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9.5.1

Contact information

Contact information for support

To find local contact information for support and sending troubleshooting reports,
visit

http://www.gelifesciences.com/contact

Manufacturing information

The table below summarizes the required manufacturing information.

Requirement

Information

Name and address of manufacturer

GE Healthcare Bio-Sciences AB
Björkgatan 30
SE 751 84 Uppsala
Sweden

Telephone number of manufacturer

+ 46 771 400 600

9 Reference information

9.5 Regulatory information
9.5.1 Contact information

158

ÄKTA ready XL Operating Instructions 29281616 AE

*** TeDIS Valid on Date Printed Printed on: 15-09-2023 11:27:35 ***

Содержание AKTA ready XL

Страница 1: ...KTA ready XL Operating Instructions Original instructions gelifesciences com TeDIS Valid on Date Printed Printed on 15 09 2023 11 27 35 185018004599...

Страница 2: ...arts and components 65 3 5 3 Gradient section and components 71 3 6 Processcontrolsoftware 72 4 Installation 76 4 1 Siterequirements 77 4 2 Transportandmovingofthesystem 78 4 3 Setup 86 4 3 1 Assembly...

Страница 3: ...ontact information 158 9 5 2 European Union and European Economic Area 159 9 5 3 Eurasian Economic Union 160 9 5 4 Regulations for USA 162 9 5 5 Regulatory statements 163 9 5 6 Declaration of Hazardou...

Страница 4: ...rmation intendeduseof KTAreadyXL andlistsofassociateddocu mentation In this chapter Section Seepage 1 1 Aboutthismanual 5 1 2 Importantuserinformation 6 1 3 Associateddocumentation 9 1 4 Abbreviations...

Страница 5: ...UNICORN softwareinstructionsareprovidedasexamples Forothercontrol softwareinstructions refertothesoftwaredocumentation Detailedinformationregardingcolumns resinandbuffertanksisnotcovered Illustrations...

Страница 6: ...softwareorothercontrolsoftwares suchas DeltaV Thesystemdesignisbasedonprovenliquidchromatographytechniques suchasion exchange affinitychromatography andhydrophobicinteraction KTAreadyXL isbiocompatib...

Страница 7: ...ces Thisuserdocumentationcontainssafetynotices WARNING CAUTION andNOTICE concerningthesafeuseoftheproduct Seedefinitionsbelow WARNING WARNINGindicatesahazardoussituationwhich ifnotavoided couldresulti...

Страница 8: ...or trouble free and optimal use of the product Tip A tip contains useful information that can improve or optimize your proce dures 1 Introduction 1 2 Importantuserinformation 8 KTAreadyXLOperatingInst...

Страница 9: ...vi ation Purpose Contents PipingandInstrumenta tionDiagram P ID Schematicoverviewoftheprocess flow componentsandinstruments andthecontrolsystem Generalspecification GS Technicaldataforthesystem Assemb...

Страница 10: ...ual 28925644 ReadyToProcess columns Datafile 28915987 Process chromatography A guide to op timization scale up and validation Handbook 18112156 Efficiency test of ReadyToProcess col umns Application n...

Страница 11: ...m Definition CU Controlunit PBS Phosphate bufferedsaline PTFE Polytetrafluoroethylene TC Hygienictubingconnection UPS Uninterruptiblepowersupply XV Pneumaticallyactuatedvalve automaticvalve 1 Introduc...

Страница 12: ...clinginformation In this chapter Section Seepage 2 1 Safetyprecautions 13 2 2 Labels 21 2 3 Emergencyprocedures 24 Important WARNING Beforeinstalling operatingormaintainingtheproduct all usersmustread...

Страница 13: ...ssmentforanyrisksdueto theprocessorprocessenvironment Evaluatetheeffectstheuse oftheproductandtheoperationalprocessesmayhaveonthe classificationofthehazardousarea Theprocessmightcausethe areatoincreas...

Страница 14: ...KOUT TAG OUT LOTO lockout tagout WARNING Onlyauthorizedpersonnelmayopentheelectricalcabinetdoors Thereishighvoltageinsidetheelectricalcabinetthatcancause humaninjuryordeath WARNING Emergencystop Press...

Страница 15: ...RNING PersonalProtectiveEquipment PPE Wheneverpacking un packing transportingormovingthesystem wearprotectivefoot wear preferablywithsteeltoecaps Installing and moving WARNING Theproductmustbeinstalle...

Страница 16: ...ystem CAUTION Beforemoving KTAreadyXL makesurethat 1 Thepowersupplytothesystemisswitchedoff 2 Allpowercordstothesystemaredisconnected 3 Allairsupplylinestothesystemaredisconnected 4 Allprocesslinestot...

Страница 17: ...switchmustalways beeasytoaccess WARNING NationalCodesandstandards NEC VDE BSI IEC ULetc andlo calcodesoutlineprovisionsforsafelyinstallingelectricalequip ment Installationmustcomplywithspecificationsr...

Страница 18: ...rainageorotheractivitiesthatmayinvolvesplashing WARNING Useaharmlessfluidinthebeginningoftheprocess Thiswill makeitpossibletodetectleakagewithminimizedconsequences andtheriskforpotentialleakageofhazar...

Страница 19: ...eoperatormustalwaysmakesurethatnooneispresent andexposedwhenthesystemisstartedandthatnooneenters theriskareaaroundthesystemduringoperation CAUTION Shutdowndoesnotautomaticallyresultindepressurizingoft...

Страница 20: ...misclearlytaggedastakenoutofoperation allprocesswettedareasareremovedorcleanedanddecon taminated WARNING Onlyauthorizedpersonnelmayperformservice installation and maintenanceofcomponentsinsidetheelect...

