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1
NOTICE:Thisstandardhaseitherbeensupersededandreplacedbyanewversionorwithdrawn.ContactASTM
International()forthelatestinformation.
Designation:F1100–90(Reapproved1997)
StandardSpecificationfor
VentilatorsIntendedforUseinCriticalCare1
ThisstandardisissuedunderthefixeddesignationF1100;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapproval.
1.Scope
1.1General—Thisspecificationestablishesminimumper-formanceandsafetyrequirementsforallventilatorsandventilatorcircuitsintendedforusewithadult,child,orinfantpatientsincriticalcarewithinthehospitalandintroducedforsaleaftertheacceptancedateofthisspecification,exceptasnotedbelow.Definitions,performancerequirements,testmeth-ods,andrationaleareincluded.SeveraldefinitionshavebeenincludedinSection
3.1
and
AppendixX1
thatarenotusedinthetextofthisspecification.Thismaterialhasbeenincludedforthesakeofcompleteness,andforanypossibleeducationalbenefitthatmaybeserved.
1.2Exclusions—ThisspecificationdoesnotapplytobodyventilatorssuchasthetankventilatororthechestcuirassnordoesitapplytoventilatorsutilizingtheSanderstechniqueor“jet”ventilation,(venturieffecttype)highfrequencyventila-tors(greaterthan2.5Hz),oranesthesiaventilators.Thisspecificationdoesnotapplytoventilatorsintendedforuseintransportapplicationsorhomecare,nordoesitapplytothoseventilatorsdevelopedforveterinaryapplications.Theapplica-tionofcriticalcareventilatorsinthehomeenvironmentisnotcoveredbythisspecificationnoristhehospitaluseoftransportorhomecareventilators.(Seealso
X2.1
.)
1.3Thefollowingprecautionarycaveatpertainstothetestmethodsportiononly,Section
6
,ofthisspecification:Thisstandarddoesnotpurporttoaddressallofthesafetyconcernsassociatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
2.ReferencedDocuments
2.1ASTMStandards:
F1054
SpecificationforConicalFittingsof15-mmand22-mmSizes2
2.2ANSIStandards:
1ThisspecificationisunderthejurisdictionofASTMCommitteeF29onAnestheticandRespiratoryEquipmentandisthedirectresponsibilityofSubcom-mitteeF29.14onVentilators.
CurrenteditionapprovedMay18,1990.PublishedJune1990.
2AnnualBookofASTMStandards,Vol13.01.
ANSIZ-79.9,1978,HumidifiersandNebulizersforMedi-calUse3
ANSIZ-79.10,1979,RequirementsforOxygenAnalyzersforMonitoringPatientBreathingMixtures3
2.3ISOStandards:
ISO4135AnesthesiologyVocabulary4
ISO5356AnestheticandRespiratoryEquipmentConicalConnectors4
2.4OtherStandards:
CGAV-5SpecificationsforDISSConnections5
MDS201ElectromagneticCompatibilityStandardforMedicalDevices6
3.Terminology
3.1DescriptionsofTerms—Forthepurposesofthisspeci-ficationthedefinitionsin
3.1.1-3.1.49
shallapply.
3.1.1airwaypressure(Paw)—pressureataspecifiedpointinthepatient’sairway.Thesiteandconditionsunderwhichmeasurementsaremadeshouldbegiven.
3.1.2alarm—ameansofalertingtheoperatorthatapar-ticularconditionexists.
3.1.3alveolarpressure(PA)—pressureinthealveoli.Inthecaseofthelungmodel,thisisrepresentedbythepressureinthecompliancechamber.
3.1.4apparatusinternalcompliance—volume/pressurere-lationship,expressedinmillilitresperkilopascal(ormillilitrespercentimetreH2O)ofthoseportionsofthepatientsystemthatarepressurizedduringtheinspiratoryphasetime(seealso
8.1)
.
3.1.5continuouspositiveairwaypressure(CPAP)—Pawmaintainedaboveambient.
Discussion—Commonusageofthistermreferencesspontaneousventilation.
3.1.6control—ameansavailabletotheoperatorofdirectlyadjustingaventilatorfunction.
