USER MANUAL - Inogen Portable Oxygen … Power Supply Options Single and Double Rechargeable Lithium...

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USER MANUAL

Transcript of USER MANUAL - Inogen Portable Oxygen … Power Supply Options Single and Double Rechargeable Lithium...

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USER MANUAL

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Contents

Chapter 1 1 Intended Use, Contraindications and General Precautions

Chapter 2 3 Description of the Inogen One® G4 Oxygen Concentrator 3 ImportantPartsoftheInogenOne®G4OxygenConcentrator 4 UserInterfaces 5 Input/OutputConnections 6 PowerSupplyOptions 8 InogenOne®G4Accessories

Chapter 3 11 Operating Instructions 11 GeneralInstructions 15 AdditionalOperatingInstructions 19 BatteryOperatingInstructions 20 BatteryCareandMaintenanceChapter 4 21 Inogen One® G4 Oxygen Concentrator Audible and Visible Signals (including Alerts)

Chapter 5 29 Troubleshooting Chapter 6 31 Cleaning, Care and Maintenance 31 CannulaReplacement 31 CaseCleaning 31 FilterCleaningandReplacement 33 InogenOne®G4ColumnChangeProcedure 36 OtherServiceandMaintenance 36 DisposalofEquipmentandAccessories

Chapter 7 37 Symbols Used on Concentrator and Accessories

Chapter 8 39 Inogen One® G4 System Specifications

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1 Intended Use, Contraindications and General Precautions

IntendedUse,ContraindicationsandGeneralPrecautionsChapter1

Intended Use

TheInogenOne®G4OxygenConcentratorisusedonaprescriptivebasisbypatientsrequiringsupplementaloxygen.Itsuppliesahighconcentrationofoxygenandisusedwithanasalcannulatochanneloxygenfromtheconcentratortothepatient.TheInogenOne®G4maybeusedinhome,institution,vehicleandvariousmobileenvironments.

CAUTION USAFederallawrestrictsthisdevicetosalebyorontheorderofaphysician.Mayalsobeapplicableinothercountries.

CAUTION Nasalcannulashouldberatedfor3litersperminute(e.g.SalterLabs16SOFT)toensureproperpatientusageandoxygendelivery.

WARNING Availabilityofanalternatesourceofoxygenisrecommendedincaseofpoweroutageormechanicalfailure.Consultyourequipmentproviderfortypeofback-upsystemrecommended.

CAUTION Itistheresponsibilityofthepatienttomakeback-uparrangementsforalternativeoxygensupplywhentraveling;Inogenassumesnoliabilityforpersonschoosingnottoadheretomanufacturerrecommendations.

TheexpectedlifefortheInogenOne®G4OxygenSystemis5years,withtheexceptionofthesievebeds(metalcolumns)whichhaveanexpectedlifeof1yearandthebatteries,whichhaveanexpectedlifeof500fullcharge/dischargecycles.

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Contraindications

WARNING ThisdeviceisNOTINTENDEDtobelifesustainingorlifesupporting. CAUTION Undercertaincircumstances,theuseofnon-prescribedoxygentherapy

canbehazardous.Thisdeviceshouldbeusedonlywhenprescribedbyaphysician.

CAUTION Additionalmonitoringorattentionmayberequiredforpatientsusingthisdevicewhoareunabletohearorseealertsorcommunicatediscomfort.Ifthepatientshowsanysignsofdiscomfort,aphysicianshouldbeconsultedimmediately.

CAUTION TheInogenOne®G4isnotdesignedorspecifiedtobeusedinconjunctionwithahumidifier,nebulizerorconnectedwithanyotherequipment.Useofthisdevicewithahumidifier,nebulizerorconnectedwithanyotherequipmentmayimpairperformanceand/ordamagetheequipment.DonotmodifytheInogenOne®G4Concentrator.Anymodificationsperformedontheequipmentmayimpairperformanceordamageequipmentandwillvoidyourwarranty.

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General Precautions

WARNING Thedeviceproducesenrichedoxygengas,whichacceleratescombustion.DoNOTALLOWSMOKINGOROPENFLAMESwithin10feetofthisdevicewhileinuse.

WARNING DonotsubmersetheInogenOne®G4oranyoftheaccessoriesinliquid.Donotexposetowaterorprecipitation.Donotoperateinexposedrain.Thiscouldleadtoelectricalshockand/ordamage.

CAUTION Donotuseoil,grease,orpetroleum-basedproductsonorneartheInogen

One®G4.

CAUTION NeverleavetheInogenOne®G4inanenvironmentwhichcanreachhightemperatures,suchasanunoccupiedcarinhightemperatureenvironments.Thiscoulddamagethedevice.

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Important Parts of the Inogen One® G4 Oxygen Concentrator

Description of the Inogen One® G4 Oxygen Concentrator2

On/Off Button

Breath Detection Light

*Display

Audible Alert Button Alert/Alert Light

Flow Control

DescriptionoftheInogenOne®G4OxygenConcentratorChapter2

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DescriptionoftheInogenOne®G4OxygenConcentratorChapter2

*Actualdisplayappearancemayvary.

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User Controls

ON / OFF ButtonPressoncetoturn“ON”;Pressandholdforonesecondtoturn“OFF”.

Audible Alert Button PressingthisbuttonwilltoggletheInogenOne®G4’sbreathdetectionaudiblealertonandoff.

BreathDetectionAlertMode.TheInogenOne®G4willalertwithaudibleandvisualsignalsfor“nobreathdetected”whenthismodeisenabledandnobreathhasbeendetectedfor60seconds.

At60seconds,thedevicewillenterintoautopulsemodeandonceanotherbreathisdetected,thedevicewillexitautopulsemodeanddelivernormallyoninspiration.Thedisplay’smodeindicationareawillshowabellicon,flashingyellowlightanddisplaymessagewhenthealertisenabled.

Ifpowerislost,thebreathdetectionaudiblealertremainssetintheuserpreferredmode.Flow Setting Control Buttons Usethe–or+flowsettingcontrolbuttonstoselectthesettingasshownonthedisplay.Therearethreesettings,from1to3.

User Interfaces

DisplayThisscreendisplaysinformationregardingflowsetting,powerstatus,batterylifeanderrors.IfyouwouldliketochangethelanguageontheInogenLCDScreencontactyourEquipmentProviderforinstructions.Actualdisplayappearancemayvary.

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User Interfaces (continued)

Indicator LightsAgreenlightindicatesbreathdetection.Ayellowlightindicateseitherachangeinoperatingstatusoraconditionthatmayneedresponse(alert).Aflashinglightishigherprioritythannon-flashing.

Audible SignalsAnaudiblesignal(beep)indicateseitherachangeinoperatingstatusoraconditionthatmayneedresponse(alert).Morefrequentbeepsindicatehigherpriorityconditions.

BacklightAbacklightwillilluminatethescreenfor15secondswhentheon/offbuttonisbrieflypressed.

Input / Output Connections

Particle FilterThefiltermustbeinplaceattheintakeendoftheconcentratorduringoperationtokeepinputairclean.

Cannula Nozzle FittingThenasalcannulaconnectstothisnozzleforInogenOne®G4outputofoxygenatedair.

