Invacare Softform PREMIER User manual

ThismanualMUSTbegiventotheuseroftheproduct.
BEFOREusingthisproduct,thismanualMUSTbereadandsavedforfuturereference.
Invacare®Softform®
enMattresses
UserManual.........................................2
deMatratzen
Gebrauchsanweisung...................................6
frMatelas
Manueld'utilisation....................................11
esColchones
Manualdelusuario....................................15
itMaterassi
Manualed’uso........................................20
nlMatrassen
Gebruiksaanwijzing....................................25
ptColchões
Manualdeutilização...................................30
svMadrasser
Bruksanvisning........................................35
noMadrasser
Bruksanvisning........................................39
daMadrasser
Brugsanvisning........................................43

Invacare®Softform®
IenI
1General
1.1Introduction
Thisusermanualcontainsimportantinformationaboutthe
handlingoftheproduct.Toensuresafetywhenusingthe
product,readtheusermanualcarefullyandfollowthesafety
instructions.
Notethattheremaybesectionsinthisdocument,whichare
notrelevanttoyourproduct,sincethisdocumentapplies
toallavailablemodels(onthedateofprinting).Ifnot
otherwisestated,eachsectioninthisdocumentreferstoall
modelsoftheproduct.
Themodelsandcongurationsavailableinyourcountrycan
befoundinthecountry-specicsalesdocuments.
Invacarereservestherighttoalterproductspecications
withoutfurthernotice.
Beforereadingthisdocument,makesureyouhavethelatest
version.YoundthelatestversionasaPDFontheInvacare
website.
Ifyoundthatthefontsizeintheprinteddocumentis
difculttoread,youcandownloadthePDFversionfromthe
website.ThePDFcanthenbescaledonscreentoafontsize
thatismorecomfortableforyou.
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,is
reducedtoaminimum.
WeonlyuseREACHcompliantmaterialsandcomponents.
1.4WarrantyInformation
Weprovideamanufacturer’swarrantyfortheproduct
inaccordancewithourGeneralTermsandConditionsof
Businessintherespectivecountries.
Warrantyclaimscanonlybemadethroughtheproviderfrom
whomtheproductwasobtained.
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.
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.
21633735-A

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.maybecombustibleand
causeare.Failuretoobservethiswarningcan
resultinaseverere,propertydamageandcause
physicalinjuryordeath.
–Takespecialcareinoxygenrichenvironments.
–Donotsmoke.
CAUTION!
RiskofInjury
Non-originalorwrongpartsmayaffectthe
functionandsafetyoftheproduct.
–Onlyuseoriginalpartsfortheproductinuse.
–Duetoregionaldifferences,refertoyour
localInvacarecatalogorwebsiteforavailable
optionsorcontactyourInvacaredistributor.See
addressesattheendofthisdocument.
2.2SafetyInformationforTransport
•Takecarewhenhandlingmattressestoensureno
damagetothecover.
•Itisrecommendedthattwopeoplelift/carrymattresses.
•Avoidcontactwithjewellery,nails,abrasivesurfacesetc.
•Donotdragmattresses.
•Avoidcontactwithwall,doorframes,doorcatchesor
locksetc.
•Donottransportinrollcagesunlesscompletely
protectedfromthesharpedgesofthecage.
3ProductOverview
3.1ProductDescription
Themattressoffersexceptionalpressurereducingqualities,
specictotheindividualsneeds.Bypromotingevenweight
distribution,theyreducetissuepressureatpotentially
vulnerableareas.
Thewater-resistantcoverprovidesavapour-permeable,multi
stretchsurface,topromotepatientcomfortandtomaximize
theeffectivenessofthefoamcore.
3.2IntendedUse
Thismattressisintendedtodelivereffectivepressure
redistributiontousers.Itisintendedtobeusedin
conjunctionwithanappropriatelysizedbedframeaspartof
anoverallpressureinjurypreventionprogramofcare.
Indications
Suitableforusers'AtRisk/HighRisk/VeryHighRisk'of
developingpressureinjuries.
3.3ScopeofDelivery
Thefollowingcomponentsareincludedwithinthescopeof
delivery*:
A
B
C
DE
AMulti-stretchwaterproofpolyurethanecover
BCastellatedfoaminsert
CSinglepiecefoam“U”core
DToughedpolyurethanecoatedbase
EUserManual
*ThisexampleisbasedontheSoftformPremier,other
mattresscongurationsmayvary.
3.4SymbolsontheProduct
MedicalDeviceEuropean
conformity
ManufacturerDateof
manufacture
European
representative
Readusermanual
Donotpierceor
cut
Linedry
DonotdrycleanMachinewash
temperature.
Max.
temperatureis
showninsymbol.
Userweightlimit.
See7Technical
Data,page6.
Donotiron
Donotputnear
ame
Tumbledrylow
heat
DonotbleachLOTnumber
1633735-A3

