<TITLE>Submission Report</TITLE>

Submission Report

eRadHealth Menu

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 FDA Electronic Submission (eSub) software is the next version of the application developed 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.

All electronic reports and correspondence can either be transferred to CD and mailed to the address below, or can be sent via the FDA Electronic Submissions Gateway to CDRH.  If you follow instructions to set up an account with the FDA Gateway, it currently may take several weeks,, but when you submit through it you will receive your acknowledgement email message with Accession Number within minutes!   Or, in the interest of faster turn-around for a one-time urgent report of if you submit few reports, you may simply fill out this template creating the submission and then at 'Packaging' follow the instructions to transfer the files to a CD to mail in. This method of submitting your report will be acknowledged by an email with the Accession Number within several days.

Information about the FDA Electronic Submissions Gateway can be found at www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm.  Please contact the Gateway Helpdesk with your questions about that system.

Electronic submissions on CD should be mailed directly to the Document Control Center at:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Attn: eSubmitter Team
Document Mail Center - WO66-0609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

Submissions received in the mail on CD will be processed within a few days of receipt.

Note about eSubmitter software:

Instructions provided in this software briefly summarize the requirements of the regulations under the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control, that applies to manufacturers of electronic products that emit radiation. The software provides questions relevant to requirements in the performance standards and may include explanations or clarification about the performance, labeling, and informational requirements of the standard. It does not replace the regulations, however, and if there is any conflict between the software and the regulations, the regulations must prevail. Throughout this application, pertinent sections of Title 21, Code of Federal Regulations, Chapter I, Subchapter J, are cited in parentheses. Please consult them before making design or procedural decisions.

 Regulatory requirements for radiological products can be found at http://www.fda.gov/Radiation-EmittingProducts/default.htm and for medical devices are located at www.fda.gov/M/devaDvices/default.htm.  If you have specific questions about the regulations, please contact us at: <a href="mailto:DSMICA<EMAIL_ADDRESS>

If you have specific questions regarding this software, please contact the eSub team by email at: <a href="mailto:eSubmitter<EMAIL_ADDRESS>you for using our electronic product reporting software. Please communicate your comments and suggestions to the eSub team as often as you like.

Thank you for your continued support of the FDA Electronic Submission Program (eSub).

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. The OMB control number for this information collection is 0910-0025 (expires January 31, 2017).

Role

What is your role?

!*

Manufacturer

Information:

The following screen provides several options for you to accurately define what type of eSubmission you intend to create for FDA.  Below are explanations of your options.  Please feel free to review this screen, advance to the next screen and view the picklists, but if you're confused, come back to read this screen again to be certain you are selecting the correct report or correspondence type you want to create.

Submission Information

Step 1

Use the radio buttons to identify the type of submission you are preparing. (Supplements should be prepared using the same document type as the original submission.)

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

!*

( )  Radiation Safety Report (Product) Report (21 CFR 1002.10)
( )  Annual Report (21 CFR 1002.13)
( )  Laser Light Show Documents (all relevant documents) (21 CFR 1040.11(c))
( )  Correspondence
(•)  Variance Request (General, not Laser Light Show) (21 CFR 1010.4)
( )  Laser Original Equipment/Component Manufacturer Registration (21 CFR 1040.10(a)(3)(ii))
( )  Abbreviated Report (21 CFR 1002.12)

Step 2

After answering the Submission Type question above, one of the questions below may become active and required (see the blue dot to the right of the question).  If there is an active question, select the appropriate product area or document type from the question's pick list.

What Type of Product is this Radiation Safety Report about?

What Type of Product is this Annual Report about?

What Laser Light Show Document are you filing?

What Type of Correspondence is this?

What Type of Product is this Variance Request about?

!*

Laser Products (Includes Projection Systems)

Manufacturer Data

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.

