Chinese (or other low-cost) Lasers with FDA Variances

[mixedgas]

[QUOTE=mixedgas;287213][QUOTE=wmodes;287210]Uh, is there a rant room reserved for people to abuse each other? It makes it a bit challenging to work through the actual information. I'm a newbie here, but public spankings -- even when someone is well-intentioned but dead wrong -- do little to preserve the friendly welcoming character of this esteemed forum. When a new person sees someone offering incorrect information and getting smacked down for it, it doesn't encourage new people to share what they know. Just sayin'.

That said, thanks for all the information. Still trying to wade through it.

END QOUTE]

In your thread right now you have three of the five people who have published the most on how to do the paperwork. The "smackdown" was needed to eliminate a persistent source of noise. Sorry for that, but he was getting annoying and off topic.

How may we help you? The actual process is easy if you have the correct information, and free.

It basically comes down to the following hardware An emission indicator, a key switch(key cannot be removed in ON position), an external interlock, the right stickers, no light leaks, and the right labels. Some of us still suggest a spring loaded master shutter, but in modern times that has been waved for low power products. If the ILDA cable is disconnected, or the lid is off, no laser emission shall occur. (defeatable interlock sticker advised for servicing and alignement) Audience scanning requires some additions to the hardware, depending on the methods used, including a scan fail interlock of some form.

You have two portions, the hardware and what could be termed a user manual, procedures / operations, safety, and record keeping portion.

I have in my hand a document with a VRA number, something many commenters here have never achieved because its too "hard". Considering the many color drawings were done in WIN 95's version of PAINT, when I was in my 20s, I'm not so sure its that difficult. Recently the paperwork has been simplified.

If you buy a already approved device, can you fill out a four page form and a cover letter? Its that easy.

Audience scanning can be done via "PASS", or doing some serious math and controlling what and how you scan. It requires additional nightly quality control steps and operator training. However the degree of training is not severe, the system designer gets to decide what is what. Without Pass(TM), you purchase a power meter, fast photodiode, and oscilloscope, and provide a live operator. For some "weak" effects, the effects can be designed so that the scan fail safeguard does not need to be so fast, but the rules speak of 200 nanoseconds to ensure shutdown.

Once upon a time, the US Government published a document on how to do audience scanning effects, it was pulled from the NTIS a while back. It is suggested the book had a few small math errors. In reality, I suspect politics was behind the culling. Drop me a PM with a phone number, and we'll talk about it. I've published parts of it on the forum. My fear is that some one will take the equations, write a so called "free app", and then we will end up with a accident, when the data is misapplied.

Before some one slams me with "withholding" information, I can make the argument that at least one error in the math is significant, and the book does not entail a "cookie cutter" approach. There is some serious algebra involved. The higher power exposures have a cumulative effect, something no "App" will manage correctly, because humans are fallible. I like the idea of trusting my eyes, and the public's eyes, only to something that has undergone peer review. (And I ain't publishing the mirror ball, trade secret)

If your installing on campus, incidentally the CDRH has reduced authority on a campus. OSHA, however, does not wave its rights to enforce laser safety. So the fallacy that shows on school campuses are exempt from laser safety is, just that, a fallacy. In fact the shift to ANSI Z136 under OSHA could be argued to be stricter then 21 CFR 1040.

Quoting PL poster Stiffler, "There are no Laser Cops". However there is the CDRH, University Health and Safety, OSHA, and the local Fire Marshal. In the US, NFPA has a "cover all" clause on laser use. I've been inspected by fire marshals more then once. I did perform once for 20,000 people on the campus I worked on. H&S wanted to see the paperwork, all "I"s dotted and "T"s crossed.


Steve

[Laser Wizardry]

" 15 characters"

[mixedgas]

Karl, I'm sending him the document that will get him out of a lot of the work in the morning before I leave to see you.
I just reviewed something he sent me, and we do have that "trade restraint" thing from one possible hardware provider, which could help.
I like his project, and its something similar to what we were going to do on the Helicopter project.

Steve

[Stiffler]

A question for Steve & Karl-

Forgive my naivety, but why would a DLP projector that projects a much brighter image than a laser at MPE be safer?? It seems to me that if the DLP can 'scan' a line brighter than a laser, that it would in fact be more dangerous than the laser line. I get that if the laser stops moving it will be much brighter, but shouldn't a scan fail eliminate protect from that?

Oh and Steve, thanks for throwing me under the bus! ;-)

[mixedgas]

Bus, I threw you under the express train...... :-)

Actually that is the best question you could have asked. Simple, if you believe the physics propoganda, laser light is coherent and focuses to a smaller spot on the retina. That has been the standard explanation for years, but it's not the coherence as much as it is the wavefront shape and initial spot size at the source. However the wavefront is enabled by the coherence, so which came first, the Hen or the Egg?. So the propaganda is simplified for public consumption. A laser projector without a diverging lens gets to a smaller spot size then the non-laser source.

In reality mW per cm^2 IS mW per cm^2 and incoherent sources should not be taken lightly. The projector output is broadly diverging and does not get to anywhere near such a tight spot as the laser at the retina. Unless your projector has a lot of UV or IR, the retina is what counts. Rules for incoherent sources have been around a long time. A few years ago, LED sources went to a new rules group and are not on the laser regulations any more. However the retinal energy density levels are similar in the various regulations.

