Invacare SoftAir EXCELLENCE User manual

Invacare®SoftAIR®Super/
SoftAIR®Excellence
enAlternatingmattresssystems
UserManual................................3
noAlternerendemadrassystem
Bruksanvisning..............................33
daAlternerendemadrassystem
Brugsanvisning..............................65
svAlternerandemadrassystem
Bruksanvisning..............................97
fiVaihtelevatpatjajärjestelmät
Käyttöohje.................................129
ThismanualMUSTbegiventotheuseroftheproduct.
BEFOREusingthisproduct,readthismanualandsaveforfuturereference.

©2016Invacare®Corporation
Allrightsreserved.Republication,duplicationormodificationinwholeorinpartisprohibitedwithout
priorwrittenpermissionfromInvacare.Trademarksareidentifiedby™and®.Alltrademarksare
ownedbyorlicensedtoInvacareCorporationoritssubsidiariesunlessotherwisenoted.
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Contents
ThismanualMUSTbegiventotheuseroftheproduct.
BEFOREusingthisproduct,readthismanualandsaveforfuture
reference.
1General........................................4
1.1Generalinformation.............................4
1.2Symbolsinthisusermanual.......................4
1.3Intendeduse..................................4
1.4Warranty....................................5
1.5ServiceLife...................................5
2Safety..........................................7
2.1Safetyinformation..............................7
2.2Symbolsontheproduct..........................8
3Components....................................9
3.1Overview....................................9
3.2Description...................................9
4Setup..........................................11
4.1Safetyinformation..............................11
4.2Installingthemattresssystem......................11
4.3Activatingthecontrolunit........................12
4.4Removingthemattresssystem.....................13
5Usage..........................................14
5.1Safetyinformation..............................14
5.2Usingthecontrolunitpanel.......................14
5.3Usingthemattresssystem........................16
5.4CPRProcedure................................16
5.5AlarmFunctions...............................17
5.6Transportingapatientonthemattress...............18
6Transport......................................19
6.1Safetyinformation..............................19
7Maintenance....................................20
7.1Inspection....................................20
7.2CleaningandCare..............................20
7.3Replacingtheairfilter...........................22
7.4Replacingfuse(1ampslowblowfuse)................22
8AfterUse.......................................23
8.1Storage......................................23
8.2Re-use......................................23
8.3Disposal.....................................23
9Troubleshooting.................................24
9.1Identifyingandrepairingfaults......................24
10Technicaldata..................................26
10.1GeneralData.................................26
10.2Guidanceandmanufacturer’sdeclaration.............28

Invacare®SoftAIR®Super/SoftAIR®Excellence
1General
1.1Generalinformation
Essentialnursingcareispivotalinpressureulcerprevention.The
SoftAIR®mattresseswillpositivelycontributetotheoutcomeofa
pressureulcerpreventioncareplan.
Education,clinicaljudgementandactionbasedplanningbasedon
vulnerabilityarefundamentalfactorsinpreventionofpressureulcers.
Arangeofassessmentscalescanbeusedasaformalmethodof
assessingriskfrompressureulcerdevelopment,andshouldbe
usedinconjunctionwithaninformalassessment(informednursing
judgement).Informalassessmentisconsideredtobeofgreater
importanceandclinicalvalue.
Pleaseheedallthenotes,particularlythesafetyinformation,and
actaccordingly.
Formoreinformationabouttheproduct,contactyourlocalInvacare
representative.Foraddressandwebsiteseebackpageofthismanual.
1.2Symbolsinthisusermanual
InthisUserManualwarningsareindicatedbysymbols.Thewarning
symbolsareaccompaniedbyaheadingthatindicatestheseverity
ofthedanger.
WARNING
Indicatesapotentiallyhazardoussituationwhichifnot
avoidedcouldresultindeathorseriousinjury.
CAUTION
Indicatesapotentiallyhazardoussituationwhichifnot
avoidedcouldresultinproductdamage,minorinjury
orboth.
IMPORTANT
Indicatesahazardoussituationwhichifnotavoided
couldresultindamagetotheproduct.
Givesusefultips,recommendationsandinformation
forefficient,trouble-freeuse.
Thisproductcomplieswiththedirective93/42/EEC
formedicalproducts.Thelaunchdateforthisproduct
isspecifiedintheCEdeclarationofconformity.
Manufacturer
1.3Intendeduse
Thispressureredistributionmattressandcontrolunitareintended
tobeusedinconjunctionwithanappropriatelysizedbedframe.
Itcanbeusedsafelyinstaticmodeforstaticpressureredistribution,
orindynamicmodeshouldanalternatingpressuresupportsurface
berequired.
Thisproducthasbeendesignedtodelivereffectivepressure
reductiontousers,whentheproductisinnormalusewhichis
definedbyInvacareLtdaswhenthesupportsurfaceiscoveredwith
acotton,cottoncombinationorlinenbedsheet,andanyoneof
thesewouldbetheonlyitemdeployedbetweenthesupportsurface
andtheuser.
Indications
TheSoftAIR®mattressesaresuitableforthepreventionand
treatmentofpressureulcersinthe'VeryHighRisk'patient.Itis
suitableforuseinallhomecare,residential,nursingandacutecare
settingsandisappropriateforthetreatmentofpressureulcersup
tograde4aswellasseverepressureulcers.
41533195-A

