Part No. 20003 Rev - 01 Part No. 20732 Rev-022014-02

Operation and Maintenance Manual(English)

User ResponsibilityThis Product will perform in conformity with the description contained in this operating manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This Product must be checked prior to use following the Pre-Use Checkout procedure described in section 3. A defective Product should not be used. Parts that are broken, missing, visibly worn, distorted or contaminated should be replaced immediately.

Should such repair or replacement become necessary, the manufacturer recommends that a telephone request for service advice be made to the local distributor. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by the manufacturer or local distributor. The Product must not be altered. The user of this Product shall have the sole responsibility for any malfunction which results

from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Mallinckrodt Representatives.

Outside the U.S.A. and Canada, check local laws for any restrictions that may apply. Caution: U.S. Federal and Canadian law restrict this device to sale by or on the order of a licensed medical practitioner.

Inhaled Nitric Oxide mixtures must be handled and stored in compliance with federal, state and local regulations.

These products have unit serial numbers with coded logic which indicate the year of manufacture and a sequential unit number for identification.

Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademark of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owner. ©2016 Mallinckrodt

BL 20051234 The first two digits indicate the product, the next four numeric digits indicate the year of manufacture, and the next four digits are the sequential unit number produced that year.

10026 INOblender (DISS, 800 ppm, English)10004 INOblender (DISS, 800 ppm, English)10021 INOblender (NIST, 400 ppm, English)10070 INOblender (NIST, 800 ppm, English)

Part No. 20732 Rev-022014-02

Part No. 20732 Rev-022014-02

1

1. General Information .............................................................................................................3 Introduction .......................................................................................................................4 DefinitionsandAbbreviations ...........................................................................................4 Theory of Operation ..........................................................................................................5 EnvironmentalEffects .......................................................................................................6

2. Setup ...................................................................................................................................7

3. Pre-UseCheckout ...............................................................................................................9

4. Operation ...........................................................................................................................12

5. Maintenance ......................................................................................................................15 ReplacingRegulatorTips................................................................................................16 CylinderLeakCheck.......................................................................................................18 PartsandAccessories ....................................................................................................19

6. Specifications.....................................................................................................................21

Contents

Part No. 20732 Rev-022014-02

2

(Intentionallyleftblank)

Part No. 20003 Rev - 01 Part No. 20732 Rev-022014-02

1/ General Information

General

Information

Part No. 20732 Rev-022014-02

1/ General Information

Gen

eral

Info

rmat

ion

Part No. 20732 Rev-022014-02

3

CautionsandWarningsWARNINGS:• The purge procedure must be followed

to help ensure NO2 is purged from the pressure regulator, INOblender and hoses before the manual resuscitator bag or nasal cannula is connected to the patient. The manual bag should be squeezed repeatedly during use to avoid NO2 building up in the bag. If the bag is not squeezed repeatedly while delivering INOMAX the bag should be removed from the patient and the purge procedure performed before continuing.

• The INOblender should only be used in accordance with the indications, usage, contraindications, warnings and precautions described in the INOMAX drug package insert and labeling. Refer to this material prior to use.

• Persons using this device should be trained on and experienced in the use of this device to assure effective administration of INOMAX and to avoid injury to the patient or others resulting from inhalation of excess INOMAX, nitrogen dioxide or other reaction products.

• The National Institute for Occupational Safety and Health (NIOSH) in the U.S. has a recommended time-weighted (8 hours) average concentration of 25 ppm for NO and a limit of 1 ppm for NO2. Persons using the INOblender who may be particularly sensitive to NO or NO2, or who may be exposed to these agents for prolonged periods as a result of the use of this device, should be aware that the INOblender does not scavenge the exhaust drug, and that this is vented at the resuscitator bag. Ambient concentrations of NO or NO2 are expected to be less than 0.2 ppm when using the INOblender, see Section 1 Environmental Effects.

Cautions:•OutsidetheU.S.andCanada,checklocallawsforanyrestrictionsthatmayapply. U.S.federallawandCanadianlawrestrictthisdevicetosalebyorontheorderofalicensedmedical practitioner.

•Properuseofthisproductdependsoncarefulreadingandunderstandingoflabelingandinstructions.

