Product Manual

SpO2 specifications (Masimo specifications, see footnotes 1, 2, 3, 4, 5, and 6)
No motion: ± 3 digits
Motion: ± 5 digits
Saturation
Note
Saturation accuracy varies by sensor type. Refer
to the sensor Directions for use for additional
accuracy information.
60% to 70%
Adults, Neonates: ± 3 digits
Nellcor sensor accuracy guide
7, 8
SpO2 measurement accuracy can only be evaluated
in vivo by comparing pulse oximeter readings with
SpO2 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.
Pulse rate 25 to 240 beats per minute (bpm) ± 3 digits (no
motion)
Saturation
Note
Saturation accuracy varies by sensor type.
70% to 100%
Adult, neonate: ± 3 digits
Low Perfusion: 0.02 % to 20 % ± 2 digits
Detected pulse rate 20 to 250 beats per minute (bpm) ± 3 digits
Nonin sensor accuracy guide
SpO2 accuracy testing is conducted during induced
hypoxia studies on healthy, non-smoking, light-to-
dark-skinned subjects during motion and no-motion
conditions in an independent research laboratory.
The measured arterial hemoglobin saturation value
(SpO2) of the sensors is compared to arterial
hemoglobin oxygen (SaO2) value, determined from
blood samples with a laboratory co-oximeter. The
accuracy of the sensors in comparison to the co-
oximeter samples measured over the SpO2 range of
70 – 100%. Accuracy data is calculated using the
root-mean-squared (A
rms
value) for all subjects, per
ISO 9919:2005, Standard Specification for Pulse
Oximeters for Accuracy.
Perfusion
40–240 BPM. Adult/Ped = +/- 3 digits; Neonate =
+/- 3 digits
Pulse rate 18 to 321 beats per minute (bpm)
No motion (18 to 300 bpm): ± 3 digits
Motion (40 to 240 bpm): ± 5 digits
Saturation
Note
Saturation accuracy varies by sensor type.
70% to 100%
Adult/Pediatrics
No Motion
70% to 100%
Neonates
No Motion
Finger Clip: ± 3 digits
132 Specifications Connex
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