ML18348A561

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NRC-2018-000497 - Resp 2 - Final, Agency Records Subject to the Request Are Enclosed
ML18348A561
Person / Time
Issue date: 12/06/2018
From:
NRC/OCIO
To:
References
FOIA, NRC-2018-000497
Download: ML18348A561 (192)


Text

May 31 , 2017 U.S. Nu c l ear Regu l atory Commission M ateria l s Safety Licens i ng Branch Office of Nuclear Material Safety and Safeguards ATI N: SSD R Washington , DC 20555-0001 RE: Request for device evaluation for the Valeo Instruments Company TGA 3000 and an exempt distribu t ion license To whom it may concern: Sta n e Va l eo In s trument s Company , In c. (" Va l eo"), r equests tha t the NRC eva l uate the Valeo TGA 3000 for a r adioac ti ve device reg ist rat ion an d exemp t distribut i on l i ce n se. The TGA 3000 is a gas detector capab l e of detecting prob l ematic impurities in U l tra High Purity Gases in o r der to alert the end user to u nacceptable l evels of conta min ants that may be det ri mental to t h ei r product quality. The TGA 3000 has been designed to be an addition t o al r eady in p l ace detection systems rather than a stand-a l one device. To support this reques t Va l eo has included the fo ll owi n g information

1. The comple t ed summary data application and the comp let ed NR C F orm 3 1 3 for thi s request are included in attachment
1. 2. A desc ri p t ion of use for the T GA 3000 is inc l uded in attachment
2. 3. Testing o n the I on Mobility Spec tr oscopy Cell Assemb l y (I MS) was performed as o utline d i n NR C NU REG 1556 , Vol. 3 , Rev. 2. Th e results o f this testing are enc l osed in attachment 3 4. A detai l ed description of the construction and design of the TG A 3000 is included in Attachment
4. 5. Va l eo confirms it shall u se a qua l ity assurance program compliant w i th Append i x G of NUREG 1556 , Vol. 3 , Rev. 2. A copy quality assurance proce dure s can be found within the TGA 3000 Manufa c tur i n g manu a l which c an be found in Attachment
5. 6. Attachment 6 con t a i ns d r aw i ngs and p i ctures of: P age 1 of 72
  • the product lab e l indicating Va l eo.as the Manuf ac tur e r of the Model TGA 3000;
  • drawings wh i ch show the l ocation of th e l abe l which sha ll be p l aced on t h e ex t erna l surface of th e I MS Ce ll Assembly ,
7. A copy of the user manual for the TGA 3000 that will be included with each TGA 3000 is provided in Attachment
7. 8. A copy of the Model TGA 3000 Datasheet that will be provided to potential custo mer s of the TGA 3000 is incl ud ed in Attachment
8. 9. Attachment 9 is Valeo In struments Company , In c. request to withhold information from public disclosure under 10 CFR 2.390. 10 Valeo is currently requesting an amendment to t heir State of Texas license #L01572 to au t horize the possession of th e NRD Model A-001 Am-241 sealed source and to manufacture the Model TGA 3000 -see Attachment 10 for a copy of the current Radioactive Materials License. 11. Enclosed with this submittal is a Compact Disc of the technical drawings and pictures which can be used , in part , for inclusion in the registration certificate. If you have any questions please call me at (713)688-93 4 5 or email me at Stan@vici.com . Sin,rly, ' /J ltW11bdl)

/f('{vlt)1 I StJnley ~S~~arns Pres ident and Radiation Safety Officer Valeo In struments Compa n y , Inc. Post Office Box 55603 Houston , Texas 77255 Page 2 of 72 Name and Comploto Mailing Address of th e Appli ca n t: Valeo Instruments Company , Inc PO Box 55603 Houston. Texas 77255 The Appl i cant Is (che ckori'e'f:

Cus t om User Man uf ac t urer Distribu t or X Man uf ac tu rer a n d D 1 s t ,1butor If the Applicant Is a Custom User , Provide the Name and Comp l ete M alling Address or the Di s tribut o r: A tta c h me nt I SU MMAR Y DATA Nam e , Title , and Te l ephone Numb er of th o Indi v idu a l To Be Contacted If Addit i onal lnfonnaUon or Clarlflcation I s N eeded by the N RC: S t anley D Stearns Jr President and Radiation Safety Officer If the Applicant Is N o t the Manufa cture r , Provide th e Nam e and Comple t e M ailing Address or tho Manu fac tur e r: N/A Provide the Name , C omplete M alling Addr o as , and Fun c tion o f Other Companies Involved: N RD-2937 Alt Boulevard , PO Box 3 1 0 , Gra n d Island. NY 1 4 072-0310/ Se a led Sou r ce Provider Modol Number: TGA 3000 Princ i pal Use C o de (se e Appendix C):32222 ---+---------------i Name U s ed by tho Industry to Iden tify tho For Use by: P r oduct (e.g., Radiography Exposure S p ec ifl c Lice n sees On ly Devic e, Teletherapy So urc e , Calib rat ion Source): General Licensees Onl y Gas and Aeroso l Detec t or Leak-Test F r equen c y: \ Periodic Leak Tes t ing ,s N ot Re q ui r ed 6 Mo n th s A tt ac h ed 1s 1us t 1 fi ca h on f or a leak t es t fre q uency o f g rea t er t ha n 6 mo nt hs Bo t h Specific and General Licensees X Pe r sons Exe mpt f r om Lice n si n g Principal Section of th e 10 C FR that Applies t o the User (e.g., General Licensees und er 10 CFR 31.5): Exempt License 10 C F R 30 20 Radionuclides and M aximum A ctivities (including l oading tolerance)

Am-2 4 1 M aximum Ac 1 1 11 1 ty 20 µCi (0 7 4 M B q) (N RD M o d el A-001) CERT I F I CATION: --_____ ..__ ________________________

--1 THE APPLICA N T U N DERSTA N DS THAT ALL STATE M E NT S A N D REPRESE N TATIO N S MA DE I N THIS AP P LICATIO N ARE BI N DI N G UPO N THE APPLICA N T THE APPLICA N T AN O A N Y OFFIC I A L EXECUTI N G T H IS CER T IFIC A TIO N O N BCH ALF o r T H C A PPLIC ANT , NAM ED AB OVE , CERTIFY THAT T HI S APPLICATIO N IS PREPAR E D IN CO N FOR M ITY W IT H T I TLE 10 OF T H E CODE OF FEDER A L REGULATIONS , PARTS 30 A N D 32 , A N D THAT ALL I N FO RMA TIO N CO N TAI N ED HERE IN IS TRUE A N D CORRECT TO THE B E ST OF THEIR KNOWLEDGE A N D BELIEF Signature: -JW.'=.&. 3 o f 7 2 Sta nl ey D. Stearns Radiation Sa fety Of f ice r ------------~

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  • ..,.,....,, , ,w11J1itntN IJA.1'1"'v.*, *I ,uu:n 2 o f 72 1 of 72 Attachment 2 Co ndition s o f Use: a) T h e Valeo I n s trum e n t s Co mpan y I n c. TGA 3000 I on M o bilt y Spectrometer , (IM S), Gas/Particulate Anal yze r M o dul e will be prim ar il y u se d for d e te c t i o n o f impuriti es , s.u c h as H 2 0 and 0 2 , in Ultra Hi g h P ur it y , (U HP) gases w id e l y u se d in th e sem i co ndu c tor , LED , and man y other manufacturin g pro cesses t h at utili ze U H P gases in th e i r manufa c turin g pro cess. T h ese processes r eq u i r e co ntinuou s m o nit o rin g fo r l eve l s o f impur i tie s that would be d e trim e nt a l to quali t y a n d product throu g hput. b) Some o th e r u ses a nd/or applica t ion s co uld in c lude but not limit ed t o th e followin g; I) D e te c t i o n o f tr ace l ev el s urfac e co nt a min a nt s o n wafe r s u se d in th e se mi co ndu c t or indu s tr y. 2) Ai r qua lit y m o n i torin g. 3) Nar co t i cs D e t ec ti o n. c) Th e ex p ec t ed u se fu l life of t h e produ c t throu g h n or mal u sage, a n d with proper care , s hould b e b e twe e n I O t o 15 yea r s. d) No A ccess t o the i o ni z ati o n so u r ce i s afforded b y th e end u ser o r any indi v i dual o t h e r th a n authorized u se r s o n ce th e T GA 3 000 m o dul e ha s bee n a ssem bled in accordance with the Valeo I n s trum e nt Company In c. assembly and sa fety manua l s. T h ere i s n o dir ec t access point to the AM-241 s ou r ce o nce assembly h as been comp l e t e d. e) Du e to th e d es ig n a nd manufactur e of th e TGA 3 000 modul e , it i s hi g h l y unlik e l y th a t ther e wi ll be a s i gn i ficant r e du c t i on in the effectiveness of t h e co ntai n m e nt , s h i elding , or o ther safe t y features of the prod u c t fr o m wear a nd ab u se like l y t o occ u r in n o rma l h a ndl i n g a nd u se of the product durin g it s u se ful l ife. f) Due to the d es ign and manufa c t u re of th e TGA 3 000 modu l e and if u se d und e r normal u se and s p ec ified opera t i o nal g uideline s t he p ro babi l i t y i s lo w that th e co nt ainment , s h ielding o r o t h e r sa f e t y fea t ure s of t h e produ c t wou l d fai l , under s u c h c ircum s tan ces , t ha t a person wou l d 2 of 72 rec i e an external radiation do e or do e commitment in exce s of the do e to the appropriate organ as speci tied in olumn II of the table in 10 CFR 32.2 , and the probability i negligible that a per on would receive an external radiation do e r do e commitment in exces of the dos to the appropriate organ a specified in Column Ill of the tab I in IO FR 32.28. Under nonn a l use and conditi n any disposal of a ingle unit or handling, shipping and storage of unit are unlikely to accumulate in one location.

A tt achment 3 Valeo TGA 3000 P ro t o typ e Te s t in g Ob j ect i ve The ob j ec tive of thi s t es ting is t o pro v id e s uffi c i e nt infonnati o n a n d data th a t ve rifie s th e I M S design of the Valeo TGA 3 000 will maintain it s integrit y when s ubj ec ted t o co ndition s o f nom ,a l u se and Lik e l y acc id e nt co nditi o n s. No r mal u se and likel y accident co ndit i ons m ay include , b ut not limit e d t o, th ose conditio n s ex p erienced dur in g in sta ll a ti o n , u se, ha n d l ing , m a int e nan ce, s tora ge, a nd tr ansportation (o nl y n o rmal conditions durin g transpo rt ation n ee d to b e considered). R a di oac ti ve So u rce associat e d w i th the Valeo T G A 3 000 Eac h TGA 3000 m o dul e wi ll u se o n e sca l ed Foil So urce NRD m o d e l numb er A-00 I. So u r ce ma t e ri a l i s AM-241 at no l ess than 1 7 micro c urie s and n o m o r e t han 2 0 micro cur i es. A m e ri c ium-24 1 C h a r ac t e ri s tic s Americium-241 is a s il ve r-gr ey m e t a l which de cays primarily by a lph a pani c l e em i ss i on t o Neptunium-237. Low e n e r gy gamma radiation acco mpani es th ese de cays. wit h th e 59.5 kcV gam m a e mi ssio n b e in g of the m os t imponan ce. A l pha 5485 k cV 84.5 % Alpha 54 4 3 k eV 1 3.0% Gamma 59.5 k c V 35.9% Gamma 26.3 k eV 2.4 % Ga mm a 1 3.9 k eV 4 2.0 % Radiation In s trum e ntation For purp oses of m eas urin g s t ray radiati o n fo r ga mma r ad i a ti o n befo r e a nd af t e r each of th e t hr ee (3) t es t s li s ted b e l ow , A Ludlum m ode l 3 s ur vey m e t e r with a m ode l 44-9 Bet a/Ga mm a d e t ecto r pancake p r ob e was u se d fo r mak i n g t h e radi a ti on m eas ur e m e nt s in the se ri e s of tes t s de sc rib ed in thi s sec tion. T h e s urve y m ete r used fo r s tr ay radia ti o n m eas ur e m e nt s befo r e a nd afte r eac h t es t s h a ll be cal ibr a ted w ithin 1 2 m ont h s a t t h e ti me of t es tin g and s h a ll be ca li b r a t ed agai n s t a ga mm a ra diati o n s tandard t o a n acC LLra cy o f+/-10 percent of fu ll sc ale a t a point w i thin th e ra t e d ene r gy range. 1 of 72 Test Parameters:

T h e Valeo In s trum e nt s Co 1 111pany TGA 30 00 s h all be m a nufa c tur e d b y Valeo In s trum e n t s Co mp a n y lo ca ted in H ousto n Texas under th e a u thority of S tat e of T ex a s i ss u e d Radioa c tiv e M a t erials License No L O 15 72. The t es t s a nd m eas ur e m e nt s d e fin e d in thi s d oc um e nt s h a ll be pe rform ed o n th e s t a ndard J on M o bility S p ec trom e t e r (IMS) ce ll asse mbl y w h ic h co nt a in s, in part , a s in g le Amer i cium 24 1 (A m-24 1) sea led fo i l so ur ce (-20 mi cro curies). T es tin g of the I MS asse mbl y was c h osen as op p osed t o th e t es tin g o f th e final M o d e l T GA 3000 d e t ector as t hi s ce ll i s th e prim ary co nt a inment for th e so ur ce and co ntain s a ll th e pro t ec ti ve eq u ip m ent. The p roto t y p e t es tin g was accomp li s hed by assemb lin g thr ee TGA 3000 m od ul es in acco r dance w i th th e a sse mbl y manual , as fo un d in attachme nt 5 o f thi s app li ca t ion. Th e asse mbl e d TG A 3000 modules were numb ered I , 2, and 3 co n sec uti ve l y, an d are r e f e rr ed t o as T GA 3000 m o dul e# I , T GA 3 000 , m o du l e #2, a nd TGA 3 000 module # 3 fo r the se t es t s. T h e AM-241 sou r ce ser ial numb e r s we r e r ecor d e d for e a c h assemb l y. TGA 3000 module# 1 was u sed! as th e co ntrol t es t asse m b l y. Exte rna l Radiation Levels Thr ee TGA 3000 modu l es asse mbled wi t h thr ee different AM-241 so ur ces, @ 20 mi cro-c urie s eac h , were used for th e ex t e rn a l radia t ion level t es tin g. Th e t es tin g was done u si n g a L u dlum model 3 survey meter having a model 44-9 Be t a/Ga mma d e t ec tor p anca k e p robe attached. Th e detailed de sc ription of the t es t s a nd th e r es ult s are in t a bl e I be l ow. Drop testing. Ce ll # I was n o t drop t es t ed and was u se d as th e co nt ro l device for th ese t es t s. Ce ll s # 2 and # 3 were dr o pp e d four tim es each fr o m h e i g h t s of 36 inche s and 4 8 in c h es o n t o a de s i g n ated safe area w ith a co n c r e t e s urfa ce, fo r a t otal of e i g ht drop s for eac h ce ll. Th e dr o p area b ac k gro und radiati o n was m eas ured a nd re co rd e d. T h e ce ll s we r e pu s h e d fr om a n a t top s urfa ce s imulatin g a n a cc idental fa ll fr o m d es k t op h e i g ht s a nd co unt e r top h e i g h ts. Th e ce ll s were exa min e d after eac h drop for v i s ibl e damage and th e n radial ion measuremen t s were m ade at 5 c m , I O c m , 3 0 , and I 00 c m aro und th e e ntir e s urfa ce a r ea. Th e co nditi o n and radiation m eas ur e m e nt s were r eco rd ed after eac h drop. Sec t ab l e 2 fo r t es t r es ult s. Afte r comp l e tion of th e drop t es t , th e d es ignat e d d ro p area was s u rveyed for s urfa ce co ntamination u s in g the Ludlum m ode l 3 Gei ge r co unt e r. Thermal br e akdown te s ting. Ce ll # I u sed as contr o l d ev i ce and was n ot heat e d for th ese te s t s. Ce ll # 2 and# 3 were di sasse mbl e d down to the cera mi c a nd K ovar ce ll body. A fl ex i bl e K ap t on h ea t e r w it h R TD 2 of 72 th e rm oco upl e a tt ac h e d w as th e n wrapp e d ar o und eac h ce ll a nd r e-ass embled. Th e h ea t e r s we re p la ce d und e r c ontrol of a di g it a l F uji t e mp era t.ur e co ntroll e r. R a di a t io n m eas ur e m e n t s we r e m a d e a t 5 c m , IO c m , 3 0 , a nd I 00 c m around th e e ntir e s urfa ce a r ea fro m th e s urfa c e a r ea of eac h ce ll asse mbl y a t roo m a mbi e nt t e mp era tur e. R es ult s we r e r ec orded. Ce ll # 2 and Ce ll # 3 we r e th e n h ea t e d to 300 d eg r ees C a nd h e ld at th a t t e mp e r a tur e fo r a p e ri o d of 2 4 h o ur s. Rad ia ti o n m e a s ur e m e nt s we r e tak e n a c t e mp e r a tur e fo r eac h ce l l a t di s tan ces o f 5 c m , I O c m , 30 c rn a nd I 00 c m a nd r eco rd e d. B ac k gro und m e a s ur e m e nt s o f th e d es i g nat e d t es t a r ea a ro und eac h ce ll we r e m a d e a nd r eco rd e d pri o r t o b eg innin g o f th e t es tin g. Th e ce ll s we r e th e n all owe d t o coo l t o room a mb ie n t a nd rad ia t i o n mea s ur e m e nt s were aga in m a d e a nd re co rd e d. Water e m e r s i o n t es tin g. I M S Ce ll # I , u se d as th e co nt ro l d ev i ce. B ac k g round m eas ur e m e nt s o f th e d es i g n a t e d t es t a r ea a nd wa t e r co nt a in e r we r e m a d e a nd r eco rd e d pr i o r t o th e s t a rt o f t es ti n g. A ll ce ll s we r e m eas ur e d a nd r eco rded fo r r a diati o n l eve l s fr o m a ll s urfa ces a t d i s tan c e s o f 5 c m , IO c m , 30 c m a n d I 00 c m. I MS Ce ll # 2 w a s co mp l e t e l y s ubm e r ge d in a co nt ai n e r of wa t e r for a p e ri o d o f t e n minut es. T h e s u r fa ce o f the wa t e r w a s s ur veye d fo r a n y co nt a min a t io n a b ove b ac k g round b efo r e r e m ov in g th e ce ll fr o m th e wa t e r. Th e ce ll was dri e d and ra di a ti o n m eas ur e m e nt s w er e t a k e n a t 5 c m , 10 c m , 30 c m , a nd I 0 0 c m a nd r eco rd e d. T es t r e p ea t e d fo r cell # 3. R es ult s of th e proto ty p e t esti ng of the product. T h e p roce dur es a nd r es ult s fo r th e pr o totyp e t es tin g o f th e TGA 3 00 0 m o du l es a r e li s t e d b e l ow. 3 of 72 E x t erna l Rad i at i on Le v e l Mea s u r e m e nt s TH REE T GA 3000 IONIZAT I ON DETECTO RS WE RE ASS E M BlED IN ACCORD AN CE WITtl Of VICI VAi.CO IN S TRU MENTS ASSEM BlY & SAFETY IN S TRUCTION S. THE AS SE M BLES W ERE MARKE D NU MBER S ONE , TWO AN D THR EE , EACH HA~G ONE AM-2 4 1@ 20 MICR.CURI ES S OURCE INS T Al.LED WITH SERIAL N UMBE RS RECORDED AS IN DICATED BElOW. THE FOL L OWING RADIATIO N LEVEL M EASUR EMENTS WERE PERFORMED BY USE Of A U.O.lll MODEL 3 S URVEY METER WITH A MOOEL 44..9 BETA.'GAMMA P ANCAKE PROB E. M REM.IHR CALCULATION S BAS E D ON L llll.tll MOOEL 3 S lRVEY M ETER SCALE , 1 M RE.WHR

  • 3300 CPM ASSE M BL Y M EASURE M ENTS BACK GROUt() I.EASURMENTS FOR TlE ASSE"'8l.

Y AA.EA WERE AVERAGED ATO 0125 mRitr , (41 CPM) ~ASSEMBlY HOUStlG A$EMSL Y HOUStlG ASSEMBl y ELECTROOK:S ASSEMBl Y AW. ASSSSEMll YITEST AVERAGE EXPQSURE UME SMIN 5 MIN AT I CM DISTANCE 2MIN AT3CMD1STANCE SM!N NORIIAL WORKliG QISTAHCE FROM S QWCE <1CM 1CM 3CM 8CM 50CM E S TMATED ANNUAL EXPOSR E B AS ED ON ES TIMAT ED 1 00 UNI T S P E R Y EAR M E AS U REM TOTAL EXPO SU RE P ER U N CALC ULATED ANN U AL E XPO S URE II RE lt AVE R MREM M RE M 0.02 73 CP-0 -018 0.02 73CPO 0.18 0.02 56CP001 06 0.01 46CPO 012 BACKGROUt-1>

2 1.08 EST I MATED ANN U AL DOSAGE 1.08 MREM PER YEAR POST ASSEMBL Y MEASUREMENTS tf ~S WERE TAKEN ARST WITH PHYSICAL SWIPE AT CARRIER lttET CI.OS E ST T O~ TIEN AT 5 , 10 , 30 and 100 CENTl~ETERS FROW Ttf EXTERNALSLWACE Of THREE TGA3000NSCELLS , EAOiOM: HAVINGA AM-2410 20 ~E SOURCE INSTAl.lfD. THE AA.EA SlRvEYED W~ AVERAGED OVER AN AREA LESS~ 10 SOUARE CENTIAETERS M REIMR CALCULA TIONS BASE D ON LUDLU M M ODE L 3 S U RVEY MET E R SCAl.f, 1 MR EWHR

  • 3300 CP U TGA T EST CELL 11 AM-2410 20 uQ sou<<:E SN-0001 T GA TES T CEL L 1 2 A.M-2410 20 uCi sou<<:E $N,QKl2 4 of 72 TE ST AREA BAC K GROU N D ACTMTY FOR CELL I 1 AVE RA G E D A T 0.0 1 25 mR/hr (4 1 CP M) SWI PE TAKEN AT CARRIER IN LET Q.OSE ST T O S OURCE RE S\!. T .l!JillHCf mB/tE SWPE 0.0125 41 CPM 5 CM 0.0125 41 CPM 10 CM 0.0125 41 CPt.l JOCM 0.0125 41 CPM 100 CM 0.0125 41 CPM TE ST AREA BACKGROU N D AC TMTY F OR CE LL I 1 AVERA G E D A T 0.0 125 mR/hr (4 1 CPM) DISTANCE SWPE SCM 10CM 30CM 100 CM MREWHR 0.0125 0.0125 0.0125 0.0125 0.0125 coorr s 41CPM 41CPM 41CPM 4 1CPM 41 CPM Water Emer ion Test Data 5 of 72 HE~'I1 AVAIIAHrn COPY T ABlE 2 ALL T GA 3000 ION!ZATION DETE CTOR CELLS WERE ASSEMBlEO COMPLETE PER ASSEMB;. YAW SAFETY HSTRUCTIONS THE RADIATION ACTMTY LEVELS WERE ~ED USING A. Lt.nUM GE IGER OOUNTER MOOEl. 3 WfTHA MODEL 44-0 PAHCAXE DETECTOR ALL INSTRVIENTS USED ARE 1H ~RENT CALIBRATION PERIOD lE FOU~\'NG TESTS \\'ERE PE RFORMED B Y FW. EMER~ Of CB.LS I 2 AK) f 3 IN A CONTAINER RU.ED Willi UNFILTERED TAP *Y ATER f'-0 A PERIOD OF 10 MNJTES EACH THE SURFACE Of TH E WATER~ TH E CCHTA.1-lER WAS SURVEYED FOR Atl'f A.CTMTY MJ<Nf. BACKGROUND BEFORE TIE CELLS WERE REMOVED FROM THE WATER nE CELLS WERE Tl£N REMOJED FROM THE WATER. DRAINED a EXCESS WATER TO SHEWED CCHTA.tlER.

TH E CEI.LS WERE THEN DRIED IN AN OYEN A T 2e04C ANO AFTER COOLING EA CH CEU WAS S\.flVEYED AAIO RESll. l AAE SHO,YN s aCM L UOl UII MOOEl.3 S U RVEY METER WITH A UODE1. U.S BETA.IGAMMA PANCAKE DETECTOR PROBE U SED FOR RADIATION UEASUREMOO}, 111@!

  • 3300 CPM Pl! lllfMl SURVEY Of ntEWATERII THE CONT AINER WAS A T BACKGROUND , 40 CPII f0..0 1 2SmR/h r) TGA TES T CEll.11 CONTROL DEVICE NOT EMERSED TEST AREA BACXGROUNO ACTMTY AVERA GED A T , 1 CP M .w.24 1 0:llhO C OHTROLDEV IC UURVEY SOURCE St+-QXl1 SWIPE 0.0125 41 T GA TEST CEll. '2 AM-24 1 20uQ SOURC E SH-Om TGA T'f§T CEU '3 AM-2'11 20uCi ~C E SM.am 6 of72 5CM 0.0125 41 10CM 0.0125 4 1 30CM 0.0 1 25 4 1 IOOCM 00 1 25 4 1 TEST AREA BA C K G ROlNl A CTMTY AVERAGE D A T , 1 CP M DETE C T OR ACTMTY BEFORE EUERSJQN mR.'lw S',\1PE. 0.0125 4 1 5CM 00125 4 1 I OCM 0.0~ 4 1 30CM 00125 4 1 IOOCM 0.0 1 25 4 1 YIET M EASURMBff DETE C TOR A C TMTY AFTER 10 MIIUTE EMER$1QN .ctM. S\\1PE 00125 4 1 ~CM D.11125 4 1 I OCM 00125 4 1 30CM 0.0125 4 1 I OOCM 0.0125 4 1 OREO MEASlREMEJfl .ctM. S\\1PE 0.0 1 25 4 1 5CM 0.0125 4 1 1 0 CM 0.0125 4 1 30CM 0.0125 4 1 1000/I 00125 4 1 TES T AREA BACXG ROUND A CTMTY AVERAGED A T , 1 CP M DETE C TOR ACTMTY BEFORE EMERSION DISTANCE mRlhr CPU OETJi CT OR A C TMTY AFTER 10 MNUTE EMERSION S\\1P E 0.0 1 25 41 5CM 0.0125 4 1 IOCM 0.0125 4 1 30CM 0.012:5 41 I OOCM 00125 4 1 YET MEASURMOO mR,'tw .ctM. SWIPE 0.0 1 25 4 1 5CM 0.0125 4 1 1 0 CM 0.0125 4 1 30CM D.O~ 4 1 I OOCM 00 1 25 4 1 OREO MEASlHIIENT m! S\'t'tPE 0.0125 4 1 5CM 0.0125 4 1 I OCM 0.0125 4 1 30CM 0.0 1 25 4 1 IOOCM 0.0125 4 1 Thcm1a l Breakdown Testing TAB L E 3 All TGAml ON!ZATIOO IEECTOR CfilS WERE ASSSBfD COlfl.flE PER AS!alll. Y 00 SAffiY 1lf RADATION AClMTY LOOS WERE t.fASUfD USN; A LlO.l.11 GEIGER COOlTER t.aE. 3 W11H A mt 44-9 PN(A.l(E IEECT~ All lNSTIUIEHTS USEDARfVt'ITKHC\fflHT

~TION PERIOO. ME>SmENTS WERE~ AT AWfifNTTSflERATUf , APRO X. 26'C MIU'd 1HE ENTIRE OUTSia: fflACE Cfllf TGA ml IMS MOOU.ES lHlR TEST AT A asl'~E Of 5 CM, 10 CM, ll CM Nil 100CM. 1lf RESll TS ARE All A'lfPJl:I.