Invacare®Softform®
4Usage
4.1SafetyInformation
WARNING!
Insufcientrepositioningofthepatientcanleadto
tissuecompressionandpotentialinjuryformation.
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,checkforanysharpedgesorburrs
beforeuse.
–Whenusingthemattressonaprolingbed
ensurethatthekneebreakisusedbeforethe
backrest.
–Attachmedicalequipmentincludinginfusion
pumpsandmonitorstoappropriatebed
accessories.
–Avoidcigaretteburnsandpetclawspuncturing
themattresscover.
4.2PreparingtheMattressforUse
CAUTION!
RiskofInjuryorDamagetoProperty
–Beforeuse,checktheproductforanydefect.
–Donotuseadefectiveproduct.
1.Removeallpackagingbeforeuse.
2.Placethemattressdirectlyonthemattresssupportof
thebedorplacethemattressoverlayontheexisting
mattress.
Compressrolledmattressesmustbelefttorecoverbefore
use.Followtheinstructionsonthepackaginginlay.
Mattressesthataredeliveredatpackedcanbeused
immediately.
5Maintenance
5.1Inspection
Checkmattresses(foamandcover)forstrike-through(this
mayincludeuidingress,stains,ripsordamage)afterthe
releaseofeachpatient,afterendingoftheperiodofuseor
onaminimummonthlybasis(dependingonwhichoccurs
rst)byasuitablyqualiedandcompetentperson.
Checkmattress
1.Unzipthecovercompletely.
2.Checkforanystainingonthewhiteundersideofthe
cover.
3.Checkforanystainingontheinteriorfoam.
4.Replaceanystaineditemsanddisposeofasperlocal
authorityprocedure.
5.2CleaningandDisinfection
GeneralSafetyInformation
CAUTION!
RiskofContamination
–Takeprecautionsforyourselfanduse
appropriateprotectiveequipment.
IMPORTANT!
Wronguidsormethodscanharmordamage
theproduct.
–Allcleaningagentsanddisinfectantsusedmust
beeffective,compatiblewithoneanotherand
mustprotectthematerialstheyareusedto
clean.
–Neverusecorrosiveuids(alkalines,acidetc.),
abrasivecleaningagentsorsolvents(cellulose
thinner,acetoneetc.).Werecommendamild
detergent.
–Alwaysmakesurethattheproductiscompletely
driedbeforetakingitintouseagain.
Forcleaninganddisinfectioninclinicalorlong-term
careenvironments,followyourin-houseprocedures.
CleaningIntervals
IMPORTANT!
Regularcleaninganddisinfectionenhances
smoothoperation,increasestheservicelifeand
preventscontamination.
Cleananddisinfecttheproduct
–regularlywhileitisinuse,
–beforeandafteranyserviceprocedure,
–whenithasbeenincontactwithanybody
uids,
–beforeusingitforanewuser.
IMPORTANT!
–Keepacleaningrecordaspartofcleaningthe
system.
CleaningInstructions
CleaningCovers
(Removalofcontaminantssuchasdustandorganicmatter)
1.Removecoverforlaundering.
2.Launderthecoverwithmaximumtemperatureasstated
onproductlabel,usingadiluteddetergentsolution
(Instructionsonlabel).
41633735-A

IMPORTANT!
Washingathighertemperatureswillcause
shrinkage.
DryingCovers
1.Hangcoverfromalineorbaranddripdryinaclean
indoorenvironment.
or
Tumbledryonalowtemperature.
IMPORTANT!
–Tumbledrysettingmustnotexceed40°C.
–Donottumbledryforlongerthan10minutes.
–Drythoroughlybeforeuse.
DisinfectionInstructions
IMPORTANT!
–Onlyusedisinfectantsandmethodsapproved
byyourlocalinfectioncontrolinstitutionand
followyourlocalinfectioncontrolpolicy.
–Followyourlocaldecontaminationprotocols.
Disinfectingcovers
(Reducingthenumberofmicroorganisms)
IMPORTANT!
Failureindisinfectionprocessmayresultinthe
accumulationofreagentthatcoulddamagethe
polyurethanecoating,reactwiththebedframe,
ornegatethebiocompatibilityresults.
–Ensurethatallcleaningagents,anddisinfectants,
arethoroughlyrinsedoff.
–Drythoroughlybeforeuse.
1.Wipedownthecoverwithasuitabledetergent.
2.Rinsethecoverthoroughlywithcleanwaterusinga
singleusenonabrasivecloth.
3.Drythecoverthoroughly.
Heavysoilage
Wherethemattressisbadlysoiled,we
recommendcleaningwithadilutecleaning
solutionatmaximumtemperatureinthewashing
machine(seeproductlabel).
–Cleanupallspillagesofbodilyuidsi.e.blood,
urine,faeces,sputum,woundexudateandall
otherbodilysecretionsassoonaspossibleusing
asuitabledetergent.
–Largespillagesofbloodshouldbeabsorbedand
removedwithpapertowelsrst.
WARNING!
–Ineventofcontamination,contactyourhygiene
specialist.
–Removecontaminatedfoamsfromuse.
Autoclavingcovers
Autoclavethecoverat110°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.
6AfterUse
6.1Storage
IMPORTANT!
–Storemattressesinadryenvironment.
–Storemattresseswithinaprotectivecover.
–Storeitemsonclean,dry(off-oor)surfacewith
nosharpedgestoavoidanypossibledamage.
–Neverstoreotheritemsontopofamattress.
–Donotstoremattressesnexttoradiatorsor
otherheatingdevices.
–Protectmattressesfromdirectsunlight.
Forenvironmentalconditionsforstorage,see7Technical
Data,page6.
6.2Reconditioning
Thisproductissuitableforreuse.Toreconditiontheproduct
foranewuser,carryoutthefollowingactions:
•Inspection
•Cleaninganddisinfection
Fordetailedinformation,see5Maintenance,page4.
Makesurethattheusermanualishandedoverwiththe
product.
Ifanydamageormalfunctionisdetected,donotreusethe
product.
6.3Disposal
Beenvironmentallyresponsibleandrecyclethisproduct
throughyourrecyclingfacilityatitsendoflife.
Disassembletheproductanditscomponents,sothedifferent
materialscanbeseparatedandrecycledindividually.
Thedisposalandrecyclingofusedproductsandpackaging
mustcomplywiththelawsandregulationsforwastehandling
ineachcountry.Contactyourlocalwastemanagement
companyforinformation.
1633735-A5