Invacare Softform User manual

Invacare® Softform®
en Mattresses
User Manual
This manual MUST be given to the user of the product.
BEFORE using this product, read this manual and save for future reference.

©2014Invacare®Corporation
Allrightsreserved.Republication,duplicationormodificationinwholeorinpartisprohibitedwithout
priorwrittenpermissionfromInvacare.Trademarksareidentifiedby™and®.Alltrademarksare
ownedbyorlicensedtoInvacareCorporationoritssubsidiariesunlessotherwisenoted.

Contents
1General........................................4
1.1Generalinformation.............................4
1.2Symbolsinthisusermanual.......................4
1.3Warranty....................................4
1.4Intendeduse..................................5
1.5Servicelife....................................5
2Safety..........................................6
2.1Safetyinformation..............................6
2.2Symbolsontheproduct..........................7
3Components....................................8
3.1Productdescription.............................8
3.2Components..................................8
4Usage..........................................9
4.1Safetyinformation..............................9
5Transport......................................10
5.1Safetyinformation..............................10
6Maintenance....................................11
6.1Inspection....................................11
6.2Cleaningandcare..............................11
7AfterUse.......................................13
7.1Storage......................................13
7.2Re-Use......................................13
7.3Disposal.....................................13
8Technicaldata...................................14
8.1GeneralData..................................14
8.2Materials.....................................15
8.3EnvironmentalParameters........................15

Invacare®Softform®
1General
1.1Generalinformation
Essentialnursingcareispivotalinpressureulcerprevention.These
mattresseswillpositivelycontributetotheoutcomeofapressure
ulcerpreventioncareplan.
Education,clinicaljudgementandactionbasedplanningbasedon
vulnerabilityarefundamentalfactorsinthepreventionofpressure
ulcers.
Arangeofassessmentscalescanbeusedasaformalmethodof
assessingriskfrompressureulcerdevelopment,andshouldbe
usedinconjunctionwithaninformalassessment(informednursing
judgement).Informalassessmentisconsideredtobeofgreater
importanceandclinicalvalue.
Thisusermanualcontainsimportantinformationaboutthehandling
oftheproduct.Inordertoensuresafetywhenusingtheproduct,
readtheusermanualcarefullyandfollowthesafetyinstructions.
ForfurtherinformationcontactInvacare®inyourcountry(addresses
seebackpageofthisusermanual).
ToaccessvaluableinformationandusefullinksforPressureArea
Caretrainingandeducation,refertowww.thinkpressurecare.co.uk.
1.2Symbolsinthisusermanual
InthisUserManualwarningsareindicatedbysymbols.Thewarning
symbolsareaccompaniedbyaheadingthatindicatestheseverity
ofthedanger.
WARNING
Indicatesapotentiallyhazardoussituationwhich,if
notavoided,couldresultindeathorseriousinjury.
CAUTION
Indicatesapotentiallyhazardoussituationwhich,if
notavoided,mayresultinpropertydamageorminor
injuryorboth.
IMPORTANT
Indicatesahazardoussituationthatcouldresultin
damagetopropertyifitisnotavoided.
Givesusefultips,recommendationsandinformation
forefficient,trouble-freeuse.
Thisproductcomplieswiththedirective93/42/EEC
formedicalproducts.Thelaunchdateforthisproduct
isspecifiedintheCEdeclarationofconformity.
Manufacturer
1.3Warranty
Weprovideamanufacturer’swarrantyfortheproductinaccordance
withourGeneralTermsandConditionsofBusinessintherespective
countries.Guaranteeclaimscanonlybemadethroughtheprovider
fromwhomtheappliancewasobtained.
StandardInvacare®Terms
ThisistocertifythatyourInvacare®Softform®Mattressiswarranted
byInvacareLtdforaperiodstatedintheTable“TechnicalData”
ofthisuserguide.
4PALIN-010-B

