UL Compliance

What does the FDA require?

Cheers

the "wrist" enclosure is hillarious. please use that one.

FDA requires 2nd edition. jess

No, FDA requires 3rd Edition.

Cheers

Thanks for sharing that UL info with me. I found the following link

The paper discusses leakage current. In my system design

1. The Enclouser will not be tied to earth because its plastic.
2. The Electronics section will be disconnected from the battery or be off when the user plugs the Battery Charger to charge the battery.

So, in my view

1. Earth leakage current
2. Enclosure leakage current or touch current do not exsist for my device

But the following leakage current test

1. Patient leakage current
2. Patient auxiliary current might exsist.

The problem is that you can see that even in these tests examples the enclouser is grounded and the transformer is plugged into the wall.

My device when plugged into the wall, does not work at all except charges battery. And my enclouser is not grounded at all.

So, How UL will test my unit. Will they short all the outputs of the AD1298 and then short it Lithium Ion battery + ve terminal or to its ground or short it to the AC voltage as shown in fig. 4b

Jess

Look at it this way, Misuse. Operator tries to use the device while charging. and connects the leads to the patient. (This is what Risk Management is all about)

You should get a 60601 rated AC adaptor at minimum.

Seriously go to UL university and take the designing for 60601 course.

Cheers

Hi,

But the Charger's data sheet says on page 2 that it is approved for

IEC 60601-1, EN 60601-1, UL 60601-1

Data Sheet link:

jess

If you try to enforce not charging the device whilst in use by just software, the user will only find that out after they are already connected to the wall wart, and experiencing whatever consequences you were trying to avoid.

Why not make the battery removable, and omit any charging socket on the device itself. You can provide a separate charging station that the battery fits into, and which connects to the wall-wart. Some parts of this arrangement might already be available off-the-shelf.

Failing that, if permitted by the standard you could place the electrode connector and charging socket such that it is mechanically impossible to connect anything to one connector whilst the other connector is in use. (e.g. a sturdy sliding door that exposes only one connector at a time.)

Both ways you can make it impractical for a user to attempt to charge the battery whilst connected to the electrodes. I'm not sure if the standards have anything to say about that as I don't have a copy.

Chris

This is pretty easy.

OP needs to use the absurd giant wristwatch enclosure, and make sure it has some real crappy metal wrist band.

The charger is a mannequin arm with a coil inside it. you place the bad sci-fi movie looking device on the arm and it magnemagically charges, like a cordless toothbrush using the 1 turn wristband.

vice >itself. You can provide a separate charging station that the battery fits >into, and which connects to the wall-wart. Some parts of this arrange ment >might already be available off-the-shelf.

The things is that the user can go and get a non UL approved LiIon Battery and use it if I go with the removable battery option.

connector and charging socket such that it is mechanically impossible to >c onnect anything to one connector whilst the other connector is in use. (e.g . >a sturdy sliding door that exposes only one connector at a time.) Both w ays >you can make it impractical for a user to attempt to charge the batter y whilst >connected to the electrodes. I'm not sure if the standards have a nything to >say about that as I don't have a copy. Chris

Sliding doors can effect the ingress rating of the enclouser.

jess