User's Manual

Radical-7R Pulse CO-Oximeter Operator’s Manual
NON-INVASIVE TOTAL HEMOGLOBIN (SpHb) ACCURACY COMPARED TO INVASIVE
LABORATORY METHODS*
In 492 comparisons of non-invasive total hemoglobin (SpHb) and invasive hemoglobin (tHb)
measurements from a laboratory CO-Oximeter, SpHb accuracy was as follows:
■ 0.90 correlation
■ 0.95 g/dL standard deviation
■ Below 12 g/dL, 99% of SpHb readings were < 2 g/dL of the laboratory tHb value
■ At or above 12 g/dL, 94% of SpHb readings were < 2 g/dL of the laboratory value
* Masimo FDA Submission Data
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
The Radical-7R Signal Extraction 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.
■ Variation in hemoglobin measurements may be profound and may be affected by
sample type, body positioning, as well as other physiological conditions. As with most
hemoglobin tests, Radical-7R test results should be scrutinized in light of a specific
patient’s condition. Any results exhibiting inconsistency with the patient’s clinical status
should be repeated and/or supplemented with additional test data.
■ Explosion hazard. Do not use the Pulse CO-Oximeter 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.
■ When monitoring Acoustic Respiration, Masimo recommends minimally monitoring
both oxygenation (SpO2) and respiration (RRa).
■ The Pulse CO-Oximeter is NOT intended for use as an apnea monitor.
■ Pulse rate measurement is based on the optical detection of a peripheral flow pulse
and therefore may not detect certain arrhythmias. The Pulse CO-Oximeter should
not be used as a replacement or substitute for ECG based arrhythmia analysis.
■ The Pulse CO-Oximeter should be considered an early warning instrument. As a
trend towards patient hypoxemia is indicated, blood samples should be analyzed
by laboratory instruments to completely understand the patient’s condition.
■ The Pulse CO-Oximeter is to be operated by qualifi ed personnel only. This
manual, accessory Directions for Use (DFU), all precautionary information, and
specifi cations should be read before use.
■ Electric shock hazard. Do not open the Pulse CO-Oximeter cover except to
replace the battery of the Handheld 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 unin-
tended current return paths when using high frequency (HF) surgical equipment.
■ As with all medical equipment, carefully route patient cabling to reduce the
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