ML20135A120

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Forwards Deficiency Ltr for IMS Detector for Distribution Under Exempt License.W/O Encl
ML20135A120
Person / Time
Issue date: 08/26/1996
From: Beverly Smith
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
CANADA
Shared Package
ML20134D368 List:
References
SSD, NUDOCS 9702270013
Download: ML20135A120 (1)


Text

{{#Wiki_filter:From: Brian Smith To: intemetcpadtech.com:almc Date: 8/26/9612:25pm Subhct: IMS Deficiency Letter AI, Attached is the deficiency letter for the IMS Detecter for distribution under an exempt license. The file was saved as a Word 6.0 file. If it does not work, please let me know. The document was also faxed. Gh" CfA0WS. Ld LC)

D 9702270013 961230 PDR RC SSD PDR

e L =r UNmED STATE 3 i t' [ S NUCLEAR REGULATORY COMMISSION l I WAsHlNeToN, D.C. SegeHOM August 27, 1996 4 i j , Mr. AlMcEachem, Director CPAD TM,r * ' 66 Sister Street' :: loc. Ottawa, Ontario Canada j K1P 5H1 i Door Mr. urs,%m: This conooms information about an ion Mobility *g+arrier (IMS) Detectorwhich was submitted with your letter received July 10,1996, and your subsequent conversation with Ms. Kathleen Dolce of Region I. We are in the process of reviewing the information and have i i identieed areas where additional information or clarification is needed. As requested in your conversation with Ms. Dolce, the information was reviewed for distribution of the devices under 4 an exempt distribution license under 10 CFR 32.26. As per 10 CFR 32.26, these devices will be i used by persons denned in 10 CFR 30.20. It is our understanding that a letter will be submitted =V'i,;rg this change. Because 10 CFR 32.26 contains different requirements than 10 CFR 32.51, which your original sutmttal requested the devices to be distributed under, additional information will be necessary and some changes will be required to be made to the information originally submitted. l Devices manufactured under 10 CFR 32.26 must be designed for the purpose of protecting life j or property from fires and airbome hazards. Accordingly, a case will need to be made for the j iMS Detector to be manufactured under use 10 CFR 32.26. . It was noted in the engineering drawings submitted that a statement was made on each that it is considered to be the property of CPAD Technologies Inc. The NRC can handle information submitted by Sensees on a company proprietary manner (i.e., not to be disclosed to the public) i when the materials are submitted in accordance with 10 CFR 2.790(b). In addition to the markings on the mate 'al to be considered proprietary, an afrxiavit is required to be submitted requesting that the materials be considered proprietary. Once this has been received, the NRC will consider the request on its merits. To aid in the development of this additional information, I have enclosed a copy of l

  • Supplemental information to Request a Safety Evaluation and Registration of Sealed Sources or Devices Containing Byproduct Material" which contains all of the regulations relevant to your i

submittal. Because of this, some of the ionowing questions will only reference sections of the I regulations instead of including the regulation text. In addition, I am including a copy of l Regulatory Guide 10.10, " Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of Devices Containing Byproduct Material," which provides i guidance on sutetting requests to the U.S. NRC for radiation safety evaluation and registration { of devices containing byproduct material. 1 _ _"1 h NM mw-r- "o Q i

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A. McEachem 2

b ti in order to complete our review, please provide the fonowing:

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With respect to the model number scheme that is proposed to be used, we recommend 1. . that you include IMS as a psefix (i.e., IMS-xxxx-yyyy). In your application, the "xxxx" represents the model number. Please explain the meaning of different model numbers, If used. i l 2. Devices distributed under 10 CFR 32.26 do not require leak testing by their users. l-3. Please provide the extremos of environmental and operating conditions (e.g., temperature, humidity, corrosive atmosphere, vibration, etc.) the devios may experience l during normal use. In addition, please provide a brief description of the function and operation of the device. 4. Please provide the expected useful life of the device. i 5. Please provide the total quantity of byproduct material expected to be distributed in the l product annually. i J 6. Devices distributed under 10 CFR 32.26 must be labeled in accordance with 10 CFR 32.29(b). The ice:;.tg requests for information all pertain to labeling. } e A label must be placed on the detector that contains the following: (1) the words "Contains Radioachve Material," (2) the name of the radionuclide and quantity of i activity, and (3) the identity of the 10 CFR 32.26 licensee. The labei must be j durable, legible, and readily visible when the detector is removed from the analytical unit (box that contains the IMS detector). Please provide the wording i or samples of the label to be placed on the detector. i e in addition to the label that will be placed on the detector itself, a label must be l placed on the outside of the analytical unit. This label must contain, as a j minimum, the same information as that required to be on the detector. Additional f information may be included. i e These labels need to be permanently affixed to the device and made of a material that will retain its integrity during use. Please indicate the materials of construchon of the labels. In addition, please provide information on the label j adhesive, such as solubility, effective temperature range, etc. e in addition to these labels, the point of sale package must be labeled or marked in accordance with 10 CFR 32.29(b)(3). This label or marking must contain the j fce:ds: (1) the name of the radionuclide and quantity of activity, (2) the identity of the 10 CFR 32.26 licensee, and (3) the following or similar words "This detector contains radioachve material and has been manufactured in compliance with U.S. NRC safety criteria in 10 CFR 32.27. The purchs:ar 4 cxumpt from any regulatory requirements." The label or marking must be legible and readily ,y visible on the package. Please provide the wording or samples of the label or l marking to be placed on the point of sale package. i, 4 m