Страница 21: ...ationcodeofthemanufacturingfacility Shortcircuitcurrentrat ing Themaximumcurrentthesystemcanwithstand TotalFLA Thefullloadampere LargestmotorFLA Thelargestmotorinstalledonthesystem Protectionclass The...

Страница 22: ...ThesystemcomplieswithapplicableEuropeandi rectives Thissymbolindicatesthattheproductcontains hazardousmaterialsinexcessofthelimitsestab lishedbytheChinesestandardGB T 26572 Require ments of concentra...

Страница 23: ...me type and rating of fuse Warning Highvoltageinsidethecabinet Author isedpersonelonly Forcontinuedprotectionagainstfirereplaceonly withsametypeandratingoffuse IMPORTANT Beforeservice maintenanceorret...

Страница 24: ...icalcabinet WARNING Emergencystop PressingtheEMERGENCYSTOPdoesnotau tomaticallydepressurizetheflowpath WARNING Powerfailure Duringapowerfailure oriftheEMERGENCY STOPbuttonispressed thesystemmayremainp...

Страница 25: ...thefollowing Pumpmotorsstopimmediately Thebuilt incomputerandothercomponentswillremainpowered Nodatawillbelost Thevalveswillshutdowninaspecificorder fordetailsseeValve shutdown order on page 26 2 Safe...

Страница 26: ...139 Valve shutdown order WhentheEMERGENCYSTOPbuttonisusedtostopthesystem thevalveswill closeinthefollowingorder 1 Inletvalves 2 Airtrapvalves 3 Filtervalves 4 Columnvalves 5 Outletvalves Restart after...

Страница 27: ...emergencyshutdown makesurealllinesandvesselsaredepressurizedbeforeopening Thesystempowerislostifthe Powerswitch ontheelectricalcabinetisturnedoff themainscableisdisconnected orifthepowersupplyfails Al...

Страница 28: ...eturnswithinoneminuteafterthepowerfailure thecommunicationtothe serverandtheinterfacecontrolunitofthecontrolsoftwarewillautomaticallystart upagain Theselectedmethodthatwasrunningwhenthepowerwaslostwil...

Страница 29: ...ollowinganemergency shutdownorpowerfailure contact GEHealthcare forfurtherad viceandassistance 2 Safety instructions 2 3 Emergencyprocedures KTAreadyXLOperatingInstructions29281616AE 29 TeDIS Valid on...

Страница 30: ...iththesystem aredescribedinSection 3 5 Flow kits on page 62 In this chapter Section Seepage 3 1 Overview 31 3 2 Illustrations 33 3 3 Flowchart 43 3 4 Systemcomponents 47 3 5 Flowkits 62 3 6 Processcon...

Страница 31: ...enticaldiaphragmpumps Thewagonisequippedwithfourcas tersmadeofpolyurethane Allofthecastersarelockable Technicalspecifications areprovidedintheBillofMaterialandinthemanufacturer suserdocumentation Onth...

Страница 32: ...iononthecomputerandcomponentsintheelectricalcabinet Ifothercontrolsoftwarethan UNICORN isused nooperatorconsoleisfittedtothe systemframe Aninterfacecontrolunitofthecontrolsoftware forexamplePI 960 for...

Страница 33: ...t and gradient section are described in Section 3 5 Flow kits on page 62 Part Function A KTAreadyXL system B KTAreadyXL flowkitandgradientsection orderedseparately 3 System description 3 2 Illustratio...

Страница 34: ...ectionpointsforthesystem seeLo cation of connectors on page 42 3 Power switch Thesystemmainspowerswitch located ontheinletside leftside ofthesystem 4 Resetbutton TheResetbuttonmustbepressedafter thesy...

Страница 35: ...rsensorAE 151communica tioncord 7 Inletvalves XV 011 to XV 014 Fourinletvalves locatedontheinletside leftside ofthesystemforpumpB 8 Inletvalves XV 001 to XV 006 Sixinletvalves locatedontheinletside le...

Страница 36: ...unction 12 Levelsen sors fitting bracketand cablesfor connectors totheairtrap levelsensors LEL 166 and LEH 167 ThelevelsensorsLEL 166andLEH 167 areusedtomeasuretheliquidlevelinthe airtrap 13 Airtrapho...

Страница 37: ...reprefitted 17 Sensorplug forpressure sensor PE 111 Sensorplugforthecommunicationcable forpressuresensorPE 111whichisprefit tedontheflowkit 18 Pumpwagon door Easyaccesstothepumpwagon 19 Sensorplug for...

Страница 38: ...tisprefittedontheflowkit 22 Column valves XV 031 to XV 035 Afive valveassemblyforcolumnbypass inline upflow anddownflow 23 Sensorplug forpressure sensor PE 113 Pressuresensorplugforthecommunica tionca...

Страница 39: ...E 121 TE 121 AcableforconnectiontopHmeter AE 121 TE 121thatisprefittedonthe flowkit 27 Cablefor connection toUVsensor AE 131 AfiberopticcableforconnectiontoUVme terAE 131thatisprefittedontheflowkit Ca...

Страница 40: ...stem Thesystemisshownwithoutflowkit 30 29 28 Part Function 28 Inletforlowercoolingunits 29 Outletforuppercoolingunit 30 Systemelectricalcabinetdoor 3 System description 3 2 Illustrations 40 KTAreadyXL...

Страница 41: ...36 35 33 37 34 35 32 Part Function 32 Pumpheaddriveunit 2pcs 33 Pressureplateforpumphead 2pcs 34 Pumpwagonhandlebar 35 Pumpwagonlock 36 Casterwheelwithwheelbrake 4pcs 37 Pumpmotor 2pcs withcovers 3 Sy...

