FDI P2131 User manual

P2131‐1‐8001Rev17
P2131
AUTOMATEDFIELDSTEAMSTERILIZER
NSN:6530‐01‐641‐4641
TECHNICALMANUAL
FortDefianceIndustriesLLC(FDI)
2411MaremontPkwy∙Loudon,TN∙37774
Phone:(865)408‐0100∙[e-mail]

ii
TheP2131AutomatedFieldSteamSterilizercomplieswiththe
applicablerequirementsofthefollowingstandards:
ANSI/AAMIST8:2013,HospitalSteamSterilizers
UL61010‐12ndEdition,SafetyRequirementsforElectricalEquipmentforMeasurement,
ControlandLaboratoryUse–Part1GeneralRequirements
IEC61010‐2‐0401stEdition,Safetyrequirementsforelectricalequipmentfor
measurement,controlandlaboratoryuse‐Part2‐040:Particularrequirementsfor
sterilizersandwasher‐disinfectorsusedtotreatmedicalmaterials
ASMEBoilerandPressureVesselCode,SectionVIII,DivisionI,CurrentEdition,Rulesfor
ConstructionofPressureVessels
U
FortDefianceIndustries(FDI)isISO13485:2016certified
andFDAcompliantforthedesignandmanufactureofmedicaldevices
andsupportiveaccessoriesforthemedicaldeviceindustry.
FortDefianceIndustriesLLC
CertifiedtoISO13485:2016
MDSAP:UnitedStates,Canada
Certificate#:US19/81841407

iii
ContinualImprovement
FortDefianceIndustriesLLC(FDI)iscommittedtoprovidingourcustomerswithasafeand
effectiveproductthatissimpleandeasytooperateandmaintain.AsanISO13485:2016certified
company,wehaveastrongdesiretocontinuallyimprove.Ifyouhaveanyfeedbackregarding
theP2131sterilizerorthistechnicalmanual,pleasecontactus.Ifanycriticalupdatestothe
P2131Sterilizerbecomenecessary,theupdateswillbecommunicatedthroughaMedicalDevice
AdvisoryNotice.Itisimperativethatthesenoticesbereadinfullandfollowed.
FEEDBACKFORIMPROVEMENTANDGENERALQUESTIONS
FortDefianceIndustriesLLC
2411MaremontPkwy
Loudon,TN37774
[email protected]
865‐408‐0100[phone]fortdefianceind.com
OperationalandMaintenanceVideos
PleasevisittheFDIvideochannelforhelpfulandinformativevideosontheoperationand
maintenanceoftheP2131AutomatedFieldSteamSterilizer.ScantheQRcodebelow,clickon
thehyperlink(ifyouareusingtheelectronicversionofthemanual),orentertheWebaddress
listedtoaccessthesevideos.
NOTE:Thischannelisupdatedasnewmaterialisproduced,socheckbackperiodicallytoview
newcontent.
https://tinyurl.com/2kraxrf9

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TABLEOFCONTENTS
SECTIONDESCRIPTIONPAGE
1INTRODUCTION1
1.1SafetyPrecautions1
2GENERALINFORMATION3
2.1IntendedUseandSystemDesign3
2.2SpecificationsandPhysicalData4
2.3SterilizationCycles–FDACleared5
2.4DescriptionofCyclePhases6
2.5WaterSupplyQuality7
2.6SterilityAssuranceProducts8
3OPERATION9
3.1Installation,Setup,andQualification(IQ,OQ,PQ)11
3.2ControlsandIndicators29
3.2.1ChamberDoorOperation30
3.3OperatingProcedure40
3.3.1 TurningtheSterilizerOn40
3.3.2 ZeroingGaugePressure(BarometricPressureSetup)41
3.3.3 RunningaNormalSterilizationCycle41
3.3.4 RunningaPerformanceTest(VacuumLeakorBowie‐DickTest)44
3.3.5 Alarms46
3.3.6 MaintenanceReminder47
3.3.7 Status47
3.3.8 ProgrammableCycles48
3.4OperationalChecklists50
3.4.1 TestingTotalDissolvedSolids(TDS)55
3.4.2 SWSDeionizedWaterCartridgeCapacity55
3.4.3 TestingFreeChlorineLevel56
3.5OperationalSituationsandResponses57
3.6AlarmCodeTroubleshootingGuide60
3.7ChecklistforTransportationandStorage69
3.8ConsumableItemsList72
4MAINTENANCE 73
4.1PreventiveMaintenance73
4.1.1PreventiveMaintenanceSummary 74
4.1.22‐MonthPreventiveMaintenance 75
4.1.36‐MonthPreventiveMaintenance 76
4.1.412‐MonthPreventiveMaintenance 77

