user manual - inogen · other than tasks described in this user manual; disassembly creates a...

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®

user manual

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Contents

Chapter 1 1 Glossary of Symbols

Chapter 2 2 Warnings, Cautions and Contraindications 2 Contraindications 2 Warnings 3 CautionsChapter 3 4 Indications for Use 4 IndicationsforUse

Chapter 4 4 User Interfaces, Controls and Serviceable Items 4 UserInterfaces 5 UserControls 5 ServiceableItems

Chapter 5 6 Operating Instructions

Chapter 6 7 Audible and Visual Indicators

Chapter 7 10 Troubleshooting

Chapter 8 10 Cleaning, Care and Maintenance 10 CleaningandCare 11 RoutineMaintenance 11 ReplacementPartsandRecommendedAccessories 11 Service 12 ColumnChangeProcedure 13 Storage

Chapter 9 13 Specifications

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1. Glossary of Symbols

Awarningindicatesthatthepersonalsafetyofthepatientmaybeinvolved.Disregardingawarningcouldresultinsignificantinjury

Acautionindicatesthataprecautionorserviceproceduremustbefollowed.DisregardingacautioncouldleadtoaminorinjuryordamagetoequipmentOn/Off(Power)

FlowsettingindicatorRedIndicatorLight

Generalalarmindicatorlight

FollowinstructionsforuseTypeBFAppliedPartClassIIEquipmentNoOpenFlames

NoSmoking

NoOilorGrease

DoNotDisassemble

U.S.FederalRegulationRestrictsthisdevicetosalebyorderofphysician.Mayalsobeapplicableinothercountries

DonotdisposeofinunsortedmunicipalwasteACPower

KeepDry

EnclosureIngressProtectionagainstsolidobjectsof12.5mmminimumdiameterandverticallyfallingdropsofwater

Manufacturer

AuthorizedrepresentativeintheEuropeanCommunity

Fragile

Humidity

Temperature

ThisSideUp

ONLY

ONLYONLY

WARNING

CAUTION

ONLY

ONLYONLY

ONLY

ONLY

As Packaged (Per Box)

Symbol Key

IP21

EC REP

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Contraindications• ThisequipmentistobeusedasanoxygensupplementandisNOT

INTENDEDtobelifesupportingorlifesustaining.

Warnings • Thedeviceproducesconcentratedoxygengaswhichaccelerates

combustion.DONOTUSETHEDEVICEWHENSMOKINGORNEAROPENFLAME,MATCHES,PETROLEUM,OIL,GREASE,SOLVENTS,RADIANTHEATERS,AEROSOLSetc.Useonlywaterbasedlotionsorsalvesthatareconcentratedoxygencompatibleduringoxygentherapy.

• Concentratedoxygenmakesiteasierforafiretostartandspread.Donotleavethenasalcannulaonupholsteryorotherfabricsuchasbeddingorpersonalclothingiftheoxygenconcentratoristurnedonbutnotinuse.Concentratedoxygenwillmakethematerialsflammable.Turnofftheoxygenconcentratorwhennotinuse.

• Donotusetheoxygenconcentratorinthepresenceofpollutants,smokeorfumes,flammableanesthetics,cleaningagentsorotherchemicalvapors.Thismayinternallycontaminatetheoxygenconcentratoranddegradeitsperformance.

• Donotusetheoxygenconcentratorifeithertheplugorthepowercordisdamagedtopreventaccidentalelectricalshock.

• Donotsubmergetheoxygenconcentratorinliquids,exposetoliquids,orotherwiseallowliquidstoenterintothecase,thismayleadtoelectricalshockand/ordamage.Iftheoxygenconcentratorisexposedtoliquidsturnitoffandunplugfromelectricaloutletbeforeattemptingtocleananddrytheliquidspill.

• Whenusingacompatiblehumidifierdonotrefillhumidifierwhileattachedtotheoxygenconcentrator.Removethehumidifierfromtheoxygenconcentratorpriortorefillingtopreventaccidentalspillsontheconcentratorandpreventelectricalshockhazard.

