3640 Laser Light Show Product Report

Submission Report
Section: Main Menu
Welcome

Welcome to the CDRH Electronic
Submissions Software (CeSub)
This software application is intended to automate the current paper submission process.
This software contains a number of data capturing tools and helpful dialog boxes to
reduce redundant responses for you, and to allow us to capture data in a more useful,
structured format. These benefits will enable CDRH to improve our review process and
reduce lengthy review times.
For your convenience, an email account has been established to support any questions
that you may have regarding the use of this software. Please email any questions or
comments to the CeSub team at: [email protected]. Please be sure to include your
name, company name and contact information in the email.
Thank you again for using our electronic product reporting software. We look forward to
hearing from you soon.
What type of product is this submission referring to?

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Radiation Emitting Product (OMB No. 0910-0025; Expiration Date: December 31, 2006)

Welcome (Cont.)

Department of Health and Human Services
Food and Drug Administration

Form Approved:
OMB Number 0910-0025
Expiration Date: December 31, 2006
Section: eRadHealth Menu
Role
What is your role?

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Manufacturer

Submission Information
What Type of Submission is this? (Supplements should be submitted selecting the same document type as the original
report.)

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Radiation Safety Report (Product Report)
What Type of Product is this Annual Report about?

What Type of Correspondence is this?

What Type of Product is this Radiation Safety Report about?
Laser Light Shows
What Type of Product is this Variance Request about?

What Laser Light Show Documents are you filing?

Section: Manufacturer Data
Introduction

Electronic Product Radiation Safety
Reporting Form
This software application is intended to automate the hard copy product reporting forms
in the effort of the Center for Devices and Radiological Health (CDRH) to become
capable of accepting electronic submissions from industry and to improve our review
process. This CDRH Electronic Submission (CeSub) software is the next version of the
application the CDRH is developing to allow us to accept all Radiological Health reports
and other submissions electronically and improve the ability of CDRH to accomplish its
mandated product and industry evaluations in a timely and efficient manner.
We have already received many electronic submissions and are looking forward to
receiving more in the future. With this new release of the software we have updated our
procedures for packaging a submission to make this a smoother process for all. All
electronic reports (your new CD-ROMs) and any other documents you are submitting in
hard copy because they cannot be provided in an acceptable electronic format must be
mailed to CDRH. A signed hard copy of the submittal letter generated by the submission
software, should be printed out and included with your electronic submission. This
printed documentation will provide the Document Control Room with enough
information to log the submission. The electronic submissions should be sent directly to
the Document Control room, which is the same process for the standard paper

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submission.
The submission must be addressed to:
Electronic Product Document Control (HFZ-309), Attn: CeSub Team, Center for
Devices and Radiological Health, 2094 Gaither Road, Rockville, MD 20850
After sending your submission to the Document Control Room, please send an email to
the [email protected] email account so we will know that your submission is
forthcoming. Please remember that all correspondence concerning your submission
MUST be sent to the Electronic Product Document Control (HFZ-309), at the above
letterhead address. Correspondence sent to any address other than the one above will not
be considered as part of your official notification submission. Please refer to this
guidance for information on current fax and e-mail practices at
www.fda.gov/cdrh/ode/a02-01.html. You should also be familiar with the regulatory
requirements for radiological products at www.fda.gov/cdrh/comp/eprc.html and medical
devices available at Device Advice www.fda.gov/cdrh/devadvice/.
If you have specific questions regarding the software, please contact the CeSub team by
email at: [email protected].
Thank you for using our electronic product reporting software. Please communicate your
comments and criticisms to the CeSub team as often as you like.
Thank you for your continued support of the CDRH eSubmission Pilot Program.
General Information

