Invacare SoftCloud Ace User manual

SoftCloud®Ace,SoftCloud®Pro
enAlternatingmattresssystems
UserManual......................................3
daAlternerendemadrassystemer
Brugsanvisning....................................21
deWechseldrucksysteme
Gebrauchsanweisung................................39
esSistemasdecolchóndeairealternante
Manualdelusuario.................................61
Vaihtelevatpatjajärjestelmät
Käyttöohje.......................................83
itSistemiamaterassialternati
Manualed’uso....................................101
noAlternerendemadrassystemer
Bruksanvisning....................................121
ptSistemasdecolchãodepressãoalternada
Manualdeutilização................................139
svMadrassystemmedväxeltryck
Bruksanvisning....................................161
ThismanualMUSTbegiventotheuseroftheproduct.
BEFOREusingthisproduct,thismanualMUSTbereadandsaved
forfuturereference.

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

Contents
ThismanualMUSTbegiventotheuseroftheproduct.
BEFOREusingthisproduct,thismanualMUSTbereadandsaved
forfuturereference.
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
2.2LabelsontheProduct...........................5
2.3Symbolsontheproduct.........................5
3ProductOverview.................................7
3.1IntendedUse.................................7
3.1.1Indications.................................7
3.2ProductDescription.............................7
3.3ControlUnit..................................7
3.4Mattress.....................................7
4Setup...........................................8
4.1Safetyinformation..............................8
4.2InstallingtheMattressSystem.....................8
4.3Activatingthecontrolunit........................9
4.4Removingthemattresssystem....................9
5Usage..........................................10
5.1SafetyInformation..............................10
5.2OperatingtheControlUnit.......................10
5.3Usingthemattresssystem........................11
5.4HeelCellZones-SoftCloudPro....................11
5.5CPRProcedure................................11
5.6AudibleWarningFunctions.......................12
5.7Transportingapatientonthemattress..............12
6Maintenance.....................................13
6.1Inspection....................................13
6.2CleaningandDisinfection........................13
6.2.1Generalsafetyinformation.....................13
6.2.2CleaningInstructions.........................13
6.2.3DisinfectionInstructions.......................14
6.3Service......................................14
6.4Replacingtheairlter...........................14
6.5Replacingfuse.................................14
7AfterUse........................................15
7.1Storage......................................15
7.2Reconditioning................................15
7.3Disposal.....................................15
8Troubleshooting...................................16
8.1IdentifyingandRepairingFaults....................16
9TechnicalData....................................17
9.1ControlUnitSpecications........................17
9.2Mattressspecications..........................17
9.3EnvironmentalConditions........................18
9.4GuidanceandManufacturer’sDeclaration............18

SoftCloud®Ace,SoftCloud®Pro
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.
41630732-C

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.
2.2LabelsontheProduct
Theshownlabelsservesasexamplesonly.Thelabelson
yourproductmightdifferslightlyfromthem.
ControlUnit
Fig.2-1
AProductnameandModelversion
BInputVoltageandFrequencyrange
CMax.InputCurrent
DIP-rating
EFusetype
FSerialnumber
GDateofmanufacture
HCountryoforigin
IManufactureraddress
JAddressofEuropeanrepresentative
Mattress/Cover
Sincetheidenticationlabelsonthemattressandcovermay
changedependingonusedmodelanddateofmanufacture,
thelabelsforthesecomponentsarenotshown.For
explanationsofthesymbols,whichareprintedonthe
mattressandcover,refertosectionSymbolsontheproduct
inthisdocument.
2.3Symbolsontheproduct
European
Conformity
Refertouser
manual
MedicalDeviceCaution
1630732-C5

SoftCloud®Ace,SoftCloud®Pro
ManufacturerDateof
manufacture
TypeBFapplied
partClassIIequipment
WEEEconformPower
SerialnumberCPRlabel
FunctionalEarth
xxx kg
Userweightlimit*
Donotpierceor
cutDonotiron
DonotbleachTumbledrylow
temperature
Donotputnear
ameLinedry
HandwashDonotdryclean
Washingmax.
95°C(coveronly)
*Minimum/maximumuserweightpermodel,seechapter
TechnicalData.
61630732-C

