User's Manual

Radius-7 Safety Information, Warnings and Cautions
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WARNING: SpO2 is empirically calibrated in healthy adult volunteers with normal levels of
carboxyhemoglobin (COHb) and methemoglobin (MetHb).
WARNING: If SpO2 values indicate hypoxemia, a laboratory blood sample should be taken to
confirm the patient’s condition.
WARNING: Inaccurate SpO2 readings may be caused by:
• Improper sensor application.
• Elevated levels of COHb and MetHb: High levels of COHb or MetHb may
occur with a seemingly normal SpO2. When elevated levels of COHb or
MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood
sample should be performed.
• Intravascular dyes such as indocyanine green or methylene blue.
• Externally applied coloring and texture such as nail polish, acrylic nails,
glitter, etc.
• Elevated levels of bilirubin.
• Severe anemia.
• Low arterial perfusion.
• Motion artifact.
WARNING: Inaccurate SpHb and SpOC readings may be caused by:
• Improper sensor application.
• Intravascular dyes, such as indocyanine green or methylene blue.
• Externally applied coloring and texture, such as nail polish, acrylic nails,
glitter, etc.
• Elevated PaO
2
levels.
• Elevated levels of bilirubin.
• Low arterial perfusion.
• Motion artifact.
• Low arterial oxygen saturation levels.
• Elevated carboxyhemoglobin levels.
• Elevated methemoglobin levels.
• Hemoglobinopathies and synthesis disorders such as thalassemias, Hb
s, Hb c, sickle cell, etc.
• Vasospastic disease such as Raynaud's.
• Elevate altitude
• Peripheral vascular disease.
• Liver disease.
• EMI radiation interference.
WARNING: Inaccurate SpCO and SpMet readings may be caused by:
• Improper sensor application.
• Intravascular dyes such as indocyanine green or methylene blue.
• Abnormal hemoglobin levels.
• Low arterial perfusion.
• Low arterial oxygen saturation levels.
• Elevated total bilirubin levels.