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Section 9: Specifications
9-3
9.7
PERFORMANCE
Measurement Range
SpO
2
:
0–100%
Pulse/Heart Rate:
20–250 bpm
Accuracy
SpO
2
Adult:
70–100% ± 2 digits
0–69% unspecified
Neonate:
70–100% ± 3 digits
0–69% unspecified
Accuracies are expressed as plus or minus “X” digits (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. Accuracy for neonatal readings 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 (optically derived)
20–250 bpm ± 3 bpm
Accuracies are expressed as plus or minus “X” bpm across the display range.
This variation equals plus or minus 1 Standard Deviation, which encompasses
68% of the population.