
Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual
iii
■ Patient Safety - If a sensor is damaged in any way, discontinue use immediately.
■ Always remove the sensor from the patient and completely disconnect the patient
from the Radical-7 before bathing the patient.
■ Interfering Substances: Dyes, or any substance containing dyes, that change usual
blood pigmentation may cause erroneous readings.
■ Do not use the Radical-7 or sensors during magnetic resonance imaging (MRI)
scanning. Induced current could potentially cause burns. The Radical-7 may affect
the MRI image, and the MRI instrument may affect the accuracy of the Radical-7
parameters and measurements.
■ The Radical-7 can be used during defi brillation, but the readings may be
inaccurate for up to 20 seconds.
■ If using Radical-7 during full body irradiation, keep the sensor out of the radiation
fi eld. If the sensor is exposed to the radiation, the reading might be inaccurate or
the instrument might read zero for the duration of the active radiation period.
■
Do not place the
Radical-7
where the controls can be changed by the
patient.
■ Do not place the Radical-7 on electrical equipment that may affect the Radical-7,
preventing it from working properly.
■ Do not expose the Radical-7 to excessive moisture such as direct exposure to
rain. Excessive moisture can cause the Radical-7 to perform inaccurately or fail.
■
Do not place containers with liquids on or near the Radical-7. Liquids spilled on the
Pulse CO-Oximeter may cause it to perform inaccurately or fail.
■
Changes or modifi cations not expressly approved by the party responsible for
compliance could void the user's authority to operate the equipment.
■ SpO
2
is empirically calibrated to functional arterial oxygen saturation in healthy adult
volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin
(MetHb). The Radical-7 can not measure elevated levels of COHb or MetHb.
Increases in either COHb or MetHb will affect the accuracy of the SpO
2
measurement.
■ Innacurate SpO2 readings can be caused by:
■ Elevated levels of COHb and MetHb
■ For increased COHb: COHb levels above normal tend to increase the level of SpO
2
.
The level of increase is approximately equal to the amount of COHb that is present.
NOTE: High levels of COHb may occur with a seemingly normal SpO
2
. When
elevated levels of COHb are suspected, laboratory analysis (CO-Oximetry) of a blood
sample should be performed.
■ For increased MetHb: the SpO
2
may be decreased by levels of MetHb of up to
approximately 10% to 15%. At higher levels of MetHb, the SpO
2
may tend to read in
the low to mid 80s. When elevated levels of 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 (such as nail polish).
■ Elevated levels of Bilirubin
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED)
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