•Tohelpensureproperoperationofthisproduct,completethepre-usecheckoutpriortoeachuse.

•Whennotinuse,theO2flowmeterandtheINOMAXcylindervalveshouldbeturnedoff.

•Whencleaning,donotsubmergeinliquid.

•Donotautoclave.

•Refertothemanufacturer’sproceduresforusingtheresuscitationbag.

WARNING:Warnings tell you about dangerous conditions that can cause injury to the operator or the patient if you do not obey all of the instructions in this manual.

Caution:Cautionstellyouabouthowtoproperlyusetheequipmentandconditionsthatcouldcausedamagetotheequipment.

Readandobeyallwarningsandcautions.

Note:Notesprovideclarificationorsupplementalinformation.

Bluearrowdenotesrequireduseraction.

Part No. 20732 Rev-022014-02

4

Pneumatic Outlet

Rx ONLY Prescriptionuseonly

Pressure

Productpackagingisabletobe recycled

Protectfromheatandradioactivesources

SN SerialNumber

StorageTemperatureLimitation

StorageHumidityLimitation

ThisproductisincompliancewiththeEuropeanCouncilDirective93/42/EECanditsamendmentsconcerningmedicaldevices

Attention,consultaccompanyingdocuments!

AuthorizedRepresentativeintheEuropeanCommunity

CatalogNumber

Date of Manufacture

Fragile,handlewithcare

Keep Dry

Manufacturer

NO or O2GasInlet

NOGasOutlet

Pneumatic Inlet

IntroductionTheINOblenderallowsuserstoselectaconcentrationofINOMAX,(nitricoxideinabalanceofnitrogen),tobemixedintoausersetflowofoxygenwhichisdeliveredtoapatient.TheintendedusefortheINOblenderisasabackuptoaprimaryINOMAXdeliverysystem;orforshorttermattendedusewhenaprimarydeliverydevicecannotpracticablybeused.Thisintendeduseincludesapplicationswithinamedicalfacilityandtransportoutsideofamedicalfacility.TheINOblenderisnotintendedforuseasaprimaryINOMAXdeliverysystemforlongtermuse.

Definitions and abbreviationsN2 NitrogenNO INOMAX(nitricoxide)forinhalationNO2 NitrogendioxideNO/N2 Nitricoxide(NO)andnitrogen(N2)gasmixtureO2 Oxygenppm PartsPerMillionSet NO ThedoseofINOMAXsetbytheuserv/v Volumetovolume

Note:ThismanualshowstheSetNOdisplaysassociatedwiththe0-80ppmrange.

Symbols used in this manual or on the systemSymbolsreplacewordsontheequipmentand/orinthismanual.Thesesymbolsinclude:

Part No. 20732 Rev-022014-02

5

INOblender Schematic Diagram

Theory of Operation1. TheINOblenderconnectstoa3-5bar(45-75psig)oxygensupply.Theoxygenflowisthen

controlledbyanintegratedoxygenflowmeter(2-14lpm).Thereisafixedrestrictorintheoxygenflowpathwhichcreatesapressureproportionaltotheoxygenflowrate.

2. TheINOblenderisalsoconnectedtoa2bar(30psig)INOMAX(800ppmor400ppm)supply.

• The INOMAXflowiscontrolledbyabalanceregulatorinproportiontotheoxygenpressurecausedbythefixedrestrictorandtheINOblendersetting.

•ThebalanceregulatormaintainsaconstantINOMAXdoseforvaryingoxygenflowrates.

3. TheflowsofO2 and INOMAXaremixedpriortoexitingtheINOblenderoutlet.

INOMAXCylinder

INOMAXRegulator

OxygenSource

BalanceRegulator

Dose Knob

INOMAX andO2 Outlet

Fixed LaminarRestrictor

INOMAXOxygenOxygen/INOMAX

Part No. 20732 Rev-022014-02

6

EnvironmentalEffectsTheNationalInstituteforOccupationalSafetyandHealth(NIOSH)hasrecommendedexposurelimitsasfollows(ref1).

NO time-weighted(8hours)average concentration limit of 25 ppm

NO2 ceiling limit of 1 ppm.