Страница 42: ...th UNICORN arelocatedonthefrontofthesystem 38 39 40 41 42 Part Functionaltagname Function 38 Pneumaticsupply Compressedairconnector 39 Profibus PROFIBUSconnector 40 Ethernet Ethernetnetworkconnector 4...

Страница 43: ...owkitcomponentsandtubing wettedcompo nents Orangecolorillustratesgradientsectioncomponentsandtubing wettedcom ponents Redcolorillustratescustomersuppliedfilter optional andcolumn wettedcom ponents 3 S...

Страница 44: ...XV 005 XV 006 BA6 BA5 BA4 BA3 BA2 BA1 M201 A P 201 B XV 012 XV 014 XV 011 XV 013 BB4 BB3 BB2 BB1 M201 B L L LEH 167 LEL 166 XV 023 W XV 021 XV 024 AT 221 XV 025 XV 026 XV 027 F1 F2 XV 022 CE 102 TE 10...

Страница 45: ...TE 102 Conductivitysensor FE 141 Flowmetercell LEL 166 Airtraplowlevelmeter LEH 167 Airtraphighlevelmeter P 201 A Isocraticpumpmotor P 201 B Gradientpumpmotor PE 111toPE 113 Pressuresensors XV 001toX...

Страница 46: ...Columntopoutletvalve XV 033 Columnbottominletvalve XV 034 Columnbottomoutletvalve XV 035 Columnbypassvalve XV 051toXV 056 Outletvalves 3 System description 3 3 Flowchart 46 KTAreadyXLOperatingInstruct...

Страница 47: ...ittersandsensors 60 Introduction Thissectionprovidesdescriptionsof KTAreadyXL andanoverviewofallcompo nents includingthecontrolsystem Forfurtherdetailsandspecifications refertothedocumentationpackagep...

Страница 48: ...nfacility Thestainlesssteeldesignsupportsprocesscomponentsandtheelectricalcabinetin oneunit Theelectricalcabinetservesasthecontainerfortheelectricalandpneu maticequipment Thesystemiseasytomoveandkeepc...

Страница 49: ...trollinginterfacebetweenthecontrolsoftwareandthecom ponentsof KTAreadyXL Forsystemwith UNICORN controlsoftware thecontrolunitCU 960islocatedinside theelectricalcabinetandhascapabilitiestostorerealtime...

Страница 50: ...lled computershutdownintheeventofapowerfailure Operator console only applicable to systems with UNICORN Thetouchscreenmonitorandkeyboardareergonomicallydesignedforusageina cleanproductionenvironment C...

Страница 51: ...equippedwithtensionrollersanda drivebeltmotor Referthemanufacturer sproductdocumentationforfurtherde tails Thepumpmotorsareconnectedtothesystemandfittedtothepumpwagonunder thesystematdelivery Thepumpw...

Страница 52: ...dtoPE 111toPE 113 Theoutput valuesofthetransmittersarehardwiredtothesafetymodule Ifanyofthemonitoredparametersreachesacriticallimit thesafetymoduleshuts downthepumpsindependentlyfromthesoftwarecontrol...

Страница 53: ...itoringlimits Steadylight Acriticallimitisdetectedbythesafetymonitoring ortheEMERGEN CYSTOPbuttonhasbeenpushed Analarmisdisplayedinthe UNICORN controlsystem Flashinglight1Hz Thecauseofthealarmisaddres...

Страница 54: ...must also be pressed after using the installation switch 3 System description 3 4 Systemcomponents 3 4 3 Systempumps 54 KTAreadyXLOperatingInstructions29281616AE TeDIS Valid on Date Printed Printed o...

Страница 55: ...fromacciden tallyclosingduringflowkitinstallation Thelargevalvesarealsoequippedwithtwo typesofvalvesafetycovers Note To open or close safety locks the installation switch must be set to Flow kitinstal...

Страница 56: ...ion of the pin to lock or unlock varies due to how the valves are fitted on the system The direction to lock the valve is indicated with an arrow and a lock symbol at each valve 2 Openthetwovalvesafet...

Страница 57: ...Slidethevalvefingerguardtoopenthevalvetubingcompartment 3 System description 3 4 Systemcomponents 3 4 4 Valves KTAreadyXLOperatingInstructions29281616AE 57 TeDIS Valid on Date Printed Printed on 15 09...

Страница 58: ...eright hand sideofthesystem Bypass XV 051to XV 056 Outletvalves locatedontheright hand sideofthesystem Closed RefertotheSoftwareDesignSpecificationformoreoptionsanddetails Air trap valves Theairtrapva...

Страница 59: ...alves Bypass XV 026 Inline default XV 025 XV 027 Column valves Thecolumnvalvesetconsistoffivevalves Seethevalvemacrosforthecolumnin structionoptionsbelow Valvepositions Openvalves Bypass XV 035 UpFlow...

Страница 60: ...lcabinet Flow transmitter KTAreadyXL isequippedwithamagneticflowtransmitterFT 141locatedoutside theelectricalcabinet Conductivity and temperature transmitter Twoconductivityandtemperaturetransmitters...

Страница 61: ...on A B Thesensorassemblyconsistsofalowlevelsensor LEL 166 A andahighlevelsen sor LEH 167 B SeealsoCalibration of level sensors on page 144 3 System description 3 4 Systemcomponents 3 4 5 Transmittersa...