A. McEachem 3 i L l 7. With respect to prototype testing, please provide details on the condetson of the devices j tested when each test was completed (i.e., did the device fall apart, any visible damage, condition of source, etc.). I 8. Please provide complete radiation proflies for the IMS Detector assembly and the l analytical unit containing the maximum activity for the source. Indicate whether the radiation profiles are derived from calculation or from surveyng the device. If they are i l derived from surveying the device, please provide a description of the instruments used ] to perform the surveys. The radiation profiles must be provided at 5 and 25 centimeters l from the extemal surface of the detector. These measurements must be made with the j detector inside and outside of the analybcal unit. 9. 10 CFR 32.29 (a) requires that adequate quality control procedures be camed out to assure that each production lot meet the quality control standards approved by the NRC. Please provide a c:1-f'-x of the quality control program that is used for the manufacture of the IMS Detector. Please note that your quality control program must ensure that devices meet all speafications provided in your application. Materials that do not meet the minimum specifications will not be authorized under the certificate. l 10. Dose assessments must be provided that demonstrate that the device meets the safety criteria in 10 CFR 32.27. (i.e., certain dose limits under normal use and disposal i conditions). Therefore, please review these requirements (see enclosure) and submit j sufficient information to prove that ;he safety criteria can be met. i 11. With respect to the degree of access to human beings to the product during normal { handling and use, the device should have safety features in place to prevent the l inadvertent access to the source by the user. Please provide a description of the safety features of the IMS Detector. Typical safety features include tamper resistant screws, use of adhesives, and filled screw heads. 12. Please address the potential for galvanic corrosion of the device, in particular the j locations where different materials come into contact. j 13. For each engineering drawing provided in your application, please provide a parts list j including the materials of canstruction. 14. The registration certificate for the Nuclear Radiation Developments, Inc. source model number N-1001 states that the source can be made with one of several backing foils. j Please provide the backing foil used for the sources to be used in the IMS Detector. I i i l i ) 3 i

.. ~... A. McEachem 5 "b We look forward to receiving the requested information as soon as possible. If you have any quest!ons, please contact me at (301) 415-5723 or Mr. John Lubinski at (301) 415-7868. Sincerely, l oricWG9ftiff Srlan W. Smith, Health Physicist Healed Source Safety Sechon Medical, Academic, and Commercial Use Safety Branch Division of Industrial and } Medical Nuclear Safety Office of Nuclear Material Safety j and Safeguards i

Enclosures:

As stated j cc: Mr. Gordon Coulter, Coulter Sales Ms. Kathleen Dolce, Region i Distribution: SSSS r/f SSD-9tM6 NE01 DOCUMENT NAME: P:\\SSSS\\CPADDEF.LTR Ta sessive a sepy of stile deemsnent, ladsete in time hem: "C" = Copy without ettechenent/ enclosure "E" = Copy with attachment / enclosure N* = No copy OFFICE SSSS lC SSSS _ 1 [C l l l NAME-BSmith 65 JLubinski X DATE 08//96 08/ @9' OFFICIAL RECORD COPY i ,.w.,.y.- -s

!? .. MANUFACTURER / DISTRIBUTOR:' $ b kb MAW 6 ' REGISTRATION #: I MODEL #: MI

REFERENCES:

i i DESCRIPTION OK/DEF COMMENTS (//D - RESP DATE) i FIRST PAGE y l Registrat's name and address ./ I M==nfacamw's and distributor's name and address v Custom user's name and address sq/, Model amnber i f Type (from Reg, Guide 10.10 or 10.11) / N User's authority to possess (specific, ganaral, both, exempt) 3 nadianacald==, activity (Max w/5 error), forin, l m===facausr, model, NRC registered ! N. (note on registration certificate if source is f[tbd i g ik regissered as part of the sit.vice) / d 1 ]EN DESCRIPTION i If registrant is requesting to register more timan one source / device on a cestificate, are designs W aimilar enough to do so? Device / source design with complete engineering drawings (dimensions, tolerances, list of .[ materials) enk M Assembly metnods (screw, welds, etc.); gm.[, av 3 p verify integrity 1 Source mounting (size and integrity) and i v security i is source ANSI classification sufficient: Radiography - Unprotected - 43515 Radiography - In Device - 43313 i l Medical - Radiography - 32312 } Medical - y Teletherapy - 53524 y Gauges - Unprotected - 43333 . y Gauges - In Device - 43232

  1. Gauges,14w Energy y Gauges, or X-ray fluor

- 33222 / yA, M, $natte Oil Well Imgging - 56522 Portable Moist / Density - 43333 Neutron Applications - 43323 y irradiators (II, III, IV) - 43424 y irradiators (I) - 43323 / Chromatography - 32211 Static Eliminatars - 22222 Smoke Detectors - 32222 (from ANSI N542-1977) Definition of shutter operation (locked in Off g fg f posit;on, not locked in On position) On-Off indsators (description, qty., location) NM 1

4 DESCRIPTION OK/DEF COMMENTS (//D - RESP DATE) 4 4 l Safety interlocks, guards, etc. to prevent access y to beem or high radiariaa levels Corrosion between unlike materials (alumi=== & steel, deplened uranium A meel, etc.) see b * #f " Corrosion" information 3 Well logging sources snust be =aadi=g= die and namaan=hla. (see JBCarrico for listing of g sealed sourms appsoved for well logging) t see " ANSI and Other Sandards' tim for i ressrences for pariscular source / device designs (e.g. radiography, brachytherapy, etc.) LABELING 4 ^ V Copy of label y M < a f s rg c.fu., Materials, dimenalons, colors (note on registration certificate if labeling is exempt from the color requirements of 10 CFR Part 20) Permanans attachment and location (s) - visible n., /.5 f, e aA<Aej 4;J / to users? Contents: Model#, Serial #, Isotope, Activity, MD/ Manufacturer, Date of Assay, Trefoil, _, / .3 r e te ' CAUTION - RADIOACTIVE MATERIAL" (Depleted Uranium information must be included) CONDITIONS OF USE Expected life of the source / device (years, y /*. operations) fas k W s,/ [ Maximum allowable temperature, vibration, ,y 4 shock, corrosion, etc. (during operation and accidental) How the device will ',e used Meets dose limits of Part 32 for G and E distribution PROTOTYPE TESTING Tests maehade and conditions (for source and device) Tests results / Years of use (incidents, failures, etc.) M M ***V/ N M% O "JN i Similarities to other sources / devices if they are '4;/ j used as basis. v 2

i 4 i .I f 1 l DESCRIPTION OrlDEF COMMENTS (//D - RESP DATE) I RADIATION PROFIIES SurveyIc unset used (type, window, j eensitivt.. etc.) j c'n aninn. Distance from somee/ surface j (per ANSI 538-1979) l Shutter On and Off/ source shielded /p/g l Sycsr (prodnet in beam) Mg l Oueds and sidelds in place l Verify radiation surveys for y radiatine meet gjg 8 lav law. I Verify radiarlan surveys for non-y radiation 2 j have not been caladanad using inv law. QUALITY ASSURANCE W D l Materials, suhamaemblies, services Assembly methods (screws, welding, etc.) 4 i j Dimensions and tolerances i; Activity, radiation levels, leak tests QA Manual INSTALLATION j Fixed, portable, movable, fixed installation but l portable source housing j inherent shielding, inacreasibility v j laterlocks, locks, barriers Beam access: size of air gap / opening to beam p (verify size with new GL rule) Mounting integrity SAFETY INSTRUCTIONS ion, maineenance, calibration, j dEg , specific warniass, leak iest, and 7I radiat eys. 3

