Sterile Tube Fuser - Wet
Operating Instructions
Original instructions
cytiva.com
Page 1: ...Sterile Tube Fuser Wet Operating Instructions Original instructions cytiva com...
Page 2: ...ation 36 5 1 Overview 39 5 2 Coverlock 42 5 3 Fusingtubes 43 5 4 Changingtubingholder 51 5 5 Inspectingweldquality 52 5 6 UpdatingtheTubingDatabase 54 6 Maintenance 55 6 1 Cleaningbeforeplannedservice...
Page 3: ...rNorth America 80 8 6 5 Regulatorystatements 81 8 6 6 DeclarationofHazardousSubstances DoHS 82 8 6 7 Otherregulationsandstandards 84 8 7 HealthandSafetyDeclarationForm 85 Index 87 TableofContents Ster...
Page 4: ...nformationabouttheSterileTubeFuser Wet instrument andlistsofassociateddocumentation Inthischapter Section Seepage 1 1 Aboutthismanual 5 1 2 Importantuserinformation 6 1 3 Associateddocumentation 8 1 I...
Page 5: ...bybolditalictext Hardwareitemsareidentifiedinthetextbyboldtext Inelectronicformat referencesinitalicsareclickablehyperlinks Illustrations Theimagesandannotationsinthisdocumentareforillustrativepurpose...
Page 6: ...Wet shallnotbeusedinanyclinicalprocedures orfordiagnostic purposes Prerequisites Inordertooperate SterileTubeFuser Wet inthewayitisintended Theusermustbeacquaintedwiththeuseofgenerallaboratoryequipme...
Page 7: ...indicatesinstructionsthatmustbefollowedtoavoid damagetotheproductorotherequipment Notesandtips Note A note is used to indicate information that is important for trouble free and optimal use of the pro...
Page 8: ...e SterileTubeFuser Wet instrumentis suppliedwithanOperatorManual Document Contents Sterile Tube Fuser Wet Operator Manual suppliedwith SterileTube Fuser Wet Howtousethesystem including concepts method...
Page 9: ...cedures Inthischapter Section Seepage 2 1 Safetyprecautions 10 2 2 Symbolsandabbreviations 20 2 3 Emergencyprocedures 23 2 4 Dangerzone 25 Important WARNING Beforeinstalling operatingormaintainingthep...
Page 10: ...emoperation Maintenance Generalprecautions WARNING Riskassessment Performariskassessmentforanyrisksdueto theprocessorprocessenvironment Evaluatetheeffectstheuseof theproductandtheoperationalprocessesm...
Page 11: ...ower cordandcontactService WARNING Donotoperatetheproductinanyotherwaythandescribedinthe userdocumentation WARNING Operationandusermaintenanceof SterileTubeFuser Wet shouldbeperformedbyproperlytrained...
Page 12: ...g installation operation inspection maintenanceandcleaningof SterileTubeFuser Wet WARNING Spreadofbiologicalagents Theoperatormusttakeallneces saryactionstoavoidspreadinghazardousbiologicalagents The...
Page 13: ...displaced upstreamordownstreamofweldandthensecureexternalclamps orplugs Usingflammableliquids WARNING SterileTubeFuser Wet isnotdesignedtohandleflammable liquids WARNING SterileTubeFuser Wet isnotappr...
Page 14: ...emovingthe unit CAUTION SterileTubeFuser Wet hasfragileitems Makesure SterileTube Fuser Wet isalwaysinuprightpositionduringtransport move mentandstorage Alsomakesurenoweightiskeptontheinstru mentorins...
Page 15: ...WARNING Removeexternalclampsonlyafterconfirmingagoodweldjoint WARNING Insetupmodeof SterileTubeFuser Wet withtheProgramming lockkeyhorizontal theinstrumentcanberunwithcoveropen The bladeposesaburnhaza...
Page 16: ...ercleaningagentdependingonthehazard leveloftheprocesschemicals biologicalsbeingusedand continuewithtubeweldingprocess WARNING Theblademustbeproperlypusheddownintoitsbladeholdersto enablethetemperature...
Page 17: ...in lesssteel Itdoesnothaveasharpenededgebutcancausecutsif handledimproperly Besuretoreadandunderstandtheprocedure forinstallingandremovingtheblade CAUTION Visuallyinspecttheweldjointforanyleakagebefor...
Page 18: ...entestedfor SterileTubeFuser Wet referto Section 8 2 Compatible tubing for on page 71 Maintenance WARNING Electricalshockhazard Allrepairsshouldbedonebyservice personnelauthorizedby Cytiva Donotopenan...