3AvailablefromtheAmericanNationalStandardsInstitute,25W.43rdSt.,4thFloor,NewYork,NY10036.
4AvailablefromtheInternationalStandardsOrganization,1,RuedeVarembe,Casepostale56,CH-1211Geneve20,Switzerland.
5AvailablefromtheCompressedGasAssociation,1725JeffersonDavisHigh-way,Suite1004,Arlington,VA22202–4102.
6AvailablefromtheNationalTechnicalInformationService(NTIS),Accession#PB271635,5285PortRoyalRd.,Springfield,VA22161.
Copyright©ASTMInternational,100BarrHarborDrive,POBoxC700,WestConshohocken,PA19428-2959,UnitedStates.
2
NOTICE:Thisstandardhaseitherbeensupersededandreplacedbyanewversionorwithdrawn.ContactASTM
International()forthelatestinformation.
F1100–90(1997)
3.1.7cyclingpressure—thatpressurewhich,whenreachedinthepatientsystem,causestheventilatortocyclefrominspiratorytoexpiratoryphaseorfromexpiratorytoinspira-toryphase.
3.1.8differentialinspiratorytriggeringpressure(ΔPtr)—changesinairwaypressureatthepatientconnectionportwhichmustbegeneratedbythepatienttoinitiatetheventilatorinspiratoryphase.
Discussion—Pressureshallbeexpressedintermsofgagepressureinunitsofkilopascals(orcentimetresH2O)tofollowthekilopascalunits.
3.1.9expiratorypausetime(TEP)—intervalfromtheendofexpiratoryflowtothestartofinspiratoryflow.
3.1.10expiratoryphasetime(TE)—intervalfromthestartofexpiratoryflowtothestartofinspiratoryflow.
3.1.11expiratorypositiveairwaypressure(EPAP)—Pawaboveambientduringtheexpiratoryphase,generallyapproxi-matedbyPps.
3.1.12expiratory(sub-atmospheric)sub-ambientpressure—pressurelowerthanambient,duringtheexpiratoryphasetime.
Discussion—Sub-ambientpressuremaybecon-stantthroughouttheexpiratoryphasetimeoritmayvarythroughthephasetime,dependinguponthemethodbywhichsuchpressureisgenerated.
3.1.13frequency(ventilatory)(f)—numberofbreathingcyclesperminute.
3.1.14heatandmoistureexchanger(HME)—apassivedevicewhichisdesignedtoconservesomeofthepatient’sexhaledmoistureandheat,andtoreleaseheatandmoisturetothepatient’sairwayduringinspiration.
3.1.15inspiratory-expiratoryphasetimeratio(I:Eratio)—ratiooftheinspiratoryphasetimetotheexpiratoryphasetime.
3.1.16inspiratoryminutevolume(I)—volumeofgasin-
spiredperminutebythepatient,measuredbylitres(L).
3.1.17inspiratorypausetime(TIP)—intervalfromtheendofinspiratoryflowtothestartofexpiratoryflow.
3.1.18inspiratoryphasetime(TI)—intervalfromthestartofinspiratoryflowtothestartofexpiratoryflow.
3.1.19inspiratorypositiveairwaypressure(IPAP)—PawaboveambientduringtheinspiratoryphaseofCPAP,generallyapproximatedbyPps.
3.1.20inspiratoryreliefvalve—unidirectionalvalvede-signedtoadmitairtothepatientsystemwhenthepatientinspiresspontaneouslyandthesupplyofinspiratorygasesfromtheventilatorisinadequate.
3.1.21inspiratoryreliefvalveresistance—pressurediffer-enceacrosstheinspiratoryreliefvalveataconstantflowof30L/min.
3.1.22inspiratorytriggeringflow(Tr)—flowwhichmust
begeneratedbythepatientatthepatientconnectionporttoinitiatetheventilatorinspiratoryphase.
3.1.23inspiratorytriggeringpressure(Ptr)—airwaypres-sureatthepatientconnectionportwhichmustbegeneratedbythepatienttoinitiatetheventilatorinspiratoryphase.
