9
Device Description
Infant Oximeter Box
The Infant Oximeter Box worn on the leg includes a Bluetooth transmitter and a
sensor chip along with electronics for vital sign measuring and analyzing. It must be
used within 32.8 feet (10 meters) to Guardian Angel® Rx Digital Vital Sign Monitoring
System.
Infant Oximeter Disposable Sensor Cable
The Infant Oximeter Disposable Sensor Cable is intended to be attached to the Infant
Oximeter Box on one end and to the toe on the other end. Discard the sensor cable
after each use. It can be purchased separately.
Infant Oximeter Reusable Sensor Cable
The Infant Oximeter Reusable Sensor Cable is intended to be attached to the Infant
Oximeter Box on one end and to the toe on the other end using the Adhesive Patch.
The sensor cable is reusable. Discard the Adhesive Patch after each use.
Device Intended Use
The Aulisa Infant Oximeter Module is intended to measure SpO2 and pulse rate of
infant patients during non-motion and under well-perfused conditions in hospitals,
medical facilities, home care, and subacute environments. The parameters derived
by Aulisa Infant Oximeter Module are transmitted to Aulisa’s Digital Vital Sign
Monitoring System for display.
Device Principle of Operation
This device measures SpO
2
and pulse rate based on non-invasive light-emitting diode
(LED) reflectance technology, measuring the absorbance of red and infrared light
passed through the perfused tissue during each pulse.
Device Set Up
Before you begin your monitoring session, unpack the device and become familiar
with its parts. It is recommended to fully charge the Infant Oximeter Box prior to
setting up. It takes approximately 1 hour to fully charge. Refer to “Device Charging”
section for detailed instructions.