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SECTIONDESCRIPTIONPAGE
4.1.5PostMaintenanceChecklist 81
4.2SpecialToolsandMaterialsRequiredforMaintenance82
4.3MaintenanceProcedures83
4.3.1ReplacingtheHTS‐1RTDSensors84
4.3.2DisinfectingCleanforWRS85
4.3.3CleaningtheSightGlass85
4.3.4ReplacingtheSWSCartridge86
4.3.5ReplacingtheHEPAFilter86
4.3.6ReplacingtheSteamTrap86
4.3.7ReplacingtheRTDSensor87
4.3.8ReplacingtheChamberDoorGasket87
4.3.9ReplacingtheChamberDoorpostO‐Ring88
4.3.10 ReplacingElectricImmersionHeatingElements89
4.3.11ReplacingthePLC90
4.3.12 PLCSoftwareUpdate92
4.3.13 PLCFirmwareUpdate92
4.3.14 VacuumLeakTestTroubleshooting95
4.3.15 DoorSwitchReprogramming96
4.3.16 ReplacingthePLCBattery 97
4.3.17RemovingBackLowerPanelandHeaterAssemblyCover99
4.4ReplacementPartsList101
4.5InteriorComponentsDiagrams105
4.6TheoryofOperation116
4.6.1ProcessFlowDescription116
4.6.2ProcessFlowDiagram117
4.7ElectricalWiringDiagram119
AAPPENDIX124
A.1SwagelokFittingInstallationInstructions125
A.2PLCDataSheet129
A.3VERIFY™ProductInformation135
A.4WRSPumpInformation141
A.5VacuumLeakTestTroubleshootingGuide152
A.6SuggestedMaximumValuesofContaminantsinFeedWater154
A.7Warranty155
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vi
COMPACTDISCTABLEOFCONTENTS
ThefollowingfilescanbefoundontheCDthataccompaniesthistechnicalmanual.
ITEMFILENAME
1.TechnicalManual–P2131AutomatedFieldSteamSterilizer
2.AnInstaller’sPocketGuideforSwagelokTubeFittings
3.ProgrammableLogicController(PLC)Manual
LISTOFACRONYMS
ACRONYMDEFINITION
AAMIAssociationfortheAdvancementofMedicalInstrumentation
AFSAutomatedFieldSteamSterilizer
ASMEAmericanSocietyofMechanicalEngineers
BIBiologicalindicator
B&PVBoilerandPressureVessel
CIChemicalintegrator
DIDeionized
FDAFoodandDrugAdministration
FDIFortDefianceIndustriesLLC
IFUInstructionsforUse
HTSHighTemperatureLimitSwitch
IQ/OQ/PQInstallation,Operational,andPerformanceQualification
IUSSImmediateUseSteamSterilization
MAWPMaximumAllowableWorkingPressure
MTTRMean‐time‐to‐repair
PCDProcesschallengedevice
PLCProgrammablelogiccontroller
PSVPressuresafetyvalve
RTDResistancetemperaturedetector
SABSterilizerAccessoryBag
SMUSterilizerMainUnit
SWSSterilizerWaterSoftener
TDSTotalDissolvedSolids
WRSWaterRecoverySystem

SECTION1–INTRODUCTION

1.1SafetyPrecautions




ThismanualcontainscriticalinformationontheproperuseoftheAutomatedFieldSteam
Sterilizer(P2131sterilizer).Alloperatorsandmaintainersofthissterilizermustbeproperly
trainedpriortooperationorserviceandareurgedtocarefullyreadthismanualinitsentiretyto
becomefamiliarwiththewarnings,cautions,andinstructionsforuse.

