mectron Piezosurgery - Electromagnetic Compatibility (EMC)

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 Manualofuseandmaintenance
12.2 Electromagnetic compatibility EN 60601-1-2
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DANGER: Contraindications. Interference from other devices.
AnelectrosurgicalknifeorotherelectrosurgicaldevicesplacedinthevicinityofthePiezosurgery
Medicaldevicemayinterferewiththecorrectfunctioningofthesamedevice.
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DANGER: Contraindications. Interference with other devices.
EvenifconformingtoECstandard60601-1-2,thePiezosurgeryMedicaldevicemayinterferewith
otherdevices.
ThePiezosurgeryMedicaldevicemustnotbeusedinproximityof,orpiledwith,otherdevices.
However,if this were necessary, check and monitor the correct functioning of the device in that
conguration.
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DANGER:ThisdeviceneedsparticularEMCprecautionsandmustbeinstalledandoperatedin
conformitywiththeEMCinformationcontainedinthisparagraph.
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DANGER: Portable and mobile radio communication devices may inuence the correct
functioningofthedevice.
Guidance and manufacturer’s declaration - Electromagnetic emissions
ThePiezosurgeryMedicaldeviceisdesignedtoworkintheelectromagneticenvironmentspeciedbelow.
TheclientoruserofthePiezosurgeryMedicaldeviceshouldalwaysmakesurethatitisusedonlyinsuch
environment.
Emissiontest Compliance Electromagneticenvironment-Guidance
RFEmissions
CISPR11
Group1 THEPIEZOSURGERYMEDICALusesRFenergyonlyforits
internaloperation.ThePiezosurgerycouldproduceemissions
atfrequenciesinterferingwithotherdevicesinitsvicinity.Install
thePiezosurgeryMedicalawayfromlife-supportequipment.
Checkcorrectoperationofalltheequipmentbeforestartingthe
operation.
RFemissions
CISPR11
ClassA ThePIEZOSURGERYMEDICALissuitableforuseinall
establishmentsotherthandomestic,andmaybeusedin
domesticestablishmentsandthosedirectlyconnectedtothe
publiclow-voltagepowersupplynetworkthatsuppliesbuildings
usedfordomesticpurposes,providedthefollowingwarningis
heeded:
WARNING:Thisdeviceisintendedforusebyhealthcare
professionalsonly.Thisdevicemaycauseradiointerference
ormaydisrupttheoperationofnearbyequipment.Itmaybe
necessarytotakemitigationmeasures,suchasre-orienting
orrelocatingthePiezosurgeryMedicaldeviceorshieldingthe
location.
Harmonicemissions
IEC61000-3-2
ClassA
Voltageuctuations/Flicker
emissions
IEC61000-3-3
Complies