1、 ETSI TR 103 451 V1.1.1 (2016-11) System Reference document (SRdoc); Short Range Devices (SRD); Technical characteristics for UHF wideband Ultra Low Power Wireless Medical Capsule Endoscopy TECHNICAL REPORT ETSI ETSI TR 103 451 V1.1.1 (2016-11) 2 Reference DTR/ERM-560 Keywords health, radio, SRdoc E
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7、zation of ETSI. The copyright and the foregoing restriction extend to reproduction in all media. European Telecommunications Standards Institute 2016. All rights reserved. DECTTM, PLUGTESTSTM, UMTSTMand the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members. 3GPPTM and LTE a
8、re Trade Marks of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. GSM and the GSM logo are Trade Marks registered and owned by the GSM Association. ETSI ETSI TR 103 451 V1.1.1 (2016-11) 3 Contents Intellectual Property Rights 4g3Foreword . 4g3Modal verbs termi
9、nology 4g3Executive summary 4g31 Scope 5g32 References 5g32.1 Normative references . 5g32.2 Informative references 5g33 Definitions and abbreviations . 6g33.1 Definitions 6g33.2 Abbreviations . 6g34 Comments on the System Reference Document 7g34.1 Statements by ETSI Members 7g35 Presentation of the
10、Wireless Medical Capsule Endoscopy system 7g36 Market information. 9g37 Technical information 10g37.1 Detailed technical description 10g37.1.1 Parameters of CCam . 10g37.1.2 Parameters of Data Recorder 10g37.2 Technical parameters and implications on spectrum 11g37.2.1 Status of technical parameters
11、 11g37.2.1.1 Current ITU and European Common Allocations . 11g37.2.1.2 Sharing and compatibility studies already available . 11g37.2.1.3 Sharing and compatibility issues still to be considered . 12g37.2.2 Transmitter parameters . 12g37.2.2.1 Transmitter Output Power / Radiated Power. 12g37.2.2.2 Ope
12、rating Frequency . 13g37.2.2.3 Bandwidth . 13g37.2.2.4 Unwanted emissions 13g37.2.3 Receiver parameters 13g37.2.4 Channel access parameters . 13g37.3 Information on relevant standard(s) . 13g38 Radio spectrum request and justification . 14g39 Regulations . 14g39.1 Current regulations . 14g39.2 Propo
13、sed regulation and justification . 15g3Annex A: Key Diagnostic Types of CCam and Medical Market Data 16g3Annex B: ITU Radio Regulations and ECA footnotes pertaining to band 430 MHz to 440 MHz 18g3Annex C: Estimating maximum sensing range of CCam emissions by other spectrum users 19g3History 20g3ETSI
14、 ETSI TR 103 451 V1.1.1 (2016-11) 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 ETS
15、I SR 000 314: “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 (https:/ipr.etsi.org/). Pursuant to the ETSI IPR Policy, no
16、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 Technical R
17、eport (TR) has been produced by ETSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). The present document has been developed to support the co-operation between ETSI and the Electronic Communications Committee (ECC) of the European Conference of Post and Telecommu
18、nications Administrations (CEPT). Modal verbs terminology In the present document “should“, “should not“, “may“, “need not“, “will“, “will not“, “can“ and “cannot“ are to be interpreted as described in clause 3.2 of the ETSI Drafting Rules (Verbal forms for the expression of provisions). “must“ and
19、“must not“ are NOT allowed in ETSI deliverables except when used in direct citation. Executive summary The present document describes the concept, technical details and operational scenario of novel professional medical Short Range Device application termed Ultra Low Power Wireless Medical Capsule E
20、ndoscopy application and designed to be operated in UHF range around the 433 MHz band. This new application would offer opportunity of performing medical examination of patients with various gastrointestinal conditions without introducing the bleeding or sedation risks associated with colonoscopy, a
21、nd therefore its use would be highly beneficial and attractive to patients and doctors. The key part of the new application is a disposable miniature optical imaging camera implemented in the shape of a capsule that is swallowed by the patient and transmits imaging data while moving through the dige
