Invacare Etude Plus User manual

Invacare®EtudePlus
EtudePlus,EtudePlusLow
enBed
UserManual
ThismanualMUSTbegiventotheuseroftheproduct.
BEFOREusingthisproduct,thismanualMUSTbereadandsaved
forfuturereference.

©2023InvacareCorporation
Allrightsreserved.Republication,duplicationormodicationinwholeorinpartisprohibitedwithoutpriorwritten
permissionfromInvacare.Trademarksareidentiedby™and®.AlltrademarksareownedbyorlicensedtoInvacare
Corporationoritssubsidiariesunlessotherwisenoted.

Contents
1General.........................................4
1.1Introduction..................................4
1.1.1SymbolsinthisDocument.....................4
1.2IntendedUse.................................4
1.2.1IntendedOperator...........................4
1.3ServiceLife...................................5
1.4Compliance...................................5
1.4.1Product-specicstandards.....................5
1.5WarrantyInformation...........................5
1.6LimitationofLiability............................5
2Safety..........................................6
2.1Generalsafetyinformation.......................6
2.2Mattresses...................................7
2.3Safetyinformationonelectromagneticinterference.....7
2.4Labelsandsymbolsontheproduct.................8
2.4.1Identicationlabel...........................8
2.4.2OtherLabels...............................8
3Setup...........................................10
3.1GeneralSafetyInformation.......................10
3.2Receivingthebed..............................10
3.3OtherItems..................................10
3.4Assemblyofthebed............................10
3.4.1AttachingLabels.............................11
3.5ControlBox...................................11
3.6Wiring......................................11
3.7Installingsiderails..............................12
3.7.1Scala2siderail.............................12
3.7.2BrittVandLinesiderail......................12
3.8Dismantlethebed..............................13
4Operatingthebed.................................14
4.1GeneralSafetyInformation.......................14
4.1.1LowHeights................................14
4.1.2Mattressretainers...........................14
4.2Handcontrol..................................14
4.2.1Lockingfunction.............................14
4.3Castorsandbrakes.............................15
4.3.1Castorbrake...............................15
4.4Operatingsiderails.............................15
4.4.1OperatingScala2siderail.....................15
4.4.2BrittVandLinesiderails......................16
4.5Liftingpole...................................16
4.5.1Placetheliftingpole.........................16
4.5.2Adjustingthehandleheight....................16
4.6Adjustingthelegsection.........................16
4.7Emergencypositions............................17
4.7.1Emergencyreleaseofamattresssupportsection....17
4.8Mattresssupportextension.......................17
4.9TransportationandStorage.......................17
5Options.........................................18
5.1Listofavailableoptions..........................18
5.2Transportbrackets..............................18
6Maintenance.....................................19
6.1Generalmaintenanceinformation..................19
6.2Dailyinspections...............................19
6.3Generalservicinginformation.....................19
6.3.1Checklistmaintenance........................19
6.4Inspectionafterrelocation-Preparefornewuser......19
6.4.1Checklist-Afterrelocation.....................19
6.5CleaningandDisinfection........................20
6.5.1GeneralSafetyInformation.....................20
6.5.2CleaningIntervals............................20
6.5.3CleaningbyHand............................20
6.5.4DisinfectionInstructions.......................20
6.6Lubrication...................................20
7AfterUse........................................21
7.1Disposal.....................................21
7.2Reconditioning................................21
8Troubleshooting...................................22
8.1Troubleshootingelectricalsystem...................22
9TechnicalData....................................23
9.1Materials....................................23
9.2Dimensions...................................23
9.3Weights.....................................23
9.4Mattresssizes.................................23
9.5Environmentalconditions........................24
9.6Electricalsystem...............................24
10Electromagneticcompatibility(EMC)..................25
10.1GeneralEMCinformation.......................25
10.2Electromagneticemission........................25
10.3ElectromagneticImmunity.......................25
10.3.1TestspecicationsforimmunitytoRFwireless
communicationsequipment...................26

