The Variance Thread

[gottaluvlasers]

Thank you Marc you are a great resource, and we appreciate you sharing your knowledge!

-Adam

No need for thanks. but i appreciate it.

If I'm not using a certified projector, then what defines if my laser sources are acceptable?

you ask a very simple, yet, impossible to answer question. lol. reason i say that is i have asked this exact same question to 3 different CDRH reps. and i have gotten 3 different answers.

the "jist" of an answer is this (and have been told that this is perfectly fine!)...

the lasers modules themselves (the raw beam sources) can be anything, from anywhere. as long as these are incorporated into a end certified laser system. When a laser module is used in this fashion it is considered an "OEM" laser. if you take "Laser X" module and put it on a bench and turn it on, without an enclosure, well then in that case that raw module itself needs to have all of the proper certifications, safety systems and paperwork completed.

If you are incorporating the module into an enclosure in which that enclosure itself will have those safety features, then the module does not need to have anything. becasue all of the safety features will be incorporated into the end result. (your laser light show projector).

If my Chinese laser has a power supply with the necessary safety features and interlocks, is that sufficient?

do you mean your chinese laser "module." or do you mean your chinese laser "projector?"

in either case, however the answer is still NO. well, no to a point. if the module or projector has all of the features, then either you or they still need to complete a product report and have the item certified.

a laser can have 10,000 laser safety features. if the product report was not completed or it is not being used as an "OEM" laser, than in essence, the laser is still "illegal" to operate in public.

If my case is not a certified case, but one that I built/modified how does this affect things?

Yes. you will need to do a product report for your case. Any enclosure needs a product report completed for it to become varianced.

The case has a hinged lid that covers the aperture. Does this count as a shutter?

No. it can be the beam attenuator. But it can not be the shutter. a shutter has to be able to be active remotely and be independent on its own power. Mechanical and/or electrical.

If I make the case so that the key lock and emission indicator on the laser's power supply accessible from outside the case is this sufficient for certification?

the enclosure itself has to have a visible emission indicator. do you mean the inddicator visible from a remote location? like on a box or control panel near the operator? no. i dont *think* (i may be incorrect on this one) this is suffivcient enough. They want the indicator to ward everyone that may be exposed to radiation to be able to see the indicator.

Are there any particular requirements of the case aside from being able to contain the workings of the projector?

whether its the case (enclosure) or a laser (module). anything that emits a laser beam has to all follow the same guidlines for th variance process.

those are found in 21 CFR part 1040. (included in the file link i posted above)

-Marc

[ElektroFreak]

do you mean your chinese laser "module." or do you mean your chinese laser "projector?"

in either case, however the answer is still NO. well, no to a point. if the module or projector has all of the features, then either you or they still need to complete a product report and have the item certified.

a laser can have 10,000 laser safety features. if the product report was not completed or it is not being used as an "OEM" laser, than in essence, the laser is still "illegal" to operate in public.

Thank you for the info! Very helpful..

I meant Chinese laser module (CNI, Laser-Wave, etc..). The unit I have in my green projector is a CNI laser with an FDA-style power supply. I have my case set up so that the control face of the power supply is accessible through a completely uncovered opening. It is part of the back of the case, more or less. Is that arrangement compliant with the emission indicator and keyswitch requirement?

[mikkojay]

Hey Marc,
Wow- that's some great info It does seem a little daunting and there are a lot of what-ifs, but it is definitely something to think about. It all makes me feel the need to conjure up a patent atty.
To Steve- yeah, this was an idea for a RGB dpss in-a-box, in the 600mw range, like what seems to be the avg Joe RGB (intro plus) box around here. I think if someone were to want something more exotic, they would be on their own- but then again, that's where they are now.
The call to CDRH is a great idea. It would probably just be a matter of getting hold of the right person on the other end, and the caller's ability to communicate the concept in a way that highlights the benefits for both sides.

Also, those are good points about keeping some constraint on the free-for-all factor.

Thanks, Mike

[gottaluvlasers]

i think that would be fine. this is how the old melles 3W greens were made.

however, you should wire a front emmision indicator. i am 99% sure that there needs to be an emission indicator on the same observable surface as the aperture.

still needs shutters, proper labels, and the rest that we spkoe of earlier.

-Marc

[platinum]

The call to CDRH is a great idea. It would probably just be a matter of getting hold of the right person on the other end. . .

That person retired.

-Jonathan

[ElektroFreak]

So basically, not only does the projector itself need a variance, but each individual component also requires a variance? That seems a bit excessive to me, but I'm sure there is a reason for it. We hobbyists have a habit of trying to be creative with our enclosures and designs, but it sounds like that is frowned upon by the authorities. It seems much easier if you just stick to already proven designs, but that robs the DIYer of some creative license.

[mixedgas]

So basically, not only does the projector itself need a variance, but each individual component also requires a variance? That seems a bit excessive to me, but I'm sure there is a reason for it. We hobbyists have a habit of trying to be creative with our enclosures and designs, but it sounds like that is frowned upon by the authorities. It seems much easier if you just stick to already proven designs, but that robs the DIYer of some creative license.

Two documents

One, the projector gets a manufacturers report that covers ALL the hardware. It covers all the components, unless amended for changes/mods.

Since your a pilot, the manufacturer's report is near equvalent to a very simple type certificate, owners manual, maint manual, and manufacturing/annual flight test procedure all in one. Yes, your supposed to a do a annual on your projector, only it doesn't cost nearly as much as it does on a bird. You also do a Quality Control check before each show, based a on a checklist in the manufacturers report, and you make a owners manual as well. Once approved, you get a accession number for the gear, and then each identical piece of gear gets its own serial number that YOU assign. You will now have a certified piece or pieces of gear.

Then the variance, covers its use in the field and the effects to be performed. Remember a variance is a permit to deviate from the class IIIA standard in public. variances refer to using specific approved hardware that has a accession number from the approval of the manufacturers report/

The vary itself if very much like a private pilots certificate, and the annual report is the flight log.

The approval letter for the variance will read something like;

http://www.fda.gov/ohrms/DOCKETS/doc...a0003-vol1.pdf

Steve




Steve

[Laserman532]

the pre approved enclosures should have never been approved, however it is a clever way to take advantage of loop holes in the laws.

pre-approved enclosures should be only allowed in cookie cutter type manufacturing, not a box where anything can be shoved into it. IMHO

defeats the spirit of the laws.

[flecom]

however, you should wire a front emmision indicator. i am 99% sure that there needs to be an emission indicator on the same observable surface as the aperture.

you sure about that? The projector that the Miami Museum of Science purchased from Laser Net did not have an emission indicator in the front and it is (supposedly) CDRH certified

their previous projector (based off a Lexel) also did not have a forward facing emission indicator, and I am fairly certain that one was (supposedly) also CDRH certified... if not it ran up there for 13~ years illegally lol

[mixedgas]

you sure about that? The projector that the Miami Museum of Science purchased from Laser Net did not have an emission indicator in the front and it is (supposedly) CDRH certified

their previous projector (based off a Lexel) also did not have a forward facing emission indicator, and I am fairly certain that one was (supposedly) also CDRH certified... if not it ran up there for 13~ years illegally lol

One of the two laser safety letters says the emission indicator is for the benefit of the operator. A example cited is would not laser survey gear thus need a long range strobe? The Answer is no, the light is for the operator and the strobe would be a greater hazard then the survey gear.

Steve