CDRH Variance..

[jayDC]

Okay, I'm at the final step.. I have my laser Projector, and a possible job. I need to get the variance. Does anyone have:

1). An approved Laser Light Show Product Report that I can look at to see how it would be properly filled out.

2). An approved Laser Light Show Variance Application that I can check out, to see how its properly filled out.

Any information in this area would be very helpful.

I went to the CDRH site to look for an Application, but I found a program that they are distributing, called "CeSub". It is a Electronic form submitter for the paper work, but I'm not in a 100% understanding of what they want me to say.

I'm am also not sure on how to take the approperiate measurements for the Applications. They want pulse duration, pulse rate, scan frequency, and scan ampiltude.

I think if we all put our heads together, we could make a faq on how to do this, and get approved. This would not just help myself, but many other hobbiest who would like to take there projects on the road.

Thanks guys!..

[yaddatrance]

I've working on building a mock application with diagrams for your reference

[jayDC]

Wow!.. Excellent Diagrams!.. I see you have a safety interlock. I have yet to discuss this with a LSO, but I have read that if you are not going to sell, or rent the projector to other laser companies, interlocks are not required.

"If you are building a projector solely for your own use, then no interlocks are required. In effect, adding interlocks would be "protecting you from yourself." The CDRH operates under the assumption since you built the projector and will be the only individual using it, then you should know of all hazards of its operation and will take proper protective measures. However, if you then sell, lease, or rent the projector(s) to others, interlocks must be added." - J&K Laser Productions

I have yet to add interlocks to my design, but I have had an Idea for how I would do it. I would use a Standard Magnetic Proximity Switch, they are commonly use for home alarm systems on windows and doors. I was thinking that I could add the switch between the laser and its power supply to cut the circuit and shut down the laser. Then I would add a bypass circuit to the key switch. That way I could defeat the interlock by turning the key the opposite direction, if I needed to.

I also have not added an emission indicator, but I have ordered some 12vdc Neon indicator lamps for this purpose. 3 lights (Green) Emission, (Amber) Armed, and (Red) Shutter Closed.

Thanks yadda for letting me look at your drawings, they help out, but the paper work is the hardest to understand, since alot of it may not apply to what I'm doing. Although I figured out my first questions about scan rate and pulse.

I ahve found some paper work online that has been filled out, and approved. Here are the links..

http://www.jklasers.com/Variance/CDRH_Variance_Info.htm - Good Information .

http://www.fda.gov/ohrms/dockets/dai...100/var001.pdf - Completed and approved variance appilcation.

I have yet to find a completed product report, or show report. I have contacted some other laserists, and hopefullly one of them will send these documents to me.

[yaddatrance]

That's sort of true... If you use screws actually, then it's not considered
"user accessible" If you make a door or some way of openning it trivially,
then you will need interlocks. My goal was always to make it a one way
trip... i.e. I send paperwork, approval comes back.... If you omit portions,
they'll often explicitly ask you about them before approval.

I'm drawing the circuit diagrams right now actually Then I'll work on
a pdf with a sample product report and request for variance. Note that
the process is sequential

[Steve]

Here this free download should help, it's called Scanguard Lite.
http://www.laservisuals.com/sglite.php

[yaddatrance]

Nice! That's a cool tool... one thing to add is that your local R/LSO sets the
allowable MPE for your area, or more accurately, uses ANSI Z136.1-1993
to interpret the 2.5mW/cm^2 MPE irradiance rule relative to the laser. Some
guys will be more stringent than others. There are several different ways
to convert the numbers and they all add up to different amounts, so don't
yell at your LSO if you're running a borderline system and your numbers don't
match up to his

The allowable standards in Z136.1 isn't merely used for IIIa lasers, there's
lots of creepy math they use to determine ambient reflections and refractions
of a higher power beams through various media...

[jayDC]

How can you locate your local LSO?.

[yaddatrance]

Your local university should have a few... That's the easiest way...

An LSO is appointed, and is not a government functionary,
the appointment *should* come with classes and paperwork.

So you can be your own local LSO... It's really just a designation of
who's butt will be up the creek if things fail... If you want formal
training you can become a CLSO... But laws only require designation
and training of an LSO (when dealing with Class IV lasers), A CLSO
is just to make other people feel good when you tell them what to do.

P.S.

Rockwell's been in the laser business for ages... they were the defacto
educational place forever... http://www.rli.com/