ProductOverview
3ProductOverview
3.1IntendedUse
Thispressureredistributionmattressandcontrolunitare
intendedtobeusedinconjunctionwithanappropriately
sizedbedframe.
Themattresscanbeusedsafelyinstaticmodeforstatic
pressureredistribution,orindynamicmodeshouldan
alternatingpressuresupportsurfaceberequired.
Thisproductdeliverseffectivepressureredistributionto
users,whenthesupportsurfaceiscoveredwithacotton,
cottoncombinationorlinenbedsheet,andanyoneofthese
istheonlyitemdeployedbetweenthesupportsurfaceand
theuser.
3.1.1Indications
Suitableforsupportingthemanagementofallcategories
ofpressureinjurieswhencombinedwithanindividualand
comprehensivepressureinjuryprotocol.
Suitableforuseinhomecare,residential,nursingandacute
caresettings.
Contraindications
Notsuitableforuserswithunstablespinalcordfractures
and/orcervicaltraction.
Alwaysconsultaphysicianpriortousingthisdevice.
3.2ProductDescription
Thefollowingcomponentsareincludedwithinthescope
ofdelivery:
C
A
B
D
AMattressSystemincludingmattressbase,CPRtag,
connector,handlewithtransportcapattached,top
coverwithzip.
BDigitalControlUnit
CCarryBag
DUserManual
MedicalGradePowerCord(notshown)
Thecontrolunitprovidestheairsupplytothemattress.Itis
controlledviaatouchpanel.Thereisavisualandaudible
warningwhenpressurefailsorpowerisinterrupted.
Thecontrolunitredistributesthepressurebyalternately
inatinganddeatingcells.Thisenablesafrequent
repositioningofthepressure.
3.3ControlUnit
KJ
G
H
I
C D E F
A
B
APowerbutton
BLock/Unlockbutton
CAlternationfailureindicator
DLowpressureindicator
EServiceindicator
FPowerlossindicator
GAudiblewarningmutebutton
HMax.rmnessbutton
IPressuresettings
JModebuttonandindicator
KAutosensingfunction
3.4Mattress
SoftCloudAce
Themattresscomprisesaircellswhichallfeaturea
permanentlyinatedinternalcelltopreventthepatient
“bottomingout”intheeventoflowpressure.
Themattressincludesthreestaticheadcellstoprovide
static“pillow”supportforoptimumusercomfort,whileair
pressureintheothercellsisalternated.
Themattressalsoincludesanindependentheelzoneofve
microcellsforindividualizedsupportforthissensitivearea.
SoftCloudPro
Themattresscomprisesaircellswhichallfeaturea
permanentlyinatedinternalcelltopreventthepatient
“bottomingout”intheeventoflowpressure.
Themattressincludesthreestaticheadcellstoprovide
static“pillow”supportforoptimumusercomfort,whileair
pressureintheothercellsisalternated.
Themattresshasahingedbacktoallowthemattressto
conformtotheproleofthebedwhenarticulated.
Themattressalsoincludesanindependentheelzoneof
veaircellsforindividualizedsupportincludingpermanent
unloadingforthissensitivearea.
Themattresshassidebolstersandthetopcoverhasa
doubleskirtwithweldedseamsformaximumantibacterial
protection.
1630732-C7

SoftCloud®Ace,SoftCloud®Pro
4Setup
4.1Safetyinformation
WARNING!
Electricalshockhazard!
–Donotremovecontrolunitshroud.
–Refertoqualiedservicepersonnel.
–Beforeperforminganymaintenancetothe
controlunit,disconnectthepowerleadfrom
thewalloutlet.
–Donotinsertitemsintoanyopeningsofthe
controlunit.Doingsomaycausereorelectric
shockbyshortingtheinternalcomponents.
–Thecontrolunitmustbekeptawayfromall
heatsourcesandradiatorsduringoperation.
–Connecttheequipmenttoatwo-orthree-prong
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!
Thismattressisrecommendedtobeinstalled
onmedicalbedframesofanappropriatesize
withbedsidesorassistrails,toaccommodate
themattress.Itispreferredthattherailsarein
theraisedpositionwheneverthepatientison
thebed.Healthcareprofessionalsassignedto
eachcaseshouldmakethenaldecisionwhether
assistrailsarewarrantedafterassessingpatient
riskofentrapment.
Controlsonthefootbedendmaybeobstructed
bythecontrolunitonafewbedframes.Itmay
benecessarytorelocatethecontrolunit.
–Beforeplacingthepatientonthebed,check
thatconnectorandpowercordareclearof
movingbedcomponents.
–Operateallmotorisedbedframefunctions
throughtheirfullrangeofmotiontobecertain
thatthereisnopulling,interferenceorpinching.
–Takecarewhenpositioningconnectorand
cablestoeliminatetheriskoftrippinghazards
orstrangulation.
IMPORTANT!
Inappropriatehandlingcandamagethemattress
cover.
–Itisrecommendedthattwopeoplelift/carry
mattresses.
–Avoidcontactwithjewellery,nails,abrasive
surfacesetc.
–Donotdragmattresses.
–Avoidcontactwithwall,doorframes,door
catchesorlocksetc.
–Donottransportinrollcagesunlesscompletely
protectedfromthesharpedgesofthecage.
4.2InstallingtheMattressSystem
IMPORTANT!
–Removeallpackagingbeforeuse.
–Keepallpackingmaterialsandinstructionsin
thecarrybagprovidedincasetheproducthas
tobeshippedtoanInvacareServiceCentre.
–Carefullyremovethecontrolunit,mattressand
accessoriesfromtheshippingcartons.
–Inspectallitemsforanydamagethatmayhave
occurredduringshipping.Anydamagedor
missingpartsmustbereportedtoanInvacare
ServiceCentreimmediately.
81630732-C