DC Power InConnectionforexternalpowerfromtheACpowersupplyorDCpowercable.

USB PortForserviceuseonly.

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Power Supply Options

Single and Double Rechargeable Lithium Ion BatteriesThebatterywillpowertheInogenOne®G4withoutconnectiontoanexternalpowersource.Whenfullycharged,asinglebatterywillprovideupto2.7hoursofoperation;adoublebatterywillprovideupto5hoursofoperation.ThebatteryrechargeswhenproperlyinstalledintheInogenOne®G4andtheconcentratorisconnectedtoACorDCpower.Rechargingtimeisupto3hoursforasinglebatteryand5hoursforadoublebattery.Seeinformationinthe“BatteryCareandMaintenance”section.

Power SupplyOverviewTheInogenOne®G4ACpowersupply(BA-401)isusedtopowertheInogenOne®G4concentratorfromanACpowersource.

DescriptionTheInogenOne®G4ACpowersupplyisspecificallydesignedforusewiththeInogenOne®G4OxygenConcentrator(IO-400).TheACpowersupplyprovidestheprecisecurrentandvoltagerequiredtosafelypowertheInogenOne®G4andisdesignedtooperatefromspecifiedACpowersources.WhenusedwithACpowersources,thepowersupplyautomaticallyadaptstoinputvoltagesfrom100Vto240V(50-60HZ)permittingusewithmostpowersourcesthroughouttheworld.

TheACpowersupplywillchargetheInogenOne®G4BatterieswhenusedwithACinputpower.Duetoaircraftpowerlimitations,theACPowerSupplycannotbeusedtochargetheInogenOne®G4Batterywhenusedonanaircraft.TheACpowersupplyisusedwiththefollowingcomponents:

•PowersupplywithattachedpoweroutputcabletoconnecttotheInogenOne®G4•ACpowerinputcable

TheDCpowercable(BA-306)isspecificallydesignedforusewiththeInogenOne®G4OxygenConcentrator(IO-400).TheDCpowerinputcableconnectsdirectlytotheautomobilecigarettelighterorauxiliaryDCpowersupply.RefertoChapter3foradditionaloperatinginstructionsforusewithDCpowersource.

7DescriptionoftheInogenOne®G4OxygenConcentratorChapter2

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*Actualproductappearancemayvary.

AC Power Plug*

Power Output Plug (Plug into Concentrator)

LED Indicator Light*AC Input

InogenOneACPowerSupplyModel#BA-401

InogenOneG4DCPowerCableModel#BA-306

DC cigarette lighter Power Plug for use in Automobile/RV/Boat/Aircraft

Power Output Plug (Plug into Concentrator)

WARNING Donotusepowersuppliesorpowercablesotherthanthosespecifiedinthisusermanual.Theuseofnon-specifiedpowersuppliesorpowercablesmaycreateasafetyhazardand/orimpairequipmentperformance.Donotwrapcordsaroundpowersupplyforstorage.Donotdrive,dragorplaceobjectsovercord.Doingsomayleadtodamagedcordsandafailuretoprovidepowertotheconcentrator.Toavoiddangerofchokingorstrangulationhazard,keepcordsawayfromchildrenandpets.

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Inogen One® G4 Accessories

WARNING Donotusepowersupplies/adaptersoraccessoriesotherthanthosespecified inthisusermanual.Theuseofnon-specifiedaccessoriesmaycreateasafety hazardand/orimpairequipmentperformance.

Nasal CannulaAnasalcannulamustbeusedwiththeInogenOne®G4toprovideoxygenfromtheconcentrator.Asinglelumencannulaupto25feetinlengthisrecommendedtoensureproperbreathdetectionandoxygendelivery.

WARNING Toavoiddangerofchokingandstrangulationhazard,keeptubingawayfromchildrenandpets.

NOTE Increasingthecannulalengthmayreducetheperceivednoiseduringoxygenbolusdelivery.

NOTE Whenusingacannula25ft.inlengthwiththeInogenOne®G4,anincreaseinflowsettingmayberequired.

Inogen One G4 Carry Strap (CA-401)Thecarrystrapisdesignedtoattachdirectlytotheconcentrator.Thereisametalslideforeaseoflengthadjustments,ashoulderpadforcomfortandasewnonvelcrotabtowrapupthatextracannulatubing.

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Carry Bag (CA-400)TheCarryBagprovidesaprotectivecoverwithahandleandshoulderstraptoenableyoutocarrytheInogenOne®G4.TheInogenOne®G4canbeoperatedusingbatterypowerduringtransportwiththeCarryBag.

Inogen One® G4 Optional Accessories

External Battery Charger (BA-403)

TheInogenOne®G4externalbatterychargerwillchargetheInogenOne®G4singleanddoublebatteries.

1.PlugtheExternalBatteryChargerACpowersupplycordintoanelectricaloutlet.

2.PlugtheExternalBatteryChargerACpowersupplyintothebatterycharger.

3.SlideyourchargerontotheInogenOneG4Battery byclickingandlockingintothecharger.4.Whenthebatteryisinthecorrectposition,asolid redlightwillindicatethatthebatteryischarging.5.Whenthegreenlightilluminates,thebatteryis fullycharged.

CAUTION AvoidtouchingtherecessedelectricalcontactsoftheExternalBatteryCharger;damagetocontactsmayaffectchargeroperation.

NOTE Thesecontactsarenotpoweredunlessabatteryisinplaceandcharging.

NOTE TocompletelyremovepowerfromtheExternalBatteryCharger, removetheplug.

DescriptionoftheInogenOne®G4OxygenConcentratorChapter2

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Operating Instructions3

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General Instructions

1. Place the Inogen One® G4 in a well ventilated location.Airintakeandexhaustmusthaveclearaccess.LocatetheInogenOne®G4insuchawaythatanyauditoryalertsmaybeheard.AlwaysoperatetheInogenOne® G4inanuprightposition(seeimageforproperorientation).

WARNING AvoiduseoftheInogenOne®G4inpresenceofpollutants,smokeorfumes.DonotusetheInogenOne®G4inpresenceofflammableanesthetics,cleaningagentsorotherchemicalvapors.

CAUTION Donotobstructairintakeorexhaustwhenoperatingthedevice.

Blockageofaircirculationorproximitytoaheatsourcemayleadtointernalheatbuildupandshutdownordamagetotheconcentrator.

CAUTION TheInogenOne®G4Concentratorisdesignedforcontinuoususe.Foroptimalsievebed(columns)life,theproductshouldbeusedfrequently.

2. Ensure particle filter is in place.

CAUTION DonotoperatetheInogenOne®G4withouttheparticlefilterinplace.Particlesdrawnintothesystemmaydamagetheequipment.

Intake

ExhaustExhaust

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3. Install the battery. InserttheInogenOne®G4batterybyslidingbatteryintoplaceuntilthelatchreturnstotheupperposition.

CAUTION TheInogenOne®G4batteryactsasasecondarypowersupplyintheevent ofaplannedorunexpectedlossoftheACorDCexternalpowersupply.When

operatingtheInogenOne®G4fromanACorDCexternalpowersupply,aproperlyinsertedInogenOne®G4batteryshouldbemaintainedintheunit.Thisprocedurewillensureuninterruptedoperationandwilloperateallalertsandalertsintheeventofalossoftheexternalpowersupply.