Of 1lf IIGH Atl) LOW REAWlS FOO 1lf ACTMTY 00 1lf SAME lofTl<<Xl WAS USED AFTER TSFERATllf Of '1J! C WA.S llAffl AtfD Fal ,. IIX.RS ON EACH TEST CELL 1lf SWIPE WAS TAKEN AT 1lf CAMiER llfT Q.OSEST TO 1rf SMCE. Ti£ RXJ.oo<<i TESINl WAS NXOlfUSIED SY .&.SS8llHl AflEXlli !£ATER IJONl Ti£ TG\ m, IISCB.lASSalil.ES

!WON() llffl lHER 1IS1 aeRliE I\AONl IT Jm 1lE NSUATO\NO INSllA~ IOJSM. 1lE IQTERS WEA£ o:MIWJDSY TBffRATI.R!:

IXW1ICl B.KOOl(S 1lE IIS CSL MBfla BQIRl ll'l1H IIIXI (HI RTtl llEIID!XlRfS t<<:Ol'ORA.!ED ti 1lE OF 1lE IEATER ~y f,ETVicNTiE CEU .IS'SEIG.

Y I.Ill 1lE IEATER OF &.CHCSL l.l<<R TEST. ll£ lBf9,A ll.R!: OF EAOl CSL Em1 n£ COO'RCl CSL f I WAS Sl<lm.Y R.WD0.9U PEROO OF 1lffl TOA 'IBftRAll.R!:

OF lXl't NO WAS IMTAl!EDAT m\T l'Df81All.R!:

Fa!A PEROOOF fWlS. CSL.SN.UlEJH~'O

>JO Tiffi MR! Tl9 SIRl£1HlAT 5Cll,t.:I C11. ,e1100 K1J CIINWCI 1lE SClm AA£A OF OF &.CHC81 lN& TEST 1lE S\\"ff WAS TAAEN A T 1lE CJJRER NEH10SES1 TO TIE TGA TES T Cfil fl C otllllOI.

DE\1CEIIOT lfATBl Ali-24 1@Il~ TEST AREABACKriROUllAClMTY AVBIAGED A T 6.012511mr , (4 1 CPII) SWIPE O 0125 4 1 ~Sll,Q'.01 TGA TES T Cfil #2 AM,24 10Il~ ~SN<<m T GA TfST Cfil :'l All,2410 II~ ~m<<m 7 of 72 TE S T AREABAC K riROUllACTMTY AVBIAGEDAT0

.01 25~.11 , (4 1 CPII) QETfCTQR A CTMTY I ROOM AII BI BIT rum lllltr SWIPE 0.0125 41 5CM 0.0125 41 1 0CM 0.0125 41 JlCM 00125 41 100CM Q.0125 41 DffiCTOR A CTMTY AITTR 2 4 1WlS I JOO'C .!mm~ CPM SWIPE 0.0125 41 5 CM 0.0125 41 10CM 0.0125 41 JlCM 00125 41 1 00CM 0.0125 41 TES T AR EA BACKGROIJll ACTMTY AffllAGEO AT Q.0125 Mrilv , (41 CPM) DrnCJORACTMTY IROOMAII Bl8fI mim mt SWIPE D 0125 41 SCM 0.0125 41 10 CM ll.0125 41 JI CM 0.0125 41 100CM ll.0125 41 DETECTOR ACJMTYAFTER 2 4 HOURS I JOO'C OSTAl(E llri1r Sl'l'IPE 0.0125 41 SCM 00125 41 1 0 CM Q.0125 41 JlCM OD12S 41 100 CM 0.0125 41 D rop T est D ata TABLE 4 All TGA 3000 I MS CEllS WERE ASSEM8lED COt.R.ETE PER ASSa.161.

Y >Kl SAFETY INSlRUCTIONS THE RAIXATIONACTMTY

~S WERE MEASURED USING A lwt.t.NGBGER COlfflER MOOE1.3WITH A MOOE!. 44-9 DETECTOR All tlSTRt.t.!EHTS USED ARE WITHIN MRfNT CALIBRATION PERIOD. t.£ASUREt,1ENTS WERE MADE AROU'IO ENTIRE StJRFACf OF THE~ TEST CEU A TS CM, 10 CM, ll CM,At() 100 CM. 1l£ RESU. TS ARE AN AVSWi E OF 1l£ ttGH At,D LOWS FOR BACKGROlN>

ACTMTY ANO 1l£ SAAi: IETliOO WAS USED AFTER ClROP SWIPES WERE TAKEN ATM CARRIER INLET Q.OSEST TO THE 5CX.fiCE.

A llOOJM t.<<>OEl. 3 SUIMY METER Willi A t.fJOEL 44-9 /GAWMA DETECTOR ~E WAS USED FOR RAIJATION l,I.EASllB£HTS TGA TEST CEll '1 COt/TROL DEVICE IIOT DROPPED AM-2410 20 uC1 TEST AREA BACKGROOIO ACTMTY AVERAGED AT 0.0125 mR l lw rmage (41 CPM I somcE SN,m,1 TGA TEST Cal #2 AM-2410 20 uC1 SOURCE SK.0002 CROP I CROP2 CROP3 CROPS OROP6 8 of 72 TEST MlfA BA O<GROIH> A CTMTY AVERAGED AT 0.0125 rr&r , (41CPM) omcTOR A CTIVITY BEFORE DROP JEST SWIPE SCM 10CM JOCM 100CM mRlhr 00125 0.0125 00125 0.0125 00 1 25 OROPHElGHT 36" QM 4 1 41 4 1 41 4 1 06SERVEO DAMA GE NONE NONE AfTE.!! OROP ACTMTY !I !!!R.!!J l!~At!CE F~ DETECTQB S~RFACE SWIPE SCM 10CM llCM 100CM SWIPE SCM 10CM llCM 100CM SWIPE SCM 10CM llCM 100CM SWIPE SCM 10CM llCM 100CM SWIPE SCM 10CM llCM 100CM SWIPE SCM 10CM llCM 100C M Mr/II 00125 0.0125 0.0125 00125 00125 0.0125 0.0125 00125 0.0125 00125 00125 0.0125 00125 0.0125 00125 00125 0.0125 00125 0.0125 0.0125 00125 0.0 1 25 0.0125 0.0125 00125 0.0125 0.0125 0.0125 0.0125 00125 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 4 1 Dr o p T es t D a t a Co ntinu e d TGA TEST C E1H 3 TEST AREA BA CKGROUN) ACTMTY A\'CRAG EO AT 0.0 1 25 mRnr , (4 1CPM) AM-241@ uCi DETECT O R A C TI VITY BEF ORE DROP TEST SOURCE~ IXSTAt lC E rnR/hr C PM SCM 0.0125 4 1 10CM 0.0125 4 1 30CM 0.0125 4 1 100CM 0.0 1 25 4 1 AFTER DR<f ACTIVITY 1 1 m R'lv DROP H E IGHT OB S ERVED D AMAG E IXS T AtlCE DETECTOR SURFA C E M rlh CPU [)R(f 1 y; to{E SW IPE 0.0125 41 SCM 0.0125 41 1 0CM 0.0125 41 30CM 0.0125 4 1 1 00CM 0.0125 4 1 ORCP2 36' SWIPE 0.0125 4 1 S C M 0.0125 4 1 1 0CM 0.0125 4 1 llCM 0.0125 4 1 100C M 0.0125 4 1 [)R(f 3 to{E SWIPE 0.0125 41 SC M 00125 4 1 1 0CM 0.0125 4 1 30C M 0.0125 4 1 1 00C M 0.0125 4 1 Oftal 4 S iji bend II meta exit l\j)e SWIPE 0.0125 4 1 5 C M 0.0125 4 1 10CM 0.0125 4 1 ll CM 0.0125 4 1 100C M 0.0125 4 1 DR(j) 5 No F IIIM D.1nage SWIPE 0.0125 4 1 SC M 0.0125 4 1 1 0C M 0.0125 4 1 30C M 0.0125 4 1 1 00C M 0.0125 4 1 DR(j)6 No F IIIM D.1nage SWIPE 0.0125 4 1 S C M 0.0125 4 1 1 0C M 0.0125 4 1 30C M 0.0 1 25 4 1 1 00 C M 0.0125 4 1 9 of 72 Attachme nt 4 D e tail s of const m c ti o n and d es ign of th e pr o du c t (as r e lat e d to containment and s hieldin g of th e byproduct mat e rial a nd any o th e r sa fet y fea t ur es und er n o rmal and severe co ndition s o f h a ndling , s t o ra ge , u se , and di spo s al of th e pr od u c t): The Valeo I nstruments Co mp a n y In c. T GA 3000 modu l es are d es i g n ed t o be ru gge d , co mpa c t , and tamp e r r e s i s t ant , u s in g m a terial s and co n s tm c ti o n m e thod s t o provide prop e r co ntainm e nt a nd s hieldin g of th e radioactive so ur ce t o maintain minimal exposure of indi v id ua l s t o r a di a ti o n from th e AM-241 so ur ce a nd t o prevent unauth o ri ze d or accidental access t o th e AM-24 1 so ur ce. D r a win g 22 10 0 I 04 below s h ow s th e o v era ll de s i g n of th e TGA 30 0 0 OEM module. I o ni za t ion So ur ce Assemb l y Th e AM-241 so ur ce assembly NRD LL C mode l A-00 I i s pur c ha sed full y assembled from NRD LL C of 2937 A L T BLVD , PO BOX 3 10 , Grand I s land , NY 1 4072-0310 per V a l eo In s trum e nt Co mp a n y drawings. Sec drawin gs 4410 0 I 04 and 44100 I 1 6 below TGA 3000 I o n Mo bilit y S p ec trom e ter , (IMS) ce ll assemb l y Th e TGA 3000 M od ul e IMS ce ll assemb l y i s purc h ased as a complete assemb l y , l ess th e AM-241 so urc e , from O ml cy Indu s tri e s In c. of 1 50 Co rp o rat e Wa y , Grants P as s, OR. 97526 , per Va l eo In s trum e nt s Compa n y spec ifi ca t io n s and drawin gs , sec asse mbl y drawin gs 44100126 a nd 44100 1 27 b e l ow TGA 3 000 Mod ul e So ur ce Assemb l v In s tallation Th e RD M o d el A-00 I so ur ce assemb l y in s tallati o n in t o th e TGA 300 0 modul e I MS Ce ll Assembly i s p e rformed by follow in g th e procedure s, guidel in es and drawin gs as se t fo rth in a tta c h men t 5 o f thi s app li ca t ion. The related safe t y procedures and safety requirement s as se t forth in Valeo In s trument s In c. R ad i a ti on Pr o t ec ti o n Pro g ram a s authorize d by the S tat e of Texas Radi oac ti ve Materia l s L icense numb er L01572. In s t a ll a ti on of th e TGA 30 00 I MS ce ll a sse mbl y int o th e TGA 3 000 In s ul ator a n d In s ulator Hou s in g. The TGA 3000 IM S ce ll asse mbl y i s in s talled in t o th e i n s ula t o r and in s ul a t o r h o u si n g by following th e procedures , drawings , figures, and g uideline s , as se t fo rth in Attachment 5 of thi s applicat i o n. Drawi n gs #### b e l ow r e pr ese nt thi s asse mbl y. In s tallation of the TGA 3 000 IM S ce ll ass e mbl y to co n trol e l ectro ni cs. The TGA 3 000 IM S modul e ass embl y i s in s ta ll ed onto th e e l ec tronic board a sse mbl y p e r figures, drawings and in s tru c tion s se t fo r th in A tta chment 5 of thi s appli ca tion. 1 of 72 Mat e rial s u se d in th e co n s truction of th e TGA 30 00 modul e. Th e m a t eria l s u se d fo r th e co n s tru c ti o n o f th e T GA 300 0 I M S ce ll asse m b l y a nd dir ec tl y o r i ndir ec tl y r e l a t e d t o th e co nt a inm e nt a n d s hi e ldin g o f th e radi o a c ti ve so ur ce, AM-2 41 @ m ax 20 mi c r o c ur ies, a r e s h ow n in dra wi n gs b el o w. Th e TG A 300 0 I M S m o dul e w a s s ubmitt e d t o 1 2 m o nth s o f u sage under norm a l o p era t i n g co nditi o n s as we ll as p e ri o d s of severe co nditi o n s. A t n o tim e did th e m eas ur e d ex t e rnal r a di a ti o n l eve l s excee d o r eve n co m e cl ose t o l eve l s r e quir e d t o t a k e ac ti o n durin g t h e p e r io d or o p e ra t in g a t norm a l or e x tr e m e co nditi o n s. Th e e xtrem e co nd i ti o n t es tin g i s d esc rib e d i n d e tail i n A tt ac hm e nt 3 of thi s a ppli ca t i on. S tor age, h a ndlin g a nd di s po s al of th e TGA 3000 module. A ft e r eac h TG A 3000 m o du l e i s asse mbl e d a nd t es t e d , th ey a r c pla ce d in ES D r esis t a nt pr o t ec ti ve b ags w h ic h a r c l abe l e d w ith m o d e l , se ri a l num be r a nd dat e. Th e b ag g e d asse mbli es a r e th e n pl ace d in a pp ro pri a t e l y l a b e l e d s t o r age co nt a i ner s a nd s hel ve d t o w a it for forth e r pr ocess in g. Ev e ry T G A 3000 m od ul e di s tribut e d co m es w ith a n o p e r a tin g manual co nt a inin g r e quir e d , s af e t y a nd h a ndlin g in s tru c t i on s, as we ll as l a b e lin g p e r IO C FR 32.29(b), a nd in s tru c ti o n s fo r safe di s p os al o r r e turn t o m a n u fac tu r e r. (se c Att ac hm e n t 7 for a co p y o f th e u se r m a nu a l) 2 of 72

(b)(4)

V ALCO INSTRUMENTS CO., INC. PN 48100101 TGA 3000 OEM MODULE MANUFACTURING MANUAL WITH QUALITY ASSURNACE CHECK POINT PROCEDURES.

TGA 3000 OEM MODULE PN 22100104 I of72 C o n t e nt s

  • Sec tion I-Safety g u i d e lin es.
  • Sect i o n 2-P a r t N um be r s R e quir e d.
  • Sec ti o n 3-AM-2 41 S our ce Asse mb l y I n s t a ll a ti o n.
  • Sec ti o n 4-H ea t e r Asse mbl y I n s t a ll a t i o n.
  • Sect i o n 5-In s ul a t o r/I n s ul a t o r H o u s in g/I M S Ce ll A sse m b l y In sta ll a t i o n.
  • Sec ti o n 6-I M S Ce ll I nt e r face P C A to P rocesso r P C A asse m b l y.
  • Sec t i o n 7-IM S ce ll asse m b l y in s t a l l a ti o n o nt o P C b oa rd asse mb l y.
  • Sec t i o n 8-Co mp l e t e d ass embl y v i ews.
  • Sec tion 9-Quali ty A ss ura n ce C h ec k Li s t R efe r e n ce. 2 of72 Section 1: Safety G u idelines.

I. Prior to a sse mb l y of th e TGA 3000 OEM Modul e , r ea d and und ers tand the Valeo Radiation Protection procedu r es. 2. Wear di s po sab l e l atex fre e , powder free, protective g l oves , a nd l ab coat while assembl in g th e AM-241 Source assemb l y into th e IMS ce ll assemb l y. 3. Wear th e pr o t ec t ive g l oves throughout the assembly process unti l the TGA 3000 IM S mod u le i s assemb l ed onto th e PC board s. 4. Have th e Ludlum Mod e l 3 with 44-9 probe readily available during assembly proces s. 5. Always u se th e s am e designated work be n c h for the AM-24 I so ur ce i nsta ll a ti o n. 6. No food or drink i s allowed at assembly stat i on. 7. Immediatel y r e port to RSO/Acti n g RSO , any s urv ey or wipe te s t r es ult that exceed s actio n level of::: 200-500 cpm / 0.05 to 0.1 Mr/hr. 8. Do not pr ocee d to next sec tion unti l t h e QA checkpoi nt ha s been clea r ed for eac h section as requir ed. Assessment and Conversion chart for Lud l um Model 3 mc*ter reading s. Survey Meter Readings A1 susmen 1 o l Measurements Converting radiation meter readings Un i ts Meter Readings op, 0 2.5 111.0 J, J. m RJ hr .... 0.2 u.3 0.5 J **!)/h r lutOl\\f'r\

IOC'Jllll l:l)'l.\bO tp111 3 of72 Sec tion 2: Parts and P a rt/Drawing N umb e r s R e quir e d. I. 44100 I 00-IM S Ce ll A sse mb l y. 2. 441 00104-NRD Model A-001 SourceAssy.

3. 34 100 IO 1-I MS h eater A ssy. 4. 44100126-IM S Cell I n s ulat o r H o u s in g, Upper. 5. 44 J 00 J 27-IM S Ce ll In s ulat or H ousi n g, L owe r. 6. 44I00 1 2 8-J MS Ce ll In s ul a t or , Up p er. 7. 44 1001 29-I MS Cell In s ul a tor , Lower. 8. 28 100 IO I-JM S Ce ll I nt erface PCA. 9. 28 100 I 02-IM S Proce sso r P CA. I 0. 44 1 00 1 52-P CA Mountin g Pl ate. 11. 44100 1 53-Uppe r S u ppo rt Mounting Bracket. 12. 46 1 00 101-R adia ti on Warning L a b e l. I 3. R o ll of Mil S p ec PTFE tap e, W' wide by 0.0032" thick , white in co l or. 14. Yiton tubin g Y.." ID by 1/2"00 c ut into I" pie ces. 1 5. D aflon S H 24 I PTFE s hrink tubing, S H 24 1-5/8 an d S H 24 l-7/8 cut int o I" piece s. 16. T orx H ea d SS ma c hin e s crew s 4/40 X Yi" quantit y 4. 17. Zinc Pl a t ed Steel s t an d offs Mal e-F e m a l e Th r ea d 1,'4" hex , 6/32 X 5/8" quantity 9. 1 8. S tain l ess S t ee l (SS) Standoff 5/16 F em al e-F e m ale H ex SS 6/32 X 3" quantit y 2. 1 9. S t ain le ss S t ee l 6/32 X 3/8" PHM S and numb e r 6 SS flat washers , quantit y 11 ea. 4 of72 Section 3: AM-24 1 So ur ce In sta llation. Note: Refer to figures 1-3 of this pro cedure for source installation. I. Put o n approved pr o t ec ti ve g l oves and lab coa t. 2. Obtain a n ew manufacturing/quality report c h eck list. 3. Pl ace a c l ean s h eet of industria l g r ade alumi num foil on s urface of work bench w h ere the AM-24 1 so ur ce w ill be in stalled in to th e JMS ce ll assem bl y. Tape edges of fo il down to work s ur face. 4. Obta in a IM S ce ll assembly from inventory. Assign a n d r ecord serial n umber. This wi ll become the TGA 3000 Modu l e seria l numb er. 5. Remove protec t ive wrap a nd a ll ca p s and p l ugs. 6. Place on clean aluminum foil surface , p rep ared in step 2 above. 7. Obta in one AM-2 41 , 44100 I 04 , source assemb l y from the RSO , o r a uth orized u s , er. Record serial number a nd ass i g n to the TGA 3000 modu l e se rial numb er. 8. Using Ze r o Grade a ir wit h approp ri ate nozz l e , blow ai r t h rough ce ll from both ends and s id e ex it tu b e. 9. Us in g designated 3/32" He x dri ver , I nstall source into the threaded so ur ce h o l der l ocated inside the IMS ce ll. T h e access is throu gh the '/.i" VCR fitti n g. Make s ur e t h e so ur ce assembly is threaded int o th e source ho l der p r operly. Be very careful to not c r oss thread th e assemb l y. 1 0. u al i ty C h eck p oi n t I.
  • QA check for proper in s t a ll atio n of so ur ce assemb l y. Note o n QA checkl i st. 11. Survey c h ec k.
  • RSO o r au th o ri zed use r , u s in g th e Lud l um Model 3 and p l ace the detector s ur face of th e 44-9 probe w ithin '/.i" of t h e e nd of the VCR fitti n g. Record ave r age mR/hr r ead in g in manufacturing qua li ty report c h eck li st. 12. In s t a ll all caps a nd p roceed to sec tion 4 , Heater insta ll atio n. 5 of72 Fi g ur e 2 6of72 Figure 3 M-241 SOURCE ASSEMBLY SHOW N BE ING INSERTED Sect i on 4: Heat e r Inst a ll atio n. Note: Refer to figure s 4-5 of thi s pro ce dur e for he a t er in s t a ll ation. I. Make s ure a ll caps are in s tall ed pri o r t o h eater in s t a llati on. 2. O btain h ea t er asse mbl y, 34 100 I O I. 3. Pl ace a I" p i ece of 1/.i ID , b l ack V i t o n tub i n g over th e drift end fitt in g so that it i s tight aga in st th e back e nd of th e end cap. 4. T ake a W' pie ce of 1-i" ID , bla c k Vit o n tub ing a nd s lit it l engt h w i se, on e cu t , and t h e n fit it ove r t h e Y..,' tub e betwee n the fro n t e nd ca p of th e IMS ce ll and th e back of th e Y..,' VCR nut. 5. Wrap the heater asse mbl y ti g htl y around I MS ce ll assy. wi t h th e heater co nn ecto r at th e drift , (bac k e n d), of th e IM S ce ll assy. 7 of 72
6. Obtain a ro ll of white Mil Spec PTFE t ape, -W' wide, 0.0032" thi ck. C ut a piece t h at i s app r oxi m a t e l y 20" l ong. Holdin g th e IM S ce ll secure l y in o ne hand , th e n start in g a t t h e front edge of the fr onte nd ca p , wrap th e t a p e ti g htl y a r o und ce ll w ith over l a ppin g turns th e e ntir e l e ngth oft: h e I MS ce ll. Mak e s ure th e h ea t er i s tig ht against th e I MS ce ll s urface as th e tape i s b e in g wrapped aro und th e IM S ce ll. See figures 4 a nd 5. 7. uality C h eck Point 2.
  • QA inspect entire IM S ce ll asse mbl y at thi s p o int t o e n s ur e the he a t er i s a t ight fit to IM S ce ll s urfa ce and proper pl acemen t o f V i ton tub e piece s and Teflon w r ap. 8. Obta in a l" l o n g sec ti o n of 5/8" Di a. DAFLON PTF E 4: I r at i o,s hrink tu b in g and s lip it over rear sectio n of IMS ce ll assy. Th e heater co n nec t o r mu s t go through first , th en the s h rink tubing wi ll eas il y sli p ove r th e othe r end sec t ion of th e I MS cell. The back e nd of th e s hrink tub e mu s t be even w i t h th e b ack e nd of the IM S ce ll e nd cap. See figure s 4 , 5. 9. Obtain a l" l o n g sect i o n of 7/8" Di a. DAFLON PTFE 4: 1 r at i o s hrink tubing and place it over the VCR nut an d over t h e fr o nt sec t i o n of the h ea te r assy. P l ace it over the IM S ce ll s o th at th e front e nd of th e s h rink tub in g w ill be eve n w ith th e front e n d of t h e IM S ce ll e nd cap. 1 0. Obta i n heat g un a nd se t th e temp e r ature for 327°C o r 62 1 °F. Place the IM S ce ll , w i t h h eater asse mbl y in sta ll ed, int o a s mall b e nch v i se by plac i ng the l egs of th e IM S ce ll between th e j aws of the v i ce and c l a mp t h e asse mbl y sec ur e l y. Rem ove all fl a mmabl e materia l s away fr o m area w h e r e th e h ea t g un w ill b e direc t ed. Make s u re a ll compo n e nt s a r c prop erly a li g ned and th e n tu m on the h eat gun a nd dir ect th e h ea t ed a ir eve n ly around th e s hrink tub e , o ne e nd at a tim e. H ea t until tubin g i s a t maximum s hrinka ge th e n remove h eat and r e p ea t a t the ot h e r e nd. L et the entire assemb l y coo l to t o u c h before pro cee din g t o n ex t s tep. 11. uality Check P oint 3. 8 of72
  • C h eck prop er pla ce m ent of a ll co mp o n e nt s.
  • C he ck prop e r gro undin g b etwee n gro und lu g of th e h ea t e r , th e dr i ft en d m e t a l com p o n e nt and th e ca rri er en d m e t a l component.

R ea din g s h ould be le ss th an .5 o hm s. R efe r to figur e 5.