Theenvironmentalbuildupofnitricoxide in a well ventilatedICUroomcanbeevaluatedusingthefollowingcalculation:

Roomsize 10ftsquare(approx.3meters)

Roomvolume 27,000L of air

Roomventilation 2,700L/min at 6 room changes/hr

NOflowintoroom 14L/minat80ppm

Averageroom 80x14/2,700=0.4ppmofNO concentration of NO

ThistheoreticcalculationcanbesupplementedbymeasurementsasperformedbyHessetal.TheNO and NO2concentrationsweremeasuredusingachemiluminescenceanalyzerwhen100ppmofNOat8L/minwasdeliveredintoaroomwithnoscavengingbeingused.ThemaximumNO and NO2 concentrationsmeasuredoveraone-hourperiodwere0.12ppmofNOand0.03ppmofNO2.

Bothmethodsshowthattheexposurelevelsaresignificantlylessthanthelevelsrecommended byNIOSH.

IfthelocationforusingNOhasuncertainventilation,thenthelocationshouldbeevaluatedforNO and NO2builduppriortouse.

Ref. 1 Centers for Disease Control, Atlanta, GA 30333 USA. NIOSH Recommendations for Occupational Safety and Health Standards 1988. August 26, 1988 / vol. 37 /No. 9.

Ref. 2 Hess et al, Use of Inhaled Nitric Oxide in patients with Acute Respiratory Distress Syndrome, Respiratory Care, 1996, vol. 41, No 5, pg. 424-446.

Part No. 20003 Rev - 01 Part No. 20732 Rev-022014-02

2/ Setup

Setup

Part No. 20732 Rev-022014-02

2/ Setup

Setu

p

Part No. 20732 Rev-022014-02

7

SetupChecktheINOMAXgascylinderforthecorrectproductidentitylabels,cylinderconcentration(800or400ppm)andexpirationdate.EnsuretheINOMAXgascylinderhas>14bar(200psig).

1.Connectahigh-pressureregulatortoan INOMAXcylinderandhandtightenthefitting totheINOMAXcylinder.

2.ConnecttheINOMAXregulatorhosetothe INOblenderinlethoseusingthequick connectfittings.

3.ConnecttheoxygensupplytotheO2 inlet fitting.(seepartlistforcorrectoxygenhose) Note:3.5bar(50psig)nominal

1.MakesuretheNOdosesettingdialis turnedtozero.

2.Attachamanualresuscitationbagtothe INOblenderoutletfitting.

Tooxygensource

TheINOblenderisnowsetup.ProceedtoSection3/Pre-useCheckout.

1

23

1

2

Note: •FortheCGA-typeINOMAXregulatorconnector,ensurethewhiteplastictipisnotchippedorcracked.Removeandreplaceasnecessary.(seeReplacingthetipontheINOMAXregulator,Page16).

•FortheISO-typeregulatorconnector,checkthattheO-ringispresentandisnotdamaged(seeReplacingthetipontheINOMAXregulator,Page17).

Part No. 20732 Rev-022014-02

8

(Intentionallyleftblank)

Part No. 20003 Rev - 01 Part No. 20732 Rev-022014-02

3/ Pre-Use Checkout

Pre-U

se Checkout

Part No. 20732 Rev-022014-02

3/ Pre-Use Checkout

Pre

-Use

Che

ckou

t

Part No. 20732 Rev-022014-02

9

Pre-useCheckout

High-Pressure Leak Test

1.MakesureNOdosesettingdialisturnedtozeroandflowmeterisOFF.

2.Openandthenclosethecylindervalve.3.Pressuregaugeshouldindicate>14bar (200psig).

4.Monitorpressuregaugefor30secondsforanysignsofpressuredecrease.Ifnopressuredecreaseisobserved,high-pressureleaktestsuccessful,proceedtoDeliveryConfirmationand Purge.

5.Ifobservedpressuredecreasecontinues,seeSection5/Maintenance;CylinderLeakCheck.

6.Ifleakcannotbetraced,replacetheINOblender.

Delivery Confirmation and Purge

1.SettheINOblenderto40ppmwhenusingan 800ppmcylinder(20ppmwhenusinga400 ppmcylinder).

