July 2011

Charles Farlow, Medtronic

Slide 1

doc.: IEEE 802.15-11-0533-01-0006

Submission Slide 1

Project: IEEE P802.15 Working Group for Wireless Personal Area Networks (WPANs)Project: IEEE P802.15 Working Group for Wireless Personal Area Networks (WPANs)

Submission Title: Active Implantable Medical Device Industry Concerns about Human Body Communication (HBC)

Date Submitted: July 20, 2011Source: Charles Farlow, Medtronic; Veronica Ivans, IMD Standards, LLCContact: Charles Farlow, MedtronicVoice: +1 (763) 742-5158, e-mail: charles.s.farlow@medtronic.comRe: Abstract: This document discusses prior concerns raised with the proponents of

Human Body Communication (HBC).Purpose: To inform TG6 members about HBC status, discuss next stepsNotice: This document has been prepared to assist the IEEE P802.15. It is

offered as a basis for discussion and is not binding on the contributing individual(s) or organization(s). The material in this document is subject to change in form and content after further study. The contributor(s) reserve(s) the right to add, amend or withdraw material contained herein.

Release: The contributor acknowledges and accepts that this contribution becomes the property of IEEE and may be made publicly available by P802.15.

July 2011

Charles Farlow, Medtronic

Slide 2

doc.: IEEE 802.15-11-0533-01-0006

Submission

Active Implantable Medical Device Industry Concerns about Human Body Communication

(HBC)

Charles Farlow, Medtronic, Inc.Veronica Ivans, IMD Standards, LLC

July 20, 2011

July 2011

Charles Farlow, Medtronic

Slide 3

doc.: IEEE 802.15-11-0533-01-0006

Submission

Agenda

• Introduction• Pacemaker/ICD sensing• HBC mode of IEEE 802.15.6 • Commitment of HBC proponents• Status• Next steps• Annex 1: Timeline of industry activity since June 2010• Annex 2: Standards that address pacemakers and ICDs

EMC

July 2011

Charles Farlow, Medtronic

Slide 4

doc.: IEEE 802.15-11-0533-01-0006

Submission

Introduction

• As an active implantable medical device industry, we have expressed concerns about the Human Body Communication (HBC) mode of the emerging IEEE 802.15.6 (Body Area Networks) standard– Our primary concern is EMI (from HBC systems) that

may degrade the sensing and/or therapeutic capability of AIMDs1

1Active Implantable Medical Devices

July 2011

Charles Farlow, Medtronic

Slide 5

doc.: IEEE 802.15-11-0533-01-0006

Submission

Pacemaker/ICD sensing

July 2011

Charles Farlow, Medtronic

Slide 6

doc.: IEEE 802.15-11-0533-01-0006

Submission

Pacemaker/ICD sensing

• A typical implantable pulse generator (pacemaker or defibrillator) has a sense amplifier “bandpass” from 10 Hz to several hundred Hz – Based on the frequency content of the physiological

signal

• Designed to sense peak values of very low level physiological signals– Sensitivity range: 0.15 - 2.1 mV for ICDs

– Sensitivity range: 0.18 - 11 mV for pacemakers

July 2011

Charles Farlow, Medtronic

Slide 7

doc.: IEEE 802.15-11-0533-01-0006

Submission

Pacemaker/ICD sensing& Human Safety Exposure Standards

• Human safety exposure standards based on average power and short–term biological effects – Emitters may produce pulsed signals where peak power

greatly exceeds pacemaker/ICD capability of rejecting noise

– Don’t ensure electromagnetic compatibility

• Emitter manufacturers encouraged to pay attention to the immunity of implantable devices and work with the AIMD manufacturers

July 2011

Charles Farlow, Medtronic

Slide 8

doc.: IEEE 802.15-11-0533-01-0006

Submission

Pacemaker/ICD sensing& Human Safety Exposure Standards

• IEEE C95.1:2005 – Safety levels with respect to human exposure to Radio Frequency Fields, 3 kHz to 300 GHz– Page 132: Another concern resulting from RF exposure

is electromagnetic interference with the operation of the active implantable medical devices (such as implantable pacemakers, implantable defibrillators, implantable neurostimulators and infusion pumps, etc.). Sufficiently high electromagnetic fields and/or modulations in the bandpass of these devices may inappropriately interfere with their intended operation.

