1、 ETSI TR 102 655 V1.1.1 (2008-11)Technical Report Electromagnetic compatibilityand Radio spectrum Matters (ERM);System reference document;Short Range Devices (SRD);Low Power Active Medical Implants (LP-AMI) operatingin a 20 MHz band within 2 360 MHz to 3 400 MHzETSI ETSI TR 102 655 V1.1.1 (2008-11)
2、2Reference DTR/ERM-RM-252 Keywords health, SRD 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
3、Individual copies of the 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 Do
4、cument Format (PDF). In case of dispute, the reference shall be the printing on ETSI printers of the PDF version kept on a specific network drive within ETSI Secretariat. Users of the present document should be aware that the document may be subject to revision or change of status. Information on th
5、e current status of this 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 re
6、produced except as authorized by written permission. The copyright and the foregoing restriction extend to reproduction in all media. European Telecommunications Standards Institute 2008. All rights reserved. DECTTM, PLUGTESTSTM, UMTSTM, TIPHONTM, the TIPHON logo and the ETSI logo are Trade Marks of
7、 ETSI registered for the benefit of its Members. 3GPPTM is a Trade Mark of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. ETSI ETSI TR 102 655 V1.1.1 (2008-11) 3Contents Intellectual Property Rights 5g3Foreword . 5g3Introduction 5g31 Scope 7g32 References 7g3
8、2.1 Normative references . 7g32.2 Informative references 8g33 Definitions, symbols and abbreviations . 10g33.1 Definitions 10g33.2 Symbols 11g33.3 Abbreviations . 12g34 Comments on the System Reference Document 12g35 Executive summary 13g35.1 Background information . 13g35.2 Market information. 13g3
9、5.2.1 Cardiac market. . 13g35.2.2 Other implanted devices . 14g35.3 Radio spectrum requirement and justification 15g35.3.1 Technical developments . 15g35.4 Regulations . 16g35.4.1 Current regulations . 16g35.4.2 Proposed regulation and justification 16g36 Expected ETSI actions . 18g37 Requested ECC
10、actions 18g3Annex A: Detailed market information . 19g3A.1 Range of applications . 19g3A.2 Expected market size and value . 19g3A.2.1 Cardiac rhythm management 19g3A.2.1.1 Bradycardia . 19g3A.2.1.2 Ventricular tachyarrhythmia . 21g3A.2.1.3 Heart Failure . 22g3A.2.2 Homecare . 25g3A.2.3 Neurostimulat
11、ors 26g3A.3 Traffic and equipment density forecast 26g3A.3.1 Spectrum use and efficiency: 26g3Annex B: Detailed technical information . 27g3B.1 Detailed technical description 27g3B.1.1 System description . 27g3B.1.2 Applications . 27g3B.2 Technical parameters and justifications for spectrum 27g3B.2.
12、1 Transmitter parameters . 27g3B.2.1.1 Radiated Power . 27g3B.2.1.1.1 Required transmitter parameters . 27g3B.2.1.2 Emissions in the spurious domain . 28g3B.3 Link budget considerations 28g3B.3.1 Introduction 28g3ETSI ETSI TR 102 655 V1.1.1 (2008-11) 4B.3.2 Body phantom 29g3B.3.3 Measurements . 31g3
13、B.3.3.1 Description test antenna 31g3B.3.3.2 Synthesis of measurements results 32g3B.3.3.3 Method of measurements 33g3B.3.3.4 Measurement results . 34g3B.3.3.4.1 Phantom influence on the impedance of the test antenna 34g3B.3.3.4.2 Phantom influence on the test antenna efficiency . 35g3B.3.4 Conclusi
14、on for propagation model . 37g3B.3.5 Simulation 37g3B.3.5.1 Description of simulation 38g3B.3.5.2 Results of the antenna impedance simulation . 38g3B.3.5.3 Simulation results of antenna radiation efficiency 39g3B.3.5.4 Comparison between measured and simulated radiation pattern 43g3B.3.6 Results on
15、the SAR evaluation . 44g3B.3.7 Conclusions 47g3B.3.8 Conclusion on Link budget model and SAR 48g3B.3.9 Receiver parameters and maximum range 50g3B.3.10 Channel access parameters . 50g3B.4 Information on relevant standard(s) . 51g3Annex C: Expected sharing and compatibility issues . 52g3C.1 Current I
16、TU and European Common Allocations 52g3C.2 Sharing and compatibility studies (if any) 53g3C.2.1 Compatibility with services in neighbouring bands . 53g3Annex D: Bibliography 54g3History 55g3ETSI ETSI TR 102 655 V1.1.1 (2008-11) 5Intellectual Property Rights IPRs essential or potentially essential to
17、 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 E
18、TSI in respect of ETSI standards“, which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web server (http:/webapp.etsi.org/IPR/home.asp). Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee can be give