ThissterilizerisequippedwithaHighTemperatureLimitSwitch.Shouldtheheatersbe
energizedinalowornowatercondition,thisswitchwillprotectthechamberandother
componentsbyswitchingoffpowertothePLCandtheHeaterContactor.Thisalarm
conditionisidentifiedbyasustainedaudibletone.

Regularlyscheduledpreventivemaintenanceisrequiredforthesafeandreliable
operationoftheP2131sterilizer.ReferenceSection4fordetails.

Serviceandmaintenanceworkmustbeperformedbyqualifiedpersonnelonly.

RepairpartsmustbeauthorizedforuseintheP2131sterilizerandshouldbesourced
fromFDI.Useofunauthorizedpartscouldcompromisethesafetyand/orefficacyofthe
sterilizerandwillvoidthewarranty.

Burnhazard:

—Chamberdoorandrack/shelveswillbehotafteracycle.Alwayswearprotective
glovesandapronwhenloadingandunloadingthechamber.

—Hotwatercanremaininthechamberafteracycle.Alwayswearprotectivegloves.

—Beforeperforminganycleaningormaintenance,allowsterilizertocooltoambient
temperature.

—Hotsteamcanflowoutofthechamberwhenthedoorisopened.Keepasafedistance
fromthedoorandopenthedoorslowlytoreducesteamexposure.Alwayswear
protectivegloves.

—WaterRecoverySystem(WRS)LeftSidePanelwillbehotduringandaftercycles.Do
nottouchthepanelorperformmaintenanceontheWRSuntilthepanelhascooled.

Electricalshockandburnhazard:Donotserviceunlessthesterilizerhasbeende‐
energizedpertheappropriatesafety‐relatedworkpracticestandards.

Explosionhazard:Donotprocessflammablematerialsinthissterilizer.Onlymedical
suppliesandmaterialspertheintendeduseasdescribedinSection2.1shouldbe
processed.
WARNINGS
1




Slippinghazard:Ensurethatanywaterleaksorspillsareimmediatelywipedup.

Triphazard:Carefullyorganizethelayoutoftheincomingpowerandwaterlinesfor
safety.

ThesterilizerhasapressurevesselthathasbeenASMEB&PVcodestamped.Itisa
violationoffederalcodetoreplacethemaindoorplateormakeanyweldrepairstothe
pressurevessel.Allrepairstothepressurevessel,includingthedoorplate,mustbemade
byFDI.

SterilitycouldbecompromisedifBowie‐Dick,vacuum‐leak,orbiologicalindicatortesting
indicatesaproblem.Referanyconcerntoaqualifiedequipmenttechnicianbefore
continuingtousethesterilizer.

Donotre‐usebiologicalindicators(BIs),chemicalintegrators(CIs)orBowie‐DickTest
Packs.Checktheexpirationdatebeforeuse.

SterilitycouldbecompromisedifAssociationfortheAdvancementofMedical
Instrumentation(AAMI)guidelinesarenotfollowedforcleaning,decontaminating,
packaging,andpreparingpriortosterilization.Inaddition,itiscriticalfortheuserto
followAAMIguidelinestoconductroutinebiologicalmonitoringtoverifythesterilization
performance.

Refertotheinstrumentdevicemanufacturer’sInstructionsforUse(IFU)beforeselecting
theappropriatecycle,includingexposureanddrytimes.

TheP2131sterilizerisdesignedtosterilizeloadsusingonlytheFDA‐clearedcyclesas
specifiedinthismanual.Ifyouhaveanyquestionorconcernaboutaspecificmaterial,
instrument,ordevice,contactthemanufacturerofthedevicetoobtainthespecificIFU.