Page 19: ...nlywithsame typeandratingoffuse RefertoSection 8 1 Specifications on page 70forfusespecification CAUTION Changethebladeaftereverycuttoavoidsterilityissues 2 Safetyinstructions 2 1 Safetyprecautions St...
Page 20: ...r Serialno Instrumentserialnumber MfgYear Year YYYY andmonth MM ofmanufacture Voltage Frequency MaxPower MaxCurrent Fuse Electricalrequirements Voltage VAC Frequency Hz Max power VA Max current A Fuse...
Page 21: ...XTM Sample Code no XXXXXXXX Serial no XXXXXXX Mfg Year 2014 Voltage IXI XXX XXX XXX VAC Frequency XX XX Hz Max Power XXX VA Fuse XX X XXAL 250 V Made in Sweden Protection Class XXXX Conforms to ANSI U...
Page 22: ...ing Readtheuserdocumentationbeforeusingthe system Donotopenanycoversorreplacepartsunless specificallystatedintheuserdocumentation Indicatesahotsurfaceandthatcaremustbeexercisedto preventinjury Indicat...
Page 23: ...hecoverlock Donottouchthebladeforapproximatelyoneminutetillitcools down Ifthereisliquidspillageduetopoorweldornoweld cleanthe spillageusingpropercleaningagentdependingonthehazard leveloftheprocesschem...
Page 24: ...on Class XXXX Conforms to ANSI UL Std 61010 1 Cert to CAN CSA Std C22 2 No 61010 1 4001767 Powerfailure Ifthepowerto SterileTubeFuser Wet failsduringtheweldingoperation thetubes maynotbecompletelyweld...
Page 25: ...Thisdanger zoneshouldbekeptclearofobstructionsduringoperation WARNING Hotsurfacesof SterileTubeFuser Wet Thecuttingblade reaches400 Cduringtheheatingcycle Donottrytoopenthe protectivecoverduringthewe...
Page 26: ...Itisusefulforconnectingtubingbetweenprocesscontainersand equipment Theunitisdesignedtoconnectlargediameterliquidfilledtubing enabling highflowratesandlargetransfervolumes Majorusesareinbioprocessingan...
Page 27: ...ton 6 CoverorLid Tubingholders Theillustrationbelowshowstheholdersusedin SterileTubeFuser Wet instrument 1 2 3 4 Part Function 1 Tophandle 2 Knob 3 Upperholderbody 4 Placeforinsertingexternalclamps 3...
Page 28: ...rileTubeFuser Wet PTFEcoatedcuttingblades Theillustrationbelowshowsthebladeusedin SterileTubeFuser Wet instrument Rearpanel Theillustrationbelowshowstherearpanelof SterileTubeFuser Wet 3 Instrumentdes...
Page 29: ...ntsreportsdisplayingtheUnitID ProgramVersion TubedataVersion thetubetypeandO D ofthetubingused andthecurrentweldnumberalongwith otherrelevantparametersrelatedtotheweldingconditionsoftheparticularweld...
Page 30: ...4 4 Electricalconnections 34 4 5 Connectingtheprinterto SterileTubeFuser Wet optional 35 Safetyprecautions WARNING Thecustomermustmakesurethatallinstallation maintenance operationandinspectioniscarri...
Page 31: ...sing Altitude Maximum2000m Pollutiondegree 2 Makesurethattheairflowtotheinstrument sventilationfansisnotblocked Theinstrumentshouldnotbeexposedtosourcesofheat suchasdirectsunlight Dustintheatmospheres...
Page 32: ...talltubing hosesandexternalcablesbeforemovingthe unit CAUTION SterileTubeFuser Wet hasfragileitems Makesure SterileTube Fuser Wet isalwaysinuprightpositionduringtransport move mentandstorage Alsomakes...
Page 33: ...acktheinstrument Step Action 1 Removetheinstrumentfromtheshippingcontainerusingthelifting handlessituatedontheinstrument 2 Removeanytapeandpackagingmaterialfromtheinstrument 3 Checktheequipmentforanya...
Page 34: ...ts on page 31formore information WARNING Protectiveground Theproductmustalwaysbeconnectedtoa groundedpoweroutlet Tubeholderinstallation TheTubingholderscanbequicklyinstalledtoconnectdifferentdiametert...
