Pl MPlazMax

AdvantagesofPlasmaTechnology

LowTemperatureSterilization

CansterilizeheatsensitiveloadsthatcannotbesubjectedtosteamjLowenergyrequirementsL tilit i t ( l t ili i t d l t i it )Lowutilityrequirements(onlysterilizingagentandelectricity)

Nodryingstage

Noventilationneeded(likeEtO)

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Pl MPlazMax

CostEffective

Aftersterilizationloadsaredryandavailableforimmediateuseorstoragewhichreducestheneedforexpensivebackupinventories.Itisrecommendedtowaitforasuccessfulbiologicaltestbeforeusingthesterilizedloads.

Sterilizedloadscanremaininpackaging(noneedforrepackaging)FastturnaroundmeansincreasedinventoryutilizationGentlesterilizationextendsyourinstrumentsusefullifespanbyminimizingdamageandreducingcostlyrepairorreplacement

Environmentallyfriendlyduetonowaterconsumption,notoxicexhaust,and low electric power needs

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andlowelectricpowerneeds

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What is Plasma?WhatisPlasma?

PlasmawasnamedafteranAmericanphysicist,IrvingLangmuir.When gas is applied with a greater energy it turns intoWhengasisappliedwithagreaterenergy,itturnsintoplasmawithionizedelements,whicharedifferentfromthepriorphases.Asthenumberofpositiveandnegativeionscompensates eachother,theoverallelectricalpropertyofplasma.isneutralizedelectrical property of plasma. is neutrali edPlasmaisknownasthefourthstateofmatterand99%ofallthematerialsinspaceisknowntobeplasma.Solidhasthelowestenergyamongstalltypesofmatter.Whensolidacquiresheat(energy),ittransformstophasesofliquidq ( gy) p qandgas,sequentially.

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TheapplicationofPlasmainPlazMaxHowissterilizationaccomplishedwithH2O2?

The PlazMax utilizes the microbicidal (bacterium killing) power of free radicalsThePlazMaxutilizesthemicrobicidal(bacteriumkilling)poweroffreeradicalsreleasedbyapplyingenergy(heatingliquidintogasviathevaporizer)tohydrogenperoxide.Bydefinition,afreeradicalisanyatom(e.g.oxygen,nitrogen)withatleastoneunpairedelectronintheoutermostshell,andiscapableofindependentexistencep , p p

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The application of Plasma in PlazMaxTheapplicationofPlasmainPlazMax

A free radical is easily formed when a covalent

Hydroxyl(OH)Freeradical

Afreeradicaliseasilyformedwhenacovalentbondbetweenentitiesisbroken(duetoheatinginourcase)andoneelectronremainswitheachnewlyformedatom.Whenfreeradicalsstealanelectronfromasurrounding compound or molecule a new free radical is formed in its place.surroundingcompoundormoleculeanewfreeradicalisformedinitsplace.Inturnthenewlyformedradicalthenlookstoreturntoitsgroundstatebystealingelectronswithantiparallelspinsfromcellularstructuresormolecules.Thus,thechainreactioncontinuesandcanbe"thousandofeventslong, gHydrogenperoxideisuniqueinthatitcanbeconvertedtotheHydroxylradical(OH)orbecatalyzed(withtheBurnerinourcase)andexcretedharmlesslyaswaterand/oroxygen

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The application of Plasma in PlazMaxTheapplicationofPlasmainPlazMax

ThesterilizingagentinPlazMaxisH2O2,namely Hydrogen Peroxidenamely,HydrogenPeroxide.Hydrogenperoxidewasfirstisolatedin1818byLouisJacquesThnard,andH2O2 haslongbeenwidelyusedinthepharmaceuticalindustry.Hydrogen peroxide has been utilized for a decade or more in a wide variety ofHydrogenperoxidehasbeenutilizedforadecadeormoreinawidevarietyoffacilitiesandhasprovencompatiblewithmaterialsincludingsensitiveelectronics,microscopes,stainlesssteel,andHEPAfilters.