22、stive system. The provided analysis recommends using the frequency band around 433 MHz band as the most optimal option, however the use of an up to 10 MHz wide channel with real-time imaging data does not fit into the existing European regulatory provisions for SRDs. It is therefore proposed that th
23、e relevant annex 2 of the CEPT Recommendation ERC/REC 70-03 i.1 is amended to include provisions for utilizing the proposed Ultra Low Power Wireless Medical Capsule Endoscopy application in the frequency band 430 MHz to 440 MHz with emitted power limit (e.r.p.) of -40 dBm outside patients body. ETSI
24、 ETSI TR 103 451 V1.1.1 (2016-11) 5 1 Scope The present document describes a new Short Range Device application in the form of Wideband Ultra Low Power Wireless Medical Capsule Endoscopy, to be deployed using one channel within UHF band, possibly around 433 MHz. Its proposed deployment in European m
25、arket may require an amendment in the present CEPT regulatory framework for Short Range Devices in the proposed band regarding intended emissions of the new application. The present document includes in particular: Use scenario for the proposed Wideband Ultra Low Power Medical Capsule Endoscopy devi
26、ces. Market information. Technical information, including expected sharing and compatibility issues, if any. Regulatory considerations. The present document is intended to provide all necessary information required by the Electronic Communications Committee (ECC) of CEPT under the MoU between ETSI a
27、nd the ECC, to enable consideration of possible regulatory changes necessary to accommodate the proposed new application. 2 References 2.1 Normative references Normative references are not applicable in the present document. 2.2 Informative references References are either specific (identified by da
28、te of publication and/or edition number or version number) or non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the referenced document (including any amendments) applies. NOTE: While any hyperlinks included in this clause were
29、valid at the time of publication, ETSI cannot guarantee their long term validity. The following referenced documents are not necessary for the application of the present document but they assist the user with regard to a particular subject area. i.1 CEPT ECC Recommendation ERC/REC 70-03: “Relating t
30、o the Use of Short Range Devices (SRD)“. NOTE: Available at www.erodocdb.dk. i.2 ECO Frequency Information System EFIS. NOTE: Available at www.efis.dk. i.3 Recommendation ITU-R RS.1260: “Feasibility of sharing between active spaceborne sensors and other services in the range 420-470 MHz“. i.4 Recomm
31、endation ITU-R M.1044: “Frequency sharing criteria in the amateur and amateur-satellite services“. i.5 ERC Recommendation 74-01: “Unwanted emissions in the spurious domain“, Cardiff 2011. NOTE: Available at www.erodocdb.dk. i.6 ETSI EG 201 788: “Electromagnetic compatibility and Radio spectrum Matte
32、rs (ERM); Guidance for drafting an ETSI System Reference document (SRdoc)“. ETSI ETSI TR 103 451 V1.1.1 (2016-11) 6 i.7 ETSI EN 300 220-1: “Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio equipment to be used in the 25 MHz to 1 000 MHz frequency range
33、 with power levels ranging up to 500 mW; Part 1: Technical characteristics and test methods“. i.8 Final Acts - WRC-07. NOTE: Available at http:/www.itu.int/pub/R-ACT-WRC.8-2007. i.9 Final Acts - WRC-12. NOTE: Available at http:/www.itu.int/pub/R-ACT-WRC.9-2012/en. i.10 Final Acts - WRC-15. NOTE: Ava
34、ilable at http:/www.itu.int/pub/R-ACT-WRC.12-2015. 3 Definitions and abbreviations 3.1 Definitions For the purposes of the present document, the following terms and definitions apply: Capsule Camera (CCam): miniature disposable capsule-shaped optical imaging camera with integrated ultra-low RF power
35、 SRD transmitter, a key element of Ultra Low Power Wireless Medical Capsule Endoscopy Application channel: small frequency sub-band within the operating frequency band into which an intended radio signal fits Data Recorder (DR): device worn by the patient in order to record the stream of images rece
36、ived from CCam and store it until it could be downloaded at the end of diagnostic procedure to doctors PC for examination duty cycle: ratio expressed as a percentage, of the total maximum transmitter “on“ time on one carrier frequency, relative to a one hour period NOTE: In accordance with CEPT Reco