Страница 62: ...mponents 71 Introduction Thischapterprovidesdescriptionsofthedisposableflowkitsandanoverviewofthe components Forfurtherdetailsandspecificationsrefertothedocumentationpackageprovided withthedelivery 3...

Страница 63: ...Flow kit ordering information on page 152 Specificationsregardingtheflowkitsandsections includingmaterialsarefoundin theproductdocumentationprovidedwiththeflowkit Forchemicalresistanceta blesseeSecti...

Страница 64: ...tedtoaperiodof14daysfromtheinitialwettingoftheflowkit After48 hoursofusageor14daysafterinitialwettingoftheflowkit thekitmustbediscar ded 3 System description 3 5 Flowkits 3 5 1 Flowkitdescription 64 K...

Страница 65: ...ectingtothepumphead includingair sensorAE 151 2 Pumpchamber head Pumpchamberwithoneconnectorfortheinlet manifoldandoneoutletforconnectingtotheair traptubing 3 Airtrap filtertub ing Tubingwithoneconnec...

Страница 66: ...13 14 15 16 17 18 Thefollowingtablegivesabriefdescriptionoftheflowkitcomponents Numbersin thetablerefertotheillustrationabove Note Several flow kit components are flow cells for sensors located on the...

Страница 67: ...hepressurebe tweenthepumpandtheairtraporfil ter andispartofthehighpressure safetymonitoring 5 Airtrap AT 221 Airtrapallowsforremovalofairinbuf fersandsample Levelcontrolisper formedviacontrolsystemsof...

Страница 68: ...corresponding tovalvesXV 051toXV 056 10 UVflowcell AE 131 FlowcellforUVdetectorAE 131 11 pHandtem peraturesen sor AE 121 TE 121 SensormeasuringpHandtemperature oftheliquid 12 Conductivity andtemper at...

Страница 69: ...ecolumnandtheoutletmanifold andispartofthehighpressuresafety monitoring 15 Columncon nectors Connectortocolumntopandbottom tubing 16 Airsensor AE 152 Anairsensormeasuringairinofthe liquidforcolumnprot...

Страница 70: ...ation Allpartsoftheflowkitaredelivereddoublebaggedandsanitizedthroughgammair radiation Labeling of flow kits Thedifferentpartsofthe KTAreadyXL flowkitsarelabeledandequippedwithbar codes Thebarcodesare...

Страница 71: ...arefoundintheproductdocumentationsup pliedwitheachsection 1 2 3 No Part Function 1 Inletmanifold Manifoldwith4inletscorrespondingto valvesXV 011toXV 014 2 Gradientpump chamber head Pumpchambertobeasse...

Страница 72: ...esponsiblefordesigningmethodswhichconformtostandard operatingproceduresandGoodManufacturingPracticeprocedures Prerequisite knowledge Aworkingknowledgeofthecontrolsoftwareisrequiredtooperate KTAreadyXL...

Страница 73: ...Processonlinecontrolandmonitoringusing pre definedmethodsormanualcontrol Evaluation Evaluationandpresentationofstoredre sults Note The modules are active when the program is operating and are not clos...

Страница 74: ...hoiceoffourdifferentpanesthatcanbeopenoneatatimeorallatonce inseparatepartsofthewindow 4 Aftercompletingtherun youcandisplaythedatainadetailedreportusing extensivetoolsprovidedbythe UNICORN Evaluation...

Страница 75: ...healarmlimitforthein strumentbelowthecurrentprocessvalue Reset Thealarmisresetthroughthecontrolsystembyacknowledgingthealarmmessage Theprocesscanbestartedagainifthesituationhasbeenrectified Methods Me...

Страница 76: ...ments 77 4 2 Transportandmovingofthesystem 78 4 3 Setup 86 4 4 Powersupply 93 Precautions WARNING Beforeattemptingtoperformanyoftheproceduresdescribedin thischapter youmustreadandunderstandallcontents...

Страница 77: ...lation Ambient environment Thefollowingconditionsshouldbeavoided Sourcesofheat suchasdirectsunlight Strongmagneticorelectricfields Vibrations Corrosivegas Dust Temperaturesoutsiderecommendedoperatingr...

Страница 78: ...age 150forthesystemweightinformation Makesurethattheintendedopeningsandaperturesarelargeenoughtoallowpas sageofthecratewhenliftedfromthefloorfortransport Remove the system from the crate Thisprocedure...

Страница 79: ...epumpwagondooratthefrontofthesystemandremovethe pumpsupportsonthecratefloor 6 Securethepumpwagontothesystemwiththetwolockingpinslocatedon theinsideofthepumpframe Closethepumpwagondoor Note Turn the lo...

Страница 80: ...stthecrateflooratthebackofthesystem Secure theramptothecratefloorwithabolt thencarefullymaneuverthesystem downtheramp Note Two persons should work together to carefully control the movement and direct...

Страница 81: ...he systemandthepumpwagonreleased Makesurethelockingpinsareinthelockedpositiononthepumpwagon Thelocking pinsoneachsideofthepumpwagonframekeepthepumpwagoninpositionwhen thesystemismoved Move the system...

Страница 82: ...systemand movethewagonandsystemusingaforklift Disconnect and move the pump wagon Step Action 1 Openthepumpwagondoorandunlockthetwolockingpinsonthepump wagonframebypullingthemandturningthemclockwise 2...

Страница 83: ...econd pump 4 Disconnectthetwocablesonthepumpmotor Theconnectionscanbe turnedforeasieraccess Note Repeat this step for the second pump 4 Installation 4 2 Transportandmovingofthesystem KTAreadyXLOperati...