Be sure to enter address information for each tab below:

Select the Manufacturer's address from the Establishment Address book:

*

Establishment Information:

Establishment Name

Mettler-Toledo AutoChem

Division Name

Home Page

Physical Location:

Address

7075 Samuel Morse Drive
Suite 100
Columbia, MD, 21046, US

Telephone Number

(410) 910-8100

Fax Number

Mailing Location:

Address

7075 Samuel Morse Drive
Suite 100
Columbia, MD, 21046, US

Telephone Number

(410) 910-8100

Fax Number

Responsible Individual

Note:

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

Select the Responsible Individual from the Contact Address book:

*

Contact Information:

Contact Name

Brenda Desormeaux

Occupation Title

Quality Manager

Email Address

<font face="arial,helvetica,georgia,verdana"<EMAIL_ADDRESS>

Establishment Information:

Establishment Name

Mettler-Toledo AutoChem

Division Name

Physical Location:

Address

7075 Samuel Morse Drive
Suite 100
Columbia, MD, 21046, US

Telephone Number

(410) 910-8100

Fax Number

Mailing Location:

Address

7075 Samuel Morse Drive
Suite 100
Columbia, MD, 21046, US

Telephone Number

(410) 910-8100

Fax Number

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.

Select the Reporting Official from Contact Address book:

*

Contact Information:

Contact Name

Brenda Desormeaux

Occupation Title

Email Address

<font face="arial,helvetica,georgia,verdana"<EMAIL_ADDRESS>

Establishment Information:

Establishment Name

Mettler-Toledo AutoChem

Division Name

Physical Location:

Address

7075 Samuel Morse Drive
Suite 100
Columbia, MD, 21046, US

Telephone Number

(410) 910-8100

Fax Number

Mailing Location:

Address

7075 Samuel Morse Drive
Suite 100
Columbia, MD, 21046, US

Telephone Number

(410) 910-8100

Fax Number

Report Submitter

Note:

The submitter may be a consulting individual or firm providing assistance in report preparation and maintenance.  Documents or submissions such as this one that are prepared by the submitter must have an accompanying authorization letter from the manufacturer's reporting official for authenticity.

Select the Submitter from the Contact Address book:

*

Contact Information:

Contact Name

Brenda Desormeaux

Occupation Title

Quality Manager

Email Address

<font face="arial,helvetica,georgia,verdana"<EMAIL_ADDRESS>

Establishment Information:

Establishment Name

Mettler-Toledo AutoChem

Division Name

Physical Location:

Address

7075 Samuel Morse Drive
Suite 100
Columbia, MD, 21046, US

Telephone Number

(410) 910-8100

Fax Number

Mailing Location:

Address

7075 Samuel Morse Drive
Suite 100
Columbia, MD, 21046, US

Telephone Number

(410) 910-8100

Fax Number

Comments:

Internal Reference Number:

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?

*

Not Applicable

Importer

Product Data

Product and Model Identification

Attention - Information about this section

In this section you'll be asked to identify several required or optional things which will help FDA/CDRH staff to prioritize their reviews.  You'll be asked to consider the following aspects:

(1) Identify your product's radiation type and the CDRH Product Code.

(2) Enter an Accession number if this will be a report supplment.  If you are preparing a supplement, you'll see that after entering a valid 7-digit  Accession number many questions will no longer be required (they will either be disabled or will be optional, meaning they will no longer have the blue dot).

(3) You will also have several questions that are of high significance for FDA/CDRH - why you might be submitting this report or correspondence.  Please read these questions carefully, referring to the 21 CFR regulations on the website www.FDA.gov if you are unsure if the question is relevant to your firm's situation.

(4) If you find that you have more information that you want the FDA/CDRH to read but it doesn't seem to fit under other questions, we have a final "Additional Information" question in this section which invites you to add comments and/or attach a file that provides further information from your firm about this submission.  This is the place to add that extra information.

Product Type Reported

What is the product code?

To select the three letter product code,

- Click the plus sign. You will see a product code filter dialog box.
- Select the appropriate category name from the pick list. You will be provided a list of product codes from which to choose.
- Select the best match to your product.
- The remaining fields will be filled in for you when you select your product code.

*

Category

RESEARCH, SCIENTIFIC, LABORATORY LASER PRODUCTS (44)

Product Code

PARTICLE-SIZE MEASURING INSTRUMENT (REN)

Performance Standard

LASER PRODUCTS. (1040.10)

If Other, provide a category name for this specific product.

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?

*

No

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?

*

No

Provide the Accession Number of the original report for which this is a supplement:
(Note: Do not enter any Device Premarket Application or Notification document number here, such as PMAs, 510(k)s, IDEs, etc.  See Accession number description below.)

Are you requesting a new variance, a renewal, extension or amendment to a previous variance?

*

New Variance

If you have a Docket Number that was issued by FDA's Division of Dockets Management, please provide it here.

