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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
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