Page 35: ...1 ConnecttheprinterACadaptertoa100to240V 50or60Hzpowersupply andtotheprinter 2 ConnectthesuppliedcommunicationcabletotheprinterDB 25connector andthe SterileTubeFuser Wet printerconnector 4 Installatio...
Page 36: ...hecustomermustmakesurethatallinstallation maintenance operationandinspectioniscarriedoutbyqualifiedpersonnelwho areadequatelytrained understandandadheretolocalregulations andtheoperatinginstructions a...
Page 37: ...WARNING Incaseofpowerfailureandinstrumentreset SterileTubeFuser Wet unlocksthecoverlock Donottouchthebladeforapproximatelyoneminutetillitcools down Ifthereisliquidspillageduetopoorweldornoweld cleant...
Page 38: ...heinstrumenttooperate Thecover interlockwillonlyallowittobeopenedwhenitissafe Thecover lockbuttonpopsouttoindicatethatthecoverisreleasedandcan beopened NOTICE OnlyusePTFEcoatedcuttingblades BLADES IR...
Page 39: ...e Prior to use make a few trial welds and examine them If the sample welds are not acceptable contact Cytiva Service Schematicoperation Thetablebelowdescribesatypicalworkflowfortubeweldingwith Sterile...
Page 40: ...blade 4 Thetubingholdersslidethecuttubingintoalignment Thehotcutting bladeisheldagainstthecuttubingtoensuresterility E indicatesthe partofthetubetobediscarded E E 5 Theblademovesupandthetubingendsaref...
Page 41: ...Stage Description 6 Theconnectedtubingisremovedandtheusedcuttingbladeandcut tubingendsarediscarded 5 Operation 5 1 Overview SterileTubeFuser WetOperatingInstructions29024010AD 41...
Page 42: ...lidis down locked up unlocked Tolockthecover pressandholdthecoverlockbuttonforafewsecondsuntilyouhear aclicksound NOTICE Makesurethatthecoverlockbuttonisdownduringthewelding andaligningoperation Cover...
Page 43: ...tion Result Thedisplayscreenshowsthesoftwareintializingandpromptstheuserto closethecoverofthe SterileTubeFuser Wet instrument 2 Pressandholdthecoverlockbuttonforafewsecondsuntilyouhearaclick Closethec...
Page 44: ...aligned Tightenthecaptivescrewasshownbelow Holdersarecodedsothattheinstrumentautomaticallyreadstheholder typeandselectstheappropriateprogram Result Theinstrumentdetectstheholderandthedisplaymessageind...
Page 45: ...ththedesireddimension Thetubingdimensionis thenautomaticallyenteredintheinstrument Tochangeatubingholder seeChanging tubing holders on page 51 Insertacuttingblade Followtheinstructionsbelowtoinsertacu...
Page 46: ...tton for locationseeChapter 3 Instrument description on page 26 Onceyoupressthecoverlockbutton thebladeautomaticallyretractsinto theinstrument 5 Waitforthecoverlocktorelease Result ThedisplayshowstheI...
Page 47: ...tfullyopen Seetotheimagebelow Open theupperholderbodyandturntheupperholderbody90degrees 4 Placethefluid filledtubesfirmlyintheholders Thetubingendsmust protrudeoutbeyondeachholder RefertoSchematic ope...
Page 48: ...he tube holders 12 Closethecover 13 Pressandholdthecoverlockbuttonforafewsecondstostarttheprogram Result Theinstrumentstartstoweldthetube Removefusedtubingandturnoffthe instrument Followtheinstruction...
Page 49: ...unblock the internal joint Note Inspect the weld carefully before use See Inspecting weld quality on page 52 9 Discardthecutends Note During the cutting operation and while removing discarded tubes s...
Page 50: ...ssthecoverlockbuttontocontinuewiththenext tubeweldingcycle Result ThedisplayshowsINSERTBLADEonthescreen Startatstep1ofInsert a cutting blade on page 45 5 Operation 5 3 Fusingtubes 50 SterileTubeFuser...
Page 51: ...adsthetubing holdertypeandselectstheappropriateprogram Followthestepsbelowtoremoveandinstallthenewholders Step Action 1 Opentheinstrument scover 2 Opentheexistingholderandlocatethecaptivescrew 3 Loose...
Page 52: ...spection Makesurethatthetubingsdonotcomeapartor starttocrack Note If fused tubes have been found joined internally press the joint with two fingers and twist gently to unblock the internal joint Then...
