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The F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring are intended for continuous wireless fetal monitoring indicated for pregnant women from about 22 weeks gestation through delivery: to be used during antepartum and intrapartum monitoring. This device is singleton pregnancies only. It is not intended for home use. The Ultrasound Transducer detects and evaluates the fetal heart rate during uterine contractions, and the Toco Transducer detects uterine contractions. The Transducers are to provide a means of sensing and function for signals to pass through from the patient to the monitoring or recording system. No other usage is intended for the transducers. The system should only be used by, or under the direct supervision of, a licensed physician or other health care practitioner who is trained in the use of fetal heart rate monitors and in the interpretation of fetal heart race traces.

The F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring is a perinatal monitoring accessory that integrates with GE Corometrics series monitors. The accessory's intended use is for antepartum and intrapartum wireless measurement and recording of fetal heart rate and maternal contractions. The intended use environment is a clinical setting, in the labor and delivery room of a hospital. The F1 is equipped with 1 Ultrasound (US) transducer, 1 Tocodynamometer (TOCO) transducer, and 1 Base Station. The Base Station transmits data wirelessly between the US/TOCO transducers (respectively) and a separate FDA-cleared fetal monitor ("monitor"), and is connected directly to the monitor via wired connection. The monitor must be used with the F1 accessory for display and recording of signals. The Ultrasound and TOCO Transducers are water-resistant and may be used in the shower and tub during the first stage of labor, but not during the second stage of labor (underwater delivery), and should not be submerged or operated underwater. The Transducers may be used in the shower and tub in the same manner as when used away from water.