ASC C63 SC 8:  Medical Device EMC

Minutes for Wednesday, March 28, 2007; 8:00 AM

Piscataway NJ

 

The meeting was called to order at 8:10 AM by Joe Morrissey, Subcommittee 8 Chairman

 

The following SC8 members were present:

Joe Morrissey, SC-8 Chairman                    Motorola

Steve Berger, WG3 chairman                      Independent Consultant

Don Heirman                                                 Independent Consultant

Dan Hoolihan                                                Independent Consultant

Victor Kuczynski                                           Vican Elecronics

Bob Hofmann                                               Independent Consultant                              

Steve Whitesell                                             TIA

Jim Turner                                                     ATIS

Steve Coston                                                SonyEricsson

Poul Anderson                                              SAE

Bob Jenkins                                                  Welch Allyn

Bill Stumpf                                                     DLS Electronics / ACIL

Ed Hare                                                          AARL

George Hirvela                                              ATT

David Zimmerman                                        TUV America

Jag Nadakuduti                                             Motorola

Dheena Moongilan                                        Alcatel / Lucent

John Lichtig                                                  Independent Consultant

Harry Levitt                                                   NYU                                    

 

The following members were absent:

Jeff Silberberg                                              FDA

Jon Casamento                                                     FDA

Mike Windler                                                 UL

Herb Mertel                                                    Independent Consultant

Werner Schaefer                                          Cisco

Matt Bakke                                                    Gallaudett

Paul Cardinal                                                 RIM

Bob DeLisi                                                     UL

Bill Hurst                                                        FCC

Ralph Showers                                              Independent Consultant

Mike Violette                                                  ACIL

Don Witters                                                   FDA

Kendra Green                                               Samsung

Richard Worley

 

The following guests observed the meeting:

Sig Soli                                                          House Ear Institute

Colin Brench                                                 HP

Masud Attayi                                                 RIM

Linda Kozma-Spytec                                    Gallaudette

Tom Victorian                                                Starkey

 

The following IEEE staff were present:

Matt Ceglia                                                    IEEE-SA

Bill Ash                                                          IEEE-SA

 

 

1.  The agenda and minutes from the last meeting were approved

2.  The membership list was reviewed and it was identified that dues and active participation would need to be reviewed. The current membership list is reflected in the attendee list (those attending and those absent) above

3.  WG-1 report was made by Joe Morrissey from Jeff Silberberg e-mail summary

4.  WG-2 was not present – no report

5.  WG-3 report by Steve Berger, outlining the status of the amendment (C63.19 2007) – C63 has petitioned FCC to adopt this amendment, and this was sent 5 days prior to the meeting. Don Hierman (personal communication with Bill Hurst) suggested the FCC in the process of reviewing the amendment for adoption. Berger gave an update on the current PINS-C, and the WG3 group confirmed that all issues for discussion were included in the current draft. One item was reworded

 

From: Review T-Coil measurement of intended and unintended signal, includes the study of changing the frequency range of the measurement from current to 800 to 5 KHz.  This item particularly intends to focus on reduction of the bandwidth to be used when making the unintended signal measurement.

 

To: Review T-Coil measurement of unintended signal.  This item particularly intends to focus on reduction of the bandwidth to be used when making the unintended signal measurement.

 

·       Vote to present this to parent committee passed unanimously, no abstentions

·       PINS-C items not expected to be complete in 2007, many items will extend > 2-3 yrs

 

6.  Steve Whitesell provided update on new TIA standard on cordless telephone HAC (applies to digital cordless and wireline telephones)

 

Presentations:

7.  Overview by Joe Morrissey – issue complex and needs additional characterization

8.  Exposure system recommendations by Joe Morrissey

9.  Overview of NIDRR / Levitt / Gallaudett research by Harry Levitt - currently looking at influence of different vocoder conditions on temporal distortions and WCDMA as an additional test signal

10.                Overview of proposed HEI research by Sig Soli – stratified sample with many controls, detectibility and intelligibility as target endpoints, subjective input only after objective data captured

11.                Tom Victorian gave an overview of Hearing Aid product performance, efforts to work with FDA on labeling strategy. Currently ~ 50% hearing aids = M2 or better, perhaps M3 or better. Delta (Denmark) testing of hearing aids to determine product performance, suggest a 30+ dB increase in immunity over last 5-10 years. Tom also provided an update on IEC TC29 – revision of 60118-13 in progress, to include 2.2-2.48 GHz band (25 V/m) in addition to 800 – 960 (75 V/m) and 1.4 – 2 GHz (50 V/m). Not clear exactly how immunity levels derived. Currently in Europe, only bystander limits apply (3 V/m), but user limits may soon apply as they do in other parts of the world. These limits ~approximate an M2 class HA immunity level per C63.19

12.                ATIS update by Jim Turner – overview of prior studies showing lack of predictability between M-class phones and M-class hearing aids. Suggested no further work in ATIS with regard to C63.19-specific issues, all work being done within C63 SC8

13.                Joe Morrissey gave a presentation on power control and DTx that should be considered in addition to data on incident RF and noise generation to determine expected conditions in real use.

14.                Liaison reports:

a.   IEC SC62A given by Joe Morrissey via Jeff Silberberg text submission

b.   Don Hierman provided AAMI EMC report and encouraged close synergy with C63.18 group

15.   Bob DeLisi was identified by unanimous vote to be presented to C63 main committee as SC8 Vice Chair

 

 

ACTION ITEMS:

 

  1. Joe Morrissey and Jag Nadakuduti to gather data on calculated and experimentally derived / simulated free space measurements for mobile phones that can be used as a look-up table / chart to estimate field strength in support of C63.18
  2. Joe Morrissey to coordinate effort to get better definition on operational performance of mobile phones and hearing aids in support of C63.19: including:

a.   DTx, specifically temporal characteristics and whether last full transmissions would overlap first incoming phonic sounds during listening phase

b.   Dynamic power control, especially the normal operational performance of GSM phones in typical networks

c.   Typical distance (separation) between nominal phone position and different classes of hearing aids

d.   Percentage of different hearing aid types on the US market

  1. Tom Victorian to supply Delta testing summary of hearing aid immunity and equivalent C63.19 M-classification
  2. Joe Morrissey to get with Steve Berger and recommend a document retention style and numbering system – updated: Joe Morrissey to work with John Lichtig to define a structure for the entire C63 committee (all SCs) for retention on the C63 website
  3. Joe Morrissey will send around list of definitions from C63.14 proposed to bee dropped (many are repetitions of IEEE STD100) [closed 4/12/07]
  4. Joe Morrissey and Jag Nadakuduti to develop a look-up Table of free space measurements from mobile phones at full power to approximate field strength measurements for C63.18 / C63.24
  5. Steve Berger to submit an FCC petition to adopt C63.19-2007 [closed 3/28/07]
  6. Joe Morrissey to check with Dan Hoolihan regarding SC8 membership and dues [closed 3/28/07]

 

NEXT MEETING OCTOBER 23-25, 2007 AT FDA in Gathersburg, MD

 

 

The meeting was adjourned at 1:00 PM