Covidien Nellcor Series, Руководство оператора

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Clinical Studies
A-28 Operator’s Manual
A.3.3
Accuracy Results (Motion)
The following describes the demographic information of the subjects enrolled into
the study: A total of 14 subjects were analyzed, 5 (35.7%) males and 9 (64.3%) female
subjects. The mean age was 31.57 ± 6.8 years, with a range of 24 to 42 years of age.
Three subjects had dark pigmentation (dark olive to extremely dark). Weight ranged
from 48.7 kg to 88.6 kg, and height ranged from 143.5 cm to 185 cm.
The accuracy results for both SpO
2
and pulse rate during motion are presented in
Table A-9 and Table A-10. As shown in the tables, both SpO
2
and pulse rate meet the
acceptance criteria for both the MAXA and MAXN sensor during motion.
Modified Bland-Altman plots for all the data are presented in Figure A-23 and Figure
A-24 for SpO
2
and pulse rate respectively.
Table A-9. SpO
2
Accuracy Results During Motion
Sensor Motion # of
Data
Points
A
RMS
(%)
SpO
2
Acceptance
Criteria
70%-100%
(%)
Pass/Fail
MAXA Yes 637 1.70

3.0 Pass
MAXN Yes 618 2.76

3.0 Pass
ALL Yes 1255 2.28

3.0 Pass
Table A-10. Pulse Rate Accuracy Results During Motion
Sensor Motion # of
Data
Points
A
RMS
(BPM)
Pulse Rate
Acceptance
Criteria
(BPM)
Pass/Fail
MAXA Yes 555 2.58

5.0 Pass
MAXN Yes 532 2.88

5.0 Pass
ALL Yes 1087 2.73

5.0 Pass