Covidien Nellcor Series, Руководство оператора

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Results
Operator’s Manual A-3
The following summary describes the demographic information of the subjects
enrolled into the SC-A sensor study: A total of 16 subjects were analyzed. There were
6 (37.5%) males and 10 (62.5%) female subjects enrolled into the study. The mean
age of study participants was 31.44 ± 6.7 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 96.9 kg, and height ranged from 143.5 cm to 188 cm.
The following summary describes the demographic information of the subjects
enrolled into the study for all other sensors (listed in Table A-1): A total of 11 subjects
were analyzed. There were 4 (36.4%) males and 7 (63.6%) female subjects enrolled
into the study. The mean age of study participants was 30.36 ± 7.85 years, with a
range of 22 to 46 years of age. Three subjects had dark pigmentation (dark olive to
extremely dark). Weight ranged from 58.4 kg to 114.4 kg, and height ranged from
159 cm to 187 cm.
Accuracy results for both SpO
2
and pulse rate can be found in Table A-1 and
Table A-2. A
RMS
(Accuracy root mean square) is used to describe the accuracy of
pulse oximetry, which is affected by both bias and precision. As shown in the tables,
both SpO
2
and pulse rate meet the acceptance criteria for all of the listed sensors
during non-motion conditions.
Table A-1. SpO
2
Accuracy Results (No Motion)
Sensor Motion # of
Data
Points
A
RMS
(%)
SpO
2
Acceptance
Criteria
70%-100%
(%)
Pass/Fail
MAXA No 976 1.54

2.0 Pass
MAXN No 723 1.41

2.0 Pass
MAXFAST No 235 1.42

2.0 Pass
SC-A No 659 1.86

2.0 Pass
DS-100A No 411 2.16

3.0 Pass
OxiCliq-A No 480 1.58

2.5 Pass
D-YSE No 458 1.96

3.5 Pass