ETSI TR 103 069 V1.1.1 (2013-07)

Electromagnetic compatibility and Radio spectrum Matters (ERM); System Reference Document (SRDoc); Short Range Devices; Low Power Cochlear Implant Systems (LP-CIS) operating in the band 2 483,5 MHz - 2 500 MHz

DTR/ERM-TG30-304

General Information

• Status: Published
• Publication Date: 18-Jul-2013
• Technical Committee: ERM TG30 - ERM Wireless Medical Devices
• Current Stage: 12 - Completion
• Due Date: 19-Jul-2013
• Completion Date: 19-Jul-2013

Standards Content (Sample)

ETSI TR 103 069 V1.1.1 (2013-07)






Technical Report
Electromagnetic compatibility
and Radio spectrum Matters (ERM);
System Reference Document (SRDoc);
Short Range Devices;
Low Power Cochlear Implant Systems (LP-CIS)
operating in the band 2 483,5 MHz - 2 500 MHz

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2 ETSI TR 103 069 V1.1.1 (2013-07)



Reference
DTR/ERM-TG30-304
Keywords
health, radio, SRD, SRDoc
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3 ETSI TR 103 069 V1.1.1 (2013-07)
Contents
Intellectual Property Rights . 5
Foreword . 5
Introduction . 5
1 Scope . 6
2 References . 6
2.1 Normative references . 6
2.2 Informative references . 6
3 Definitions, symbols and abbreviations . 7
3.1 Definitions . 7
3.2 Symbols . 8
3.3 Abbreviations . 8
4 Comments on the System Reference Document . 9
5 Executive summary . 9
5.1 Background information . 10
5.2 Market information. 10
5.2.1 Cochlear implants . 10
5.3 Radio spectrum requirement. 11
5.3.1 Justification . 11
5.3.2 Technical developments . 11
5.4 Regulations . 11
5.4.1 Long-term regulations. 11
5.4.2 Current regulations in ERC/REC 70-03, annex 12 sub-band (e) . 12
5.4.3 Proposed regulation and justification . 12
6 Expected ETSI actions . 13
7 Requested ECC actions . 13
Annex A: Detailed market information . 15
A.1 Range of applications . 15
A.2 Expected market size and value . 17
A.3 Market growth and therapeutic value . 18
A.4 Spectrum use and efficiency . 20
Annex B: Detailed technical information . 21
B.1 Cochlear implant system . 21
B.1.1 CIS description . 21
B.1.2 Applications . 21
B.1.3 CIS data communication requirements. 21
B.2 Technical parameters and justifications for spectrum . 22
B.2.1 Transmitter parameters . 22
B.2.1.1 Radiated Power . 22
B.2.1.1.1 Required transmitter parameters . 22
B.2.1.1.2 Emissions in the spurious domain . 22
B.3 Link budget . 22
B.3 Link budget considerations . 25
B.3.1 Introduction . 25
B.3.2 C/I robustness of the receiver . 25
B.3.3 Body phantom . 26
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4 ETSI TR 103 069 V1.1.1 (2013-07)
B.3.4 RF Exposure . 26
B.4 Information on relevant standard(s) . 26
Annex C: Expected sharing and compatibility issues . 27
C.1 Current ITU and European Common Allocations . 27
C.2 Sharing and compatibility studies to other in-band radio communication services . 27
C.2.1 Compatibility with services in neighboring bands . 28
C.3 Sharing with other SRD (Intra-sharing) . 28
Annex D: Bibliography . 29
History . 30

