Owlet Band Safety

How does the Band work?

The Owlet Band is a wearable fabric band made up of multiple sensors that detect the natural low-level electrical signals normally produced by the mother’s and baby’s heart. The Owlet Band’s algorithm analyzes these bioelectrical signals to estimate mother’s heart rate, as well as that of the baby’s. As is the case with most wearables, the Owlet Band collects raw data and translates that information into valuable customer-facing information such as audio of baby’s heartbeat, mother/baby’s heart rate, and sleep position for the mom.

 

Ensuring Band safety

Customer safety is Owlet’s top priority. We test our products to meet and exceed our customer’s expectations in addition to applicable regulatory requirements. With respect to safety, we focus on three key aspects: (1) the band fabric that has electrodes built into the band that touch the skin and measure the electrical signal; (2) heart rate sensing technology; and (3) Bluetooth communication.

The Band’s fabric and electrodes has been tested to confirm that there are no irritants or sensitizers, against all mandatory and voluntary chemical and biocompatibility standards such as the PROP65.

The heart rate sensing technology uses passive listening to measure electrical signals from the body through the electrodes. The passive nature of its sensing is key to safeguarding the safety of the mother and the baby.

Finally, the Band uses Bluetooth technology to communicate, using an extremely low and safe Radio Frequency (RF). For example, the level of RF is at 1/100th of the levels that require absorption testing: the regulatory testing that ensures the body is not absorbing harmful amounts of RF. This Band’s Bluetooth technology is certified to FCC standards (Part 15 Subpart B, Part 15 Subpart C, KDB 447498 D01 General RF Exposure Guidance v06) and holds a Grant of Equipment Authorization.

 

How is the technology used in the Owlet Band different from a doppler?

There is a distinct difference between a fetal doppler ultrasound monitor and the Owlet Band. Fundamentally, the former uses active sensing which sends high, inaudible frequency sound through the body tissue.

FDA recommends against using ultrasound outside of a trained healthcare setting due to the risks associated with it. Specifically, it introduces the risk of tissue overheating which can lead to cavitation in cases of prolonged exposure. As such, the doppler ultrasound is meant to be used by medical professionals that are trained in how to operate and interpret these devices. Using these devices without training can increase the stress for pregnant mothers and provide incorrect information regarding Baby’s wellbeing.

On the other hand, as mentioned above, the Owlet Band uses passive sensing and picks up low-level electrical signals normally produced by the mother’s and baby’s heart rate, similar to an electrocardiogram technology (ECG). It is a listening device and does not send any signal back through the body. The band’s algorithm uses the signals collected to estimate heart rate for the mom as well as the baby.

 

*The Band is an information-gathering device designed to help women have a healthy pregnancy and provides sleep position and heartbeat audio at a glance in the Owlet Pregnancy App. It is not a medical device and will not diagnose, cure, treat, alleviate or prevent any disease or health condition

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