4. Connect the Power Supply. ConnecttheACinputplugtothepowersupply.ConnecttheACpowerplugtothepowersourceandconnectthepoweroutputplugtotheInogenOne®G4.ThegreenLEDonthepowersupplywillbeilluminatedandabeepwillsoundfromtheconcentrator.

CAUTION Ensurethepowersupplyisinawellventilatedlocationasitrelieson aircirculationforheatdissipation.Thepowersupplymaybecomehotduring operation.Makesurethepowersupplycoolsdownbeforehandling.

CAUTION Thepowersupplyisnotwaterresistant.

CAUTION Donotdisassemblethepowersupply.Thismayleadtocomponentfailure and/orsafetyrisk.

CAUTION Donotplaceanythinginthepowersupplyportotherthanthesuppliedwallcord.AvoidtheuseofelectricalextensioncordswiththeInogenOne®G4.

Ifanextensioncordmustbeused,useanextensioncordthathasanUnderwritersLaboratory(UL)Markandaminimumwirethicknessof

18gauge.Donotconnectanyotherdevicestothesameextensioncord.

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NOTE Undercertainconditions(seeTechnicalSpecifications)thepower supplymayshutdown.ThegreenLEDwillblinkorwillnolongerbe

illuminated.Ifthisoccurs,disconnectthepowersupplyforatleast10secondsandreconnect.

NOTE WhenthepowersupplyisdisconnectedfromtheACoutlet,alsodisconnectitfromtheconcentratortoavoidunnecessarybatterydischarge.

5. Connect the nasal cannula tubing to the nozzle fitting.NozzlefittingislocatedonthetopoftheInogenOne®G4.Useofasinglelumencannulaupto25feetinlengthisrecommendedtoensureproperbreathdetectionandoxygendelivery.Additionaltitrationmaybeneededtoensureproperoxygendeliverywhenusingaparticularcannula.

CAUTION Toensureoxygenflow,ensurethatthenasalcannulaisproperlyconnectedtothenozzlefittingandthatthetubingisnotkinkedorpinchedinanyway.

CAUTION Replacethenasalcannulaonaregularbasis.Checkwithyourequipmentproviderorphysiciantodeterminehowoftenthecannulashouldbereplaced.

6. Turn on your Inogen One® G4 by pressing the ON/OFF Button.AsingleshortbeepwillsoundaftertheInogenlogoisdisplayed.“PleaseWait”willappearwhiletheconcentratorstartsup.Thedisplaywillindicatetheselectedflowsettingandpowercondition.Followingabriefstart-upsequence,awarmupperiodupto2minuteswillinitiate.Duringthistimeperiodtheoxygenconcentrationisbuildingtobutmaynothavereachedspecification.AdditionalwarmuptimemaybeneededifyourInogenOne®G4hasbeenstoredinextremelycoldtemperatures.

7. Set the Inogen One® G4 Concentrator to the flow rate prescribed by your physician or clinician. Usethe+or–settingbuttonstoadjusttheInogenOne®G4tothedesiredsetting.Thecurrentsettingcanbeviewedonthedisplay.

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8. Position the nasal cannula on your face and breathe through your nose. TheInogenOne®G4willsensetheonsetofinhalationanddeliveraburstofoxygenataprecisetimewhenyouinhale.TheInogenOne®G4willsenseeachbreathandcontinuetodeliveroxygeninthismanner.Asyourbreathingratechanges,theInogenOne®G4willsensethesechangesanddeliveroxygenonlyasyouneedit.Attimes,ifyouinhaleveryquicklybetweenbreathstheInogenOne®G4mayignoreoneofthebreaths,givingtheappearanceofamissedbreath.ThismaybenormalastheInogenOne®G4sensesandmonitorsthechangesinyourbreathingpattern.TheInogenOne®G4willnormallysensethenextbreathanddeliveroxygenaccordingly.

Agreenlightwillflasheachtimeabreathisdetected.Makecertainthatthenasalcannulaisproperlyalignedonyourfaceandyouarebreathingthroughyournose.

WARNING Ifyoubegintofeelillorareexperiencingdiscomfortwhileusingthisdevice,consultyourphysicianimmediately.

CAUTION TheInogenOne®G4isdesignedtoprovideaflowofhighpurityoxygen.An

advisoryalert,“OxygenLow”,willinformyouifoxygenconcentrationdrops.Ifalertpersists,contactyourequipmentprovider.

GeneralToremovepower,unplugtheinputcordfromitssource(i.e.,ACwalloutlet,DCcarcigarettelighteradapter)anddisconnectitfromtheInogenOne®G4.

CAUTION Ensurethepowersupplyispoweredfromonlyonepowersource(ACorDC)atanygiventime.

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Additional Operating Instructions

For Use In Home with AC PowerForoperationofthepowersupplyusinganACpowersource,followtheseinstructions:

1. ConnecttheACinputtothepowersupply.2. ConnecttheACpowerplugtothepowersourceandconnectthepoweroutputplug

totheInogenOne®G4.ThegreenLEDwillbeilluminated,indicatingthe powersupplyhasinputpower.

Traveling with your Inogen One® G4 System

TheInogenOne®G4Systemmakestravelbyboat,carortrainmoreconvenientforoxygenusersthaneverbefore.Nowyougetthesamequalityperformanceandconveniencewhileonthegothatyou’reusedtoreceivingfromyourInogenOne®G4athome.HerearesomeusefulandimportantinstructionsformaximizingperformanceandconveniencewhenusingyourInogenOne®G4whiletraveling.

Youshouldbeginplanningforatripwithachecklistofitemstoremember.Thischecklistshouldinclude:

✓ ACpowersupplyandDCpowercable✓ ExtraBattery(s)ifrequired✓ Importantphonenumbers,suchasthoseofyourphysicianandhomehealthcare provider,orprovidersintheareayouwillbetraveling✓ Planforbackupoxygenintheeventofaprolongedpoweroutageor mechanicalfailure

For Use In Automobile/RV/Boat/AircraftForoperationusingaDCpowersource,followtheseinstructions:

1.ConnecttheDCpoweroutputplugtotheInogenOne®G4.2.ConnecttheDCpowerplug(CigaretteLighterAdapter)to

thepowersource.3. Theplugshouldinsertintothesocketwithoutexcessive

forceandsecurelyremaininplace.

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4. Checkthedevicedisplayscreentoconfirmthatanexternalpowersupplyisconnected. AniconofabatterywithalightningboltoranACpowerplugwillbedisplayedonthe

screen,indicatingthatexternalpowerisconnectedandfunctioningproperly.

WARNING EnsurethattheautomobilepowersocketisadequatelyfusedfortheInogenOne®G4powerrequirements(minimum15Amp).Ifthepowersocketcannotsupporta15Ampload,thefusemaybloworthesocketmaybedamaged.

WARNING ThetipoftheCigaretteAdapterPlugbecomesHOTwheninuse.Donottouchthetipimmediatelyafterremovalfromanautocigarettelightersocket.

