EBME Forums Forums Maintenance Technical Assistance Printer inside the patient area

I'm developing a new fetal monitor package and can't seam to get round using a printer in a patient area.

The system I want to provide is a touchscreen pc, printer, iso-transformer cart and battery back up as an option.

When I look at the 60601-1 standards I can use a medical grade touchscreen PC but cant find anything resembling a medical grade inkjet.

Is a standard inkjet acceptable as long as it is isolated?

Why should the printer (or anything else, other than the actual, patient contact or patient connected, medical equipment) be "medical grade" just as long as it is nicely secured on a decent cart and powered via an appropriate (yes, "medical grade") isolation transformer?

I reckon you need to establish exactly what the various codes require, what is actually meant by "the patient area", distances from the equipment to the "patient zone", and all the rest. And then proceed accordingly. It would pay you to have all relevant standards available "chapter and verse", especially when the time comes when you are trying to sell your systems into the hospitals.

Thanks Geoff

Thats where the codes are unclear - or more probably my interpretation of them.

I know that other manufacturers sell devices on carts with standard printers into hospitals for use in the patient zone i.e. within 1.5m of the patient. and are still classed as compliant with the standards.

My issue comes in with ingress of fluids, buttons etc. I can isolate the printer for electrical safety but standard printers would not comply.

Maybe im thinking about it too much (or not enough!)

I would look carefully at the overall design of the system. For instance, if the printer was placed at the top of the stack, it would be less likely to receive fluid ingress (we hope) ... but there again, how would the paper tray (or whatever) be accessed?

Also, have you considered using wireless technology to keep the "non-medical" items well away from the patient (and the patient zone)? Or, why include a printer at all? Just provide some sort (or many sorts of) memory device, and/or interface to the intranet ... and let the user worry about the printer.

Integrating equipment components into a well thought out system is always interesting, but without seeing the actual kit involved, it's a bit difficult to comment further.

But, as I tried to stress earlier, you will have your ducks in a row later on, when you get challenged by every clever Tom, Dick and Ali you encounter in the hospitals.

By the way, was I dreaming, or did I hear recently that legislation is on the way that will require a centralised protective earth point in every "patient environment" by the year 20?? (whenever)? Remember the famous "equipotential point", so beloved by DIN (I think it was)?

OK, another year (month), another standard. Necessary? I doubt it, but there won't be any choice whether to implement or not, of course. Especially if it gets handed down by our "superiors" in Brussels.

Meanwhile (banging once again on my worn-out old drum), many hospitals in the world still struggle on with diesel generator sets, and ECG recorders "earthed" via the plumbing (not to mention lack of a decent water supply, and all the rest).

I think used a isolation transformer can solve this problem.

Yes, but only the electrical aspects to Chris' questions!

Have you thought about using a remote printer on the network, or a printer that is wifi enabled.

See the post four steps back (do try to keep up, please)!

As Geoff says you can't just look at it from an electrical point of view as 60601 requires you to look at all aspects of the design including mechanical, functional and even the colour of indicators. You would need to submit your completed design for examination including a full written risk assessment in order to be able to prove you comply with 60601 before the device can be brought to market or used within a patient environment.

Many think that just sticking an isolation transformer on any device makes it comply with 60601 but this is not the case and has never been.

As always the problems will begin if there is ever an incident involving a device and then you better be sure you can prove your work is bullet proof! (Just sticking an isolation transformer on something will not be good enough!)

Hi Chris,

Yes, you can see standard printers within 1.5 meters of the patient. To give you an example, we have a Natus Algo 5 Newborn Hearing Screener, below are the specs:

Specifications
Note: Specifications are subject to change without notice
Power Supply: Power Rating 120 V~, or 240 V~; 600VA, 50/60Hz
Nominal Dimensions: Cart 64” (163 cm) x 20” (51 cm) x 20” (51 cm) (H x W x D)
Nominal Weight: Cart 110 lbs (50 kg)
Cart fully equipped: 140 lbs (63.5 kg)

Compliance Standards:
EN60601-1
EN60601-1-2
EN60601-1-4
UL60601-1
CAN/CSA 22.2 601-1

Classifications
Electrical Safety Class 1 equipment, BF type applied part
Ordinary equipment for protecting against ingress of water

Safety testing
The safety tests meet the standards and are performed in accordance with, IEC 60601-1, (Amendment 1, Amendment 2,) and UL 60601, for instruments as Class 1 and Type BF and ANSI/NFPA Standard 99.
Applicable tests for these standards are listed in following sections (2.3.1-2.3.3).
Technicians must be familiar with the standards applicable to their institution and country.

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Unit uses an isolation tranformer and came with 2 printers - Label Printer Seiko SLP 440 and HP laser jet P1006 . The printers are placed in the lowest shelf of the cart.

I'll echo what Geoff posted - "I reckon you need to establish exactly what the various codes require, what is actually meant by "the patient area", distances from the equipment to the "patient zone", and all the rest. And then proceed accordingly."