Operator's Manual

Rad-97 Safety Information, Warnings and Cautions
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• 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).
• Hypotension, severe vasoconstriction, severe anemia, or hypothermia.
WARNING: ORi is not intended as a replacement for SpO
2
monitoring, PaO
2
monitoring, or as
a sole indicator of the patient condition.
WARNING: Wireless communication of alarms to a secondary monitoring station should not
be relied upon as a primary alarm.
CAUTION: ORi may not indicate additional changes in oxygen states above 200 mmHg of
PaO
2
.
CAUTION: If using Rad-97 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.
CAUTION: When patients are undergoing photodynamic therapy they may be sensitive to
light sources. Pulse oximetry may be used only under careful clinical supervision for short
time periods to minimize interference with photodynamic therapy.
CAUTION: High ambient light sources such as surgical lights (especially those with a xenon
light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight
can interfere with the performance of the sensor.
CAUTION: To prevent interference from ambient light, ensure that the sensor is properly
applied, and cover the sensor site with opaque material, if required. Failure to take this
precaution in high ambient light conditions may result in inaccurate measurements.