AirSep VisionAire 5 User manual

PatientManual
AirSep Corporation
401 Creekside Drive
Buffalo,NewYork14228 USA
Tel: [phone]
Fax: [phone]
0459

VisionAire™ EN
DO NOTOPERATETHISEQUIPMENTWITHOUTFIRST
READING AND UNDERSTANDING THISMANUAL. IFYOU
AREUNABLETO UNDERSTAND THEWARNINGSAND
INSTRUCTIONS, CONTACTYOUR EQUIPMENTPROVIDER
BEFOREATTEMPTINGTO USE THISEQUIPMENT;
OTHERWISE, INJURYORDAMAGEMAYRESULT.
Smoking whileusingoxygenisthenumberonecauseoffire,
injury, anddeath. Youmustfollow thesesafetywarnings:
Donot allowsmoking,candles,oropenflameswithinthesame
roomofthedeviceor theoxygen-carryingaccessories.
Smokingwhilewearinganoxygencannulamayresultinfacial
burnsandpossiblydeath.
Removingthecannulaandplacing it onsurfacessuchas
bedding,sofas, orothercushionmaterialwill causeaflashfire
whenexposedtoacigarette, heatsource,orflame.
Ifyousmoke,youmust followthese3life-savingsteps: turnoff
theoxygenconcentrator, take off thecannula,and leavethe
room wherethisdeviceislocated.
“NoSmoking
–
OxygeninUse”signsmustbeprominently
displayedinthehome,orwheretheoxygenconcentratoris
inuse.Patientsand theircaregiversmustbeinformedabout
thedangersofsmokinginthepresenceof,orwhileusing,
medicaloxygen.
EN VisionAire™
ImportantSafetyRules PageEN1-6
Section1 Introduction PageEN7
WhyYourPhysicianPrescribedOxygenPageEN7
What isan OxygenConcentrator? PageEN7-8
OperatorProfile PageEN8
Section2 ConcentratorComponents PageEN9
2.1 Frontof Concentrator PageEN9-10
2.2 Back ofConcentrator PageEN11
2.3 HumidifierBottle(optional) PageEN12
2.4Accessories PageEN13
2.5 Materialsindirectorindirect
contactwiththepatient PageEN14
2.6 SafetyFeatures PageEN15
Section3 HowtoOperateYourOxygenConcentrator PageEN16
3.1 HumidifierBottle PageEN16
3.2 CannulaConnection PageEN17
3.3 Starting theConcentrator PageEN17-18
3.4 Turning theConcentratorOff PageEN18
Section4 CareandCleaning PageEN19
4.1 HumidifierBottle(optional) PageEN20
4.2 OutsideCabinet PageEN20
Section5 Troubleshooting PageEN21-23
Section6 ProductSpecifications PageEN24-27
Section7 Symbols/Abbreviations PageEN28-29
Section8 ConformitywithEN60-601(§6.8.2b)/
Classification PageEN30-31

VisionAire™ EN
AirSep®Corporation EN-1
MN137-1rev. D
ImportantSafetyRules
Carefullyreviewand familiarizeyourselfwiththefollowing importantsafety
informationaboutthe VisionAire™ OxygenConcentrator.
Thisdevicesupplieshigh-concentrationoxygenthatpromotes
rapidburning. Donotallowsmokingoropenflameswithinthe
sameroomof(1)thisdevice, or(2)anyoxygen-carrying
accessory. Failuretoobservethiswarning canresultinsevere
fire, propertydamageand /orcausephysicalinjuryordeath.
Thisunit isnottobeusedforlife-support. Geriatric, pediatric,
oranyotherpatientunabletocommunicatediscomfortwhile
usingthisoxygenconcentratormayrequireadditional
monitoring. Patientswithhearingand/orsightimpairments
mayneedassistancewithmonitoringthealarms.
Ifyoufeeldiscomfortorareexperiencing amedical
emergency,seekmedicalassistanceimmediately.
Useno oil,grease, orpetroleum-basedorotherflammable
productsonornearnasalend ofcannulaorontheunit.
Oxygenacceleratesthecombustionofflammablesubstances.
Electricalshockhazard.Disconnectthepowercordfromthe
electricoutletbeforeyouclean theunittoprevent accidental
electricalshockand burnhazard.OnlyyourEquipment
Provideroraqualifiedservicetechnician shouldremovethe
coversorservicetheunit.
EN VisionAire™
EN-2 AirSep®Corporation
MN137-1rev. D
Donotleaveanasalcannulaunderbedcoveringsorchair
cushions.If theunitisturnedonbutnotinuse,theoxygenwill
makethematerialflammable.SettheI/0powerswitchtothe0
(off)position whentheVisionAireunitisnotinuse.
Donot useextension cordswiththisunitorconnect too many
plugsintothesameelectricaloutlet.Thiscan resultinan
overloadtotheelectricalpanelcausing thebreaker/fuseto
activate.
Useonlyvoltagespecifiedonbackpanellabel.
Donot useyouroxygenconcentratorinthepresenceof
flammablegases.Thiscanresultinrapidburningcausing
propertydamage,bodilyinjuriesordeath.
Careshouldbetakentoprevent unitfromgettingwet or
allowingwatertoentertheunit. Thiscan causetheunitto
malfunctionorshutdown, and causeanincreasedriskfor
electricalshockorburns.
Disconnectthepowercordfromtheelectricaloutlet before
you clean theunittoprevent accidentalelectricalshock
hazards. OnlyyourEquipmentProvideroraqualified
service technicianshouldremove thecoversorservice
theunit.
Donot useliquiddirectlyontheunit. Alistofundesirable
chemicalagentsincludesbutisnotlimitedtothefollowing:
alcoholandalcohol-basedproducts,concentratedchlorine-
basedproducts(ethylenechloride),andoil-basedproducts
(Pine-Sol®, Lestoil®).Theseare NOT tobeusedtoclean the
plastichousingon theunit, astheycan damagetheunit’s
plastic.

