipment) will tend to
prevent such systems from offering the required reliability as their use increases within healthcare facilities.
Medical Body Area Network System (MBANS) is a low power radio system used for the transmission of non-voice
data to and from medical devices for the purposes of monitoring, diagnosing and treating patients by duly authorized
healthcare professionals. A MBANS consists of one or more on-body wireless sensors—to simultaneously collect
multiple vital sign parameters—and/or medical actuator devices that can communicate with a monitoring device placed
on/around (up to 10 meters from) the human body. Such monitoring devices, in their role of MBANS hub, display and
process vital sign parameters from MBANS devices and may also forward them (e.g. to a central nurse station) by using
wired or wireless technologies other than MBANSs. MBANS hubs also control MBANS devices for the purpose of
providing monitoring, diagnosis and treatment of patients. Implantable devices are not part of MBANSs. It is expected
that, as most typical configuration, a MBANS hub will be associated to only one patient; in the same fashion as a
patient monitor is typically wired up to a single patient today. Two MBANS examples are depicted in figure 1.
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14 ETSI TR 101 557 V1.1.1 (2012-02)

Patient
monitor
ECG ECG
Oxygen Oxygen
Patient sat. sat.
monitor
Sensor data Sensor data
Commands Commands
a) MBANS with portab-ble patient monitor ) MBANS with bedside patient monitor

Figure 1: MBANS examples
MBANSs aim at enabling wireless monitoring, diagnosis and treatment of patients, and are hence defined in the context
of medical applications only.
Although the first MBANSs will be mostly deployed in hospitals, they will later extend into the patient's home in order
to enable home healthcare. Whereas MBANS-enabled in-hospital patient monitoring may be applied to high acuity and
low acuity medical conditions, home monitoring will obviously be restricted to the latter. An example of a high acuity
condition (i.e. acute health state) would be that of a patient that lies in the intensive care unit (ICU) right after an
invasive surgery operation. An example of a low acuity condition would be that of a patient a few days after surgery
and who has a low relapse probability but is still under the doctor's observation. The last phase of low acuity monitoring
is currently taking place in hospital but will increasingly occur also at the patient's home. In addition to in hospital (or
emergency care facility) and at the patient's home, MBANSs are also expected to be used in ambulances for monitoring
patient vital signs during patient transportation. It is intended that deployment and usage of MBANSs will be at the
direction of healthcare professionals. This restriction applies to MBANS operation in both healthcare facilities and out
of healthcare facilities (e.g. at patient's home).
5.2 Societal benefits
Europe, as well as other regions in the world, are facing a serious ageing problem. The number of people in the EU aged
65+ will grow by 70 % and the 80+ age group will grow by 170 % by 2050 due to low birth rates and increasing
longevity [i.22]. These changes are likely to raise demand for healthcare significantly and, at the same time, decrease
the working population. This may increase healthcare spending by 1 % to 2 % of GDP in EU Member States by 2050
and on average this would amount to about a 25 % increase in healthcare spending as a share of GDP [i.14].
The introduction of MBANSs will enable wireless patient monitoring, diagnosis and treatment solutions that fully meet
clinical reliability standards. These solutions would entail clear societal benefits, both in terms of quality of healthcare
and reduction of healthcare costs.
A higher quality of healthcare would be achieved due to:
• Shorter recovery times by increased patient mobility and comfort
• Shorter recovery times by early discharge to the patient's home
• Earlier detection of worsening health state (previous to a preventable acute condition) by extension of patient
monitoring to most, if not all, patients in many hospitals
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15 ETSI TR 101 557 V1.1.1 (2012-02)
• Lower risk of cross-infections by easier disinfection of wireless patient sensors (no wires to disinfect and
easier sensor handling) or by deployment of disposable wireless sensors
At the same time—and strongly related to the higher quality of healthcare—cost reductions would be achieved due to:
• Lower treatment costs by shorter overall recovery times
• Lower hospital lodging costs by shorter hospital stays
• Lower number of cost-intensive high acuity cases by early detection and prevention
• Lower sepsis- and infection related costs by lower risk of cross infections
• Improved hospital workflow and efficiency of nursing staff
6 Market information
6.1 Wireless patient monitoring - general trends
According to "The European Market for Wireless patient Monitoring devices" (Frost & Sullivan 2009) [i.47], t
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