
73
SPECIFICATIONS
Performance
Electrical
Environmental Conditions
Physical Characteristics
Compliance
PERFORMANCE
Measurement Range
SpO2 1 - 100%
Pulse Rate 20 - 250 beats per minute (bpm)
Accuracy
1
Saturation (%SpO2 ±1 SD)
Without Motion:
Adults 70 - 100% ±2 digits
Neonates 70 - 100% ±3 digits
1 - 69% unspecified
With Motion:
2
Adults and Neonates 70 - 100% ±3 digits
1 - 69% unspecified
1
Accuracies are expressed as plus or minus “X” digits (oxygen saturation percentage points)
between saturation of 70% and 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.
2
For a definition of motion, as applicable to the N-395, contact Mallinckrodt’s Technical Services
Department.
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