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Aquatec orca - 1 General; Information about the User Manual; Symbols in this User Manual; Warranty

Aquatec orca
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Aquatec®ORCA/ORCAF/ORCAXL
1General
1.1Informationabouttheusermanual
Thisusermanualcontainsimportantinformationaboutthehandling
oftheproduct.Inordertoensuresafetywhenusingtheproduct,
readtheusermanualcarefullyandfollowthesafetyinstructions.
Thepositionspecifications(A,B,C,etc.)inthehandlinginstructions
alwaysrefertotheprecedingfigure.
1.2Symbolsinthisusermanual
Inthisusermanual,warningsaremarkedwithsymbols.Thetitlenext
tothewarningsymbolindicatesthelevelofdanger.
WARNING
Indicatesadangeroussituationwhichcouldleadto
deathorseriousinjuryifnotavoided.
CAUTION
Indicatesadangeroussituationwhichcouldleadto
minorinjuriesifnotavoided.
IMPORTANT
Indicatesadangeroussituationwhichcouldleadto
damageifnotavoided.
Usefultips,recommendationsandinformationto
ensureefficientandsmoothoperation.
Thisproductcomplieswiththedirective93/42/EEC
formedicalproducts.Thelaunchdateforthisproduct
isspecifiedintheCEdeclarationofconformity.
Manufacturer
1.3Warranty
Weprovideamanufacturer’swarrantyfortheproductinaccordance
withourGeneralTermsandConditionsofBusinessintherespective
countries.Warrantyclaimscanonlybemadethroughtheprovider
fromwhomtheappliancewasobtained.
Coversandsuctioncupsareexcludedfromthis.
1.4Standardsandregulations
Qualityisoftheutmostimportanceforourcompany;allprocesses
arebasedontheISO9001andISO13485standards.
ThisproductfeaturestheCEmark,incompliancewiththeMedical
DeviceDirective93/42/EECClass1.
TheproductmeetstherequirementsofthestandardsENISO
14971(Medicaldevices-Applicationofriskmanagementto
medicaldevices),DINENISO10535(Hoistsforthetransferof
disabledpersons-Requirementsandtestmethods),IEC60601-1
(Medicalelectricalequipment-Part1:Generalrequirementsfor
basicsafetyandessentialperformance).IEC60601-1-2(Medical
electricalequipment-Part1-2:Generalrequirementsforbasicsafety
andessentialperformance-Collateralstandard:Electromagnetic
disturbances-Requirementsandtests)andDINENISO10993–1
(Biologicalevaluationofmedicaldevices-Part1:Evaluationand
testingwithinariskmanagementsystem).
Ithasaliftcapacitygreaterthan1.5timesthenominalload.
Invacare®iscontinuouslyworkingtowardsensuringthatthe
company’simpactontheenvironment,locallyandglobally,isreduced
toaminimum.
Wecomplywiththecurrentenvironmentallegislation(e.g.
WEEEandRoHSdirectives).
WeonlyuseREACHcompliantmaterialsandcomponents.
4
1574469-A

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