Table 1.
Validation results – Microlife WatchBP O3
| ||||||
---|---|---|---|---|---|---|
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 | 64 | 86 | 94 | Fail | 0.3 | 7.8 |
DBP | 62 | 93 | 101 | Fail | −1.9 | 6.4 |
| ||||||
Part 2 | 2/3≤5 mmHg | 0/3≤5 mmHg | Grade 2 | Grade 3 | ||
| ||||||
Pass requirements | ≥24 | ≤3 | ||||
Achieved | ||||||
SBP | 22 | 6 | Fail | Fail | ||
DBP | 20 | 6 | 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.