ML20199F548
| ML20199F548 | |
| Person / Time | |
|---|---|
| Issue date: | 01/19/1999 |
| From: | Bhachu U NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Demeke T AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9901210350 | |
| Download: ML20199F548 (4) | |
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January 19, 1999 Mr. Thomas A. Demeke Regulatory Programs Manager General Electric Medical System P.O. Box 1414, W-641 Milwaukee, WI 53201-0414.
Dear Mr. Demeke:
We have reviewed your application dated March 8,1998, requesting registration of the V-Transact Rod Unit-Attenuation System to be manuf actured by Elgems and marketed by GE Medical Systems and Elcint Inc. In reviewing the application information, we find the application is lacking the required information. Therefore, we request that you forward to us the following information so that we can continue the review and evaluation of your application.
1.0 A Reauest for Withholdina of information 1.1 By affidavit, signed by Mr. Nathan Hermony and certified by a General Counsel, you requested Nuclear Regulatory Commission (NRC) to withhold from public information appearing in Appendices 'A', ' B' & 'C', of your application binder.
Pursuant to your request we reviewed your application and material in accordance with the requirements of 10 CFR 2.790. We are unable to grant your blanket request for withholding of infor nation as stated in your application. We have determined that only certain portions of the requested information to be withheld contain trade secrets, and proprietary commercial information. In general, only that information which cannot be obtained through observations or measurements of components or documentation j
obtainable by a member of the public can be withheld as proprietary material.
With regards to engineering drawings, information generally considered being proprietary includes information such a:: dimensional tolerances, technical specifications of materials, manufacturing notes or specific assembly directions. Any remaining information on the drawings would be released. Please identify specific information on each drawing that you wish to withhold as proprietary, and provide nonproprietary versions in accordance with 10CFR 2.790(b)(1)(ii).
Operational and service manuals are normally provided to the purchasers of the equipment. We are unable to grant at this time that the information contained in these manuals is proprietary. Based on this finding you may wish to address the contents of these manuals. Please provide NRC with proprietary and nonproprietary packages or marked documents. An affidavit attested by Notary Public must be submitted prior to the staff making its final determination. The revised affidavit and documents must be submitted to the NRC within 30 days from the date of this letter, if not in accordance with 10 CFR 2.790 (c) the information sought to be withheld will be placed in the Commissions Public Document Room.
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1.2 10 CFR 2.790 (9) (V) requires that an assessment be made of substantial harm to the
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competitive position of the owner taking in to account the value of the information to the 0
owner. Please provide the estimated effort or money expended by the owner in k
developing the information, and the ease and difficulty with which the information could be properly acquired or duplicated.
2.0 Desian & Drawinas 9901210350 990119 PDR RC SSD PDR
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2.1 The application states that the source to be used in the device is a Dupont model NES-8429, registration number NR-0476-S-117-S. However, the only models indicated in the registration certificate are NES-8412 through NES-8425.
We have read the letter from Dupont Pharma to Eigems, dated January,1998, regarding an amendment to the device registration. However, as Dupont is located in an Agreement State, it will be necessary for Dupont's request to be addressed and processed by the Commonwealth of Massachusette prior to the approval of the device, or for you to obtain approval from NRC for custom use of a source with a device. The custom source approval may be obtained by providing the information about a source to NRC as described in NUREG 1556 Vol. 3..
2.2 Radiation profiles for iso-distances are shown for single sources in the Appendix 'P of the application. The application is for 'L' configuration and two source housing deployments would suggest that the above tests will yield significantly different results.
Please submit actual radiation profiles reflecting the use of the source housing.
2.3 Please provide the specifications of the adhesive used to retain the sealed source in the aluminum source holder, in particular with respect to content, service life, and resistance j
to deterioration from radiation. Also please elaborate as to why the configuration of the aluminum source holder in contact with stainless steel will not create a galvanic cell, and include a description of the term " black oxide" as applied to the surface treatment of the aluminum per the engineering drawirig.
l 2.4 Drawings submitted with the application do not address adequately the following:
screw on shipping holder / housing interfaces the plastic rod insertion tool / the source rod interface l
how the plastic rod is held in place during installation by pressure, the means with which pressure is applied, and subsequently how the hoider is closed l
details of spring solenoid and shutter mechanism and its operations explain the term, " captive screw" We would appreciate receiving drawings and description which will clearly and concisely illustrate the above indicated areas and interfaces.
