operating manual - nocturna sleepnocturnasleep.com/_pdf/sleepstyle_240_operating_manual.pdf ·...
TRANSCRIPT
Operating Manual Model HC244, HC242
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Table of ConTenTs1. SymbolDefinitions................................................................................................................................................................... A-2
2. IntendedUse............................................................................................................................................................................ A-2
3. Warnings,Cautions,Contraindications.................................................................................................................................. A-2
4. DescriptionoftheDevice........................................................................................................................................................ A-3
4.1PackageContents.............................................................................................................................................................. A-3
4.2ImportantPartsofYourDevice......................................................................................................................................... A-3
4.3Accessories......................................................................................................................................................................... A-3
5. DeviceTechnology................................................................................................................................................................... A-3
5.1AmbientTracking™Plus................................................................................................................................................... A-3
6. SetupInstructions.................................................................................................................................................................... A-4
6.1SystemSetup...................................................................................................................................................................... A-4
6.2UpdatingSettings.............................................................................................................................................................. A-4
7. OxygenUse.............................................................................................................................................................................. A-4
8. ControlsandDisplay................................................................................................................................................................ A-5
8.1DisplayDescriptionsandFunctions................................................................................................................................. A-5
8.2PatientMenuSummary..................................................................................................................................................... A-6
8.3PatientMenu-AdditionalSettingsSummary................................................................................................................. A-6
9. CleaningandMaintenance..................................................................................................................................................... A-7
10.FrequentlyAskedQuestions................................................................................................................................................... A-7
11. ProductSpecifications............................................................................................................................................................. A-8
12. OperatingConditions.............................................................................................................................................................. A-8
13. StorageandTransport............................................................................................................................................................. A-8
14. Troubleshooting....................................................................................................................................................................... A-8
15. DeviceandConsumablesDisposalInstructions................................................................................................................... A-8
P L E A S E R E A D A L L I N S T R U C T I O N S B E F O R E I N I T I A L U S ECaut ion: USA Federa l Law rest r ic ts th is dev ice for sa le by or on the order of a phys ic ian.
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SleepStyle™ 200 SeriesHumidified CPAP SyStemS
the SleepStyle™ 200 Series is a range of CPAP systems designed for use in the home for the treatment of OSA. this manual is specific to the operation of CPAP models HC244 and HC242*.
Forfurtherassistance,pleasecontactyourlocalFisher&PaykelHealthcareoffice–seereverseforaddresses.Pleasekeepthismanualforfuturereference.
*SleepStyle™242isnotavailableinallcountries.
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1.SymbolDefinitionS
Type BFApplied Part
AlternatingCurrent Drip-proof
93/42/EECClass IIb
Class ll Double-insulated
Standby
2. intenDeDUSe TheSleepStyle™200SeriesCPAPHumidifier(HC244/HC242)isforuseonadultpatientsforthetreatmentofObstructiveSleepApnea.
Thedeviceisforuseinthehomeorsleeplaboratory.
Notes• ThismanualreferstotheSleepStyle™200CPAPSeriesunitas"the
device".• IfrequiredtouseCPAPbyareferringphysician,youshoulduse
yourdeviceeverytimeyousleep.Shouldyourdevicestopworkingforanyreason,contactyourhealthcareproviderimmediately.
• Theuserofthissystemshallhavesoleresponsibilityandliabilityforanyinjurytopersonsordamagetopropertyresultingfromoperationofthedevicewhichisnotinaccordancewiththeoperatinginstructionssupplied.
• ThedeviceshouldonlybeusedwithISO17510-2compliantmasks,connectorsanddeliverytubesrecommendedbyFisher&PaykelHealthcare,oryourhealthcareprovider.
• WerecommenduseofFisher&PaykelHealthcaremaskstoensuretruedataaccuracy.
• Undernormaloperatingconditions,theairsuppliedbythedevicewillnotexceed105.8ºF(41ºC).
