Safety-related information | EN
7
3. Safety-related information
3.1. General safety-related information
AllseriousincidentsrelatedtothedevicemustbereportedtothemanufacturerandthecompetentauthorityoftheMemberStatewheretheuserand/orthepatient
is resident.
3.2. Safety instructions
Assembly,modicationsorrepairsmayonlybecarriedoutbyauthorisedqualiedpersonnelwhoguaranteecompliancewiththeEN60601-1standard(international
standardonMedicalElectricalEquipmentandSystems,inparticularpart1:Generalrequirementsforbasicsafety).
TheelectricalinstallationmustcomplywiththeregulationsoftheIEC(InternationalElectrotechnicalCommission).
Medicaldevicesshouldbehandledwithcarewithregardtoelectromagneticcompatibility.Specialsafetymeasuresmustthereforebetaken.
Thedeviceisnotsuitableforoperationinexplosiveareasorinammableatmospheres.
3.3. Warnings
Danger Warningofadangerthatwilldirectlyresultinseriousinjuryordeath
Warning Warningofadangerthatcanresultinseriousinjuryordeath
Caution Warningofadangerthatcanresultinminorinjury
Attention Warning of a danger that can result in extensive damage to property