Rad-5/5v
Safety Information, Warnings and Cautions
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11
Masimo
WARNING:
Select a well perfused site for monitoring, very low perfusion at the monitored
site may result in no or incorrect readings.
WARNING:
Do not use Rad-5/5v on patients that have been injected with dyes or any
substance containing dyes, the change in usual blood pigmentation may cause no or
incorrect readings.
WARNING:
If SpO
2
values indicate hypoxemia, a laboratory blood sample should be taken to
confirm the patient’s condition.
WARNING:
Optical, pleth-based measurements (e.g. SpO
2
) 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).
CAUTION:
Do not place the Rad-5/5v on electrical equipment that may affect the Rad-5/5v,
preventing it from working properly.
CAUTION:
If using pulse oximetry during full body irradiation, keep the sensor out of the
radiation field. If sensor is exposed to the radiation, the reading might be inaccurate or the
unit might read zero for the duration of the active radiation period.
CAUTION:
Failure of Operation - If the Rad-5/5v fails any part of the setup procedures
remove the Rad-5/5v from operation until qualified service personnel have corrected the
situation.
