1、 ETSI TR 102 316 V1.1.1 (2004-03)Technical Report Electromagnetic compatibilityand Radio spectrum Matters (ERM);Ultra Low Power Animal Implantable Devices (ULP-AID)operating in the frequency band 315 kHz to 600 kHz;System Reference DocumentETSI ETSI TR 102 316 V1.1.1 (2004-03) 2 Reference DTR/ERM-RM
2、-026 Keywords Inductive, MF, radio, 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
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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, send your comment to: editoretsi.org Copyright Notification No part may be reproduced except as authorized by written permission. The copyright and
6、 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 benefit of its Members. TIPHONTMand the TIPHON logo are Trade Marks currently being reg
7、istered 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 102 316 V1.1.1 (2004-03) 3 Contents Intellectual Property Rights4 Foreword.4 1 Scope 5 2 References 5 3 Definitions, symbols
8、and abbreviations .6 3.1 Definitions6 3.2 Symbols6 3.3 Abbreviations .6 4 Executive summary 7 4.1 Status of the System Reference Document (SRDoc)7 4.2 Technical Issues .7 4.2.1 System description7 4.2.2 Short market information7 4.2.3 Spectrum requirement and justifications.7 4.2.4 Current regulatio
9、ns .7 4.2.5 Proposed regulation 8 4.2.6 Compatibility issues8 5 Main conclusions8 5.1 Expected timing for products to market .8 5.2 Requested ETSI and ECC actions 8 Annex A: Detailed market information .10 A.1 Range of applications .10 A.2 Market size and value.10 A.3 Traffic evaluation .10 Annex B:
10、 Technical information 11 B.1 Detailed technical description 11 B.1.1 Magnetic field requirements for inductive systems11 B.2 Technical justifications for spectrum .11 B.2.1 Field strength11 B.2.2 Frequency.12 B.2.3 Bandwidth and other radio parameters.12 B.3 Information on current version of releva
11、nt ETSI standard.12 Annex C: Expected compatibility issues 13 C.1 Coexistence studies 13 C.2 Current ITU allocations13 C.3 Sharing issues.14 History 15 ETSI ETSI TR 102 316 V1.1.1 (2004-03) 4 Intellectual Property Rights IPRs essential or potentially essential to the present document may have been d
12、eclared 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 respect of ETSI standards“, wh
13、ich 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 existence of other IPRs n
14、ot 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 Matters (ERM). ETSI ETSI
15、 TR 102 316 V1.1.1 (2004-03) 5 1 Scope The present document defines the requirements for radio frequency usage for inductive loop Ultra Low Power-Animal Implantable Devices (ULP-AID) to be used by the medical and pharmaceutical industries in medically related studies using animals for determining th
16、e efficacy and safety of drug and surgical procedures. These devices are typically simplex short range transmitters and receiver systems operating on various frequencies within the range of 315 kHz to 600 kHz. The present document includes necessary information to support the co-operation between ET
17、SI and the Electronic Communications Committee (ECC) of the European Conference of Post and Telecommunications Administrations (CEPT), including: detailed market information (see annex A); technical information (see annex B); expected compatibility issues (see annex C). 2 References For the purposes
18、 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 ETSI EN 302 195-2 (V1.1.1): “Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 9 kHz to 315 kHz f
19、or Ultra Low Power Active Medical Implants (ULP-AMI) and accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R - incorporation of the band c with the requested parameters in annex 12 of ERC Recommendation 70-03 1 by the ECC; - adoption of an ECC DECISION for this
20、 application by the ECC. ETSI ETSI TR 102 316 V1.1.1 (2004-03) 9 ETSI actions: - The spectrum parameters for inductive loop ULP-AID systems that are the subject of the present document are intended to be included as a normative annex to EN 302 195-2 2 as a revision to include the 315 kHz to 600 kHz
21、frequency band. ETSI ETSI TR 102 316 V1.1.1 (2004-03) 10Annex A: Detailed market information A.1 Range of applications ULP-AID systems find applications in small (mice), medium (rat), large (dogs) and primate animals. Small size devices are typically single channel using blood pressure, temperature,
22、 and/or biopotential sensors. Medium size devices use the same types of sensors as the small animal series, however, they can accommodate multiple sensors in 3 to 4 channel versions. Large devices can use the above sensor devices with the ability to couple multiple sensors in 2 and 3 channel version
23、s. The market for these devices includes hospitals, laboratories involved in medical research and pharmaceutical manufacturing facilities. As such, they are all within industrialized areas with high levels of existing ambients in the band. ULP-AID systems covered by the present document use transmit
24、ters designed to transmit digital information for the purpose of providing a radio link between an active animal implant and an external receiver. These implants find wide acceptance for applications such as measuring animal physiological parameters such as body temperature, blood pressure, heart ra
25、te, biopotential, etc., either as a single physiologic parameter measurement or in multiple configurations. A.2 Market size and value Animal implants used world-wide in medically related studies total approximately 15 000 units yearly. Of the 15 000 units, there are about 5 200 units in Europe. ULP-
26、AID for use in these animal studies are the only technology capable of providing continuous pulse coded data which is required due to the need for constant monitoring of the study subject. These studies ultimately serve to preserve and enhance the quality of life for millions of patients worldwide a
27、s physicians prescribe the various medications developed using this technology. A.3 Traffic evaluation Spectrum use and efficiency: - The emission of magnetic fields and the actual frequency usage is extremely low. The reasons are that: a) There are relatively very few animal implant transmitters in
