1、ETSI TR 101 981 1.2.1 (2002-04) Technical Repor Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); System Reference Document for inductive Loop - Ultra Low Power Active Medical Implants (ULP- AMI) - systems operating in the frequency bands 9 kHz to 315 kHz 2 E
2、TSI TR 101 981 VI .2.1 (2002-04) Reference RTR/ERM-RM-009 Keywords magnetic, power, radio ETSI 650 Route des Lucioles F-O6921 Sophia Antipolis Cedex - FRANCE Tel.: +33 4 92 94 42 O0 Fax: +33 4 93 65 47 16 Siret No 348 623 562 00017 - NAF 742 C Association but non lucratif enregistre la Sous-prfectur
3、e de Grasse (06) No 7803/88 Important notice Individual copies of the present document can be downloaded from: http:/w.etsi.orq 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 version
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6、ssion. The copyright and the foregoing restriction extend to reproduction in all media. O European Telecommunications Standards Institute 2002. All rights reserved. DECTTM , PLUGTESTSTM and UMTSTM are Trade Marks of ETSI registered for the benefit of its Members. TIPHONTM and the TIPHON logo are Tra
7、de 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 3 ETSI TR 1 O1 981 VI . 2.1 (2002-04) Contents Intellectual Property Rights 4 Foreword . 4 1 Scope 5 2 Re
8、ferences 5 Definitions, symbols and abbreviations . 6 3 3.1 . . 3.2 . . 3.3 . . 6 6 7 4 Executive summary 7 Annex A (informative): Detailed market information 12 5 Main conclusions 10 A . 1 A.2 Market size 12 A.3 Traffic evaluation 12 Range of applications . 12 . . Annex B (informative): Technical i
9、nformation . 13 Detailed technical description 13 Technical justifications for spectrum . 14 B . 1 B.2 B.2.1 Power . B . 2.2 Frequency . . B.2.3 Transmission mask . B.3 . Information on current version of relevant ETSI standard . 14 Annex C (informative): Expected compatibility issues . 15 Coexisten
10、ce studies (if any) . 15 Current ITU allocations 15 C . 1 C.2 C.3 Sharing issues . 15 History 16 ETSI 4 ETSI TR 101 981 VI .2.1 (2002-04) Intellectual Property Rights IPRs essential or potentially essential to the present document may have been declared to ETSI. The information pertaining to these e
11、ssential IPRs, if any, is publicly available for ETSI members and non-members, and can be found in ETSI SR O00 3 14: “Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notijied to ETSI in respect of ETSI standards“, which is available from the ETSI Secretariat. Latest up
12、dates are available on the ETSI Web server (5). 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 not referenced in ETSI SR O00 3 14 (or the updates on the ETSI Web server) which are, o
13、r 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). Directive 90/3 85/EC (AIMD Directive) has established requirements for active implantable medi
14、cal apparatus. This directive is used throughout Region 1 for insuring active medical implants and their accessories meet the standards that are necessary to insure the safety of these products as they are used in the medical community. ETSI 5 ETSI TR 101 981 VI .2.1 (2002-04) 1 Scope The present do
15、cument applies to the radio sections of inductive loop Ultra Low Power Active Medical Implants in the field of Short Range Devices (SRDs) transmitters and receiver systems operating on various frequencies within the range of 9 kHz to 3 15 kHz. The present document gives guidance on the definition of
16、 a transmitter mask for the operating frequencies, analyses and the spectrum requirements for transmission of power and data from/to stationary programmers or mobile neurostimulation systems (pain control) to/from active medical implants. The present document considers the ERC Report 44, i and conta
17、ins the technical characteristics for radio equipment as given in CEPT/ERC Recommendation 70-03 2. Therefore, the frequency range 9 kHz to 135 kHz is already sufficiently regulated for inductive systems in CEPT/ERC Recommendation 70-03 2. The necessary operation for the frequency range 135 kHz to 3
18、15 kHz is not addressed in CEPT/ERC Recommendation 70-03 2 and is addressed in the present document. The spectrum parameters for inductive loop ULP-AMI devices that are the subject of this document are intended to be included as a normative annex in the EN 300 330-2 3 or in a new European Harmonized
19、 Standard. They are submitted for consideration to CEPT/ERC WGSE for compliance studies and in WGFM/SRD MG for inclusion in the CEPT/ERC Recommendation 70-03 2, annex 12. 2 Refe re nces The following documents contain provisions which, through reference in this text, constitute provisions of the pre
