F15 Series Fetal & Maternal Monitor User Manual Fetal Monitoring
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Chapter7 Fetal Monitoring
WARNING
1 The monitor is not intended for use in intensive care units (ICU), operating rooms or for
home use.
2 Do not apply this monitor during electro-surgery or MRI; otherwise it might result in
harming the patient or the operator.
3 Always check if the alarm settings are appropriate for your patient before starting
monitoring.
7.1 Confirming Fetal Life
Fetal monitoring with ultrasound or DECG cannot differentiate a fetal heart rate signal source from a
maternal heart rate source in all situations. These are some of the signal sources that might be taken
as FHR signal source by mistake:
- High maternal heart rate signal.
- Maternal aorta or other large vessels signals.
- Electrical impulse from the maternal heart transmitted through a recently deceased fetus.
These are some of the signal sources that might be taken as fetal movement signal source by
mistake:
-Movement of the ultrasound transducer.- Movement of the deceased fetus during or following
manual palpation of fetal movement.
- Movement of the deceased fetus during or following maternal movement.
So you need to confirm fetal life by other means before starting to use the fetal monitor, such as using
a fetoscope, stethoscope, Pinard stethoscope or obstetric ultrasonography.
7.2 FHR Monitoring FHR with Ultrasound
The ultrasound monitoring is a method to obtain FHR on maternal abdominal wall. Place a US
transducer (Ultrasound transducer) on maternal abdomen. It transmits low energy ultrasound wave to
the fetal heart, and receives the echo signal. Monitoring FHR using ultrasound is recommended from
the 24th week of gestation.
WARNING
1 Make sure you have confirmed the fetal life by other means before using this monitor for
FHR monitoring.
2 When monitoring with wireless US transducer, make sure the transducer has connected to
the monitor successfully, i.e. device no. and icon are displayed on the screen of the
transducer.
3 FHR should not be monitored until a clear fetal heart signal is detected.
4 If FHR reduces more than 10 bpm suddenly, or the beat of fetal heart sounds slower
abruptly, please check if it is the MHR that is being monitored by the transducer. If so,
relocate the transducer for the best fetal heart signal.
5 The sphere of activity for the fetus is much larger during mid-trimester of gestation (from
24
th
week to 28
th
week). When fetal heart moves away from the US transducer, please
redetermine the fetal heart position and relocate the transducer.
WARNING
Traditional 510(k) of Fetal & Maternal Monitor
014_14.1_F15_Series_User_Manual
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