EDAN F15 Series - Page 150

F15 Series Fetal & Maternal Monitor User Manual Product Specificaiton
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*Ultrasound Output
Isppa.3<190W/cm
2
Ispta.3<94mW/cm
2
Iob≤3.6 mW/cm
2
Isata≤.6 mW/cm
2
TI<1.0 MI<1.0
*Temperature Rise
When applied to the patient, the ultrasound
transducer may warm slightly (less than 10℃
(18ºF) above ambient temperature). When NOT
applied, the ultrasound transducer may warm
slightly (less than 10℃ (18ºF) above ambient
temperature).
p- <1 MPa
I
spta
<100 mW/cm
2
Max Output Power <15mW
Effective Radiating Area (12
Crystals)
(942 ± 15%) mm
2
Effective Radiating Area (7
Crystals)
(550 mm ±15%) mm
2
Dielectric Strength
4000Vrms
TOCO
*TOCO Range
0~100
*Non-linear Error
±10%
Resolution
1%
Baseline Drift due to
Temperature Changes
1 unit/min/°C (free air)
5 units/min/°C (underwater)
Zero Mode
Automatic (TOCO value becomes zero or below
lasting for 30 seconds)/ Manual
Dielectric Strength
4000Vrms
DECG
*DFHR Measurement Range
30bpm ~ 240bpm
Resolution
1bpm
*Accuracy
±1bpm
*Alarm
DFHR Alarm
Input Impedance
> 10M (Differential, DC50/60Hz)
Input Impedance
> 20M (Common Mode)
CMRR
> 110dB
Noise
< 30µVp-p
Skin Voltage Tolerance
±500mV
Fetal Input Voltage Current
20µVp-3mVp
IUP
*Pressure Range
0mmHg ~100mmHg (0.0 kPa~13.3 kPa)
Resolution
1mmHg (0.1 kPa)
Traditional 510(k) of Fetal & Maternal Monitor
014_14.1_F15_Series_User_Manual
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