1. ETSI IN SUPPORT OF EHEALTH
Presented by Dr Saad Mezzour ‐ Medtronic ‐ ETSI TG30 Chairman
© ETSI 2014. All rights reserved

2. ETSI is …
Independent, not‐for‐profit
organization, created in 1988
A recognized European Standards
More than 700 members from more
than 60 countries
Offering direct participation andA recognized European Standards
Organization
Setting global standards for all areas
Offering direct participation and
Membership voting
Organisational partner of 3GPP
of ICT
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3.  ETSI produces standards for the whole Telecommunications
field
 Applicable harmonized standards from ETSI can be used to
show compliance with European legal requirements in the field
of EMC and radio spectrum useof EMC and radio spectrum use.
 ETSI standards are also used in many countries outside Europe
– e.g. EN301 839 for Ultra Low Power Active Medical implants is
used in Japan, Australia, New Zealand, Canada etc
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4. European radio spectrum management
 The overall body is the CEPT – the European Conference of
Post and Telecommunications
 It is an organisation of 48 countries
 Telecommunications matters are handled by the ECC –
Electronic Communications CommitteeElectronic Communications Committee
 There are three Working Groups:
• Regulatory Affairs (RA)Regulatory Affairs (RA)
• Frequency Management (FM)
• Spectrum Engineering (SE)
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5. European radio spectrum management
 E h f h h h P j T d li i h Each of the three groups have Project Teams dealing with
particular areas. All three groups have some representation
from industry, although only Administrations have voting
rights. Decisions are usually reached by consensus.
 The Short Range Device Maintenance Group (SRD/MG) is a
sub group of WGFM: it advises WGFM on frequency
management matters including such matters as power,
frequency assignment etc.frequency assignment etc.
 Compatibility studies before new assignments are made are
carried out by a WGSE project team.y p j
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6. European radio spectrum management
 The European Union has a Radio Spectrum Policy Group drawn
from the spectrum administrations in each EU country. RSPG o t e spect u ad st at o s eac U cou t y S G
assists the European Commission in the development of
spectrum policy throughout the EU
h k h h The RSPG works with the CEPT and ETSI
 The Radio Spectrum Committee (RSCOM) implements RSPG
policypolicy
National
administrations
48
CEPT
Harmonizing National Frequency Allocations
Harmonizing National Regulatory Authority activities
Coordinating International Negotiations
WG FM
WG/SE
SRD/MG
MoU
Industry
ETSI
ERM
ERM RM
ERM TG30 / EP eHEALTH
TCAM
RSPG
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Industry
Harmonized Standards and other
standards & specifications to support
legislation & market development
Policy positions
Legal certainty
Political support
ERM TG30 / EP eHEALTHRSPG

7. ETSI Organisation
 The work of ETSI is carried out in Technical Committees and ETSI
Projects.
 TC_ERM is the technical committee responsible for EMC and
radio policy matters: its various task group committees have
responsibility for defined areas e.g. TG28 Short Range Devicesresponsibility for defined areas e.g. TG28 Short Range Devices
(SRD), TG30 Wireless Medical Devices etc. The Task Groups
produce standards for various equipments: some standards are
generic while some are specific to a particular productgeneric, while some are specific to a particular product.
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8. ETSI Organisation
G l A blGeneral Assembly
ETSI Board
Operational
C di ti G
ETSI
S t i t
TSI oard
Coordination Group
OCG R&TTED
Technical Committees
Including
TC ERM
Secretariat
EP eHealth
TC_ERM TC SmartBAN
ERM_TG30
Wireless Medical
ERM_TG17
Wireless Audio
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Wireless Medical
ApplicationsERM_TG28 Short
Range Devices
ERM_RM
Radio Policy Matters

9. ETSI ERM_TG30 organisation
Officials - ERM TG30 :
Chairman : Saad Mezzour (Medtronic)
Secretary : Phillip Inglis (Medtronic)Secretary : Phillip Inglis (Medtronic)
TG30 Participants:
Medtronic
St Jude Medical
Biotronik
Zarlink
ELA/Sorin
Boston Scientific
Philips Healthcare
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Toumaz

