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cytiva Sterile Tube Fuser, Operating Instructions Manual

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cytiva Sterile Tube Fuser Operating Instructions Manual Download Page 29

3

Instrument description

About this chapter

This chapter gives an overview of the Sterile Tube Fuser - Dry and Hot Lips Tube Sealer
instruments, and a brief function description.

In this chapter

Section

See page

3.1

Instrument description of Sterile Tube Fuser - Dry

30

3.2

Instrument description of Hot Lips Tube Sealer

32

3 Instrument description

Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG

29

Summary of Contents for Sterile Tube Fuser

Page 1: ...Sterile Tube Fuser Dry and Hot Lips Tube Sealer Operating Instructions Original instructions cytiva com...

Page 2: ...Coverlockfor SterileTubeFuser Dry 42 5 2 SterileTubeFuser Dry 43 5 2 1 Operationaloverview 44 5 2 2 Fusingtubes 46 5 2 3 Inspectingweldquality 53 5 3 HotLipsTubeSealer 54 5 4 UpdatingtheTubingDatabase...

Page 3: ...tion 101 8 7 Regulatoryinformation 102 8 7 1 Contactinformation 103 8 7 2 EuropeanUnion andEuropeanEconomic Area 104 8 7 3 EurasianEconomicUnion 105 8 7 4 RegulationsforNorthAmerica 107 8 7 5 Regulato...

Page 4: ...formation intendeduseoftheSterileTubeFuser Dry and HotLipsTube Sealer instruments andlistsofassociateddocumentation Inthischapter Section Seepage 1 1 Aboutthismanual 5 1 2 Importantuserinformation 6 1...

Page 5: ...italictext Hardwareitemsareidentifiedinthetextbyboldtext Inelectronicformat referencesinitalicsareclickablehyperlinks Illustrations Theimagesandannotationsinthisdocumentareforillustrativepurposesonly...

Page 6: ...ubeFuser Dry and HotLipsTubeSealershallnotbeusedinanyclinicalproce dures orfordiagnosticpurposes Prerequisites InordertooperateSterileTubeFuser Dry and HotLipsTubeSealerinthewayitis intended Theusermu...

Page 7: ...notto proceeduntilallstatedconditionsaremetandclearlyunderstood NOTICE NOTICEindicatesinstructionsthatmustbefollowedtoavoid damagetotheproductorotherequipment Notesandtips Note A note is used to indic...

Page 8: ...Sealer Operator Manual suppliedwith HotLipsTubeSealer Relateddocumentation Sterile Tube Fuser Dry and Hot Lips Tube Sealer Tube Data Management Tool User Manualissuppliedwithaninstallationkit availab...

Page 9: ...esrecyclinginformation Important WARNING Beforeinstalling operatingormaintainingtheproduct all usersmustreadandunderstandtheentirecontentsofthis chaptertobecomeawareofthehazardsinvolved Inthischapter...

Page 10: ...Generalprecautions SterileTubeFuser Dry and HotLipsTubeSealer WARNING Riskassessment Performariskassessmentforanyrisksdueto theprocessorprocessenvironment Evaluatetheeffectstheuseof theproductandtheop...

Page 11: ...approvedorsuppliedby Cytiva maybeusedformaintainingor servicingtheproduct WARNING Useappropriatepersonalprotectiveequipmenttopreventinhala tionoftoxicfumeswhenheatingandtreatingthermoplastics Makesure...

Page 12: ...ollowlocaland or nationalregulationsforsafeoperationandmaintenanceofthis product WARNING Spreadofbiologicalagents Theoperatormusttakeallneces saryactionstoavoidspreadinghazardousbiologicalagents The f...

Page 13: ...beeasytodisconnect CAUTION Disconnectalltubing hosesandexternalcablesbeforemovingthe unit CAUTION Theproductand HotLipsTubeSealer havefragileitems Makesure thattheproductand HotLipsTubeSealer arealway...