Setup
IMPORTANT!
–Ensurethatthefootbedendisrobustenough
tosupportthecontrolunitsafely.
–Ensuretherearenosharpobjectswhichmay
comeintocontactwiththemattresssystem.
–Checkthattheattachmentofthemattressdoes
notinterferewiththemovementoroperation
ofthebed.
–Donotsecurestrapstobedsiderailsasstraps
willtear.
–Ensurethatthepositioningofthesystemdoes
notinterferewiththeabilitytodisconnectthe
electricalpower.
–PriortoactivationensuretheCPRvalvelocated
neartheheadendofthemattressisfully
engagedandthatthemattressconnectoris
rmlyconnectedtothecontrolunit.
1.Removeallcovers,sheetsandmattressfromthebed.
2.Placethemattressdirectlyontheframeofthebed.
3.Positionthemattresstopcoverfacingupwardsandair
hosesatfootofbedforcontrolunitpositioning.
4.Onastandardbed,attachtothebedbysecuringthe
twoadjustablestrapsundereachendofthebed.Ensure
bucklesaresecurelyfastenedandstrapsarepulledtight.
Or
Onaprolingbed,securethetwoadjustablestraps
aroundthemoveablesectionsofthebed.
4.3Activatingthecontrolunit
1.Positionthecontrolunitbyhangingthehooksoverthe
footboardofthebedorsiderails,ensuringthatthey
arerobustenoughtoholdthecontrolunit.
CAUTION!
–Ensuretheairhosedoesnotkinkbetweenthe
bedframeandcontrolunit.
2.Connectthemattressconnectortothecontrolunit.
IMPORTANT!
–Ensurethatthepowercordisingoodcondition.
3.Insertthepowercordintothecontrolunitthenplug
intoagrounded220V50Hzelectricaloutlet.
4.Pressthepowerbuttonforapproximatelythreeseconds
toactivatethecontrolunit.
ThepressureLEDswillashindicatingthesystem
hasactivated.
IMPORTANT!
–PriortopumpactivationensuretheCPRvalve
locatedneartheheadendofthemattressis
fullyengaged.
–Ensurethatthemattressconnectorisrmly
connectedtothecontrolunit.
5.Allowapproximately30minutesforthemattresstofully
inate.Onceready,youshouldseethefourthpressure
LEDplusalternatingmodeLEDilluminatetoindicate
thatthesystemisreadyforuse(systemautomatically
defaultstoAlternatingModeafterstart-up).Forfurther
detailssee5.3Usingthemattresssystem,page11.
6.OncetheMattressisfullyinatedthebeddingcanbe
placed.Fitsheetslooselyenoughtoallowforfree
movementofthemattressaircells.
7.Ensureeachsheetcornerisplacedthroughretaining
buckle.
4.4Removingthemattresssystem
A
B
C
1.Switchoffthecontrolunitanddisconnectfrommains
supplyA.
2.RemovethemattressconnectorBfromthecontrolunit
anddisconnecttheCPRtagC.
3.Placecontrolunitandpowercordontopofthemattress
anddetachmattressfromthebedframe.
4.Onceairhasbeenreleasedfromallcells,rollupthe
mattressandreturnallitemstothecarrybagforsafe
keeping.
IMPORTANT!
–Alwaysfollowthecorrectprocedurewhen
switchingoffthecontrolunit.Whentheunit
isswitchedoff,itwillissueapowerlossalert.
Thisalertcanbecanceledbypressingthe
powerbuttonforaminimumoftwoseconds.
IMPORTANT!
–Priortorestartingthesystem,ensurethe
CPRtagisreplacedandallsealingconnectors
arermlyattached;andthatthemattress
connectorisreplacedandrmlyconnectedto
thecontrolunit.
–Usetargetdesigntolineupeachplugwithits
correspondingsocket.
1630732-C9

SoftCloud®Ace,SoftCloud®Pro
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.
5.2OperatingtheControlUnit
TurningOnandOffPower
1.Presspowerbuttonforapproximatelythree
secondstoturnonoroffthepower.
SwitchingtheMode
1.Pressmodebuttontoswitchbetween
AlternationMode(alternativecells
cyclicallyinatinganddeating)and
StaticMode(allcellsfullyinatedwith
nodynamicalternation).ThebrightLED
indicatestheactivemode.
2.InordertoactivateorinactivateCLP
function(ContinousLowPressure),press
modebuttonfortwoseconds.
Changingthepressuresettings
Fivepressuresettingsareavailablefromsoft(15mmHg)to
rm(55mmHg)withstepsof10mmHg.
WhenusingtheCLPfunction,thevepressuresettingsare
from15mmHgto23mmHgwithstepsof2mmHg.
1.PressPlusbutton(+)toincrease
pressure.
2.PressMinusbutton(-)todecrease
pressure.
ThebrightLEDsindicatetheselectedsetting.
LockingandUnlockingbuttons
1.PressLock/Unlockbuttonforapproximately
threesecondstolockallbuttonsonthecontrol
unit.
AbeepsoundsandtheamberLEDilluminates
toindicatethesystemislocked.
2.Tounlock,pressagainforatleastthreeseconds
(beepsoundsandamberLEDturnsoff).
Thecontrolunitwillautomaticallyunlockintheeventof
apowerfailure.
MutingAudibleWarningSignals
Anaudiblewarningsignalcanbemutedwhileresolvingthe
causeofthefailure.Ifnotresolved,theaudiblewarning
signalwillresumeafter17±3minutes.
1.Pressmutebuttontomuteanaudiblewarning
signal.
EnablingRapidInationtoMaximumPressure
1.PressMax.rmnessbuttontoenablerapid
inationtomaximumpressure(60mmHg).
2.Todisablemaximumpressure,pressbutton
againforthreeseconds.
Ifnotdisabled,after30±3minutesthesystem
willautomaticallyrevertbacktoalternation
modewithmediumpressure,forpatientsafety.
AutoSensing(notapplicableonallmodels)
TheAutosensingfunctionisusedwhenthemattressis
transferredtoanewuser.
101630732-C

