Invacare ML6 - Intended Use and User Profile; Service Life and Limited Warranty

General
1.2IntendedUse
Thiscylinderassemblyisintendedtostore,regulate,anddeliver
supplementaloxygentopatientswhomayhavedifficultyextracting
oxygenfromtheairtheybreathe.Itisforpatientswhowould
normallyreceivetheoxygenviaanasalcannula.Thisdevicedelivers
USP93±3%oxygenatanumberofdifferentflowsettingsandmay
increasethedryingoutofairways.Thisproductistobeusedas
anoxygensupplementandisnotintendedtobelifesupportingor
lifesustaining.
DANGER!
RiskofInjuryorDeath
Thisproductistobeusedasanoxygensupplementand
isnotintendedtobelife-supportingorlife-sustaining.
ONLYusethisproductifthepatientiscapableof
spontaneousbreath,abletoinhaleandexhalewithout
theuseofamachine.
WARNING!
RiskofInjuryorDamage
Useofthisproductoutsideoftheintendeduseand
specificationshasnotbeentestedandmayleadto
productdamage,lossofproductfunction,orpersonal
injury.
–DONOTusethisproductinanywayotherthan
describedinthespecificationsandintendeduse
sectionsofthismanual.
1.3UserProfile
Nospecificproductknowledgeortrainingisrequired,otherthan
whatiscontainedinthismanual,tooperatetheproduct.Itisnot
intendedforsupplyingoxygentherapyduringrefilling.Thisproductis
intendedtobeusedbyorunderadultsupervisiononlyafterreading
andunderstandingtheinstructionsandwarningsofthisusermanual.
OnlypersonnelinstructedandtrainedintheuseoftheHomeFill®
cylinderassemblyshouldoperatethisproduct.
Theuseofthisproductislimitedtotheoxygenpatient.Cylinder
assembliesMUSTbeusedonlybytheoxygenpatientandarenotto
bedistributedtoanyotherindividualforanypurpose.
ThisproductisNOTtobeusedbypatientswhobreathethrough
theirmouths.
1.4ServiceLife
WARNING!
RiskofInjuryorDamage
Theproducthasbeentestedfortheservicelifestatedin
thismanual.Useoftheproductbeyondthistimeperiod
maycauseinjuryorproductdamage.
–ONLYusetheproductfortheservicelifestatedin
thismanual.DONOTexceedtheservicelifeofthe
product.
–Performallmaintenanceaccordingtothe
recommendedscheduleinthismanual.
Theexpectedservicelifeoftheconserver/regulatorisfiveyears
whenusedinaccordancewiththesafetyinstructions,maintenance
intervalsandcorrectusestatedinthismanual.Refertothe
Maintenancesection.
Theexpectedservicelifeofthecylinderisbasedontestingthe
cylindereverytenyearsandusingitinaccordancewiththesafety
instructions,maintenanceintervalsandcorrectusestatedinthis
manual.Refertothefollowingprocedures:
1176098-B-025