1 i ) 1 l i DESCRIPTION OK/DEF COMMENTS i (//D - RESP DATE) j l f ACCOMPANYING DOCUMENTATION j imak tests results and radiation surveys L,74 /, 45 l Tr-.=: k darn =*ma h)h. I Operation. =aine*= , calibration, 4 damage / failure, specific warnings, leak test, and radimiaa survey lastructions if applicable e For OL dist. Verify NRC Regions and ' Agreement State listing is up-i to< late and copies of all pertinent regnimiaan i SERVICING i l Manufacturer provides or user performs: g., Installation ' d Calibration Relocation (4 Lesk Test [ M t->=== padimion Survey ) f, Repair Training g Source Change / Installation - FOREIGN MANUFACTURERS ' Drop ship h3 6[pf h Who and where is source installed 6(6 Leak test and radiation surveys QA in the U.S. 't i h dd.r 4

1 l n ,r l ETG. Inc.

  • NRC Application for Exempt Item Distribution License l

3.0 Chemical and Physical Form 70 3.1 Chemical and Physical Form The sources used in the IMS cells are 63Ni electroplated onto a substrate which consists of a brass cylindrical ring with a length of 7.70 mm and a diameter of 7.0 mm. The wall i l thickness is 0.15 mm. The 63Ni is electroplated over the entire surface of the ring. 75 i 3.2 Potential Chances Durine Useful Life Standard plated 63Ni sources may oxidize and degrade with exposure to air and chemicals. In addition traces of air pollutants hydrogen sulfide and sulfur dioxide, react with nickel to form 80 corrosion. '4.0MSolubility in Water-and' Body Fluids ? 4.1 Solubility in Water '85 The solubility of nickel compounds (CRC 1990) are shown in the following table: i Selected Nickel Compounds Solubility Class Carbonate (NiCO ) sparingly soluble in water 3 Oxide (NiO) insoluble in water Hydroxide (Ni(OH)2) sparinely soluble in water Sulfate (NiSO ) soluble in water 4 Sulfide (NiS) insoluble in water 4.1 Solubility in Body Fluids 90 ICRP 30 reports the following data for nickel (ICRP 1982): [ The fractional gastrointestinal absorption of dietary nickel is thought to be low. The fractional gastrointestinal absorption of nickel oxide is probably less than that for dietary nickel. The k-i - value for fi s 0.05 for all compounds of the element. J 95 W ICRP 30 assigns oxides, hydroxides and carbides of nickel to inhalation class W. All other i commonly occurring compounds of the element are assigned to inhalation class D. 5.0 Details of Construction and Desien 100 5.1 Conditions of Use In operation, the cell is maintained within a particular temperature range by use of a conductive coating or external heater on the cell body. A resistive ink is used on the inside of the cell within the drift region to maintain an electric field of 125 V per em supplied by a high voltage 105 power supply. An ambient air sample is drawn into the inlet and across a semi-permeable membrane by a pump or venturi. The materials of interest permeate through the membrane and the remaining sample is exhausted outside the instrument. On the other side of the l ETG. Inc.

  • NRC Application for Exempt item Distnbution License Pace 3 l

) = PAGE1 ] NRC FORM 567 U. S. NUCLEAR REOULATORY COMM SiON i (ses) REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION INSTRUCTIONS: Send tNs request AND a copy of a8 related letters / appl 6cahons and drawings to: The Sealed Source Sofety Sectxe, ATTN: CNef, OWFN Mail Stop 6 H3. Change the License Tracidng System milestone to 19 and assign to reviewer code I-5. NOTE: Retain a copy of tNs request with the apphcation and background files. RE. STER REGION / LOCATION: f i 11 til IV RV R HQ R LFDCB i VELEPHONE NUMBER DATE TYPE OF ACTION REQUESTED (Check as appropriate) SOURCE REVIEW AMENDMENT OF g 'g REGISTRATION SHEET MAa. CONTROL NUMBER (S) J DEVICE REVIEW BER(S) l /93 W O K:A DATE LICENSE NUMBER (S) CUSTOM REVIEW b WS (D cOMMtNTS: ' i FOR 8888 USE ONLY REVIEWER MODEL NUMBERS NUMBER AS$10NED fb h* DATE RECEIVED DATE AS$1GNED DATE TO FEES TYPE OF ACTION (Indicate the number of each type) l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM) SOURCE (90) DEVICE (9A) SOURCE (9D) DEVICE (98) ]NEW EW ]NEW NEW AMENDMENT AMENDMENT AMENDMENT AMENDMENT j NO SAFETY EVALUATION REQUIRED jLICENSING ACTION REQUIRED IF KNOWN NO FEES REQUIRED NO j OTHER (Specity) i 1&^e'W""";" ' >l")(use 6ew<x &&" %[ f(M b 4 NUMBER OF DEFICIENCY LETTERS NUMBER OF hp I/ DEFICIENCY CALLS FOR BILLINO PURPOSES ONLY NEW REGISTRATION - ] MODUCT INACTM - NAME CHANGE ADDRESS CHANGE ADD TO BILLING REMOVE FROM BILLING / FOR FEE USE ONLY / ~ 9C U 9D / 98 N a h 4 p g h m, '"w; - = " =^" U -~ y07f b gy,sW j MATSYS UPDATED Le AS REQUIRED l APPROVED BY DATE RETDRN DATE 1% vinh L COMMENTS NRC FORM $67 (843) NTO SSSS

1.0 APPLICANT This application is being submitted by CPAD Technologies Inc., a Canadian firm. The device referred to in this application is manufactured by CPAD and will be transferred to the U.S. through the U.S. office under a possession license issued under 32.51. CPAD is submitting this application for a device review and a general license under provisions 31.5. Head Office: CPAD Technologies Inc. 66 Stater Street Ottawa, Ontario Canada K1P SH1

Contact:

