ETSI TR 102 655 V1.1.1 (2008-11)

Electromagnetic compatibility and Radio spectrum Matters (ERM); System reference document; Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) operating in a 20 MHz band within 2 360 MHz to 3 400 MHz

DTR/ERM-RM-252

General Information

• Status: Published
• Publication Date: 24-Nov-2008
• Technical Committee: ERM WGRM - ERM Radio Matters
• Current Stage: 12 - Completion
• Due Date: 17-Dec-2008
• Completion Date: 25-Nov-2008

Standards Content (Sample)

Technical Report
Electromagnetic compatibility
and Radio spectrum Matters (ERM);
System reference document;
Short Range Devices (SRD);
Low Power Active Medical Implants (LP-AMI) operating
in a 20 MHz band within 2 360 MHz to 3 400 MHz

2 ETSI TR 102 655 V1.1.1 (2008-11)

Reference
DTR/ERM-RM-252
Keywords
health, SRD
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ETSI
3 ETSI TR 102 655 V1.1.1 (2008-11)
Contents
Intellectual Property Rights . 5
Foreword . 5
Introduction . 5
1 Scope . 7
2 References . 7
2.1 Normative references . 7
2.2 Informative references . 8
3 Definitions, symbols and abbreviations . 10
3.1 Definitions . 10
3.2 Symbols . 11
3.3 Abbreviations . 12
4 Comments on the System Reference Document . 12
5 Executive summary . 13
5.1 Background information . 13
5.2 Market information. 13
5.2.1 Cardiac market. . 13
5.2.2 Other implanted devices . 14
5.3 Radio spectrum requirement and justification . 15
5.3.1 Technical developments . 15
5.4 Regulations . 16
5.4.1 Current regulations . 16
5.4.2 Proposed regulation and justification . 16
6 Expected ETSI actions . 18
7 Requested ECC actions . 18
Annex A: Detailed market information . 19
A.1 Range of applications . 19
A.2 Expected market size and value . 19
A.2.1 Cardiac rhythm management . 19
A.2.1.1 Bradycardia . 19
A.2.1.2 Ventricular tachyarrhythmia . 21
A.2.1.3 Heart Failure . 22
A.2.2 Homecare . 25
A.2.3 Neurostimulators . 26
A.3 Traffic and equipment density forecast . 26
A.3.1 Spectrum use and efficiency:. 26
Annex B: Detailed technical information . 27
B.1 Detailed technical description . 27
B.1.1 System description . 27
B.1.2 Applications . 27
B.2 Technical parameters and justifications for spectrum . 27
B.2.1 Transmitter parameters . 27
B.2.1.1 Radiated Power . 27
B.2.1.1.1 Required transmitter parameters . 27
B.2.1.2 Emissions in the spurious domain . 28
B.3 Link budget considerations . 28
B.3.1 Introduction . 28
ETSI
4 ETSI TR 102 655 V1.1.1 (2008-11)
B.3.2 Body phantom . 29
B.3.3 Measurements . 31
B.3.3.1 Description test antenna . 31
B.3.3.2 Synthesis of measurements results . 32
B.3.3.3 Method of measurements . 33
B.3.3.4 Measurement results . 34
B.3.3.4.1 Phantom influence on the impedance of the test antenna . 34
B.3.3.4.2 Phantom influence on the test antenna efficiency . 35
B.3.4 Conclusion for propagation model . 37
B.3.5 Simulation . 37
B.3.5.1 Description of simulation . 38
B.3.5.2 Results of the antenna impedance simulation . 38
B.3.5.3 Simulation results of antenna radiation efficiency . 39
B.3.5.4 Comparison between measured and simulated radiation pattern . 43
B.3.6 Results on the SAR evaluation . 44
B.3.7 Conclusions . 47
B.3.8 Conclusion on Link budget model and SAR . 48
B.3.9 Receiver parameters and maximum range . 50
B.3.10 Channel access parameters . 50
B.4 Information on relevant standard(s) . 51
Annex C: Expected sharing and compatibility issues . 52
C.1 Current ITU and European Common Allocations . . 52
C.2 Sharing and compatibility studies (if any). 53
C.2.1 Compatibility with services in neighbouring bands . 53
Annex D: Bibliography . 54
History . 55

ETSI
5 ETSI TR 102 655 V1.1.1 (2008-11)
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://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 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
CEPT/ERC Recommendation 70-03 [i.1], annex 12 and EC Decision "2006/771/EC [i.44] on harmonization of the
radiospectrum for use by short range devices" define frequencies for wireless applications in healthcare, in parallel.
