Itamar Medical OM2196470 Operation Manual page 69

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Itamar Medical Ltd.
Reference: Bland-Altman Range
Linear Regression (Bland Altman)
Mean Bias
# pts
Upper 95% Limits of Agreement
Lower 95% Limits of Agreement
Source of data
Title:
Date:
Clinical Investigator(s):
Sponsor:
Device(s):
Study Date(s):
NOTE:
The clinical study was conducted with the WP300 with the same Pulse Oximetry
System for the measurement of functional oxygen saturation of arterial
hemoglobin (SpO2) that is used with the WatchPAT device.
NOTE:
A Functional tester cannot be used to assess the accuracy of the internal pulse
oximeter.
WatchPAT™ONE System
70-100%
y = 3.7344 + -0.03937 x
0.41
1350
4.02
-3.21
WatchPAT Accuracy Validation via Reference CO-Oximetry
Study ID# PR 2017-247
2018-01-23
Clinimark
80 Health Park Drive, Suite 20
Louisville, Colorado 80027, USA
Itamar Medical, Ltd. 9 Halamish St PO 3579, Caesarea
3088900, Israel
Non-Motion: Itamar Medical WatchPAT Pulse Oximetry
December 13-15, 2017
68
Operation Manual

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