Invacare®EtudePlus
1General
1.1Introduction
Thisusermanualcontainsimportantinformationaboutthe
handlingoftheproduct.Toensuresafetywhenusingthe
product,readtheusermanualcarefullyandfollowthe
safetyinstructions.
Onlyusethisproductifyouhavereadandunderstood
thismanual.Seekadditionaladvicefromahealthcare
professionalwhoisfamiliarwithyourmedicalconditionand
clarifyanyquestionsregardingthecorrectuseandnecessary
adjustmentwiththehealthcareprofessional.
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.
1.1.1SymbolsinthisDocument
Symbolsandsignalwordsareusedinthisdocumentand
applytohazardsorunsafepracticeswhichcouldresultin
personalinjuryorpropertydamage.Seetheinformation
belowfordenitionsofthesignalwords.
WARNING
Indicatesahazardoussituationthatcouldresult
inseriousinjuryordeathifitisnotavoided.
CAUTION
Indicatesahazardoussituationthatcouldresult
inminororslightinjuryifitisnotavoided.
NOTICE
Indicatesahazardoussituationthatcouldresult
indamagetopropertyifitisnotavoided.
TipsandRecommendations
Givesusefultips,recommendationsand
informationforefcient,trouble-freeuse.
OtherSymbols
(Notapplicableforallmanuals)
UKR P
UKResponsiblePerson
Indicatesifaproductisnotmanufacturedin
theUK.
Triman
Indicatesrecyclingandsortingrules(only
relevantforFrance).
1.2IntendedUse
Themedicalbediselectricallyoperated,adjustableinheight
andfeaturesaprolingsupportsurfaceintendedtobeused
incombinationwithamattress.Medicalbedsaredesigned
forsupportofthepatientandusedforthemitigation,
relief,andrecoveryfromcertainmedicalconditions.The
medicalbedalsosupportsandeasesthecaregivers’working
environment.
TheMedicalbedisintendedtobeusedon:
•Applicationenvironment3;Long-termcareina
medicalareawheremedicalsupervisionisrequired
andmonitoringisprovidedifnecessaryandmedical
electricalequipmentusedinmedicalproceduresmay
beprovidedtohelpmaintainorimprovethecondition
ofthepatient.
•Applicationenvironment4;Careprovidedinadomestic
areawheremedicalelectricalequipmentisusedto
alleviateorcompensateforaninjury,disabilityor
disease.
IntendedUsers
Apersonwithamedicalconditionthatneedstobecared
forinbed.
Indications
Thebedisintendedforadultusers,havingaphysicalsize
equaltoormorethan146cm,aweightequaltoormore
than40kgandabodymassindex(BMI)equaltoormore
than17.
Thebedisintendedforindooruseonly.
Maximumuserweightis165kgandsafeworkingloadis
200kg.
Contra-indications
Thebedisnotintendedfortransportationofusers.Itis
mobilewithinaroomwithauserinit.Castorsarelockable.
Thebedisnotintendedforpersonswithapsychosocial
disability.
WARNING!
Anyotherorincorrectusecouldleadtohazardous
situations.
Invacareacceptsnoliabilityforanyuse,change
orassemblyoftheproduct,otherthanstatedin
thisusermanual.
1.2.1IntendedOperator
Ahealthcareprofessionalorprivatepersonwhohasreceived
propertrainingistheintendedoperatorofthisproduct.
Thehandcontrolcanalsobeoperatedbytheoccupantof
thebed.
460128467-B

General
1.3ServiceLife
Theexpectedservicelifeofthisproductissevenyearswhen
useddailyandinaccordancewiththesafetyinstructions,
maintenanceintervalsandcorrectuse,statedinthismanual.
Theeffectiveservicelifecanvaryaccordingtofrequencyand
intensityofuse.
1.4Compliance
Qualityisfundamentaltothecompany’soperation,working
withinthedisciplinesofISO13485.
ThisproductfeaturestheCEmark,incompliancewiththe
MedicalDeviceRegulation2017/745ClassI.
ThisproductfeaturestheUKCAmark,incompliancewith
PartIIUKMDR2002(asamended)ClassI.
Wearecontinuouslyworkingtowardsensuringthatthe
company’simpactontheenvironment,locallyandglobally,
isreducedtoaminimum.
WeonlyuseREACHcompliantmaterialsandcomponents.
WecomplywiththecurrentenvironmentallegislationsWEEE
andRoHS.
1.4.1Product-specicstandards
TheproducthasbeentestedandconformstoIEC60601-2-52
(Particularrequirementsforthebasicsafetyandessential
performanceofmedicalbeds)andallrelatedstandards.
Forfurtherinformationaboutlocalstandardsandregulations,
contactyourlocalInvacarerepresentative.Seeaddresses
attheendofthisdocument.
1.5WarrantyInformation
Weprovideamanufacturer’swarrantyfortheproduct
inaccordancewithourGeneralTermsandConditionsof
Businessintherespectivecountries.
Warrantyclaimscanonlybemadethroughtheprovider
fromwhomtheproductwasobtained.
1.6LimitationofLiability
Invacareacceptsnoliabilityfordamagearisingfrom:
•Non-compliancewiththeusermanual
•Incorrectuse
•Naturalwearandtear
•Incorrectassemblyorset-upbythepurchaserorathird
party
•Technicalmodications
•Unauthorisedmodicationsand/oruseofunsuitable
spareparts
60128467-B5