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5 ETSI TR 103 069 V1.1.1 (2013-07)
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 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 (http://ipr.etsi.org).
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 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).
Introduction
ECC/ERC Recommendation 70-03 [i.4], annex 12 and EC Decision "2006/771/EC [i.9] on harmonization of the radio
spectrum for use by short range devices" lists frequency bands and legislative parameters for Active Medical Implants
(AMI) and their associated peripherals. ETSI has published standards based on the legislative parameters specified in
ECC/ERC Recommendation 70-03 for the bands that have been harmonized under the R&TTE Directive.
Rapid developments of new technologies and applications for active medical implants are occurring that require either
modification of an existing spectrum allocation or a new allocation of spectrum for their operation. This document
proposes to accommodate this evolving technology that is related to new very low power cochlear implant systems to
allow their operation in the 2 483,5 MHz to 2 500 MHz band. Providing spectrum for this industry will allow product
developers of these very low power cochlear implant systems to design, develop, and quickly bring new and innovative
products to the market while avoiding any harmful interference to other services and equipment.
The present document proposes to operate these devices in the existing designation in ECC/ERC Recommendation
70-03 [i.4], annex 12 band (e) authorizing use of the 2 483,5 MHz to 2 500 MHz band for low power active medical
implant (LP-AMI) devices. Currently, this allocation restricts devices that are peripheral to the implant to indoor
operation only. However, as discussed later, for the application of cochlear implant system operation, outdoor operation
of peripheral devices is required. It is the eventual goal to pursue designation of this band as a world-wide frequency
band for LP-AMI, including cochlear implants and related peripheral devices, to allow patients with these implants to
travel freely internationally.
The present document is being developed by ERM_TG30 and should ultimately be approved for publication by ERM at
th
its 49 meeting, 2013.
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6 ETSI TR 103 069 V1.1.1 (2013-07)
1 Scope
The present document defines the necessary adaptation for radio frequency spectrum usage for low power active
medical cochlear implants and related peripheral radio systems that will operate in the band 2 483,5 MHz to
2 500 MHz. The present document proposes to build on the existing regulations to permit cochlear implant systems in
the above band under a harmonized regulatory framework on a license exempt arrangement.
The present document includes necessary information to support the co-operation between ETSI and the Electronic
Communications Committee (ECC) of the European Conference of Post and Telecommunications Administrations
(CEPT).
It includes:
• Detailed market information.
• Detailed technical information.
• Expected sharing and compatibility issues.
2 References
References are either specific (identified by date 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
reference document (including any amendments) applies.
Referenced documents which are not found to be publicly available in the expected location might be found at
http://docbox.etsi.org/Reference.
NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee
their long term validity.
2.1 Normative references
The following referenced documents are necessary for the application of the present document.
Not applicable.
2.2 Informative references
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] Cochlear Implants.
NOTE: Available at http://www.nidcd.nih.gov/health/hearing/coch.asp.
[i.2] Results of the yearly inquiry on implantations; European Association of Cochlear Implant Users;
CIU 2010; Ruud van Hardeveld.
[i.3] Cochlear implants in deaf children; Report drawn up by Professor Gunilla Preisler; Department of
Psychology; Stockholm University.
[i.4] ECC/ERC Recommendation 70-03: "Relating to the use of Short Range Devices (SRD)";
Annex 12 - Active Medical Implants and their associated peripherals - 7 May 2012.
[i.5] ERC Report 149 (September 2010): "Analysis on compatibility of Low Power-Active Medical
Implant (LP-AMI) applications within the frequency range 2360-3400MHz in particular for the
band 2483,5-2500 MHz with incumbent services".
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7 ETSI TR 103 069 V1.1.1 (2013-07)
[i.6] IEEE, G.A. Conway: "Low-profile microstrip patch antenna for over-body surface communication
at 2.45 GHz".
NOTE: Available at http://www.4taconic.com/dielctrc/pdf/technicalarticles--
patch_antenna_body_communication.pdf.
[i.7] Council recommendation 1995/519/EC of 12 July 1999 on the limitation of exposure of the
general public to electromagnetic fields (0 Hz to 300 GHz).
[i.8] CEPT/ERC Recommendation 74-01:" Unwanted emissions in the spurious domain".
[i.9] EC Decision 2006/771/EC on harmonization of the radio spectrum for use by short range devices.
[i.10] Wireless link budget analysis (01/09/2012).
NOTE: Available at http://www.tranzeo.com/allowed/Tranzeo_Link_Budget_Whitepaper.pdf.
[i.11] Laurens Roelens, promoter Luc Martens, Ghent University: "Path loss model for wireless
narrowband communication near biological tissue" (Sixt FirW PhD Symposium, Faculty of
Engineering, paper nr. 120, 30 November 2005).
[i.12] J.Ryckaert, P. De Doncker, R. Meys, de Le Hoye and Stéphane Donnay: "Channel model for
wireless communication around human body" (Electronic Letters, 29th April, 2004 Vol.40 No.9).
[i.13] J. Keshvari, S. Lang: "Comparison of radio frequency energy absorption in ear and eye region of
