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Joined: Sep 2006
Posts: 2
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Joined: Sep 2006
Posts: 2
Dear collegues

I come accross medical equipment manufacturers that supply their Class 2 equipment (electrical safety achieved by double insulation) with a mains cable of the following description: A three pin IEC (kettle lead) type connector on one hand and a three pin UK plug, where the earth pin is plastic.

There is obviousy a problem if such a mains cable is accidentally used with a class one equipment(electrical safety achieved through safety earth).

When challenging the equipment manufacturers on this they wave a BSEN60601 test certificate in front of me and that's that.

Have you experienced this problem?
What is your view, is such a mains cable acceptable?
In my view it isn't but I have yet to identify the right standards to proof this, may be someone can help?
When you experience the problem what do you do about it?

Yours sincerely

Martin Becker

Joined: Dec 2002
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Dear Martin

You don't need a standard for an issue like this. Do a risk assessment of the problem and put in an incident report to your Risk department.

Since according to electrical safety test standards the removal of an earthing connection constitutes a "single fault condition" and that's exactly what transferring this lead to an item requiring an earth will do (inevitably it will wander about the hospital) its a straight forward unacceptable risk.

All the best

Marc

Joined: Feb 2004
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Super Hero
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Outrageous! Bin the lead, and replace it with a standard earthed IEC lead. And then chastise the supplier! frown

But surely something like this would be picked up during Acceptance? smile


If you don't inspect ... don't expect.
Joined: Sep 2002
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I agree with both comments bin it & do a risk assessment and submit to your risk management team. Furthermore I would report to MHRA as they are the ones who are responsible for collating the info and they are best place and have the weight of authority behind them to challenge the offending company(ies)


Time is of the essence. Don't abuse it. Just make the most of it.
Joined: Apr 2003
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I have seen cables like the one that you describe in the dim and distant past.

But they do not have the hole in the socket end for the “Earth” pin, so that they can not be used on electrical safety “Class 1” equipment.

I expect that there was a cost saving, as that type of cable would use a 1/3 less copper then 3 core cables, but even with the current high cost of copper I can not believe this cost saving would be as great as the economy of scale saving to be made from using 3 core IEC cables.

Chilly


No Polar Bears were harmed in making this post.
Joined: Sep 2006
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Dear collegues

Thanks for this input. As expeted you feel similar about this issue than I do. I will talk about this issue with the manufacturer (again!) and see if I get a more favourable response.

Thanks again.

Martin Becker


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