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Equipment Response Time
If the signal from the sensor in inadequate, the last measured SpO
are then replaced with dashes.
SpO
Standard/Fast Averages SpO
Pulse Rate Values
Standard/Fast Averages Pulse Rate
Equipment Delays
Display Update Delay
Example: SpO
SpO
decreases 0.75% per second; pulse rate = 75 BPM
2
The response of the 4-beat average is 1.5 seconds.
Testing Summary
SpO
accuracy and low perfusion testing was conducted by Nonin Medical, Incorporated as described below.
2
SpO
2
At an independent research laboratory, SpO
healthy, male and female, non-smoking, light-to-dark-skinned subjects that are aged 18 years and older. The
measured arterial hemoglobin saturation value (SpO
(SaO
) value, determined from blood samples with a laboratory co-oximeter. The accuracy of the device is in
2
comparison to the co-oximeter samples measured over the SpO
using the root-mean-squared (A
for Pulse Oximeters for Accuracy.
Low Perfusion Testing
This test uses an SpO
SpO
levels. The device must maintain accuracy in accordance with ISO 80601-2-61 and ISO 9919 for pulse rate
2
and SpO
Principles of Operation
Pulse oximetry is a non-invasive method that passes red and infrared light through perfused tissue and detects the
fluctuating signals caused by arterial pulses. Well-oxygenated blood is bright red, while poorly oxygenated blood is
dark red. The pulse oximeter determines functional oxygen saturation of arterial hemoglobin (SpO
difference by measuring the ratio of absorbed red and infrared light as volume fluctuates with each pulse.
Values
2
2
Exponential Averaging
2
Accuracy Testing
value) for all subjects, per ISO 80601-2-61 and ISO 9919, Standard Specification
rms
Simulator to provide a simulated pulse rate, with adjustable amplitude settings of various
2
at the lowest obtainable pulse amplitude (0.3% modulation).
2
and pulse rate values freeze for 10 seconds and
2
Average
Latency
4 beat exponential
2 beats
Response
Latency
4 beat exponential
2 beats
Delay
1.5 seconds
accuracy testing is conducted during induced hypoxia studies on
2
) of the device is compared to arterial hemoglobin oxygen
2
range of 70 – 100%. Accuracy data is calculated
2
) from this color
2
5
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