EDAN F15 Series User Manual

F15 Series Fetal & Maternal Monitor User Manual Product Specificaiton
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*Accuracy
±3mmHg
MFM & AFM
*Display Range
0 ~ 999
*FM Mode
Automatic/Manual
*AFM Mode
Trace (default) or Black Mark
AMF Technique
Pulsed Doppler ultrasound
MECG
*MHR Measurement Range
30bpm ~ 240bpm
*MHR Measuring Accuracy
±2bpm
Resolution
1 bpm
MHR Alarm Limits
28bpm ~ 243bpm
*Alarm
HR Alarm
Anti-electric Shock Type
Type CF(complies with IEC 60601-2-27:2011
except clauses about defibrillation-proof)
Input Signal Range
◆0.5mV~8mV (lead wire)
◆50uV~8mV (electrode sleeve)
ECG Waveform
Manual control ECG waveform display
ECG falls off
Detect automatically
Patient Leakage Current
(Limit)
N.C. S.F.C.
d.c. 10µA 50µA
a.c. 10µA 50µA
Patient Auxiliary Current
(Limit)
N.C. S.F.C.
d.c. 10µA 50µA
a.c. 10µA 50µA
Differential Input Impedance
>2.5MΩ
Display Sensitivity
2.5mm/mV (X1/4), 5mm/mV (X1/2), 10mm/mV
(X1), 20mm/mV (X2), 40mm/mV (X4)
Waveform Scan Speed
25mm/s
Electrode Offset Potential
Tolerance
±500mV
Auxiliary Current (Leads off
detection)
Active electrode: < 100 nA
Reference electrode: < 900 nA
Accuracy and Response to
Irregular Rhythm
Not Supported
Bandwidth(-3dB)
Diagnosis: 0.05 Hz to 120 Hz
Monitor: 0.5 Hz to 40 Hz
Response time to Change in
MHR
MHR range: 80bpm ~ 120bpm
Range: 7s ~ 11s (average:9s)
MHR range: 80bpm ~ 40bpm
Range : 8s ~ 12s (average: 10s)
Tall T-wave Rejection
Exceeds ANSI/AAMI EC13-2002 Sect. 3.1.2.1
(C)
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