Introduction to the BabySat Monitoring System
3.1 What is the BabySat Monitoring
System
BabySat is a Pulse Oximeter for home use. The
Sock secures the Sensor to the baby’s foot. The
Sensor measures the baby’s readings (SpO2 and
Pulse Rate) and transmits the baby’s readings to
the Base Station. The Base Station monitors the
baby’s readings and alarms if the readings are
outside specific limits. The Base Station also
relays the data to the App, which displays the
baby’s readings and any active alarms
3.2 Who Use BabySat?
(Indications for Use
The BabySat pulse oximeter is indicated for use
in measuring and displaying functional oxyge
saturation of arterial hemoglobin (SpO2) and
heart rate. It is indicated for spot-checking and/
or continuous monitoring of well-perfused
patients greater than one month old and
weighing between 6 and 30 lbs., in the home
environment
Should
3.3 Who Use BabySat?
(Contraindications
Not for patients under 1 month old or
weighing less than 6 lbs
Not for patients weighing more than 30 lbs
Not a substitute for Caregiver supervision
Not for use as an apnea monitor.
Should Not
Rx Only
Federal law (U.S.) restricts the sale of this device
to, or by the order of, a physician.
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