Rad-67
Safety Information, Warnings and Cautions
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13
Masimo
WARNING:
Optical, pleth-based measurements (e.g. SpO
2
and SpHb) 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 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.
CAUTION:
If using Rad-67 during full body irradiation, keep the sensor out of the radiation
field. If the sensor is exposed to the radiation, the reading might be inaccurate or the device
might read zero for the duration of the active irradiation period.