Page 53: ...ubingsizeandformulationareused Insertanewblade Makesurethattheholdersareclosedandproperlylatched Ifyouareunabletogetauniformflange contactServiceforhelp Goodtensilestrength Makesurethatthetubesareprop...
Page 54: ...eand size Theseincludetemperature positioningdataandsequencetiming Contact Cytiva ifyouneedtoupdatetheTubingDatabase NOTICE Improperuseoftubedatamaycausedamagetotheunitandisnot coveredunderthewarranty...
Page 55: ...eaning 57 6 3 Regularmaintenance 60 6 4 Replacementoffuses 61 6 5 Storage 63 Safetyprecautions WARNING Hazardoussubstances Whenusinghazardouschemicaland biologicalagents takeallsuitableprotectivemeasu...
Page 56: ...ealth and Safety Declaration FormortheHealth and Safety Declaration Form for Product Return or Servicing dependingonwhethertheinstrumentisgoingtobeservicedonsiteorreturnedfor service respectively Heal...
Page 57: ...ocleantheinstrument holdersandclampsdependingonthehazardleveloftheprocesschemicals biological beingused Step Action 1 Switchofftheinstrumentanddisconnectthepowercord beforeinitiating thecleaningproces...
Page 58: ...Cleanthepolycarbonatelidwith40 ethanolor40 isopropanol Dangerzone ThedangerzoneunderthecoverseeSection 2 4 Danger zone on page 25canbe cleanedperiodically usingasmallhandheldvacuumcleaner Anyspillagec...
Page 59: ...6 Maintenance 6 2 Cleaning SterileTubeFuser WetOperatingInstructions29024010AD 59...
Page 60: ...lderisintact Tightenthecaptivescrew iftheinstalledtubeholdersarefoundtobeslack Cleantheinstrumentsurface weldingregion andtubeholdersfromanyliquid spillageaftertubeweldingoperation Performsafetychecks...
Page 61: ...tinuedprotectionfromfirehazard replaceonlywithsame typeandratingoffuse RefertoSection 8 1 Specifications on page 70forfusespecification Instructions Followthestepsbelowtoreplacethefuses Step Action 1...
Page 62: ...Step Action 6 Connectthepowercord 7 Switchonthepowertotheinstrumentbypressingthepowerswitchtothe I position 6 Maintenance 6 4 Replacementoffuses 62 SterileTubeFuser WetOperatingInstructions29024010AD...
Page 63: ...tions CAUTION SterileTubeFuser Wet hasfragileitems Makesure SterileTube Fuser Wet isalwaysinuprightpositionduringtransport move mentandstorage Alsomakesurenoweightiskeptontheinstru mentorinstrumentpac...
Page 64: ...uses on page 61forinstruc tionsonhowtoreplacefuses Ifproblempersists contactService Theinstrumentdoesnot recognizethattheholdersare installed Tightenthecaptivescrew ifinstalledtube holdersarefoundtobe...
Page 65: ...tertube Makesuretheholdersarelockedincorrectly withthecaptivescrew Checkthatthetubingisofthecorrectsize Checkthattheinstrumentissettothe correcttubingtype Tryusinganewcuttingblade Iftheinstrumentstill...
Page 66: ...cannotbeconfirmedwithoutcausingdamage totheequipment Error13canbeuserconfirmedifnecessary ErrorNo Message Possiblecause Correctiveaction ERROR1 INITIALIZATION FAIL Theinstrumentwasnot abletoinitialize...
Page 67: ...Switchonthepowertothe instrumentandfollowthe displaymessages Ifthemotorfailstomove contactService ERROR7 ALIGNMOTOR FAIL Thealignoperationfailedto alignthecuttubesinthe specifiedtime Switchoffthepowe...
Page 68: ...eckthatalltubesareremoved andthatnothingisobstructing themovementofthemotors ERROR13 REMOVETUBES Theinstrumentwas poweredupwithtubesstill insertedintheholders Removealltubesandcycle poweroff ontoresta...
Page 69: ...Inthischapter Section Seepage 8 1 Specifications 70 8 2 Compatibletubingfor 71 8 3 Bladecontactmaterials 72 8 4 Furtherinformation 73 8 5 Recyclinginformation 74 8 6 Regulatoryinformation 75 8 7 Healt...
Page 70: ...Maximumcurrent 3 3A Fusespecification 2xT4 0AL250V Dimensions W D H 395 370 265mm Weight 16kg Acousticnoiselevel 70dBA Operatingtemperature 2 Cto35 C Storagetemperature 2 Cto35 C Relativehumiditytole...