General Information for Radiological
Health Products
Manufacturers of products subject to performance standards under the Federal Food,
Drug, and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product
Radiation Control are required to furnish various reports to the Center for Devices and
Radiological Health (CDRH).
The Radiological Health staff, CDRH developed this software application for the Product
and Annual reports. This application will assist manufacturers of electronic products that
emit radiation in providing adequate reporting of radiation safety testing and compliance
with federal performance standards. Title 21 of the Code of Federal Regulations (CFR),
Parts 1002 and 1003 specify Reporting and Notification requirements 1,2,3.
Reports submitted on radiation safety of electronic products must follow the appropriate

form (21 CFR 1002.7). This software application serves the same report responsibility, so
long as the submitter or manufacturer prints out the cover letter and sends it in along with
the CD containing the report files. The submitter of the report will receive an
acknowledgment letter (or email message) with the accession number that CDRH assigns
to the report. Please reference this accession number in the future when providing
additional information about this model family in either a supplement or the annual
report. If a report is incomplete or inadequate CDRH may reject it and return it for
completion. CDRH will not enter a rejected report into our database.
CDRH DOES NOT APPROVE THESE REPORTS OR THE PRODUCTS BEING
REPORTED. It is the manufacturer's responsibility to certify that their products comply
with all applicable standards (21 CFR 1010 - 1050), based on a testing program in
accordance with good manufacturing practices. Prior to the shipment of products in
interstate commerce, 21 CFR 1002 requires the manufacturer to submit the product and
Annual Reports and to comply with all applicable importation requirements (21CFR
1005). If there are deficiencies, CDRH may disapprove the firm's quality control and
testing program, determine that the product contains a radiation defect, or determine that
the product fails to comply with a standard. CDRH will notify the manufacturer if we
make such a determination. CDRH may require the manufacturer to cease introduction
into U.S. commerce until deficiencies are corrected, and to initiate a corrective action
program (21CFR 1003 - 1004) for products already introduced into commerce.
CDRH can now accept and process 'CeSub' electronic submissions at this time, if all
attachments are PDF files only, and the cover letter is printed out and included with a real
signature. Translate any text that appears in a language other than English into English in
a complete and accurate manner. Keep a copy (save a copy to your hard drive) of the
completed report in your records.
We are providing our new software applications for the old reporting forms upon request
during this beta testing period of development in Spring, 2005. Other regulatory
information is still available on the Internet under
http://www.fda.gov/cdrh/comp/eprc.html. No copyright exists for these forms.
Reproduce these forms as needed. If you would like to comment on the reporting forms,
website, or future electronic submissions, you may direct the comments to the address
below.
A complete Product Report is required for each product model or model family. Product
Reports are now more generally referred to as Radiation Safety Reports to distinguish the
Radiological Health submissions from medical device submissions. CDRH suggests that
a complete report on one model of a family be submitted, with a separate Supplemental
Report for each of the other models in the family. The Supplemental Report should
respond in detail to the parts of the form where there are differences to report, referencing
the number of the affected item. Items that are unchanged will still appear in the
supplement from the original report.

When new models of a product are introduced, if the models satisfy the criteria for an
established reporting exemption or if the new models do not involve changes in radiation
emission or performance requirements, then the manufacturer need not report the models
prior to introduction into commerce. Rather, the manufacturer is only required to identify
them in the annual report, or in quarterly updates to the annual report. Quarterly updates
to annual reports may be submitted using the Annual Report software included in this
application. [See 21 CFR 1002.13(c).]
All symbols, units, and unusual terms in the report must be adequately defined and
consistently used. Please use the terms as defined in Section 1040.10(b) and in the IEEE
Standard Dictionary of Electrical and Electronic Terms (IEEE Std. 1001972 and ANSI
C42.1001972).
Definitions

Definitions for Rad Health Products
Manufacturers
Manufacturer is any person or organization engaged in the business of manufacturing,
assembling, or importing of electronic products (21 CFR1000.3(n)). Manufacturers of
electronic products subject to 21CFR1000-1050 must:
•
•
•
•
•

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•
•

Design and manufacture their products to be in compliance with applicable
performance standards;
Test their products to assure compliance;
Certify compliance of their products;
Maintain test and distribution records and a file of correspondence concerning
radiation safety, safety complaints, and inquiries;
Use the published reporting forms or electronic software application to submit
reports to CDRH, including Product reports describing the manner of compliance
of the product design and testing program and Annual Reports summarizing their
compliance testing;
Report accidental radiation occurrences (i.e., possible, suspected,or known
exposures);
Report any radiation defects or noncompliances; and
Recall (i.e., repair, replace, or refund the purchase price of) defective or
noncompliant products.