ETSI has published several Harmonized European product Standards for wireless applications in healthcare.
Rapid developments within the active medical implant area are expected, requiring new applications and additional
spectrum. To control and monitor these devices in hot-spot areas with many patients such as hospitals, clinics and
assisted living facilities, require increased system capacity.Future medical applications may require significant higher
data rates. The present document covers the spectrum request for these applications that may be possible due to the
development of the semiconductor technology.
The purpose of producing the present document is to lay a foundation for industry to quickly bring innovative and
useful products to the market while avoiding any harmful interference with other services and equipment.
A license exempt regulation for this type of application is required.
The present document proposes to operate these devices in an approximately 20 MHz wide sub-band inside the
2 360 MHz to 3 400 MHz frequency range. It is realized that it may be difficult to obtain this goal below 2 GHz. It is
mandatory to designate a world-wide frequency band due to travelling of patients with implants.
In 2005, 17 000 people worldwide had cochlear devices implanted. In the U.S. alone some 900 000 people are believed
to be deaf or near deaf [i.30]. As cochlear implants need high duty cycle transmissions this application is not considered
to be suitable for the frequency range 2 483,5 GHz to 2 500,0 GHz. Therefore, this need will addressed in a separate
document at a later stage.
It is envisioned that the proposed radio systems may require a change of utilization of the present regulatory framework
for the proposed band(s).
Status of pre-approval draft
th
The present document was developed by ERM/TG30 and approved for publication by ERM at its 36 meeting,
November 2008. The information in the present document has undergone coordination by ERM. It contains final
information.
ETSI
6 ETSI TR 102 655 V1.1.1 (2008-11)
Table 1: Current status of the present document
Target version Pre-approval date version
(see note)
V1.1.1 a s m Date Description
0.0.1 0.0.3 22 January 2008 Draft for TG 30 review
0.0.1 0.0.4 30 May 2008 Draft for ERM-TG30 review
0.01 0.0.5 3 June 2008 ERM-TG30 approved
subject to editorial
0.01 0.0.6 10 June ERM-TG30 editorial
comments
0.0.1 0.0.7 11 June Version with BNetzA
comments
1.1.1 0.0.9 27 June ETSI mini enquiry Version
1.1.1 0.0.10 21 August Final document including
mini consultation comments
1.1.1 0.0.11 26 August Minor editorials done
NOTE: See clause A.2 of EG 201 788 [i.45] (V1.2.1).

ETSI
7 ETSI TR 102 655 V1.1.1 (2008-11)
1 Scope
The present document defines new requirements for radio frequency spectrum usage for low power, active medical
implants and their peripheral radio control systems.
It is noted that the present document proposes a concept that should permit a harmonized regulatory framework for
these systems and provides a basis for a licence exempt arrangement preferably on a secondary allocation.
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 a specific reference, subsequent revisions do not apply.
• Non-specific reference may be made only to a complete document or a part thereof and only in the following
cases:
- if it is accepted that it will be possible to use all future changes of the referenced document for the
purposes of the referring document;
- for informative references.
Referenced documents which are not found to be publicly available in the expected location might be found at
http://docbox.etsi.org/Reference.
For online referenced documents, information sufficient to identify and locate the source shall be provided. Preferably,
the primary source of the referenced document should be cited, in order to ensure traceability. Furthermore, the
reference should, as far as possible, remain valid for the expected life of the document. The reference shall include the
method of access to the referenced document and the full network address, with the same punctuation and use of upper
case and lower case letters.
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 indispensable for the application of the present document. For dated
references, only the edition cited applies. For non-specific references, the latest edition of the referenced document
(including any amendments) applies.
Not applicable.
ETSI
8 ETSI TR 102 655 V1.1.1 (2008-11)
2.2 Informative references
The following referenced documents are not essential to the use of the present document but they assist the user with
regard to a particular subject area. For non-specific references, the latest version of the referenced document (including
any amendments) applies.
[i.1] CEPT/ERC Recommendation 70-03: "Relating to the use of Short Range Devices (SRD)".