VisionAire™ EN
AirSep®Corporation EN-3
MN137-1rev. D
Clean thecabinet,controlpanel,andpowercordonlywitha
mildhouseholdcleanerappliedwithadampclothorsponge,
and thenwipeallsurfacesdry. Donotallowanyliquidto
getinsidethedevice.
Nomodificationofthisequipmentisallowed.
Theunit shouldnotbeusedadjacenttoorstackedwithother
equipment. Ifadjacentorstackeduseisunavoidable, the
deviceshouldbeobservedtoverifynormaloperation.
Federal(USA)lawrestrictsthisdevicetosaleorrentalby
orderofaphysician orotherlicensedhealthcareprovider.
AirSeprecommendsanalternatesourceofsupplemental
oxygenintheevent ofapoweroutage,alarmcondition, or
mechanicalfailure. Consultyourphysician orEquipment
Providerforthetypeofreservesystemrequired.
Itisveryimportanttofollowtheprescribedlevelof oxygen
flow. Donotincreaseordecreasetheflowuntilyou first
consultyourphysician.
Ensureconcentratorisoperatedinan upright position.
EN VisionAire™
EN-4 AirSep®Corporation
MN137-1rev. D
Positiontheunitawayfromcurtainsordrapes,hotair
registersorheaters. Becertaintoplacetheunitonaflat
surfaceandmakesureallsidesareat least1foot(30cm)
awayfromawallorotherobstruction. Donotplacetheunitin
aconfinedarea.Chooseadustand smokefree-locationaway
fromdirectsunlight. Donotoperatetheunitoutdoors.
Donot operatethisunit inarestrictedorconfinedspace
whereventilationcan belimited. Thiscancausethedeviceto
overheat andaffectperformance.
Intheevent ofanalarmoryouobservetheunit isnotworking
properly;consultthetroubleshootingsectionofthismanual.If
you cannotresolvetheproblem,consultyourEquipment
Provider.
TheOxygenConcentratormaybeusedduring sleepunder
therecommendationof aqualifiedclinician.
Ifthehumidifierbottletubingisnotproperlyconnectedtothe
humidifierbottlefittingortotheoxygenoutlet,anoxygenleak
can occur.
Storingthedeviceoutsideofitstemperaturespecifications
mayaffectperformance(refertothespecificationsectionof
themanual).
Donot position theunitsothat it isdifficulttoaccessthe
powercord.

VisionAire™ EN
AirSep®Corporation EN-5
MN137-1rev. D
Theconcentratorshouldbelocatedastoavoidpollutantsor
fumes.
Ifoxygendoesnot seemtoflow,firstverifythattheflowmeter
ballisregistering aflow.Then, placethetipofthecannulainto
aglassof water;ifbubblescomeoutofthecannula,oxygenis
flowing.If bubblesdo notappear,refertoSection5.0.
Troubleshooting.
Toprevent avoidedAirSepwarranty,followallmanufacturers’
instructions.
Replacethedisposablecannulaperiodicallyfollowingnormal
usageaccording toyourEquipmentProviders
recommendations.
AirSepdoesnotrecommend thesterilizationofthis
equipment.
Donot attemptanymaintenanceotherthan thepossible
solutionslistedbelow.
Iftheunit hasnotbeenusedforanextendedtimeperiod,it
needstooperateforseveralminutesbeforepowerfailure
alarmcanbecomeactivated.
PortableandmobileRFcommunicationsequipmentcanaffect
medicalelectricalequipment.
EN VisionAire™
EN-6 AirSep®Corporation
MN137-1rev. D
Theconcentratorreleaseswarmairoutthebottomof theunit
whichcanpermanentlydiscolortemperaturesensitiveflooring
surfacessuchasvinyl.Theconcentratorshouldnot beused
overflooring thatissensitivetoheatstaining. AirSepisnot
responsibleforflooring that becomesdiscolored.
“NoSmoking –OxygeninUse” signsmustbeprominently
displayedinthehomeorwheretheoxygenconcentratorisin
use. Patientsandtheircaregiversmustbeinformed aboutthe
dangersofsmoking inthepresenceof, orwhileusing,medical
oxygen.