General
TheWarrantyofyourInvacare®Softform®productisvalidfrom
timeofshipping.
IfadefectorfaultisdiscoveredtheInvacare®customerorLocal
BusinessDevelopmentManagerfromwhomtheappliancewas
obtainedmustbenotifiedimmediately.Themanufacturerwillnot
acceptresponsibilityfordamagecausedbymisuseornon-observance
oftheinstructionssetoutinthisuserguide.
Duringtheperiodofthewarranty,anyproductsthathave
becomedefectiveduetofaultyworkmanshipormaterialswillbe
renewedwithoutcharge.Thewarrantywillbeforfeitedshouldany
unauthorizedalterationbemadetotheequipment.Bothwarranty
andfireretardancyCertificationwillbecomenullandvoidif
non-Invacare®sparesareusedonanyInvacare®Mattressproducts.
Thepurchaser’sstatutoryrightsundertheConsumerProtection
Actarenotaffected.
Qualityandflameretardancy
Qualityisfundamentaltothecompany’soperation,workingwithin
thedisciplinesofISO9001andISO13485.
AllInvacare®Softform®MattressproductsfeaturetheCEmark,in
compliancewiththeMedicalDeviceDirective93/42/EECClass1.
Invacare®iscontinuouslyworkingtowardsensuringthatthe
company’simpactontheenvironment,locallyandglobally,isreduced
toaminimum.ItisInvacare’sgoaltoensurethatwe,atthewidest
possiblerange,useREACHcompliantmaterialsandcomponents.
ThefoamandcoverusedtomanufacturetheInvacare®Softform®
rangeofmattressesareindependentlytestedandcertifiedin
accordancewithEN597-1andEN597-2(Assessmentofthe
ignitabilityofmattressesandupholsteredbedbases-ignitionsource:
smoulderingcigarette(1)andmatchflameequivalent(2).
Allproductsintherangeareindividuallytestedasacompositein
accordancewithBS7177ignitionsources0,1andcrib5,bothtop
andbottomtestscomply.
ForfurtherinformationpleasecontactInvacare®inyourcountry
(addressesseebackpageofthismanual).
1.4Intendeduse
Thispressureredistributionmattressisintendedtobeusedin
conjunctionwithanappropriatelysizedbedframe,aspartofan
overallpressureulcerpreventionprogramofcare.
Anyotheruseisprohibited.
Thisproducthasbeendesignedtodelivereffectivepressure
reductiontousers,whentheproductisinnormalusewhichis
definedbyInvacareLtdaswhenthesupportsurfaceiscoveredwith
acotton,cottoncombinationorlinenbedsheet,andanyoneof
thesewouldbetheonlyitemdeployedbetweenthesupportsurface
andtheuser.
1.5Servicelife
Weestimatealifeexpectancyoffiveyearsfortheseproducts,
providedtheyareusedinstrictaccordancewiththeintended
useassetoutinthisdocumentandallmaintenanceandservice
requirementsaremet.Theestimatedlifeexpectancycanbe
exceedediftheproductiscarefullyusedandproperlymaintained,and
providedtechnicalandscientificadvancesdonotresultintechnical
limitations.Thelifeexpectancycanalsobeconsiderablyreduced
byextremeorincorrectusage.
Thefactthatweestimatealifeexpectancyfortheseproductsdoes
notconstituteanadditionalwarranty.
PALIN-010-B5

Invacare®Softform®
2Safety
2.1Safetyinformation
WARNING!
–Donotusethisproductoranyavailableoptional
equipmentwithoutfirstcompletelyreadingand
understandingtheseinstructionsandanyadditional
instructionalmaterialsuchasusermanuals,service
manualsorinstructionsheetssuppliedwiththis
productoroptionalequipment.Invacare®product
manualsareavailableatwww.invacare.co.ukoryour
localdealer.Ifyouareunabletounderstandthe
warnings,cautionsorinstructions,pleasecontacta
healthcareprofessional,dealerortechnicalpersonnel
beforeattemptingtousethisequipment–otherwise,
injuryordamagemayoccur.
WARNING!
Riskofdevelopingpressureulcers
Bedsheetsmustbelooselyfitted,withcreases
smoothedout.Caremustalwaysbetakentoensure
thatthesupportsurfaceincontactwiththeuseris
keptfreefromcrumbsandotherfooddebris,andthat
dripcables,stents,andotherforeignobjectsdonot
becomeentrappedbetweentheuserandthepressure
reducingsurfaceofthemattress,asthismayresultin
thedevelopmentofpressureulcers.
WARNING!
Invacare®productsarespecificallydesignedand
manufacturedforuseinconjunctionwithInvacare®
accessories.Accessoriesdesignedbyother
manufacturershavenotbeentestedbyInvacare®and
arenotrecommendedforusewithInvacare®products.
Theintroductionofcertainthirdpartyproductsbetween
themattresssurfaceandtheusermayreduceorimpede
theclinicaleffectivenessofthisproduct.
’Thirdpartyproducts’mayinclude,butarenotlimited
toitemsincludingunderblankets,plasticsheetsand
sheepskins,etc.Heatedoverblanketsmustonlybe
usedinconsultationwithasuitablyqualifiedhealthcare
professional,asanincreaseintemperaturecanincrease
theriskofdevelopingpressureulcers.
WARNING!
Riskoffireorexplosion!
Acigarettecanburnaholeinthebedsurfaceand
causedamagetothemattress.Also,patientclothing,
bedsheets,etc,maybecombustibleandcauseafire.
Failuretoobservethiswarningcanresultinasevere
fire,propertydamageandcausephysicalinjuryordeath.
Donotuseinoxygenrichenvironments(Asmall
electricalsparkinsidepumpmaycauseexplosion).
–Donotsmoke.
6PALIN-010-B