General
1.4Warranty
Weprovideamanufacturer’swarrantyfortheproductinaccordance
withourGeneralTermsandConditionsofBusinessintherespective
countries.Guaranteeclaimscanonlybemadethroughtheprovider
fromwhomtheappliancewasobtained.
StandardInvacareTerms
ThisistocertifythatyourSoftAIR®mattressiswarrantedby
InvacareLtdforaperiodstatedintheTable“TechnicalData“of
thisuserguide.Thisissubjecttotheindividualcountry‘sSales
Agreements.
PleasecontactyourlocalInvacareSalesOfficeforfurtherinformation.
TheWarrantyofyourInvacareSoftAIR®productisvalidfromtime
ofshipping.
Ifadefectorfaultisdiscoveredpleasecontactandnotifytheprovider
fromwhomtheappliancewasobtainedimmediately.
Themanufacturerwillnotacceptresponsibilityfordamagecaused
bymisuseornon-observanceoftheinstructionssetoutinthisuser
guide.
Duringtheperiodofthewarrantyanyproductsthathavebecome
defectiveduetofaultyworkmanshipormaterialswillberenewed
withoutcharge.
Thewarrantywillbeforfeitedshouldanyunauthorizedalterationbe
madetotheequipment.
BothwarrantyandfireretardancyCertificationwillbecome
nullandvoidifnon-InvacaresparesareusedonanyInvacare
SoftAIR®Mattressproducts.
Thepurchaser’sstatutoryrightsundertheConsumerProtection
Actarenotaffected.
QualityandFlameRetardancy
Qualityisfundamentaltothecompany’soperation,working
withinthedisciplinesofISO9001(Qualitymanagementsystems-
Requirements)andISO13485(Medicaldevices-Qualitymanagement
systems-Requirementsforregulatorypurposes).
TheInvacareSoftAIR®mattressesfeaturetheCEmark,in
compliancewiththeMedicalDeviceDirective93/42/EECClass1.
Invacare®iscontinuouslyworkingtowardsensuringthatthe
company’simpactontheenvironment,locallyandglobally,isreduced
toaminimum.
•Wecomplywiththecurrentenvironmentallegislation(e.g.
WEEEandRoHSdirectives).
•WeonlyuseREACHcompliantmaterialsandcomponents.
Thecontrolunitistestedaccordingto3rdversionsafetystandard
IEC/EN60601-1(Medicalelectricalequipment-Part1:General
requirementsforbasicsafetyandessentialperformance)&EMC
standardIEC/EN60601-1-2(Collateralstandard:Electromagnetic
compatibility-Requirementsandtests).
TheSoftAIR®mattressisfiresafetytestedandcertifiedinaccordance
withEN597–1&–2.
ForfurtherinformationpleasecontactInvacareinyourcountry
(addressesseebackpageofthismanual).
1.5ServiceLife
Weestimatealifeexpectancyoffiveyears(5yrs)forthese
products,providedtheyareusedinstrictaccordancewiththe
intendeduseassetoutinthisdocumentandallmaintenanceand
servicerequirementsaremet.Theestimatedlifeexpectancycanbe
exceedediftheproductiscarefullyusedandproperlymaintained,and
providedtechnicalandscientificadvancesdonotresultintechnical
1533195-A5

