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Angie98 Offline OP
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May I know how do you convince the manufacturer to give your BME dept a copy of the technical manual so that we can perform a first level troubleshooting. Some oversea manufacturer refuse to cooperate with the BME Dept so that the local vendor can charge the dept for responding to the service call.
Please advise your experience and how you overcome it?
Thank you very much!

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Super Hero
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This is an age-old problem.

Your purchasing department needs to be "advised" to include all required technical information in the initial purchase order. In other words, it should be one of the purchase conditions:- "No manuals - no sale"!

Another, albeit "robust", approach is to refuse to accept equipment without manuals (but be prepared to take some flak from the medical folk who "must have" that equipment).

It can be very difficult to obtain manuals once (after) the equipment has been bought and paid for. In the scenario you outline, you could try talking with the local agent along the lines of a promise of a service contract (2nd line) if they release the manuals so you can maintain at 1st line.

But in short, you always have to retain some form of leverage in situations like this.


If you don't inspect ... don't expect.
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Angie98 Offline OP
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Thank you, Geoff.
We have stated upfront in the specification but like you mentioned the medical staff think it is not necessary as the feedback from other users is the system is very reliable.
My advise to them is they chose with their eyes and mind open that we may not be able to support them when it fails.

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Super Hero
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It sounds like your user staff need a bit of education.

As you know, rumours regarding reliability (or not) have nothing to do with it. The equipment will still need to be looked after (aka maintained) somehow, regardless of its reputation.

Although users have failed to follow your advice, no doubt they will still expect "five star" service when the equipment fails. Notice that (like you) I said "when", not "if".

Who pays for the maintenance, by the way?


If you don't inspect ... don't expect.
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Angie98 Offline OP
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Geoff, the user indirectly pays them as they are sharing the maintenance funds manage by the BME dept. Does UK or CE regulate the manufacturer provide the manual to the local hospital BME dept?

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Super Hero
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I'm not aware of any proper (that is, enforceable) regulations in that regard. There may well be some "guidance" published by one of our Government Agencies, or by one of the many "quangos" ... all of which are next to useless (or at least, "toothless") in my opinion.

As I say, the best way of ensuring that you receive proper documentation is to include the request clearly in the initial Purchase Order.

"Shall include one copy of all available technical documentation (service manual, circuit diagrams, spare parts lists etc.) plus X copies of user instructions" ... something like that.

And then refuse to accept the new equipment onto the inventory if the required documentation is not forthcoming.

Don't forget that some equipment needs special servicing software, service passwords and what-have-you. Again, if you plan to service to that level, then that stuff needs to be included up front.


If you don't inspect ... don't expect.
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Angie98 Offline OP
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Thanks!

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DTP Offline
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Have you got a PAQ/PPQ for the device? If so, does it say that manuals are available?

I won't mention the company's name but I've had equipment replaced outside of warranty because the PPQ said manuals and spares were available - but it turned out neither could be supplied.

As suggested above, we try to make sure manuals/training to access manuals, are included as part of the purchase process. Doesn't help though when departments go out and buy equipment and just dump it at your door.

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Super Hero
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As we all know, some vendors will say anything just to get a sale. So (yet again) that's the time to get their obligations agreed (and written down) ... just before signing on the bottom line.

And regarding "dumping equipment at your door" (again, not completely unknown) ... many (thirty-plus) years ago whilst setting up a contract for a service provider ("Operations & Maintenance") I included in my forms a "Maintenance Advice Note".

This would be sent to the user (owner, customer) if we could not attend to the equipment within the usual expected period (which was a contractual obligation) ... that way we hoped to avoid penalty payments.

The form included the phrase "Please be advised that the equipment cannot be repaired immediately for the following reasons ...".

In the case mentioned the main reason would be stated as the "Unavailability of Service Manual" (etc.).

Farther down the page "The following action has been taken" would be "Service Manual requested from user" ... or if (when) failing that, "Service Manual ordered" (etc.).

Another "trick" from my contracting days would be to charge for any necessary manual as a Spare Part. This would end up itemised on the Job Report with the aim of getting the customer to pay for it. In such cases I would offer the manual purchased to the owner when the equipment was returned; but I recall that they would let us (me) hang on to it at least 50% of the time.

The bottom line of all this is to get the user to provide (pay for) the manual(s) ... especially in cases where your purchasing advice was ignored.


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

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