Requirements and responsibilities of an FDA Laser Light Show Variance holder/show producer.

• An approved laser light show variance will contain a descriptive list of very specific procedural and documentation requirements you must follow.


• Some of the requirements you have already been practicing as you have studied how to safely set up and operate your projector.


• Carefully read through the following 14 ‘operating conditions’ which are typical for most US laser light show variances. Notes have been included to help your understanding:

1. ‘This variance is not transferable to any other firm or person and applies only to the specific products identified in Section D of the variance.’ 

   Your variance will be yours exclusively. Your responsibility as a variance holder is to manage all aspects of the use of the laser projector. As you will read later, a variance holder may only allow trained, qualified operators to operate the projector. Operators must be only the variance holder, or a legal employee of the variance holder.




2. ‘All laser products, systems, shows, and projectors shall be certified to comply with applicable requirements of 21 CFR 1040.10 and the conditions of this variance and be reported as required by 21 CFR 1002.10 and 1002.11 using the reporting guides provided for such purpose. These actions shall be accomplished prior to any introduction into commerce.’

   Proper reporting is your legal responsibility. The projector(s) you purchase from Technological Artisans are properly certified, varianced and reported to the US FDA CDRH to the 21CFR standards. However, the show(s) you produce will each need to be documented and reported. You will learn how to do this later as a part of this training.




3. ‘Effects not specifically indicated in this variance approval shall not be performed. Any additional effects require the submission of an amendment request (using Form 3147 or in accordance with 21 CFR 1010.4) and the filing of product reports or supplements as applicable.’

   Only specific laser effects permitted when using the Technological Artisans projectors. These effects are specifically defined in the approved variance letter you will receive. Approved effects include ‘front screen projection’, ‘rear screen projection’ and fully terminated ‘aerial beam effects’. All beams must terminate on a common screen surface or ceiling, etc. No highly reflective surfaces intended to direct the beam elsewhere (such as bounce mirrors) are permitted. The beams should only become visible via the scattering of atmospheric smoke, fog, or other similar scattering medium, or, the highly diffuse reflection of the screen surface.




4. ‘Laser projection systems and light shows manufactured, assembled, produced, or distributed under this variance shall not be transferred to any other party until the recipient has demonstrated that they have a variance, as required, in effect that permits them to produce certified laser light shows incorporating these laser projection systems. A notation of the recipient's variance number and its effective date, as applicable, shall be entered and retained in the records of compliance test results required by 21 CFR 1002.30.’

   Here you see that only variance holders are allowed to use your projector(s)*. If you allow another person whom is a variance holder to use your projector(s), you must gather their variance approval information and record along with your testing results documentation. Such testing results documentation will be discussed later.

   * A legal employee of yours whom has been properly trained may be an operator of the projector(s).




5. ‘Scanning, projection, or reflection of laser and collateral radiation (light show radiation) into audience or other accessible, uncontrolled areas shall not be permitted at any point except for diffuse reflections produced by the atmosphere, added atmospheric scattering media, and target screens.’

   As discussed previously, effects are very limited when using the Technological Artisans projectors. All beams must terminate on a common ‘screen’ surface. No highly reflective surfaces intended to direct the beam elsewhere are permitted. The beams should only become visible via the scattering of atmospheric smoke, fog, or other similar scattering medium, or, the highly diffuse reflection of the screen surface.

   Audience scanning is strictly prohibited! DO NOT intentionally or accidentally allow the beam to enter into the audience area where laser light can be reached by audience members. Always maintain minimum clearance distances as described later in this training. Direct eye exposure to the laser beam, even if scanning, can result in serious injury including instant permanent blindness!




6. ‘Access to radiation levels in excess of the limits of Class I by any person other than operators, performers, or employees shall not be permitted at any point less than 3.0 meters above any surface upon which such persons are permitted to stand or 2.5 meters below or in lateral separation from any place where such persons are permitted. Operators, performers, and employees shall not be required or allowed to view radiation above the limits of Class I or be exposed to radiation above the limits of Class II.’

   The Technological Artisans projectors are Class 4 (US 21CFR ‘Class IV’ equivalent). This mandates that all persons shall not be allowed, by means of protective barriers or other control mechanisms, within the above mentioned 3 meter vertical and 2.5 meter horizontal clearances. In practice, employees, operators and performers could access areas within the boundaries which are not within the beam path (areas that would not allow exposures to greater than Class I and Class II as described above) as necessary to conduct the show production.




7. ‘Any product which relies on scanning to meet access, exposure, or product class limits shall incorporate a scanning safeguard system which directly senses scanner motion and which will react fast enough to preclude exceeding the applicable limit.’ 

   The Technological Artisans projectors are Class 4 (21CFR ‘Class IV’ equivalent). They do not depend on scanning for their classification. Therefore, this requirement is not applicable to current Technological Artisans laser projector models.




