Table 4.
Validation results for the three devices
| Part 1 | ≤5 mmHg | ≤10 mmHg | ≤15 mmHg | Grade 1 | Mean (mmHg) | SD (mmHg) |
|---|---|---|---|---|---|---|
| Pass required | ||||||
| Two of | 73 | 87 | 96 | |||
| All of | 65 | 81 | 93 | |||
| Omron HEM-7120 achieved | ||||||
| SBP | 73 | 94 | 96 | Pass | 1.3 | 5.3 |
| DBP | 73 | 91 | 96 | Pass | -2.0 | 5.6 |
| Yuwell YE680A achieved | ||||||
| SBP | 50 | 79 | 91 | Fail | 1.0 | 9.0 |
| DBP | 67 | 87 | 95 | Fail | -1.1 | 6.5 |
| Cofoe KF-65B achieved | ||||||
| SBP | 53 | 79 | 91 | Fail | 4.1 | 7.0 |
| DBP | 65 | 89 | 96 | Pass | -3.3 | 5.3 |
| Part 2 | 2/3 ≤5 mmHg | 0/3 ≤5 mmHg | Grade 2 | Grade 3 | ||
| Pass required | ≥24 | ≤3 | ||||
| Omron HEM-7120 achieved | ||||||
| SBP | 27 | 2 | Pass | Pass | ||
| DBP | 24 | 2 | Pass | Pass | ||
| Yuwell YE680A achieved | ||||||
| SBP | 16 | 4 | Fail | Fail | ||
| DBP | 24 | 2 | Pass | Fail | ||
| Cofoe KF-65B achieved | ||||||
| SBP | 16 | 4 | Fail | Fail | ||
| DBP | 24 | 2 | Pass | Pass | ||
| Part 3 | Result | |||||
| Omron HEM-7120 | Pass | |||||
| Yuwell YE680A | Fail | |||||
| Cofoe KF-65B | Fail | |||||