Invacare InvaSoft Hybrid User manual

Invacare®InvaSoft®Hybrid
enMattresssystem
UserManual......................................3
frSystèmedematelas
Manueld'utilisation................................13
daMadrassystem
Brugsanvisning....................................23
deMatratzensystem
Gebrauchsanweisung................................33
esSistemadecolchón
Manualdelusuario.................................43
ptSistemadecolchões
Manualdeutilização................................53
itSistemaamaterasso
Manualed’uso....................................63
nlMatrassysteem
Gebruiksaanwijzing.................................73
Patjajärjestelmä
Käyttöohje.......................................83
svMadrassystem
Bruksanvisning....................................93
ThismanualMUSTbegiventotheuseroftheproduct.
BEFOREusingthisproduct,thismanualMUSTbereadandsaved
forfuturereference.

©2021InvacareCorporation
Allrightsreserved.Republication,duplicationormodicationinwholeorinpartisprohibitedwithoutpriorwritten
permissionfromInvacare.Trademarksareidentiedby™and®.AlltrademarksareownedbyorlicensedtoInvacare
Corporationoritssubsidiariesunlessotherwisenoted.

Contents
ThismanualMUSTbegiventotheuseroftheproduct.
BEFOREusingthisproduct,thismanualMUSTbereadandsaved
forfuturereference.
1General.........................................4
1.1Introduction..................................4
1.2SymbolsinthisDocument........................4
1.3Compliance...................................4
1.4WarrantyInformation...........................4
1.5LimitationofLiability............................4
1.6ServiceLife...................................4
2Safety..........................................5
2.1SafetyInformation..............................5
2.2SafetyInformationforTransport...................5
3ProductOverview.................................6
3.1ProductDescription.............................6
3.2IntendedUse.................................6
3.2.1Indications.................................6
3.2.2Contraindications............................6
3.3Components..................................6
3.4SymbolsonProduct............................6
4Usage..........................................8
4.1SafetyInformation..............................8
4.2PreparingMattressforUse.......................8
5Maintenance.....................................9
5.1Inspection....................................9
5.2CleaningandDisinfection........................9
5.2.1GeneralSafetyInformation.....................9
5.2.2CleaningIntervals............................9
5.2.3CleaningInstructions.........................9
5.2.4DisinfectionInstructions.......................9
5.3ReplacingCover...............................10
6AfterUse........................................11
6.1Storage......................................11
6.2Reconditioning................................11
6.3Disposal.....................................11
7TechnicalData....................................12
7.1MattressSpecications..........................12
7.2Materials....................................12
7.3EnvironmentalConditions........................12

Invacare®InvaSoft®Hybrid
1General
1.1Introduction
Thisusermanualcontainsimportantinformationaboutthe
handlingoftheproduct.Toensuresafetywhenusingthe
product,readtheusermanualcarefullyandfollowthe
safetyinstructions.
Notethattheremaybesectionsinthisdocument,whichare
notrelevanttoyourproduct,sincethisdocumentapplies
toallavailablemodels(onthedateofprinting).Ifnot
otherwisestated,eachsectioninthisdocumentreferstoall
modelsoftheproduct.
Themodelsandcongurationsavailableinyourcountrycan
befoundinthecountry-specicsalesdocuments.
Invacarereservestherighttoalterproductspecications
withoutfurthernotice.
Beforereadingthisdocument,makesureyouhavethe
latestversion.YoundthelatestversionasaPDFonthe
Invacarewebsite.
Ifyoundthatthefontsizeintheprinteddocumentis
difculttoread,youcandownloadthePDFversionfromthe
website.ThePDFcanthenbescaledonscreentoafont
sizethatismorecomfortableforyou.
Formoreinformationabouttheproduct,forexampleproduct
safetynoticesandproductrecalls,contactyourInvacare
distributor.Seeaddressesattheendofthisdocument.
Incaseofaseriousincidentwiththeproduct,youshould
informthemanufacturerandthecompetentauthorityin
yourcountry.
1.2SymbolsinthisDocument
Symbolsandsignalwordsareusedinthisdocumentand
applytohazardsorunsafepracticeswhichcouldresultin
personalinjuryorpropertydamage.Seetheinformation
belowfordenitionsofthesignalwords.
WARNING
Indicatesahazardoussituationthatcouldresult
inseriousinjuryordeathifitisnotavoided.
CAUTION
Indicatesahazardoussituationthatcouldresult
inminororslightinjuryifitisnotavoided.
IMPORTANT
Indicatesahazardoussituationthatcouldresult
indamagetopropertyifitisnotavoided.
TipsandRecommendations
Givesusefultips,recommendationsand
informationforefcient,trouble-freeuse.
1.3Compliance
Qualityisfundamentaltothecompany’soperation,working
withinthedisciplinesofISO13485.
ThisproductfeaturestheCEmark,incompliancewiththe
MedicalDeviceRegulation2017/745ClassI.Thelaunchdate
ofthisproductisstatedintheCEdeclarationofconformity.
Wearecontinuouslyworkingtowardsensuringthatthe
company’simpactontheenvironment,locallyandglobally,
isreducedtoaminimum.
WeonlyuseREACHcompliantmaterialsandcomponents.
WecomplywiththecurrentenvironmentallegislationsWEEE
andRoHS.
1.4WarrantyInformation
Weprovideamanufacturer’swarrantyfortheproduct
inaccordancewithourGeneralTermsandConditionsof
Businessintherespectivecountries.
Warrantyclaimscanonlybemadethroughtheprovider
fromwhomtheproductwasobtained.
1.5LimitationofLiability
Invacareacceptsnoliabilityfordamagearisingfrom:
•Non-compliancewiththeusermanual
•Incorrectuse
•Naturalwearandtear
•Incorrectassemblyorset-upbythepurchaserorathird
party
•Technicalmodications
•Unauthorisedmodicationsand/oruseofunsuitable
spareparts
1.6ServiceLife
Theexpectedservicelifeofthisproductisveyearswhen
useddailyandinaccordancewiththesafetyinstructions,
maintenanceintervalsandcorrectuse,statedinthismanual.
Theeffectiveservicelifecanvaryaccordingtofrequencyand
intensityofuse.
460130102-B