Страница 84: ...ocksontheliftingforks 8 Carefullypositiontheliftingforkssothattheyarepositionedunderthe pumpwagon Therecommendedpositionisillustratedbelow 9 Carefullyliftthewagon nohigherthannecessaryforclearance and...

Страница 85: ...ftthesystem nohigherthannecessaryforclearance andmove thesystemtoitsdesignatedlocation Makesuretoreconnectthepumpwagontothesystemandrepositionitunderthe systematitsfinallocation Reassemblyofthepumpwag...

Страница 86: ...euse In this section Section Seepage 4 3 1 Assembly 87 4 3 2 Setupofcontrolsystemandnetwork 90 4 3 3 Connectcompressedairsupply 91 4 3 4 Guidelinesforconnections 92 4 Installation 4 3 Setup 86 KTAread...

Страница 87: ...veredwith UNICORN CAUTION Makesurethattheoperatorconsolearmisfirmlypositionedwith thetoppartofthehandlefullyinserted sothatthebushingis abletoabsorbtheweightoftheconsolewhentheconsolearmis fullyextend...

Страница 88: ...ly tothetouchscreenmonitor Thesetwocablesareattachedtothesystemlocatedonthefrontofthesystem Assemble the operator console optional Forthisproceduretwopeopleworkingtogetherarerecommendedduetotheopera t...

Страница 89: ...rotection A inplacewhenattachingthe consolearm A B 3 Removethefoamprotection 4 Fitthetwocablestotheconnectorsonthebackoftheconsole Thecables willclickintoplace 4 Installation 4 3 Setup 4 3 1 Assembly...

Страница 90: ...betweenthepre configuredsoftwareandother softwaresystems e g UNICORN DeltaV LIMS laboratoryinformationsystems etc For UNICORN theOPCserverisincludedintheregularinstallationandthe softwaremaybesetupeit...

Страница 91: ...ons on page 150 Connect compressed air supply Step Action 1 Connectcompressedairtotheairsupplyconnectionontheelectricalcabi net 2 Makesurethattheairsupplypressureisbetween6 5to10barg Theregu latorisse...

Страница 92: ...hnicalinformationinthesys tem specificdocumentationpackage DonotovertightenTCclamps asthismayleadtomalfunctionofthesystem Makesurethatallcontainersaredimensionedformaximumpossiblevolume whentheequipme...

Страница 93: ...representativetoarrangeassistanceifre quired Usethesuppliednetworkcablesforconnectiontonetworkasappropriate NOTICE Usethesuppliednetworkcabletoprotectfromliquids Donotre placethiscablewithanunprotect...

Страница 94: ...stallfilter optional 129 Precautions WARNING Beforeattemptingtoperformanyoftheproceduresdescribedin thischapter youmustreadandunderstandallcontentsofthe correspondingsection s inthelinksaslistedbelow...

Страница 95: ...thesensors NOTICE Disconnectpower Topreventequipmentdamage alwaysdis connectthepowerfromtheproductbeforeaninstrumentmod uleisremovedorinstalled oracableisconnectedordisconnec ted 5 Preparation KTAread...

Страница 96: ...hePowerswitchtotheON position 2 PresstheResetbuttonwhenitisflashing 3 LogontoWindows 4 Start UNICORN bydouble clickingonthe UNICORN iconontheWindows desktop 5 WhentheLogondialogboxappears selectauserf...

Страница 97: ...dairtraptubing installtheAinletmanifoldforan isocraticsetupandboththeAandBinletmanifoldforagradientsetup 7 Positionandinstallthecolumntubing 8 Positionandinstalltheoutletmanifold 9 Installsystemcompon...

Страница 98: ...nlockalllargepinchvalvesonthesystembysettingeachlockingpinto theunlockedposition Note The valves are located on three sides of the system 2 TurntheinstallationswitchtoFlowkitinstall 5 Preparation 5 2...

Страница 99: ...es is done to prevent the valves from actuating and closing while installation is occurring Install the pump chamber Followtheinstructionsbelowandfitonepumpchamberatatime 5 Preparation 5 2 Installdisp...

Страница 100: ...hersideofthepumpwagonframe A C B B B 2 Pulloutthepumpwagonfromunderthesystemwithoutpullingthecables C 3 Lockthefrontwheelsofthepumpwagon 4 Locatethepumpchamber head intheisocraticflowkit 5 Preparation...

Страница 101: ...ow Holdthepressureplateandwhileremovingthefourhexscrewshold ingthepressureplateinplaceusingthetool Thenremovethepressure plate E 7 WrapnewPTFEtapearoundthethreadsofthefourhexscrewstoprevent threadseiz...

Страница 102: ...p motor P 201 B and the pres sure plate to the pump head F 9 Attachthepumpchamberandthepressureplatewiththefourhexscrews loosely Thentighteningthemcrosswisetoatorqueof25Nmusingthe toolandthe8mmattachm...

Страница 103: ...en gotostep3andrepeattheproceduretofitthepumpchamberfromthe gradientflowkit 14 Makesurethepowercablestothepumpmotorsareplacedonhookson thebackofthepumpwagon 15 Unlockthefrontwheelsofthepumpwagon Thenp...

Страница 104: ...inletlabeledINusingaTCclamp B A B 3 Ifyourplannedprocessrequiresasinglepump gotoPosition the air trap tubing on page 107 IfyourplannedprocessrequiresasecondpumpgotoPosition gradient in let manifold on...

Страница 105: ...ctthegradientinletmanifoldtothegradientpump chamberinletlabeledINwithaTCclampasillustratedbelow Install gradient jumper tubing Theseinstructionsareonlyrelevantforthegradientsetup 5 Preparation 5 2 Ins...