children and adults at 900, 1800 and 2450MHz" (Physics in Medicine and Biology 50 (2005)
4355-4369).
[i.14] ERC Report 150 (September 2010): "Compatibility studies between RDSS and other services in
the band 2483,5-2500 MHz".
[i.15] ERC Report 165 (May 2011): "Compatibility study between MSS complementary study between
complementary ground component operating in the bands 1610.0-1626.5 MHz and
2 483,5-2 500.0 MHz and other systems in the same bands or in adjacent bands".
3 Definitions, symbols and abbreviations
3.1 Definitions
For the purposes of the present document, the following terms and definitions apply:
Active Implantable Medical Device (AIMD): any Active Medical Device (AMD) which is intended to be totally or
partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and
which is intended to remain after the procedure including any accessories or software for its proper functioning
Cochlear Implant (CI): implantable portion of the LP-CIS or the surgically implanted active medical device that
stimulates the auditory nerve directly by electrical pulses or indirectly by mechanical stimulation or vibration
Cochlear Implant System (CIS): active implantable medical system consisting of external peripheral device(s)
together with a low power active medical implanted device that provides stimulation to the patient's cochlea
Medical Device (MD): any instrument, apparatus, appliance, material or other article, whether used alone or in
combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be
used for human beings in the:
• diagnosis, prevention, monitoring, treatment or alleviation of disease or injury and for prolongation of life;
• investigation, replacement or modification of the anatomy or of a physiological process;
• control of conception;
and which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic
means, but which may be assisted in its function by such means.
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8 ETSI TR 103 069 V1.1.1 (2013-07)
Low Power Active Medical Implant (LP-AMI): low power radio part of any Active Medical Device (AMD), which is
intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention
into a natural orifice, and which is intended to remain after the procedure
Low Power Active Medical Device Peripheral (LP-AMD-P): low power radio part of medical equipment outside the
human body that communicates with the CI
NOTE: LP-AMD-P may only communicate with the CI
Low Power Cochlear Implant System (LP-CIS): low power radio part of the cochlear implant system (CIS), which is
intended to be totally or partially introduced, surgically or medically, into the human body, and which is intended to
remain after the procedure
Low Power Body Worn Device (LP-BWD): external portion of the LP-CIS in close proximity (6 cm or less) to the CI
and is used to communicate with the CI
3.2 Symbols
For the purposes of the present document, the following symbols apply:
dB deciBel
dBi deciBel relative to an isotropic radiator
dBm dB referred to 1mW
g gram
f frequency
mW milliwatt
P Power
R radius, distance
t time
3.3 Abbreviations
For the purposes of the present document, the following abbreviations apply:
ABI Auditory Brainstem Implant
AFA Adaptive Frequency Agility
AIMD Active Implantable Medical Device
AMI Active Medical Implants
ANSI American National Standards Institute
ASK Amplitude Shift Keying
BER Bit Error Rate
BPSK Binary Phase Shift Keying
BTE Behind-The-Ear
C/I Carrier-to-interference ratio
CEPT Conference of European Postal and Telecommunications Administration
CI Cochlear Implant
CIS Cochlear Implant System
CPFSK Continuous Phase Frequency Shift Keying
CRC Cyclic Redundancy Check
DACI Direct Acoustic Cochlear Implant
DPSK Differential Phase Shift Keying
e.i.r.p./EIRP effective isotropic radiated power
e.r.p./ERP effective radiated power
ECA European Common Allocation Table
ECC Electronics Communications Committee
ENG/OB Electronic News Gathering/Outside Broadcasting
ERC European Radiocommunications Committee
FDA Food and Drug Administration
FEC Forward Error Correction
FHSS Frequency Hopping Spread Spectrum
FS Fixed Service
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9 ETSI TR 103 069 V1.1.1 (2013-07)
FSK Frequency Shift Keying
FSPL Free Space Path Loss
GMSK Gaussian Minimum Shift Keying
ICNIRP International Commission on Non-Ionizing Radiation Protection
ISM Industrial Scientific Medical applications
ITU International Telecommunications Union
LBT Listen Before Talk
LM Land mobile
LNA Low Noise Amplifier
LP-AMD-P Low Power Active Medical Device Peripheral
LP-AMI Low Power Active Medical Implant
LP-BWD Low Power Body Worn Device
LP-CIS Low Power Cochlear Implant System
MBANS Medical Body Area Network System
MD Medical Device
MEI Middle Ear Implant
MSS Mobile Satellite System
MTP Monosyllable, Trochee, Polysyllable Test
OOK On-Off Keying
QPSK Quadrature Phase Shift Keying
R&TTE Radio and Telecommunications Terminal Equipment
REC RECommendation
RF Radio Frequency
RX Receive
SAP/SAB Services Ancillary to Programme making/Services Ancillary to Broadcasting
SAR Specific Absorption Rate
sFHSS Slow Frequency Hopping Spread Spectrum
SRD Short Range Device
TBCI Transcutaneous Bone Conduction Implant
TDD Time Domain Duplex
TTE Telecommunications Terminal Equipment
TX Transmit
US United States
4 Comments on the System Reference Document
The opinion of the Netherlands and France administrations is that MBANS and all LP-AMI devices coexist in the band
2 483,5 MHz to 2 500 MHz on the basis of equal access to the spectrum. The compatibility issues if any will be
addressed in the respective standards.
The opinion of the BMWi is that for MBANs and LP-AMI equipment operating in the band 2 483,5 MHz to 2 500 MHz
an adequate spectrum sharing mechanism should be implemented to facilitate sharing between these technologies and