2.SettheoxygenflowontheINOblenderflow meterto10L/mintobeginpurge.

3.Ensurethepressuregaugedecreases approximately14bar(200psig)in10seconds (+2sec.).

4.Continuepurginguntilpressuregauge readszero.

Caution: Tohelpensureproperoperation,completethepre-usecheckoutpriortoeachuse.

Set-uptheINOblenderasdescribedinSection2/Setup

TheINOblenderisnowreadyforuse.ProceedtoSection4/Operation.

2

3

1

2

4 Note: Ifthepressuredoesnotdecrease,then

theINOblenderisnotdeliveringNOandtheINOblendershouldbereplaced.

3

Part No. 20732 Rev-022014-02

10

(Intentionallyleftblank)

Part No. 20003 Rev - 01 Part No. 20732 Rev-022014-02

4/ Operation

Operation

Part No. 20732 Rev-022014-02

4/ Operation

Ope

ration

Part No. 20732 Rev-022014-02

11

(Intentionallyleftblank)

Part No. 20732 Rev-022014-02

12

Operation

Cautions:• Whennotinuse,theoxygenflowmeterandtheINOMAXcylindervalveshouldbeturnedoff.

• WhentheINOblenderisusedwithanoxygen/airblender:

- ThespecificationforINOMAXdeliverywhenusingtheINOblenderwith100%oxygenis+/-20%ofsettingor2ppm(whicheverisgreater).Theuseof100%oxygenat3.4bar(50psig)isthelabeledspecificationfortheINOblender.

- Ausermaydeterminethatsomeclinicalconditionsmaynecessitatetheuseofanoxygen/airblenderwiththeINOblendertoachieveFiO2levelslessthan100%.

- Usingoxygen/airmixtures(21%to95%v/v)willreducethedeliveredNOconcentrationbyupto10%ofsettingor1ppm(whicheverisgreater)comparedtousing100%oxygenalone,resultinginacumulativeerrorupto+/-30%ofsettingor3ppm(whicheverisgreater).

• Refertothemanufacturer’sprocedureswhenusingthemanualresuscitatorbag.• Whenfinished,turntheNOcylindervalveOFFandallowtheoxygentoflowuntiltheNOpressuregaugereadszero,thenturntheoxygenflowOFF.

WARNINGS:• The purge procedure must be followed to help ensure NO2 is purged from the system before the

manual resuscitator bag is connected to the patient.

• The manual bag should be squeezed repeatedly during use to avoid NO2 from building up in the bag.

• If the bag is not squeezed repeatedly while delivering INOMAX, the bag should be removed from the patient and the bag purge procedure performed before continuing.

• The INOblender should be upright when setting the oxygen flowrate for accurate setting.

• Do not use pneumatically powered nebulizers with the INOblender. This will result in significant over delivery of INOMAX (nitric oxide) for inhalation in excess of 80 ppm (40 ppm with a 400 ppm cylinder).

- The INOblender outlet pressure has been validated for use up to 400 millibar (5.8 psig) pressure. The amount of back-pressure generated by pneumatic nebulizers is significantly greater [1.4 - 2.0 bar (20-30 psig)] and will result in over delivery of INOMAX in excess of 80 ppm with an 800 ppm cylinder (40 ppm with a 400 ppm cylinder). The user adjusted dose setting on the INOblender will not correlate with, or have an effect on, the actual delivered dose.

- In addition, the INOblender flowmeter is not back-pressure compensated and will display a lower than actual flow rate when pressure is applied to the outlet.

Part No. 20732 Rev-022014-02

13

ThepurgeprocedurecontainedinthePre-useCheckouthelpsensureanyNO2ispurgedfromthepressureregulator,INOblenderandhosesbeforethemanualresuscitatorbagisconnectedtothepatient.

1.OpentheINOMAXcylindervalve.

2.Checkforsupplypressureof>14bar (200psig).

1

2

Adjust Settings

1.TurntheINOblendersettingdialtothe desiredconcentration(5to80ppmforan 800ppmcylinderand2.5to40ppmfora 400ppmcylinder).

2. Turn the O2flowmetertothedesiredflowrate (5to14L/min).

3.Squeezethemanualresuscitator3-4times to purge the NO2fromthesystem.