2.5 Not all the engineering drawings which were submitted indicate the units, and in some cases, e.g., portions of Detail"D" of drawing marked "A-22," End View on drawing marked "A-26" annotations appear in a foreign language. While many of the dimensions on the engineering drawings you supplied appear to be in millimeters (mm) there appears to be some mixed units on drawings marked "A-5" & "A-6" in the narrative and the drawings. Please resubmit these drawings which contain information in language other than English with the data in English, and verify the units of measurement for each drawing. It is not essential to convert units from metric, but the units should be consistent.
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2.6 Please elaborate on the built in design elements that will not allow an incorrect indication
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of the shutter position.
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9 2.7 Manual shutter levers are installed on both the assemblies. Please confirm that the operator will be able to see the lever position of both the shutters during normal operations.
2.8 Is this application also for a mobile van unit, if so, please explain how the unit has been designed and tested to maintain its integrity during transportation.
2.9 Section 3.3.10 of your application includes a maintenance responsibility matrix. Please define the type and the extent of maintenance to be undertaken by the user and/or vendor.
2.10 Please describe what additional inspection GE will undertake to ensure the integrity of the device received from Israel.
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Operational Procedures.
3.1 Page 2-2 Item 9 deals with a malfunction of a device or as a result of an accident situation. We recommend that you list the telephone and fax number. of the service office, on this page in bold letters. This will ensure speedy access.
4.0 Testina 4.1 The source mechanism is tested by sensing the position of two slotted switches mechanically attached to the tungsten rod shutter which icdicates whether the shutter is open or closed. Please provide the means and method of attachment of the switch.
Also, provide NRC with the test data that establishes the reliability and failure rate acceptance criteria for the switch.
j 5.0 Service Manual On Page 1-4. Please re-word the label as it appears to direct the user to look into the source aperture. It should read " indicator window" On Page 2-2. Please define," parked position."
6.0 Prototvoe Testina 6.1 Please define the type of drop test conducted. A visual test as primary test following a drop test of the source is not acceptable. A leak test or survey must be done to assure the integrity of the source and source housing. Please submit the leak tests or survey results.
Please confirm whether the drop test performed as a part of the prototype tests, which you have stated were in accordance with ANSI N542-1997, were the class 2 drop test's Table therein. In particular state whether the test was performed as indicated per table 1 (10 timea to a steel surface from a height of 1.5m) and,ection 7.4.3 of the standard.
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January 19, 1999 7.1 Please demonstrate how vibration test are satisfactory for the transportation of the device l
from Israel to USA locations.
7.2 Please provide a copy of Standard EN46001 in the English language, l
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Work In Proaress The application states in a number of places that work is in progress, i.e., Trouble Shooting
( Page 5-1), Adjustments to Rods, QC Procedures ( Page 6-8) and Mechanical adjustments, Planned Maintenance Page 6-8). Please provide complete final manuals-l Please respond within 30 days of the date of this letter and be cortain to address all the areas of concern cited herein. Please include sufficient information so that NRC is in a position to review l
the radioactive source as a custom use, or resubmit your application in its entirety that addresses all the issues in duplicate after you have obtained a copy of an approved registration certificate for the appropriate Dupont source.
If we can be of any assistance please do not hesitate.o call me on (301)415-7894.
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Sincerely, l
l original signed by Ujgar Bhachu Ujagar S. Bhachu, Mechanical Engineer Materials Safety Branch, l
Division of Industrial and Medical Nuclear Safety l
Office of Nuclear Material Safety j
and Safeguards.
Ditribution:
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SSSS r/f SSD-98-39 NEO1*
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NMSS r/f k
DOCUMENT NAME: P:\\ELGEMSFC.WP C hypvigiout attachment! enclosure
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OFFICE MSB C MW\\ \\ \\d if l
l NAME USBhachu $V CtR/thdaIz\\
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DATE 01/13/99 01/Y8/94 1
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