Mr. AlMcEachern -- Tel: 613-230-0609 Director, Business Development Fax: 613-230-3805 U.S. Office: Coulter Sales 444 Bamey's Joy Road South Dartmouth, Massachusetts 02748-1004 Contact Mr. Gordon Coulter Tel: 508-636-6?44 Fax: 508-636-3948 2.0 DEVICE TYPE The device is intended for use under a generallicense, specifically 31.5, for the purnoso cf detecting organic compounds. The device is called an ion Mobility Spectrometer (IMS) Detector. This device contains a Nickel-63 source. 3.0 MODEL NUMBER The designated model number for a device containing the Nickel 43 source will be xxxxx followed by the serial number yyyyy. t xxxxx yyyyy 4.0 OTHER COMPANIES INVOLVED CPAD Technologies Inc. of Canada purchases the Nickel source from a U.S. firm: NRD Static Control Products 2937 Alt Boulevard North f Grand Island, NY 14072-1292 5.0 RA0lOACTIVE SOURCE MODEL DESIGNATION The Nickel source purchased from NRD is registered with the NRC as N1001. 6.0 RADIONUCLlDES AND MAXIMUM ACTIVITY Each device contains a Nickel-63 source of 3.3 millicuries. 7.0 LEAK TEST FREQUENCY t A leak test will be conducted before shipment and a copy of the test results will accompany the system. Follow on leak tests will be conducted every twelve months. 8.0 PRINCIPAL USE CODE 4 The principal use code is "N." The Nickel 43 is used as an ion generating source for the IMS Detector.

9.0 DESCRIPTION

OF THE DEVICE i The device referred to in this application is called an ton Mobility Spectrometer (IMS). This device is used to detect organic compounds. These compounds are injected into me IMS via a carrier gas (air i I or nitrogen). Upon entering the IMS, the molecules contained in the carrier gas are ionized by the Nickel 43 source. These ionized molecules then drift down a drift region and are separated according to their mass. The IMS Detector measures 1.86" in length and 2.5" in diameter. The IMS Detector is then placed inside a metal box measuring 12" in length,6" in height, and 2"in depth. This box is referred to as the Anslytical Unit. \\ N_ {:t.s, i 10.0 PURPOSE OR INTENDED USE OF THE DEVICE t It is intended that this device will be used in a number of products manufactured by CPAD for the purpose of detecting organic compounds. CPAD currently manufactures Explosives Detection Systems and Narcotics Detection Systems, which incorporate one or two of the devices referred to in this application. Although these detection systems may change and new products will be introduced, the " device" referred to in this application, which will be used as a component in many of these systems, will not change from the description contained in this application, without an amendment j request. The device is designed to be installed in a fixed location within the system; it does not move. J

11 0 RADIATION SAFETY FEATURES OF THE DEVICE in this particular case, the safety concerns revolve around the Nickel 43 source. Specifically. Its mounting, access to the source. shielding. matenals of construction. Its ability to withstand harsh conditions with no extemal radiation leaks, and the proper labelling of the device. 11.1 Method of Construction Materials for construction are aluminium and teflon, with all screws and bolts being stainless steel. The specific materials for each component is indicated in the appropriate drawings. J Figure A (drawing number MA-A-077) depicts the final assembly of the IMS Detector. The Detector is then installed inside the Analytical Unit shown in Figure B (drawing number MA-i A-078). 11.2 General Desenption The IMS is composed of: i) The source holder sub-assembly. Drawing number IM-B-035. ii) The source cover sub-assembly. Drawing number IM-B-037 iii) The base. Drawing numberIM-B-001. iv) The source base. Drawing number IM-0-002. The source holder sub-assembly is attached to the source base, then the base is slid over the source holder sub-assembly and firmly secured to the source base enclosing the entire IMS. See drawing number IM-B-040. 11.3 Method of Assembiv a. Source Holder Sub-Assembly The assembly of the source is depicted in drawing number IM-0-035. A breakdown of the specific iterns found in this drawing are as follows: item # 3 reference drawing number IM-B-020 Item # 4 reference drawing number IM-B-022 Item # 5 reference drawing number IM-B-023 Item # 6 reference drawing number IM-B-024 ltem # 7 stainless steel screen item # 10 Nickel 43 source l

1 i l Method of assembly. Reference drawing number IM-B-035.

) The Nickel-63 source, item # 10 is pressed into the back of the recessed hole located in the centre of item # 4. which is constructed of aluminium ii) Item # 4 containing the Nickel 43 source is placed into item # 3, which is constructed of teflon.

iii) ltem # 5 is then placed on the front of item # 4. j I iv) Item # 7, the stainless steel screen, is then placed in the centre of the front face i on item # 5.

j v) Item # 6, constructed of aluminium, is used to secure the Nickel-63 source firmly into item # 3. Item # 6 fits tightly into item # 3, and is secured by two stainless steel bolts, item # 15, and the nuts and washers item #s 1,16, and 17.

This process sandwiches the Nickel-63 source into a securely tight enclosure and does not allow any movement. i b. Assembly of the Source Holder Sub-assembly to the Source Base. i) The source base is constructed from aluminium bar stock as per drawing number IM-B-002. ii) The completed source holder sub-assembly is then attached to the source base. This is accomplished by insertinr ' source holder sub-assembly item # 1 on drawing number IM-B-036 at the teflon end, into the source base item # 2 drawing number IM-B-036. These two components are then screwed together usirg the screws designated as item # 5 on the drawing. c. Assembly of the Base to the Source Base. i) The base is constructed from aluminium bar stock as per drawing number IM-B-001. ii) The base is then secured to the source base as depicted in drawing number IM-B-040 with four stainless steel screws item # 7. The completed IMS Detector showing the overall dimensions can be seen in Figure A (drawing number MA-A-077). d. Assembly of IMS Detector in the Analytical Unit. The completed IMS Detector is securely fastened inside the Analytical Unit, sandwiched between the two sides and screwed to the box using three stainless steel screws as depicted in Figure B (drawing number MA-A-078). The method and materials of construction outlined above allows for optimal security and safety of the Nickel-63 source by: -

l l l i i

) The method of mount:ng the Nickel-63 source in the source holder sub-assembly ensures the source will stay put in the sub-assembly even under extreme conditions ii) Shielding of the source is three fold. First, in the source holder, second, in the source base assembly, and third, by plactng the IMS Detector in the_ Analytical Unit.