F i gu r e 4 HEAT E R CO NN ECTOR F igure 5 9of72 VITO N TUBE S P ACER Ground Re s i sta nce C heck VITO N TUBE SP A CER PTFE TAPE WRAP Section 5: Insulator an d In s ul ato r H ous in g Asse mbl y. Note: R efer to fig ur es 6, 7, a nd 8 for thi s sec ti o n. I. Ob t ai n P N 4 4 1001 26, in s ul a tor H o u s in g U pp e r. P N 44 1 0 0 1 27, In s u l a t o r H o u s in g L owe r. P N 4 41001 28, In s ul a t o r Up p er. P N 44 1 0 0 1 29, In s u l a t o r l ower. 2. I nsert SS 6/32 X W' PHM S thro ugh h ole in t o p o f th e uppe r in s ul a t or h o u s in g. Sec ur e w ith SS #6 l oc k was h e r a nd SS 6/32 h ex nut. See fi g ur e 8. 3. In sta ll R ad i a ti o n W a rnin g l ab el , 46 100 I O I , a n d TGA 3000 se ri a l num be r a nd date of ma n ufac tur e l abe l as s h own in fi g u r e 8. 4. I nse r t u pper a nd l owe r i n s ul a t o r s int o upp er a nd l ower in s u l a t or h ous in gs so th at th e in s ul a t o r m a t e r ia l i s flu sh to th e e d ges of th e in s u l a to r h o u s in gs. See fi g u re 6 a n d 7. 5. In s t a ll t h e I MS ce ll/hea t er asse mbl y int o th e l owe r in s ul a t o r hous i ng assem bl y by pl ac i ng t h e l egs of th e I MS ce ll asse mbl y in to t h e c ut o ut s l o t a t th e b o tt o m of t h e l owe r in su l ator h o u s in g asse mb l y. M ake s ur e th e exi t p o rt tu be i s a li gned wi th th e back m os t c ut o ut in th e l ower in s ul a t or h o u s in g. See fi g u re 6. 6. H o ldin g th e b o tt o m asse mb l y sec ur e l y, p l ace th e uppe r in su l a t o r h o u s in g asse mb ly , fi gu r e 7, over t h e l o w e r asse mb l y a nd s nap c l ose d. M ake s ur e th e 4 sc r ew h o l es are a li g n ed, fig u re 8. Secur e upper h o u s in g t o l ow e r h o u s in g u s in g fo u r 4/40 X W' Torx h ead m ac hin e screws. Secu r e h ea t e r g r o und lu g i n p os iti o n 2 as s h ow n i n fi gure 9. Ti g ht en sec ur e l y be in g ca r ef ul n ot t o ove rti g ht e n. 7. Q u a l it y C h ec k P o i nt 4. 1 0 o f 72

  • C h e ck for p ro p e r fas t e n in g o f sc r ews a nd gro und lu g p os iti o n.
  • C h eck fo r pr o p e r in s t a ll a t io n of R a di a ti o n P rot e c t io n L abe l.
  • Ma k e s ur e dr i ft , ca rri e r a nd ex i t p o rt s a r e ca pp ed/pl ugge d.
  • Survey c h eck. R SO or a uth o r i ze d u se r , u sing th e L u dlum M o d e l 3 a nd pl ace t h e d e t ec t o r surface o f th e 44-9 pr o b e w i thin Y4" of th e e nd of th e VC R fittin g. R eco rd average mR/hr r ea din g i n th e m a nu fac tur i n g q u a li ty r epo rt c h eck lis t.

Fig u re 6 Figure 7 11 of72 INSULATO R FLU SH T O INSULATOR H OUS G LOWER INSULA TOR HOUSING ASSEMBLY ~E ATERCONECTOR 6/32 PHMS INSTALLED FROM BOTTOM PR IOR TO IN STALLING INSULATOR.

ECURE WITH #6 LOCKWASHER AND 6/32 HEX NUT MAKE SURE TOP AND BOTTOM ASSEMBLIES NAP TOGETHER AND ALL HOLES ARE Figure 8 NfATUGflOUNOlUG 12 of72 Sect ion 6: IMS Cell Interfac e P CA to Proces so r PC A assembly. 1 3 of72 I. Obtain IMS C ell In te r fac e P C A , 28100 IO I , a nd I MS Pro cess or P C A , 2 8 1 00 I 0 2. 2. Obt a in P CA M o untin g Pl a t e , 4410015 2. 3. Obt a i n h ar dw a r e it e m s 16 throu g h 19 l i s t e d in se ction 2. 4. I n s tall 5 z in c pl a t e d s t ee l s tando ffs to b o ttom o f th e I M S Ce ll Int e rfa ce P C A , th e mal e thr e ad e d sec tion g oe s throu g h the bottom o f th e P C A , i n s t a ll 4 of s am e into rear se cti o n of I M S Ce ll In t e rfa ce P C A b y thr ea din g t hem o nto th e mal e thr ea d ed p o rti o n s ti c kin g up thr o u g h the P C A , in s tall 2 of th e S S 5/16 h ex X 3" l o n g s t a nd o ff s o n th e tw o front h ol es in th e P C A b y threadin g th e m ont o th e m a l e thr ea d s proj ec t i n g throu g h the bott o m o f th e P CA. S e e fi g u re 9 for h a rd wa r e p os i t i o n s. 5. On ce a ll s t a nd o ff s a r e in s t a ll e d and ti g ht e n e d i n s t a ll th e Pro cesso r P C A o nt o t h e r ear s tand o ff s. B e v ery ca r e ful t o properl y a li g n th e tw o co nn ec t o r s o n th e b o tt o m o f th e pr ocess o r P C A, F e m a l e r ece iv e r s to th e mal e c onn ec t o r s o n t h e t o p o f t h e IM S C ell Int e rfa ce P C A. 6. S e c ur e th e P roc e sso r board t o th e I M S Ce ll In t e r face P C A with th e thr e e n y l o n 6/3 2 thr ea d e d s tandoff s. 7. Qua l ity C he c k Point 5.

  • Ch e ck ali g nment of the matin g connector s from the top of th e IM S Ce ll Int e rfa ce P C A t o the Matin g c onn ec t o r s o n th e b o ttom of th e P rocessor P C A. N o pin s s h o uld b e s howin g.
  • C h e ck ti g htn ess of a ll fa s t e ner s. Ca ution No te: Improper a li g nm ent w ill cause immediate electrica l damage to the Processor PCA upon power up.

Fig ur e 9 Hard wa r e Positions.

14 of72 Sectio n 7: IM S ce ll assemb l y installation onto PC board assembl y. I. Obtain QA c h ecked IMS assembly and in s tall asse m b l y in s i ng l e row t ermina l blo ck co nn ec t o r on the IM S ce ll interface P CA as s h oWTll in figure I 0. 2. In s t a ll as s h own i n figures IO a n d 11. I t i s cri ti ca l to make s ur e every pin is properly positio n ed w h e n i n se rted a n d th at th e sc r ews o n the t e rminal block for eac h IM S ce ll pin i s ti g ht e n e d sec ure l y , t h e n d o ubl e chec k ed for eac h screw. Sta rt fro n t t o back th en d o u ble check fr om back to front. See figure 11. 3. In s t a ll h ea t er con ne c t or o nt o IMS Ce ll In te r face mal e h eater con ne c t or. See fi g ur e 1 2. 4. In s t a ll U pp er s upp ort and m ou nti ng b r acke t, 44100 1 53. Obtain mounti n g bracket, two SS 6/32 X 3/8" PHM S, w ith flat washe r s a nd o n e 6/32 l ock nut. Fit s upp ort bracket o nt o th e 3" s t an d offs as s h own in fi g u re 13. Sec ur e th e upper s upp o rt a nd mounti n g bracket as s h own in fi gu r e 14. 5. In s t a ll IM S Ce ll Int erface P CA gro und w ir e t o p osit i o n 2 o f the u pper in s ul ato r housing as s h own in fi g ur e 1 3. 6. Q u a l ity C h ec k P o i n t 6. Final QA c h ec k co mpl ete a s se mbl y. 1 5 of72

  • C h eck a l ignment o f IM S pin s t o terminal blo ck.
  • C h eck eac h screw in IM S ce ll m o untin g termina l block for t i g htn ess.
  • C h eck a ll mou n ting h ar d ware fo r prop er in s tall a ti on a nd ti g h t n ess.
  • C he c k fo r pr o per g round a t a ll gro un d p o in t s. From c arri er inlet fittin g t o IM S ce ll int erface g r o und poi nt o n th e b oa rd , sa m e from drift e nd fittin g , sa m e for I MS insu l a t or h o u si ng s ur face to 1MS ce ll int erface gro und.

Figure I 0 Figure 11 1 6 of72 Figure 1 2 F i g ur e 1 3 *, 1 7 of 72 F i g u r e 14 1 8 of72 O N E SS 6/32 PH M S WI TH SS FLAT W AS H ER HERE Sec ti o n 8. TGA 3 000 Fi ni s h e d Asse mbl y V i e w s. Rig h t S id e V i ew. Ex i t P o r t S id e. L ef t Si d e V i ew. Gro und S tud Si d e 1 9 of72 Front V i ew (Drift Inl et End) Rear View (Carr i er Inlet End) 20 of72 Se ction 9. T G A 3000 O E M Modul e Quali ty As suran ce C h ec k Li s t. Valeo In s trum e nt s C o., Inc. TGA 3000 OEM MOD U L E Q A C H EC K LI ST T G A 3 000 SE RI A L NU MB E R:-------DA TE: _____ _ Q A I NS P ECT OR N AM E: ---------Q A C H EC K POI N T 1-So ur ce A sse mbl y Inst a ll a ti o n C h ec k. P ASS 0 FA I L 0 C OMM ENTS: ________________________

_ QA C H EC K POI NT 2-IM S H ea t e r A sse mbl y C h e ck. P ASS 0 F A I L 0 C OMM ENTS: _______________________

_ QA C H EC K POI N T 3-H e at e r S hrink Tubin g A sse mbl.y a nd G round C h ec k. I NS T A LL A TION P ASS 0 F A IL 0 C OMM ENTS: _______________________

_ 21 of72 QA CHECK PO I NT 4-l ns ul ator/l n s ul ator Hous in g Assemb l y C h eck. PASS 0 FA I L 0 COMMENTS:

_______________________

_ QA CHECK PO I NT 5-I MS Ce ll I nterface PCA t o P roces s or PCA Assemb l y C h eck. PASS 0 FA I L 0 COMMENTS:

_______________________

_ QA CHECK POINT 6-F in a l Assemb l y C h eck. PASS D FA I L D C OMMENTS: _______________________

_ ADD I TONAL COMMENTS:

________________________ _ 22 of72 Attachment 6 Radi oactive Labelin g Ea c h Valeo I n s trum e nt s TGA 30 00 wi ll be l abe l e d in acco rdan ce with IO C FR 32.29(b) a s s ho w n below. Pi c tur es of th e pla ce m e nt of thi s l a b e l ca n b e foun d in th e Vale o TGA 3000 manufacturing manual w h ich i s in c lud e d in attachment 5 of thi s appli c ation. 1 of 72 1* 0.68 0 i---------2.500-------

-CONTAINS RAD I O ACTI~ MATERIAL RAOIONUCI..UO E: AM-2 41 A C llVllY: 20 uCI MANUFA Cl\JRED B Y V AL CO IN STRU MENTS J 0.450 L. C OMPAN Y IN C. UNOER U.S. LIC EN S E AN O 0.340 IN C OMPLIANCE

\\llH NR C I OC F'R 32.26 ~------------,--

  • _l U o.275 R 0.100 4 P LA C E S LABE L S: RED TEXT ON CHROME BACKING, MI N IM U M 10 PO I NT PR INT. RAD IATI ON SY MB O L -M AJENTA O N YELLOW. P ERM>\NENT AD HE SIVE BACKING, (P EEL AN D Sl 1 C K LABELS) 2 of 72 V I C I Valeo t nst r ..... , nt~ Co.

3 of 72 li:il __ _ --... W&taa*-----44 1N1*1H' .. CIU lalAMII IG8NII IMII, Ill IH>~TQI IHILDNt 0-t:==1-+1 r-T'--b--~~u

'ataxc~~"U.<nON

..... .... l"IOMUT , ~a.II -.. ,..,. ---* -

4 of 72 6/32 PHMS INSTflllEO FROM B OTIOM PR I OR T O I NSTA L L ING INSULATOR. ECURE WrTH 116 L OCKWASHER A N O 6/32 HEX NUT I of72 VALCO INSTRUMENTS C O., I NC. TGA 3000 OPERA TOR MANUAL PN 48100102 PN 22 100104 C ON TE NT S Sec ti o n I: Unpa c kin g a nd s a fety co n s i d e rati o n s. Sec t i o n 2: D oc um e nt P ac ka ge Co nt e nt s. S ec ti o n 3: F a mili a ri za tion. Sec tion 4: P C a nd P o w er S uppl y r e quir e m e nt s. Sec ti o n 5: TGA 3 00 0 S o ftw a r e In s tall a t i on Sec ti o n 6: Se t up. Se ct i o n 7: Op e r a t i o n. Sec ti o n 8: Shutd ow n 2 of72 Section 1 : Unpacking and safety considerations.

CAUTION:*.*

THE TGA 3000 OEM MODULE CONTAINS RADIOACTNE MAT ERIAL, RADIONUCLIDE:

AM-241 ACTIVITY S 20 MICROCURJES MANUFACTURED BY VALCO INSTRUMENTS CO., INC. THE RADIOACTIVE SOURCE IS SHIELDED SO THAT NO RADIATION ABOVE NORMAL BACKGROUND LEV ELS BACKGROUND ARE EMITTED. 1. Locate Wipe Te st document with s hippin g document s and retain for safe keeping. 2. R emove TGA 3000 OEM modul e, AC/DC power s upply from packaging and examine for damage. If damage i s evident notify shipper and Valeo Customer Service Immediately.

Have serial number and order number read y for Valeo customer serv ic e. Contact infonnation will be with the s hippin g d oc ument s. 3. Place TGA 3000 OEM module on a clean sta tic free work s urfac e. 4. The TGA 3000 OEM module ba s areas of hi g h heat and high voltage , observe label s and take n ecessary precaution

s. The high voltage areas are s hown in figure 2 of thi s manual. 5. Ke e p liquid s away from work area. 6. Handle with care always. 3 of72 Sect i on 2: Document P ac k age Co ntent s. 1. Valeo I n s trument C o., In c. W ip e T es t Letter. 2. TGA 3000 OEM Modul e Operat o r Manual. 3. Va l eo C u s tomer Servi c e Co nta c t I nfo rm atio n. 4. TGA 3 000 Software Di sc and Softwar e In s ta ll at i on G uid e. 5. Return Shippin g Do c umentation fo r TGA 3 000 OEM Module ifne e de~. 4 of72 Section 3: TGA 3000 O E M Modul e Familiarization.
1. See figur e I for nomen c l atu re. Figure I MO\JNT I IIG PIATt 2. The carrier inl et , drift inlet, and exit port s urface s w ill be hot when the TGA 3000 OEM Modul e i s powered up and running at normal operating par a meters. The se s urfa ces cou ld get as hot as 200°C (392°F) during a bak e out run. 3. To prevent contamination , the carrier inlet plug , drift inlet plu g, and ex it port plug shou ld be left in place until the TGA 3000 Module i s made ready for u se. 4. There i s a AC/D C converter power s upply provided with the TGA 3000 OEM module. See figure 3. It is recommended that thi s power supply or 5 of 72 e qui va l e nt b e u s ed with th e TGA 3 000 OEM M o dule. Section 4 w ill d etai l power r e quirem e nt s. Figure 3 6of72 'C/OC CONV(Rl(R POWlR SUPPlY* INPUl VOllAGf 80-26-' VAC. CURRENl IIANG[ CH.QA. OUlPUT VOllAG[ I S VOC. l~W. WOIIKING T[MP{RATUR[
  • l010*60C.

Section 4: P C and Power Supply r e quirement s. 1. D eskto p , laptop with Window s 7 , Window s 10 OS. Mu st h ave at le as t o n e USB port and one ethernet port for co nnection t o TGA 3 000 OEM M o dul e. C D/DVD play e r/re a der , int e rnal o r ex ternal. 2. There is a A C/D C converter pow e r s upply pro v id ed wit h th e TGA 3 000 , h owever if a pplication i s s uch that another p o w e r s upply i s required. T h e a lt e rnat e AC/D C co nverter pow e r s upply mu st be ab l e to pro v id e hi g hl y re g ulat e d l 5VDC output , 0 to 7 Amps minimum , wit h l ow rippl e 1 80 m Vp-p , havin g continuous operational temperature range of -3 0°C to +60°C. Section 5: TGA 3 000 Softwa r e In s tallation. 1. In s tall C D 2. Folder TGA 3 000 _V J J .2.4 s h o uld appear 3. Open fo ld e r be l ow icon s s hould appear. C li ck on TGA3000.m s i. ic o n. Nam e Date mod1f1ed Type vc redis Lx86 4/19/2017 4:52 PM File folder ;t; setu p.e xe 12/5/201611.05 PM Apphcatton

{I TGA3000.msi 12/5/2016 1105 PM Windows Installer Pa ... 4. The below window s hould appear , click next and fo ll ow install e r in s tru c tion s. 7 of72 Size 366 KB 3.048 KB

~TGA 3000 X Welcome to the TGA 3000 Setup Wizard The installer will guide you through the steps required to install TGA 3000 on your computer WARNING: This computer program is protected by copyright l aw and international treaties. Unauthorized duplication or distribution of this program. or any portion o f it. may result in severe c i vil or criminal penalties. and will be prosecuted to the maximum extent possible under t he law. Cancel Next> 5. C reat e Desktop Shortcut Icon if de s ired. 8 of 72 Sec tion 6: Se tup 1. Pla ce t h e TG A 3 0 00 Modul e o n a c l ea n , flat , s tati c free s urfa ce. 2. R e mo ve a ll ca p s a nd plu gs fr o m c arr i e r , d ri ft and ex it p o rt fittin g s. B e p a rt i c ul a rl y ca r ef ul w ith th e d r i ft a nd ex it p o ri fittin gs , th ese a r e fr ag il e a nd co u l d br ea k i f improp e rl y ti g ht e n e d o r lo ose n e d. Alw ays u se two w r e n c h es , on e o n int e ri o r fittin g a nd on e o n out e r fitti n g t o l oo se n o r ti g ht e n h a rd wa r e, 3. Mak e s ur e U HP gas s uppl y i s o ff durin g in s t allati o n t o th e T GA 300 0 M o dul e. I n s t a ll d es ir e d U HP r eg u l a t e d gas l ine s w ith prop e r fi tt in gs , o n e to ca rri e r a nd o n e t o dr i ft. Th e ex it port c an b e l eft o p e n o r plumb e d t o ve nt in a n o th e r a r ea. E n s ur e ID o f ex it p o rt tubin g u se d i s s uffi c i e nt t o av oid a n y b ac k pr es s ur e on th e TG A 3 000 modul e. It i s hi g hl y r eco mm e nd e d that th e V C R gas ket s a nd V a leo fitt i n g g a s k e t s b e of h i g h qu a li ty t o e n s ur e l e ak free co nn ec ti o n s. 4. Th e m ax imum flo w throu g h TG A 3 0 0 0 IMS ce ll i s 3 00 cc/m fo r a s t ab l e s p ec trum. Th e t y pi ca l d es ir e d flo w would b e I 00 cc ca rri e r a nd I 00 cc drift. Thi s i s a ll m eas ured a t th e e xit p o rt fo r t o tal fl ow o f 2 00 t o 3 00 cc/m. 5. See tab l e b e l ow fo r appro x im a t e r eg ulator pr ess ur e in p s i g t h a t w ill pro v id e 2 00c c t o 3 00 cc tot a l fl ow. I n lin e r es tri c tor s m ay b e u s ed t o o p t imi ze fl ows. U HP S UPPLY GA S I N L E T PRESSU RE Ar g on 2 0 p s i g N itro ge n 25 p s i g O xyge n 22 p s i g H e l i um 1 5 p s i g 9 of 72

6. Tum on UHP gas s uppl y in accorda n ce w ith table above. Note the TGA 3 000 ma y be run in s tatic c ondition with port s op e n in room air w ith a bru s h l ess DC pump w ith s uction s id e attached to ex it po r t to create flo w of ambie nt room air throu g h th e TGA 3 000. Thi s would be t h e d es ired m e th od for m o nit o rin g ro o m ai r co nt aminants e t c. 7. In s t a ll AC/D C co n ve rt e r pow e r s upp l y provid e d. 8. Slid e on/off sw it c h to o n. Li s ten for o n e s hort b ee p. Thi s indicat es that sec h ec k i s c omplete a nd i s TGA 3 000 i s r eady. A se rie s of b ee p s indi cates error. 9. Open th e TGA 3 000 fold er on th e PC de s ktop a nd u se s h o rt c ut s a se l ect pro g ram o n d es kt o p and wa i t for window to appear. F o ll ow in s tru c ti o n s in fi g ur es 4 , Sa nd 6. 10 of72 F i g ur e 4 1 1 of72 Operation The on board PC w ill have a " TGA 3000" folder located on the desktop , open the folder then use the shortcuts labeled for t he analyte and base gas for wh i ch i t was tested. For example , if the TGA3000 was shipped to measure H20 in nitrogen , the icon located in the " TGA 3000" desktop folder will be labeled , " H20 i n nitrogen. 1. After the initial power u p, verify the sample i n i s the correct base gas. 2. Double click the appropriate shortcut located in the 'TGA 3000" desktop folder. 3. Click OK on the following screen(s) which will allow the PC to connec t to the detector cell 4. Click on the wvf tab to ve r ify the " CONNECT" t ab i s active on the top row. If t he tab shows CONNECT , the user o press this tab and the name should change to DISCONNECT.

Figure 5 5. The initial analyte concentration will read > 30 ppb until the system is purged with " clean" gas. The total internal TGA300o volume Is < 10 cubic centimeters and typical drydown / purge times can vary depending on the previous use (shut down procedure) and qual ity of sample gas being used. Start up times of< 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> to reach < 10 ppb H20 o r 02 readings can be achieved The concentration is displayed on the main screen: I H 2 0 in N itro gen I -l ppb 2013-02-18 [ -=--11: 26: 49 r= e ~atus Off-line -1 2 of72 Figure 6 Concentration Screen The actual spectrum is also available by clic king on the VfVF tab: , , Spectrum Screen The user can save a spectrum " snapshot" by clicking on the Windows FILE/SAVE icons. This spectrum fi le should default to a ".bwv format which can be sent to a qualified service agent for review. The CFG , MEAS , CAL and ID tabs/screens are for qualified service personnel reference only. 1 3 of72 Figure 7 Shows typica l dry Spectrum in Argon. After co nnection are made allow severa l hour s of dry down time for s table spec trum. Section 8: Shutdown I. Turn off the power. 2. Cap the exit port 3. S hut off regulator or su ppl y gas. 14of72

  • Real-t ime , esu lu , in si tu or on&ne
  • Sample flow less than 200 m l/min
  • No V ilwum pump. no moving parts
  • Ope r ati ng r ilflgt of 0-30 ppb U11diluted or 0-1 000 ppb d a uted
  • Onboard PC operation/concentration dispby
  • V arie ty of ,vailable outputs: RS-232. etherne t. **20mA. log fil e f<< many ye~ the Ion Mobility Sped,ometer OMS) has been successfully used to detect phase trace con~ts in a v-ty of ;appl,uuons.

I n general tenm. the IMS is a n elewONC. 4PS phase, atmospheric preiS!Ke, trace chemical -lyzer provicmg Sl.b-ppb detection limits with chemica l disoinw,ation b~ upon ion mobility.

IM S has been shown to bt an effectM technique for the detection of many imporUn t trace conlilminilnts in five major UHP bullc gases. OetK1Jon limits less than 0.1 ppb have been demonstrated.

1 of 72 N 0 -...... N C3 c::::J ITT) c::::J i "' . 'tJ,'J,t

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iJjf.f~J i. 1'l~ti[If~it1ffjJ r itP'hl l,!(l _... i*Ji[(li!I JiJ 1{; tf1!t[II t19~f 11r11 tlr! i 1 1*i1 1 f t ,Jl 11:fi' :-i:E l tf II.I ., ~II. J t I trit it1r.i !11.it 1iIJI1 JJli J{i! uhii ~1 il IJlfl JJIL*c.-r .JJ }Ii ltjfj ti~f , lt J!1 Ii r1; Atfac hm cn t 9 REQUEST TO WIT II OLO I NFO RMAT I ON F ROM P U BLI C DI SCLOSU R E UNDER 10 CF R 2.390 The technical drawings marked " P ROPRIETARY" in red cap it al letter s in cluded in th e Attachments of this app li cation for the Valeo In struments Compa n y, In c. Model TGA 3000 OEM Module are cons id e r ed the prope rt y or Valeo I nstruments Comp.my, In c. and repre se nt information or a proprietary nature. Valeo In s trument s Co mp any, I nc. hereby reque s ts that thi s info r mation be wi thh e ld from public disclosure.

Thi s information contains detail s on the design or the Model TGA 3000 and wou ld cause substantial harm irrcvca l cd lo our com p etito r s. Thi s information i s sent t o the NRC in co nfidence a nd i s unavailab l e in any other public document.

If th e N R C determine s that this information i s n o t neces s ary to o ur application, we reque s t th at it be returned to u s o r destroyed.

