A portable, hand-held, battery-powered device assembly consisting of a measuring and display unit with attached probe or interchangeable probes designed to noninvasively detect fetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly 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 fetal viability.
1. Water proof probes for minimum 2 MHZ frequency continuous wave
2. Auto Shut Oﬀ Facility to save Battery Power.
3. Built-in Speaker.
4. Volume Control Facility and Audio Output for Ear Phone.
5. Heart Rate Range should be from 50 to 200 bpm with accuracy of + /-2%, Should be Water Proof Body.
Power Requirements: AA or 9V batteries.
Doppler probe, Ultra sound Gel
Clinical purpose: Detect, measure, and display fetal heart activity.
Level of use: Obstetrics and Gynecology, gynecology physician office Obstetrics and Gynecology, gynecology physician office
Staff requirements: Fetal heart detectors are routinely used by physicians, obstetric nurses, and community midwives to record FHR values.
Risk classification: Type B or BF
FDA or CE approved product.