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DragersafetyFebruary 27, 2006United States Nuclear Regulatory CommissionMaterials Safety and Inspection BranchDivision of Industrial and Medical Nuclear SafetyTwo White Flint North11545 Rockville PikeNorth Bethesda, MD 20852Subject: Request for an amendment to Materials License number 42-23903-01E andregistry of radioactive sealed source safety evaluation NR-1 199-D-101-EDear Sir / Madam:Please accept this request for an amendment to our subject Materials Licese to iucludethe radioactive sealed source module (SSH 0000).Our original Materials License (42-23903-0lE) and Exempt Poduct Registration (NR1199-D,101-E) was for the device models 5000,5100,5600 and 5700. The deviceincludes a single:sealed source module along with the associated electronics and pumps.Draeger Safety is requesting to apply for licensing and evaluation of the sealed source,rather than the devices, as we are constantly upgrading the electronics, software andhardware for future devices but the sealed source remains the same.Enclosed are two checks for the application p.a registry for the safety evaluation of thesealed source. If this request is approved by the NRC, please advise if it is still necessaryfor Draeger Safety to continually possess the Materials License and Exempt ProductRegistration for the devices rather than for just the sealed sources. Or would combiningthe aforementioned into one registration certificate be more feasible?Thank you for your assistance and we look forward to your guidance and forth comingreply.Victor HoangSenior EngineerAlternate Radiation Safety OfficerE-mail: VictorJioang@Dmcger.com-rseaeSB- r -no teWSym m50 JdM NlM.ROOwaedsL#1SOSugar Land. Tom 77478Tatc (280 4549

IcUAL NUCLEAR REGULATORY COSISM1SNNR FOM 67REQUEST FOR A SEALED SOURCE ORDEVICE EVALUATIONcafe I-&unto 19 OWdassign boMA&lWaMal ftp 040 H& CMan fte Uoen T ft dSystammucNOTE- Ret ain cWpd tueotaemmct"iq wbI ft applicaftin and badtmwA fbREGIOM.OCAflON:IzDgerSafetylKTux"[,IILIVHQ [] LFABPAT9TYPE OF ACTION ATION SHEETNUMBER(S)SOURCE REVIEWVictor HongMWLErEMWAP4.AT10DATELU[]DEVICE REVIEWCUSTOM REVIEW3-1EMBNR-1199-D-1014E50TJulle Riven RoadSuite 150Sugar Land, TX 77478FORSWU MJmoo"ummmNima Asebow d,8M USE ONLYMAIMASMS00N, 5100, 5700D ustu06-19TOFEEDAABOMMDATETYP-Eor-FAcTION a/ri/cato Whe numberof gafh ftI'COMMERCIAL DISTRIBUTION (FORMAL)SOURCE (SC)LiNEWE]AMENDMENTsur.(O)LiNEWDEVM(8)Li AMENDMENTE] AMENDMENTLiNoSAFETY EVALUAT1ON REQUIREDNO FEES REQUIREDI.Li USE BY A SINGLE APPLICANT (CUSTOM)DEVICE SW)W AMENDMENT" LIUCENSING ACTI]ONREQUIRED(IFKNOWN)LiYESNOOTHER (Spec)TOTAL NUMBER OFNoTErREVIEW HOURSAmendment for NR-11*9-D-101-E & E-fiemeNUMBER OFDEFICIENCY LETTERSNUMBER OF42-23903-OIEDEFICIENCY CALLSFORFFMET L,Wr0%OF PM.EU&6 9AAMO w-F-dtchbenrt*ww*eI-,a"

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APPLICATION FOR RADIOACTIVE SEALED SOURCEAND DEVICE EVALUATION AND REGISTRATIONDATE: 2003-05-13 - AMENDED IN ITS ENTERETY 2006402-27MANUFACTURER:9499FcSafety AO &Go. KGO424S9-BaFMDrager Safety AG & Co. KGaARevalstrsae 123560 LObeckGermanyPon;: '.40 30 632 20 1Few: -W91930 830.2 2990Phone: 49 451 882 3613Fax: 49 451 882 1977Mall to:-P f. Dr. J. Lc,. ,ehwdResponsiility Changed to Dr. Stefan MorleyNew e-mall: stefan.modaey@draeger.comDISTRIBUTOR:Draeger Safety, Inc.Gas Detection Systems505 Julle Rivers. Suite 150Sugar LandTexas 77478U.SA.Phone: 1-281498-1082Fax: 1-281-498-6190Mall to: Victor Hoangvlctor.hoang draeger.comCUSTOM USER ORCUSTOM DEVICE:NoOTHER COMPANIES:NoneDEVICE NAME[DEVICE TYPE:Ion Mobility Spectrometer (IMS)STR 0000 (Spectrometer Type Transmitter)consists of enclosure I electronics and8SH 0000 (Spectrometer Type Sensing Headconsists of the Sealed Source module Detector Unit)Note: We are proposing the sealed source module terminology, in order to makelabeling, communication, future amendments etc. simpler. Request for thisamendment shall be the SSH 0000, as this module contains the radioactive source.Every transmitter STR 0000 Includes one sealed source module SSH 0000.See also MODELS ISSUED IN THE AMENDMENT.I

