Masimo Radical Signal Extraction Instrukcja Operatora Pobierz pdf (Strona 4)

Radical-7 Signal Extraction 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-7 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.

■ The Radical-7 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.

■ 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-7 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 Radical-7 in the presence of ﬂ ammable

anesthetics or other ﬂ ammable substance in combination with air, oxygen-

enriched environments, or nitrous oxide.

■ Electric shock hazard. Do not open the Radical-7 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.

■ High intensity, extreme lights (including pulsating strobe lights) directed on the sensor

may not allow the Radical-7 to obtain readings.

■ The Radical-7 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.

■ If patient hypoxemia is indicated, blood samples should be analyzed by laboratory

devices to completely understand the patient's condition.

■ The Radical-7 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 Radical-7 should not be used

as a replacement or substitute for ECG based arrhythmia analysis.

■ As with all medical equipment, carefully route patient cabling to reduce the

possibility of patient entanglement or strangulation.

■ Do not place the Radical-7 or accessories in any position that might cause it to

fall on the patient. Do not lift the Pulse CO-Oximeter by the power cord or any

other cable.

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