Re: Pacemakers

2009-01-07 Thread John Woodgate 

In message 
<201048ea81ba0745aca78e4cc883900104203...@desmdswms201.des.grplnk.net>, 
dated Wed, 7 Jan 2009, "Haynes, Tim (SELEX GALILEO, UK)" 
 writes:

>Is WG15 also dealing with combined pacemaker/defibrillator units?

I think so, but I'm not a member. I think the work is proceeding rather 
slowly.
-- 
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
Things can always get better. But that's not the only option.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

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RE: Pacemakers

2009-01-07 Thread Haynes, Tim (SELEX GALILEO, UK) 
John,

Is WG15 also dealing with combined pacemaker/defibrillator units?

I have a friend who emigrated to Greece from the UK because the anti-theft
devices at UK shop entrances use to trip the defibrillator into action.
A couple of joules across the heart is apparently equivalent to a couple of
hundred joules across the chest - not nice!
 
Regards
Tim






Tim Haynes A1N10
Electromagnetic Engineering Specialist
SELEX Sensors and Airborne Systems
300 Capability Green
Luton LU1 3PG
Tel  : +44 (0)1582 886239
Fax : +44 (0)1582 795863
Mob: +44 (0)7703 559 310
* E-mail : tim.hay...@selexgalileo.com

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There are 10 types of people in the world-those who understand binary and
those who don't. J. Paxman



From: emc-p...@ieee.org [mailto:emc-p...@ieee.org <mailto:emc-p...@ieee.org> ]
On Behalf Of John Woodgate
Sent: Wednesday, January 07, 2009 3:07 PM
To: Helge Knudsen
Cc: emc-p...@ieee.org
Subject: Re: Pacemakers

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In message <2f29d35299a4dc4bae37325d0a8be6148df...@nfexc1.daniro.dk>,
dated Wed, 7 Jan 2009, Helge Knudsen  writes:

>I do not think Cenelec TC 106X work with this issue:

 I do: their WG15 is studying the subject.
>
>Scope (en) TC 106X deals with various aspects of the exposure of people
>to electromagnetic fields from 0 Hz to 300 GHz.

Yes, and that includes exposure of the pacemakers to those fields.
--
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk Things
can always get better. But that's not the only option.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

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RE: Pacemakers

2009-01-07 Thread John McAuley 
Helge

If you go to www.cenelec.eu and put 50527 in the Database search window you 
will find it.

Best regards

John McAuley

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From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Helge Knudsen
Sent: 07 January 2009 14:56
To: John Woodgate; emc-p...@ieee.org
Subject: RE: Pacemakers

Hello John,
I do not think Cenelec TC 106X work with this issue:

Scope (en) TC 106X deals with various aspects of the exposure of people to 
electromagnetic fields from 0 Hz to 300 GHz.

http://www.cenelec.eu/Cenelec/Code/Frameset.aspx
Insert CLC/TC 106X as Technical body and click on "Run Report"
Click on "CLC/TC 106X" and you will have access to: 
Meetings 
Work program 
Environmental statement  



Med venlig hilsen / Best regards

Helge Knudsen

Direct:   +45 44 34 22 51
Fax: +45 44 99 28 08
e-mail: h.knud...@niros.com
Niros Communications A/S â–ª Hirsemarken 5 â–ª DK-3520 Farum â–ª Tel. +45 44 99 
28 00 â–ª www.niros.com





From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of John Woodgate
Sent: 7. januar 2009 14:49
To: emc-p...@ieee.org
Subject: Re: Pacemakers

In message <009d01c970cb$a4087720$ec196560$@dk>, dated Wed, 7 Jan 2009, 
Niels Hougaard  writes:

>I am looking for the field strength that implantable pacemakers are 
>designed to work perfect at. Frequency range in question is 10 - 50 kHz.

This is a very complex issue, still under study in CENELEC TC106X. 
Someone at Danish Standards may well be able to give you the up-to-date 
situation.
-- 
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
Things can always get better. But that's not the only option.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

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Re: Pacemakers

2009-01-07 Thread John Woodgate 
In message <2f29d35299a4dc4bae37325d0a8be6148df...@nfexc1.daniro.dk>,
dated Wed, 7 Jan 2009, Helge Knudsen  writes:

>I do not think Cenelec TC 106X work with this issue:

 I do: their WG15 is studying the subject.
>
>Scope (en) TC 106X deals with various aspects of the exposure of people
>to electromagnetic fields from 0 Hz to 300 GHz.