Page 71: ...rands Thetestedtubingbrandsarelistedinthetablebelow Tubingdimension I D xO D ininches Dataver 1 0Date 09 11 Tubingbrand 1 8x1 4 1 4x7 16 C Flex 0821 1 Factoryloadedtubingtypes Note The tubing brand na...
Page 72: ...nminimalsmearing Theinertnature ofthecoatingalsoeliminatesanypotentialcontamination Theblack reflection freecoatingalsoimprovestheinfra redemissivityoftheblade makingitpossibletoaccuratelyestimateblad...
Page 73: ...onorderinginformationandforinformationaboutsparepartsand accessories visit cytiva com bioprocess orcontactyourlocal Cytiva representative 8 Referenceinformation 8 4 Furtherinformation SterileTubeFuser...
Page 74: ...recycledaccordingtonationalandlocalenvironmentalregulations Recyclingofhazardoussubstances SterileTubeFuser Wet containshazardoussubstances Detailedinformationisavail ablefromyour Cytiva representativ...
Page 75: ...information 76 8 6 2 EuropeanUnionandEuropeanEconomicArea 77 8 6 3 EurasianEconomicUnion 78 8 6 4 RegulationsforNorthAmerica 80 8 6 5 Regulatorystatements 81 8 6 6 DeclarationofHazardousSubstances DoH...
Page 76: ...ufacturinginformation Thetablebelowsummarizestherequiredmanufacturinginformation Requirement Information Nameandaddressofmanufacturer CytivaSwedenAB Bj rkgatan30 SE75184Uppsala Sweden Telephonenumbero...
Page 77: ...includedwiththeproduct acopyoftheEUDeclarationofConformityisavailable onrequest CEmarking TheCEmarkingandthecorrespondingEUDeclarationofConformityisvalidforthe instrumentwhenitis usedaccordingtotheOpe...
Page 78: ...tableprovidessummaryinformationaboutthemanufacturerand importer inaccordancewiththerequirementsoftheTechnicalRegulationsofthe CustomsUnionand or theEurasianEconomicUnion Requirement Information Name a...
Page 79: ...system label ThisEurasiancompliancemarkindicatesthattheproductis approvedforuseonthemarketsoftheMemberStatesofthe CustomsUnionoftheEurasianEconomicUnion 8 Referenceinformation 8 6 Regulatoryinformatio...
Page 80: ...e equip ment ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaClassAdigital device pursuanttopart15oftheFCCRules Theselimitsaredesignedtoprovide reasonableprotectionagainstharmfulinterferenc...
Page 81: ...otectiontoradioreceptionin suchenvironments SouthKorea RegulatoryinformationtocomplywiththeKoreantechnicalregulations NOTICE ClassAequipment equipmentforbusinessuse Thisequipmenthasbeenevaluatedforits...
Page 82: ...kormutateundernormal operatingconditionssothattheuseofsuchelectricalandelectronicproductswillnotresultin anysevereenvironmentalpollution anybodilyinjuryordamagetoanyassets Theunitofthe periodis Year I...
Page 83: ...nallofthehomogeneous materialsforthispartisbelowthelimitrequirementinGB T26572 X Indicatesthatthishazardoussubstancecontainedinatleastoneofthe homogeneousmaterialsusedforthispartisabovethelimitrequire...
Page 84: ...ficationinformationprovidedinthedocumentation packagedeliveredwitheachequipment Regulatorycomplianceofconnected equipment Anyequipmentconnectedto SterileTubeFuser Wet mustmeetthesafetyrequire mentsofI...
Page 85: ...nstrument 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...
Page 86: ...st be decontaminatedprior 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 equipme...
Page 87: ...nditions 31 Environmentalrequirements 31 Errormessages 66 F FCCcompliance 80 Fuses replacement 61 Fusingtubes 43 G Generalprecautions 10 I Illustrations 26 28 SterileTubeFuser Wet 26 28 Importantuseri...
Page 88: ...SterileTubeFuser Wet 25 28 39 43 57 60 64 65 71 72 Bladecontactmaterials 72 Cleaning 57 Compatibletubing 71 COVERLOCK 42 Dangerzone 25 Fusingtubes 43 Illustration 26 28 Maintenance 60 Schematicoperati...
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Page 90: ...ird partytrademarksarethepropertyoftheirrespectiveowners 2020 Cytiva AllgoodsandservicesaresoldsubjecttothetermsandconditionsofsaleofthesupplyingcompanyoperatingwithintheCytiva business Acopyofthosete...
