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Invacare Softform Premier Active 2 - Product Overview; Product Description; Intended Use and Indications; Contraindications and Components

Invacare Softform Premier Active 2
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Invacare®SoftformPremierActive2withRXpump
3ProductOverview
3.1ProductDescription
Themattresssystemactsasastaticpressurereducing
support/mattressforpatientsatHigh/VeryHighriskthatcan,
byfacilitatingtheairpump,introduceeffectivealternating
pressureifthepatientsconditionrequiresalternating
pressuretherapy.
Thewater-resistantcoverprovidesavapor-permeable,multi
stretchsurface,topromotepatientcomfortandtomaximise
theeffectivenessofthefoamcore.
Themattressistheonlypartintendedtocomeinto
physicalcontactwiththepatient(theonlyappliedpartwith
temperatureofmaximum106°F).
3.2IntendedUse
Thispressureredistributionmattressandcontrolunitare
intendedtobeusedinconjunctionwithanappropriately
sizedbedframe.
Themattresscanbeusedsafelyinstaticmodeforstatic
pressureredistribution,orindynamicmodeshouldan
alternatingpressuresupportsurfaceberequired.
Thisproductdeliverseffectivepressureredistributionto
users,whenthesupportsurfaceiscoveredwithacotton,
cottoncombinationorlinenbedsheet,andanyoneofthese
istheonlyitemdeployedbetweenthesupportsurfaceand
theuser.
3.2.1Indications
Suitableforsupportingthemanagementofallcategories
ofpressureinjurieswhencombinedwithanindividualand
comprehensivepressureinjuryprotocol.
Suitableforuseinhomecare,residential,nursingandacute
caresettings.
3.2.2Contraindications
Notsuitableforuserswithunstablespinalcordfractures
and/orcervicaltraction.
Alwaysconsultaphysicianpriortousingthisdevice.
3.3Components
Thefollowingcomponentsareincludedwithinthescope
ofdelivery:
81632862-A