10. • A typical generic standard is EN 300 220, for generic short
range devices in the frequency range 25 to 1000MHz.
A l f ifi d d i EN301 839 (fi• An example of a specific standard is EN301 839 (first
published in 2002) for Ultra Low Power Active Medical
Implants and associated peripherals
• EN 301 839 specifically excludes audio applications
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11. ETSI medical SRDs
Some ERM_TG30 deliverables_
 Wireless Medical devices (ERM_TG30)
 Ultra Low Power Active Medical Implants (ULP‐AMI)
• 9 kHz to 315 kHz: EN 302 195• 9 kHz to 315 kHz: EN 302 195
• 30 MHz to 37,5 MHz: EN 302 510
• 402 MHz to 405 MHz: EN 301 839402 MHz to 405 MHz: EN 301 839
 EN 302 537 ULP‐AMI
Medical Data Service Systems in 401 MHz to 402 MHz and 405
MHz to 406 MHz;
 EN 302 536 ULP AID 315 kHz to 600 kHz
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 EN 302 536 ULP‐AID 315 kHz to 600 kHz

12. Short Range Devices (SRD)
 SRD are devices that can have an e.i.r.p. ranging from 25W to
400W, depending on frequency band and applications
 Th d b Ad i i i h b i h They are accepted by many Administrations on the basis that
they must not cause any interference to, and must accept any
interference from, other radiocommunication services.
 They have no status in the international Radio Regulations as a
f h h h f h d ld!service – in fact, they are the pariahs of the radio world!
 The European regulatory ‘bible’ for SRD is the Recommendation
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 The European regulatory bible for SRD is the Recommendation
ERC/REC 70‐03

13. European frequencies for SRDs
 9 – 600 kHz in various bands and power levels for inductive
devices, some with specific applications e.g. animal implants.
 3.155 – 3.4, 6.765 – 6.795,7.4 – 7.8, 10.2 – 11, 13.553 – 13.567,
26.957 – 27.283 MHz, all inductive coupling only, and many for
specific applications.p pp
 40.66 – 40.7, 138.2 – 138.45, 401 – 406 (limited to ultra‐low
power medical implants) 433.05 – 434.79,
 863 – 870 MHz, 2.4 – 2.4835GHz , 5.725 – 5.875 GHz, 24 –
24.25 GHz, 61 – 61.5GHz , 122 – 123 GHz, and 244 – 246 GHz
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14.  The European Generic SRD bands 863 – 870MHz and
2400MHz‐2483.5MHz are planned with various
segments and various powers for a number of
applications.
 With the use of either ‘Low Duty Cycle’ (LDC) or ‘Listen
Before Talk’ (LBT) as a media access method, optimum
spectrum sharing for all users is achieved.
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15. European Medical Implant
communication bands
 9 - 315kHz for implant communication – typically, a
pacemakerpacemaker
 30 – 37.5MHz for membrane implants
 401 – 406MHz for Ultra Low Power Active Medical
Implants (ULP-AMI)
 2483 5 2500MH L P A ti M di l I l t 2483.5 – 2500MHz Low Power Active Medical Implants
(ULP-AMI)
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16. Implant receiver power requirements
Depending upon the demand on the pacemaker, an implant can
last between 5 and 20 years
The average is about 8 to 10 years before implant replacement is
required
Rechargeable batteries have been used in certain implanted
devices, but problems of energy density, heat while recharging,devices, but problems of energy density, heat while recharging,
and physical problems of coupling, as well as difficulties with
patients forgetting to charge the battery, remain
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17. Power management in implant receivers
Because of limited power availability, implant receivers have to
‘sleep’ for the majority of the time.
‘Wake up’ can be achieved in several ways, and the lowest
component count is with band scanning p g
Interference during wake up sniffing can increase current
consumption as the wake up system must use processing powerconsumption as the wake up system must use processing power
to discriminate the interferer from a wanted signal
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High duty cycle interferers are particularly problematic and will
adversely affect battery life

18. Access Protocols and Power Management
 100% duty cycle applications without access protocol in ULP AMI 100% duty cycle applications without access protocol in ULP‐AMI
bands are a major problem, and need to be avoided, especially
with the large installed base of implants
 The 401 – 406MHz band is shared with the Primary Service ‐
meteorological aids – mainly meteorological weather balloons
 These are rarely transmitting close enough to patients with
implants to lead to extended wake up power demands
 No Non – implant applications in these bands especially those No Non – implant applications in these bands, especially those
used close to patients, require a limitation on duty cycle and a
polite access protocol to avoid prematurely discharging the
implant battery and to avoid interference with implant
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implant battery and to avoid interference with implant
transmissions