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The application of Plasma in PlazMaxTheapplicationofPlasmainPlazMax

ApplyingenergycausesalterationofOH(Hydroxyl)fromabonderbetweenthemoleculesintheliquidstateintoafreeradicalinthegasstate

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Free

Radical

ExampleofanElectronstealingfromthebacteriabythefreeradical

Bacteria FreeBacteriaRadicals

Afterthealteration,theBacteriaceasestofunctionasBacteriaandbecomesafreeradicalofitsown.Asone,stealsanElectronfromanotherBacteria,andaltersittoafreeradicalandsoforth.AchainreactionoccurseffectinganddestroyingallBacteriumandthus,sterilizingthematerial.

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The application of Plasma in PlazMaxTheapplicationofPlasmainPlazMax

The Plasma application is used in the Plazmax expressed by utilizing the BurnerThePlasmaapplicationisusedinthePlazmax,expressedbyutilizingthe BurnerItspurposeistobreaktheH2O2 moleculesdownafterthesterilizingphase.Thesystemconsistsofahighvoltagegenerator,whichapplieshighvoltage to two electrodes located a few millimetres apart from each othervoltagetotwoelectrodeslocatedafewmillimetresapartfromeachotherInsidetheBurner.

Whenhighvoltageisappliedtotheelectricplatesfacingeachother,g g pp p g ,theH2O2 thatpassesthroughthespacebetweentheplatesisionizedandPlasmaisgeneratedandbreaksdownthegasintomoleculesofwaterandoxygen.

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The application of Plasma in PlazMaxTheapplicationofPlasmainPlazMax

Vaporized Hydrogen Peroxide (H2O2) (A)Vaporized Hydrogen Peroxide (H2O2) (A)

HighVoltage

Plasmao tage(B)

(C)

GND2H2O (Water) + O2 (Oxygen)

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The application of Plasma in PlazMaxTheapplicationofPlasmainPlazMax

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Cycle graphsCyclegraphs

Normalcycle

Averagecycletemp.50C

1000mBar

Preparation

Aeration

Exhaustion

PreparationFor

diffusionDiffusion

1Plasma

1

PreparationFor

diffusion

Diffusion2

Plasma2

0Vaporization

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Cycle graphsCyclegraphs

Advancedcycle

Averagecycletemp.50C

1000mBar

Preparation

Aeration

Exhaustion

PreparationFor

diffusionDiffusion

1Plasma

1

PreparationFor

diffusion

Diffusion2

Plasma2

0Vaporization

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Cyclegraphsy g p

Preparation

EndoscopecycleAveragecycletemp.40C

1000mBar

Fordiffusion

Aeration

Exhaustion

PreparationFor

diffusion

Diffusion1

Plasma1

Diffusion2

Plasma2

0

Vaporization

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Cyclegraphsy g pLeakagetest

1000mBar

Achievingdeep vacuum Chamberissealedandmonitoredforleaks

Thelinerepresentstheallowedlimitofpressureincrease

0p

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Cyclegraphsy g pPenetrationtest

1000mBar

Aeration

Exhaustion PreparationFor

diffusion

Diffusion Plasma

00

Vaporization

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Cyclegraphsy g pPenetration&leaktestcombined

1000mBar Achievingdeepvacuum

Chamberissealedandmonitoredforleaks

PreparationFor

diffusion

Diffusion

Plasma Aeration

0Vaporization

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Indicators&consumables

Biologicalindicator

TheBiologicalindicatorcontainsadefinedquantityofinoculatedsporesinpopulationof1.9x10,placedonastainlesssteeldisc.The BI (biological indicator) has a breakable glass ampouleTheBI(biologicalindicator)hasabreakableglassampoulewhichincludesaculturemediatoallowthegrowthofthespores.Thediscandtheampoulearebothplacedinsideaplastictube.The BI has a chemical indicator which will indicate if the BITheBIhasachemicalindicator,whichwillindicateiftheBIwasexposedtoH2O2.TheBIisdesignedforhydrogenperoxideplasmasterilizationprocesses,andutilizesGeobacillusStearothermophilusspores.As the spores are highly resistant sterilizing them serves as aAsthesporesarehighlyresistant,sterilizingthemservesasagoodindicationofthePlazMaxabilities.

