EDAN F15 Series User Manual page 152

Traditional 510(k) of Fetal & Maternal Monitor
F15 Series Fetal & Maternal Monitor User Manual
*Measurement
(EDAN)
*Measurement
Range(Nellcor)
Resolution
*Measuring Accuracy
(EDAN)
*Measuring Accuracy
(Nellcor)
*Data update period (EDAN)
*Data update period (Nellcor) 2s
SpO2
PR Measurement
SpO2 Alarm Limits
*Alarm
Wavelength
Information about the wave length range can be especially useful to clinicians (for
instance, when photodynamic therapy is performed.)
*Measurement
Method
*Measurement Range
Resolution
NIBP
*Measuring Accuracy
Measuring Time (MAX)
Alarm Limits
014_14.1_F15_Series_User_Manual
maximum recommended 1.5mV T-Wave
amplitude
Range
50% ~ 100%
50% ~ 100%
1 %
70% ~ 100% ± 2%
50 ~ 69%
70% ~ 100% ± 3%
50 ~ 69%
1s
*Range: 30~240bpm
Resolution: 1 bpm
*Accuracy: ± 2 bpm(EDAN)
*Accuracy: ± 3 bpm(Nellcor)
50% ~ 100%
PR Alarm and SpO2 Alarm
Red light: (6603) nm
Infrared light: (90510) nm
Emitted light energy: < 15 mW
Systolic Pressure, Diastolic Pressure, Mean
pressure
Oscillometric Method
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)
1 mmHg (0.1 kPa)
Max. average deviation
kPa)
Max. standard deviation ≤ 8mmHg (≤1.2 kPa)
120s
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
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Product Specificaiton
unspecified
unspecified
≤ 5mmHg (≤ 0.8
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