WARNING: USE DREAM SOCK AS INDICATED AND REGULATED FOR USE. Components of this product may or may not be a regulated medical device, as determined by the FDA or other regulatory agencies. Dream Sock is not intended to diagnose, cure, treat, alleviate, or prevent any disease or health condition. The display and notification of Oxygen Saturation and Pulse Rate are regulated by the FDA. It is important to use the device and notifications as intended and described in this manual. Only a healthcare provider can diagnose a medical condition such as hypoxia (low Oxygen Saturation levels).
WARNING! DO NOT RELY SOLELY ON DREAM SOCK TO ASSESS HEALTH CONDITION OR OXYGEN SATURATION LEVEL. Focusing solely on a pulse oximeter measurement may give you a false sense of security. Dream Sock does not notify at every unexpected occurrence of an elevated or depressed Pulse Rate or a low Oxygen Saturation level. Dream Sock notifications are intended to identify instances when the infant’s Pulse Rate and/or Oxygen Saturation level moves outside a preset range and are provided only when sufficient data are available for analysis. You should seek medical attention if the infant is not feeling well even if the reading is normal.
DREAM SOCK IS NOT A SUBSTITUTE FOR ADULT SUPERVISION OR SAFE SLEEP PRACTICES. Do not rely solely on the notifications to determine if the baby is safe.
Dream Sock Health Notifications function is not intended for use with babies less than one-month-old or weighing less than 6 pounds.
Health Notifications Details
What the Dream Sock Health Notifications function is indicated for
- For in-home surveillance of healthy babies
- For children from 1 month to 18 months of age weighing from 6 to 30 lbs
What the Dream Sock Health Notifications function is NOT for
- Not for babies and children with ongoing health conditions.
- Not for infants under 1 month old or weighing less than 6 pounds.
- Not for children weighing more than 30 pounds.
- Not for substituting Caregiver supervision.
- Not for substituting safe sleep practices.
When the Health Notifications function is enabled, Dream Sock allows Caregivers to view live health readings such as Pulse Rate and Oxygen Saturation values (“Health Readings”) during a monitoring session and notifies Caregivers via a high-priority notification if the baby’s Oxygen Saturation or Pulse Rate leave preset ranges. These preset ranges are not adjustable, they are fixed preset values. The Pulse Rate Notification will occur when the measured Pulse Rate goes below 50 BPM (beats per minute) or above 220 BPM. The Oxygen Notification will occur when the measured Oxygen Saturation level goes below 80%. New devices have the Health Notifications function disabled by default and it must be manually enabled.
The Dream Sock Health Notifications function can be enabled via the Sock settings in the Owlet Dream App. If the App detects the Health Notifications function is disabled, a banner is displayed on the Home Page confirming Health Notifications are disabled. Once in Sock settings, you can begin the process to enable the Health Notifications function by tapping the toggle button [to the “on” position]. The Caregiver will then need to complete the required learning about Health Notifications and how to respond to each different priority notification. It is required that the Caregiver tests these notifications to complete the enabling process.
Once the required learning is completed, the Health Notifications function will be enabled. Health Notifications will remain enabled until they are manually disabled. The required learning can always be reviewed in the Sock settings.
Dream Sock Health Notifications function also includes historical charts and graphs for the 10-minute average Pulse Rate and 10-minute average Oxygen Saturation level, sleep, and movement under the history tab.