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Indicators&consumables

Biologicalindicator

Plastic tube

Cap

Plastictube

Breakableglassampoule

DiscinoculatedwithsporesExposedtoH2O2andsterilized

ExposedtoH2O2andwasnotsterilized

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Indicators&consumables

Incubators

Th i b t i d i d t t i th BI d l th t tTheincubatorisdesignedtocontaintheBIsandsupplythecorrectamountofheatneededforthesporestogrow.Wecurrentlyhave24hoursresultsusingthestandardBrownincubator,During the coming weeks we should have the Smart well incubatorDuringthecomingweeksweshouldhavetheSmartwellincubator,Whichincludesprinter,touchscreenandresultsgatheredin610hours.

Smart Well incubatorBrownincubator

SmartWellincubator

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Indicators&consumables

Chemicalindicator

ThechemicalindicatorIndicatesthatthesterilizingagentunderwentexposure.IfitwasexposedtoH2O2 thecolorwillchangefrompurpletopink..

H OH2O2

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Indicators&consumables

ChemicalTape

Thechemicaltapehastwoapplications:1. IndicatesexposuretoH2O2.2. TapesareusedtoclosepolypropylenePackagingmaterials

BeforeAfter

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Indicators&consumablesLumensPCDkit

Monitoringthesterilizationprocesscanbeperformedwithflexiblelumenkits.Th PCD (P Ch ll D i ) ki i 4 fl ibl lThePCD(ProcessChallengeDevice)kitcontains4flexiblelumens;2withopeningsonbothsides,And2withopeningsononeside:

10meterLumen:Consistsofacylinderforpositioningtheindicators.Oneachsideofthecylinderisalumenof5meterslongwith1mmdiameter.g

5meterLumen:

Consistsofacylinderforpositioningtheindicators.Ony p geachsideofthecylinderisalumenof2,5meterslongwith1mmdiameter.

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Indicators&consumablesLumensPCDkit

3meterLumen:

Consistsofacylinderforpositioningtheindicators.It is sealed on one end with a lumen of 3 metersItissealedononeendwithalumenof3meterslongwith1mmdiameterontheotherside.

2meterLumen:

Consistsofacylinderforpositioningtheindicators.Itissealedononeofthesideswithalumenof2meterslongwith1mmdiameterontheotherside.

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Indicators&consumables

LumensPCDkit

PCD di t ib ti di t lPCDsusagedistributionaccordingtocycles:

AdvancedCycle 4PCDs(10meters,5meters,3metersand2meters)Normal Cycle 2 PCDs (5 meters and 2 meters)NormalCycle 2PCD s(5metersand2meters)EndoscopesCycle 4PCDs(10meters,5meters,3metersand2meters)PenetrationCycle 2PCDs(5metersand2meters)

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Indicators&consumables

Packagingmaterials

TyvecReels TyvecPouches

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Pl MPlazMax

Sterilizingagentconsumption

H2O2 Bottle cat. no. Supplier cat. No.

PlazMax Model No. of cycles

PLZ094-0001 AS040400 P50 12

PLZ094-0002 AS080400 P80 7

PLZ094-0003 AS100400 P110 5

PLZ094-0004 AS150400 P160 4

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Pl M d i i J&JPlazMaxadvantagesincomparisontoJ&J

Cycleduration:1.Shortercycledurationscomparedtoboth100s&NXsystems:

Cycle name Tuttnauer J&JCyclename Tuttnauer J&J

Tuttnauer J&J PlazMax NX system 100s

Normal Standard 26Min. 28Min. 51Min.

Advanced Advanced 34Min. 38Min. 72Min.

EndoscopeNotApplicable

25Min.NA NA

Applicable

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Pl M d i i J&JPlazMaxadvantagesincomparisontoJ&J

Testcycles:3testcyclesincomparisontononeonJ&J,Theyclaimtodoitaspartofthecycle wereachdeepervacuumonatestcycleh h i l iThantheoperationcyclessetpoints.

Installation:V t i t ll l 1 h 230 i d i l i t d dVeryeasytoinstall;only1phase230vrequired,nospecialrequirementsneededfromtheclient.

