www.masimo.com
7
Masimo
Product Description
The O3
®
Regional Oximeter System (O3
®
System), which consists of the O3
®
Module and O3
®
Sensor, is a patient-connected, noninvasive oximeter designed to continuously measure and
monitor regional hemoglobin oxygen saturation in the tissue (rSO
2
), including cerebral
tissue. It can be used in any hospital and hospital-type facility where rSO
2
measurements
might improve patient outcomes.
The O3
®
Regional Oximeter System (O3
®
System) should not be used as the sole basis for
diagnosis or therapy.
Indications for Use
The noninvasive Masimo O3
®
Regional Oximeter System and accessories are intended for use
as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of
blood (rSO
2
) in the cerebral region under the sensors. The Masimo O3
®
Regional Oximeter
System and accessories are indicated for use on adults ≥ 40 kg and on pediatrics ≥ 5 kg and <
40 kg in healthcare environments.
Contraindication
There are no contraindications.