3.1.24inspiratorytriggeringresponsetime(Ttr)—timede-laybetweenthesatisfactionoftheinspiratorytriggeringpressureorflow,orboth,volumerequirements,andthestartofinspiratoryflow.
3.1.25inspiratorytriggeringvolume(Vtr)—volume,mea-suredatthepatientconnectionport,whichmustbemovedbythepatienttoinitiatetheventilatorinspiratoryphase.
Discussion—Insomedevicesthereexistsacom-plexrelationshipbetweenthemultipleparametersasdefinedin
3.1.22-3.1.25.
3.1.26intermittentmandatoryventilation(IMV)—amodeofoperationoftheventilatorthatpermitsspontaneousbreath-ingofacontrolledinspiratorygasmixturebetweenthepredeterminedventilator-derivedbreaths,usingthesamein-spiratorygasmixture.
3.1.27maximumlimitedpressure(PLmax)—thehighestgagepressurewhichcanbeattainedinthepatientsystemduringmalfunctionoftheventilatorbutwithfunctioningsafetymechanisms.
Discussion—ThetitleofthisdefinitionisdifferentfromthetitlegiveninISO4135.However,thetextisidenticaltothatinISO4135.ThetitleoftheISOdefinitionismaximumsafetypressure.
3.1.28maximumworkingpressure(Pwmax)—thehighestgagepressurewhichcanbeattainedinthepatientsystemduringtheinspiratoryphasewhentheventilatorisfunctioningnormally.
Discussion—ThismaybelimitedbyacontrollableventilatormechanismtolessthanPLmax.
3.1.29minimumlimitedpressure(PLmin)—thehighestnu-mericalvalueofsub-atmosphericgagepressurewhichcanbeattainedinthepatientsystemduringmalfunctionoftheventilatorbutwithfunctioningsafetymechanisms.
Discussion—ThetitleofthisdefinitionisdifferentfromthetitlegiveninISO4135.However,thetextisidenticaltothatinISO4135.ThetitleofthedefinitioninISO4135isminimumsafetypressure.
3.1.30minimumworkingpressure(Pwmin)—highestnu-mericalvalueofsub-atmosphericgagepressurewhichcanbeattainedinthepatientsystemduringtheexpiratoryphasewhentheventilatorisfunctioningnormally.
Discussion—Thismaybelimitedbyacontrollableventilatormechanismtoasub-atmosphericpressurethatisnumericallysmallerthanPLmin.
3.1.31minutevolume()—volumeofgas,expressedin
litresperminuteenteringorleavingthepatientorlungmodel.Thephysicalconditionsunderwhichmeasuringwasmadeshouldbegiven.
3.1.32monitor(indicatordisplay)—ameansofinformingtheoperatorofthestatusornumericalvalueofventilationoraventilator.
3.1.33nebulizinghumidifier—devicedesignedtoaddwatertotheinspiredgasintheformofdroplets.
3.1.34negativeendexpiratorypressure(NEEP)—thePpsattheendofexpiration,belowambient.
3.1.35patientsystem—thatpartofthegassystemofaventilatorthroughwhichrespiredgastravelsatappropriaterespiratorypressures.
3
NOTICE:Thisstandardhaseitherbeensupersededandreplacedbyanewversionorwithdrawn.ContactASTM
International()forthelatestinformation.
F1100–90(1997)
3.1.36patientsystemcompliance—volume/pressurerela-tionship,expressedinmL/kPa(ormL/cmH2O),ofthoseportionsofthepatientsystemthatarepressurizedduringtheinspiratoryphasetime.
3.1.37positiveend-expiratorypressure(PEEP)—Ppsattheendofexpiration,aboveambient.
3.1.38pressure,patientsystem(Pps)—pressureataspeci-fiedpointinthepatientsystem.
Discussion—Conditionsunderwhichmeasure-mentsaremadeshallbegiven.
3.1.39pressuresupport—aventilatormodedesignedtoaugmentthepatient’sventilationsynchronouslywithhisin-spiratoryeffortuntilapresetpressureismet.
3.1.40sigh(ventilator)—deliberateincreaseintidalvolumeforoneormorebreathsatintervals.
3.1.41spirometer—devicedesignedtomeasureavolumeofgas.