CAUTION Ensuretheautomobilepowersocketiscleanofcigaretteashandtheadapterplugfitsproperly,otherwiseoverheatingmayoccur.

CAUTION Donotusethepowersupplywithacigaretteplugsplitterorwithan extensioncable.ThismaycauseoverheatingoftheDCpowerinputcable.

CAUTION DonotjumpstarttheautomobilewiththeDCpowercableconnected.Thismayleadtovoltagespikeswhichcouldshutdownand/ordamagetheDCpowerinputcable.

CAUTION WhenpoweringtheInogenOne®G4inanautomobileensurethevehicle’sengineisrunningfirst,beforeconnectingDCcableintocigarettelighteradapter.Operatingthedevicewithouttheenginerunningmaydrainthevehicle’sbattery.

CAUTION Achangeinaltitude(forexample,fromsealeveltomountains)mayaffecttotaloxygenavailabletothepatient.Consultyourphysicianbeforetravelingtohigherorloweraltitudestodetermineifyourflowsettingsshouldbechanged.

Traveling By AirTheInogenOne®G4conformstoallapplicableFAArequirementsforPOCuseonboardanaircraft.

Planning Your FlightWhenflyingwiththeInogenOne®G4,youmustinformtheairlinethatyouwillbeusingyourInogenOne®G4onboardtheaircraft.YoushouldcontacttheSpecialAssistancedeskoftheairlineonwhichyouwillbetravelingtolearnofanypaperwork,etc.thatmightbeneeded.

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•Someairlinesmayequiptheiraircraftwithonboardelectricalpower.YoumayhaveanopportunitytorequestaseatwithapowerportwhichcanbeusedtopoweryourInogenOne®G4.However,availabilityvariesbyairline,typeofaircraftandclassofservice.Youshouldcheckwithyourairlinesforavailabilityandalwaysplanonhavingsufficientbatterypowerfornolessthan150%oftheexpecteddurationoftheflight.Airlinesmayhavespecificrequirementsforbatterylifeduration,socheckwiththeairlinebeforetraveling.

•YourDCPowerCableisequippedwithacommonlyusedcigarettelighteradapter.However,aircraftsusedifferentpowerportconfigurationsanditisdifficulttodeterminewhichtypeofpowerportcompatibilityyouraircraftmaysupply.It’sagoodideatopurchaseanadapter,foundatelectronicandtravelstores.

Before Your FlightHerearesomethingstokeepinmindthedayyourflightdeparts:

•EnsureyourInogenOne®G4isclean,ingoodconditionandfreefromdamageorothersignsofexcessivewearorabuse.

•BringenoughchargedbatterieswithyoutopoweryourInogenOne®G4fornolessthan150%oftheexpecteddurationoftheflight,plusaconservativeestimateofunanticipateddelays.

•Regional/Commuterairlinesdonotofferonboardelectricalpower.Ifyourtravelplanscallforflightsonregionalairlines,bringenoughchargedbatterieswithyoutopoweryourInogenOne®G4fornolessthan150%oftheexpecteddurationoftheflight,plusaconservativeestimateofunanticipateddelays.

•Arriveattheairportearly.AirportsecurityscreeningpersonnelmayrequireextratimetoinspectyourInogenOne®G4.

•Whilewaitingtoboardyourflight,youmaybeabletoconservebatterypowerbyusingtheACPowerSupplytopoweryourInogenOne®G4fromanelectricaloutletintheairportterminalifavailable.

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During Your Flight1. Ifusingairlinepowerport,removetheBatteryfromtheInogenOne®G4Oxygen

Concentrator.Duetoaircraftpowerlimitations,theACPowerSupplycannotbeusedtochargetheInogenOne®G4Batterywhenonboardaircraft.

2. ConnecttheDCPowerPlugforavailableairlinepower.Checkwithairlinepersonneltoensurecompatibility.

•Duringtaxi,takeoffandlanding,stowyourInogenOne®G4undertheseatinfrontofyou.YourInogenOne®G4willfituprightundermostairlineseats.

•ItisnotnecessarytoturnoffyourInogenOne®G4duringtaxi,takeoffandlanding.

CAUTION Achangeinaltitude(forexample,fromsealeveltomountains)mayaffecttotaloxygenavailabletothepatient.TheInogenOne®G4hasbeenverifiedtoprovideoxygentospecificationupto10,000ft.(3048m).Consultyourphysicianbeforetravelingtohigherorloweraltitudestodetermineifyourflowsettingsshouldbechanged.

After Your Flight•Remembertorechargeadditionalbatteriesyoumayhaveusedpriortoyournextflight.

Traveling By Bus, Train or BoatContactyourcarriertofindoutaboutpowerportavailability.

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OperatingInstructionsChapter3

Battery Operating InstructionsEnsurethatthebatteryisinplaceandcharged.DisconnecttheInogenOne®G4fromitspowersource.WhiletheInogenOne®G4isoperatingonbatterypower,thebatterywilldischarge.Thedisplaywillindicatetheestimatedremainingpercentage(%)orminutesofuse.

Whentheconcentratordetectsthatthebatterylifeislow,withlessthan10minutesremaining,alowpriorityalertwillsound.Whenthebatteryisempty,thealertwillchangetoahighpriority.

Whenbatterylifeislow,dooneofthefollowing:• PlugtheInogenOne®G4intoanACorDCpowersourceusingtheACpowersupplyor DCcable.•ReplacethebatterywithachargedbatteryafterturningofftheInogenOne®G4 (bypressingtheON/OFFbutton).Toremovebatterypressandholdthebatterylatch buttonandslidebatteryofftheconcentrator.• Ifthebatteryisdrained,chargethebatteryorremoveitfromtheconcentrator.

IftheInogenOne®G4isbeingpoweredbytheACpowersupplyorDCpower,batterieswillchargeduringoperation.LeavingyourInogenOne®G4pluggedinpastthefullchargetimewillnotharmtheconcentratororthebattery. WARNING Itistheresponsibilityofthepatienttoperiodicallycheckthebatteryand replaceasnecessary.Inogenassumesnoliabilityforpersonschoosingnotto adheretomanufacturersrecommendations.

Normal Battery ChargingToensurethatyourbatteryisproperlycharging,inspectthatthecorrectACandDCpoweroutputplugadapterisbeingusedandthattheadapterisproperlyinsertedintothepoweroutlet.Observethedisplayorlightsthatindicatechargingstatus.

NOTE Whenstartingtochargeafullydischargedbattery,thechargingprocessmay startandstopduringthefirstfewminutes.

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Battery Care and MaintenanceYourInogenOne®G4LithiumIonBatteryrequiresspecialcaretoensureproperperformanceandlonglife.UseonlyInogenOne®G4BatterieswithyourInogenOne®G4Concentrator.

Keep DryAlwayskeepliquidsawayfrombatteries.Ifbatteriesbecomewet,discontinueuseimmediatelyanddisposeofbatteryproperly.

Effect of Temperature on Battery PerformanceTheInogenOne®G4singlebatterypowerstheInogenOne®G4Concentratorupto2.7hoursundermostenvironmentalconditions.Toextendtherun-timeofyourbattery,avoidrunningintemperatureslessthan41˚F(5˚C)orhigherthan95˚F(35˚C)forextendedperiodsoftime.

