Invacare Softair excellence, Softair super 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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medmindreanneterangitt.
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—
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lisensoimia,elleitoisinoleilmoitettu.

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.

4

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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(Qualitymanagementsystems­Requirements)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

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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.

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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

Donotdryclean

Declarationof
conformity

Donotputnear
flame

95°

Maximum
95°C

xxx kg

Userweightlimit*

Donotiron

DonotbleachTumbledrylowheat

RefertousermanualManufacturer

TypeBappliedpart

ClassIImedical
equipment

WEEEconformAuthorised

Representative
intheEuropean
Community

Serialnumber

Power

Dateofmanufacture

*Minimum/Maximumuserweightaspersection10Technicaldata,
page26.

81533195-A

Components

3Components

3.1Overview

Thefollowingcomponentsareincludedwithinthescopeofdelivery:

SoftAIR®Excellence/SoftAIR®Super

A

B

C

D

E

A

SoftAIR®MattressSystemincludingMattressBase,CPRTag,
AirHoses,HandlewithTransportCapattached,Topcover
withquickreleasezip.

Twoinflatablesideformers(onlySoftAIR®Excellence)

B

DigitalControlUnit

C

CarryBag

D

QuickSetupGuide

E

UserManual
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,page14

forfurtherinstruction.

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.

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