3.1.42synchronousintermittentmandatoryventilation(SIMV)orassistedventilation—aventilatormodewhichprovidesamechanismforsynchronizingtheventilator-deliveredbreathswithapatient’sinspiration,asdetectedbytheventilator.
3.1.43tidalvolume(VT)—volumeofgas,expressedinmillilitres(mL),enteringorleavingthepatientorthelungmodelduringtheinspiratoryorexpiratoryphasetime.Thephysicalconditionsunderwhichgasvolumesaremeasuredshouldbegiven.
3.1.44timeconstant—timeinwhichanexponentialprocessis63%complete.
3.1.45vaporizinghumidifier—devicedesignedtoaddwatertotheinspiredgasintheformofvapor.
3.1.46ventilatorexpiratoryresistance—forventilatorsinwhichexpirationisnotassisted,thetotalresistancetogasflowfromthepatientconnectionportthroughtheexpiratoryportofthepatientsystemtoatmosphere.ThisisexpressedinkPa(orcmH2O)referredtoaflowof0.5L/s.
3.1.47ventilatorpressure(Pvent)—pressureataspecifiedpointintheventilator.Thesiteandconditionsunderwhichmeasurementsaremadeshouldbegiven.
3.1.48ventilatorsintendedforusewithanesthesia—ventilatordesignedtobeusedwithorintegraltoananesthesiabreathingsystem.
3.1.49volumetricdisplacement—thatvolume,underspe-cificconditionsandexpressedinmillilitres,passedpercycleduringtheinspiratoryphasethroughthepatientconnectionportwhenthepressureattheintaketotheventilatorandtheoutletfromthepatient’sconnectionportisequaltotheatmosphericpressure.
3.2Symbols:
3.2.1C—complianceinunitsofmL/kPa(ormL/cmH2O),forexample,C20=2.0mL/kPa(20mL/cmH2O).
3.2.2R—resistancetoflowinunitsofkPa/L/s(orcmH2O/L/s),forexample,R5=0.5kPa/L/s(5cmH2O/L/s).
Discussion—Intheinterestofbrevityandclarity,allotherabbreviationshavebeenprovidedinparenthesesfollow-ingtherelatedterminSection
3.
4.MaterialsandManufacture
4.1Componentsofaspirometerthatcomeindirectcontactwiththepatient’sexhaledgasshallbecapableofbeingsterilizedordisinfectedorshallbelabelledforsingleuseonly,orisolatedinsomemannerfromtherespiredgasinthepatientbreathingcircuit.(Seealso
X2.2
.)
5.PerformanceRequirements
5.1DeterminationofVentilatorEndurance,Wave-form,andVolumeCharacteristics—General—Compliancewiththere-quirementsgivenin
5.2-5.4
shallbedeterminedwithoneormoresamplesofproductionventilatorswiththeassurancethattheresults,whichshallbemadeavailabletocustomers,arerepresentativeofallproductionventilatorsofthattype.
NOTE1—Therequirementsgivenin
5.2-5.4
andthetestsdescribedin
6.3
delineatefirstarticleordesignqualificationtestsandarenotintendedtobelotsamplingtests.Thedisclosureofinformationreferredtoin
6.3
isintendedtoincludeperiodicmaintenancenecessaryduringtheendurancetestandtheresultsofworkperformed.
5.2VentilatorEndurance—Eachventilator(asdescribedin
5.1
)shallbetestedforenduranceasdescribedin
6.3.1
withrespecttoeachgroupofpatientsforwhichitsuseisrecom-mended,thatis,foradults,forchildren,andforinfants.Theventilatorshallrunfor2000hagainsttheappropriatecondi-tionsasshownin
Table1
.Aseparatemachinemaybeusedforeachgrouportheperiodoftestsmaybedividedequallybetweengroups.Iftheventilatorisprovidedwithanassistmechanism,themechanismshallbepartofthetest.IfIMVorSIMVisprovided,thatmechanismshallbeapartofthetest.Dataresultingfromthesetestsshallbeavailableonrequestfromthemanufacturer.