VisionAire™ EN
AirSep®Corporation EN-7
MN137-1rev. D
1.0 Introduction
ThisPatientManualwillacquaintyou withAirSep’sVisionAireOxygen
Concentrator.Makesureyou read andunderstand all oftheinformation
containedinthisguidebeforeoperating yourconcentrator.Shouldyouhaveany
questions,yourEquipmentProviderwillbehappytoanswerthemforyou.
WhyYourPhysicianPrescribedOxygen
Manypeopletodaysufferfromavarietyofheart,lung,and otherrespiratory
diseases.Asignificantnumberofthesepatientscan benefitfromsupplemental
oxygentherapyforrespiratorycareathome,inthehospital,oratamedical
facility.
Oxygenisagasthatmakesup 21%oftheroomairwebreathe.Ourbodies
depend on asteadysupplytofunctionproperly.Yourphysician hasprescribed
supplementaloxygentherapybecauseyourbodyisnotabletogetenough
oxygenfromroomair.Oxygenisanon-addictivedrug,and yourphysician
prescribedaflowsufficienttoimproveyourcondition.
Pleasekeepinmindthatunauthorizedoxygentherapycanbedangerous.You
mustseekmedicaladvicebeforeyou usethisunit. TheEquipmentProviderwho
suppliesyouroxygenequipmentwilldemonstratehowtosettheprescribed
flowrate.
WhatisanOxygenConcentrator?
Oxygenconcentratorswereintroducedinthemid-1970sandhavebecomethe
mostconvenient,reliablesourceofsupplementaloxygenavailabletoday.
Withoutan oxygenconcentrator,theaveragepatientwouldrequireadeliveryof
12 bottles/cylindersofoxygeneachmonth.Youroxygenconcentratorproduces
alltheoxygenyou need, withnodeliveriesrequired.
Theairwebreathecontainsapproximately21%oxygen,78%nitrogen,and 1%
othergases.IntheVisionAireunit, roomairpassesthrough aregenerative
adsorbentmaterialcalledmolecularsieve.Thismaterialseparatestheoxygen
fromthenitrogenand othergases.Theresultisaconstantsupplyofhigh
concentration supplementaloxygenthatisdeliveredtothepatient.
EN VisionAire™
EN-8 AirSep®Corporation
MN137-1rev. D
Note:Thereisneveradangerofdepleting theoxygeninaroomwhenyou use
yourVisionAireunit.
OperatorProfile:
AirSep’sStationaryConcentratorsareintendedtosupplysupplementalOxygen
touserssufferingfromdiscomfortduetoailmentswhichaffecttheefficiency of
oneslungstotransfertheoxygeninairtotheirbloodstream.Userscanbenefit
fromsupplementaloxygentherapyforrespiratorycareathome,inthehospital,
oratamedicalfacility.OxygenConcentratoruserequiresaphysician’s
prescription,and arenotintendedforlifesupportuse.
Although oxygentherapycan beprescribedforpatientsofall ages,thetypical
oxygentherapypatientisolderthan 65yearsofageand suffersfromchronic
obstructivepulmonarydisease(COPD).Patientstypicallyhavegood cognitive
abilitiesand mustbeabletocommunicatediscomfort.If the userisunableto
communicatediscomfort,orunabletoread and understand theconcentrator
labeling and instructionsforuse,thenuseisrecommendedonlyunderthe
supervision of onewho can. If anydiscomfort isfelt whileusing theconcentrator,
patientsareadvisedtocontacttheirhealthcareprovider.Patientsarealso
advisedtohaveback-up oxygenavailable(i.e.cylinderoxygen)intheeventofa
poweroutageorconcentratorfailure.Thereareno otheruniqueskillsoruser
abilitiesrequiredforconcentratoruse.

VisionAire™ EN
AirSep®Corporation EN-9
MN137-1rev. D
2.0ConcentratorComponents
Reviewthefiguresbelowand becomefamiliarwiththeimportantparts
ofyour VisionAire OxygenConcentrator.
2.1 FrontofConcentrator
Figure1
Figure1a
OxygenOutlet
LowOxygen
Concentration
Indicator
(optional–mandatedfor
EU and specificcountries)
Top Handle
Specification
Label
Flowmeter
Adjustment
Knob
HourMeter
SideHandles
CircuitBreaker
ResetButton
ON/OFF (I/0)
PowerSwitch
Operating
Instructions
Label
Caster(s)
EN VisionAire™
EN-10 AirSep®Corporation
MN137-1rev. D
ØTop andSideHandles:
oEnablesconvenienceincarryingtheunit.
ØOn/Off(I/0)PowerSwitch:
oStartsandstopstheoperation oftheunit.
ØOxygenOutlet
oProvidesconnectionforahumidifier(ifrequired)orcannula.
ØCircuitBreakerResetButton:
oResetstheunitafterelectricaloverload shutdown
ØFlowmeterAdjustmentKnob:
oControlstheoxygenflowrateinlitersperminute(LPM).
ØLowOxygenConcentrationIndicator (optional–mandatedforEU
and specificcountries)
oWhenequippedwithan OxygenMonitor –awarning LED
(amber) isactivatedonthefrontpanel (seeSection 2.6‘Safety
Features’fordetails)
ØHourMeter:
oRecordstheconcentrator’scumulativehoursofoperation.
ØOperatingInstructionsLabel:
oDirectsusageoftheunit.
ØCasters:
oFourcastersenableunittobeeasilymoved,asneeded.
ØSpecification Label:
oDisplayselectricalspecificationsandserialnumber.