Safety
IMPORTANT!
Theinformationcontainedinthisdocumentissubject
tochangewithoutnotice.
–Checkallpartsforshippingdamageandtestbefore
using.
–Incaseofdamage,donotuse.
–ContactInvacare®/Carrierforfurtherinstructions.
2.2Symbolsontheproduct
Donotpierceor
cut
Linedry
Donotdryclean
CEconform
xxx kg
Userweightlimit*
80°
Recommended
80°C
Donotputnear
flame
Donotiron
Donotbleach Tumbledrylowheat
Dateofmanufacture Refertousermanual
*Maximumuserweightaspersection8Technicaldata,page14.
PALIN-010-B7

Invacare®Softform®
3Components
3.1Productdescription
TheInvacare®Softform®mattressoffersexceptionalpressure
reducingqualities,specifictotheindividualsneeds.Bypromoting
evenweightdistribution,theyreducetissuepressureatpotentially
vulnerableareas.
Thewater-resistantcoverprovidesavapour-permeable,multi
stretchsurface,topromotepatientcomfortandtomaximisethe
effectivenessofthefoamcore.
3.2Components
Thefollowingcomponentsareincludedwithinthescopeofdelivery*:
A
B
C
DE
AMulti-stretchwaterproofpolyurethanecover
BCastellatedfoaminsert
CSinglepiecefoam“U”core
DToughedpolyurethanecoatedbase
EUserManual
*ThisexampleisbasedontheSoftform®Premier,othermattress
configurationsmayvary.
8PALIN-010-B

Usage
4Usage
4.1Safetyinformation
1.Removeallpackagingbeforeuse.
2.Placethemattressdirectlyontheframeofthebed.
Themattressisdesignedforbedswithadjustablelyingsurface.
WARNING!
Itisveryimportantforthepatienttoreposition
themselves,ortoberepositioned,onaregularbasis.
Thismustbebasedontheclinicaljudgementofa
qualifiedhealthcareprofessional.Thisrelievespressure
whichhelpspreventbothtissuecompressionand
potentialulcerformation.
–Alwaysconsultaqualifiedhealthcareprofessional
beforeusingtheproduct.
–Monitorthepatientfrequently.
CAUTION!
–Makesurethattheprintedsideofthemattresscover
alwaysfacesupwards.
–Makesurethatthedistancebetweenthesurfaceofthe
mattressandthetopofthesiderailisatleast220mm.
IMPORTANT!
Ifholesarepresentinthemattresscover,thereisa
dangerthatliquidsmayingressandcontaminationmay
occur.
–Medicalequipmentincludinginfusionpumpsand
monitorsshouldbeattachedtoappropriatebed
accessories.
–Forhomeusecommoncausesofdamageinclude
cigaretteburnsandtheclawsofpetsthatpuncture
sheets,allowingfluidingressandstaining.
IMPORTANT!
Riskofdamagetothemattresscover
–Topreventaccidentaldamage,donotplace
hypodermicneedles,venflons,scalpelsorother
similarlysharpobjectsontothemattress.
–Ensurethatallvenflonsaretapeddowncorrectlywith
nosharpedgesexposed.
–Whenusingpatienttransferaids,careshouldbetaken
nottodamagethemattress.Alltransferaidsshould
becheckedforanysharpedgesorburrsbeforeuse
asthesecandamagethemattress.
–Makesurethatthemattressesarenotjammedor
damagedbysharpedgeswhenusedonbedswithan
adjustableframe.
–Whenusingthemattressonaprofilingbedensure
thatthekneebreakisusedbeforethebackrest.
PALIN-010-B9

Invacare®Softform®
5Transport
5.1Safetyinformation
IMPORTANT!
–Takecarewhenhandlingmattressestoensureno
damagetothecover.Itisrecommendedthattwo
peoplelife/carrymattresses.
–Avoidcontactwithjewellery,nails,abrasivesurfaces
etc.
–Donotdragmattresses.
–Avoidcontactwithwall,doorframes,doorcatches
orlocksetc.
–Donottransportinrollcagesunlesscompletely
protectedfromthesharpedgesofthecage.
1.Refertothestorageandshippingconditionsinsection8.3
EnvironmentalParameters,page15.
10PALIN-010-B