• ReferallrepairsandmaintenancetoFisher&PaykelHealthcare.• OnlyinsertorremovetheSmartStick™whenthedeviceisin
standbymodeornotconnectedtomainspower.• TheSmartStick™shouldonlyberemovedwhendownloadable
dataisrequiredbyyourhealthcareprovider.• Toavoiddataloss,donotremovetheSmartStick™fromthedevice
whilethelightisflashing.• UseonlyFisher&PaykelHealthcare-suppliedSmartSticks™.• DonotoperatethedevicewithouttheSmartStick™capsecured
overtheSmartStick™port.• Donotoperatethedevicewithoutthecoverovertheserialport
adapter.
WARNINGsto avoid electric shock from your device, do not:• Operatethedeviceifthepowercordorplugisdamaged.• Operatethedeviceifithasbeendroppedinwater.• Plugthedeviceintothepowersocketifitiswet.• Cleanthedevicewhileconnectedtothepowersocket.• Storeorusethedevicewhereitcantilt,fallorbepulledintowater. Ifwaterhasenteredtheunitenclosure,disconnectthepowercord
anddiscontinueuse.SeekadvicefromFisher&PaykelHealthcare.
to avoid choking or inhalation of a foreign body:• Neverplaceanyobjectintoanyopeningofthetube.• Ensuretheairfilterisfittedduringdeviceuse.
to ensure optimal therapy, do not:• InserttheSmartStick™intoanyPCthatdoesnothave PerformanceMaximizer™softwareinstalled.Changingthe
directoriesontheSmartStick™orattemptingtoviewthedatacollectedwithoutthecorrectsoftwarewillresultinalldatastoredontheSmartStick™beinglost.Ifthatweretohappen,follow-uptherapywouldnotbepossible.
• Operatethedeviceifdroppedordamaged.• Operatethedeviceifnotworkingproperly.• Adjustthepressure.Pressuremustonlybeadjustedbyahealthcare
professional.• Operatethedeviceifthetubehasbeendamagedwithholes,tears
orkinks.• Blocktheexhaustflowontheinterface.• Usethemaskiftheunitisnotturnedonornotoperatingproperly.
to avoid burns, do not:• Fillthechamberwithboilingwater.• Touchtheexposedheaterplateorchamberbase.
to avoid the risk of fire while using oxygen, do not:• Turnoxygenflowonwhenthedeviceisnotoperating;thiscanlead
toaccumulationofoxygenwithinthedevice.• Locatethedeviceinapositionwhereventilationaroundthedevice
isrestricted.• Useoxygenwhilesmokingorinthepresenceofanopenflame.• Useanymaterialswhichwillburninairorigniteeasilyathigh
oxygenconcentration.• Keepanysourceofignitionneartheproduct.Toavoidignition,it
ispreferabletokeepallsourcesofignitionoutoftheroomwheresupplementaloxygenisbeingused.
• Keepoxygenregulators,cylindervalves,tubing,connectionsandallotheroxygenequipmentnearoil,greaseorgreasysubstances.Spontaneousandviolentignitionmayoccurifthesesubstancescomeintocontactwithoxygenunderpressure.
other:• Placethedeviceonalevelsurfacelowerthanheadheightto
preventwaterenteringthetubing.Ifwaterdoesenterthetubing,drainexcesscondensate.Waterinthetubingmayresultinaspiration.
• ThedeviceisintendedtobeusedwithCPAPmasksandconnectorsthathaveexhaustflowholestoallowcontinuousflowofairoutofthemask.Whenthedeviceisturnedonandoperatingproperlynewairflushesexhaledairoutofthemaskthroughtheexhaustflowholes.AtlowCPAPpressuresandintheeventofpowerfailureormachinemalfunction,removethemaskimmediately,asflowthroughthemaskmaybeinsufficienttoclearallexhaledgasandCO2re-breathingmayoccurwhichcanbehazardous.
• Failuretoselectthecorrectaltitudelevel(foranygivenlocation)willhaveanadverseeffectondeliveredpressure.