Yes, and that includes exposure of the pacemakers to those fields.
-- 
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
Things can always get better. But that's not the only option.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

-

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RE: Pacemakers

2009-01-07 Thread Helge Knudsen 
Hello John,
I do not think Cenelec TC 106X work with this issue:

Scope (en) TC 106X deals with various aspects of the exposure of people to 
electromagnetic fields from 0 Hz to 300 GHz.

http://www.cenelec.eu/Cenelec/Code/Frameset.aspx
Insert CLC/TC 106X as Technical body and click on "Run Report"
Click on "CLC/TC 106X" and you will have access to: 
Meetings 
Work program 
Environmental statement  



Med venlig hilsen / Best regards

Helge Knudsen

Direct:   +45 44 34 22 51
Fax: +45 44 99 28 08
e-mail: h.knud...@niros.com
Niros Communications A/S â–ª Hirsemarken 5 â–ª DK-3520 Farum â–ª Tel. +45 44 99 
28 00 â–ª www.niros.com





From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of John Woodgate
Sent: 7. januar 2009 14:49
To: emc-p...@ieee.org
Subject: Re: Pacemakers

In message <009d01c970cb$a4087720$ec196560$@dk>, dated Wed, 7 Jan 2009, 
Niels Hougaard  writes:

>I am looking for the field strength that implantable pacemakers are 
>designed to work perfect at. Frequency range in question is 10 - 50 kHz.

This is a very complex issue, still under study in CENELEC TC106X. 
Someone at Danish Standards may well be able to give you the up-to-date 
situation.
-- 
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
Things can always get better. But that's not the only option.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

-

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RE: Pacemakers

2009-01-07 Thread John McAuley 
Niels
 
EN 45502-1 only gives induced levels into leads (the last time I looked) and
is difficult to correlate to field strengths.
 
Cenelec TC106X is working on a proposed standard and a preliminary draft is
out on which you have to contact your National Committee. 
 
A good starting point is to look at manufacturers environmental specifications
and the EU EMF Recommendation 1999/519/EC is also a useful reference.
 
Best Regards
 
John McAuley


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From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Niels Hougaard
Sent: 07 January 2009 13:27
To: emc-p...@ieee.org
Subject: Pacemakers
 
Dear list members,
 
I am looking for the field strength that implantable pacemakers are designed
to work perfect at. Frequency range in question is 10 - 50 kHz.
 
The medical standard EN 60601-1-2 has no requirements in that frequency range.
I have found EN 45502-1 and ISO 14708-2 as standards for implantable
pacemakers but we do not have these standards. Do you know if one of these
standards, or the both, would be relevant for answering the question?
Or maybe someone is able to toss off an answer?
 
Regards, and thanks in advance,
Niels Hougaard
 
Niels Hougaard
Bolls Rådgivning
Ved Gadekæret 11F
DK-3660 Stenløse
Denmark
 
T: +45 48 18 35 66
F: +45 48 18 35 30
n...@bolls.dk
www.bolls.dk   
 
 
-

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Re: Pacemakers

2009-01-07 Thread John Woodgate 

In message <009d01c970cb$a4087720$ec196560$@dk>, dated Wed, 7 Jan 2009, 
Niels Hougaard  writes:

>I am looking for the field strength that implantable pacemakers are 
>designed to work perfect at. Frequency range in question is 10 - 50 kHz.

This is a very complex issue, still under study in CENELEC TC106X. 
Someone at Danish Standards may well be able to give you the up-to-date 
situation.
-- 
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
Things can always get better. But that's not the only option.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

-

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RE: Pacemakers

2002-07-19 Thread richwoods 

Check the AAMI site for possible US standards. 
http://www.aami.org/

Devices are tested to FDA requirements by Georgia Tech Research Institute.
Contact Jimmy Woody for info.
http://www.gtri.gatech.edu/

A1:1995 of EN 50061:1988 covers immunity of implantable pacemakers.

PrEN 45502-2-1 is a new immunity standard for pacemakers and is being
prepared for national voting.

