Variance Application - Technological Artisians

Intro

Variance Application

Note - for Technological Artisans products only

Laser Light Show Variance Application Process

As a US purchaser of Technological Artisans Class 4 laser display product, you will need to complete this variance application process, receive an approved variance and report the receipt of an approval to Technological Artisans prior to operating the Technological Artisans laser projector. The government requirements detailed in this presentation apply only to US purchasers and operators of Class 3B and Class 4 Laser Light Show Projectors. However, the safety data contained herein should be reviewed by all users of the Technological Artisans Class 4 laser projector.

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What is a Laser Lightshow Variance and why you need one?

FDA Laser Light Show Variance

A "Laser Lightshow Variance" (LLSV) is a special permit issued and regulated by the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). This permit is required for ownership and operation of all Class 3B and Class 4 laser projectors due to their potential hazard for instant serious injury, including blindness. Variances are used to ensure adequate safety control measures shall be utilized whenever these lasers are operated, to protect the operator, viewer and audience.

The final variance document indicates the control measures which must be used to ensure safety during laser operation. Operation within these requirements is required by US federal law. If you are already a holder of a qualified (Class 4) laser light show variance, then you only need to provide Technological Artisans with your current variance number and its effective date.

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Get Ready to Become A Laser Lightshow Expert! - copy - copy

Get Ready to Become A Laser Lightshow Expert!

You will not be able to obtain a pre-formatted laser light show variance application form until after you have read and completed all the training and informational steps. Get yourself comfortable and be ready to learn about becoming a Laser Light Show Producer!

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Application Process Outline

Completing this application process will require your attention as you study the information and materials provided. There will not be a test, though once a you are approved as a variance holder, you are legally required to perform all responsibilities of a laser light show producer as required by the FDA. Note: As a variance holder, the FDA CDRH may visit you with short notice and inspect your paperwork and observe show operation to ensure you are fully compliant.

What is included

Process includes the following:

Training: An introduction to laser safety principles
The requirements and responsibilities of an FDA Laser Light Show Variance holder/show producer.
Example of documents required for the production of each laser light show.
An opportunity to download show documents for your use.
A discussion of the FDA’s annual reporting requirements and a tour of the FDA’s annual reporting form.
An opportunity to download the FDA’s annual reporting guide and form.12
A discussion of the FDA’s “Report on Laser Light Show or Display”.
An opportunity to download a copy of the “Report on Laser Light Show or Display” your variance application will reference.
An opportunity to download the FDA’s Laser Notice #5514
A discussion of additional laser safety informational resources, with web links.
A form to provide your business and personal information as needed for the ‘Laser Light Show Variance’ application.
Instructions of what you need to do with the printed / signed form.
Instructions of what will happen after you have returned the Laser

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Basics of Laser Safety

Note: Laser lighting systems operate differently from just about any other lighting effect, and because of that, laser users must take care to protect themselves and their audiences. Technological Artisian laser projectors are only to be used for indoor applications, never project laser beams into the sky and to keep laser beams 10 ft. (3m) above where the audience can stand and a 2.5m horizontal clearance from any location in the venue where members of the public may gain access during the display. Eye safety is key, and one should never shine laser beams into an audience.

As a laser operator and/or producer of laser light shows and displays, I understand and acknowledge the following:

Above any other considerations, a laser show must be safe for all persons at the show. This means:
- The laser light must not cause injury (harmful changes) to eyes or skin.
- The laser light must not create a potentially injurious condition, such as causing curtains or other materials to ignite.
- Non-laser safety must also be maintained, in areas such as mechanical mounting (no hazards from falling equipment) and electrical safety
I understand that I am ultimately responsible for the laser show’s safety and will ensure to follow regulations requiring a minimum separation of 3 meters (9.8 feet) vertically, and 2.5 meters horizontally (about 8 feet), between high powered laser effects and any area where the audience is permitted.

PROPER INSTALLATION

SAFETY IS ALWAYS THE FIRST CONCERN

warning height lasers

Laser safety regulations require that the laser display products operated in public must be setup with a minimum of 3 meters (9.8 ft) if vertical separation between the floor and the lowest laser light emission. Laterally, a 2.5 meter (8 ft) clearance is observed.

All public shows produced with Class 3B or Class 4 laser projectors (powered with 5mW or more) are subject to on-site inspection by FDA, CDRH agents and any infractions due to non-compliance with any Laser Variance requirements can result in fines up to $300,000. Get your Show Variance today!