• Thisdeviceisnotintendedforlifesupport.
CAUtIoNsto prevent water damage to your device:• Removethehumidificationchamber fromthedevicebefore filling.• Emptywaterfromthechamberbeforetransportingthedevice.
Ifthedeviceisrequiredtobehandledwithwaterinthechamber,avoidtiltingthedevicetopreventwaterenteringitsenclosure.
other:• TopreventdamagetoyourPC,onlyoperatethedeviceifitis
connectedtoaPCviaanisolatedserialportadapter(900HC236).• Topreventairwayirritation,donotusethedevicewhenroom
temperatureexceeds95°F(35°C).
CoNtRAINDICAtIoNs• Researchindicatesthefollowingpre-existingconditionsmay
contraindicatetheuseofpositivepressureforsomepatients:pneumothorax,bullouslungdisease,pneumocephalus,cerebrospinalfluidleak,recentcranialsurgeryortrauma,abnormalitiesofthecribriformplate,pathologicallylowbloodpressureorinpatientswhoseupperairwaysarebypassed.
PReCAUtIoNs• Thesafetyandeffectivenessofpositivepressurehasnotbeen
establishedinpatientswithrespiratoryfailureorCOPD.
ADVeRse eFFeCts• Nosebleeds,earandsinusdiscomfortmayoccurfromtheuseof
positivepressuretherapy.Pleasecontactyourphysicianifyouhaveanyquestionsconcerningyourtherapy.
3.WarningS,CaUtionS,ContrainDiCationS
ATTENTIONConsult accompanying
documents
Do not throw away
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4.DeSCriptionoftheDeviCe
4.1PackageContents
4.2ImportantPartsofYourDevice
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POWERCORD
900HC221BREATHINGTUBE
900HC010CONNECTOR
WATERCHAMBER
FINGERGUARD
HEATERPLATE
WATERLEVELLINE
ON/OFFBUTTON
4.3Accessories
HC385S StandardHumidificationChamber
HC355* ExtendedLifeHumidificationChamber
900HC010 Connector
900HC221 BreathingTube
900HC240 AirFilter
900HC611 SmartStick™(5-Pack)
900HC225 WaterFunnel(10-Pack)
900HC630 SmartStick™Mailer(25pack)
*Notavailableinallcountries
DISPLAY
FILTERHOLDER
AIRFILTER
FUNNEL
DISPLAY
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SERIALPORTNote:Forserialdatacommunicationonly
SmartStick™PORT
SmartStick™CAP
SmartStick™
5.DeviCeteChnology5.1 AmbientTracking™Plus AmbientTracking™Plusprovideseffectivehumidificationunderchangingconditionsbyautomaticallyadjustingtheheater
plateinresponsetochangesinroomtemperatureandleakscausedbythemouthand/ormaskleak.Thishumidificationtechnologymaximizeshumidityunderambientconditionsandminimizescondensationtoreducemaskpressurefluctuations,ensuringthemosteffectiveperformanceofthedevice.
1x
1x1x
1x
2xHC385Sor1xHC355*
* Depending on model of device
1x
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6.SetUpinStrUCtionS
6.1 SystemSetup 1. Removethedevicefromitspackaging.
2. Placethedeviceonalowshelforonthefloorbesideyourbed,sothedeviceispositionedbelowheadheight.
3. ChamberSetup a. Removeonewaterchamberfromthepackaging. b.Removethebluecapsanddiscardthem(Fig.1). c. Fillthechamberuptothewater-fillinglinewithdistilledwateronly;an
optionalfunnelissuppliedforeasyfilling(Fig.2). Neverfillthechamberwhileitisattachedtothedevice.
Whenmovingyourdevice,ensurethewaterchamberisempty.Machinefailureduetowaterdamageisnotcoveredbywarranty.
d.Toattachthewaterchambertothedevice,pressdownthefingerguard,lineuptherearchamberholetotheCPAPoutletandslidethechamberon(Fig.3,Fig.4).
e. Whenthechamberisfittedcorrectly,thefingerguardwillclickintoplace.