Invacare®SoftAIR®Super/SoftAIR®Excellence
limitations.Thelifeexpectancycanalsobeconsiderablyreduced
byextremeorincorrectusage.
Thefactthatweestimatealifeexpectancyfortheseproductsdoes
notconstituteanadditionalwarranty.
61533195-A

Safety
2Safety
2.1Safetyinformation
WARNING!
–Donotusethisproductoranyavailableoptional
equipmentwithoutfirstcompletelyreadingand
understandingtheseinstructionsandanyadditional
instructionalmaterialsuchasusermanuals,service
manualsorinstructionsheetssuppliedwiththis
productoroptionalequipment.Invacareproduct
manualsareavailableatyourlocaldealerorInvacare
inyourcountry,addressesareonthebackpageofthis
manual.Ifyouareunabletounderstandthewarnings,
cautionsorinstructions,pleasecontactahealthcare
professional,dealerortechnicalpersonnelbefore
attemptingtousethisequipment–otherwise,injury
ordamagemayoccur.
WARNING!
Therearesiginificantrisksofreciprocalinterference
posedbythepresenceofthesystemduringspecific
investigationsortreatments.
–Intheeventofelectromagneticorotherinterference
betweenthesystemandotherdevices,movethe
equipmentawayfromthesensitivedevicesorcontact
themanufacturer.
WARNING!
–Unplugthecontrolunitfromthemainspowersupply
todisconnectthepower.
WARNING!
Invacareproductsarespecificallydesignedand
manufacturedforuseinconjunctionwithInvacare
accessories.Accessoriesdesignedbyother
manufacturershavenotbeentestedbyInvacareandare
notrecommendedforusewithInvacareproducts.
Theintroductionofcertainthirdpartyproductsbetween
themattresssurfaceandtheusermayreduceorimpede
theclinicaleffectivenessofthisproduct.
’Thirdpartyproducts’mayinclude,butarenotlimited
toitemsincludingunderblankets,plasticsheetsand
sheepskins,etc.
WARNING!
Riskofdevelopingpressureulcers
–Bedsheetsmustbelooselyfitted,withcreases
smoothedout.Caremustalwaysbetakentoensure
thatthesupportsurfaceincontactwiththeuseris
keptfreefromcrumbsandotherfooddebris,andthat
dripcables,stents,andotherforeignobjectsdonot
becomeentrappedbetweentheuserandthepressure
reducingsurfaceofthemattress,asthismayresultin
thedevelopmentofpressureulcers.
1533195-A7

Invacare®SoftAIR®Super/SoftAIR®Excellence
WARNING!
Riskoffireorexplosion!
Acigarettecanburnaholeinthebedsurfaceand
causedamagetothemattress.Also,patientclothing,
bedsheets,etc,maybecombustibleandcauseafire.
Failuretoobservethiswarningcanresultinasevere
fire,propertydamageandcausephysicalinjuryordeath.
Thereisanexplosionriskifusedwithflammable
anesthetics.
Thereisapossiblefirehazardwhenusedwithoxygen
administeringequipmentotherthannasalmaskorhalf
bedtenttype.
–Donotsmokewhileusingthisdevice.
–Anoxygententmaynotextendbelowmattress
supportlevel.
IMPORTANT!
Theinformationcontainedinthisdocumentissubject
tochangewithoutnotice.
–Checkallpartsforshippingdamageandtestbefore
using.
–Incaseofdamage,donotuse.Contact
Invacare/Carrierforfurtherinstructions.
2.2Symbolsontheproduct
Donotpierceor
cut
Linedry
DonotdrycleanDeclarationof
conformity
Donotputnear
flame
95°
Maximum
95°C
xxx kg
Userweightlimit*Donotiron
DonotbleachTumbledrylowheat
RefertousermanualManufacturer
TypeBappliedpartClassIImedical
equipment
WEEEconformAuthorised
Representative
intheEuropean
Community
SerialnumberPower
Dateofmanufacture
*Minimum/Maximumuserweightaspersection10Technicaldata,
page26.
81533195-A