Special Considerations

Noncompliances or Defects

Does this document or any of its attachments contain:

A notification of noncompliance or defect?

*

No

You may provide an explanation and/or attach a document here:

Details

Responses to Noncompliances or Defects

Does this document or any of its attachments contain any of these responses concerning noncompliances or defects?

A refutation of noncompliances or defects identified to your firm?

*

No

A request for an exemption from notification to purchasers (see 21 CFR 1003.21 and 1003.30)?

*

No

Corrective action plans you intend to implement to correct noncompliances or defects discovered in past or current production?

*

No

Note:

If you are submitting a Corrective Action Plan (CAP) following 21 CFR 1004 and information on design changes for future production, the design change information must be submitted in a Radiation Safety (Product) Report or supplemental report.  Both the proposed CAP and the design changes may be submitted in one document if you prepare a product report and choose to include the CAP in it as a file attachment.  Alternatively, you may create a separate eSubmission for the CAP using the "Correspondence" type template and selecting "Follow-up correspondence to FDA."

A description of any design changes that correct noncompliances for future production?

*

No

Note:

If you are submitting information on product design changes for future production due to a discovery of noncompliances or defects in current production,  you must  use the Radiation Safety (Product) Report template to create the report . Correspondence templates may be used to submit other information such as a proposed corrective action plan pertaining to a noncompliance or defect.

You may add an explanation and/or attach a document here:

Details

Exemption Requests

Does this document or any of its attachments contain:

Exemption of a product for government use from a standard (21 CFR 1010.5)?

*

No

Exemption for products for government use from reporting and recordkeeping (21 CFR 1002.51)?

*

No

Special exemption of products from reporting and/or recordkeeping (21 CFR 1002.50)?

*

No

Request for approval of alternate labeling?

*

Yes

Application for alternate test procedures (21 CFR 1010.13)?

*

No

You may provide an explanation and/or attach any relevant documents here:

*

Area for labeling on the product is too small for certification labeling. Certification label is located in the Safety Manual.

File Attachment

ParticleView V19 Safety Manual

Variance Requests

Information:

Please note: in addition to responding to these questions below, a separate General Variance Request or Laser Light Show Variance Request form must be completed and submitted to CDRH, with a hard copy sent to FDA's Division of Dockets Management as instructed below for any variance request.  The  information requested on this screen does not constitute the full structured content of the variance request.  The 2 types of Variance forms can be created in eSubmitter by  selecting the appropriate Variance submission type under the eRad Health Menu section of this application.

Message:

Click the plus sign to list the requirements from which you are requesting a variance.

This submission includes an application for a variance from certain requirements.

*

Item 1

[1010.2] Certification Label

Provide an explanation and attach supporting files, if necessary.  Click on the plus sign below to attach files.

Details

      Area on the product for applying the certification label is too small.
      Device is Class 1. Requesting variance to put the certification label in
      the Safety Manual. See attached manual.

File Attachment

ParticleView V19 Safety Manual

Stop:

For all Variance requests, two submissions must be made to the FDA.

The electronic version should be submitted following the Packaging Files for Submission instructions located under Output in the Menu bar, and explained in subsection 4.3 of the User Manual.  If sending a CD & submittal letter, please mail to:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Attn: eSubmitter Team
Document Mail Center - WO66-0609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

Additionally, a paper version (hard-copy) of the signed Variance request document should be submitted to:

Food and Drug Administration
Division of Dockets Management (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20857

Responses to Communications from FDA

Does this document or any of its attachments contain:

A response to an FDA inspection?

*

No

What was the date of the inspection?

A response to a Warning letter or a Notification of Noncompliance or Defect from the FDA?

*

No

What was the date of the Warning Letter or other notification letter?

A response to a report review inquiry from the CDRH (the inquiry may have been in the form of a letter, email, or phone call)?

*

No

What was the date of the inquiry?

A response to any other communication from FDA?

*

No

What was the date of the communication?

Provide an explanation:

Additional Information

Here's your opportunity to add anything else to this submission that you want to tell the FDA!

Is there any other relevant information or additional comments that would help expedite the review of this submission?  Click the plus sign below to attach any supporting files.