[i.2] Void.
[i.3] ITU-R Recommendation SA 1346: "Sharing between the Meteorological Aids Service and the
Medical Implant Communications Systems (MICS) operating in the Mobile Service in the
Frequency Band 401-406 MHz".
[i.4] CEPT/ERC Report 25: "The European Table of Frequency Allocations and Utilisations in the
Frequency Range 9 kHz to 1000 GHz: Lisboa 02 - Dublin 03 - Kusadasi 04 - Copenhagen 04 -
Nice 07".
[i.5] International Diabetes Federation.
NOTE: Available at http://www.idf.org/e-atlas/home/index.cfm?node=84.
[i.6] "Implanted Antennas inside a human body: simulations, designs and characterizations: J. Kim,
Y. Rahmat-Samii.
NOTE: IEEE Transactions on Microwave Theory and Techniques, vol. 52, n 8, August 2004, pp. 1934-1943.
[i.7] "Design of implantable Microstrip Antenna for communication with medical implants": P.
Soontornpipit, C.M. Furse Y.C. Chung.
NOTE: IEEE Transactions on Microwave Theory and Techniques, vol. 52, n°8, August 2004, pp. 1944-1951.
[i.8] "FDTD analysis of a coupled close-coupled 418 MHz radiating devices for human biotelemetry":
Phys. Med. Biol., vol. 44, n 2, pp. 335-345, Feb. 1999. W.G. Scanlon, N.E. Evans, J.B. Burns.
[i.9] M.W.S., Computer System Technology (C.S.T.), GmbH, Darmstadt, Germany.
[i.10] "Antennas and propagation for body-centric wireless communications": Artech House Inc., 2006.
P. S. Hall, Yang Hao.
[i.11] "Compilation of the dielectric properties of body tissues at RF and microwave frequencies":
Armstrong Lab., CITY, STATE. C. Gabriel, S. Gabriel.
NOTE: Available at http://www.brooks.af.mil/AFRL/HED/hedr/reports/dielectric/home.html.
[i.12] ETSI EN 301 839-1 (V1.1.1): "Electromagnetic compatibility and Radio spectrum Matters (ERM);
Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and
Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Part 1:
Technical characteristics and test methods".
[i.13] "Composition And Electrical Properties Of A Liquid That Has The Electrical Properties Of
Tissue": Hartsgrove and Kraszewski 1984.
[i.14] USAFSAM-TR-85-73: RADIOFREQUENCY RADIATION DOSIMETRY HANDBOOK
(Fourth Edition), in line document. Carl H. Durney, Ph.D., Habib Massoudi, Ph.D., Magdy F.
lskander.
[i.15] Agilent: "85070E Dielectric Probe Kit, 200 Mhz to 50 Ghz.
[i.16] Void.
[i.17] "An internet resource for the calculation of the dielectric properties of body tissues", Institute for
Applied Physics, Italian National Research Council.
NOTE: Available at http://niremf.ifac.cnr.it/tissprop/.
ETSI
9 ETSI TR 102 655 V1.1.1 (2008-11)
[i.18] ETSI EN 301 839-2: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Short
Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals
(ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Part 2: Harmonized EN
covering essential requirements of article 3.2 of the R&TTE Directive".
[i.19] ETSI EN 301 489-27: "Electromagnetic compatibility and Radio spectrum Matters (ERM);
ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 27:
Specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI) and related
peripheral devices (ULP-AMI-P)".
[i.20] ETSI EN 301 489-29: "Electromagnetic compatibility and Radio spectrum Matters (ERM);
ElectroMagnetic Compatibility (EMC) standard for radio equipment operating in the 401 MHz to
402 MHz and 405 MHz to 406 MHz bands; Part 29: Requirements for Medical Data Service
Devices (MEDS)".
[i.21] ETSI EN 302 537-1: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Short
Range Devices (SRD); Ultra Low Power Medical Data Service Systems operating in the frequency
range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Part 1: Technical characteristics and test
methods".
[i.22] ETSI EN 302 537-2: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Short
Range Devices (SRD); Ultra Low Power Medical Data Service Systems operating in the frequency
range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Part 2: Harmonized EN covering essential
requirements of article 3.2 of the R&TTE Directive".
[i.23] 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.24] CEPT/ERC Recommendation 74-01:" Unwanted emissions in the spurious domain".