For the applicant:

Signature [)Amw,IJ _ Date:~ 2S)2[,/y-Print Name: Stan l ey D. S t earns Title: President and Radiation Safety Officer Valeo Instruments Co mp any, In c. Post Office B ox 55603 I louston , Texas 77255 (7 1 3)688-9345 Stan@V I Cl.com 68 of 72 69 of72 Attachme n t l 0 ,.,. I of* Dqun111c111 ofSt:uc lkallll Scn1.01.'\

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,~mb<r 1.(11572 27 R AD 1 0AC11Vc ~I A I WUAL Al T II OR l/1: D PREV l Ol:'S AMCN DMl:NTS ARI* VOID -4 b p 1 t"llllon D.ilc -+------\_ta_rrh J I , 2021 .\. RaJi."""IIC A. H 3 c r~ n1 D. C5 137 I* -;a 22 6 r orm 111 Ma:c11.ol 7 \1*\lmwn """"Y A. S~le\l Mlu n:c A No ,i nplc ,;ourcc to (S I (' or l SK(' M odel ucetd I ~uru.: LAB 508 31 l<>tal: 50 cum.~ II. '>c.tll-J

'iltll~C 1 Dul>\1111 Mudd '\hlU)O.I or -;l{D Mo.lei NIOOl1 II -;o '1 0 S l c \l>Urt C 10 c~, e1.'\I 10 nnll 1<.u nc, T1>1:al 2S curio C SealcJ \OOrcc (F 7 C. 250 microcuric~

Model '>enc, R\-XXXt l). Scak'\I wun:c: (l.:L 0. S nu l hcunc, Model m: o l'.17) r: &.l i ed source c CZ L 100 m1<.n11.unl:'

Model ~ri,.,, t, t-aaaa) <>. Radi u JW>.: material ,11.,II he *U>r\.'ll unJ ""ti at: Sn~ 'llumhcr K A u1llu<11al ll"' A. R occ1p1 , 1~1 i n g. r, 1 ,a1r/re foil. manufal.lurc. r .. ..,..*:mh anJ llc,*clop m cnt, .ind dl\lt1>>ttt1 nn o r t h e: li ccn..ce', M N!els 100 <>r 1 00 11 det ector ,ell, to pe~m* 11cncra ll) hi;cn..._'11 (IIINld nl 111 2, I A('~ §289.2.S 1(()(4 )(II). D. R e;;dpt. 1 c>1 i n 11, n:p J1 r/rc foil. 111Jm1f ao.: t un: , mcarch a nd de\ el!>Jlmenr. and di,1r1'1111~1n of t he: lil.c1\"-"C'\ Mud cls 140011: dcu.*u o r o:11) 1 0 pe~ll\ aencrall>

hccn\ed pur,;uant 1 11 25 TAC' §289 . .251(()(4)(1 1). C. C 11 hbra 11 011, rcfcn:01;c ,m J M nragc p~n1tur) 10 tra~kr I>. ('ahh rat i on. rctcrcnc:c o nd Mnmsc prcpa,.,tury III tran ,tcr F.. ('a hh rn11tm. rctcrcn.;.:

1nJ ,1111111:.:

pn.'J'.mitnl')

to tran,tcr. 00:1 l l<'mlon 8300 Waterbury l..:ine. Rooms 401 A and 4010 70 o f 72 Ot:panmenr of S 1 a1e ll eal1h Ser. iC<."1 RADIOAC TI VE MATER I AL LI CE NS E ,...., ,..,, * .,., ~'"'-".,...,.."'"""'"'" ,....,---,*,..,",..,"-: " c-: " ,.., ,..., ,..,._.,.., , ,,, , ,n=-, l.01572 27 IO. *1 he loccn,c.: ,hnll cumpl) \\-ilh 1h c pro, ,~ion~ la~ amended) on ill<: 25 Tex:,,., Admmismnivc Coli c \TAC) §289.20 1. §289 202. f289.203, §289.2(>4 , §289.20S. !!289.25 1, §289.252 an d U119.257. 11. F.nch ,i1e sha ll ma1mai11 documc nh and record~ penmen l 1 0 1hc opcm1 io11\ a , 1 h.11 ~ire Copii:~ of all documc111, Jnd rc.:unl~ required by 1his li cense ,ha ll he rru , i m amcd for Agc l lC) review .11 Sile 00 3. 12. Radioac1i,*c 11~11crial s ha ll he u~,-J only by St1111 lc y D. S 1 car11>. John Durr, Sieve Wcrocr. fananU~,n MadJhu,h, and/or Uob Sternberg. 1 3. I he md1v1dual dcs 1 g n a1cd 1 0 perform lh c func11ons of R a ll1a1 io n Sa (i:1) O ffi ce r (RSO) lo ra c 11 vi 1i i.::. cow r cd by thi5 license i s S 1anle) 0. S1cam,. 14. lklt.'1:lllr cells containing 11-3 fo i l , ha ll only he U M!d i n co n iu n c11on wnh a properly o perat i n g 1 cmpcmturc c onrml mcchani\m "hi c h prc,enls foi l tc111r1en1 1 urc from cxcc,'lling 225° Cc rlli J.lmdc lor 1i1an1um 1 ri11dc lo1b and 325° <.:cnt 1 grJ1lc f 1 1r 'IC: tndium rr itide fo i l5. 1 5. Dctt."<:lnr cell\ contninm g 11 3 shall be umalled ~) c hm lltc e, tmu n L, ,coled to 1h c o uhidc uuno:.pherc.

t o a h o od ;)', t e nt vcn l s'll tn 1hc uumdc alnM11rli.:rc, or 11110 1hc procc~* \trc.,m lb. n ,c ltccn~--c

<h nll r*'f)l>n to rh c Al(cne)* all 11111~,rcr\

of llcvicc,i d is1rihu 1 ed unller 1his licen\e 10 perwll.\ gcncmlly li c emoo un.Jcr the pruvhiuns uf 25 TA C ~.!89.2.S 1(1)(4)(11). Such rcp on ,h11ll u.lc1111l)

' each j!cncra l liccn<cc by rumc and addrcs\, 1hc t ype of device cmnsfcrrcd, and th e qu a 111i1 y and t)pc o f r , 1llt0acmc nJJtcrial comninl'\J 1111hc device. I he rcpon ,hull he ,u h m med wnhin th1ny d a y, after 1h e e nd of c.u.: h c.ilendnr quaner in "hich any such de, ice i; tm lblcrr.'ll 10 a gene rall y liccn<K-d pcrwn. 1 7 The li c ensee s hall furmsh a copy of 2.S TAC §289.251 (1)(4 X H I 10 cmch gcncml l kcnsl'C 10 \\-h Om thc llcvN: c i, 1 mn'lfcmd. 18. Ille l i ccrt~ <hall t c~t eac h dev,cc d i, rri bu"'<l under thi s ltcen~ for leJkage n r co nr a111in.1 1i on of m<lio.1ctl\

e material 1 1rior to 1ra11~fcr. 1<> 111 1: llcen'lec ,hall c o 110u c 1 a pll)Slcal lnvcmory cvef) \I, 111 0 111 11, io ac*ou 111 ror nil ,cakd ,oun;cs n;'Cciv,'\l a n<l po,-.c~~'ll under the lt ccn...:. I he n;'Cord~ o f t he i111*cn1or i e5 ma ll be maintained for t\\O }Cars l rom the date of the inventory (o r in~p crnon b) t h e., Agency an<l ~hall iriclu<lc th e l(UAnlitics an<l c hi: kind) of rad t 1>ac11vc ma1cnal. IC1Cn11on o f 'ICalct.l

~ourcc~. and l hc dale of t he m, c nl OI) 20. I h e licc n.~ 1hall no t 1nn1tcr r:ulioaui~e material co 01her pcnons until II is ~erificd that the recipient u authont.'J to poi.SC)) lhc l) pc and amouru of material 1 0 he lmn ,11:mxl. Z I. Il ic lt<.c1tJ,<.'C

~11.1 11 m.iim.a i n rcconl~ for m ,pec t ion by rhe Agency of radiation sun*ey1 and wipe ~une y\ Cont am i~1 1 ion i n all ar.:a, nf r he fo ci lit y, e~ccp l for 1 h c ho1 lab, sha ll be L epe below 1000 <l1>in1cgra11on, pi:r nunuLc of r cmovnb l c ummr m n: tt ron per 1 00 q1 u n re ce ni ime t el"! of area wrped.

71 of 72 1~< k*al l 1 l*.OI Depanmcnt of SU11c llt.-alth Services RADIOACTIVE MAT ER I AL LI CENSE -.-.... -,-.. -"'-"-.~,.--,-\1,-,-.,-... -.-,-.-.. -... -. l.0 1 572 27 22. 'I he h ccn~cc i< a111hmiz~

10 t est for lca~ugc o f Ni 63 u,i1111 the lice1l5CC', Lc.ik I <:.'II Ku. Such tcs u 5 h all be cnpable uf detecting 0.005 micr ocuric:5 o f c ontamin;ition o n the t es t s ample. Th e ~..,ult~ of <11th tc<t< ~h all he pmvided 10 the customer in mi c mc:uril.'S. 23. A. Pu r,ll11111 t o the Tcuu Katl1 u 1i1111 Control Act and 25 fAC §289 2S I un ucknow k dgcmcm is hcr chy "~ut.*d to the h cclb(.'C li~tod in Cond it ion I of thil Ik e~ 115 a General Li ceruee for Ilic possc.,s1un.

u se and tran<fcr of rndioa c t i~c m.1t eria l co 111ain1 ,'tl III dcvic,-, oht~int.'tl und er 1J 1 c pmv i ,ion~ of 25 TAC §289.251(g).

The gcncra l h cc n~c i~ \llhJect ro all applicab l e mies. regu l ations and ortlers of the Ocpanmem o f State ll c:11th Servi ces (Agency) n ow or hereon er in cffoc1. 8. *nic &cncral lic:ell)t.'C )h all co n~>ly with the np pl ica h lc prov1,ion\

or2~ I AC §289.2:1 1 , §289.20 1. §289.20 2(w,q anu Cu). §289.2(),1, §289.205.

and ~289.257. C 'f11e lolluwin11 radiwcmc m:ucnal po~,.<,ci.St.'t.l under the a111hon1a11 o n of the general li cense gr: 1 n1cd m 25 Ti\C §2 89.251(g) sh.Ill he o,t'd o n ly for rhr purpo-e for which the tl rv icc cnnrninina th~ l'lld10.1c 1 1vc ma t eria l WM ap p roved as spec ified in th e K cgutry or Radioocti~c Scak'tl Source~ and D e, ice!, Ponnhlt1 a nd/o r mobile dovi<:c s may al'l<l he u,l'<l tit temporary

<ttc,. in arca_1 not under c,clu,avc F l'dc ral 1 uri$<l1cuun.

11t ro uglrou1 r e~a5. Dr11.'" , , * .,., .... " I Dn-.it \b U H, Zrii crmo N i ton XI (ll!1 8W I -** So~* N,, f ..... -,. J 14706 unknown D. Th e gencra l li1.en'ICe ~hall pi<~"i~ and uw rhc rnd10:1c1hc m.11crial amhori,ed hy 1 he p ro vi sio n, of25 I AC' §21!\l.25 l{g) 11111ccord anc c wnh , 1 a1cme nt s n od reprt$COtmi ons contnined in li re lcuer dat~'tl M ay 15, 2007. Ti l le 25 or the TAC. C hapt e r 289 i hall prevail over \tarcmcnt, co ntr11ncd in th e alore 111 cntio1k.-tl applicat io n unlc 5.1 ,ud 1 , mtcmcnl5 an: more rc.,1ric 11v.: 1 h;in 25 f AC Cha peer 289. 24. l\~;c,s 1on ,mtl ,tor.1gc nl thc ,oun:e identified m Cond1 11 01\S 5. 6. 711 1kl 8 , P.in, C E of th1\ licen se" authori,c:d preparatory 10 lratl\l c r u l tl 1 e5c ~o u l'Ce:\ tu :rnu th cr hceu:,t:d cntity before: Ma y 3 1 , 2013. Thi.i 11ut h ori1,111ion

,..;11 c,pirc: 011 May ) I, ZOil.

72 of72 H U,: h.'ta ll l Q<,)I Dc11anmcn1 ur S111e I l ca llh Services RA:010/\CT f VE MAT E RIAL LI CENSE r---:,"",°"'

1 ~'°'""°'l'M=ll-:, A-,--, A ,:,"::,l,"'<>>t

=L_, Sl .... J L OIS72 27 25. r~c cp1 ns specifi c all> prnvi,kd u 1 hcl'\\ i..c hy 1h1 s liccll5e.

the license,:

~bull po)!>Cs.1 antl u.~c the radmacm e m:ucnal a u1h orl2ed hy 1hi~ li c.:nse in acoon l arx.-c wi 1b ,u 11 emcn1~. represen1a1ion.s.

a nd pruct.'durc, comainw in 1h.: followintt

KEE Da te ap pli ca 1i un diltt.'CI l\1Rrd1 1 5, 200S , lcucrs dated Jnmmry M. 2007. M urch 14. 2007, April 2.S. 2007 and l*cb ru ary 1 0. 20 1 1. 25 T AC §289 )hn ll pre, :iii me r s1ntcmcn1~

conu1 i ncd m l he above documcn1s unl ess i u c h ~1 atc111.:111*

arc more rcs<<ri c ll\'c 1han th e rcgu l aii o n s. Octobe r 25. 2011 FOR TII E D E PARTM ENT 0 1* STA TF. HF ALTII S l3RVI C CS Rll)'Fltt1J!~

'rugram Cuo l'llillll m r A1han c oo Techn o lo g y Liccn~ing Prugrnm N ovember 20 , 2017 Ri cha rd K. Struckmeyer and H ernando Torres M ate ri a l s Safety Li censi n g Branch Di vision of Materia l Sa f ety , S t a t e , Tribal , and Rulemaking Programs Office of Nu clear Material Safety and Safeguards U.S Nuclear Regulatory Commission 11555 Rockville Pike Rockville , MD 20852 RE: NRC Request for Additional Information, Valeo Instruments letter dated October 26 , 2017; Docket# 030-39061 Dear Mr. Stryckmeyer and T o rre s: In r esponse to your letter of October 26 , 2017 , Va l eo Instruments offers the information be l ow. For your convenience , I have rewritten your questions prior to each response.

A.1. The Valeo I nstruments Company (Va l eo) application dated May 28 , 2017, provides a mailing address for Valeo. Please provide the add r ess of the facility where the TGA 3000 will be manufactured. The TGA 3000 will be manufactured at: Valeo Instruments Company , Inc. 8300 Wate r bury Drive Houston , Texas 77055 A.2. The Va l eo application states that the TGA 3000 has been designed to be an addition to the al r eady in p la ce detectio n systems rather than a stand-a l one device. Please disc u ss how the TGA 3000 will be distributed, whether it will be distributed as a component to a detection system , or sepa ratel y. Please identify and provide details on the detection system s that will u s e the TGA 3000. The TGA 3000 OEM Module is designed to be a stand-alone detector, with the core technology being Ion Mobi l ity Spectrometry , (I MS}, which may be used in many different app l ications where IMS wou l d be the techno l ogy of choice. The original reference to u already in place detection systems" was to indicate that customers may i n stall the device i nto existi n g gas sampling systems tha t may or may not use other radioactive devices. Depending on their application , the customer wi ll have the option to choose whether to install t he TGA 3000 as a singular gas detection device or in-line with another gas sampling system. The T GA 3000 will perform its detection and impurity analysis indepe n dent of any Pag e 1 o f 11 other sys t em. As described 1n section 4 of attachment 7 (The " T GA 3000 Operators Man u al") after the TGA 3000 is p l ugged i nto a gas sampli n g l ine , the only additional r equirement is a computer with a USB and an Et h erne t port c apable of running the Valeo TGA 3000 analysis software. A.3. In your application you indicated that the expected useful life of the product through normal usage, and with proper care , should be between 10 to 15 years. Please discuss what factors would cause the device to have a useful life of 15 years vs. lasting 10 years. The expected useful life of the TGA 3000 OEM Modu l e was de t ermi n ed by using the informa t ion supplied by the manufacturer of the custom heater used on the TGA 3000 I MS cell. The heater 1s the one component t h at would be under t h e most s tr ess du r ing normal operatio n. The TGA 3000 can be turned on and l e ft on for as l ong as desired or it can be cycled on and off at various intervals. The heater manufacturer stated that given our design specs and operating parameters the heater life expectancy would be app r oximately 10 years if cycled on/off severa l times a day and approximately 15 years if cycled on/off on a month l y sched u le. Thus the 10 to 15 years was indicated in the appl i cation. I f it pleases, the 10-year expected useful life may be used rather than the 10 to 15 years stated. A.4. The engineering drawings submitted did not include complete dimensions of the TGA 3000. Please resubmit the engineering drawings to include all of the overall dimensions and the units of measure. If the TGA 3000 will be distributed as a component to a detection system , provide engineering drawings that include dimensions and units of measure for the de*tection systems. See attachment 6 Rev 1 for complete dimensions in inches , unless o t he rw ise spec ifi ed , as we ll as labels to be used. A.5. Discuss the assembly methods used by the detection systems. The assembly methods are exp l ained in attac h me n t 5 along with the quality ass ur ance check poi n ts

  • A.6. Indicate if the ionization source assembly , assembled by NRD LLC , includes the installation of the source in to the source holder. This is indicated in attachment 4 , pa r ag r aph 3 , w ith refe r e n ce t o drawings 4 4 100 1 04 , and 44100116 of attac h ment 4 The 20uCi AM-241 foi l source i s ins t a ll ed in t o a specially designed stainless-s t eel source holder , and s h ipped as a sea l ed source assembly. T h e sou r ce cavity edges a r e peened so t hat t he sou r ce cannot be removed or fall out. The cavity is so small t hat h uman contact wi t h th e sou r ce , o n ce insta ll ed , i s h ig hl y imp r obab l e. The sea l ed so ur ce is s h ipped comp l etely installed a n d sealed in the source holder and leak tested and certi fi ed by NR D LLC. P rior to shipment t o Va l eo. Page 2 of 11 A. 7. Provide the materials o f construction used for the TGA 3000 and the detection systems. The TGA 3000 is an OEM Module. See new attachment 11 for drawings and material call out lists. A.8. Discuss whether there is any potential for corrosion between unlike material s used in the const ruction o f the TGA 3000 and detection systems. There 1s no potential for corrosion under normal operating cond1t1ons. The TGA 3000 OEM IMS Cell Assembly is constructed with Kovar, and 96-97.5% AL203 , and 18-8 Stainless steel. These materials were selected for similar thermal expansion coefficients for high temp brazing , as well as non-c orrosive properties. A.9. Identify the material used for the label on the TGA 3000. See 44100101 Rev 1 , and 44100102 , of attachment 6 for drawings and material specs. A.10. Based on your description of the TGA 3000, it appears that the TGA 3000 will be incorporated in stand-alone device. Provide the labeling to be used on the alone device to identify the use of radioactive material.

See Attachment 6 drawing s 44100101 rev 1 and 44100102. A.11. Please provide the maximum allowable temperature, vibration , and shock for the TGA 3000. Minimum operational temperature

-25°C Max i mum allowable operating temperature

+75°C Vibration Failure at 35 Grms (Gravity Root Means Squared) Shock 48" static drop failure was bent exit tube. There were no measured radiat i on levels above ba c kground fo r any of the tests A.12. Please indi cate where the IMS cells were hit when the drop te st was performed.

Indicate which part of the ce ll will be more vulnerable when dropped. The nature of the I MS cell construction has the majority of the weight being at the front end , or c arrier inlet end where the~-VCR fitting i s placed. The majority of the stat i c drops resulted in the IMS cell assembly impacting the concrete floor at approximately 45 degrees and the impact po i nt would always be with the front , VCR fitt i ng , making impact first. The IMS cells were always dropped from a flat surface by being pushed off the edge of the flat surface The drop tests showed that the weak point of the IMS cell would be around the side exit port. None of the cells tested resulted m any breakage of any sort that would diminish the shielding of the AM-241 source. This was sh o wn in the drop test tables in attachment

4. Page 3 of 11 A.13. Your application indi cates that the TGA 3000 IMS module was submitted to 12 months of usage under normal operating conditions as well as periods of severe conditions. Please describe these severe conditions.

The periods of severe conditions were 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> operating at 0°F then removed from freezer environment , allowing for ambient equilibration whi l e running. No failures during this course of action. The other severe condition was operating i n a closed lab oven set to 65°C for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. Again. there were no failures noted at 65°C These conditions were repeated 12 times o v er the course of several months The carr i er and drift gas used for te s ting under these conditions was UHP Argon. A.14. The Va l eo app l ication provided qua l i t y control procedures for th e TGA 3000. NUREG-1556, Volume 3 , Revision 2 states that a minimum a Quality Assurance Program needs to ensure that (i) the materials of const ru ctio n and the final assembly meet th e design specifications

(ii) the final product is leak tested; (iii) a final radiation profile is performed; (iv) a te st if performed that ve rifi es th at the product ope rate s as intended , including all safety features; and (v) a visual and me c hani ca l inspection is performed of components that are conside red related to safety or are expected to be susceptible to fa ilure under extreme or unu sua l co nditions. Discuss how Valeo intends to meet these items and provide a description of th e Valeo Quality Assurance Program on how Va l eo will ensure oversight and control over all activities applicable to the design , fabrication , inspe ction, testing , maintenance , repair , modification , and distribution of the TGA 3000. See the QA pro c edure checkpoint s in Attachment 5 Rev 2 and the QA procedures found in New attachment 13 A.15. Please di scuss whether the TGA 3000 or the s tand-alone detection systems are fixed or portable. The TGA 3000 can be either portable or fixed depending on application and end user requirements. Sin c e the TGA is des i gned to be plug and play , the end user may choose to install the TGA 3000 into a fixed installation for gas sampling or to install into a portable format that cou ld be moved to different sampling locations. 8.1. Section 32.30(b)(3) requires the app l icant to submit information concerning the c hemical and ph ysica l form of the byproduct material in the product and c hanges in che mi cal and physical form that may occ ur during the useful life of the product. The NRD A-001 Am-241 source used in the TGA 3000 is a foil source. The foil construction is comprised of a gold or silver overcoat and undercoat , gold or silver plus americium-241 oxide active layer and silver or gold backing 0.006-0.007 inch 1n thickness that are welded and rolled to give complete sealage. The entire surface of the sealed unit is gold plated. The standard foil is fabricated with the active layer centered between two inactive margins Page 4 of 11 The properties of the precious metals are well known and there will be no significant change in the chemical or physical form of the sources during their useful life. A study was made by R. G. Niemeyer ("Containment Integrity of 226 Ra and 241 Am Foils Employed in Smoke Detectors ," ORNL-TM-2684 (1969) on foils which had been in normal use m smoke alarms for 5-14 years and no aging effects were observed. Niemeyer concluded that the foils could adequately contain the radioactive material , in normal use environments , for a 50-year lifetime. The projected useful life of the TGA 3000 is a maximum of 15 years. B.2. Section 32.30(b)(4) requires the applicant to submit information concerning the solubility in water and body fluids of the forms of the byproduct material contained in the product. REF
R. S. Neimeyer {ORNL-TM-2684) performed a total of 23 twenty four hour water leach tests and 15 three week water leach tests on eight Am241 foi l s which had been r emoved from five to six year old smoke alarms. The sources contained approximately 15 microcuries of Am241 each and half of the sources were deliberately damaged by drawing a sharp tool along the entire length of the foi l before the leach tests. The maximum activity leached in these tests was 0.0045 microcuries. which was less than the 0.005 microcuries of leakage allowed by NRC's standard leak test condition for alpha sources. The average activity leached during the 38 tests was 0.9 nanocuries and 11 of the 38 tests leached less than 0.02 nanocuries. Ref: Dale H. Denman , Batelle Pacific Northwest Laboratory , Health Physics 1.§., 480 ( 1969} stated , with a l i terature citation to ICRP Report 1 1. "Because most of the compounds of the transplutonium elements are insoluble in biological fluids , ingestion and percutaneous absorption are unlikely to result in significant body burdens. For example , less than 0.01 %of the Americium 241 taken into the gut ultimately reaches the critica l organ , bone. Hence , at least 500 Micro C1 of insoluble Am241 must be ingested to product one bone burden (0.05 M i cro Ci}." Since the Am241 used in the Va l eo TGA 3000 is Am0 2, intimate l y bound in a matr i x of precious me t als, l eaching of Am241 i nto body fluids from these sources would be less than stated above for insoluble compounds of Americium. 8.3. Section 32.30(b)(5) requires the applicant to submit information concerning details of construction and design as re la ted to containment and shield i ng and other safety features under normal and severe conditions of handling , storage, use , and disposal.

The response to this item may be provided in conjunction with items 4 through 7 in Part A of this enclosure. See the responses A4 through A?. 8.4. Section 32.30(b)(6) requires the applicant to submit information concerning maximum externa l radiation le ve ls at 5 and 25 cm from external surface of product and the method of measurement.

Your application provided radiation profiles at 5 , 10 , 30, and 100 cm, but not 25 cm as required by Section 32.30(b}(6).

The response to this item may be provided in conjunction with item 14(iii} in Part A of this enclosure.

Page 5 of 11 See the revised test results found in attachment 3 rev 1. 8.5. Section 32.30(b}(7) requires the applicant to submit information concerning the degree of access to human beings during normal use. In Enclosure 2, Item (d) of your application, you stated: "No access to the ionization source is afforded by the end user or any individual other than authorized users once the TGA 3000 module has been assembled in accordance with the Valeo Instrument Company Inc. assembly and safety manuals. There is no direct access point to the AM-241 source once assembly has been completed." Please explain what is meant by "authorized users" and how they differ from "end users." The statement as written appears to be self-contradictory. As shown and explained in the attachments under normal use conditions there is no access to the source. The source can only be accessed by disassemb ly of the IMS cell which is only authorized to be done by Valeo employees.

Authorized users , as listed in enclosure 2 should have been defined as only Valeo employees trained in all aspects of operation, assembly , radiation safety and quality control for the TGA 3000. This is what was meant by authorized user. 8.6. Section 32.30(b)(8) requires the applicant to submit information concerning the total quantity of byproduct material expected to be distributed annually.

Projections for demand and manufacturing schedules indicate that in the first year of production a max i mum of 25 units would be distributed. Within 3 years 1t is anticipated that the maximum manufacture and distribution of TGA 3000 will be 100 units per year. 8.7. Section 32.30(b)(10) requires the applicant to submit information concerning the proposed method of labeling or marking the product and its point of sale package to satisfy the requirements of§ 32.32(b}.