Invacare®EtudePlus
2Safety
2.1Generalsafetyinformation
Thissectionofthemanualcontainsgeneralsafety
informationaboutyourproduct.Forspecicsafety
information,refertotheappropriatesectionofthemanual
andprocedureswithinthatsection.
WARNING!
Riskofinjuryordamage
–Donotusethisproductoranyavailableoptional
equipmentwithoutrstcompletelyreading
andunderstandingtheseinstructionsandany
additionalinstructionalmaterialsuchasuser
manualsorinstructionsheetssuppliedwith
thisproductoroptionalequipment.Ifyouare
unabletounderstandthewarnings,cautionsor
instructions,contactahealthcareprofessional,
Invacareproviderorqualiedtechnicianbefore
attemptingtousethisproduct.
–Donotmakeanyunauthorizedalterationsor
modicationstotheproduct.
WARNING!
Riskofentrapment/suffocation
There’sariskofentrapment/suffocation
betweenmattresssupport,siderailandbedend
orbetweenmovingpartsandobjectsplaced
nearbythebed.
–Thebedmustnotbeusedbypersonsunder12
yearsofage,orbypersonswithabodysize
equivalenttoanaverage12yearsoldorsmaller.
–Thebed,incombinationwithsiderailsmust
notbeusedbypersonshavingaphysicalsize
lessthan146cm,aweightlessthan40kgora
bodymassindex(BMI)lessthan17.
–Duetomattresscompression,anincreased
riskmayoccurovertime.Periodicallymonitor
gapsbetweenthebed,mattressand/orside
rail.Replacemattressifthegapsmayleadto
entrapment.
WARNING!
Riskofslippingthroughtheopenings
Thebedfullsallrequirementsregarding
maximumdistances.However,itispossible
thatpersonswithsmallbodydimensionsslip
throughtheopeningsbetweenthesiderailsor
throughtheopeningbetweenthesiderailand
themattresssupport.
–Payspecialattention,ifthebedisusedforthe
careofpersonswithsmallbodydimensions.
WARNING!
Riskofinjuryordamage
Inappropriatehandlingofcables,incorrect
connectionsanduseofunauthorizedequipment
cancauseelectricalshockandproductfailure.
–Donotkink,shearorotherwisedamagethe
cablesoftheproduct.
–Makesurethatnocablesarejammedor
damaged,whentheproductisused.
–Disconnecttheplugfromthemainsbefore
movingthebed.
–Makesurethewiringiscorrectandconnections
areproper.
–Donotuseunauthorizedequipment.
WARNING!
Riskoftripping,entanglementorstrangulation
Improperroutingofcablesmaycausetripping,
entanglementorstrangulationhazard.
–Ensureallcablesareroutedandsecured
properly.
–Ensuretherearenoloopsofexcesscable
extendingawayfromtheproduct.
WARNING!
Riskofinjuryordamage
Ignitionsourcescancauseburnsorre.
–Bedmustbeplacedwithasafetyspacefrom
possibleignitionsources(heater,replace,etc.)
–Thepatientandassistantsmustnotsmoke
whileusingoroperatingthebed.
WARNING!
Riskofinjuryordamage
Toavoidinjuryordamagewhenoperatingthe
product:
–Closesupervisionisnecessarywhentheproduct
isusednearchildrenorpets.
–Donotletchildrenplaywiththeproduct.
CAUTION!
–Forapersonenteringorexitingthebed,always
lowerthebedtoanappropriateheight.For
enteringorexitingthebed,thebackrestsection
ofthemattresssupportcanbeusedasan
assistance.Makesurethepatientislaiddown
atthecentreofthebackrestsection.When
thebackrestsectionisbeingraisedtheallowed
maximumweightforthebackrestsectionis
45%ofmaximumsafeworkingload.
–Alwayslowerthebedtothelowestposition
beforeleavingapersoninthebedunattended.
–Makesurethatthereisnothingunder,over,
ornearthebedthatcanobstructtheheight
adjustment,likeforexamplefurniture,liftsor
windowframes.
660128467-B

