ETSI TR 102 343-2004 Electromagnetic compatibility and Radio spectrum Matters (ERM) Ultra Low Power Active Medical Implants (ULP-AMI) operating in the 401 MHz to 402 MHz and 405 MH.pdf

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1、 ETSI TR 102 343 V1.1.1 (2004-07)Technical Report Electromagnetic compatibilityand Radio spectrum Matters (ERM);Ultra Low Power Active Medical Implants (ULP-AMI)operating in the 401 MHz to 402 MHzand 405 MHz to 406 MHz bands;System Reference DocumentETSI ETSI TR 102 343 V1.1.1 (2004-07) 2 Reference

2、DTR/ERM-RM-033 Keywords SRD, SRDoc 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 c

3、opies 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 Document Forma

4、t (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 the current st

5、atus 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, send your comment to: editoretsi.org Copyright Notification No part may be reproduced except as authorized by written permission. The copyright and the foregoi

6、ng restriction extend to reproduction in all media. European Telecommunications Standards Institute 2004. All rights reserved. DECTTM, PLUGTESTSTM and UMTSTM are Trade Marks of ETSI registered for the benefit of its Members. TIPHONTMand the TIPHON logo are Trade Marks currently being registered by E

7、TSI 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 102 343 V1.1.1 (2004-07) 3 Contents Intellectual Property Rights4 Foreword.4 1 Scope 5 2 References 5 3 Definitions, symbols and abbrevia

8、tions .6 3.1 Definitions6 3.2 Symbols6 3.3 Abbreviations .7 4 Executive summary 7 4.1 Status of the System Reference Document.7 4.1.1 Position of Biotronik.7 4.1.2 Reaction of Medtronic to position in clause 4.1.1 7 4.2 Technical Issues .7 4.2.1 System description8 4.2.2 Applications8 4.2.3 Short ma

9、rket information8 4.2.4 Spectrum requirement and justifications.9 4.2.5 Current regulations .9 4.2.6 Proposed regulation 9 4.2.7 Compatibility issues10 5 Main conclusions10 5.1 Business importance.10 5.2 Expected timing for products to market .11 5.3 ECC and ETSI actions11 Annex A: Detailed market i

10、nformation .12 A.1 Range of applications .12 A.2 Market size and value.12 A.3 Traffic evaluation .12 Annex B: Technical information 13 B.1 Detailed technical description 13 B.2 Technical justifications for spectrum .13 B.2.1 Power13 B.2.2 Frequency.13 B.2.3 Bandwidth and other radio parameters.14 B.

11、3 Information on current version of relevant ETSI standard.14 Annex C: Expected compatibility issues 15 C.1 Coexistence studies (if any) .15 C.2 Current ITU allocations15 C.3 European Common Allocation (ECA) table.15 C.4 Sharing issues.16 History 17 ETSI ETSI TR 102 343 V1.1.1 (2004-07) 4 Intellectu

12、al 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 (I

13、PRs); 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:/webapp.etsi.org/IPR/home.asp). Pursuant to the ETSI IPR Policy, no investigation, including IPR sea

14、rches, 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

15、ETSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). ETSI ETSI TR 102 343 V1.1.1 (2004-07) 5 1 Scope The present document defines the requirements for radio frequency spectrum usage for ULP-AMI active medical implants and peripherals operating in the 401 MHz to 40

16、2 MHz and 405 MHz to 406 MHz frequency bands. It further defines the technical characteristics of these devices and proposes interference mitigation technologies to avoid interference to and from primary users (meteorological aids) and other medical wireless applications, to ensure reliable communic

17、ation links. It 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), including: Detailed market information (annex A); Technical information (annex B

18、); Expected compatibility issues (annex C). 2 References For the purposes of this Technical Report (TR) the following references apply: 1 CEPT/ERC Recommendation 70-03: “Relating to the use of Short Range Devices (SRD)“. 2 Directive 1999/5/EC of the European Parliament and of the Council of 9 March

19、1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity. 3 ITU-R Recommendation SA.1346: “ Sharing between the meteorological aids service and medical implant communication systems (MICS) operating in the mobile service in the frequency band 4

20、01-406 MHz“. 4 ETSI EN 301 839-1 (V1.1.1): “Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories; Part 1: Technical characteristics, including electromagnetic compatibilit

21、y requirements, and test methods“. 5 ETSI EN 301 839-2 (V1.1.1): “Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories; Part 2: Harmonized EN covering essential requiremen

22、ts of article 3.2 of the R Frequency-agile Generic Short Range Devices using Listen-Before-Transmit (LBT) Technical Report“. 11 ETSI EN 300 220: “Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio equipment to be used in the 25 MHz to 1 000 MHz frequency

23、 range with power levels ranging up to 500 mW“. ETSI ETSI TR 102 343 V1.1.1 (2004-07) 6 12 DTR/ERM-RM-030: “Electromagnetic compatibility and Radio spectrum Matters (ERM); System Reference Document for TETRA Enhanced Data Service (TEDS). 13 ETSI EN 301 489-27: “Electromagnetic compatibility and Radi

24、o spectrum Matters (ERM); 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 devices (ULP-AMI-P)“. 14 ETSI TR 101 445: “Electromagnetic compatibility and Radio spectr

25、um Matters (ERM); Short-Range Devices (SRD) intended for operation in the 862 MHz to 870 MHz band; System Reference Document for Radio Frequency Identification (RFID) equipment“. 15 ITU Radio Regulations (2001). 3 Definitions, symbols and abbreviations 3.1 Definitions For the purposes of the present

26、 document, the following terms and definitions apply: active medical device: any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity active implantable medical device: any active medical de

27、vice which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure medical device: any instrument, apparatus, appliance, material or other article, whether u

