Mindray P7-3T - Electrical Safety; Electrical Leakage Current Test

TransducerControlsandInspection
20 Operator's Manual
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3.3 Electrical Safety
TheelectricalleakagecurrenttestshouldbeperformedontheTEEtransduceraftertaking
itoutoftheboxandpriortoeachexam,alternatively,ifthebite-guardinspectiontestis
donepriortoeachexam,thentheelectricalleakagecurrenttestshouldbedoneyearlyata
minimum.
3.3.1 Electrical Leakage Current Test
Mindrayultrasoundsystemswithaccessoriesaredesignedtomeettherequirementsfor
patientsafetydescribedinIEC60601-1MedicalElectricalEquipment-Part1.General
RequirementsforSafety.Tomaintainpatientsafetyitisimportanttohavealowelectrical
leakagecurrentintheproduct.
Theendoscopeshafthasnoelectricallyconductingsurfaces,andiscoveredwithalayer
ofmaterial,whichpermitsneitheruidsnorelectricitytopassthroughit.Electricalsafetyis
maintainedforthetransducerbykeepingthismaterialintact.EachTEEtransduceristested
forelectricalisolationandleakagecurrentbeforeitisshippedtoacustomer.
WARNING
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To avoid injury to the patient, do not use the transducer if the insulating material
has been punctured or otherwise compromised.
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Measuring electrical leakage current should only be done by qualified personnel.
Take all necessary precautions to avoid contact with non-insulated parts that
have applied voltage.
Checkingtheintegrityoftheinsulatingmaterialcannotalwaysbeaccomplishedbyvisual
inspections.Aprogramformeasuringtheelectricalleakagecurrentonaregularbasis
shouldbeestablished.Asaminimum,leakagetestsaccordingtoEN60601-1/IEC60601.1
§19mustbeperformedonceayear,orasrequiredbylocalregulation.Theleakage
limitsassociatedwithTypeBFAppliedPartmustbemet.Thetestrequiresaccesstothe
ultrasoundsystemandtostandardizedtestequipment.Thetransducerhastobeimmersed
inaNormalSalinesolution(50gNaClperliterwater)toabovethe40cmmark(butbelow
thehandle).
Mindrayrecommendskeepingawrittenlogoftheresults.