Covidien Nellcor Series, Operator'S Manual

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Clinical Studies
A-36 Operator’s Manual
The results are presented in Table A-11, showing an increase in percent modulation
greater than 2.5-fold during motion.
Pulse oximeters have been known to perform better at the higher saturation levels
compared to the lower end. Though, when presenting the A
RMS
, the common
methodology is to provide the data across the whole range (70% to 100%). The data
below is presented to show each decade, which includes the RMSD and N values.
There is no acceptance criteria associated with decade levels of hypoxia. In Table A-
12, SpO
2
RMSD is presented per decade.
RMSD for each decade are well within the acceptance criteria of 3%. The plateaus
that were used during the study were 70 - 76, 76.01 - 85, 85.01 - 94 and >94%, as pre-
sented in Table A-13.
Table A-11. Percent Modulation During Motion
Quiescent
Periods
Motion
Periods
Ratio
Percent
Modulation (%) 1.63 4.14 2.54
Table A-12. RMSD of SpO
2
per Decade (Motion)
SpO
2
Range
100%-90% 89%-80% 79%-70%
N 589 322 344
RMSD (%) 2.36 1.97 2.41