Safety
CAUTION!
Non-originalorwrongaccessoriesmayaffectthe
functionandsafetyoftheproduct.
–Onlyuseoriginalaccessoriesfortheproduct
inuse.
–Duetoregionaldifferences,refertoyour
localInvacarecatalogorwebsiteforavailable
accessoriesorcontactyourlocalInvacare
representative.Seeaddressesattheendof
thisdocument.
CAUTION!
Riskofinjuryordamage
Theproductcangethotwhenexposedtosunlight
orotherheatsources.
–Donotexposetheproducttodirectsunlightfor
prolongedperiods.
–Keeptheproductawayfromheatsources.
CAUTION!
Thereisariskofentrapmentofngersinthe
bedmovingparts.
–Payattentiontoyourngers.
NOTICE!
Thebedhasnoisolator(mainswitch).Ifthebed
needstobeelectricallydisconnected,ithastobe
unpluggedfromthemainssocket.
–Alwaysplacethebedinawaysothemains
socketiseasilyaccessibletounplugthebed.
NOTICE!
Accumulationoflint,dustandotherdirtcan
impairtheproduct.
–Keeptheproductclean.
2.2Mattresses
WARNING!
Safetyaspectsregardingcombinationofside
railsandmattresses:
Togetthehighestpossiblesafetylevel,when
usingsiderailsonthebed,theminimumand
maximummeasuresformattresses,mustbe
respected.
–Forcorrectmattressmeasuresseemattress
tableinchapter9TechnicalData,page23.
WARNING!
Riskofentrapmentand/orsuffocation
–Theusercouldgettrappedand/orsuffocate,if
thehorizontalspace,betweenthemattressside
andtheinsideofthesiderail,istoobig.Follow
theminimumwidth(andlength)ofmattresses
incombinationwithasiderail,asstatedin
themattresstableinchapter9TechnicalData,
page23.
–Beawarethatusingverythickorsoft
mattresses(lowdensity),oracombinationof
these,increasestherisk.
A
WARNING!
Riskoffalling
Theusercanfallovertheedgeandgetseriously
injured,iftheverticaldistanceAbetweenthe
topofthemattressandtheedgeoftheside
rail/bedend,istooshort.Seeimageabove.
–AlwayskeepaminimumdistanceAof22cm.
–Followthemaximummattressheightin
combinationwiththesiderailasstatedinthe
mattresstableinchapter9TechnicalData,
page23.
2.3Safetyinformationon
electromagneticinterference
WARNING!
Riskofmalfunctionduetoelectromagnetic
interference
Electromagneticinterferencebetweenthis
productandotherelectricalequipmentcanoccur
anddisturbtheelectricaladjustmentfunctions
ofthisproduct.Toprevent,reduceoreliminate
suchelectromagneticinterference:
–Onlyuseoriginalcables,accessoriesandspare
parts,tonotincreaseelectromagneticemission
orreduceelectromagneticimmunityofthis
product.
–Donotuseportableradiofrequency(RF)
communicationsequipmentcloserthan30cm
toanypartofthisproduct(includingcables).
–Donotusethisproductnearactive
high-frequencysurgicalequipmentandthe
RFshieldedroomofasystemformagnetic
resonanceimaging,wheretheintensityof
electromagneticdisturbancesishigh.
–Ifdisturbancesoccur,increasethedistance
betweenthisproductandtheotherequipment
orswitchitoff.
–Refertothedetailedinformationandfollow
theguidanceinchapter10Electromagnetic
compatibility(EMC),page25.
60128467-B7