Although you provided information concerning this requirement that pertains to Sections 32.26 and 32.29, you should submit such information to show how you would satisfy Sections 32.30 and 32.32. The response to this item may be provided in conjunction with Items 9 and 10 in Part A of the enclosure. Please provide revised drawings that show labeling that complies with § 32.30 and § 32.32. As noted in response A9 and A 10 above , attachment 6 contains the requested information showing labels. Section 32.32(b) provides the details of the requirements of Section 32.30(b)(10) pertaining to labeling. Section 32.32(b) requires the applicant to submit the following information concerning product labeling: Label or mark each device and its point-of-sale package so that: Each item has a durable, legible , readily visible label or marking on the external surface of the devi , ce containing

Page 6 of 11 The following s tat e m ent: "C ON TAIN S RAD IOA CT I VE MATERIAL"; The name of the radionuclide(s) a n d q u a ntit y(ies) of activi t y; An id entification of th e person licensed under§ 32.30 to transfer the device for use under § 30.22 o f th i s chap t er o r equiva l e n t r eg ul a ti ons of an Ag r ee m e n t State; and In structio n s a nd precautions necessary to ass u re safe ins t alla ti on, opera ti on, and serv i cing of t h e d ev i ce (doc ument s suc h as operat in g and service manua l s may be ident ified in the label a n d u se d to provid e t hi s information). T h e ex t e rn al s urfac e of th e poi nt-of-sa l e package has a l eg ibl e, read il y visible l abe l or ma r ki ng co nt ai ning: T h e name of the r adio nu clide and quantity o f activ it y; An identification of th e person li ce n sed under§ 32.30 t o transfer t h e device for use un de r§ 30.22 of th i s chap ter or eq ui va l e nt r egu l a ti ons of a n Agreement State; a nd T he following or a s u bsta nti ally simi l ar stateme nt: " THI S DEVICE CON TAIN S RADIOACTIVE MATERIAL AND HA S BEEN MANUFACTURED I N COMPLIANCE WITH U.S. NUCLEAR REGULATORY COM MI SS ION SAFETY CRITERIA IN 10 CFR 32.3 1. T HE PURCHASER I S EXEMPT FROM ANY REGULATORY REQUIREM EN T S. S ee the label in Attachment 6 The follow in g two requirements from Sec ti on 32.30 w ill be satisfied provided tha t s uffi c ien t information is s uppl ied that addresses the r efe ren ced portions of Section 32.31 , which i s discussed i n g r eate r detail below. Sect ion 32.30(b)(13) requires th e a ppli ca nt to s ubmit information co n ce rnin g th e est im ate d exte rnal radiation doses and co mm itte d doses r esu ltin g fr o m th e intake o f byproduct material in any one year re l eva n t to t h e sa f e t y cr iteria in§ 32.31 and the basis for these estimates; Sect i on 32.30(b)(14) requires the applicant to s ubmit information concern i ng t he determination t hat the probabilities with r es pe c t to th e d oses referred to in § 32.31 (a)(4) m eet the c r ite ria of that paragraph; Wi th regard to it ems 8 an d 9 below , yo u pr ov id ed statements , without supporti n g evi d ence, th at were intended to address th e r equ irem ents of 10 C FR 32.28. T h e re quir eme nt that s h ou ld be ad dre ssed is 10 CFR 32.31, which i s s imilar. Specifica ll y, in Enclosure 2, It em (e) of yo ur application , you s t a ted: Due to t h e de s ign and manufacture of the TGA 3000 module , it i s h igh l y unl ike l y that th ere will be a significa n t reducti on in the effectiveness of the containment , s hi e ldin g, or o ther sa fet y features of th e product from wea r and abuse likel y to occur i n normal handling and use of the product during it s u sef ul lif e. Page 7 of 11 Also, in Enclosure 2, Item (f) of your application , you s tated: Due to the design and manufa ctu r e of the TGA 3000 mo d ule and if used under normal use and specified operational guidelines the probability is low that the contai nm en t , shie lding o r other safety features of the p r oduct would f ail, under suc h c ircum s tanc es, that a person would re ceive a n external radiat ion dose or dose commi tment in excess of the dose to the appropriate organ as specified in Column II of the t a ble in 10 CFR 32.28, and the probability is negligible that a person would receive an external radiation dose o r dose comm itm ent in excess of the dose to the appropriate organ as spec ified in Co lum n Ill of the tabl e in 10 CFR 32.28. Under normal use and conditions any dispo sa l of a single unit or handling , shipping and storage of un i ts are unlikely to acc umulat e in one lo c ation. The q u oted statements do not by themselves satisfy the requirements of 1 O CFR 32.31. To do so, you shou ld provide the details requested in It ems 8 and 9. See t he " Radio l ogical Assessmen t o f Th e Va l eo TGA 3000" f o un d i n t he new Attac hm e n t 1 4. B.8. Section 32.3 1(a) requires an app l icant for a li cense und e r§ 32.30 to demonstrate that the device is designed and will be manufactured so that: In normal use, ha nd li ng, and storage of the quantities of exempt units likely to accumulate in one location , including during marketing , distribution , installation , and servicing of th e device, it is unlikely that the ex t erna l radiation dose in anyone year, or the co mmitted dose re s ulting from the intake of radioactive material i n any one year, to a s uitable s ample of the group of individual s expec t ed to be most highl y exposed to radiation or radioa c tive material from th e device will exceed 200 µSv (20 mrem). Please provide an eva luati o n which demonstrates t hat this requirement will be met. Methodologies for making s u c h a demon s trati on are provided in NURE G-1717 , "Sys tematic Radiological Assessment of E xe mptions for Source and Byproduct Materials ," available at: https://www.nrc.gov/reading-r m/docco ll ections/n ureg s/staff/sr17 17/. N o t e that NUREG-1717 was published pirior t o the estab li sh m ent o f the regulations in 10 CFR 30.22 and 10 CFR 32.30; however , the m e th odo logie s provided for gas a nd aerosol detectors a re ge n era ll y applicable to th e t ype of industrial device in your application. It i s unlik ely that the external radiation dose in any 1 year, or the co mmitte d dose resulting f r o m the intake of radio active material in a n y 1 year, to a su itabl e samp l e of th e group o f individuals expected to be most highly exposed to rad ia tion or radioactive material from disposal of the quantitie s of units likely t o accumulate in th e same disposal site will exceed 10 µSv (1 mrem). Please provide an evaluation which demonstrates that this requirement will be met. P age 8 of 11 It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the device from wear and abuse likely to occur in normal handling and use of the device during its useful life. Please provide an evaluation which demonstrates that this requirement will be met. In use, handling, storage , and disposal of the quantities of exempt units likely to accumulate in one location, including during marketing, distribution, installation, and servicing of the device, the probability is low that the containment , shielding, or other safety features of the device would fail under such circumstances that a person would receive an external radiation dose or committed dose in excess of 5 mSv (500 mrem), and the probability is negligible that a person would receive an external radiation dose or committed dose of 100 mSv (10 rem) or greater. See the " Radiological Assessment of The Valeo TGA 3000" found in the new Attachment
14. (The footnote to Section 32.31 (a)(4) state s: "It is the Intent of this paragraph that as the magnitude of the potential dose Increases above that permitted under normal conditions, the probability that any individual will receive such a dose must decrease. The probabilities have been expressed In general terms to emphasize the approximate nature of the estimates that are to be made. The following values may be used as guides In estimating compliance with the criteria: Low -not more than one such failure/incident per year for each 10,000 exempt units distributed. Negligible

-not more than one such failure/incident per year for each one million exempt units distributed

.") Please provide an evaluation which demonstrates that this requirement will be met. B.9. Section 32.31(b) requires an applicant for a license under§ 32.30 to demonstrate t hat, even in unlikely scenarios of misuse, including those resulting In direct exposure to the unshielded source removed from the device for 1 , 000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> at an average distance of 1 meter and those resulting in dispersal and subsequent intake of 10-4 of the quantity of byproduct material (or in the case of tritium, an intake of 10 percent), a person will not receive an external radiation dose or committed dose in excess of 100 mSv (10 rem), and, if the unshielded source is small enough to fit in a pocket, that the dose to localized areas of skin averaged over areas no larger than 1 square centimeter from carrying the unshielded source in a pocket for 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> will not exceed 2 Sv (200 rem). Please provide an evaluation which demonstrates that this requirement will be met. Page 9 of 11 See the " Rad1olog1cal Assessment of The Valeo TGA 3000" found in the new Attachment 14 I believe that the above and t he attached answers your reque s t for more i nformation concerning the Valeo TGA 3000. Should you ha v e any questions please call me at (713)688-9345 or email me at Stan@vic i.com. Sincerely , ~dh Stanley D. Steams President and Rad i ation Safety Officer Valeo Instruments Company , Inc. Post Office Box 55603 Houston, Texas 77255 Page 10 of 11 5 of72 Atta c hment 2 Co ndition s o f Use: a) Th e Va l e o Instrument s Co mp a n y In c. TGA 3 000 I o n Mobilt y Sp e ctrom e te r. (IM S). G as/P a rti c u l a t e Ana l yze r M o dul e w ill b e primaril y u se d for d e tecti o n of impuriti es. s u c h as H 2 0. 0 2. a n d N H 3, in U ltra Hi g h Purit y. (U HP) gas e s wi d e l y u s ed in th e se mi co nduct o r , L E D , a nd m a n y o th e r m a nufa c ntring proce sses th a t uti li ze U J-IP g a ses i n th e ir manufa c turin g p ro c ess. The s e pr ocess e s r e quir e c ontinu o u s m o nitorin g for l eve l s o r impuritie s th at w ould b e d e trim e ntal to qu..ilit y a nd produ c t th ro u g hput. b) S o m e o ther u ses a nd/o r applica t i o n s co uld in c lud e, but ar e ce riainl y not I imit e d t o th e foll o wi n g; I) Det ec tion o f tra ce l ev el s u r face co nt a minant s o n w afer s u s ed in th e s emi co ndu ct or indu s tr y. 2) Air qual it y mon i torin g for p e r s o n nel s afe t y. 3) N a r co ti c s D e t ec ti o n. 4) Ex pl os iv es D e t ec ti o n. c) Th e e xp e ct e d u se ful lif e of th e pr o du c t through n o rmal usa ge, and w ith pr o p e r ca re , s h o uld b e IO ye ar s. S in ce th e T G A 3 0 00 h as n o m ov in g p a rt s th e I 0 yea r lif e e xpe c t a n cy wa s d e t e rmin e d b y u s in g th e s h o rte s t e nd o f l i fe s pec fo r a n y e l ec tr o ni c co mp o n e nt s c rn c ial t o o p e rati o n o f the TGA 3 000 in s trum e nt. d) No A ccess t o th e i o ni z ati o n so ur ce i s aff o rded b y t h e e nd u se r or an y i ndividual o th e r th a n a uth o ri ze d u se r s o n ce th e TGA 30 00 m o dul e h as b ee n asse mbl ed in acco rdan ce with th e Val eo I n s trum e nt C omp a n y In c. asse m b l y and s af e t y manu a l s. Th e r e i s n o dir ec t a ccess p o int t o th e AM-2 41 so ur ce o n ce ass embl y ha s b ee n compl e ted. e) Du e t o th e de s i g n and ma n ufa c tur e o f th e T GA 3 000 modul e, it i s hi g h l y unlik e l y that ther e will be a s ignificant reduction in th e effe c tiven ess o f th e c ontainment

., s hi e lding , or othe r s a fe ty features of th e produ c t from wear a nd a bu se lik e l y to occ ur in normal handlin g a nd u se of the produ cl durin g it s u se ful life.

6 of 72 f) Due t o the d esig n and manufa c tur e of the TGA 3 000 modul e and i f u sed un der n o r m a l u s e and s p ec ifi e d operationa l g uid e l in es th e prob a bilit y i s l ow that th e co ntainm e nt. s hi e ldin g o r othe r sa f e t y fe a tur es of the product would fail. under s uch c ircum s tanc es, th a t a p e r so n would rec eive an ex ternal radiatio n dose or dose co mmitm ent in excess of the d ose to th e app r opria t e organ as s pecifi e d in Co lumn II of th e tabl e in l 0 C FR 32.28 , a nd th e probability i s n eg li g ib l e that a p erso n would receive a n ex t erna l radia ti o n dose o r do se co mmitm en t in excess o f th e d ose t o th e approp riat e organ as spec i fied in Column m of the table in 10 CF R 32.28. Under normal u se and co nditi o n s an y di s po sa l of a si ngle unit or handling , s hi ppi n g and s t orage o f unit s a r e unl ike l y t o acc umulat e in one lo ca ti o n.

c 1 mrem = 0.01 mSv; 1 rem= 0.01 Sv. d D ose estima t e applies to an operator who i s exposed to a s i ngle chemica l detector unit during r outine use (see Section 2.15.5.2 of NUREG 1717). e Limit on whole-body dose and active bloo d-forming o rg ans during normal use and handling of a single exemp t unit (see Section 2.15.1 of NUREG 1717). , Dose estimate app l ies to a person who vandalizes a chemica l detec to r unit a nd ingests radioactive materia l due t o con t am i nation of hands (see Section 2.15.5.4 of NURE G 1 717). 9 Limit on whole-body dose and dose to active blood-forming organs when probabi l i t y of f a ilur e of safety features in product is less than one failure per year for each 10 , 000 exempt units , distri but ed (see Section 2.15.1 of N U REG 1717). 11 Limi t on whole-body dose and dose to active blood-forming organs when probabili t y of failure of safe t y features i n product is l ess than o n e fa i lure per year for eac h 1 million exemp t unit s distributed (see Section 2.15.1 of N U R EG 1717). 1 Do se es t imate applies to lo ca l parcel-delive r y driver who i s exposed to mu l tiple c hemical detector units du r ing d i stribution and transport (see Sec tion 2.15.5.1 of NUREG 1717). 1 Limit on whole-body dose and dose to active blood-fo rming organs dur i ng normal handling and storage of mu ltipl e exempt un it s (see Section 2.1 5.1 of NU REG 1 7 1 7) . ... Dose es t imate applies t o a worker who i nha l es radioact i ve material from multip l e c hemical detector unit s during c l eanup after a t ranspo rt ation fire (see Section 2.15.5.4 o f NUREG 1 717). 1 Bone s urfa ce dose o r red marrow do se to a person who va n dali zes a chemical detec t or u nit and Ingests r adioactive materia l due to co ntamin a tion of hands (see Section 2.15.5.4 of NUIREG 17 1 7) m Bone surface dose or red marrow dose to worker who Inha l es rad i oactive material fr om mul tipl e chemica l detector uni t s during c l eanup a ft er a tran sporta ti o n f i re (see Sec ti on 2.1 5.5.4 o f NUREG 1717). n Limit on " other organ" doses when probability of failure of safety features of the product is less than one fa ilur e pe r year for each 10 ,000 exemp t ed uni t s distribu t ed (see Section 2 .15.1 of NUREG 1717). " Limi t o n " o th er o r gan doses when probability of failure o f safety feature s o f the p r oduct is les s t h an one failure per year for each 1 mi lli on exempt units di s tributed (see Section 2.15.1 of NUREG 1717).

estima tes are slgnilicanlly Jess for workers at landfill s, off-site members of the publ i c, and fu tu re on-site residents (s ee Section 2.15.5.3 of NUREG 17 1 7). f Dose es timate app l ies t o waste co ll ectors exposed to multiple c hem ica l dete cto r s during di s po sa l at incinerator s; dose es t ima te s a re s ignifi c antly l es s for other worker s at inci nerator s and off-s it e mem bers of the public (see Sect i on 2.15.5.3 of NUR EG 1717). g Dose estimate app lie s to a work e r who are invo l ved In t h e c l eanup following the transportation fire involving mu lti p l e c h emica l detecto r s with 24 1 Am sources (see Sect ion 2.15.5.4 o f NU R EG 1717). h Dose es t ima t e app li e s to in ge s t ion of 241Am by a p erson who finds and dest roys a c h emica l de t ecto r containing an 241Am source. (see Sec t ion 2.1 5.4.4 N UREG 1717). Table 2 Comparison of Estimated Maximum Individual Doses from the TGA 3000 and limiting Organ Doses from 10 CFR 32.27 Exposure Conditions

  • Maximum Individual Regulatory limit for Dose b Organ Dose (mREM , REM , mREM/vr)* (m/REM , REM , or mREM/yr)* Effective dose equivalent R o utine U se a n d disposal 0.25 mREM/yr" 5 mREM/y re o f a sinq l e exempt unit A ccide nt s i n vo lving sing l e 7.5 mREM1 0.5 REM 9 exe mp t unit 15 REM h Normal handling and 0.05 mREM/yr 1 5 mREM/yr storage of multiple exempt units Accide nt s involving mul t ip l e 3.7 5 mREM* 0.5 REM 0 exempt u n it s 15 REM h Dose equivalent to red marrow Ac c ident s in vo l vi n g a sing l e 11.25 mREM' 0.5 REM O exempt unit 1 5 REM h Ac c i de nts i n vo lvin g multip l e 5 mREM"' 0.5 REM O exempt unit s 15 REM h Dose equivalent to bone surfaces Ac c idents involving a s i ngle 0.1 25 REM' 1.5 REM" exempt un it 50 REM 0 Ac c idents involving multiple 62.5 mREM'" 1.5 REM" exempt unit s 50 REM 0 See following page for foo t notes a See Section 2.15.4 of NUREG 1717. b M ax imum individua l dose based on t h e typical quantity used (i.e ... 02 mCi) of 241 Am). H owever , the ac tivity of the source cou l d be increased until the regulatory limit for organ do se is reached.

Discussion

Radiological Assessment Of the Valeo TGA 3000 I n order, to eva l uate the potentia l doses from the distribution of the TGA 3000, exis t ing data on chemical detectors containing Am-241 was g l eaned fr om NU REG 1717. NU REG 1717 presents dose data for the distribution of chemica l detectors contain i ng 160 µCi of Am-241. The TGA 3000 on ly contains a maximum activ ity of 20 µCi of Am-241. This is an activ ity red u ction of 87.5%. Addi t iona ll y , Collec t ive Effectiv e Dose Equivalent estima t es were made assuming an a n nual distribution of 10 , 000 dete c t ors , whi l e it is anticipated that the TGA 3000 wi ll have a max i mum d i stribution of just 100 units annua ll y which is a 99% diffe r ence. Thus , the result s given in t h e dose tables below for the TGA 3000 were reduced by 87.5% for I ndividua l Annua l Effec ti ve D ose Equivalent and by 99% f or the " Co ll ec ti ve Effective Dose Equival en t". All ot h er conclusions and assumptions discussed in NU REG 1717, rega rdi ng the ana l ysis of c h em i cal detectors (including D is tributi on and T ransport; Routine Use; Disposal; Accidents and Misuse; and Safety Criteria), were conside r ed to be app l icab l e to the TGA 3000 es t imates of dose. T a bles: Table 1 Pote n tial Radiation Doses From The TGA 3000 Exposure Pathway Individual Annual Collective Effective Dose Eff e ctive Dose Equivalent Equivalent b (mREM)* (Person-REM)

Dist r ibution and tran s port 0.05< 0.00075 Routine use 0.25 d 1 Di s p osa l Landfills 0.00375* 0.05 In cine rator s 0.025 1 0.0008 A cci d e nt s and Mi s u se Fire 3.75* V an d a li sm o f det ecto r unit 7.5* a 1 mrem = 0.0 1 mSv; 1 person-rem

= 0.0 1 person-Sv.

b Co ll ect ive d oses are based on (1) a n assumed annua l distribution of 10 0 TGA 3000's co ntain ing 0.2 mCi of 241A m e ac h a nd (2) an ass um ed 10-y ear effective l ife t i m e for the dete c tor s. c Dose es tim ate applies to lo ca l parcel-delivery drivers exposed to m u l ti p l e exemp t u nits in wholesale w arehouses during distribution and tran sport; dose estimates are s ignifican tl y le ss for o th e r tru ck drivers , workers in t ru c k termina l s , and member s of publ ic a l ong t ruck route s (see Sec t ion 2.1 5.5.1 of NUR EG 1717). d Dose es tim a t e app l ies to a user o f a portable chemica l dete c tor con t ain i ng an 241Am sour c e: dose estimate s are l es s f or a u ser o f a fixed c hem i c al detector con t a inin g an 241Am source (see Section 2.1 5.5.2 o f NUR EG 1 717). e Dose es ti ma t e applie s to w as t e c o ll ector s exposed t o mu l tiple chemica l detectors du ring dispo s al a t lan dfi ll s; dose VALCO I NSTRUMENTS CO., I NC. W I 1 005 I MS UPPER/LOWER HEATER I NSULATORS RE C E I V I NG INSPECT I ON ACTION YES/NO NOTES/ Q T Y/PO#/ ETC INSPECT PACKA G E/ OK U SING NITRILE NON-POWDERED GLOV E S OR EQUIVALENT PACKING LIST PURCHASE ORDER NUMBER QTY RECE I VED QTY ORDERED c o c INSPECT RANDOM 3 UPPER AND LOWER INSULATORS FOR DIMENSIONS PER Y2 5 939 AND Y2 5 940 INSPECT ALL HOUSINGS FOR ANY DAMAGE MAKE SURE UPPER AND LOWER S ECTION S ALIGN PROPERLY 3 COP I ES OF DOCS DISTRIBUTION O F DOC S PUR C HA S ING , QUALITY , MANU F A C TURIN G INFORM QUALITY OF ANY DISCREPANCIES. Li s t a ny discr e pan c i es ________________________

_ Re c eiving Inspector:

Print Name ______ _ R e ceiving Inspector:

Signature

_______ _ Date: _____ Time: ___ _ Quality Assurance:

Print Name ______ _ Quality A s surance: Signature

_______ _ Date: ____ _ Tim e: ___ _ Wl-1 005 V ALCO I NSTRUMENTS CO., I NC. WI 1004 I MS UPPER/LOWER H EATE R HOUSINGS RECEIVING I NSPECTION ACTION YES/NO NOTES/ QTY /PO#/ ETC INSPECT PACKAGE/ OK USING NITRILE NON-POWDERED GLOVES OR EQUIVALENT PAC KIN G LIST PURCHASE ORDER NUMBER QTY RECEIVED QTY ORDERED CDC INSPECT RANDOM 3 UPPER AND LOWER HOUSINGS FOR DIMENS I ONS PER Y25937 AND Y25938 INSPECT ALL HOUSINGS FOR ANY DAMAGE MAKE SURE UPPER AND LOWER SECT I ONS SNAP TOGETHER AND SCREW HOLE BOSSES ARE ALIGNED 3 COPIES OF DOCS DISTRIBUTION OF DOCS PURCHASING , QUALITY , MANUFACTURING INFORM QUALITY OF ANY DISCREPANCIES.

List any discrepancies

________________________

_ Receiving In spec tor: Print Name _______ _ Receiving Inspector: Signature

_______ _ Date: Time: ----------Quality As su rance: Print Nam e ______ _ Quality As sura nce: Signature

_______ _ Da t e: _____ Time: ___ _ Wl-1004 V ALCO I NSTRUMENTS CO., I NC. W J 1003 I MS HEATER ASSEMBLY R ECE J VTNG I NSPECTION ACTION YES/NO NOTES/ QTY /PO#/ ET C INSPECT PACKAGE/ OK USING NITRILE NON-POWDERED GLOVES OR EQUIVALENT PACKING LIST PURCHASE ORDER NUMBER QTY RECEIVED QTY ORDERED coc INSPECT RANDOM 3 HEATERS FOR DIMENSIONS PER Y25942 INSPECT ALL HEATERS FOR ANY DAMAGE, CRACKS/TEARS, DELAMI NATI ON 3 COP IE S OF DOCS DISTRIBUTION OF DOCS PURCHA S ING , QUALITY , MANUFACTURING INFORM QUALITY OF ANY DISCREPANCIES. List any discrepancies

________________________

_ Receiving Inspector:

Print Name ______ _ Receiving I nspector:

Signature

_______ _ Date: ___ _ Time: ___ _ Quality Assurance:

Print Name ______ _ Quality Assurance:

Signature

_______ _ Date: _____ T im e: ___ _ Wl-1003 VALCO I NS T RUMEN T S CO., INC. W I I 00 2 I MS ASS EM B LY R ECE I V I NG INS P EC TI ON ACTION YES/NO NOTES/ QTY /PO#/ ETC INSPECT PAC K AGE/ OK INSPECT INDIVIDUAL CELL PACKAGING/OK USING N I TRILE NON-POWD E RED GLOVES OR EQUIVALENT PACKING LIST PURCHASE ORDER NUMBER QTY R E CEIVED QTY ORDERED coc HELIUM LEAK TEST CERT I FICATE MEGGER TEST CERTIFICATE MAKE SU RE ALL CELL OP E N I NGS ARE CAPPED AS RECEIVED MAKE SURE EACH CELL HAS DOCUMEN T ATION CHECK 3 CELLS FOR OVERAL L DIMENS I ONS P E R Y25894 CHEC K ALL CE L LS FOR EXCESS This is dark lines sourcing from the metal guard ring BRAZ I NG FLOW across the white ceramic isolator.

Transition across ce rami c, ring to ring , is a failure. 3 COP I ES OF DOCS D IS TR I BUTION OF DOCS PURCHASING, QUALITY , MANUFACTURING INFORM QUALITY OF ANY DISCREPANCIES.

list any discrepancie s _________________________

_ Receiving Inspector:

Print Name _______ _ Receiving I n spector: Signature

_______ _ Date: ____ _ Time: ___ _ Qua l ity Assurance: Print Name ______ _ Qual i ty Assurance: Signature

_______ _ Date: _____ Time: ___ _ Wl-1002 V ALCO I NST RU MENTS CO., I NC. W I 1 00 1 A M-24 1 R ECE I V I NG I NS P ECT I ON ACTION YES/NO NOTES/ QTY /PO#/ ETC RSO CO N T ACTED INCOM I NG LEAK TEST CONDUCTED BY RSO INCOMI N G LEAK TEST OK PER RSO PURCHASE ORDER NUMBER QTY RECE I VED QTY ORDERED coc LEAK TEST CERT I F I CATE SEALED SOURCE CERTIFICATE 3 COPIES OF DOCS LEAK TESTCERTIF I CATE, SEALED SOURCE CERTIFICATE, AND CERT IF ICATE OF CO M PLIANCE (COC) DISTRIBUTION OF DOC S PUR C HA S I NG, QUA LI TY , MANUFA CT UR I NG RSO H AS POSSESION OF AM-241 SOURCE S HIPMENT INFORM QUALITY OF ANY DISCREPANCIES.

li st any discrep a n c ie s ________________________

_ R ecei v i ng In s pector: Print N ame ______ _ Receiving I nspector:

Signature

_______ _ Date: _____ Tim e: ___ _ RSC/A ss istant RSO: Print Nam e _______ _ RSC/As s istant RSO: Signature

________ _ Date: ____ _ Time: ___ _ Quality Assurance:

Pri n t N ame ______ _ Quality Assurance:

Signature

_______ _ Date: ____ _ Time: ____ , Wl-1001 V ALCO INSTRUM ENTS CO., INC. RECEIVING INSPECTION WORK INSTRUCTION FOR TGA 3000 I MS CR I TI CA L COMPONENTS

.>>-U se Valeo Work Instruction Wl-1 004-Upper and Lower Heat er Hou si ng Assembly Check List for receiving in s pe ct ion. *!* Receiving inspection for Upper and Lower Heater Insulators PN Y25939 and Y25940. };:-Open packaging and in s pect for any damage . .>>-Inform purcha s ing that order ha s been received.

Mak e 3 copies of packing li s t, and COC. .>>-Use N i trile Powder Free gloves for handling and inspection of Heate r assembly.