Components
3Components
3.1Overview
Thefollowingcomponentsareincludedwithinthescopeofdelivery:
SoftAIR®Excellence/SoftAIR®Super
A
B
C
D
E
ASoftAIR®MattressSystemincludingMattressBase,CPRTag,
AirHoses,HandlewithTransportCapattached,Topcover
withquickreleasezip.
Twoinflatablesideformers(onlySoftAIR®Excellence)
BDigitalControlUnit
CCarryBag
DQuickSetupGuide
EUserManual
MedicalGradePowerCord(notshown)
3.2Description
SoftAIR®AlternatingMattressSystems
TheSoftAIR®ExcellenceandSoftAIR®Superarealternating
MattressSystemsthatprovidealternatingpressuretopatientswho
arevulnerableto,orsufferfrom,pressureulcers.Theyaredesigned
toreplaceyourexistingmattressandcanbeusedonbothstandard
andprofilingbedframes.
DigitalControlUnit
TheControlUnitprovidestheairsupplytotheMattress.
•Itiscontrolledviaatouchpanel.Thereisavisualandaudible
alarmwhenpressurefailsorpowerisinterrupted.AlarmMute
silencesthealarmforamaximumof20minutes–thealarm
resumesifcauseoffailureisnotresolved.TheAlarmwillsound
foruptotwohoursfollowinganinterruptiontopower.As
soonaspowerisrestored,thebatterymemorybackupwill
restorethepreviouspressure/usersetting.
•TheControlUnitincludesabatteryfordigitalmemoryback
up.Thisbatteryiscontinuouslyre-chargedandwilllastthelife
timeoftheproduct.
•Buttonsonthecontrolpaneladjusttheeightalternating
pressuresettings.
•ThesystemwillautomaticallyreverttoAlternationModeupto
20minutesafterstaticmodehasbeenselected.See5.2Using
thecontrolunitpanel,page14forfurtherinstruction.
Thevisibleandaudiblealarmfunctionhasanumberofindications
dependingonthecauseofthefailure.Seechapter5.5Alarm
Functions,page17.
Onthesideofthecontrolunitarefourmaleairconnectorsfor
connectingtheHandle.
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Invacare®SoftAIR®Super/SoftAIR®Excellence
TherapidreleaseHandleincludesanattachedtransportcapwhich
canbeinsertedintotheopeningtosealairinthesystemforupto
72hoursasatransportfeature.
ThemainssupplytotheControlUnitcanbeeasilydisconnectedand
isdesignedtodetachiftuggedtoofirmly-protectingtheinternal
wiringoftheunit.
Shouldthisoccur,thealternationsequenceissuspendedandthe
Mattresscellsremaininflatedand/ordeflatedbasedonthecurrent
cycle.ThePowerfailureindicatorwillsound.
SoftAIR®Super
TheSoftAIR®SuperMattresscomprises21highdensitycellswhich
allfeatureapermanentlyinflatedinternalcelltopreventthepatient
“bottomingout”intheeventoflowpressureduetoincorrect
settings,electricalorcellfailure.
Thissystemincludesthreestaticheadcellstoprovidestatic“pillow”
supportforoptimumusercomfort,whileairpressureintheother
18cellsisalternatedovera10~12minutecycle.Thisprovides
regularperiodsofpressurereductiontoaidbloodandlymphatic
flowtovulnerabletissue.
SoftAIR®Excellence
TheSoftAIR®ExcellenceMattresscomprises19highdensitycells
whichallfeatureapermanentlyinflatedinternalcelltopreventthe
patient“bottomingout”intheeventoflowpressureduetoincorrect
settings,electricalorcellfailure.
Thissystemincludesthreestaticheadcellstoprovidestatic“pillow”
supportforoptimumusercomfort,whileairpressureintheother
16cellsisalternatedovera10~12minutecycle.Thisprovides
regularperiodsofpressurereductiontoaidbloodandlymphatic
flowtovulnerabletissue.
TheSoftAIR®Excellencehasahingedbacktoallowthemattressto
conformtotheprofileofthebedwhenarticulated.TheSoftAIR®
Excellencealsoincludesanindependentheelzoneoffivemicrocells
forindividualizedtherapytothissensitivearea.
Inaddition,twopermanentlyinflatedsideformersassistinlateral
supportfortheuserandcarer,whileincreasingtheeffectiveness
oftheoneinthreealternationcycle.Thehingedmattressbase
conformstoprofilingbedmovement.
101533195-A