Invacare Softform Premier Active 2 User manual

Invacare®
SoftformPremierActive2
withRXpump
enHybridmattress
UserManual
ThismanualMUSTbegiventotheuseroftheproduct.
BEFOREusingthisproduct,thismanualMUSTbereadandsavedfor
futurereference.

©2020InvacareCorporation
Allrightsreserved.Republication,duplicationormodicationinwholeorinpartisprohibited
withoutpriorwrittenpermissionfromInvacare.Trademarksareidentiedby™and®.Alltrademarks
areownedbyorlicensedtoInvacareCorporationoritssubsidiariesunlessotherwisenoted.
MakingLife'sExperiencesPossibleisaregisteredtrademarkintheU.S.A.

Contents
1General.........................................4
1.1Introduction..................................4
1.2SymbolsinthisDocument........................4
1.3WarrantyInformation...........................4
1.4LimitationofLiability............................5
1.5ServiceLife...................................5
2Safety..........................................6
2.1SafetyInformation..............................6
2.2EMCinformation...............................7
2.3SafetyInformationforTransport...................7
3ProductOverview.................................8
3.1ProductDescription.............................8
3.2IntendedUse.................................8
3.2.1Indications.................................8
3.2.2Contraindications............................8
3.3Components..................................8
3.4LabelsontheProduct...........................9
3.5SymbolsontheProduct.........................10
4Setup...........................................11
4.1Safetyinformation..............................11
4.2Installingthesystem............................12
5Usage..........................................13
5.1SafetyInformation..............................13
5.2Controlunitmenudisplay........................14
5.3CPRprocedure................................15
5.4TransportMode...............................16
6Maintenance.....................................17
6.1Inspection....................................17
6.2CleaningandDisinfection........................17
6.2.1GeneralSafetyInformation.....................17
6.2.2CleaningIntervals............................18
6.2.3CleaningInstructions.........................18
6.2.4DisinfectionInstructions.......................19
6.3ReplacingCover...............................19
7AfterUse........................................21
7.1Storage......................................21
7.2Reconditioning................................21
7.3Disposal.....................................21
8Troubleshooting...................................22
8.1Identifyingandrepairingdefects...................22
9TechnicalData....................................24
9.1MattressSpecications..........................24
9.2ControlUnitSpecications........................24
9.3Materials....................................25
9.4EnvironmentalConditions........................25
9.5Guidanceandmanufacturer’sdeclaration.............26

Invacare®SoftformPremierActive2withRXpump
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,forexample
productsafetynoticesandproductrecalls,contactyour
Invacaredistributor .Seeaddressesattheendofthis
document.
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.
1.3WarrantyInformation
Weprovideamanufacturer’swarrantyfortheproduct
inaccordancewithourGeneralTermsandConditionsof
Businessintherespectivecountries.
Warrantyclaimscanonlybemadethroughtheprovider
fromwhomtheproductwasobtained.
41632862-A

General
1.4LimitationofLiability
Invacareacceptsnoliabilityfordamagearisingfrom:
•Non-compliancewiththeusermanual
•Incorrectuse
•Naturalwearandtear
•Incorrectassemblyorset-upbythepurchaserora
thirdparty
•Technicalmodications
•Unauthorisedmodicationsand/oruseofunsuitable
spareparts
1.5ServiceLife
Theexpectedservicelifeofthisproductisveyearswhen
useddailyandinaccordancewiththesafetyinstructions,
maintenanceintervalsandcorrectuse,statedinthismanual.
Theeffectiveservicelifecanvaryaccordingtofrequency
andintensityofuse.
1632862-A5

Invacare®SoftformPremierActive2withRXpump
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
Themattressdeliverseffectivepressurereduction,
whenthesupportsurfaceiscoveredwitha
cotton,cottoncombinationorlinenbedsheet,
andanyoneoftheseistheonlyitemdeployed
betweenthesupportsurfaceandtheuser.
–Bedsheetsmustbelooselytted,withcreases
smoothedout.
–Ensurethatthesupportsurfaceincontactwith
theuseriskeptfreefromcrumbsandother
fooddebris,andthatdripcables,stents,and
otherforeignobjectsdonotbecomeentrapped
betweenthesupportsurfaceandtheuser.
–Heatedoverblanketsmustonlybeused
inconsultationwithaqualiedhealthcare
professional,asanincreaseintemperature
canincreasetheriskofdevelopingpressure
injuries.
WARNING!
Riskofreorexplosion!
Acigarettecanburnaholeinthebedsurface
andcausedamagetothemattress.Also,patient
clothing,bedsheets,etc.maybecombustible
andcauseare.Failuretoobservethiswarning
canresultinaseverere,propertydamageand
causephysicalinjuryordeath.
–Takespecialcareinoxygenrichenvironments.
–Donotsmoke.
61632862-A

