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natural light or other illumination sources to that taken in darkroom
condition, the deviation is smaller than ± 1%.
6.2
Technical Description
1. Oxygen Saturation Accuracy
The accuracy is ±2% (in the absence of movement) between 70% to
100%.
Note: The oxygen saturation accuracy is a root mean square of the
difference. The measured values of the device are distributed
according to statistical probability. Only about two thirds of the
measured values of the Pulse Oximeter fall within ±Arms of the
measured values of a carbon-monoxide-blood-gas analyzer.
2. Determination of Oxygen Saturation Accuracy
The claimed oxygen saturation is supported by coverage of the entire
range of clinical research measurements.
3. Data Collection
In the clinical test process, data points are recorded with comparable
density in the entire claimed range.
4. Data Analysis