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1.1

About this manual

Purpose of this manual

The Operating Instructions provide you with the instructions needed to handle Sterile
Tube Fuser - Wet in a safe way.

Typographical conventions

Software items are identified in the text by

bold italic text.

Hardware items are identified in the text by

bold text.

In electronic format, references in italics are clickable hyperlinks.

Illustrations

The images and annotations in this document are for illustrative purposes only. The
configuration of individual products may vary, and therefore illustrations may not
reflect the actual system delivered.

1 Introduction

1.1 About this manual

Sterile Tube Fuser - Wet Operating Instructions 29024010 AD

Содержание Sterile Tube Fuser - Wet

Страница 1: ...Sterile Tube Fuser Wet Operating Instructions Original instructions cytiva com...

Страница 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...

Страница 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...

Страница 4: ...nformationabouttheSterileTubeFuser Wet instrument andlistsofassociateddocumentation Inthischapter Section Seepage 1 1 Aboutthismanual 5 1 2 Importantuserinformation 6 1 3 Associateddocumentation 8 1 I...

Страница 5: ...bybolditalictext Hardwareitemsareidentifiedinthetextbyboldtext Inelectronicformat referencesinitalicsareclickablehyperlinks Illustrations Theimagesandannotationsinthisdocumentareforillustrativepurpose...

Страница 6: ...Wet shallnotbeusedinanyclinicalprocedures orfordiagnostic purposes Prerequisites Inordertooperate SterileTubeFuser Wet inthewayitisintended Theusermustbeacquaintedwiththeuseofgenerallaboratoryequipme...

Страница 7: ...indicatesinstructionsthatmustbefollowedtoavoid damagetotheproductorotherequipment Notesandtips Note A note is used to indicate information that is important for trouble free and optimal use of the pro...

Страница 8: ...e SterileTubeFuser Wet instrumentis suppliedwithanOperatorManual Document Contents Sterile Tube Fuser Wet Operator Manual suppliedwith SterileTube Fuser Wet Howtousethesystem including concepts method...

Страница 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...

Страница 10: ...emoperation Maintenance Generalprecautions WARNING Riskassessment Performariskassessmentforanyrisksdueto theprocessorprocessenvironment Evaluatetheeffectstheuseof theproductandtheoperationalprocessesm...

Страница 11: ...ower cordandcontactService WARNING Donotoperatetheproductinanyotherwaythandescribedinthe userdocumentation WARNING Operationandusermaintenanceof SterileTubeFuser Wet shouldbeperformedbyproperlytrained...

Страница 12: ...g installation operation inspection maintenanceandcleaningof SterileTubeFuser Wet WARNING Spreadofbiologicalagents Theoperatormusttakeallneces saryactionstoavoidspreadinghazardousbiologicalagents The...

Страница 13: ...displaced upstreamordownstreamofweldandthensecureexternalclamps orplugs Usingflammableliquids WARNING SterileTubeFuser Wet isnotdesignedtohandleflammable liquids WARNING SterileTubeFuser Wet isnotappr...

Страница 14: ...emovingthe unit CAUTION SterileTubeFuser Wet hasfragileitems Makesure SterileTube Fuser Wet isalwaysinuprightpositionduringtransport move mentandstorage Alsomakesurenoweightiskeptontheinstru mentorins...

Страница 15: ...WARNING Removeexternalclampsonlyafterconfirmingagoodweldjoint WARNING Insetupmodeof SterileTubeFuser Wet withtheProgramming lockkeyhorizontal theinstrumentcanberunwithcoveropen The bladeposesaburnhaza...

Страница 16: ...ercleaningagentdependingonthehazard leveloftheprocesschemicals biologicalsbeingusedand continuewithtubeweldingprocess WARNING Theblademustbeproperlypusheddownintoitsbladeholdersto enablethetemperature...

Страница 17: ...in lesssteel Itdoesnothaveasharpenededgebutcancausecutsif handledimproperly Besuretoreadandunderstandtheprocedure forinstallingandremovingtheblade CAUTION Visuallyinspecttheweldjointforanyleakagebefor...

Страница 18: ...entestedfor SterileTubeFuser Wet referto Section 8 2 Compatible tubing for on page 71 Maintenance WARNING Electricalshockhazard Allrepairsshouldbedonebyservice personnelauthorizedby Cytiva Donotopenan...

Страница 19: ...nlywithsame typeandratingoffuse RefertoSection 8 1 Specifications on page 70forfusespecification CAUTION Changethebladeaftereverycuttoavoidsterilityissues 2 Safetyinstructions 2 1 Safetyprecautions St...

Страница 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...

Страница 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...

Страница 22: ...ing Readtheuserdocumentationbeforeusingthe system Donotopenanycoversorreplacepartsunless specificallystatedintheuserdocumentation Indicatesahotsurfaceandthatcaremustbeexercisedto preventinjury Indicat...