Page 14: ...nforma tion WARNING Inspectallconnectionsandtubingbeforestartandreplaceany defectiveparts CAUTION Makesurethatalltubing hosesandcablesareplacedsothatthe riskoftrippingaccidentsisminimized CAUTION Remo...

Page 15: ...r Dry WARNING Insetupmodeof SterileTubeFuser Dry withtheProgramming lockkeyhorizontal theinstrumentcanberunwithcoveropen The bladeposesaburnhazardandmovablepartsposesapinchhazard iftheweldprocessissta...

Page 16: ...ION Thecuttingbladeof SterileTubeFuser Dry isathinpieceofstain lesssteel Itdoesnothaveasharpenededgebutcancausecutsif handledimproperly Besuretoreadandunderstandtheprocedure forinstallingandremovingth...

Page 17: ...jawsduringoperation WARNING Pinchhazardwhenusing HotLipsTubeSealer Thejawsare movingduringclampingandcalibration Keepawayfromthejaws whenclampingtubesandduringthecalibrationprocedure CAUTION Ifthereis...

Page 18: ...artsunlessspecificallystatedintheuserdocumentation WARNING Disconnectpower Alwaysdisconnectpowerfromtheinstru mentbeforeperforminganymaintenancetask WARNING Ifafuserequiresrepeatedreplacement donotcon...

Page 19: ...efollowingsymbolsandtextmaybepresentonthesystemlabel Symbol text Meaning Codeno Instrumentassemblynumber Serialno Instrumentserialnumber MfgYear Year YYYY andmonth MM ofmanufacture Voltage Frequency M...

Page 20: ...user Dry Thesafetylabelsarelocatedon SterileTubeFuser Dry asillustratedbelow Thelabels warntheuserofriskofpersonalinjury 2 Safetyinstructions 2 2 Labels 20 SterileTubeFuser DryandHotLipsTubeSealerOper...

Page 21: ...beSealer Thesafetylabelsarelocatedon HotLipsTubeSealer asillustratedbelow Thelabels warntheuserofriskofpersonalinjury 2 Safetyinstructions 2 2 Labels SterileTubeFuser DryandHotLipsTubeSealerOperatingI...

Page 22: ...thepotentialhazardsindicatedbythelabels Symbol Description Warning Readtheuserdocumentationbeforeusingthe system Donotopenanycoversorreplacepartsunless specificallystatedintheuserdocumentation 2 Safet...

Page 23: ...esahotsurfaceandthatcaremustbeexercisedto preventinjury Indicatesapinchhazardandthatcaremustbeexercised topreventinjury 2 Safetyinstructions 2 2 Labels SterileTubeFuser DryandHotLipsTubeSealerOperatin...

Page 24: ...ibestheresultin theeventofpowerfailure Emergencyshutdownof SterileTube Fuser Dry Switchoffthepowerbypressingthepowerswitchtothe O position Thepowerswitchislocatedattherearoftheinstrument seetheillustr...

Page 25: ...interruptediftheGObuttonisreleased Powerfailure Powerfailureto Willresultin SterileTubeFuser Dry duringthewelding operation Thetubesmaynotbecompletelywelded HotLipsTubeSealer duringthesealing operatio...

Page 26: ...nitiatetheweldingprocessbyfollowingtheinstruc tionsdisplayedontheTouchScreen HotLipsTubeSealer Re initiatethesealingprocess 2 Safetyinstructions 2 3 Emergencyprocedures 26 SterileTubeFuser DryandHotLi...

Page 27: ...cesof SterileTubeFuser Dry Thecuttingblade reaches400 Cduringtheheatingcycle Donottrytoopenthe protectivecoverduringthewelding HotLipsTubeSealer Thefollowingdiagramshowsthedangerzoneon HotLipsTubeSeal...

