[PSES] Haefley Surge and EFT equipment

[Wiseman, Joshua]

Through an acquisition of an EMC lab we have a few items that we have no use 
for.  The items are currently installed in a rack together but we are willing 
to part them out.  The list of equipment is below.  Anyone who is interested 
let me know.


* FP-Surge 32.1 - Coupling Filter

* IP 6.2 - Coupling Network

* DEC1A - Decoupling Unit

* EP-EFT 32.1 - Coupling Filter

Thanks,
Josh

Joshua Wiseman
Staff Engineer, Product Safety/EMC
Ortho Clinical Diagnostics
100 Indigo Creek Dr
Rochester, NY 14626
T: +1 (585) 453-4231
joshua.wise...@orthoclinicaldiagnostics.com
www.orthoclinicaldiagnostics.com


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Re: [PSES] Medical device risk assessment - faulty chargers

[Mike Sherman]

There are a number of documented cases of counterfeit or knock off Apple USB 
chargers that do not pass dielectric testing; a couple have been suspected in 
shock related deaths. This is an unstated background to this discussion. 

Mike Sherman 
Graco Inc. 

- Original Message -

From: "Ari Honkala"  
To: "EMC-PSTC"  
Sent: Wednesday, April 11, 2018 5:20:35 AM 
Subject: Re: [PSES] Medical device risk assessment - faulty chargers 

My first thought: what has the origin of the charger has to do with it being 
potentially faulty? Any device may broke; that's why there are requirements for 
single fault condition. 

with best regards, 

Ari Honkala 

-Original Message- 
From: Nick Williams [mailto:nick_willi...@conformance.co.uk] 
Sent: tiistai 10. huhtikuuta 2018 19:21 
To: EMC-PSTC@LISTSERV.IEEE.ORG 
Subject: [PSES] Medical device risk assessment - faulty chargers 

Colleagues, 

EN 60601-1 3rd ed. requires the manufacturer to take a risk assessment based 
approach to the safety of their electrical medical products. 

With the increased used of universal USB power as a source for battery 
charging, it’s easy for the risk assessment to identify use of the medical 
device with a potentially faulty charger either because the device manufacturer 
has not included a USB power adapter/charger wth the product or because the 
user has chosen to use a charger other than the one supplied by the 
manufacturer. 

How far does the manufacturer need to go in order to provide protection against 
the hazards from a faulty charger, not supplied by them? Bear in mind the 
hazardous scenarios may include a patient contact device being used while being 
charged. 

I await opinions with interest! 

NIck. 

- 
 
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- 
 
This message is from the IEEE Product Safety Engineering Society emc-pstc 
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Re: [PSES] Medical device risk assessment - faulty chargers

[Ari Honkala]

My first thought: what has the origin of the charger has to do with it being 
potentially faulty? Any device may broke; that's why there are requirements for 
single fault condition.

with best regards,

Ari Honkala

-Original Message-
From: Nick Williams [mailto:nick_willi...@conformance.co.uk] 
Sent: tiistai 10. huhtikuuta 2018 19:21
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] Medical device risk assessment - faulty chargers

Colleagues,

EN 60601-1 3rd ed. requires the manufacturer to take a risk assessment based 
approach to the safety of their electrical medical products. 

With the increased used of universal USB power as a source for battery 
charging, it’s easy for the risk assessment to identify use of the medical 
device with a potentially faulty charger either because the device manufacturer 
has not included a USB power adapter/charger wth the product or because the 
user has chosen to use a charger other than the one supplied by the 
manufacturer. 

How far does the manufacturer need to go in order to provide protection against 
the hazards from a faulty charger, not supplied by them? Bear in mind the 
hazardous scenarios may include a patient contact device being used while being 
charged. 

I await opinions with interest!

NIck.

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


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Attachments are not permitted but the IEEE PSES Online Communities site at 
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formats), large files, etc.

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List rules: http://www.ieee-pses.org/listrules.html

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