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Bionet FC1400 - Intended Use

Bionet FC1400
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FC1400 User Manual
FC1400OM-2.04 81 / 95
FC1400 Operation Manual
Intended Use
FC1400 is a fetus monitoring device used to measure Fetal Heart Rates (FHR), degree of maternal
uterine contraction (UA: Uterine Activity), fetal movements (FM). FC1400 shoots ultrasounds to the
abdomen of the patient. From the signals returned after being reflected by the heart of the fetus,
FC1400 extracts Doppler frequencies that vary with the movements of the heart of the fetus to output
changes in the heartbeats of the fetus as sounds for the analysis of the signals; thus detecting the
heart rates and fetal movements of the fetus. In addition, it detects the degrees of uterine contraction
of the patient using a pressure sensor. It indicates the fetal heart rates, maternal uterine activity, fetal
movements, on its LCD screen as figures and saves the information to its memory.
Claimed indications
- Previous history of stillbirth
- Complications of pregnancy
- Induction of Labor
- Preterm labor
- Nonreassuring fetal status; fetal movement
Contraindications : Unknown
Monitor Environmental Specifications
· Operating Temperature 15°C to 40°C (59°F to 104°F)
· Storage Temperature - 10°C to 60°C (14°F to 140°F)
· Humidity 20% to 95% RH
· Operating Attitude 70(700) to 106Kpa(1060mbar)

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