Accidental Radiation Occurrences
An accidental radiation occurrence means a single event or series of events that has/have
resulted in injurious or potentially injurious exposure of any person to electronic product

radiation as a result of the manufacturing, testing, or use of an electronic product.

Importers
Importer is any person of organization engaged in the business of importing electronic
products. An importer is considered to be a manufacturer. The requirements for
Manufacturers given above also apply to importers if the requirements have not been
done by the foreign manufacturer.

United States Agent for Foreign Manufacturers
Every manufacturer of electronic products, prior to offering such product for importation
into the United States, shall designate a permanent resident of the United States as the
manufacturer`s agent upon whom service of all processes, notices, orders, decisions, and
requirements may be made for and on behalf of the manufacturer as provided in section
536(d) of the Radiation Control for Health and Safety Act of 1968 (21U.S.C. 360mm(d))
and this section. The agent maybe an individual, a firm, or a domestic corporation. For
purposes of this section, any number of manufacturers may designate the same agent.

From The Federal Food, Drug, and Cosmetic Act
Sec 536 [21 U.S.C. 360mm](d) Designation of agent for purposes of service
It shall be the duty of every manufacturer offering an electronic product for importation
into the United States to designate in writing an agent upon whom service of all
administrative and judicial processes, notices, orders, decisions, and requirements may be
made for and on behalf of said manufacturer, and to file such designation with the
Secretary, which designation may from time to time be changed by like writing, similarly
filed. Service of all administrative and judicial processes, notices, orders, decisions, and
requirements may be made upon said manufacturer by service upon such designated
agent at his office or usual place of residence with like effect as if made personally upon
said manufacturer, and in default of such designation of such agent, service of process,
notice, order, requirement, or decision in any proceeding before the Secretary or in any
judicial proceeding for enforcement of this part or any standards prescribed pursuant to
this part may be made by posting such process, notice, order, requirement, or decision in
the Office of the Secretary or in a place designated by him by regulation.
Sec. 531 [21 U.S.C. 360hh] (1) the term ''electronic product radiation''means:
(A) any ionizing or non-ionizing electromagnetic or particulate radiation, or
(B) any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic
product as the result of the operation of an electronic circuit in such product.

Sec. 531 [21 U.S.C. 360hh](2) the term ''electronic product''means:
(A) any manufactured or assembled product which, when in operation,(i) contains or
acts as part of an electronic circuit and (ii) emits (or in the absence of effective
shielding or other controls would emit) electronic product radiation, or
(B) any manufactured or assembled article which is intended for use as a component,
part, or accessory of a product described in clause (A) and which when in operation
emits (or in the absence of effective shielding or other controls would emit) such
radiation.
Burden to Industry

Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average 24 hours
per response, including the time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, completing, and reviewing the
collection of information. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden to:
Food and Drug Administration CDRH (HFZ-240)
1350 Piccard Drive Rockville, MD 20850

Please DO NOT RETURN this application to this address.
"An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number."
Manufacturer Responsible for Product Compliance
Note:

This is the firm that takes responsibility for certification that the product meets the performance standard. This
firm develops and maintains the quality control and testing program that is the basis for the certification of this
product. Additionally, this firm usually is the owner of the product design and manufacturing process design.

Copy from the establishment address book
Establishment Information:
Establishment Name
Division Name
Home Page
Physical Location:
Address
Telephone Number

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Fax Number
Mailing Location:
Address

Responsible Individual
Note:

The responsible individual is the highest level and most responsible individual affiliated with this
establishment.

Copy from contact address book

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Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

Manufacturer's Reporting Official
Note:

This is the person at the manufacturing facility that is knowledgeable and responsible for addressing all
aspects of the testing and quality control procedures for certification as reported to FDA in the product report.
Documentation of changes intesting and quality control procedures submitted to FDA must be signed by this
individual.

Copy from contact address book
Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

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Electronic Signature
Electronic signature (not available in this release of the software)

File Attachment

Report Submitter
Note:

The submittermaybe a consulting individual or firm providing assistance in report preparation and
maintenance. All documents prepared by the submitter must have the manufacturer's reporting official
signature for authenticity of submitted documentation.

