ISO80601測(cè)試綜合項(xiàng)目

201.9ProtectionagainstmechanicalHAZARDSofMEEQUIPMENTandMESYSTEMS

IEC60601-1:+A1:，Clause9applies，exceptasfollows:

Additionalsubclauses:

201.9.6.2.1.101*Additionalrequirementsforaudibleacousticenergy

TheA-weightedsoundpressurelevelemittedbytheSLEEPAPNOEABREATHINGTHERAPYEQUIPMENTshallbemeasuredinaccordancewithISO4871:1996andISO3744：usingengineeringmethodgrade2anddisclosedintheinstructionsforuse.TheA-weightedsoundpowerlevelshallbecalculatedaccordingto8.1ofISO3744：anddisclosedintheinstructionsforuse.

Checkcompliancewiththefollowingtest:

a)PlacetheSLEEPAPNOEABREATHINGTHERAPYEQUIPMENTonasound-reflectingplaneandattachtheleastfavorableBREATHINGGASPATHWAYfromthoseindicatedintheinstructionsforuse.

NOTEtheleastfavorableBREATHINGGASPATHWAYconfigurationcanvarybymode，asapplicable.

b)IfaHUMIDIFIERisprovidedwithorspecifiedintheACCOMPANYINGDOCUMENTSoftheSLEEPAPNOEA

BREATHINGTHERAPYEQUIPMENT，includetheHUMIDIFIERinthetest.FilltheHUMIDIFIERtotheleastfavorablelevel.

c)Connectthestandardresistance，40mmlengthandoutletangleof45°(asindicatedinFigure201.101)tothePATIENT-CONNECTIONPORT.

d)AcousticallyisolatetheBREATHINGTUBESandthegasleavingattheresistanceplacedatthePATIENTCONNECTIONPORTbyasuitablemeansoutofthetestingareasothatthenoisecausedbytheBREATHINGTUBEandthegasflowdonotinterferewiththesoundmeasurementoftheSLEEPAPNOEABREATHINGTHERAPYEQUIPMENT.

e)SettheSLEEPAPNOEABREATHINGTHERAPYEQUIPMENTtotheleastfavourablemodeandflowpattern，asapplicable，thatgeneratesacontinuouspressureof10hPa(10cmH2O)atthePATIENT-CONNECTIONPORT.

NOTETheleastfavorablemode，breathtypeandflowpatterncanvarybyBREATHINGGASPATHWAYconfiguration.

f)Usingamicrophoneofthesoundlevelmetercomplyingwiththerequirementsoftype1instrumentsspecifiedinIEC61672-1:，measurethesoundpressurelevelsat10positionsinahemispherewitharadiusfromthegeometriccentreoftheSLEEPAPNOEABREATHINGTHERAPYEQUIPMENTasspecifiedin7.2ofISO3744:.

g)CalculatetheA-weightedsoundpressurelevelaveragedoverthemeasurementsurfaceaccordingto8.1ofISO3744:.

h)CalculatetheA-weightedsoundpowerlevelaccordingto8.6ofISO3744:.

i)VerifythattheA-weightedbackgroundlevelofextraneousnoiseisatleast6dBbelowthatmeasuredduringthetest.

j)Takemeasurementsusingthefrequency-weightingcharacteristicAandthetime-weightingcharacteristicFonthesoundlevelmeterinafreefieldoverareflectingplaneasspecifiedinISO3744:.Averagethevaluesinaccordancewithsubclause8.1ofISO3744:.

k)Repeatb)toj)foreachHUMIDIFIERprovidedwithorspecifiedintheACCOMPANYINGDOCUMENTS.

l)Ensurethatthemeasuredsoundpressurelevelislessthanthatdisclosedintheinstructionsforuse.

201.11.1.2.2APPLIEDPARTSnotintendedtosupplyheattoaPATIENT

Amendment(addbetweentheexistingparagraphs):

OvertheRATEDflowraterangeandatthemaximumRATEDoperatingtemperature，thetemperatureofthedeliveredgasofSLEEPAPNOEABREATHINGTHERAPYEQUIPMENT，bothwithandwithoutahumidifier，shallnotexceedanenergyequivalentto43°Cand100%relativehumidity(aspecificenthalpynottoexceed

197kJ/m3drygas)whenaveragedover120s.

Table201.101containsexamplesofcombinationsoftemperatureandrelativehumiditywithsuchaspecificenthalpy.