iii) Access to the source by human hands is impossible as there are no openings or orifices large enough in the Analytical Unit to allow human hands to penetrate. i 11.4 Labellina A warning label (drawing number LA-B-007) will be affixed to the device in the location depicted in Figure C (drawing number MA-A-079). This location should ensure visibility of the label in most cases regardless of the type of equipment the device will be installed in. If - the installation does not allow for easy visibility, a second label will be affixed to a surface that is visible. The label will be an adhesive type with the radiation symbol being a magenta colour on a yellow background. The label will read as follows: WARNING -- RADIATION HAZARD O THIS ANALYTICAL UNIT CONTAINS A 5[ALED RADICACTIVE SOURCE. Ni 63 AI 3 3 MILUCME3 { h DISASSEMBLY AND PEMOVAL Of THE RADI0 ACTIVE SOURCE MUST NOT BE ATTEMPTED EXCEPT Bf CPAD TECHNOLOGIES INC. TWELVE MDNTH LEAK TESTING OF THIS DEVICE IS REQUIRED IN ACCORDANCE WITH UCENSING RE0ulREMENTS Of THE APPLICABLE NUCLEAR REGULATORY AGENC1 THE RECEiPI, POSSESSION. USE AND TRAN5fER OF THl5 UNIT MODEL _________________ SERIAL. ________________, ARE SUBJECT TO A GENERAL LICENSE OR THE EOUlvALENT AND THE REGL1ATIONS Of THE U S NRC OR OF THE STATE WITH WHICH THE NRC HAS ENTERED INTO AN ACFEEMENT FOR THE EXERCISE Of RECULATORY AUTHORITY TH15' LABEL 7ALL B[ MAINTAINED CN THE UNil IN A LEGIBLE CONDlil0N REMOVAL OF THl$ LABEL IS PROHIBITED i L J j 11.5 Manual All manuals supplied with any systems containing a Nickel-63 source will have: a. On the inside of the front cover an 81/2" x 11" page containing the same words as depicted on the label above, and an additional sentence located at the end stating: "For additional instructions on leak testing and servicing refer to the section entitled " Radioactive Device" contained in this manual". l b. A separate section entitled " Radioactive Device", containing the following information: l General This equipment contains a radioactive device (s). Which is licensed under the U.S. NRC and is subject to licensing requirements. Each device contains 3.3 millicuries of Nickel-63. There is no direct radiation hazard from this source which is sealed inside the IMS Detector. No attempt should be made to open and service the device or to remove the source. l l,

l l Leak Test Requirements .}, Each device must be leak tested at regular intervals, not to exceed twelve months. Leak-i test kits and the required analysis may be obtained from the National Leak Test Centre.

)

Procedure for Leak Testing Turn the system off and let stand for one hour, Using the swabs supplied with the leak i test kit, wipe the entire outer surface of the device including the gas flow line labelled - " EXIT' attached to the device. Handle the sampled in accordance with the instructions provided with the test kit. Servicing Under no circumstances should any attempt be made to open and service this device. in the event the device requires servicing, contact the CPAD U.S. representative at: Coulter Sales 444 Bamey's Joy Rd. South Dartmouth, Massachusetts 02748-1004

Contact:

Mr. Gordon Coulter i' Tel: 508 4 36 4 944 Fax: 5084 36-3948 .11.6 Prototvoe Testing j CPAD has been manufacturing and selling Explosives Detection Systems commercially in Canada cnd other parts of the world for three yearc. To date no contamination or leakage ' i has been recorded. As part of the prototype testing, a device which was manufactured in j 1992 will be wiped, and _the results submitted along with the results from an evaluaton 1 according to ANSI N542. l The designated classification code of this device is ANSI 77C32211. The following tests have been conducted in accordance with the ANSI standard. Testing was carried out in the first instance with the IMS Detector installed in the Analytical Unit; to l get closer to the " source", the IMS was removed from the Analytical Unit. The IMS selected for testing is identified as IMS-1-013, and contained a Nickel 43 source supplied by NRD in September 1994. (See Appendix A for test results) i t l'.

l I i I 1) Baseltne Test The Analytical Unit with the IMS installed was wiped tested to determine the baseline. The results are identified as Code A-1 and Code A-2. 2) Extemal Pressure Test A vacuum chamber was constructed, and the IMS Detector installed in the Analytical Unit was placed in the chamber. Using a vacuum pump, the pressure in i I the chamber was brought down to 4 psi, and held there for five minutes. The chamber was then brought back to atmospheric pressure, and the procedure repeated a second time. The IMS Detector was then wipe tested. A second set of tests was done with the IMS removed from the Analytical Unit. The results are identified as Code B-1, Code B-2, Code C-1, and Code C-2. i 3) The Hammer impact Test l A steel hammer of 50.9 g mass was constructed according to the ANSI standard and dropped once from a height of 1 m on the IMS Detector. The IMS Detector was placed on a cement floor during this test. A dry wipe test was performed. The results are identified as Code D-1 and Code D-2. i 4) High Temperature Test j The IMS Detector was placed in a convection oven at 36 degrees C and was - brought to a temperature of 260 degrees C in 6 minutes, and was maintained at that temperature for one hour. Air was passed through the IMS during the one hour heating period. Tne IMS was removed from the oven and left to cool for 40 minutes, after which a wipe test was performed. The results are identified as Code E-1 and Code E-2. ) 5) Low Temperature Test The IMS Detector was placed into a styrofoam container, which was filled with dry ice, and left there for one hour. The IMS was removed from the container and was allowed to warm up for one hour and thirty minutes. Air was passed through the IMS for 10 minutes, after which a wipe test was carried out. The results are identified as Code F-1 and Code F-2. 6) The Drop Test The IMS Detector was dropped ten times from a height of 1.5 m on a steel plate in such a way that all surfaces were impacted at least once. A dry wipe test was performed. The results are identified as Code G-1 and G-2. 7) History Test l A device similar to the one tested above that was Manufactured in September 1992, was wipe tested using the dry wipe method. In this case, the Analytical Unit containing the IMS was wiped and then a side panel was removed to expose the IMS, which was also wiped. The results are identified as Code H-1. l l l

