New 3 Watt Customer Build

[carlos3621]

"impatiently awaiting slicklasers response" .........

[carlos3621]

you know it kills me that due to the insanity of getting a projector certified they can charge $2500 for a fancy box and people pay it... :facepalm:

2500 for a "easily certified enclosure"
2500 - 6000 - to pay someone to "certify yours"

hmmmmm......... your "f__cked" either way

[flecom]

2500 for a "easily certified enclosure"
2500 - 6000 - to pay someone to "certify yours"

hmmmmm......... your "f__cked" either way

lol, and then people are shocked when they discover places are doing shows/have lasers with out variances... oh noes!

if i put my lasers in THAT box they are safe... another aluminum box... nope, not safe at all!!

lol

[ElektroFreak]

In no way am I sanctioning the breaking of US law, but given the fact that so many other countries don't require half the crap the the CDRH does AND have very few injuries, it sometimes seems to me that the whole variance thing is in place more to protect the "pros" from too much competition by making the variance process a very costly and time-consuming proposition than it is to protect the audience members from injury..

just my $.02

[Doc]

In no way am I sanctioning the breaking of US law, but given the fact that so many other countries don't require half the crap the the CDRH does AND have very few injuries, it sometimes seems to me that the whole variance thing is in place more to protect the "pros" from too much competition by making the variance process a very costly and time-consuming proposition than it is to protect the audience members from injury..

just my $.02

The CDRH's adoption of IEC60825 (i.e. the international standard) should rationalise things for you guys in th US, as it is very much a common sense document.

[flecom]

The CDRH's adoption of IEC60825 (i.e. the international standard) should rationalise things for you guys in th US, as it is very much a common sense document.

does it still require eleventy billion reports and a crack-team of legal experts?

[buffo]

If you choose to certify under IEC regs (as allowed under the terms of Laser Notice 50), you must explicitly state this in your product report. And yes, in any event you still need to file the laser product report, which at 34 pages + supporting documents, is the largest part of the hassle. By comparison, the variance request itself is just a few pages.

Regarding a case intrusion interlock, this was optional even under 21 CFR 1040 rules under two conditions: 1) if the operator is also the manufacturer, thus you would be protecting yourself from, well, yourself, or 2) if there are no user-serviceable parts inside and proper warning labels are applied.

Regarding the start-up delay, I accept Marc's statement that it's not required for solid state lasers. I still feel this is a good thing to have, however, which is why my interlock circuit includes a start-up delay for each and every start or re-start.

I also believe that there is a potential problem lurking in many solid state laser projector designs that do not incorporate a "run" or "start" button. Namely, it is possible to have an un-commanded projector start-up by unplugging the ILDA cable (thus breaking the interlock loop) and then plugging it back in. *Most* projectors will start right back up all on their own in such a case, and this is against the spirit, if not the letter of the CDRH regs. In my opinion, if the projector shuts down for *any* reason, it must require an operator-commanded event to re-start.

Adam

[slicklasers]

If you choose to certify under IEC regs (as allowed under the terms of Laser Notice 50), you must explicitly state this in your product report. And yes, in any event you still need to file the laser product report, which at 34 pages + supporting documents, is the largest part of the hassle. By comparison, the variance request itself is just a few pages.

Regarding a case intrusion interlock, this was optional even under 21 CFR 1040 rules under two conditions: 1) if the operator is also the manufacturer, thus you would be protecting yourself from, well, yourself, or 2) if there are no user-serviceable parts inside and proper warning labels are applied.

Regarding the start-up delay, I accept Marc's statement that it's not required for solid state lasers. I still feel this is a good thing to have, however, which is why my interlock circuit includes a start-up delay for each and every start or re-start.

I also believe that there is a potential problem lurking in many solid state laser projector designs that do not incorporate a "run" or "start" button. Namely, it is possible to have an un-commanded projector start-up by unplugging the ILDA cable (thus breaking the interlock loop) and then plugging it back in. *Most* projectors will start right back up all on their own in such a case, and this is against the spirit, if not the letter of the CDRH regs. In my opinion, if the projector shuts down for *any* reason, it must require an operator-commanded event to re-start.

Adam

He is not the end user, and with any class 4 the intrusion interlock is required if the manufacturer is not the end user. On a class 3b you can get away with no interlock if properly labeled. That is what I have read everywhere.

One other question, from what I understand the law to read, the manufacturer who is variainced in building a laser projector must check the final build of a system before it is certified if someone other than the manufacturer of the housing builds it, is that correct?

