Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
The Rad-57™ Handheld 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.
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Explosion hazard. Do not use the Pulse CO-Oximeter in the presence of flammable
anesthetics or other flammable substance in combination with air, oxygen-enriched
environments, or nitrous oxide.
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High intensity extreme lights (such as pulsating strobe lights) directed on the sensor,
may not allow the Pulse CO-Oximeter to obtain vital sign readings.
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The Pulse CO-Oximeter is NOT intended for use as an apnea monitor.
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A 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.
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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.
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The Pulse CO-Oximeter is to be operated by qualified personnel only. This manual,
accessory directions for use, all precautionary information, and specifications should
be read before use.
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Electric shock hazard. Do not open the Pulse CO-Oximeter cover except to replace
the batteries. Only a qualified operator may perform maintenance procedures
specifically described in this manual. Refer servicing to Masimo for repair of this
equipment.
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As with all medical equipment, carefully route patient cabling to reduce the possibility
of patient entanglement or strangulation.
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Do not place the Pulse CO-Oximeter or accessories in any position that might cause
it to fall on the patient. Do not lift the Pulse CO-Oximeter by the patient cable.
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Interfering Substances: SpO
2
is a functional calculation
of arterial oxygen saturation.
Carboxyhemoglobin and methemoglobin may erroneously increase SpO
2
readings.
The level of increase is approximately equal to the amount of carboxyhemoglobin and/
or methemoglobin present. Dyes, or any substance containing dyes, that change usual
blood pigmentation may cause erroneous readings.
■
Severe anemia may cause erroneous SpO
2
readings.
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Elevated levels of Total Bilirubin may lead to inaccurate SpO2 measurements.
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Hemoglobin synthesis disorders may cause erroneous SpHb readings.
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Do not use the Pulse CO-Oximeter or oximetry sensors during magnetic resonance
imaging (MRI) scanning. Induced current could potentially cause burns. The Pulse
CO-Oximeter may affect the MRI image, and the MRI unit may affect the accuracy of
the oximetry measurements.
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If using Pulse CO-Oximetry during full body irradiation, keep the sensor out of the
radiation field. If sensor is exposed to the radiation, the reading might be inaccurate
or the device might read zero for the duration of the active radiation period.
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