Usage
Thesystemstartsfromapressurereference
valuewhencalculatingtheindividualpressure
setting.Whentheuserislyingonthemattress
thedifferencesbetweenthe“unloaded”andthe
“loaded”pressurearecomparedtoamatrixand
1of5pressurestepsisselected.Whenadjusting
thepressuretheautosettingsareoverruledbythe
manualsettings.
5.3Usingthemattresssystem
EstablishingPressure(supine/faceupposition)
1.Thesystemissetupandinatedinstaticmode.
2.Whenthesystemisready,theautosensingfunction
willindicatewitha“beep”thattheusercanlaydown
onthemattress.
3.After10-15secondsthesystemhasmeasuredthe
impacttheuserhaveonthesystemandcalculateda
pressuresetting.
4.Thesystemisnowreadytouseandwillturnto
alternatingtherapyunlessotherselectionsaremade.
5.Iffurtheradjustmentsareneeded,thepressuresettings
canbealteredwiththepressurearrowbuttons.
6.Assesswhetherthepatientiscomfortableandthe
systemisfunctioningcorrectlybyperforminga
“bottomingout”test.
Thesystemrunsonthechosensettingbutwhenthe
userchangesandstaysinanewpositionthepressure
inthemattresscanadjust(higher/lower).Thesensor
inthecontrolunitwillreactandadjustthepressure
ifrequiredtocompensateforthenewposition.
“BottomingOut”Test
Whenalteringthepressuresetting,ensurethepatientisnot
“bottomingout”(insufcientlysupportedbytheaircellsand
thereforecomingincontactwithbedbase).
1.Ensuresystemisinalternationmodebutisnot
undergoinganalternation.
2.Withthepatientlyinginasupineposition,unziptop
coverjustpastsacral(bottom)region.
3.Slideyourhandalongadeatedcellunderthepatients
sacralarea(bottom).Theinnerstaticcellwillremain
inatedbutyourhandshouldslideeasilybetween
patientandbase.
4.Ifhandcanpassunderpatientthenpatientisadequately
suspendedandpressurecanbelowered.
5.Repeat“bottomingout”testafterpressurehasbeen
lowered.
Intheeventofasystemmalfunction,thealarmwill
activateandpressureLEDswillash.
EstablishingPressure(inclinedposition)
Thesystemrunsonthechosensettingbutwhenthe
userchangesandstaysinanewpositionthepressure
inthemattresscanadjust(higher/lower).Thesensor
inthecontrolunitwillreactandadjustthepressure
ifrequiredtocompensateforthenewposition.
IMPORTANT!
–Returntotheoriginalpressuresettingwhen
thepatientreturnstothesupineposition,and
performa“bottomingout”test.
–Waitaminimumof10-12minutesbetween
pressureadjustmentandpatientassessment,as
itmaytakeafullcycleforthesystemtoadjust
toanynewsetting.
5.4HeelCellZones-SoftCloudPro
ForSoftCloudPro,theveheelcellsincorporateanoption
whichallowsthecarertopermanentlyofoadtheheelof
theuser,idealforthemostvulnerableuserssuchasthose
withlimbischaemiaorexistingwounds.
CAUTION!
Insufcientpressurerelief
–Deatingmorethanoneadjacentaircellcan
affectthesupportoftheuserduringthenormal
alternatingsupportcycle.Thisfunctionshould
onlybeusedfortemporaryprocedures.
AB
1.OpenthepushbuttonapAatthefootendofthe
mattresstoaccessthe5releaseconnectors.
2.DisconnectthechosenconnectorBforpermanent
ofoading.
•Topconnectorisclosesttotheknee.
•Connector4–2isbelowthekneeandgoes
towardstheheel.
•Bottomconnectoristhelastheelcellclosest
totheendofthemattress.
Itisnotrecommendedtodeatemorethanone
aircelldirectlybeneaththeareawhererelief
isneeded.
3.Reconnecttheconnector(s)todisengagepermanent
ofoading.Theaircellwillbeinatedagainandreturn
tonormaloperationmode.
4.ClosethepushbuttonapA.
5.5CPRProcedure
A
1630732-C11