[buffo]

He is not the end user

Ahhh. Good point. If he's building it for another customer, then you're right.

On a class 3b you can get away with no interlock if properly labeled.

I seem to remember something about "no user-serviceable parts", but I could be confusing this with the class 3B exemption you mention. I had thought that if the case required tools to open, and that it was explicitly stated that the user had no business being inside, then you didn't need a case intrusion interlock. I may have been mistaken...

If you always need one on a class IV laser, doesn't that mean that *every* cover has to have an interlock switch on it then? After all, what if the idiot operator decides to remove the side of the projector housing, rather than the standard access panel, right? Not trying to split hairs here; I'm genuinely curious... Because I've seen projector housings that only had a single switch on a small access panel. You could pull the side plate off though, and have full access to the guts with everything still powered up, if you were so inclined.

the manufacturer who is varianced in building a laser projector must check the final build of a system before it is certified if someone other than the manufacturer of the housing builds it, is that correct?

Hmmm... I was under the impression that by filing even a modified laser product report, you become a manufacturer by default. By referencing the existing accession number for the pre-varianced case, you are simply making it easier to certify your new projector. But you're still the one doing the certification, and in the end you'll receive your own accession number for your modified LT-1000-based projector.

Marc, care to comment?

Adam

[gottaluvlasers]

Marc, care to comment?

Sure.

He is not the end user, and with any class 4 the intrusion interlock is required if the manufacturer is not the end user. On a class 3b you can get away with no interlock if properly labeled. That is what I have read everywhere.

I will try to make this as quick as possible...

This is what I did. I called my EOS, and spoke again with him on these issues, these are the responses.

First thing out of his mouth was, "Please refer to LN50"

OK, we'll start there and i will comment as needed...

Effective immediately, and until the effective date(s) of any amendments of the Federal regulations affecting laser products, CDRH will not object to conformance with the comparable sections of IEC 60825-1, Editions 1.2 or 2 or 60601-2-22 in lieu of conformance with the following sections of 21 CFR §1040:
1040.10(b) Definitions
1040.10(c)(1) Classification
1040.10(d) Accessible emission limits
1040.10(e) Tests for determination of compliance
1040.10(f)(1) Protective housing
1040.10(f)(2) Safety interlocks
1040.10(f)(3) Remote Interlock connector
1040.10(f)(4) Key control
1040.10(f)(5) Laser radiation emission indicator
1040.10(f)(6) Beam attenuator
1040.10(f)(7) Location of controls
1040.10(f)(8) Viewing optics
1040.10(f)(9) Scanning safeguard
1040.10(g) Labeling requirements
1040.10(h)(1) User information
1040.11(a) Medical laser products

My exact, to the point question to my EOS *again* was this....

Q- "Do i need to have an interlock on *ANY* laser light show system I build, use, sell, borrow, buy, trade, steal or give away"

A- NO! Interlocks are, and/or were required on laser system that, if unmodified, the *LASER SOURCE* can be removed from the laser system as a whole (i.e.- your certified product) can provide an **easily accessible danger** to laser radiation above class I limits. And/or if the laser system was in an "always lasing" state at maximum power outputs as with ion laser systems.

When you build a certified laser projection system, you are certifying the *system as a whole* to be in conformance with safety standards. This is why the LT1000 as a *CERTIFIED* projector must use Allen heads for the fasteners on the panels. It *does not* provide an "easily accessible" danger to hazardous radiation. If they were regular philips screws or flat head screws, the system would no longer be considered a certified projector.

However- you do need to have lables on EACH panel stating that if this panel is removed, exposure to hazardous radiation is possible. And/or labels stating that there are no user serviceable parts inside.

If the laser *by itself* can be removed from the CERTIFIED housing and *EASILY* (without modification) lase, than that laser needs to, ON ITS OWN, conform to all safety regulations and at that point, the laser source BY ITSELF must contain at least one system interlock.

Why you ask? becasue if you take the laser BY ITSELF, and plug it in, it can lase at unsafe levels and provide unsafe access to Class 3B/4 conditions.

When we all build our systems, we wire our lasers and build our products such that the laser can not lase unless given a modulation signal input. NOW- if you remove that laser module and it can lase without any sort of input, you bet it needs to have an interlock, attenuator, emission indicator, delay and all that other stuff.

after reading more of LN50....

