1、 ETSI TR 102 434 V1.1.1 (2005-06)Technical Report Electromagnetic compatibilityand Radio spectrum Matters (ERM);Short Range Devices (SRD);Alternative Interference Mitigation Technologies to Listen Before Talk (LBT)for Ultra Low Power Active Medical Implants (ULP-AMI) operating from403,5 MHz to 403,8
2、 MHz with a duty cycle of less than or equal to 0,01%;System Reference DocumentETSI ETSI TR 102 434 V1.1.1 (2005-06) 2 Reference DTR/ERM-RM-039 Keywords radio, short range, SRDoc, UHF 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 S
3、iret 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 present document can be downloaded from: http:/www.etsi.org The present document may be made available in more than one electronic version
4、 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 case of dispute, the reference shall be the printing on ETSI printers of the PDF version kept on a specific network drive within ETSI Secre
5、tariat. Users of the present document should be aware that the document may be subject to revision or change of status. Information on the 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 sen
6、d 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 authorized by written permission. The copyright and the foregoing restriction extend to reproduction in all media. European Telecommunications S
7、tandards Institute 2005. 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 ETSI for the benefit of its Members. 3GPPTM is a Trade Mark of ETSI registered for
8、 the benefit of its Members and of the 3GPP Organizational Partners. ETSI ETSI TR 102 434 V1.1.1 (2005-06) 3 Contents Intellectual Property Rights4 Foreword.4 1 Scope 5 2 References 5 3 Definitions, symbols and abbreviations .6 3.1 Definitions6 3.2 Symbols7 3.3 Abbreviations .7 4 Executive summary 8
9、 4.1 Status of the System Reference Document.8 4.1.1 Statement from Medtronic 8 4.1.2 Statement from Secrtariat dEtat lIndustrie and Bundesministerium fr Wirtschaft und Arbeit9 4.1.3 Position of Biotronik, St. Jude, Ela Medical, Zarlink and Bolt Consult .10 4.2 Technical issues10 4.2.1 System descri
10、ption10 4.2.2 Applications11 4.2.3 Short market information11 4.2.4 Spectrum requirement and justifications.11 4.2.4.1 Advantages of very low-duty cycle in relation to LBT.12 4.2.4.1.1 Simplified Access Method.12 4.2.4.1.2 Reduced Timing Synchronization Requirements 12 4.2.4.1.3 Extended Battery Lif
11、e12 4.2.4.1.4 Allows Unidirectional Transmission .12 4.2.5 Current regulations .13 4.2.6 Current ETSI Standard13 4.2.7 Proposed regulation 13 4.2.8 Proposed Modified ETSI Standard .13 4.2.9 Sharing issues .14 5 Main conclusions14 5.1 Business importance.14 5.2 Expected timing for products to market
12、.14 Annex A: Detailed market information .16 A.1 Range of applications .16 A.2 Market size and value.16 Annex B: Technical information 17 B.1 Information on current version of relevant ETSI standard.17 Annex C: Expected compatibility issues 18 C.1 Coexistence studies (if any) .18 C.2 Current ITU all
13、ocations18 C.3 European Common Allocation (ECA) Table .18 C.4 Sharing issues.19 C.4.1 Risks associated with the downlink19 C.4.2 Risks associated with the uplink.19 History 20 ETSI ETSI TR 102 434 V1.1.1 (2005-06) 4 Intellectual Property Rights IPRs essential or potentially essential to the present
14、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 respec
15、t 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 given as to the e
16、xistence 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
17、Matters (ERM). ETSI ETSI TR 102 434 V1.1.1 (2005-06) 5 1 Scope The present document defines the requirements for radio frequency spectrum usage for single channel ULP - AMI active medical implants and peripherals operating from 403,5 MHz to 403,8 MHz (nominal centre frequency of 403,65 MHz) and havi
18、ng a duty cycle of less than or equal to 0,01 %. The technical characteristics of these devices along with the benefits of this access method are described. A single channel, low duty cycle (less than or equal to 0,01 %) ULP-AMI is proposed as an alternative option to LBT and frequency agility as in
19、terference mitigation technology which ensures the assigned spectrum remains clear and available to all users of the spectrum. This type of operation is limited only to ULP-AMI (implants) and is not permitted for ULP-AMI-P (peripheral equipment). The proposed SRDoc prohibits external device to exter
20、nal device communication. 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), including: Detailed market information (annex A);
21、 Technical information (annex B); Expected compatibility issues (annex C). It is not proposed to change the current regulations. 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 (S
22、RD)“. 2 Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity (R Radio equipment in the frequency range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implan
23、ts and Accessories; Part 1: Technical characteristics, including electromagnetic compatibility 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
24、 Active Medical Implants and Accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R Frequency-agile Generic Short Range Devices using Listen-Before-Transmit (LBT) Technical Report“. ETSI ETSI TR 102 434 V1.1.1 (2005-06) 6 9 International Telecommunications Union,
25、ITU Radio Regulations, Article 5, 2004. NOTE: See http:/www.itu.int/dms_pub/itu-r/opb/reg/R-PN-119-04-R1-PDF-E.pdf. 10 “The World Survey of Cardiac Pacing and Cardioverter Defibrillators: Calendar Year 2001“, in Pacing and Clinical Electrophysiology (PACE), Volume 27 Issue 7 Page 955 - July 2004, Do
26、i:10.1111/j.1540-8159.2004.00565.x. NOTE: See http:/www.blackwell- 11 ETSI TR 102 343 (V1.1.1): “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 MHz to 406 MHz bands; System Reference Docume
27、nt“. 12 ERC/DEC (01)17: “ERC Decision of 12 March 2001 on harmonised frequencies, technical characteristics and exemption from individual licensing of Short Range Devices used for Ultra Low Power Active Medical Implants operating in the frequency band 402 - 405 MHz“. 13 ISO 14971 (2000): “Medical de