• Donotusecleaningagentsotherthanthosespecifiedinthismanual.Alwaysunplugtheoxygenconcentratorbeforeperforminganycleaning.Donotusealcohol,isopropylalcohol,ethylenechloride,orpetroleumbasedcleaners.Thismayimpairtheproperfunctionand/orincreasetheriskoffireandburns.

• Donotdisassembletheoxygenconcentratororattemptanymaintenanceotherthantasksdescribedinthisusermanual;disassemblycreatesahazardofelectricalshockandwillvoidthewarranty.Servicingoftheconcentratoristobeperformedbyqualifiedandtrainedpersonnelonly.

• Donotuseanycolumnsotherthanthosespecifiedinthisusermanual.Theuseofnon-specifiedcolumnsmaycreateasafetyhazardand/orimpairequipmentperformanceandwillvoidthewarranty.

2. Warnings, Cautions and Contraindications

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• Toavoiddangerofchokingandstrangulationhazard,keeptubingawayfromchildrenandpets.

• Ifyoubegintofeelillorareexperiencingdiscomfortwhileusingtheoxygenconcentrator,consultyourhealthcareproviderimmediately.

Cautions• USAFederallawrestrictsthisdevicetosaleorrentalbyorontheorderof

aphysician,oranyotherpractitionerlicensedbytheStateinwhichhe/shepracticestouseorordertheuseofthisdevice;mayalsobeapplicableinothercountries.Undercertaincircumstances,theuseofnon-prescribedoxygentherapycanbehazardous.

• Availabilityofanalternatesourceofoxygenisrecommendedincaseofpoweroutageormechanicalfailure.Consultyourequipmentproviderfortypeofback-upsystemrecommended.

• Additionalmonitoringorattentionmayberequiredforpatientsusingthisdevicewhoareunabletohearorseealarmsorcommunicatediscomfort.Ifthepatientshowsanysignsofdiscomfort,aphysicianshouldbeconsultedimmediately.

• Accessoriesnotspecifiedforusewiththeoxygenconcentratormayimpairperformance.Alwaysuseaccessoriesaccordingtomanufacturer’sinstructions.

• Nasalcannulashouldberated5litersperminutetoensureproperpatientusageandoxygendelivery.

• Replacethenasalcannulaonaregularbasis.Checkwithyourequipmentproviderorhealthcareprofessionaltodeterminehowoftenthecannulashouldbereplaced.

• Itisrecommendedtheoxygenconcentratoraccessorytubingandcannulaincludeameanstoreducethepropagationoffire.

• Donotoperatetheconcentratorwithouttheintakefilterandparticlefilterinplace.Particlesdrawnintotheoxygenconcentratormaydamagetheequipment.

• Refertotheenvironmentalrangespecificationsforproperstorageanduseconditions.Temperaturesinexcessoftheindicatedrangemaycausedevicemalfunction.

• Donotobstructairintakeorexhaustwhenoperatingtheoxygenconcentrator.Blockageofaircirculationorproximitytoaheatsourcemayleadtointernalheatbuildupandshutdownordamage.Alwaysmaintainaminimumofsixinchesofclearance.

• Donotplaceanythinginthepowersupplyportotherthanthesuppliedwallcord.Avoidtheuseofelectricalextensioncordswiththeconcentrator.Ifanextensioncordmustbeused,useanextensioncordthathasanUnderwritersLaboratory(UL)Markandaminimumwirethicknessof18gauge.Donotconnectanyotherdevicetothesameextensioncord.

• Donotsitorstandontheconcentrator,doingsocanbehazardous.

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InordertoensureasafeinstallationandoperationoftheInogenAtHomeOxygenConcentratorModelGS-100,readandunderstandthisentiremanualbeforeusingthedevice.

TheInogenAtHomeOxygenConcentratorhasa5yearexpectedlifeexcept1yearexpectedlifeforuserserviceablesievebedcolumns.

3. Indications for UseTheInogenAtHomeOxygenConcentratorisusedonaprescriptivebasisbypatientsrequiringsupplementaloxygen.Itsuppliesahighconcentrationofoxygenandisusedwithanasalcannulatochanneloxygenfromtheconcentratortothepatient.TheInogenAtHomeOxygenConcentratormaybeusedinahomeorinstitution.

