STAN S31 is an intrapartum Fetal Heart Monitor that records FHR, contractions, and performs real-time ST Analysis of the fetal ECG during labor. STAN consists of two parts - the patient interface box where the signal is processed, and the display unit where data is processed and presented on the 15” touch-screen.
The STAN system is equipped with all the functionality of a standard FHR monitor, but also offers additional information from the ST Analysis. Prior to use of the system, the user should refer to the User Manual, Clinical Use Guide and Information for Prescribers.
For a complete list of indications, contraindications, warnings and precautions, see here.
The Center for Devices and Radiological Health of the Food and Drug Administration (FDA) has reviewed and approved the pre-market approval application (PMA) for STAN S31 on November 1st 2005.