TheINOblenderisnowreadyforpatientuse.

1

2

3

Priortooperation,completethePre-UseCheckoutinSection3.

Note: DepressurizetheINOMAXregulatorbyusingthepurgeportonthebackoftheINOmaxDSIR prior toremovingfromthecylindervalve.

Part No. 20732 Rev-022014-02

14

(Intentionallyleftblank)

Part No. 20003 Rev - 01 Part No. 20732 Rev-022014-02

5/ Maintenance

Maintenance

Part No. 20732 Rev-022014-02

5/ Maintenance

Mai

nten

ance

Part No. 20732 Rev-022014-02

15

Cautions: • Whencleaning,donotsubmergeinliquid.• Donotautoclave.

Cleaning Procedure

Maintenance

CleaningAgent ActiveIngredientsPrecise Hospital Foam Cleaner DisinfectantbyCaltechIndustries

o-Phenylphenol<0.37%Otheringredients99.63%

Pure Green 24byPureGreen,LLC SDC–silverions0.003%Citricacid4.84%Otheringredients95.157%

PDI Super Sani ClothbyPDI n-Alkyl(68%C12,32%C14)dimethylethylbenzylammoniumchlorides0.25%n-Alkyl(60%C14,30%C16,5%C12,5%C18)dimethylbenzylammoniumchlorides0.25%Isopropylalcohol55%Inertingredients44.50%

Sani Cloth HBbyPDI n-Alkyl(60%C14,30%C16,5%C12,5%C18)dimethylbenzylammoniumchlorides0.07%n-Alkyl(68%C12,32%C14)dimethylethylbenzylammoniumchlorides0.07%Inertingredients99.86%

Asepti-HBbyEcolabInc. n-Alkyl(60%C14,30%C16,5%C12,5%C18)dimethylbenzylammoniumchlorides0.07%n-Alkyl(68%C12,32%C14)dimethylethylbenzylammoniumchlorides0.07%Inertingredients99.86%

Cavicide and CaviWipesbyMetrex Diisobutylphenooxyethoxyethyldimethylbenzylammoniumchloride0.28%Isopropylalcohol17.2%Inertingredients82.52%

Caution:• Applycleaningagenttoaclothbeforeapplication;donotspraycleaningagentdirectlyonthedevice. Itisimportanttopreventpoolinganddirectcontactwithopenconnectionswhichcancausedamage overtime.- CleantheoutersurfaceoftheINOblenderwithasoftclothdampenedinamildsoapandwatersolution(Example:PalmoliveUltraantibacterial,4dropsper50mLofwarmwater),isopropylalcohol(70%),orwithoneofthefollowingcleaningagentswhilefollowingthemanufacturer’srecommendations.

Note: TheINOblenderdoesnotcontainanyuserrepairableparts.

Bioquell Hydrogen Peroxide SterilantBioquellHydrogenPeroxideSterilantandhydrogenperoxidevaporgeneratorsareregulatedbytheUSEnvironmentalProtectionAgency(EPA)aspesticidechemicalsinaccordancewithFederalInsecticide,Fungicide,andRodenticideAct(FIFRA).Useoftheseproductsincleaning/disinfectionprocesseshavenotbeenvalidatedwiththeINOblender.DonotusetheseproductstodecontaminatetheINOblenderoranyancillaryproductsusedwiththeINOblender.

Part No. 20732 Rev-022014-02

16

ReplacingtheCGA626tipontheINOMAXregulator

YearlyCalibrationTheINOblendercalibrationshouldbecheckedevery12monthsusingtheNOmonitoroftheprimaryNOdeliverysystem.Thetestpointsshouldincludeallthecontrolsettingsatoxygengasflowsof5and14L/min.IftheINOblenderisoutsideoftheaccuracyspecification,itshouldnotbeused.

ContactCustomerSupportatthenumberonthebackcoverofthismanualforrepair.

Figure 5-1

1.DisconnecttheregulatorfromtheINOMAX gascylinder.

2.RemovetheoldCGA626tip(forISOsee Figure5-2)bypullingonthetip(a)andturning itcounterclockwise(b)(seeFigure5-1).