Nev e r allow h a ndlin g with bar e hand s, always provide a clean d ry s urfa ce for in s p ect ion. Clean indu stria l g rade a lum i num foil i s pr efe r red . .>>-U se Valeo Work Instru c tion W l-1005-Upp e r and Lower Heater In s ul ator Assemb l y Check List for receiving in spectio n. Valeo WI-1000 V ALC O I NSTRUMENTS CO., I NC. RECEIVING IN SPEC TION WORK INSTRUCT I ON FOR TGA 3000 IM S CR ITICAL COMPO NENT S >" U se Valeo Work Instruction W l-1001-AM-2 41 Source Assy. Check Li s t for r ece iving. :,.. Inform RSO, Purchasing and Manufactur i ng of any discrepan c ie s. Retain copy of comp l eted checkl i st for records. *!* Receiving in spec tion of IM S Cell A ssy. PN Y25894. Op e n packaging and in s p ec t for any d a mage. ).-Inform purcha s ing that order h as b ee n re ce ived. M a ke 3 co pi es o f packing list , COC, Helium L eak Test and Megger re s i s tance test doc s. ).-U se Nitri l e Powder Free glove s for handling and in s pection of I MS ce l l assemb l i es. N e v e r allow handling with b a re hand s , always provide a clean dry s urfa ce for in spec tion. C lean indu s trial grad e aluminum foi l is pref e rred. Y Use Va l eo Work In st ruction Wl-1002-IMS Cel l Assy. C h eck Li s t for r ece iving in s pection. *!* R ece iv i n g in spect ion for Min co He ater Assy. PN Y 259 42/HSFAP228674.

Y Open pack ag ing and inspect for any damag e. ).., I nfo rm purcha s ing that order ha s bee n received. Make 3 c opie s of packing li st, and COC. Y Use Ni t ril e Powder Fr ee gloves for handling a nd in spec tion of H ea ter a ssem b l y. N eve r allow handling with bare hand s, always provide a c l ean dry s urfa ce for inspection.

C l ean indu s trial g rad e aluminum foil i s preferred. };.-Use Valeo Work I nstruction Wl-1003-Min co H ea t e r As s y. Check Li s t for receiving in spec ti on. *!* Re ce iving in s p ec t i on for Upp e r and L ower H eater H ous in gs PN Y25937 a n d Y25938. );.-Open p ackag in g and inspe ct for any damage. );.-I nform purchasing that order h as b ee n received. Make 3 copies o f packing li s t, and COC. );.-U se Nitri l e Powder Free g l oves for handling and in s pection of H eater assem bly. N eve r a ll ow handling with bare hand s, a lw ays provide a clean dry surface for inspection. C lean industria l grade a luminum fo il i s preferred.

Val eo WI-1000 VALCO INSTRUM EN TS C O., IN C. RECEIVING INSPECTION WORK I NSTRUCTION FOR TGA 3000 I MS CR I TICAL COMPONENTS Copies of this Work I nstruction are to be is s ued to Receiving Department, Qual ity , RSO , a nd M anufactur in g Department

s. Th e intent of thi s Work Instruction (WI) i s Quality A ss uran ce that the Va l eo d es ign e d/ e ngin ee red c ritical co mpon e nt s re ce ived , m ee t al l the requi r ements as spec ified , p e r pur c has e order, Va l eo drawing s, and all Val eo r e quir e d certifications.

T ab l e of Critical Compone nt s. T ab l e 1 CO MPON E NT P/N lms Cell A ss y. Y2S894 Source A ssy. Y25897 Heater Assy. Y25942/HSFAP228674 Upper/Lower Y2 5 937/Y25938 Heater Hou sings Upper/Lower Y25939/Y25940 Heater In sula tor s VENDOR Omley I ndustrie s -NR D LLC Min co 30 So l utions In c Z I RCI , Inc. Actions R e qu i r ed for eac h co mponent. POii REQUIRED y es ye s Y es ye s Yes *!* Receiving in spec tion of AM-241 so urce s. coc OTHER REQUIREMENTS REQUIRED y es Helium leak te s t and /Megger resista nc e t est re s ul t s heet y es Se a l ed Source Certificate/Leak Test Certificate/Lot

  1. /Total Activity yes none yes none yes non e )., Do n ot open package. Make sure the package i s p l aced in a sa fe area away from worker s. ).-Notify RSO immedia t e l y of r eceipt of s ource s. :,.. When RSO ha s wip e tested, checked documents a nd cle a red package for hand l ing , r ece ive package, and make 3 copie s of th e packing li s t, S ea led Sou r ce Certificate, and Leak Te st Certificat
e. RSO wi l l retain the or i gina l s of each, se nd one copy , each, to Quality , Pu r c h asing, and ret ai n one copy of each for receiving record s. Once the cop ie s have been made have the RSO take control of the received sou rc e pa ckage/conta in er for prop e r s torage. Va l eo WI-1000

(b)(4)

(b)(4)

(b)(4)

(b)(4)

(b)(4)

(b)(4)

(b)(4)

(b)(4)

(b)(4)

(b)(4)

(b)(4)

(b)(4)

(b)(4)

Figure 7 Shows typica l dry Spectrum i n Argon. After connection are made allow seve r a l hour s of dry down time for s tabl e s pectrum. Section 8: Shutdown I . Turn off the p ower. 2. Ca p th e ex it p ort 3. Shut off regulator or s upply gas. 65 o f72 Figure 6 Concentration Screen The actual spect rum is also avai labl e by c l icking on the vyvF tab: , Spectrum Screen The user can save a spectrum " snapshot" by clicking on the Windows FILE/SAVE icons. This spectrum file should default to a *.bwv format which can be sent to a qualified serv ice agent for review. The CFG, MEAS , CAL and ID tabs/screens are for qualified service personnel reference only. 64 of72 Figure 5 5. The initia l analyte concentration will read > 30 ppb until the system is purged with " clean" gas. The total internal TGA300o volume is < 1 O cubic centimeters and typical drydown I purge times can vary depending on the previous use (shut down procedure) and quality of sample gas being used. Start up times of< 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> to reach < 10 ppb H20 or 02 readings can be achieved. The concentra t ion is displayed on the main screen: I H 20 in Nitrogen -F I D*te 2013-02-18 11: 26: 49 Time -r Status Off-line 63 of72 Figure 4 62 of72 Operation The on board PC will have a " TGA 3000" folder located on the desktop , open the folder then use the shortcuts labeled for the analyte and base gas for which it was tested. For example, if the T GA3000 was shipped to measure H20 in nitrogen, the icon located in the "TGA 3000" desktop f older will be labeled , " H20 in nitrogen. 1. After the initial power up, verify the sample i11 is the correct base gas. 2. Double click the appropriate shortcut located in the " TGA 3000" desktop folder. 3. C l ick OK on the following screen(s) which w i ll allow the PC to connect to the detector cell. 4. Click on the wvf tab to verify the "CONNECT" tab is active on the top row. If the tab shows CONNECT, the user press this tab and the name should change to DISCONNECT.

6. Turn o n U HP gas s upp l y i n acco r dan ce w ith t ab l e a bo ve. No t e t h e TG A 3 000 m ay be run i n s t a t i c co nd it i o n w i t h p o r ts o p e n in r oo m a i r w it h a bru s h l ess D C pump w it h s u c ti o n s i de a tt ac h e d t o ex it po rt t o c r ea t e flo w o f a mb i e nt roo m a ir t h ro u g h th e TGA 3 000. T h i s wou ld be th e d es i re d m e th o d fo r m o nit o rin g room a ir co n ta min a 1 1 t s etc. 7. J n s t a ll AC/D C co n ve rt e r p owe r s up p l y p rovi d e d. 8. S l id e o n/o ff s w i t c h to on. L i s t e n for o n e s h o rt b ee p. T h i s ind i cates th a t se l fc h eck i s co mpl e t e a nd i s TGA 3 000 i s r ea d y. A ser i es of bee p s i nd ica t es e r ro r. 9. Op e n t h e T GA 300 0 fo l d e r o n th e P C d es kt o p a n d u se s h ort cu ts a se l ec t p rog r a m o n d es k to p a nd wa it fo r w ind ow t o a pp ea r. F o ll ow i n s tru c ti o n s in fi g u res 4 , Sa nd 6. 61 uf72 Sect i on 6: Setup 1. Pla ce th e TGA 30 00 Module on a c l ean, flat , s t at i c free s urfa ce. 2. Rem ove a ll ca p s a nd plu gs fr om ca rrier , drift a nd ex i t p o rt fittin gs. Be parti c ul a rl y carefu l w ith the drift and exi t p ort fittings , these a r e fragi l e and could br ea k if imp rope rl y ti g ht e n e d o r l oose n ed. A l ways u se two w r e n c h es, one o n int e ri o r fittin g and o n e o n o ut er fittin g to loo sen or ti g ht e n h ardwa r e, 3. Mak e s ure UHP gas s uppl y i s off during in sta ll at i on to the T GA 3 00 0 Modul e. In st all desired UH P r egu l ated gas li n es wi th prop e r fitt in gs , o n e to ca rri e r and o n e to drift. Th e ex it port can b e l eft ope n or plumb e d to ve nt in a n ot h e r area. En s ure ID of exi t port tub in g u se d i s s uffi c i e n t to avo i d any ba ck pr ess u re on th e TG A 3 000 modu l e. Jt i s hi g hl y recomme nd e d that the VCR gaske t s and Valeo fit tin g gaske t s be o f hi g h quali ty t o ensure l ea k free co nn ect i ons. 4. The m aximum flo w through TG A 3000 IMS ce ll i s 300 cc/m for a s table s pe c trum. The typi ca l desired fl ow wou l d be 100 cc carr i er and l 00 cc drift. Th i s i s all m eas ur e d a t th e ex it port fo r tota l flow of 200 t o 3 00 cc/m. 5. See table below for approx i m ate r egu l ato r pr ess ur e in p s i g th at w ill pro v id e 200cc t o 300cc t o t a l fl ow. In lin e re s tricto r s m ay be u se d to o p t imi ze fl ows. 60 of 72 U HP SUPPLY GAS Argo n N i trogen O xyge n H elium I NLE T PR ESSU R E 20 p s i g 25 p s i g 22 p s i g 1 5 psig r/!) TGA 300 0 Welcome to the TGA 3000 Setup Wizard The installer will guide you through the steps required to install TGA 3000 on your computer X WA R NING: This co mputer program is protected by copyright law and int e rnational treaties. Unautho , r ized duplicat i on or distribut i on of this program. or any portion of it. ma y result in severe civil or criminal penalt ie s , and will be prose c uted to the max i mum extent possible under the law. Cancel Next> 5. Create Desktop S h ortc ut Icon if desired. 59 of72 Section 4: PC and P ower Supp l y r e quir e m e nt s. 1. D esk top , laptop with Window s 7 , Window s IO OS. Must ha ve at l eas t one USB port and one ethemet port for co nne ctio n to TGA 3 000 O E M Mo dule. CD/DVD player/rea der , internal o r external.
2. Th e r e i s a AC/DC conve rt er po we r s uppl y provided w ith the TGA 3000, h oweve r if app li catio n i s s u c h th a t another po we r s upply i s required.

The alternate AC/DC co n verter pow e r s uppl y mu s t b e ab l e to pro vi d e hi gh l y re g ul ate d I 5V D C output , 0 to 7 Amps minimum , w i th l ow rippl e :S 180 m Vp-p, ha v in g continuous operational temperatur e r ange of -30°C to +60°C. Section 5: TGA 3 000 Software In s tallation. 1. ln s tall CD 2. Folder TGA 3 000 _ V 11.2.4 s hould a ppear 3. Open fo ld e r b e l ow icon s s h o uld appear. C lick on TGA 3 000.m s i. i con. Name Date modified Type vcredist_x86 4/19/2017 4:52 PM File folder :D setup.exe 12/5/2016 11.05 PM ApplJCat1on r/J TGA3000.msi 12/5/2016 11.05 PM Windows Installer Pa .. 4. The bel ow w indow s hould a pp ear , cli ck n ex t and fo ll ow in s t a ll e r in s tructi o n s. 58 of72 Size 366 KB 3,048 KB equiva l ent be used with the TGA 3000 OEM Module. Section 4 will detail power requirements.

Figure 3 57 o f72 'A C/OC CONVERlER POWER SUPPLY* I NPUl VOLTAGE 80-264 VAC , CURRENT RANG[ ().7.0A, OUTPUT VOlTAGE 15 V0C. IOSW , WORKING T!MPERATURE

,]OTO *60C.

Section 3: TGA 3000 OEM Module Familiari z ation. 1. See figure 1 for nomenclature.

Figure 1 Shown with Top P l ate Removed M OUNTING PLAT( 2. The carrier inlet , drift inlet , and ex it port surfaces wilJ be hot when the TGA 3000 OEM Module i s powered up and mnning at normal operating parameters.

These surfaces could get as hot as 200°C (392°F) during a bake out mn. 3. To prevent contamination, the carrier inlet plug , drift inlet plug , and exit port plug s hould be l eft in place until the TGA 3000 Module i s made ready for use. 4. There is a AC/DC converter power s upply provided with the TGA 3000 OEM module. See figure 3. It is recommended that this power supply or 56 of 72 Section 2: Docum e nt Pack age Conte nt s. J. Valeo In s trum e nt Co., In c. W i p e T es t L e tt e r. 2. TGA 3 000 OEM Modu l e Operator Manual. 3. Valeo C u s t omer Service Co ntact In forma ti on. 4. T GA 3 000 Softwa r e Di sc and Softwa r e In s tallation G uid e. 5. R e turn Shippin g Documentat i o n for TGA 3 000 OEM M o dul e if needed. 55 of72 Section 1 : Unpacking and sa fety considerations . *** CAUTION: a THE TGA 3 000 OEM MODULE CONT AfNS RADIOACTIVE MATERIAL , RADIONUCLIDE

AM-241 ACTIVITY 20 MICROCURJES MANUFA C TURED BY V ALCO fNSTRUMENTS CO., fNC. THE RADIOA C TIVE SOURCE I S SH I ELDED SO THAT NO RADIATION ABOVE NORMAL BACKGROUND LEVELS BACKGROUND ARE EM ITT ED. I. Locate Wipe Te s t document with s hippin g do c ument s and retain for safe keeping. 2. Remov e TGA 3 000 OEM module, AC/DC pow e r s upply from packa g in g and examine for damage. If damage i s evident notify s hipper and Valeo Customer Service Imm ediately. Hav e se rial numb e r and order number ready for Valeo c u s tomer se rvi ce. Co ntact informati o n wi ll be wi th the shipping document s. 3. Pl ace TGA 3000 OEM module on a clean static free work s urface. 4. The TGA 3000 OEM module ha s area s of high heat and high vo ltage , observe label s and take nece ssary precauti o n s. The high vo ltag e area s are shown in figure 2 of thi s manual. 5. Keep liquid s away from work area. 6. Handle with care alway s. 5 4 of 72 L CONTENTS Sect i o n I: U np ack in g and sa f ety co n s id e r a t i on s. Sect i o n 2: D oc um en t P ac k age Co nt e n t s. Sec ti on 3: Famili a ri zat i on. Sect i on 4: PC a nd Pow e r Supp l y r e quir e m e nt s. Sect i on 5: TGA 30 00 Software In s ta ll a tion S ec ti o n 6: Se t up. Sectio n 7: Ope r ation. Sectio n 8: S hutd ow n 53 of72 52 of72 VALCO INSTRUMENTS CO., IN C. TGA 3 000 OPERA TOR MANUAL P N 4 8 100102 PN 22100104 Fi gu r e 4 T o p Plate C o ve r Lab e lin g YA&CO INSTIUMENTS CDM/IAHY INC. 5 1 o f 72 tKIC)[Vl(X<XlN!AINS~

... ,_NC HASICE>l-.-ct\ROIYV...C,:,INSTIU,OC=

a.--NC "'~WITMUI

""JClV,11 ROI.U l OIIY coY,tss,o,.

INOY CJl<lt.lllA IN THE P U R CHASER IS EXE M PT FROM I ANY RE GULA T ORY RE QUIR EMEN TS Figure 3 P o i nt of Sale Label THI S D EVI C E CONTAl'II S RAD I OAC TIVE MA TE RIAL AND HA S B EEN MANUFACTURED BY V AL CO IN S T RUM ENT S COMPANY I NC., IN CO M PLIA'IC E WITH U.S NUCLEAR R E GU LA TORY CO VMI SS I ON SAFETY CRIT ERIA I N 10 C FR 32 31 l THE PURCHAS E R I S E XEMP T FROM ANY 1.:ioo ..._R_E_G_

L_LA_T_O_R_Y_R-EO_U_

I_R-EM_E_N_T_S ____ __.J i----------3.000 ---------LA B EL S: BLAC K TE X T ON W H ITE BA C K GOUND. MI NI M UW 10 PO I N T PR I N T FOR RADIATION WA RN IN G S E CTION AND '2 POI NT F OR PURC H AS ER S E C TI O'II. MA TE RIAL S?E C: 2 MIL PO L Y IW ID E P E R MANENT ACRYLIC PSA ADHESIVE BA.CK I NG OP ERATI OI\A L TEMPERATURE

-60 f TO 450F rT[1,1 P,RJ OR q(T O TY POI DASH NO Ml IOOIT -.0 O£SIC SO of72 1 Sl'C C/STD Figure 2 Radiation Warn in g Label 1---------2.500 -------~ I CONTAINS RADICW:T1VE MATERIAL.

RADtONUCWOE:

~41 ACTMTY: 20 uCI MANLFACT\JRED BY V~ 1.,0 0 NSTRUMENTB COIPAHV IC. l.N>ER U.S. 10CRISUO PRlOR TO UBE RER:R TO TOA 3000 OPERATOR MAM.JAL..

PN 41 1 00102. FOR SAFETY AND OPERATIOfW.

GlJIONa. -l L UCEHSE AND .. OQMll..lANCE wrTH IR: .______ o *oo O CT.AI L "A" 0 100 LA B E L S. R E D TE XT ON ALUt.llN U M SACKGO\.J'IIO, ~INIMUM 10 PO I N T PRINT RA DIATION SVM80\4AJ E'.T A OR B LA CK T R EFOIL ON YELLOW BACKGROUND. ' MA TE R IAL SP E C: .003" Mil PHOTO CT CH E D AI..U\A IN UM P ERt.lANENT A CRYL I C AO HE S M: BA CKING OP E RAR TI ONAL TEMPERATUR E -60 F T O t.50 F 49 of 72 0 4 50 _1 Q.t.50 i--

Attachment 6 Radi oact ive Labe l ing Each Valeo In s trum e nt s TGA 3000 will be l abele d in acco rdanc e with I O C FR 32.3 2(b) as s hown b e l ow. Pl acement l oca t i o n oflabcls arc s hown i n figur e I b e l ow. Figures 2 and 3 of attachme n t 6, are t h e engineering drawin gs for the lab e l s. Figure 4 s h ows propo sed l abe l ing of top cove r. Fi g ur e I ---...... ~/ ---N!Nl*llli&LM&

    • fll.MIII ... ..... _ ... JU& 1---------------a.-------------

1 48 of 72 -------**---------

=--=-.r.:.-==:---..,_

~a.::-:-:..-==.-::-

___ -----...a.l'*-..&11

........ ~.------fillllll6.

,.._..._......, ...........

.. .... -.....llal.

..... -.... ...... ..,... __________

ca&,. =.-==-.:.::-.=:-.::.:.. ---

Record spec trum CONC tab working CONC table s howing CFG tab working CFG columns s h owing CFG Polarity Posit iv e CFG Drift Temp SP 120.0°c CFG Date and Time Correct CFG MCD Q Ver 2.13.0 CFG SN Correct CFG So ur ce Vo l t S P 850.0 CFG Drift Vo l t SP 690.6 MEAS Tab working MEAS Table showing CAL Tab working C AL tab Table s h owing VALCO IN STRUMEN TS CO., I N C FORM QA 1001 TGA 3000 OEM FINAL TEST C HE CK S HEET Yes N otes -N o Yes -No Yes -N o Yes -N o Yes -No Yes -No Yes -No -Yes -N o Yes -N o Yes -No Yes -No Yes -N o Yes -N o Yes -No Yes -N o Yes -N o -Name o f Qua l ity Te ste r: Pri nt ed _______ _ Name o f Quality Tester: Signat ur e ______ _ Da t e: _____ _ TGA 3000 OEM Serial Num ber-------FORM QA 1001 VALCO IN STRUMENTSCO., IN C FORM QA 1001 TGA 3000 OEM FINAL TE ST C HEC K SHEET Test Equipment Required.

  • DVM, capable of measuring 1000 VDC off ground or appropriate High Voltage Adapter Probe to b e used with DVM without the HV capability.
  • PC-laptop or desk top with Windows 7 min imum OS.
  • USB cable-USB 8-Type to USB A-Type, minimum 3 feet in length.
  • AC/DC power supply input voltage 80-264 VAC , current r ange 0-7.0A, Output Voltage 15+/-1 VDC, ambient o p erating t em p eratu r e -30°C to+ 6D 0 C. Refer to T GA 3000 Quality Assurance Test Procedure for completion of this form. Visual Checks. TGA 3000 OEM Serial Notes Number Required labels attached correctly Yes -No No visible damage Yes -No All metal caps and p l ugs in place at carrier, drift , and Yes -exit ports No Powered up Checks. Power up Ye s -Notes N o High Voltage Yes -measurement N o -850+/- s voe Connect i vity to Yes -PC No TGA 3000 Yes -password No -window open Program Yes -running No WVF tab Yes -working No S p ect rum Yes -Visib l e No FORM QA 1001

'"" ..... *c.t ,ooo 58 of72 l'\ll .,....~., r .... UOl, 0 ., , *~ Pl.RIC 1rt111.-:,..w1 0 '000 l'\AIC Figure 7. MEA S tab check .. _,_._ , ...... ... 0.1 .f .....

  • 1'1>11 !t 11 JJJI _...,,_ '" 57 of72 o..t r"""' u 11 ,0111s-,.

llU't "' l llDC ,..,.., , .. DJ 1101 °' "" -~* 1 , oa, 11,., ~~~---

    • WI 1-""' ..... -.. --IIICCWl V" , ,. .. 1111 "'°C.. I *---.. -* lJ-* IUOC -tt,V t*fl' ISV \al'IC r u """' IS A 111.,aD ........ . .. ,........., .... _.,_ -..........

..... _., __ '° G..--. *--c.........

    • --"--.......

... .. """" --_,_,, IJM'( ~NW llllwC' Oollt...,11'

  • u<< Mt~W 1111.ll 56 o f 72 arameter c he c k.

55 o f 72 0.008 ppb 0.000 1017.03h P a 2017-1 1*16 12.32 16 400 400 OK

11. Once the F i n al QA Test has been satisfactori l y comp l eted. Sign and date the QA 1001 form and make three copies of the comp l eted form QA 1001. Retain one copy for Qual i ty , one stays w ith the TGA 3000 , and one for manufa ct uring. Notif y the RSO that the testing has been completed and the T GA 3000 OEM is ready for further leak tests that may be requir ed. 54 of72 -"'-1 , .. _ -c...c-ooa,,,qv., 1"' I/W V* Ut j/W .. *---*Hilt 0-WUll Drift, .... IJU'( -*-., .. _ .........

111noc Orih ,... tJI 1 Jl ..... _,,__IIOa, c--.., fl,() ... _ '-""""' -*'-_, ) °""" * ..,... '-~* a.,,-* ..,.. c-v_, c-v_, c-v_, UODH-C-Y-* .... Ootl u on,_ -0.,) *-*-. .,,,. ,,..,.

3. Power up PC Refer to TGA 3000 Operator manual for start-up procedure. 4. Start the TGA 3000 Program and enter the assigned password to start the program. Allow at least 20 minutes for operational temperatures to stabilize. 5. Refer to Figures 4, 5, 6 , 7, and 8 , for reference to spectrum and tab selection. 6. Se lect the WVF tab at the bottom of the screen, refer to Figure 4 below. When the WVF tab is selected a typical spectrum similar to what is displayed in Figure 5 should be seen. This indicates the TGA 3000 is working. Check appropriate box on QA 1001 to confirm. 7. Next Click on the CONC tab. Reference Figure 5, This gives a table that shows conce ntration s o f things like H 2 0 , and Oxygen. The concentrations in the table will be d i fferent than shown in the figure. This i s to only test and make sure the table is presented when the CONC tab is selected. Check appropriate box on QA 1001 to confirm CONC tab works. 8. Next click on the CFG tab and refer to Figure 6. Check appropriate box on form QA 1001 that shows that some value was shown in each box under the Instr. Column. The values will differ and will depend on the calibration for gas chosen. This checks that the CFG tab is working and values are displayed. 9. Next click on the MEAS tab. Refer to Figure 7, the display table should look the same but may have different values in the blocks. Check the appropriate box on form QA 1001 to indicate the MEAS tab is working properly. 10. Next click on the CAL tab and refer to Figure 8 for what that display should look like.The numbers will appear different dependent upon user calibration selected.

Check the appropriate box on form QA1001 to indicate that the CAL tab is working properly. 53 o f 72 Figure 2. Section 2: TGA 3000 operational check. 1. Turn off power and install top plate. 2. I nstall USS cab l e between TGA 3000 , reference Figure 3 , and PC being used for testing. Note: PC must have l atest Rev. TGA 3000 Software I nstalled for proper configuration.

This check is done at amb i ent pressure room air with zero ga s flow. 5 2 of 72 QUALITY ASSURANCE FINAL TEST

  • Section 1: Power up and DC voltage check.
  • Section 2: Spectrum Check. Note: Fill out form QA 1001 TGA 3000 Fina l Test , during the course of this procedure Section 1: Initial power up. 1. Remove Top Plate for this procedure.

Leave all plugs and ca ps in place. 2. Using AC/DC converter power supply as indicated i n Figure 1. T urn on switch S1 on the TGA 3000. 3. Using a Volt Meter that can read a minimum of 1000 VDC off ground. Check to make sure there i s a reading of 850 +/- 5 VDC between ground and R12. See Figur e 2. Enter Voltage in designated box on form QA 1001. Note: the Processor board is pre-programmed with firmware/software with TGA 3000 standard operational parameter s prior to assembly. Figure 1 51 o f 72 'C/OC COIIV£RT£R POWER SIJPP L Y , INPVl VOi.TAG£ 8().26' VA(, CURRENT AANG[ 0-7.0A. OUTPUl VOlTAG[ 15 V0C. 105W , WORK I N G 'TEMPERATURE

-30 TO *60C.