Page 28: ...facesof HotLipsTubeSealer Thejawsreachover200 C duringtheheatingcycle Donottouchthejawsduringoperation 2 Safetyinstructions 2 4 Dangerzone 28 SterileTubeFuser DryandHotLipsTubeSealerOperatingInstructi...

Page 29: ...and HotLipsTubeSealer instruments andabrieffunctiondescription Inthischapter Section Seepage 3 1 Instrumentdescriptionof SterileTubeFuser Dry 30 3 2 Instrumentdescriptionof HotLipsTubeSealer 32 3 Ins...

Page 30: ...hemainpartsof SterileTubeFuser Dry Part Description 1 Tubingholders blueandred 2 Bladeholders 3 Liftinghandle 4 Touchscreen 5 Coverlockbutton 6 CoverorLid Rearpanel Theillustrationbelowshowstherearpan...

Page 31: ...amVersion TubedataVersion thetubetypeandO D ofthetubingused andthecurrentweldnumberalongwith otherrelevantparametersrelatedtotheweldingconditionsoftheparticularweld beingperformed Inadditiontodisplayi...

Page 32: ...gdiameters Majorusesareinbioprocessingandinasepticapplica tions HotLipsTubeSealer isequippedwithanembeddedsoftwareforcontrolandsupervi sion Mainparts Theillustrationbelowshowsthemainpartsof HotLipsTub...

Page 33: ...1 Powerswitch 2 Fuseholder 3 Powerconnector 4 Keylock 5 Dataconnector 3 Instrumentdescription 3 2 Instrumentdescriptionof HotLipsTubeSealer SterileTubeFuser DryandHotLipsTubeSealerOperatingInstructio...

Page 34: ...tionandinspectioniscarriedoutbyqualifiedpersonnelwho areadequatelytrained understandandadheretolocalregulations andtheoperatinginstructions andhaveathoroughknowledgeof theproductandtheentireprocess In...

Page 35: ...temperature 0 Cto30 C Humidity 20 to80 non condensing Pollutiondegree 2 Altitude Maximum2000m HotLipsTubeSealer Parameter Requirements Allowedlocation Indooruseonly Electricalpower 100 120 220 240V 50...

Page 36: ...eSection 2 4 Danger zone on page 27 shouldbekeptclearof obstructions Theinstrumentisdesignedfornormallaboratoryenvironmentsandmustbe protectedfromsplashesordustyoperations Theinstrumentisequippedwithv...

Page 37: ...e unit CAUTION SterileTubeFuser Dry and HotLipsTubeSealer havefragile items Makesurethat SterileTubeFuser Dry and HotLipsTube Sealer arealwaysinuprightpositionduringtransport movement andstorage Alsom...

Page 38: ...rument Step Action 1 Removetheinstrumentfromtheshippingcontainerusingthelifting handlessituatedontheinstrument 2 Removeanytapeandpackagingmaterialfromtheinstrument 3 Checktheequipmentforanyapparentdam...

Page 39: ...l on page 30 and toagroundedpoweroutlet SeeSection 4 1 Site requirements on page 35formore information WARNING Protectiveground Theproductmustalwaysbeconnectedtoa groundedpoweroutlet 4 Installation 4...

Page 40: ...heprinterACadaptertoa100to240V 50or60Hzpowersupply andtotheprinter 2 ConnectthesuppliedcommunicationcabletotheprinterDB 25connector andthe SterileTubeFuser Dry printerconnector 4 Installation 4 5 Conn...

Page 41: ...ulations andtheoperatinginstructions andhaveathoroughknowledgeof theproductandtheentireprocess WARNING Useappropriatepersonalprotectiveequipmenttopreventinhala tionoftoxicfumeswhenheatingandtreatingth...

Page 42: ...n locked up unlocked Tolockthecover pressandholdthecoverlockbuttonforafewsecondsuntilyouhear aclicksound NOTICE Makesurethatthecoverlockbuttonisdownduringthewelding andaligningoperation Coverlockbutto...

