版權(quán)說(shuō)明：本文檔由用戶提供并上傳，收益歸屬內(nèi)容提供方，若內(nèi)容存在侵權(quán)，請(qǐng)進(jìn)行舉報(bào)或認(rèn)領(lǐng)
文檔簡(jiǎn)介
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
溫馨提示
- 1. 本站所有資源如無(wú)特殊說(shuō)明，都需要本地電腦安裝OFFICE2007和PDF閱讀器。圖紙軟件為CAD,CAXA,PROE,UG,SolidWorks等.壓縮文件請(qǐng)下載最新的WinRAR軟件解壓。
- 2. 本站的文檔不包含任何第三方提供的附件圖紙等，如果需要附件，請(qǐng)聯(lián)系上傳者。文件的所有權(quán)益歸上傳用戶所有。
- 3. 本站RAR壓縮包中若帶圖紙，網(wǎng)頁(yè)內(nèi)容里面會(huì)有圖紙預(yù)覽，若沒(méi)有圖紙預(yù)覽就沒(méi)有圖紙。
- 4. 未經(jīng)權(quán)益所有人同意不得將文件中的內(nèi)容挪作商業(yè)或盈利用途。
- 5. 人人文庫(kù)網(wǎng)僅提供信息存儲(chǔ)空間，僅對(duì)用戶上傳內(nèi)容的表現(xiàn)方式做保護(hù)處理，對(duì)用戶上傳分享的文檔內(nèi)容本身不做任何修改或編輯，并不能對(duì)任何下載內(nèi)容負(fù)責(zé)。
- 6. 下載文件中如有侵權(quán)或不適當(dāng)內(nèi)容，請(qǐng)與我們聯(lián)系，我們立即糾正。
- 7. 本站不保證下載資源的準(zhǔn)確性、安全性和完整性, 同時(shí)也不承擔(dān)用戶因使用這些下載資源對(duì)自己和他人造成任何形式的傷害或損失。
最新文檔
- 裝修合同書(shū)標(biāo)準(zhǔn)
- 項(xiàng)目環(huán)保技術(shù)開(kāi)發(fā)合作合同
- 建筑工程設(shè)備購(gòu)銷合同
- 師德主題活動(dòng)方案
- 臺(tái)式電腦租賃服務(wù)協(xié)議
- 商品買賣協(xié)議
- 第五單元名著導(dǎo)讀《昆蟲(chóng)記》教學(xué)設(shè)計(jì)-2024-2025學(xué)年統(tǒng)編版語(yǔ)文八年級(jí)上冊(cè)
- 德育常規(guī)檢查方案
- 第8課《列夫.托爾斯泰》教學(xué)設(shè)計(jì)+2024-2025學(xué)年統(tǒng)編版語(yǔ)文八年級(jí)上冊(cè)
- 思想政治理論課課程建設(shè)方案
- 牛頓第三定律說(shuō)課市公開(kāi)課一等獎(jiǎng)省賽課微課金獎(jiǎng)?wù)n件
- (2024年)北京師范大學(xué)網(wǎng)絡(luò)教育《教育學(xué)原理》歡迎您
- 火車站物流園區(qū)建設(shè)項(xiàng)目物有所值評(píng)價(jià)報(bào)告
- 2024年工裝夾具相關(guān)項(xiàng)目營(yíng)銷策略方案
- 《養(yǎng)老護(hù)理員》-課件為老年人布置睡眠環(huán)境
- 初三學(xué)業(yè)水平考試美術(shù)試題含答案(最終)
- 鋼筋優(yōu)化技術(shù)創(chuàng)效手冊(cè)（2022年）
- 職業(yè)生涯規(guī)劃醫(yī)學(xué)生
- (完整word版)現(xiàn)代漢語(yǔ)常用詞表
- 拜占庭歷史與文化智慧樹(shù)知到期末考試答案2024年
- 反應(yīng)釜驗(yàn)證方案樣本
評(píng)論
0/150
提交評(píng)論