VALCO J NST R UMENTS COMPANY, INC. LEAK TEST CERTIFICATE SOURCE DATA D TGA 3000 Assembly S/N: --------Reason for Leak Test: 0 Sealed Source Lot #: ______ _ Reason for Leak Test: Source Owned by: VALCO I NSTRUMENTS COMPA N Y , I NC. Sample Location: Source Model No: A-001 Source Serial No: -----------

Radioisotope

_AM-241 Activity:

20uCi Date Sample was Taken: Date of Last Leak Test: INSTRUMENT DATA Ludlum Model 3 W I T H 44-9 PANCAKE BETNGAMMA PROBE S/N: --------Calibration D u e Date: ----------

Ca Ii brat ion to Cs137. Calcu l ations based on 1 mR/HR equa l s 3000CPM. LEAK TEST R E SULTS Background Carrier l nlet ___ cpm Sample Swipe Carrier I nlet ___ cpm Background Drift I nlet cpm Samp l e Swipe Drift Inlet cpm Background Exit Port cpm Sample Swipe Ex i t Port cpm CERTIFICATION I hereby certify t he results of this swipe analysis ind i cate the activity to be less than 0.005 µCi (185 Bq) of removable contamination.

L eak Test Performed By: 50 o f 72 Date: --------

QA C H EC K POI NT 7-F iual Assemb l y C h eck. PASS 0 FAIL 0 COMMENTS:

________________

_______ _ ADDITONAL CO MMENTS: _______________________

_ 49 of 72 PASS 0 FAIL 0 COMMENTS:

_______________________

_ QA CHECK P O I NT 5-IM S Ce ll Int erface P C A to Processor P CA Asse mbl y C h eck. PASS D FAIL D CO MM ENTS: _______________________

_ QA CHEC K PO INT 6-Top Plat eAsse mbl y C h eck. P ASS 0 FAIL D COMMENTS:

_______________________

_ ADDITONAL COMMENTS:

_______________________

_ 4 8 of72 Sectio n 9. TGA 3 000 OEM Modu l e Qua li ty Ass ur a n ce C h ec k List. Valeo In st rum e nt s Co., In c. TGA 3000 OEM MODULE QA C H ECK L I S T TGA 3000 SERJAL NUMBER: D ATE: -------------QA I NSPECTOR NAME:---------QA C HE CK PO I NT 1-So ur ce Assemb l y I n sta llati on C heck. PASS 0 FAIL D COMMENTS:

_______________________

_ QA C HE C K POINT 2-IM S H eate r Asse mbl y C heck. PASS 0 FAIL 0 COMMENTS:

____________________

___ _ QA C HE C K PO I NT 3-H eater S hrink T ubin g Asse m b l y a nd Gro und C h eck. I NSTALLAT I ON PASS 0 FA IL D COMMENTS:

________________________

_ 4 7 o f 72 46 of72 Section 8. TGA 3000 Finished Assembly Views. R ig ht Side View. Exit Port Side. L e ft Side View. Ground Sttud Side 4 5 o f 72 Figure 14 Top plate installation Section 9: Final Assembly Quality In s pection and Radiation Leak T est. QA Check point I. Check all fasteners for tightne ss on upper and low e r plate s. 2. Check for required radiation labels on IMS ce ll upper housing and Pont of Sale label on top plate. 3. Ensure se rial number on cell hou s ing mat c he s seria l number on top plate. 4. Check screw ti g htness on cell assembly pins to ce ll interface tenninal block. 5. RSO Perfonn leak te s t at drift, exit , and carrie r port s. Record readings on l eak test certificate, make two copies keeping one for leak te s t record s and one to stay with th e assembled TGA 3000 OEM module 44 of 72 Section 8: Top plat e assembly and fina l QC assemb ly in spec tion. l. Ob t a in top pl ate asse mbl y , 4410015 2 r ev I , w ith requir ed l abe l s. 2. Ob tain qt y. 2, 6-32 X 5/8" z inc pl ate d s teel sta nd-offs, qty. 2 , 6-32 X 3" z in c plated s tee l s tand-offs , and qty.4 , 6-32 SS n y lon l ock nut s. 3. Install as shown in fi g ur e 1 3. 4. In s tall top p l ate w ith required l abe l s as s h own in figure 1 4. 5. Sec ur e top pl a t e w ith qty. 4 , 6-32 SS n y l on l oc k nut s as s hown in figure 14. Figure 1 3. H a rdwar e for Top Pl a t e assembly.

43 of72 F igure 11 H ea t er connector insta ll a ti o n Figure 1 2 Upper IM S ce ll s upport b racket in sta ll ation. 42 o f 72 Fi gure I O Screw c h eck. 41 of72 Fi g ur e 9 I MS CE LL P I N ALIGNMENT TO P C A CO NN EC TOR ASSEMB LY. 40 of72 Section 7: IMS ce ll assembly insta llation onto PC board assembly. J. Obtai n QA checked lMS assemb l y a nd i n sta ll assemb l y in sing l e row terminal block connector on the fMS ce ll int erface PCA as s h ow n in figure 9. 2. In stall as shown in figures 9 and I 0. It i s cri ti ca l to make s ur e every pin i s properly positioned w h e n in serted and that the sc r ews on the terminal b l ock for each TMS ce ll pin is ti ghte n ed securely , then double checked for each screw. Start front to back t h e n doub l e check from back to front. See figure I 0. 3. In sta ll heater connector onto IMS Ce ll Int erface ma l e h eater co nn ector. See figure 11. 4. I nstall Uppe r suppont and mounting brack et , 44 1 00153. Obtain mounting bracket , two 6-32 X 5/8" z i nc plat ed stee l stand-offs a nd one 6/32 lo ck nut. Fit support bracket onto the 3" stan doffs as shown i n figure 1 2. Sec ure the upper s u pport and mounting bracket as s ho wn in figure 12. 5. In sta ll LMS Cell Int erface PCA grou nd wi r e to position 2 of the upp er insu l ator housing as shown in figure 12. 6. Qu a lit y C h ec k P o int 6. QA check PCA and upper support assembly. 39 of72

  • C h eck a lignm ent of I MS pi n s to tenninal bl.ock.
  • C he ck eac h screw in IM S ce ll mountin g terminal block for tight n ess.
  • Check a ll mounting h ardware for proper in sta ll ation and tightness.
  • Check for proper gro und at all gro und p oints. From ca rrier inl et fitting to I MS cell interface ground point on the board, sa m e from drift end fitting , same for IMS insula t o r hou sing surface t o IMS ce ll int erface gro und.
  • C he ck fo r no movement of I MS cell in any dir ection with upper support in pl ace.

Section 6: IMS Cell Interface PCA to Processor PCA assembly.

38 o f72 I. Obtain IMS Ce ll Interface P CA , 28100 IO I, and IM S Pre-Pro grammed Processor P CA , 28 10010 2. 2. Obtain 2 PCA Mounting Plate , 44 I 00 I 52. 3. Obtain hardware it e m s I 6 through 19 li ste d in sec tion 2. 4. In stall 5 zinc plated stee l sta n doffs to bottom of the IM S Cell Int erface PCA, the ma l e threaded sect i on goe s throu g h th e bottom of the PCA, install 4 of same int o rear sect i on of IM S Cell Int e rfa ce P CA by threadin g th em onto the male th r eade d portion stick in g up through the P CA , in sta ll 2 of th e SS 5/16 h ex X 3" l ong standoffs on the two front hol es in the PCA by threading them onto the ma l e threads projecting through th e bottom of the PCA. Sec fig ur e 9 for hardware positions. 5. Onc e all s t andoffs are in sta ll ed a nd tightened in sta ll the Processor PCA onto the rear s t a ndoff s. Be very care fu l to properly al i gn the two con n ectors on the bottom of the processor PCA , Female receivers to the male connectors on the top of the IM S Cell In terface PCA. 6. Secure the Processor board to the I MS Cell I nterface PCA with the three nylon 6/32 t hread ed standoffs.

7. u a lit y C he c k P o int 5.
  • C h eck al i gnme nt of th e mating connector s from the top of the IMS Cell Int e r face PCA to the Mating connectors on the botto m of the Processor PCA. No pins shou ld be showing.
  • Check tightness of all fasteners.

Caution Note: lmproper alignment will cause immediate electrical damage to the Processor PCA upon power up.

F i gure 8 M (ATtllC,.OUNDl UG 37 of72 Figure 6 Figure 7 36 of72 I N SULA TOR FL USH TO I N SULATOR H O U S G LOWER I N S ULAT OR H O U S I N G ASS EMB L Y ~EATE R C ON ECT O R 6/32 PHMS I NSTALLED FROM BOTIOM P RIOR TO INSTALLING INSULATOR. ECURE WITH #6 LOCKWASHER AND 6/32 HEX NUT MAKE SURE TOP AND BOTIOM ASSEMBLIES NAP TOGETHER AND ALL HOLE S ARE PROPERLY ALIGNED.

Section S: I ns ul ator an d In s ul ator Housing Assemb l y. Note: Refer t o figures 6 , 7 , a nd 8 for t h is sec ti on. 1. Obtain PN 44100 1 26 , In sulator Housing Upper. PN 44I00127 , Insulator Housing Lower. PN 44100128 , Insulator Upper. PN 44100 I 29 , Insulator l ower. 2. lnsert SS 6/32 X W' P H MS throu g h hole in top of the upp er insulator housing. Secure w i th SS #6 l ock washe r and SS 6/32 h ex nut. See figure 8. 3. In sta ll Radiat i on Wa rn ing lab el , 46 1 00 I O I , a nd TGA 3000 ser i a l numb er and date of manufacture label as. shown in figure 8. 4. In sert upper and l ower in su l ators into upp er a nd lower in sulato r h ousings so that the insulator mat e ri a l is flush t o t h e edges of the in s ul ator h ousings. See figure 6 and 7. 5. In sta ll the I MS ce l l/heat e r assemb l y into t h e l ower i n s ulat or housing assemb l y b y placing th e l egs of the IM S ce ll assemb l y into the c u t out slot at the bottom of t h e l ower in su l ator h ous in g assemb l y. Make s ur e the ex i t port tube is a li gne d w ith the back most cutout in the l owe r insulato r housing. See figure 6. 6. Ho l ding the bottom assemb l y secure l y , place the upper insulator h o u s i ng assemb l y , figure 7 , over the l ower assembly a nd snap closed. Make s ur e th e 4 screw holes are a lign ed , figure 8. Sec ure upper h o u s i ng to l ower hou s in g us in g fo ur 4/40 X Yi" T orx he ad machine screws. Secure h eater gro und lu g in position 2 as s ho wn in figure 9. Tighten secure l y being ca r ef11.1 l not to overtighten. 7. Q u a li ty C h ec k Point 4. 35 of 72

  • C h eck for proper fastening of sc r ews and gro und lug p os iti on.
  • C h ec k for p r oper installation of Radiation Protection Label.
  • Make sure drift. carr i e r and ex it ports a r e capped/p lu gge d.
  • Survey check. RSO or authorized user, using the Lud l um Mode l 3 and p l ace the detector surface of t he 44-9 probe w i thin W' of the end of the VCR fitting. Record average mR/hr r ea d ing in th e m an ufa cturi n g qu a li ty report c h ec k li st.

Figure 4 HEATER CONNECTOR Figure 5 34 of72 VITON TUBE SPACER VITON TUBE SPACER PTFE TAPE WRAP DAFLON 7/8" SHRINK TUBE IMS CELL CONNECTOR PINS Gro u n d R esista n ce Check

6. Obtain a roll o f w hit e Mil Sp ec PTF E t a p e ,% w id e, 0.00 32" thi c k. C u t a pi ece th a t i s app rox imatel y 20" lon g. Holdin g th e IM S ce ll se cur e ly in on e hand , th e n s t a rtin g a t th e fr o nt edge of th e fr o nt e nd ca p , w r ap th e ta p e t ightl y aro und ce ll w ith o v er l app in g turn s th e e ntir e l e n g th o f th e IM S ce ll. Mak e s ur e th e h ea t e r i s ti g ht aga in s t th e IM S ce ll s urfa ce as th e t a p e i s be in g w r a pp e d a ro und th e IMS ce ll. See fi g u res 4 a nd 5. 7. Quality C h ec k Po i n t 2.
  • Q A in s p ec t e ntir e IM S ce ll a sse mbl y at thi s p o int t o ens ur e th e h ea l e r i s a ti gh t fit to IM S ce ll s u rface a nd prop er pl ace m e nt o f Vi t o n tub e pi eces a nd T e flon wra p. 8. O b t ain a 1" l o n g sec ti o n of 5/8" Dia. DAFLO N PT FE 4: 1 r at io , s hrin k tubin g a nd s lip it ove r r ea r sec ti o n of IM S ce ll assy. T h e h ea t e r co nn ec t o r mu s t go th ro u g h fir s t , th e n th e s hrink t ubin g w ill eas il y s lip over th e o th er e nd sec ti o n o f th e IM S ce ll. Th e b ac k e nd o f t h e s hrink tub e mu s t b e eve n wi t h th e b ac k e nd of th e IM S ce ll e nd cap. See fig ur es 4 , 5. 9. O bt a in a I lo n g sec t io n of7/8" Dia. D A FL ON PTF E 4: l r at i o s h ri nk tubi ng a nd pl ace it ove r th e V C R nut a nd ove r th e front se c t ion o f th e h e ater assy. Pl ac e it o ver th e IM S ce ll so th a t th e fr o nt e nd of th e s hrink tu b in g w ill b e eve n w ith th e fr o nt e nd of th e IM S ce ll e nd ca p. I 0. O bt a in h ea t gun and set th e t e mp e ratur e fo r 327°C o r 62 1 °F. Pl ace th e IM S ce ll , wi t h h ea t e r ass embl y in s t a ll e d , int o a s m a ll b e n c h v i se b y pl ac in g th e l egs o f th e IMS cel l b e tw ee n the j a w s of t h e v i ce and c lamp t he ass embl y se curel y. Rem ove all flamm a ble m a t er i a l s away fr o m area wh e r e the h ea t g un w ill be dir ec t e d. M a k e s ur e a ll co mp o nent s a r e prop e rl y a li g n e d a nd th e n tum o n th e h ea t g u n a nd dir ec t th e h ea t e d a ir eve nl y a ro und th e s hrink tub e, o n e e nd a t a tim e. H ea t unti l tubin g i s at maximum s hrink age then r e m ove h e at a nd r e p e at a t th e o th e r e nd. Le t th e e ntir e assemb l y coo l t o t o u c h b efore pro ceed in g t o n ex t s t e p. 11. Qua li t y C h eck Point 3. 33 o f 72
  • C heck proper plac e m e nt o f all compon e nt s.
  • C h ec k proper gro undin g b e tw e en gr ound lu g of th e h e at e r , th e drift e nd met a l c o mp o nent and t h e ca rri e r e nd m e t a l co mp o n e nt. R ea din g s hould b e l ess th a n .5 ohm s. Refer t o fi g ur e 5.

Figure 3 M-241 SOURCE ASSEMBLY SHOWN BEING INSERTED Sectio n 4: H ea t e r In sta ll atio n. Note: R efer t o figures 4-5 of this pro ce dure for he a t e r ins tallati on. I. Make su r e all ca p s are installed prior to heater insta ll ation. 2. Obtain heater assembly, 3410010 I. 3. Place a I" piece of if.." ID , black Viton tubing over the drift end fitting so that it is ti g ht against the back e nd of the e nd ca p. 4. Tak e a %" piece of if.." ID , b l ack Viton tubing and slit it lengthwise , one cut, and then fit i t o ver the if.." tube between the front end cap of the IMS cell a nd th e back of the if.." VCR nut. 5. Wrap th e heater assemb l y tight l y around IMS cell assy. w ith the he a t er co nne cto r a t the drift, (back end), of the I MS cell assy. 32 of72 Fi gu r e 2 3 1 of72 Se ction 3: AM-2 4 1 S ou r c e In s t a ll at ion. Note: Refer t o figures 1-3 of this procedure for so urce installation. I. Put on approved protective glov e s and lab coat. 2. Obtain a n ew manufa c turin g/q uality r e p ort c h eck list. 3. Plac e a c le an shee t of industrial grade a luminum foil on s urface of work bench where th e AM-241 sou r ce wi ll be in s tall ed int o the IMS c e ll assemb l y. Tape edges of foil down to work surface. 4. Obtain a I MS cell assembly from inventory.

As s ign and record serial number. Thi s w i ll become th e TGA 3000 Module serial number. 5. R emove protective wrap an d a ll caps and plugs. 6. Place on clean aluminum foil surface, prepared in s t ep 2 above. 7. Obtain one AM-241, 44100 I 04 , source a ss embly from the RSO , or auth o rized u s er. Record serial number and assign to the TGA 3000 module seria l number. 8. Using Zero Grade a ir with appropriate nozzle , blow air throu g h ce ll from both e nd s a nd s i de ex it tub e. 9. Using de s ignated 3/32" He x driver , In s tall source into the thr eade d so urce holder located inside the T MS ce l l. Th e access i s throu g h the W' VCR fining. Make sure the s ou r ce assembly i s thr eaded into th e so urce holder properly.

Be very c areful to n o t cross thread the assembly. 10. Quali ty C h ec k p o int I.

  • QA check for proper insta ll ation of source assembly.

Note on QA c h eckl i s t. 11. Su r v ey check.

  • RSO or authorized u se r , u si n g the Ludlum Model 3 a nd place the detector su r face of th e 44-9 probe wi t hin W' of the end of the VCR fining. Record average mR/hr r ead in g in m a nufa ct uring quality report c h ec k li st. 1 2. I n sta ll all caps and proceed t o s ection 4 , Heater installation. 30 of72 Section 2: Part s and Par t/Drawing Numbers R eq uir e d. I. 44100100-I MS Ce ll Assemb l y. 2. 44100 I 04-NRD Model A-00 I Source Assy. 3. 34100101-IMS hea t er Assy. 4. 44100126-I MS Cell Insulator H o using. Upper. 5. 44100127-I MS Cell In s ulator H ousing. Lower. 6. 44100128-I MS Ce ll I nsulator.

Up per. 7. 44100129-I MS Ce ll I nsulator.

Lower. 8. 28 1 00101-IMS Ce ll I nterface PCA. 9. 28100 I 02-IMS Pr ocessor PCA. I 0. 44100152 rev I -PCA B o ttom Mou n ting and Top Plate quantity 2. 11. 44100 I 53-Upper Support Mounting Bracket. 12. 46 I 00 IO I rev I -Radiation Warning Label. 13. Roll of Mil Spec PTFE tape , 31,.** wide by 0.0032" thick , white in color. 1 4. Viton tubing 1/a" ID by 1/2"0D cut into I"' pieces. I 5. Datl o n SH24 I PTFE s hrink tubing. S H 24 1-5/8 and S H 241-7/8 cut into 1 ** pieces. I 6. Torx Head SS machine sc r ews 4/40 X 1/2** quantity 4. 17. Z in c Plated Stee l stand offs Male-Female Thread Y.i" hex , 6 32 X 5/8" quantity 9. 1 8. Stainle ss Stee l (SS) Standoff 5/16 Female-Female Hex SS 6/32 X 3" quantity 4. 19. Stainless Stee l 6/32 X 3/8.'PHMS and number 6 SS flat washers. quanti t y I I ea. 29 of 72 L Section 1: Safety Gu i delines. I. P rior to asse m b l y of t h e TGA 3000 OE M M od ul e, r ea d a nd understand the Valeo R adiatio n Protection procedures.

2. Wear di sposab l e l a t ex free , powder free. p rotective glove s, and lab coat whi l e a s sembling the AM-24 1 Sou r ce assembly into the TM S cell asse mbl y. 3. Wear the pro t ec ti ve g l oves throu gho ut th e a s se mbl y process unti l th e TGA 3000 IMS m odu l e i s asse mble dl on t o t h e P C boards. 4. H ave th e Ludlum Model 3 wi th 44-9 probe r eadi l y ava i l a bl e durin g as s embly proce s s. 5. A l ways u se t h e same designated work b e n c h for th e AM-241 source i nsta llati on. 6. No food or drink i s a ll owed at assembly s tation. 7. I mm ed i ate l y repo rt t o R SO/Act i n g R SO, any survey o r wipe test result th at exceed s action l evel of 2: 200-500 c pm / 0.05 to 0.1 Mr/hr. 8. Do n o t pro cee d to next s ect i on until th e QA checkpo in t ha s been clea r e d for each sec ti o n as required. A ss e s s m e nt a nd Convers i o n c h art for Ludlum Model 3 m e t er readings.

Survey M e t er Reading> A!se>>menl of M easurements 0*.:00 ,vm IO 0.05 mR tbt tl.Jt .. J,rVIIDd n-JdJn"" ,4w rpm I ,0.1 mR. hr toOl,i.mln.1lklll C o nv e rt i ng r a d i at io n me t e r r e a din gs Units Melt/ Rtad l ng s *r* n **~ S, O 7.r, 10.0 HA: ,$ J u\R/h r .... 0 ,2 O ,;\ ... 0.5 .L i i S/h r 0 .s 5 1 ,. ,*nu*wrl tu qun c p, , (t(i

  • C"f'IH 28 of72 Co nt e nt s
  • S e cti o n 1-Sa fe ty g uid e lin es.
  • Se cti o n 2-P a rt Numb e r s R eq uir e d.
  • S e ction 3-A M-2 41 So ur ce Asse mbl y I n s t a ll a tion.
  • Se cti o n 4-H ea t e r Asse mbl y I n s t a ll a ti o n.
  • S e cti o n 5-In s u l at o r/l n s ul a t or H o u s in g/I M S Ce ll Asse mbl y I n s t a ll a tion.
  • Se c ti o n 6-IM S Ce ll Int e r face P CA t o P rocesso r P CA a sse mbl y.
  • S ec tion 7-IMS c ell asse mbl y in s t a ll a t i o n ont o P C b o arda sse mbl y.
  • Sec t i o n 8-Co mp l e t e d asse mbl y v i ews.
  • S ec ti o n 9-Quali ty Ass uran ce C h eck L i s t Re fe r e n ce. 27 of72 V ALCO INSTRUMENTS CO., INC. PN 48100101 TGA 3000 OEM MODULE MANUF ACTURIN , G MANUALWITH QUALITY ASSURNACE CHECK POINT PROCEDURES.

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TABLE 2 WATER EMERS I O N TEST DATA RE V 1 "1.L TGA 3000 IONIZATION DETECTOR crus WERE ASSE M BLED CO MPLET E PER ASSEMBI. Y AND SAFETV "'STRUCTIONS THE RAOIATION ACTIVflY LEVELS WERE M EASURED USIN<<l A LUDLUM GEIGER COUNTER MODEL l Wl'!11 A M ODEL *H PAN C A KE DETECTOR AU. IN STRU M E NT S USED ARE IN CURRE NT CAl.l!lRATION PERIOD. THE FOLLOW"'G TESTS WERE PER.O RME O B Y F U U EMERSION Of CEU.S t 2 ANO t 3 IN A CONTAINER FIi.LEO WI TH \JNFIL TEREO T N> WATER FOR A PERIOD Of 10 MINUTES EACH. THE SURFACE Of !11E WATER IN THE CONTAI N ER WAS SURVEYED FOR NN AC !MTV Al!OVE BACKCAOUNO B EFORE THE CELLS WERE RE M OVED F"ROt.1 THE W A TER THE CELLS WERE THE N REMOVl:O FROM THE WATER. ORAt<EO Of EXCESS WATER "'TO SHIE:lOEDCONT AIN ER. Tl1E C ELL S WERE THE N D R IED IN AN OVE N AT :2GO'C ANO AFTER coot.ING EACH CELL W AS SURVEYED A N O RE SUL T S ARE SHOW N BELOW. t.UOLUM ._OOEU IURYEl III ETER WITH A MOOE b 44::f BEJA/GAMMA PANCAKE PEIECTOR PROB£ USED FOR RApfATIQ H M EASYRP!EHTS , 1mMv * >>oo CPM et! m,nual. SURVEY Of' THE WATER II THE CONTAINER W.U AT BACIKGROUND , 40 CPM (D.11125 mR/h!\ T'OA TES T CEU 11 C~TROl OEVoCE NOT £MERSlD TEST AREA BACKGROU ND ACTMTY AVERAGED AT 41 CPM -2"0 20 uC 1 CONTROL DEVICE SURVEY R11IMa l!l.l!lb!

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ft DI),!, .1;1 (:Pf,,11 IC,,, 001~ 41tl"M '"l.."" oo,:..; *1CPM ,.(.lo! 0011! 4 10,M >OC~ u ,:,o. 41C.Pt,t THJ AALt.~~A C Tl'trTYf°" Clll t 1AW:IIAGl:O!U l,01H""""""f0 C""'I 0-1.tltC.l C OUl<<t Valeo Instruments Co. Inc. An a lyt ical dev ices/s y s t e m s January 5, 2018 Tomas Herrera Materials Safety Licensing Branch Division of Material Safety , State , Tribal , and Rulemaking Programs Office of Nuclear Material Safety and S a feguard s U.S. NRC 11555 Rockville Pike Rockville , MD 20852 RE: NRC Request for Additional Information, Valeo Instruments letter dated December 13, 2017; Docket# 030-39061

Dear Mr. Herrera:

In response to your email of December 13 , 2017 , Valeo In struments offers the information below. For your convenience, I have rewritten your questions prior to each response.

1. Please resubmit the drawing in Attachment 6 "Radioactive labe l ing," so that is legible. We intend to use this drawing in the sealed source and device r e g i stration certificate. In addition , please provide the overall width of the TGA 3000. Please f in d a c l ean pdf of t h e requested "Rad i oactive Label i ng" draw i ng in attachment 1 of th i s response.

As for the overall d i mens i ons of the TGA 3000 , these are called out in draw in g 22100104 Rev 1 sheet 3 of 4; sheet 4 of 4; and in drawing 44100152 Y25932 (f ound in attachme nt 2 , 3 , and 4 of th i s response). As noted on t hese d r aw i ng the overall d i mensions of a completed TGA 3000 a r e 1 0.250 inches (L) x 4. 75 in ches (W) x 3.57 inches (Hor thickness).

