Invacare Softform Premier Active 2S User manual

Invacare® Soform® Premier
Acve 2S
en Mattresses
UserManual .................................. 3
de Matratzen
Gebrauchsanweisung . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
fr Matelas
Manuel d'ulisaon ............................. 49
it Materassi
Manuale d’uso ................................. 73
es Colchones
Manual del usuario ............................. 95
pt Colchões
Manual de ulização ............................117
nl Matrassen
Gebruiksaanwijzing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
da Madrasser
Brugsanvisning.................................161
no Madrasser
Bruksanvisning.................................183
sv Madrasser
Bruksanvisning................................. 205
This manual MUST be given to the user of the product.
BEFORE using this product, read this manual and save for future reference.

©2017Invacare®Corporation
Allrightsreserved.Republication,duplicationormodicationinwholeorinpartisprohibited
withoutpriorwrittenpermissionfromInvacare.Trademarksareidentiedby™and®.Alltrademarks
areownedbyorlicensedtoInvacareCorporationoritssubsidiariesunlessotherwisenoted.

Contents
ThismanualMUSTbegiventotheuseroftheproduct.
BEFOREusingthisproduct,readthismanualandsaveforfuture
reference.
1General.........................................4
1.1Generalinformation............................4
1.2Symbolsinthisusermanual......................4
1.3Warranty.....................................5
1.4Standardsandregulations........................5
1.5Intendeduse..................................5
1.6Servicelife...................................6
2Safety..........................................7
2.1Safetyinformation..............................7
2.2EMCinformation...............................8
2.3Symbolsontheproduct.........................8
3Components......................................9
3.1Productdescription.............................9
3.2Components..................................9
4Setup...........................................10
4.1Safetyinformation..............................10
4.2Installingthesystem............................11
5Usage..........................................12
5.1Safetyinformation..............................12
5.2CPRprocedure................................13
5.3Unitdisplay...................................14
6Transport........................................15
6.1Safetyinformation..............................15
6.2TransportMode...............................15
7Maintenance.....................................16
7.1Inspection(multipleuse).........................16
7.2Cleaningandcare..............................16
8AfterUse........................................19
8.1Storage......................................19
8.2Re-Use......................................19
8.3Disposal.....................................19
9Troubleshooting...................................20
9.1Identifyingandrepairingdefects...................20
10Technicaldata...................................22
10.1GeneralData.................................22
10.2Controlunit..................................23
10.3Materials....................................23
10.4EnvironmentalParameters.......................23
10.5Spareparts..................................23

Invacare®Softform®PremierActive2S
1General
1.1Generalinformation
Essentialnursingcareispivotalinpressureulcerprevention.
Thesemattresseswillpositivelycontributetotheoutcome
ofapressureulcerpreventioncareplan.
Education,clinicaljudgementandactionbasedplanning
basedonvulnerabilityarefundamentalfactorsinthe
preventionofpressureulcers.
Arangeofassessmentscalescanbeusedasaformalmethod
ofassessingriskfrompressureulcerdevelopment,and
shouldbeusedinconjunctionwithaninformalassessment
(informednursingjudgement).Informalassessmentis
consideredtobeofgreaterimportanceandclinicalvalue.
Thisusermanualcontainsimportantinformationaboutthe
handlingoftheproduct.Inordertoensuresafetywhen
usingtheproduct,readtheusermanualcarefullyandfollow
thesafetyinstructions.
ForfurtherinformationcontactInvacare®inyourcountry
(addressesseebackpageofthisusermanual).
Toaccessvaluableinformationandusefullinksfor
PressureAreaCaretrainingandeducation,referto
www.thinkpressurecare.co.uk.
1.2Symbolsinthisusermanual
InthisUserManualwarningsareindicatedbysymbols.
Thewarningsymbolsareaccompaniedbyaheadingthat
indicatestheseverityofthedanger.
WARNING
Indicatesapotentiallyhazardoussituation
whichifnotavoidedcouldresultindeathor
seriousinjury.
CAUTION
Indicatesapotentiallyhazardoussituation
whichifnotavoidedcouldresultinproduct
damage,minorinjuryorboth.
IMPORTANT
Indicatesahazardoussituationwhichifnot
avoidedcouldresultindamagetotheproduct.
Givesusefultips,recommendationsand
informationforefcient,trouble-freeuse.
Thisproductcomplieswiththedirective
93/42/EECformedicalproducts.Thelaunch
dateforthisproductisspeciedintheCE
declarationofconformity.
Manufacturer
41627426-A

