User's Manual

Table Of Contents
68
•AcousticOutputMeasurementStandardforDiagnosticUltrasoundEquipment,NEMA
UD22004.
•AcousticOutputMeasurementandLabelingStandardforDiagnosticUltrasound
Equipment,AmericanInstituteofUltrasoundinMedicine,1993.
StandardforRealTimeDisplayofThermalandMechanicalAcousticOutputIndiceson
DiagnosticUltrasoundEquipment,NEMAUD32004.
•Guidanceonthe interpretationof
TIandMItobeusedtoinformtheoperator,AnnexHH,
BSEN60601237reprintedatP05699.
Transducer surface temperature rise
Table 6andTable 7listthemeasuredsurfacetemperaturerisefromambient*oftransducers
usedontheultrasoundsystem.ThetemperaturesweremeasuredinaccordancewithEN
60601237section42wherecontrolsandsettingswerepositionedtogivemaximum
temperatures
Test1:Thetransducersurfacetemperaturetestontissuemimicking
material(TMM)isbased
onthefollowingstandard:42.3(a)1,TestMethodB(IEC60601237,Amendment1).Thelimit
isa10°Crisefromambient,asmeasuredontheTMM.
Test2:Thetransducersurfacetemperaturetestinairisbasedonthefollowingstandard:
42.3(a)2(IEC60601
237,Amendment1).Thelimitisa27°Crisefromambient.
Test3:ThetransducersurfacetemperaturetestonTMMisbasedonthefollowingstandard:
42.3(a)1,TestMethodB(IEC60601237,Amendment1).Thelimitisa6°Crisefromambient,
asmeasuredontheTMM.
*The
ambienttemperatureshallbe23°C±3°C.
Table 6: Transducer Surface Temperature Rise EN 60601-2-37 (External Use)
Test C11x C60x HFL38x L25x L38x P21x
1 9.2°C 9.0°C 9.5°C 9.5°C 9.6°C 9.0°C
2 19.0°C 18.0°C 19.0°C 18.2°C 20.0°C 20.0°C
Table 7: Transducer Surface Temperature Rise IEC 60601-2-37 (Internal Use)
Tes t IC Tx
35.5°C
2 12.0°C