5.3Wave-formPerformance—Theventilatorshallbetestedasdescribedin
6.3.2
witheachofthecomplianceandresis-tancecombinationsappropriatetoitsintendeduse(thatis,foradults,forchildren,orforinfants),intheordershownin
Table
2.
5.4VolumePerformance—Theventilatorshallbetestedagainstthecombinationsofcompliance(C)andresistance(R)appropriatetoitssphereofuse,asshownin
Table3.
Themanufacturershalldeterminetherangeoftidalvolumesthattheventilatoriscapableofdeliveringtothelungatthespecifiedfrequencieswithaninspiratory/expiratoryphasetimeratioascloseto1:2aspossible.Furthermeasurementsatdifferentfrequenciesandwithdifferentcomplianceandresis-tancecombinationsmaybeincludedifdesired.Allresultsshallbeexpressedintheformofatableoradiagramsimilarto
Fig.
1
.Theconditionsunderwhichthetestsarecarriedoutshallbestated(see
6.3.2and)
.
5.5PowerSources:
TABLE1EnduranceTest
Group
Minute
VolumeVE,L
VentilatoryFrequency,f,breaths/minA
Compliance
Resistance
Adult
Child
10
20
C50
R20orRp20
4.5
30
C20
R50orRp50
Infant
0.8
60
C3
R200orRp200
AOrnearestpossible.
4
NOTICE:Thisstandardhaseitherbeensupersededandreplacedbyanewversionorwithdrawn.ContactASTM
International()forthelatestinformation.
F1100–90(1997)
TABLE2ProcedureforPerformanceTest—WaveformA
TestNumberB
Compliance
Resistance
TidalVolumeVt65%,mL
Ventilation
Frequency
f:65%
(breaths/min)
SampleTimeConstant,s
Ventilation
Pressure
Limit,cmH2OC
Linear
Parabolic
Adult
[1]
C50
R5
Rp5
500
20
0.25
12.5
2
C50
R20
Rp20
500
20
1.0
20.0
3
C20
R5
Rp5
500
20
0.1
27.5
4
Children
C20
R20
Rp20
500
20
0.4
35.0
[1]
C20
R20
Rp20
300
20
0.4
21.0
2
C20
R50
Rp50
300
20
1.0
30.0
3
C10
R20
Rp20
300
20
0.2
36.0
4
C10
R50
Rp50
300
20
0.5
45.0
[5]
C3
R20
Rp20
50
30
0.06
18.5
6
C3
R50
Rp50
50
30
0.15
20.8
7
Infant
C3
R200
Rp200
50
30
0.6
32.0
[1]
C3
R50
Rp50
30
30
0.15
12.3
2
C3
R200
Rp200
30
30
0.6
19.0
3
C1
R50
Rp50
30
30
0.05
32.3
4
C1
R200
Rp200
30
30
0.2
39.0
[5]
C1
R200
Rp200
15
60
0.2
24.0
AInspiratory/expiratoryphasetimeratioascloseto1:2aspossible;see
6.3.2.
BTheventilatorcontrolsshallberesettosuitthechosenstandardconditions(bracketed)beforeundertakingeachsubsequenttest.Thus,theorderofrecordingsobtainedonadultswouldbeTest[1];Test2(controlsunchanged);Test2(controlsadjustedifnecessary);controlsresettosatisfyTest[1]conditions;Test3(controlsunchanged);Test[3](controlsreadjustedifnecessary),etc.
CVentilationPressureLimit=Calculatedpressureappliedbyconstant-flowgeneratorsatthemachinesideoftheairwayresistancetoachievetherequiredtidalvolumeduringthesetinspiratorytime.Thesepressureswillbeinexcessofthecorrespondinglungpressurethatwillbedevelopedbytheendoftheinspiratoryphase.
TABLE3VolumePerformanceTest
TypeofVentilator
Compliance
Resistance
VentilatoryFrequencies
Linear
Parabolic
Adult
Child
C20
C10
C3
R20
R50
R200
Rp20
Rp50
Rp200
10,15,20,30
15,20,30,40
15,20,30,40
Infant
C1
R200
Rp200
20,30,40,60
TidalVolume,
VT
(ml)
VentilatoryFrequency,f(bpm)
10
15
20
30
Max
—
—
—
—
Min
FIG.1SuggestedFormatforVolumePerformanceTestReportForm
5.5.1Electrical—Theventilatorshallcontinuetofunctionwithinthemanufacturer’sspecificationsatanycontrolsettingthroughoutarangeof610%fluctuationofthestatednominalvoltageand61%fluctuationofthestatedfrequencyforelectricalpowersources.