TheP2131sterilizerdoesnotincludeasterilizationcycleforliquids.DONOTATTEMPT
TOSTERILIZEANYLIQUIDSINTHISSTERILIZER.
Aftertransportandrelocation,theinstallationmustincludeproperInstallation,
Operational,andPerformanceQualification(IQ/OQ/PQ)testingperAAMIstandards.
ReferenceSection3.1.

Donotusecompressedairtohastenthedrainingordryingprocessasthehighpressure
coulddamagethepressurevessel(40psigMAWP),WRSwatertank,orinstrumentation.

Donotremoveorange‐coloredinsulationsleevesthatareusedthroughoutthesterilizer.
Theinsulationsleevesprotectstheuserfrompotentialburnsandensurescorrect
performanceoftheSterilizer.Replaceifitbecomesdamagedand/orlostduring
maintenance.
WARNINGS
2

SECTION2–GENERALINFORMATION

2.1IntendedUseandSystemDesign

TheP2131sterilizerisdesignedforsterilizationofporousandnonporousandheat‐andmoisture‐
stablematerials(e.g.,surgicalinstrumentsandtextiles)usedinhealthcarefacilities.TheP2131
sterilizerisarugged,transportabledevicedesignedforfielduseinavarietyofaustere
environments.Ambientoperatingconditionsincludesealevelto8,000feetaltitudeand40°Fto
130°F.

TheP2131sterilizerisapre‐vacuumandpost‐vacuumsterilizerthathasaconditioningstagewith
vacuumairremovalbeforethestartoftheexposurestage,aswellasapost‐exposuredrying
stagethatisbasedonthecombinedoperationofheatandvacuum.Thesterilizationagentis
steamthatiselectricallygeneratedinajacketedboiler.

TheP2131sterilizerconsistsofthreecomponentsthatworktogetherasoneintegratedsystem.
Thesecomponentsarethe(1)SterilizerMainUnit(SMU),(2)WaterRecoverySystem(WRS),and
(3)SterilizerWaterSoftener(SWS).TheWRSreclaimshotcondensateandexhauststeamforre‐
usebytheSMU.TheWRSalsoincludesawatereductor,whichprovidesthevacuumcapability
forthepreandpost‐vacphasesofsterilization.TheSWSdeionizestheincomingwatertoprevent
scalebuildupandreducetheeffectsofwateronthemetalcomponents.Amanualhandpump
isalsoprovidedwiththeSWStopullwaterfromaJerrycanorbucketifapressurizedwater
systemisnotavailable.

TheP2131sterilizerisanautomated,microprocessor‐controlled,pre‐vacuumautoclave.Avisual
alertindicator(LEDlight)andanaudiblealarmnotifytheoperatorofanyabnormalcondition
duringoperation.Ithasafullyjacketed,horizontal‐typepressurevesselandisdesignedasa
transportablesterilizationunit.TheP2131sterilizerisofwelded‐aluminumalloyconstructionto
minimizeweight.Thechamberassembly,withinternaldimensionsof16″diameterx36″long,is
supportedinacombinationframeandendcapassemblytoproviderigidityandprotection.The
endcaps,whenclosed,completelyencloseandprotectthesterilizerandprovidethecapability
toserveasashippingcontainer.Whentheendcapsareopenedtheyprovideanintegralstand,
placingthesterilizingchamberandoperatingcontrolsataconvenientworkingheight.

