ETSI TR 102 315-2004 Electromagnetic compatibility and Radio spectrum Matters (ERM) Short Range Devices (SRD) Ultra Low Power Animal Implant Devices (ULP-AID) operating in the freq.pdf

1、 ETSI TR 102 315 V1.2.1 (2004-11)Technical Report Electromagnetic compatibilityand Radio spectrum Matters (ERM);Short Range Devices (SRD);Ultra Low Power Animal Implant Devices (ULP-AID)operating in the frequency band: 12,5 MHz to 20 MHz;System Reference DocumentETSI ETSI TR 102 315 V1.2.1 (2004-11)

2、 2 Reference RTR/ERM-RM-040 Keywords SRDoc, radio, SRD, HF, MF 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 I

3、mportant 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 or in print. In any case of existing or perceived difference in contents between such versions, the reference version is

4、 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 Secretariat. Users of the present document should be aware that the document may be subject to revision or change of status. I

5、nformation 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 send your comment to one of the following services: http:/portal.etsi.org/chaircor/ETSI_support.asp Copyright Notification N

6、o part may be reproduced except as authorized by written permission. The copyright and the foregoing 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 b

7、enefit 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 the benefit of its Members and of the 3GPP Organizational Partners. ETSI ETSI TR 102 315 V1.2.1 (2004-11) 3 Contents Int

8、ellectual Property Rights4 Foreword.4 1 Scope 5 2 References 5 3 Definitions, symbols and abbreviations .6 3.1 Definitions6 3.2 Symbols6 3.3 Abbreviations .6 4 Executive summary 6 4.1 Status of the System Reference Document.6 4.2 Technical issues7 4.2.1 System description7 4.2.2 Market briefing .7 4

9、.2.3 Spectrum requirement and justifications.7 4.2.4 Current regulations .7 4.2.5 Proposed regulation 7 4.2.6 Compatibility issues8 5 Main conclusions8 5.1 Expected timing for products to market .8 5.2 ECC and ETSI actions8 Annex A: Detailed market information .9 A.1 Range of applications .9 A.2 Mar

10、ket size and value.9 A.3 Traffic evaluation .9 Annex B: Technical information 10 B.1 Detailed technical description 10 B.1.1 Magnetic field requirements for inductive systems10 B.2 Technical justifications for spectrum .11 B.2.1 Maximum Field Strength Level11 B.2.2 Frequency.11 B.2.3 Bandwidth and o

11、ther radio parameters.11 B.3 Information on current version of relevant ETSI standard.11 Annex C: Expected compatibility issues 12 C.1 Coexistence studies 12 C.2 Current ITU allocations12 C.3 Sharing issues.14 History 15 ETSI ETSI TR 102 315 V1.2.1 (2004-11) 4 Intellectual Property Rights IPRs essen

12、tial 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 potential

13、ly 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 searches, has been carried out b

14、y 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 Elec

15、tromagnetic compatibility and Radio spectrum Matters (ERM). ETSI ETSI TR 102 315 V1.2.1 (2004-11) 5 1 Scope The present document applies to the radio sections of inductive loop ULP-AID systems to be used by the medical and pharmaceutical industries in medically related animal studies of the efficacy

16、 and safety of drug and surgical procedures. These devices are typically simplex short-range transmitters and receiver systems that will operate in the following band, 12,5 MHz to 20 MHz. This spectrum is required due to European Treaty Series legislation 4 and 5 that stipulates certain requirements

17、 for housing animals used for experimental and scientific research. These devices are expected to be license exempt on a non-interference non-protection basis. The present document includes necessary information to support the co-operation between ETSI and the Electronic Communications Committee (EC

18、C) of the European Conference of Post and Telecommunications Administrations (CEPT), including: Detailed market information (annex A); Technical information (annex B); Expected compatibility issues (annex C). 2 References For the purposes of this Technical Report (TR) the following references apply:

19、 1 ETSI EN 302 195-1 (V1.1.1): “Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories; Part 1: Technical characteristics and test methods“. 2 ETSI EN 302 195-2 (V1.

