Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual
ii
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
The Rad-8 Pulse 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-8 in the presence of fl ammable anesthetics or other fl ammable
substance in combination with air, oxygen-enriched environments, or nitrous oxide.
■ High intensity extreme lights
(including pulsating strobe lights) directed on the sensor, may not allow
the Pulse Oximeter to obtain readings.
■ The Rad-8 is NOT intended for use as an apnea monitor.
■ The Pulse 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-8 is to be operated by qualifi ed personnel only. This manual, accessory directions for use, all
precautionary information, and specifi cations should be read before use.
■ Electric shock hazard. Do not open the Rad-8 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 possibility of patient
entanglement or strangulation.
■ Do not place the Rad-8 or accessories in any position that might cause it to fall on the patient. Do not
lift the Rad-8 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 volunteers 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.
■ Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO
2
measurements. When
elevated levels of MetHb are suspected, laboratory analysis (co-oximetry) of a blood sample should
be performed.
■ Elevated levels of Carboxyhemoglobin (COHb) will lead to inaccurate SpO
2
measurements. When elevated
levels of COHb are suspected, laboratory analysis (co-oximetry) of a blood sample should be
performed.
■ Elevated levels of Total Bilirubin may lead to inaccurate SpO
2
measurements.
■ Severe anemia may cause erroneous SpO
2
readings.
■ Do not use the Rad-8 or sensors during magnetic resonance imaging (MRI) scanning. Induced current
could potentially cause burns. The Rad-8 may affect the MRI image and the MRI device may affect the
accuracy of the Pulse Oximetry parameters and measurements.
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