Universalshelvesaresuppliedtoprovidethreeshelflevels,thetoptwoinanycombinationto
provideflexibility.Theshelvesareremovableandstackforcompactstorage.Thesterilizeris
designedtousethejacketasasteamboiler.Electricimmersionheatersboilthewaterand
producesteam.Waterisretainedinthejacketofthesterilizer,andwhenitisheated,thesteam
isdirectedthroughasolenoidvalveandtubingintothechamber.Abaffledispersesthesteam
asitentersthechamber.AwaterlevelsightglassislocatedattherearoftheSMU.Alow‐water
cutoffswitchisprovidedforprotectionoftheelectricheatingelements.Inaddition,asa
3

secondarysafeguard,theunitisequippedwithaHighTemperatureLimitSwitchtoturnoffpower
totheheatersandPLC.HotcondensateexitstheSMUtotheWRSthroughachamberdrain
screen,drainmanifold,andhose.AirandsteamcanexhaustrapidlytotheWRSthroughthe
samedrainmanifoldviahosesandthevacuum/exhaustsolenoidvalve.TheWRSsitsunderneath
theSMUandhasthreemainpurposes:(1)tocaptureexhauststeamandcondensate,thus
creatingaclosed‐loopsystemtoreclaimnearlyallthewaterusedduringsterilization,(2)tocool
andthenpumptherecoveredwaterbacktotheboilerforreuse,and(3)togeneratevacuum
throughawatereductorforthepre‐andpost‐vacphasesofoperation.

2.2SpecificationsandPhysicalData

SterilizerMainUnit(SMU):
Electricalratings208‐230VAC,3phase,30amps,50/60Hz
Sterilizingtemperature  270°F(132°C)
Pre‐vacuumphase3pressure/vacuumpulses
Maximumworkingpressure/vacuum40psig/fullvacuum
Electricalreceptacle  MIL‐C‐22992cordconnectingclassL
Length(endcapsclosedfortransport)46.00”
Length(endcapsopenforoperation)38.00”
Width26.75”
Height(endcapsclosedfortransport)31.00”
Height(endcapsopenforoperation)62.00”
Chambersize16”diamx36”long(4.2ft3)
SMUweight(dry)306lbs.
SABweight17lbs.
Jacket(boiler)watercapacity 4.25gallons
NEMAClassification1  2–dryLocation
Operatingaltitude0–8,000feet
Operatingambienttemperature 40°F–130°F

WaterRecoverySystem(WRS):
LengthxWidthxHeight  30”x23.75”x24.5”
Weight(dry,S/N’s:AFS‐0001‐0236)170lbs.
Weight(dry,S/N’safterAFS‐0236)151lbs.
Watercapacity6gallons
Vacuumeductorcapacity  25”Hg.
Electricalratings115VAC,1phase(suppliedfromSMU)
Soundlevel78dBA
NEMAClassification1  2–drylocation

SterilizerWaterSoftener(SWS):
LengthxWidthxHeight  15”x15”x38.75”
Weight(dry)35lbs.
ElectricalPowerN/A

1NEMA2.Designedforoperationindrylocation.Protectionprovidedfromfallingdirtandwaterduringtransport/storage.
4

2.3SterilizationCycles–FDACleared

CycleRecommendedUse
Maximum
Load
Exposure
Temperature1
(°F/°C)
Exposure
Time
(minutes)
DryTime
(minutes)
Immediate
Use
(IUSS)
Unwrapped
nonporous
(e.g.,instruments)
andporousitemsin
mixedloads
36lbs.270/13240
TextilesTextilepacks3textile
packs2270/132453
Wrapped
Instruments
Wrapped
instruments/utensils36lbs.270/1324203
Wrapped
Instruments
Wrapped
instruments/utensils36lbs.270/132104203
Bowie‐Dick
TestTestNA273/1343.50
VacuumLeak
TestTestNANATesttime 200

1TheAAMIminimumtemperatureis270°F(132°C)forallcyclesexceptBowie‐Dickwhichis273°F(134°C).TheP2131
sterilizersetpointtemperatureis273°F(134°C)forallcyclesexceptBowie‐Dickwhichis274°F.
2AAMIstandard16‐towelpack(9”x9”x6”).
3Drytimesarepre‐settoestablishedstandardconditions,butcanbemanuallyincreased.
4TheFDA‐clearedProcessChallengeDevice(PCD)forthis10‐minutecyclecanbepurchasedfromFDIat
(865)408‐0100orviaemailat[email protected].ReferenceAppendixA.3foradditionalinformation
onthisPCD.



