EDAN F15 Series User Manual

F15 Series Fetal & Maternal Monitor User Manual Product Specificaiton
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maximum recommended 1.5mV T-Wave
amplitude
SpO2
*Measurement Range
(EDAN)
50% ~ 100%
*Measurement
Range(Nellcor)
50% ~ 100%
Resolution
1 %
*Measuring Accuracy
(EDAN)
70% ~ 100% ± 2%
50 ~ 69% unspecified
*Measuring Accuracy
(Nellcor)
70% ~ 100% ± 3%
50 ~ 69% unspecified
*Data update period (EDAN)
1s
*Data update period (Nellcor)
2s
PR Measurement
*Range: 30~240bpm
Resolution: 1 bpm
*Accuracy: ±2 bpm(EDAN)
*Accuracy: ±3 bpm(Nellcor)
SpO2 Alarm Limits
50% ~ 100%
*Alarm
PR Alarm and SpO2 Alarm
Wavelength
Red light: (6603) nm
Infrared light: (90510) nm
Emitted light energy: < 15 mW
Information about the wave length range can be especially useful to clinicians (for
instance, when photodynamic therapy is performed.)
NIBP
*Measurement
Systolic Pressure, Diastolic Pressure, Mean
pressure
Method
Oscillometric Method
*Measurement Range
Systolic Pressure: 40 mmHg ~ 270 mmHg (5.3
kPa~36.0 kPa)
Diastolic Pressure: 10 mmHg ~ 215 mmHg (1.3
kPa~28.7 kPa)
Mean pressure: 20 mmHg ~ 235 mmHg (2.8
kPa~31.3 kPa)
Resolution
1 mmHg (0.1 kPa)
*Measuring Accuracy
Max. average deviation ≤ 5mmHg (≤ 0.8
kPa)
Max. standard deviation ≤ 8mmHg (≤1.2 kPa)
Measuring Time (MAX)
120s
Alarm Limits
Systolic Pressure: 40 mmHg ~ 270 mmHg (5.3
kPa~36.0 kPa)
Diastolic Pressure: 10 mmHg ~ 215 mmHg (1.3
kPa~28.7 kPa)
Mean Artery Pressure: 20 mmHg ~ 235 mmHg
Traditional 510(k) of Fetal & Maternal Monitor
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EDAN F15 Series Specifications

General

Brand	EDAN
Model	F15 Series
Category	Monitor
Language	English