ETSI TR 101 557-2012 Electromagnetic compatibility and Radio spectrum Matters (ERM) System Reference document (SRdoc) Medical Body Area Network Systems (MBANSs) in the 1 785 MHz to_1.pdf

1、 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 Technical Report ETSI ETSI TR 101 557 V1.1.1 (2012-02) 2Reference DTR/ERM-TG30-100 Keywo

2、rds SRD, SRdoc, health ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE Tel.: +33 4 92 94 42 00 Fax: +33 4 93 65 47 16 Siret N 348 623 562 00017 - NAF 742 C Association but non lucratif enregistre la Sous-Prfecture de Grasse (06) N 7803/88 Important notice Individual copies of the

3、 present document can be downloaded from: http:/www.etsi.org The present document may be made available in more than one electronic version or in print. In any case of existing or perceived difference in contents between such versions, the reference version is the Portable Document Format (PDF). In

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5、 and other ETSI documents is available at http:/portal.etsi.org/tb/status/status.asp If you find errors in the present document, please send your comment to one of the following services: http:/portal.etsi.org/chaircor/ETSI_support.asp Copyright Notification No part may be reproduced except as autho

6、rized by written permission. The copyright and the foregoing restriction extend to reproduction in all media. Some material contained herein is the copyright of, or has been supplied by ITU-T. European Telecommunications Standards Institute 2012. All rights reserved. DECTTM, PLUGTESTSTM, UMTSTMand t

7、he ETSI logo are Trade Marks of ETSI registered for the benefit of its Members. 3GPPTM and LTE are Trade Marks of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. GSM and the GSM logo are Trade Marks registered and owned by the GSM Association. ETSI ETSI TR 101

8、 557 V1.1.1 (2012-02) 3Contents Intellectual Property Rights 5g3Foreword . 5g3Executive summary 5g3Introduction 6g31 Scope 7g32 References 7g32.1 Normative references . 7g32.2 Informative references 7g33 Definitions, symbols and abbreviations . 10g33.1 Definitions 10g33.2 Symbols 11g33.3 Abbreviatio

9、ns . 11g34 Comments on the System Reference Document 13g34.1 Statements by ETSI Members 13g35 Presentation of the system or technology . 13g35.1 Definition and applications. 13g35.2 Societal benefits . 14g36 Market information. 15g36.1 Wireless patient monitoring - general trends 15g36.2 Wireless pa

10、tient monitoring in hospitals 16g37 Technical information 16g37.1 Detailed technical description 17g37.2 Technical parameters and implications on spectrum 17g37.2.1 Status of technical parameters 18g37.2.1.1 Current ITU and European Common Allocations . 18g37.2.1.2 Sharing and compatibility studies

11、(if any) already available 20g37.2.1.3 Sharing and compatibility issues still to be considered . 20g37.2.2 Transmitter parameters . 22g37.2.2.1 Transmitter Output Power / Radiated Power. 22g37.2.2.1a Antenna Characteristics 22g37.2.2.2 Operating Frequency . 23g37.2.2.3 Bandwidth . 23g37.2.2.4 Unwant

12、ed emissions 23g37.2.3 Receiver parameters 23g37.2.3.1 Receiver Sensitivity 23g37.2.3.2 Receiver blocking . 24g37.2.3.3 Interference criteria . 24g37.2.4 Channel access parameters . 24g37.3 Information on relevant standard(s) . 24g38 Radio spectrum request and justification . 25g38.1 Preliminary fre

13、quency band evaluation 25g38.1.1 1 785 MHz to 1 805 MHz . 25g38.1.2 2 360 MHz to 2 400 MHz . 26g38.1.3 2 400 MHz to 2 483,5 MHz (2,4 GHz generic SRD band) . 26g38.1.4 2 483,5 MHz to 2 500 MHz 27g38.2 Summary of the preliminary assessment of the frequency bands . 27g39 Regulations . 28g39.1 Current r

14、egulations . 28g39.1.1 ITU-R Radio Regulations . 28g39.1.2 European Common Allocation Table . 29g3ETSI ETSI TR 101 557 V1.1.1 (2012-02) 49.2 Proposed regulation and justification . 32g3Annex A: Detailed technical information . 34g3A.1 Technical parameters and justifications for spectrum 34g3A.1.1 Ma

15、ximum Radiated Power . 34g3A.1.1.1 Proposed Maximum Radiated Power 34g3A.1.1.2 Link Budget Analysis . 34g3A.1.1.2.1 MBANS Radio Parameters . 34g3A.1.1.2.2 Link Budget Analysis for In-hospital MBANS Applications . 35g3A.1.1.2.3 Link Budget Analysis for Home Healthcare MBANS Applications . 39g3A.1.2 E

16、mission Bandwidth. 41g3A.1.2.1 Proposed Emission Bandwidth . 41g3A.1.2.2 Technical Justification 42g3A.1.3 Total amount of Spectrum Designation 45g3A.2 RF safety considerations 49g3Annex B: Bibliography 50g3History 51g3ETSI ETSI TR 101 557 V1.1.1 (2012-02) 5Intellectual Property Rights IPRs essentia

17、l 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

18、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 guarante

19、e 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 compati

20、bility 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 candida

21、te 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 SR

22、D 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 patients home. In any case the environment for the application is far away from the application of e.g. wireless sensors used for machine automation

23、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 rema

24、ins 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 s

25、ituations such as ambulances and the patients 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

26、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

27、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

28、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 rol

29、e 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-densit

30、y 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 ETSI TR 101 557 V1.1.1 (2012-02) 6Initially, only the band 2 360 MHz to

31、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

32、 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 use

33、d 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 th

34、e 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-b

35、and (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 re

36、duce 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-B

37、efore-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 re

38、quired 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 t

39、he 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

40、 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 whil

41、e 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 ETSI TR 101 557 V1.1.1 (2012-02) 71 Scope The present document describes Medical Body Area Network Systems (MBA

42、NSs), 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). Implantabl

43、e 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 editi

44、on 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 locat

45、ion 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 presen

46、t 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

47、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 f

48、requency range 9 kHz to 3000 GHz“. i.4 ITU-R Radio Regulations, Edition 2008; Article 5. i.5 ERC/REC 62-02 E (Troms 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 v

49、ideo SAP/SAB links“ (incl. ENG/OB). ETSI ETSI TR 101 557 V1.1.1 (2012-02) 8i.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 EN