8-5
■
8.2 Quantity of ultrasonic energy
Ispta.3 : 17 mW/cm2 or less
Isppa.3 : 28 W/cm2 or less
MI : 0.23 or lower
Standards for ultrasonic wave output in an eyeball based on the 510(k) guidelines
of FDA
Ispta.3 : Spatial peak temporal average strength
Isppa.3 : Spatial peak pulse average strength
MI : Mechanical index
The ultrasound wave output table based on IEC60601-2-37 is as shown below.
Ultrasound wave output table (IEC60601-2-37)
Associated
acoustic
parameters
Min.of [Pα(zs),Ita,α(zs)]
Operating
control
conditions