General
1.3Warranty
Weprovideamanufacturer’swarrantyfortheproduct
inaccordancewithourGeneralTermsandConditionsof
Businessintherespectivecountries.Guaranteeclaims
canonlybemadethroughtheproviderfromwhomthe
appliancewasobtained.
StandardInvacare®Terms
ThisistocertifythatyourInvacare®Softform®Mattressis
warrantedbyInvacareLtdforaperiodstatedintheTable
“TechnicalData”ofthisuserguide.TheWarrantyofyour
Invacare®Softform®productisvalidfromtimeofshipping.
IfadefectorfaultisdiscoveredtheInvacare®customer
orLocalBusinessDevelopmentManagerfromwhomthe
appliancewasobtainedmustbenotiedimmediately.The
manufacturerwillnotacceptresponsibilityfordamage
causedbymisuseornon-observanceoftheinstructionsset
outinthisuserguide.Duringtheperiodofthewarranty,
anyproductsthathavebecomedefectiveduetofaulty
workmanshipormaterialswillberenewedwithoutcharge.
Thewarrantywillbeforfeitedshouldanyunauthorized
alterationbemadetotheequipment.Bothwarrantyand
reretardancyCerticationwillbecomenullandvoidif
non-Invacare®sparesareusedonanyInvacare®Mattress
products.Thepurchaser’sstatutoryrightsunderthe
ConsumerProtectionActarenotaffected.
1.4Standardsandregulations
Qualityisfundamentaltothecompany’soperation,working
withinthedisciplinesofISO9001andISO13485.
AllInvacare®Softform®MattressproductsfeaturetheCE
mark,incompliancewiththeMedicalDeviceDirective
93/42/EECClassI.
Invacare®iscontinuouslyworkingtowardsensuringthatthe
company’simpactontheenvironment,locallyandglobally,
isreducedtoaminimum.
•Wecomplywiththecurrentenvironmentallegislation
(e.g.WEEEandRoHSdirectives).
•WeonlyuseREACHcompliantmaterialsand
components.
ThefoamandcoverusedtomanufacturetheInvacare®
Softform®rangeofmattressesareindependentlytested
andcertiedinaccordancewithEN597-1,EN597-2and
BS7177Crib5.
ThecontrolunitistestedtoECDirective2004/108/EECand
EN55011.ManufacturedtocomplywithEN60601-1.
ForfurtherinformationpleasecontactInvacare®inyour
country(addressesseebackpageofthismanual).
1.5Intendeduse
Thispressureredistributionmattressandcontrolunitare
intendedtobeusedinconjunctionwithanappropriately
sizedbedframe,aspartofanoverallpressureulcer
preventionprogramofcare.
Itcanbeusedsafelyinstaticmode(deated)forstatic
pressureredistribution,orindynamicmode(inated)should
analternatingpressuresupportsurfaceberequired.*
1627426-A5

Invacare®Softform®PremierActive2S
Anyotheruseisprohibited.
Thisproducthasbeendesignedtodelivereffectivepressure
reductiontousers,whentheproductisinnormalusewhich
isdenedbyInvacareLtdaswhenthesupportsurface
iscoveredwithacotton,cottoncombinationorlinen
bedsheet,andanyoneofthesewouldbetheonlyitem
deployedbetweenthesupportsurfaceandtheuser.
*Operatoractionisrequiredtochangesettingsonly.
1.6Servicelife
Weestimatealifeexpectancyofveyearsforthese
products,providedtheyareusedinstrictaccordance
withtheintendeduseassetoutinthisdocumentand
allmaintenanceandservicerequirementsaremet.The
estimatedlifeexpectancycanbeexceedediftheproduct
iscarefullyusedandproperlymaintained,andprovided
technicalandscienticadvancesdonotresultintechnical
limitations.Thelifeexpectancycanalsobeconsiderably
reducedbyextremeorincorrectusage.
Thefactthatweestimatealifeexpectancyforthese
productsdoesnotconstituteanadditionalwarranty.
61627426-A

Safety
2Safety
2.1Safetyinformation
WARNING!
–Donotusethisproductoranyavailable
optionalequipmentwithoutrstcompletely
readingandunderstandingtheusermanual
supplied.Invacare®productmanualsare
availableonyourlocalInvacarewebsite
oratyourlocaldealer.Ifyouareunable
tounderstandthewarnings,cautionsor
instructionspleasecontactahealthcare
professional,dealerortechnicalpersonnel
beforeattemptingtousethisequipment–
otherwise,injuryordamagemayoccur.
WARNING!
Riskofdevelopingpressureulcers
Bedsheetsmustbelooselytted,withcreases
smoothedout.Caremustalwaysbetakento
ensurethatthesupportsurfaceincontactwith
theuseriskeptfreefromcrumbsandother
fooddebris,andthatdripcables,stents,and
otherforeignobjectsdonotbecomeentrapped
betweentheuserandthepressurereducing
surfaceofthemattress,asthismayresultinthe
developmentofpressureulcers.
WARNING!
Invacare®productsarespecicallydesigned
andmanufacturedforuseinconjunctionwith
Invacare®accessories.Accessoriesdesignedby
othermanufacturershavenotbeentestedby
Invacare®andarenotrecommendedforusewith
Invacare®products.
Theintroductionofcertainthirdpartyproducts
betweenthecushionsurfaceandtheusermay
reduceorimpedetheclinicaleffectivenessofthis
product.
’Thirdpartyproducts’mayinclude,butare
notlimitedtoitemsincludingunderblankets,
plasticsheetsandsheepskins,etc.Heatedover
blanketsmustonlybeusedinconsultationwitha
suitablyqualiedhealthcareprofessional,asan
increaseintemperaturecanincreasetheriskof
developingpressureulcers.
WARNING!
Riskofreorexplosion!
Acigarettecanburnaholeinthebedsurface
andcausedamagetothemattress.Also,patient
clothing,bedsheets,etc,maybecombustible
andcauseare.Failuretoobservethiswarning
canresultinaseverere,propertydamageand
causephysicalinjuryordeath.
Donotuseinoxygenrichenvironments(Asmall
electricalsparkinsidepumpmaycauseexplosion).
–Donotsmoke.
1627426-A7

