Covidien Nellcor Series, Operator'S Manual

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Clinical Studies
A-2 Operator’s Manual
End tidal CO
2
, respiratory rate, respiratory pattern and electrocardiogram were con-
tinuously monitored throughout the study.
A.2.2
Low Saturation Methodology (Low Saturation Study Only)
The methodology and purpose of the Low Saturation study is the same as the
hypoxia methodology. Reference
Hypoxia Methodology (Accuracy, Low Saturation,
and Motion Studies) , p. A-1. However, the desaturation is to 60% instead of 70%. This
lower saturation is obtained by the addition of a new plateau at 60% SaO
2
, increas-
ing the range from 70 to 100% to 60 to 100%. This results in approximately 30 arterial
samples instead of 24 for this study.
A.2.3
Motion Methodology (Motion Study Only)
Standard motions include tapping and/or rubbing at aperiodic intervals with ampli-
tudes of 1-2 cm and 1-4 Hz with a random variation in frequency to simulate physi-
ological motion. In this study, the subject was instructed to tap with finger tips to
maintain consistency of area of effect on the pressure pad and to prevent resting
hand on pressure pad between motions so that only qualified taps are recorded by
the pressure pad system.
Each plateau (70 to 100%) has both an interval of tapping and rubbing. In this study,
the order of tapping and rubbing was alternated between subjects.
Two video cameras were used to capture motion of the subjects. These videos were
then reviewed to determine if any data points should be removed if the appropriate
amplitudes were not being reached during the blood samples.
A.3
Results
A.3.1
Accuracy Results (No Motion)
The following summary describes the demographic information of the subjects
enrolled into the MAXA, MAXN, and MAXFAST Accuracy and Low Saturation study:
A total of 11 subjects were analyzed, 5 (45%) males and 6 (55%) females. The mean
age of the subjects was 31.8 ± 5.2 years, with a range of 25 to 42 years of age. Two
subjects had dark pigmentation (dark olive to extremely dark). Weight ranged from
49 kg to 103.6 kg, and height ranged from 143.5 cm to 192 cm.