8. ‘All laser light shows shall be under the direct and personal control of a trained, competent operator(s). The operator(s) shall:

   • Be an employee of the variance holder who shall be responsible for the training and conduct of the operator;’
     
     

     Persons whom run the projector(s) are considered ”operators”. You, as the variance holder will be considered a qualified operator. If you allow any other person to operate the projector(s), they must be legally employed by you, and qualified as a Class 4 laser operator. (They must have received both adequate laser safety training, and laser system operation training.)

   • Be located where all propagating beam paths, their terminations, and the audience can be directly observed at all times;’
     
     

     The qualified operator must be able to see and maintain sight of the projected laser beams (including laser graphics) at all times. The operator must be able to see all areas that audience members are able to travel and verify that the laser beams are adequately removed (distanced) from the audience at all times.

   • Be in communication with personnel assisting in surveillance of the laser display;’
     
     

     If additional persons are utilized to monitor the safe operation of the show, they must maintain instant reliable communication with the projector operator.

   • Immediately terminate (or designate the termination) of the emission of light show radiation in the event of any unsafe condition and, for open air shows, at the request of any air traffic control officials;
     
     

     The operator must have instant and easy access to the capability of turning off the laser beams. The Technological Artisans projectors are not to be used for “open air” shows. The lasers shall only be operated indoors (within an enclosed space/structure). Laser beams must not be permitted to exit indoor areas via windows, doors, skylights, etc.
     
     The Magnum Lighting projectors are not to be used for “open air” shows. The lasers shall only be operated indoors (within an enclosed space/structure). Laser beams must not be permitted to exit indoor areas via windows, doors, skylights, etc.

   • Ensure one or more readily accessible controls are provided to immediately terminate laser radiation.
     
     

     Operators can shut off Technological Artisans projectors by utilizing the users software interface. Alternately, the interconnection USB cable can be removed to immediately shut off the laser. Keep the user interface device within quick reach of the operator at all times.




9. ‘The maximum laser projector output power shall not exceed the level required to obtain the intended effects.’

   To minimize the potential hazards during a laser light display, reduce the output power of the projector to a minimum acceptable brightness level.

   Your projector’s power can be reduced within the (user interface software). See the user manual for specific instructions.




10. ‘The projection system (i.e., the projector and all other components used to produce the lighting effects) shall be securely mounted or immobilized to prevent unintended movement or misalignment. In addition:’

    Secure mounting of the projector(s) and the projection screen surface (where a separate screen is used) is essential to safe operation. Any unintended movement could allow a laser beam to enter a human occupied space. Additionally, be sure to securely gather and retain interconnection cables so that they will not become a trip hazard and inadvertently move the projector(s).

    • Electronic controls and circuits shall be adequately shielded to prevent electromagnetic sources (e.g., walkie-talkies, headset radios, wireless microphones, cellular telephones, etc.) in the vicinity of the projector, its active projection heads, and control system(s) from causing the laser emissions to be misdirected from their intended target area.’

      In rare cases, strong radio frequency (‘RF’) interference can cause laser scanners to act erratically potentially directing laser beams in unwanted directions. Your Technological Artisans projector has been designed to minimize the possibility of radio frequency interference. However, do not use the projector in close proximity to high power transmitters such as walkie talkies, ham radios, C.B. or FMRS radios, etc. Additionally, software or mobile device malfunction could also potentially cause scanners to direct laser light beyond the defined scan angle. Because of this potential always mount the laser projector with the base down, and adjust the front mounted beam block to prevent misdirected or ‘over-scanned’ laser beams from entering the audience accessible areas below 3 meters.

    • Beam masking to prevent projections into prohibited areas or directions or overfilling of screens, beam stops, targets, etc. shall be incorporated as an inherent part of the system design. Such devices may be adjustable if the system's intended use environment requires such capability.’

      Your Technological Artisans projector incorporates a built-in adjustable ‘beam block’. This sliding cover mounted to the laser projector aperture allows protection of the window when not in use, but also serves as a device to prevent ‘overscan’ into audience areas. Software use, or mobile device malfunction could potentially cause scanners to direct laser light beyond the desired scan angle (such as into an audience area). Because of this potential, always mount the laser projector with the base down, and adjust the front mounted beam block to prevent misdirected or ‘over-scanned’ laser beams from entering the audience accessible areas below 3 meters, or any other location which is accessible. Prior to show playback, carefully adjust this cover with the laser at very low power (1mW or below) by standing behind the projector. Do not place face in front of projector.




11. ‘In addition to the requirements of 21 CFR 1040.10(h), the manufacturer of laser projectors/systems shall provide to parties who purchase, lease, or borrow the equipment, adequate user's instructions for safe installation and operation. These instructions shall also explain the responsibility of the recipient as an independent light show manufacturer to submit the required reports and apply for and obtain a variance from the Center for Devices and Radiological Health (CDRH) prior to the introduction into commerce of any laser light shows.’

