Accuracy Results (Low Saturation; Table A-6. Pulse Rate Accuracy Results (60 To 80% Sao 2 - Covidien Nellcor Series Operator's Manual

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.

Accuracy Results (Low Saturation)

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