Documentos de Académico
Documentos de Profesional
Documentos de Cultura
Greg Kiemel
Outline
Wireless Trends
Latest News
Medical Wireless Technologies
Risks
Regulatory
Standards
Beyond EMC
Compliance Considerations
Wireless Trends
Approvals
40000
30000
FCC
20000
TCB
10000
0
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Year
Source: https://apps.fcc.gov/oetcf/eas/reports/GenericSearch.cfm
Application Trends
Jan 1, 2014 Dec 31, 2014
Usable Range
Miles
4G LTE
GSM, GPRS,
Edge, HSPA
802.16e
(WiMax)
WLAN
802.11a/b/g/n
802.11ad
WPAN
802.15.1
(Bluetooth)
802.15.3
(UWB)
802.11ac
802.15.4
(Zigbee)
WBAN
Feet
802.15.6
MBAN
MedRadio
Inductive
Telemetry
Wireless
Telecommunications
Medical
Internet
9
4G Cellphone with
Wi-Fi, Bluetooth,
NFC, and GPS
10
New Technologies
Spectrum Efficiency is the driving forcemore users
require more throughput while occupying the same
finite chunk of frequency spectrum
Biggest Breakthroughs
Smart Antenna Systems
MIMO (Multiple Input and Multiple Output)
Adaptive Beam forming
11
12
14
Latest News
FCC will no longer accept applications for certification. All grants will be
issued by TCBs.
The Permit But Ask procedure will be codified.
Clarification of TCB responsibilities for performing market surveillance.
Specify steps for addressing instances of deficient TCB performance,
including sanctions and rescinding TCB authority.
Modify the rules to reference new standards (ISO/IEC 17065) used to accredit
TCBs
Require labs that test for certification or DoC to be accredited. [Testing
laboratories located in non MRA countries are not FCC recognized as
accredited under the current procedures.]
Codify a procedure through which the Commission currently recognizes new
laboratory accreditation bodies;
Update references to industry measurement procedures in the Commissions
rules (e.g. ANSI C63.4-2014 and ANSI C63.10-2013); and
Provide greater flexibility to enable the FCCs OET to address minor technical
issues that may be raised when updating to the latest versions of industry 16
standards that are referenced in Parts 2, 5, 15, and 18 of the Commissions
rules.
New rules for U-NII devices (e.g. 802.11an) became effective on June 2,
2014. Transition period, see FCC KDB 926956:
New devices can be approved until June 1, 2015 under either the old or new rules.
Starting June 2, 2015, new approvals must be to the new rules.
Starting June 2, 2016, permissive changes must be to the new rules. Also products previously
certified under the old rules cant be marketed unless they meet the new rules (C2PC
application required).
Indoor-only restriction removed from the 5.2 GHz band. Also increased the
output power in that band.
Extended the upper frequency edge of the 5.8 GHz band to match FCC
15.247. They are now both 5725 5850 MHz
Harmonized the rules between 15.247 and 15.407 for DTS device operating in
the 5.8 GHz band.
U-NII device software must be secured to prevent its modification
New DFS radar waveform and new test requirements.
17
Published in the OJEU on April 16, 2014 will be applicable June 13, 2016.
No one can claim compliance with this new directive until then.
However, if equipment meets the requirements of the R&TTE Directive before
June 13, 2016, compliance with the RED is not mandatory until June 13,
2017. For new equipment placed on the EU market after June 12, 2016
must meet the requirements of the RED.
Sound and TV broadcast receivers will be included in the RED
Telecom Terminal Equipment will be excluded
Radio determination will be included, e.g. RFID, movement detection.
Radio equipment operating below 9 kHz will be included
ISM equipment (generates RF to perform work, not telecommunications) will
be excluded.
Role of a Notified Body is still to assess compliance at the request of the
manufacturer. This is optional if harmonized standards have been applied in
full. Notified Bodies will issue an EU-Type Examination Certificate that
documents their assessment of the manufacturers supplied Technical
Documentation (see Annex V of the RED)
18
EN 300 328 V1.8.1 and EN 301 893 V1.7.1 required starting Jan 1, 2015.
Even products that have been selling for years under the previous version
must now meet the latest version if they are still being shipped into the EU.
Products already in the EU prior to Jan 1, 2015 do NOT need to be recalled or
retested.
The main differences between the old and new versions of the standards are
significant and can be summarized as follows:
Adequate spectrum sharing. The efficiency of the various sharing mechanisms
must be tested per the procedures of the harmonized standards. Previous
versions permitted just an attestation from the manufacturer.
An output power test methodology that would address a wide-range of
technologies. This new approach is completely different from what was included in
V1.7.1 of the standard.
A power spectral density test methodology that would permit a higher output power.
Many devices are not limited by the 100mW EIRP limit, but instead by the
10mW/MHz power spectral density (PSD) limit. EN 300 328 V1.8.1 has very
different and much more complex method of measuring power spectral density.
