Invacare BS7177 Manual do usuário

Invacare®SoftformActive®2Rx

enMattresssystem

UserManual......................................3

daMadrassystem

Brugsanvisning....................................21

deMatratzensystem

Gebrauchsanweisung................................39

esSistemadecolchón

Manualdelusuario.................................59

Patjajärjestelmä

Käyttöohje.......................................79

frSystèmedematelas

Manueld'utilisation................................97

itSistemaamaterasso

Manualed’uso....................................117

nlMatrassysteem

Gebruiksaanwijzing.................................137

noMadrassystem

Bruksanvisning....................................157

ptSistemadecolchões

Manualdeutilização................................175

ruСистемаматраца

Руководствопоэксплуатации........................195

svMadrassystem

Bruksanvisning....................................217

ThismanualMUSTbegiventotheuseroftheproduct.

BEFOREusingthisproduct,thismanualMUSTbereadandsaved

forfuturereference.

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

2.2EMCinformation...............................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®2Rx

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.

41630000-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

Thedevicedeliverseffectivepressurereduction,

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

andcausedamagetothedevice.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

•Takecarewhenhandlingtheproducttoensureno

damagetothecover.

•Itisrecommendedthattwopeoplelift/carrythe

product.

•Avoidcontactwithjewellery,nails,abrasivesurfaces,

etc.

•Donotdragtheproduct.

•Avoidcontactwithwall,doorframes,doorcatchesor

locks,etc.

•Donottransportinrollcagesunlesscompletely

protectedfromthesharpedgesofthecage.

1630000-D5

Invacare®SoftformActive®2Rx

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.

61630000-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

1630000-D7

Invacare®SoftformActive®2Rx

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.

81630000-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.

1630000-D9

Invacare®SoftformActive®2Rx

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.

101630000-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.

1630000-D11

Invacare®SoftformActive®2Rx

6Maintenance

6.1Inspection

Itisrecommendedtocheckmattresses(aircellsandcover)

forstrike-through(thismayincludeuidingress,stains,rips

ordamage)afterthereleaseofeachpatientoraftereach

periodofusebyasuitablyqualiedandcompetentperson.

Checkmattresses

1.Unzipthecovercompletely.

2.Checkforanystainingonthewhiteundersideofthe

cover.

3.Checkforanystainingontheinternalelements.

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.

121630000-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.

1630000-D13

Invacare®SoftformActive®2Rx

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.

141630000-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).

1630000-D15

Invacare®SoftformActive®2Rx

9TechnicalData

9.1MattressSpecications

Dimensions[mm]

ProductLengthWidthHeight

Aircellheight

[mm]

Maximum

userweight

[kg]

Weightof

product[kg]1

SoftformActive2Rx1810—2100830—90015275247.614

1.Weightcanvarydependingonmattresssize.Averageweightusedasanindication.

161630000-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

1630000-D17

Invacare®SoftformActive®2Rx

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:

181630000-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.

1630000-D19

Invacare®SoftformActive®2Rx

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.

201630000-D

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