Class II power supply in a hospital environment?

[CaliforniaMike]

Hello,
We are developing a product that will be a Class II, home use, product. I can easily purchase a 60601-1 certified class II supply. However, the standard of care requires that the patient be trained in the hospital for several days prior to taking the device home. Unfortunately, I am running in to a requirement for a hospital grade cord if the device is going to be used in the hospital. My understanding is that these are always grounded. However, we are a Class II device, which cannot rely on a ground. But we need a grounded cord for the hospital, but we are a class II device, but.....

Am I missing something here? Do we need to certify the device as both Class I and Class II and supply two different power supplies and apply all kinds of warnings about not using the Class I supply at home?

Thanks in advance for any guidance.

 

[Peter Selvey]

It might be worth checking the detail or source of the requirement to use a hospital grade cord, as this doesn't seem to make sense to have as a strict rule. It essentially prohibits any medical device that doesn't have that style of cord. I can understand a preference, and also strict in limited situations (e.g. ICU, or extension cables), but not as a general rule.

 

[lauxt]

The company I work for sells Class II medical power supplies with a 2-blade C18 inlets, which can be used with a 3-conductor medical grade C13 input cable. I am sure other companies have similar offerings.

 

[mr9000]

What is the requirement for the hospital cord? Having a ground connection and using a ground connection are also two different things.

 

[CaliforniaMike]

Thanks all. I think we have it sorted. Basically, the requirement was old and there were some hardliners in some of the hospitals that we sell to. However, apparently, this has been worked out and can be removed. That said, the C18/C13 idea is a thought. I might bring this up.

 

[lauxt]

Is it an old requirement? As far as I know, the requirement for hospital grade power supply cords comes from the US National Differences per AAMI/ANSI 60601-1.

I have no experience on your side of things. I suppose a hospital is allowed to make its own call to some degree(?).