Rad-97
Safety Information, Warnings and Cautions
www.masimo.com
17
Masimo
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Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin
synthesis disorders (quantitative defects such as Thalassemias).
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Extremely elevated hemoglobin levels.
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Low arterial perfusion.
•
Low arterial oxygen saturation levels including altitude induced hypoxemia.
•
Motion induced artifact.
•
Severe anemia.
WARNING:
SpCO readings may not be provided if there are Low arterial oxygen saturation
levels or elevated methemoglobin levels.
WARNING:
Inaccurate SpMet readings may be caused by:
•
Elevated carboxyhemoglobin levels in the range of > 3%.
•
Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin
synthesis disorders (quantitative defects such as Thalassemias).
•
Extremely elevated hemoglobin levels.
•
Low arterial perfusion.
•
Low arterial oxygen saturation levels including altitude induced hypoxemia.
•
Motion induced artifact.
•
Physiological conditions that can significantly shift the oxygen disassociation
curve.
•
Severe anemia.
WARNING:
Inaccurate RRa measurements may be caused by:
•
Improper sensor application or use of use of incorrect sensor.
•
Abnormal pulse rhythms due to physiological conditions or induced through
external factors (e.g. Cardiac arrhythmias, intra-aortic balloon, etc.).
•
Motion artifact.
•
Excessive ambient or environmental noise.
WARNING:
Inaccurate RRp readings may be caused by:
•
Low arterial perfusion.
•
Motion induced artifact.
•
Severe anemia.
WARNING:
Inaccurate ORi readings may be caused by:
•
Low arterial perfusion.
•
Motion induced artifact.
•
Elevated COHb and/or MetHb levels.
•
Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin
synthesis disorders (Quantitative defects such as Thalassemias).