4. User Interfaces, Controls and Serviceable Items

On/Off Button

Flow Setting IndicatorRed Indicator

Light

General Caution Indicator

Flow Control

User Interfaces General Caution Indicator Light (Low, Medium Priority Alarm)Ayellowlightindicateseitherachangeinoperatingstatusoraconditionthatmayneedresponse.Aflashinglightishigherprioritythannon-flashing.Red Indicator Light (Change Column Soon) Columnmaintenanceisrequiredwithin30days.Contactyourequipmentprovidertoarrangeservice.

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Flow Control

User Interfaces Audible IndicatorsAnaudiblealarm(beep)indicateseitherachangeinoperatingstatusoraconditionthatmayneedresponse(alarm).Morefrequentbeepsindicatehigherpriorityconditions.

Flow Setting IndicatorAgreenindicatorlightindicatestheselectedflowsetting.

User ControlsON / OFF ButtonPressoncetoturn“ON”;Pressandholdforonesecondtoturn“OFF”.Flow Setting Control Buttons Usethe–or+flowsettingcontrolbuttonstoselectthesettingasshownonthedisplay.Therearefivesettings,from1to5.

Serviceable ItemsParticle FilterThefiltermustbeinplaceattheintakeendoftheconcentratorduringoperation.

Air Inlet FilterThefiltermustbeinplaceatthetopoftheconcentratorduringoperation.

Cannula Nozzle FittingThenasalcannulaconnectstothisnozzleforoutputofoxygen.

Nasal CannulaNasalcannulasshouldbereplacedonaregularbasis,consultwithyourphysicianorequipmentprovider,orcannulamanufacturer’sinstructions.

Nozzle Fitting

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5. Operating Instructions1. Placetheconcentratorinawell-ventilatedlocation;air

intakeandexhaustmusthaveclearaccess.Ensurethattheconcentratorisatleast6inches(15cm.)awayfromwalls,furnitureandcurtainsthatcouldimpedeadequateairflowtothedevice.

2. Ensureparticlefilterisinplace.3. Ensureintakefilterisinplace.4. FollowinstructionsAorBbelow: A. Ifyouarenotusingahumidifierbottle,connect yournasalcannulatubingtothenozzlefitting. Nozzlefittingislocatedonthetopofthe concentrator.Seeillustrations4A1and4A2. B. Ifyouareusingahumidifierbottle,followthe manufacturer’sinstructions.Placethehumidifier bottleinthedesignatedholder. Seeillustrations4B1and4B2.5. Attachthepowercordtothebackoftheconcentrator andplugtheotherendintoanelectricaloutlet.Donot positiontheconcentratorsothatitisdifficultto disconnectthepowercord.Turnontheconcentratorby pressingtheON/OFFbutton. Seeillustration5.Asingleshortbeepwillsoundandall indicatorlightswillilluminateforafewseconds.6. Usetheorbuttonstoadjustthedevicetothe prescribedsetting.Therearefiveflowsettings,from 1literperminuteto5litersperminute.Thecurrent settingcanbeviewedonthedisplay.ThegreenLEDwill illuminateoncethesetflowrateofoxygenisachieved. Youmaybeginbreathingfromthedevice;therequired oxygenconcentrationisnormallyreachedwithinfive minutesafterdeviceispoweredon.7. Ensurethatthetubingisnotkinkedorpinchedinany wayandthatoxygenisflowingthroughthenasal cannula.Ifoxygenisnotflowing,thegreenLEDwillnot beilluminated.Refertothetroubleshootingguide sectionofthismanual.8. Adjustthenasalcannulasothatitisproperlyaligned onyourfaceorasdirectedbyyourhealthcareprovider.9. TurnofftheconcentratorbypressingtheON/OFF button.Turnofftheconcentratorwhennotinuse.

4A2

4A1

Nozzle Fitting

4B1

4B2

5

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6. Audible and Visual Indicators

Theconcentratorhasanaudiblealarmandthreevisualindicators(green, yellow and red).