Richard Woods
Sensormatic Electronics
Tyco International

-Original Message-
From: rehel...@mmm.com [mailto:rehel...@mmm.com]
Sent: Friday, July 19, 2002 4:39 AM
To: emc-p...@majordomo.ieee.org
Subject: Pacemakers



Is anyone aware of any radiated immunity standards or test limits for
pacemakers (national, international, or industry)?

Bob Heller
3M Product Safety, 76-1-01
St. Paul, MN 55107-1208
Tel:  651- 778-6336
Fax:  651-778-6252


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RE: Pacemakers

2002-07-19 Thread Robert F. Martin ITS/ES-Box 

Industry (and international) standard as listed by AAMI (Association for the
Advancement of Medical Instrumentation):

IEC 60601-2-31:1994 -- Medical electrical equipment, Part 2: Particular
requirements for the safety of external cardiac pacemakers with internal
power source
Item: Final
Document Type: International Standard
Abstract: Specifies the particular safety requirements for external
pacemakers.

Format: Print
Publication Date: 01-Oct-1994   Availability: Actual
Order Notes: Available in the U.S. from ANSI. 
Category: Electromedical equipment
Subcategory: Therapy and surgery; Cardiovascular
Activity: STANDARDS
Keywords: medical equipment, pacemakers, safety, power source,
electromedical equipment

Staff Contact: ntong...@aami.org
Project Type: New document
Project Status: Completed
Project Notes: Harmonized; mandate BC/CLC/93-01 (MDD)

Document Status: Current
Ballot Committee: IEC/SC 62D, Electromedical Equipment
Committee Author: IEC/SC 62D/WG 06, Cardiac pacemakers
Tag: AAMI/PC, Pacemaker Committee
FDA Recognition Info: FDA-recognized
Extent Of Recognition: Complete standard for SAFETY ONLY
Link to FDA List: Choose Category "Cardiovascular/Neurology"

 
Bob Martin, P.E., N.C.E.

Sr. Technical Manager

Intertek Testing Services NA, Inc.

ETL SEMKO

70 Codman Hill Road

Boxborough, MA 01719

Tel (978) 263-2662 Fax (978)263-7086

www.etlsemko.com r...@etlsemko.com  




-Original Message-
From: rehel...@mmm.com [   mailto:rehel...@mmm.com]
Sent: Friday, July 19, 2002 4:39 AM
To: emc-p...@majordomo.ieee.org
Subject: Pacemakers



Is anyone aware of any radiated immunity standards or test limits for
pacemakers (national, international, or industry)?

Bob Heller
3M Product Safety, 76-1-01
St. Paul, MN 55107-1208
Tel:  651- 778-6336
Fax:  651-778-6252


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RE: pacemakers

2002-01-21 Thread richwoods 

It is well known in the medical device community that the immunity standards
for implanted medical devices and the emissions standards for electrical
devices are not compatible. Pacemakers have an operations mode that is used
when excessive noise is detected. That mode goes by several names including
fixed rate pacing, noise mode and reversion. The FDA is well aware of the
issue and finds that the reversion mode is safe. Nevertheless, in some noise
cases the PM may not properly detect the noise situation and operation may
become affected including loss of a pacing pulse or an extra pulse may be
generated. In the case of rate adaptive PMs, the pulse rate may increase. In
some cases, the patient may become aware of the affected operation and find
the effect to be undesirable. This is why the patient manual warns to avoid
many types of field sources or specifies how the patient should not linger
near other types of sources. Again, the FDA is well aware of the noise issue
but has concluded that the PM design is acceptable when accompanied by the
user warnings. No patient should be overly concerned, but should discuss the
situation with their doctor in consultation with the medical device
manufacturer. In all cases, they should follow the advice of their doctor.

Richard Woods
Sensormatic Electronics
Tyco International


-Original Message-
From: geor...@lexmark.com [mailto:geor...@lexmark.com]
Sent: Friday, January 18, 2002 4:26 PM
To: emc-p...@ieee.org
Subject: pacemakers





A few observations..

APS--An APS camera is one that uses Kodak's patented Advanced
Photo System film cartridge.  The only big difference from other
35mm film cartridges is that you just pop it in and close the lid.
It self winds.  No film trailer to fool with.

Electronics--An APS camera's electronics is not that much different
from any other electronic camera.  All such devices must operate at
very low power levels to avoid changing batteries every month.  My
wife's APS can go a year or more on a battery, and that's including
use of the built in flash.