5.5.2Pneumatic—Whentestedaccordingtothemethodsoutlinedin
6.5
,theventilatorshallcontinuetofunctionwithinthemanufacturer’sspecificationsatanycontrolsettingthroughoutarangeofsupplypressuresof379kPa(55psig)+20%,−25%.(SeealsoAppendixX3.3.2.)
Theventilator’sgasconnection(s)shallbenon-interchangeable.Ifthedevicehasathreadedconnection,itshallconformtotheappropriateCGAV-51978specification
forDISSconnections.Iftheventilatoriscapableofbeing
independentlyconnectedtothegaspipingsystemitshallhavepermanentlyattachedaNutandGlandFittingNo.1240(oxygen),ifintendedtobepoweredbyoxygen,oraNutandGlandFittingNo.1160(air),ifintendedtobepoweredbyair,orbothfittingsifbothgasesareused.(SeealsoAppendixX
.)
5.6AccuracyofCalibratedControls,Indicators,andPres-sureReliefDevices:
5.6.1CalibratedControls—Whentestedaccordingtothemethodsoutlinedin
6.6.1,
controlsforPwmaxoninfantventilatorsshallbeaccuratetowithin60.196kPa(62cmH2O)overtheentirerange.ControlsforPwmaxinallotherventilatorsshallbeaccuratetowithin60.49kPa(65cmH2O)upto2.94kPa(30cmH2O)and60.98kPa(610cmH2O)forsettingsabove30cmH2O.Allothercalibratedcontrols,whenworkingatnominalpowerinputs,shouldbeaccuratetowithin610%ofthesetting.(Seealso
X
.)
MaximumWorkingPressure—Ifprovidedinthepatientbreathingcircuit,positivepressurecontroldevicesshallrestricttheairwaypressuretowithin60.49kPa(65cmH2O)uptoapointof2.94kPa(30cmH2O)andtowithin60.98kPa(610cmH2O)forsettingsabove30cmH2O,whentestedbythemethodsdescribedin
6.6.2
.(Seealso
X
.)
5
NOTICE:Thisstandardhaseitherbeensupersededandreplacedbyanewversionorwithdrawn.ContactASTM
International()forthelatestinformation.
F1100–90(1997)
5.6.2Indicators—Allotherindicatorsshouldbeaccuratetowithin610%ofthereading.
5.6.3LimitedPressureReliefControls—Ifthepressureinthebreathingcircuitreachesalevelgreaterthantheusualoperatoradjustedpeakpressure,thedevice(ventilator)shallactivateapressurereductionmechanismwithin3swhentestedasoutlinedin
6.6.3
.Thispressurereductionmechanismshallbringthebreathingcircuittoapredeterminedbaselinepressureequaltoorlessthantheend-expiratorypressure.Thelimitedpressurereliefmechanismmayalsobeactivatedwithoutdelaywhenthepresetmaximumlimitingpressureisreached.Acoupledvisual/audiblealarmshallbeactivatedinthisevent.Thevisualsignalshallberetainedwhenthepressureisreducedandshallrequireamanualreset.(Seealso
X
.)
5.6.4Whentestedbythemethodsdescribedin
6.6.4,
devicesindicatingventilatoryfrequencyshallbeaccuratetoonebreathperminuteor10%ofthesetting,whicheverisgreater.
Whentestedbythemethodsdescribedin
6.6.4,
devicescontrollingventilatorfrequencyshallbeaccuratetowithinonebreathperminuteor10%ofthesetting,whicheverisgreater.(Seealso
X
.)
5.7SpirometersandOtherDevicesforIndicationofVenti-latorFunctionIntegraltotheVentilator:
NOTE2—Continuousflowventilatorsareexemptfromtherequire-mentsof
5.7.
