Table 2.
Validation results for Omron RS6® according to the ESH-IP 2010
| Validation results – Omron RS6
| ||||||
|---|---|---|---|---|---|---|
| Part 1 | ≤5 mmHg | ≤10 mmHg | ≤15 mmHg | Grade 1 | Mean mmHg | SD mmHg |
| Pass requirements | ||||||
| Two of | 73 | 87 | 96 | |||
| All of | 65 | 81 | 93 | |||
| Achieved | ||||||
| SBP | 42 | 75 | 89 | Fail | 2.7 | 9.9 |
| DBP | 42 | 69 | 87 | Fail | 3.5 | 11.1 |
|
| ||||||
| Part 2 | 2/3≤5 mmHg | 0/3≤5 mmHg | Grade 2 | Grade 3 | ||
|
| ||||||
| Pass requirements | ≥24 | ≤3 | ||||
| Achieved | ||||||
| SBP | 13 | 10 | Fail | Fail | ||
| DBP | 13 | 12 | Fail | Fail | ||
|
| ||||||
| Part 3 | Result | |||||
|
| ||||||
| Fail | ||||||
Notes: Accuracy is determined by the number differences in these ranges both for individual measurements (Part 1) and for individual subjects (Part 2). To pass, a device must achieve all the minimum pass requirements shown.
Abbreviations: DBP, diastolic blood pressure; ESH, European Society of Hypertension; IP, International Protocol; SBP, systolic blood pressure; SD, standard deviation.