User's Manual

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Chapter 6: Safety 107
Safety
Fixedpathtissuemodels,inwhichsofttissuethicknessisheldconstant,sometimesareusedto
estimateIn Situacousticexposureswhenthebeampathislongerthan3cmandconsistslargely
offluid.Whenthismodelisusedtoestimatemaximumexposuretothefetusduring
transabdominalscans,avalueof
1dB/cmMHzmaybeusedduringalltrimesters.
Existingtissuemodelsthatarebasedonlinearpropagationmayunderestimateacoustic
exposureswhensignificantsaturationduetononlineardistortionofbeamsinwaterispresent
duringtheoutputmeasurement.
Themaximumacousticoutputlevelsofdiagnosticultrasounddevicesextendoverabroad
rangeofvalues:
•Asurveyof1990equipmentmodelsyieldedMIvaluesbetween0.1 and1.0attheirhighest
outputsettings.MaximumMIvaluesofapproximately2.0areknowntooccurforcurrently
availableequipment.MaximumMIvaluesaresimilarforrealtime2DandMModeimaging.
•Computedestimatesof upperlimitsto
temperatureelevationsduringtransabdomina lscans
wereobtainedinasurveyof1988and1990pulsedDopplerequipment.Thevastmajorityof
modelsyieldedupperlimitslessthanand4°C(1.8°and 7.2°F)forexposuresof
firsttrimesterfetaltissueandsecondtrimesterfetalbone,respectively.Thelargestvalues
obtained
wereapproximately1.5°C(2.7°F)forfirsttrimesterfetaltissueand7°C(12.6°F)for
secondtrimesterfetalbone.Estimatedmaximumtemperatureelevationsgivenherearefor
a“fixedpath”tissuemodelandarefordeviceshavingI
SPTA
valuesgreaterthan500 m W/
cm
2
.Thetemperatureelevationsforfetalboneandtissuewerecomputedbasedon
calculationproceduresgiveninSections4.3.2.14.3.2.6in“BioeffectsandSafetyofDiagnostic
Ultrasound”(AIUM,1993).
Acoustic output tables
Table 8throughTable 31indicatetheacousticoutputforthesystemandtransducer
combinationswithaTIorMIequaltoorgreaterthanone.Thesetablesareorganizedby
transducermodelandimagingmode.Foradefinitionoftermsusedinthetables,see“Terms
usedintheacousticoutputtables”
onpage 132.