Copy from contact address list

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Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

Parent Establishment
Is there a parent establishment?
Copy from contact address book
Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:

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Address

Manufacturer Designated United States Agent
Note:

Manufacturers exporting to the U.S. must designate a U.S. agent, see 21 CFR 1005.25.

Is there a United States agent that has been designated by the manufacturer?

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Section: Product Data
Product Type Reported
What product type is being reported? *Please note that this list of 66 product types are grouped according to their radiation
type and applicable regulations (e.g., laser products, microwave products, ionizing products, etc.)

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What is the product code?

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If you know the three letter code, enter it in the space provided.
If you do not,
- Click the filter search icon (next to the trash can). You will see a product code filter dialog box.
-Enter a keyword to search the database. You will be provided a list of product codes from which to choose.
(If you are not finding the correct product, try other words and/or variations of the keywords.)
- Select the best match to your product.
- The remaining fields will be filled in for you when you select your product code.
- If you do not find the code that you are looking for, use RZZ (Other)
Product Code
Device Class
Classification Panel
C.F.R. Section
If Other, please identify the specific product type.

Report Information
Is this the first time you've submitted a report on the particular type of product selected in the
Product Type Reported section?

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Since this is not the first time you've reported on this type of product, then is this a report supplement to
a previously reported model family?
Provide the Accession Number of the report for which this is a supplement (Do not enter any Device
Premarket Application or Notification document number here, such as PMAs, 510(k)s, IDEs, etc.):
Are you requesting a new variance, a renewal, extension or amendment to a previous variance?

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If you are requesting a renewal, extension, or amendment, please provide the variance number that
was issued by CDRH.
Error:

If you are requesting a new variance, renewal, extension, or amendment, you must file a Variance Request
separate from this report. To do this, open a new report (File > New) and select either "Laser Light Show
Variance Request" or "Variance Request, Other" as your Type of Submission in the Submission Information
Screen. If you select "Variance Request, Other" you must select the product for which you are requesting a
variance at the end of the screen.

Noncompliances or Defects
Does this document or any of its attachments contain:
A self-declaration or notification of noncompliance or defect?

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Provide an explanation:

Responses to Noncompliances or Defects
Does this documentor any of its attachments contain:
A refutation of noncompliances?

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A request for an exemption from notification and corrective action?

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Information on corrective actions you may be conducting?

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A description of any design changes for future production?

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Provide an explanation:

Exemption Requests
Does this document or any of its attachments contain:
Exemption of a product for government use from a standard (1010.5)?

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Exemption for products for government use from reporting and recordkeeping (1002.51)?

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Special exemption of products from reporting and/or recordkeeping (1002.50)?

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Request for approval of alternate labeling?

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Application for alternate test procedures (1010.13)?

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Provide an explanation:

Attach any necessary files.

File Attachment

Variance Requests
Message:

Click the "Add" button to select the desired requirement from which you are seeking a variance.

This submission includes an application for a variance from certain requirements.
Item
Provide an explanation and attach supporting files, if necessary. Click on the Add... button below to attach files.
Details

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File Attachment
Error:

In addition to the electronic copy of this submission, please be sure to submit one hard-copy of the signed
variance request document to the following address:
Division of Dockets Management (HFA-305)
Food and Drug Administration
Rm 1061, 5630 Fishers Lane
Rockville, MD 20852

Responses to Communications from FDA
Does this document or any of its attachments contain:
A response to an inspection?

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What was the date of the inspection?
A response to a warning letter from the Food and Drug Administration (FDA)?

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What was the date of the Warning Letter?
A response to a report review inquiry from the Center for Devices and Radiological Health (CDRH) (the
inquiry may have been in the form of a letter, email, or phone call)?