20、sent document. References are either specific (identified by date of publication andor edition number or version number) or non-specific. For a specific reference, subsequent revisions do not apply. For a non-specific reference, the latest version applies. il ERC Report 44: “Sharing between inductiv
21、e systems and radiocommunication systems in the band 9-135 kHz“, Jan 97. 21 31 CEPT/ERC Recommendation 70-03: “Relating to the use of Short Range Devices (SRD)“ ETSI EN 300 330-2 (Vi. 1.1): “Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio equipment in
22、 the frequency range 9 kHz to 25 MHz and inductive loop systems in the frequency range 9 kHz to 30 MHz; Part 2: Harmonized EN under article 3.2 of the R Uncertainties in the measurement of mobile radio equipment characteristics“. ETSI 6 ETSI TR 101 981 VI .2.1 (2002-04) 91 ETSI EN 300 330: “ElectroM
23、agnetic Compatibility and Radio Spectrum Matters (ERM); Short Range Devices (SRD); Technical characteristics and test methods for radio equipment in the frequency range 9 kHz to 25 MHz and inductive loop systems in the frequency range 9 kHz to 30 MHz“. 3 3.1 Definitions, symbols and abbreviations De
24、 fin it ions For the purposes of the present document, the following terms and definitions apply: assigned frequency band: frequency band within which the device is authorized to operate conducted measurements: measurements that are made using a direct connection to the equipment under test dedicate
25、d antenna: removable antenna supplied and tested with the radio equipment, designed as an indispensable part of the equipment fixed station: equipment intended for use in a fixed location H-field test antenna: electrically screened loop or equivalent antenna, with which the magnetic component of the
26、 field can be measured full duplex: method of information exchange in which the information is communicated while the transceiver transmits the activation field half duplex: method of information exchange in which the information is communicated after the transceiver has stopped transmitting the act
27、ivation field integral antenna: permanent fixed antenna, which may be built-in or designed as an indispensable part of the equipment magnetic dipole moment: product of (Number of coil turns) x (coil area) x (coil current) x (Air coils only) portable station: equipment intended to be carried, attache
28、d or implanted radiated measurements: measurements that involve the absolute measurement of a radiated field Ultra Low Power Active Medical Implant (ULP-AMI) system: consists of a programmer/controller, used by a medical professional or by a patient, and an active medical implant that has been place
29、d in the body of a patient 3.2 Symbols For the purposes of the present document, the following symbols apply: Eo f H Ho m P R Ro t reference electrical field strength, (see annex A) frequency magnetic field strength reference magnetic field strength, (see annex A) magnetic dipole moment power distan
30、ce Reference distance, (see annex A) time ETSI 7 ETSI TR 101 981 VI .2.1 (2002-04) 3.3 Abbreviations For the purposes of the present document, the following abbreviations apply: IDEA IDentification Electronique des Animaux JRC Joint Research Centre (of the EU Commission) ULP-AMI Ultra Low Power Acti
31、ve Medical Implant 4 Executive summary Background Ultra Low Power Active Medical Implant systems (ULP-AMI) using inductive loop techniques in the Low Frequency (LF) range have found wide acceptance and application for many medically related applications. LF magnetic field technology allows lossless
32、penetration of most materials encountered in medical environments including human body tissue, which is very desirable for medical applications. Todays inductive loop active medical implant communication system is a biomedical telemetry system that provides communication capability between an extern
33、al programmer/controller and a therapeutic medical implant placed inside a human body. Typically, they use magnetically coupled coils operating at single fixed frequencies within the region of spectrum from 9 kHz to 3 15 kHz. Data rates vary according to manufacturer with typical rates of 2 to 6 kbi
34、ts/s generally using pulse position modulation. A magnetic sensing head associated with the programmer/controller must be placed and maintained in near perfect alignment directly over the implant during communications sessions with a separation distance of approximately 6 cm or less. This requiremen
35、t is directly related to the extremely low magnetic fields the implants are capable of generating. Alignment requirements and physician time constraints limit typical communication sessions to reprogramming the implant and retrieval of reasonably small amounts of stored data with calculated duty cyc