Страница 106: ...eledOUT withthepumpjumper tubingusingTCclamps Note The T connection on the pump jumper tubing must be positioned closest to the gradient pump 5 Preparation 5 2 Installdisposableflowkits 106 KTAreadyXL...

Страница 107: ...sensorsCE 101 TE 101 PE 111 PE 112 andAE 152 2 Holdtheairtrapatitsbasewithyourlefthandandthefiltertubingloop withyourrighthand thenpushintheairtrapinitssnapholder 5 Preparation 5 2 Installdisposablefl...

Страница 108: ...be fitted after the installation test because the installation test is performed on a dry flow kit See Section 5 5 Install filter optional on page 129 for instructions 4 Locatethetubingsizeadapter re...

Страница 109: ...etubingsizeadapter B A B Theillustrationaboveshowstheisocraticsetup 6 Forthegradientsetup connecttheairtraptubingtothejumpertubing withoutusingthetubingsizeadapter 5 Preparation 5 2 Installdisposablef...

Страница 110: ...lockwiseonthecable connector Theillustrationshowstheisocraticsetup 8 Unlockthefrontwheelsofthepumpwagon 9 Pushinthepumpwagonallthewayinunderthesystemandlockitinplace withthelockingpins Thenclosethepum...

Страница 111: ...Position the tubing and open the valve safety cover 2 Slide back the valve finger guard 3 Insert the tubing by squeezing the tubing on each side of the valve 4 Close the valve safety cover 1 2 4 3 5 P...

Страница 112: ...the inlet tubing rest on the covers before starting to inserting the tubing 2 Insertthetubingoftheisocraticinletmanifoldintotheinletvalves then closethevalves Tip Push the isocratic inlet manifold ba...

Страница 113: ...enclosethevalves Position and install the column tubing Step Action 1 Locatethecolumntubingoftheflowkit 5 Preparation 5 2 Installdisposableflowkits KTAreadyXLOperatingInstructions29281616AE 113 TeDIS...

Страница 114: ...ubinginthecolumnvalvesstartingfromthetopandclosethe valves 4 ConnectthecolumntubingtotheairtraptubingwithaTCclamp MakesurethatthefasteninghandleoftheTCclampisfacingoutwards 5 Preparation 5 2 Installdi...

Страница 115: ...theoutletmanifoldonthecorrespondingoutletvalvesonthe rightsideofthesystem 3 Openthevalvesandinsertthetubingintothevalves thenclosethevalves 5 Preparation 5 2 Installdisposableflowkits KTAreadyXLOperat...

Страница 116: ...thecolumntubingwithaTCclamp MakesurethatthefasteninghandlesoftheTCclampsarefacingout wards 5 Preparation 5 2 Installdisposableflowkits 116 KTAreadyXLOperatingInstructions29281616AE TeDIS Valid on Date...

Страница 117: ...dentionontherightsideofthesystem a Openthetubeholder A b InserttherigidKrohnetube B c Closethetubeholder C Aclickverifiesthatthetubeholderisclosed A B C 5 Preparation 5 2 Installdisposableflowkits KTA...

Страница 118: ...velsensorsLEL 166andLEL 167 thelever andthestraponthesystem Note Note that the level sensor fixture level sensors lever and the strap are reus able parts of the system Do not remove these items when r...

Страница 119: ...ngthelever B Thebaseofthelevel sensorshouldbepositionedflushtotheairtraprim A B 3 Fittheairtrapventtubingintotheairtrapventvalve XV 023 andclose thevalvelock 5 Preparation 5 2 Installdisposableflowkit...

Страница 120: ...cabinet 2 Connectthethreepressurecells PE 111 PE 112 andPE 113 withca blesfromtheirrespectivecableglands A B andC onthefrontandinlet right sideofthesystemcabinet A B C 5 Preparation 5 2 Installdisposa...

Страница 121: ...the pH calibration values on the sensor label When using UNICORN enter the values under System Settings For other control software refer to the information provided in the docu mentation package 5 Con...

Страница 122: ...esetbut ton 9 Theflowkitisassembledandthesystemcanbepreparedfortherelevant flowkitinstallationtest seeSection 5 3 Perform flow kit installation test on page 123 5 Preparation 5 2 Installdisposableflow...

Страница 123: ...ry flow kit Note Priming is performed after the installation test Note For testing of ancillary filters mixing tanks and bags refer to the relevant user documentation for information Overview Theinsta...

Страница 124: ...l enterthevaluesunderSystems Settings Monitors AE121_Gain Perform a dry flow kit installation test Stage Description 1 OpenMethod EditorandimporttheInstallationtestmethod File Import Method s Installa...

Страница 125: ...esult testreport byfollowingtheinstructionsbelow Step Action 1 OpenEvaluation Modulein UNICORN 2 Opentheresultfile SelectResult Navigator Recent RunsorResults 3 SelecttherelevantresultfileInstallation...

Страница 126: ...lets you can fit a Y or T tube to any inlet except for InletA1 Step Action 1 Checkthattheinletandoutlettubingarecorrectlyconnected 2 Checkthatthebuffertanksarefilledwithasufficientamountofasuitable li...

Страница 127: ...st etc 3 Filltheflowkittubingfromtheconnectedinletlocatedfurthestfromthe pumpusingPump ManFlowsettoapproximately30 ofthemaximum flowrate 4 Filltheflowkittubingofeachoftheconnectedinlets byopeningthese...

Страница 128: ...e pump InletB3 is the second furthest etc InletB1 is the recommended inlet to use for prime flow as it leads straight to the pump 9 SelectENDtostopthepumpandclosethevalves Result Theairhasbeenremovedf...