SoftCloud®Ace,SoftCloud®Pro
1.FirmlypulltheyellowrapidreleaseCPRtagAfromthe
sideofthemattresstodeatethewholesystem.
2.Switchoffthecontrolunit.
Mattresswillstarttodeate.
3.
WhenCPRiscompletereplacetheyellowCPRTag
ensuringthesealingconnectorsarermlyattachedand
restartthecontrolunitfollowingchapter“Activatingthe
controlunit”.Usingthetargetdesigntolineupeach
plugwithit'scorrespondingsocket.
IMPORTANT!
–Waitforthemattresssystemtogainoptimal
pressure.
–Performa“bottomingout”testafterinating
themattressfollowingrapiddeation.
5.6AudibleWarningFunctions
TheaudiblewarningLEDashes,andanaudiblewarning
sounds,toindicatethatthecontrolunitormattresspressure
hasfailed.TheLEDwillremainilluminateduntilappropriate
pressureisrestored.Theaudiblewarningcanbesilencedby
pressingtheaudiblewarningmutebutton.
Thesystemhasfourdifferentaudiblewarningsignalsand
oneserviceindicator,identiedbyvedifferentsymbols.
Thesymbolsareillustratedbelow.
DisplayAudibleWarning
Signal
Description
AlternatingMode
failure
Indicateswithanaudible
sound(pressmutebutton
tosilence)andaashing
LEDlightwhenthereisno
alternation.TheLEDlight
willchangetoaxedlight
within5min.
LowPressureIndicatesthatpressurehas
fallenbelowthetolerance
limit(belowsetting
pressure–5mmHg)or
more.Thiswilltrigger
theaudiblewarning(press
mutebuttontosilence)
andaashingLEDlight.
TheLEDlightwillchange
toaxedlightwithin7
min.
DisplayAudibleWarning
Signal
Description
PowerfailureIndicatesnopressure
outputduetomains
powerfailure.This
willtriggertheaudible
warning(pressmute
buttontosilence)anda
ashingLEDlight.TheLED
lightwillchangetoaxed
lightwithin3seconds.
Whenthepowerisback
on,theaudiblewarning
andtheLEDlightwill
reverttonormalmode.
Initialfailure(the
mutebuttonLED
willbeconstantly
lit)
Indicatesthatthe
systemdidnotcomplete
initializationwithin50
minutes,themutebutton
LEDlightwillhaveaxed
light.
ServiceindicatorIndicatesthatserviceis
needed,theLEDlightwill
haveaxedlight.Thiswill
occurwhenthecontrol
unithasbeenrunningfor
approximately9000hours.
Ifaudiblewarningactivatesandthesystemfailsto
inateorlosespressure,refertosection“Identifying
andrepairingfaults”.
5.7Transportingapatientonthe
mattress
1.Beforepatienttransport,presstheModebuttonand
waitatleast12minutesforcellstoinatetomaximum
pressure.
Ifaquickerresponseisrequired(upto5-10
minutes),thenusetheMaxFirmnessbutton.
2.Oncemattresspressurehasreachedmaximumination,
pressthePowerbuttontoswitchoffthecontrolunit.
Switchoffmainssupplyandunplugthepowercord.
3.Removetheconnectorfromthecontrolunitandallow
airtoescapeforafewsecondsbeforeinsertingthe
transportcapintotheconnectorairoutletstosealthe
system.Thisreleasesoftensthemattresssurfacefor
pressurereliefandcomfort.Ensurethecapisrmly
securedacrossbothairhoseoutlets.
CAUTION!
Airpressureisreleasedfromallinternalstatic
cellsaswellasalternatingsections.
–Regularlyperforma“bottomingout”testto
ensurethepatientisappropriatelysupported.
121630732-C

Maintenance
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.)
orabrasivecleaningagents.Werecommend
anordinaryhouseholdcleaningagentsuchas
dishwashingliquid,ifnotspeciedotherwisein
thecleaninginstructions.
–Neveruseasolvent(cellulosethinner,acetone
etc.)thatchangesthestructureoftheplastic
ordissolvestheattachedlabels.
–Alwaysmakesurethattheproductiscompletely
driedbeforetakingintouseagain.
Forcleaninganddisinfectioninclinicalorlong-term
careenvironments,followyourin-houseprocedures.
CleaningIntervals
IMPORTANT!
Regularcleaninganddisinfectionenhances
smoothoperation,increasestheservicelifeand
preventscontamination.
Cleananddisinfecttheproduct
–regularlywhileitisinuse,
–beforeandafteranyserviceprocedure,
–whenithasbeenincontactwithanybody
uids,
–beforeusingitforanewuser.
IMPORTANT!
–Keepacleaningrecordaspartofcleaningthe
system.
6.2.2CleaningInstructions
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.
1630732-C13