VisionAire™ EN
AirSep®Corporation EN-11
MN137-1rev. D
2.2 Back ofConcentrator
Figure2
ØPowerCord:
oAllowsconnection oftheunittoanelectricaloutlet.
ØHumidifierBottleRecess:
oAreatoplacetheoptionalhumidifierbottle.
PowerCord
HumidifierBottle
Recess
EN VisionAire™
EN-12 AirSep®Corporation
MN137-1rev. D
2.3 HumidifierBottle(optional)
Figure3
ØHumidifierBottle(optional):
oHumidifiestheoxygenbeforeitreachesthepatient.
ØHumidifierBottleOxygenOutlet:
oConnectionforoxygentubing/cannula.
Humidifier
Bottle
Humidifier
Bottle
Fitting
Humidifier
BottleTubing Humidifier
Bottle
Oxygen
Outlet
Oxygen
Tubing/
Cannula

VisionAire™ EN
AirSep®Corporation EN-13
MN137-1rev. D
2.4 Accessories:
Recommendedforusewith VisionAire2 and VisionAire3.
Theuseof certainadministrationaccessorieswhicharenotspecifiedfor
usewiththisconcentratormayreduceperformanceand voidthe
manufacturer’swarranty.
ØHumidifierBottle
oAirSeppartnumber–HU003-1
ØCannula, 25feet(7.6m)
oAirSeppartnumber–CU002-4
ØHumidifierBottleTubing
oAirSeppartnumber–TU176-160
ØHumidifierBottleFitting
oAirSeppartnumber–F0655-1
ØOxygenTubing, 25feet(7.6m)
oAirSeppartnumber–CU004-3
ØTubing/CannulaConnector
oAirSeppartnumber–CU009-1
EN VisionAire™
EN-14 AirSep®Corporation
MN137-1rev. D
2.5Materialsindirectorindirectcontactwiththepatient
oConcentratorCabinet(allparts)..........NOVA PS6201 SuperHigh
ImpactPolystyrene
oGasOutlet,Nozzle.............................Aluminum, Black Anodized
oOn/ Off Switch..................................DuPontFR50
oHourMeter........................................AcrylonitrileButadieneStyrene
(ABS)Plastic&Acrylic
oFlowmeter.........................................ABS (STAT-TECH AS1000)
oGasoutlet ..........................................Brass
oCircuit Breaker...................................Button–MelamineorUrea
Formaldehyde,
Mounting Bushing –Polyamide
66 (Nylon)
oUnitLabels........................................Lexan
oPowerCord........................................PolyvinylChloride(PVC),Metal
oCordStrainrelief................................Nylon
oCordWrap .........................................Velcro
oDustFilter..........................................Polyester
oHumidifierStrap.................................Yarn,Rubber
oHumidifierBottle................................Top –AcrylonitrileButadiene
Styrene(ABS)Bottle–
Polypropylene(PP), Diffuser-
Polyvinyl
Chloride(PVC)
oCannula(Tubing)................................PolyvinylChloride(PVC),

VisionAire™ EN
AirSep®Corporation EN-15
MN137-1rev. D
2.6 SafetyFeatures:
ØCompressorMotor: Thermalsafetyisensuredbyathermostat
situatedinthestatorwinding(135°C/275 °F).Asafetyreliefvalve
isfittedtothecompressoroutletand iscalibratedto280 kPa(40
psig).
ØPowerFailure: Intheeventtheunitisoperatingand aloss of
poweroccurs,an audiblesingle–pulseintermittentalarmwill
activate.
ØOxygenMonitor: Theoxygenmonitordetectsanydrop in
concentration below82%(±3%)andactivatesavisualalarm
(amberLEDindicatoron front panel). If theconcentration continues
tooperatebelow82%,an audible2–pulseintermittentalarmwill
alsoactivate.
ØHiPressure: Anover-pressuresafetyfeaturepreventspotential
damagetodevicecomponentsat apressureof 228 kPa(33 psig(±
2psig)). Anaudible4-pulseintermittent alarmwill activate.
ØLowPressure: Anaudible3-pulseintermittent alarmwillactivateif
thedevicepressurereducesto ≤35kPa(5psig(±1psig)).
ØNoFlowWarning: Anobstruction totheflowofoxygen,suchasa
pinchorkinkinthedeliverycannula,willactivatean audible6-
pulseintermittent alarm.
ØProductFilter:≥10µmfilter
EN VisionAire™
EN-16 AirSep®Corporation
MN137-1rev. D
3.0HowTo OperateYourOxygenConcentrator
Reviewthefollowinginformationbeforeyou operateyouroxygenconcentrator.
Theconcentratorreleaseswarmairoutthebottomof theunit
whichcanpermanentlydiscolortemperaturesensitiveflooring
surfacessuchasvinyl.Theconcentratorshouldnot beusedover
flooringthatissensitivetoheatstaining.AirSepisnotresponsible
forflooring thatbecomesdiscolored.
3.1 HumidifierBottle
(Optional)
If additionalhumidification isrequiredwithyouroxygentherapy, perform
thefollowingstepseachtimeyou fillorclean thehumidifier,whichmay
havebeeninitiallyset upforyouruse.
1. Removethehumidifierbottlefromthehumidifierbottlerecess.
2. Openthehumidifierbottle.Ifyouhaveapre-filledbottle,do not
performthisstep.Proceedtostep5.
3. Fillthehumidifierbottlewithcoolorcoldwater(distilledwateris
preferred)tothefilllineindicatedon thebottle.DONOT
OVERFILL.
4. Re-connect thetopcovertothehumidifierbottle.
5. Placethehumidifierbottleinthehumidifierbottlerecess on the
back oftheconcentratorand connect thehumidifierbottletubing to
theoxygenoutlet andthehumidifierbottlefitting.
Ifthehumidifierbottletubingisnotproperlyconnectedtothe
humidifierbottlefittingortotheoxygenoutlet,anoxygenleak
can occur.