"Which applicable sections of 21 CFR are unaffected by this guidance?
The following sections are unaffected. Laser products must conform to the following sections of the CDRH standards:
1010.2 Certification
1010.3 Identification
1010.4 Variances
1040.10(a) Applicability
1040.10(c)(2) Removable laser systems
1040.10(f)(10) Manual reset mechanism"

I proceded to ask the question about manual reset, as the above states it *IS* still required...

Q- do my systems need to have any sort of a manual reset for a fault condition?

A- We would still prefer it, but we know that many of you are using computer controls and software controls and therefore, any fault condition is also controllable by terminating software and/or shuttering situations.

I asked to please explain a little further...

If there is a power outage, the laser system (which again, is certified as a whole and is therefore wired and certified to NOT lase without an input mod. signal) will turn back on, but can not and will not lase until the operator again restarts the computer, and re-opens any sort of software control. this is *MORE* of resettable condition anyway if you think about it (his exact comment to me). If you have a reset switch, you walk up to it and hit a little red button. this way, takes time for the laser to restart (granted, thats instantaneous). But the computer re-boot and software re-start takes ~1-5 minutes.

i went even further to ask him....

Well, what if *just* the laser loses power for some strange reason.

A- then you hit "escape" on the keyboard dont you? or you terminate the software dont you? therefore...you are becoming the reset condition. instead of hitting a little pretty red switch labeled "reset" you hit a key that says "ESC." (or whatever).

One other question, from what I understand the law to read, the manufacturer who is variainced in building a laser projector must check the final build of a system before it is certified if someone other than the manufacturer of the housing builds it, is that correct?

The manufacturer is the person/company that originally certifies the enclosure. In this case, OSLS is still considered the manufacturer becasue they provide the certified enclosure. In their product report and variance, they provide a set of guidelines in which i need to build that system to. If i build it *outside* of those guidelines, you bet i am liable. ABSOLUTELY!!! However, i am still not considered the manufacturer. you are correct. However, checking the final system build has, in the words of my EOS, "Never happened in the history of Laser light show projector builds." (as he is giggling). Unless the manufacturer and the builder were one of the same. In other words, obviously when OSLS builds a system for a client, they are now the manufacturer and the "Seller." and obviously they inspect the system.

If you always need one on a class IV laser, doesn't that mean that *every* cover has to have an interlock switch on it then? After all, what if the idiot operator decides to remove the side of the projector housing, rather than the standard access panel, right?

We touched on this. this was actually one of the biggest reasons why the "no interlock" was begining to become the norm. Even when the interlocks are/were incorporated into systems. they were ALWAYS defeated out of convenience. Has anyone in the history of laser shows ever had some joe schmo come up to their systems and try to undo side panels? LOL. it started to become more of a common sense issue than a safety issue. I'll tell you all something, if someone unauthorized , got that far into my laser system, the LEAST of their worries would be a laser beam hitting them!!

Anyway, the fact also that every panel would need an interlock was just silly. Becasue every panel is removalbe on our systems.

Hmmm... I was under the impression that by filing even a modified laser product report, you become a manufacturer by default

this i did not ask Emir about. However, from what i do know and what i have experience with, YES- the second you modify an already approved certified product, you now become the manufacturer. If i remove the allen head screws from the LT1000 and use regular screws, i would need to file a modification and i now become the new manufacturer.

By referencing the existing accession number for the pre-varianced case, you are simply making it easier to certify your new projector. But you're still the one doing the certification, and in the end you'll receive your own accession number for your modified LT-1000-based projector.

i am not 100% certain on this. But i would say with 99% certainty that that comment is correct.


Here is everything pretty much summed up...

Interlocks:

Yes, i agree. a valuable safety restraint if used. however, according to *MY* EOS, other companies, Other manufacturers, and my EOS's (well, your EOS also) boss, NOT required!

this has been confirmed via phone, writing, numerous, multiple variances not just by my company but by NUMEROUS other companies.

Time Delays:

Satisfied by Lasers being incorporated into show systems not being able to lase without input from an external source of modulation. if the laser is by itself, yes...it needs a delay. (if it can turn on as soon as power is applied).

Resets:

Pretty much the same as above and explained in detail earlier in my post.

I tried to be as forthcoming as i could for these questions and answers. I couldnt get any more clear responses.

Again, it comes down also to, as of this week, 23 Laser system builds without a *single* interlock, time delay and/or reset utilized. Variances have been approved, certifications have been granted, and inspections have been passed. Short of GOD him/herself interjecting at this point, i dont know what else i can say.

-Marc