SoftCloud®Ace,SoftCloud®Pro
6.2.3DisinfectionInstructions
IMPORTANT!
–Onlyusedisinfectantsandmethodsapproved
byyourlocalinfectioncontrolinstitutionand
followyourlocalinfectioncontrolpolicy.
–Additionalinformationonrecommended
disinfectantscanbefoundon
https://vah-online.de/en/for-users.
DisinfectingtheControlUnit
1.Wipedownallgenerallyaccessiblesurfaceswithacloth
anddisinfectant.
2.Allowtheproducttoair-dry.
DisinfectingtheAirCells
IMPORTANT!
–Donotdisconnectthepipesfromindividualair
cells.
–Donotmachinewashordrytheaircells.
1.Disconnectaircellsfromthebasebyunfasteningthe
pressstudsateachend.
2.Disconnectairpipesfrommainairhoses.
3.Slideeachcelloutfromthecellstraps.
4.Swabwithaclothdampedwithwarmwatercontaining
anappropriatedisinfectant(dependentoninfection
controlprotocolsandlocalmarketrequirements).
5.Drythoroughlywithasoftclothbeforerefastening.
6.3Service
IMPORTANT!
–Theserviceindicatorwillbeactivatedwhenthe
controlunithasbeenrunningforapproximately
9.000hours,indicatingthatserviceisneeded.
IMPORTANT!
–Donotattempttorepairorservicethecontrol
unityourself!Alwayscontactanauthorised
servicetechnician.
6.4Replacingtheairlter
IMPORTANT!
Goodltermaintenanceiscriticaltomaintain
yourmattresssysteminoptimaloperating
condition.Failuretokeepthelterscleanwill
resultinsystemdowntimeandincreaserepair
costs.Itisrecommendedthattheairlteris
replacedannually.Replacementairltersare
availablefromanInvacareServiceCentre.
1.Turnoffthepowersupplytothecontrolunit.
2.Disconnectthepowercordandairhoses.
3.Placethecontrolunitonaatsurfacewithitsback
paneluppermost(placesoftclothunderunittoprevent
scratches).
4.Carefullyremovetheairltershroud.Removeand
discardthelterandattachwithnewlter.
5.Re-attachtheairltershroudtothecontrolunit.
Thecontrolunitisnowreadyforre-connection.
6.5Replacingfuse
CAUTION!
–Ensurethereplacementoffusesiscarriedout
inaccordancewithlocallegislation.
–Alwaysusethesamefuseratingwhenreplacing
adefectfuse.
1.Turnoffthepowersupplytothecontrolunit.
2.Removethepowercordfromtheelectricalsocketon
thesideofthecontrolunit.
3.Insertaatscrewdriverintothesmallcutoutabovethe
powercordinlet.
4.Pullthescrewdrivercarefullytowardstoopentheplastic
carrier.
5.Removeanddiscardthe“blown”fuse.
6.Insertanewfuseandclosetheplasticcarrier.
7.Reversestepsfourtooneinordertoreinstatethefuse
carrier.
Seealsosection“Activatingthecontrolunit”for
moreinformation.
141630732-C

AfterUse
7AfterUse
7.1Storage
IMPORTANT!
–Storemattressesinadryenvironment.
–Storemattresseswithinaprotectivecover.
–Carefullyrollupthemattressandstoreiton
aclean,dry(off-oor)surfacewithnosharp
edgestopreventpossibledamage.
–Neverstoreotheritemsontopofamattress.
–Donotstoremattressesnexttoradiatorsor
otherheatingdevices.
–Protectmattressesfromdirectsunlight.
Environmentalconditionsforstorage,see“Environmental
conditions”.
7.2Reconditioning
Thisproductissuitableforreuse.Toreconditiontheproduct
foranewuser,carryoutthefollowingactions:
•Inspectionaccordingtoserviceplan
•Cleaninganddisinfection
Fordetailedinformationaboutinspection,cleaningand
disinfection,referto6Maintenance,page13.
7.3Disposal
WARNING!
EnvironmentalHazard
Devicecontainsbatteries.
Thisproductmaycontainsubstancesthatcould
beharmfultotheenvironmentifdisposedof
inplaces(landlls)thatarenotappropriate
accordingtolegislation.
–DONOTdisposeofbatteriesinnormal
householdwaste.
–BatteriesMUSTbetakentoaproperdisposal
site.Thereturnisrequiredbylawandfreeof
charge.
–Doonlydisposedischargedbatteries.
–Coverterminalsoflithiumbatteriespriorto
disposal.
–Forinformationonthebatterytypeseebattery
labelorchapter9TechnicalData,page17.
Beenvironmentallyresponsibleandrecyclethisproduct
throughyourrecyclingfacilityatitsendoflife.
Disassembletheproductanditscomponents,sothedifferent
materialscanbeseparatedandrecycledindividually.
Thedisposalandrecyclingofusedproductsandpackaging
mustcomplywiththelawsandregulationsforwaste
handlingineachcountry.Contactyourlocalwaste
managementcompanyforinformation.
1630732-C15

