5.3 Health Notifications Function
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 is
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.
The Dream Sock Health Notifications function is not intended for use with babies less than one month old or
weighing less than 6 pounds.
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
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