2. In your letter dated November 20 , 2017, in your response to A.6, you reference a drawing number 4410016. We were not able to lo cate a drawing with that num b er in the response. Plea s e resubmit drawing number4410016. The drawing number g i ven as 44 1 00 1 6 was a typo and shou l d have been 44100106 Y25903. P l ease see the correct drawing in attachme nt 5 of this response. 3. Please identify the material used in the in the construction of the frame for the Page 1 o f 3 P.O. Box 55603 H ouston, T exas 77255 Telephone (713) 688*9345 Fax (7 1 3) 688*8 1 06 www.vici.com TGA 3000. As identified in sheet 4 of 4 of drawing 22100104 Rev 1 (Attachment 3 of this response), the top and bottom plates of the TGA 3000 are machined from 5052 H32 aluminum sheet. The supports are nickel plated stain l ess steel , 0.250 hex stand offs. The fasteners are made from 18-8 stainless steel. 4. Please confirm as part of Va l co's Qua lity Assurance program that Valeo wi ll perform a final radiation s urv ey to verify that the radiation l eve l s do not exceed th e maximum val u es stated in the app li cation p r ior to distribution of th e product. Valeo confirms that as a part of the quality assurance program each completed TGA w i ll have a final radiation survey performed and documented as shown i n the TGA 3000 shipping survey instructions PN 48100102 (attachment 6 of this response) the TGA 3000 Final Radiation Survey Form RAF 1001 (attachment 7 of this response), and Rad i oactive Materia l Container Survey Form RAF 1002 (attachment 8 of th i s response).

A copy of this final survey will be i ncluded w i th each TGA 3000 sh i pped to the end user. 5. I n response to Ques tio n 8.9 yo u sta t ed th at the requ i red a n a l ysis ca n be found in "Rad i ologica l Assessment of The Va l eo TGA 3000," Attachment

14. However, it does not appea r that the requ ir ement of Section 32.3 1(b) was addressed.

As stated i n o ur first RAI, Sect i on 32.3 1(b) requires an app l icant for a license undeir § 32.30 to demonstrate that, eve n in un lik ely scenarios of mis u se, in cluding those resulting in direct exposure to t h e unshielded source removed from the device fo r 1,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> at a n ave r age distance of 1 meter and those r esu lting in dispersa l and subsequent intake of 10-4 of the quan ti ty of byproduct material (or in the case of trit i um, an intake of 10 percent), a person wi ll not rece i ve a n external rad i ation dose or co mmi tted dose in excess of 100 mSv (10 rem), and, if the unsh i elded source is sma ll enough to fit in a pocket, th at t h e dose t o local i zed areas of skin averaged over areas no l arger than 1 square centimeter from carrying the uns h ie l ded so ur ce in a pocket for 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> w ill not exceed 2 Sv (200 rem). Please provide a n eva lu ation which demonstrates that t hi s requirement will be m e t. Please find a revised version of the " Radiolog i ca l Assessment of the Valeo TGA 3000" in attachment 9 o f this response that i ncludes these eva l uations. 6. In Attachment 6, "Radio l ogical Assessment of th e Valeo TGA 3000," you r eva lu ation appears t o overestimate th e pote n t i al doses from th e dis t ribution of the TGA 3000. You sta t ed tha t the quant i ty of Am-24 1 in your product i s 20 µCi, which is 12.5% (20 I 160 = 0.125) of th e quantity used in NURE G-1717. A l so, yo u Page 2 of 3 stated that 100 units would be distributed annua ll y, which is 1% (100 I 10 , 000 := 0.01) of the number assumed in NUREG-1717.

Therefore, it appears that for " distribution and transport" the va lu e for " Individual Annua l Effective Dose Equivalent" should be (0.4)*(0.125)*(0.01)

= 0.0005 mrem, and the other resu lt s should adjusted according l y. Please see the revised tables in attachment 9 of this response. 7. Question B.7 of our first RAI stated that Section 32.30(b)(10) requires the applicant to submit information concerning the proposed method of labeling or marking the product and its point of sa l e package to satisfy the requirements of§ 32.32(b). In addition to providing a new drawing for Attachment 6 , " Radioactive

labeling," that is more l egib l e and includes the overall width of the device, plea s e ensure that all of the requirements stated in question B.7 a r e met and are described in your reply. As stated in response 1 above , a cleaner copy of the radioactive warning label can be found in attachment 1 of this response.

Additiona ll y , in attachment 10 of this response please find a drawing showing the Po i nt of Sale labeling that meiets the requirements of 32.32(b). I believe that the above and the attached answers your request for more information concerning the Valeo TGA 3000. Shou l d you have any questions please call me at (713)688-9345 or email me at Stan@vici.com . :Je~y ,)) -rti~~ President and Radiation Safety Officer Valeo I nstrum e nts Company, Inc. Post Off i ce Box 55603 Houston , Texa s 77255 Pa g e 3 of 3 Radiological Assessment Of the Valeo TGA 3000 Discussion:

In order , to eva l ua t e the p ote ntial doses from t h e distribution of the TGA 3000, ex isting data o n chemica l detectors co nt ai n ing Am-24 1 was g l ea n ed from NUR EG 1 7 1 7. NUREG 1717 prese nt s dose data for the distribution of che mi ca l detecto r s con t ai nin g 1 60 µCi of Am-24 1. Th e T GA 3000 only contains a max imum activ it y of 20 µCi of Am-2 41. This is an act i v it y reduction of 87.5%. Additiona ll y, Co ll ec ti ve Effect iv e Dose Equiva l ent est im ates were made assuming an annual distribution of 10,000 detectors , while it i s a nti c ip a t ed that the TGA 3000 w ill have a maximum dis tributi on o f just 100 unit s a nnu a ll y w h ic h is a 99% difference. Thu s, the r esu lt s given in t h e dose tab l es be l ow for the TG A 3000 were reduced by 87.5% for " Ind ivid ual Annual Effe c ti ve D ose Equ iv a lent and by 99% for the "Co ll ec ti ve Effective D ose Equiva l ent". All other conc lu sions and assumpt ion s discussed in NUREG 17 17 , regarding the ana l ysis of che mi cal detectors (in c luding Di s tr ibut i o n and Transport; Routine U se; D isposa l; Acciden t s and Misuse; and Safety C riteria), were co n sidered to be app l icab l e to the TGA 3000 estimates of dose. Tables: Table 1 Potential Radiation Doses From T he TGA 3000 Exp osure Pathway Individual Annu a l Collective Effective Dose Effective Dose Equivalent Equivalentb (mREM)1 (Pers on-REM) Distribution and transport 0.0005 , 0.0000075 Routine use 0.0025 d 0.01 Di sposa l Land fills 0.0000375* 0.0005 Incinerators 0.00025' 0.000008 Accident s a nd Misuse Fire 0.0375* Vandalism of detector uni t 0.075 h a 1 mrem = 0.01 mSv; 1 person-rem=

0.01 person-Sv.

b Collective doses are based on (1) an assumed annual distribution of 100 TGA 3000's containing 0.2 mCi of 24 1Am each and (2) an assumed 10-year effective lifetime for the detectors. c Dose estimate applies to local parcel-delivery drivers exposed to multiple exemp t units in wholesale warehouses during distribution and transport; dose estimates are s ignificantly less for other tru ck drivers , workers in truck terminals , and members of public along tr uck routes (see Section 2.15.5.1 of NURE G 1717). d Dose estimate appl i es to a use r of a portable chemical detector containing an 241Am source; dose estimates are less for a user of a fixed chemical detector containing an 241 Am source (see Sec t ion 2.15.5.2 o f NU REG 1717). e Dose estimate applies to waste co lle ctors exposed to multiple chem i ca l detectors during disposal at landfills; dosu estimates are significantly less for wo r kers at landfills, off-site members of the public, and future o n-site r es i dents (see Section 2.15.5.3 of NUREG 1717). f Dose est i mate applies to waste collectors exposed to multiple chemical detectors during disposal at incinerators; dose estimates are significantly l ess for other workers at incinerators and off-site members of t he pub l ic (see Section 2.15.5.3 of NUREG 1717). g Dose estimate applies to a worker who are in volved in the cleanup follow i ng the t r anspo rt a t ion fire involving mult i ple chemical detectors with 241Am sources (see Section 2.15.5.4 o f NUREG 1717). h Dose estimate applies to ingestion of 24 1 A m by a p erson who finds and destroys a che m ica l detecto r cont ai n i ng an 241Am source, (see Section 2.15.4.4 NUREG 1717). Table 2 Compari s on of E stimated M a ximum Individual Do s es from the TGA 3000 and Limiting O r g a n Dos e s from 1 0 C FR 32.2 7 Expo s ur e Cond i t i ons* Maximum Individu a l Regulatory Limit for Dos eb Organ Dose (mREM. REM, mR E M/vr)< (m/REM , REM, or mREM/yr)< Effective do se e auiv a lent R o utin e U se a n d di s p osa l 0.0 0 25 mREM/yr<! 5 m RE M/yr" of a si n g l e exe m p t unit Acc i d e nt s in vo lvi ng s in g l e 0.0 7 5 mREM 1 0.5 REM g exe mp t un i t 1 5 R EM h N or m a l h a n d li ng and 0.0005 m R E M/yr 5 m R E M/yri storage o f m ul t i p l e ex em pt un i ts Acc i dents in vo l v i ng m u l ti p l e 0.0 375 m R E M k 0.5 R E M g exem p t un i t s 1 5 REM h D os e e quiv a len t to red m a rrow Accide n ts invo l ving a s i ng l e 0.1125 m RE M 0.5 R EM 0 exe m pt u ni t 1 5 R E Mh Acc i de n ts i n vo l ving m ult ip l e 0.05 mREMm 0.5 REM o exempt un i t s 15 R E M h Dos e equiva le nt to bon e s urf ac es Accide n ts i n vo l v i ng a s i ng l e 0.00125 R E M' 1.5 R E M" exe m pt uni t 50 REM 0 Acc id ents in vo l ving m u lt ip l e 0.625 mREM m 1.5 REM" exem p t un its 50 R EM 0 See fo ll ow i ng p age for f oo tn otes a See Section 2.15.4 of N UREG 1 7 1 7. bMaximum individual dose based on the ty p ical quanti t y used (i.e., .02 mC i) of 241Am). H oweve r , t h e activity of the source could be inc r eased un t i l t h e regulatory l imit fo r organ dose is reached.

c 1 mrem = 0.01 mSv; 1 rem = 0.0 1 Sv. d Dose est i mate applies to an operator who is exposed to a sing l e chem i cal detector unit during routine use (see Section 2.15.5.2 of NUREG 1717). e Li mit on whole-body dose and active blood-forming organs du r ing normal use and hand lin g of a sing l e exempt unit (see Section 2.15.1 of N U REG 17 1 7). 1 Dose estima t e app li es to a person who vanda li zes a c h em i cal detector unit and ingests radioac t ive mater i al due to contaminatio n of hands (see Sect i on 2.15.5.4 of NUREG 1717). 9 Limit on whole-body dose and dose to active b l ood-forming orga n s w h en probabi l ity of failure of safety features in product is less than one fai l ure per year for each 10,000 exempt units distributed (see Section 2.15.1 of NUREG 1717). h Limit on whole-body dose and dose to act i ve b l ood-forming organs when probabi l ity of failure of safety features in product is l ess than one failure per year for eac h 1 million exempt units distributed (see Section 2.15.1 of NUREG 1717). 1 Dose es t imate app l ies to l ocal parcel-delivery driver who is exposed to mu l tiple chem i cal detector units duri n g distr i bution and transport (see Section 2.15.5.1 of NU REG 1717). i Limit on w h o l e-body dose and dose t o active blood-form i ng organs during n orma l handling and storage of mu l tiple exempt u ni ts (see Section 2.15.1 of NUREG 17 1 7). k Dose estimate applies to a worker who inha l es radioact i ve materia l from multip l e chemical detector units du r ing clean u p after a t r ansportation fire (see Section 2.1 5.5.4 of NUREG 1717). 1 Bone surface dose or red marrow dose to a person who vandalizes a chemica l detector unit and ingests radioactive material due to co n tamina t ion of hands (see Section 2.15.5.4 of NUREG 1717) m Bone surface dose or red marrow dose to worker who inhales radioactive material from m u ltip l e chemical detector units du ri ng cleanup after a transportation fire (see Section 2.15.5.4 of NUREG 1717). n Lim i t on " other organ" doses when probability of failure of safety features of the product is less than one fa il ure per year for each 10 , 000 exempted un i ts distributed (see Section 2.15.1 of NUREG 1717). o Limit on " other organ" doses when probability of failure o f safety features of the product is less than one failure per year for each 1 mill i on exempt un i ts d i stributed (see Section 2.15.1 of NUREG 1717).

Estimate of external dose commitment from exposure to the unsh i elded 20 1,1Ci Tl3A Am-241 source for 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> at an average distance of 1 meter from the source: Pe r the guidance i n NU REG 1717 Sectio n 2.15.4.4 the dose rate at one meter from a 1 µCi Am-24 1 source is 9 nrem/hr. The TGA 3000 contains a 20 µC i source and therefom the dose rate can be calcu l ated as 180 nrem/hr. Us i ng this dose rate to ca l culate the tota l dose from a bare TGA 3000 source for 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> the resu l t is 180 1,1rem (0.00018 rem). Estimated Internal Dose Commitments do to the ingestion of 10 4 of the 20 µCurie foil from a TGA 3000: The Am-241 is intimately bound in a foil matrix of precious metals which i s then crimped into a meta l holder. I ngestion of a source is virtua ll y impossible except by deliberate disassembly of the TGA 3000 and de l iberate destruction of the source. However, in the un l ike l y event that the 20 µCurie source was destroyed it i s assumed that 1Q-4 is ingestHd.

The SO-year dose commitment i s calculated as: I ngestion Activity = 0.002 µCi Critical Organ = Bone Fraction of ingested Am0 2 that reaches the bone = 1 Q-4 Effective energy per disintegration

= 5.5 MeV = 0.002µCi x 10-4 x 2.2 x 1 0 6 d/m/u Ci x 5.5 MeV/d x 1.6 x 10 8 g. rad/MeV x 10 rem/rad J< 1 /5 x 10 1 g bone x 60 m/hr x 24 hr/d x 365 d/y x oi5° e-'1 dt Where: A= 0.693/458y t =50y 0.002 µCi x 960 mrem/µCi = 1.92 mrem (0.00192 rem) Dose Estimates to Skin due to carrying an unshielded 20 1,1Ci Am-241 source in a pocket for 80 hour9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />s: Per NUREG 1717 the dose equivalent to the skin at a nominal distance of 1 cm from handling a 1 µCi Am-241 source for 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> is ca l culated to be 30 mrem. Based on this informat i on the dose equivalent to the skin for the 20 µCi Am-241 source for 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> would be 600 mrem or 60 mrem/hr. Using this information the result for the 20 µCi sour c e in a pocket for 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> is 4800 mrem (4.8 rem)

VALCO INSTRUMENT S COMPANY, INC. RADIOA C TIVE MA T ERIAL SHIPPING CONTAIN E R RECEIPT/SHIPPED SURV E Y Date: I nst r ument Mode l N o: L udlum 3 W I TH 44-9 PROBE Time: I nstrument Seria l N o: Received From: Calibration Due Date: Rece i ved Bv: Backaround

Descrlotion of Shipment: N ame of Authorized User Notified:

Sianature of Aut h or i zed U ser Rece i vina Sh i oment: Ex eo s ur e R a t es M eas ur ed In mR/h r, un l ess o th e rwi se n o t e d Wi 12e Sa m 12 l e s h a ll b e 3 00 c m 2 o r t h e e ntir e e ac k a g e i f l ess th a n 3 00 c m 2 {Not e: 100 cm 2 I s -4" x 4" a r ea l Atta c hed a ll wip e sa mpl e r es ul ts t o thi s s urv e y form. L imit s: / / < 0.5 mR/hr (500 uR/hr) V Perform a radiation survey of the each package and record the highest exposure rate here mR/hr , and note the l ocation of the highest exposure rate on the package with an***. If the entire package is below 0.5 mR/h r (!>00 uR/hr), enter< 0.5 in the space above. Not e: A se p ara t e r adi at ion s urv e y and r e mov a ble c ont a min a tion su rve y f o rm s hall be compl e t ed for EAC H p ac k age s hi p p e d/r ece iv e d. C OMMEN TS: ______________________________ -----3 Su r vey Perfor m ed By:--------------

--Date: ______ _ Survey Approved By: ----------------D a t e: ______ _ I certif y t he package(s) receiv e d and s urv e yed do no t e xc ee d 0.5 mR/hr on contact with t h e pa c k a ge(s) a nd t h e removabl e c ontamination lev e l s do not exce e d 0.5 mR/hr Notify t h e R a di a t i on Safety Offic e r imm e di a tely if a p a ckage is discovered damaged or a ny surv ey res ult s ex c ee d the limits stated abo ve. 1 o f 1 V ALCO INSTRUMENTS COMPANY , INC. FINAL RADIATION SURVEY TGA 3000 OEM Assembly S/N: --------1:8:1 Sealed Source L ot#: ______ _ TGA 3000 OEM Shipped to: ---------------------

Survey Loc at ion: Source Model No: A-001 Source Serial No: -----------

Radioisotope:

_A M-241 Activity:

20uCi Date Survey was Taken: ______ _ INSTRUMENT DATA Ludlum Model 3 WITH 44-9 PANCAKE BETA/GAMMA PROBE S/N: -------Calibration Due Date: ----------

Calibration to Cs137. Survey Results Background Swipe. ___ mR/hr Sample Swipe Carrier In l et ___ mR/hr Sample Swipe Drift Inlet mR/hr Sample Swipe Exit Port mR/hr Sample Swipe Bottom Plate mR/hr Sample Swipe Top Plate mR/hr Limits < 0.5 mR/hr (500 uR/hr) CERTIFICATION I hereby certify the results of this survey indicates the activity to be less than 0.5 mR/hr , (500 uR/hr), of removable contamination.

Date: _______ _

________ _ Print Name Date:--------RSO Signature:.

_________

_ RAF 1001 1of 1 VALCO INSTRUMENTS CO., INC. PN 48100102 SHIPPING SURVEY INSTRUCTIONS.

Instruction s for s u rvey TGA 3000 OEM mod u le prior to packaging.

I. Afte r a l l exit a nd inlet ports have bee n sealed perform a survey u si n g the Ludlum Model 3 w i t h 44-9 pancake prob e. 2. Use Sam pl e Swab D SA PN: DSW8055. Use c l ean swab for each samp l e. 3. Use Valeo form RAF I 001, Fin al Radiation Survey fonn fill in a ll r equ ir ed s pa ces. 4. Swipe known c l ean area to obtai n b ackgro und readi n g. 5. Use clean swab for eac h sw i pe on places i ndica t ed on Va l eo form RAF I 00 I. Note readings o n fo r m. 6. Notify RSO if readings a r c a b ove li m it s indicated o n form RAF I 00 I. 7. Print nam e and date and h ave R SO sign t h e form. 8. Make 2 copie s, retain one for records an d one goes inside document enve l ope sh i pped with instrument.

Instructions for survey of TGA 3000 OEM sh i pp i ng conta i ner. I. Once t h e T GA 3000 OEM unit has been properly p ackaged perform a s urvey using th e Lud lum Model 3 w i th 44-9 pan cake probe. 2. Use Sam pl e Swab D SA PN: D SW8055. Use c l ean swab for each sample. 3. Use Valeo form RAF I 002, Con t aine r Sh ippin g/receiving S urv ey fo m1. 4. Fo ll ow instruct i ons on form RAF I 002. 5. Print name and date and ha ve R SO sig n the fom1 6. Make 2 copie s, retain one for records and one goe s i n s ide document e nve l ope s hipped with instrument.

End of I nstructions.


2.500 ---------CONTAINS RADIOAC TI VE MATERIAL RADIONUCLUDE:

AM-241 A CT IV ITY: 20 uC I MANUFACTUREDB Y VALCO INSTRUMENTS COMPANY INC. UNDER U.S. L I CENSE AND IN COMPLIANCE WITH NRC 10CFR32.31 PRIOR TO USE REFER TO TGA 3000 OPERATOR MANUAL, PN 48 1 00 1 02 , FOR SAFETY AND OPERAT I ONAL GU I DANCE. -I t 0.100 DETAIL "A" 0.100 LABELS: RED TEXT ON ALUMINUM BACKGROUND, MINIMUM 10 POINT PRINT. RADIATION MAJENTA OR BLACK TREFOIL ON YELLOW BACKGROUND.

1 MATERIAL SPEC: .003" MIL PHOTO ETCHED ALUMINUM PERMANENT ACRYLIC ADHESIVE BACKING OPERARTIONAL TEMPERATURE

-60F TO 450F ITEM PART OR ,____QlY-P~E-R -DAS~H_N_O__, NO IDENT NO REF DESIG UNLESS OTHER SPECIFIED:

D:tv1ENSIONS ARE IN INCHES. -J 0.450 NOMENCLATURE OR DESCRIPTION PARTS UST OR MATERIAL 0.450 SPEC/STD .. B.KAYE 04 2017 Mn~n . \,Ml\ \!/ u~u Vo.lea Ins"truMents Co., Inc. TOLERANCES ON f--------1 D6~c Pp+/- +/-:g~5 ~Nts~. 6 5' RMS i..:.~:...:.F~----4-------r Tr,G""A~3zr0v0vO""RA)Af'D"IAT-Tnl R 0.:1 N----rr W TA AcR"'Nml N;:-.;G;=;:-----; t-------1 ANGLES +/- 30' 1-QA-----+----11->LA=<...>>-,<.b.b,~__,"""="'a=""T""-------r-==-1 FINAL PROTECTIVE FINISH: S~E 4 6 1 Q Q 1 Q 1 ,EV SEE NO TES 1--Fl-LE_NAM_E:_* ----'---L-----+-

S-C_AL ....... E .....:.2-=-..:-r-=

SH'-'E=-ET....:......:::a....

1 ....:...OF----'---'-

1 ----1 THIS DEVICE CONTAINS RADIOACTIVE MATERIAL RADIONUCLIDE

AM-241 ACTIVl1Y:

20 microCI MANUFACTURED BY VALCO INSTRUMENTS COMPANY INC., IN COMPLIANCE WITH U.S. NUCLEAR REGULATORY COMMISSION SAFElY CRITERIA IN 10 CFR 32.31 1.500 THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS I 3.000 LABELS: BLACK TEXT ON WHITE BACKGROUND, MINIMUM 10 POINT PRINT FOR RADIATION WARNING SECTION AND 12 POINT FOR PURCHASER SECTION. MATERIAL SPEC: 2 MIL POLYIMIDE PERMANENT ACRYLIC PSA ADHESIVE BACKING OPERATIONAL TEMPERATURE

-60F TO 450F I I I 1TE M I PART OR I REF ;I NOMENCLATURE OR I SPEC/STD QlY PER DASH NO I NO IDENT NO DESIG DESCRIPTION PARTS UST OR MATERIAL UNLESS OTHER SPECIFIED:

DR 8.KAYE 04/2017 w,n~n . . D1tw1ENSJONS ARE IN INCHES. CHK \!/ UWU Vo.lea InstruMents Co., Inc. TOLERANCES ON ENG XX DEC P +/- .02 FINISH 63 RMS XXX DEC P +/-.005 VP 2* O' MFG TGA 3000 POINT OF SALE LABEL ANGLES +/- 30' QA ::,A~ 1 4 6 1 0 0 1 0 2 I REV MATERIAL:

FINAL PROTECTIVE FINISH: USED ON SEE NOTES I SEE NOTES FILENAME:

SCALE 2 I SHEET 1 OF 1 --

+ TOP AND BOTTOM PLATES ARE MACHINED FROM 5052 H32 ALUMINUM SHEET. REFERENCE DRAWING 44l00I52_Y25932 ATTACHED WITH THIS SECTION. SUPPORTS ARE NICKEL PLATED STAINLESS STEEL, 0.250 HEX STAND OFFS. FASTENERS ARE MADE FROM 18-8 STAINLESS STEEL. 3,570' TOP PLATE SUPPORTS 2.857' BOTITOM PLATE ---------4.750'---------All. DRAWING DIMENSIONS I N INCHES UNLESS OlHERWISE SPECIFIED

.........


VJCI Vo.l ea lnstl"unents Co., Inc. GA 3000 OEM MODULE FRONT VIEW DIMENSIONS ii' ----22100104 -;,__ ____________

___. ___________________________ ... _______ -_____ __,

2.857' / I ----------1


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Wl'NICIIII I.,_ ~.......;:c.

iiiiii~ ........................

iliii ---TNl_llllllm

____ CIU. ~-----TNI_CIU. _______ _ ---MWBLM ___ __ _____ ,. ____ au. ----~--1111--------. -m-... -. ALL DRAWING DIMENSIONS IN INCHES UN.E.SS <>nERWl8E 8PEC1AB> ---------i --22100104 -

8.900-r---------------, 8.650*----j* (2X) 8.275 (2X) -& 3.9 1 1

  • STAMP/ETCH TEXT (.20 HGHT) *
  • 0.149THRU !9X) -.--.o~ REF. DWG: 44100152 (REV. 1) REVISIONS REV. DESCRIPTION DATE IN t'TIATEO DATE APPROVED A. ECN#24034 NEWDWG MATL: 5052 H32 (ALUM) NOTES: 03123/17 DA.LE A. 1. ALL SURFACES T O BE SMOOTH , AND FREE OF DEFECTS. FILLETS: , CORNERS~ X 45* UNLESS OTHERWISE SPEC I FIED. THS DOCUMENT ANO THE N'ORMA.TlON WHICH IT CONTAINS SHAU. NOT 8E USED. EXP\.DITEO OR SOLO. ANO SHAU. NOT BE REVEAl£D OR OISCI.OSEO TO OTHERS WITHOUT THE EXPRESS8 WRITTEN PERMISSION OF VAi.CO. THS OOCUMENT SHAU.REMANllE PROPERTY OF VAL CO ANO SHAU. BE RETURNED UPON DEw.NO. VICI Valeo lns t ume nt s Co.~I~ ---------------< TOP AND BOTTOM PLATE, PCB MOUNTING IMS-25932 ORA'MNGNO. -Y2 5 932 44100152 ,.._ .....,. USA PROJECTION

-,, -'""' SHEET 1 OF I --------*--

Y2S9=::: 32=--__ ,.;.TGA.;:..c;3K

'-'--'------------*-*-~------Thursday, April 6 , 2017 3: 12:35 PM (b)(4)