Rad-97 Safety Information, Warnings and Cautions
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WARNING: SpO
2
is empirically calibrated in healthy adult volunteers with normal levels of
carboxyhemoglobin (COHb) and methemoglobin (MetHb).
WARNING: Optical, pleth-based measurements (e.g. SpO
2
, SpHb, SpOC, SpMet, SpCO, RRp,
and ORi) can be affected by the following:
• Improper sensor application or use of use of incorrect sensor.
• Blood pressure cuff applied to the same arm as the sensor site.
• Intravascular dyes such as indocyanine green or methylene blue.
• Venous congestion.
• Abnormal venous pulsations (e.g. tricuspid value regurgitation, Trendelenburg
position).
• Abnormal pulse rhythms due to physiological conditions or induced through
external factors (e.g. cardiac arrhythmias, intra-aortic balloon, etc.).
• Externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc.
• Moisture, birthmarks, skin discoloration, nail aberration, deformed fingers, or
foreign objects in the light path.
• Elevated levels of bilirubin.
• Physiological conditions that can significantly shift the oxygen disassociation
curve.
• A physiological condition that may effect vasomotor tone or changes in vasomotor
tone.
WARNING: Inaccurate SpO
2
readings may be caused by:
• Elevated levels of COHb and/or MetHb.
• Severe anemia.
• Extremely low arterial perfusion.
• Excessive induced motion.
• Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin
synthesis disorders (Quantitative defects such as Thalassemias).
WARNING: Inaccurate SpHb and SpOC readings may be caused by:
• Low arterial perfusion.
• Motion induced artifact.
• Low arterial oxygen saturation levels.
• Elevated COHb and/or MetHb levels.
• Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin
synthesis disorders (quantitative defects such as Thalassemias).
• Severe anemia.
WARNING: Inaccurate SpCO readings may be caused by:
• Elevated methemoglobin levels in the range of >15%.
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