Masimo O3 User Manual

O3 Regional Oximeter Safety Information, Warnings and Cautions
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Performance Warnings and Cautions
WARNING: The O3 Module may be used during electrocautery, but this may affect the
accuracy or availability of the parameters and measurements.
WARNING: The O3 Module may be used during defibrillation, but this may affect the accuracy
or availability of the parameters and measurements.
WARNING: The O3 Module may be used during defibrillation; however, the display may
require up to 15 seconds to return to normal operation.
WARNING: The O3 Module is intended only as an adjunct device in patient assessment. It
should not be used as the sole basis for diagnosis or therapy decisions. It must be used in
conjunction with clinical signs and symptoms.
WARNING: If the desired tissues cannot be palpated or visualized, it is recommended to use a
secondary method of confirmation, such as ultrasound or X-ray.
WARNING: Inaccurate rSO
2
readings or no rSO
2
readings may be caused by:
• Anemia or low hemoglobin concentrations.
• Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb
c, sickle cell, etc.
• Hemoglobin synthesis disorders.
• Elevated levels of carboxyhemoglobin (COHb), methemoglobin (MetHb), or
other dyshemoglobins.
• Elevated level of total bilirubin.
• Non-normocapnic conditions or other conditions that affect blood volume.
• Hypotension, severe vasoconstriction, or hypothermia.
• Induction of extracranial hypoxia-ischemia.
• Cardiac arrest.
• Venous congestion and pooled blood under the skin.
• Intravascular dyes or externally applied coloring (such as indelible ink).
• Birthmark(s) or skin discolorations in sensor path.
• Moisture on the skin.
• Excessive motion.
• Metal plate or other foreign object in sensor path.
• Excessive ambient light or direct sunlight.
• Electrosurgical interference.
• Improperly applied sensor.
• Incorrect sensor type
• Adjacent placement of any sensor that is not connected to the same O3
Module.
WARNING: For patients experiencing complete bilateral ECA occlusion, rSO
2
measurements
may be lower than expected.

Masimo O3 Specifications

General

Brand	Masimo
Model	O3
Category	Medical Equipment
Language	English