I believe that charging a device within the MDD when connected to a
patient is not normal use but to be classified (foreseeable) misuse.
Some remarks:
1. An apparatus that requires charging is most often meant to be used
while not connected to the mains; why use a battery otherwise. Most
equipment i have encountered using 25 years of product testing included
a clear disabling mechanism while charging.
2. Often equipment that is not designed to meet the double MOPP/MOOP
requirements (mostly for cost reasons) uses a battery to meet
insulation/touch current requirements "the easy way". Connecting the
device to a charger will immediately make the device unsafe.
3. I have not yet seen a medically approved USB charger, and most
approved IT chargers do not meet the (constructional) reinforced
insulation requirements between primary and secondary to be used in ME
equipment or leakage/touch currents.
Gert Gremmen
On 14-4-2018 0:59, Leo Eisner wrote:
Nick,
This is an in process interpretation that is being currently developed
by IEC TC62 SC 62A WG14 and was supposed to be discussed today in our
London meeting but the submitter of the request for interpretation was
not able to make the meeting today. Part of the draft interpretation
does mention there are fake chargers out there and they definitely
will not meet Dielectric, spacings, and leakage current limits. Also,
they can reboot computers connected to the network, The submitter of
the request says: "It has been noted in health care facilities
recently that certain ME Equipment have rebooted, close down
prematurely, changed alarm setting, change patient setting due to
interconnection of other electrical equipment intended to be charged
or powered.”
USB is not the wisest choice for power as you also have data issues
potentially depending on the Medical device and it’s connection. The
best solution I have seen is 1) turn off or disable patient circuitry
when connected to USB.
2) disable the software the controls the device.
3) provide additional Reinforced or Double Insulation 2 Means of
Patient Protection (dielectric and spacings requirements)
4) Do a thorough Risk Analysis per ISO 14971:2007 (that is what IEC
60601-1:2005 + A1:2012) or in the EU use EN 14971:2012 with the
associated EN 60601-1, ed. 3.1
Hope this helps,
photo Leonard (Leo) Eisner, P.E.
Principal Consultant, Eisner Safety Consultants
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On Apr 11, 2018, at 8:12 AM, Mike Sherman <msherma...@comcast.net
<mailto:msherma...@comcast.net>> wrote:
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.
------------------------------------------------------------------------
*From: *"Ari Honkala" <ari.honk...@sesko.fi
<mailto:ari.honk...@sesko.fi>>
*To: *"EMC-PSTC" <EMC-PSTC@LISTSERV.IEEE.ORG
<mailto:EMC-PSTC@LISTSERV.IEEE.ORG>>
*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 <mailto: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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