Table 6.
Validation results for the Omron M6 IT Comfort® BP device according to the ESH-IP 2010
| Validation Results Omron M6 IT Comfort®
| ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 | ≤5 mmHg | ≤10 mmHg | ≤15 mmHg | Grade 1 | Mean (mmHg) | SD (mmHg) | ||||
| Pass req. | Two of | 73 | 87 | 96 | ||||||
| All of | 65 | 81 | 93 | |||||||
| Achieved | SBP | 83 | 94 | 97 | Pass | –1.4 | 4.7 | |||
| DBP | 77 | 93 | 99 | Pass | –2.1 | 4.3 | ||||
| Part 2 | 2/3≤5 mmHg | 0/3≤5 mmHg | Grade 2 | Grade 3 | |
|---|---|---|---|---|---|
| Pass req. | ≥24 | ≤3 | |||
| Achieved | SBP | 29 | 0 | Pass | Pass |
| DBP | 26 | 2 | Pass | Pass |
| Part 3 | Result | |||||
|---|---|---|---|---|---|---|
| Pass |
Notes: Pass Req: as required by the IP; achieved: as recorded by the device. Refer to the text for more explanations about parts 1–3.
Abbreviations: BP, blood pressure; DBP, diastolic blood pressure; IP, International Protocol; ESH-IP, European Society of Hypertension International Protocol; SBP, systolic blood pressure; SD, standard deviation.