Invacare Softform Active 2 RX User manual

Invacare®SoftformActive®2with
RXpump
enMattresssystem
UserManual
ThismanualMUSTbegiventotheuseroftheproduct.
BEFOREusingthisproduct,thismanualMUSTbereadandsaved
forfuturereference.

©2020InvacareCorporation
Allrightsreserved.Republication,duplicationormodicationinwholeorinpartisprohibitedwithoutpriorwritten
permissionfromInvacare.Trademarksareidentiedby™and®.AlltrademarksareownedbyorlicensedtoInvacare
Corporationoritssubsidiariesunlessotherwisenoted.
MakingLife'sExperiencesPossibleisaregisteredtrademarkintheU.S.A.

Contents
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
2.2EMCinformation...............................5
2.3SafetyInformationforTransport...................5
3ProductOverview.................................6
3.1Productdescription.............................6
3.2IntendedUse.................................6
3.2.1Indications.................................6
3.2.2Contraindications............................6
3.3Components..................................6
3.4LabelsontheProduct...........................6
3.5Symbolsontheproduct.........................7
4Setup...........................................8
4.1Safetyinformation..............................8
4.2Installingthesystem............................8
5Usage..........................................9
5.1SafetyInformation..............................9
5.2Controlunitmenudisplay........................10
5.3CPRprocedure................................10
5.4TransportMode...............................11
6Maintenance.....................................12
6.1Inspection....................................12
6.2CleaningandDisinfection........................12
6.2.1GeneralSafetyInformation.....................12
6.2.2CleaningIntervals............................12
6.2.3CleaningInstructions.........................12
6.2.4DisinfectionInstructions.......................13
6.3ReplacingCover...............................13
7AfterUse........................................14
7.1Storage......................................14
7.2Reconditioning................................14
7.3Disposal.....................................14
8Troubleshooting...................................15
8.1Identifyingandrepairingdefects...................15
9TechnicalData....................................16
9.1MattressSpecications..........................16
9.2Controlunit..................................17
9.3Materials....................................17
9.4EnvironmentalConditions........................17
9.5Guidanceandmanufacturer’sdeclaration.............17

Invacare®SoftformActive®2withRXpump
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.
41627707-D

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
Themattressdeliverseffectivepressurereduction,
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
andcausedamagetothemattress.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.
2.2EMCinformation
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.
1627707-D5

Invacare®SoftformActive®2withRXpump
3ProductOverview
3.1Productdescription
TheInvacare®SoftformActive®2Rxmattresssystemacts
asastaticpressurereducingsupport/mattressforpatients
atHigh/VeryHighriskthatcan,byfacilitatingtheairpump,
introduceeffectivealternatingpressureifthepatients
conditionrequiresalternatingpressuretherapy.
Thewater-resistantcoverprovidesavapor-permeable,multi
stretchsurface,topromotepatientcomfortandtomaximise
theeffectivenessofthefoamcore.
Themattressistheonlypartintendedtocomeinto
physicalcontactwiththepatient(theonlyappliedpartwith
temperatureofmaximum41.1°C)
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:
AU-shape,non-castellatedbaselayer
BAlternatingaircellinsert
CCastellatedinsert
DMicro-processorcontrolledcontrolunit
ECPRconnector
FMulti-stretchvapour-permeablecover
GToughenedPUcoatedbase
HUserManual
*Powerleadsuppliednotshown.
3.4LabelsontheProduct
Theshownlabelsservesasexamplesonly.Thelabelson
yourproductmightdifferslightlyfromthem.
ControlUnit
Fig.3-1
AProductnameandModelversion
BInputVoltageandFrequencyrange
CMax.InputCurrent
DIP-rating
EFusetype
FSerialnumber
GDateofmanufacture
HCountryoforigin
IManufactureraddress
JAddressofEuropeanrepresentative
Mattress/Cover
Sincetheidenticationlabelsonthemattressandcovermay
changedependingonusedmodelanddateofmanufacture,
thelabelsforthesecomponentsarenotshown.For
explanationsofthesymbols,whichareprintedonthe
mattressandcover,refertosection3.5Symbolsonthe
product,page7inthisdocument.
61627707-D