Страница 23: ...hecoverlock Donottouchthebladeforapproximatelyoneminutetillitcools down Ifthereisliquidspillageduetopoorweldornoweld cleanthe spillageusingpropercleaningagentdependingonthehazard leveloftheprocesschem...

Страница 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...

Страница 25: ...Thisdanger zoneshouldbekeptclearofobstructionsduringoperation WARNING Hotsurfacesof SterileTubeFuser Wet Thecuttingblade reaches400 Cduringtheheatingcycle Donottrytoopenthe protectivecoverduringthewe...

Страница 26: ...Itisusefulforconnectingtubingbetweenprocesscontainersand equipment Theunitisdesignedtoconnectlargediameterliquidfilledtubing enabling highflowratesandlargetransfervolumes Majorusesareinbioprocessingan...

Страница 27: ...ton 6 CoverorLid Tubingholders Theillustrationbelowshowstheholdersusedin SterileTubeFuser Wet instrument 1 2 3 4 Part Function 1 Tophandle 2 Knob 3 Upperholderbody 4 Placeforinsertingexternalclamps 3...

Страница 28: ...rileTubeFuser Wet PTFEcoatedcuttingblades Theillustrationbelowshowsthebladeusedin SterileTubeFuser Wet instrument Rearpanel Theillustrationbelowshowstherearpanelof SterileTubeFuser Wet 3 Instrumentdes...

Страница 29: ...ntsreportsdisplayingtheUnitID ProgramVersion TubedataVersion thetubetypeandO D ofthetubingused andthecurrentweldnumberalongwith otherrelevantparametersrelatedtotheweldingconditionsoftheparticularweld...

Страница 30: ...4 4 Electricalconnections 34 4 5 Connectingtheprinterto SterileTubeFuser Wet optional 35 Safetyprecautions WARNING Thecustomermustmakesurethatallinstallation maintenance operationandinspectioniscarri...

Страница 31: ...sing Altitude Maximum2000m Pollutiondegree 2 Makesurethattheairflowtotheinstrument sventilationfansisnotblocked Theinstrumentshouldnotbeexposedtosourcesofheat suchasdirectsunlight Dustintheatmospheres...

Страница 32: ...talltubing hosesandexternalcablesbeforemovingthe unit CAUTION SterileTubeFuser Wet hasfragileitems Makesure SterileTube Fuser Wet isalwaysinuprightpositionduringtransport move mentandstorage Alsomakes...

Страница 33: ...acktheinstrument Step Action 1 Removetheinstrumentfromtheshippingcontainerusingthelifting handlessituatedontheinstrument 2 Removeanytapeandpackagingmaterialfromtheinstrument 3 Checktheequipmentforanya...

Страница 34: ...ts on page 31formore information WARNING Protectiveground Theproductmustalwaysbeconnectedtoa groundedpoweroutlet Tubeholderinstallation TheTubingholderscanbequicklyinstalledtoconnectdifferentdiametert...

Страница 35: ...1 ConnecttheprinterACadaptertoa100to240V 50or60Hzpowersupply andtotheprinter 2 ConnectthesuppliedcommunicationcabletotheprinterDB 25connector andthe SterileTubeFuser Wet printerconnector 4 Installatio...

Страница 36: ...hecustomermustmakesurethatallinstallation maintenance operationandinspectioniscarriedoutbyqualifiedpersonnelwho areadequatelytrained understandandadheretolocalregulations andtheoperatinginstructions a...

Страница 37: ...WARNING Incaseofpowerfailureandinstrumentreset SterileTubeFuser Wet unlocksthecoverlock Donottouchthebladeforapproximatelyoneminutetillitcools down Ifthereisliquidspillageduetopoorweldornoweld cleant...

Страница 38: ...heinstrumenttooperate Thecover interlockwillonlyallowittobeopenedwhenitissafe Thecover lockbuttonpopsouttoindicatethatthecoverisreleasedandcan beopened NOTICE OnlyusePTFEcoatedcuttingblades BLADES IR...

Страница 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...

Страница 40: ...blade 4 Thetubingholdersslidethecuttubingintoalignment Thehotcutting bladeisheldagainstthecuttubingtoensuresterility E indicatesthe partofthetubetobediscarded E E 5 Theblademovesupandthetubingendsaref...

Страница 41: ...Stage Description 6 Theconnectedtubingisremovedandtheusedcuttingbladeandcut tubingendsarediscarded 5 Operation 5 1 Overview SterileTubeFuser WetOperatingInstructions29024010AD 41...

Страница 42: ...lidis down locked up unlocked Tolockthecover pressandholdthecoverlockbuttonforafewsecondsuntilyouhear aclicksound NOTICE Makesurethatthecoverlockbuttonisdownduringthewelding andaligningoperation Cover...

