EDAN F15 Series User Manual

F15 Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety
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Nominal Frequency: 1.0MHz
Operating Mode: PW Mode
Acoustic Output
MI
I
SPTA.3
(mW/cm
2
)
I
SPPA.3
(W/cm
2
)
Global Maximum Value
0.045
21.18
0.12
Associated
Acoustic
Parameter
p
r.3
(MPa)
0.045
P
o
(mW)
11.41
11.41
f
c
(MHz)
1.00
1.00
1.00
Z
sp
(cm)
0.50
0.50
0.50
Beam
dimensions
x
-6
(cm)
0.53
0.53
y
-6
(cm)
0.44
0.44
PD (usec)
89.52
89.52
PRF (Hz)
2000.00
2000.00
EBD
Az. (cm)
Φ3.46
Ele. (cm)
Φ3.46
Operating Control
Conditions
Focus(mm)
Fixed
Depth(mm)
Fixed
Frequency(MHz)
1.0
Acoustic output reporting table
(IEC60601-2-37:2007+AMD1:2015, table 201.103)
Transducer Model: US-SAF
Nominal Frequency: 1.0MHz
Operating Mode: PW Mode
Index label
MI
TIS
TIB
TIC
At
surface
Below
surface
At
surface
Below
surface
Maximum index value
0.036
0.0071
0.11
N/A
Index component value
N/A
0.0071
N/A
0.11
Acoustic
Parameters
p
r.α
at z
MI
(MPa)
0.036
P (mW)
11.38
11.38
N/A
P
1x1
(mW)
N/A
N/A
z
s
(cm)
4.05
z
b
(cm)
4.05
z
MI
(cm)
0.50
z
PII.α
(cm)
0.50
f
awf
(MHz)
1.00
1.00
1.00
N/A
Other
Information
prr (Hz)
2000.00
srr (Hz)
N/A
n
pps
N/A
I
pa.α
at z
PII.α
(W/cm
2
)
0.075
I
spta.α
at z
PII.α
or
z
SII.α
(mW/cm
2
)
13.57
I
spta
at z
PII
or z
SII
(mW/cm
2
)
14.14
p
r.
at z
PII
(MPa)
0.037
Operating
control
conditions
Focus(mm)
Fixed
N/A
Fixed
N/A
Fixed
N/A
Depth(mm)
Fixed
N/A
Fixed
N/A
Fixed
N/A
Frequency(MHz)
1.00
N/A
1.00
N/A
1.00
N/A
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
Traditional 510(k) of Fetal & Maternal Monitor
014_14.1_F15_Series_User_Manual
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EDAN F15 Series Specifications

General

Brand	EDAN
Model	F15 Series
Category	Monitor
Language	English