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Pl M d i i J&JPlazMaxadvantagesincomparisontoJ&J

Endoscopecycle:WeofferaspecificcycleforEndoscopes,J&JperformitontheiradvancedcycleatahighertemperatureandexposuretoH2O2.

Theshortcycletimehelpsinsurethatnodamagingmethodisapplied

Add d l l (4th l )Addedvaluecycle(4th cycle):WegivetheabilitytosuitaspecialneededprogramtospecificinstrumentsthatwillallowTheclienttomonitortheminaccordancetothestrictmanufacturerlimitations.

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Pl M d i i J&JPlazMaxadvantagesincomparisontoJ&J

Flexibility:Themachinescanbechangedfromsingledoorintoa2doormachineduetotheDesignappliedandtheupgradecanbeperformedonsite.

Comfortableoperation:UnlikeJ&Jthechamberisnotsensitivetotouch.O ti i d d t bli th li t t t k i lOperatingisveryeasyanddoesnotobliges theclienttotakespecialcareintheloadpositioning.

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Pl M d i i J&JPlazMaxadvantagesincomparisontoJ&J

H2O2decomposingmethod:J&Jperformthedecomposinginthechamber.Itislessreliablethanoursystemthatforceallparticlesthroughtheburneranddecompose.

Maintenancecosts:UnlikeJ&JthatchargebigamountsonmaintenancekitsandserviceagreementsO i t t i l t d l b hOurmaintenancesystemrequireslesspartsandlaborhours.

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Pl M d i i J&JPlazMaxadvantagesincomparisontoJ&J

CompleteCSSDsolution:TuttnauerhastheabilitytoprovidefullCSSDsolutionandturnkeyprojectsUnlikeJ&Jthathasnoothertechnologies.

UseableVolume:

I i t 100 d l th t h d d h bIncomparisonto100smodelthathasroundedchambers,resultinginalossofabout30%involume,weofferarectangularchamberwithfullusablevolume.In comparison to NX system that has an inner casing we have also an advantage onIncomparisontoNXsystemthathasaninnercasing,wehavealsoanadvantageonof15%usablevolume.

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sPlazMax

Materials that can be sterilized by PlazMax

Common materials to sterilize with Plasma:Common materials to sterilize with Plasma:Stainless steelPolyethyleneTeflonTeflon

MetalsStainless steel 300 seriesAluminum 6000 seriesTitanium

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Non-Metals

PlazMaxMaterials that can be sterilized by PlazMax

NonMetals

Acrylnitritebutadienestyrene(ABS)DelrinEVA(Etheylvinylacetate)Fluorinated ethylene propylene (PTFE)

PolycarbonatePolyethyleneterephthalate(PET)Polymethylmethacrylate(PMMA)Polyphenyl sulfoneFluorinatedethylenepropylene(PTFE)

Glass,USPtypeIborosilicateLowdensitypolyethyleneLatexLow density polyethylene

PolyphenylsulfonePolypropylenePolystyrenePolysulfoneTeflon (PTFE)Lowdensitypolyethylene

MonelNeoprenerubber(polychloroprene)NylonPhenolic resin

Teflon(PTFE)PolyurethanePolyvinylchloride(PVC)Silicone

Phenolicresin

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PlazMax

MaterialsthatcannotbesterilizedbythePlazMax

Paper(butverysmallamountsofpaperarepossible.e.g:smallbarcodelabel).Absorbentmaterials(cellulose) Wood linen paper spongy materialsWood,linen,paper,spongymaterialsLiquidsPowder OilOilInstrumentswithlumen,havinglessthan1mmdiameterand/orover10mlength

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Whatever your application may be, Tuttnauer makes the right A t l ith th i ht it !Autoclave with the right capacity !

Tuttnauer Europe b.v.

Paardeweide 36 P.O.B. 7191

4800 GD Breda, The Netherlands

Tuttnauer USA Co. Ltd.

25 Power Drive Hauppauge, NY,11788,USA

Tel: (31) 76 5423510,

Fax: (31) 76 5423540

Email: tuttnauer@tip.nl

Tel: (631) 737 48 50, (800) 624 5836

Fax: (631) 737 07 20

Email: info@tuttnauer.com

98www.tuttnauer.com www.tuttnauer.com

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