4. Oneendofthetubehasawhiteplasticconnector.Pushthisontotheoutletontopofthechamber(Fig.5).
5. Connecttheotherendofthetubetothemask.
6. Plugthedevicepowercordintotherearofthedeviceandintoyourhouseholdpowersocket.
7. Whenconnectedtomainspowerthedevicewillbeinstandbymode.
8. TheSmartStick™islocatedattherearofthedevice.DetachthecapandensuretheSmartStick™isinsertedinthecorrectorientation.The"Fisher&PaykelHealthcare"logoshouldbetherightwayup.IfthelabelisupsidedownremovetheSmartStick™andreinserttheSmartStick™inthecorrectorientation.WhentheSmartStick™isinsertedintothedeviceasmalllightattheendoftheSmartStick™willflash.ThelightwillremainilluminatedindicatingthatdataisbeingloggedtotheSmartStick™(Fig.6).
NOTES: •Todownloadorupdatesettings,onlyinsertorremovetheSmartStick™
whenthedeviceisinstandbymodeordisconnectedfrommainspower.DonotinsertorremovetheSmartStick™whilethepressureison.
•OnlySmartSticks™suppliedbyFisher&PaykelHealthcarecanbeusedinthedevice.
9. OncetheSmartStick™iscorrectlyinserted,securetheSmartStick™capovertheSmartStick™.IftheSmartStick™isnotbeingused,thecapmuststillbesecuredinplace(Fig.7).
10.Activatethedevicebypressingtheon/offbutton(Fig.8).Uponactivation,"ON"willflashthreetimesontheLCDdisplayfollowedbyahumiditysetting(factorydefaultsetting-seeSection8.1).
11.ForchangingsettingsrefertoSection8:ControlsandDisplay.
Yourdeviceisnowreadyforuse.
6.2 UpdatingSettings 1. TheSmartStick™canbeusedbyyourhealthcareprovider,toremotelyviewyourcomplianceorefficacydataandmake
adjustmentstothesettings.
2. Oncethedeviceisinstandbymodeordisconnectedfrommainspower,theSmartStick™canbesafelyremovedandsenttoyourhealthcareprovider.
3. WhentheSmartStick™isreturned,followinstructionsabovetoensuretheSmartStick™isreinsertedcorrectly.AbluelightwillilluminateontheendoftheSmartStick™whenitisinsertedcorrectlyand«USB»willflashonthedeviceLCD.
4. Whenthebluelighthasstoppedflashing,pressanybuttononthedevicetoacknowledgedatadownload.Thesettingswillnowbeupdatedonthedevice.
7.oxygenUSe Ifoxygenisrequired,itisrecommendedthatsupplementaloxygenbeadministeredatthemask.Pleaseseeinstructions
specifictoyourmasktype.
NOTE:
• Atafixedflowrateofsupplementaloxygen,theinhaledoxygenconcentrationwillvary,dependingonthepressuresettings,patient'sbreathingpattern,maskselectionandleakrate.
Beforeusingoxygenwiththedevice,pleaseseeoxygenwarningsinSection3.
fig.1 fig.2
fig.3 fig.4
fig.5 fig.6
fig.8fig.7
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8.ControlSanDDiSplay
*Activated by your healthcare provider; if not activated, will not be displayed. Refer to your interface instructions regarding exhaust flow characteristics.
8.1 DisplayDescriptionsandFunctions
NOTES:
DefaultDisplay
• Forinitialusethedevicewilldefaulttodisplayhumidity( )asperfactorysettings.
• Whenhumidityisdisplayed,thelevelofhumiditycanbechangedusing and buttons:increaseifexperiencingairwaydryness;decreaseifexperiencingexcessivecondensation.
