Nonin 9570, Руководство пользователя

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ENGLISH
Testing Summary
SpO
2
accuracy and low perfusion testing were conducted by Nonin Medical, Inc., as described below:
SpO
2
Accuracy Testing
SpO
2
accuracy testing is conducted during induced hypoxia studies on healthy, non-smoking, light- to dark-
skinned subjects during motion and no-motion conditions in an independent research laboratory. The measured
arterial hemoglobin saturation value (
SpO
2
) of the sensors is compared to arterial hemoglobin oxygen ( SaO
2
)
value, determined from blood samples with a laboratory co-oximeter. The accuracy of the sensors in comparison
to the co-oximeter samples measured over the
SpO
2
range of 70 - 100%. Accuracy data is calculated using the
root-mean-squared (Arms value) for all subjects, per ISO 9919:2005, Medical Electrical Equipment–Particular
requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.
Pulse Rate Motion Testing
This test measures pulse rate oximeter accuracy with motion artifact simulation introduced by a pulse oximeter
tester. This test determines whether the oximeter meets the criteria of ISO 9919:2005 for pulse rate during
simulated movement, tremor, and spike motions.
Low Perfusion Testing
This test uses a SpO
2
Simulator to provide a simulated pulse rate, with adjustable amplitude settings at various
SpO
2
levels for the oximeter to read. The oximeter must maintain accuracy in accordance with ISO 9919:2005
for heart rate and SpO
2
at the lowest obtainable pulse amplitude (0.3% modulation).