3. I will not present a show which is hazardous (potentially unsafe), or change or modify a safe show so that it becomes hazardous.

4. I will not allow others to override safety considerations, such as show producers or clients.

5. My shows will be continuously monitored so that hazardous conditions can be detected if they occur. In such a case, the condition will be corrected or the laser emission will be immediately terminated (within a few seconds).

- - This is to be performed by using a trained operator who knows what hazardous conditions to monitor, and who knows how to immediately terminate the laser emission.

6. Laser safety standards and guidelines shall be followed at all times, including during setup/installation, and for all persons in the area, whether general audiences, performers, production staff, etc.

7. I will use backup methods to ensure that if beams do not hit a target, they will not pose a hazard. This can include physical barriers such as beam stops or having the beam terminate on a screen.

8. I understand that Technological Artisian projectors shall not be used for any kind of audience scanning. Audience scanning is NOT LEGAL to perform with your Technological Artisian projector because it requires a different variance and type of projector along with significant laser safety training on audience scanning.

9. I understand that Technological Artisians’ fixtures are ONLY for indoor use and will never project laser beams into the sky.

Additional laser safety informational resources

Your responsibilities of operating potentially hazardous laser equipment demand that you further study (and have access to) additional sources of laser safety regulation and practices information.

Investigate and study the following links:

FDA CDRH, https://www.fda.gov
ANSI Z136.1* ‘Safe Use of Lasers’ (currently available, but general for all laser use)
ANSI Z136.10* (to be published shortly, but specifically covers laser light show safety)

ANSI standards can be purchased from:
www.ansi.org or www.laserinstitute.org

The FDA’s “Report on Laser Light Show or Display”.

Technological Artisans has applied for and received a variance for the production of laser light shows. Technological Artisans submitted an ‘initial show report’ report describing the manner such shows will be produced and how they will meet the FDA requirements. Your variance application will reference the initial show report already submitted by Technological Artisans . Your variance, when granted will allow the terms of operation previously approved by the FDA.

Therefore, you will need to download a copy of the initial show report, study it carefully and execute your shows as described.

A downloadable copy of the report is available below.

Download the Annual reporting guide and form.

The U.S. FDA’s annual reporting requirements

As a laser light show variance holder, you are required to report information about the shows you produce to the FDA on an annual basis. By properly logging show information as described previously, you will have accumulated most of the information you will need for your annual report.
In most cases, annual reports are due before September 1st of each year for shows produced that calendar year. See your variance for the exact due dates for annual reports
Find the report and detailed instructions of how to properly fill out an annual report within the “FORM FDA 3636”. (In support Docs )
Also see the FDA’s Laser Notice #55 (In support Docs)

Download the Annual reporting guide and form.

FDA’s Laser Notice #55

Download a copy of Laser Notice #55 (In Support Docs)
Read to understand how this document affects your variance’s expiration date and it’s relationship to Annual Reporting.
Print a copy for safekeeping and additional copies to have on hand at each show.

Download Laser Notice #55

Download the Annual reporting guide and form.

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Documents Always Required to be On-Site During Laser Projector Operation.

The following documents must be with you at all times when you are operating your class 4 laser projector:

1. Your Laser Light Show Variance document from FDA CDRH
2. Initial Laser Show Report (originally created by Technological Artisians).
3. Your most recent Annual Show Report* (submission of your annual report auto renews your variance)
4. Copy of the confirmation letter (a.k.a. ‘accession letter) confirming FDA receipt of your laser annual report*
5. Laser Show Notification
6. Pre-show Safety Checklist
7. Operator’s Log

*Note: only required after the submission of your first annual report

Operators Log Sheet

Provide this form for each show location performed.
The laser operator shall perform the indicated tests prior to each show performance.
Fill in this form, one entry for each show performed, at the location performed.
Keep the original at show location, once the show run has ended, store for safekeeping.

Documents required for the production of each laser light show.

Laser Show Notification Form

- Once all relevant agencies have been determined, provide this form to each agency at least 24 hours prior to performance. (where required)

- Completely fill in each section as indicated in red. If additional space is required, provide and attachment.

- Be sure to sign, date and provide contact information.

Keep a copy at show location

Pre-Show Safety Checklist Form

Fill this form for each new show location/installation.

Utilize this document as a set up and test safety guide
Sign and Date
Keep the original at show location, produce a copy and store for safekeeping
This procedure and record keeping in legally required by the terms of your variance.
Keep records for at least 5 years.