WatchPAT™300 System
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Operation Manual
APPENDIX G: SPO2 ACCURACY IN THE WATCHPAT™300
The WatchPAT™300 device uses Itamar Medical Pulse Oximetry system for the
measurement of functional oxygen saturation of arterial haemoglobin (SpO2). This
appendix includes information regarding the accuracy of these measurements following a
clinical study of Itamar Medical Pulse Oximetry.
1.
Overall, the Arms is estimated to be 1.9 for the range 70-100%
2.
The next table shows SpO2 Accuracy Results:
Comparison to Reference CO-Oximetry
WP300
* 70
—100
90--100
80--<90
67--<80
A
RMS
Spec 3% for
range of 70-100%
# pts
1350
415
460
475
Pass
Bias
0.4
-0.4
0.6
0.9
A
RMS
1.88
1.10
1.62
2.54
* Note: The range of 70% to 100% includes reference data down to 67%
3.
The next plot shows the Bland-Altman plot for Itamar-Medical WP300: