Covidien Nellcor Series, Operator'S Manual

Page: 141 / 160

Results
Operator’s Manual A-23
The plateaus that were used during the study were 70 - 76, 76.01 - 85, 85.01 - 94 and
>94%, as presented in Table A-4.
A.3.2
Accuracy Results (Low Saturation)
The accuracy results for both SpO
2
and pulse rate can be found in Table A-5 and
Table A-6 across a SaO
2
range of 60 to 80%. (Reference Accuracy Results (No Motion) ,
p. A-2, for results for SaO
2
range 70 to 100%.) As shown in the tables, both SpO
2
and
pulse rate meet the acceptance criteria for the MAXA, MAXN, and MAXFAST sensors
during non-motion conditions.
Table A-4. RMSD of SpO
2
per Plateau (No Motion)
SpO
2
Range
Room Air
Plateau
90%
Plateau
80%
Plateau
70%
Plateau
N 978 1102 1034 828
RMSD (%) 1.27 1.65 1.69 2.15
Table A-5. SpO
2
Accuracy Results (60 to 80% SaO
2
)
Sensor Motion # of
Data
Points
A
RMS
(%)
SpO
2
Acceptance
Criteria
60%-80%
(%)
Pass/Fail
MAXA No 610 2.40

3.0 Pass
MAXN No 453 1.92

3.0 Pass
MAXFAST No 143 2.41

3.0 Pass
ALL No 1206 2.24

3.0 Pass
Table A-6. Pulse Rate Accuracy Results (60 to 80% SaO
2
)
Sensor Motion # of
Data
Points
A
RMS
(BPM)
Pulse Rate
Acceptance
Criteria
(BPM)
Pass/Fail
MAXA No 1154 0.76

3.0 Pass
MAXN No 874 0.74

3.0 Pass