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Product Description
The O3 System is a patient-connected, noninvasive oximeter designed to monitor regional
hemoglobin oxygen saturation in the tissue (rSO
2
), including cerebral tissue. It can be used in
any healthcare environment where rSO
2
measurements might improve patient outcomes.
The 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 in healthcare environments.
Contraindication
The O3™ Regional Oximeter System is not indicated for use on patients <40 kg.
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