Page 43: ...ngprocess describeshowtofusetubes andhowtoinspectthewelding Inthissection Section Seepage 5 2 1 Operationaloverview 44 5 2 2 Fusingtubes 46 5 2 3 Inspectingweldquality 53 5 Operation 5 2 SterileTubeFu...

Page 44: ...plasticmaterialssuch asPTFEorsilicone The SterileTubeFuser Dry canhandlevarioustubingdiametersspecifiedin Section 8 2 Compatible tubing for Sterile Tube Fuser Dry on page 95 Schematicoperation Stage D...

Page 45: ...slypushedtogethertoformtheconnection 6 Theconnectedtubingisremovedandtheusedcuttingbladeandcut tubingendsarediscarded Priortouse Priortouse theinstrumentshouldbetestedbymakingafewtrialweldswhichshould...

Page 46: ...partsundertheprotectivecover Donottrytoopenthe protectivecoverduringthewelding WARNING Incaseofpowerfailureandinstrumentreset SterileTubeFuser Dry unlocksthecoverlock Donottouchthebladeforapproxi mate...

Page 47: ...thenewdisplay Ifnotubingtypes appearonthefirstscreen presstheNEXTbuttontoopenthesecond screen Note If you have already inserted the blade and wish to change the tubing type simply remove the blade to...

Page 48: ...ion RemovalToolas shownbelow 2 UseInstallation RemovalTooltoinstallthebladebypressingthetopofthe toolwiththepalmofthehand Duringthebladeinstallation securethe bladewithinthetoolbycompressingwiththethu...

Page 49: ...rfirstandslideittowardsthered right holder Clampitdownsecurely 4 Closetheredholderandtightentheclamp 5 Closethecover 6 Pressandholdthecoverlockbuttonforafewsecondstosequencethe program Removeconnected...

Page 50: ...6 Closethecoverandpressthecoverlockbuttontoresettheinstrument 7 Optional Startatstep3inStart instrument and set tubing brand and dimension on page 47tomakeadditionaltubingwelds Eachweldcycletakesabout...

Page 51: ...epairmustmatch 4 PlaceeachTubingholderonitsplatform Note Ensure that the alignment pins under the Tubing holder are placed into holes in the platform 5 Pullthelockingtabstowardsthefrontoftheinstrument...

Page 52: ...id Pumpouttheexcess fluidbeforeweldingtubing Stopliquidfromre enteringbyclampingthetubing All clampsmustbeplacedoutsidethelid 5 Operation 5 2 SterileTubeFuser Dry 5 2 2 Fusingtubes 52 SterileTubeFuser...

Page 53: ...radialdirection Ifyoudonotseeaflangeallthewayaround thendiscardtheweld Checkforthe followingandweldagain Makesurethatcorrecttubingsareused Makesurethatcorrectholdersareused Makesurethatapprovedtubings...

Page 54: ...vedtubingtypes Itisnotpossibletosealnon thermo plasticmaterialssuchasPTFEorsilicone HotLipsTubeSealer canhandlevarioussizetubingdiametersspecifiedinSection 8 3 Compatible tubing for Hot Lips Tube Seal...

Page 55: ...Pinchhazardwhenusing HotLipsTubeSealer Thejawsare movingduringclampingandcalibration Keepawayfromthejaws whenclampingtubesandduringthecalibrationprocedure WARNING Useappropriatepersonalprotectiveequip...

Page 56: ...ion i d o d ininches TheREADY lightalsoturnson 2 Tochangetubingtypeandtubingdimension PresstheMENUbutton PresstheCursoruporCursordownbuttonsuntilthedesiredtubing typeanddiameteraredisplayed PresstheEn...

Page 57: ...rationsbelowshowtheinstrumentfromthetop left andfromthe right handside right 1 3 2 1 3 4 Placethetubingbetweenthejawsrestingonthestainlesssteelplatform 5 PresstheLIFTUPTOLOADTUBEhandle 1 andverifythat...

