1、 ETSI TR 102 309 V1.1.1 (2004-05)Technical Report Electromagnetic compatibilityand Radio spectrum Matters (ERM);Ultra Low Power Active Medical Implants (ULP-AMI);“Membrane Implant“ devices operating in the30 MHz to 37,5 MHz band;System Reference DocumentETSI ETSI TR 102 309 V1.1.1 (2004-05) 2 Refere
2、nce DTR/ERM-RM-029 Keywords SRDoc, radio, SRD, VHF 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 not
3、ice 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 Portabl
4、e 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. Information o
5、n 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, send your comment to: editoretsi.org Copyright Notification No part may be reproduced except as authorized by written permission. The copyright
6、 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 benefit of its Members. TIPHONTMand the TIPHON logo are Trade Marks currently being
7、 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 102 309 V1.1.1 (2004-05) 3 Contents Intellectual Property Rights4 Foreword.4 1 Scope 5 2 References 5 3 Definitions, symb
8、ols 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 (SRDoc)6 4.2 Technical Issues .7 4.2.1 System description7 4.2.2 Applications7 4.2.3 Short market information7 4.2.4 Spectrum requirement and justifications.7
9、 4.2.5 Current regulations .7 4.2.6 Proposed regulation 8 4.2.7 Compatibility issues8 5 Main conclusions8 5.1 Business importance.8 5.2 Expected timing for products to market .9 5.3 ECC and ETSI actions9 Annex A: Detailed market information .10 A.1 Range of applications .10 A.2 Market size and value
10、.10 A.3 Traffic evaluation .10 Annex B: Technical information 11 B.1 Detailed technical description 11 B.1.1 Inductive system operation.11 B.1.2 Membrane implant transmitter .11 B.1.3 Membrane implant receiver13 B.2 Technical justifications for spectrum .13 B.2.1 Power13 B.2.2 Frequency.13 B.2.3 Ban
11、dwidth and other radio parameters.13 B.3 Information on current version of relevant ETSI standard.13 Annex C: Expected compatibility issues 14 C.1 Coexistence studies (if any) .14 C.2 Current ITU allocations14 C.3 European Common Allocation (ECA) Table .14 C.4 Sharing issues.15 History 16 ETSI ETSI
12、TR 102 309 V1.1.1 (2004-05) 4 Intellectual 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 0
13、00 314: “Intellectual Property Rights (IPRs); 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 Pol
14、icy, no investigation, including IPR searches, 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 Tec
15、hnical Report (TR) has been produced by ETSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). ETSI ETSI TR 102 309 V1.1.1 (2004-05) 5 1 Scope The present document defines the requirements for radio frequency usage for ULP - AMI membrane medical implants operating i
16、n the frequency range from 30 MHz to 37,5 MHz. It defines the radio-communication link between the implanted membrane device, the associated transmitter to activate and power the membrane, and to the associated receiver for registering the blood pressure data. It includes necessary information to su
17、pport 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). Expected compatibility issues (annex C). 2 Refere
18、nces For the purposes of this Technical Report (TR) the following references apply: 1 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 1999 on radio equipment and telecommunications terminal e
19、quipment and the mutual recognition of their conformity. 3 Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (AMD Directive). 4 ETSI EN 302 195-2: “Electromagnetic compatibility and Radio spectrum Matters
20、 (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 Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medi
21、cal Implants (ULP-AMI) and accessories; Part 1: Technical characteristics and test methods“. 7 CEPT/ERC Report 25: “The European Table of Frequency Allocations and Utilisations Covering the Frequency Range 9 kHz to 275 GHz: Lisboa January 2002 - Dublin 2003 - Turkey 2004“. 8 ITU Radio Regulations (e
22、d. 2001). 9 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“. ETSI ETSI TR 102 309 V1.1.1
23、(2004-05) 6 3 Definitions, symbols and abbreviations 3.1 Definitions For the purposes of the present document, the following terms and definitions apply: ULP-AMI “membrane implant“ transmitter: device containing resonant circuit components that is implanted in the body of a patient NOTE 1: The reson
24、ant frequency of the circuit is expected to vary as a function of the measured parameter. NOTE 2: Typical sizes and shapes are provided in clause B.1.2 of the present document. ULP-AMI “membrane system“: system consisting of an energy source delivering power via RF magnetic field coupling to a membr
25、ane implant that uses the energy to transmit its internally generated resonate frequency to a receiver outside the body vascular: of or pertaining to the arterial or venous system contained within the human body 3.2 Symbols For the purposes of the present document, the following symbols apply: f Fre
26、quency H Magnetic field strength P Power R Distance t Time 3.3 Abbreviations For the purposes of the present document, the following abbreviations apply: AIMD Active Implantable Medical Device CT Computer Tomography dB decibel erp effective radiated power ECA European Common Allocation IF Intermedia
27、te FrequencyPMR Private Mobile Radio R b) a separate internal transmitting device (membrane implant, ULP-AMI) that has been implanted in a patient that communicates to c); and c) an external receiver (ULP-AMI-P) that decodes the signal from the “membrane implant“. 4.2.2 Applications Membrane technol
28、ogy is specifically targeted for providing a non-invasive technique for pressure monitoring. Specifically, the initial application is in the field of vascular surgery where blood pressure levels must be closely monitored with a highly accurate readout of systolic and diastolic pressures. 4.2.3 Short
29、 market information The current market for this application in Europe is about 8 000 activators. Expected growth rate is about 30 % each year for 6 years. 4.2.4 Spectrum requirement and justifications This technology has several factors that influence the decision as to what constitutes a suitable f