Table201.101—Examplesofpermissiblecombinationsoftemperatureandrelativehumidity

Temperature°C

Relativehumidity%

43

100

44

95

45

90

48

76

50

68

201.12.1.101StabilityofstaticAIRWAYPRESSUREACCURACY(long-termaccuracy)

ThestabilityofthestaticAIRWAYPRESSUREACCURACYforanytypeofSLEEPAPNOEABREATHING

THERAPYEQUIPMENTwhenoperatinginNORMALCONDITIONshallbedisclosedintheinstructionsforuse，asthemaximumbiaserrorandmaximumlinearityerror.

EXAMPLE±(3,0hPa+5%ofthesetpressure)

NOTE1Thisinformationshouldbeexpressedingraphicalortabularform.

TheaccuracyoftheperformanceoftheSLEEPAPNOEABREATHINGTHERAPYEQUIPMENTshalleitherbe：determinedforeachBREATHINGGASPATHWAYconfigurationindicatedintheinstructionsforuse；ordeterminedfortheworstcaseBREATHINGGASPATHWAYconfigurationindicatedintheinstructionsforuse.

IfworstcaseBREATHINGGASPATHWAYconfigurationsareused，therationalefortheirselectionshallbedocumentedintheRISKMANAGEMENTFILE.

CheckcompliancebyinspectionoftheRISKMANAGEMENTFILEfortherationale，ifapplicable，andbyinspectionoftheinstructionsforusewiththefollowingtests:

a）SetuptheSLEEPAPNOEABREATHINGTHERAPYEQUIPMENTforNORMALUSEaccordingtoFigure201.102withthepressuresetto10hPa(10cmH2O)inCPAPmode.ForBI-LEVELPAPSLEEPAPNOEABREATHINGTHERAPYEQUIPMENTwithoutaCPAPmode，adjusttheinspiratoryandexpiratorypressurestothesamevalue.SwitchoffallcomfortfeaturesoftheMEEQUIPMENT.Placethestandardresistance(Figure201.101)atthePATIENT-CONNECTIONPORT.

NOTE2Comfortfeaturesdoinclude，butarenotlimitedto，e.g.automaticstart/stopfunction，fall-to-sleepramps，automaticinspiratorypressureincreaseorautomaticexpiratorypressuredecrease.

b)Usingapressure-measuringdevice，measurethepressureatleastoncepersecondatthePATIENTCONNECTIONPORToftheBREATHINGGASPATHWAYandrecord，eachminute，theaveragepressureovereachaveragingintervalof1minforaperiodof8h.

c)Calculatethemostpositiveandmostnegativepressuredifference(ifapplicable)referencedtothesetpressureontheSLEEPAPNOEABREATHINGTHERAPYEQUIPMENT.

d)VerifythattheaveragemeasuredstaticpressureiswithinthestaticAIRWAYPRESSUREACCURACYlimitdisclosedintheinstructionsforuse.

Key

1–SLEEPAPNOEABREATHINGTHERAPYEQUIPMENT

2–BREATHINGGASPATHWAY

3–standardresistance(seeFigure201.101)

4–pressuremeter

5–PATIENT-CONNECTIONPORT

Figure201.102–Testset-upforstaticAIRWAYPRESSUREACCURACYinNORMALUSE

201.12.1.102StabilityofdynamicAIRWAYPRESSUREACCURACY(short-termaccuracy)

201.12.1.102.1CPAPmode

WiththeSLEEPAPNOEABREATHINGTHERAPYEQUIPMENToperatinginCPAPmodeinNORMALCONDITION，thestabilityofthedynamicAIRWAYPRESSUREACCURACYshallbedisclosedintheinstructionsforuse，asthemaximumbiaserrorandmaximumlinearityerror.

EXAMPLE±(3,0hPa+5%ofthesetpressure)

NOTE1Thisinformationshouldbeexpressedingraphicalortabularform.

TheaccuracyoftheperformanceoftheSLEEPAPNOEABREATHINGTHERAPYEQUIPMENTshalleitherbe:

-determinedforeachBREATHINGGASPATHWAYconfigurationindicatedintheinstructionsforuse；or

-determinedfortheworstcaseBREATHINGGASPATHWAYconfigurationindicatedintheinstructionsforuse.

IfworstcaseBREATHINGGASPATHWAYconfigurationsareused，therationalefortheirselectionshallbedocumentedintheRISKMANAGEMENTFILE.

CheckcompliancebyinspectionoftheRISKMANAGEMENTFILEfortherationale，ifapplicable，andbyinspectionoftheinstructionsforusewiththefollowingtests:

a)ConnectthePATIENT-CONNECTIONPORTtoapressure-measuringdeviceandapumpthatproducesasinusoidalcyclewithaninspiratory：expiratoryphasetime(I/Eratio)of1/1andabreathingfrequencyof10breaths/minaccordingtoFigure201.103.SwitchoffallcomfortfeaturesoftheMEEQUIPMENT.Monitorandmeasuretheflowrateandpressureusingapressure-andflowrate-measuringdeviceatthePATIENTCONNECTIONPORT.