WARNING:TheP2131sterilizerdoesnotincludeasterilizationcycleforliquids.DONOT
ATTEMPTTOSTERILIZEANYLIQUIDS.
5

2.4  DescriptionofCyclePhases



SchematicofaDynamicAirRemoval(Pre‐Vac)Cycle

BelowisadescriptionofthevariousphasesofaP2131sterilizertextileorwrappedinstrument
cycle.NOTE:TheIUSScyclehasnodryphase.

1. Preconditioning(pre‐vacuum)

a. SteamFlush–Aninitialpulseofsteamisreleasedintothechamberandflows
directlyoutofthechamberintotheWRS.Thissteamflushremovesmostofthe
airfromthechamber.

b. VacuumPulse#1–Amediumvacuumispulledonthechambertoremovemore
air.

c. SteamPulse#1–Steamisreleasedintothechambertoincreasepressureand
temperaturetoheatuptheload.

d. VacuumPulse#2–Aslightlydeepervacuumispulledonthechambertoremove
evenmoreair.

e. SteamPulse#2–Steamisreleasedintothechamberagaintoincreasepressure
andtocontinueheatinguptheload.

f. VacuumPulse#3–Thisisthefinalanddeepestvacuumpulseduringwhichnearly
alloftheairisremovedfromthechamber.

2. Heatup–Duringthisphase,steamfillsthechambertobuilduppressureandtemperature
untiltheexposuretemperatureisreached.
6


3. Exposure–Steamflowingintothechamberslowsandthetemperaturesensor,PLC,and
heatersbegincontrollingthetemperatureinsidethechambersothatitstayswithina
specifiedrangeduringtheentireexposuretimeselected.

NOTE:TheP2131iscontrolledbytemperature,notbypressure,duringexposure.

4. Drying–Adeepvacuumisdrawnonthechambertoremovethesteamandresidual
moisturefromthesterilizeditems.

5. Venting–ThevacuumisreleasedbybringinginoutsideairthroughtheHEPAfiltersothe
chamberdoorcanbeopenedbytheoperator.


2.5WaterSupplyQuality

Itiscriticaltothelong‐termreliabilityandperformanceoftheP2131sterilizerthatonlypotable
water(i.e.,watersafeforhumanconsumption)shouldbeusedasthefeedwatertotheSWS.The
feedwatershouldmeetFDAbottledwatercriteriafortotalcoliform(i.e.,adisinfectantsuchas
chlorineshouldbepresent).ReferenceAppendixA.6forsuggestedmaximumvaluesof
contaminantsinthefeedwater.

TheP2131sterilizercanoperatefor14daysor100cycleswithonly10gallonsofwater.However,
theFDArequiresthatthewaterintheSMUandWRSmustbedrainedandrefilledevery14days
or100cycles(whichevercomesfirst).ReferenceSection3.4.

CAUTION:ItiscriticaltouseandmaintaintheSWS.ReferenceSections3.4and4.3.4.

Ifapressurizedpotablewatersystemisavailable,ahosecanbeconnecteddirectlytotheinlet
oftheSWS.AswaterflowsthroughtheSWS,calcium,magnesium,andothercontaminantsare
removedfromthewater,preventingdeposits(i.e.,scalebuildup)ontheheatingelements,jacket
walls,andothercomponents.Thisdeionizedwaterwillalsopreventprematurecorrosionofthe
metalcomponents.Ifapressurizedwatersystemisnotavailable,theSWSisequippedwitha
manualhandpump,suctionhose,andinletstrainer.Thiswillallowpotablewatertobemanually
pumpedfromabucketorJerrycanthroughtheSWSandintotheWRSforuseintheSMU.The
threeimportantbenefitsofusingtheSWSare:

1. Eliminatescostlysterilizerdowntimeandmaintenancelabortoreplaceheatingelements
andtoscrapeandcleantheboilersurfaces.
2. Improvessterilizercycletimesbykeepingheatuptimesshort(1.6mmofscalebuildupon
theheatingelementscausesa12%lossinheatingefficiency).
3. Improvessafetybyeliminatingthepotentialforsterilizerruptureduetolocalizedhot
spotsorprematurecorrosionthatcauseweakeningofthealuminum.
7

2.6  SterilityAssuranceProducts

FDIrecommendseitherofthetwooptionslistedbelowtoensuresuccessfulsterilizationwith
eachloadprocessed.Option1isacombinationofVERIFY™and3M®products,andOption2is
the3M®lineofproductsonly.

