Doppler FHR Detector (BF-500D+, BF-560)

The Doppler FHR Detector (BF-500D+, BF-560) is designed to non-invasively monitor fetal heart rate (FHR) in real-time using Doppler ultrasound technology. It transmits low-frequency sound waves through the maternal abdomen to detect and amplify the fetal heartbeat, providing both auditory and visual feedback for obstetric assessment. This allows clinicians to continuously evaluate fetal well-being during pregnancy and labor without inserting instruments into the body.

The Doppler FHR Detector (BF-500D+, BF-560) is supplied as a reusable medical instrument, but it is intended to be used with single-use probes or gel applications. This design allows for cost-effective clinical use while maintaining hygiene standards, as the reusable main unit can be cleaned and sterilized between patients, while disposable components (like probes or gel) reduce cross-contamination risks.

The device has undergone FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR). It is classified as a Class II medical device under FDA regulations (21 CFR 884.2660), indicating it has undergone rigorous review for safety and effectiveness. This regulatory clearance ensures the device meets established performance standards for obstetric monitoring, providing confidence in its clinical reliability and compliance with global medical device regulations.

The device follows standard sterile or non-sterile medical device protocols for storage and handling, as outlined by the manufacturer. Since it is reusable, the main unit should be cleaned and sterilized between uses, while single-use components (like probes or gel) should be handled according to their specific guidelines. Proper storage conditions—such as protecting it from extreme temperatures, moisture, or physical damage—are critical to preserving its functionality and ensuring accurate fetal heart rate monitoring.