ML20202H338
| ML20202H338 | |
| Person / Time | |
|---|---|
| Issue date: | 12/05/1997 |
| From: | Jankovich J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Beatty C CANADA |
| References | |
| SSD, NUDOCS 9712100251 | |
| Download: ML20202H338 (3) | |
Text
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UNITED STATES ye
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NUCLEAR REGULATORY COMMISSION t
WASHINGTON, D.C. 20566 4 001 December 5, 1997
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Mr. C. D. Beatty, Regulatory Affairs Theratronics Intemational Limited i
413 March Road Kanata, Ontario, Canada K2K 287
Dear Mr. Beltty:
This letter is in response tu your spotications dated November 1,1996, requesting amendments to Registration Certificates NR 687 D 105-S and NR 687 D 101 S to modify the T780 and T1000 series teletherapy units. We are currently processing your request based on the information provided in the applications and in our conference call conducted on December 3,1997. However, to continue with our evaluation, we need the following information:
Construction (for both models) 1.
Pease describe in detail the technical changes regarding radiation shielding that Theratronics made to meet the requirements of IEC Publication 601211. Specifically, please delineate whether additional tungsten shielding is provided for all units because the application, for example, for the T780 series (Part 1, Section 2.) states that
- tungsten shielding is available as an option.' Provide information of such details as drawings for both models that show the construction of the tungsten shielding, its relationship to adjacent components, dimensions, material specifications for the components itsolved, and method of attachment to the head.
2.
In your application for the Model T1000E, you provided us with drawing No. A119702-019, ' Head Welding and Final Machining (Pictorial).* However, this drawing specifies the Model T780E, Please verify that the drawing applies to the Model T1000E as well.
Radiation Protection (for both models) 3.
In the application for the Model T1000E, Part 4 contains the 'lEC validation Report for Theratron 780E." Please provide the appropriate report.
4.
Pact 2, page 2 in this report states that the survey was conducted 'according to DG 0019 G22." ; We understand that the document is a Theratronics procedure. Please provide a 7
copy of the procedure so that we could review your survey method.
l S.
Regarding the survey readings transmitted to us with your letter dated November 24, I
1997, please indicate (a) what position the source was for the readings, (b) what was the qA activity of the sources, (c) that the activity levels that were used for the surveys did represent the maximum activity permitted for the devices, and (d) why only two survey readings are shown at the 5 cm location from the surface of the unit. In addition, please L
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provide survey data similar to those in yeur letter of November 24,1997, but with the sources in the exposed position for both models.
i Operations (for both models) 6.
P:aame provide the changes in the operator's manual that reflect the conclusions of NRC Information Notice 97-64 regarding loss of ciectrical power in teletherapy units. Please also indicate whether such a change will be implemented for both models.
7.
Table #1, 'Substahtial Equiva%nce Comparison
- In your application refers to a number
- cranges with respect to the predicate models. Please describe the following changes in further detail (the numbers are the ' Reference" numbers of Column 1, Table #1):
i 4.2, Extemal Connections (how change affects emergency response, could the emergency switch be used to turn on the system) 7.6, Inhibit State Interlocks (does it affect radiation safety in emergency stops or restarts after such stops) 7.14, Gantry Faul' Protection (please indicate how this feature is addressed in t
the operator's manual) 8.
Please provide copies of FDA Form 510K for both models.
Editorial Correct!ons 9.
A page is missing from the T1000E application. Please provide the information missing betwet.n Sections 2.1.2 and 2.5, Part 1.
10.
Is the weight the same for both models, as listed in Section 20.1, Part 17 a
11.
The unit weight for Model T1000E shows two different values in Section 20.1, Part 1 vs.
Section 1.4.1, Part 2.
12.
Physical dimensions for Models T780E and T1000E show differi,1g values in Section 20.3, Part 1 vs. In Section 1.4.2.2, Part 2.
We look forward to receiving the requested information. Please provide the information within 30 days so we could continue our review. If you have any questions, please contact me at (301) 415 7904 or Mr. D. Broaddus at (301) 415-5847.
Sincerely,
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GW ohn P. Jankovich, Ph.D., Sr. Engineer l~
Sealed Source Safety Section Division of Industrial and Medical Nuclear Safety Office of Nuclear Materials Safety and Safeguards
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