APPLICATION FOR RADIOACTIVE SEALED SOURCEAND DEVICE EVALUATION AND REGISTRATIONDATE: 2003-05-13 -AMENDED IN ITS ENTIRETY 2006402-27MODELS:Drfger IMS 5700Drdger IMS 5600DrAger IMS 5100Driger IMS 6000STR 0000 transmitter Includes the Detector UnitSSH 0000 sealed source module.PREVIOUS MODELSThe hardware of the models 5600 and 5700.Ia Idenical. The models 5000 and 5100represent a downgrade (minus 3 parts: GC column , one circulation filter, one pump)of the 5600/5700 models. Different chemical compounds can be detected by themodels using different kinds of software. The hardware Is contained inan aluminiumbox (for 19" standard rack mounting) with overall dimensions 350 x 480 x 130 cms(Fig. 1). It contains the following main components:* detector unit: IMS cell with radioactive source and current amplifier,circulation fifter and internal gas flow loop" gas system: gas pumps, Inlet system willt sampling unit - magnetic valves,flexdble tubes, dust Mater, GC (Gas crmagraphlc)column, circulation filter" electronic boards: mirocomputer, dia,hv unit, pulse unit, I/O portsFig. 1: View of the device; the detector unit is cognizable at the right side, theelectronic boards on the left sideMODELS ISSUED IN THE AMMENDMENT:.The STR 0000 contains a detector unit of the'SSH 0000 sealed source. type moduleand electronics for signal processing, datat.rAnnsmiualon, power supply, .display andhuman Interface. The 8TR 0000 does not contain any part of relevance for radiationprotection.Different chemical compounds can be detected by SSH 0000 sealed source module,using different kinds of software. The hardvOa is contained In an aluminum box (for19' standard rack mounting) with overall dimensions 390 x 436 x 133 cM3 (Fig. Ia).2

APPLIAJJQNFOP,RAIQAC TIV SAEQtAN 011W. EVA WAAND REC3ISTAIDATE: 2003 05-13 - AMENDED IN: ITS-ENTIRTY 200"-027.i.bi.i, i.llN\,Fig.4.b.Wý00 ? ,Gas.fo,-,. . ,. at. .diagram Wof 6ensing head, Indludin OppinlG0J3jl rJ3 tit,Zo

APPUCATION-FOR RADIOACTIVE SEALED SOURCEAND DEVICE EVALUATION AND REGISTRATIONDATE: 2003-013 - AMENDED IN ITSNTT2006 02-27PRINCIPAL USE CODE:(N), Ion Generators, ChromatographyFOR USE BY:Persons Exempt from LicensingRADIONUCUDES USED:Trdum (Hydrogen-3) of Maximumr Actift 9 1 GBqgettered In a Titanium Layer on a Stainless SteelDisk and covered (sealed) by Layersof SiliconDioxide (SIN0) and Alumlnlwn and/or GoldSEALED SOURCEMODEL DESIGNATION:BH 3.21 (Rltverc GmbH, 2-Wd Murinsky;Ave. 25,194021 St Petersburg, Russia)180 CLASSIFICATION:C33131SEALED SOURCE APPUEDFOR REGISTRATION:As Part of the DeviceLEAK TEST FREQUENCY:Not required (Tritium Source only)CONDITONS OF USE:The devlces are expecWd to be used* for the detection of gaseous chemcal warfareagents In public and official.buldings.9 fbr seWcive and very seie detecton ofgases and vapours In Industial fadclite(chemical and petrol Industry),* for extremely sensitive monitoring of molecularcontamination In semiconductor plants.* and In analytical laboratories.4