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What was the date of the inquiry?
A response to any other communication from FDA?
What was the date of the communication?
Provide an explanation:

Use Environment
Who are the intended users?
[
[
[
[
[
[
[
[
[

] Children and/or Youth
] Consumers
] Elderly
] Employees/Workers
] Engineers or Scientists
] General Public
] Medical Staff
] Patients
] Other

What is the use environment?
[
[
[
[
[
[
[
[
[
[

] Consumer Home
] Hospital or Clinic
] Industrial Facility or Factory
] Office/Warehouse/Store
] Outdoors
] Public Arena
] Schools, Gymnasium/Auditorium
] Lab or Research Facility
] Transportation Facility
] Other

Please select the best match for the affected population:
[
[
[
[
[

] Children and/or Youth
] Consumers
] Elderly
] Employees/Workers
] Engineers or Scientists

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[
[
[
[

] General Public
] Medical Staff
] Patients
] Other

Additional Information
Is there any other relevant information or additional comments that would help expedite the review of this submission? Click the
Add... button below to attach any supporting files.
File Attachment
Details

Private Labeling
Is the product sold by other companies under different brand names?

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Medical Devices
Provide the premarket 510(k), IDE, HDE, PDP, or PMA filing numbers related to this medical product, if one of these numbers has
been assigned by FDA yet.

If it has not been assigned yet, provide an explanation and submit it as soon as you receive such a filing number.

Electromagnetic Compatibility and Interference

Electromagnetic Compatibility with other Products
Provide description of analysis and indicate any shielding you have for your product to protect other products from EMI:

Susceptibility to EMI from other Products
Provide description of analysis and indicate any protective shielding your product has to protect it from EMI:

Section: Report Identification
1.0 General Definitions

General Definitions
This software application should be followed for all lasers and products containing,

incorporating, or intended to incorporate, a laser or laser system [see the definition of
"laser product" in section 21 CFR1040.10(b)(21)].

Laser Reporting and Recordkeeping (21 CFR 1002)
Applicability of reporting and recordkeeping requirements for laser products:
Class I, IIa, II, and IIIa laser products and laser products containing such lasers will
require: Product Report, Annual Report, test records, manufacturer's distribution
records, and dealer/distributor distribution records.
Note that for Class I laser products containing lasers of Class I, IIa, II, or IIIa no
Supplemental Reports are required.Furthermore, some Class I laser products have
already been exempted from the requirement for distribution records (see Notice to
Industry dated August 9, 1988, Laser Notice # 41).
Class IIIb and IV laser products require all of the above plus Supplemental Reports
when the criteria requiring submission of Supplemental Reports are met.
The laser standard applies to all laser products manufactured after August 1, 1976
(1040.10(a)), unless the products are either: sold to a manufacturer for use as components
(or replacements) in products that will be certified (1040.10(a)(l)); sold by or for a
manufacturer as repair or replacement components if they are properly labeled as such
and have installation instructions (1040.10)(a)(2)); or intended for export only, are
labeled as such, and comply with the requirements of the importing country (1010.20).
Manufacturers of laser products that are sold to other manufacturers for use as
components in their products are required to register and list such products.

Laser Definitions from 21 CFR 1040.10(b)
Laser means any product that can be made to produce or amplify electromagnetic
radiation at wavelengths greater than 250 nm but less than or equal to 13,000 nm or, after
August 20, 1986, at wavelengths equal to or greater than 180 nm but less than or equal to
1.0X106 nmprimarily by the process of controlled stimulated emission.
Laser energy source means any product intended for use inconjunction with a laser to
supply energy for the operation of the laser. General energy sources such as electrical
supply mains or batteries shall not be considered to constitute laser energy sources.
Laser product means any manufactured product or assemblage of components which
constitutes, incorporates, or is intended to incorporate a laser or laser system. A laser
product is any device that constitutes, incorporates, or is intended to incorporate a laser or
laser system (1040.10(b)(21)). A laser or laser system that is intended for use as a
component of an electronic product shall itself be considered a laser product.
Laser radiation means all electromagnetic radiation emitted by a laser product within

the spectral range specified in paragraph1040.10(b)(19) that is produced as a result of
controlled stimulated emission or that is detectable with radiation so produced through
the appropriate aperture stop and within the appropriate solid angle of acceptance, as
specified in 1040.10(e).
Laser system means a laser in combination with an appropriate laser energy source with
or without additional incorporated components. See paragraph 1040.10(c)(2) of the laser
product performance standard for an explanation of the term "removable laser system."
2.0 Specific-Purpose Product Definitions

