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Goldtrace FSE is indicated for patients requiring continuous electronic intrapartum monitoring of the fetal heart rate during labor and delivery.

Goldtrace FSE is a sterile, single use device transmitting the fetal ECG signal for continuous electronic intrapartum monitoring. The device consists of gold-plated stainless steel spiral needle electrode that attaches to the fetal presenting part. The device includes a reference plate to measure the reference voltage level in the amniotic fluid. A guide tube and drive tube are used for application to the fetal presenting part. The subject device is connected to a compatible monitor (e.g., Philips Avalon FM30) via Philips DECG Reusable Legplate adaptor cable to provide a fetal ECG signal to the monitor. The subject device does not perform any conversion, analysis, quantification, or modifications to the fetal ECG.

For patients requiring fetal heart rate monitoring during labor.

The device consists of a stainless steel spiral needle electrode. It is fixed to the fetal scalp by penetration of the skin by the spiral needle and thereby obtains the fetal ECG signal. A guide tube and a drive tube are required to place the electrode and are then removed before monitoring is begun. A stainless steel reference electrode is included close to the body housing the spiral electrode. The electrode is connected to the fetal monitor using a reusable adapter cable. A disposable maternal reference electrode connection is built into the adapter cable.