Invacare®EtudePlus
WARNING!
Riskofmalfunctionduetoelectromagnetic
interference
Donotusethisbedadjacenttoorstackedwith
otherelectricalequipment,thanspeciedinthe
following,asitcouldresultinimproperoperation.
Ifsuchuseisnecessary,thebedandtheother
equipmentmustbecloselyobservedtoverify
thattheyareoperatingnormally.
ThisbedcanbeusedtogetherwithInvacare
approvedaccessoriesandmedicalelectrical
equipmentconnectedtotheheart(intracardially)
orbloodvessels(intravascularly)providedthat
followingpointsarerespected:
–Medicalelectricalequipmentshouldnotbe
xedonthebed’smetallicaccessoriessuchas
siderails,liftingpole,driprod,bedends,etc.
–Themedicalelectricalequipmentpowersupply
cordshouldbekeptclearoftheaccessoriesor
anyothermovingpartsofthebed.
2.4Labelsandsymbolsontheproduct
2.4.1Identicationlabel
Theidenticationlabelisplacedontheframeofthebedand
containsthemainproductinformation,includingtechnical
data.
YYYY-MM
Invacare Portugal, Lda
Rua Estrada Velha 949
4465-784 Leça do Balio, Portugal
XXXXXX XXXXX_XX
XXXXXXXXXXXXX
SN
= xxx kg
= xxx kg
XXXXXXXXXXXXX
XXX XXX XX XX XX X
XXX XXX XX XX XX X
XXX XXX XX XX XX X
XXX XXX XX XX XX X
XXX XXX XX XX XX X
Serialnumber
Referencenumber
Manufacturer
Dateofmanufacture
Medicaldevice
Max.userweight
Max.safeworkingload
CLASSIIequipment
TypeBappliedpart
WEEEconform
EuropeanConformity
UKConformityAssessed
Abbreviationsfortechnicaldata:
•Iin=IncomingCurrent
•Uin=IncomingVoltage
•Int.=Intermittence
•AC=AlternatingCurrent
•Max=maximum
•min=minutes
Formoreinformationabouttechnicaldata,referto9
TechnicalData,page23.
2.4.2OtherLabels
Readtheusermanualbeforeusingthisproductandfollow
allinstructionsforsafetyanduse.
Denitionofmin.weight,min.heightand
min.bodymassindexofanadultuser.
SeeIntendedUse.
Refertouserdocumentationforthe
correctmattressmeasures.
See9TechnicalData,page23.
XX
XX
XX
XX
XX
XX XXX
XXX =XXX
Totalweightoftheproductwiththe
maximumsafeworkingloadapplied
Temperaturelimit
Humiditylimitation
Atmosphericpressurelimitation
860128467-B

Safety
Transportandstorageconditions
Operationconditions
Indicatesareaswithincreasedriskofsqueezingfeeton
thelowersidesofthebedendsnearthecastors.
See4.1.1LowHeights,page14
(Onlypresentonthelowversionsofthisproduct)
Indicatesdetachablepartswithamassofmorethan20kg.
See9TechnicalData,page23.
Labelon3/4lengthsiderails
< 6 cm
Indicatesthemaximumspacebetweensiderailandthe
headbedend.
Seethemountinginstructioninthismanualorthe
instructiondeliveredwiththesiderail.
60128467-B9

Invacare®EtudePlus
3Setup
3.1GeneralSafetyInformation
WARNING!
Riskofinjuryordamage
Damagedpartsmayaffectthesafetyofthe
product.
–Checkallpartsforshippingdamagebeforeuse.
–Incaseofdamage,donotusetheproduct
andcontactyourInvacareproviderforfurther
instructions.
WARNING!
Riskofinjuryordamagetoproperty
Theassemblyofthebedandinstallationof
accessoriesmustonlybeperformedbyaqualied
technicianorapersonwhohasreceivedproper
training.
–Followinstructionscarefully.Ifyouhaveany
questionregardingtheassembly,contactyour
Invacareprovider.
–Theelectricalequipmentofthebedmustnot
bedismantledorcombinedwithotherelectrical
equipment.
–Aftereachassembly,checkthatallttingsare
properlytightenedandthatallpartshavethe
correctfunction.
NOTICE!
–Topreventcondensation,thebedshould
notbeuseduntilithasreachedoperating
temperature.See9TechnicalData,page23
3.2Receivingthebed
AB
C
D
E
G
F
H
I
J
Scopeofdelivery:
AMattresssupport,headend
BMattressretainers,4pcs
CSiderails(woodorsteel),2pcs
DMattresssupport,footend
EMotorforbedend
FCastors,4pcs
GMotorforheadend
IMotorforlegend
JBedends,2pcs
Handcontrol(notshown)
Optional
HMattresssupportextension(10or20cm)
Liftingpole
Transporttting
Siderailsmightnotbepartoftheconguration.For
moreinformationaboutsiderailsandotheroptions,
contactyourInvacarerepresentative.
3.3OtherItems
Thefollowingitemsarealsoprovidedwithinthescopeof
delivery:
PartQuantity
Usermanual1
Entrapmentlabel4
3.4Assemblyofthebed
WARNING!
–Aftereachassembly,checkthatallttingsare
tightenedcorrectlyandthatthefunctionofall
partsisgiven.
Mattresssupport
1.Placethetwoinsertsintheupperhalfofthemattress
support.Theinsertsmustbemountedinsuchaway
thatoneextendsfurtheroutofthesidetubethanthe
other.
2.Looselyscrewinthetwothumbscrews.
3.Pushthelowerhalfofthemattresssupportontothe
twoinserts.
4.Tightenwithtwothumbscrews.
5.Retightenthetwothumbscrewsattheheadendof
thetopframe.
6.Turnupthefourmattresssupportbrackets.
7.Turnthehandleofthelegsectionup.
1060128467-B