Страница 43: ...tion Result Thedisplayscreenshowsthesoftwareintializingandpromptstheuserto closethecoverofthe SterileTubeFuser Wet instrument 2 Pressandholdthecoverlockbuttonforafewsecondsuntilyouhearaclick Closethec...

Страница 44: ...aligned Tightenthecaptivescrewasshownbelow Holdersarecodedsothattheinstrumentautomaticallyreadstheholder typeandselectstheappropriateprogram Result Theinstrumentdetectstheholderandthedisplaymessageind...

Страница 45: ...ththedesireddimension Thetubingdimensionis thenautomaticallyenteredintheinstrument Tochangeatubingholder seeChanging tubing holders on page 51 Insertacuttingblade Followtheinstructionsbelowtoinsertacu...

Страница 46: ...tton for locationseeChapter 3 Instrument description on page 26 Onceyoupressthecoverlockbutton thebladeautomaticallyretractsinto theinstrument 5 Waitforthecoverlocktorelease Result ThedisplayshowstheI...

Страница 47: ...tfullyopen Seetotheimagebelow Open theupperholderbodyandturntheupperholderbody90degrees 4 Placethefluid filledtubesfirmlyintheholders Thetubingendsmust protrudeoutbeyondeachholder RefertoSchematic ope...

Страница 48: ...he tube holders 12 Closethecover 13 Pressandholdthecoverlockbuttonforafewsecondstostarttheprogram Result Theinstrumentstartstoweldthetube Removefusedtubingandturnoffthe instrument Followtheinstruction...

Страница 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...

Страница 50: ...ssthecoverlockbuttontocontinuewiththenext tubeweldingcycle Result ThedisplayshowsINSERTBLADEonthescreen Startatstep1ofInsert a cutting blade on page 45 5 Operation 5 3 Fusingtubes 50 SterileTubeFuser...

Страница 51: ...adsthetubing holdertypeandselectstheappropriateprogram Followthestepsbelowtoremoveandinstallthenewholders Step Action 1 Opentheinstrument scover 2 Opentheexistingholderandlocatethecaptivescrew 3 Loose...

Страница 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...

Страница 53: ...ubingsizeandformulationareused Insertanewblade Makesurethattheholdersareclosedandproperlylatched Ifyouareunabletogetauniformflange contactServiceforhelp Goodtensilestrength Makesurethatthetubesareprop...

Страница 54: ...eand size Theseincludetemperature positioningdataandsequencetiming Contact Cytiva ifyouneedtoupdatetheTubingDatabase NOTICE Improperuseoftubedatamaycausedamagetotheunitandisnot coveredunderthewarranty...

Страница 55: ...eaning 57 6 3 Regularmaintenance 60 6 4 Replacementoffuses 61 6 5 Storage 63 Safetyprecautions WARNING Hazardoussubstances Whenusinghazardouschemicaland biologicalagents takeallsuitableprotectivemeasu...

Страница 56: ...ealth and Safety Declaration FormortheHealth and Safety Declaration Form for Product Return or Servicing dependingonwhethertheinstrumentisgoingtobeservicedonsiteorreturnedfor service respectively Heal...

Страница 57: ...ocleantheinstrument holdersandclampsdependingonthehazardleveloftheprocesschemicals biological beingused Step Action 1 Switchofftheinstrumentanddisconnectthepowercord beforeinitiating thecleaningproces...

Страница 58: ...Cleanthepolycarbonatelidwith40 ethanolor40 isopropanol Dangerzone ThedangerzoneunderthecoverseeSection 2 4 Danger zone on page 25canbe cleanedperiodically usingasmallhandheldvacuumcleaner Anyspillagec...

Страница 59: ...6 Maintenance 6 2 Cleaning SterileTubeFuser WetOperatingInstructions29024010AD 59...

Страница 60: ...lderisintact Tightenthecaptivescrew iftheinstalledtubeholdersarefoundtobeslack Cleantheinstrumentsurface weldingregion andtubeholdersfromanyliquid spillageaftertubeweldingoperation Performsafetychecks...

Страница 61: ...tinuedprotectionfromfirehazard replaceonlywithsame typeandratingoffuse RefertoSection 8 1 Specifications on page 70forfusespecification Instructions Followthestepsbelowtoreplacethefuses Step Action 1...

Страница 62: ...Step Action 6 Connectthepowercord 7 Switchonthepowertotheinstrumentbypressingthepowerswitchtothe I position 6 Maintenance 6 4 Replacementoffuses 62 SterileTubeFuser WetOperatingInstructions29024010AD...

Страница 63: ...tions CAUTION SterileTubeFuser Wet hasfragileitems Makesure SterileTube Fuser Wet isalwaysinuprightpositionduringtransport move mentandstorage Alsomakesurenoweightiskeptontheinstru mentorinstrumentpac...