[i.25] Eurostat (year): The source of harmonized and comparable statistical information of the European
Union.
NOTE: Available at http://ec.europa.eu/eurostat/.
[i.26] "Heart Disease and Stroke Statistics, 2008 Update, Circulation 2008".
[i.27] The Euro Heart Failure Survey Programme: "A Survey of the Quality of Care Among Patients
with Heart Failure in Europe. Part 1: Patient Characteristics and Diagnosis". Eur Heart J 2003;24:
442-463 Cleland JG, Swedberg K, Follath F et al.
[i.28] International Diabetes Federation, 2007: Diabetes Atlas, third edition.
[i.29] The Neurotechnology Industry 2005: "Strategic Investment and Market Analysis Report of the
Global Neurological Disease and Psychiatric Illness Market. San Francisco: NeuroInsights; 2006:
Introduction".
[i.30] http://www:businessweek.com/magazine/content/05-46/b3959101.htm.
[i.31] The heart, arteries and veins: New York: McGraw-Hill, 1998:1081-1112. RC, Fuster V, eds.
[i.32] Cardiac arrest and sudden cardiac death: In: Braunwald E, ed. Heart disease: a textbook of
cardiovascular medicine. Philadelphia: WB Saunders, 1997:742-779. Myerburg RJ, Castellanos A.
[i.33] Out-of-hospital cardiac arrest in the 1990s: a population-based study in the Maastricht area on
incidence, characteristics and survival. J Am Coll Cardiol 1997;30:1500-1505. [PubMed]
de Vreede-Swagemakers JJ, Gorgels AP, Dubois-Arbouw WI, et al.
[i.34] Heart Failure Facts and Figures: OU Medical Centre.
NOTE: Available at www.oumedcenter.com [last accessed 26-09-05].
[i.35] The Task Force for the diagnosis and treatment of CHF of the European Society of Cardiology.
Eur Heart J 2005;26:1115-40; Swedberg k., Cleland J., Dargie H., et al.
NOTE: Full guidelines online at www.escardio.org/knowledge/guidelines/Chronic_heart_failure.htm.
ETSI
10 ETSI TR 102 655 V1.1.1 (2008-11)
[i.36] Heart Disease and Stroke Statistics - 2005 Update, American Heart Association.
NOTE: Available at www.americanheart.org/downloadable/heart/1105390918119HDSStats2005Update.pdf [last
accessed 22-09-05].
[i.37] EUCOMED data: Pacemaker implant rates, 2007.
NOTE: Available at http://www.eucomed.org/press/~/media/5D7FDD75E5A84547945D1C83E8C8CDE3.ashx.
[i.38] EUCOMED data: CRT-Defibrilator implant rates, 2007.
NOTE: Available at http://www.eucomed.org/press/~/media/F6FA04CF29564206B742ED19B87E0395.ashx.
[i.39] EUCOMED data: CRT-Pacemaker implant rates, 2007.
NOTE: Available at http://www.eucomed.org/press/~/media/2CD88BC32C0E401AA874C0FF4AFE525F.ashx.
[i.40] EUCOMED data: ICD implant rates, 2007.
NOTE: Available at http://www.eucomed.org/press/~/media/E60CE28CFAFE4E30AE3575BDE9AAFEB2.ashx.
[i.41] EUCOMED data: Reference regarding the number of employee and turnover for medical devices
in Europe.
NOTE: Available at
http://www.eucomed.org/press/~/media/pdf/tl/2008/portal/aboutindustry/medtechbrief2007.ashx.
[i.42] US FCC (United States Federal Communications Commission), DA 08-953: "Office of
Engineering and Technology to treat ex parte comments of GE Healthcare as Petition for Rule
Making and seeks comment".
[i.43] ERC Decision ERC/DEC(97)03 of 30 June 1997 on the Harmonised Use of Spectrum for Satellite
Personal Communication Services (S-PCS) operating within the bands 1 610 to 1 626,5 MHz,
2 483,5 to 2 500 MHz, 1 980 to 2 010 MHz and 2 170 to 2 200 MHz.
[i.44] EC Decision 2006/771/EC on harmonization of the radiospectrum for use by short range devices.
[i.45] ETSI EG 201 788: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Guidance
for drafting an ETSI System Reference Document".
[i.46] ITU Radio Regulations.