3.Ensurethethreadsarecleanonthe regulatortip(ifrequired,usealintfreecloth).

4.Installthenewtip: Flexthefourprongsbysqueezingtwoprongs atatimeusingonlyyourfingers.Thiswillhelp startthenewtipintothethreads.Turnthetip clockwisewhenthreadingthetip.Whenthe tipisfullyinserted,itshouldturnfreely.

a

b

Note: • DepressurizetheINOMAXregulatorbyusingthepurgeportonthebackoftheINOmaxDSIR prior toremovingfromthecylindervalve.

•ChecktheINOblenderandconnectionhosesforsignsofwearanddamage. •FortheCGA-typeregulatorconnector,ensurethewhiteplastictipisnotchippedorcracked.Remove

andreplaceasnecessary.(seeFigure5-1).

Part No. 20732 Rev-022014-02

17

Figure 5-2

1.DisconnecttheregulatorfromtheINOMAXtherapygascylinder.

2.RemovetheoldISOO-ringbyrollingitoffitsgroove(seeFigure5-2).

3.Cleantheconnectortip(ifrequired,usealintfreecloth).

4.RollthenewO-ringintoitsgroove.Whencorrectlyinstalled,itshouldnotberemovablebyturningit.

Caution: DonotusehardobjectstoremovetheO-ringastheymaydamagethemetalglandand causealeak.

O-ring

Gland

ReplacingtheO-ringontheISO5145INOMAXregulatorfitting

Note: DepressurizetheINOMAXregulatorbyusingthepurgeportonthebackoftheINOmaxDSIRpriortoremovingfromthecylindervalve.

Note: • DepressurizetheINOMAXregulatorbyusingthepurgeportonthebackoftheINOmaxDSIR prior toremovingfromthecylindervalve.

•ChecktheINOblenderandconnectionhosesforsignsofwearanddamage. •FortheISO-typeregulatorconnector,checkthattheO-ringispresentandisnotdamaged

(seeFigure5-2).

Part No. 20732 Rev-022014-02

18

CylinderLeakCheckIfaleakissuspectedduringthehigh-pressureleaktest(seeSection3/Pre-UseCheckout;HighPressureLeakTest),thefollowingstepscanbetakentocheckforleaks(seeFigure5-3forpossiblecylindergasleaklocations)intheINOMAXregulatororINOMAXcylinder.

Figure 5-3

1. CylinderValveRegulatorConnection2. INOMAXRegulatorHandWheelConnection3. RegulatorEndCapConnection4. TamperEvidentTape5. ValveNut6. SafetyPressureReleaseDevice

1. EnsurethatINOMAXregulatorisconnectedtocylindervalveoutlet(hand-tightenonly),thatthecylindervalveisopen,andthatthecylinderhasmorethan14bar(200psig).

2. Applysoapywatertopoints1,2,3,5and6(seeFigure5-3);ifbubblesform,thereisaleak.

3. Iftherearenobubbles,leakmaybeinsideINOblenderorINOmaxDSIRandcannotberepaired.ReplaceINOblenderorINOmaxDSIR andcontactCustomerSupport.

Recommended actions should a leak be detected:

1. Aleakdetectedatpoints1and2(seeFigure5-3)maybecorrectedbytighteningtheINOMAXregulator hand wheel.a. Ifcylindervalveisopen,closecylindervalve

andtightenINOMAXregulatorhandwheel.b.Opencylindervalveandreapplysoapywater

topoints1and2.c.Ifbubblesform,thereisaleak.d.RemoveINOMAXregulatorandcheckwhite

plastictiponINOMAXregulatorforchipsorcracks.Replaceifnecessary(seereplacingthetipontheINOMAXregulator,page16).FortheISOtyperegulatorconnector,checkthattheO-ringispresentandisnotdamaged.Replaceifnecessary(seereplacingtheO-ringontheINOMAXregulator,page17).Repeatstepb(note:Ifleakremains,replaceINOMAXregulator).

2. Ifaleakisdetectedbetweentheregulatorbodyandregulatorendcap(seepoint3),replaceINOMAXregulatorandcontactCustomerSupport.