Invacare®Softform®PremierActive2S
IMPORTANT!
Theinformationcontainedinthisdocumentis
subjecttochangewithoutnotice.
–Checkallpartsforshippingdamageandtest
beforeusing.
–Incaseofdamage,donotuse.
–ContactInvacare®/Carrierforfurther
instructions.
2.2EMCinformation
ThereisnoknownriskofadverseeffectsontheActive
2Scontrolunitcausedbyotherelectromagneticdevices,
presentatthetimeoftreatment.Similarlythereisno
knownriskoftheActive2Scontrolunitcausingadverse
effectsonotherelectromagneticdevices.
2.3Symbolsontheproduct
Donotpierceor
cut
Linedry
DonotdrycleanCEconform
247.6 kg
Userweightlimit
80°
Recommended
80°C
Donotputnear
ame
Donotiron
DonotbleachTumbledrylow
heat
ClassIImedical
equipment
Refertouser
manual
TypeBFapplied
part
Dateof
manufacture
WEEEconformKeepdry
81627426-A

Components
3Components
3.1Productdescription
TheSoftform®PremierActive2Smattresssystemactsasa
staticpressurereducingsupport/mattressforpatientsat
highriskthatcan,byfacilitatingtheairpump,introduce
effectivealternatingpressureifthepatientscondition
requiresalternatingpressuretherapy.
Thewater-resistantcoverprovidesavapor-permeable,multi
stretchsurface,topromotepatientcomfortandtomaximise
theeffectivenessofthefoamcore.
Themattressistheonlypartintendedtocomeinto
physicalcontactwiththepatient(theonlyappliedpartwith
temperatureofmaximum41.1°C)
3.2Components
Thefollowingcomponentsareincludedwithinthescope
ofdelivery:
AU-shape,non-castellatedbaselayer
BAlternatingaircellinsert
CCastellatedinsert
DMicro-processorcontrolledcontrolunit
ETwinairconnectorhose
FMulti-stretchvapour-permeablecover
GToughedPUcoatedbase
HUserManual
*Powerleadsuppliednotshown.
1627426-A9

Invacare®Softform®PremierActive2S
4Setup
4.1Safetyinformation
WARNING!
Electricalshockhazard!
–Donotremovecontrolunitcover.
–Refertoqualiedservicepersonnel.
–Beforeperforminganymaintenancetothe
controlunit,disconnectthepowerleadfrom
thewalloutlet.
–Donotinsertitemsintoanyopeningsofthe
controlunit.Doingsomaycausereorelectric
shockbyshortingtheinternalcomponents.
–Thecontrolunitmustbekeptawayfromall
heatsourcesandradiatorsduringoperation.
–Connecttheequipmenttoatwoorthree
prongwalloutletusingthevemeterpower
leadprovidedwiththeproduct.
–Positionthedeviceensuringthataccesstothe
connectionsonthedevicearenotobscured
andhaseaseofaccess.
WARNING!
Ifthisequipmentismodied,appropriate
inspectionandtestingmustbeconductedto
ensurecontinuedsafeuseoftheequipment.
–Donotmodifythisequipmentwithout
authorizationofthemanufacturer.
WARNING!
Riskofentrapment!
Patiententrapmentwiththebedsiderails
maycauseinjuryordeath.Athoroughpatient
assessmentshouldbecompletedandmonitored
andtheequipmentshouldbeusedasspecied
andmaintainedtoreducetheriskofentrapment.
Variationsinbedraildimensions,andmattress
thickness,sizeanddensitycouldincreasetherisk
ofentrapment.
–Mattressmusttbedframeandsiderailsto
preventpatiententrapment.Followthebed
manufacturer’sinstructions.
–Afteranyadjustments,repairorserviceand
beforeuse,makesureallattachinghardware
istightenedsecurely.Railswithdimensions
differentfromtheoriginalequipmentsupplied
orspeciedbythebedmanufacturermay
notbeinterchangeableandmayresultin
entrapmentorotherinjury.
101627426-A