[i.47] Decision 2008/477/EC; Commission Decision of 13th June 2008 on the harmonisation of the
2500-2690MHz frequency band for terrestrial systems capable of providing electronic
communications services in the Community.
[i.48] ECC Decision ECC/DEC/(05)05 of 18 March 2005 on harmonised utilisation of spectrum for
IMT-2000/UMTS systems operating within the band 2500 - 2690 MHz.
[i.49] ETSI TS 125 104: "Universal Mobile Telecommunications System (UMTS); Base Station (BS)
radio transmission and reception (FDD) (3GPP TS 25.104 version 8.1.0 Release 8)".
3 Definitions, symbols and abbreviations
3.1 Definitions
For the purposes of the present document, the following 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
ETSI
11 ETSI TR 102 655 V1.1.1 (2008-11)
Active Medical Device (AMD): any medical device relying for its functioning on a source of electrical energy or any
source of power
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
Ultra Low Power Active Medical Implant (ULP-AMI): ultra 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 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
NOTE: LP-AMI may communicate with another LP-AMI or with a LP-AMI-P, LP-BWD, LP-AMD and
LP-AMD-P.
Low Power Active Medical Implant Peripheral (ULP-AMI-P) device: low power radio part of medical equipment
outside the human body that communicates with another LP-AMI-P or with a LP-AMI, LP-AMD, LP-BWD
Low Power Active Medical Device (LP-AMD): low power radio part of any active medical device (AMD) outside the
human body which has its radio antenna external to the body and is used to communicate with another LP-AMD or with
a LP-AMD-P, LP-AMI, LP-BWD LP-AMI-P
Low Power Active Medical Device Peripheral (LP-AMD-P): low power radio part of medical equipment outside the
human body that communicates with a LP-AMD, LP-BWD, LP-AMI or other LP-AMD-P
Low Power Body Worn Device (LP-BWD): low power radio part of a medical device, such as a physiological
parameter sensor or handheld device, that is intended to operate in proximity to the human body (6 cm or less from the
skin surface) which has its radio antenna external to the body and is used to communicate with another LP-BWD or
LP-AMI, LP-AMD, LP-AMI-P, LP-AMD-P
3.2 Symbols
For the purposes of the present document, the following symbols apply:
dB deciBel
dBi deciBel relative to an isotropic radiator
f Frequency
P Power
R Distance
t Time
ETSI
12 ETSI TR 102 655 V1.1.1 (2008-11)
3.3 Abbreviations
For the purposes of the present document, the following abbreviations apply:
AFA Adaptive Frequency Agility
AIMD Active Implantable Medical Device
AMD Active Medical Device
ARQ Automatic Repeat reQuest
AV Atrio-Ventricular
CEPT Conference of European Postal and Telecommunications Administration
CHF Congestive Heart Failure
CNS Central Nervous System
CRC Cyclic Redundancy Check
CRT Cardiac Resynchronization Therapy
CST Computer System Technology (GmbH) (DE)
ECA European Common Allocation
ECC Electronics Communications Committee
e.i.r.p. effective isotropically radiated power
EMC Electro Magnetic Compatibility
ESC European Society of Cardiology
EUCOMED EUropean Confederation Of MEDical suppliers association
FEC Forward Error Correction
ICD Implantable Cardioverter Defibrillators
LAN Local area Network
LP - AMD - P Low Power Active Medical Device Peripheral
LP - AMD Low Power Active Medical Device
LP - AMI - P Low Power Active Medical Implant Peripheral
LP - AMI Low Power Active Medical Implant
LP-AMD Low Power Active Medical Device
LP-AMD-P Low Power Active Medical Device Peripheral
LP-AMI Low Power Active Medical Implant
LP-AMI-P Low Power Active Medical Implant Peripheral
LP-BWD Low Power Body Worn device
MD Medical Device
MICS Medical Implant Communications Systems
MWS Micro Wave Studio
NCHS National Center for Health Statistics (USA)
NHANES National Health And Nutrition Examination Survey (USA)
NHLBI National Heart, Lung, and Blood Institute (USA)
R&TTE Radio and Telecommunications Terminal Equipment
RF Radio Frequency
SAR Specific Absorption Rate
SCD Sudden Cardiac Death
SRD Short Range Device
ULP-AMI Ultra Low Power Active Medical Implant
4 Comments on the System Reference Document
Comments from Vodafone, Deutsche Flugsichering GmbH (DFS) and Ministry of Economic Affairs NL were received
on during the ETSI ERM correspondence approval procedure. All comments have been accepted and included in the
present document.