Battery Time Remaining ClockTheInogenOne®G4continuouslydisplaysbatterytimeremaining.Thisdisplayedtimeisonlyanestimateandtheactualtimeremainingmayvaryfromthisvalue.

Please Follow These Important Guidelines to Maximize Battery Performance and Life:• Storebatteryinacool,dryplace.Storewithachargeof40-50%.• Ifusingmultiplebatteries,makesurethateachbatteryislabeled(1,2,3orA,B,C,etc.) androtateonaregularbasis.Batteriesshouldnotbeleftdormantformorethan 90daysatatime.

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Display

TheInogenOne®G4displaycontainspowerstatusicons,modeicons,textwithinformationalmessagesanderrornotifications.

Power Status Icons

Theseiconsareexamplesofthoseshowninthedisplay’swindowwhentheInogenOne®G4isoperatingonbatterypower.

Inogen One® G4 Oxygen Concentrator Audible and Visible Signals

AudibleandVisibleSignalsChapter4

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Meaning

Batteryisempty.

Batteryhaslessthan10%chargeremaining.Thisiconflashes.

Batteryhasapproximately40%to50%chargeremaining.

Batteryisfull.

Icon

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Power Status Icons (continued)ThemodeiconsbelowareexamplesofthoseshownwhentheInogenOne®G4isoperatingfromanexternalpowersupplyandchargingthebattery.Thelightningboltindicatesthatanexternalpowersupplyisconnected.

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Batteryischargingwithchargelevelbetween60%and70%.

Thebatteryisfullychargedandischargingasnecessarytomaintainitscharge.

Batteryischargingwithchargelevellessthan10%.

TheInogenOne®G4isoperatingfromanexternalpowersourcewithnobatterypresent.

Icon

Mode IconsThesearethemodeiconsshowninthedisplay’swindow.

Display Text

NOTE Whentwoconditionsoccursimultaneously,theconditionwiththehigherprioritywillbedisplayed.

Meaning

Thebreathdetectionaudiblealerthasbeenenabled.

Thebreathdetectionaudiblealertisdisabled.Thisisthedefaultcondition.

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Informational MessagesThefollowinginformationdisplaysarenotaccompaniedbyanyaudiblefeedbackoranyvisualchangeintheindicatorlights.

Condition/Action/Explanation

TheInogenlogoisdisplayedatstartup.

Displayedduringwarmup.“X”representstheselectedflowsetting(eg.,Setting2).

Defaultdisplaywhenoperatingonbatterypower.“X”representstheselectedflowsetting(e.g.,Setting2).“HH:MM”representstheapproximatetimeremainingonthebatterycharge(e.g.,1:45).

Defaultdisplaywhenoperatingonanexternalpowersupplyandthebatteryischarging.“xx%”representsthepercentbatterycharge(e.g.,86%).

Defaultdisplaywhenthebatteryisnotchargingorwhenthetimeremainingisnotavailablefromthebattery.

Displayedwhentheconcentratorispluggedinandbeingusedtochargeabattery(notbeingusedforoxygenproduction).Itisnormaltoseeafullychargedbatteryreadbetween95%and100%whenexternalpowerisremoved.Thisfeaturemaximizestheusefullifeofthebattery.

Message Display & Text

SettingXPleaseWait

SettingXBatteryHH:MM

SettingXChargingxx(or)BatteryFull

SettingXBatteryxx%

Chargingxx%(0r) BatteryFull

Notifications

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WARNING Audiblenotifications,rangingfrom55dbato65dbadependingontheusersposition,aretowarntheuserofproblems.Toinsurethataudiblenotificationsmaybeheard,themaximumdistancethattheusercanmoveawayfromitmustbedeterminedtosuitthesurroundingnoiselevel.

24

Low Priority AlertsThefollowinglowpriorityalertmessagesareaccompaniedbyadouble beepandasolid yellow light.

Condition/Action/Explanation

Batterypowerislow,withlessthan10minutesremaining.Attachexternalpowersupplyorpowerdownandinsertafullychargedbattery.

Columnmaintenanceisrequiredwithin30days.Contactyourequipmentprovidertoarrangeforservice.

Message Display & Text

BatteryLow AttachPlug

Replace Columns

Notifications (continued)TheInogenOne®G4monitorsvariousparametersduringoperationandutilizesanintelligentalertsystemtoindicateamalfunctionoftheconcentrator.Mathematicalalgorithmsandtimedelaysareusedtoreducetheprobabilityoffalsealertswhilestillensuringpropernotificationofanalertcondition.Ifmultiplealertconditionsaredetected,thehighestpriorityalertwillbedisplayed.Notethatfailuretorespondtothecauseofanalertconditionforlow,mediumandhighpriorityalertspotentiallywillresultindiscomfortorreversibleminorinjuryonlyanddevelopwithinaperiodoftimesufficienttoswitchtoabackupsourceofoxygen.Thefollowingnotificationmessagesareaccompaniedbyasingle, short beep.

Condition/Action/Explanation

On/Offbuttonhasbeenpressedfortwoseconds.Concentratorisperformingsystemshutdown.

AudibleAlertbuttonhasbeenpressedforfiveseconds.

Message Display & Text

PleaseWait ShuttingDown

HH:MM Vx.x:SerialNumber

25AudibleandVisibleSignalsChapter4

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Low Priority Alerts (continued)Condition/Action/Explanation

Batteryerrorhasoccurred.Checktheconnectionofyourbatteryandensurethatitisproperlyattachedandlatchedonconcentrator.Ifbatteryerrorrecurswithsamebattery,stopusingthebatteryandswitchtoanewbatteryorremovebatteryandoperateconcentratorusingexternalpowersupply.

Concentratorisproducingoxygenataslightlylowlevel(<82%)foraperiodof10minutes.Ifconditionpersists,contactyourequipmentprovider.

Batteryhasexceededitschargingtemperatureandcharginghasstopped.Thebatterywillnotchargewhilethisalertispresentbutwillbegintochargewhenthebatterytemperaturereturnstothenormaloperatingrange.Ifbatterychargingisdesiredsooner,removethebatteryfromtheconcentratorandallowittocoolinanopenareaforapproximately10-15minutes.Then,re-insertthebatteryintotheInogenOne®G4.Iftheproblemstillpersists,contactyourequipmentprovider.

Theconcentratorrequiresservicingattheearliestconvenience.Theconcentratorisoperatingtospecificationandmaycontinuetobeused.Contactyourequipmentprovidertoarrangeforservice.

Theconcentrator’soxygensensorhasmalfunctioned.Youmaycontinuetousetheconcentrator.Iftheconditionpersists,contactyourequipmentprovider.

Message Display & Text

CheckBattery

OxygenLow

RemoveBatterytoCool

ServiceSoon

SensorFail

26

Condition/Action/Explanation

Concentratorhasnotdetectedabreathfor60seconds.Checkthatcannulaisconnectedtoconcentrator,therearenokinksintubingandcannulaispositionedproperlyinyournose.