Страница 129: ...stall filter Step Action 1 OpentheTCclampbyFilterpositionabovepinchvalveXV 025 2 Openthetwofilterattachmentstraps 3 Fitacustomersuppliedfilterandattachitwiththestraps 4 Connectthetubingtothefiltertopa...

Страница 130: ...rformed In this chapter Section Seepage 6 1 Connectacolumn 131 6 2 Runamethod 134 6 3 Controlledshutdownandremovalofflowkit 139 Precautions WARNING Beforeattemptingtoperformanyoftheproceduresdescribed...

Страница 131: ...rdingly NOTICE Makesurethattheconnectionstothecolumnandsystemcom plywiththerequirementsinthecolumnandsystemOperating In structions NOTICE Ifthepressurelimitforanycomponentconnectedtothesystem islowert...

Страница 132: ...ngtothesystemvalvemarkedCOLUMNBOTTOM butdo notconnecttheotherendofthetubingtothebottomofthecolumnatthis time 2 SetthesystemcolumnvalvestotheUpFlowposition 3 Usingthepump fillthesystemwithanappropriate...

Страница 133: ...mcolumnvalvestotheUpFlowposition 4 Usingthepump fillthesystemwithanappropriateliquidforcolumnin stallation 5 Whenthesystem includingthetubingconnectedtothecolumn isfilled withliquid stopthepump 6 Uset...

Страница 134: ...efertothesoftwaredocumentationtocreatesimilar methods Precautions WARNING Beforeattemptingtoperformanyoftheproceduresdescribedin thischapter youmustreadandunderstandallcontentsofthe correspondingsecti...

Страница 135: ...theruncanbeviewedindetailinthe UNICORN System Control module Uptofourdifferentpanelscansimultaneouslydisplaydifferentaspectsoftherun To customizecontentandlayoutofapanel right clickandthenclickCustomi...

Страница 136: ...Thiswillproduceaconfirmationdialogbox ClickOKinthedialogboxtoendtherun orclickCanceltokeeprunning Inthedialogbox youcanchoosetosavethe partial resultsfromtherunsofar Ifthe runispartofascoutingrun youa...

Страница 137: ...stodisplaybyclickingtheminthe Curvestab Click OK Refertothe UNICORN manualsformoreinformationaboutviewingresultsandcus tomizinglayout Print results Step Action 1 Openthechromatogramyouwanttoprintinthe...

Страница 138: ...mise Reportwindow verifythatthelayoutiscorrect 6 ClickExittoreturntothePrint Chromatogramsdialogbox 7 ClickOK Refertothe UNICORN User Manualformoreinformationaboutprintingresults 6 Operation 6 2 Runam...

Страница 139: ...heoptionalproceduresaredescribedbelow Note Column removal is not described Follow the instructions in the column user documentation for disposal Alternative 1 Remove the entire flow kit Toremovetheent...

Страница 140: ...a tions Alternative 2 Drain and remove the flow kit by section Todraintheflowkit andthenremoveeachsectionoftheflowkitfollowtheinstruc tionsbelow NOTICE Theinletsandpumpsectionsarenotentirelydrainedusi...

Страница 141: ...asthetubingisremovedfromthevalve Closeeachvalveafterthe tubingisremoved 10 Disposeoftheflowkitsectionsinaccordancewithlocalregulations Alternative 3 Drain and remove the entire flow kit Todraintheflow...

Страница 142: ...bingisremoved fromthevalve Closeeachvalveafterthetubingisremoved 9 Disposeoftheflowkitsectionsinaccordancewithlocalregulations Shutdown procedure Theexamplebelowdescribestheshutdownprocedurefor UNICOR...

Страница 143: ...ion s inthelinksaslistedbelow General precautions on page 13 Flammable liquids and explosive environment on page 14 Personal protection on page 15 Operation on page 18 Maintenance on page 20 Regular m...

Страница 144: ...structions Replacetheconductivitysensorcablesyearly Storage Ifthesystemisnotusedforalongertimeperiod morethanafewdays Removetheflowkit Cleantheoutsideofthesystem Ifthesystemneedstobemoved thesystempow...

Страница 145: ...ocalibratethehigh levelsensorusingair 4 Filltheairtrapuntilliquidcomesoutthroughthetopvalvebypumpingin liquidusingtheFillinstruction 5 Turnoffthepump 6 UsetheinstructionSystem Calibrate LSL166_liquidt...

Страница 146: ...your GEHealthcare representative Precautions WARNING Beforeattemptingtoperformanyoftheproceduresdescribedin thischapter youmustreadandunderstandallcontentsofthe correspondingsection s inthelinksaslist...

Страница 147: ...er is broken Data are stored locally and are transferred to the computer as soon as communi cation is restored Communicationfailure CheckthattheResetbuttonispressedafterthe changeofmodeontheinstallati...

Страница 148: ...ssue 1 Checkthattheflowkitisinstalledaccordingto theOperatingInstructions SeeSection 5 3 Per form flow kit installation test on page 123forde tails 2 Checkthatthesensorcablesarefittedproperly 3 Checkt...

Страница 149: ...n this chapter Section Seepage 9 1 Specifications 150 9 2 Flowkitorderinginformation 152 9 3 Chemicalresistance 153 9 4 Recyclinginformation 156 9 5 Regulatoryinformation 157 9 6 HealthandSafetyDeclar...

Страница 150: ...Maximumcurrentconsumption ULListed 3 5A CEmarked 3 5A Japan 6 6A Ingressprotection IP55 Leakagecurrent RefertoFunctionaltestrecords Shortcircuitcurrentrating RefertoGeneralspecification Maximumsupplys...

