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Bloomlife MFM-Pro is indicated for monitoring of maternal heart rate (MHR) and fetal heart rate (FHR) during the antepartum period for singleton pregnancies 32 weeks gestation or later. It is to be used by healthcare professionals, clinics, physicians' offices, antepartum rooms, and in the patient's home on the order of a physician. Bloomlife MFM-Pro is not intended for use in critical care situations or those patients hospitalized for or suspected to have preterm labor. Bloomlife MFM-Pro is not intended to be used for antepartum monitoring (e.g., non- stress testing).

Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate (FHR) and maternal heart rate (MHR) during the antepartum period on pregnant women with a singleton pregnancy at 32 weeks gestation or later. The healthcare professional applies the device to the patient and uses Bloomlife MFM-Pro to generate the Bloomlife MFM-Pro report that provides 5 minutes of fetal heart rate (FHR) and maternal heart rate (MHR) monitoring to the clinic. A typical Bloomlife MFM-Pro session is expected to take 12 minutes; approximately 7 minutes to perform system quality checks and 5 minutes to record data. Signal quality checks continue during recording to ensure data quality. Bloomlife MFM-Pro consists of three main components: the Bloomlife Sensor, the Bloomlife App, and the Bloomlife Cloud. The Bloomlife Sensor measures biopotential signals picked up on the abdominal surface using electrodes and transfers the data to the Bloomlife App via Bluetooth Low Energy. The Bloomlife App is used by a healthcare professional to enter patient information, start'stop recording sessions, and get feedback on data quality and recording status during a recording. The App does not process or visualize data; it acts as a gateway for the raw data measured by the sensor. The Bloomlife Cloud receives the data from the app, stores and processes the data into a Report, which is provided to the clinic via electronic fax. The Cloud Algorithm extracts the maternal heart rate from 50 bpm to 240 bpm within ±7 beats per minute, and fetal heart rate from 50 bpm to 240 bpm within ±10 beats per minute at a sample rate of 4 samples per second.