28、vices - Application of risk management to medical devices“. 3 Definitions, symbols and abbreviations 3.1 Definitions For the purposes of the present document, the following terms and definitions apply: Active Medical Device (AMD): any medical device relying for its functioning on a source of electri
29、cal energy or any source of power other than that directly generated by the human body or gravity Active Implantable Medical Device (AIMD): any active medical device (AMD) which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention
30、 into a natural orifice, and which is intended to remain after the procedure Adaptive Frequency Agility (AFA): performance requirement for LBT specifying the usage of at least nine channels (see EN 301 839-1 4 for more details) Listen Before Talk (LBT): performance requirement, usually in the form o
31、f a protocol, that requires a communications system to determine if the channel it intends to communicate in is occupied by another user and select from the available spectrum a channel for communication that reduces, to the extent possible, the potential for interference to/from another user of the
32、 spectrum Medical Device (MD): means any instrument, apparatus, appliance, material or other article, whether used 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, mo
33、nitoring, treatment or alleviation of disease or injury; investigation, replacement or modification of the 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
34、may be assisted in its function by such means. ETSI ETSI TR 102 434 V1.1.1 (2005-06) 7 medical implant event: occurrence or the lack of an occurrence recognized by a medical implant device or duly authorized health care professional that requires the immediate transmission of data from a medical imp
35、lant transmitter in order to protect the safety of the person in whom the medical implant transmitter has been placed NOTE: It is not permitted that this is the only mechanism a medical implant transmitter can use to access spectrum. All medical implant transmitters must have the ability and typical
36、ly use this ability to transfer information to/from a medical implant programmer/control transmitter on a frequency that has been selected by the programmer/control transmitter using the LIC spectrum access protocol specified in the present document. monitoring device: ULP-AMI-P equipment used to mo
37、nitor a ULP-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 safety: freedom from unacceptable risk Ultra Low Power Active Medical Implant (ULP-AMI): the radio part of an AIMD Ultra Low Power Active
38、Medical Implant Peripheral (ULP-AMI-P): the radio part of equipment outside the human body that is designed to communicate with an ULP-AMI 3.2 Symbols For the purposes of the present document, the following symbols apply: f frequency P Power R Distance t Time 3.3 Abbreviations For the purposes of th
39、e present document, the following abbreviations apply: AFA Adaptive Frequency Agility AIMD Active Implantable Medical Device AMD Active Medical Device CEPT European Conference of Post and Telecommunications Administrations dB deciBel dBi deciBel relative to an isotropic radiator DBS Deep Brain Stimu
40、lation e.r.p. effective radiated power ECA European Common Allocation ECC Electronic Communications Committee EMC ElectroMagnetic Compatibility LBT Listen Before Talk LDC Low Duty CycleLIC Least Interfered Channel MD Medical Device MICS Medical Implant Communications System R r) that the ITU-R, in a
41、dopting ITU-R Recommendation SA.1346 3, considered Medical Implant Communication Systems to require a single band available worldwide, and may operate in the mobile service currently allocated on a secondary basis in the band 401 MHz to 406 MHz;“ reaction to point 7 of clause 4.1.1: the band 402 MHz
42、 to 405 MHz is not preserved for LBT nor AFA since neither ERC/DEC(01)17 12 nor CEPT/ERC Recommendation 70-03 1 “decides“ / “recommends“ the use of such mitigation techniques; ETSI ETSI TR 102 434 V1.1.1 (2005-06) 10 reaction to point 8 of clause 4.1.1: EN 301 839-1 4 and EN 301 839-2 5 do not requi
43、re the use of LBT but only propose it as a possible option; reaction to point 9 of clause 4.1.1: low duty cycle has also been recognized both by ETSI and CEPT as an effective technique for enabling successful spectrum sharing and avoiding interference. UNQUOTE 4.1.3 Position of Biotronik, St. Jude,
44、Ela Medical, Zarlink and Bolt Consult Biotronik, St. Jude, Ela Medical, Zarlink and Bolt Consult support this SRDoc without any reservation. 4.2 Technical issues ULP - AMI and ULP - AMI - P devices currently provide significant life saving and quality of life benefits for medical patients afflicted
45、with a variety of heart conditions, nerve disorder and other afflictions. The systems operating in the 402 MHz to 405 MHz band consist of devices that are implanted in the body that only communicate with an external peripheral device. Examples of implanted devices are defibrillators, pacemakers, and
46、 various types of nerve stimulators. In current systems typically used in the patients home (“Home Monitoring“) the ULP-AMI device sends data to the ULP - AMI - P device. Patient monitoring is also possible in clinics, hospitals and managed care facilities. In addition, there will be other systems w
47、here data will also be sent from the ULP-AMI-P to the ULP-AMI (e.g. “programming“). The latter systems will typically be used in hospitals and/or doctors office environments. The performance of systems compliant with EN 301 839-1 4 (i.e. those implementing LBT and AFA) may be degraded if the 403,5 M
48、Hz to 403,8 MHz channel is selected as the Least Interfered Channel (LIC). In such a scenario, the communication link may be interrupted by a low duty cycle system that does not implement LBT and AFA. The degradation is minimized if the single channel (403,5 MHz to 403,8 MHz) is excluded from the se
49、t of operating channels for systems compliant with EN 301 839-1 4. Two types of devices are envisioned with the present document: the first is a single frequency transmit-only LDC system, the second is a device that uses LDC to initiate an LBT/AFA session. Single-frequency transmit-only Low Duty Cycle (LDC) systems cannot change frequency to avoid interference from the primary user of the band (Meteorological Aids), multi-user (MICS band devices), or man-made (