VisionAire™ EN
AirSep®Corporation EN-17
MN137-1rev. D
3.2 CannulaConnection
Connectthetubingand cannulatotheunit’soxygenoutlet,ortothe
optionalhumidifier’soxygenoutlet.
3.3 StartingtheConcentrator
NO SMOKING
signsmust beprominentlydisplayedinthe
homeorwhereverunitisinuse. Patientsand theircontacts
shouldbeinformed aboutthedangersofsmoking inthe
presenceofmedicaloxygen.
Donot useextension cordswiththisunitorconnect too many
plugsintothesameelectricaloutlet.Thiscan resultinan
overloadtotheelectricalpanelcausing thebreaker/fuseto
activate.
Positiontheunitawayfromcurtainsordrapes,hotairregisters
orheaters. Becertaintoplacetheunitonaflat surfaceand
makesureall sidesareatleast1foot(30cm)awayfromawall
orotherobstruction. Donot placetheunitinaconfinedarea.
Chooseadustandsmokefree-locationawayfromdirect
sunlight.Donotoperatetheunitoutdoors.
1.Locatetheunitneartheelectricaloutletintheroomwhereyou
spend mostofyourtime.
2.Insertthepowercordplugintotheelectricaloutlet.
3.SettheI/0powerswitchtothe“I”position toturntheuniton.
Anaudiblealarmwill loudlysoundforapproximately5seconds.
4.Thelowoxygenconcentration indicatorremainson forafew
minutesanduntiltheoxygenconcentration reachesminimum
concentration requirements,(onlypertainstounitequippedwithan
OxygenMonitor)
5.Tosettheflowofsupplementaloxygen,turntheflowmeter
adjustmentknob left orrightuntil theball insidetheflowmeter
centerson theflowlinenumberprescribedbyyourphysician.
Toviewtheflowmeterattheproperangle,notethattheback line
and thefrontnumberlinemustgiveappearanceofoneline.
6.Theconcentratorisnowreadyforuse.
EN VisionAire™
EN-18 AirSep®Corporation
MN137-1rev. D
Optimaloxygenconcentrationisobtainedwithin10 minutes
afterthedeviceisswitchedon (90%oftheconcentrationis
obtainedafterapproximately5minutes).
Itisveryimportanttofollowtheprescribedlevelof oxygenflow.
Donotincreaseordecreasetheflowuntil youfirstconsultyour
physician.
Normally,youshouldnotneedtoadjusttheflowmeteron yourunit. Ifyou turn
theflowmeteradjustmentknob clockwise,you willdecreaseand can shutoff the
flowof oxygenfromyourunit.
Ifoxygendoesnot seemtoflow,firstverifythattheflowmeter
ballisregistering aflow.Then, placethetipofthecannulainto
aglassof water;ifbubblescomeoutofthecannula,oxygenis
flowing.If bubblesdo notappear,refertoSection5.0.
Troubleshooting.
Ensureconcentratorisoperatedinan upright position.
3.4 TurningtheConcentratorOff
•Set theI/0powerswitchtothe“0”position toturnoff theunit.

VisionAire™ EN
AirSep®Corporation EN-19
MN137-1rev. D
4.0 CareandCleaning
Disconnectthepowercordfromtheelectricaloutlet beforeyou
clean theunittoprevent accidentalelectricalshock hazards.
OnlyyourEquipment Provideroraqualifiedservicetechnician
shouldremovethecoversorservicetheunit.
Donot useliquiddirectlyontheunit. Alistofundesirable
chemicalagentsincludesbutisnotlimitedtothefollowing:
alcoholandalcohol-basedproducts,concentratedchlorine-
basedproducts(ethylenechloride),andoil-basedproducts
(Pine-Sol®, Lestoil®).TheseareNOTtobeusedtoclean the
plastichousingon theunit, astheycan damagetheunit’s
plastic.
Clean thecabinet,controlpanel,andpowercordonlywitha
mildhouseholdcleanerappliedwithadampclothorsponge,
and thenwipeallsurfacesdry. Donot allowanyliquidtoget
insidethedevice.
Replacethedisposablecannulaperiodicallyfollowingnormal
usageaccording toyourEquipmentProviders
recommendations.
Toprevent avoidedAirSepwarranty,followallmanufacturers’
instructions.
AirSepdoesnotrecommend thesterilizationofthisequipment.
EN VisionAire™
EN-20 AirSep®Corporation
MN137-1rev. D
4.1 HumidifierBottle(optional)
•Check waterleveldailyandaddwaterasneeded
•Toclean and disinfectthehumidifier,followyourEquipment
Provider’sinstructions,ortheinstructionsincludedwiththe
humidifierbottle.
4.2 OutsideCabinet
Useamildhouseholdcleanerappliedwithadampclothorspongeto
clean theexterioroftheconcentrator,and thenwipeall surfacesdry.
Donot allowanyliquidtogetinsidethedevice.

