Rad-97 Safety Information, Warnings and Cautions
www.masimo.com 17 Masimo
• 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.
• 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).