Foetal Doppler system

Intended purpose

A portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to non-invasively detect foetal heart beats, at early gestation and for foetal screening from early gestation through to delivery, using ultrasound/Doppler technology. It provides an audible foetal heart sound and a numeric/graphical display of foetal heart rate via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability. This device is intended for use by qualified healthcare professionals within hospital or clinical environments. It is not intended for over-the-counter sale or use in home settings by consumers, without the supervision of a qualified healthcare professional.