Safety
2Safety
2.1SafetyInformation
Education,clinicaljudgementandaction-basedplanning
basedonvulnerabilityarefundamentalfactorsinprevention
ofpressureinjuries.
Arangeofassessmentscalescanbeusedasaformalmethod
ofassessingriskfrompressureinjurydevelopment,and
shouldbeusedinconjunctionwithaninformalassessment
(informednursingjudgement).Informalassessmentis
consideredtobeofgreaterimportanceandclinicalvalue.
WARNING!
RiskofSeriousInjuryorDamage
Improperuseofthisproductmaycauseinjury
ordamage.
–Ifyouareunabletounderstandthewarnings,
cautionsorinstructions,contactahealthcare
professionalorproviderbeforeattemptingto
usethisequipment.
–Donotusethisproductoranyavailable
optionalequipmentwithoutrstcompletely
readingandunderstandingtheseinstructions
andanyadditionalinstructionalmaterialsuch
asusermanual,servicemanualorinstruction
sheetsuppliedwiththisproductoroptional
equipment.
WARNING!
RiskofDevelopingPressureInjuries
Thedevicedeliverseffectivepressurereduction,
whenthesupportsurfaceiscoveredwitha
cotton,cottoncombinationorlinenbedsheet,
andanyoneoftheseistheonlyitemdeployed
betweenthesupportsurfaceandtheuser.
–Bedsheetsmustbelooselytted,withcreases
smoothedout.
–Ensurethatthesupportsurfaceincontactwith
theuseriskeptfreefromcrumbsandother
fooddebris,andthatdripcables,stents,and
otherforeignobjectsdonotbecomeentrapped
betweenthesupportsurfaceandtheuser.
–Heatedoverblanketsmustonlybeused
inconsultationwithaqualiedhealthcare
professional,asanincreaseintemperaturecan
increasetheriskofdevelopingpressureinjuries.
WARNING!
Riskofreorexplosion!
Acigarettecanburnaholeinthebedsurface
andcausedamagetothedevice.Also,patient
clothing,bedsheets,etc.maybecombustible
andcauseare.Failuretoobservethiswarning
canresultinaseverere,propertydamageand
causephysicalinjuryordeath.
–Takespecialcareinoxygenrichenvironments.
–Donotsmoke.
CAUTION!
RiskofInjury
Non-originalorwrongpartsmayaffectthe
functionandsafetyoftheproduct.
–Onlyuseoriginalpartsfortheproductinuse.
–Duetoregionaldifferences,refertoyour
localInvacarecatalogorwebsiteforavailable
optionsorcontactyourInvacaredistributor.
Seeaddressesattheendofthisdocument.
2.2SafetyInformationforTransport
•Takecarewhenhandlingmattressestoensureno
damagetothecover.
•Itisrecommendedthattwopeoplelift/carrymattresses.
•Avoidcontactwithjewellery,nails,abrasivesurfacesetc.
•Donotdragmattresses.
•Avoidcontactwithwall,doorframes,doorcatchesor
locksetc.
•Donottransportinrollcagesunlesscompletely
protectedfromthesharpedgesofthecage.
60130102-B5