NotificationsTheconcentratormonitorsvariousparametersduringoperationandutilizesanintelligentalarmsystemtoindicateamalfunctionoftheconcentrator.MathematicalalgorithmsandtimedelaysareusedtoreducetheprobabilityoffalsealarmswhilestillensuringpropernotificationofanalarmconditionIfmultiplealarmconditionsaredetected,thehighestpriorityalarmwillbedisplayed.Toinsurethataudiblenotificationsmaybeheard,theoperatorspositionmustbedeterminedtosuitthesurroundingnoiselevel.Notethatfailuretorespondtothecauseofanalarmconditionforlow,mediumandhighpriorityalarmspotentiallywillresultindiscomfortorreversibleminorinjuryonlyanddevelopwithinaperiodoftimesufficienttoswitchtoabackupsourceofoxygen.Thefollowingnotificationmessagesareaccompaniedbyanaudibleand/orvisualindicator.

Yellow Indicator Light

Red Indicator Light

Flow Setting Indicator

Condition/Action/ExplanationCurrentflowrateofoxygenbeingdisplayedatasettingfrom1-5litersperminute.

Flowstatusindicatorisgreen. Columnmaintenanceisrequiredwithin30days.Contactyourequipmentprovidertoarrangeservice.

Indicator

FlowrateonLED Display

Flowrateindicator

RedIndicatorLight

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Low Priority AlarmsThefollowinglowpriorityalarmmessagesareaccompaniedbyadouble beepandasolid yellow light.

Concentratorisproducingoxygenataslightlydecreasedlevel.Contactyourequipmentprovidertoarrangeservice.

Theconcentratorisoperatingtospecificationbutrequiresserviceattheearliestconvenience.Contactyourequipmentprovidertoarrangeservice.

Oneoftheconcentrator’ssensorshasmalfunctioned.Iftheconditionpersists,contactyourequipmentprovidertoarrangeservice.

Theconcentratorisproducingoxygenataslightlydecreasedrate.Ifconditionpersists,contactyourequipmentprovidertoarrangeservice.

LowOxygen

ServiceNeeded

SensorFail

LowFlow

4

3

2

Action/ ExplanationConditionIndicator

Properoxygendeliveryhasnotbeendetected.Checkforkinkedtubing.Ifconditionpersists,switchtoabackupoxygensourceandcontactyourequipmentprovidertoarrangeservice.

FlowError4

Action/ Explanation

Theconcentratorisproducingoxygenatalowconcentration.Switchtoabackupoxygensourceandcontactyourequipmentprovidertoarrangeservice.

Condition

OxygenError

Indicator

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Medium Priority AlarmsThefollowingmediumpriorityalarmmessagesareaccompaniedbyatriplebeep,repeatedevery25seconds,andaflashing yellow light.

Flowsettingflashing

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Medium Priority AlarmsThefollowingmediumpriorityalarmmessagesareaccompaniedbyatriplebeep,repeatedevery25seconds,andaflashing yellow light.

High Priority Alarms Thefollowinghighpriorityalarmmessagesareaccompaniedbyafivebeeppattern,repeatedevery10secondsandaflashing yellow lightwarningindicatingimmediateresponsebytheoperatorisrequired.

Action/ Explanation

Smokehasbeendetectedinsidethedeviceanddeviceisshuttingdown.Allowtheconcentratortoairoutinasmoke-freeenvironmentandrestart.Ifconditionpersists,switchtoabackupsourceofoxygenandcontactyourequipmentprovider.

Condition

FireHazard

Indicator

5

Concentratortemperatureistoocoldforoperation.Allowtheconcentratortowarmupinaroomtemperatureenvironmentfor10minutesandrestart.Ifconditionpersists,switchtoabackupsourceofoxygenandcontactyourequipmentprovider.

Switchtoabackupsourceofoxygenandcontactyourequipmentprovider.

Concentratorlostpowerduringoperation.Tryunpluggingthepowercordandpluggingitbackin.Ifalarmdoesnotreset,pressandholdthepowerbuttondownfor2seconds.Ifconditionpersists,switchtoabackupsourceofoxygenandcontactyourequipmentprovider.

Concentratortemperatureistoohighforoperation.Ensureairintakeandoutletventshaveclearaccessandparticlefiltersareclean.Allowtheconcentratortocoolfor10minutesandrestart.Ifconditionpersists,switchtoabackupsourceofoxygenandcontactyourequipmentprovider.

