Invacare Matrx - Product Setup and Safety; Warning Symbol Definitions; Intended Use, Scope, and Service Life; Mounting Hardware and Headrest Pads

1.2Symbolsinthisusermanual
InthisUserManualwarningsareindicatedbysymbols.Thewarning
symbolsareaccompaniedbyaheadingthatindicatestheseverityof
thedanger.
WARNING
Indicatesapotentiallyhazardoussituationwhichifnot
avoidedcouldresultindeathorseriousinjury.
CAUTION
Indicatesapotentiallyhazardoussituationwhichifnot
avoidedcouldresultinproductdamage,minorinjury
orboth.
IMPORTANT
Indicatesahazardoussituationwhichifnotavoided
couldresultindamagetotheproduct.
Givesusefultips,recommendationsandinformation
forefficient,trouble-freeuse.
Thisproductcomplieswiththedirective93/42/EEC
formedicalproducts.Thelaunchdateforthisproduct
isspecifiedintheCEdeclarationofconformity.
Manufacturer
1.3Warranty
Weprovideamanufacturer’swarrantyfortheproductinaccordance
withourGeneralTermsandConditionsofBusinessintherespective
countries.Warrantyclaimscanonlybemadethroughtheprovider
fromwhomtheappliancewasobtained.
1.4Standardsandregulations
Qualityisoftheutmostimportanceforourcompany;allprocesses
arebasedontheISO9001andISO13485standards.
ThisproductfeaturestheCEmark,incompliancewiththeMedical
DeviceDirective93/42/EECClass1.
TheproductmeetstherequirementsofthestandardsDINEN12182
(Technicalaidsfordisabledpersons-generalrequirementsandtest
methods),DINENISO14971(Medicaldevices-Applicationofrisk
managementtomedicaldevices)andDINENISO10993–1(Biological
evaluationofmedicaldevices-Part1:Evaluationandtestingwithina
riskmanagementsystem).
Invacare®iscontinuouslyworkingtowardsensuringthatthe
company’simpactontheenvironment,locallyandglobally,isreduced
toaminimum.WeonlyuseREACHcompliantmaterialsand
components.
ForfurtherinformationpleasecontactInvacare®inyourcountry(for
addresses,seebackpageofthismanual).
1.5Intendeduse
TheMatrx®Elanheadresthardwareandheadrestpadsaredesigned
tooffercomfortandposteriorheadsupport.Itwillprovidesimple,
comfortableandeffectivesupporthelpingtomaximisefunctionand
seatingtolerance.
1.6Scopeofdelivery
Thefollowingcomponentsareincludedinthescopeofdelivery:
•Matrx®ElanHardware(MEHW,postlength356mm)or
Matrx®ElanMiniHardware(MEMH,postlength254mm)
(seeFig.1)
•Headrestpad(seeFig.2andfollowingtableforoptions)
Option
Designation
A
ElanStandardPad150mmx90mm–SMALL
B
ElanStandardPad250mmx130mm–MEDIUM
C
ElanStandardPad360mmx130mm–LARGE
D
ElanOccipitalPad230mmx180mm
E
ElanOccipitalPad300mmx200mm
F
Elan4–PointPad280mmx260mm
•Usermanual
1.7Servicelife
Theexpectedservicelifeofthisproductisthreeyearswhenusedin
accordancewithsafetyinstructionsandintendeduse,statedinthis
manual.Theeffectiveservicelifecanvarydependingonfrequency
andintensityofuse.
2Setupandusage
2.1Installingthemountinghardware/headrest
pads(Fig.1)
WARNING!
Riskofseriousinjury
Injurymayoccurduringuseofthewheelchairifa
headrestiswronglyadjustedornotinstalledcorrectly.
Theusersneckmaybecomehyperextendedintheevent
ofacollision,orwhenthesystemistiltedorreclined.
–Thisitemmustbefittedbyanexperiencedclinician
ortechnician.
–Beforeeachuse,checkthatallscrewsaresecurely
fastened.
WARNING!
Riskofsevereinjurywhentransportingtheclient
withinawheelchairfittedwithanInvacare®
Matrx®ELANheadrestinamotorvehicle.
–WhereverpracticableInvacarerecommendsthatthe
clientistransferredoutofthewheelchairintoavehicle
seatusingalapanddiagonalseatbeltoranappropriate
childsafetyseat.
–Invacare®Matrx®ELANheadrestsmayonlybeused
inconjunctionwithwheelchairsthatcomplywiththe
performancerequirementsofRESNAWC19orISO
7176–19.
–Forsafetransportationofaclientwithinawheelchair
inamotorvehicle,refertotheusermanualsofthe
wheelchairandthetie-downandoccupantrestraint
system(WTORS).
1.Removetheheadrestassemblyandcomponentsfromthe
packaging.
WARNING!
Riskofinjury
–Inspecttheheadresthardwaretoensurethatthereare
nomissingordamagedparts.
WARNING!
Riskofinjury
–Beforedrillingormodifyinganybackshell,always
contactthebackmanufacturertoensurethebackis
recommendedforaheadrestapplication.
Tools:
Allenkeys2.5mm/4mm/5mm(provided)
Hacksaw,Powerdrill,6mmdrillbit
1603314-A3