Hans van den Heuvel

3 The Omron HEM-9210T passed the EHS 2010 validation criteria with 85/94/99 of 99 device-observer SBP measurement comparisons and 82/95/99 of 99 device – observer DBP measurement comparisons within the 5/10/15 mmHg boundaries respectively (See Table 3 for pass requirements and results) The mean difference (SD) between de observers and the iHealth Track was -0,8 (3,7) for systolic BP and -1,1 (-4,2 ) for diastolic PB measurements, respectively. Table 3. Pass requirements and validation results for Omron HEM-9210T automated BP device according to the European Society of Hypertension International Protocol Revision 2010. Results are in absolute numbers (measurements in Part 1, subjects in Part 2). Part 1 ≤ 5 mmHg ≤ 10 mmHg ≤ 15 mmHg Grade 1 Mean difference SD Required Two of 73 87 96 All of 65 81 93 Achieved SBP 85 94 99 PASS -0,8 mmHg 3,7 mmHg DBP 82 95 99 PASS -1,1 mmHg 4,2 mmHg Part 2 2/3 ≤ 5 mmHg 0/3 ≤ 5 mmHg Grade 2 Grade 3 Required ≥ 24 ≤ 3 Achieved SBP 30 1 PASS PASS DBP 30 0 PASS PASS Part 3 PASS Legend: DBP, diastolic blood pressure; SBP, systolic blood pressure; SD, standard deviation Bland-Altman plots of the results are shown for both systolic and diastolic blood pressure (Fig. 2) and present the differences between the Omron HEM-9210T readings and its corresponding observer reading (the better of the previous and next observer readings) plotted against the mean of the device and the better observer measurements. As shown in the Bland- Altman plots for both devices (Figure 1 and Figure 2), agreement between each of the two automated devices and the better observer readingswas satisfactory too in the higher BP range, as the majority of the differences is within the 95% limits of agreement. Most of these readings are from preeclampsia patients, presented by the white dotted bullets. VALIDATION STUDY OF TWO BLOOD PRESSURE MONITORS IN PREGNANCY 47