Page 58: ...1 4 2 5 3 6 Whenthesealcycleiscomplete theinstrumentopenstothereleaseposi tionandthesealingjawsarecoolenoughtotouch 7 WhentheREADYlightturnson removethetubing 8 Ifanothertubesealingisdesired pressthe...

Page 59: ...hilethetubingissealed Theliquidisdisplaced bythespeciallycontouredjawsandthesealareaisfreeofliquidorbubbles Note No clamps plugs or seals should be inside the danger zone of the instru ment see Sectio...

Page 60: ...en it was not centered properly in the sealer jaws Cutsealedtubing HotLipsTubeSealer producesasealthatiswideenoughtobeeasilycut Simplyuse scissorstocutthroughthemiddleoftheseal Thisprocedureisusefulfo...

Page 61: ...Theseincludetemperature positioningdataandsequencetiming Contact Cytiva ifyouneedtoupdatetheTubingDatabase NOTICE Improperuseoftubedatamaycausedamagetotheunitandisnot coveredunderthewarranty 5 Operati...

Page 62: ...Dry and HotLipsTubeSealer instruments Inthischapter Section Seepage 6 1 Cleaningbeforeplannedservice 63 6 2 Cleaningtheinstrument 64 6 3 Regularmaintenanceof SterileTubeFuser Dry 69 6 4 Maintenanceof...

Page 63: ...Safety Declaration FormortheHealth and Safety Declaration Form for Product Return or Servicing dependingonwhethertheinstrumentisgoingtobeservicedonsiteorreturnedfor service respectively Healthandsafet...

Page 64: ...describeshowtocleantheinstrument Inthissection Section Seepage 6 2 1 Cleaningof SterileTubeFuser Dry 65 6 2 2 Cleaningof HotLipsTubeSealer 68 6 Maintenance 6 2 Cleaningtheinstrument 64 SterileTubeFuse...

Page 65: ...dclampsdependingonthehazardleveloftheprocesschemicals biological beingused Step Action 1 Switchofftheinstrumentanddisconnectthepowercord beforeinitiating thecleaningprocess 2 Unlockthetubeholders open...

Page 66: ...th40 ethanolor40 isopropanol Dangerzone ThedangerzoneunderthecoverseeSection 2 4 Danger zone on page 27canbe cleanedperiodically usingasmallhandheldvacuumcleaner Anyspillagecanbe cleanedwithalintfreec...

Page 67: ...6 Maintenance 6 2 Cleaningtheinstrument 6 2 1 Cleaningof SterileTubeFuser Dry SterileTubeFuser DryandHotLipsTubeSealerOperatingInstructions28964139AG 67...

Page 68: ...t andalintfreeclothcanalsobeusedtoclean surfacesoftheinstrument Switchofftheinstrumentanddisconnectthepowercord beforeinitiatingthecleaning process PTFEjawcovers WipetheblackPTFEjawcovers seearrow wit...

Page 69: ...nthecaptivescrew iftheinstalledtubeholdersarefoundtobeslack Cleantheinstrumentsurface weldingregion andtubeholdersfromanyliquid spillageaftertubeweldingoperation Performsafetychecksoninstrumentandsurr...

Page 70: ...ection 6 5 Replacement of fuses on page 82formoreinformation Itisrecommendedtoservicetheinstrumenteverysixmonthsincludingcleaning FunctionalvalidationorCalibration retestandsafetycheck ContactServicef...

Page 71: ...heTubeRestrictorsasapartoftheroutinemaintenanceof HotLipsTubeSealer Formoreinformationaboutinspectingthequalityoftheseal seeInspect seal quality on page 59 Toolsrequired Torx wrenchesT8andT10 Needleno...

Page 72: ...sen or fasten them RemovetheTubeRestrictors FollowthestepsbelowtoremovetheTubeRestrictors Step Action 1 Switchonthepowertothe HotLipsTubeSealer bypressingthepower switchtothe I position andwaitforthei...