Maintenance
6Maintenance
6.1Inspection
Itisrecommendedthatthemattressischecked(foamandcover)for
strike-through(thismayincludefluidingress,stains,ripsordamage)
afterthereleaseofeachpatient,afterendingoftheperiodofuseor
onaminimummonthlybasis(dependingonwhichoccursfirst)bya
suitablyqualifiedandcompetentperson.
Checkmattress
1.Unzipthecovercompletely.
2.Checkforanystainingonthewhiteundersideofthecover.
3.Checkforanystainingontheinteriorfoam.
4.Replaceanystaineditemsanddisposeofasperlocalauthority
procedure.
6.2Cleaningandcare
IMPORTANT!
Allcleaningagentsanddisinfectantsusedmustbe
effective,compatiblewithoneanotherandmustprotect
thematerialstheyareusedtoclean.
–Forfurtherinformationondecontaminationinhealth
careenvironments,pleasereferto‘TheNational
InstituteforClinicalExcellence’guidelinesonInfection
Controlwww.nice.org.uk/CG139andyourlocal
infectioncontrolpolicy.
Cleaningcovers
(Removalofcontaminantssuchasdustandorganicmatter)
1.Removeallcoversforlaundering.
2.Launderthecoverswiththerecommendedtemperatureat
80°Cusingadiluteddetergentsolution(Instructionsonlabel).
IMPORTANT!
Washingathighertemperatureswillcauseshrinkage.
Dryingcovers
1.Hangmattresscoversfromalineorbaranddripdryinaclean
indoorenvironment.
or
Tumbledryonalowheatsetting.
IMPORTANT!
–Tumbledrysettingmustnotexceed40°C.
–Donottumbledryforlongerthan10minutes.
–Drythoroughlybeforere-fittingtothefoam.
Disinfectingcovers
(Reducingthenumberofmicroorganisms)
Pleasecontactyourhygienespecialistintheeventofcontamination.
IMPORTANT!
–Ensurethatanyresidualdetergenthasbeenremoved
priortodisinfection.
Lightsoilage
1.Wipedownthecoverwitha0.1%ChlorineSolution(1,000ppm).
2.Rinsethecoverwithcleanwaterusingasingleusenonabrasive
cloth.
3.Drythecoverthoroughly.
PALIN-010-B11

Invacare®Softform®
Heavysoilage
Wherethemattressisbadlysoiled,werecommendcleaningwitha
dilutecleaningsolutionat80°Cinthewashingmachine.
Largespillagesofbloodshouldbeabsorbedandremoved
withpapertowelsfirst,followedbyasabove.
1.Cleanupallspillagesofbodilyfluidsi.e.blood,urine,faeces,
sputum,woundexudaterandallotherbodilysecretionsassoon
aspossibleusinga1%ChlorineSolution(10,000ppm).
2.Rinsewithcleanwaterusingasingleusenonabrasivecloth.
3.Drythecoverthoroughly.
IMPORTANT!
Polyurethanecoatedfabricscanabsorbliquidsforshort
periodscausingatemporarychangetothepolyurethane
characteristics.Themattresscoverswellstemporarily
andismorevulnerabletophysicaldamageforaperiod
afteritiscompletelysurfacedried,bywhichtimeitwill
reverttoitspreviousstate.
IMPORTANT!
1%ChlorineSolutionusedonaregularbasiscandiminish
thelifeofthecoverifnotrinsedanddriedproperly.
–Donotusegranules.
WARNING!
–Removecontaminatedfoamsfromuse.
CAUTION!
–Keepclearofopenheatsources.
IMPORTANT!
–Donotusephenols,alcohols,bleaches,orother
abrasivematerials.
Replacingcovers
1.Unzipthecoverandremoveitcarefullyfromthefoamcore.
2.Placenewcoverontothefoamcore.
3.Thenclosethezipper.
IMPORTANT!
–Ensurethatthecornersofthefoamcoreare
positionedcorrectlyintothecornersofthecover.
–Ensurethattheprofiledsideofthefoamisfacing
uppermostwhenpackedintoitscover.
FortheSoftform®mattresses,anantimicrobialSoftform®Silver3™
coverisavailableasanoptionalextra.
12PALIN-010-B