Details

Private Labeling

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

*

No

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.

not applicable

If it has not been submitted yet, or if your device is exempt from premarket clearance or approval, please provide an explanation.  The device regulations can be found in 21 CFR 807 - device manufacturer registration and device listing.

not a medical product

Laser Product

PART 1: 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)]. A separate form for reporting additional information concerning laser light shows is being published concurrently with this form and must be used in conjunction with this form when appropriate (Reporting Guide for Laser Light Shows and Displays).

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 1.0 x 10 to the power of 6 nm primarily by the process of controlled stimulated emission.

Laser energy source means any product intended for use in conjunction 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 or laser system that is intended for use as a component of an electronic product shall itself be considered a laser product  (1040.10(b)(21)).

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."

Specific-Purpose Products

Medical laser product means any laser product which is a medical device as defined in 21 U.S.C. 321(h) and is manufactured, designed, intended or promoted for in vivo laser irradiation of any part of the human body for the purpose of: (i) Diagnosis, surgery, or therapy; or (ii) relative positioning of the human body. Class IIIa, IIIb, and IV medical laser products must contain a means for measuring the delivered exposure or treatment level of radiation, accurate within plus or minus 20 percent. This requirement is not applicable to Class IIIa aiming devices except ophthalmic application.The instruction manual must include a procedure and schedule for recalibration of the measurement system. A modified aperture label is also specified (1040.11(a)).

Surveying, leveling, or alignment laser product means a laser product manufactured, designed, intended or promoted for one or more of the following uses:

(i) Determining and delineating the form, extent, or position of a point, body, or area by taking angular measurement.

(ii) Positioning or adjusting parts in proper relation to one another.

(iii) Defining a plane, level, elevation, or straight line.

Surveying, leveling, and alignment laser products are generally used in agriculture and in the construction industry. They are restricted to 5mW visible radiant power and to Class I for other wavelengths and pulses less than 3.8 x 10 to the power of negative 4 seconds (1040.11(b)).

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 invisible wavelengths(1040.11(c)). Because these levels are too low for effective use in commercial 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 public equivalent 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.

PART 2: PRODUCT AND MODEL IDENTIFICATION

!  Attention  !

In the following sections of the report template you will see references to "Laser Notice #NN" and the "Compliance Guide for Laser Products.'"  You can find these documents and other information relating to laser products on the page Laser Products and Instruments.

On the Laser Products page you can click on the button link at the top, right side of the page Notices to the Laser Industry and you will be taken to the page which lists links to the Laser Notices and the Compliance Guide for Laser Products sorted in date order.

The Compliance Guide itself may be found at this link: Compliance Guide for Laser Products (FDA 86-8260)

2.1 Model Designation

Note:

Report the model name and/or number, model family, brand name, or other designation of the product.  If reporting a model family, provide the model designation of each model.  If you do not use a model family or brand name, leave the field blank.

Model Designation (Names and/or Numbers):

*

Item

Model Name

Family Name

Brand Name

Item 1

ParticleView V19

2.2 Approval of Alternate Means

Does this document or any of its attachments contain:

An application for approval of alternate means of providing the equivalent or superior protection that a required performance feature or labeling would provide (this is applicable to the beam attenuator requirements and alternate labeling)?

*

Yes

What requirement are you requesting an approval of alternate means from?

*

Certification label

Provide an explanation:

*

Area for labeling is too small on the product. Label will be part of the Safety Manual for the product.

2.3 Product without a Laser

Is it a product that does not incorporate a laser but is intended to incorporate a laser?

*

No

If the product as introduced into commerce does not incorporate a laser, identify the manufacturer and models of the laser that you recommend:

Item

Is it a product that is intended to be used with a laser?

*

No

If the product as introduced into commerce is intended to be used with a laser, identify the manufacturer and models of the laser that you recommend:

Item

If your product does not incorporate a laser or you do not recommend a specific laser for use with the reported product, state the specifications of the laser or laser system which may beincorporated in or used with your product.  This would include wavelengths, power or energy levels, etc.

2.4 Modification of a Laser Product

Note:

Modification involves any changes to the product that affect its classification, performance or labeling requirements (as required by the standard or an approved variance).

Is your laser product the result of the modification of a laser product certified by another manufacturer?

*

No

2.5 Incorporation of Unmodified, Certified Laser Product

Does your laser product incorporate an unmodified, certified laser product?

*

No

2.6 Incorporation of Uncertified Laser Product

Does your laser product incorporate an uncertified laser product as a component or component subsystem?