SoftCloud®Ace,SoftCloud®Pro
8Troubleshooting
8.1IdentifyingandRepairingFaults
WARNING!
Electricshockhazard!
Openingthecontrolunitcouldcausepersonalinjuryorequipmentdamage.
–Donottrytoopenthecontrolunit.
IMPORTANT!
–Iftheproblemisnotresolved,contactanInvacareproviderorInvacarerepresentative.
Warning/FaultCauseSolution
Controlunitdoesnot
operate;nodisplaylights
TheControlUnitmaynotbe
attachedtoapowersource
Afusemayneedreplacing
inthecontrolunit
1.Checkthatthecontrolunitisconnectedtomainspoweroutletwith
thecorrectvoltage.
2.Checkthatthecontrolunitisswitchedon.
3.Checkthemainsplugfuse.Checkbothcontrolunitfuses(1ampslow
blowfuse)–fusescanbereleasedusingascrewdrivertopushandturn.
Patientissinkingor
“bottomingout”whilst
lyingatontheMattress
Thepressuremaybesettoo
lowforthepatient’sweight
1.Increasethepressuresettingbypressingupthepressurearrow.
2.Tocheckeffectivesystemperformance,performa“bottomingout”test.
Seesection“Usingthemattresssystem”.
AudibleWarningMuteLED
lightsuppermanently
Initialfailure1.Mutetheaudiblewarningandturnoffpower.
2.Checkthatthehandleisintact,ensuringallfoursealingconnectors
arermlyattachedtocontrolunitandairhoses.ChecktheCPRTagis
attachedandallfoursealingconnectorsarermlysecured.
3.Checkallairhosesalongtheinsideofthemattress–eachshould
bermlyconnected.Checkeachaircellissecurelyattachedtoits
connectingairpipe.
4.Checkallcells,pipesandhosesforanyairleakage.
5.TurnonPower.
LowpressureindicatorLED
lightsup
+audiblewarning
Pressuretoolow1.Mutetheaudiblewarningandturnoffpower.
2.Checkthatthehandleisintact,ensuringallfoursealingconnectors
arermlyattachedtocontrolunitandairhoses.ChecktheCPRTagis
attachedandallfoursealingconnectorsarermlysecured.
3.Checkallairhosesalongtheinsideofthemattress–eachshould
bermlyconnected.Checkeachaircellissecurelyattachedtoits
connectingairpipe.
4.Checkallcells,pipesandhosesforanyairleakage.
5.Checkthattheairltershroudiscorrectlysecuredandtheairlter
isclean.
6.TurnonPower.
AlternationFailureindicator
LEDlightsup
+audiblewarning
AlternatingModeFailure(no
alternation)
1.Mutetheaudiblewarningandturnoffpower.
2.Disconnecttheairhosestoreducepressure–reconnectwhenpressure
hasdecreased.
3.Restartthesystembyswitchingthepowerbuttonoffandon.Thesystem
automaticallystartsinStaticModeandwillswitchtoAlternatingMode
whenoperationalpressureisreached.
4.Resetthepersonalsettings.
PowerlossindicatorLED
lightsup
+audiblewarning
Powerfailure1.Mutetheaudiblewarning.
2.Checkthatthepowercableisrmlypluggedintothemainsoutletand
thecontrolunit.Checkthatthemainspowerisswitchedon.
3.Checkbothcontrolunitfuses(1ampslowblowfuse)–fusecanbe
releasedusingascrewdrivertopushandturn.
Ifpowerisrestoredwithin20minutesoffailure,thesystemwillrunaninitial
startupsequencebeforereturningtothelastsettings.
ServiceIndicatorLEDlights
up
Serviceneeded1.ContactanInvacareproviderorInvacarerepresentative.
ThereisnoriskforcontinueduseeveniftheServiceIndicatorLED
lightsup.
161630732-C

TechnicalData
9TechnicalData
9.1ControlUnitSpecications
ControlUnit1in3
CycleControlPurposedesigneddistributorvalvesupplyingoperatingairtotheinatablecells
CycleTime12minutes
SupplyVoltage220-240V50/60Hz
AirCapacity10lpm
NoiselevelBelow30dB
FuseRating1A/250V
BatterySourceVARTA,V80H,1.2VDC,70mAh
PowerRatingmax.1A
ControlUnitDimensions:
Length
Width
Height
123(±10)mm
243(±10)mm
250(±10)mm
Controlunitweight4.2kg
HoseConnectionPushonconnectionhandle
EmergencyCPRTag
ModeofOperationNon-continuous
DegreeofprotectionIP21—Protectedagainstsolidobjectsover12.5mme.g.hands,largetools.
Protectedagainstverticallyfallingdropsofwaterorcondensation.
9.2Mattressspecications
SoftCloudAceSoftCloudPro
NarrowWideLargeXLNarrowWide
NumberofCells21(cellincell)including3staticheadcellsand5heelcells22(cellincell)including3static
headcellsand5heelcells
CellHeight200mm200mm
Dimensions:
Length
Width
Height
2000mm
830mm
200mm
2000mm
880mm
200mm
2000mm
1030mm
200mm
2000mm
1160mm
200mm
2000mm
830mm
200mm
2000mm
880mm
200mm
Alternationtype1in3cellcycles1in3cellcycles
Mattressweight8.0kg10.0kg11.2kg11.2kg9.8kg10.0kg
Minimum/
maximumUser
Weight
0–220kg0–350kg0–220kg
CellMaterial0.15mmTPUlmlaminatedon210deniernylonfabric
BaseMaterialNylonfabric420denierwitha0.1mmTPUcoating
CoverMaterial100%Polyurethanesurface,100%Polyesterinside
1630732-C17