For modern video projectors, I still say it hurts, and may be a risk for secondary reaction, or disorientation. The odds for damage are far less with the DLP then the laser. I still do see projectors with Caution and Danger risk tags, so the rules are in effect. However the in-coherent tags I've seen are no where near as Colorful, Dramatic or Stylish as the Laser warning stickers.

I was unaware of the LED rules change until I went to the ILDA LSO course.

So LEDS are now under their own standard, IEC 62471-2006 instead of IEC 60825, which is the Laser standard.

This is a good read for incoherent light, note the limits are similar to 21 CFR and IEC 60825

http://www.icnirp.de/documents/broadband.pdf

This has a good read for LEDs by CREE:

http://www.google.com/url?sa=t&rct=j...LqI8hR5WCP9HNw

The Movie Projector Safety Lobby is Here:

http://lipainfo.org/laser-projection/laser-regulations/

LIPA wants (Understandably so) Laser Based Cinema projectors taken off variances.
Steve

[buffo]

They'll have to file their own show variance anyway. Buffo in another thread said it's not very hard to do either.

Just to clarify this point: The thread where I said that was discussing how to file for a basic laser light show variance, assuming you already had a certified projector. And it's true, once you have a certified projector, the laser light show application is not that difficult to fill out. (Just two pages for the application, plus a simple show report that describes how the projector will be set up and used in a venue.)

This only applies to standard laser shows that obey the 3 meter rule, however. If you want to apply for an audience-scanning laser light show variance (as the OP would need), you will need to supply considerable extra information with the application (including a highly detailed show report and copies of your QA/QC program, to name just a few of the highlights). Then too, the projector itself will need to be certified for audience-scanning applications, which is another huge hurdle.

Bottom line: Audience-scanning is a complex and dangerous task. It's not something a new laserist should even think about doing. I agree with others above: Either hire a professional company with the proper credentials to do the audience scanning safely and legally, or use a DLP video projector instead of a laser projector. (Pangolin's Beyond software will allow you to send laser frames to a video projector as if it was an actual laser projector. The results are quite impressive and will fool just about anyone.)

Adam

[yeping123]

Hello All.

Would like to upload some documents about our US variance #.
ABLE was told by Emir from FDA if customer want us to show own variance just give them below documents.




And laser is ready to ship out to USA, should post below labels

And need to attach products report and a FDA-2877 document.

For our lasers, 5 sec delay, electronic shuttler, interlock key, indicator led lights, remote control box.......

And i still remember a gentle man,sorry forgot his name, who told me at LDI show last Nov that he works at ILDA and was responsible for checking ALL laser exhibitors. He checked our lasers and all documents and gave us a pass.

We will submit our annual report in July or Aug, and will post it here later.

I like everybody to discuss ABLE laser, any feedback, suggestion, comments would be appreciated.
You all could send me email at able@able-laser.com, so that, i can read it in time.

BTW, a video of 2.5w for your reference, pls take a look.
https://www.youtube.com/watch?v=357ShC4Sm-w

Best regards
Crystal

[dsli_jon]

Hello Crystal -

..Would like to upload some documents about our US variance #... to ship out to USA, should post below labels.....and a FDA-2877 ..

Without wishing to 'turn this into a commercial endorsement' would just like to say Thank You, and your Company, for being responsible-enough to get a US Variance, and *follow* the Regulations / require Variances / use the 2877, etc, etc.

..Just as I am sure your Gov. / people appreciate when Americans follow laws / regulations when conducting commerce in your country, those of us, here, in this country, appreciate the 'respect for public-safety' and the constructs of 'our industry'. It really-does do everyone good when potentially-dangerous / injurious Products are held to certain manufacturing-standards, for the sake of safe-operation / no 'nasty surprises' for Operators or public-audiences, and-indeed, helps to 'keep the Government off our backs', even more.

..I hold up the 'imported fireworks industry' as an obvious example And imo, Class IV Lasers / Projectors should be manufactured and operated with as-much respect and care. It pains us to see 'cheap imports' flooding this country that are *not* compliant with basic-safety control-Regs / manufacturing-quality, and just sold to 'whomever has the $$', w/O regard for their qualifications... Just-like, if anybody could import high-power fireworks - Too-bad Class IV laser-products are not 'regulated' with such 'sold only to those who possess proper knowledge / training to use / operate safely'-enforcement. Thank You, and Able Laser, for 'doing your part' to help keep laser-shows safe and in 'educated hands'.

Thanks, too, for 'uploading those document's, but FYI, a great-repository to point people to, respecting your Variance / products-covered, and all Gov-correspondence (except, yes, for the 'Annual Reports' - they don't publish those docs for any of us.. Not sure why, but, they don't.. I guess that would-be a rather large volume of docs to-store, from over the years, and 'laser shows' are a *fraction of a fraction* of all what-products the CDRH-regulates, etc...) Anyhoo, here's where anyone can access Able Lasers' app / approval, and any future 'big steps' / changes, etc, documents:

http://www.regulations.gov/#!docketD...DA-2009-V-0307

fwiw..
cheers..
j