NOTE2Thedeadspaceofthetestlungshouldbelessthanthetidalvolumeused.

NOTE3Allmeasurementuncertaintiesofthetestapparatususedforthesetests(specifiedina)andb)aretobeincludedinthecalculationoftheresults，i.e.uncertaintiesaretobeaddedtothedifferencesmeasured.

b)Setthepressuretotheminimumpressuresetting.

c)SetlungparametersaccordingtoTable201.102withatidalvolume，Vt，ofapproximately500ml.

d)Simulateanapnoeaeventbyturningthepumpoffforatleast1min.

e)Foreachcycle，calculatethemostpositiveandnegativepressuredifferencefromthesetvalue.Averagetheseresultsoveraperiodof5min.

f)Recordthepressureandflowratewaveforms.Ifnecessary，adjustthesettingsuntilthebreathingfrequencyandstrokevolumematchthedesiredsettings.

g)Recordthedynamichighandlowpressuremeasurementsaspeak-to-peakvalues.Subtracttherecordeddynamiclowpressurefromtherecordeddynamichighpressure.

h)VerifythattheaveragemeasureddynamicpressureiswithinthestaticAIRWAYPRESSUREACCURACYlimitdisclosedintheinstructionsforuse.

i)Repeatstepsd)toh)foreachsetpressureindicatedinTable201.102.

j)Repeatb)toi)foreachbreathrateindicatedinTable201.102.

Key

1–SLEEPAPNOEABREATHINGTHERAPYEQUIPMENT

2–BREATHINGGASPATHWAY

3–Standardresistance(seeFigure201.101)

4–Flowmeter

5–Pressure-measuringdevice

6–Pumpthatproducesasinusoidalcycle

7–PATIENT-CONNECTIONPORT

Figure201.103–Testset-upfordynamicAIRWAYPRESSUREACCURACYinNORMALUSE

Table201.102—ParametersfordynamicAIRWAYPRESSUREACCURACYtesting

Fractionofthemaximumadjustablepressure

Pa

(hPa)

(cmH2O)

Pmin

Pmin+

?(Pmax-Pmin)

Pmin+

?(Pmax-Pmin)

Pmin+

?(Pmax-Pmin)

Pmax

f

(breaths/min)

10，15，and20

Vt

(ml)

500

aSetpressureroundedtothenearestwholeinteger

Where

Pministheminimumpressuresetting.

Pmaxisthemaximumpressuresetting.

201.12.1.102.2BI-LEVELPOSITIVEAIRWAYPRESSUREmode

WiththeSLEEPAPNOEABREATHINGTHERAPYEQUIPMENToperatinginNORMALCONDITION，thestabilityofthedynamicAIRWAYPRESSUREACCURACYforboththeinspiratoryandexpiratorypressurelevelsshallbedisclosedintheinstructionsforuse，asthemeanandstandarddeviationoftheerrorbetweenthesetvaluesandthedeliveredvalues.Thetechnicaldescriptionshalldisclosewhichpercentageofeachinspiratoryandexpiratoryphaseistakenintothecalculationfordeterminingtheaccuracyaswellaswherethesetimeslotsarelocatedwithintheinspiratoryandtheexpiratoryphases.

NOTE1Thisinformationshouldbeexpressedingraphicalortabularform.

TheaccuracyoftheperformanceoftheSLEEPAPNOEABREATHINGTHERAPYEQUIPMENTshalleitherbe:

-determinedforeachBREATHINGGASPATHWAYconfigurationindicatedintheinstructionsforuse；or

-determinedfortheworstcaseBREATHINGGASPATHWAYconfigurationindicatedintheinstructionsforuse.

IfworstcaseBREATHINGGASPATHWAYconfigurationsareused，therationalefortheirselectionshallbedocumentedintheRISKMANAGEMENTFILE.

CheckcompliancebyinspectionoftheRISKMANAGEMENTFILEfortherationale，ifapplicable，andbyinspectionoftheinstructionsforusewiththefollowingtests:

a)ConnectthePATIENT-CONNECTIONPORTtoapressure-measuringdeviceandapumpthatproducesasinusoidalcyclewithaninspiratory:expiratoryphasetime(I/Eratio)of1/1andabreathingfrequencyof10breaths/minaccordingtoFigure201.103.SwitchoffallcomfortfeaturesoftheMEEQUIPMENT.Monitorandmeasuretheflowrateandpressureusingapressure-andflowrate-measuringdeviceatthePATIENTCONNECTION

PORT.

NOTE2Thedeadspaceofthetestlungshouldbelessthanthetidalvolumeused.