Harmonize test methods with other ETSI standards operating in the same bands.
EN 300 328 V1.9.1 published in the OJ on April 17, 2015. Mandatory starting
Nov. 30, 2016. Contains minor fixes to previous version.
19
21
DIGI FIT LIFE, Wearble, Wireless Technology to Generate Minimum $6 Billion by 2016, August 2012, retrieved from
http://digifitlife.com/wearable-wireless-technology-to-generate-minimum-6-billion-by-2016/#.VL_xwkfF-So
Inductive
Typically below 200 kHz
Very short range, low level
Inductive charging
24
25
Wireless Technology
Wi-Fi connectivity of monitors
92% Wi-Fi penetration into large (500+
employees) healthcare facilities now &
100% by 2016
17% of the worlds population uses Wi-Fi
Wi-Fi Alliance working on WLAN best
practices & Risk Mgmnt, plus personal
home healthcare architecture
27
Wireless Technology
Bluetooth low power, secure, interoperability
2 billion BT products ship in 2012
Bluetooth 4.0 is capable of Basic Rate and Enhance Data Rate
operation (BR/ EDR) as well as Low Energy (LE), or LE only.
Bluetooth BR and EDR modes operate on 79 hopping channels
that are tested at: 2402, 2441, and 2480 MHz
Bluetooth LE Advertising mode utilizes only three
channels: 2402, 2426, and 2480 MHz
Bluetooth LE Data mode has 37 hopping channels: 2404, 2442,
and 2478 MHz
28
Wireless Technology
RFID equipment or people tags
Zigbee some but mostly industrial
devices
Cell bands mobile communication/
apps
29
Risks
Legal Perspective
http://www.fr.com/files/uploads/attachments/FinalRegulatoryWhitePaperWirelessMedicalTechnologies.pdf
31
RF Wireless Coexistence
Due to the increasing number of wireless devices, the
risk of interference with wireless medical devices is
also increasing
Critical data transmitted by medical devices could be
delayed or blocked by other nearby wireless devices.
Current EMC standards are inadequate. In-band
interference is specifically excluded. Manufacturers
cannot claim the safe operation of their wireless
medical device based solely on EMC test results.
Test methods are under development to assess the risk of
interference. (ANSI, Univ of Oklahoma)
32
33
Regulatory
Regulatory
US
FDA Medical
Regulates all medical devices & general public health and
safety
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Guidanc
eDocuments/ucm077210.htm
Regulatory
EU
Medical & Wireless - Directives
Radio (RTTE) / EMC (EMCD)
RTTE repealed and RED begins June 13, 2016
Old EMCD repealed and New EMCD begins April 20,
2016
Output Power
Effective Radiated Power
Frequency Stability
Occupied Bandwidth
Emissions Mask
Power Spectral Density
Spurious Emissions
Immunity
37
38
Torso Simulator
Cylindrical Plexiglas container with
a size of 30 cm by 76 cm with a
sidewall thickness of 0.635 cm.
A mounting grid for the implant and
associated leads must be provided
inside the container that permits the
implant to be positioned vertically
and horizontally
The implant must be mounted 6 cm
from the sidewall and centered
vertically within the container.
39
EUT
Horizontal
40
41
Standards
Standards
Inductive (communications)
US
FCC Part 15.209 / 207 (tested in air)
EU
ERC/REC 70-03
ETSI EN 302 195-2 / -1 (tested in saline)
ETSI EN 301 489-31 / -1
44
Standards
Inductive (charging portion only)
US
FCC Part 18
RF Exposure (KDB 680106)
EU
CISPR 11
IEC 60601-1-2
45
Standards
ISM/SRD
US
15.209 / 15.109 / 15.107
15.247 2.4 - 2.4835 GHz Band
15.249 902-928 MHz
EU
ERC/REC 70-03
EN ETSI 300 220-2/-1 / 300 440 /300 328
EN ETS 301 489-3 / -1
46
Standards
MedRadio/MICS
US
Part 95I / 2
15.109 / 107
EU
ERC/REC 70-03
EN ETSI 301 839-2 / -1
EN ETS 301 489-27 / -1
Other
Torso simulator
47
MBAN
Standards
US
Part 95I
EU
ERC/REC 70-03
Unknown we are to assume Part of MICS but
could also be Wi-Fi stds or some combo
EN ETSI 301 839-2 / -1
EN ETS 301 489-27 / -1
48
Standards
Wi-Fi/BT
US
Part 15.407 / 15.247
15.207
EU
ERC/REC 70-03
EN ETSI 300 328
EN ETS 301 489-17 / -1
49
50
51
Beyond EMC
53
Exposure Categories
Fixed
Mobile
Portable
54
Exposure Limits
56
57
58
59
Compliance Considerations
63
67
Thank You!
68