applications and in case of congestion, to ensure equal access.
5 Executive summary
New very low power cochlear implant technologies offer solutions for profound hearing loss for moderate conductive
or sensorineural hearing losses.
Currently, there is no spectrum, shared or otherwise which is designated for use by the cochlear implant industry in
Europe.
The present document proposes to build on the existing regulations to permit cochlear implant systems in the
2 483,5 MHz to 2 500 MHz band under a harmonized regulatory framework on a license exempt arrangement.
Cochlear implant systems include low to moderate data rate transfers at 1 Mbps to 2 Mbps symbol rate between the
different external devices and the implantable portion of the LP-CIS at low RF power and duty cycles (0,1 % to 12,5 %)
for indoor and outdoor operation.
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10 ETSI TR 103 069 V1.1.1 (2013-07)
5.1 Background information
Europe is facing the challenge of delivering improved medical care to all its citizens including those afflicted with
hearing loss. Worldwide hearing loss affects approximately 219 thousands of new individuals yearly and in Europe
there are 80 thousands afflicted [i.2]. Modern technology can greatly improve the quality of life of individuals with
hearing loss due to damage to any of several parts of the human hearing system such as the cochlea or aural nerve.
These patients are, or will become, part of a growing mobile community of individuals implanted with some type of
active medical implant to treat their hearing loss affliction. Individuals ranging in age from infants 1 year old to the
elderly of any age with severe or profound hearing loss are candidates, as determined by medical authorities, for
wireless active cochlear implant systems of one type or another. Suitable spectrum is required for the operation of these
emerging wireless devices.
A wireless active medical implant system for hearing impaired patients is composed of devices that are implanted in the
body communicating with related external support peripheral devices. These devices will require the capability for
communications with each other on and as needed basis whether they are outdoors or indoors under the provisions
currently implemented in ECC/ERC Recommendation 70-03, annex 12 band (e) [i.4], external LP-AMI peripheral units
are only permitted to be used in indoor environments. This constraint limits the full utilization of the band by the
medical industry supporting therapy for hearing impaired patients because it limits the availability of system
applications and devices that can be deployed in the band. An example of a cochlear implant system that is basically
precluded from use of the band are peripherals delivering commands to an implant for controlling, monitoring or
programming the implant. Another exclusion is the transfer of stimulation data and/or control data from the external
LP-CIS portion to the implantable portion in the near field allowing external hearing processing.
The full potential for the treatment and maximum achievement of the therapeutic value of cochlear implant systems
require communications between external and implanted devices to be accommodated in the outdoor as well as the
indoor environment.
Current cochlear implant devices are typically used in home environments with additional ambulatory usage in the
patient's normal daily activity environment. Active medical implant device development for the profoundly deaf
includes a communication link between devices such as hand held, body-worn, remote control, monitoring equipment
and the fully implanted cochlear implant for patient use at home, both in- and outdoor. Devices intended for cochlear
implant programming are mainly intended for indoor use.
All of the above rely on spectrum providing a high quality of service for wireless connectivity.
5.2 Market information
5.2.1 Cochlear implants
According to the U.S. Food and Drug Administration (FDA), as of December 2010, approximately 219 000 people
worldwide have received cochlear implants [i.3] whereof 80 000 are European cochlear implant recipients [i.2]. As
progress is made in development of hearing processing algorithms, these devices are seeing increased acceptance by
hearing impaired people. In addition, very young children are now able to receive a cochlear implant which was
previously not permitted. It is now realized that children born with significant hearing deficiencies have much better
results when receiving implants as early as 1 year of age [i.3]. The number of new implants per year in Europe is of the
order of 15 000 to 20 000 [i.2].
Cochlear implants consist of a device that is typically inserted in an area behind the ear at a depth that precludes the
appearance of a protrusion under the skin. The implant depth is typical 15 mm measured from skin to the centre of the
implant body. This device has a very thin cable attached to it that is about 15 cm to 20 cm long containing up to
23 wires with electrodes attached to the end of each wire. This cable is inserted into the cochlea with a special tool such
that the various electrodes attached to the wires are in contact with the aural nerve in the cochlea. These electrodes are
stimulated in various ways as a function of proprietary software that is developed by each manufacturer. To date there
are at least 3 selectable programs based on differing algorithms for unique applications as a function of the environment
the patient is in. For example, a noisy environment will have a program that reduces the impact on understanding that
results from the noise. Other programs have been developed that conduct information sequentially in serial fashion to
stimulate the aural nerve while others conduct information simultaneously in
...