28、 use at one time. With a total population of 5 200 units in Europe, only about 500 or less are actually in use at a given time and these would be deployed at numerous locations. It is expected that no more than 20 to 30 units would ever be active at a specific location at one time and even this woul
29、d be rare. The duty cycle for these devices is less than 10 %. b) Transmitters are only activated on demand and have a limited battery life on average of one month before implant replacement is required. Further, there are only approximately 250 locations within Europe where these medical studies ar
30、e performed. ETSI ETSI TR 102 316 V1.1.1 (2004-03) 11Annex B: Technical information B.1 Detailed technical description These devices are very low power animal implant transmitters providing a simplex communications link to an associated nearby receiver. The implant and one or more of a series of dif
31、ferent sensors is implanted in an animal being used in a laboratory to determine the efficacy of a drug product or medical technique. The data is transmitted using a pulse position coding providing minimal battery drain to maximize the life of the implant. The associated receiver is located very nea
32、r the cage containing the implanted animal (typically directly under the cage) to maximize coupling between the implant and receiver. Animal implants consist of two sections, the physiologic parameter sensor or sensors and the transmitter to enable the telemetry function. The RF pulse drive circuit
33、is typically integrated into a hybrid chip that drives an external coil capacitor circuit. This coil is the radiating antenna for the implant. Generally, the package is sealed in a suitable polymer case with sensor leads extending through the case. B.1.1 Magnetic field requirements for inductive sys
34、tems Implant transmitter field These systems use a variety of coil configurations using various core sizes. Maximum antenna size is approximately 10 cm diameter with a 20 turn coil. Due to the varied construction used to accommodate different types of animals, a number of units were tested. For the
35、implanted devices the maximum H field measured was -9 dBA/m and minimum H field was -60 dBA/m. The requested level of -5 dBA/m is to address manufacturing tolerances and measurement variations. Characteristics of this equipment are: a) they are totally implanted within an animal body; b) the functio
36、n they perform in providing physiological data cannot reasonably be obtained by any other method; c) they are expected to reliably transmit low duty cycle data continuously in performing their intended function for periods of time on average of a month; d) they are capable of being refurbished and r
37、eused at the end of their life cycle; e) generally they are not capable of being programmed by a programming device. B.2 Technical justifications for spectrum B.2.1 Field strength The maximum requested carrier power level is -5 dBuA/m measured at a 10 m distance. Further, to limit any possible use o
38、f this band for devices other than animal implantable devices used in support of medically related scientific studies, it is requested that annex 12, which covers ULP-AMI equipment, be revised to list band c: 315 kHz to 600 kHz only for animal implants. The ambient noise is dependent on the location
39、 of the equipment. Medical facilities can be considered an industrial or commercial environment. In these environments the ambient noise is very high. The main noise sources are the harmonics of different electric equipment, for example switch mode power supplies, PCs, other medical equipment, ISM d
40、evices, fluorescent lights, electric distribution in general, etc. According to ERC Report 44 5, the noise level in this type of environment, measured in a 1 kHz bandwidth, is expected to vary in the range 5 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
41、 dB/octave and it is typically 1 dBA/m at 600 kHz. ETSI ETSI TR 102 316 V1.1.1 (2004-03) 12Thus, at the requested power level, ULP-AID devices will be required to operate in close proximity to their associated receiver. Typical operating distances are less than 1 m. B.2.2 Frequency The band from 9 k
42、Hz to 315 kHz is generally recognized within the CEPT countries for ULP-AMI applications where primary usage is centered in hospital and clinical environments. The manmade contribution to the ambient noise in the band is gradually increasing as the proliferation of noise sources continues to increas
43、e. Because this band is in general use by very low power ULP-AMI devices and co-location with those devices would at a minimum raise the noise floor in the band, a new band should be opened for ULP-AID devices. Opening a new band for ULP-AID devices will preclude any increase in the noise floor in t
44、he ULP-AMI band and will minimize any disturbance threat that would otherwise exist to the potential co-location of the two types of devices. Due to the very low power levels from this equipment, the extremely low numbers of active units, the very low duty cycle and the locations of the use of the t
45、ransmitters in commercial laboratory environments, there is no expectation of interference to any existing services. It is concluded the risk of interference is so low as to be negligible. B.2.3 Bandwidth and other radio parameters Several factors have bearing on the circuitry used and therefore the
46、 devices operating bandwidth. Prime consideration 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.
47、 Another issue is output filtering. Such 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
48、 data source for the transmitters. A high data rate system (15 kHz) has a 20 dB bandwidth of approximately 300 kHz when measured in accordance with the test set up in EN 302 195-2 2. EN 302 195-2 2 will be revised to cover the band 315 kHz to 600 kHz. B.3 Information on current version of relevant E
49、TSI standard ETSI intends to revise the current ETSI draft standard, EN 302 195-2 2, to incorporate the additional frequency band for ULP-AID equipment. ETSI ETSI TR 102 316 V1.1.1 (2004-03) 13Annex C: Expected compatibility issues C.1 Coexistence studies Work has already been done in this area by CEPT, see in particular: Doc SE24M16-57R1: “LS to SRDMG; Generic Limit below 30 MHz for SRD inductive systems“ 4. ECC/SE(04)015 (2004) “Protection distances for radiocommunication services from inductive SRD applications in the frequency range 135 kH