*

Yes

2.6.1 Other Manufacturers

Item: 1

Give the name and address and/or firm establishment registration number of the other manufacturer:

*

Laser Diodes, Inc., 4 Olsen Avenue, Edison, New Jersey 08820

Identify the other manufacturer's model(s) and brand name(s):

*

Item 1

Model CVD4S5000METR

Provide the other manufacturer's accession number, if known:

*

unknown

Show how your model designations and brand names correspond with the other brand names and model designations listed:

*

No other designations

2.7 Incorporation of Removable Laser System

Does your laser product incorporate a removable laser system or systems as defined by 21 CFR 1040.10(c)(2)?

*

No

Technical Data

PART 3: DESCRIPTION OF THE PRODUCT

Note:

In this section, you are asked to provide descriptions of the product, its intended function, and the laser radiation fields or paths and collateral radiation that may be accessible in operation, maintenance, or service modes of the product.  This section was previously Part 5 of the product reporting guide.

3.1 Product Description and Function

Note:

You may refer to brochures and manuals submitted as attachments to this report.

Describe the product and its function:

*

File Attachment

ParticleView V19 Safety Manual

Details

      The ParticleView V19 is an in-situ microscope. It is designed to acquire
      microscope images directly inside a fluid medium. A video camera and
      microscope optics are mounted inside a metal probe body. The fluid
      medium is viewed through a sapphire probe window at the distal end of
      the probe. The illumination system is housed inside a metal enclosure
      mounted to the proximal end of the probe. The Introduction section of
      the attached Safety Manual provides a more in-depth description.

3.2 External and Internal Laser Radiation Fields and Paths

Note:

Include beam path diagrams indicating protective housing, beam attenuators, viewports, scanners, targets, etc. Indicate energy and power levels at locations inside and outside the product.

Describe the external and internal laser radiation fields and paths:

*

The ParticleView V19 uses an illumination system comprising eight laser diodes, each permanently coupled to a multimode optical fiber. Each of the laser diodes is enclosed in a metal housing, no collateral radiation is emitted at this point. A gradient index lens is used to focus the light emitted from the multimode fiber through a sapphire probe window on to the field of view, the diameter being 1.5mm. Each beam is tilted with respect to the probe axis. Under normal operating conditions the operator is never exposed to light from the instrument. If an operator could turn the instrument to look straight in the probe, the eye will not be exposed to light from more than one beam at a time. The image is observed by a digital camera; there is no viewport for direct observation.

3.3 Operational Procedures and Accessible Radiation

Note:

Describe here the procedures used during operation and the laser or collateral radiation that is accessible during these procedures.

List the procedures performed during operation:

*

The user is advised about the intended use of the instrument (see attached User Manual). Under normal operating conditions the probe is inserted into a vessel containing a liquid. The operator could only be exposed to light scattered from individual particles present in the liquid. The light scattered by the particles would be several orders of magnitude lower than those of the illumination fields as discussed in Section 6.

The instrument is operated from a Personal Computer; all functions of the instrument are controlled by software. The software allows the operator to choose the intensity levels of each one of the eight illumination lasers individually to a maximum as specified in Section 6. The pulse repetition rate is software controlled up to a maximum rate of 15 pulses per second. It is not possible by use of software commands to exceed the intensity levels as described in Section 6.

No other laser or collateral radiation fields are emitted from the probe.

Do these procedures provide human access to ANY laser or collateral radiation?

*

No

Do the levels of laser or collateral radiation exceed the limits of Class I or Table VI?

Indicate those collateral and laser radiation fields to which human access is possible during those operation procedures. Include the locations and identifications of laser and collateral radiation made accessible by viewing optics, viewports, and display screens:

3.4 Maintenance Procedures and Accessible Radiation

Note:

Describe here the procedures used during maintenance and the laser or collateral radiation that is accessible during these procedures.

List the procedures performed during maintenance:

*

The ParticleView V19 requires no maintenance that would affect the radiation levels as described in Section 6.

The operator is informed in the user manual that no user serviceable parts are inside the enclosure or probe.

Do these procedures provide human access to laser or collateral radiation levels in excess of Class I or Table VI?

*

No

Indicate those collateral and laser radiation fields to which human access is possible during those maintenance procedures:

3.5 Service Procedures and Accessible Radiation

Note:

Describe here the procedures used during service and the laser or collateral radiation that is accessible during these procedures.

List the procedures performed during service:

*