3. Aleakdetectedatcylindervalvenutconnection(seepoint5)maynotberepaired. ReplaceINOMAXcylinderandcontactCustomerSupport.

4. Aleakdetectedatsafetypressurereleasedevice(seepoint6)maynotberepaired.ReplaceINOMAXcylinderandcontactCustomerSupport.

6

5

1

2 3

4

Note: Refertohospitalpoliciesandproceduresfordealingwithleakinggascylinders. Additionalinformationregarding environmentaleffectscanbefoundin thesection1/GeneralInformation.

Part No. 20732 Rev-022014-02

19

PartsandAccessories

WARNING: Use only parts/accessories designated for use with this system.

Parts/Accessories Part Number ClampAssembly 10008HoseAssembly,OxygenGreen,DISStoDISS,15Feet 80344HoseAssembly,OxygenWhite,DISStoDISS,15Feet 80345HoseAssembly,OxygenWhite,DISStoSIS,15Feet 80353HoseAssembly,OxygenWhite,NISTtoNIST,15Feet 80481INOMAXRegulator,CGA626 10006INOMAXRegulator,ISO5145 10020INOMAXRegulatorExtensionHose 10014Operation and Maintenance Manual 20732O-ring,ISO5145INOMAXRegulator 80470Tip,CGA626INOMAXRegulator 1605-3149-000TransportMountingBracketAssembly/Spacer 50041

Operation and Maintenance Manual Part NumberEnglish 20732Czech 20795Danish 20809Dutch 20823Finnish 20837French-EU 20851French-Canadian 20873German 20892Hungarian 20906Italian 20920Japanese 20935Korean 20956Norwegian 20961Polish 20975Portuguese 20989Spanish-EU 21024Spanish-LATAM 21022Swedish 21039

Part No. 20732 Rev-022014-02

20

(Intentionallyleftblank)

Part No. 20003 Rev - 01 Part No. 20732 Rev-022014-02

6/ Product Specifications

Part No. 20732 Rev-022014-02

6/ Product Specifications

Part No. 20732 Rev-022014-02

21

Specifications

INOblender

Ü NOSetRange 5to80ppm(800ppmcylinder) 2.5to40ppm(400ppmcylinder) Settingaccuracy +/-20%indicatedor2ppm,whicheverisgreater Gasflowrange 5to14L/minofO2 O2inletconnection DISS(male),3.4bar(50psig,nominal) NO/N2inletpressure 1.7to2.4bar(25to35psig) NOinlet Quickdisconnectwithshut-off(Female) NO/O2outlet Barbfittingforoxygensupplytubing Max.Dimensions 200mm(W)X120mm(H)X110mm(D)DISS(clampincluded) 200mm(W)X120mm(H)X131mm(D)NIST(clampincluded) Max.weight 1.7kg(clampincluded)

Operating and Storage Conditions

OperatingTemperature 10to40°C OperatingHumidity 15%to95%non-condensing OperatingBarometricPressure 57to110kPa StorageTemperature -40to+70°C StorageHumidity 15%to98%noncondensing StorageBarometricPressure 57to110kPa

INOMAX Pressure Regulator

CylinderValveConnector CGA626orISO5145valve InletPressure 14to155bar(200to2,248psig) NOOutletPressure 1.7to2.4bar(25to35psig)

Manual ResuscitatorsThe INOblender is compatible with most types of manual resuscitation bags when used within the specifications of this device. The INOblender has been validated against the following manual resuscitation bags.*

*AirlifeAdultManualResuscitatorwithreservoirtubing *Allegiance½LPediatricManualResuscitatorwithreservoirtubing

Part No. 20732 Rev-022014-02

22

(Intentionallyleftblank)

17Part No. 20732 Rev-02

2014-02

23

(Intentionally left blank)

AustraliaAustralia RepresentativeIkaria Australia Pty Ltd.

1300-198-565

EuropeEuropean Authorized Representative

MDSS GmbHSchiffgraben 41

30175 Hannover, Germany

Part No. 20732 Rev-022014-02

ManufacturerNorth America

Mallinckrodt Manufacturing LLC6603 Femrite Drive,

Madison, WI 53718-6801 USA877-566-9466

www.mallinckrodt.com

Europe