NOTE3Allmeasurementuncertaintiesofthetestapparatususedforthesetests(specifiedina)andb))aretobeincludedinthecalculationoftheresults，i.e.uncertaintiesaretobeaddedtothedifferencesmeasured.

b)Setthepressuretotheminimumpressuresetting.

c)SetlungparametersaccordingtoTable201.103withatidalvolume，Vt，ofapproximately500ml.

NOTE4Toaccommodatethedifferentcontrolmechanismsofdifferentdesignsduringthechangefromtheinspiratoryphasetotheexpiratoryphaseandviceversameasuretheinspiratorypressureandexpiratorypressuresasspecifiedinthetechnicaldescription.

d)Recordthepressureandflowratewaveforms.Ifnecessary，adjustthesettingsuntilthebreathingfrequencyandstrokevolumematchthedesiredsettings.

e)Simulateanapnoeaeventbyturningthepumpoffforatleast1min.

f)Foreachcycle，determinetheextremeinspiratorypressuredifferencefromtheinspiratorysetvalue.Calculatethemeanandstandarddeviationofthesepressuresoveraperiodof5min.

g)Foreachcycle，determinetheextremeexpiratorypressuredifferencefromtheexpiratorysetvalue.Calculatethemeanandstandarddeviationofthesepressuresoveraperiodof5min.

h)Verifythatthemeanandstandarddeviationofthedynamicinspiratoryandexpiratorypressureerrorsarewithinthelimitsdisclosedintheinstructionsforuse.

i)Repeatstepse)toh)foreachsetpressureindicatedinTable201.103.

j)Repeatb)toi)foreachbreathrateindicatedinTable201.103.

Table201.103—ParametersfordynamicAIRWAYPRESSUREACCURACYtestingforPOSITIVEAIRWAYPRESSUREmode

Fractionofthemaximumadjustablepressure

Pa，inspiratory

(hPa)

(cmH2O)

Pmin+4

Pmin+2+

?(Pmax-Pmin)

Pmin+2+

?(Pmax-Pmin)

Pmin+2+

?(Pmax-Pmin)

Pmax

Pa，expiratory

(hPa)

(cmH2O)

Pmin

Pmin-2+

?(Pmax-Pmin)

Pmin-2+

?(Pmax-Pmin)

Pmin-2+

?(Pmax-Pmin)

Pmax-4

f

(breaths/min)

10，15，and20

Vt

(ml)

500

aSetpressureroundedtothenearestwholeinteger

Where

Pministheminimumpressuresetting.

Pmaxisthemaximumpressuresetting.

201.12.1.103Maximumflowrate

TheflowratecapabilityofSLEEPAPNOEABREATHINGTHERAPYEQUIPMENToverthesetpressurerangeshallbedisclosedintheinstructionsforuse.Thedisclosuremaybeintabularform.

Checkcompliancebyinspectionoftheinstructionsforuseandwiththefollowingtests:

a)SetupSLEEPAPNOEABREATHINGTHERAPYEQUIPMENTwitha1,9±0,15mBREATHINGTUBE.SwitchoffallcomfortfeaturesoftheMEEQUIPMENT.

b)Applyapressure-measuringdeviceandflowratemetertothePATIENT-CONNECTIONPORT.

c)ApplyanadjustablevalveatthePATIENT-CONNECTIONPORT.

d)Setthepressuretotheminimumsettingandadjustthevalvetoachieve(40±2)l/minandmeasuretheactualpressuredeliveredtothePATIENT-CONNECTIONPORT.

e)Adjustthevalveuntiltheactualmeasuredpressureisreducedby1hPa±0,1hPa

(1cmH2O±0,1cmH2O).Readthecorrespondingmeasuredpressureandflowratevalue.

f)Repeatstepe)10timesandrecordtheaveragevalueofthese10measurements.

g)VerifythattheSLEEPAPNOEABREATHINGTHERAPYEQUIPMENTcandeliveratleastasmuchflowasisindicatedintheinstructionsforuse.

h)Repeatstepd)tog)witheachpressureasindicatedinTable201.104.

Table201.104–SLEEPAPNOEABREATHINGTHERAPYEQUIPMENTflowrateperformanceatsetpressures

Testpressuresa

Pa，expiratory

(hPa)

(cmH2O)

Pmin

Pmin+

?(Pmax-Pmin)

Pmin+

?(Pmax-Pmin)

Pmin+

?(Pmax-Pmin)

Pmax

Measuredpressureatthepatient-connectionport(hpa)

Averageflowatthepatientconnectionport

(l/min)

aSetpressureroundedtothenearestwholeinteger

Where

Pministheminimumpressuresetting.

Pmaxis