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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
P
f
c
Z
Associated
Beam
Acoustic
dimensions
Parameter
PD
PRF
EBD
Focus(mm)
Operating Control
Depth(mm)
Conditions
Frequency(MHz)
(IEC60601-2-37:2007+AMD1:2015, table 201.103)
Transducer Model: US-SAF
Nominal Frequency: 1.0MHz
Operating Mode: PW Mode
Index label
Maximum index value
Index component value
Acoustic
p
at z
r.α
MI
Parameters
(MPa)
P
P
1x1
z
s
z
b
z
MI
z
PII.α
f
awf
Other
prr
Information
srr
n
pps
I
pa.α
2
(W/cm
)
I
at z
spta.α
z
(mW/cm
SII.α
I
at z
spta
(mW/cm
p
at
r.
(MPa)
Operating
Focus(mm)
control
Depth(mm)
conditions
Frequency(MHz)
NOTE: N/A indicates that there is no corresponding intended use or no data reported.
Acoustic Output Reporting Table for Track 1(Non-autoscanning Mode)
Transducer Model: US-SAF
014_14.1_F15_Series_User_Manual
(MPa)
r.3
(mW)
o
(MHz)
(cm)
sp
x
(cm)
-6
y
(cm)
-6
(usec)
(Hz)
Az.
Ele.
Acoustic output reporting table
MI
0.036
0.036
(mW)
(mW)
(cm)
(cm)
(cm)
0.50
0.50
(cm)
(MHz)
1.00
(Hz)
2000.00
(Hz)
N/A
N/A
at
z
0.075
PII.α
or
13.57
PII.α
2
)
or z
14.14
PII
SII
2
)
z
0.037
PII
Fixed
Fixed
1.00
MI
0.045
0.045
1.00
0.50
89.52
2000.00
(cm)
(cm)
TIS
At
Below
surface
surface
0.0071
N/A
0.0071
11.38
N/A
4.05
1.00
N/A
Fixed
N/A
Fixed
N/A
1.00
- 153 -
Ultrasound Intensity and Safety
I
I
SPTA.3
SPPA.3
2
(mW/cm
)
(W/cm
21.18
0.12
11.41
11.41
1.00
1.00
0.50
0.50
0.53
0.53
0.44
0.44
89.52
2000.00
Φ3.46
Φ3.46
Fixed
Fixed
1.0
TIB
At
Below
surface
surface
0.11
N/A
0.11
11.38
N/A
4.05
1.00
N/A
Fixed
N/A
Fixed
N/A
1.00
2
)
TIC
N/A
N/A
N/A
N/A
N/A
N/A
169／202
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