Page 73: ...otblockthe topTubeRestrictor andpulloutthetopTubeRestrictor SlightlyloosenHexpanheadscrew2usingaT10Torxwrench 6 Maintenance 6 4 Maintenanceof HotLipsTubeSealer 6 4 1 TubeRestrictorreplacement SterileT...

Page 74: ...inapositionwhereitdoesnotblockthe newtopTubeRestrictor andinsertthenewtopTubeRestrictor 3 FastenHexpanheadscrew1usingaT8Torxwrench TightenHexpanheadscrew2usingaT10Torxwrench 4 Switchonthepowertotheuni...

Page 75: ...lvalidationfails theoperatororserviceengineermanuallytriggersthecali brationroutine Safetyprecautions WARNING Pinchhazardwhenusing HotLipsTubeSealer Thejawsare movingduringclampingandcalibration Keepa...

Page 76: ...ttontoperformthe Functionalverificationgauge validationtest 4 WhenINSERTGAUGEANDPRESSENTERisshownontheLCDdisplay insertthe Functionalverificationgauge andpresstheEnterbutton 6 Maintenance 6 4 Maintena...

Page 77: ...l verificationgauge passesthroughthe jaws presstheCursordownbutton Result ThedisplayshowsCALIBRATIONFAIL Calibratetomakesurethatjawsarewithinthe specifiedtolerance Calibration Followthestepsbelowtocal...

Page 78: ...ws fromclosingcompletelyagainsteachother asshownintheillustration below 3 WhileholdingdowntheGObutton switchthepowerswitchtothe I posi tion 4 ReleasetheGObuttonwhentheLCDdisplayshowsREADYTOCAL 6 Maint...

Page 79: ...ing to calibrate again Thejawswillclosetoapproximately5mmapartandthenstartmoving togetherslowly TheLCDshowstheincrementedpositioncountinforma tion Whenthejawstouch thezerocalibrationiscomplete andthej...

Page 80: ...ntheLCDdisplay insertthe Functionalverificationgauge asshownandpresstheEnter button 6 Maintenance 6 4 Maintenanceof HotLipsTubeSealer 6 4 2 Functionalvalidationandcalibration 80 SterileTubeFuser Dryan...

Page 81: ...AIL endofthe Functional verificationgauge passesthroughthe jaws presstheCursordownbutton Result ThedisplayshowsCALIBRATIONFAIL ContactServiceformoreinformation RefertoSection 6 4 1 Tube Restrictor rep...

Page 82: ...ectionfromfirehazard replaceonlywithsame typeandratingoffuse RefertoSection 8 1 Specifications on page 94forfusespecification Instructions Followthestepsbelowtoreplacethefuses Step Action 1 Disconnect...

Page 83: ...n 6 Connectthepowercord 7 Switchonthepowertotheinstrumentbypressingthepowerswitchtothe I position 6 Maintenance 6 5 Replacementoffuses SterileTubeFuser DryandHotLipsTubeSealerOperatingInstructions2896...

Page 84: ...and HotLipsTubeSealer havefragile items Makesurethat SterileTubeFuser Dry and HotLipsTube Sealer arealwaysinuprightpositionduringtransport movement andstorage Alsomakesurenoweightiskeptontheinstrument...

Page 85: ...urwhenoperatingtheproduct Ifthesuggestedactionsinthisguidedonotsolvetheproblem oriftheproblemisnot coveredbythisguide contactyour Cytiva representativeforadvice Inthischapter Section Seepage 7 1 Steri...

Page 86: ...andfirmlyseatedintheinstrument Checktheholdercodeplateattachedtothe bottomoftheleft blue holder Theinstrumentdoesnot recognizethatthetubingis inserted Makesureyouareusingthecorrecttubing O D forthehol...

Page 87: ...orrecttubingtype Tryusinganewcuttingblade Iftheinstrumentstilldoesnotperformprop erly contactService Automaticerrorchecking The SterileTubeFuser Dry isdesignedtomonitorallaspectsofitsoperation Ifastep...

