O3® Regional Oximeter
Safety Information, Warnings and Cautions
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10
Masimo
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:
Optical measurements (rSO
2
) can be affected by the following:
•
Improper sensor application or use of incorrect sensor.
•
Intravascular dyes such as indocyanine green or methylene blue or externally
applied coloring (such as indelible ink).
•
Venous congestion and pooled blood under the skin.
•
Moisture, birthmarks, skin discoloration or foreign objects (e.g. metal plate)
in the light path.
•
Elevated level of total bilirubin.
•
A physiological condition that may effect vasomotor tone or changes in
vasomotor tone.
•
Excessive ambient light, high intensity light, or direct sunlight.
•
Adjacent placement of optical sensors that are not connected to the same
O3
®
Module.
•
Abnormal venous pulsations (e.g. tricuspid value regurgitation,
Trendelenburg position).
WARNING:
Inaccurate rSO
2
readings or no rSO
2
readings may be caused by:
•
Anemia or low hemoglobin concentrations.
•
Hemoglobinopathies (qualitative defects including sickle cell) and
Hemoglobin synthesis disorders (Quantitative defects such as
Thalassemias).
•
Elevated COHb and/or MetHb levels.
•
Non-normocapnic conditions or other conditions that affect blood volume.
•
Hypotension, severe vasoconstriction, or hypothermia.
•
Induction of extracranial hypoxia-ischemia.
•
Cardiac arrest.
•
Electrosurgical interference.
•
Excessive induced motion.
WARNING:
For patients experiencing complete bilateral External Carotid Artery (ECA)
occlusion, rSO
2
measurements may be lower than expected.
CAUTION:
To ensure that alarm limits are appropriate for the patient being monitored, check
the limits each time the O3
®
Module is used.
CAUTION:
Do not place the O3
®
Module on electrical equipment that may affect the device,
preventing it from working properly.
CAUTION:
To minimize radio interference, other electrical equipment that emits radio
frequency transmissions should not be in close proximity to the O3
®
Module.