Altitudeunits Displays altitude units Select "m" for meters or "ft" for feet using and buttons
Altitudelevel Displays altitude level Press and buttons to alter altitude
PATIENT MENU - ADDITIONAL SETTINGS DISPLAY OPERATION
To access additional settings: From the default display Press the button for three seconds
To view subsequent items: Press the button
NOTE: To exit menu, wait six seconds for LCD to revert to default display
PATIENT MENU DISPLAY OPERATION
For viewing settings: Humidity and Usage Data.
Starting from the default display, press sequentially to view
NOTE: To exit menu, wait six seconds for LCD to revert to default display
Displayshumiditysetting Adjust humidity to minimize upper airway side effects from treatment. Press and to adjust humidity setting
Systemleak* Displays system leak history for the last treatment session in liters per minute
(LPM). System leak is comprised of exhaust flow, mask leak and mouth leak. Exhaust flow is the expected leak at the interface exhalation port required to flush C02 from the mask. A reading of 60 or below indicates an acceptable level of leak
Totalrunhours Displays the total hours the device has been run with the pressure on
Averageusagehourspernight Displays the average number of hours per night the device has been used
ApneaHypopneaIndex(AHI)* Displays the average AHI for the last treatment session
KEY FUNCTION AND DESCRIPTION OPERATION
STANDBY Switches the pressure ON and OFF
RAMPReduces pressure to a lower level to help you fall asleep. The pressure will gradually return to full operating pressure over 20 minutes
INCREASE/DECREASE Adjusts settings up or down
MODETo step through options
<
<
TO START PRESSURE (pressure on) Press button briefly. "ON" will flash three times on the LCD, then the default
will display
TO STOP PRESSURE (pressure off) Remove your mask Press button briefly. "OFF" will flash three times on the LCD, then the device
will return to standby mode and the default will display
TO START PRESSURE (pressure on) Press the button
Note: To reset ramp during a cycle, the device must be switched off first
TO SWITCH "OFF" Press the button
Press and buttons to raise or lower settings
Press sequentially to step through and view options available
Mode buttonStep through options
Down buttonDecrease setting
Up buttonIncrease setting
StandbyTurns pressure ON/OFF
Ramp button
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8.2PatientMenuSummary
Humidity Setting(default)
Average Usage Hour/night
Altitude
0,1,2,3,4
± 0.5 INCREMENT
8.3PatientMenu-AdditionalSettingsSummary
Mode
RETURN
TO DEFAULT
Altitude Units
<
<or
Increase/DecreaseAltitudeLevel
<
<or
Total Run Hours
Apnea Hypopnea Index
System Leak*
<
<or
SelectUnitsforAltitude
Pressure Setting
Warning: Failure to select correct altitude setting (for any given location) will have an adverse effect on delivered pressure.NOTE: To exit menu, wait six seconds for LCD to revert to default display.
MODELHC244HC242
NOTE: To exit menu, wait six seconds for LCD to revert to default display.* Only displayed if activated by healthcare provider.
MODELHC244HC242
*
Altitude Level
RETURN TO DEFAULT cmH2O
Actual Pressure
Increase
Press to activateRamp
Press once to switch device on/off
Display
Mode
Decrease
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10.freqUentlyaSkeDqUeStionS WhenIwakeupinthemorning,mynoseandthroatfeeldry.WhatcanIdo? Tryincreasingyourhumiditysetting.Ifthisdoesnothelp,pleasecontactyourhealthcareproviderforadvice.
HowdoIpreventcondensationinthetubing? Thehumiditysettingenablesadjustmentofhumidity,sothatthereshouldbefinemistinginthesixinches(15cm)ofthe
breathingtubeclosesttoyourface.Ifthehumiditysettingistoohighfortheconditions,condensationmayoccurinthebreathingtube.
NOTE:Usinggreaterthan6ft(183cm)oftubingwillincreasecondensation. Thereareseveralwaystoreducecondensationinthetube: i. Ensurethedeviceisnotpositionedinacooldraft. ii. Decreasethehumiditysettingonyourdeviceslightly.Graduallydecreasethesettinguntilthecondensation
nolongeroccurs. iii. Warmtheairintheroom.