Pacemakers--My father-in-law had one of these twenty years ago.  The
early models were (or were thought to be) susceptible to higher than
ambient electromagnetic waves.  Wearers were warned to avoid microwave
ovens and the like. However, note that microwave ovens operate at
100s of watts, not microwatts, like consumer portable electronics.

Opinion--It is my opinion that any electrical appliance that falls
under FCC (and similar) guidelines will not produce adequate EMF to
interfere with today's pacemakers.  I think I'd be more cautious of
non-regulated appliances which one might have near their chest cavity,
e.g. electric blankets, electric razors, hairdryers, etc.

George Alspaugh



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RE: Pacemakers and ANSI standard...?

2000-12-08 Thread WOODS 

ANSI/IEEE C95.1 is for human exposure but it does not cover pacemakers.

Draft VDE0848 part 2 (1991) covers 30 kHz-300Ghz and does have limits for
pacemakers. An English translation is available from BSI.

There is no relationship between the limits for human exposure and limits
for pacemakers. The limits for human exposure are based upon induced current
density at the lower frequencies and SAR at the higher frequencies. The
limits for pacemakers are based upon the induced voltage in the lead.

The ANSI limits are as follows:

3kHz-100kHz: 614V/m and 163A/m
100kHz-3MHz: 614V/m and 16.3/f A/m where f is in MHz

the limits are based upon SAR, so the square of values are averaged over any
6 minute period.


Richard Woods

--
From:  david_l_tarnow...@email.whirlpool.com
[SMTP:david_l_tarnow...@email.whirlpool.com]
Sent:  Friday, December 08, 2000 11:22 AM
To:  emc-p...@ieee.org
Subject:  Pacemakers and ANSI standard...?


 What is the ANSI standard or regulation for safe limits for people 
 exposed to electromagnetic fields?  How about people with pacemakers?
 
 I've been informed that there may have been a German study done in 
 1988 concluding that these field limit values could be used in testing 
 the pacemaker immunity.
 
 Can anyone help me to get these ANSI values, at least for the magnetic 
 fields below 400 kHz?
 
 
 David Tarnowski
 Whirlpool Corp.
 
 
 
 
 

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Re: Pacemakers

1999-06-25 Thread Paul Cook 

The FDA does look over the shoulder of pacemaker manufacturers to check
their immunity performance.  They test to AAMI standards and to their own
internal
standards, with many of the tests being performed at levels from 100 to 200
Volts per meter.

TUV Product Service in St. Paul MN does a great deal of pacemaker testing,
possibly testing more pacemakers each year than any other lab.  Also, some
EMC consultants in Minneapolis are very familiar with pacemaker testing
issues.

Paul Cook
NARTE Certified EMC Engineer
Alpha EMC Inc
8540 West River Rd
Minneapolis, Minnestoa 55444
Tel # (612)-561-2844
Fax #(612)-561-3400
E-mailpaulc...@skypoint.com
Specialty  -  EMC Consulting



-Original Message-
From: WOODS, RICHARD 
To: IEEE Group 
List-Post: emc-pstc@listserv.ieee.org
Date: Monday, June 21, 1999 10:26 AM
Subject: RE: Pacemakers


>
>Brian, in the EU all pacemakers must comply with the immunity requirements
>of EN50061/A1:1995. There are no real requirements in the US.
>
>Pacemakers must not malfunction when a 1V peak to peak sine signal with a
>frequency range of 20 Hz-500 Hz is applied to a tissue interface simulation
>circuit connected to the pacemaker.
>
>In another test, the pacemaker must continue to function normally when a
>modulated signal is applied. 2 mVpp, 20 Hz-1 kHz; 2 mVpp X f/1 kHz from 1
>kHz-8 MHz; 16 Vpp, 8 MHz-30MHz.
>
>If you have some real concerns, Georgia Tech Research Institute can test
>your equipment with pacemakers. Contact Jimmy Woody at (404) 894-3535.
> --
> From:  Brian At Work [SMTP:bkundew...@qtm.net]
> Sent:  Friday, June 18, 1999 4:01 PM
> To:  IEEE Group
> Subject:  Pacemakers
>
> How do I know if a product MIGHT interfere with a Pacemaker or not?
>What types of emissions and levels are Pacemakers sensitive to?  Does a
>product evaluation check list exist to help determine this.
>
> I know nothing about Pacemakers. BTW, we manufacture laboratory and
>IT equipment.
>
> Thank you,
> Brian
>
>-
>This message is coming from the emc-pstc discussion list.
>To cancel your subscription, send mail to majord...@ieee.org
>with the single line: "unsubscribe emc-pstc" (without the
>quotes).  For help, send mail to ed.pr...@cubic.com,
>jim_bac...@monarch.com, ri...@sdd.hp.com, or
>roger.volgst...@compaq.com (the list administrators).
>
>
>


