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Conclusion
Operator’s Manual
A-37
A.4
Conclusion
A.4.1
No Motion
The pooled results indicate that the observed SpO
2
A
RMS
values met the system's
specification dependent on the sensor used with the Nellcor™ bedside SpO
2
patient
monitoring system during non-motion conditions across the SaO
2
saturation range
of 70 to 100%.
The pooled results indicate that for a saturation range of 60-80% for SpO
2
, the accep-
tance criterion was met for the monitoring system when tested with MAXA, MAXN,
and MAXFAST sensors.
The pooled results indicate that the observed pulse rate A
RMS
values met the sys-
tem's specification of 3 BPM when tested with the Nellcor™ bedside SpO
2
patient
monitoring system during non-motion conditions across the SaO
2
saturation range
of 60 to 100%.
A.4.2
Motion
The pooled results indicate that the observed SpO
2
A
RMS
values met the system's
specification of 3% when tested with MAXA, MAXN sensors and the
Nellcor™ monitoring system for SpO
2
during motion conditions across the SaO
2
sat-
uration range of 70 to 100%.
The pooled results indicate that the observed pulse rate A
RMS
values met the sys-
tem's specification of 5 BPM when tested with MAXA, MAXN sensors and the Nell-
cor™ bedside SpO
2
patient monitoring system during motion conditions across the
SaO
2
saturation range of 70 to 100%.
Table A-13.
RMSD of SpO
2
per Plateau (Motion)
SpO
2
Range
Room Air
Plateau
90%
Plateau
80%
Plateau
70%
Plateau
N
318
330
318
289
RMSD (%)
2.61
1.96
2.19
2.33
Summary of Contents for Nellcor Series
Page 1: ...Operator s Manual Nellcor Bedside SpO2 Patient Monitoring System TM...
Page 8: ...Page Left Intentionally Blank vi...
Page 12: ...Page Left Intentionally Blank x...
Page 20: ...Introduction Page Left Intentionally Blank 1 8 Operator s Manual...
Page 36: ...Installation Page Left Intentionally Blank 3 8 Operator s Manual...
Page 118: ...Product Specifications Page Left Intentionally Blank 11 18 Operator s Manual...
Page 156: ...Clinical Studies Page Left Intentionally Blank A 38 Operator s Manual...
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