.. -. ~... - =. f. I l i 1 l i l 12.0 . INSTALLATION i ' The IMS will be installed in the Analytical Unit by CPAD Technologies Inc. of Canada and therefore l will never come in contact with any other person other than the manufacturer. l '13.0 SERVICING i l i - in the event a device requires servicing, the device will be returned to Canada where a person at the i licensed facility will perform the work No servicing or opening of the device is to be performed in the l U.S. office. i a i l 1 -l 4 h l l l ' i 1 l 4 i _9_

APPEND!X A LEAK TEST RESULTS I l l t

Atemic E ergy Commiss:cn de certr$te I9g n 1 5 Contrei Boarc ce renerpe a:cmict.e Citaa8 c4"3:4 KtP !s? DIRECTORATE OF FUEL CYCLE AND MATERIALS REGULATION %, s, e,.,, -c, Telephone: (613) 943-1568 0,,,,,, January 31,1996 15-1-12086 N. Barton Radiation Protection Services 38 Auriga Drive Suite 269 Nepean, Ontario K2E 8A5

Dear Mr. Barton:

This is to inform you that your equipment and procedures have been assessed by Atomic Energy Control Board (AECB) staff and found to satisfy the criteria set out in regulatory guide R-116 (Requirements for Leak Testing Selected Sealed Radiation Sources). The name and location of your organization and the name of the appropriate contact person will be maintained in our database. This information will be provided to AECB licensed users ofleak test services upon request and to applicants for new licences. Please note that this is restricted to the isotopes specified in your submission, namely: 1. Co-60 4. Am/Be 7. Am-241

10. Cd-109 2.

Sr-90 5. Ir-192 8. Fe-55 3. Cs-137 6. Cm-244 9. Ni-63 Future re-assessments of your equipment and procedures will be done periodically. If future assessments continue to be positive, information on your organization will continue to be made available as described above. Future re-assessments will likely be coordinated with your regularly scheduled licence inspections. If you have any questions regarding this matter, please forward them to the Materials Regula ' Division at the above address. nqerel, s M. Tay(or Director Materials Regulation Division C.C.: CRO ASG/MRW%QW C d(,k I*I Fas/Telecopieur (6 3)995-5086 Envoy AECBREG WlPE TEST INFORMATION l l i CODE A initial test on complete Analytical Unit 27 May 96 Counts /50 min 2096 paper ' Counts /50 min 2132 cotton swab CODEB Pressure test on Complete Analytical Unit 27 May 96 Counts /50 min 2184 paper 1 Counts /50 min 2024 cotton swab CODE C Pressure test IMS 27 May 96 Counts /50 min 2119 paper Counts /50 min 2147 cotton swab CODE D Hammerimpact test IMS 28 May 96 Counts /50 min 2089 paper Counts /50 min 2016 cotton swab CODE E High temperature test IMS 28 May 96 Counts /50 min 2040 paper _ Counts /50 min 2139 cotton swab CODE F Low temperature test IMS 29 May 96 Counts /50 min 2103 paper Counts /50 min 2073 cotton swab l l CODE G Drop test IMS 29 May 96 Counts /50 min 2213 paper Counts /50 min 2077 cotton swab I CODE H History test complete Analytical Unit 29 May 96 plus exposed surface of IMS Counts /50 min 2123 paper L.-

4 Leak Tes: Measurir.; Certifi: ate ircEMSEE Co.Name: CPAS Technelegies Inc. Address: 40 Ca.melet Drive, Nerean, Ontarie M20 SX9 AECB Lic.#: 5-10913-98 Telephone #: 613-224-9939 Contact Person: Al McEachern - MEASURER Name: P. Finnigan Address: 1612 Orake Avenue, ottawa. Ontario K1G OL9 Telephone: (613) 731-0643 Sampling Date: May 27 1996 Sample I.D.: Code A - 1 Date of last calibration and verification check: May 1. 1996 MEASUREMENT Measuring method:HP-260 probe with scaler Background (counts /12 min. ) : 2065 Sample tcounts/10. min.): 2211 E = detector efficiency: .003 Activity (Bq) < 19.7 counts - bkgd. 3000 sec x E

== Conclusions:==

< the AECB leak test criteria of 200 Bq Actions:

None required Measuring Date: May 30, 1996 Signature of Measurer: . M A 9 1 ? i 1 l Leak Tes: Measuring Certificate

  • +-rugtr i

a-"- ' 7'a= inc. Co.Name: coin m Address: 40 carelet Drive. Nepean. Ontarie M2G SX* AECB Lic.#: 5-10813-98 Telephone #: 613-224-9939 Contact Person: Al McEachern MEASURER Name: P. Finnigan Address: 1612 Drake Avenue, ottawa. ontario K1G OLE Telephone: f613) 731-0643 Sampling Date: May 27 1996 i Sample I..D.: code A - 2 Date of last calibration and verification check: May 1. 1996 MEASUREMENT I Measuring method: HP-260 probe with scaler l Background (counts /la min.): 2065 Sample (counts /12 min.): 2132 E = detector efficiency: .003 Activity (Bq) < 18.7 counts - bkgd. 3000 sec x E

== Conclusions:==

< the AECB leak test criteria of 200 Bq Actions:

None recuired Measuring Date: May 30. 1996 Signature of Measurer: 624 4 v t l l l

l l I l 'eak Test Measur;ng Certif;:a e

  • ITEM 3EE Co.Name:

CPAD Technelecies Inc. l Address: 40 Ca.melet Drive. Nepean. ontarie M2G 5x9 AECB Lic.#: 5-10813-98 Telephone #: 613-224-9939 Contact Person: Al McEachern MEASURER l i Name: P. Finnigan Address': 1612 Drake Avenue, ottawa, Ontario K1G OL9 l Telephone: (613) 731-0643 Sampling Date: May 27, 1996 a Sample I.D.: Code B-1 Date of last calibration and verification check: May 1. 1996 MFASURFMENT i Measuring-method:HP-260 probe with scaler r l Background (counts /12 min.): 2065 Sample (counts /12 min.): 2194 E = detector efficiency: .003 l l Activity (Bq) < 18.7 counts - bkgd. 3000 sec x E

== Conclusions:==

< the AECB leak test criteria of 200 Bq Actions:

