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The Team3 fetal monitors are indicated for use by trained healthcare professionals in noninvasive and invasive monitoring of physiological parameters in pregnant women and fetuses, during the antepartum and intrapartum periods of pregnancy.

The Team3 fetal monitors are intended for pregnant women with singleton or twin pregnancies from the 28th week of gestation, through to term and delivery.

In cases of triplet, the Team3 fetal monitors are intended for use from 30th week of gestation through 35 weeks gestation.
The devices are intended for use in clinical and hospital-type facilities.

Sonicaid Team3 Antepartum is suitable for use when there is a need to monitor the following physiological applications:

• Single, twin or triplet fetal heart rates by means of ultrasound
• Uterine activity - externally sensed
• Manual fetal movement detection - maternally identified using the event marker
• Automatic fetal movement detection (defaults to OFF / Not for use in twin or triplet pregnancies)
• Maternal heart rate and oxygen saturation via pulse oximetry
• Maternal non-invasive blood pressure
• The DAWES REDMAN Cardiotocography (CTG) analysis output - advises whether a number of defined criteria indicative of a normal cardiotocograph record has been met for singleton pregnancies but not for triplet pregnancies. It provides nonspecific analysis in twin pregnancies due to nonspecific fetal movement input

Sonicaid Team3 Intrapartum is suitable for use when there is a need to monitor the following Physiological applications:

• Single, twin or triplet fetal heart rates by means of ultrasound and/or FECG
• Manual fetal movement detection - maternally identified using the event marker
• Maternal heart rate via ECG electrodes
• Uterine activity - externally or internally sensed
• Maternal heart rate and oxygen saturation via pulse oximetry
• Maternal non-invasive blood pressure

The Sonicaid Team3 is a fetal monitoring device designed for perinatal monitoring. The subject device provides non-invasive and invasive monitoring of physiological parameters in pregnant women and fetuses, including singleton, twin, and triplet fetal heart rate monitoring, during antepartum and intrapartum periods. The subject device includes systems and accessories intended to perform perinatal monitoring as aligned with product code HGM.

The subject device is a modification to the Sonicaid Team3 (K241368) to allow for triplet fetal heart rate monitoring. This modification affects the hardware of the device only. An additional port has been made available on the front of the monitor to allow for a third ultrasound transducer to be connected, so three fetal heart rates can be monitored at once.

All other parameters, materials, software and technology remain identical to the predicate device.

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