DoIhavetousedistilledwaterwithmydevice? Theuseofdistilledwaterwillmaximizethelifeofthewaterchamber.Waterfromthefaucet(evenifitispassedthrough
afilter)willoftencontainmineralswhichcandamagethechamber,causingpittinginthebase,corrosionandpossiblyleaks.
WhendoIreplacemywaterchamber? Itisrecommendedthatthechamberisreplacedeverysixmonthsoriftheplasticwallsofthechamberbecomecracked
ordiscoloredorthechamberbasebecomespitted.Regularcleaningwillincreasethelifespanofyourchamber. (NOTE:Ifthechamberleaksatall,itshouldbereplacedimmediately.)
WhendoIreplacemybreathingtube? Itisrecommendedthatthebreathingtubeisreplacedeverysixmonthsorifthereareanysignsofcrackingor
deterioration.Regularcleaningwillincreasethelifespanofyourbreathingtube.
CanIusemydeviceinothercountries? Yes.Simplyusetheappropriateelectricalsocketadapterandthedevicewillautomaticallyadapttoanyvoltagesupply. (NOTE:Whenmovingyourdevice,ensurethatthewaterchamberisempty.Machinefailureduetowaterdamageisnot
coveredbywarranty.)
CanIusesupplementaloxygenwithmydevice? Yes,oxygencanbeadministeredatthemask.Turnthedeviceonbeforeturningontheoxygen.Ensurethattheoxygen
sourceisturnedoffbeforeturningoffthedevicetoavoidoxygenaccumulatinginthemachine.SeeSection7formoredetails.
WhichmasksaresuitableforusewithaSleepStyle™200CPAPSeriesdevice? ItisrecommendedthatyouuseaFisher&PaykelHealthcaremask.Consultyourhealthcareproviderregardingmask
selection.
Whathappenstomydeviceduringpowerfailure? Uponrestorationofthepowersupply,thedevicewillrestartinthesameoperationmodewiththesamesettingsas
beforethepowerfailure.
9. CleaninganDmaintenanCe PLEASENOTE:Thedeviceshouldbecleanedasrequired. 1. Unplugthedevicefrommainspower. 2. Wipetheexteriorofthedevicewithaclean,damp(notwet)clothandmilddishwashingdetergent.
Donotuseharshabrasivesorsolvents,asthesemaydamagethedevice. 3. DAILY
Cleanchamberandtube. • Removethebreathingtubefromthechamberandmask. • Cleanthetubewithwarmsoapywater.Rinsethetubethoroughly.Hangupthetubewith
thetubeendspointingtothefloortodry. • Removethechamberbypushingdownthefingerguardandpullingoutthechamber. • Pouroutanddiscardtheremainingwater. NOTE:Tocompletelyremovewater,guideresidualwaterbetweenvanesandshakewell(Fig.1). • Forstandard(HC385S)chambers,cleanandwashwithsoapywater,thenrinseanddry.
Extendedlifechambers(HC355)canbecleanedinadomesticdishwashingmachine. 4. WEEKLY Thoroughlycleanthechamber. • Soaktheinsideofthechamberfor10minutesinasolutionofonepartwhitevinegarto
twopartswater.Emptythevinegarsolutionandrinsechamberwellwithwater. 5. Replacetheairfilterwhenitbecomessignificantlydiscolored,atleastonceeverythree
monthsorafter1000hours'machinerunningtime. • Removethefilterholderfromthebackofthedeviceandtakeoutthefilter. • Replacetheoldfilterwithanewfilter:ensuretheverticalblacklineisfacingtowardsthe
device(Fig.2).
Thisdevicedoesnotrequireroutineservicingorcalibration.