None required Measuring Date: May 30, 1996 tb6WI i Signature of Measurer: / l y 5 i l (~ i -

i t l 1 l

  • eak Ces: Measur;..; Certif;; ate

--eyeer Co.Name: cPAD Technelegies Inc. I i l Address: 40 Camelot Drive. Nepean. Ontarie v?c Eva l l j l-AECB Lic.#: 5-10813-98 Telephone #: 613-224-9939 i Contact Person: Al McEachern MEASURER j Name: P. Finnigan Address: 1612 Drake Avenue. Ottawa. Ontarie K1G OL8 j Telephone: (613) 731-0643 i Sampling Date: May 27 1996 Sample I.D.: Code B -2 ~ Date of last calibration and' verification check: May 1, 1996 MEASUREMENT j Measuring method: HP-260 probe with scaler Background (counts /11 min.): 2065 i Sample (counts /la min.): 2024 1 i l E = detector efficiency: .003 l Activity-(Bq) < 18.7 counts - bkgd. 3000 sec x E

== Conclusions:==

< the AECB leak test criteria of 200 Bq Actions:

None recuired Measuring Date: May 30, 1996 ll Signature of Measurer: +e v 4 1 ( a 16 - l l

l l i Leak Test Xeas'; ring Cer;ifi ate l ircEMsEE i f Co.Name: CPAD Teeb_elecies Inc. ( Address: 40 carelet trive, Nepean, entarie g2a syg l AECB Lic.#: 5-10813-98 Telephone #: 613-224-9939 Contact Person: Al McFachern MEASURER j Name: P. Finnigan i Address: 1612 Drake Avenue. Ottawa. Ontario K1G OL8 Telephone: (613) 731-0643 Sampling Date: May 27, 1996 Sample I.D.: cede c - 1 Date of last calibration and verification check: May 1. 1996 MFASU9FMFMT Measuring method: HP-260 probe with scaler ' Background (counts /la min.): 2065 Sample (counts /12_ min.): 2119 E'= detector efficiency: .003 L Activity (Bq) < 18.7 counts - bkgd. \\ 3000 sec x E i

== Conclusions:==

< the AECB leak test criteria of 200 Bq Actions:

Nene required Measuring Date: May 30. 1996 Signature of Measurer: N _ghl 1 3

l Leak Test Measuring Certi'i ate LICEif9EE Co.Name: CPAD"Technelecies Inc. Address: 40 Camelot Drive. Nerean. Ontario K2G SM8 AECB Lic #: 5-10813-98 Telephone #: 613-224-9939 . Contact Person: Al McEachern 1 MEASUPER Name: P. Finnican Address: 1612 Drake Avenue. Ottawa, Ontario K1G OL8 Telephone: 1613) 731-0643 j Sampling Date: May 27. 1996 Sample I.D.: Code CL _2 Date of last calib ation and' verification check: May 1. 1996 MFASU9FMFMT Measuring method: HP-260 crobe with scaler Background (counts /la min.): 2065 Sample (counts /la min.): 2132-E = detector efficiency: .003 Activity (Bq) < 18.7 counts - bkgd. 3000 sec x E

== Conclusions:==

< the AECB leak test criteria of 200 Bq i

Actions: None recuired Measuring Date: May 30. 1996 Signature of Measurer: tEev/ / ( I -

.~. i

l l

i I Leak est Measurir.g Certificate irc M?rt Co Mame: CPAS Technelecies Inc. Address: 40 carelet Drive. Nepean. Ontarie M2c,EX9 AECB Lic.#: 5-10913-98 Telephone #: 613-224-9939 l Contact Person: Al McEachern McASUPER I Name: P. Finnigan Address: 1612 Drake Avenue. Ottawa. Ontario K1G OL8 r Telephone: (6131 731-0643 Sampling Date: May 27. 1996 Sample I.D.: cede D -1 j Date of last calibration and verification check: May 1. 1996 'MEASUprMENT' l Measuring method: HP-260 crobe with scaler Background (counts /la' min.): 2065 Sample (counts /12 min.): 2089 E = detector efficiency: .003 Activity (Bq) < 18.7 counts - bkgd. = 3000. sec x E

Conclusions:

< the AECB leak test criteria of 200 Bq Actions:

None recuired Measuring Date: May 30, 1996 Signature of Measurer: N l f k i l i i l I _eak ~es: Measuring Certifi: ate 1 TENFEE Co.Name: cPAD Tech-clegies T-- Sv9 L Address: 40 carelet Drive, Nepean. Ontario K2G AECB Lic #: 5-10813-98 Telephone #: 613-224-9939 Contact Person: Al McEachern MEASURER ~Name: P. Finnigan Address: 1612 Drake Avenue, ottawa, Ontario K1G OLB Telephone: (6131 731-0643 Sampling Date: May 27, 1996 i Sample I.D.: Code D --2 Date of last calibration and verification check: Mav 1. 1996 MFASUPEMENT Measuring method:HP-260 probe with scaler E Background (counts /12 min. ) : 2065 1 l Sample (counts /12 min.): 2016 E = detector efficiency: .003 1 Activity (Bq) < 18.7 counts - bkgd. 3000 sec x E

== Conclusions:==

< the AECB leak test criteria of 200 Bq.

f Actions: None recuired l -a l ' Measuring Date: May 30. 1996 ' Signature of' Measurer: 4te-df a .20 - i. I

1 Leak Tes Measuri..; ertifi: ate irritisEE Co.Name: CPAD Technoicgies-Inc. , Address: 19 Camelet Drive. Nepean, Ontario K2O EX8 AECB Lic.#: 5-10813-98 Telephone #: 613-224-9939 Contact Person: Ai McEachern ' MEASURER Name: P. Finniaan 1 Address: 1612 Drake Avenue. Ottawa. ontario K1G OL8 Telephone: (613) 731-0643 Sampling Date: May 27 1996 Sample I.D.: Code E -1 Date of last calibration and verification check: May 1, 1996 MEASUREMENT Measuring method: HP-260 probe with scaler Background (counts /12 min.): 2065 1 Sample (counts /1Q min.-): 2040 E = detector efficiency: .003 Activity (Bq) < 18.7 counts - bkgd. 1Q29. sec x E l

== Conclusions:==

< toe AECB leak test criteria of 200 Bq Actions:

None required Measuring Date: May 30. 1996 Signature of Measurer: M / f V i Leak Test Measurin; Certifi:ste ir EN3rr Co.Name: CPAS Technelegies Inc. Address: 40 Ca. relet Drive. Nepgan. Ontarie F2G EM9 AECB Lic.#: 5-10913-98 . Telephone #: 613-224-9939 Contact Person: Al McFachern MEASURER Name: P. Finnigan Address: 1612 Drake Avenue. Ottawa. ontarie K1G ole i Telephone: (613) 731-0643 Sampling'Date: May 27, 1996 Sample I.D.: Code E -2 Date of last calibration and, verification check: May 1. 195i MEASUREMENT Measuring method:HP-260 probe with scalgt i Background (counts /12 min.): 1065 ] 1 Sample (counts /12 min.): 2139 i E = detector efficiency: .003 Activity (E < 19.7 counts - bkgd. B 3000 see x E

== Conclusions:==

< the AECB leak test criteria of 200 Bq Actions:

None required Measuring Date: May 30, 1996 Signature of Measurer: (luJ i [ - -.. - - ~. l i

I i

Leak Test Measuring Certifi:a e U ' c 7str ) 1 l Co.Name: CPAD Technelecies Inc. ) Address: 40 camelet Drive. Necean. Ontario M2G Sv9 j AECB Lic.#: 5-10813-98 I Telephone #: 613-224-9939 Contact Person: Al McEachern MEASUFFR 1 Name: P. Finnigan Address: 1612 Drake Avenue. Ottawa. ontario ric ots Telephone: (6131 731-0643 Sampling Date: May 27. 1996 ) ) Sample.I.D.: Code-F - 1 Date of last calibration and verification check: May-1. 1996 MEASUFFMENT Measuring method:HP-260 probe with scaler Background (counts /12 min.): 2065 Sample (counts /la min. ) : 2103 E = detector efficiency: .003 Activity (Bq) < 18.7 counts - bkgd. 3000 sec x E

== Conclusions:==

< the AECB leak test criteria of 200 Bq Actions:

None required Measuring Date: May 30. 1996 Signature of Measurer: y l l 4 i l l l l l l-i- l Leak ~es: Measurir.; Certificate it E! sEr Co.Name: CPAE Technolecies Inc. Address: 40 camelet O ri're. Necean. ontario K2G 5xo 4 AECB Lic.#: 5-10813-98 ] Telephone #: 613-224-9939' i ' Contact Person: Al McEachern l MEASUPER Name: P. Finnican Address: 1612 Drake Avenue, ottawa, ontario KiG OL8 Telephone: (6131 731-0643 1 ) l Sampling Date: May 27. 1996 Sample'I.D.: Code F - 2 Date of last calibration and verification check: May 1. '1996 j MEASUREMENT Measuring method:HP-260 probe with scaler ~ Background (counts /la min.): 2065 Sample (counts /la min.): 2073 E = detector efficiency: .003 Activity (Bq) < 18.7 counts - bkgd. 3000 sec x E i i conclusions: < the AECB leak test criteria of 200 Bq l l l i Actions: None recuired -Measuring Date: May 30._L111 ' Signature of Measurer:_ - gle d 4 4 i . l \\ 1

-~ I. Leak Test Measuri..; Certift:ste ircEMere 1 Co.Name: CPAS Technelegies Inc. j i [ Address: 40 camelet Drive. Nepean. Ontarie y2G 5xg l AECB Lic.#: 5-10813-99 I Telephone #: 513-224-9939 Contact Person: Al McEachern MEASUPER l l Name: P. Finnigan Address: -1612 Dbake Avenue. Ottawa. ontario yiG OL8 l Telephone: J613) 731-0643 ' Sampling Date: May 27. 1996 l Sample I.D.: Code G-1 Date of last calibration and verification check: May 1. 1996 MEASUPEMEMT 't l Measuring method:HP-260 probe with scaler i Background -(counts /11 min. ) : 2065 Sample (counts /10. min.): 2211 l E = detector efficiency: .003 l Activity (Bq) < 18.7 counts - bkgd. 3000 sec x E l

== Conclusions:==

< the AECB leak test criteria of 200 Bq Actions:

None required l Measuring Date: May 30. 1996 signature of Measurer: M v r a 6 4 h r h,

I l .l Leak Test Measuring Certifi: ate .ETE"MF-- .) Cc.Name: CPAD Technologies Inc. ( Address: 40 Camelot Drive. Necean. ontario M2G SYB { AECB Lic.#: 5-10913-98 5 1 1 Telephone #: 613-224-9939 Contact Person: Al McEachern MEASURER I Name: P. Finnigan Address: 1612 Drake Avenue, ottawa, Ontario K1G OLB Telephors: f613) 731-0643 l Sampling Date: May 27 1996 Sample I.D.: Code G - 2 Date of last calibration and verification check: May 1. 1996 l MEASUREMENT Measuring method:HP-260 probe with scaler i Background (counts /52 min. ) : 2065 Sample (counts /12 min.): 2077 i E = detector efficiency: .003 ] Activity (Bq) < 19.7 counts - bkgd. 3000 sec x E

== Conclusions:==

< the AECB leak test criteria of 200 Bq Actions:

None required l Measuring Date: May 30. 1996 Signature of Measurer: 426-/ V / t i

  • l l

l Leak Test Measuri..; Certificate

    • Crygpr Co.Name:.

CPAS Technologies Inc. Address: 40 carelet orive. Nepean. Ontarie K20 5X9 A AECB Lic.#: 5-10813-99 Telephone #: 613-224-9939 Contact Person: Al McEachern MEASURER Name: P. Finnigan Address: 1612 Drake Avenue, ottawa, Ontarie K1G OL8 Telephone: f6131 731-0643 Sampling Date: May 29. 1996 Sample I.D.: Code H 'Date of last calibration and verification check: May 1. 1996 MEASUREMENT Measuring method: HP-260 probe with scaler Background (counts /12 min.): 2065 Sample (counts /la min.): 2123 E = detector efficiency: .003 Activity (Bq) < 19.7 counts - bkgd. 2222 sec x E

== Conclusions:==

< the AECB leak test criteria of 200 Bq l

Actions: None recuired l ~ l Measuring Date: May 30. 1996 Signature of Measurer: M Jh N >

I l i I l l l t APPENDIX B 4 i l 1 i l l i ASSOCIATED DRAWINGS Il t 1 1 i i i 1 t 1

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