The Owlet Smart Sock (OSS) is not the same as a hospital pulse oximeter and should not be used in place of a medical pulse oximeter or any other medical device. There are a number of differences between the Owlet and a medical monitor.
- Medical monitors are for babies who are ill and have been prescribed a medical monitor by their physician.
- Medical monitors are configured by the baby's physician to have appropriate heart rate and oxygen alarm thresholds for the baby's condition(s).
- Medical monitors are approved by the FDA and have been through a rigorous validation process to ensure they are appropriate for clinical use. Here at Owlet, we are working to ensure that our product is reliable and safe for your baby, but as a consumer product, we have not yet been approved by the FDA for use in medical applications.
- The Owlet Smart Sock is not used by medical professionals and is not intended for use on critically ill babies. Therefore, the alarm thresholds are fixed at relatively conservative values in order to reduce false alarms and to allow the monitor to function on a wide range of babies. Thus, the Owlet will usually alert later than a hospital monitor that has been fine-tuned to the specific condition of a medical-needs baby.
Do not replace your medical monitor with the Owlet Smart Sock. If your doctor tells you that your baby no longer needs a medical monitor, you can use the Owlet Smart Sock to continue bringing you peace of mind. Once you are cleared by your doctor to discontinue use of the medical monitor, ask your doctor if you can begin using the Owlet Smart Sock.