37、mmendation ERC/REC 70-03 i.1. Short Range Devices (SRDs): radio devices which provide either unidirectional or bi-directional communication and which have low capability of causing interference to other radio equipment and thus permitted to operate on non-protected/non-interference basis, normally u
38、nder “license exempt“ regulatory regime ultra-low power wireless medical capsule endoscopy: type of SRD to be used for performing medical observation of human gastrointestinal tract by swallowing a Capsule Camera and receiving obtained images by external dedicated receiver, a Data Recorder 3.2 Abbre
39、viations For the purposes of the present document, the following abbreviations apply: AMI Active Medical Implant CCam Capsule Camera CD Crohns DiseaseCEPT Conference Europenne des Postes et Tlcommunications CPU Central Processing Unit CRC ColoRectal Cancer CT Computed Tomography DC Duty Cycle DR Dat
40、a Recorder e.r.p. Effective radiated power ECA European Common (frequency) Allocations table, see CEPT ECC Report 25 ECC Electronic Communications Committee of the CEPT GI GastroIntestinal IBD Inflammatory Bowel Disease ETSI ETSI TR 103 451 V1.1.1 (2016-11) 7 IDA Iron Deficiency Anaemia ISM Industri
41、al, Scientific, Medical frequency band ITU International Telecommunication Union LED Light Emitting Diode MCL Minimum Coupling Loss MSK Minimum Shift Keying (modulation type) OGIB Obscure GastroIntestinal Bleeding PC Personal Computer Pfd Power flux density RF Radio Frequency RMS Root Mean Square RR
42、 Radio RegulationsRX ReceiverSAR Synthetic Aperture Radars SRD Short-Range DeviceTX Transmitter UC Ulcerative Colitis UHF Ultra-High Frequency USB Universal Serial Bus NOTE: A computer interface connector. 4 Comments on the System Reference Document 4.1 Statements by ETSI Members Add here possible d
43、ifficulties encountered (e.g. reservations on the present document and corresponding reasons). This clause should not be systematically filled; the aim is to provide to CEPT-ECC, as far as possible, a totally approved document, achieved as the result of a consensus between all ETSI members. ETSI mem
44、bers are entitled to include a statement at this point in the present document, if their concerns cannot be included elsewhere. Such statements should be clearly attributable to the ETSI member(s) making these statements. However, members are encouraged to try to reflect alternative viewpoints withi
45、n the body of the present document. 5 Presentation of the Wireless Medical Capsule Endoscopy system Wireless Medical Capsule Endoscopy is a novel SRD application aimed at offering professional health care providers a range of innovative options for visualizing, diagnosing and monitoring the human Ga
46、strointestinal (GI) tract, i.e. the digestive system. The key part of this application is a medical SRD device, implemented as a miniature endoscope camera made in the shape of a capsule like a pharmaceutical pill. It is intended to be swallowed by the patient as any regular pill and then transmits
47、optical images obtained while moving through the digestive system. Accordingly this device is here forth termed a Capsule Camera (CCam). There may be different types of CCam, with one or more optical imaging sensors pointing in different directions, developed specifically for observations of differe
48、nt parts of human GI tract and different diagnostic objectives. Regardless of the diagnostic application type, all CCams are to share the same wireless uplink parameters, as they would use the same family of RF transmitters. It is envisaged that some types of CCam may also include a receiver for pro
49、viding a control return channel through which the capsules parameters may be ordered to change from time to time, e.g. enabling more tailored management of diagnostic data flow from the CCam. However such a control return channel may be realized using any of the available general purpose narrow-band SRD bands (e.g. at 13,56 MHz) and therefore is not the subject of the new technical requirements described in the present document. The high level composition of CCam is shown in figure 1, while figure 2 provides an illustration of a real p