19. ISM and SRD
 Some frequency bands are often referred to as ‘ISM bands’
(Industrial, Scientific, Medical). Although radio‐communications
services operating in such bands must accept any interference p g p y
from ISM, these bands are allocated to radio‐communications
on a primary basis e.g. 2400 to 2483.5MHz is allocated to fixed
and mobile services on a primary basis, and to radiolocation on a d ob e se ces o a p a y bas s, a d to ad o ocat o o
a secondary basis in some regions and on a primary basis in
others
h b f b l These bands are convenient for use by licence exempt SRD
(sometimes referred to as ‘gadgets’) because of global
harmonization and also because of the lack of protection thus
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afforded through RR1.15 and RR5.150

20. ITU and Medical Implant Communication
frequenciesq
 The 401 – 406MHz range was assigned for use by Medical
Implant Communication Systems (MICS) in ITU‐R
Recommendation SA (now RS)1346Recommendation SA (now RS)1346
 This was as a result of sharing studies with meteorological aids,
and on the basis of very limited or no outdoor useand on the basis of very limited or no outdoor use
 Some Administrations treat MICS as a ‘Mobile’ service within the
ITU terms: most others treat it as ‘SRD’, and thus an ‘orphan’, p
 Some Administrations also feel that some protection greater
than that afforded to SRDs is justified for medical implants
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21. European frequency allocation and MBANS
 In February 2014 CEPT published in Recommendation ERC/REC
70‐03 a new entry for MBANS operating in the 2483.5‐
2500MHz band2500MHz band
 ETSI TG30 has finalised and approved (this morning) the new
draft Standard EN 303 203draft Standard EN 303 203
 The Draft Standard EN 303 203 will be submitted to TC_ERM
pproval and is expected to be published for Public Enquirypproval and is expected to be published for Public Enquiry
 EN 303 203 is expected to be published by ETSI in January 2015
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22. Typical Medical Implant Communication
System Spectrum usage scenariosy p g
Remote
• Pre-scheduled
device checks
In-office
• Complete wireless
follow-up
Implant
• Streamlined
implant procedure
• Replaces regularly
scheduled clinic
visits
• Physician selected
• Improved comfort for
patient
• Real-time
communication of
critical data
• Physician selected
alert conditions
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23. New devices leveraging existing technologies
Algorithms from
ICD and CRT
ed
Micro-Electronics
& Advanced
Packaging
Miniaturization
Leverag
Electrode
Materials &
Instruments &
Data
Intra-body
Communication
nologyL
Materials &
Battery Tech.
Data
Management
Interfaces
Remote monitoring
and programming
Techn
Advanced
Sensors
Development
Communication/
Telemetry
Protocols
New Market with
advanced
injectable Platform
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24. Trends driving wireless medical innovation
Device miniaturization On-body networks
Injectable DeviceLeadless Pacemaker Injectable DeviceLeadless Pacemaker
Remote monitoring and programminge ote o to g a d p og a g
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25. Diabetes therapy system
The pump can numerically and
graphically display wirelesslygraphically display wirelessly
transmitted data from a
continuous glucose sensor
glucose sensor
The pump has the ability to
wirelessly download pump data to
a PC for retrospective analysis of
Insulin Pump
glucose meter
therapy.
glucose meter
Remote control
The pump can wirelessly receiveThe pump can wirelessly receive
and store blood glucose
measurements from a paired
blood glucose meter.
The pump can wirelessly receive
commands from a remote
control device.
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26. Technology Trends – Wireless
Medical Device Proliferation
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27. The Expense ?
Taking part in Standards and Regulatory work is
expensive butexpensive, but ……
Not doing Regulatory and Standards work can be eveng g y
more expensive
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28. Thank you for your attention
Dr. Saad Mezzour
ETSI TG30 Chairman
saad mezzour@medtronic comsaad.mezzour@medtronic.com
© ETSI 2014. All rights reserved