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RE: Pacemakers

1999-06-22 Thread Cortland Richmond 

This month's issue of the ARRL amateur radio magazine QST has in
interesting article about one ham radio operator's experience with a
pacemaker. In his case, he was afraid he cold lose his hobby forever, but
tests by one of the manufacturer's engineers, at his station, established
that he could operate normally.

Cortland (KA5S) Richmond

== Original Message Follows 

 >> Date:  21-Jun-99 05:06:07  MsgID: 1068-85694  ToID: 72146,373
From:  "WOODS, RICHARD" >INTERNET:wo...@sensormatic.com
Subj:  RE: Pacemakers
Chrg:  $0.00   Imp: Norm   Sens: StdReceipt: NoParts: 1


 

Brian, in the EU all pacemakers must comply with the immunity requirements
of EN50061/A1:1995. There are no real requirements in the US.

Pacemakers must not malfunction when a 1V peak to peak sine signal with a
frequency range of 20 Hz-500 Hz is applied to a tissue interface simulation
circuit connected to the pacemaker.

In another test, the pacemaker must continue to function normally when a
modulated signal is applied. 2 mVpp, 20 Hz-1 kHz; 2 mVpp X f/1 kHz from 1
kHz-8 MHz; 16 Vpp, 8 MHz-30MHz.

If you have some real concerns, Georgia Tech Research Institute can test
your equipment with pacemakers. Contact Jimmy Woody at (404) 894-3535.
--
From:  Brian At Work [SMTP:bkundew...@qtm.net]
Sent:  Friday, June 18, 1999 4:01 PM
To:  IEEE Group
Subject:  Pacemakers

How do I know if a product MIGHT interfere with a Pacemaker or not?
What types of emissions and levels are Pacemakers sensitive to?  Does a
product evaluation check list exist to help determine this.
 
I know nothing about Pacemakers. BTW, we manufacture laboratory and
IT equipment.
 
Thank you,
Brian

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== End of Original Message =

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Re: Pacemakers

1999-06-21 Thread rayg 


Brian,

Unfortunately the european standard EN50061 still has EMC requirements tbd.

However if you look in 
www.gtri.gatech.edu/res-hor/
and open winter 99 and go to the article "protecting the Beat of Life" you will 
find information and links that may help you.

regards 
Ray Garner 
Datel Ferranti Group

RCIC - http://www.rcic.com
Regulatory Compliance Information Center




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RE: Pacemakers

1999-06-21 Thread WOODS, RICHARD 

Brian, in the EU all pacemakers must comply with the immunity requirements
of EN50061/A1:1995. There are no real requirements in the US.

Pacemakers must not malfunction when a 1V peak to peak sine signal with a
frequency range of 20 Hz-500 Hz is applied to a tissue interface simulation
circuit connected to the pacemaker.

In another test, the pacemaker must continue to function normally when a
modulated signal is applied. 2 mVpp, 20 Hz-1 kHz; 2 mVpp X f/1 kHz from 1
kHz-8 MHz; 16 Vpp, 8 MHz-30MHz.

If you have some real concerns, Georgia Tech Research Institute can test
your equipment with pacemakers. Contact Jimmy Woody at (404) 894-3535.
--
From:  Brian At Work [SMTP:bkundew...@qtm.net]
Sent:  Friday, June 18, 1999 4:01 PM
To:  IEEE Group
Subject:  Pacemakers

How do I know if a product MIGHT interfere with a Pacemaker or not?
What types of emissions and levels are Pacemakers sensitive to?  Does a
product evaluation check list exist to help determine this.
 
I know nothing about Pacemakers. BTW, we manufacture laboratory and
IT equipment.
 
Thank you,
Brian

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