EDAN F15 Series User Manual

F15 Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety
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PD (usec)
91.78
91.78
PRF (Hz)
2000.00
2000.00
EBD
Az. (cm)
Φ2.65
Ele. (cm)
Φ2.65
Operating Control
Conditions
Focus(mm)
Fixed
Depth(mm)
Fixed
Frequency(MHz)
1.0
A4.6.2 Test of Wireless Transducer(F15 Air)
Acoustic output reporting table
(IEC60601-2-37:2007+AMD1:2015, table 201.103)
Transducer Model: US-TAF
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
0.045
0.0076
0.082
N/A
Index component value
N/A
0.0076
N/A
0.082
Acoustic
Parameters
p
r.α
at z
MI
(MPa)
0.045
P (mW)
11.41
11.41
N/A
P
1x1
(mW)
N/A
N/A
z
s
(cm)
5.25
z
b
(cm)
5.25
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
)
0.12
I
spta.α
at z
PII.α
or
z
SII.α
(mW/cm
2
)
21.18
I
spta
at z
PII
or z
SII
(mW/cm
2
)
21.93
p
r.
at z
PII
(MPa)
0.046
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-TAF
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