User's Manual

Rad-87 Pulse CO-Oximeter Operator’s Manual
ii
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 environments, or nitrous oxide.
■ High intensity extreme lights
(including pulsating strobe lights) directed on the sensor, may not allow the Pulse
CO-Oximeter to obtain readings.
■ Excessive ambient noise may affect the accuracy of the
respiration rate reading from the Acoustic Respiration
Sensor.
■ SpO
2
monitoring is required when monitoring RRa (Acoustic Respiration).
■ 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 directions for use, all
precautionary information, and specifi cations should be read before use.
■ Electric shock hazard. Do not open the Rad-87 instrument. Only a qualifi ed operator may perform maintenance
procedures specifi cally described in this manual. Refer servicing to Masimo for repair of this equipment.
■ Ensure that the HF surgical neutral electrode is properly connected to help prevent unintended
current return paths when using high frequency (HF) surgical equipment.
■ As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement
or strangulation.
■ Use cables only from the instrument manufacturer to provide protection against the effects of
discharge from a cardiac defibrillator and burns.
■ 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 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.
■ 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.