ETSI
13 ETSI TR 102 655 V1.1.1 (2008-11)
5 Executive summary
5.1 Background information
Europe is facing the challenge of delivering quality healthcare to all its citizens, at affordable cost. Prolonged medical
care for the ageing society, the costs of managing chronic diseases, and the increasing demand by citizens for best
quality healthcare are major factors. Healthcare expenditure in Europe is already significant (8,5 % of the GDP on
average) and rising faster than overall economic growth itself. Personalized Monitoring is a way to address this issue.
Active Implantable Medical Devices (AIMD) are currently instrumental in saving or enhancing a significant number of
the lives of patient inflicted with various kinds of heart conditions, nervous disorders and diseases, which otherwise
would have resulted in death or disability and which devices can also significantly improve the quality of life.
The active medical implant system consists of devices that are implanted in the body. These devices can currently only
communicate with an external peripheral radio device. Examples of these implanted devices are defibrillators,
pacemakers, various types of nerve stimulators, sensors, implantable infusion pumps and cardiac resynchronization
devices. Current systems are typically used in hospitals and/or doctor's office environments with increasing ambulatory
remote monitoring in the patient's normal environment. Additionally, this development will include body-worn devices,
patient peripherals for use both in- and outside hospitals and clinics.
Due to the rapid development and increased use of Active Implantable Medical Devices it is desirable to increase the
range and system capacity significantly. Both higher data rates and sufficient memory are available technologically and
are already provided by other non-medical systems, for example Bluetooth, Radio LAN. However, such systems use
spectrum with high user density and, because of the protocols used, require several orders of magnitude higher current
consumption than is practical for medical implant systems. Therefore, a new spectrum able to handle the increased
demand is required. It is important to note that the spectrum should be worldwide to the maximum extent possible.
5.2 Market information
5.2.1 Cardiac market.
For further details on market information, see annex A.
In 2006, according to EUCOMED data, more than 400 000 implants were implanted within the European Community.
This number will increase due to aging population. Within 10 years it expected to have more than 3 million European
patients with implanted devices.
Heart failure incidence approaches a large population as expressed in figure 1. Source: "Heart Disease and Stroke
Statistics_2008 Update, Circulation 2008", Chart 7-1 [i.26].
ETSI
14 ETSI TR 102 655 V1.1.1 (2008-11)

Sources: NCHS and NHLBl
Figure 1: Prevalence of heart failures by sex and age (NHANES: 1999 to 2004)
In 2015, the population of heart failure patients will be spread to 12 million people, according to table 2.
Table 2: European population of heart failures
European Male Male European Female Female
population Heart Failures population Heart Failures
Age
in 2015  in 2015 in 2015 in 2015
(see note 1) (see note 2) (see note 1) (see note 2)
20 to 39 67 858 986 203 577 65 684 972 131 370
40 to 59 71 617 141 1 432 343 72 252 697 1 083 790
60 to 79 45 763 736 3 294 989 53 267 523 2 769 911
80+ 9 333 440 1 082 679 16 979 589 2 105 469
Total 194 573 303 6 013 588 208 184 781 6 090 541
Sources:
NOTE 1: Eurostat (year):(http://ec.europa.eu/eurostat/ The source of harmonised and comparable
statistical information of the European Union) [i.25].
NOTE 2: Heart Disease and Stroke Statistics, 2008 Update, Circulation 2008 [i.26].
Cleland JG, Swedberg K, Follath F et al.The EuroHeart Failure Survey Programme-
A Survey of the Quality of Care Among Patients with Heart Failure in Europe.
Part 1: Patient Characteristics and Diagnosis. Eur Heart J 2003;24:442-463 [i.27].

Of these 12 million, according to the European Society of Cardiology (ESC) approximately 40 %, 4,8 million patients
are candidates for active implantable medical device implants, CRT.