APPUCATION FOR RADIOACTIVE SEALED SOURCEAND DEVICE EVALUATION ANDREGISTRATIONDATE: 2003-05-13 - AMENDED IN HS ENTIRTY 2006402-27The devices are designed for the following environmental conditions (nrmal ue):& Temperature:60S0 "C to 50 "C for use; -26 "C to 70 6C for transportationand storagenot effected by pressureup to 90 % relative humidity (non-condensing)during transportatlon the device may experience typicalvibration and shockPressure:Humidity.Vibration:Unlikely event accident conditions;Inthe unlikely event accident conditions that the device does not operate, the sourceremains sealed.0 Impact:source remains sealed (fall off from 2 m height)Extreme accient conditis:* Corrosion:not fully resistant under extreme conditions ofcorosion* Excessive hightemperatures/Fire:* Spontaneous Ignition:* Explosion:* Flooding:not fully resistantlow risknot resiant with regard to external explosiondevice does not operate, source remains sealedAssuming regular service Intervals (ilter, mechanical pumps. coience check) theproduc's estimated workdng UsfIs 10 years.CONSTRUCTION OF THE DEVICE:. ntsDee borw tPartsW80ewN.AmflwRadbosdt soureekadw literGas S smbe:eateals"s PTe,E PEEK-SNUMedftahm 9ATel.rl810g.AAut kdew rl. modcusr uvsva vWtonPTFSiaftn nd "p lowFke tubeaCkOC coumaSH 0000 mosty herd-W,,,8oa 01MR wtbDtnen sogth. 1cmdfamterMae". pW,,WoSatinfer Melshd*s"9eel,PTIFE VftenQuuUz. metS cumn mdaelSSH30000 pneWnal module PEEKmo , )Ep oxy588H 0000: as& drawingEM2447 (aambet to U"moin 35 x 100 ammimnx220x 100 nn2

APPLICATION FOR RADIOACTIVE SEALED SOURCEAND DEVICE EVALUATION AND REGISTRATIONDATE. 2003-05-13 - AN]MED IN rrs ]NTIRETY 200"42-27Doetctor unitThe basic components of the IMS are- shown In Fig. 2 and, mora schematically, InFt. 3 (STROO0 and 810 sealed source modukL. See attachment to theamendment pages I and 2). The detector unitIls the core of the device. its pafts arehoused In a self-contained plastic box (Polypropylene) with heavy wails of 8 mmthickness (Fig. 4). The radioactive source Is tightly mounted at one end of thecylindrical IMS cell (Fig. 6). So it Is sealed twofold, by the IMS cell as well as by theplastic housing.Device operationA sample flow containing chemical compounds Is Ionized at the surface of thesource (ionization space) by Its A-radiation (fast electrons). The various ione enterthe drift region of the IMS cell:be means. of a shutter grid (electrical pulses of 500 Vwith microsecond duration). In the -drift regon an electrifield of 400 Vlcm Ismaintained. Due to their mobility different Ions reach the collector electrode at theend of the drift cell at different times. These so called drift times are used for Ionklenificadon and concentration -easurement A drift tme spectrum represents theIon current (output signal of the amplier)'In dependence on time. Positive andnegative Ions can be detected by reversing fleld-polarity.Trtltum leakeaoSinai amounts of desorbedTritlru gas merge Into the drift and sample gas flows.They are absorbed in the circulation filter. This.filter has to be replaced by .theDistributor every 6 month.Redboacdve sourceA stainless steel (1.4302, 2: 10,5 %Cr). of 10 mm dameter and2 mm thicknessIs the basic body of the radioactive source e(Rg, 8). A 5 pm Titanium layer isdeposited at one side of the diso by vacuum evaporatio This layer Is charged withTritium at a temperature of 400 C. Hereafter, Silicon dioxide Is deposited asprotectie layer. It prevents any abrasion of the Titanium. Finally conductingAlumInlum and/or Gold top layers are deposited, preventing static electric charges onthe source.Safety featuresThe Integrity, shielding and normal operationofv the radioactive source within the IMScell can be evaluated at any tkne by the.so.clled Reaction Ion Peak (RIP). This peakalways appears in a measured drift. g'e spectrum. It is caused by positive ornegative ions arising directly from air molecules. Fig. 9 shows a typical example ofthe Ion. current (output signal) at the collector eecftrd for positive and negative Ionsrespectively. Now, both the time window. and the amplitude of these peaks arewatched by software means. In cae of no orusmall RIP, among: other reasons. theIMS cel may be out of work. Aflushinga' (SSH 0000: alure) LED located atthe front panel of the device end a falure rFely for remote control Indicate this state.The User Manual demands a service call (on page 21), If straightforward reasonscould be excluded.6

IAPPUCATION FOR RADIOACTIVE SEALED SOURCE.AND DEVICE EVALUATION AND REGISTRATIONDATE: 2003-05-13 - AMENDED IN rTS ENTIRETY 2006-02-27Fig. 2a (6X00): IMS components (2 - detector unit with IMS cell containingradioactive source)STR 0000 tmnsmlter contains no components of relevance for radiation protection (Itcontains electronics and hardware, e.g. pumps).7