Specific-Purpose Product Definitions
Demonstration laser product means any laser product manufactured, designed,
intended, or promoted for purposes of demonstration, entertainment, advertising display,
or artistic composition. The term "demonstration laser product" does not apply to laser
products which are not manufactured, designed, intended, or promoted for such purposes,
even though they may be used for those purposes or are intended to demonstrate other
applications. Demonstration laser products(1040.10(b)(13)) include:
laser products promoted for classroom demonstration of optical phenomena;
artistic displays and their associated apparatus;
laser light show projectors; and
laser light shows and displays themselves.
A general-purpose, scientific, medical or industrial laser product is not considered to be a
demonstration laser product when it is demonstrated to a prospective purchaser.
Demonstration laser products are restricted in their outputs to Class IIIa with its
accompanying restrictions to Class I for short pulses and
invisiblewavelengths(1040.11(c)). Because these levels are too low for effective use
incommercial theatrical lighting effects, CDRH may grant variances (1010.4) to
manufacturers of laser light shows and display devices. As a condition of the variance,
the manufacturer must agree to adhere to several safety conditions to provide a level of
safety to the publice quivalent to a fully compliant product. Consult the Compliance
Guide for Laser Products, September 1985, Appendix B, Clarification of Certain Laser
Light Show Requirements, for more information.
3.0 Show Name
3.1 What is (are) the name(s) of the light show or display?

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Item

4.0 Variance
Attach a copy of your variance application (FDA Form 3147) and/or, if approved, attach your variance approval letter (or
variance number). Click on the Add... button below to attach any supporting files.

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File Attachment

»

Is variance application attached?

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»

Is a copy of your variance approval letter attached?

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»

Or provide current variance number:

Section: Equipment Information
6.0 Show Venue
The laser light show or display takes place in:

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Item

»

If "other" has been selected, please specify:

Note:

Be sure to provide beam path diagrams/floor plans for each of the types of venues listed above, unless certain
drawings are general enough to cover more than one type. Drawings shall be attached following Part 9.0
Diagrams and Drawings of Show Venue.

The laser light show or display takes place:

*

Item

»

If "other" has been selected, please specify:

7.0 Show Locations, Dates, and Times
Note:

Give specific location(s), date(s), and time(s) for the show if this information is known at the time this report is
submitted. If not, advanced written notification must be made as early as possible to appropriate Federal,
State, and local authorities. To be considered timely, this written notice must be submitted 30 days prior to the
opening of the show. When the show dates become known to the manufacturer less than 30 days prior to the
show date, the required information must be provided verbally by phone or by FAX to CDRH. A confirming
formal written notice, including the date of the phone notification and the name of the CDRH individual to
whom the information was given must be submitted within 14 days. Written confirmation would not be needed
following a FAXed notification. CDRH must be notified of every show that your firm intends to produce. If
notifications are not routinely received in a timely manner your variance may be revoked.

Click on the Add... button below to attach any supporting files.
File Attachment
Details

8.0 Light Show Effects Produced

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The laser light show uses the following laser effects:

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Item
If "other" has been selected, please specify:

Note:

Be sure that the beam path diagrams included in your response to Part 9.0 are sufficient to illustrate all of the
effects indicated above. Several effects may be included in a single diagram.

9.0 Diagrams and Drawings of Show Venue
9.1 Provide both plan and elevation drawings with dimensions of the show or display. If the setup varies from show to
show, then provide this information for a typical show. * If no drawings are attached, please add an explanation in the
text box. Click on the Add... button below to attach any supporting files.

*

File Attachment

Are drawings attached?

10.0 Laser Radiation Levels
10.1

Describe how each of the laser radiation levels, indicated on the drawings attached in 9.0, were determined. If
any levels were derived from calculations rather than directly measured, provide the actual calculations that were
made. Click on the Add... button below to attach any supporting files.

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File Attachment

11.0 Scanning Safeguards
11.1

Will there be audience scanning* from any of the planned effects?

Note:

*

* Audience scanning is considered to be any scanning, projection, or reflection of laser or collateral radiation
into audience or other accessible, uncontrolled area. Scattered radiation coming from diffuse reflectors such
as fog, smoke, mist or similar diffusing media is not considered audience scanning. However, all radiation
must be below Class I levels if it reaches into audience or other uncontrolled areas. A scanning safeguard is
required whenever a laser light show includes audience scanning to assure that the laser radiation levels in
audience areas will not exceed Class I limits if there is a scan failure. See the companion publication,
"Compliance Guide for Laser Products," for further discussion.