Invacare®InvaSoft®Hybrid
3ProductOverview
3.1 Product Description
The Invacare InvaSoft® Hybrid mattress acts as a reactive
pressure redistributing support/mattress for patients at
High Risk that can, by the airow t hroughout t he a ir cells,
promote a pressure distribution support surface.
Due to its unique construction combining foam, noodle
material, and air, this mattress provides high user comfort,
as well as a solution for pressure care and microclimate
management without the need for an external pump
or electricity. The system uses the user weight and its
movements to distribute the internal air reservoir amongst
the cells, to always maintain optimal pressure redistribution.
The mattress has a sloped heel section for protection of
the vulnerable heels.
The high-breathability water-resistant cover provides a
vapor-permeable, multi-stretch surface, with enhanced
microclimate properties, to promote patient comfort,
contribute to skin integrity and maximize the effectiveness
of the underlying layers.
The InvaSoft® mattress is produced in high-quality materials
for function and durability.
3.2 Intended Use
This pressure redistribution mattress is intended to be used
in conjunction with an appropriately sized bed frame and
side rails. Check the bed’s user manual for the appropriate
size of the mattress to be used.
This product delivers effective pressure redistribution to
users, when the support surface is covered with a cotton,
cotton combination or linen bed sheet, and any one of these
is the only item deployed between the support surface and
the user.
3.2.1 Indications
Suitable for supporting the management of all categories
of pressure injuries when combined with an individual and
comprehensive pressure injury protocol.
Suitable for use in home care, residential, nursing and acute
care settings.
3.2.2 Contraindications
Not suitable for users with unstable spinal cord fractures
and/or cervical traction.
Always consult a physician prior to using this device.
3.3 Components
The following components are included within the scope
of delivery:
Fig.3-1
ATopcover
BNon-woventoplayer
CNoodlelayer
DHeadrestfoam
EInternalspacers
FAircellassembly
GAnti-shearmaterial
HHeelslopedfoam
IU-corefoam
JBottomcover
KUserManual
Stockinetteencapsulatingallmattresscomponents
withinthecover(notshown)
3.4SymbolsonProduct
European
Conformity
European
representative
MedicalDevice
Dateof
manufacture
Manufacturer
Userweightlimit.
See7Technical
Data,page12.
LOTnumber
Donotputnear
ame
Donotpierceor
cut
Handwash
660130102-B

ProductOverview
Machinewash
temperature.
Max.
temperatureis
showninsymbol.
Donotbleach
Donotdryclean
Tumbledrylow
temperature
Linedry
Donotiron
Readusermanual
60130102-B7

Invacare®InvaSoft®Hybrid
4Usage
4.1SafetyInformation
WARNING!
Insufcientrepositioningofthepatientcan
leadtotissuecompressionandpotentialinjury
formation.
Torelievepressure,itisveryimportantfor
thepatientstorepositionthemselves,ortobe
repositioned,onaregularbasis.
–Beforeusingtheproduct,alwaysconsulta
qualiedhealthcareprofessionalforclinical
judgement.
–Monitorthepatientfrequently.
CAUTION!
–Makesurethattheprintedsideofthemattress
coveralwaysfacesupwards.
–Ensurethatthedistancebetweenthesurface
ofthemattressandthetopofthesiderailis
atleast220mm.
CAUTION!
Riskofdamagetothemattress
Ifholesarepresentinthemattresscover,thereis
ariskthatliquidsmayingressandcontamination
mayoccur.
–Ensurethatthemattressisnotjammedor
damagedbysharpedges.
–Donotplacehypodermicneedles,venons,
scalpelsorothersimilarlysharpobjectsonor
underthemattress.
–Donotuseelectricallyheatedblanketsdirectly
onorunderthemattress.
–Ensurethatallvenonsaretapeddown
correctlywithnosharpedgesexposed.
–Whenusingbridgingboardsorotherpatient
transferaids,checkforanysharpedgesor
burrsbeforeuse.
–Whenusingthemattressonaprolingbed
ensurethatthekneebreakisusedbeforethe
backrest.
–Attachmedicalequipmentincludinginfusion
pumpsandmonitorstoappropriatebed
accessories.
–Avoidcigaretteburnsandpetclawspuncturing
themattresscover.
4.2PreparingMattressforUse
CAUTION!
RiskofInjuryorDamagetoProperty
–Beforeuse,checktheproductforanydefect.
–Donotuseadefectiveproduct.
1.Removeallpackagingbeforeuse.
2.Placemattressdirectlyonbedframe.
3.Makesurethatheelslopesectionisorientedatfoot
endofbedframe.
860130102-B