VERIFY™and3M®System 3M®System
4‐Minute
Exposure


ReusableProcessChallengeDevice
P/N:P2131‐1‐9003 




Class5ChemicalIntegrator
P/N:P2131‐1‐9004


1292‐BiologicalIndicator
P/N:P2131‐1‐9012 
OR


1296‐BiologicalProcessChallengeDevice
P/N:P2131‐1‐9010 


1243‐Class5ChemicalIntegrator
P/N:P2131‐1‐9011 


1292‐BiologicalIndicator
P/N:P2131‐1‐9012 
10‐
Minute
Exposure


ReusableProcessChallengeDevice
P/N:P2131‐1‐9003 


ExtendedCycleTube
P/N:P2131‐1‐9005 


1292‐BiologicalIndicator
P/N:P2131‐1‐9012 



NOTE:TherearecurrentlynootherFDA‐Cleared
PCDsfora10‐minutepre‐vacuum
cycle.
Bowie‐
DickTest




ReusableProcessChallengeDevice
P/N:P2131‐1‐9003 


BowieDickTestStrip
P/N:P2131‐1‐9006 
OR

1233L‐Bowie‐DickTestPack
P/N:P2131‐1‐9013 

NOTE:TheFDA‐clearedVERIFY™ReusableProcessChallengeDevice(PCD),alongwithotherSTERIS®products,can
bepurchasedfromFDIat(865)408‐0100orviaemailat[email protected].ReferenceAppendix
A.3foradditionalinformationonthisPCD.
8

SECTION3–OPERATION

TheP2131sterilizersystemincludesthefollowing:
1. OneSMU
(P/N:P2131‐1) 
2. OneWRS (P/N:P2131‐2) 
3. OneSWS (P/N:P2131‐3) 
4. OneSAB (P/N:P2131‐4) 







SterilizerMain
Unit(SMU)
WaterRecovery
System(WRS)
SterilizerWater
Softener(SWS)
SterilizerAccessory
Bag(SAB)
9

SterilizerAccessoryBag(SAB):

TheSABisstoredintheSMUchamberduringtransportbutcontainsitemsnecessaryforboth
setupandmaintenance.Theitemsfoundinthisbaginclude:
1. OneSterilizerAccessoryBag (P/N:P2131‐1‐7000) 
2. ThreeSMUtoWRSconnectionhoses
RecoveredWaterHose (P/N:P2131‐1‐3101) 
Vacuum/ExhaustHose (P/N:P2131‐1‐3102) 
CondensateHose (P/N:P2131‐1‐3103) 
3. Onehigh‐temperaturedrainhose (P/N:P2131‐1‐3104) 
4. Sixshelves (P/N:P2131‐1‐2002) 
5. Twelvelevelingshims (P/N:P2131‐1‐2016) 
6. HandheldTDS(TotalDissolvedSolids)Meter (P/N:P2131‐3‐9010) 
7. Twenty‐fivesparehosefittingO‐rings (P/N:P2131‐1‐3408) 
8. OnesparedoorO‐ringgasket (P/N:P2131‐1‐1029) 
9. Threespare30‐ampfuses (P/N:P2131‐1‐4012) andthreespare750‐milliampfuses
(P/N:P2131‐1‐4013) inrigidplasticcontainer
10. Onesetupmulti‐toolforS/N’sAFS‐0001throughAFS‐0215 (P/N:P2131‐1‐2020) 
 *ForS/N’safterAFS‐0215,themulti‐toolisstoredintherearendcap 
11. OneTechnicalManualwithadigitalversiononCD (P/N:P2131‐1‐8001) 
12. OneMicroSDw/adapter (P/N:P2131‐1‐4020) andMicroSDextender (P/N:P2131‐1‐4028) 
13. FivespareChamberDrainScreenO‐rings (P/N:P2131‐1‐1150)
 ForS/N’sAFS‐0001throughAFS‐0203:ChamberDrainScreenisinSAB.(P/N:P2131‐1‐0019).
 *ForS/N’safterAFS‐0203,ChamberDrainScreenisstoredinchamberandsnapsinwithO‐ring.
14. Fiftywaterchlorinelevelteststrips (P/N:P2131‐3‐9007) 
 AfterAFS‐0236,waterchlorinelevelteststripsincludedinSAB.
15. OneHTS‐1TestJumper (P/N:P2131‐1‐4034) 
16. OneSpareDeionizedHousingO‐ring (P/N:P2131‐3‐9011) 

