Quantity Of Ultrasonic Energy - Tomey UD-800 Instruction Manual

8.2 Quantity of ultrasonic energy

The ultrasound wave output table based on IEC60601-2-37 is as shown below.
Ultrasound wave output table (IEC60601-2-37)
Index label
Maximum index value
pr,α[Mpa]
P[mW]
Min.of [Pα(zs),Ita,α(zs)]
Zs
Zbp
Associated
Zb
acoustic
Z at max.Ipi,α [cm]
parameters
deq(zb)
fawf[MHz]
Dim of Aaprt [cm]
Td[us]
Prr[Hz]
Other
Pr at max.Ipi [MPa]
information
deq at max.Ipi
Ipa,α at max.MI [W/ cm
Operating
Control
control
conditions
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
X
Y
2 ]
MI:
10M B probe
0.207
0.648
N/A
N/A
N/A
N/A
N/A
1.85
N/A
9.83
N/A
N/A
0.131
2620
1.2113
N/A
12.227
N/A
TIS Scan
10M B probe
0.06481
N/A
0.06671
N/A
N/A
N/A
N/A
N/A
N/A
9.83
0.52
0.52
N/A
N/A
N/A
N/A
N/A
N/A
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