Oxygenoutputconcentrationhasbeenbelow50%for10minutes.Ifconditionpersists,switchtoyourbackupoxygensourceandcontactyourequipmentprovidertoarrangeforservice.

Abreathhasbeenrecognized,butproperoxygendeliveryhasnotbeendetected.

Batteryhasexceededtemperaturelimitwhileconcentratorisrunningonbatterypower.Ifpossible,moveconcentratortoacoolerlocationorpowerunitwithanexternalpowersupplyandremovebattery.Ifconditionpersists,contactyourequipmentprovider.

Message Display & Text

NoBreathDetect CheckCannula

OxygenError

O2DeliveryError

BatteryHOT Warning

Medium Priority AlertsThefollowingmediumpriorityalertmessagesareaccompaniedbyatriple beep,repeatedevery25seconds,andaflashing yellow light.

27

Condition/Action/Explanation

Concentratorhasinsufficientbatterypowertoproduceoxygen.Attachexternalpowersupplyorexchangebattery,thenrestartunitifnecessarybypressingOn/Offbutton.

Batteryhasexceededtemperaturelimitwhileconcentratorisrunningonbatterypower.Concentratorhasstoppedproducingoxygen.Ifpossible,moveconcentratortoacoolerlocation,thenturnpoweroffandbackon.Ensureairintakeandoutletventshaveclearaccessandparticlefiltersareclean.Ifconditionpersists,switchtoabackupsourceofoxygenandcontactyourequipmentprovider.

Concentratortemperatureistoohighandoxygenproductionisshuttingdown.Ensureairintakeandoutletventshaveclearaccessandparticlefiltersareclean.Ifconditionpersists,switchtoabackupsourceofoxygenandcontactyourequipmentprovider.

Message Display & Text

BatteryEmpty AttachPlug

BatteryHOT

SystemHOT

High Priority Alerts

CAUTION IfyouarenotneartheInogenOne®G4youmaynotbeabletohearorseethehighpriorityalerts.MakesuretheInogenOne®G4isinalocationwherethealertsandalertswillberecognizediftheyoccur.

Thefollowinghighpriorityalertmessagesareaccompaniedbyafive beep pattern,repeatedevery10secondsandaflashing yellow light.

AudibleandVisibleSignalsChapter4

English

28

Condition/Action/Explanation

Thismayresultfromtheconcentratorbeingstoredinacoldenvironment(below0ºC(32ºF)).Movetoawarmerenvironmenttoallowtheunittowarmupbeforestartingit.Ifconditionpersists,switchtoabackupsourceofoxygenandcontactyourequipmentprovider.

Concentratorhasstoppedproducingoxygenandisshuttingdown.Youshould:

1. Switchtobackupoxygensource2.Contactyourequipmentprovider

Message Display & Text

SystemCOLD

SystemError

High Priority Alerts (continued)

29

Troubleshooting

TroubleshootingChapter5

Useexternalpowersupplyorreplacebatterywithonethatisfullycharged

Checkpowersupplyconnectionandverifygreenlightissolid

CheckDCCableconnectionattheConcentratorandatcigarettelighterorauxiliaryDCpowersource

Contactyourequipmentprovider

Batteryisdischargedornobatteryispresent

ACPowersupplyisnotconnectedproperly

DCCableisnotconnectedproperly

Malfunction

ConcentratordoesnotpoweronwhenOn/Offbuttonispressed

Recommended Solution

RefertoChapter4

Possible Cause

RefertoChapter4

Problem

Anyproblemaccompaniedbyinformationonconcentratordisplay,indicatorlightsand/oraudiblesignals

Solutionstosomepossibleissuesyoumayencounteraredescribedinthissection.

Inogen One® G4 Oxygen Concentrator

5English

30

PressOn/Offbuttontopowerconcentrator

Checkcannulaanditsconnectiontoconcentratornozzle

Concentratorisnotpoweredon

Cannulaisnotconnectedproperlyoriskinkedorobstructed

Nooxygen

Recommended SolutionPossible CauseProblem

Troubleshooting (continued)

31

Cannula Replacement

Yournasalcannulashouldbereplacedonaregularbasis.Consultwithyourphysicianand/orequipmentproviderand/orcannulamanufacturer’sinstructionsforreplacementinformation.Asinglelumencannulaupto25feetinlengthisrecommendedtoensureproperbreathdetectionandoxygendelivery.

Case CleaningYoumaycleantheoutsidecaseusingaclothdampenedwithamildliquiddetergent(suchasDawnTM)andwater.

WARNING DonotsubmersetheInogenOne®G4oritsaccessoriesinwaterorallowwatertoenterintothecase;thismayleadtoelectricalshockand/ordamage.

WARNING DonotusecleaningagentsotherthanthosespecifiedinthisUserManual.Donotusealcohol,isopropylalcohol,ethylenechlorideorpetroleumbasedcleanersonthecasesorontheparticlefilter.

Filter Cleaning and ReplacementTheparticlefiltermustbecleanedweeklytoensuretheeaseofairflow.Removefiltersfromthefrontofthedevice.Cleantheparticlefilterswithamildliquiddetergent(suchasDawnTM)andwater;rinseinwateranddrybeforereuse.

Cleaning, Care and Maintenance

Cleaning,CareandMaintenanceChapter6

6

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! C

English

32

NOTE Itmaybenecessarytocleantheparticlefiltermoreoftenindustyenvironments.

TopurchaseadditionalparticlefilterscontactyourequipmentproviderorInogen.

Output FilterTheoutputfilterisintendedtoprotecttheuserfrominhalationofsmallparticlesintheproductgasflow.TheInogenOne®G4includesanoutputfilterconvenientlylocatedbehindtheremovablecannulanozzlefitting.Inogenrequiresthatthisfilterbereplacedbetweenpatients.

TheoutputfiltermaybereplacedbytheequipmentproviderorbytheownerusingtheOutputFilterReplacementKit(RP-404).

TheInogenOneG4Concentratormustbecleanedanddisinfectedaspertheaboveinstructionsforeachnewpatient.Nospecialmaintenanceneedstobecarriedoutbythepatient.YourequipmentproviderperformsmaintenanceoperationstoassurecontinuedreliableservicefromyourInogenOneG4.Themanufacturer’sinstructionsforthepreventativemaintenanceofthedevicesaredefinedintheservicemanual.Allworkmustbeperformedbytrainedtechnicianscertifiedbythemanufacturer.

DC Input Cable Fuse ReplacementTheCigaretteLighterDCpowerplugcontainsafuse.IftheDCinputcableisbeingusedwithaknowngoodpowersourceandtheunitisnotreceivingpower,thefusemayneedtobereplaced.

Toreplacethefuse,followtheseinstructionsandrefertothephotographbelow.1. Removethetipbyunscrewingtheretainer.Useatoolifnecessary.2. Removetheretainer,tipandfuse.3. ThespringshouldremaininsidetheCigaretteLighterAdapterhousing.Ifthespring

isremoved,makesuretoreplacethespringfirstbeforeinsertingthereplacementfuse.

33Cleaning,CareandMaintenanceChapter6

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4. Installareplacementfuse,InogenRP#125(BUSSMDA-12)andreassemblethetip.Ensuretheretainerringisproperlyseatedandtightened.