20、1.1): “Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R b) the function they per

21、form in providing physiological data cannot reasonably be obtained by any other method; c) they are expected to reliably transmit data continuously with a duty cycle of 10 % or less in performing their intended function for periods of time on average of a month; d) they are capable of being refurbis

22、hed and reused at the end of their life cycle; e) they are not capable of being programmed by a programming device. The ambient noise level: The ambient noise is dependent on the location of the equipment. Medical facilities can be considered an industrial or commercial environment. In these environ

23、ments the ambient noise is very high. The main noise sources are the harmonics of different electric equipment, for example switch mode power supplies, personal computers, other medical equipment, ISM devices, fluorescent lights, electric distribution in general, etc. According to CEPT/ERC Report 44

24、 6, the noise level in this type of environment, measured in a 1 kHz bandwidth, is expected to vary in the range 5 dBA/m to 30 dBA/m at 50 kHz. A typical level is 13 dBA/m at 50 kHz. The noise level falls at a 3,5 dB/octave, and it is typically -1 dBA/m at 1 MHz. At 20 MHz the noise floor will be ap

25、proximately -15 dBA/m. ETSI ETSI TR 102 315 V1.2.1 (2004-11) 11B.2 Technical justifications for spectrum B.2.1 Maximum Field Strength Level A maximum field strength level of -7 dBA/m measured at 10 m distance is requested using the standard CISPR QP detector and measurement bandwidth. This level wil

26、l allow for production tolerance relative to the measured maximum field strength level of -9 dBA/m at 10 m when implanted in the animal. B.2.2 Frequency The band from 9 kHz to 315 kHz is generally recognized within the CEPT countries for ULP-AMI applications where primary usage is centred in hospita

27、l and clinical environments at a field strength level of 30 dBA/m at 10 m. The manmade contribution to the ambient noise in the spectrum below 1 MHz is increasing as the proliferation of noise sources continues to increase. Co-band, co-location operation on frequencies with ULP-AMI is not desirable

28、and new bands must be opened for ULP-AID devices to satisfy the requirement for humane treatment of these animals. Opening new bands for ULP-AID devices will preclude any increase in the noise floor in the ULP-AMI band and will minimize any disturbance threat that would otherwise exist due to the po

29、tential co-location of the two types of devices. The band 315 kHz to 600 kHz is available for the application of ULP-AID systems, however, the 315 kHz to 600 kHz band will not permit co-location of multiple animals that have ULP-AID implanted at the same laboratory. Current devices have a maximum du

30、ty cycle of 10 %, typically of the order of 1 % to 1,5 %. However, this fact does not enable multiple devices to share the band if they are in close proximity to each other. Band sharing under these conditions requires each device to be aware of the existence of the other devices. This means the tra

31、nsmitters must be synchronized such that no two transmitters will attempt to transmit at the same time. Synchronization requires very stable long-term time bases or alternatively each transmitter must have some way of sensing that another device is using the spectrum (LBT). The incorporation of eith

32、er of the above technologies in these devices would so limit their lifetime due to battery drain, that they would be basically useless for even short term projects of one to two weeks. Therefore, it is absolutely necessary to have additional bands available for this application at the same site (e.g

33、. research centre) to permit multiple implanted animals to be co-located in the same cage. Further, there is currently a European treaty obligation, ETS 123 4, that endeavours to protect the rights of animals used in scientific studies. The document is the subject of a pending amendment that will re

34、quire more humane conditions to be afforded to caged animals used in scientific studies such as medically related testing to insure the safety and efficacy of newly developed drugs. The effect of these new regulations will in many cases require certain species of animals to be housed in groups in a

35、single cage. This treaty obligation will require additional bands to be made available in order to accommodate large groups of closely located animals. B.2.3 Bandwidth and other radio parameters Several factors have bearing on the circuitry used and therefore the devices operating bandwidth. Prime c

36、onsideration relative to design is to conserve power to the extent possible. Reduced battery life causing replacement of an implant during a study could invalidate the entire study. One technique to reduce power is the use of pulse position modulation techniques. Another issue is output filtering. S

37、uch filtering would obviously have losses. Such losses reduce battery life and thus minimal filtering is incorporated in ULP-AID transmitters. Bandwidth is also a function of the data rate which is related to the number of sensor information channels that are the data source for the transmitters. A

38、high data rate system (15 kHz) has a 20 dB bandwidth of approximately 300 kHz. B.3 Information on current version of relevant ETSI standard ETSI intends to revise the current EN 302 195-1 1 and EN 302 195-2 2, to incorporate the additional frequency bands for ULP-AID equipment or develop a new produ

39、ct standard. ETSI ETSI TR 102 315 V1.2.1 (2004-11) 12Annex C: Expected compatibility issues C.1 Coexistence studies Work has already been done in this area by CEPT, see in particular: ERC Report 44: “Sharing between inductive systems and radiocommunication systems in the band 9 - 135 kHz“. C.2 Curre