28、sed alone or in combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be used for human beings in the: - diagnosis, prevention, monitoring, treatment or alleviation of disease or injury; - investigation, replacement or modification of the

29、anatomy or of a physiological process; - control of conception, and which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means, but which may be assisted in its function by such means monitoring device: ULP-AMI-P equipment used to monitor a UL

30、P-AMI patient activator: ULP-AMI-P equipment intended to be used by a patient programmer/controller: ULP-AMI-P equipment used by a physician or patient Ultra Low Power Active Medical Implant: radio part of an AIMD Ultra Low Power Active Medical Implant Peripheral: radio part of equipment outside the

31、 human body that is designed to communicate with an AIMD 3.2 Symbols For the purposes of the present document, the following symbols apply: f Frequency P Power R Distance t Time ETSI ETSI TR 102 343 V1.1.1 (2004-07) 7 3.3 Abbreviations For the purposes of the present document, the following abbrevia

32、tions apply: AIMD Active Implantable Medical Device CRC Cyclic Redundancy Check E/S Earth-to-space ECA European Common Allocation EMC Electro Magnetic Compatibility FEC Forward Error Correction IDF International Diabetic Foundation LBT Listen Before Talk MICS Medical Implant Communications Systems R

33、 (a) a part of the system or a system device is implanted within a human body and (b) the function they perform in providing medical treatment to individuals cannot reasonably be provided for by any other means. Patient quality of life and mobility require these devices to be self-contained, be as s

34、mall as possible in size, have a very long operational life, and be exceptionally reliable over their lifetime. At a minimum ULP-AMI devices must communicate with an associated external device containing a radio system that is a peripheral (ULP-AMI-P) to the implanted device. This allows the transfe

35、r of data from one device to the other that can be either stored data or telecommand or telemetry in content. Other than the unique technological requirements that are attendant to the implanted radio systems (size limits, power consumption and impedance considerations), they can be considered as ty

36、pical data telemetry and telecommand devices using conventional modulation formats with proprietary telemetry protocols. B.2 Technical justifications for spectrum B.2.1 Power As previously stated an implanted active medical radio system must consume very little power and be extremely small in size.

37、The implant itself must contain a medically therapeutic section as well as an interface circuit to a radio system and the radio system itself. Based on the sharing analysis and the usage conditions envisioned for these devices, a power level of a maximum of 25 microwatts e.r.p. was determined as ade

38、quate for medical systems. This power level permits a highly reliable communications link at a distance of 2 meters to 3 meters. B.2.2 Frequency The 401 MHz to 402 MHz and the 405 MHz to 406 MHz frequency bands were selected for these emerging medical implant technologies based on an analysis of man

39、y factors including the proximity to the existing 402 MHz to 405 MHz band for ULP-AMI and ULP-AMI-P equipment. The frequency band has a relatively low ambient noise due to its primary usage by the meteorological aids service, they are sufficiently wide to be capable of reliably supporting high data

40、rate transmissions, miniature manufacturing components are readily available, the band lends itself to small antenna designs and most importantly, electromagnetic fields can propagate acceptably through human tissue in this frequency band. These factors are critical in developing technology that can

41、 be implanted in patients and still have a life expectancy of 5 to 10 years before requiring replacement. With this additional spectrum, other types of communication links and devices can be provided to the medical community that would not otherwise be available such as continuous transmission and r

42、elay of data to mass storage equipment. ETSI ETSI TR 102 343 V1.1.1 (2004-07) 14B.2.3 Bandwidth and other radio parameters The primary factor relative to bandwidth considerations was to ensure that high data rate transmission capability would be provided. Data storage technology has advanced to the

43、extent that implants can now provide information that physicians have requested for many years. The technological ability to internally store multiple records of significant medical events as well as records of other physiological parameters that are sampled at high rates is currently available; how

44、ever, the ability to transfer these records at a high data rate was not available until the advent of MICS technology for the 402 MHz to 405 MHz band. High data rate capability is necessary to minimize battery power drain over the life of an implant and provide for a reasonable data recovery downloa

45、d time frame. Battery power budget analysis has shown a power drain of 30 mWhr over the lifetime of the implant will not significantly alter an implants life expectancy of 5 to 10 years. The development of this new medical communications system permits the deployment of technology capable of providi

46、ng the data requested by physicians. B.3 Information on current version of relevant ETSI standard The present document is asking that CEPT/ERC Recommendation 70-03 annex 12 1, be modified to include the additional bands of 401 MHz to 402 MHz and 405 MHz to 406 MHz as separate sub-bands. There is no

47、current ETSI standard that covers the operational characteristics proposed for these bands. ETSI ERM_TG30 will undertake development of standards to cover the operation of these devices. ETSI ETSI TR 102 343 V1.1.1 (2004-07) 15Annex C: Expected compatibility issues C.1 Coexistence studies (if any) T

48、wo studies related to coexistence between the meteorological aids service and MICS have been previously performed. The ITU-R 3 and ECC spectrum engineering project team SE24 8 have analysed the systems and concluded that sharing is possible between the meteorological aids service and MICS. C.2 Curre

49、nt ITU allocations The ITU Radio Regulations 15 show the following allocations for Region 1 in this frequency band: Table C.2.1 401 MHz to 402 MHz EARTH EXPLORATION-SATELLITE (E/S) METEOROLOGICAL AIDS METEOROLOGICAL-SATELLITE (E/S) SPACE OPERATION (S/E) Fixed Mobile except Aeronautical Mobile 403 MHz to 406 MHz METEOROLOGICAL AIDS Fixed Mobile except Aeronautical Mobile C.3 European Common Allocation (ECA) table The European Common Allocation table 6 shows the following information: Table C.3.1 Frequency band European Common Allocation Utiliz