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Traditional 510(k) of Fetal & Maternal Monitor
F15 Series Fetal & Maternal Monitor User Manual
Nominal Frequency: 1.0MHz
Operating Mode: PW Mode
Acoustic Output
Global Maximum Value
p
r.3
P
f
c
Z
Associated
Beam
Acoustic
dimensions
Parameter
PD
PRF
EBD
Focus(mm)
Operating Control
Depth(mm)
Conditions
Frequency(MHz)
A4.6.3 Standard Parameter Equal Contrast List
IEC60601-2-37 standard parameter equal contrast list
IEC60601-2-37 parameter
p
r.α
p
P
z
P
(Z
α
I
(Z
ta.α
z
bp
z
I
pi.α
I
pi
d
(Z
eq
f
awf
X
Y
t
d
prr
d
eq
FL
014_14.1_F15_Series_User_Manual
(MPa)
(mW)
o
(MHz)
(cm)
sp
x
(cm)
-6
y
(cm)
-6
(usec)
(Hz)
Az.
Ele.
r
s
)
s
)
s
b
)
b
x
MI
0.036
0.036
1.00
0.50
91.41
2000.00
(cm)
(cm)
Attenuated Peak-rare-factional Acoustic Pressure
Peak-rare-factional Acoustic Pressure
Depth for Soft Tissue Thermal Index
Attenuated Output Power
Attenuated Temporal-average Intensity
Break-point Depth
Depth for Bone Thermal Index
Attenuated Pulse-intensity Integral
Pulse-intensity Integral
Equivalent Beam Diameter at the point of Z
Center Frequency, Acoustic Working Frequency
-12dB Output Beam Dimensions
Pulse Duration
Pulse Repetition Frequency
(Pulse Repetition Rate)
Equivalent Beam Diameter
- 154 -
Ultrasound Intensity and Safety
I
SPTA.3
2
(mW/cm
)
13.57
11.38
1.00
0.50
0.49
0.44
Φ2.65
Φ2.65
Fixed
Fixed
1.0
NOTE
Output Power
Focal Length
I
SPPA.3
2
(W/cm
)
0.075
11.38
1.00
0.50
0.49
0.44
91.41
2000.00
sp
170／202
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