ML20134Q092

Requests Additional Info Re Ion Mobility Spectrometer Detector

ML20134Q092
Person / Time
Issue date:	09/05/1996
From:	Beverly Smith NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Mceachern A CANADA
Shared Package
ML20134D368	List: ML20134D365 ML20134N762 ML20134P263 ML20134P268 ML20134P315 ML20134P385 ML20134P425 ML20134P502 ML20134P512 ML20134P523 ML20134P957 ML20134P979 ML20134P992 ML20134Q022 ML20134Q065 ML20134Q092 ML20134Q101 ML20134Q114 ML20134Q118 ML20134Q248 ML20135A102 ML20135A110 ML20135A115 ML20135A120 ML20135A148 ML20135A288
References
SSD, NUDOCS 9702260243
Download: ML20134Q092 (2)

Text

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September 5,1996 i

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CPAD Technologies Inc.

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66 Stater Street

_ Ottawa, Ontario Canada

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K1P SH1 -

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Dear Mr. McEachem:

This concoms information about an ion Mobility Spectrometer (IMS) Detector which was submitted with your facsimile received September 4,1996, in response to the deficiency letter i

dated August 27.. I have performed a cursory review of the information and have identified areas where additional information or clarification is needed.

1.

Your request for an exempt distribution license has not been received. If this has not been submitted yet, it is recommended that you do so as soon as possible.

2.

With respect to the environmental and operating extremes the device may experience, you state that the device will be used for exterior operations. Does this mean the device p

is portable or moveable, or will it be installed in a fixed position outside, open to the environment?

3.

The labels on the analytical unit you state will be expected to remain intact on the device

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j at temperatures up to 100 degrees C. What is the maximum temperature of the surface the labelis attached to will reach?

4 4.

Per our conversation on September 3, you stated that the label on the detector wi1 have the information engraved in the aluminum. Your letter did not address this. Please _

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verify how the information will be applied to the label.

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5.

What material will be used for the label attached to the analytical unit? _in addition, what j

adhesive will be used to attach this label to the analytical unit?

i 6.

With respect to the quality assurance program, please provide a description of the quality control program that is used for the manufacture of the IMS Detector. Please

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note that your quality control program must ensure that devices meet all specifications provided in your application. Please address how this will be accomplished as well as leak testing of the devices. Coulter Sales will have to do a visualinspection to ensure.

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that devices meet all specifications provided in your application and perform a leak test j

of all devices shipped or if this is performed by CPAD Technologies Inc., Coulter Sales l

will have to perform periodic audits to ensure CPAD Technologies Inc. maintains c,n i

adequate quality control program.

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7.

Please provide scenarios and dose assessments in accordance with 10 CFR 32.27.

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8. -

Please explain the tamper proof screws and their locations on the device.

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9702260243 961230 i

PDR RC -

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SSD PDR

Sincerely, Brian W. Smith, Health Physicist Sealed Source Safety Section Madical, Academic, and Commercial Use Safety Branch -

Division ofIndustrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

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