Страница 64: ...uses on page 61forinstruc tionsonhowtoreplacefuses Ifproblempersists contactService Theinstrumentdoesnot recognizethattheholdersare installed Tightenthecaptivescrew ifinstalledtube holdersarefoundtobe...

Страница 65: ...tertube Makesuretheholdersarelockedincorrectly withthecaptivescrew Checkthatthetubingisofthecorrectsize Checkthattheinstrumentissettothe correcttubingtype Tryusinganewcuttingblade Iftheinstrumentstill...

Страница 66: ...cannotbeconfirmedwithoutcausingdamage totheequipment Error13canbeuserconfirmedifnecessary ErrorNo Message Possiblecause Correctiveaction ERROR1 INITIALIZATION FAIL Theinstrumentwasnot abletoinitialize...

Страница 67: ...Switchonthepowertothe instrumentandfollowthe displaymessages Ifthemotorfailstomove contactService ERROR7 ALIGNMOTOR FAIL Thealignoperationfailedto alignthecuttubesinthe specifiedtime Switchoffthepowe...

Страница 68: ...eckthatalltubesareremoved andthatnothingisobstructing themovementofthemotors ERROR13 REMOVETUBES Theinstrumentwas poweredupwithtubesstill insertedintheholders Removealltubesandcycle poweroff ontoresta...

Страница 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...

Страница 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...

Страница 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...

Страница 72: ...nminimalsmearing Theinertnature ofthecoatingalsoeliminatesanypotentialcontamination Theblack reflection freecoatingalsoimprovestheinfra redemissivityoftheblade makingitpossibletoaccuratelyestimateblad...

Страница 73: ...onorderinginformationandforinformationaboutsparepartsand accessories visit cytiva com bioprocess orcontactyourlocal Cytiva representative 8 Referenceinformation 8 4 Furtherinformation SterileTubeFuser...

Страница 74: ...recycledaccordingtonationalandlocalenvironmentalregulations Recyclingofhazardoussubstances SterileTubeFuser Wet containshazardoussubstances Detailedinformationisavail ablefromyour Cytiva representativ...

Страница 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...

Страница 76: ...ufacturinginformation Thetablebelowsummarizestherequiredmanufacturinginformation Requirement Information Nameandaddressofmanufacturer CytivaSwedenAB Bj rkgatan30 SE75184Uppsala Sweden Telephonenumbero...

Страница 77: ...includedwiththeproduct acopyoftheEUDeclarationofConformityisavailable onrequest CEmarking TheCEmarkingandthecorrespondingEUDeclarationofConformityisvalidforthe instrumentwhenitis usedaccordingtotheOpe...

Страница 78: ...tableprovidessummaryinformationaboutthemanufacturerand importer inaccordancewiththerequirementsoftheTechnicalRegulationsofthe CustomsUnionand or theEurasianEconomicUnion Requirement Information Name a...

Страница 79: ...system label ThisEurasiancompliancemarkindicatesthattheproductis approvedforuseonthemarketsoftheMemberStatesofthe CustomsUnionoftheEurasianEconomicUnion 8 Referenceinformation 8 6 Regulatoryinformatio...

Страница 80: ...e equip ment ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaClassAdigital device pursuanttopart15oftheFCCRules Theselimitsaredesignedtoprovide reasonableprotectionagainstharmfulinterferenc...

Страница 81: ...otectiontoradioreceptionin suchenvironments SouthKorea RegulatoryinformationtocomplywiththeKoreantechnicalregulations NOTICE ClassAequipment equipmentforbusinessuse Thisequipmenthasbeenevaluatedforits...

Страница 82: ...kormutateundernormal operatingconditionssothattheuseofsuchelectricalandelectronicproductswillnotresultin anysevereenvironmentalpollution anybodilyinjuryordamagetoanyassets Theunitofthe periodis Year I...

Страница 83: ...nallofthehomogeneous materialsforthispartisbelowthelimitrequirementinGB T26572 X Indicatesthatthishazardoussubstancecontainedinatleastoneofthe homogeneousmaterialsusedforthispartisabovethelimitrequire...

Страница 84: ...ficationinformationprovidedinthedocumentation packagedeliveredwitheachequipment Regulatorycomplianceofconnected equipment Anyequipmentconnectedto SterileTubeFuser Wet mustmeetthesafetyrequire mentsofI...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 89: ...Pageintentionallyleftblank...

Страница 90: ...ird partytrademarksarethepropertyoftheirrespectiveowners 2020 Cytiva AllgoodsandservicesaresoldsubjecttothetermsandconditionsofsaleofthesupplyingcompanyoperatingwithintheCytiva business Acopyofthosete...

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