SystemCold

SystemError

PowerError

SystemHot

3

2

Soundindicatoronly

4

NOTE Whenpowerislostduringoperation,thebuzzerwillalarm continuously.

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8. Cleaning, Care and Maintenance Cleaning and Care

Periodicallyyoumaycleantheoutsidecaseusingaclothdampenedwithamildliquiddetergent(suchasDawn™)andwater.Followmanufacturer’sinstructionsoncleaningandcareofconcentratoraccessories;cleanorreplacetheseaccessoriesaccordingtoyourhealthcareproviderorrespectivemanufacturer’sinstructionsforuse.

7. Troubleshooting

Checkpowercordforproperconnection

Contactyourequipmentprovider

PressOn/Offbuttontopowerconcentrator

Checkcannulaanditsconnection

Inspectandreplacetheitemsifnecessary

Powercordisnotconnectedproperly

Malfunction

Concentratorisnotpoweredon

Cannulaisnotconnectedproperlyoriskinkedorobstructed

Theoxygentubingorcannulaisfaulty

ConcentratordoesnotpoweronwhenOn/Offbuttonispressed

Nooxygen

Recommended SolutionRefertoChapter4

Possible CauseRefertoChapter4

ProblemAnyproblemaccompaniedbyinformationonconcentratordisplay,visualand/oraudibleindicators

Contactyourhomecareproviderifyouneedassistancewiththedevice.

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Filter Cleaning and ReplacementTheparticlefiltermustbecleanedweeklytoensuretheeaseofairflow.Removefilterfromthesideofthedevice.Cleantheparticlefilterwithamildliquiddetergent(suchasDawnTM)andwater;rinseinwateranddrybeforereuse.Ensurethefilteriscompletelydrybeforereinstallingintotheconcentrator.

Air Inlet Filter Replacewhenfilterisdirtyaccordingtovisualindicator.Theairinletfiltermaybereplacedbytheequipmentproviderorbytheuser.

Output FilterTheoutputfilterisintendedtoprotecttheuserfrominhalationofsmallparticlesintheproductgasflow.Thedeviceincludesanoutputfilterconvenientlylocatedbehindtheremovablecannulanozzlefitting.Inogenrequiresthatthisfilterbereplacedbetweenpatients.Theoutputfiltermaybereplacedbytheequipmentproviderorbytheuser.

Routine MaintenanceNospecialmaintenance,otherthanweeklyparticlefiltercleaning,needstobecarriedoutbytheuser.

Replacement Parts and Recommended AccessoriesContactyourhomecareproviderifyouhaveanyquestionsaboutequipment.Useonlythefollowingreplacementpartsandaccessorieswiththisdevice:

• InogenAtHomeParticleFilter(RP-400)• InogenAtHomeOutputFilterReplacementKit(RP-107)• InogenAtHomeAirInletFilter(RP-401)• InogenAtHomeColumnPair(RP-402)• HumidifierConnectorTube(SalterLabs#S0-676)• HumidifierBottle(SalterLabs#7600)• NasalCannula(SalterLabs#16SOFT)• ACPowerCord(RP-109)

ServiceTheconcentratorisspecificallydesignedtominimizeroutinepreventativemaintenance.

Air Inlet Filter

Particle Filter

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Forassistance,ifneeded,insettingup,using,maintaining,orreportingunexpectedoperationorevents,contactyourequipmentprovider,orthemanufacturer.