1
2
3
4
5
7 8
9
*10
12
11
*13
14
6 15 16
10

3.1INSTALLATION,SETUP,ANDQUALIFICATION(IQ,OQ,PQ)





1. TheP2131sterilizerisdesignedtobecarriedby6people.





2. PlacetheSMUononeofitsends.





WARNING:Topreventpotentialinjuriesduringtransport,installationandsetup,FDI
recommendsasix‐personteamliftfortheSMUandafour‐personteamliftforthe
WRS.
11


3. Unlockthetwolatchesholdingtheendcapagainstthemainframe.



4. HoldingsecurelyontotheSIDESoftheendcap,slowlypivottheendcaptothefullyopen
position(donotallowendcaptodrop).


 


5.Oneachside,screwtheblackendcapknobsdownsecurely.Ensuretheendcapknobsare
fullyseatedbycheckingtoseeifthewhitewasherinbetweentheknobandthespringdoes
notspin.Donotovertighten.


WARNING:Apotentialpinchpointexistsnearthehingeareaoftheendcap.Itisvery
importanttokeephandspositionedontheSIDESoftheendcapandaway
fromthepinchpoint.
Properhand
placementisontheside
oftheendcap,away
fromthepinchpoint.
Thiswillhelpavoidinjury
whenopeningthe
endcap.
Placingyourhand
nearthehingecanresult
ininjury.Keephands
positionedonthesides
oftheendcapandaway
fromthepinchpoint.
12

6. TilttheSMUdownontotheendcapthatwasjustopened.




7.PositiononepersononeachsideoftheSMU.Usingtheside‐carryhandles,liftthe
unopenedendoftheunit,pivotingontheendcapthatisalreadyopenedandsecured.As
theSMUisraisedintoposition,resttheweightoftheunitonyourthigh,allowingyouto
unlockthetwolatchesholdingtheendcapagainstthemainframe.Ifathirdpersonis
availabletohelp,theyshouldbepositionedattheendoftheSMUtohelpunlockthe
latches.






13

8.Onceunlocked,slowlylowertheendcapintoposition(donotallowendcaptodrop).



 

9.Oncetheendcapisloweredintoposition,screwthetwoblackendcapknobsdown
securely.Ensuretheendcapknobsarefullyseatedbycheckingtoseeifthewhitewasher
inbetweentheknobandthespringdoesnotspin.Donotovertighten.



10. RemovetheSABfromthechamberoftheSMU.TheSABcontainsitemsnecessaryto
completetheassemblyoftheunit.RefertoSection3.2.1–ChamberDoorOperationfor
instructionsonoperatingthechamberdoor.Themulti‐toolisstoredintherearendcap
andwillalsobeused(forS/N’sAFS‐0001throughAFS‐0215,themulti‐toolisintheSAB). 


WARNING:Apotentialpinchpointexistsnearthehingeareaoftheendcap.Itis
 veryimportanttokeephandspositionedontheSIDESoftheendcap.
Multi‐tool
(P/N:P2131‐1‐2020)
14