VisionAire™ EN
AirSep®Corporation EN-21
MN137-1rev. D
5.0 Troubleshooting
Ifyourconcentratorfailstooperateproperly,consultyourEquipmentProvider,
and refertothetroubleshooting chart on thefollowing pagesforprobablecauses
and solutions.
Donot attemptanymaintenanceotherthan thepossiblesolutions
listedbelow.
Iftheunit hasnotbeenusedforanextendedtimeperiod,itneeds
tooperateforseveralminutesbeforepowerfailurealarmcan
becomeactivated.
Problem
ProbableCause
Solution
Unitdoesnot
operate. Power
failurecondition
causesanalarmto
sound.
Thepowercordisnot
connectedtothe
electricaloutlet.
Nopoweratthe
electricaloutlet.
Circuit breakeron
concentratorunitis
activated.
Check powercordatthe
electricaloutletforaproper
connection.
Check powersource, wall
switch, in-housefuseorcircuit
breaker.
Press (donotholdin)thecircuit
breakerreset buttoninthefront
oftheunit.
Ifthecircuitbreakertripsagain
orthealarmcontinuestosound
aftertheunitisturnedon,
contactyourEquipment
Provider.
EN VisionAire™
EN-22 AirSep®Corporation
MN137-1rev. D
Problem
ProbableCause
Solution
Limitedorno
oxygenflow.Dirtyorobstructed humidifierbottle,or
leakpresent.
Defectivenasal
cannula,orother
oxygenaccessories,
i.e.oxygentubing.
Cannulatubing loose.
Removethehumidifierbottle,
and ifflowisrestored,clean or
replacethehumidifierbottle.
Removeandcheckaccessories
forkinksorobstructions.
Replaceifneeded.
Check cannulatubing
connectionatcontrolpanel.
Condensation
collectsinthe
oxygentubingwhen
you useahumidifier
bottle
Unitnotproperly
ventilated.
Elevatedoperating
temperatures.
Makesureunitispositioned
awayfromcurtainsordrapes,
hotairregistersorheaters,Be
certaintoplacetheunitsoall
sidesareatleast 1foot(30 cm)
awayfromawallorother
obstruction.Donotplacethe
unitinaconfinedarea.
Refillhumidifierbottlewith
COLDwater.
DO NOTOVERFILL.Allow
oxygentubingtodryout,or
replacewithnewtubing.
Intermittent alarm
soundsatone
second intervals.
Seesection2.6
‘SafetyFeatures’fora
description ofauditory
indicators.
Set I/0powerswitchto
0position,useyourreserve
oxygensupply(if provided), and
consultyourEquipmentProvider
immediately.

VisionAire™ EN
AirSep®Corporation EN-23
MN137-1rev. D
Problem
ProbableCause
Solution
Allotherproblems. Set I/0powerswitchtothe
0position,useyourreserve
oxygensupply(if provided), and
consultyourEquipmentProvider
immediately.
Oxygen
Concentration
Indicatorremainslit
(amber)
Oxygenconcentration
is ≤82%(±3%). Set I/0powerswitchtothe
0position,useyourreserve
oxygensupply(if provided), and
consultyourEquipmentProvider
immediately.
EN VisionAire™
EN-24 AirSep®Corporation
MN137-1rev. D
6.0 ProductSpecifications
VisionAire
™
OxygenConcentrator
Flow Specifications(1) 1lpm–5lpm
±10%of indicated setting,or200mL,
whicheverisgreater(1)
OxygenConcentration(1) 90%(+5.5%/–3%)
ElectricalRequirements 115 VAC/60Hz, 3.0A 230 VAC/50Hz, 1.5A
230 VAC/60Hz, 1.5A
PowerConsumption 290 Watts
Sound 40 dBa
Dimensions 14.1in. Wx11.5in. Dx20.8in. H
(35.8cmWx29.2cmDx52.8cmH)
Weight 30 lbs(13.6kg)
ElectricalShock Protection ClassII, TypeB
EnvironmentalLimit
Conditions(2)
Operatingconditions: 5
o
Cto40
o
C
(41 oFto105 oF)ataltitudesupto10,000ft.
(523mmHg)abovesealevel.
Storage: -20oC–60 oC(-4°F–140°F)
Relative Humidity:up to95%RH
(non–condensing)
(1)Based on21°C(70°F)at anominaloperating pressurerangeof
0-7kPa(0-1psigback pressure).Maximumoutputpressure: 55 kPa
(7.98psig)
(2)Operating outside oftheseoperationalspecificationscan limitthe
concentrator'sabilitytomeetOxygenConcentration specification at
higherliterflowrates.