19、n 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 Ra
20、dio spectrum Matters (ERM). Introduction CEPT/ERC Recommendation 70-03 i.1, annex 12 and EC Decision “2006/771/EC i.44 on harmonization of the radiospectrum for use by short range devices“ define frequencies for wireless applications in healthcare, in parallel. ETSI has published several Harmonized
21、European product Standards for wireless applications in healthcare. Rapid developments within the active medical implant area are expected, requiring new applications and additional spectrum. To control and monitor these devices in hot-spot areas with many patients such as hospitals, clinics and ass
22、isted living facilities, require increased system capacity.Future medical applications may require significant higher data rates. The present document covers the spectrum request for these applications that may be possible due to the development of the semiconductor technology. The purpose of produc
23、ing the present document is to lay a foundation for industry to quickly bring innovative and useful products to the market while avoiding any harmful interference with other services and equipment. A license exempt regulation for this type of application is required. The present document proposes to
24、 operate these devices in an approximately 20 MHz wide sub-band inside the 2 360 MHz to 3 400 MHz frequency range. It is realized that it may be difficult to obtain this goal below 2 GHz. It is mandatory to designate a world-wide frequency band due to travelling of patients with implants. In 2005, 1
25、7 000 people worldwide had cochlear devices implanted. In the U.S. alone some 900 000 people are believed to be deaf or near deaf i.30. As cochlear implants need high duty cycle transmissions this application is not considered to be suitable for the frequency range 2 483,5 GHz to 2 500,0 GHz. Theref
26、ore, this need will addressed in a separate document at a later stage. It is envisioned that the proposed radio systems may require a change of utilization of the present regulatory framework for the proposed band(s). Status of pre-approval draft The present document was developed by ERM/TG30 and ap
27、proved for publication by ERM at its 36thmeeting, November 2008. The information in the present document has undergone coordination by ERM. It contains final information. ETSI ETSI TR 102 655 V1.1.1 (2008-11) 6Table 1: Current status of the present document Target version Pre-approval date version (
28、see note) V1.1.1 a s m Date Description 0.0.1 0.0.3 22 January 2008 Draft for TG 30 review 0.0.1 0.0.4 30 May 2008 Draft for ERM-TG30 review 0.01 0.0.5 3 June 2008 ERM-TG30 approved subject to editorial 0.01 0.0.6 10 June ERM-TG30 editorial comments 0.0.1 0.0.7 11 June Version with BNetzA comments 1
29、.1.1 0.0.9 27 June ETSI mini enquiry Version 1.1.1 0.0.10 21 August Final document including mini consultation comments 1.1.1 0.0.11 26 August Minor editorials done NOTE: See clause A.2 of EG 201 788 i.45 (V1.2.1). ETSI ETSI TR 102 655 V1.1.1 (2008-11) 71 Scope The present document defines new requi
30、rements for radio frequency spectrum usage for low power, active medical implants and their peripheral radio control systems. It is noted that the present document proposes a concept that should permit a harmonized regulatory framework for these systems and provides a basis for a licence exempt arra
31、ngement preferably on a secondary allocation. The present document includes necessary information to support the co-operation between ETSI and the Electronic Communications Committee (ECC) of the European Conference of Post and Telecommunications Administrations (CEPT). It includes: Detailed market
32、information. Detailed technical information. Expected sharing and compatibility issues. 2 References References are either specific (identified by date of publication and/or edition number or version number) or non-specific. For a specific reference, subsequent revisions do not apply. Non-specific r
33、eference may be made only to a complete document or a part thereof and only in the following cases: - if it is accepted that it will be possible to use all future changes of the referenced document for the purposes of the referring document; - for informative references. Referenced documents which a
