ASTM F1100-90(1997)危险期病人护理用通风机

1

NOTICE:Thisstandardhaseitherbeensupersededandreplacedbyanewversionorwithdrawn.ContactASTM

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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

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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.

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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.

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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

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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,