The Owlet Smart Sock 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 been cleared by the FDA for use in any medical applications. Smart sock meets and exceeds relevant industry accuracy, safety and regulatory standards, you can read more here [link to: https://blog.owletcare.com/smart-sock-safety/].
- 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 notify later than a hospital monitor that has been fine-tuned to the specific condition of a medical-needs baby.
- The Owlet Smart Sock is a wireless device while medical monitors are wired directly into a display. As such, there can be latency between data from the Smart Sock to the app as data must travel to the cloud from the Base Station and then to the app. The Sock sensor collects data and sends it to the Base Station. The Base Station notifies as needed based on the data sent from the Sock. The Base Station is your primary notification device and as such should be placed in a location where you can hear it if it sounds.
Do not use the Owlet Smart Sock in place of your doctor prescribed medical monitor. Wait for clearance from your doctor to discontinue use of the medical monitor, before considering the use of the Owlet Smart Sock for continued peace of mind.