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SECTION 8: SPECIFICATIONS
8.1 Performance
8.2 Electrical
8.3 Environmental
8.4 Physical
8.1 PERFORMANCE
Measurement Range
SpO2
0–100%
Pulse Rate
20–250 beats per minute (bpm)
Accuracy
SpO2
Adults
70–100% ± 2 digits
0–69% unspecified
Neonates
70–100% ± 2 digits
0–69% unspecified
Note: Accuracies are expressed as plus or minus “X” digits (oxygen
saturation percentage points) between saturations of 70-100%. This
variation equals plus or minus one standard deviation (1SD), which
encompasses 68% of the population. All accuracy specifications are
based on testing the subject monitor on healthy adult volunteers in
induced hypoxia studies across the specified range. Adult accuracy is
determined with Oxisensor® II D-25 sensors. Neonatal accuracy is
determined with Oxisensor II N-25 sensors. In addition, the neonatal
accuracy specification is adjusted to take into account the theoretical
effect of fetal hemoglobin in neonatal blood on oximetry
measurements.
Pulse Rate
20–250 bpm ± 3 bpm
Note: Accuracy is expressed as plus or minus 3 bpm across the display
range. This variation equals plus or minus one standard deviation
(1SD), which encompasses 68% of the population.
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