Inogen One® G4 Column Change Procedure

NOTE Columnchangeinstructionsareonlytobeusedwhenmaintenanceis requiredandarenotintendedforpracticepurpose.

1. TurnofftheInogenOne®G4concentratorbypressingthepowerbuttontoshutdownthedevice.

2.RemovetheInogenOne®G4concentratorfromthecarrycase,ifapplicable.

3.RemovethebatteryfromtheInogenOne®G4concentrator.

4.PlacetheInogenOne®G4concentratoronitssidesothattheundersideisvisible.Themetalcolumnas-semblycanbeseenononesideofthedevice.

FuseCigarette Adapter Plug Retainer Tip Retainer

CAUTION Forcontinuedprotectionagainstriskoffire,onlyusefusespecified.

34

Inogen One® G4 Column Change Procedure (continued) 5.Unlockthecolumnassemblybypushingthelatch

buttonawayfromthecolumns.

6.Whileholdingthebuttonopen,slidethecolumnassemblyoutofthedevicebypullingonthecolumnpullhandle.

7. RemovethecolumnscompletelyfromtheInogenOne®G4.Bothcolumnsareremovedasonepiece.

Column(metaltube)Installation8.Removedustcapsofnewcolumnassembly.Make

surethereisnodustordebriswherethedustcapswerelocated.

Openandunlocked

35Cleaning,CareandMaintenanceChapter6

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Inogen One® G4 Column Change Procedure (continued)

9.InsertcolumnassemblyintotheInogenOne®G4concentrator.Donotleavethecolumnendsexposed;columnassemblyshouldbeinsertedintotheIno-genOne®G4assoonasthedustcapshavebeenremoved.

10.Pushthecolumnassemblyintothedevicesuchthat thecolumnsarefullyseatedintotheInogenOne®

G4concentrator.Thespringloadedlatchbuttonshouldfullyreturntotheclosedposition.

11. ConnecttheACpowersupplycordtotheInogen One®G4andplugthepowersupplyACcordintoan electricaloutlet.DoNotPowerontheInogenOne® G4concentrator.

12.Pressandholdtheplus(+)and(-)minusbuttonfor5

seconds.Thescreenwilldisplay“sievereset” message.Releasebuttononcemessageisdisplayed

onscreen.

13.Pressthealert buttononceandscreenwill display“sieveresetsuccess”.

14.PressthepowerbuttontoturnontheInogenOne®G4,andusenormally.

WARNING Donotuseanycolumnsotherthanthosespecifiedinthisusermanual.Theuseofnon-specifiedcolumnsmaycreateasafetyhazardand/orimpairequipmentperformanceandwillvoidyourwarranty.! C

Closedandlocked

36

Disposal of Equipment and AccessoriesFollowyourlocalgoverningordinancesfordisposalandrecyclingoftheInogenOne®G4andaccessories.IfWEEEregulationsapply,donotdisposeofinunsortedmunicipalwaste.WithinEurope,contacttheEUAuthorizedRepresentativefordisposalinstructions.Thebatterycontainslithiumioncellsandshouldberecycled.Thebatterymustnotbeincinerated.

Maintenance Items List• InogenOne®G4singlebattery(model#BA-400)• InogenOne®G4doublebattery(model#BA-408)• Replacementintakeparticlefilters(model#RP-405)• OutputFilterReplacementKit(model#RP-404)• InogenOne®G4columns(model#RP-406)

Forassistance,ifneeded,insettingup,using,maintaining,ortoreportunexpectedoperationorevents,contactyourequipmentprovider,ormanufacturer.

Other Service and Maintenance WARNING DonotdisassembletheInogenOne®G4oranyoftheaccessoriesor

attemptanymaintenanceotherthantasksdescribedinthisusermanual;disassemblycreatesahazardofelectricalshockandwillvoidyourwarranty.Donotremovethetamperevidentlabel.Foreventsotherthanthosedescribedinthismanual,contactyourequipmentproviderforservicingbyauthorizedpersonnel.

CAUTION DonotuselubricantsontheInogenOne®G4oritsaccessories.

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37

Symbols Used On Concentrator and Accessories

SymbolsUsedonConcentratorandAccessoriesChapter7

7English

Meaning

Awarningindicatesthatthepersonalsafetyofthepatientmaybeinvolved.Disregardingawarningcouldresultinsignificantinjury.

Acautionindicatesthataprecautionorserviceproceduremustbefollowed.Disregardingacautioncouldleadtoaminorinjuryordamagetoequipment.

SeeUserManualforInstructions.

U.S.FederalRegulationRestrictsthisDevicetoSalebyOrderofPhysician.MayalsobeapplicableinotherCountries.

ACPower

DCPower

NoSmokingwhiledeviceisinuse.

NoOpenFlames(Concentrator);Donotincinerate(Battery).Refertoinstructionmanual/booklet.

Manufacturer

Symbol

WARNING

CAUTION

ONLY

ONLY

ONLY

ONLY

ONLY

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EC REP AuthorizedRepresentativeintheEuropeanCommunity

38

Meaning

KeepDry

IndoororDryLocationUseOnly,DoNotGetWet

UseNoOilorGrease

DoNotDisassemble(contactyourequipmentproviderforservicingbyauthorizedpersonnel)

DoNotDisposeofInUnsortedMunicipalWaste

TypeBFAppliedPart,NotIntendedforCardiacApplication

ClassIIDevice

ElectricalSafetyAgencyCertificationLogo

CompliesWithApplicableEUDirectivesIncludingMedicalDeviceDirective

Symbol

ONLYONLY

ONLY

ONLYONLY

User Interface Label

Meaning

ON/OFFButton

IncreaseFlowSetting

DecreaseFlowSetting

AudibleAlertButton

Symbol

0123

93-01213-00-00 rev1

0123

COLOR SUMMARY: 1. Black

39InogenOne®G4SystemSpecificationsChapter8

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Inogen One® G4 ConcentratorDimensions:Withsinglebattery

L/W/H:5.91in.(15.01cm.)/2.68in.(6.8cm.)/6.5in.(16.3cm.)L/W/H:5.91in.(15.01cm.)/2.68in.(6.8cm.)/7.2in.(18.2cm.)