VisionAire™ EN
AirSep®Corporation EN-25
MN137-1rev. D
Specificationscontinued
MedicalequipmentneedsspecialprecautionsregardingEMCand needsto
beinstalledand putintoserviceaccording totheEMCinformation providedin
thissection.
Guidance and manufacturer
’
sdeclaration
±
electromagneticimmun
ity
The VisionAireisintended foruseinthe electromagneticenvironmentspecified below.The customerorthe userof the
VisionAireshouldassurethatit isused insuchan environment.
IMMUNITYtest
IEC 60601 test
level Compliance level Electromagneticenvironment ± guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6kVcontact
±8kVair
±6kVcontact
±8kVair
Floorsshouldbe wood, concreteorceramic tile.
If floorsarecovered withsynthetic material, the
relativehumidityshouldbe atleast 30 %.
Electricalfast
transient/burst
IEC 61000-4-4
±2kVforpower
supplylines
±1kVfor
input/outputlines
±2kVforpowersupply
lines
Not Applicable
Mainspowerqualityshouldbe that of atypical
commercialorhospitalenvironment.
Surge
IEC 61000-4-5
±1kVlinetoline
±2kVlineto
earth
±1kVlinetoline
±2kVlinetoearth
Mainspowerqualityshouldbe that of atypical
commercialorhospitalenvironment.
Voltage dips,short
interruptionsand
voltage variations
on power.
IEC 61000-4-11
<5%
U
T
(>95 %dipin UT)
for0,5cycle
40 % UT
(60 %dipin UT)
for5cycles
70 % UT
(30 %dipin UT)
for25 cycles
<5% UT
(>95 %dipin UT)
for5s
<5%
U
T
(>95 %dipin UT)
for0,5cycle
40 % UT
(60 %dipin UT)
for5cycles
70 % UT
(30 %dipin UT)
for25 cycles
<5% UT
(>95 %dipin UT)
for5s
Mainspowerqualityshouldbe that of atypical
commercialorhospitalenvironment. If the user
of the VisionAirerequirescontinued operation
during powermainsinterruptions,it is
recommended that the VisionAirebe powered
froman uninterruptiblepowersupply(UPS)or
abattery.
Powerfrequency
magneticfield
IEC 61000-4-8
3A/m3A/m Powerfrequencymagnetic fieldsshouldbe at
levels characteristicof atypicallocation ina
typicalcommercialorhospitalenvironment.
NOTE U T is the a.c.mainsvoltage priortoapplication of thetestlevel.
EN VisionAire™
EN-26 AirSep®Corporation
MN137-1rev. D
Guidance and manufacturer
’
sdeclaration
±
electromagneticimmunity
The VisionAireisintended foruseinthe electromagneticenvironmentspecified below.The customerorthe userof the
VisionAireshouldassurethatit isused insuchan electromagnetic environment.
IMMUNITYtest
IEC 60601 TESTLEVEL
Compliance level
Electromagneticenvironment
±
guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3Vrms
150 kHzto80 MHz
3V/m
80 MHzto2.5GHz
3Vrms
3V/m
Portableand mobileRFcommunicationsequipment
shouldbeusedno closertoanypart of the VisionAire
including cables, thanthe recommended separation
distancecalculated from the equation applicableto
the frequencyof the transmitter.
Recommendedseparationdistance
D=1.2x √P
D=1.2x √Pfrom80MHzto800MHz
D=2.3x √Pfrom800MHzto2.5GHz
where P is the maximumoutput powerrating of the
transmitterinwatts(W)according tothe transmitter
manufacturerand d is therecommended separation
distancein meters(m).
Fieldstrengthsfromfixed RFtransmitters, as
determined byan electromagneticsitesurveya
shouldbeless than the compliancelevelineach
frequencyrange.b
Interferencemayoccurinthe vicinityof equipment
marked withthefollowing symbol:
NOTE1At 80 MHzand 800 MHz, the higherfrequencyrange applies.
NOTE2Theseguidelinesmaynot applyinallsituations.Electromagnetic propagation is affected byabsorption and reflection
fromstructures,objectsandpeople.
a. Fieldstrengthsfromfixed transmitters, suchasbasestationsforradio(cellular/cordless)telephonesand land mobile
radios, amateurradio, AMand FMradiobroadcastand TVbroadcastcannot bepredicted theoreticallywithaccuracy.
Toassess the electromagnetic environment due tofixed RFtransmitters, an electromagneticsitesurveyshouldbe
considered. If the measured fieldstrengthinthe location inwhichthe VisionAireisused exceedsthe applicableRF
compliancelevelabove, the VisionAireshouldbe observed toverifynormaloperation. If abnormalperformanceis
observed, additionalmeasuresmaybe necessary, suchasre-orienting orrelocating the VisionAire.
b. Overthe frequencyrange 150 kHzto80 MHz, fieldstrengthsshouldbe lessthan 3V/m.

