Legal Varianced Chinese Laser

[Bradfo69]

Humm.... I would have bet money that the emissions indicator was pretty much a must. What is the correct verbage in a product report explaining why it's ok to vary from the standard by not having the indicator? I know you can get away with using a LED that comes on when you flip on the power switch, with the argument being an emissions indicator warns someone in front of it the laser it could lase at any time, and therefore if power is applied to the box, then it "could" possibly lase. You're erring on the side of "more" safety. I've heard, perhaps incorrectly, that a lighted power switch mounted on the front of the projector has even been approved.

Anyone??

[JD3]

I 3 lasertainment projectors are varianced and have no emissions indicator on the front.

I posted a link a few posts ago to the regulations PDF that talks more about this

[DanG]

I had been keeping my mouth shut about the "opt out" that you mentioned a bit ago but, now that this has gone further, I feel the need to chime in.

There is no 'opting out' of the Federal performance standard. There are also no recommendations, they are all requirements. What may be confusing you is that there are different ways of MEETING the requirements, but if your projector does not meet the requirements then it is non-compliant. Remember, having a variance does not mean a hill of beans if the projector does not match the certification and you can't get a certification on non-compliant hardware.

Everyone gets so focused on the variance like that is the end-all of laser safety. The projector is significantly more important from a safety perspective and yes, Brad is correct, an emission indicator is required. It does not NEED to be located on the front as far as I am aware, but most are.

[JD3]

Maybe I was wrong by using the term "recommended".
But many of the big manufacturers that are varianced seem to no incorporate all the requirements in that PDF from the FDA.
At what point do we draw the line on who is meeting what requirements.

With that being said, does every laser made by X-Laser conform to every standard on that list?
Do you have case open interlocks? Or did you "opt-out" by choosing to afix a warning label that stated there is laser radiation present when the case is open.

See where I'm going with this?


(All in good discussion, not calling anyone out. I'm calling the rules out)

[DanG]

Well the short answer is that there is no "line" to be drawn... An electronic products market is a big, complicated and difficult thing to wrangle with manu manufacturers making a wide variety of products for a wide variety of purposes. There are always exceptions, but there is no "opt out."

Yes, every single X-Laser conforms to every single item on that list in one approved way or another. The whole purpose of a variance is to be allowed to VARY from 1040.10 so manufactures describe an intended use and then come up with ways to meet each requirement of the standard in a way that is appropriate for their intended use.

For example, if the end user is not allowed to open the housing and there are no user serviceable parts, what is the purpose of a housing panel interlock system? In that scenario the only people opening the housing would be trained technicians who do not require a safety system to mitigate the potential hazards and in fact the safety system, unless defeated, would prevent them from doing much of their work. Why engineer a system in at additional cost and burden to industry when the system is only going to be defeated whenever it would be in use?

That is a good example of when a particular requirement is met in a different and by a more logical means given the intended use of the products. The standard is full of these common exceptions - but no one gets to just say ... nah, we don't want to.

The part you are quite right about is that is gets REALLY hairy for end users because you really have no idea, and no way of knowing, what any given manufacturer has certified as compliant in their products. That information only exists in a product report, which is proprietary. This is where reputability and resources like PL come into play where people who have some experience with this can say "Yeah, that's pretty commonly accepted," or "No, I don't think so." CDRH is the final arbiter of what is acceptable and it is the responsibility of the company to sell you a compliant product.

Sometimes you have to do a little investigating to make sure your butt is covered because LOADS of people skirt the rules hoping they won't get caught but as we have seen recently, they do.

[JD3]

I'm following you and agree on all the above.
Which brings me back to emissions indicator. Is there an exception to this? Some other thing that can be done to meet that requirement besides and indicator?

[DanG]

No, as far as I know that one is pretty hard and fast. I have never heard of anyone trying to come up with an alternative because its so easy to do.

[JD3]

With that being said the entire line of X series lasers from Lasertainment do not meet that requirement

[JD3]

Attachment 40627Attachment 40628

Front and back of my x series

[DanG]

Setting aside Lasertainment for a moment, if you are concerned that a manufacturer is producing non-compliant products, you can and should report that to CDRH for investigation. You are already in contact with Dale so I would suggest dropping him a note with pictures and asking whether or not the unit can be used under a variance. This is their job, and getting a ruling on a particular product will help to keep your liability down for using potentially non-compliant laser products.