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Super Hero
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Super Hero
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Originally Posted by brompton

... if I've ordered 300 infusion pumps, I don't want 300 manuals.


Good point; well made. smile

On the other hand, Richard, I have never heard of any petition* (about anything) obtaining the hoped-for result. frown

Like almost everything else that gets discussed on here - the situation is one that needs to be managed. If the NHS as a whole was well-managed (not to mention, well led), issues like this would be dealt with at National Policy level (rather than leaving individual departments to struggle on as best they can without the benefit of any official "guidance").

* It's the same with "marches" (protests) by the way. A complete waste of time - apart from "virtue signalling", of course.


If you don't inspect ... don't expect.
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Hero
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Hero
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I am with Richard,
but... MDD rules state: Guidance Notes for Manufacturers - 3d:
Prepare Instructions for Use and Labelling
Each device must be accompanied by the information needed to use it safely and to identify the
manufacturer or authorised representative, taking account of the training and knowledge of the
potential users.

https://ec.europa.eu/docsroom/documents/10272/attachments/1/translations

I will bring this up during the open debate at the EBME Expo on 29th April (I know you will be there Richard); lets see if we can get some ideas on how we can reduce 'unnecessary instructions and CD's.


Be Proactive and reactive.
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Super Hero
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Super Hero
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As I reminded everyone recently, we shall be leaving the EU shortly.

Perhaps then the MHRA (or its successor) can go back to (thinking for itself and ...) acting in the UK's best interests.

It should also mean that bids for government contracts won't need to be invited across Europe. smile


If you don't inspect ... don't expect.
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Philosopher
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I seem to remember, back in the dim and distant past when I was working for one of the big patient monitoring companies, that we had the ability to define the number and type of manuals that would be supplied when a new install was being done. From the OEMs point of view this simply meant that manuals were not packed in each monitor box but rather supplied as a separate item so we could ask the factory to provide a specific number and type (user or service) as agreed with our client. This saved a lot of waste.

The alternative in today's world is of course to provide on-line access, including "user cheat sheets" so that the customers can print what they feel they need post in-service completion.


Thoughts and information provided on this forum are mine and mine alone and do not necessarily reflect the policy of NSW Health. They may also be complete bollocks!!
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Super Hero
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All that sounds very sensible to me, Dave (but there again, you're not in the EU). As I say, hopefully things like this may well get "back to normal" soon.

I also don't remember being flooded with operators' manuals "back in the day" (usually the exact opposite, in fact). But there again, I have never held any management positions in "first world" hospitals. whistle

PS: I hope you're well away from the "climate emergency" where you are.


If you don't inspect ... don't expect.
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Hero
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Hi Geoff, not sure that leaving the EU means manufacturers will do something different for the UK.
Hi Dave, Sounds like a sensible solution.


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Super Hero
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Super Hero
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Time will tell, John. But if the legislation changes, at least the manufacturers won't be able to use that as an excuse for dumping tons (tonnes?) of multi-lingual (and often poor quality) documents on you. smile

Re: Dave ... yes, operator's (and service) manuals should have a separate part number (stock number, catalogue number) - and often do - so they can be ordered as required (and in the quantities required, as well).

It would be better if regulations stated that (for example) "all operators' and technical information is to remain available for [so many] years following purchase of the equipment" - ie, available for purchase - although FOC would be so much better ... rather than to be supplied with each item of equipment. That's one of the problems with "regulations" (and/or legislation) - so much of it is badly drafted. frown

Personally, I would go farther than that, and include:- "technical information shall include functional descriptions, maintenance procedures, all available circuit diagrams ("schematics") and parts lists".


If you don't inspect ... don't expect.
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Hero
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Make it part of your purchase agreement that all service/operator manuals must be in digital format


If you think hiring professionals is expensive, try hiring amateurs!
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Philosopher
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One manual for each pump and all going to the same ward. Shame really, probably 18 or 19 of the manuals will end up in the recycle bin having been transported all the way from France to Australia. The last remaining one will sit on a shelf somewhere and never see the light of day again most likely.

HeyHo.............

Attached Images
IMG_0891.JPG (120.88 KB, 40 downloads)

Thoughts and information provided on this forum are mine and mine alone and do not necessarily reflect the policy of NSW Health. They may also be complete bollocks!!
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Super Hero
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But surely at least one (or possibly more) will be retained in your library? think

One day, all that kit will come up for disposal. They will be much more saleable if the deal includes the manual(s) (as well as any residual spare parts). Sadly, back in my days of involvement with the "charity sector", I never came across donated equipment as complete as that. It is also rare for equipment being sold at auction to include a manual. I have always put this down to "lack of training" ... the "complete equipment" always includes the manual(s)! frown

I wish I had a big shed to squirrel away - for a "rainy day" - all these unwanted manuals being discussed. smile


If you don't inspect ... don't expect.
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