Respironics REMstar - Intended Use; Warnings, Cautions, and Contraindications

1-2
REMs t a R M sE R i E s Us E R Ma n U a l
1.2 in t E n d E d Us E
eRespironicsREMstarMSeriessystemisaCPAP(ContinuousPositiveAirwayPressure)
device designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing
patientsweighingmorethan66lbs(30kg).
e device is to be used only on the instruction of a licensed physician. Your home care provider
willmakethecorrectpressuresettingsaccordingtoyourhealthcareprofessional’sprescription.
1.3 Wa R n i n g s , Ca U t i o n s , a n d Co n t R a i n d i C a t i o n s
Caution: US federal law restricts this device to sale by or on the order of a physician.
1.3.1 Wa R n i n g s
A warning indicates the possibility of injury to the user or the operator.
• ismanualservesasareference.einstructionsinthismanualarenotintendedtosuper-
sedethehealthcareprofessional’sinstructionsregardingtheuseofthedevice.
• The operator should read and understand this entire manual before using the device.
• isdeviceisnotintendedforlifesupport.
• edeviceshouldbeusedonlywithmasksandconnectorsrecommendedbyRespironics
orwiththoserecommendedbythehealthcareprofessionalorrespiratorytherapist.Amask
should not be used unless the device is turned on and operating properly. e exhalation
port(s)associatedwiththemaskshouldneverbeblocked.
Explanation of the Warning: edeviceisintendedtobeusedwithspecialmasksorcon-
nectorsthathaveexhalationportstoallowcontinuousowofairoutofthemask.Whenthe
deviceisturnedonandfunctioningproperly,newairfromthedeviceushestheexhaledair
outthroughthemaskexhalationport.However,whenthedeviceisnotoperating,enough
freshairwillnotbeprovidedthroughthemask,andexhaledairmayberebreathed.
• Ifoxygenisusedwiththedevice,theoxygenowmustbeturnedowhenthedeviceisnot
in use.
Explanation of the Warning:Whenthedeviceisnotinoperationandtheoxygenowis
lefton,oxygendeliveredintothetubingmayaccumulatewithinthedevice’senclosure.Oxy-
genaccumulatedinthedeviceenclosurewillcreateariskofre.
• Oxygensupportscombustion.Oxygenshouldnotbeusedwhilesmokingorinthepresence
ofanopename.
• Whenusingoxygenwiththissystem,aRespironicsPressureValvemustbeplacedin-line
withthepatientcircuit.Failuretousethepressurevalvecouldresultinarehazard.
• Donotusethedeviceinthepresenceofaammableanaestheticmixtureincombination
withoxygenorair,orinthepresenceofnitrousoxide.