July 2011

Charles Farlow, Medtronic

Slide 9

doc.: IEEE 802.15-11-0533-01-0006

Submission

Pacemaker/ICD sensing& other industries

• The AIMD industry has worked with the EASS (Electronic Article Surveillance Systems) and RFID (Radio Frequency Identification) manufacturers to:– Educate the manufacturers of emitters on how AIMDs

(Active Implantable Medical Devices) operate and the potential for interference

– Ensure the emitting equipment does not operate in ways that would interfere with AIMDs

– Medical device standards have included appropriate testing

July 2011

Charles Farlow, Medtronic

Slide 10

doc.: IEEE 802.15-11-0533-01-0006

Submission

HBC mode of IEEE 802.15.6

• AIMD industry collective goal - proactively engage IEEE during the standards development process to prevent future EMI issues– Unlike wireless modes of IEEE 802.15.6, HBC

transfers information via electrodes close to (or touching) the skin

– HBC’s center frequencies are relatively low (21 MHz and 32 MHz) and the -3 dB emission bandwidths are relatively wide (5.25 MHz and 8 MHz, respectively)

July 2011

Charles Farlow, Medtronic

Slide 11

doc.: IEEE 802.15-11-0533-01-0006

Submission

HBC mode of IEEE 802.15.6

Figures from IEEE P802.15-10-0049-02-0006

July 2011

Charles Farlow, Medtronic

Slide 12

doc.: IEEE 802.15-11-0533-01-0006

Submission

Commitment of HBC proponents

July 2011

Charles Farlow, Medtronic

Slide 13

doc.: IEEE 802.15-11-0533-01-0006

Submission

Status

• Some progress has been made– Samsung agreed

to add a transmit filter and specify a spectral mask

– A transmit power limit “to the human body” of -36 dBm has been specified

July 2011

Charles Farlow, Medtronic

Slide 14

doc.: IEEE 802.15-11-0533-01-0006

Submission

Status

• Actions for HBC proponents that remain open after three conference calls with the AIMD industry– Physics of propagation

– Field strength in the chest cavity for various HBC electrode locations

– Potential low frequency artifacts from data packet on-off keying

– Ambiguity regarding transmit power spec in standard; “The radiation power to the human body shall be less than -36 dBm as total power in the operating band.”

July 2011

Charles Farlow, Medtronic

Slide 15

doc.: IEEE 802.15-11-0533-01-0006

Submission

Status

• A face-to-face meeting between AdvaMed members and HBC proponents was discussed in the May 2011 Interim Session (and documented as such in minutes)– Proposed by AdvaMed in early June to TG6 chair

• The face-to-face meeting did not occur during this July IEEE 802 Plenary Session because HBC proponents did not respond to meeting proposals and questions in a timely manner

July 2011

Charles Farlow, Medtronic

Slide 16

doc.: IEEE 802.15-11-0533-01-0006

Submission

Next steps

• Excerpts of an e-mail from Bernie Liebler, AdvaMed, 14 July 11– “… I still think that the issues can be resolved if

Samsung can provide industry with the data requested during our last conference call. …”

– “… An alternative possibility could be to meet either at AdvaMed or at Samsung during a visit you might make to the Samsung headquarters in New Jersey. I would be glad to host a meeting here, and I'm sure that the industry people would be willing to travel to New Jersey. …”

July 2011

Charles Farlow, Medtronic

Slide 17

doc.: IEEE 802.15-11-0533-01-0006

Submission

Annex 1 – Timeline of industry activity since June 2010 (1 of 5)

• 8 July 2010: C. Farlow files comments in response to IEEE 802.15 Letter Ballot #55 (802.15.6); includes comments on HBC