Column Change Procedure Therearetwocolumns(metaltubes)ontheconcentratorlocatedbehindtheparticlefilter.Thesetwocolumnswillberemovedandreplacedwhenserviceisrequired.Ensureadequatetimetocompleteallstepswithoutdisruptionisallottedwhenperformingthismaintenance.1.Turnofftheconcentratorbypressingthepowerbuttontoshutdownthedevice.2.Unplugtheconcentratorfromtheelectricaloutlet.3.Laydowntheconcentratoronitsside.4.Pressthetwolatchbuttonsonthesidesofthedevicetoremovethecoverfromthebottomoftheconcentratorinordertoaccessthetwocolumns.5.Pressthelatchbuttonwiththumborfingerandpullthecolumnoutoftheconcentratorusingthepullringattachedtothebottomofthecolumncap.6.Removethecolumncompletelyfromtheconcentrator.7.Repeatsteps5-6toremovetheothercolumn.Installation of the new columns (metal tubes):8.Removetheupperandlowerdustcapsfromeachcolumn.Thereshouldbeatotaloftwodustcapsremovedfromeachcolumn.Makesurethereisnodustordebriswherethedustcapswerelocated.9.Insertthenewcolumnintotheconcentrator.Donotleavethecolumnexposedafterthedustcapsareremoved;itshouldbeinsertedintotheconcentratorassoonasthedustcapshavebeenremoved,tominimizeenvironmentalexposure.10.Thespringloadedlatchbuttonshouldfullyreturntotheclosedpositionwhenthecolumniscompletelyinserted.11.Repeatsteps9-10toinstalltheothercolumn.12.Replacethelowercoverandreturntheconcentratortoitsuprightposition.13.Connectthepowersupplycordfromtheconcentratorandplugintoanelectricaloutlet.Do Not Power Ontheconcentrator.14.Pressandholdtheplusbuttonfortenseconds.Flowindicators1,3&5willbeilluminatedandcolumnwillbereset.Releasetheplusbutton.15.Pressthepowerbuttontoturnontheconcentratorandusenormally. NOTE Columnchangeinstructionsareonlytobeusedwhenmaintenanceis required.Columnsshouldonlyberemovedduringthismaintenance procedure.

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StorageWhennotinuse,storeindoorsawayfromexcessivemoistureandtemperatures.Storageconditionsoutsideofrangespecifiedmayresultindamageanddevicemalfunction.

Disposal of Equipment and AccessoriesFollowyourlocalgoverningordinancesfordisposalandrecyclingoftheconcentratorandaccessories.

Dimensions: 16.5”Hx13”Wx7”D

Weight: 18lbsWarm-UpTime: Lessthan5minutesOxygenConcentration: 90+6%/-3%atallsettingsACPower: 100-240VAC,275WMax,50-60HzEnvironmentalRangesforUse:

Temperature:41to104°F(5to40˚C) Humidity:15to95%,non-condensing Altitude:0to10,000ft(0to3048m)

EnvironmentalRangesforShipping&Storage:

Temperature:-13to158°F(-25to70˚C)Humidity:0to93%non-condensingAltitude:n/a

MaximumOutletPressure: 19.6-40.6psia(135-280KPaAbsolute)@20˚C

FlowControlSettings: 5Settings:1to5litersperminute

9. Specifications, Inogen At Home, Model GS-100

Standards ComplianceThisdeviceisdesignedtoconformtothefollowingstandards:

• ENISO8359:2012,OxygenConcentratorsforMedicalUse–SafetyRequirements(ISO8359:1996,Secondedition,Amendment1)

• ASTMF1464:2005,OxygenConcentratorsforDomiciliaryUse• IEC60601-1:Edition3.1:2012,MedicalElectricalEquipment

--Part1:Generalrequirementsforbasicsafetyandessentialperformance

Classification:• IECClassIIEquipment• TypeBFAppliedPart• IP21EnclosureIngressProtectionagainstsolidobjectsof12.5mmminimum

diameterandverticallyfallingdropsofwater• Notsuitableforuseinthepresenceofaflammableanestheticmixture

withairorwithoxygenornitrousoxide• ContinuousOperation

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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


<5%UT(>95%dipinUT)for5sec

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



<5%UT(>95%dipinUT)for5sec

3A/m 3A/m

15

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.TheuseroftheconcentratorcanhelppreventelectromagneticinterferencebymaintainingaminimumdistancebetweenportableandmobileRFcommunicationsequipment(transmitters)andthisconcentratorasrecommendedbelow,accordingtothemaximumoutputpowerofthecommunicationsequipment.

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,wherePisthemaxi-mumoutputpowerratingofthetransmitterinwatts(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.

HarmonicEmissionsIEC61000-3-2

ClassA

Voltagefluctuations/flickeremissionsIEC61000-3-3

Complies

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