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Rad-87 Pulse CO-Oximeter Operator’s Manual
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
The Rad-87 Pulse CO-Oximeter is designed to minimize the possibility of hazards from
errors in the software program by following sound engineering design processes, Risk
Analysis and Software Validation.
■
Explosion hazard. Do not use the Rad-87 in the presence of fl ammable anesthetics
or other fl ammable substance in combination with air, oxygen-enriched environ-
ments, or nitrous oxide.
■
High intensity extreme lights (including pulsating strobe lights) directed on the sen-
sor, may not allow the Pulse CO-Oximeter to obtain readings.
■
The Rad-87 is NOT intended for use as an apnea monitor.
■
The Pulse CO-Oximeter should be considered an early warning device. As a trend
towards patient hypoxemia is indicated, blood samples should be analyzed by
laboratory instruments to completely understand the patient’s condition.
■
Pulse rate measurement is based on the optical detection of a peripheral flow pulse
and therefore may not detect certain arrhythmias. The pulse oximeter should not be
used as a replacement or substitute for ECG based arrhythmia analysis.
■
The Rad-87 is to be operated by qualifi ed personnel only. This manual, accessory direc-
tions for use, all precautionary information, and specifi cations should be read before use.
■
Electric shock hazard. Do not open the Rad-87 device. Only a qualifi ed operator
may perform maintenance procedures specifi cally described in this manual. Refer
servicing to Masimo for repair of this equipment.
■
As with all medical equipment, carefully route patient cabling to reduce the possibil-
ity of patient entanglement or strangulation.
■
Do not place the Rad-87 or accessories in any position that might cause it to fall
on the patient. Do not lift the Rad-87 by the power cord or any other cable.
■
Interfering Substances: Dyes, or any substance containing dyes, that change usual
blood pigmentation may cause erroneous readings.
■
SpO
2
is empirically calibrated to functional arterial oxygen saturation in healthy adult vol-
unteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb).
A pulse oximeter can not measure elevated levels of COHb or MetHb. Increases in either
COHb or MetHb will affect the accuracy of the SpO
2
measurement.
■
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.
■
Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO
2
and SpCO
measurements.
■
Elevated levels of Carboxyhemoglobin (COHb) will lead to inaccurate SpO2
measurements.
■
Elevated levels of Total Bilirubin may lead to inaccurate SpO2, SpMet and SpCO
measurements.
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Summary of Contents for Rad-87
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