40、nt ITU allocations The ITU Radio Regulations (ed. 2003) 9 lists in Region 1: 12 500 - 13 200 kHz MARITIME MOBILE 5.109 5.110 5.132 5.145 13 200 - 13 260 kHz AERONAUTICAL MOBILE (OR) 13 260 - 13 360 kHz AERONAUTICAL MOBILE (R) 13 360 - 13 410 kHz FIXED RADIO ASTRONOMY 5.149 13 410 - 13 570 kHz FIXED

41、Mobile except aeronautical mobile (R) 5.150 13 570 - 13 600 kHz BROADCASTING 5.134 5.151 13 600 - 13 800 kHz BROADCASTING 13 800 - 13 870 kHz BROADCASTING 5.134 5.151 13 870 - 14 000 kHz FIXED Mobile except aeronautical mobile (R) 14 000 - 14 250 kHz AMATEUR AMATEUR-SATELLITE 14 250 - 14 350 kHz AMA

42、TEUR 5.152 14 350 - 14 990 kHz FIXED Mobile except aeronautical mobile (R) 14 990 - 15 005 kHz STAND FREQUENCY AND TIME SIGNAL (1 500 kHz) 5.111 15 005 - 15 010 kHz STANDARD FREQUENCY AND TIME SIGNAL Space research 15 010 - 15 100 kHz AERONAUTICAL MOBILE (OR) 15 100 - 15 600 kHz BROADCASTING 15 600

43、- 15 800 kHz BROADCASTING 5.134 5.146 15 800 - 16 360 kHz FIXED 5.153 16 360 - 17 410 kHz MARITIME MOBILE 5.109 5.110 5.132 5.145 17 410 - 17 480 kHz FIXED 17 480 - 17 550 kHz BROADCASTING 5.134 5.146 17 550 - 17 900 kHz BROADCASTING 5.148 17 900 - 17 970 kHz AERONAUTICAL MOBILE (R) 17 970 - 18 030

44、kHz AERONAUTICAL MOBILE (OR) 18 030 - 18 052 kHz FIXED 18 052 - 18 068 kHz FIXED Space research 18 068 - 18 168 kHz AMATEUR AMATEUR SATELLITE 5.154 ETSI ETSI TR 102 315 V1.2.1 (2004-11) 1318 168 - 18 780 kHz FIXED Mobile except aeronautical mobile 18 780 - 18 900 kHz MARITIME MOBILE 18 900 - 19 020

45、kHz BROADCASTING 5.134 5.146 19 020 - 19 680 kHz FIXED 19 680 - 19 800 kHz MARITIME MOBILE 5.132 19 800 - 19 990 kHz FIXED 19 990 - 19 995 kHz STANDARD FREQUENCY AND TIME SIGNAL Space research 19 995 - 20 000 kHz STANDARD FREQUENCY AND TIME SIGNAL Footnotes: 5.109 The frequencies 2 187,5 kHz, 4 207,

46、5 kHz, 6 312 kHz, 8 414,5 kHz, 12 577 kHz and 16 804,5 kHz are international distress frequencies for digital selective calling. The conditions for the use of these frequencies are prescribed in Article 31. 5.110 The frequencies 2 174,5 kHz, 4 177,5 kHz, 6 268 kHz, 8 376,5 kHz, 12 520 kHz and 16 695

47、 kHz are international distress frequencies for narrow-band direct-printing telegraphy. The conditions for the use of these frequencies are prescribed in Article 31. 5.111 The carrier frequencies 2 182 kHz, 3 023 kHz, 5 680 kHz, 8 364 kHz and the frequencies 121,5 MHz, 156,8 MHz and 243 MHz may also

48、 be used, in accordance with the procedures in force for terrestrial radiocommunication services, for search and rescue operations concerning manned space vehicles. The conditions for the use of the frequencies are prescribed in Article 31 and in Appendix 13. The same applies to the frequencies 10 0

49、03 kHz, 14 993 kHz and 19 993 kHz, but in each of these cases emissions must be confined in a band of 3 kHz about the frequency. Footnote 5.134 has been modified by WRC-07 to read: 5.134 The use of the bands 5 900 to 5 950 kHz, 7 300 to 7 350 kHz, 9 400 to 9 500 kHz, 11 600 to 11 650 kHz, 12 050 to 12 100 kHz, 13 570 to 13 600 kHz, 13 800 to 13 870 kHz, 15 600 to 15 800 kHz, 17 480 to 17 550 kHz and 18 900 to 19 020 kHz by the broadcasting service as from 1 April 2007 is subject to the application of the procedure of Article 12. Administrations