Maintenance
5Maintenance
5.1Inspection
Itisrecommendedtocheckmattresses(aircellsandcover)
forstrike-through(thismayincludeuidingress,stains,rips
ordamage)afterthereleaseofeachpatientoraftereach
periodofusebyasuitablyqualiedandcompetentperson.
Checkmattresses
1.Unzipthecovercompletely.
2.Checkforanystainingonthewhiteundersideofthe
cover.
3.Checkforanystainingontheinternalelements.
4.Replaceanystaineditemsanddisposeofasperlocal
authorityprocedure.
5.2CleaningandDisinfection
5.2.1GeneralSafetyInformation
CAUTION!
RiskofContamination
–Takeprecautionsforyourselfanduse
appropriateprotectiveequipment.
IMPORTANT!
Wronguidsormethodscanharmordamage
theproduct.
–Allcleaningagentsanddisinfectantsusedmust
beeffective,compatiblewithoneanotherand
mustprotectthematerialstheyareusedto
clean.
–Neverusecorrosiveuids(alkalines,acidetc.)
orabrasivecleaningagents.Werecommend
anordinaryhouseholdcleaningagentsuchas
dishwashingliquid,ifnotspeciedotherwisein
thecleaninginstructions.
–Neveruseasolvent(cellulosethinner,acetone
etc.)thatchangesthestructureoftheplastic
ordissolvestheattachedlabels.
–Alwaysmakesurethattheproductiscompletely
driedbeforetakingitintouseagain.
Forcleaninganddisinfectioninclinicalorlong-term
careenvironments,followyourin-houseprocedures.
5.2.2CleaningIntervals
IMPORTANT!
Regularcleaninganddisinfectionenhances
smoothoperation,increasestheservicelifeand
preventscontamination.
Cleananddisinfecttheproduct
–regularlywhileitisinuse,
–beforeandafteranyserviceprocedure,
–whenithasbeenincontactwithanybody
uids,
–beforeusingitforanewuser.
IMPORTANT!
–Keepacleaningrecordaspartofcleaningthe
system.
5.2.3CleaningInstructions
IMPORTANT!
–Theproductdoesnottoleratecleaningin
automaticwashingplants,withhigh-pressure
cleaningequipmentorsteam.
Acleaningrecordshouldbekeptaspartofcleaning
thesystem.
Cleaningcovers
(Removalofcontaminantssuchasdustandorganicmatter)
1.Removeallcoversforlaundering.
2.Laundercoverswithmaximumtemperatureasstated
onproductlabel,usingadiluteddetergentsolution
(Instructionsonlabel).
IMPORTANT!
Washingathighertemperatureswillcause
shrinkage.
Dryingcovers
1.Hangcoversfromalineorbaranddripdryinaclean
indoorenvironmentortumbledryonalowheatsetting.
IMPORTANT!
–Tumbledrysettingmustnotexceed40°C.
–Donottumbledryforlongerthan10minutes.
–Drythoroughlybeforeuse.
5.2.4DisinfectionInstructions
IMPORTANT!
–Onlyusedisinfectantsandmethodsapproved
byyourlocalinfectioncontrolinstitutionand
followyourlocalinfectioncontrolpolicy.
–Followyourlocaldecontaminationprotocols.
Disinfectingcovers
(Reducingthenumberofmicroorganisms)
IMPORTANT!
Failureindisinfectionprocessmayresultinthe
accumulationofreagentthatcoulddamagethe
polyurethanecoating,reactwiththebedframe,
ornegatethebiocompatibilityresults.
–Ensurethatallcleaningagents,and
disinfectants,arethoroughlyrinsedoff.
–Drythoroughlybeforeuse.
1.Wipedownthecoverwithasuitabledetergent.
2.Rinsethecoverthoroughlywithcleanwaterusinga
singleusenonabrasivecloth.
3.Drythecoverthoroughly.
60130102-B9

Invacare®InvaSoft®Hybrid
Heavysoilage
Wherethemattressisbadlysoiled,we
recommendcleaningwithadilutecleaning
solutionatmaximumtemperatureinthewashing
machine(seeproductlabel).
–Cleanupallspillagesofbodilyuidsi.e.blood,
urine,faeces,sputum,woundexudateandall
otherbodilysecretionsassoonaspossible
usingasuitabledetergent.
–Largespillagesofbloodshouldbeabsorbed
andremovedwithpapertowelsrst.
WARNING!
–Ineventofcontamination,contactyourhygiene
specialist.
–Removecontaminatedfoamsfromuse.
Autoclaving covers
Autoclave the cover at 110 °C.
IMPORTANT!
–Makesurethecoverisoutstretched(not
folded).
–Donotplacecoversontopofeachother.
5.3ReplacingCover
1.Unzipcoverandremoveitcarefullyfromfoaminsert.
2.Placenewcoverontofoaminsert.
3.Closezipper.
IMPORTANT!
–Ensurethatthecornersofthefoaminsertare
positionedcorrectlyintothecornersofthe
cover.
–Ensurethatthecastellatedfoamisfacing
upwardswheninsertedintoitscover.
WARNING!
–Ineventofcontamination,contactyourhygiene
specialist.
–Removecontaminatedfoamsfromuse.
1060130102-B