SoftCloud®Ace,SoftCloud®Pro
9.3EnvironmentalConditions
OperationStorageand
Transport
Ambient
temperature
10°C–40°C-10°C–60°C
Relativehumidity30%–75%,
non-condensing
10%–70%,
non-condensing
Atmospheric
pressure
70–106kPa50–106kPa
9.4GuidanceandManufacturer’sDeclaration
Themattresssystemisintendedforuseintheelectromagneticenvironmentspeciedbelow.Thecustomerortheuserofthe
mattresssystemshouldensurethatitisusedinsuchanenvironment.
ElectromagneticEmissions
EmissiontestComplianceElectromagneticenvironment–guidance
RFemissions
CISPR11
Group1ThemattresssystemuseRFenergyonlyfortheirinternalfunctions.Therefore,its
RFemissionsareverylowandarenotlikelytocauseanyinterferenceinnearby
electronicequipment.
RFemissions
CISPR11
ClassB
Harmonicemissions
IEC61000-3-2
ClassA
Themattresssystemissuitableforuseinallestablishments,includingdomestic
establishmentsandthosedirectlyconnectedtothepubliclow-voltagepower
supplynetworkthatsuppliesbuildingsusedfordomesticpurposes.
Voltageuctuations/icker
emissions
IEC61000-3-3
Complies
ElectromagneticImmunity
ImmunitytestIEC60601testlevelCompliancelevelElectromagneticenvironment–guidance
Electrostaticdischarge(ESD)
IEC61000-4-2
±8kVcontact
±15kVair
±8kVcontact
±15kVair
Floorsshouldbewood,concreteorceramic
tile.Ifoorsarecoveredwithsynthetic
material,therelativehumidityshouldbeat
least30%.
Electricalfasttransient/burst
IEC61000-4-4
±2kVforpowersupplylines±2kVforpowersupplylinesMainspowerqualityshouldbethatofa
typicalcommercialorhospitalenvironment.
Surge
IEC61000-4-5
±1kVline(s)toline(s)±1kVdifferentialmodeMainspowerqualityshouldbethatofa
typicalcommercialorhospitalenvironment.
Voltagedips,short
interruptionsandvoltage
variationsonpowersupply
inputlines
IEC61000-4-11
<5%UT(>95%dipinUT)
for0.5cycle
40%UT(60%dipinUT)
for5cycles
70%UT(30%dipinUT)
for25cycles
<5%UT(>95%dipinUT)
for5sec
<5%UT(>95%dipinUT)
for0.5cycle
40%UT(60%dipinUT)
for5cycles
70%UT(30%dipinUT)
for25cycles
<5%UT(>95%dipinUT)
for5sec
Mainspowerqualityshouldbethatofa
typicalcommercialorhospitalenvironment.
Iftheuserofthemattresssystemrequires
continuedoperationduringpowermains
interruptions,itisrecommendedthat
themattresssystembepoweredfroman
uninterruptiblepowersupplyorabattery.
Powerfrequency(50Hz)
magneticeld
IEC61000-4-8
3A/m3A/mPowerfrequencymagneticeldsshould
beatlevelscharacteristicofatypical
locationinatypicalcommercialorhospital
environment.
NOTE:UTisthea.c.mainsvoltagepriortoapplicationofthetestlevel.
181630732-C

TechnicalData
ImmunitytestIEC60601testlevelCompliancelevelElectromagneticenvironment–guidance
ConductedRF
IEC61000-4-6
3Vrms
150kHzto80MHz
3Vrms
RadiatedRF
IEC61000-4-3
3V/m
80MHzto2.5GHz
3V/m
PortableandmobileRFcommunicationsequipment
shouldbeusednoclosertoanypartoftheCT515,
includingcables,thantherecommendedseparation
distancecalculatedfromtheequationapplicableto
thefrequencyofthetransmitter.
Recommendedseparationdistance:
d=1.167√P
d=1.167√P80MHzto800MHz
d=2.333√P800MHzto2.5GHz
wherePisthemaximumoutputpowerratingofthe
transmitterinwatts(W)accordingtothetransmitter
manufactureranddistherecommendedseparation
distanceinmeters(m).
FieldstrengthsfromxedRFtransmitters,as
determinedbyanelectromagneticsitesurveya),
shouldbelessthanthecompliancelevelineach
frequencyrangeb).
Interferencemayoccurinthevicinityofequipment
markedwiththefollowingsymbol:
NOTE1:At80MHzand800MHz,thehigherfrequencyrangeapplies.
NOTE2:Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreectionfrom
structures,objectsandpeople.
a)Fieldstrengthsfromxedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandlandmobileradios,amateur
radio,AMandFMradiobroadcastandTVbroadcastcannotbepredictedtheoreticallywithaccuracy.Toassesstheelectromagnetic
environmentduetoxedRFtransmitters,anelectromagneticsitesurveyshouldbeconsidered.Ifthemeasuredeldstrengthinthe
locationinwhichthemattresssystemisusedexceedstheapplicableRFcompliancelevelabove,themattresssystemshouldbeobserved
toverifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmaybenecessary,suchasreorientingorrelocating
themattresssystem.
b)Overthefrequencyrange150kHzto80MHz,eldstrengthsshouldbelessthan3V/m.
RecommendedseparationdistancesbetweenportableandmobileRFcommunicationsequipmentandthemattresssystemAlternating
ControlUnit
ThemattresssystemisintendedforuseinanelectromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled.Thecustomer
ortheuserofthemattresssystemcanhelppreventelectromagneticinterferencebymaintainingaminimumdistancebetweenportable
andmobileRFcommunicationsequipment(transmitters)andthemattresssystemasrecommendedbelow,accordingtothemaximum
outputpowerofthecommunicationsequipment.
Ratedmaximumoutputpower
oftransmitter(W)
Separationdistanceaccordingtofrequencyoftransmitter(m)
150kHzto80MHz
d=1.167√P
80MHzto800MHz
d=1.167√P
800MHzto2.5GHz
d=2.333√P
0.010.1170.1170.233
0.10.3690.3690.738
11.1671.1672.333
103.6893.6897.379
10011.66711.66723.333
Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommendedseparationdistancedinmeters(m)canbe
estimatedusingtheequationapplicabletothefrequencyofthetransmitter,wherePisthemaximumoutputpowerratingofthe
transmitterinwatts(W)accordingtothetransmittermanufacturer.
NOTE1:At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrangeapplies.
NOTE2:Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreectionfrom
structures,objectsandpeople.
1630732-C19

Notes