Page 88: ...ingdamage totheequipment Error13canbeuserconfirmedifnecessary ErrorNo Message Possiblecause Correctiveaction ERROR1 INITIALIZATION FAIL Theinstrumentwasnot abletoinitializethemotors andheatingsystemwi...

Page 89: ...instrumentandfollowthe displaymessages Ifthemotorfailstomove contactService ERROR7 ALIGNMOTOR FAIL Thealignoperationfailedto alignthecuttubesinthe specifiedtime Switchoffthepowertothe instrument Swit...

Page 90: ...sareremoved andthatnothingisobstructing themovementofthemotors ERROR13 REMOVETUBES Theinstrumentwas poweredupwithtubesstill insertedintheholders Removealltubesandrestartthe instrument N A ERFF Timeout...

Page 91: ...byclickingonthe MENUbuttonandco relatingthe tubeinsertedtotheselected tubing Checkthatyouareusingthe correcttubing Checkthattubingiscenteredinthe jaws Performmechanicalassemblycali brationaccordingto...

Page 92: ...othenextstepoftheoper ation Step Instrumentchecks Initialization Checkthatcomponentshavethecorrectposi tioning Clamptubing CheckthattheGObuttonispresseduntilthe jawsreachthefinalposition Heattubing Ch...

Page 93: ...hischapter Section Seepage 8 1 Specifications 94 8 2 Compatibletubingfor SterileTubeFuser Dry 95 8 3 Compatibletubingfor HotLipsTubeSealer 97 8 4 Bladecontactmaterialsfor SterileTubeFuser Dry 99 8 5 O...

Page 94: ...0 C Relativehumiditytolerance 20 to80 non condensing HotLipsTubeSealer Parameter Value Supplyvoltage 100 240V Maximumvoltagefluctuation 10 fromthenominalvoltage Frequency 50 60Hz Maximumpower 350VA Fu...

Page 95: ...types Tubingdimension I D xO D ininches Dataver 4 03Date 09 11 Tubing brand 1 8 x 1 4 3 1 6x 5 1 6 3 1 6x 3 8 1 4 x 3 8 1 4 x 7 1 6 5 1 6x 7 1 6 1 4 x 1 2 3 8 x 1 2 7 1 6x 9 1 6 3 8 x 5 8 1 2 x 3 4 5...

Page 96: ...47 Updatetubingtypes ToreplacethefactoryloadedtubingtypesortoaddtheReadyToProcesstubesizes refertotheSterile Tube Fuser Dry and Hot Lips Tube Sealer Tube Data Management Tool User Manualthatissupplied...

Page 97: ...nsion I D xO D ininches Dataver 0809Date 09 11 Tubing brand 1 8x 1 4 3 16 x 5 16 3 16 x 3 8 1 4x 3 8 1 4x 7 16 5 16 x 7 16 1 4x 1 2 3 8x 1 2 3 8x 5 8 1 2x 3 4 5 8x 7 8 3 4x 9 8 3 4x 5 4 Bioprene C Fle...

Page 98: ...dtheReadyToProcesstubesizes refertotheSterile Tube Fuser Dry and Hot Lips Tube Sealer Tube Data Management Tool User Manual thatissuppliedwithaninstalla tionkit availableuponrequest 8 Referenceinforma...

Page 99: ...mearing Theinertnature ofthecoatingalsoeliminatesanypotentialcontamination Theblack reflection freecoatingalsoimprovestheinfra redemissivityoftheblade makingitpossibletoaccuratelyestimatebladetemperat...

Page 100: ...nformationandforinformationaboutsparepartsand accessories visit cytiva com bioprocess orcontactyourlocal Cytiva representative 8 Referenceinformation 8 5 Orderinginformation 100 SterileTubeFuser Dryan...