Weight: 2.8pounds(1.27Kg.)(includessinglebattery)Noise: 40dBA(onsetting2)Warm-UpTime: 2minutesOxygenConcentration: 90%-3%/+6%atallsettingsFlowControlSettings: 3settings:1to3Power:ACPowerSupply:

DCPowerCable:RechargeableBattery:

ACInput: 100to240VAC50to60Hz

Auto-Sensing: 1.0A

DCInput: 13.5-15.5VDC,10AMax.Voltage: 12.0to16.8VDC

BatteryDuration: Upto2.7hourswithsinglebatteryUpto5hourswithdoublebattery

BatteryChargingTime: Upto3hoursforasinglebatteryUpto5hoursforadoublebattery

EnvironmentalRangesIntendedforUse:

Temperature:41to104˚F(5to40˚C)Humidity:0%to95%,non-condensingAltitude:0to10,000ft(0to3048meters)

EnvironmentalRangesIntendedforShippingandStorage:

Temperature:-13to158˚F(-25to70˚C)Humidity:0%to95%,non-condensingStoreinadryenvironmentAltitude:0to10,000ft(0to3048meters)

Transportation: KeepDry,HandleWithCare

Inogen One® G4 System Specifications8

40

Inogen One® G4 Concentrator (continued)

Classifications

ModeofOperation: ContinuousDutyTypeofProtectionAgainstElectricalShock:

ClassII

DegreeofProtectiontoConcentratorComponentsAgainstElectricalShock:

TypeBFNotintendedforcardiacapplication

DegreeofProtectiontoConcentratorComponentsAgainstIngressofWater:

IP22-Verticallydrippingwatershallhavenoharmfuleffect&protectagainstingressofsolidobjects>12.5mm.diameterwhentheenclosureistiltedatanangleupto15˚fromitsnormalposition*

DegreeofSafetyforApplicationinPresenceofAnestheticGases:

Notsuitableforsuchapplication

TestedbyIndependentLaboratory:

Safety:IEC60601-1CAN/CSAC22.2No.60601-1ElectromagneticCompatibility:IEC60601-1-2RTCADO160

*NormalpositionoftheInogenOne®G4isuprightwiththeuserinterfacedisplayfacingupward.

41

PortableandmobileRFcommunicationsequipmentshouldbeusednoclosertoanypartofthedevice,includingcables,thantherecommendedseparationdistancecalculatedfromtheequationapplicabletothefrequencyofthetransmitter.

Recommendedseparationdistance:d=1.2√P150kHzto80MHzd=1.2√P80MHzto800MHzd=2.3√P800MHzto2.5GHz

WherePisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufactureranddistherecommendedseparationdistanceinmeters(m).

FieldstrengthsfromfixedRFtransmitters,asdeterminedbyanelectromagneticsitesurveya,shouldbelessthanthecompliancelevelineachfrequencyrangeb.

Interferencemayoccurinthevicinityofequipmentmarkedwiththefollowingsymbol:

3Vrms150kHz to80MHz

3V/m80MHz to2.5GHz

3Vrms

3V/m

ConductedRFIEC61000-4-6

RadiatedRFIEC61000-4-3

Compliance Level

IEC 60601 Test Level

Immunity Test Electromagnetic Environment - Guidance

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity: TheConcentratorisintendedforuseintheelectromagneticenvironmentspecifiedbelow.TheuseroftheConcentratorshouldmakesureitisusedinsuchanenvironment.

Floorsshouldbewood,concreteorceramictile.Iffloorsarecoveredwithsyntheticmaterial,therelativehumidityshouldbeatleast30%.

Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.

Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.

Electrostaticdischarge(ESD)

IEC61000-4-2

Electricalfasttransient/burst

EC61000-4-4

Surge

IEC61000-4-5

±6kVcontact

±8kVair

±6kVcontact

±8kVair

±2kVforpowersupplylines

±1kVforinput/outputlines

±2kVforpowersupplylines

±1kVforinput/outputlines

±1kVline(s)toline(s)

±2kVline(s)toearth

±1kVline(s)toline(s)

±2kVline(s)toearth

Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.Iftheuserofthe[MEEQUIPMENTorMESYSTEM]requirescontinuedoperationduringpowermainsinterruptions,itisrecommendedthatthe[MEEQUIPMENTorMESYSTEM]bepoweredfromanuninterruptedpowersupplyorabattery.

Powerfrequencymagneticfieldsshouldbeatlevelscharacteristicofatypicallocationinatypicalhospitalorhomeenvironment.

Voltagedips,shortinterruptionsandvoltagevariationsonpowersupplyinputlines

IEC61000-4-11

Powerfrequency(50/60Hz)magneticfield

IEC61000-4-8

<5%UT(>95%dipinUT)for0.5cycle

40%UT(60%dipinUT)for5cycles

70%UT(30%dipinUT)for25cycles

<5%UT(>95%dipinUT)for5sec

<5%UT(>95%dipinUT)for0.5cycle

40%UT(60%dipinUT)for5cycles

70%UT(30%dipinUT)for25cycles

<5%UT(>95%dipinUT)for5sec

3A/m 3A/m

English

42

NOTE At80MHzand800MHz,thehigherfrequencyrangeapplies.

NOTE Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstructures,objects,andpeople.

NOTE UTisthea.c.mainvoltagepriortoapplicationofthetestlevel.

a:Fieldstrengthfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandlandmobileradios,amateurradio,AMandFMradiobroadcastandTVbroadcastcannotbepredictedtheoreticallywithaccuracy.ToassesstheelectromagneticenvironmentduetofixedRFtransmitters,anelectromagneticsitesurveyshouldbeconsidered.IfthemeasuredfieldstrengthinthelocationinwhichtheconcentratorisusedexceedstheapplicableRFcompliancelevelabove,theconcentratorshouldbeobservedtoverifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmaybenecessary,suchasre-orientingorrelocatingthedevice.

b:Overthefrequencyrange150kHzto80MHz,thefieldstrengthsshouldbelessthan3V/m.Recommended Separation Distances between Portable and Mobile RF Communications Equipment and This Device:

ThisconcentratorisintendedforuseinanelectromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled.TheuseroftheconcentratorcanhelppreventelectromagneticinterferencebymaintainingaminimumdistancebetweenportableandmobileRFcommuni-cationsequipment(transmitters)andthisconcentratorasrecommendedbelow,accordingtothemaximumoutputpowerofthecommuni-cationsequipment.

150 kHz to 80 MHzd=1.2√P

0.120.381.23.812

0.120.381.23.812

0.230.732.37.323

0.010.11

10100

80 MHz to 800 MHzd=1.2√P

800 MHz to 2.5 GHzd=2.3√P

Separation Distance According to Frequency of Transmitter (M)Rated Maximum Power Output of Transmitter (W)

Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommendedseparationdistancedinmeters(m)canbeestimatedusingtheequationapplicabletothefrequencyofthetransmitter,wherePisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufacturer.

Guidance and Manufacturer’s Declaration – Electromagnetic EmissionsTheconcentratorisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Theuseroftheconcentratorshouldassurethatitisusedinsuchanenvironment.

NOTE At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrangeapplies.

NOTE Theguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstructures,objects,andpeople.

Emissions Test Compliance Electromagnetic Environment - Guidance

RFemissionsCISPR11

Group1 TheconcentratorusesRFenergyonlyforitsinternalfunction.ThereforeitsRFemissionsareverylowandnotlikelytocauseanyinterferenceinnearbyequipment.

RFemissionsCISPR11

ClassB Theconcentratorissuitableforuseinallestablishments,includingdomesticestablishmentsandthosedirectlyconnectedtothepubliclow-voltagepowersupplynetworkthatsuppliesbuildingsusedfordomesticpurposes.HarmonicEmissions

IEC61000-3-2ClassA

Voltagefluctuations/flickeremissionsIEC61000-3-3

Complies

PN 96-06728-00-02 A

Inogen, Inc.326 Bollay DriveGoleta, CA 93117Toll Free: 877-466-4362 +1-805-562-0515 (Outside the USA) E-mail: [email protected] www.inogen.com

®

©2017 Inogen. All rights Reserved.