Table of Contents
Advertisement
Traditional 510(k) of Fetal & Maternal Monitor
F15 Series Fetal & Maternal Monitor User Manual
Chapter9 Monitoring Mother and Fetus Using FECG
FECG is only indicated for use on women who are at >36 completed weeks, with singleton
pregnancies.
9.1 Confirming Fetal Life
Fetal monitoring with FECG cannot differentiate FECG signal source from a MECG source or
other interfering signal source in all situations. These are some of the signal sources that might be
taken as FECG signal source by mistake:
- High amplitude MECG signal.
- Interfering signal generated by maternal tense muscles.
- Interfering signal generated by power frequency.
-Noise generated by maternal body.
-Interfering signal generated by maternal or fetal movement that leads to deflections from
baseline.
- Electrical stimulation signal generated by analgesia during laboring.
- Interfering signal generated by movement of ECG leads or electrodes.
Besides, fetal monitoring with FECG cannot always capture the FECG signal as the FECG signal
itself is very weak and it will be attenuated gradually after transmission through the fetal body, and
amniotic fluid till the maternal abdomen and in the end cannot be detected by the device and FHR
calculation cannot be performed.
Here are some examples where the FECG signal cannot be detected.
-Preterm gestation (i.e. ≤ 36 completed weeks gestation).
-The fetal vernix caseosa is too thick to conduct the FECG signal.
The skin of locations where the electrodes will be placed is not prepared and the FECG signal is
attenuated completely by grease or dead skin on the surface of the abdomen
So you need to confirm fetal life by other means before starting to use the monitor, such as using
a fetoscope, stethoscope, Pinard stethoscope or obstetric ultrasonography. At the same time, when
fetal monitoring with the device, if FHR cannot be detected for a long time, please change another
monitoring method, such as ultrasound or DECG monitoring.
9.2 Start Monitoring
9.2.1 Introduction
FECG Fetal&Maternal Module not only monitors eFHR, HR and eTOCO by fetal ECG(FECG)
technology, but also TOCO by pressure sensor technology. The ECG lead is configured with a remote
event marker. Press the remote event marker button when feeling fetal movement.
1
The monitor is not a diagnostic ECG device. The ECG lead system of the monitor is not the
standard one. The ECG waveform displayed is different from that of the standard ECG lead
system, so it is not intended for diagnosis.
2
Make sure you have confirmed the fetal life by other means before using this monitor for
FHR monitoring.
3
Fetal vernix caseosa can block the conduction of FECG signals. Optimal FECG signals
may not be obtained from fetus in the vernix caseosa period. If the maternal-fetal heart rate
cannot be detected for a long time, it's suggested to change the monitoring method to
ultrasound or DECG monitoring.
014_14.1_F15_Series_User_Manual
Monitoring Mother and Ferus Using FECG
WARNING
- 113 -
129／202
Advertisement
Table of Contents