Page 101: ...aterialsmustbeseparatedand recycledaccordingtonationalandlocalenvironmentalregulations Recyclingofhazardoussubstances Theproductcontainshazardoussubstances Detailedinformationisavailablefrom your Cyti...

Page 102: ...3 8 7 2 EuropeanUnionandEuropeanEconomicArea 104 8 7 3 EurasianEconomicUnion 105 8 7 4 RegulationsforNorthAmerica 107 8 7 5 Regulatorystatements 108 8 7 6 Otherregulationsandstandards 109 8 7 7 Declar...

Page 103: ...information Thetablebelowsummarizestherequiredmanufacturinginformation Requirement Information Nameandaddressofmanufacturer CytivaSwedenAB Bj rkgatan30 SE75184Uppsala Sweden Telephonenumberofmanufactu...

Page 104: ...ththeproduct acopyoftheEUDeclarationofConformityisavailable onrequest CEmarking TheCEmarkingandthecorrespondingEUDeclarationofConformityisvalidforthe instrumentwhenitis usedaccordingtotheOperating Ins...

Page 105: ...essummaryinformationaboutthemanufacturerand importer inaccordancewiththerequirementsoftheTechnicalRegulationsofthe CustomsUnionand or theEurasianEconomicUnion Requirement Information Name addressandte...

Page 106: ...el ThisEurasiancompliancemarkindicatesthattheproductis approvedforuseonthemarketsoftheMemberStatesofthe CustomsUnionoftheEurasianEconomicUnion 8 Referenceinformation 8 7 Regulatoryinformation 8 7 3 Eu...

Page 107: ...nt ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaClassAdigital device pursuanttopart15oftheFCCRules Theselimitsaredesignedtoprovide reasonableprotectionagainstharmfulinterferencewhentheeq...

Page 108: ...adioreceptionin suchenvironments SouthKorea RegulatoryinformationtocomplywiththeKoreantechnicalregulations NOTICE ClassAequipment equipmentforbusinessuse Thisequipmenthasbeenevaluatedforitssuitability...

Page 109: ...rovidedinthedocumentation packagedeliveredwitheachequipment Regulatorycomplianceofconnected equipment AnyequipmentconnectedtoSterileTubeFuser Dry and HotLipsTubeSealermust meetthesafetyrequirementsofI...

Page 110: ...ndernormal operatingconditionssothattheuseofsuchelectricalandelectronicproductswillnotresultin anysevereenvironmentalpollution anybodilyinjuryordamagetoanyassets Theunitofthe periodis Year Inordertoma...

Page 111: ...nallofthehomogeneous materialsforthispartisbelowthelimitrequirementinGB T26572 X Indicatesthatthishazardoussubstancecontainedinatleastoneofthe homogeneousmaterialsusedforthispartisabovethelimitrequire...

Page 112: ...service repair or installation In some cases this may require customer to move equipment from normal operating location prior to Cytiva arrival Consumables such as columns or gels have been removed or...

Page 113: ...taminatedprior to service return Provide a telephone number where Cytiva can contact you for additional information concerning the system equipment Telephone No Liquid and or gas in equipment is Water...

Page 114: ...91 Cleaning 68 Controlpanel 54 Dangerzone 27 Illustration 32 Maintenance 71 Sealingtubes 59 Troubleshooting 91 I Illustrations 30 32 HotLipsTubeSealer 32 SterileTubeFuser Dry 30 Importantuserinformati...

Page 115: ...rials 99 Cleaning 65 COVERLOCK 42 Dangerzone 27 Fusingtubes 47 Illustration 30 Maintenance 69 Schematicoperation 44 Troubleshooting 86 Storage 84 Systemoperation precautions 14 T Transport 37 Troubles...

Page 116: ...arksofSaint GobainPerformancePlasticsCorporation BiopreneisatrademarkofTechneoproLtd Torxisatrademarkof AcumentIntellectualProperties LLC Allotherthird partytrademarksarethepropertyoftheirrespectiveow...

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