Fig.1
Fig.2
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12.operatingConDitionS
AmbIeNt temPeRAtURe: 41-95°F(5-35°C)
HUmIDIty: 10-95%RelativeHumidity
AltItUDe: 0-9000ft(0-3000m)
NOTE:Above4500ft(1500m),themaximumoperatingpressurewillbereduced.
13.StorageanDtranSport Thedeviceshouldbestoredandtransportedinenvironmentalconditionsof:14to140°F(-10to60°C).
14.troUbleShooting Ifyoufeelthatyourdeviceisnotoperatingcorrectly,pleasecontactyourlocalFisher&PaykelHealthcareoffice–see
backcoverforaddressesandcontactinformation.
15.DeviCeanDConSUmableSDiSpoSalinStrUCtionS
• UnitDisposalInstructions Thisunitcontainselectronics.Pleasedonotdiscardasregularrubbish.Disposeaccordingtolocalguidelinesfor
disposingofelectronics.
• ConsumableDisposalInstructions Placethemask,breathingtubeandwaterchamberinarubbishbagattheendofuseanddiscardwithnormal
rubbish.
Fisher&PaykelHealthcarehasapolicyofcontinuedproductimprovementandreservestherighttoalterspecificationswithoutnotice.
DImeNsIoNs: 10.8"x6.7"x5.5" (275mmx170mmx140mm)
WeIGHt: 4.2lbs(1.9kg) (3.0kgpackagedinbagincl.accessories)
PeRFoRmANCe: Pressure Range: 4to20cmH2O
(Intheunlikelyeventoffaultconditionspressuremayreachupto30cmH2O)
Altitude Range: 0to9000ftor0to3000m
11.proDUCtSpeCifiCationS
stANDARDs ComPlIANCe: Complies with: EN/IEC60601-1 AS3200.1.0 UL60601-1
eleCtRICAl RAtINGs:Supply Frequency: 50-60HzSupply Voltage and Current: 1.2A,1.3A~(100-115Vmax), 0.8A,1.8A~(220-240Vmax)NOTE:Thesevaluesrepresentaveragecurrent.
DC to AC Inverter Requirements: 115V-200W/300Wsurge 230V-300W/500WsurgeHeater Plate: 85Wmax
Heater Plate Temperature: 149°F(65°C)max
The device complies with the electromagnetic compatibilityrequirements of IEC 60601-1-2. In certain circumstances the devicemayaffectorbeaffectedbynearbyportablemobileradiofrequencycommunication equipment, due to the effects of electromagneticinterference. If this should happen, try moving your device or thelocationoftheequipmentcausinginterference,oralternativelyconsultyourhealthcareprovider.
Humidity: MaximumHumidity=43.9mg/L(BTPS),100%RHat4cmH2O,withhumiditysetting4TypicalHumidity=27.2mg/L(BTPS),99.2%RHat10cmH2O,withhumiditysetting4
Gas Temperature: Max=105.8ºF(41ºC)Noise Level: <30dBA
Maximum Flow RatesCPAPPressureSetting(cmH2O) 4 8 12 16 20
measured pressure at the patient connection 3 7 11 15 19 port (cmH2O)
maximum flow rate (L/min) at mask 76 85 85 85 86 connection port
Static Pressure Stability (long term)-0.05 to 0.18 cmH2O pressure difference, measured at the mask connection port, at the pressure setting of 10 cmH2O
Dynamic Pressure Stability (short term)CPAPPressureSetting(cmH2O) 4 8 12 16 20
PressureDifference -0.61 -0.66 -0.77 -0.91 -0.98(cmH2O)atmask to to to to toconnectionport +0.94 +0.90 +0.86 +0.85 -0.86
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Fisher & Paykel Healthcare Offices:MANuFACTuRERFisher&PaykelHealthcareLtd,15MauricePaykelPlace,EastTamaki,Auckland2013,POBox14348,Panmure,Auckland1741,NewZealandTel:+6495740100Fax:+6495740158Email:[email protected]:www.fphcare.com
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