AfterUse
7AfterUse
7.1Storage
Toeasestorageandhandlingthemattressesaresometimescompact
rolleddependingoncustomerrequirements.Thisinnowayaffects
theperformanceandlongevityoftheproduct.Whenthemattress
isunrolledforthefirsttime,allowittorecoverforaminimumof
1hourbeforeusetooptimizeperformance.
IMPORTANT!
–Storemattressesinadryenvironment.
–Storemattresseswithinaprotectivecover.
–Storeitemsonclean,dry,off-flooringfreefromsharp
edgestoavoidanypossibledamage.
–Neverstoreotheritemsontopofamattress.
–Donotstoremattressesnexttoradiatorsorother
heatingdevices.
–Protectmattressesfromdirectsunlight.
1.Refertothestorageandshippingconditionsinsection8.3
EnvironmentalParameters,page15.
7.2Re-Use
Acleaningrecordmustbekeptaspartofcleaningthesystem.
Theproductissuitableforrepeateduse.Thenumberoftimesitcan
beuseddependsonhowoftenandinwhichwaytheproductisused.
1.Beforereuse,cleantheproductthoroughly,
→6.2Cleaningandcare,page11.
7.3Disposal
Thedisposalandrecyclingofuseddevicesandpackagingmustcomply
withtheapplicablelocallegalregulations.
1.Ensurethatthemattressiscleanedpriortodisposaltoavoid
anyriskofcontamination.
PALIN-010-B13

Invacare®Softform®
8Technicaldata
8.1GeneralData
ProductWarranty1)FiretestingGraderef&
Colour
Nominal
density
range
[kg/m3]
Nominal
hardness
range[N]
Maximum
userweight
[kg]
Weight
of
product
[kg]2)
PREMIERCover:5years
Foam:10years
EN597-1,2
BS7177:Crib5
RX39/120Pink
RX39/200Blue
38–40
38–40
105–135
180–200247.614
MAXIGLIDECover:4years
Foam:8years
EN597-1,2
BS7177:Crib5
RX39/120Pink
RX39/200Baltic
Blue
38–40
38–40
105–135
180–200247.613.5
PREMIERVISCOCover:4years
Foam:4years
EN597-1,2
BS5852:Crib5
RX39/120Pink
RX39/200Blue
VC55085White
38–40
38–40
55
105–135
180–200
85
247.614
EXCELCover:2years
Foam:2years
EN597-1,2
BS7177:Crib5
RX39/120Pink
RX39/200Blue
38–40
38–40
105–135
180–20014010
PREMIER
ORIGINAL
Cover:4years
Foam:8years
EN597-1,2
BS7177:Crib5
RX39/120Orange
RX39/200Blue
38–40
38–40
135-165
180-200247.613
A&ETROLLEY
MATTRESS1yearEN597-1,2
BS5852:Crib5
RX39/120Beige
RX39/200Blue
35–37
38–40
110–140
180–200
108
(TM20/TM40)
140(TM60)
5.5
BIRTHING
MATTRESS
Cover:1years
Foam:4years
EN597-1,2
BS7177:Crib5RX39/200Blue38–40180–200247.615
NEWBORN1yearEN597-1,2C28/100White26–2986–110100.5
INCUBATORPAD1yearEN597-1,2C28/100White26–2986–110100.5
COTMATTRESS1yearEN597-1,2C28/100White26–2986–110102.7
14PALIN-010-B

Technicaldata
1)Warrantyisagainstmanufacturingdefects.
2)Basedontheweightofastandardsizemattress.Thiscanchangeifdifferentsizesareordered.
8.2Materials
Invacare®Softform®
FoamPolyurethaneCombustionModifiedHigh
ResilienceFoam
CoverPolyurethanetransfercoatingonweftknitted
fabric
Cover(A&E
Trolleymattress)
Polyurethanetransfercoatingonweftknitted
fabricwithenhancedelectricalconductivity
AllmattresscomponentsareLatex-free.
8.3EnvironmentalParameters
Operatingconditions
Ambienttemperature10-35°C
Relativehumidity30%-75%Non-Condensing
Atmosphericpressure70-106kPa
Storageandshippingconditions
Ambienttemperature-40-70°C
Relativehumidity10%-100%
Atmosphericpressure50-106kPa
PALIN-010-B15

Invacare®distributors
UnitedKingdom:
InvacareLimited
PencoedTechnologyPark,Pencoed
BridgendCF355A
Tel:[phone]
Fax:[phone]
[email protected]om
www.invacare.co.uk
InvacareUKOperationsLimited,
PencoedTechnologyPark,Pencoed,
BridgendCF35-5A–Wales–UnitedKingdom
SwitchboardTel:(44)(0)1656776200,Fax:[phone]
CustomerserviceTel:(44)(0)1656776222,Fax:[phone]
Email:[email protected]om
Web:www.invacare.co.uk
PALIN-010-B2014-09-09
*PALIN-010B*
MakingLife’sExperiencesPossible™