VisionAire™ EN
AirSep®Corporation EN-27
MN137-1rev. D
Recommendedseparationdistances betweenportableandmobileRFcommunicationsequipment andtheVisionAire
The VisionAireisintended foruseinan electromagneticenvironmentinwhichradiated RFdisturbancesarecontrolled. The
customerorthe userof the VisionAirecanhelpprevent electromagneticinterferencebymaintaining aminimumdistancebetween
portableand mobileRFcommunicationsequipment (transmitters)and theVisionAireasrecommended below, according tothe
maximumoutput powerof the communicationsequipment.
Ratedmaximum
outputpowerof
transmitter
W
Separation distance according to frequencyof transmitter
(m)
from150kHzto 80MHz
d=1.2x √P
from80MHzto 800MHz
d=1.2x √P
from800MHzto 2.5GHz
d=2.3x √P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
Fortransmittersrated at a maximumoutput powernotlisted above, the recommended separation distance d inmeters(m)canbe
estimated using the equation applicabletothe frequencyof the transmitter, where P isthe maximumoutput powerratingof the
transmitterinWatts(W)according tothe transmittermanufacturer.
NOTE1At 80 MHzand 800 MHz, the separation distanceforthe higherfrequencyrange applies.
NOTE2Theseguidelinesmaynot applyinallsituations.Electromagnetic propagation is affected byabsorption and reflection from
structures, objectsandpeople.
Guidance and manufacturer
’
sdec
laration
–
electromagneticemissions
The VisionAireisintended foruseinthe electromagneticenvironmentspecified below.The customerorthe userof the VisionAire
shouldassurethat itis used insuchan environment.
Emissionstest
Compliance
Electro
magneticEnvironment guidance
RFemissions
CISPR 11 Group 1
The VisionAireusesRFenergyonlyforitsinternal
function. Therefore, itsRFemissionsareverylow
and arenot likelytocauseanyinterferenceinnearby
electronic equipment.
RFemissions
CISPR 11 ClassB The VisionAireissuitableforuseinall
establishments,including domesticestablishments
and thosedirectlyconnected tothe public low-
voltage powersupplynetworkthatsuppliesbuildings
used fordomesticpurposes.
Harmonic emissions
IEC 61000-3-2 ClassA
Voltage fluctuations/flickeremissions
IEC 61000-3-3 Complies
EN VisionAire™
EN-28 AirSep®Corporation
MN137-1rev. D
7.0 Symbols/Abbreviations
Symbolsarefrequentlyusedon equipmentinpreferencetowordswiththe
intention oflessening anypossibilityofmisunderstanding causedbylanguage
differences. Symbolscan alsopermit easiercomprehension of aconcept withina
restrictedspace.
Thefollowing tableisalistofsymbolsand definitionsthatmaybeusedwith
AirSep’sVisionAireOxygenConcentrator.Thesesymbolsarereferencedfrom
theappropriateInternationalElectro-technicalCommission (IEC)standards:
Symbol
Description
Symbol
Description
ON (powerswitchon) OFF (powerswitchoff)
Nosmoking
Donot disassemble
Type Bequipment Consult instructionsforuse
Warning –Describesa
hazardorunsafepracticethat
if not avoidedcan result in
severebodilyinjury, deathor
propertydamage Class II Device
Caution –Describesahazard
orunsafepracticethat if not
avoided can result inminor
bodilyinjuryorproperty
damage
Complieswiththe 93/42/EEC
directivedrawnupbythe
approvedorganization No.
0459
Note–Providesinformation
important enough to
emphasizeorrepeat
SafetyagencyforCAN/CSA
C22.2No.601.1M90 for
medicalelectricalequipment
Consult the accompanying
documents Keep unit and accessoriesdry
Useno oil orgrease
Properdisposalof wasteof
electricaland electronic
equipment required

VisionAire™ EN
AirSep®Corporation EN-29
MN137-1rev. D
Oxygenoutlet connection to
the cannula
Donot exposetoopenflames
Caution: Federallaw (USA)
restrictsthis forsaleorrental
byoron the orderof a
physician orlicensed health
careprovider. Keep intheverticalposition
Fragile–handlewithcare
Oxygenconcentration warning
LED
See Instructions
Method ofdisposing ofwaste: AllwastefromAirSep’sVisionAireOxygen
Concentratormustbedisposedusingtheappropriatemethodsspecifiedbylocal
authorities
Method fordisposingofthedevice: Inordertopreservetheenvironment,the
concentratormustbedisposedusingtheappropriatemethodsspecifiedbylocal
authorities.
EN VisionAire™
EN-30 AirSep®Corporation
MN137-1rev. D
8.0 ConformitywithEN60-601(§ §6.8.2b)/ Classification
“Themanufacturer,assembler,installerorimporterarenotconsidered toberesponsible
themselvesfortheconsequenceson thesafety,reliabilityand characteristics ofadevice
unless:
-Theassembly, fitting, extensions,adjustments,modificationsorrepairshavebeen
performed bypersonsauthorized bythepartyinquestion,
-Theelectrical installationofthecorrespondingpremisescomplieswithIECregulations.
-Thedeviceisusedinaccordancewiththeinstructionsforuse.“Ifthereplacementparts
usedfortheperiodicservicingbyanapprovedtechnician donot complywiththe
manufacturer’sspecifications,thelatterisabsolvedfromallresponsibilityintheevent of an
accident.Donotopenthedevicewhileinoperation:risk of electricalshock.Thisdevice
complieswiththerequirementsoftheMDD(93/42/EEC:2007/47/EC)AnnexI European
directivebut itsoperationmaybeaffected byotherdevicesbeingusedcloseby,suchas
diathermyand highfrequencyelectro-surgicalequipment,defibrillators, short wavetherapy
equipment, mobiletelephones, CBandotherportabledevices,microwaveovens,induction
platesorevenremotecontrol toysandmoregenerallyelectromagneticinterferenceswhich
exceedthelevelsspecifiedbytheECN 60601-1-2standard.

VisionAire™ EN
AirSep®Corporation EN-31
MN137-1rev. D
Classification
Typeof protection againstelectricshock:
ClassII Protection fromelectricshockisachieved byDOUBLEINSULATION.
Protectiveearthingorrelianceupon installation conditionsarenot
required.
Degree ofprotection againstelectricshock:
TypeB Equipmentprovidingaparticulardegree ofprotection againstelectric
shock,particularlyregarding:
1)Allowableleakagecurrent;
2)Reliabilityofprotectiveearthconnection (ifpresent).
Notintended fordirect cardiacapplication.
Method ofcleaningandinfection control allowed:
PleaserefertoyourEquipmentProviderandtheVisionAireService
Manual.
Degree ofsafetyof application inthepresenceofflammablegases:
Equipmentnot suitableforsuchapplication.
Modeof operation: Continuousduty.
ForEuropeanRepresentative:
GavinAyling
9BunghamLane
PenkridgeStafford
StaffordshireST 19 5NH England
E-mail: [e-mail]
EN VisionAire™
EN-32 AirSep®Corporation
MN137-1rev. D