How-To Guide

P25
Electrical Safety
T hetransducerandsoftw are,alongw itharepresentativedevice,havebeenverified as
com pliantw ithIEC 60601-1.T hetransducersm eetT ypeBFisolatedappliedpartrequirem ents.
W henthetransducerand softw areareusedinconjunctionw ithadevicecom pliantw ithIEC
60950-1,the system m eetsIEC 60601-1 requirem entsforClassII/internally pow ered
equipm ent.(T hesafety standardsm etby thissystem areincludedinthe“ S pecifications”
section.)Form axim um safety,observethesewarningsand cautions:
♦ 根據 NCC 低功率電波輻射性電機管理辦法規定
：
第十二條 經型式認證合格之低功率射頻電機，非經許可，公司、
商號或使用者均不得擅自變更頻率、加大功率或變更
原設計之特性及功能
。
第十四條 低功率射頻電機之使用不得影響飛航安全及干擾合法通信
；經發現有干擾現象時，應立即停用，並改善至無
干擾時方得繼續使用。前項合法通信，指依電信法規定作業之無線電通信
。低功率射頻電機須忍受合法通信或工業、科
學及醫療用電波輻射性電機設備之干擾
。
♦ 減少電磁波影響，
請妥適使用。
• Donotoperatethissystem inthepresenceofflam m ablegasesoranesthetics.
Explosioncanresult.T he system isnotcom pliantinAP /AP G environm entsas
definedby IEC 60601-1.
• T oavoid riskofelectricalshockhazards,alw aysinspectthetransducerbeforeuse.
Checktheface,housing,and cablebeforeuse.Donotuseifthefaceiscracked,
chipped,ortorn;thehousingisdam aged;orthecableisabraded.
• U ltrasoundequipm entinnorm aloperation,asw ithotherm edicalelectronic
diagnosticequipm ent,useshigh-frequency electricalsignalsthatcaninterfere w ith
pacem akeroperation.T houghthepossibility ofinterferenceisslight,bealerttothis
potentialhazardand stopsystem operationim m ediately ifyou noteinterference
w ithapacem aker.
• W henusingadditionalperipheralequipm entthatisto beinterconnectedby
functionalconnection,thecom binationisconsideredtobeam edicalelectrical
system .Itisyourresponsibility tocom ply w ithIEC 60601-1 andtestthesystem to
thoserequirem ents.Ifyou havequestions,contactyourL eltekrepresentative.
• P atient-applied partsm eetthe standardIEC 60601-1.Applied voltagesexceeding
the standard,although unlikely,m ay resultinelectricalshocktothepatientor
operator.
• T oavoid riskofelectricalshock,donotuseany transducerthathasbeenim m ersed
beyondthespecifiedcleaningordisinfectionlevel.
• Electrosurgicalunits(ES U s)and otherdevicesintentionally introduceradio
frequency electrom agneticfieldsorcurrentsintopatients.Becauseim aging
ultrasoundfrequenciesarecoincidentally intheradiofrequency range,ultrasound
transducercircuitsaresusceptibletoradiofrequency interference.W hile anES U is
inuse,severenoiseinterferesw iththeblack-and-w hiteim ageand com pletely
obliteratesthecolorim age.