36、les of less than 10 % averaged over one hour according to CEPT/ERC Recommendation 70-03 2. System operation and rationale ULP-AMI systems use telemetry techniques based on low frequency inductive loops to control, programme and communicate with active implantable medical devices such as e.g. pacemak
37、ers, defibrillators, nerve stimulators, infusion pumps, etc. Implantable pulse generators were developed in the 1960s and used discrete components typical of most electrical apparatus of that period. In the mid-70s simplex communication from an external device (programmer) was introduced which allow
38、ed adjustment of the heart pacing parameters of the implant. In the late OS, the first half- duplex communications systems were introduced using inductive loop radiators. These systems used pulse position modulation techniques to transmit information which coupled with careful design reduced power c
39、onsumption from the internal battery to acceptable levels. Low frequency magnetic fields have little if any attenuation from passing through human body tissue and were ideal from the standpoint of frequency selection and power consumption. This is an extremely important consideration since typical a
40、ctive medical implants must operate reliably for periods from 7 to 10 years Current ULP-AMI systems use external programmer/controllers incorporating tuned medium Q coil antennas to emit a modulated magnetic field for telemetry to and reception from the implant. Modulation type is generally pulse po
41、sition encoded but other forms of modulation may occasionally be used. Implant transceiver circuitry is usually activated by placing a strong permanent magnet over the implant. Once activated the implant will “listen“ for a signal from the programmer/controller RF head which is aligned directly over
42、 and within 6 cm of the implant. The programmer/controller and the active medical implant transmit signals which have been encoded with specific data which must agree before the implant will establish a link to permit either reprogramming of the implant or data retrieval from the implant by the prog
43、rammer/controller. Implants generally use tiny coils that are part of the resonant circuit as antennas to radiate the pulsed magnetic field. Data integrity is insured by CRC and FEC check codes coupled with a very limited instruction command set that is recognized by the implant. The above measures
44、protect patient safety from data corruption due to ambient signals. ETSI 8 ETSI TR 101 981 VI .2.1 (2002-04) Market briefing Heart failure affects about 22,5 million persons worldwide, with about 2 million new cases diagnosed each year. About 6,6 million Europeans are victims, with approximately 590
45、 O00 new cases diagnosed each year. Of these approximately one half are candidates for heart implants. In addition, nerve stimulation implants and drug delivery infusion pumps are finding success in controlling various bodily functions such as urinary incontinence, uncontrollable muscular spasms, in
46、sulin injection, and delivery of pain medication to mention a few. Active medical implants are the only technology capable of full time non-stop delivery of medically necessary therapy that is required to preserve and enhance the quality of life for many for this category of patients worldwide. Spec
47、trum requirement and justifications Frequencies currently used by LF ULP-AMI telemetry systems are within the range of 9 kHz to 3 15 kHz. Magnetic field strength levels from the external programmer/controllers used by medical professionals, or in rare cases by patients, are typically of the order of
48、 a magnitude or more below the current ETSI magnetic field strength levels specified in clause 4.1.1.1 of EN 300 330-2 3. Magnetic field strength levels from the implants are so low that measurements must be made at distances of one meter or less. Using the theoretical inverse cube attenuation rate,
49、 to compare implant H field strength levels to the H field strength levels in clause 4.1.1.1, gives implant levels that are from 85 dB to 95 dB below the level in clause 4.1.1.1 of EN 300 330-2 3. At 10 m, the implant levels are well below the existing ambient noise levels at these frequencies. Current regulations CEPT/ERC 70-03 specifies in annex 9 for inductive loop applications the following parameters. Frequency Band NOTE 1 : Other types of anti-theft systems can be operated in accordance with other relevant annexes. NOTE 2: In the case of loop an