5.2.2 Other implanted devices
There are several emerging therapies that will benefit from implanted devices. For example, nerve stimulation implants
and drug delivery infusion pumps are finding success in controlling and/or treating various bodily functions and
diseases such as urinary incontinence, uncontrollable muscular spasms, insulin injection, and delivery of pain
medication to mention a few. Active implantable medical devices are the only technology capable of full time non-stop
delivery of these types of necessary medical therapies that are required to preserve and enhance the quality of life for
many in this group of patients. Further details on other implanted devices are given in clause A.1.
ETSI
15 ETSI TR 102 655 V1.1.1 (2008-11)
5.3 Radio spectrum requirement and justification
The advent of technology permitting implanted devices to communicate with external devices at distances of a few
meters over extended periods of time has opened up a new era in medical treatment. Considerations of tissue loss,
battery life, existing users, and ambient signal levels in the selected spectrum result in the selection of bands below
3 GHz as the most suitable for implant technology. Today, medical device manufacturers have developed applications
for implant technology that will place much greater demands on the available spectrum due to increased proliferation of
implanted devices and a need for much greater transmission speed. Additional frequency spectrum is required to handle
the increased demand for transmission bandwidth.
There is not sufficient capacity in the existing band; a significantly increased bandwidth is required.
The use of wireless communications to implanted devices will increase dramatically over the next 10 years. Further
details are given in clause 5.3.1.
5.3.1 Technical developments
The following important technical developments is to be noted:
• It is now feasible to support RF telemetry in most active implanted medical devices. Additionally, many
traditionally non-active medical implants may become active like artificial hips, knees, grafts, stents and many
others.
• There are on-going efforts to enable remote monitoring and programming by incorporating RF telemetry into
applications such as implantable drug pumps, orthopaedics, artificial limbs, neurostimulators, functional
electrical stimulations, implantable diagnostics, bladder stimulators, cochlear implants.
• Wireless remote monitoring of patients with active implanted medical devices will become the standard of
care in hospitals, clinics, assisted living facilities (homes for the elderly), and their daily living environment.
Growth in telemetry range is driven by:
• The need for greater patient mobility. Physicians and patients will require Active Implantable Medical Devices
to have increased ranges to allow patients greater mobility and patient convenience and compliance will
continue to drive this.
Ranges in an order of magnitude larger than currently achieved will be needed to reliably monitor patients throughout
their daily living environment.
Remote monitoring demand will continue to grow:
• As remote monitoring / programming becomes increasingly more adopted, physicians and patients will require
more access points.
• Limits on allowable data latency will increase demands on the link availability.
Long-term wireless implantable medical application needs to include the following:
• World-wide available spectrum (sharing within already harmonized frequency band).
• Licence exempt.
- LP-AMI has interference mitigation techniques to protect primary and secondary users.
- LP-AMI has robust interference mitigation techniques to protect itself against interference from primary
and secondary devices.
• LP-AMI (future) designated spectrum should have low density occupation by other users.
• Support for relatively high data rate at short range and decreased data rate at long range.
ETSI
16 ETSI TR 102 655 V1.1.1 (2008-11)
• Bidirectional communication modes:
- Implant to external communication.
- External to external communication in which an implant is present in the system.
- Implant to implant communication.
Additional spectrum for medical systems with higher user density and data rate will permit the expansion of different
types of communication links. This will permit downloading large amount of patient data from implant to mass storage
facilities and from a peripheral device to a central communication system for further review and analysis. In addition, it
is possible to extend these communications from programmer to central communication system using the same band if
and or when the capacity allows.
An accumulation of a large database of retrieved data over time can be analysed by physicians to diagnose a patient's
condition. This will improve the therapy delivered by the implant.
5.4 Regulations
5.4.1 Current regulations
Ultra Low Power Active Medical Implants (ULP-AMI) and peripherals are currently permitted to operate in the MICS
band 402 MHz to 405 MHz as class 1 devices. These operate in compliance with spectrum regulatory requirements
described in ITU-R Recommendation SA 1346 [i.3] and EC Decision [i.23]. Harmonized emissions and EMC standards
have been adopted for these applications, EN 301 839-1 [i.12], EN 301 839-2 [i.18], and EN 301 489-27 [i.19].
In the bands 401 MHz to 402 MHz and 405 MHz to 406 MHz all in compliance with spectrum regulatory requirements
as provided for in ERC/REC 70-03 [i.1], annex 12 bands (a), (a1) and (a2) [i.1]. Harmonized emissions and EMC
standards have been
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