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