Philips Avalon FM20, Instructions For Use Manual

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26 Specifications and Standards Compliance
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WARNING
The fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal
ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the
ECG waveform.
When in doubt, it can be used to identify sources of compromised signal quality, such as noise or
muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them
(e.g., checking ECG cable connections or adapting the fetal
ArtifactSuppress
configuration).
The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e., P, QRS and T
segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated.
Filter Bandwidth 0.8 to 80 Hz
Inop Auxiliary Current (Leads Off Detection) < 100 µA
Input Signal Range DECG 20 µVpp to 6 mVpp
MECG 150 µVpp to 6 mVpp
Dielectric Strength 1500 Vrms
Defibrillator Protection None
ESU Protection None
Performance Specifications
Fetal Heart Rate (Ultrasound/DECG) Alarm Specifications
FHR Alarm Limits Range Bradycardia
(low limit) 60 to 200 bpm
adjustable in 10 bpm steps
Default: 110 bpm
Tachycardia
(high limit) 70 to 210 bpm
adjustable in 10 bpm steps
Default: 170 bpm
FHR Alarm Delay Range Bradycardia
(low limit) Delay 10 to 300 seconds in steps of 10s
Default: 240 s
Tachycardia
(high limit) Delay 10 to 300 seconds
in steps of 10s
Default: 300s
Signal Loss Delay 10 to 300 seconds
in steps of 10s