ProductOverview
3.5Symbolsontheproduct
European
ConformityReadusermanual
MedicalDeviceCaution
ManufacturerEuropean
representative
SerialnumberDateof
manufacture
LOTnumberPartnumber
Donotdisposein
normalhousehold
waste
Userweightlimit.
See9Technical
Data,page16.
TypeBFapplied
partClassIIequipment
Donotpierceor
cut
Donotputnear
ame
Machinewash
temperature.
Max.
temperatureis
showninsymbol.
Handwash
DonotdrycleanDonotbleach
LinedryTumbledrylow
temperature
DonotironCPRlabel
1627707-D7

Invacare®SoftformActive®2withRXpump
4Setup
4.1Safetyinformation
WARNING!
Electricalshockhazard!
–Donotremovecontrolunitshroud.
–Refertoqualiedservicepersonnel.
–Beforeperforminganymaintenancetothe
controlunit,disconnectthepowerleadfrom
thewalloutlet.
–Donotinsertitemsintoanyopeningsofthe
controlunit.Doingsomaycausereorelectric
shockbyshortingtheinternalcomponents.
–Thecontrolunitmustbekeptawayfromall
heatsourcesandradiatorsduringoperation.
–Connecttheequipmenttoatwoorthreeprong
walloutletusingthevemeterpowerlead
providedwiththeproduct.
–Positionthedeviceinsuchawaythatensures
accesstothepowerswitchandCPRConnector
atalltimes.
WARNING!
Ifthisequipmentismodied,appropriate
inspectionandtestingmustbeconductedto
ensurecontinuedsafeuseoftheequipment.
–Donotmodifythisequipmentwithout
authorizationofthemanufacturer.
WARNING!
Riskofentrapment!
Patiententrapmentwiththebedsiderails
maycauseinjuryordeath.Athoroughpatient
assessmentshouldbecompletedandmonitored
andtheequipmentshouldbeusedasspecied
andmaintainedtoreducetheriskofentrapment.
Variationsinbedsideraildimensions,and
mattressthickness,sizeanddensitycouldincrease
theriskofentrapment.
–Mattressmusttbedframeandsiderailsto
preventpatiententrapment.Followthebed
manufacturer’sinstructions.
–Afteranyadjustments,repairorserviceand
beforeuse,makesureallattachinghardwareis
tightenedsecurely.Siderailswithdimensions
differentfromtheoriginalequipmentsupplied
orspeciedbythebedmanufacturermay
notbeinterchangeableandmayresultin
entrapmentorotherinjury.
WARNING!
Thismattressisrecommendedtobeinstalledon
medicalbedframeswithbedsiderailsorassist
rails.Itispreferredthattherailstobeinthe
raisedpositionwheneverthepatientisonthe
bed.Healthcareprofessionalsassignedtoeach
caseshouldmakethenaldecisionastowhether
sideassistrailsarewarrantedafterassessing
patientriskofentrapment.
Controlsonthefootboardmaybeobstructedby
thecontrolunitonafewbedframes.Itmaybe
necessarytorelocatethecontrolunit.
–Beforeplacingthepatientonthebed,check
thatairhosesandpowercordareclearof
movingbedcomponents.
–Operateallbedframemotorizedfunctions
throughtheirfullrangeofmotiontobecertain
thatthereisnopulling,interferenceorpinching.
–Takecarewhenpositioninghosesandcables
toeliminatetheriskoftrippinghazardsor
strangulation.
4.2Installingthesystem
A
C
D
B
1.Hangthecontrolunitbymeansofthe2builtinhangers
Aattheendofthebedorplaceitonahorizontal
surface.(Placingthecontrolunitontheoorwillnot
affecttheperformance,butmayexposeittoaccidental
damage.)
E
B
2.ConnecttheCPRhoseEtoairoutletsonthemattress
andcontrolunitB,ensuringthatthehoseisnotkinked
ortwisted.Allowspaceforbedrailstodropfreely.
3.Connectthemainspowercabletothepowersupply
socketCofthecontrolunitandasuitableoutlet.
4.Switchonmainspoweroftheoutletifpresent.
5.MovethemechanicalswitchDontheleftsideofthe
ControlunittotheOnposition.Afaintsinglebeep
soundsandthesystemincyclelightasheswhilethe
systempowersup.
Referto8Troubleshooting,page15iftheindicatorisnot
ashing.
81627707-D

Usage
5Usage
5.1SafetyInformation
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 .
1627707-D9

Invacare®SoftformActive®2withRXpump
5.2Controlunitmenudisplay
Overview
E D C B A
Pos.DescriptionFunction
AMutebuttonTherelevantaudible/visibleindicatorturnsonwhenlowpressure,
powerfailureoralternatefailureisrecognised.Tomutetheaudible
signal,presstheMutebutton.Thevisibleindicatorwillashuntilthe
problemissolved.Iftheproblemindicatedhasnotbeensolvedwithin
10minutes,theindicatorwillsoundagain.PresstheMutebuttonto
mutetheaudibleindication,theindicatorwillnotsoundagain.Referto
chapter8Troubleshooting,page15.
BSystemincycle/Setupindicator
(OperativeLED)
GreenLEDindicatorasheswhilstsystemissettingup–SolidgreenLED
indicatesnormaloperational.
CAlternatingsystem/Timingfailure
indicator
RedLEDindicatorashesandaudiblebuzzersoundsifthesystem
recognisesacycletimeproblem.
DPowerfailureindicatorRedLEDindicatorashesandaudiblebuzzersoundsifthesystemhas
nopowerconnected.Thiscouldbeintheeventofapowerfailure,for
examplecausedbypowercordunpluggedorpoweroffwhencontrol
unitisworking.Whenpowerisrestored,controlunitwillautomatically
startworking.
EPressurefailure/Lowpressure
indicator
RedLEDindicatorashesandaudiblebuzzersoundsifthesystem
recognisesalowpressurefailure.
Operation
1.Thepowerindicatorwillashandcontrolunitwillenterstaticmodeinitiallyuntilpressurereaches15mmHg.Thencontrol
unitwillenteralternatemodeandpowerindicatorwillremainon.Thecycletimeissetat10min,andthepressureis
setat60±3mmHg.
Therstinationofnewmattress:theindicatorfunction(visibleandaudibleindicators)willactivateifthemattress
doesnotinatecompletelywithin15minutes.
Operationfailures
•Duringcontrolunitoperation,lowpressureindicatorwillactivatewithin1minutesifairhosesaredisconnectedor
aircellsarebroken.
•Inthecaseofabnormalalternateornoalternate,theaudiblesignalwillbeactivatedandalternatefailureindicator
willash.
5.3CPRprocedure
TheInvacare®SoftformActive®2Rxmattresshasbeenfully
testedtocomplywiththecurrentCPRstandardof5-6
cmcompressiondepth.Thiswasachievedatallstagesof
ination/deation.
A
B
1.HolddownRedCPRbuttonA.
2.PullhoseconnectorrmlyawayfromthecontrolunitB.
3.Switchoffthecontrolunit.
101627707-D

Usage
Mattresswillstarttodeate.Thedeationtimeis
20seconds.
4.WhenCPRiscompletereactivatethesystemfollowing
section4.2Installingthesystem,page8.
5.4TransportMode
Ifitisnecessarytomovethebedormattresssimply:
1.Turnoffpowersupply.
2.Disconnectcontrolunitpowerlead(ifnecessarytheair
hose).
3.Whensystemisreadytoreactivatefollowingsection4.2
Installingthesystem,page8.
Airsupplyhoseshouldbestoredbyattachingtothefastener
atfootofthemattress.
ForActiveCaremattress,theairhoseislocatedinsidethe
mattress.ToaccessthehoseUnzipthemattresstakeout
hoseandconnecttothecontrolunit,ensurethatzipis
closedonceconnectionismade.
1627707-D11

Invacare®SoftformActive®2withRXpump
6Maintenance
6.1Inspection
Itisrecommendedtocheckmattresses(aircellsandcover)
forstrike-through(thismayincludeuidingress,stains,rips
ordamage)afterthereleaseofeachpatientoraftereach
periodofusebyasuitablyqualiedandcompetentperson.
Checkmattresses
1.Unzipthecovercompletely.
2.Checkforanystainingonthewhiteundersideofthe
cover .
3.Checkforanystainingontheinterioraircells.
4.Replaceanystaineditemsanddisposeofasperlocal
authorityprocedure.
6.2CleaningandDisinfection
6.2.1GeneralSafetyInformation
CAUTION!
RiskofContamination
–Takeprecautionsforyourselfanduse
appropriateprotectiveequipment.
CAUTION!
Riskofelectricshockandproductdamage
–Switchoffthedeviceanddisconnectfrom
mains,ifapplicable.
–Whencleaningelectroniccomponentsconsider
theirprotectionclassregardingwateringress.
–Makesurethatnowatersplashestotheplug
orthewalloutlet.
–Donottouchthepowersocketwithwethands.
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.
6.2.2CleaningIntervals
IMPORTANT!
Regularcleaninganddisinfectionenhances
smoothoperation,increasestheservicelifeand
preventscontamination.
Cleananddisinfecttheproduct
–regularlywhileitisinuse,
–beforeandafteranyserviceprocedure,
–whenithasbeenincontactwithanybody
uids,
–beforeusingitforanewuser.
IMPORTANT!
–Keepacleaningrecordaspartofcleaningthe
system.
6.2.3CleaningInstructions
IMPORTANT!
–Theproductdoesnottoleratecleaningin
automaticwashingplants,withhigh-pressure
cleaningequipmentorsteam.
Acleaningrecordshouldbekeptaspartofcleaning
thesystem.
Cleaningcontrolunit
1.Wipedownthecontrolunitcasingandhosettingswith
adampclothandsuitabledetergent.
2.Usinganylonbrush,gentlycleanallcrevicesasthey
canharbormicroorganisms.
3.Wipeoffthecontrolunitcasingandhosettingswitha
dampclothtoremovealldetergent.
4.Airdryalltreatedsurfaces.
Cleaninghangers
1.Wipedowntheexteriorofthehangersperiodically,
usingadampclothandsuitabledetergent.
Cleaningcovers
(Removalofcontaminantssuchasdustandorganicmatter)
1.Removeallcoversforlaundering.
2.Launderthecoverswithmaximumtemperatureas
statedonproductlabel,usingadiluteddetergent
solution(Instructionsonlabel).
IMPORTANT!
Washingathighertemperatureswillcause
shrinkage.
Dryingcovers
1.Hangcoversfromalineorbaranddripdryinaclean
indoorenvironmentortumbledryonalowheatsetting.
IMPORTANT!
–Tumbledrysettingmustnotexceed40°C.
–Donottumbledryforlongerthan10minutes.
–Drythoroughlybeforeuse.
121627707-D

Maintenance
6.2.4DisinfectionInstructions
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.
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.
Autoclavingcovers
Autoclavethecoverat110°C.
IMPORTANT!
–Makesurethecoverisoutstretched(not
folded).
–Donotplacecoversontopofeachother.
6.3ReplacingCover
1.Unzipcoverandremoveitcarefullyfromfoaminsert.
2.Placenewcoverontofoaminsert.
3.Closezipper.
IMPORTANT!
–Ensurethatthecornersofthefoaminsertare
positionedcorrectlyintothecornersofthe
cover .
–Ensurethatthecastellatedfoamisfacing
upwardswheninsertedintoitscover.
WARNING!
–Ineventofcontamination,contactyourhygiene
specialist.
–Removecontaminatedfoamsfromuse.
1627707-D13

Invacare®SoftformActive®2withRXpump
7AfterUse
7.1Storage
IMPORTANT!
–Storemattressesinadryenvironment.
–Storemattresseswithinaprotectivecover.
–Ensuremattressiscarefullyrolledandstored
inprotectivebagprovidedonclean,dry,
off-ooringfreefromsharpedgestoavoidany
possibledamage.
–Neverstoreotheritemsontopofamattress.
–Donotstoremattressesnexttoradiatorsor
otherheatingdevices.
–Protectmattressesfromdirectsunlight.
Forenvironmentalconditionsforstorage,seechapter9
TechnicalData,page16.
7.2Reconditioning
Thisproductissuitableforreuse.Toreconditiontheproduct
foranewuser,carryoutthefollowingactions:
•Inspection
•Cleaninganddisinfection
Fordetailedinformation,see6Maintenance,page12.
Makesurethattheusermanualishandedoverwiththe
product.
Ifanydamageormalfunctionisdetected,donotreuse
theproduct.
7.3Disposal
Beenvironmentallyresponsibleandrecyclethisproduct
throughyourrecyclingfacilityatitsendoflife.
Disassembletheproductanditscomponents,sothedifferent
materialscanbeseparatedandrecycledindividually.
Thedisposalandrecyclingofusedproductsandpackaging
mustcomplywiththelawsandregulationsforwaste
handlingineachcountry.Contactyourlocalwaste
managementcompanyforinformation.
141627707-D

Troubleshooting
8Troubleshooting
8.1Identifyingandrepairingdefects
Thereareaudioandvisualalarmspresentonthecontrolunit.
Problem/AlarmCauseSolution
MattressCPRhosedisconnected.ConnectCPRhoseconnector,lockitinplace.
Powercableandfusehasbeenchecked,control
unitdoesnotoperate.
SendcontrolunitbacktoInvacareforrepair.
Mattressnotinating
(notalternating
properly).
Alternatingsystem
/Timingfailure
indication
Majorleakinaircellorcompleteairinsert.Replaceleakingaircell.
CPRhoseortubeconnectorskinkedorsplit.UnkinkorreplacesplitCPRhoseortube
connectors.
Notalternating,rotorfailure.SendcontrolunitbacktoInvacareforrepair.
Noair(controlunitfailure).SendcontrolunitbacktoInvacareforrepair.
Controlunitoff.Checkpowersource,turnuniton.
Nopower/
Powerfailure
indication
Powercorddisconnected.Connectpowercordandensurethepower
sourceison.
Nopowerinthepoweroutlet.Switchonthepoweroutlet(ifpoleswitch
available).
Havethepoweroutletrepairedbyanelectrician.
Poweroutage.Waituntilthepowersourcehaspower .
Fuseblown.Changefuseonpowerinletconnectorwithspare
fuseoridenticalreplacementonly(consulta
trainedengineerifyouareunsurehowtochange
afuse).
DisconnectionofCPR(connectionhose).Connecthoseproperly.
Disconnectionofconnectortubestoaircellsin
airinsert.
Checkindividualaircellsininsertarecorrectly
connectedtoconnectortubes.
Pressurefailure/Low
pressureindication
KinkedconnectionhoseMakesurethattherearenokinksorbendsin
thehose.
Incaseofissueswithtroubleshooting,pleasecontactInvacareforfurtherassistance(contactdetailsontheback
pageofthisUserManual).
1627707-D15

Invacare®SoftformActive®2withRXpump
9TechnicalData
9.1MattressSpecications
Dimensions[mm]
ProductLengthWidthHeight
Aircellheight
[mm]
Maximum
userweight
[kg]
Weightof
product[kg]1
SoftformActive2Rx1810—2100830—90015275247.614
1.Weightcanvarydependingonmattresssize.Averageweightusedasanindication.
161627707-D

TechnicalData
9.2Controlunit
MainSupply220–240V~,50/60Hz
RatedInputCurrent1A
SupplyFuse1A
NoiseLevel≤24dB
ClassicationClassIITypeBF
CycleTime10min,A/B+/-1min
Size275mmX155mmX105mm
Weight1.75kg
AirFlow4l/min
OperatingPressure60mmHg(8kPa)
Power23VA
ControlunitfuseT1AL250V
IngressprotectionIP21*
*Protectedfromtouchbyngersandobjectsgreaterthan12millimeters.Protectedagainstverticallyfallingdrops
ofwaterorcondensation.
9.3Materials
FoamPolyurethaneCombustionModiedHighResilienceFoam
CoverPolyurethanetransfercoatingonweftknittedfabric
AirCellsPolyurethanecoatednylon
GlideMembranePolyurethaneFilm
Controlunitandmattresscomponentsdonotcontainnaturalrubberlatex.
9.4EnvironmentalConditions
OperationStorageandTransport
Ambienttemperature10°C–35°C-15°C–50°C
Relativehumidity20%–80%,non-condensing10%–90%,non-condensing
Atmosphericpressure70–106kPa50–106kPa
9.5Guidanceandmanufacturer’sdeclaration
Thedeviceisintendedforuseintheelectromagneticenvironmentspeciedbelow.Thecustomerortheuserofthedevice
shouldassurethatitisusedinsuchanenvironment.
Electromagneticemissions
EmissiontestComplianceElectromagneticenvironment–guidance
RFemissions
CISPR11
Group1ThedeviceusesRFenergyonlyforitsinternalfunction.Therefore,itsRF
emissionsareverylowandarenotlikelytocauseanyinterferencein
nearbyelectronicequipment.
RFemissions
CISPR11
ClassB
Harmonicemissions
IEC61000-3-2
ClassA
Thedeviceissuitableforuseinallestablishments,includingdomestic
establishmentsandthosedirectlyconnectedtothepubliclow-voltage
powersupplynetworkthatsuppliesbuildingsusedfordomesticpurposes.
Voltageuctuations/
ickeremissions
IEC61000-3-3
Complies
1627707-D17

Invacare®SoftformActive®2withRXpump
Electromagneticimmunity
ImmunitytestIEC60601testlevelCompliancelevelElectromagneticenvironment–guidance
Electrostaticdischarge
(ESD)
IEC61000-4-2
±8kVcontact
±2kV,±4kV,±8kV,
±15kVair
±8kVcontact
±2kV,±4kV,±8kV,
±15kVair
Floorsshouldbewood,concreteorceramictile.
Ifoorsarecoveredwithsyntheticmaterial,the
relativehumidityshouldbeatleast30%.
Electricalfast
transient/burst
IEC61000-4-4
±2kVforpowersupply
lines
±1kVforInput/output
lines
±2kVforpowersupply
lines
±1kVfor
interconnectingcable
Mainspowerqualityshouldbethatofatypical
commercialorhospitalenvironment.
Surge
IEC61000-4-5
±1kVlinetoline
±2kVlinetoearth
±1kVlinetolineMainspowerqualityshouldbethatofatypical
commercialorhospitalenvironment.
Interruptionsand
voltagevariationson
powersupplyinput
lines
IEC61000-4-11
<5%UT(>95%dipin
UT)
for0.5cycle
40%UT(60%dipinUT)
for5cycles
70%UT(30%dipinUT)
for25cycles
<5%UT(>95%dipin
UT)
for5sec
<5%UT(>95%dipin
UT)
for0.5cycle
40%UT(60%dipinUT)
for5cycles
70%UT(30%dipinUT)
for25cycles
<5%UT(>95%dipin
UT)
for5sec
Mainspowerqualityshouldbethatofa
typicalcommercialorhospitalenvironment.
Iftheuserofthedevicerequirescontinued
operationduringpowermainsinterruptions,itis
recommendedthatthedevicebepoweredfrom
anuninterruptiblepowersupplyorabattery.
Powerfrequency
(50/60Hz)magnetic
eld
IEC61000-4-8
30A/m30A/mPowerfrequencymagneticeldsshouldbeat
levelscharacteristicofatypicallocationina
typicalcommercialorhospitalenvironment.
NOTE:UTisthea.c.mainsvoltagepriortoapplicationofthetestlevel.
ImmunitytestIEC60601testlevelCompliancelevelElectromagneticenvironment–guidance
PortableandmobileRFcommunicationsequipment
shouldbeusednoclosertoanypartoftheCT515,
includingcables,thantherecommendedseparation
distancecalculatedfromtheequationapplicabletothe
frequencyofthetransmitter.
Recommendedseparationdistance:
3Vrms
150kHzto80MHz
3Vrms
150kHzto80MHz
ConductedRF
IEC61000-4-6
6VrmsinISMbands6VrmsinISMbands
d=[3.5/V1]x√P
RadiatedRF
IEC61000-4-3
10V/m
80MHzto2.7GHz
10V/m
80MHzto2.7GHz
d=1.12x√P80MHzto800MHz
d=2.3x√P800MHzto2.5GHz
385MHz-5785MHz
Testspecications
forENCLOSURE
PORTIMMUNITY
toRFwireless
communication
equipment(Refer
totable9ofIEC
60601-1-2:2014)
385MHz-5785MHz
Testspecications
forENCLOSURE
PORTIMMUNITY
toRFwireless
communication
equipment(Refer
totable9ofIEC
60601-1-2:2014)
WherePisthemaximumoutputpowerratingofthe
transmitterinwatts(W)accordingtothetransmitter
manufactureranddistherecommendedseparation
distanceinmeters(m).
FieldstrengthsfromxedRFtransmitters,as
determinedbyanelectromagneticsitesurveya),should
belessthanthecompliancelevelineachfrequency
rangeb).
Interferencemayoccurinthevicinityofequipment
markedwiththefollowingsymbol:
181627707-D