5.7.1Provisionshallbemadeforconnectionofaspirometerorotherdeviceforthemeasurementofexpiredvolumeifnotprovidedasanintegralpartoftheventilator.Thefittingfortheattachmentofthisspirometershallbeastandard30-mmconicalmaleconnector.
5.7.2Whentestedasdescribedin
6.7
,anyspirometerintegralwiththeventilatorshallbeaccuratetowithin610%ofthereadingovertheflowrangesspecifiedbythemanufac-turer.Thepressuredropwithasteadygasflowof50L/minshallnotexceed0.196kPa(2.0cmH2O).Conditionsofcalibrationshallbedisclosed.(Seealso
X
.)
5.7.3Whentestedasdescribedin
6.7.2
,thespirometershallcontinuetofunctionwithinthelimitsofaccuracydelineatedin
5.7.2
whateverthehumidityandwithinthetemperaturerangeof20to37°C(dueallowancebeingmadeforthedifferencebetweengastemperatureandhumidityinthespirometerandthetemperatureandhumidityatwhichthespirometerwascalibrated).Spirometersshouldbedesignedinsuchamannerthattheycannotbecomeobstructedbysecretionsfromthepatient.(Seealso
X
.)
5.8AccuracyofGasMixtureControls:
5.8.1Whentestedasdescribedin
6.8
,ventilatorsthatincorporateasaprimarycontrolaninspiratorygasmixturecontrolshallprovideameandeliveredoxygenconcentrationwithin610%ofthesetoxygenconcentrationor3%oxygen,whicheverisgreater,throughouttherangeofpressures,fre-quencies,andtidalvolumesforwhichtheventilatoriscapable.Atagivensettingoftheventilator,themeandeliveredoxygenconcentrationshallbewithin63%oxygenforatleastonehour.(Seealso
X2.3.5
.)
5.9ExpiratoryResistance:
5.9.1AdultandChildVentilators—Whentestedinaccor-dancewiththemethodsdescribedin
6.9
,andintheabsenceofexpiratoryresistorsorpositiveendexpiratorypressuredevices,thepressureatthepatientconnectionportforadultandchildventilatorsshallnotexceed0.49kPa(5cmH2O)ataflowof50LPMwhenspirometerorbreathingattachments,orboth,asspecifiedbythemanufacturerareused.(Seealso
X2.3.6
.)
5.9.2ConstantFlowInfantVentilators—Whentestedac-cordingtothemethodsdescribedin
6.9,
positiveend-expiratorypressureinherentinthedesignofconstantflowinfantventilatorsshallnotexceed0.29kPa(3cmH2O)ataconstantmachineflowof20L/min,60breathsperminute,1:1I:Eratio,R=4.9kPa/L/s(50cmH2O/L/s),andC=3mL/0.29kPa(3mL/cmH2O).Ifexpiratoryassistanceisnecessarytocomplywiththisrequirement,itshallbesostated.(SeealsoAppendixX2.6.)
5.10FittingsConnectingAdultVentilator,Patient,andSpirometer—Thepatientconnectionportshallbea15⁄22mmconicalcoaxialfittinginaccordancewithSpecification
F1054.
5.10.1Forflowdirection-sensitivedevices,thedirectionofflowshallbepermanentlymarkedontheconnector,andtheconnectorshouldbedesignedsothatitcannotbeinstalledinthereversedirection.(Seealso
X
.)
5.10.2Ifaconnectorforabagformanualventilationisprovidedontheventilator,itshallfacedownwardandshallbesituatedawayfromtheconnectorsforthepatientbreathingtubes.Thebagmountshouldprovideasecureconnection.Thetermbagshallbemarkedontheconnector.(Seealso
X
.)
5.10.3Ifthereisaseparateoutletforthespirometeronthebreathingtubesorthemachine,thegasoutletleadingtothespirometershouldbea30-mmmaleconeinaccordancewithISO5356.Inanycase,itshallnotbecompatiblewitha15,19,or22-mmfitting.(Seealso
6.10.3
and
X
.)
5.10.4Ifanambientairinletisfittedtotheventilator,itshallnotbea19,22,
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