30、requency band. Membrane implants for blood pressure measurement are intended to be installed in the blood vessel of the patient at the time surgery to repair the vessel is performed. This drastically limits the size of the sensor since the method of delivery is by catheter through vessels to prevent
31、 the need for surgical insertion of the implant. Tissue absorption must be minimized due to the very low electromagnetic field radiated by the implant. Power must be supplied via magnetic coupling to the membrane implant from an external source. The system design requirement is to provide accurate p
32、ressure measurements over a range of 200 mm of mercury accounting for a maximum frequency variation of over 2 MHz due to blood pressure variation. Taking into account the above factors, the band 30 MHz to 37,5 MHz was selected as the best compromise. Radiated power from the external transmitter (ULP
33、-AMI-P) measured with the appropriate test set-up for simulating the real use conditions is of the order of 1 mWatts. Radiated power from the membrane implant transmitter (ULP-AMI) is of the order of 600 picoWatts or less. Typical bandwidth of the signal during a measurement sequence is of the order
34、 of 550 kHz representing a frequency variation associated with a systolic diastolic pressure difference of 50 mm. Measurement time is of the order of 30 seconds. Maximum duty cycle is less than 10 % with a typical duty cycle of less than 1 %. 4.2.5 Current regulations For spectrum conformity testing
35、 the radio will comply with revised harmonized standards EN 302 195-1 6 and EN 302 195-2 4. This work will be undertaken by ERM-TG30 that has responsibility for standardization of ULP-AMI systems. ETSI ETSI TR 102 309 V1.1.1 (2004-05) 8 4.2.6 Proposed regulation It is proposed that CEPT adopt provis
36、ions in annex 12 of ERC Recommendation 70-03 1 for ULP-AMI equipment to permit operation of active implantable devices using membrane technology, as described, in the frequency band d listed in the table below. Incorporation of the additional frequency band d in annex 12, specifically for ULP-AMI “m
37、embrane implant“ equipment, will provide that other SRDs will not proliferate in this frequency band. The proposed maximum power limit of 1 mWatt e.r.p. (for the complete system “Implanted membrane + External activator“) is an order of magnitude below those provided for other SRD devices that operat
38、e in portions of this band and consequently cannot reasonably be expected to cause interference to the existing users of the band. Frequency band Power Duty cycle Channel spacing ERC Decision Notes a 402 MHZ to 405 MHz 25 uW e.r.p. No Restriction 25 kHz ERC DEC (01)17 Individual transmitters may com
39、bine adjacent channels for increased bandwidth up to 300 kHz b 9 KHz to 315 kHz 30 dBuA/m at 10 m 10 % No spacing d 30 MHz to 37,5 MHz 1 mWatt e.r.p. 10 % No spacing The Application is for ULP-AMI “Membrane implants“ for blood pressure measurement 4.2.7 Compatibility issues The ITU allocation for th
40、e frequency band 30 MHz to 37,5 MHz is given in clause C.2. The relevant clause of the European Common Allocation (ECA) table is given in clause C.3. From the ECA table, the primary co-existence issue to consider is that of interference to the mobile services in the band with utilizations by defence
41、 systems, radio microphones, model control, and PMR. Model control and radio microphones operate in the band, however, these are SRDs and shall not cause harmful interference to, and shall not claim protection from harmful interference caused by, a station operating in accordance with the provisions
42、 of the Constitution, the Convention and the Radio Regulations. Due to the hospital environment that membrane technology will be used in and the extremely low power, it is reasonable to conclude that no interference to the PMR service will occur from these systems. 5 Main conclusions 5.1 Business im
43、portance The ability to measure pressure within the human body will become a powerful tool for physicians who diagnose, manage and treat venous disease. One example of the utility of this concept is non-invasive pressure monitoring in patients who undergo endovascular aneurysm repair. Following thei
44、r surgery, these patients are subjected to an extensive and expensive series of non-invasive and invasive studies including enhanced CT and duplex ultrasound for monitoring the durability of the repair. These tests are surrogate measurements for intra-sac pressure, which is believed to be the critic
45、al variable that determines the risk of aneurysm rupture. An implantable pressure sensor strategically located within the excluded aneurysm sac provides long term, non-invasive, real-time measurements of intra-sac pressure. The capability to perform this measurement wirelessly has been termed “the h
46、oly grail in vascular surgery“ in a prominent, peer-reviewed, medical journal. Business, social, humanitarian, international manufacturing, trade and use considerations underline the importance and benefit for society in general, dependent patients in particular, and reduction in patient related med
47、ical cost justifies the request to permit ULP-AMI devices to use the spectrum in the range of 30 MHz to 37,5 MHz. ETSI ETSI TR 102 309 V1.1.1 (2004-05) 9 Implanted patients are mobile and may require emergency medical assistance while they are travelling. These patients should have assistance availa
48、ble at the closest medical facility regardless of the individual country. It is the responsibility of government authorities to provide for a maximum availability of medical services to active medical implant patients in order to cover emergency medical situations that may occur during their intra-
49、or inter-country travels. 5.2 Expected timing for products to market Products for use by the medical community are currently undergoing clinical trials. These trials are expected to be completed in mid 2004 at which time the products will be made available to physicians for use. 5.3 ECC and ETSI actions ETSI requests the ECC to consider the following actions: a) approval by CEPT-ECC WG FM of the band d in annex 12 of ERC Recommendation 70-03 1; b) adoption of band d in annex 12 of ERC Recommendation 70-03 1 and; c) adoption of a CEPT Decision for t