TechnicalData
NOTE1:At80MHzand800MHz,thehigherfrequencyrangeapplies.
NOTE2:Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionand
reectionfromstructures,objectsandpeople.
a)Fieldstrengthsfromxedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandlandmobileradios,
amateurradio,AMandFMradiobroadcastandTVbroadcastcannotbepredictedtheoreticallywithaccuracy.Toassess
theelectromagneticenvironmentduetoxedRFtransmitters,anelectromagneticsitesurveyshouldbeconsidered.Ifthe
measuredeldstrengthinthelocationinwhichthedeviceisusedexceedstheapplicableRFcompliancelevelabove,the
deviceshouldbeobservedtoverifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmaybe
necessary,suchasreorientingorrelocatingthedevice.
b)Overthefrequencyrange150kHzto80MHz,eldstrengthsshouldbelessthan3V/m.
1627707-D19

Invacare®SoftformActive®2withRXpump
RecommendedseparationdistancesbetweenportableandmobileRFcommunicationsequipmentandthedevice
ThedeviceisintendedforuseinanelectromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled.The
customerortheuserofthedevicecanhelppreventelectromagneticinterferencebymaintainingaminimumdistance
betweenportableandmobileRFcommunicationsequipment(transmitters)andthedeviceasrecommendedbelow,according
tothemaximumoutputpowerofthecommunicationsequipment.
Ratedmaximumoutput
poweroftransmitter(W)
Separationdistanceaccordingtofrequencyoftransmitter(m)
150kHzto80MHz
d=1.12√P
80MHzto800MHz
d=1.12√P
800MHzto2.5GHz
d=2.3√P
0.010.120.120.23
0.10.380.380.73
11.21.22.3
103.83.87.3
100121223
Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommendedseparationdistancedinmeters(m)
canbeestimatedusingtheequationapplicabletothefrequencyofthetransmitter,wherePisthemaximumoutputpower
ratingofthetransmitterinwatts(W)accordingtothetransmittermanufacturer .
NOTE1:At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrangeapplies.
NOTE2:Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionand
reectionfromstructures,objectsandpeople.
201627707-D