• 21 July 2010: AdvaMed files letter with IEEE

• 26 July 2010: EMI and IEEE 802.15.6 mentioned in AdvaMed presentation during joint FDA-FCC meeting

• 2 Aug 2010: IEEE SA sends response to AdvaMed (dated 30 July 2010)

• 13 Aug. 2010: AdvaMed files letter in FDA-FCC meeting’s docket (FDA 2010-N-0291); references HBC

July 2011

Charles Farlow, Medtronic

Slide 18

doc.: IEEE 802.15-11-0533-01-0006

Submission

Annex 1 – Timeline of industry activity since June 2010 (2 of 5)

• 11 Nov. 2010: Chair of IEEE 802.15.6 posts assessment (to IEEE 802.15 reflector) from IEEE legal staff– Excerpt of direction from IEEE Legal Staff “.. Further, if the

proper transmit power is a matter of concern, it should be discussed further with members of the implantable medical device industry ..”

• 12 Jan. 2011: Medtronic votes “no” and provides two comments related to HBC in Letter Ballot #66

• 1 Mar. 2011: First teleconference held between AdvaMed members and HBC proponents (essentially, Samsung)

July 2011

Charles Farlow, Medtronic

Slide 19

doc.: IEEE 802.15-11-0533-01-0006

Submission

Annex 1 – Timeline of industry activity since June 2010 (3 of 5)

• 8 Mar. 2011: Second teleconference held between AdvaMed members and HBC proponents

• 12 Apr. 2011: Minutes from the second conference call “AdvaMed IEEE 802.15 TG6 HBC Conference Call Report” published on the IEEE server with document number P802.15-11-0326-00-0006

• 2 May 2011: Samsung and ETRI post a document “Response to action for HBC(EFC) conference call” as P802.15-11-0344-00-0006

• 3 May 2011: Third teleconference held between AdvaMed members and HBC proponents

July 2011

Charles Farlow, Medtronic

Slide 20

doc.: IEEE 802.15-11-0533-01-0006

Submission

Annex 1 – Timeline of industry activity since June 2010 (4 of 5)

• 5 May 2011: Medtronic votes “no” and provides two comments related to HBC in Letter Ballot #71

• 10 May 2011: Chuck Farlow and Paul Stadnik engage with HBC proponents (Samsung and ETRI) in a break-out meeting held during an IEEE 802 Wireless Interim Session; no progress

• 12 May 2011: ETSI Liaison Statement received by IEEE 802.15.6 Task Group; mentions concerns about HBC

• 8 June 2011: Minutes from the third conference call published on the IEEE server with document number P802.15-11-0441-00-0006

July 2011

Charles Farlow, Medtronic

Slide 21

doc.: IEEE 802.15-11-0533-01-0006

Submission

Annex 1 – Timeline of industry activity since June 2010 (5 of 5)

• 16 June 2011: Medtronic votes “no” and provides two comments related to HBC in Letter Ballot #76

• 13 July 2011: Medtronic votes “no” and provides two comments related to HBC in Letter Ballot #79

July 2011

Charles Farlow, Medtronic

Slide 22

doc.: IEEE 802.15-11-0533-01-0006

Submission

Annex 2 – Standards that address implantable pacemakers and ICDs EMC

• CENELEC EN 45502-2-1:2003 / ISO 14708-2:2005 / Japanese Pacemaker Standard:2007

• EN 45502-2-2:2008 / ISO 14708-6:2010

• ANSI/AAMI PC69:2007, 2nd edition: Active Implantable Medical Devices - Electromagnetic Compatibility - EMC Test Protocols for Implantable Cardiac Pacemakers and Implantable Cardioverter Defibrillators

• ISO FDIS 14117, 1st edition (adoption of the AAMI standard above): Active Implantable Medical Devices - Electromagnetic Compatibility - EMC Test Protocols for Implantable Cardiac Pacemakers and Implantable Cardioverter Defibrillators – to be published by the end of 2011