11.2

Do any of the planned effects require laser radiation (direct or scanned beams) to be viewed by operators,
performers, or employees?

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If the answer to 11.1 or 11.2 is yes, describe how the radiation levels that reach into audience areas are maintained at
Class I levels by scanning. Your attached description must include details of the required scan failure safeguard,
including a discussion of the means of detection of the scanning, the theory of the operation of the scanning safeguard,
and its speed of response in order to show that it will prevent the scanned radiation from exceeding the Class I limits.
File Attachment

11.3

Will any laser radiation greater than Class I STRIKE BUT NOT BE VIEWED by operators, performers or
other employees?

»

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Describe, in detail, the operation of the scan failure safeguard or other means which will prevent exposure to beams
exceeding Class II. If a scan safeguard is used, include a discussion of the detection of scanning, the operation, and
the speed of response of the safeguard to show that it will prevent the scanned radiation from exceeding the limits of
Class II. If other means are used, such as pressure pads or infared beams, describe in detail as well.

File Attachment

12.0 Operator Controls
12.1

Is the show under the continuous control of an operator?

12.2

Does the laser operator perform tasks in addition to operation of the laser projector?

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12.3

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Describe those tasks:

Can the operator see all of the propagating beam paths, their terminations and the audience at all times during
the performance?

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12.4

Explain how adequate surveillance is provided:

Do any other personnel assist in providing surveillance of the laser display?

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State the number of persons, their identification (job titles), their duties, and how they assist in providing surveillance.
Describe how they are in constant communication with the operator.
File Attachment

What qualifications* are required of laser operators for your show?

Note:

* Holders of variances are required by the variance to employ trained operators or to assure that the operators
receive adequate training to qualify them for the safe use of the laser projection system and presentation of
the light show effects. Useful information including training films, reference books, and programs on the safe
use of lasers may be obtained from the Laser Institute of America (LIA) and from the American National
Standards Institute (request ANSI standard Z136.1).

12.6

If your show is not under the continuous control of an operator, is a person
designated to be responsible for the immediate termination of the laser radiation in
the event of equipment malfunction, audience unruliness, or other unsafe conditions?

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Explain alternate control:

12.7

How is this person designated? What are his or her duties?

12.8

What qualifications are required for this person?

13.0 Projection Equipment Controls
13.1

Are one or more readily accessible controls provided to immediately terminate laser radiation?

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13.2

Number of controls:

Describe the location of these controls and their operation relative to your show.

Section: Test and Notification Procedures
14.0 Test Procedures
14.1

Attach a copy of the written setup, alignment, and test procedures to be followed prior to the operation of the laser
light show at each location. If setup procedures are not a seperate form, provide a detailed description below of
procedures that are followed. Click on the Add... button below to attach any supporting files.

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File Attachment

14.2

When are these setup, alignment, and test procedures performed?

14.3

What laser radiation levels are used during setup, alignment, and checkout? (in milliwatts)

14.4

Is a written record of the results of the setup, alignment, and test procedures maintained?

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Explain how adequate quality assurance is maintained:

»

You may attach records such as Standard Operating Procedures (SOPs), Quality Safety Checklists, and Daily Logs.

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File Attachment
Details
Note:

Adequate recordkeeping would include, but not limited to: (1) sketches showing the location of the laser
projector(s), operator(s), performer(s), audience, beam paths, viewing screens, wall mirrors, mirror balls, and
other surfaces that may be struck by the laser beams; (2) information on scanning patterns, velocity, and
frequency; and/or (3) laser radiation levels used in each effect.

15.0 Notification Procedures
15.1

What procedures are followed for notification of appropriate Federal (CDRH, FAA), State and local agencies?
Either attach a file, form letters, or describe procedures in the text box below. Click on the Add... button to attach
any supporting files.
File Attachment

What Federal, State and local agencies are notified or would be notified?
Item
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Form FDA 3640 Reporting Guide for Laser Light Shows and Displays (03/06)

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