Страница 151: ...F Altitude 2000m System capacity Property Withflowkit Inch Withflowkit1Inch Volumetricflowrates 45to1900L h 90to3500L h Maximumoperating pressure 4 0barg 4 0barg Flow kit specifications Refertotheflo...

Страница 152: ...kit options Product CodeNo KTAreadyXL Flowkit inch 29482435 KTAreadyXL Flowkit1inch 29482436 KTAreadyXL Gradientsection inch 29279665 KTAreadyXL Gradientsection1inch 29281931 9 Reference information...

Страница 153: ...ouarenotsureofthecompati bilityofyourchemicals List of chemicals allowed Thetablebelowlistschemicalsthatcanbeusedwith KTAreadyXL flowkits The concentrationslistedarenotnormallyexceededduringanoperatin...

Страница 154: ...68 1 Polyethyleneglycol PEG500 5 Polyethyleneglycol PEG1000 1 Polyethyleneglycol PEG5000 1 Potassiumphosphate 1M 1 propanol 5 2 propanol 30 SDS 1 Sodiumacetate 1M Sodiumchloride 4M Sodiumcitrate 1M So...

Страница 155: ...1M Tween 20 1 Tween80 1 Urea 8M 1 RepeatedexposuretosodiumhydroxidewilldecreasepHsensorperformance 9 Reference information 9 3 Chemicalresistance KTAreadyXLOperatingInstructions29281616AE 155 TeDIS Va...

Страница 156: ...Detailedinformationisavailablefrom your GEHealthcare representative Disposal of electrical components Wasteelectricalandelectronicequipmentmustnotbedisposedofasunsortedmu nicipalwasteandmustbecollect...

Страница 157: ...ageforapplicablecodesandstandards In this section Section Seepage 9 5 1 Contactinformation 158 9 5 2 EuropeanUnionandEuropeanEconomicArea 159 9 5 3 EurasianEconomicUnion 160 9 5 4 RegulationsforUSA 16...

Страница 158: ...Thetablebelowsummarizestherequiredmanufacturinginformation Requirement Information Nameandaddressofmanufacturer GEHealthcareBio SciencesAB Bj rkgatan30 SE75184Uppsala Sweden Telephonenumberofmanufact...

Страница 159: ...opyoftheEUDeclarationofConformityisavaila bleonrequest CE marking TheCEmarkingandthecorrespondingEUDeclarationofConformityisvalidforthe instrumentwhenitis usedaccordingtotheOperating Instructionsoruse...

Страница 160: ...ssummaryinformationaboutthemanufacturerandim porter inaccordancewiththerequirementsoftheTechnicalRegulationsoftheCus tomsUnionand or theEurasianEconomicUnion Requirement Information Name addressandtel...

Страница 161: ...liancemarkindicatesthattheproductis approvedforuseonthemarketsoftheMemberStatesof theCustomsUnionoftheEurasianEconomicUnion 9 Reference information 9 5 Regulatoryinformation 9 5 3 EurasianEconomicUnio...

Страница 162: ...Healthcare could void the user s authority to operate the equipment ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaClassAdig italdevice pursuanttopart15oftheFCCRules Theselimitsaredesigne...

Страница 163: ...ents South Korea RegulatoryinformationtocomplywiththeKoreantechnicalregulations NOTICE ClassAequipment equipmentforbusinessuse Thisequipmenthasbeenevaluatedforitssuitabilityforuseina businessenvironme...

Страница 164: ...atingconditionssothattheuseofsuchelectricalandelectronicproductswillnotre sultinanysevereenvironmentalpollution anybodilyinjuryordamagetoanyassets Theunit oftheperiodis Year Inordertomaintainthedeclar...

Страница 165: ...alsforthispartisbelowthelimitrequirementinGB T26572 X Indicatesthatthishazardoussubstancecontainedinatleastoneoftheho mogeneousmaterialsusedforthispartisabovethelimitrequirementin GB T26572 Datalisted...

Страница 166: ...posable flowkit Additional design considerations Foradditionaldesignconsiderations suchasASME BPE GMPandcGMPsinforma tionrefertotheproduct specificspecificationinformationprovidedinthedocumen tationpa...

Страница 167: ...Adequate space andclearance is providedto allowsafe access forinstrumentservice repairor installation Insome cases this mayrequirecustomerto move equipmentfrom normaloperatinglocation prior to GE arr...

Страница 168: ...substances pleasespecify OtherHazardous Chemicals please specify Equipment must be decontaminatedpriortoservice return Pleaseprovide atelephone number whereGE cancontact youfor additionalinformationco...

Страница 169: ...ismanual Pleasecontactyourlocal GEHealthcare representativeforadvice Contactinformationisfoundonthebackcoverofthismanual Training GEHealthcare recommendsthatallnewoperatorsattendthetrainingcoursesavai...

Страница 170: ...test 123 124 introduction 123 overview 123 prepare 124 G Gradientflowkit 71 mainparts 71 Gradientpump 45 Gradientsection 71 I Importantuserinformation 6 Installation 76 L Labels 21 22 safetylabels 22...

Страница 171: ...fetynotices 7 Safetyprecautions 6 generalprecautions 6 Service 169 Shutdown 139 142 Skid 48 Spareparts 169 Startthesystem 96 Systemcapacity 151 Systemnameplate 21 T Testreport 125 Training 169 Tubing...

Страница 172: ...mentforLifeSciencesSoftware Products AcopyofthisStandardSoftwareEnd UserLicenseAgreementisavailableonrequest Anyuseofthe GEHealthcare configurationof DeltaV softwareissubjecttoavalidSoftwareLicenseAgr...

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