Product Manual

Nellcor specifications (for additional information, refer to the directions for use that
accompanies each accessory)
SpO2
Unit of measure %
Measurement range 1% to 100%
Nellcor sensor accuracy guide SpO2 measurement accuracy can only be evaluated in vivo
by comparing pulse oximeter readings with SaO2
measurements obtained from simultaneously sampled
arterial blood made using a laboratory CO-oximeter. SpO2
accuracy was validated through breathe-down-equivalent
testing by Covidien using electronic measurements to prove
equivalence to the Nellcor N600x predicate device. The
Nellcor N600x predicate device was validated by performing
human-subject, “breathe-down” clinical trials.
Accuracy
Note
Saturation accuracy varies by sensor type.
The worst case accuracy range of the
module or the attached sensor will apply.
Saturation accuracy (module)
±3 digits
70% to 100%
Adult, Pediatrics: ± 2 digits
Neonate: ± 3 digits
Low Perfusion: 0.02 % to 20 % ± 2 digits
Saturation accuracy (sensors)
Sensor Accuracy
60% to 80% MAX-AI, MAX-
PI, MAX-II
±3 digits
70% to 100% DS-100A ±3 digits
D-YS Infants, Pediatrics, Adults: ±3 digits
Neonates: ±4 digits
D-YSE ±4 digits
D-YSPD ±4 digits
MAX-AI, MAX-
PI, MAX-II
±2 digits
OXI-A/N Adults: ±3 digits
Neonates: ±4 digits
OXI-P/I ±3 digits
Pulse rate
Unit of measure beats per minute
Directions for use Specifications 167