Operating Manual - Nocturna Sleepnocturnasleep.com/_PDF/SleepStyle_240_Operating_Manual.pdf ·...

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Operating Manual Model HC244, HC242

Transcript of Operating Manual - Nocturna Sleepnocturnasleep.com/_PDF/SleepStyle_240_Operating_Manual.pdf ·...

Page 1: Operating Manual - Nocturna Sleepnocturnasleep.com/_PDF/SleepStyle_240_Operating_Manual.pdf · Operating Manual Model HC244, ... 12. Operating Conditions ... • Refer all repairs

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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