    Retain the original user manual for your Technological Artisans projector as it contains the above required information. Be ready to pass the manual off to other operators or owners.




12. ‘The requirements of 21 CFR 1002.30(a)(1) and (2) shall be accomplished through the use of written procedures for setup, alignment, testing, and performance of each show. These procedures shall be in sufficient detail to ensure compliance with 21 CFR 1040.10, the conditions of this variance, and any emergency shutdown requirements, and the control of access to radiation areas using the procedures described in the ANSI Z136.1:2007 Standard For The Safe Use of Lasers (available from The Laser Institute of America, 1242 Research Parkway, Suite 130, Orlando, Florida 32826) or any other equivalent user consensus standard and, where applicable, State or local requirements.’

    Documents for recording such testing as required above you will be able to view and download later in this training session.

    A. ‘Laser radiation areas which can contain radiation levels above Class I or II as applicable, shall be clearly identified by the posting of warning signs and/or restricting access through physical means (such as pressure switches, photocells, barriers, guards, etc.). These requirements apply to temporary areas (such as during setup and alignment procedures) and to final or permanent areas.’ 

    Appropriate signs warning of the Technological Artisans projector hazards can be found as a download later in this training session. Place warning signs at the entrances to show area, this includes stage entrances as well as audience entrances.

    B. ‘The variance holder shall retain the records of these procedures and the results of all tests as required by 21 CFR 1002.31. A copy of the variance application, the approval letter, Laser Notice 55, the most recent annual report, CDRH acknowledgment of receipt for the annual report, current procedures, and records relating to each particular show shall be with the operator or other responsible individual and shall be made available for inspection by FDA and other responsible authorities.’

    For each show location, you will need to have a file close at hand containing these required documents.

    • Variance application (a signed a copy which you will generate at the end of this training)
    • Approval letter (The FDA’s approval document of your variance, contains a variance number)
    • Laser Notice #55 (FDA issued guidance of renewal and amendment of LLS variances)
    • Most recent ‘annual show report’ (to be provided to the FDA prior to December 31st each year)
    • CDRH acknowledgment of receipt of annual report (a copy of that provided by the FDA, keep the original in a safekeeping file)
    • Show set-up procedures (shown on page 38)
    • Past show records (shown on pages 37, 37 and 40)



13. ‘The firm or person to whom this variance is issued shall maintain complete records of all show itineraries with dates, locations, operator name, and contact information clearly and completely identified. Records shall contain the specific equipment used, a basic description of proposed effects and a statement of the maximum power output used. These records shall be available to the FDA upon request.’

    Establish a secure place to store your above mentioned show documentation. You will need easy access to these records if/when the US FDA CDRH performs a laser show audit on-site. They may visit your offices, or your show, or both as part of an inspection.
    See page 37 (Laser Show notification)




14. ‘Advance written notification shall be made as early as possible to appropriate Federal, State, and local authorities providing show itinerary with dates and locations clearly and completely identified, and a basic description of proposed effects including a statement of the maximum power output intended. Such notifications shall be made, but not necessarily be limited, to:’

    A. ‘The Federal Aviation Administration (FAA) and the Department of Defense (DOD) for any projections into open airspace at any time (i.e., including setup, alignment, rehearsals, performances, etc.). If the FAA or DOD objects to any laser effects, the objections shall be resolved and any conditions requested by FAA and DOD will be adhered to. If these conditions cannot be met, the objectionable effects shall be deleted from the show.’

    The Technological Artisans projectors are not to be used for “open air” shows*. The lasers shall only be operated indoors (within an enclosed space/structure).
    For this reason, this requirement is not applicable.

    *If you should ever desire to operate a laser light show projector outdoors, you will need to obtain a variance by providing the FDA with a variance application requesting this option. You must do so independently of Magnum Lighting. This process usually requires several months.

    B. ‘State and local radiation control offices/agencies for all shows to be performed within their jurisdictions. All requirements of State and local law shall be satisfied and any objections raised by local authorities shall be resolved or the effects deleted.’

    Plan ahead when and where you intend on using your Technological Artisans projector. You will need to investigate the local governmental authorities (City, State) requirements for conditions of use of a Class 4 ‘laser display’ (laser light show) system, and then supply any required notifications to appropriate state or local government agencies. If you will be performing reoccurring shows at the same location, you will need to generate a show notification for the first show(s), but you do not need to generate recurring notifications. It is no longer necessary to file the ‘show notifications’ with the FDA prior to the show. FDA now allows you to retain the show notifications in your files, but they must still be generated prior to the show. See page 37. This relaxation does not apply to ‘variance applications’, or ‘annual reports’.