Safety
CAUTION!
RiskofInjury
Non-originalorwrongpartsmayaffectthe
functionandsafetyoftheproduct.
–Onlyuseoriginalpartsfortheproductinuse.
–Duetoregionaldifferences,refertoyour
localInvacarecatalogorwebsiteforavailable
optionsorcontactyourInvacaredistributor .
Seeaddressesattheendofthisdocument.
2.2EMCinformation
ThisproductneedsspecialprecautionsregardingEMCand
needstobeinstalledandputintoserviceaccordingtothe
EMCinformationprovided,andthisunitcanbeaffectedby
portableandmobileRFcommunicationsequipment.
CAUTION!
–Donotuseamobilephoneorotherdevices
thatemitelectromagneticelds,neartheunit.
Thismayresultinincorrectoperationofthe
unit.
–Thisdeviceshouldnotbeusedadjacentto
orstackedwithotherequipmentandthatif
adjacentorstackeduseisnecessary,thisdevice
shouldbeobservedtoverifynormaloperation
inthecongurationinwhichitwillbeused.
2.3SafetyInformationforTransport
•Takecarewhenhandlingmattressestoensureno
damagetothecover.
•Itisrecommendedthattwopeoplelift/carrymattresses.
•Avoidcontactwithjewellery,nails,abrasivesurfacesetc.
•Donotdragmattresses.
•Avoidcontactwithwall,doorframes,doorcatchesor
locksetc.
•Donottransportinrollcagesunlesscompletely
protectedfromthesharpedgesofthecage.
1632862-A7

Invacare®SoftformPremierActive2withRXpump
3ProductOverview
3.1ProductDescription
Themattresssystemactsasastaticpressurereducing
support/mattressforpatientsatHigh/VeryHighriskthatcan,
byfacilitatingtheairpump,introduceeffectivealternating
pressureifthepatientsconditionrequiresalternating
pressuretherapy.
Thewater-resistantcoverprovidesavapor-permeable,multi
stretchsurface,topromotepatientcomfortandtomaximise
theeffectivenessofthefoamcore.
Themattressistheonlypartintendedtocomeinto
physicalcontactwiththepatient(theonlyappliedpartwith
temperatureofmaximum106°F).
3.2IntendedUse
Thispressureredistributionmattressandcontrolunitare
intendedtobeusedinconjunctionwithanappropriately
sizedbedframe.
Themattresscanbeusedsafelyinstaticmodeforstatic
pressureredistribution,orindynamicmodeshouldan
alternatingpressuresupportsurfaceberequired.
Thisproductdeliverseffectivepressureredistributionto
users,whenthesupportsurfaceiscoveredwithacotton,
cottoncombinationorlinenbedsheet,andanyoneofthese
istheonlyitemdeployedbetweenthesupportsurfaceand
theuser.
3.2.1Indications
Suitableforsupportingthemanagementofallcategories
ofpressureinjurieswhencombinedwithanindividualand
comprehensivepressureinjuryprotocol.
Suitableforuseinhomecare,residential,nursingandacute
caresettings.
3.2.2Contraindications
Notsuitableforuserswithunstablespinalcordfractures
and/orcervicaltraction.
Alwaysconsultaphysicianpriortousingthisdevice.
3.3Components
Thefollowingcomponentsareincludedwithinthescope
ofdelivery:
81632862-A

ProductOverview
AU-shape,non-castellatedbaselayer
BAlternatingaircellinsert
CCastellatedinsert
DMicro-processorcontrolledcontrolunit
ECPRconnector
FMulti-stretchvapour-permeablecover
GToughenedPUcoatedbase
HUserManual
*Powerleadsuppliednotshown.
3.4LabelsontheProduct
Theshownlabelservesasexamplesonly.Thelabelsonyour
productmightdifferfromtheseexamples.
ControlUnit
Fig.3-1
AProductnameandModelversion
BInputVoltage,FrequencyrangeandInput
Current
CSerialnumber
DDateofmanufacture
ECountryoforigin
Mattress/Cover
Sincetheidenticationlabelsonthemattressandcovermay
changedependingonusedmodelanddateofmanufacture,
1632862-A9

Invacare®SoftformPremierActive2withRXpump
thelabelsforthesecomponentsarenotshownhere.For
explanationsofthesymbolswhichareprintedonthe
mattressandthecover,seesection3.5Symbolsonthe
Product,page10inthisdocument.
3.5SymbolsontheProduct
ReadusermanualMedicalDevice
ManufacturerDateof
manufacture
SerialnumberLOTnumber
TypeBFapplied
partCaution
WEEEconform
Userweightlimit.
See9Technical
Data,page24.
Donotpierceor
cut
Donotputnear
ame
Machinewash
temperature.
Max.
temperatureis
showninsymbol.
Donotiron
DonotdrycleanDonotbleach
Tumbledrylow
temperatureCPRlabel
ULCertication
number
101632862-A