34、re not found to be publicly available in the expected location might be found at http:/docbox.etsi.org/Reference. For online referenced documents, information sufficient to identify and locate the source shall be provided. Preferably, the primary source of the referenced document should be cited, in
35、 order to ensure traceability. Furthermore, the reference should, as far as possible, remain valid for the expected life of the document. The reference shall include the method of access to the referenced document and the full network address, with the same punctuation and use of upper case and lowe
36、r case letters. 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 indispensable for the application of the present document. For dated references, on
37、ly the edition cited applies. For non-specific references, the latest edition of the referenced document (including any amendments) applies. Not applicable. ETSI ETSI TR 102 655 V1.1.1 (2008-11) 82.2 Informative references The following referenced documents are not essential to the use of the presen
38、t document but they assist the user with regard to a particular subject area. For non-specific references, the latest version of the referenced document (including any amendments) applies. i.1 CEPT/ERC Recommendation 70-03: “Relating to the use of Short Range Devices (SRD)“. i.2 Void. i.3 ITU-R Reco
39、mmendation SA 1346: “Sharing between the Meteorological Aids Service and the Medical Implant Communications Systems (MICS) operating in the Mobile Service in the Frequency Band 401-406 MHz“. i.4 CEPT/ERC Report 25: “The European Table of Frequency Allocations and Utilisations in the Frequency Range
40、9 kHz to 1000 GHz: Lisboa 02 - Dublin 03 - Kusadasi 04 - Copenhagen 04 - Nice 07“. i.5 International Diabetes Federation. NOTE: Available at http:/www.idf.org/e-atlas/home/index.cfm?node=84. i.6 “Implanted Antennas inside a human body: simulations, designs and characterizations: J. Kim, Y. Rahmat-Sa
41、mii. NOTE: IEEE Transactions on Microwave Theory and Techniques, vol. 52, n 8, August 2004, pp. 1934-1943. i.7 “Design of implantable Microstrip Antenna for communication with medical implants“: P. Soontornpipit, C.M. Furse Y.C. Chung. NOTE: IEEE Transactions on Microwave Theory and Techniques, vol.
42、 52, n8, August 2004, pp. 1944-1951. i.8 “FDTD analysis of a coupled close-coupled 418 MHz radiating devices for human biotelemetry“: Phys. Med. Biol., vol. 44, n 2, pp. 335-345, Feb. 1999. W.G. Scanlon, N.E. Evans, J.B. Burns. i.9 M.W.S., Computer System Technology (C.S.T.), GmbH, Darmstadt, German
43、y. i.10 “Antennas and propagation for body-centric wireless communications“: Artech House Inc., 2006. P. S. Hall, Yang Hao. i.11 “Compilation of the dielectric properties of body tissues at RF and microwave frequencies“: Armstrong Lab., CITY, STATE. C. Gabriel, S. Gabriel. NOTE: Available at http:/w
44、ww.brooks.af.mil/AFRL/HED/hedr/reports/dielectric/home.html. i.12 ETSI EN 301 839-1 (V1.1.1): “Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402
45、 MHz to 405 MHz; Part 1: Technical characteristics and test methods“. i.13 “Composition And Electrical Properties Of A Liquid That Has The Electrical Properties Of Tissue“: Hartsgrove and Kraszewski 1984. i.14 USAFSAM-TR-85-73: RADIOFREQUENCY RADIATION DOSIMETRY HANDBOOK (Fourth Edition), in line do
46、cument. Carl H. Durney, Ph.D., Habib Massoudi, Ph.D., Magdy F. lskander. i.15 Agilent: “85070E Dielectric Probe Kit, 200 Mhz to 50 Ghz. i.16 Void. i.17 “An internet resource for the calculation of the dielectric properties of body tissues“, Institute for Applied Physics, Italian National Research Co
47、uncil. NOTE: Available at http:/r.it/tissprop/. ETSI ETSI TR 102 655 V1.1.1 (2008-11) 9i.18 ETSI EN 301 839-2: “Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the fr
48、equency range 402 MHz to 405 MHz; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 27: Specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral dev
49、ices (ULP-AMI-P)“. i.20 ETSI EN 301 489-29: “Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment operating in the 401 MHz to 402 MHz and 405 MHz to 406 MHz bands; Part 29: Requirements for Medical Data Service Devices (MEDS)“. i.21 ETSI EN 302 537-1: “Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Medical Data Service Systems operating in the frequency range 401 MHz to
